Lay health workers in primary and community health care

  • Review
  • Intervention

Authors


Abstract

Background

Lay health workers (LHWs) are widely used to provide care for a broad range of health issues. However, little is known about the effectiveness of LHW interventions.

Objectives

To assess the effects of LHW interventions in primary and community health care on health care behaviours, patients' health and wellbeing, and patients' satisfaction with care.

Search methods

We searched the Cochrane Effective Practice and Organisation of Care and Consumers and Communication specialised registers (to August 2001); the Cochrane Central Register of Controlled Trials (to August 2001); MEDLINE (1966- August 2001); EMBASE (1966-August 2001); Science Citations (to August 2001); CINAHL (1966-June 2001); Healthstar (1975-2000); AMED (1966-August 2001); the Leeds Health Education Effectiveness Database and the reference lists of articles.

Selection criteria

Randomised controlled trials of any intervention delivered by LHWs (paid or voluntary) in primary or community health care and intended to promote health, manage illness or provide support to patients. A 'lay health worker' was defined as any health worker carrying out functions related to health care delivery; trained in some way in the context of the intervention; and having no formal professional or paraprofessional certificated or degreed tertiary education. There were no restrictions on the types of consumers.

Data collection and analysis

Two reviewers independently extracted data onto a standard form and assessed study quality. Studies that compared broadly similar types of interventions were grouped together. Where feasible, the results of included studies were combined and an estimate of effect obtained.

Main results

Forty three studies met the inclusion criteria, involving more than 210,110 consumers. These showed considerable diversity in the targeted health issue and the aims, content and outcomes of interventions. Most were conducted in high income countries (n=35), but nearly half of these focused on low income and minority populations (n=15). Study diversity limited meta-analysis to outcomes for five subgroups (n=15 studies) (LHW interventions to promote the uptake of breast cancer screening, immunisation and breastfeeding promotion [before two weeks and between two weeks and six months post partum] and to improve diagnosis and treatment for selected infectious diseases). Promising benefits in comparison with usual care were shown for LHW interventions to promote immunisation uptake in children and adults (RR=1.30 [95% CI 1.14, 1.48] p=0.0001) and LHW interventions to improve outcomes for selected infectious diseases (RR=0.74 [95% CI 0.58, 0.93) p=0.01). LHWs also appear promising for breastfeeding promotion. They appear to have a small effect in promoting breast cancer screening uptake when compared with usual care. For the remaining subgroups (n=29 studies), the outcomes were too diverse to allow statistical pooling. We can therefore draw no general conclusions on the effectiveness of these subgroups of interventions.

Authors' conclusions

LHWs show promising benefits in promoting immunisation uptake and improving outcomes for acute respiratory infections and malaria, when compared to usual care. For other health issues, evidence is insufficient to justify recommendations for policy and practice. There is also insufficient evidence to assess which LHW training or intervention strategies are likely to be most effective. Further research is needed in these areas.

Plain language summary

Lay health workers in primary and community health care

Consumers, who are not certified health care professionals, may be trained to promote health and provide health care services. To determine whether these 'lay health worker' programmes are effective, 43 studies were found and analysed. The studies took place mostly in USA, Canada and the UK. Overall, lay health worker programmes appear to be effective for some kinds of healthcare, but there is not yet enough evidence to say that this is true for all or most kinds of healthcare. Compared to usual care,lay health worker programmes to increase immunization (vaccination) in children and adults and programmes to improve health in people with lung infections and malaria may be effective. These programmes may also be effective in increasing breastfeeding, and in decreasing death in the elderly through providing home aide services. They may also have a small effect in increasing the uptake of breast cancer screening. There is not enough evidence to show whether lay health worker programmes are effective for other health care problems (for example, for managing high blood pressure or supporting alcoholics or mothers of sick children). It is also not known how best lay health workers should provide services and how much training they need to be effective.

Background

The 1970s saw the initiation and rapid expansion of lay health worker (LHW) programmes in low and middle income settings, stimulated by the primary health care approach adopted by the WHO at Alma-Ata (Walt 1990). LHW programmes also became more widespread in high income settings (Rosenthal 1998). Economic recession and political and policy changes throughout the developing world in the 1980s led to reduced investments in primary health care, including LHW programmes. By the mid-1980s the effectiveness and cost of such programmes was being questioned, particularly at a national level in developing countries, and several evaluations were conducted (Walt 1990; Frankel 1992). However, most of these were uncontrolled case studies that could not produce robust assessments of effectiveness due to selection bias and confounding.

Interest in community or lay health worker programmes in low and middle income countries became more prominent again in the 1990s prompted by the AIDS epidemic; the resurgence of other infectious diseases; and the failure of the formal health system to provide adequate care for people with chronic illnesses such as cancer, epilepsy and mental illness (Maher 1999; Hadley 2000). The growing emphasis on decentralisation and partnership with community based organisations was also important. In industrialised settings, a perceived need for mechanisms to deliver health care to minority communities and to support consumers for a wide range of health issues (Witmer 1995) also led to the growth of a wide range of LHW interventions. For example, a national survey in 1998 in the United States documented 12,500 LHWs in a large number of programmes (Rosenthal 1998).

Overall, however, this growth of interest in LHWs developed in the absence of robust evidence of their effects. Five systematic reviews have examined interventions with a lay health worker component, these focusing on breast cancer screening (Bonfill 2004); breastfeeding (Sikorski 2004); support during pregnancy (Hodnett 2004a; Hodnett 2004b); and the effectiveness of community health workers in the United States (Swider 2002). However, no reviews have attempted to examine the global evidence for the effects of LHWs, as compared to other interventions, for all conditions and types of interventions in primary and community health care. As new LHW programmes, for example in home-based care and treatment support, are developed (Foster 1996; Masood 1999; Unaids 1999), reliable reassurance should be sought that these interventions do more good than harm. Such interventions also have considerable direct and indirect costs. This systematic review therefore examines the effects of lay health worker (paid and voluntary) interventions in primary and community health care on health care behaviours, people's health and wellbeing, and their satisfaction with care.

Objectives

We address the following question:
Are lay health workers effective in improving the delivery of health care and health care outcomes?

To answer this question, we attempted to address the following comparisons:

  • LHW interventions compared to no intervention.

  • LHW interventions involving activities not now undertaken by health professionals and delegated to LHWs compared to no intervention.

  • LHW interventions involving activities not now performed adequately by health professionals and delegated to LHWs compared to no intervention.

  • LHW interventions involving activities now performed by health professionals but delegated to LHWs to reduce resource consumption compared to the same activities performed by health professionals.

  • The effectiveness of the lay health worker intervention related to intensity of training.

Methods

Criteria for considering studies for this review

Types of studies

Randomised controlled trials.

Types of participants

Types of health care providers:

Any lay health worker (paid or voluntary) including community health workers, village health workers, cancer supporters, birth attendants etc.

For the purposes of this review, a 'lay health worker' was defined as any health worker:

  • carrying out functions related to health care delivery

  • trained in some way in the context of the intervention

  • having no formal professional or paraprofessional certificated or degreed tertiary education.

Exclusions:

Interventions in which a health care function was performed as an extension to a participants' profession, where profession refers to work done for pay and which required a formal tertiary education (e.g. teachers provided health promotion in Schools - also see below).

Formally trained nurse aides, medical assistants, physician assistants, paramedical workers in emergency and fire services and other self-defined health professionals or health paraprofessionals. LHWs included in this review from industrialised or less industrialised settings may have received training recognised by a Ministry of Health or other certifying education, but this training did not form part of a tertiary education certificate or degree.

Interventions involving patient support groups only as these interventions were seen as different to LHW interventions. Another review (now at the protocol stage in the Consumers and Communication Review Group) will examine this area.

Interventions involving teachers delivering health promotion or related activities in schools as this large and important system of LHWs constitutes a unique group (teachers) and setting (schools) which would be better addressed in a separate review.

Interventions involving peer health counselling programmes in schools in which peers [pupils] teach other pupils about a health issue as part of the curriculum. Again, this constitutes a unique group and setting which would be better addressed in a separate review.

LHWs in non-primary level institutions (e.g. referral hospitals) because of the focus of the review on primary and community health care.

RCTs of interventions to train self-management tutors who were not lay persons (i.e. they were health professionals). Furthermore, RCTs simply comparing lay self-management with other forms of management (i.e. do not focus on the training of tutors etc.) were also excluded because they are concerned with the effects of empowering people to manage their own health issues rather than with the effects of interventions by LHWs who are providing services to others. Our review is primarily concerned with the latter. The former is being addressed by a review lay self-management review (now at the protocol stage in the Consumers and Communication Review Group). RCTs of interventions to train self-management tutors who were themselves lay persons were eligible for inclusion in this review.

Studies which measured only consumers' knowledge, attitudes or intentions, for example knowledge of what constitutes a 'healthy diet' or attitudes towards people with HIV/AIDS. These measures were not considered useful indicators of the effectiveness of LHW interventions.

Types of consumers:

There were no restrictions on the types of patients / recipients for whom data was extracted.

Types of interventions

Any intervention delivered by lay health workers and intended to promote health, manage illness or support people. An intervention was included if the description of the intervention was adequate to allow reviewers to establish that it was a lay health worker intervention (see definition above).

RCTs comparing one form of LHW intervention with another were not excluded from this review. However, these studies (n = 5) have not yet been analysed and will be considered in the next update of this review.

Types of outcome measures

Studies were included if they assessed any outcome measures within the following groups:

(1) Utilisation of lay health worker services

(2) Consultation processes

(3) Consumer satisfaction with care

(4) Health care behaviours such as types of care plans agreed, adherence to care plans (medication, dietary advice etc), attendance at follow-up consultations and health service utilisation

(5) Health care outcomes, as assessed by a variety of measures including physiological measures such as blood pressure or blood glucose levels, patient self-reports of symptom resolution or quality of life and patient self-esteem

(6) Cost

(7) Social development measures such as the creation of support groups or the promotion of other community activities.

Search methods for identification of studies

The following electronic databases were searched:

MEDLINE (1966 - August 2001)
CENTRAL and specialised Cochrane Registers (EPOC and Consumers and Communication Review Groups) (to August 2001)
Science Citations (to August 2001)
Embase (1966 -August 2001)
CINAHL ( 1966 - August 2001)
Healthstar (1975-2000)
AMED (1966- August 2001)
Leeds Health Education Effectiveness Database (http:// www.hubley.co.uk)

We retrieved documents that included both one or more terms relating to lay health workers and one or more terms suggesting a RCT. Search strategies were tailored to each database. The strategy for MEDLINE is presented as an example. Bibliographies of studies assessed for inclusion were also searched and all contacted authors were asked for details of additional studies.

MEDLINE search strategy

1.controlled clinical trial.pt
2.randomized controlled trial.pt
3.randomized controlled trials/
4.random allocation/
5.double blind method/
6.single blind method/
7.or/1-6
8.clinical trial.pt
9.exp clinical trials/
10.(clin$ adj25 trial$).ti,ab.
11.((singl$ or doubl$ or trebl$ or tripl$) adj25 (blind$ or mask$)).ti,ab.
12.placebos.sh
13.placebo$.ti,ab
14.random$.ti,ab.
15.research design.sh
16. or/8-15
17. 7 or 16
18.animal/
19.human/
20.18 not 19
21.17 not 20
22.community health aides/
23.home health aides/
24.exp voluntary workers/
25.home nursing/
26.community networks/
27.(lay adj5 (worker? or visitor? or attendant? or aide? or support$ or personnel)).tw.
28.(birth adj1 attendant?).tw.
29.monitrice?.tw.
30.(train$ adj1 volunteer?).tw.
31.paraprofessional.tw.
32.((health or care or healthcare) adj1 worker?).tw
33.((health or medical or care or nurs$ or psychiatric) adj1 (aide or aides)).tw.
34.((health or medical or care or nurs$ or psychiatric) adj1 attendant?).tw.
35.((nurs$ or care or home) adj1 support).tw
36.(support adj1 (program$ or service? or social)).tw.
37.or/22-36
38.21 and 37

Data collection and analysis

Selection of trials:
Two reviewers independently assessed the potential relevance of all titles and abstracts identified from the electronic searches. Full text copies of all articles that were identified as potentially relevant by either reviewer were retrieved.

As assessment of the eligibility of interventions can vary between reviewers, each full paper was assessed independently for inclusion by at least two reviewers. When reviewers disagreed the decision was referred to a third reviewer. If agreement could still not be reached, the decision was referred to the entire group to resolve by consensus. Where necessary, the study authors were asked for further information. Studies that were so flawed in their design or execution as to be unlikely to provide reliable data were excluded. Such exclusions are explained in the table of excluded studies.

Assessment of methodological quality:

Two reviewers independently assessed the quality of all eligible trials using the methodological quality criteria for RCTs listed in the Cochrane EPOC Review Group module (see ADDITIONAL INFORMATION, ASSESSMENT OF METHODOLOGICAL QUALITY under GROUP DETAILS). Studies were assessed as high quality if they reported allocation concealment, higher than 80% patient follow up and intention to treat analysis. Studies were assessed as low quality if they did not meet these criteria or if they did not report the information necessary for assessment.

Data extraction:

Two reviewers independently extracted data from all included studies on to a standard form. The data were then checked against each other and, if necessary, reference was made to the original paper. Any outstanding discrepancies between the two data extraction sheets were discussed by the data extractors and resolved by consensus. If necessary, other members of the review team considered these discrepancies. Attempts were made to contact study authors to obtain any missing information.

Data relating to the following was extracted from all included studies:

(1) participants (LHWs and consumers). For LHWs this included information on the term/s used to describe the LHW, selection criteria, basic education, tasks performed. For consumers, this included the health problems / treatment received, their age and demographic details and their cultural background.

(2) health care setting (home, primary care facility or other); geographic setting (rural, formal urban or informal urban settlement) and country.

(3) study design and the key features of studies (e.g. whether allocation to groups was at the level of individual health care provider or village/suburb).

(4) intervention (specific training and ongoing monitoring and support [including duration, methods, who delivered by etc.] and the health care tasks performed with consumers). A full description of the intervention was also extracted.

(5) the number of LHWs that were approached, trained and followed up; the number of consumers enrolled at baseline and the number and proportion followed up.

(6) outcomes assessed and timing of outcome assessment.

(7) results (effects), organised into 7 areas (consultation processes, utilisation of lay health worker services, consumer satisfaction with care, health care behaviours, health status and well being, social development measures and cost).

(8) consumer involvement in the selection, training and management of the LHW interventions.

Data synthesis:

We grouped together studies that compared broadly similar types of interventions (n = 32), as listed below. The remaining eleven studies were very diverse and could not be usefully grouped.

(1) LHW interventions to promote the uptake of breast cancer screening compared with usual care.

(2) LHW interventions to promote breastfeeding compared with usual care.

(2.1) LHW interventions to promote breastfeeding up to 2 weeks post partum compared with usual care.

(2.2) LHW interventions to promote breastfeeding between 2 weeks and 6 months post partum compared with usual care.

(3) LHW interventions to promote immunization uptake in children and adults compared with usual care.

(4) LHW interventions to reduce morbidity and mortality from acute respiratory infections and malaria compared with usual care.

(5) LHW interventions to improve hypertension treatment compared with usual care.

(6) LHW interventions to provide support for recovering alcoholics compared with usual care or office based support.

(7) LHW interventions to provide support for mothers of sick children compared with usual care.

(8) LHW interventions to provide home aide services for the elderly compared with usual care or day care services

(9) LHW interventions to promote mother-child interaction / health promotion compared with usual care.

The comparisons made in the included studies did not allow us to address the other comparison groups listed under 'Objectives'.

Where feasible, the results of included studies were combined and an estimate of effect obtained. This was possible for the following four study subgroups: LHW interventions to promote the uptake of breast cancer screening; to promote breastfeeding; to promote immunization uptake; and to provide health care and treatment. Outcomes comparisons for LHW interventions to promote the uptake of breast cancer screening, breastfeeding and immunization are expressed as adherence to a beneficial health behaviour. Outcomes for the 'LHW interventions to reduce morbidity and mortality from acute respiratory infections and malaria' comparison are expressed as number of events (mortality and morbidity). Primary outcome measures were entered for all studies except Johnson 1993, where we selected a single relevant outcome (immunization status) from those measured. Only dichotomous outcomes were included in meta-analysis owing to the methodological complications involved in combining and interpreting studies using different continuous outcome measures and because of missing data in some studies. Differences in baseline variables were rare and not considered influential. Data were re-analysed on an intention-to-treat basis where possible.

Adjustment for clustering was made where necessary, assuming an intracluster correlation coefficient (ICC) of 0.02 which is typical of primary and community care interventions (Campbell 2000). Log relative risks and standard errors of the log relative risk were then calculated for both individual and adjusted cluster RCTs and analysed using the generic inverse variance method in Review Manager 4. Relative risks were preferred to odds ratios because event rates were often high and, in these circumstances, odds ratios can be difficult to interpret (Altman 1998). Random effects meta-analysis was preferred because the studies were heterogenous.

For the remaining five study subgroups (LHW interventions to improve hypertension treatment ; to provide support for recovering alcoholics; to provide support for mothers of sick children; to provide home aide services for the elderly; and to promote mother-child interaction / health promotion), the outcomes assessed and the settings in which the studies were conducted were very diverse. We therefore judged it inappropriate to combine the results of included studies quantitatively, as an overall estimate of effect would have little practical meaning. We therefore present a brief descriptive review of these subgroups.

The diversity of studies, the small number of studies in each subgroup and the limited intervention descriptions precluded examination of the relations between the characteristics of the interventions and their effects. The feasibility of such analysis will be re-assessed when the review is updated.

Results

Description of studies

Searching

Electronic searching identified 8,637 titles or abstracts written both in English and foreign languages. Approximately 400 of these studies were considered potentially eligible for inclusion and full text articles were ordered. 43 studies fully met our inclusion criteria including 33 individual randomised controlled trials and 10 cluster randomised control trials (Caulfield 1998; Chongsuvivat' 1996; Duan 2000; Haider 2000; Kidane 2000; Lin 1997; Morrow 1999; Mtango 1986; Ramadas 2003; Voorhees 1996). All included studies were published in English language journals.

The majority of included studies (n = 27) compared a LHW intervention arm against a control arm receiving either no intervention or usual care but three studies (Leigh 1999; Olds 2002; Tudiver 1992) compared a LHW system of care against a professional system. A further thirteen studies examined more than one intervention arm, but in all cases a control group receiving no intervention services was included for comparison. Searching also identified five studies comparing different types of LHW intervention only and three studies that examined LHWs as part of a wider range of interventions. These studies were not included in this review because they do not allow the specific assessment of LHW success when compared against usual or professional care systems.

The included studies show considerable heterogeneity in terms of their setting; the health issues on which they focused; the aims, format and content of interventions; and the outcomes measured.

Setting

Fourteen different countries were represented in the included studies. Most trials took place in North America, 24 in the U.S.A. and four in Canada. A further four studies were based in the United Kingdom and one in Ireland. In the Southern hemisphere further studies were included from New Zealand (Bullock 1995), Australia (Heller 1995), Tanzania (Mtango 1986) and South Africa (Zwarenstein 2000) and in the Northern hemisphere from Thailand (Chongsuvivat' 1996), Mexico (Morrow 1999), Ethiopia (Kidane 2000), India (Ramadas 2003), Bangladesh (Haider 2000) and Taiwan (Lin 1997).

In 28 studies the intervention was delivered to patients based in their homes. Four interventions were based solely in a primary care facility (Barnes 1999; Caulfield 1998; Komaroff 1974; Von Korff 1998). A further nine studies involved a combination of home, primary care and community based interventions (Andersen 2000; Ireys 1996; Ireys 2001; Krieger 1999; Leigh 1999; Silver 1997; Wan 1980; Weinberger 1989; Wertz 1986). One study (Lapham 1995) took place in purpose run transitional housing facilities and one study (Voorhees 1996) was organised from and conducted using local church facilities.

Intervention characteristics

Objective of the interventions

Studies were grouped into three broad categories based upon the primary health care intention of the intervention. The first category contained interventions designed to provide or to improve treatment for a health related condition (n=11). Included in this category were two studies using LHWs to detect and treat acute respiratory infections (Chongsuvivat' 1996; Mtango 1986). One study (Kidane 2000) examined the use of similar LHW services to detect and treat malaria, including the monitoring and provision of chemotherapy. Three studies focused on hypertension control through approaches that included physician assistant care (Komaroff 1974); screening and referral for treatment (Krieger 1999); and lifestyle education (Lin 1997). Other studies in the group used LHWs to screen and refer the elderly to formal health care (Carpenter 1990); to screen for oral cancer (Ramadas 2003); to provide therapy and care for aphasic patients (Wertz 1986); to improve existing treatment procedures for osteoarthritis (Weinberger 1989); to supervise directly observed therapy for tuberculosis patients (Zwarenstein 2000).

Interventions intended to change people's health related knowledge, attitudes or behaviours constituted a second category (n=20). Within this diverse grouping were four interventions promoting breast feeding practices (Caulfield 1998; Dennis 2002; Haider 2000; Morrow 1999). Another four provided counselling to promote the uptake of breast and cervical cancer screening services (Andersen 2000; Duan 2000; Hoare 1994; Sung 1997) and three attempted to increase immunization uptake through outreach and follow up services (Barnes 1999; Johnson 1993; Krieger 2000). Six studies evaluated the impact of LHW visiting and education programmes on mother-infant interaction and health behavioural outcomes (Barth 1991; Bullock 1995; Johnson 1993; Olds 2002; Schuler 2000; Siegel 1980). Other studies in this category offered telephone support and advice for coronary heart disease patients (Heller 1995); AIDS primary prevention strategies (Tudiver 1992); self treatment education for back pain sufferers (Von Korff 1998); and smoking cessation strategies (Voorhees 1996).

The third category includes interventions in which the LHWs' primary purpose was to provide psycho-social support (n=6). However, it should be noted that, in some studies, the intervention had the subsidiary effect of changing people's behaviour. For instance two studies evaluated LHW support to recovering substance users enrolled in treatment programmes (Lapham 1995; Leigh 1999). Three studies assessed social support for mothers of children with chronic health problems (Ireys 1996; Ireys 2001; Silver 1997) and one study providing practical and emotional support for new mothers (Morrell 2000).

Multifaceted interventions were included in a fourth category if they aimed explicitly to provide more than one type of service in roughly equal measure. Four studies provided in home services for the elderly (McNeil 1995; Nielsen 1972; Wan 1980; Williams 1992); one intervention was directed at improving growth and development among children with non-organic failure to thrive (NOFTT) (Black 1995); and one used LHW home visiting to help reduce the incidence of low birth weight babies (Graham 1992).

These intervention groups were further divided for meta-analysis, as described above.

Mode of delivery

There was great variety in the mode of intervention delivery adopted in different studies. Some trials used very specific delivery techniques, often tailored to the individual recipient. Some studies used face-to-face contact together with some form of telephone campaign whereas others set up community meetings and activities, such as themed bingo nights (Andersen 2000). However, no trials examined the passive delivery of health education, neither through the media nor through other activities like pamphlet distribution. In one study LHWs mailed educational brochures (Andersen 2000) but this was done together with numerous other interventions. In two studies (Tudiver 1992; Von Korff 1998) volunteers held educational meeting sessions at which messages about self care health behaviour were delivered. In total eleven studies examined interventions that involved some form of telephone contact. In certain studies the intervention was delivered entirely by telephone (Heller 1995) but in others telephone counselling was part of a more complex intervention and in some it was compared against personal contact methods (Barnes 1999). Twenty two studies used home visits to deliver at least part of the intervention and six studies used primary care facilities as a base for face-to-face contact. Other methods of intervention delivery included community meetings and discussion sessions (n=6), video presentations (Caulfield 1998) and family orientated activity sessions (Ireys 2001). One study (Voorhees 1996) used church meetings and facilities to deliver coronary heart disease education and a smoking cessation strategy respectively. Another (Duan 2000) used church volunteers to contact parishioners with an intervention promoting breastfeeding.

Other characteristics

A few trial reports gave information about the organisational base of the intervention. In fourteen studies a non-governmental organisation, charitable organisation or community group was responsible for elements of the intervention including organisation, training and delivery. Consumer involvement was integral to the intervention in eleven studies (Duan 2000; Heller 1995; Ireys 1996; Ireys 2001; Kidane 2000; Lapham 1995; Silver 1997; Tudiver 1992; Von Korff 1998; Wertz 1986; Zwarenstein 2000). Most often, former sufferers of a particular health condition were recruited to deliver the intervention to current sufferers. No study recorded that patients had been involved in the selection of LHWs. However, a number of trials recruited LHWs from participant communities, often to represent its demographic characteristics.

Participants

Lay health workers

There were considerable differences in the number of LHWs employed to deliver the interventions (range = 2 (Graham 1992) to 150 (Chongsuvivat' 1996)). It is difficult to group trends in the selection and training of lay health workers. Individuals were sometimes recruited because they were familiar with a target community or because they had experience of a particular health condition. In other studies (Carpenter 1990; McNeil 1995), volunteers were recruited but no selection process appeared to be used. For some trials selection criteria were not described.

The amount of training afforded lay health workers varied greatly between trials. In some the training consisted only of an hour long introduction to the aims and principles of the intervention (Carpenter 1990), or a 2½ hour orientation session (Dennis 2002). More complex interventions however could be preceded by longer training periods. For example, two studies reported 100 hours of training (Barth 1991; Krieger 1999), while others reported eight theoretical and practical sessions (Black 1995), eight weeks of national vocational level training (Morrell 2000) or specific health condition training lasting months (Kidane 2000; Olds 2002; Morrow 1999; Ramadas 2003; Siegel 1980; Sung 1997; Wertz 1986).

Recipients

A total of 210110 individuals were targeted in the 43 studies. Nineteen studies targeted interventions towards children and five delivered interventions specifically to the elderly. A large group of studies (n=15) recruited families, or mothers, of children with a specific health problem. Included in this group were studies aimed at breastfeeding mothers (Caulfield 1998; Dennis 2002; Haider 2000; Morrow 1999) and studies that attempted to improve the mother-infant relationship for mutual benefit (Barth 1991; Johnson 1993; Olds 2002; Schuler 2000; Siegel 1980; Ireys 1996; Ireys 2001; Morrell 2000; Silver 1997; Black 1995; Graham 1992). Only one intervention was designed specifically for men. This was an education programme about high risk sexual practices delivered to homosexual men in Canada (Tudiver 1992). Nearly half the interventions focused on low income and minority populations (n=19), especially those studies set in inner city U.S.A. and in middle and low income countries.

Outcomes

Most studies reported multiple measures of effect and many did not specify a primary outcome. For example, many different psychometric scoring systems were used and generally different trials chose to measure different aspects of psychosocial health.

1. Morbidity and mortality
Five studies recorded morbidity and mortality data as primary outcomes in evaluating LHW interventions to improve diagnosis and treatment for acute respiratory infections (ARI) and malaria (Chongsuvivat' 1996; Kidane 2000; Mtango 1986) and screening for oral cancer (Ramadas 2003). Three of these trials used measures specific to children under the age of five while the oral cancer screening trial recorded adult mortality. In response to an education program for sufferers of back pain, Von Korff 1998 recorded pain intensity, disability and mental health indicators.

2. Treatment assessment measures
Six studies assessed the effect of LHWs on successful treatment of a particular health condition. Three of these studies (Komaroff 1974; Krieger 1999; Lin 1997) evaluated hypertension management practices, recording the successful completion of treatment and referral, patient and practitioner satisfaction as well as knowledge scores and blood pressure. A theoretically similar intervention (Weinberger 1989) aimed at osteoarthritis sufferers also measured consumer satisfaction with health care, compliance with medication and the impact of their arthritis on sufferers. Zwarenstein 2000 recorded successful treatment rates for tuberculosis patients. One study (Carpenter 1990) did not focus on a single health condition and evaluated the time elderly patients spent in health care institutions and used an 'activities of daily living' scale to assess quality of life.

3. Health service uptake
Five studies (Caulfield 1998; Dennis 2002; Haider 2000; Morrell 2000; Morrow 1999) promoted breastfeeding, evaluating initiation, duration and type of the adopted practice. One study also recorded maternal satisfaction and diarrhoea incidence in infants (Morrow 1999). Three studies (Barnes 1999; Johnson 1993; Krieger 2000) assessed the effect of a LHW intervention on immunization uptake by recording individual immunization status in the study population.

4. Behaviour change
Two studies (Heller 1995; Voorhees 1996) recorded changes in cigarette smoking behaviour, in the first study as an indicator of lifestyle practices and in the second as a direct measure of a smoking cessation strategy. Tudiver 1992 assessed the effect of an education program on AIDS risk knowledge score and sexual practices.

5. Psycho-social measurements and assessment of quality of life
Many studies used psychological tests and mental health scoring systems to assess the effects of the intervention. Measures of infant-parent well being and interaction were common to six studies (Barth 1991; Bullock 1995; Johnson 1993; Olds 2002; Schuler 2000; Siegel 1980), some of which also recorded maternal drug use, satisfaction scales and child nutritional status. Four studies (Ireys 1996; Ireys 2001; Morrow 1999; Silver 1997) combined psychological measurement with an assessment of both the perceived and the actual availability of support to mothers. Four studies providing home aide services to the elderly (McNeil 1995; Nielsen 1972; Wan 1980; Williams 1992) combined psychological health and contentment scores with formalised activities of daily living scales and measures of physical health, such as aerobic capacity and number of admissions to health care institutions.

6. Drug rehabilitation
Two studies (Lapham 1995; Leigh 1999) supported recovering substance users. Efficacy of the intervention was measured by recent drug and alcohol use as well as study attrition and treatment attendance.

7. Child physical health
Black 1995 measured infant growth and development and parent-child interaction among children with non-organic failure to thrive. Graham 1992 recorded the proportion of low birth weight babies born to high risk mothers following an intervention during pregnancy.

Included studies recorded both dichotomous and continuous outcomes. Dichotomous measures were presented in studies (n=14) examining the treatment of ARI and malaria, promoting the uptake of breast and oral cancer screening, breastfeeding and immunization. Continuous outcomes were generally reported in studies promoting parent-child health, supporting mothers of sick children, supporting substance users and providing home aide services for the elderly.

Risk of bias in included studies

Assessments of the methodological quality of included studies are shown in Additional Table 1 and Table 2. Fifteen studies were assessed as high quality, with low susceptibility to bias. The remaining 29 studies were considered low quality, meaning that bias was of greater concern. Allocation concealment was 'done' in 32 studies and in the all of the remainder it was scored 'unclear'. Loss to follow was scored 'done' in 21 studies (i.e. more than 80% of patients followed up), unclear in twelve studies and not done in ten studies. Intention to treat analysis was performed in 27 studies, in twelve the procedure was not described and in four it was 'not done'.

Table 1. Methodological quality assessment using EPOC criteria for included studies
StudyAllocation procedureLevel of allocationBaseline measurePrimary outcomeLoss to follow upContaminationAssessors blindIntention to treatUnit analysis error
Andersen 2000DoneDoneDoneDoneDoneDoneDoneDoneYes, adjustment unclear
Barnes 1999UnclearDoneDoneDoneUnclearDoneNot doneUnclearNo
Barth 1991UnclearDoneDoneDoneNot doneUnclearUnclearUnclearNo
Bullock 1995DoneDoneDoneDoneDoneDoneUnclearDoneYes, adjustment unclear
Carpenter 1990DoneDoneDoneUnclearNot doneDoneNot doneUnclear 
Caulfield 1998UnclearDoneUnclearUnclearNot doneUnclearNot doneUnclearYes, adjustment unclear
Chongsuvivatwong 1996UnclearDoneDoneDoneDoneUnclearUnclearDoneYes, adjustment made
Dennis 2002DoneDoneDoneDoneDoneDoneDoneDoneNo
Duan 2000UnclearDoneDoneUnclearUnclearUnclearNot doneUnclearYes, adjustment unclear
Graham 1992DoneDoneDoneDoneUnclearUnclearUnclearDoneNo
Haider 2000DoneDoneDoneDoneDoneUnclearNot doneUnclearYes, adjustment made.
Heller 1995DoneDoneDoneDoneNot doneDoneNot doneDoneNo
Hoare 1994DoneDoneDoneDoneNot doneNot doneUnclearDoneNo
Hutcheson 1997DoneDoneDoneDoneDoneDoneDoneUnclearNo
Ireys 1996DoneDoneUnclearUnclearDoneUnclearUnclearUnclearNo
Ireys 2001DoneDoneDoneDoneDoneDoneDoneDoneNo
Johnson 1993DoneDoneUnclearUnclearDoneUnclearNot doneUnclearNo
Kidane 2000DoneDoneDoneDoneDoneUnclearDoneDoneYes, adjustment made
Komaroff 1974UnclearDoneDoneDoneUnclearNot doneUnclearUnclearNo
Krieger 1999DoneDoneDoneDoneNot doneDoneDoneNot doneNo
Krieger 2000UnclearDoneDoneDoneDoneUnclearUnclearNot doneNo
Lapham 1995DoneDoneDoneDoneUnclearUnclearDoneDoneNo
Leigh 1999UnclearDoneDoneDoneNot doneUnclearDoneUnclearNo
Lin 1997DoneDoneDoneUnclearNot doneDoneDoneUnclearYes, adjustment unclear
McNeil 1995DoneDoneDoneDoneUnclearDoneUnclearDoneNo
Morrell 2000DoneDoneDoneDoneDoneUnclearNot doneDoneNo
Morrow 1999DoneDoneDoneUnclearDoneDoneNot doneDoneYes, adjustment made
Mtango 1986DoneDoneNot doneNot doneUnclearUnclearUnclearDoneYes, adjustment unclear
Nielsen 1972DoneDoneDoneDoneDoneUnclearUnclearDoneNo
Olds 2002DoneDoneDoneUnclearDoneDoneDoneDoneNo
Sankanarayanan 2000UnclearDoneDoneDoneUnclearDoneUnclearDoneYes, adjustment unclear
Schuler 2000DoneDoneDoneUnclearDoneDoneDoneDoneNo
Siegel 1980DoneDoneDoneDoneUnclearDoneDoneDoneNo
Silver 1997DoneDoneUnclearUnclearDoneUnclearDoneDoneNo
Sung 1997UnclearDoneDoneDoneUnclearUnclearNot doneDoneNo
Tudiver 1992UnclearDoneDoneDoneUnclearNot doneNot doneDoneNo
Van Korff 1998DoneDoneDoneDoneDoneUnclearDoneDoneYes, adjustment made
Voorhees 1996DoneDoneDoneDoneDoneDoneDone (biochemical measure only)DoneYes, adjustments made
Wan 1980DoneDoneDoneUnclearNot doneUnclearUnclearNot doneNo
Weinberger 1989DoneDoneDoneDoneDoneUnclearDoneDoneNo
Wertz 1986DoneDoneDoneDoneUnclearDoneDoneDoneNo
Williams 1992DoneDoneDoneDoneNot doneUnclearUnclearNot doneNo
Zwarenstein 2000DoneDoneDoneDoneDoneUnclearUnclearDoneNo
Table 2. Methodological quality summary scores for all included studies
StudySummary score
Andersen 2000H (High)
Barnes 1999L (Low)
Barth 1991L
Bullock 1995H
Carpenter 1990L
Caulfield 1998L
Chongsuvivatwong 1996L
Dennis 2002H
Duan 2000L
Graham 1992L
Haider 2000L
Heller 1995L
Hoare 1994L
Hutcheson 1997L
Ireys 1996L
Ireys 2001H
Johnson 1993L
Kidane 2000H
Komaroff 1974L
Krieger 1999L
Krieger 2000L
Lapham 1995L
Leigh 1999L
Lin 1997L
McNeil 1995L
Morrell 2000H
Morrow 1999H
Mtango 1986L
Nielsen 1972H
Olds 2002H
Ramadas 2003L
Schuler 2000H
Siegel 1980L
Silver 1997H
Sung 1997L
Tudiver 1992L
Van Korff 1998H
Voorhees 1996H
Wan 1980L
Weinberger 1989H
Wertz 1986L
Williams 1992L
Zwarenstein 2000H
  
  

The grouping of studies according to methodological quality is not intended as a platform for deciding which studies should be included in the meta analysis. It is rather intended to illustrate the quality range for research on the effects of LHW interventions.

Effects of interventions

Lay health workers have been employed to deliver a very wide variety of interventions in many different health care settings. Trying to group studies by intervention type is therefore problematic and a more useful discussion can be generated by concentrating on the intended outcome or objective of each study. For the purposes of discussion and meta-analysis 32 studies have been organised into ten groups, each group containing studies that used broadly similar methods to influence a single health care outcome. Meta-analysis was performed on five of the ten groups, including a total of fifteen studies. In the others, outcomes were considered too diverse to be usefully pooled. In the majority of cases it is the primary study outcome that has been included in the analysis. The additional tables list all of the study outcomes.

The effects described in this section all favour the intervention arm of the trials, unless stated otherwise.

LHW interventions to promote breast cancer screening compared with usual care (see meta view)

Four studies (Andersen 2000; Duan 2000; Hoare 1994; Sung 1997) employed LHWs to increase the uptake of breast cancer screening services. Duan 2000 analysed separately the effect on users and non users at baseline. The pooled RR for the five comparisons was 1.05 [95% confidence intervals (CI) 0.99, 1.12], providing little evidence for a beneficial effect of the intervention [p=0.10]. Heterogeneity between study outcomes was extremely low [p=0.86; I2=0%].

LHW interventions to promote breastfeeding up to 2 weeks post partum compared with usual care (see meta view)

Four studies (Caulfield 1998; Dennis 2002; Haider 2000; Morrow 1999) examined the short term post partum effects of LHW interventions to promote breastfeeding. Meta-analysis indicated that breastfeeding promotion may increase the uptake of breastfeeding practices (RR=1.69 [95% CI 0.91, 3.12] p=0.10). The heterogeneity of the studies' outcomes raises doubts about the suitability of a pooled estimate (p<0.00001; I2=89.6%).

LHW interventions to promote breastfeeding between two weeks and six months post partum compared with usual care (see meta view)

The pooled RR for the four studies that examined the longer term influence of breastfeeding promotion interventions (Dennis 2002; Haider 2000; Morrell 2000; Morrow 1999) was 2.93 [95% CI 0.88, 9.71] p=0.08). This result should be interpreted with some caution as individual study estimates ranged from 1.06 [0.64, 1.75] (Morrell 2000) to 11.64 [7.09, 19.09] (Haider 2000). Although between study heterogeneity was substantial (p<0.00001; I2=95.7%), the effect is large and the individual study results all favour the intervention. A possible explanation for the observed variation could be the extensive differences in the intensity of the intervention between studies. The extremely large RR in Haider 2000 coincides with an extremely intensive, one to one intervention strategy. Another influential factor may be the prevailing breastfeeding practices within the study areas: for example, Haider 2000 was done in a region where exclusive breastfeeding is very rare. It may also be problematic to combine 'exclusive breastfeeding' and 'any breastfeeding' measures.

LHW interventions to promote immunisation uptake in children and adults compared with usual care (see meta view)

Three studies (Barnes 1999; Johnson 1993; Krieger 2000) provide strong evidence that LHW based promotion strategies can increase the uptake of immunisation in both adults and children (RR=1.30 [95% CI 1.14, 1.48] p=0.0001). There was little heterogeneity (p=0.95; I2=0%).

LHW interventions to provide health care and treatment specific to a medical condition compared with usual care (see meta view)

Two studies (Chongsuvivat' 1996; Mtango 1986) used LHWs to diagnose and treat acute respiratory infection (ARI) in children under five years old and one study (Kidane 2000) used LHWs to treat malaria episodes in children of the same age. Two of the studies (Kidane 2000; Mtango 1986) recorded all cause mortality outcome data whereas Chongsuvivat' 1996 recorded morbidity data for ARI. The pooled RR for mortality for the two studies was 0.69 [95% CI 0.51, 0.94] (p=0.02). When morbidity data were included the pooled RR remained significant (RR=0.74 [95% CI 0.58, 0.93) p=0.01) although heterogeneity affected both the mortality RR (p=0.02; I2=81.4%) and the mortality and morbidity combined RR (p=0.02; I2=75.8%).

LHWs interventions to improve treatment of hypertension compared with usual care

Evidence from the three studies using LHWs to treat hypertension (Lin 1997; Komaroff 1974; Krieger 1999) was mixed: one study reported that LHWs could significantly lower both systolic and diastolic blood pressure (Lin 1997) but another (Komaroff 1974) found no significant differences. Krieger 1999 found that significantly more patients receiving the LHW intervention (p=0.001) completed follow-up appointments with health care providers within 90 days of referral.

LHW interventions to promote mother-infant interaction / health promotion compared with usual care

Six studies examined the effect of LHWs on mother-child health promotion (Barth 1991; Bullock 1995; Johnson 1993; Olds 2002; Schuler 2000; Siegel 1980). The results of these studies were highly variable, with many of the studies reporting multiple outcome measures. The effects could therefore not be summarised and results for individual studies are presented in Additional Table 3.

Table 3. LHWs to promote mother-child interaction compared with usual care
StudyOutcome typeControl groupIntervention groupStatistical sig.
Barth 1988Health care behavioursPrenatal care: 1/ Summary score for eating unhealthy items: mean = 8.28, SD = 2.88 2/ Summary score for eating healthy items: mean = 6.10, SD = 2.83 3/ Frequency of visit to doctor in 2nd and 3rd trimesters: mean = 9.73, SD = 3.48.Prenatal care: 1/ Summary score for eating unhealthy items: mean = 8.12, SD = 2.38 2/ Summary score for eating health items: mean = 6.21, SD = 2.81 3/ Frequency of visit to doctor in 2nd and 3rd trimesters: mean = 9.90, SD = 3.17p=NS for all measures
 Health status and wellbeingParent well-being: 1/ The Center for Epidemiological Studies Depression Scale (CES-D): mean = 41.4, SD = 12.38 2/ The State-Trait Anxiety Inventory (STAI): mean = 40.41, SD = 13.23 3/ The Pearlin Mastery Scale: mean = 20.28, SD = 3.52 4/ The Child Abuse Potential Inventory (CAPI): mean = 93.37, SD = 46.61 5/ Goal level: mean = 2.98, SD = 1.02 Birth outcomes: 1/ Pregnancy problems (adverse events during delivery): mean = 1.36, SD = 1.09 2/ Total days mother and newborn were in hospital around delivery: mean = 9.80, sd = 4.57 3/ Birthweight (grams): mean = 3255, SD = 625 4/ Score of discrepancy between expected and actual discomfort during pregnancy and delivery: mean = 1.36, SD = 0.45 5/ Score of degree to which client worried about issues related to having a newborn: mean = 24.19, SD = 6.48 Child Temperament (subscales of Infant Temperament Questionnaires): 1/ Activity: mean = 50.18, SD = 8.75 2/ Mood: mean = 23.91, SD = 4.93 3/ Distractibility: mean = 24.59, SD = 6.44 Child welfare: 1/ Ratings of common illnesses experienced by child: mean = 5.43, SD = 2.96 2/ Whether the child's client has been removed from her care or if a neighbour cared for the child because the mother did not: mean = 2.06, SD = 0.29 3/ Number of times the client has taken the newborn to emergency medical services: mean = 1.44, SD = 0.50 4/ Combined number of times that a baby has had check ups, DPT shots and polio shots: mean = 7.09, SD = 3.89Parent well-being: 1/ CES-D score: mean = 39.54, SD = 12.30 2/ STAI score: mean = 39.25, SD = 12.98 3/ Pearline score: mean = 19.98, SD = 3.73 4/ CAPI score: mean = 99.76, SD = 45.82 5/ Goal level: mean = 2.29, SD = 1.03 Birth outcomes: 1/ Pregnancy problems (adverse events during delivery): mean = 1.49, SD = 1.06 2/ Total days mother and newborn were in hospital around delivery: mean = 8.41, SD = 3.88 3/ Birthweight (grams): mean = 3396, SD = 683 4/ Score of discrepancy between expected and actual discomfort during pregnancy and delivery: mean = 1.31, SD = 0.19 5/ Score of degree to which client worried about issues related to having a newborn: mean = 25.04, SD = 7.55 Child Temperament (subscales of Infant Temperament Questionnaires): 1/ Activity: mean = 48.05, SD = 9.35 2/ Mood: mean = 22.05, SD = 4.54 3/ Distractibility: mean = 24.11, SD = 6.50 Child Welfare: 1/ Ratings of common illness experienced by child: mean = 5.62, SD = 2.92 2/ Whether the child's client has been removed from her care or if a neighbour cared for the child because the mother did not: mean = 2.08, SD = 0.31 3/ Number of times the client has taken the newborn to emergency medical services: mean = 1.44, SD = 0.50 4/ Combined number of times that a baby has had check ups, DPT shots and polio shots: mean = 7.43, SD = 3.55p=NS for all measures
 Social development measuresFormal and informal support 1/ Community Resources Use Scale (CRUS): mean = 1.94, SD = 2.17 2/ Social Supports and Preparation Scale: mean = 2.44, SD = 1.99 3/ Inventory of Social Supportive Behaviours (ISSB): mean = 44.62, SD = 15.32 4/ Social Support Inventory: mean = 12.02, SD = 2.56Formal and informal support: 1/ CRUS: mean = 2.0, SD = 1.86 2/ Social Supports and Preparation Scale: mean = 2.5, SD = 1.64 3/ ISSB: mean = 45.78, SD = 13.29 4/ Social Support Inventory: mean = 12.11, SD = 2.52p=NS for all measures
Bullock 1995Health care behaviours1/ smokers: baseline = 35 (56%); 34 weeks = 30 (48%) 2/ women drinking alcohol in last month: baseline = 17 (27%); 34 weeks = 18 (29%) 3/ >3 drinks on any one occasion: baseline = 7 (11%); 34 weeks = 6 (10%) 4/ marijuana use: baseline = 5 (8%); 34 weeks = 4 (6%) 5/ <3 meals/day: baseline = 23 (37%); 34 weeks = 23 (37%) 6/ Not utilizing any community resources: baseline = 45 (71%); 34 weeks = 35 (52%)1/ smokers: baseline = 31 (53%); 34 weeks = 29 (49%) 2/ women drinking alcohol in last month: baseline =15 (25%); 34 weeks = 19 (32%) 3/ >3 drinks on any one occasion: baseline = 6 (10%); 34 weeks = 3 (5%) 4/ marijuana use: baseline = 4 (7%); 34 weeks = 2 (3%) 5/ <3 meals/day: baseline = 15 (25%); 34 weeks = 10 (17%) 6/ Not utilizing any community resources: baseline = 35 (59%); 34 weeks = 17 (29%)5/ p = 0.03 6/ p = 0.02
 Health status and wellbeing1/ Stress: baseline =19.3; 34 weeks =18.4 2/ social support - partner: baseline =52.7; 34 weeks =52.7 3/ Social support- other: baseline =51.3; 34 weeks =49.7 4/ Self esteem: baseline =32.0; 34 weeks =32.5 5/ Depression (i) somatic: base =3.9; 34 =4.4 (ii) mood: base=7.2 34=8.1 (iii) other: base=4.0; 34 = 4.1 (iv) overall: base =15.3; 34= 17.0 6/ State anxiety: base = 34.3; 34 = 34.1 7/ Trait anxiety: base =41.8; 34 =39.41/ Stress: baseline =18.8; 34 weeks =16.5 2/ social support - partner: baseline =54.4; 34 weeks =56.9 3/ Social support- other: baseline =54.3; 34 weeks =52.5 4/ Self esteem: baseline =33.3; 34 weeks =34.9 5/ Depression (i) somatic: base =3.9; 34 =4.3 (ii) mood: base=7.2 34=6.6 (iii) other: base=3.9; 34 = 4.4 (iv) overall: base =14.8; 34= 15.3 6/ State anxiety: base = 32.8; 34 = 30.0 7/ Trait anxiety: base =40.3; 34 =35.21/ Stress: baseline p=0.02 2/ social support - partner: p=0.09 3/ Social support- other: p=0.49 4/ Self esteem: p=0.008 5/ Depression (i) somatic: p=0.86 (ii) mood: p =0.02 (iii) other: p=0.84 (iv) overall: p=0.10 6/ State anxiety: p=0.05 7/ Trait anxiety: p=0.04
Johnson 1993Health care behaviours1/ Proportion of children who received all 3 shots of primary immunizations by first birthday: 65% (n=68) 2/ Proportion of children who received at least one shot of their primary immunization schedule who received the DPT vaccine: 68% (n=71) 3/ Number of children in each trial arm admitted to hospital during the study: n= 21 (20%) 4/ Mean number of days spent in hospital for children: 1.3 days 5/ Mean length of stay in hospital in days: 7.0 6/ Length of time child kept on formula feeds: 28.0 weeks (SD 15.2) 7/ Proportion of mothers who gave their child cow's milk before 26 weeks: 47% (n=49) 8/ 24 hour dietary nutrition intake: - child: 6 measures - mother: 6 measures. 9/ Number of mothers who read to their child: 54% (n=57) 10/ Developmental score: -cognitive games: mean=1.62 (SD 1.39) -motor games: mean=0.76 (SD 0.84) 11/ The extent to which mothers used song and nursery rhyme with their child: mean=3.50 (SD3.24)1/ Proportion of children who received all 3 shots of primary immunizations by first birthday: 85% (n=108) 2/ Proportion of children who received at least one shot of their primary immunization schedule who received the DPT vaccine: 77% (n=98) 3/ Number of children in each trial arm admitted to hospital during the study: n=24 (19%) 4/ Mean number of days spent in hospital for children: 2.6 days 5/ Mean length of stay in hospital in days: 14.0 days 6/ Length of time child kept on formula feeds: 38.1 (SD 13.5) weeks 7/ Proportion of mothers who gave their child cow's milk before 26 weeks: 19% (n=24) 8/ see control 9/ Number of mothers who read to their child: 98% (n=125) 10/ Developmental score: -cognitive games: mean=3.75 (SD 2.11) -motor games: mean=0.83(SD 0.76) 11/ The extent to which mothers used song and nursery rhyme with their child: mean=7.74 (SD1.65)1/ p<0.001; RR 1.31; CI 1.12-1.54 2/ NS 3/ NS 4/ p=0.88 5/ p = <0.05 6/ 95%CI 6.4-13.8 weeks; p=<0.001 7/ RR = 0.40; 95%CI 0.27-0.61); p=<0.0001 8/ child: all significant in favour of the intervention at p=0.001 level (see page 1451) mother: all significant in favour of the intervention group at p=<0.01 level (see page 1451) 9/ p<0.0001; RR 1.81; 95% CI = 1.52-2.16 10/ Developmental score: -cognitive games: 95% CI = 1.65-2.60 (significant) -motor games: 95% CI: -0.13 - 0.28 (NS) 11/ nursery rhymes: 95% CI: 3.59-4.88.
 Health status and well being1/ Mothers' self esteem - tired: yes = 90% (n=95); no = 10% (n=10) -headaches: yes= 50% (n=52); no=50% (n=53) -miserable: yes=76% (n=80); no= 24% (n=25) -staying in: yes= 54% (n=57); no=46 (n=48). 2/ Relative risk of having an accident: no data provided 3/ Mothers' feelings in the year since their child was born\; - positive: mean=1.17 (SD 1.01) - negative: mean = 1.42 (SD 1.25)1/ Mothers' self esteem - tired: yes = 78% (n=99); no = 22% (n=28) -headaches: yes= 49% (n=62); no=51% (n=65) -miserable: yes=57% (n=73); no= 43% (n=54) -staying in: yes= 31% (n=40); no=69 (n=87). 2/ Relative risk of having an accident: no data provided 3/ Mothers' feelings in the year since their child was born\; - positive: mean=2.61 (SD 1.28) - negative: mean = 0.93 (SD 0.87)1/ Mothers' self esteem - tired: p=<0.01; RR=0.86 (95%CI 0.77-0.97) -headaches: p=0.92; RR=0.99 (95%CI 0.76-1.28) -miserable: p=<0.003; RR=0.75 (95%CI 0.63-0.90) -staying in: p=<0.001; RR=0.58 (95%CI 0.43-0.79) 2/ RR=0.3 (95%CI 0.08-1.14) 3/ Mothers' feelings in the year since their child was born\; - positive: diff in means=1.44 (95%CI = 1.14-1.75); p=<0.01 - negative: diff in means= -0.5 (95%CI = -0.77to -0.23); p=<0.01
Olds 2002Consultation process1/ length visit pregnancy 2/ length visit infancy 3/ Total visit time pregnancy 4/ Total visit time infancy 5/ Contact areas: a) Personal health pregnancy b) Personal health infancy c) Environ. health pregnancy d)Environ. health infancy e) Life course development pregnancy f) Life course development infancy g) Parental care giving pregnancy h) parental care giving infancy i) Friends and family pregnancy j) Friends and family infancyIntervention 1: paraprofessionals 1/ length visit (pregnancy) = 85.24 2/ Length visit (infancy) = 78.49 3/ Total visit time (pregnancy) = 542 4/ Total visit time (infancy) = 1299 5/ Contact area scores: a) Personal health (pregnancy) = 26.56 b) Personal health (infancy) = 15.30 c) Environ. health (pregnancy) = 15.14 d) Environ. health (infancy) = 15.16 e) Life course development (pregnancy) = 15.43 f) Life course development (infancy) = 19.41 g) Parental care giving (pregnancy) = 23.70 h) Parental care giving (infancy) = 31.51 i) Friends and family (pregnancy) = 18.78 j) Friends and Family (infancy) = 18.39 Intervention 2: nurses 1/ length visit (pregnancy) = 77.25 2/ Length visit (infancy) = 71.82 3/ Total visit time (pregnancy) = 503 4/ Total visit time (infancy) = 1498 5/ Contact area scores: a) Personal health (pregnancy) = 38.11 b) Personal health (infancy) = 14.87 c) Environ. health (pregnancy) = 7.30 d) Environ. health (infancy) =7.93 e) Life course development (pregnancy) = 13.97 f) Life course development (infancy) = 16.23 g) Parental care giving (pregnancy) = 25.03 h) Parental care giving (infancy) = 46.09 i) Friends and family (pregnancy) = 15.42 j) Friends and Family (infancy) = 14.761/ p<0.001 2/ p<0.001 a) p<0.001 c) p<0.001 d) p<0.001 e) p<0.05 f) p<0.001 h) p<0.001 i) p<0.001 j) p<0.001
 Utilization of LHWs1/ Program dropout 2/ Relationship continuity 3/ No visits infancy 4/ Attempted visits pregnancy 5/ Attempted visits infancy 6/ Relationship disruptionIntervention 1: paraprofessionals 1/ Program dropout = 117 (48%) 2/ Relationship continuity = 6.32 3/ No visits infancy = 16.49 4/ Attempted visits pregnancy = 1.73 5/ Attempted visits infancy = 7.63 6/ Relationship disruption = 35% Intervention 2: nurses 1/ Program dropout = 89 (38%) 2/ Relationship continuity = 6.51 3/ No visits infancy = 21.34 4/ Attempted visits pregnancy = 1.33 5/ Attempted visits infancy = 5.25 6/ Relationship disruption = 11%1/ p=0.004 2/ p=NS 3/ p<0.001 4/ p<0.05 5/ p<0.001 6/ p<0.001
 Consumer satisfaction1/ Mothers' rating of relationshipIntervention 1: paraprofessionals 1/ Mothers' rating of relationship = 4.06 Intervention 2: nurses 1/ Mothers' rating of relationship = 4.141/ p=NS
 Health care behaviours1/ Number/timing of subsequent pregnancies at 24 months = 41 2/ Mother-infant interaction = 98.99 home environment = 37.10 3/ Cotinine reduction = 12.32Intervention 1: paraprofessionals 1/ Number/timing of subsequent pregnancies at 24 months = 33 2/ Mother-infant interaction 100.15 home environment = 37.40 3/ Cotinine reduction = 88.51 Intervention 2: nurses 1/ Number/timing of subsequent pregnancies at 24 months = 29 2/ Mother-infant interaction = 100.31 home environment = 37.79 3/ Cotinine reduction = 259.001/ Mean difference 0.70 (0.46-1.06) p<0.1 2/ Mean difference 1.16 (-0.11-2.42) p<0.1 home environment 0.30 (-0.49-1.10) 3/ -76.19 (-302.21-149.82)
 Health status and well being1/ Child's language development = 99.49 2/ Mental Development Index (MDI) = 89.38 3/ Behaviour problems score = 45.26Intervention 1: paraprofessionals 1/ Child's language development = 99.89 2/ MDI = 89.45 3/ Behaviour problems score = 45.49 Intervention 2: nurses 1/ Child's language development = 101.22 2/ MDI = 90.13 3/ Behaviour problems score = 43.711/ Mean difference 0.40 (-1.94-2.74) 2/ Mean difference 0.07 (-2.39-2.53) 3/ Mean difference 0.23 (-3.58-4.03)
 Other1/ Educational achievement = 11.51Intervention 1: paraprofessionals 1/ Educational achievement = 11.62 Intervention 2: nurses 1/ Educational achievement = 11.511/ Mean difference 0.11 (-0.17-0.39)
Schuler 2000Health care behaviours% drug use: 1/ Cocaine/heroin 44.0 2/ Marijuana 37.8 3/ Alcohol 68.0% drug use: 1/ Cocaine/heroin 45.6 2/ Marijuana 25.4 3/ Alcohol 64.8 
 Health status and well being1/ Maternal responsiveness score 3.3 2/ Infant warmth score 2.51/ Maternal responsiveness score 3.6 2/ Infant warmth score 2.5 
 Other% use of services: 1/ AFDC 85.1 2/ medical assistance 93.1 3/ WIC 89.7 4/ Food stamps 87.4 5/ Protective services 31.0% use of services: 1/ AFDC 89.3 2/ medical assistance 91.7 3/ WIC 95.2 4/ Food stamps 91.7 5/ Protective services 11.95/ p<0.01
Siegel 1980Health care behaviours1/ Acceptance score: 4 months 0.217 12 months 0.084 2/ Interaction/ stimulation score: 4 months 0.198 12 months 0.190 3/ Consoling score: 4 months 0.102 4/ Positive/ negative score: 12 months 0.046Intervention 1: home visit and extended contact 1/ Acceptance score: 4 months 0.258 12 months 0.091 2/ interaction/stimulation score: 4 months 0.209 12 months 0.203 3/ Consoling score: 4 months 0.136 4/ Positive/negative score: 12 months 0.078 Intervention 2: extended contact only 1/ Acceptance score: 4 months 0.245 12 months 0.085 2/ Interaction/stimulation score: 4 months 0.203 12 months 0.201 3/ Consoling score: 4 months 0.135 4/ Positive/negative score: 12 months 0.078 Intervention 3: home visit only 1/ Acceptance score: 4 months 0.221 12 months 0.085 2/ Interaction/stimulation score: 4 months 0.198 12 months 0.193 3/ Consoling score: 4 months 0.110 4/ Positive/negative score: 12 months 0.0461/ 4 months p<0.0001 12 months p=NS 2/ 4 months p<0.0002 12 months p<0.004 3/ p<0.02 4/ p=NS
 Health status and well being1/ Child abuse/neglect = 3/52Intervention 1: home visit and extended contact 1/ Child abuse/neglect = 4/47 Intervention 2: extended contact only 1/ Child abuse/neglect = 3/50 Intervention 3: home visit only 1/ Child abuse/neglect = 7/53 
 OtherHealth care utilization by infants 1/ Hospitalizations = 3 2/ ER visits = 13 3/ Prev. care visits = 4.1 4/ Immunizations = 4.5Intervention 1: home visit and extended contact 1/ Hospitalizations = 4 2/ ER visits = 9 3/ Prev. care visits = 3.8 4/ Immunizations = 4.7 Intervention 2: extended contact only 1/ Hospitalizations = 1 2/ ER visits = 13 3/ Prev. care visits = 3.8 4/ Immunizations = 4.4 Intervention 3: home visit only 1/ Hospitalizations = 4 2/ ER visits = 11 3/ Prev. care visits = 4.1 4/ Immunizations = 5.1 

LHWs providing support for recovering alcoholics compared with office based support or usual care

The effect of LHW support on recovering alcohol users was examined in two studies (Lapham 1995; Leigh 1999). Neither found a significant effect on any of the 'alcohol use' measures reported. Nor were there any significant differences in the employment or housing status, nor social stability and the use of leisure, nor the average income of participants in the control and treatment groups. However, Leigh 1999 noted that physical health and emotional function were significantly more improved in a control arm receiving 'office-based' rather than LHW support.

LHWs providing support to mothers of sick children compared with usual care

Three studies (Ireys 1996; Ireys 2001; Silver 1997) reported maternal health outcomes following interventions to provide support for mothers of sick children. Two studies (Ireys 2001; Silver 1997) reported that maternal anxiety was lower in the intervention group but this was the only significant outcome of many reported. The same two studies also reported child mental health scores. Three scores (hostility; anxiety/depression; summary score of mental health) favoured the intervention group in one study (Ireys 2001). Other differences were not significant.

LHWs providing home aide services for the elderly compared with day care services or usual care

Four studies examined home aide services for the elderly (McNeil 1995; Nielsen 1972; Wan 1980; Williams 1992) and assessed mental and physical functioning. Multiple outcomes were reported and results were very variable. Two studies recorded general mortality in the elderly: Nielsen 1972 found no significant impacts of the intervention but Wan 1980 measured significant impacts for the LHW intervention compared to control.

Owing to the range of interventions described and outcomes measured, eleven studies could not be assigned to subgroups. The outcomes for individual studies are reported in Additional Table 4 .

Table 4. LHW interventions not grouped by intention
StudyOutcome typeControl groupIntervention groupStatistical sig.
Carpenter 1990Health care behaviours1/ Total number of days spent in institutions = 16088 (16103)
2/ Number of people admitted for >6 months = 20 (21)
3/ No admissions (individuals) = 252(107)
4/ mean length of stay = 63.8
5/ Pattern of admissions to institutions
6/ Rate of referral for domiciliary visits from geriatric or psychogeriatric services - data not provided
7/ Rate of referral to the psychogeriatric day hospital - data not provided
8/ Rate of referral to the community psychiatric nursing service - data not provided
9/ Number of referral to the geriatric day hospital = 14
10/ Number of referrals for meals on wheels = 12
11/ Number of referrals for home helps = 23
12/ Number of referrals for aids to daily living = 118
13/ Pattern of referral for community support services - data not provided
14/ Primary health care team contacts - data not provided
1/ Total number of days spent in institutions = 12079 (12064)
2/ Number of people admitted for >6 months = 8
3/ No admissions (individuals) = 335(121)
4/ mean length of stay = 36.1
5/ Pattern of admissions to institutions
6/ Rate of referral for domiciliary visits from geriatric or psychogeriatric services - data not provided
7/ Rate of referral to the psychogeriatric day hospital - data not provided
8/ Rate of referral to the community psychiatric nursing service - data not provided
9/ Number of referrals to the geriatric day hospital = 29
10/ Number of referrals for meals on wheels = 23
11/ Number of referrals for home helps = 29
12/ number of referrals for aids to daily living = 144
13/ data not provided
14/ data not provided
1/ not reported
2/ p=0.03
3/ not reported
4/ data not provided
5/ p<.001
6/ data not provided
7/ data not provided
8/ data not provided
9/ p<.05
10/ p=.06
11/ not reported
12/ not reported
13/ data not provided
14/ no significant difference between
 Health status and well being1/ Change in activities of daily living score (primary outcome) = mean(SD) disability score rose from 20.2 (5.6) to 23.1 (7.9)
2/ Mortality = 54
3/ Number of falls - from 17 to 36
1/ Change in activities of daily living score (primary outcome) = mean(SD) disability score rose from 19.7 (4.7) to 22.3 (6.9)
2/ Mortality = 66
3/ Number of falls remained at 12
1/ not significant
2/ data not provided
3/ p<.05
Graham 1992Health care behavioursFrequency of clinic attendance:
0.93 (n=48)
Frequency of clinic attendance:
4 home visits: 1.17 (n=49)
Some home visits: 1.12 (n=49)
4 visits: p=0.007
some visits: p=0.029
 Health status and well beingProportion of LBW babies born to high risk mothers:
7.5% (n=53)
Proportion of LBW babies born to high risk mothers:
4 home visits: 7.7% (n=52)
Some home visits: 12.9% (n=62)
4 visits: p=0.98
some visits: p=0.51
Heller 1995Health care behaviours10% still smoking
44% changed diet
6% still smoking
54% changed diet
P not reported
p=0.03
 Health status and well beingQuality of life factor scores
1/ Emotional
6 weeks=4.98 (0.11)
6 weeks change from baseline=
-0.33 (0.10)
6 months= 5.22 (0.11)
6 months change=
-0.12 (0.11)
2/ Physical
6 weeks=4.97 (0.10)
6 months=5.29 (0.11)
3/ Social
6 weeks=5.31 (0.09)
6 months 5.65 (0.10)
Quality of life factor scores
1/ Emotional
6 weeks=5.07 (0.11)
6 weeks change from baseline=
-0.13 (0.09)
6 months= 5.32 (0.12)
6 months change=
-0.02 (0.11)
2/ Physical
6 weeks=5.02 (0.10)
6 months=5.35 (0.11)
3/ Social
6 weeks=5.45 (0.09)
6 months=5.72 (0.10)
1/ Emotional;
6 weeks: p=0.54
6 weeks change: p=0.14

6 months=0.55
6 months change=0.54

6 weeks=0.72
6 months=0.67

6 weeks=0.28
6 months=0.62
Black 1995Health status and well being (Black 1995)Control children aged 1-12 months at recruitment
1/ Growth
Weight for age score
-1.1 (SD = 1.0)
Weight for height score -0.8 (SD = 1.1)
Height for age score
-1.0 (SD = 1.0)
2/ Cognitive development score 86.1 (SD = 18.7)
3/ Motor development score 91.5 (SD = 18.7)
4/ Language development scores
Receptive 88.0 (SD = 15.9)
Expressive 86.1 (SD = 18.2)
5/ Parent-child interaction scores
Child interactive competence 3.31 (SD = 0.48)
Parent nurturance 2.21 (SD = 0.71)
Negative control 3.89 (SD = 0.61)
6/ Home Observation for Measurement of the Environment (HOME) score
29.3 (SD = 4.2)

Control children aged 12.1-24.9 months at recruitment
1/ Growth
Weight for age score
-1.7 (SD = 0.7)
Weight for height score -1.3 (SD = 0.6)
Height for age score
-0.9 (SD = 1.0)
2/ Cognitive development score 80.8 (SD = 15.2)
3/ Motor development score 91.6 (SD = 14.2)
4/ Language development scores
Receptive 82.7 (SD = 17.2)
Expressive 83.3 (SD = 19.0)
5/ Parent-child interaction scores
Child interactive competence 3.64 (SD = 0.69)
Parent nurturance 2.42 (SD = 0.78)
Negative control 3.77 (SD = 0.72)
6/ HOME score
30.3 (SD = 5.7)
Intervention children aged 1-12 months at recruitment
1/ Growth
Weight for age score -1.3 (SD = 1.1)
Weight for height score -1.0 (SD = 1.4)
Height for age score
-0.8 (SD = 1.1)
2/ Cognitive development score 89.3 (SD = 17.4)
3/ Motor development score 92.0 (SD = 14.6)
4/ Language development scores
Receptive 88.5 (SD = 14.0)
Expressive 86.1 (SD = 16.9)
5/ Parent-child interaction scores
Child interactive competence 3.33 (SD = 0.66)
Parent nurturance 2.24 (SD = 0.65)
Negative control 3.78 (SD = 0.69)
6/ HOME score
31.6 (SD = 3.6)

Intervention children aged 12.1-24.9 months at recruitment
1/ Growth
Weight for age score
-1.8 (SD = 0.6)
Weight for height score -1.5 (SD = 0.5)
Height for age score
-0.7 (SD = 1.1)
2/ Cognitive development score 81.9 (SD = 12.5)
3/ Motor development score
92.0 (SD = 12.2)
4/ Language development scores
Receptive 83.2 (SD = 10.2)
Expressive 83.4 (SD = 11.7)
5/ Parent-child interaction scores
Child interactive competence 3.66 (SD = 0.51)
Parent nurturance 2.46 (SD = 0.85)
Negative control 3.66 (SD = 0.59)
6/ HOME score
32.4 (SD = 5.1)
p=NS
 Helath status and well being (Hutcheson 1997)Cognitive development (Batelle Developmental Inventory):
1/ Children of mothers with high levels of negative affectivity: mean = 77.8, SD = 12.2
2/ Children of mothers with low levels of negative affectivity: mean = 71.6, SD = 17.9
Motor development (Batelle Developmental Inventory):
1/ Children of mothers with high levels of negative affectivity: mean =89.0, SD = 20.5
2/ Children of mothers with low levels of negative affectivity: mean = 75.7, SD = 19.2
Task engagement during play:
1/ Children of mothers with high levels of negative affectivity: mean = 3.2, SD = 0.4
2/ Children of mothers with low levels of negative affectivity: mean = 3.7, SD = 0.3
Negative affect during play:
1/ Children of mothers with high levels of negative affectivity: mean = 3.6, SD = 0.3
2/ Children of mothers with low levels of negative affectivity: mean = 3.4, SD = 0.6
Warmth during play:
1/ Children of mothers with high levels of negative affectivity: mean = 2.9, SD = 0.5
2/ Children of mothers with low levels of negative affectivity: mean = 2.5, SD = 0.5
Cognitive development (Batelle Developmental Inventory):
1/ Children of mothers with high levels of negative affectivity: mean = 77.4, SD = 18.3
2/ Children of mothers with low levels of negative affectivity: mean = 84.9, SD = 13.2
Motor development (Batelle Developmental Inventory):
1/ Children of mothers with high levels of negative affectivity: mean =85.0, SD = 21.0
2/ Children of mothers with low levels of negative affectivity: mean = 95.6, SD = 13.3
Task engagement during play:
1/ Children of mothers with high levels of negative affectivity: mean = 2.9, SD = 0.6
2/ Children of mothers with low levels of negative affectivity: mean = 3.2, SD = 0.5
Negative affect during play:
1/ Children of mothers with high levels of negative affectivity: mean = 3.5, SD = 0.5
2/ Children of mothers with low levels of negative affectivity: mean = 3.7, SD = 0.2
Warmth during play:
1/ Children of mothers with high levels of negative affectivity: mean = 2.8, SD = 0.5
2/ Children of mothers with low levels of negative affectivity: mean = 2.9, SD = 0.5
Cognitive development: Significant in favour of home-based (LHW) intervention, particularly for children of mothers with low levels of negative affectivity
Motor development: Significant in favour of home-based (LHW) intervention, particularly for children of mothers with low levels of negative affectivity
Task engagement: Significant in favour of home-based (LHW) intervention, particularly for children of mothers with low levels of negative affectivity
Negative affect: Significant in favour of home-based (LHW) intervention, particularly for children of mothers with low levels of negative affectivity
Ramadas 2003Health status and well being1/ Number incident oral cancers: Early=16 Interim=106 2/ Mortality: Early=9/16 (56.3%) Interim=62/106 (58.5%)1/ Number incident oral cancers: Early=47 Interim=149 2/ Mortality: Early=7/47 (14.9%) Interim=65/149 (43.6%)Sensitivity: Early=76.6% Interim=81.5% Specificity: Early=76.2% Interim=84.8% Positive Predictive Value: Early=1.0% Interim=39.6%
Tudiver 1992Health care behavioursQuestionnaire (%)
1/ i. practicing unsafe anal sex: -13.7%
ii. practicing safer anal sex:
+3.9%
iii. practicing no anal sex:
+4.2%
2/ Number of sexual partners: no significant changes
3/ Anal intercourse knowledge: no significant changes
4/ Knowledge of AIDS risk: 3% increase, no significant difference between groups
5/ Condom efficacy: no change
Intervention 1: LHWs
Questionnaire response (%)
1/ i. practicing unsafe anal sex:
-40%
ii. practicing safer anal sex:
+13.3%
iii. practicing no anal sex:
+13.3%
2/ Number of sexual partners: no significant changes
3/ Anal intercourse knowledge: no significant changes
4/ Knowledge of AIDS risk: 7% increase, no significant difference between groups
5/ Condom efficacy: 4% increase

Intervention 2: Professionals
Questionnaire response (%)
1/ i. practicing unsafe anal sex: -14.1%
ii. practicing safer anal sex:
+14.8%
iii. practicing no anal sex:
-2.5%
2/ Number of sexual partners: no significant changes
3/ Anal intercourse knowledge: no significant changes
4/ Knowledge of AIDS risk: 10% increase, no significant difference between groups
5/ Condom efficacy: 5% increase
1/ not stated
4/ Knowledge of AIDS risk: adjusted final scores were 0.32% higher for combined treatment groups than the controls = effect size of 0.20 standard deviation units [not sure if this is relevant to the review, given that the treatment groups have been combined]
5/ not reported. Mean final score for combined treatment groups was 0.33% higher than for adjusted means of controls = 0.17 std deviation units
Voorhees 1996Health care behaviours1/ Quit rate among smokers [primary outcome]:
- self reported quit = 21.5% (20/93)
- biochemically validated quit = 15.05% (14/93)
2/ Shifts in stages of change among smokers [primary outcome]
- proportions in the no change, and regression outcome groups = 66%
1/ Quit rate among smokers [primary outcome]:
- self reported quit = 27.13% (54/199)
- biochemically validated quit = 19.59% (39/199)
2/ Shifts in stages of change among smokers [primary outcome]
- proportions in the no change, and regression outcome groups = 54%
1/
- self report: chi squared = 1.06, p = .48
- biochemical: chi squared = 0.88; p = .35
2/ Shifts in stages of change among smokers [primary outcome]
- proportions in the positive progress, no change, and regression outcome groups: chi squared = 3.78; p = .05
- crude OR comparing intervention groups and progress status (positive vs no change and regression) = 1.73 (p = .037)
Von Korff 1998Health status and well being1/ Pain intensity:
- baseline: 5.66 (SD=2.06)
- 3 months: 4.02 (2.13)
- 6 months: 4.07 (0.85)
- 12 months: 3.79 (2.35)
2/ Roland Disability Questionnaire score
- baseline: 9.42 (6.45)
- 3 months: 7.4 (SD = 6.33)
- 6 months: 7.23 (6.51)
- 12 months: 6.75 (6.39)
3/ Short-Form 36 Mental Health Inventory
- baseline: 68.6 (19.7)
- 3 months: 72.7 (SD = 19.7)
- 6 months: 76.1 (18.4)
- 12 months: 75.8 (16.3)
4/ Interference rating:
- baseline: 5.19 (2.43)
- 3 months: 3.55 (SD = 2.49)
- 6 months: 3.35 (2.59)
- 12 months: 3.1 (2.66)
1/ Pain intensity:
- baseline: 5.36 (1.99)
- 3 months: 3.87 (SD = 2.21)
- 6 months: 3.37 (0.82)
- 12 months: 3.22 (2.03)
2/ Roland Disability Questionnaire score
- baseline: 9.50 (6.11)
- 3 months: 6.56 (SD = 5.61)
- 6 months: 5.83 (5.89)
- 12 months: 5.75 (6.31)
3/ Short-Form 36 Mental Health Inventory
- baseline: 70.3 (18.2)
- 3 months: 74.8 (SD = 16.4)
- 6 months: 75.9 (15.6)
- 12 months: 77.8 (16.1)
4/ Interference rating:
- baseline: 5.07 (2.44)
- 3 months: 3.24 (SD = 2.4)
- 6 months: 2.77 (2.45)
- 12 months: 2.78 (2.38)
1/ Pain intensity:
- 3 months: p = .748
- 6 months: p = .064
- 12 months: p = .19
2/ Roland Disability Questionnaire score
- 3 months: p = .088
- 6 months: p = .007
- 12 months: p = .092
3/ Short-Form 36 Mental Health Inventory
- 3 months: p = .631
- 6 months: p = .990
- 12 months:
p = .828
4/ Interference rating:
- 3 months: p = .737
- 6 months: p = .204
- 12 months: p = .76
 Other1/ Attitudes towards back pain self-care
- baseline: 2.70 (0.70)
- 3 months: 3.0 (SD = 0.74)
- 6 months: 2.96 (0.85)
- 12 months: 3.04 (0.82)
2/ Back pain worries
- baseline: 6.44 (2.81)
- 3 months: 4.62 (SD = 3.17)
- 6 months: 4.28 (3.15)
- 12 months: 3.83 (3.08)
3/ The next time I have back or leg pain, I will try to manage problem without seeing a HCP
- baseline: 46.8%
- 3 months: 62%
- 6 months: 66.1%
- 12 months: 60%
1/ Attitudes towards back pain self-care
- baseline: 2.70 (0.71)
- 3 months: 3.15 (SD = 0.8)
- 6 months: 3.22 (0.82)
- 12 months: 3.24 (0.81)
2/ Back pain worries
- baseline: 5.80 (2.55)
- 3 months: 4.0 (SD = 2.82)
- 6 months: 2.97 (2.65)
- 12 months: 2.63 (2.58)
3/ The next time I have back or leg pain, I will try to manage problem without seeing a HCP
- baseline 50.4%
- 3 months: 69.1%
- 6 months: 78.6%
- 12 months: 76.8%
1/ Attitudes towards back pain self-care
- 3 months: p = .047
- 6 months: p = .032
- 12 months: p = .10
2/ Back pain worries
- 3 months: p = .612
- 6 months: p = .013
- 12 months:
p = .013
3/ The next time I have back or leg pain, I will try to manage problem without seeing a HCP
- 3 months: p = .242
- 6 months: p = .034
- 12 months:
p = .008
Weinberger 1989Utilization of LHWMean number of contacts between patients and LHWs = 0Intervention 1: Telephone
Mean number of contacts between patients and LHWs = 2.95
Intervention 2: Clinic
Mean number of contacts between patients and LHWs = 9.52
Intervention 3: Both
Mean number of contacts between patients and LHWs = 8.53
p<0.0001
 Consumer satisfactionRand Corporation satisfaction with health care scale = 13.5Intervention 1: Telephone
Rand Corporation satisfaction with health care scale = 13.5
Intervention 2: Clinic
Rand Corporation satisfaction with health care scale = 13.9
Intervention 3: Both
Rand Corporation satisfaction with health care scale = 13.9
p = NS
 Health care behaviours% non-compliant with medications over the preceding week = 30.4Intervention 1: Telephone
% non-compliant with medications over the preceding week = 26.6
Intervention 2: Clinic
% non-compliant with medications over the preceding week = 34.4
Intervention 3: Both
% non-compliant with medications over the preceding week = 24.5
p =NS
 Health status and well being1/ Arthritis Impact Measurement Scales (AIMS)
(a) psychological health = 3.04
(b) physical health = 2.65
(c) pain = 6.58
2/ Philedelphia Geriatric Center Morale Scale = 7.9
3/ AIMS on subgroup of patients whose records showed (a) radiographic confirmed OA of the knee and (b)no change in OA medication or referral for physical therapy during the study (Rene et al 1992 (c) were in control(n=15) or telephone only (n=22) groups
- pain = 6.53 (SD 2.99)
- physical function = 2.8 (SD 1.78)
Intervention 1: Telephone
1/ Arthritis Impact Measurement Scales (AIMS)
(a) psychological health = 2.94
(b) physical health = 2.47
(c) pain = 5.76
2/ Philedelphia Geriatric Center Morale Scale = 7.3
3/
- pain 4.59 (SD2.43)
- physical 1.86 (SD1.35)

Intervention 2: Clinic
1/ Arthritis Impact Measurement Scales (AIMS)
(a) psychological health = 3.27
(b) physical health = 2.97
(c) pain = 6.24
2/ Philedelphia Geriatric Center Morale Scale = 8.1

Intervention 3: Both
1/ Arthritis Impact Measurement Scales (AIMS)
(a) psychological health = 2.88
(b) physical health = 2.67
(c) pain = 6.04
2/ Philedelphia Geriatric Center Morale Scale = 8.2
1/ (a) psychological health = NS
(b) physical health = NS
(c) pain = NS
2/ NS
3/
- pain: p=<.01
- physical: p=0.16
Between group effect size
Pain=0.65
Physical
=0.53
 OtherInterpersonal support Evaluation List (ISEL) = 28.9Intervention 1: Telephone
ISEL = 28.9
Intervention 2: Clinic
ISEL = 28.0
Intervention 3: Both
ISEL = 28.9
p = NS
Wertz 1986Health status and well beingPorch Index of Communication Ability (PICA), mean change between entry and week 12
1/ gestural score = 12.96
2/ verbal score = 9.85
3/ graphic score = 10.20
4/ overall score = 12.23
Intervention 1: Home
PICA mean change between entry and week 12:
1/ gestural score = 13.99
2/ verbal score = 13.10
3/ graphic score = 16.11
4/ overall score = 16.86
Intervention 2: Clinic
PICA mean change between entry and week 12:
1/ gestural score = 17.50
2/ verbal score = 13.85
3/ graphic score = 17.03
4/ overall score = 18.16
Only significant result is overeall difference between groups 1 and 3 (+5.93) p<0.05 based on pairwise multiple comparisons
Zwarenstein 2000Health status and well beingClinic DOT
1/ Successful TB treatment completion, including patients cured and those who completed treatment = 33 (57%)
2/ Successful TB treatment in new patients = 24 (67%)
3/ Successful TB treatment in retreatment patients = 9 (41%)
4/ Successful TB treatment in women patients = 26 (67)
5/ Successful TB treatment in male patients = 7 (37%)
Intervention 1: LHW observed
1/ Successful TB treatment completion, including patients cured and those who completed treatment = 40 (74%)
2/ Successful TB treatment in new patients = 30 (91%)
3/ Successful TB treatment in retreatment patients = 10 (48%)
4/ Successful TB treatment in women patients = 17 (63%)
5/ Successful TB treatment in male patients = 23 (85%)

Intervention 2: Self observed
1/ Successful TB treatment completion, including patients cured and those who completed treatment = 26 (59%)
2/ Successful TB treatment in new patients = 14 (52%)
3/ Successful TB treatment in retreatment patients = 12 (71%)
4/ Successful TB treatment in women patients = 16 (64%)
5/ Successful TB treatment in male patients = 10 (52%)
1/ p= 0.136
2/ LHW vs clinic difference = 24.2% (6-42.5%); LHW vs self difference = 39.1 % (17.8-60.3)
3/ LHW vs clinic 6.7% (-22.9-36.3); LHW vs self difference = -23% (-53.4 - 7.5)
4/ LHW vs clinic difference = 48.3% (22.8-73.8); LHW vs self difference = 32.6% (6.4-58.7)
5/ LHW vs clininc difference = -3.7% (-27.2-19.8); LHW vs self = -1% (-27.2-25.2)

Discussion

This review identified 43 RCTs evaluating the effects of LHW interventions in primary and community health care. The diversity of included studies limited meta-analysis to outcomes for five study subgroups (n = 15 studies in total). Of these, LHW interventions to promote immunization uptake in children and adults and to improve outcomes for ARI and malaria show promising benefits, when compared with usual care. There is also evidence that they may be effective in promoting the uptake of breastfeeding and of a small, non-significant effect of LHW interventions in promoting the uptake of breast cancer screening. The effect size for LHW interventions to promote breast cancer screening uptake was comparable to that demonstrated elsewhere (Bonfill 2004). However, recent reviews suggest that mass cancer screening may not result in survival benefit (Olsen 2004). For interventions to promote any breastfeeding, our effect estimates are a little larger than those previously reported (Sikorski 2004), probably because of differences in both the studies and outcomes included in these analyses.

The remaining subgroups (LHW interventions to improve hypertension treatment; promote parent-child interaction and health; provide support for mothers of sick children; provide support for recovering alcoholics; and provide home aide services for the elderly), including 18 studies, reported many continuous and dichotomous outcomes using a wide range of indicators and measures. These outcomes were considered too diverse to allow meaningful statistical pooling. One study examining LHWs providing home aide services for the elderly suggest that these may significantly reduce mortality (Wan 1980). This promising effect needs confirmation. For the other subgroups, it is difficult to draw any conclusions on the effectiveness of interventions.

The meta-analysis findings need to be interpreted with caution for several reasons. All subgroups included few studies and many of these had small sample sizes. Furthermore, three subgroups (LHW interventions to increase breastfeeding in the first 2 weeks post-partum and between 2 weeks and 6 months post-partum and LHW interventions to improve treatment of ARI and malaria) showed significant statistical heterogeneity.

Caution is also needed in extrapolating the meta-analysis findings to large scale programmes. LHWs in experimental studies may be more carefully selected; receive substantial training and support from highly motivated project leaders; and work with carefully selected consumer groups. Furthermore, most trials did not measure the effectiveness of LHW programmes over long periods. These factors may be important to the long term success and sustainability of large routine LHW programmes (Berman 1987; Walt 1989), although such hypotheses need further evaluation. In addition, few studies described how LHW-provided services linked with other health system components, creating difficulties or at least uncertainties for scaling up.

Most studies in this review did not compare LHW interventions with similar services delivered by professionals (substitution), but rather compared LHW interventions with 'usual care'. The few studies that compared LHW programmes with similar services delivered by professionals (e.g. Leigh 1999; Olds 2002; Tudiver 1992) reported mixed findings, with different outcomes favouring professional or LHW interventions. It is therefore possible that replacing professional care with LHWs may in some circumstances do harm and this should be considered more carefully in future studies. However, any such inferences must be viewed with caution given the diversity of the studies and the multiple outcomes reported. We would suggest that the available data allow no overall conclusions to be drawn regarding the effectiveness of LHWs in substituting for professional providers. Only four studies reported cost data (Carpenter 1990; Krieger 2000; Morrell 2000; Olds 2002). These included the running costs of the intervention (Carpenter 1990); the marginal costs per additional person immunized (Krieger 2000); cost effectiveness (Morrell 2000); and the costs of the programme (Olds 2002). We are therefore unable to draw any conclusions regarding the cost of LHW interventions compared to similar interventions delivered by health professionals.

Although participants were very varied, fewer than 50% of included studies explicitly stated that they were targeting low income or minority consumer groups. This suggests that, at least for experimental programmes, LHWs are not being used only to provide services to poorer populations. Few studies reported involving consumers in the development of the interventions; the selection of LHWs; or the support of the LHW programmes and we therefore could not assess the impacts of such involvement on intervention effectiveness.

The review identified a number of methodological problems. Firstly, there are significant difficulties in locating RCTs of LHW interventions due to the poor indexing of the term 'lay health worker' within the major health literature databases and the large number of other terms used in the literature to describe LHWs. We identified over forty such terms in the course of this review. Secondly, there is no single widely accepted definition of this cadre of health workers (Love 1997; Witmer 1995). Furthermore, applying any definition to published studies is difficult as many do not describe adequately the training and background of health workers.

Thirdly, poor descriptions of the LHW interventions, particularly with regard to the training and support, precluded assessment of the relationship between health outcomes and the type and intensity of LHW training and support (Ward 2004). Information on this relationship would help those designing LHW programs. Inadequate intervention descriptions also make difficult the development of a typology of LHW training interventions, which could be useful for grouping studies for analysis. Finally, poor intervention descriptions create difficulties in exploring the inter-relationships between different elements of these complex interventions (Campbell 2000), which may include provision of information, support and treatment.

Fourthly, many studies did not clearly specify a primary outcome creating difficulties in deciding which outcomes should be included in meta-analysis (Chan 2003). Some studies assessed large numbers of outcomes, increasing the probability of finding statistically significant differences by chance. Furthermore, the diversity of the psychometric and other outcome measures used made statistical pooling of outcome data difficult. Finally, a number of cluster randomized studies reported outcomes for individual participants without adjusting for the possible effects of clustering.

Authors' conclusions

Implications for practice

LHW interventions show promising benefits in promoting the uptake of immunization in children and adults and for improving outcomes for malaria and ARI in children, when compared with usual care. Health planners could consider including LHW interventions as components of health service strategies in these areas, particularly where other effective and feasible interventions do not exist. LHWs also appear promising for breastfeeding and may also reduce mortality in the elderly. They appear to have a small, and probably not clinically relevant, effect for breast cancer screening.

For other health issues, evidence of the effectiveness of LHW interventions is so far insufficient to allow recommendations for policy and practice. There is also insufficient evidence to assess which LHW training or intervention strategies are likely to be most effective. However, LHWs are most likely to be useful as a cadre of health care providers when they have an effective health care intervention to deliver. LHWs could also potentially reduce the costs of health care if substituted for professionals, by providing care at a level closer to consumers, but evidence for this is currently lacking.

Given the growing interest in the use of LHWs for a range of health issues, for example in the delivery of home care for people with HIV/AIDS (Farmer 2001, Loewenson 2004), policy makers, funders and researchers need to be encouraged to use rigorous designs in evaluating these programs.

Implications for research

For a wide range of health issues, further rigorous research on the effectiveness of LHW interventions is needed. Greater attention needs to be paid to the quality of study designs, particularly where cluster randomisation is used. Also, investigators should specify a primary outcome; consider whether the measurement of large number of related outcomes is useful; describe more thoroughly the training and support strategies used, any co-interventions and health care organisation and system issues; and assess possible harms of the interventions.

For health issues where LHW interventions demonstrate benefits, research needs to shift to understanding which components of these often multifaceted interventions are most effective. Further research should also explore the transferability of these findings to other settings and consumer groups and the effectiveness of different approaches to the training of LHWs and the delivery of LHW-led services.

Given the wide range of health issues, consumers, settings, training strategies and delivery mechanisms for LHW interventions, there is an urgent need for the development of a coherent typology of LHW interventions that could help to guide research and practice in this field. While the RCTs included in this review cover a wide range of health issues, researchers in these fields appear to be working largely in isolation from one another, as evidenced by the failure to date to attempt to assemble the global evidence on the effectiveness of these interventions. The absence of a widely accepted definition of LHWs as well as the poor conceptualisation of the field (Love 1997) contribute to this problem. There may be potential for better sharing of knowledge across hitherto isolated health specialty areas if a coherent typology of LHW interventions was developed. Such a typology would allow LHW interventions to be conceptualised in terms of their 'lay' component rather than in terms of the specific health issues on which they focus.

Greater efforts need to be made to involve consumers in the planning and support of studies of the effectiveness of LHW programs. The effects of consumer involvement also require further research.

Economic studies should accompany trials to establish the cost-effectiveness of different LHW interventions.

Studies are needed to evaluate the effectiveness of LHWs as compared to professional health care providers in delivering interventions in the fields of health education, promotion and the management of disease.

Acknowledgements

Our thanks to the many study authors who gave us additional information regarding study designs and interventions.

Past and present staff at the editorial bases for the Cochrane Effective Practice and Organisation of Care and Consumers and Communication Review Groups also provided considerable assistance and support: Hilda Bastian, Cynthia Fraser, Sophie Hill, Laura McAuley, Jessie McGowan and Graham Mowatt. Particular thanks to our contact editor, Andy Oxman, for his ongoing support and advice; to Craig Ramsay for statistical advice; and to Marina Clarke for assisting with inclusion assessments.

Administrative support was ably provided by Sylvia Louw at the Medical Research Council, South Africa and Anna Gaze at the London School of Hygiene and Tropical Medicine. Our thanks also to Simon Goudie for assistance with graphics and editing.

We are also grateful for the comments of several consumer representatives; several anonymous peer-reviewers; and many others who shared with us their insights into lay health worker programs.

Funding for this review was provided by German Technical Development (GTZ) (95.2068.5-001.00); WHO (M12/370/1); and the European Union funded AFDOT project (ICFP500A4PRO2). Additional funding for members of the review team was provided by the Medical Research Council of South Africa. Our thanks to Andy Haines at the London School of Hygiene and Tropical Medicine for his support in obtaining funding to complete the review.

Data and analyses

Download statistical data

Comparison 1. LHW interventions to promote breast cancer screening uptake compared with usual care
Outcome or subgroup titleNo. of studiesNo. of participantsStatistical methodEffect size
1 Breast cancer screening uptake4 Adjusted RR (Random, 95% CI)1.05 [0.99, 1.12]
1.1 General promotion3 Adjusted RR (Random, 95% CI)1.05 [0.98, 1.13]
1.2 Promotion among non-users1 Adjusted RR (Random, 95% CI)1.04 [0.76, 1.42]
1.3 Promotion among users1 Adjusted RR (Random, 95% CI)1.09 [0.88, 1.36]
Analysis 1.1.

Comparison 1 LHW interventions to promote breast cancer screening uptake compared with usual care, Outcome 1 Breast cancer screening uptake.

Comparison 2. LHWs to promote breastfeeding up to 2 weeks postpartum compared with usual care
Outcome or subgroup titleNo. of studiesNo. of participantsStatistical methodEffect size
1 Breastfeeding up to 2 weeks postpartum4 Adjusted RR (Random, 95% CI)1.69 [0.91, 3.12]
Analysis 2.1.

Comparison 2 LHWs to promote breastfeeding up to 2 weeks postpartum compared with usual care, Outcome 1 Breastfeeding up to 2 weeks postpartum.

Comparison 3. LHWs to promote breastfeeding (2 weeks and 6 months postpartum) compared with usual care
Outcome or subgroup titleNo. of studiesNo. of participantsStatistical methodEffect size
1 Breastfeeding between 2 weeks and 6 months postpartum4 Adjusted RR (Random, 95% CI)2.93 [0.88, 9.71]
Analysis 3.1.

Comparison 3 LHWs to promote breastfeeding (2 weeks and 6 months postpartum) compared with usual care, Outcome 1 Breastfeeding between 2 weeks and 6 months postpartum.

Comparison 4. LHW interventions to promote immunization uptake compared with usual care
Outcome or subgroup titleNo. of studiesNo. of participantsStatistical methodEffect size
1 Immunization uptake3 Adjusted RR (Random, 95% CI)1.30 [1.14, 1.48]
1.1 Children2 Adjusted RR (Random, 95% CI)1.28 [1.00, 1.64]
1.2 Adults1 Adjusted RR (Random, 95% CI)1.31 [1.12, 1.53]
Analysis 4.1.

Comparison 4 LHW interventions to promote immunization uptake compared with usual care, Outcome 1 Immunization uptake.

Comparison 5. LHWs to reduce morbidity and mortality from ARI and malaria compared with usual care
Outcome or subgroup titleNo. of studiesNo. of participantsStatistical methodEffect size
1 Morbidity and mortality3 Adjusted RR (Random, 95% CI)0.74 [0.58, 0.93]
1.1 Mortality2 Adjusted RR (Random, 95% CI)0.69 [0.51, 0.94]
1.2 Morbidity1 Adjusted RR (Random, 95% CI)0.86 [0.68, 1.07]
Analysis 5.1.

Comparison 5 LHWs to reduce morbidity and mortality from ARI and malaria compared with usual care, Outcome 1 Morbidity and mortality.

What's new

DateEventDescription
21 August 2008AmendedConverted to new review format.

History

DateEventDescription
8 November 2004New citation required and conclusions have changedSubstantive amendment

Contributions of authors

SL, JD and MZ wrote the protocol, with contributions from GA and BvW. All authors assessed studies for inclusion; participated in data extraction; and contributed to data analysis. SL and PP undertook the meta-analysis with assistance from the other authors. PP and SL drafted the study report and all authors commented on this.

Declarations of interest

None known

Sources of support

Internal sources

  • Medical Research Council, South Africa.

External sources

  • German Technical Co-operation (GTZ), Germany.

  • World Health Organisation, Switzerland.

Characteristics of studies

Characteristics of included studies [ordered by study ID]

Andersen 2000

MethodsRCT
ParticipantsLHW: lay health workers were recruited by mail from participating community.
TRAINING: trained by field workers, organised by Community Trial of Mammography Promotion.
PATIENTS: women aged 50-80 years. 37% had completed high school and 21% reported incomes <$15,000 per year.
TOTAL=9484; INTERVENTION 1=2369; INTERVENTION 2=2376; INTERVENTION 3=2369; CONTROL=2370.
InterventionsOBJECTIVE: to promote mammography uptake among women.
INTERVENTION 1: individual telephone counselling (ITC).
INTERVENTION 2: community activities.
INTERVENTION 3: ITC and community activities.
CONTROL: no intervention.
MODE OF DELIVERY: LHWs delivered barrier specific telephone counselling (BSTC) to individuals and mailed brochures. Community activities included the showing of videos, themed bingo nights and beauty shop promotions, designed to present the benefits of mammography.
CONSUMER INVOLVEMENT IN DESIGN/DEVELOPMENT/DELIVERY: not described.
ORGANISATIONAL BASE OF THE INTERVENTION: not described.
GEOGRAPHICAL SETTING: Rural U.S.A.
HEALTH CARE SETTING: home and community.
OutcomesHEALTH CARE BEHAVIOURS: frequency of mammography use.
FOLLOW UP TIME: 3 years after intervention.
NotesThree intervention arms: individual telephone counselling, community activities, both.
Risk of bias
BiasAuthors' judgementSupport for judgement
Allocation concealment?Low riskA - Adequate

Barnes 1999

MethodsRCT
ParticipantsLHW: most of the volunteers were bilingual.
TRAINING: not described.
PATIENTS: children <2 years of age who enrolled in one of two ambulatory clinics and were not immunized. Predominantly Hispanic low income children, part of a highly mobile immigrant community from the Dominican Republic.
TOTAL=434; INTERVENTION=218; CONTROL=216.
InterventionsOBJECTIVE: to increase rate of immunization in children <2 years of age .
INTERVENTION: immunization outreach, tracking and follow up.
CONTROL: no intervention.
MODE OF DELIVERY: LHWs contacted participants offering basic immunization education and referral, reminders of upcoming vaccinations and contact to ensure that vaccination was received. They also provided support/assistance to obtain immunization services eg clinic contact, escort for appointments. Control families were informed of child's immunization record and told to reschedule missed appointments.
CONSUMER INVOLVEMENT IN DESIGN/DEVELOPMENT/DELIVERY: not described.
ORGANISATIONAL BASE OF THE INTERVENTION: not described.
GEOGRAPHICAL SETTING: urban U.S.A.
HEALTH CARE SETTING: primary care facility.
OutcomesHEALTH CARE BEHAVIOURS: immunization status (up to date/due/late).
FOLLOW UP TIME: minimum of 5 months follow up.
Notes 
Risk of bias
BiasAuthors' judgementSupport for judgement
Allocation concealment?Unclear riskB - Unclear

Barth 1991

MethodsRCT
ParticipantsLHW: all parenting consultants were either mothers or had significant experience of bringing up infants and were recrutied to represent ethnic and geographical communities in the service area.
TRAINING: volunteers were trained for over 100 hours about the perinatal period, community resources, child abuse, and child abuse reporting and team building. They were also taught the basics of a task centered approach which focuses on the identification of goals for self improvement and child care, and enhances the client's ability to identify and complete tasks that forward goal attainment. Training organised by Child Parent Enrichment Project (CPEP), a community based, private, non profit agency.
PATIENTS: mainly white women with a high school education and a mean age of 22.4 years. Most had one child already and 72% had a family income <$10,000 per year. The mean duration of pregnancy on recruitment was 5 months.
TOTAL=65; INTERVENTION=29; CONTROL=36.
InterventionsOBJECTIVE: to prevent abuse in children using a perinatal prevention program involving pre-natal education and support; early/extended post partum contact; parent education; home visitation by professionals, paraprofessionals or volunteers.
INTERVENTION: parenting consultants.
CONTROL: no intervention.
MODE OF DELIVERY: Services were provided for 6 months and home visits occurred approximately twice a month. Consultants saw approximately 10 families and worked for 20 hours per week. LHWs assisted mothers to identify goals for improved self and child care; enhanced the mothers ability to identify and complete tasks that forward goal attainment; tasks were recorded on sheets for clients and LHWs and accountability of task achievement; tasks included preparing a clean room for the infant to come home to, visiting the labor room prior delivery, etc.
CONSUMER INVOLVEMENT IN DESIGN/DEVELOPMENT/DELIVERY: not described.
ORGANISATIONAL BASE OF THE INTERVENTION: CPEP.
GEOGRAPHICAL SETTING: urban U.S.A.
HEALTH CARE SETTING: home.
OutcomesHEALTH STATUS AND WELL BEING: psychological measures of parent and infant well being.
FOLLOW UP TIME: 6 months after birth of infant.
Notes 
Risk of bias
BiasAuthors' judgementSupport for judgement
Allocation concealment?Unclear riskB - Unclear

Black 1995

MethodsRCT
ParticipantsLHW: 3 lay home visitors were recruited. Each had experience with children, interpersonal skills and community knowledge. TRAINING: visitors received an 8 session training program featuring lectures, discussions on children's health/nutrition, infant/toddler development, activities to promote child's development, parent-child interaction, behavior management, relationship building, family relationships, child/family advocacy, problem solving strategies, community resources and services. Training organised by university growth and nutrition clinic and community based agency.
PATIENTS: children <25 months of age. Weight for age below the 5th percentile based on National Centre for Health statistics growth charts; gestational age of at least 36 weeks; birth weight appropriate for gestational age; no significant history of perinatal complications, no congenital disorders. Patients were recrutied from clinics serving low income families.
TOTAL=130; INTERVENTION=64; CONTROL=66.
InterventionsOBJECTIVE: to improve growth and development among children with non-organic failure to thrive (NOFTT). INTERVENTION: home visits and clininc services.
CONTROL: clinic services.
MODE OF DELIVERY: The home visiting program involved a mean number of visits = 19.2 (SD = 11.5) lasting for approximately 1 hour at a time. Home visits using an individualized family service plan to assist the formation of a therapeutic alliance/support to the mother's familial, personal and environmental needs. The Hawaii Early Learning Program was used as curriculum and home visitors demonstrated developmentally appropriate activities to facilitate parent-child interaction and supported recommendations from clinic nutritionist. CHARACTERISTICS OF TRAINING ORGANISATION: CONSUMER INVOLVEMENT IN DESIGN/DEVLOPMENT/DELIVERY: not described.
ORGANISATIONAL BASE OF THE INTERVENTION: not described.
GEOGRAPHICAL SETTING: urban U.S.A.
HEALTH CARE SETTING: home.
OutcomesHEALTH STATUS AND WELL BEING: growth, cognitive development, motor development, language development, parent-child interaction, home environment.
FOLLOW UP TIME: 12 months after intervention.
NotesHome visitors were supervised by a community health nurse and accompanied on some visits by an off-duty police officer.Both intervention and control groups received nutrition information/support from the clinic.
Risk of bias
BiasAuthors' judgementSupport for judgement
Allocation concealment?Low riskA - Adequate

Bullock 1995

MethodsRCT
ParticipantsLHW: 19 volunteers were recruited although the procedure is not described.
TRAINING: intial training included information about the research program, research methods, communication techniques and general information about normal occurrences in antenatal/prenatal periods. It was followed by periodic meetings to give information/support to the volunteers.
PATIENTS: antenatal women who were either single/in relationship where partner was unemployed (53% single; 18% married; 21% de facto married: 8% separated). Mean age = 24 years.
TOTAL=131; INTERVENTION=65; CONTROL=66.
InterventionsOBJECTIVE: to provide support for pregnant women.
INTERVENTION: telephone support.
CONTROL: no intervention.
MODE OF DELIVERY: weekly telephone calls unto 12 weeks after birth of baby. 8 check-off questions to be asked weekly. Referred women to health care provider if there was medical problem and encouraged women to seek assistance from community agencies.
CONSUMER INVOLVEMENT IN DESIGN/DEVELOPMENT/DELIVERY: not described.
ORGANISATIONAL BASE OF THE INTERVENTION: not described.
GEOGRAPHICAL SETTING: urban New Zealand.
HEALTH CARE SETTING: home.
OutcomesHEALTH CARE BEHAVIOURS: smoking, drinking, marijuana use, nutrition, utilization of community resources.
HEALTH STATUS AND WELL BEING: stress, social support from partner, social support from others, self esteem, anxiety.
FOLLOW UP TIME: 34 weeks after gestation.
Notes 
Risk of bias
BiasAuthors' judgementSupport for judgement
Allocation concealment?Low riskA - Adequate

Carpenter 1990

MethodsRCT
ParticipantsLHW: 41 volunteers were recruited through mother/toddler groups or as students.
TRAINING: one hour training session, during which the principles/aims of project were explained and they were introduced to questionnaire. 4 monthly meetings were then held to maintain interest/exchange information.
PATIENTS: 467 participants aged 75-84 years and 72 participants aged >85 years.
TOTAL=539; INTERVENTION=272; CONTROL=267.
InterventionsOBJECTIVE: to improve referral of elderly persons to care institutions.
INTERVENTION: screening interviews.
CONTROL: no intervention.
MODE OF DELIVERY: volunteers administered scored activity of daily living questionnaires using the Winchester Disability Rating Scale. A daily living test score used to cover home conditions and companionship. Individuals with an increase in score of 5 or more were referred to GPs for further action. Specific requests were also referred.
CONSUMER INVOLVEMENT IN DESIGN/DEVELOPMENT/DELIVERY: not described.
ORGANISATIONAL BASE OF THE INTERVENTION: not described.
GEOGRAPHICAL SETTING: urban U.K.
HEALTH CARE SETTING: home.
OutcomesHEALTH CARE BEHAVIOURS: admissions and referrals to care institutions.
HEALTH STATUS AND WELL BEING: change in activities of daily living score, mortality.
CONSUMER SATISFACTION WITH CARE: general opinions.
COSTS: running costs of the project.
FOLLOW UP TIME: 39 months after start of intervention.
Notes 
Risk of bias
BiasAuthors' judgementSupport for judgement
Allocation concealment?Low riskA - Adequate

Caulfield 1998

MethodsCluster RCT
ParticipantsLHW: peer counsellors were former women, infants and children (WIC) clinic clients who had successfully breast fed at least one child.
TRAINING: all counselors completed a 5-week training programme adapted from a WIC Manual and administered by the study investigators and staff.
PATIENTS: pregnant women who were before 24 weeks gestation and were WIC eligible, carrying single pregnancy, planning to keep the baby, remain in clinic's catchment area. Women were excluded if pregnancy was contra-indicated. 64-86% of women had <high school education; 82-89% were single; 23-37% <18 years of age; 40-53% 18-25 years; 20-27% >25 years of age.
TOTAL=548.
InterventionsOBJECTIVE: to promote and support breastfeeding.
INTERVENTION 1: peer counsellors.
INTERVENTION 2: video education.
INTERVENTION 3: peer counsellors and video education.
CONTROL: no intervention.
MODE OF DELIVERY: peer counsellors followed up those women interested in breastfeeding three or more times during pregnancy and then weekly to 16 weeks postpartum as long as they continued to breastfeed. One clinic in the study received a video based intervention as well. A random quality assurance visit was made to one clinic each week during the study. A checklist was completed to assess whether the intervention was being delivered as planned and any problems were rectified.
CONSUMER INVOLVEMENT IN DESIGN/DEVELOPMENT/DELIVERY: not described.
ORGANISATIONAL BASE OF THE INTERVENTION: WIC clinics.
GEOGRAPHICAL SETTING: urban U.S.A.
HEALTH CARE SETTING: primary care facility (WIC clinics).
OutcomesHEALTH CARE BEHAVIOURS: initiated breastfeeding, still breastfeeding at 7-10 days.
FOLLOW UP TIME: 7-10 days post partum.
NotesThree intervention arms: peer counsellors, video, both.
Risk of bias
BiasAuthors' judgementSupport for judgement
Allocation concealment?Unclear riskB - Unclear

Chongsuvivat' 1996

MethodsCluster RCT.
ParticipantsLHW: there were approximately 10 volunteers for each of the 15 villages included in the study.
TRAINING: health workers trained by pediatricians at regional hospital conducted 2 day training workshop for health volunteers from intervention villages. Training included a video program, lecture, demonstration and simulation, was conducted in Thai/local Malay dialect. The curriculum/media for training was modified from those developed by WHO
PATIENTS: children <5 years of age. Mean age = 2.0 years in intervention group and 2.2 years in control control group. There were slightly more males than females.
TOTAL=1313; INTERVENTION=664; CONTROL=649.
InterventionsOBJECTIVE: to improve detection of serious acute respiratory infection (ARI).
INTERVENTION: village health volunteers.
CONTROL: no intervention.
MODE OF DELIVERY: volunteers detected serious ARI, gave initial care by sponging and advised referral of cases to a health centre where antibiotics could be given and made a referral to hospital if necessary.
CONSUMER INVOLVEMENT IN DESIGN/DEVELOPMENT/DELIVERY OF INTEVENTION: not described.
ORGANISATIONAL BASE OF THE INTERVENTION: not described.
GEOGRAPHICAL SETTING: rural Thailand.
HEALTH CARE SETTING: home.
OutcomesHEALTH CARE BEHAVIOUR: health care utilization in past week.
HEALTH STATUS AND WELL BEING: ARI event in the last week, severity of ARI attack.
FOLLOW UP TIME: up to a maximum of 19 weeks.
Notes 
Risk of bias
BiasAuthors' judgementSupport for judgement
Allocation concealment?Unclear riskB - Unclear

Dennis 2002

Methods 
ParticipantsLHW: 58 volunteer mothers, with minimum of 6 months previous breast feeding experience and a positive breast feeding attitude, were recruited into the participating community organization specifically for the trial. 86.9% had post secondary education.
TRAINING: mothers completed a 2.5 hour orientation session. The focus of the orientation session was to develop the peer volunteers' telephone support and referral skills; role playing and the verification of problem-solving skills were important components of the session.
PATIENTS: mothers with singleton births at 37 weeks gestation or greater. All participants >16 years of age. Majority (75%) aged 25-34 years; approximately 90% married; >60% had college or undergraduate university training; approximately 40% had an annual household income of 40000-79999 Can$.
TOTAL=258; INTERVENTION=132; CONTROL=126.
InterventionsOBJECTIVE: to provide peer support to increase breastfeeding duration.
INTERVENTION: peer support by volunteers.
CONTROL: no intervention.
MODE OF DELIVERY: volunteers contacted a new mother by telephone within 48 hours after hospital discharge and as frequently thereafter as the mother deemed necessary: 97% telephone interactions; 3% face-to-face meetings. The mean duration of contact: 53.1 days and 96% contacts made within the first week post partum. Volunteers provided peer support, defined as specific type of social support that incorporates informational, appraisal (feedback) and emotional assistance.
CONSUMER INVOLVEMENT IN DESIGN/DEVELOPMENT/DELIVERY: not described.
ORGANISATIONAL BASE OF THE INTERVENTION: not described.
GEOGRAPHICAL SETTING: urban Canada.
HEALTH CARE SETTING: home.
OutcomesHEALTH CARE BEHAVIOURS: self reported breast feeding (exclusive, almost excluse, high, partial, token, bottle feeding).
LENGTH OF FOLLOW UP: 12 weeks post partum.
NotesA 43-page handbook was distributed to all peer volunteers. The handbook outlined provisional services available for referral and was to be used as a reference guide.
Risk of bias
BiasAuthors' judgementSupport for judgement
Allocation concealment?Low riskA - Adequate

Duan 2000

MethodsCluster RCT
ParticipantsLHW: 45 peer counsellors hired from participating churches. Potential candidates were evaluated through telephone interviews, group orientation sessions, written applications and personal references.
TRAINING: involved approximately 8-12 hours of workshop training and at least 8-12 hours of additional on-site training at the phone centres.
PATIENTS: women from participating churches. 56-61% aged 50-64 years (vs 65-80 years); 55-60% married or cohabiting; >90% had health insurance; >80% had high school or more; >83% had income >$10000.
TOTAL=1113
InterventionsOBJECTIVE: to increase the uptake of mammographic screening for breast cancer.
INTERVENTION: telephonic mammography counselling.
CONTROL: no intervention.
MODE OF DELIVERY: counsellors called participants from churches to provide mammography counselling over the phone. The intervention was based on the Health Belief Model which advocates increasing awareness of vulnerability as well as cues to action. The counselling was individualized to address barriers. Women were informed about their risk status and about breast cancer prevalence rates. They were also encouraged to ask their physicians for a referral and information about convenient screening facilities. Counsellors were asked to commit to a minimum of 6 hours of phone work over a 3-4 week period. Selected counsellors received small stipends and transport allowances. Some received token gifts at dinners held during each intervention year.
CONSUMER INVOLVEMENT IN DESIGN/DEVELOPMENT/DELIVERY: participating churches provided volunteers and facilities for delivery.
ORGANISATIONAL BASE OF THE INTERVENTION: participating churches.
GEOGRAPHICAL SETTING: urban U.S.A.
HEALTH CARE SETTING: home.
OutcomesHEALTH CARE BEHAVIOURS: maintenance of adherence to mammography screening; conversion of adherence to mammography screening.
LENGTH OF FOLLOW UP: 1 year.
NotesMaterials available to counsellors: barrier specific telephone counseling script; counselling questionnaire; mammography resources guide; call record and counseling record; counselor self-evaluation.
Survey firm hired to collect baseline data on the participants
Risk of bias
BiasAuthors' judgementSupport for judgement
Allocation concealment?Unclear riskB - Unclear

Graham 1992

MethodsRCT
ParticipantsLHW: 2 home visitors were non-professional Black women who demonstrated rapport with patients from clinic population and had children of their own.
TRAINING: specific training was in childbirth education, community resources, and nutrition during pregnancy. The training included reading, discussion groups, weekly meetings, and attendance at hospital prenatal classes.
PATIENTS: low income, Black inner city mothers at risk of low birth weight babies. Mean age was 24 years with 21% being between 14 and 20 years and 4% over the age of 35 years. Mothers lived within a 5 mile radius of the hospital. Only 'high risk' participants, initially identified by a medical/psychosocial screening questionnaire, were randomized; a low risk category formed another, non-randomized control population.
TOTAL=232; 4 HOME VISITS=87; SOME HOME VISITS=87; CONTROL=58.
InterventionsOBJECTIVE: to reduce the incidence of low birth weight babies (<2500g) among high risk mothers.
INTERVENTION: non professional home visitors.
CONTROL: no intervention.
MODE OF DELVIERY: 4 x 1 hour home visits at 2 to 4 week intervals. Intervention was family focused with goal of strengthening intrafamilial interpersonal support system. Home visitors provided psychosocial support, made efforts to reduce family stress, provided information on health risks during pregnancy (smoking, drinking cessation techniques), provided nutrition education/information for prenatal/childbirth and gave a small gift at each visit.
CONSUMER INVOLVEMENT IN DESIGN/DEVELOPMENT/DELIVERY: not described.
ORGANISATIONAL BASE OF THE INTERVENTION: not described.
GEOGRAPHICAL SETTING: urban U.S.A.
HEALTH CARE SETTING: home.
OutcomesHEALTH CARE BEHAVIOURS: frequency of clinic attendance.
HEALTH STATUS AND WELL BEING: proportion of low birth weight babies born to high risk mothers.
LENGTH OF FOLLOW UP: not described.
Notes 
Risk of bias
BiasAuthors' judgementSupport for judgement
Allocation concealment?Low riskA - Adequate

Haider 2000

MethodsCluster RCT
ParticipantsLHW: counsellors were local mothers with personal breastfeeding experience, at least 4 years schooling, a willingness to help other mothers and residence in the intervention areas.
TRAINING: 40 hours (4 hours x 10 days) by demonstrators and role play using WHO/UNICEF breastfeeding counseling course and King's book (1992).
2 week pilot where volunteers practiced with pregnant mothers and mothers with newborns. Performance monitored at least 3 times during study by breast feeding supervisors.
PATIENTS: pregnant women of lower-middle and lower socioeconomic status, aged 16-35 years, with 3 living children or less or parity 5.
TOTAL=726; INTERVENTION=363; CONTROL=363.
InterventionsOBJECTIVE: the promotion of exclusive breastfeeding among pregnant women.
INTERVENTION: community based peer counsellors.
CONTROL: no intervention.
MODE OF DELIVERY: one counsellor responsible for 12-25 mothers residing in the same zone. During 15 visits (20-40 mins long) over 5 months counsellors explained the benefits of exclusive breastfeeding for 5 months. Prenatally, mothers were encouraged to eat more and avoid exhaustion. Mothers were also encouraged to hold babies within a few minutes of delivery, and initiate breast feeding within one hour of delivery. Prelacteal and postlacteal foods were discouraged. 15 homebased counselling visits were scheduled, with 2 visits in the first trimester, three in early post partum and the 2/52 until the infant was 5 months old.
CONSUMER INVOLVEMENT IN DESIGN/DEVELOPMENT/DELIVERY: not described.
ORGANISATIONAL BASE OF THE INTERVENTION: WHO/UNICEF breastfeeding counselling course.
GEOGRAPHICAL SETTING: informal urban Bangledesh.
HEALTH CARE SETTING: home.
OutcomesHEALTH CARE BEHAVIOURS: holding infants after delivery, breastfeeding initiation, exclusive breastfeeding, use of prelacteal foods, use of post lacteal foods.
LENGTH OF FOLLOW UP: 5 months.
Notes 
Risk of bias
BiasAuthors' judgementSupport for judgement
Allocation concealment?Low riskA - Adequate

Heller 1995

MethodsRCT
ParticipantsLHW: members of the Australian Cardiacs Association (ACA), a community based non medical intervention whose members have suffered from heart disease.
TRAINING: no details given.
PATIENTS: aged 25-74 years discharged from hospital with diagnosis of ischaemic heart disease or MI. Patients were excluded if unable to speak English, aphasic, confused or too ill to be disturbed.
TOTAL=424; INTERVENTION=202; CONTROL=222
InterventionsOBJECTIVE: to provide support to patients after cardiac surgery.
INTERVENTION: telephone calls from members of the ACA.
CONTROL: no intervention.
MODE OF DELIVERY: based on nurse advice program.
CONSUMER INVOLVEMENT IN DESIGN/DEVELOPMENT/DELIVERY: ACA members have themselves suffered from heart disease.
ORGANISATIONAL BASE OF THE INTERVENTION: ACA, a community-based non-medical organisation.
GEOGRAPHICAL SETTING: urban Australia.
HEALTH CARE SETTING: home.
OutcomesHEALTH CARE BEHAVIOURS: changes in cigarette smoking and diet.
HEALTH STATUS AND WELL BEING: quality of life factors - emotional, physical, social.
LENGTH OF FOLLOW UP: 6 months after discharge.
Notes 
Risk of bias
BiasAuthors' judgementSupport for judgement
Allocation concealment?Low riskA - Adequate

Hoare 1994

MethodsRCT
ParticipantsLHW: 2 linkworkers able to speak Pakistani and Bangladeshi.
TRAINING: only describe as 'appropriate'.
PATIENTS: Pakistani and Bangladeshi women aged 50-64 years who were registered with a general practitioner and eligible for NHS Breast Screening Programme.
TOTAL=498; INTERVENTION=247; CONTROL=251
InterventionsOBJECTIVE: to encourage uptake of breast screening for the early detection of breast cancer.
INTERVENTION: home visits by linkworkers.
CONTROL: no intervention.
MODE OF DELIVERY: followed up of women; carried out interviews in the appropriate language using a semi-structured questionnaire; gave a short explanation about breast screening. Home visits featured information and encouragement.
CONSUMER INVOLVEMENT IN DESIGN/DEVELOPMENT/DELIVERY: not described.
ORGANISATIONAL BASE OF THE INTERVENTION: not described.
GEOGRAPHICAL SETTING: urban U.K.
HEALTH CARE SETTING: home.
OutcomesHEALTH CARE BEHAVIOURS: breast screening attendance.
LENGTH OF FOLLOW UP: continuous.
Notes 
Risk of bias
BiasAuthors' judgementSupport for judgement
Allocation concealment?Low riskA - Adequate

Ireys 1996

MethodsRCT
ParticipantsLHW: 5 mothers (mentors) with children aged 18 to 24 who had juvenile rheumatoid arthritis (JRA) since childhood.
TRAINING: the mentors participated in a 30 hour training programme. The programme focused on enhancing three types of social support: (1) informational support (2) affirmational support (3) emotional support. No information on methods used.
PATIENTS: mothers who had been active patients of the pediatric rheumatology clinic at Johns Hopkins Hospital. 87.2% were married; 91.7% had at least high school education; 64.6% worked outside of home at least part-time. Children with (JRA). Mean age = 7.7 years; 75% were female; 76% of the children had had JRA for 3 years or more.
TOTAL=45; INTERVENTION=25; CONTROL=20.
InterventionsOBJECTIVE: to provide social support for mothers with children who have juvenile rheumatoid arthritis (JRA).
INTERVENTION: A-PLUS mentors.
CONTROL: no intervention.
MODE OF DELIVERY: the mentors aimed to enhance social support (informational, affirmational and emotional) and overall mental health. Their protocol specified that they should (1) make telephone contacts of 5 minutes or more with each assigned mother every 2 weeks (2) meet individually with each mother every 6 weeks (3) hold occasional special events such as picnics. Weekly supervision was provided by the programme coordinators - a psychologist and a social worker. Each mentor also met individually with the social worker once a month to review all assigned families.
CONSUMER INVOLVEMENT IN DESIGN/DEVELOPMENT/DELIVERY: social support provided by mothers with older children who had previously suffered from JRA.
ORGANISATIONAL BASE OF THE INTERVENTION: A-PLUS (Arthritis Parents: Learning, Understanding Sharing) mentors, a commnuity based scheme.
GEOGRAPHICAL SETTING: urban U.S.A.
HEALTH CARE SETTING: home and community.
OutcomesHEALTH STATUS AND WELL BEING: maternal mental health, perceived availability of social support.
LENGTH OF FOLLOW UP: 15 months after intervention.
Notes 
Risk of bias
BiasAuthors' judgementSupport for judgement
Allocation concealment?Low riskA - Adequate

Ireys 2001

MethodsRCT
ParticipantsLHW: 39 'veteran mothers' or 'experienced' mothers with young adult children affected by chronic disease (diabetes, sickle cell anaemia, moderate to severe asthma and cystic fibrosis). The Network Mothers (NM) were recruited by asking directors and staff of speciality clinics to nominate suitable mothers whose affected child was 18 years or older.
TRAINING: network mothers: 30 hour training program, focusing on enhancing skills in listening, reflecting and "story swapping". Role plays, videotaped interviews, and in-class practice interviews were used. Successful graduates of the training were invited to participate in the programme and then underwent an additional 20 hours of training along with the child life specialists to reinforce the team aspects of the program and to review operational procedures. The network mothers and child life specialists met together weekly with a paediatrician and a social worker to ensure that the intervention was being delivered as planned. These meetings served to co-ordinate efforts within and across teams, address ongoing problems, and review issues related to recent or upcoming contacts or special events.
PATIENTS: Women with children aged 7 to 11 years with one of the following chronic illnesses: diabetes (40%), sickle cell anaemia (19%), cystic fibrosis (9%), moderate to severe asthma (32%). 29% were single mothers of whom 35% only had high school education or less. 70% of mothers had some form of employment.
TOTAL=161; INTERVENTION=86; CONTROL=75.
InterventionsOBJECTIVE: to provide social support for mothers of children suffering from chronic illness.
INTERVENTION: social support from 'network mothers'.
CONTROL: mothers were given a telephone number through which they could reach an experienced parent is they so wished. The experienced parent did not go through any training and did not initiate telephone calls.
MODE OF DELIVERY: volunteer mothers performed the following tasks. 7 visits of 60 to 90 minutes to each assigned family, either alone or with the child life specialist; biweekly telephone contacts of at least 5 minutes to build and maintain support, follow up on issues previously discussed or plan future meetings; participation in 3 special events, such as bowling parties or small-group lunches that would allow program parents to meet each other in a nonstressful venue. Through these interventions, the LHWs provided 3 types of support. 1/ informational support, by linking families with existing health and community resources and by sharing information among mothers about child behaviour, parenting and coping. 2/ affirmational support, by enhancing a mother's confidence in parenting and by reassuring her that her concerns and issues were appropriate. 3/ emotional support, by being available to listen to a parent's concerns, demonstrating a continued interest in the mother's viewpoints and experiences, and effectively communicating an understanding of the mother's feelings and concerns.
Each network mother had 1 to 7 assigned families and was paid hourly for all program-related efforts.
CONSUMER INVOLVEMENT IN DESIGN/DEVELOPMENT/DELIVERY: social support provided by mothers with older children who had previously suffered from a chronic illness.
ORGANISATIONAL BASE OF THE INTERVENTION: not described.
GEOGRAPHICAL SETTING: urban U.S.A.
HEALTH CARE SETTING: home and community.
OutcomesHEALTH STATUS AND WELL BEING: maternal physical health, maternal anxiety, maternal depression, stressful life events, child psychological adjustment, child depression, child report of general anxiety, child self esteem.
CONSULTATION PROCESS: number of contact minutes.
NotesChild life specialists: this component was designed to enhance the mental health, adjustment and self-esteem of children with selected conditions and was delivered by professionals. It was analysed separately.
Risk of bias
BiasAuthors' judgementSupport for judgement
Allocation concealment?Low riskA - Adequate

Johnson 1993

MethodsRCT
ParticipantsLHW: community mothers living in disadvantaged areas who were identified by a local public nurse and interviewed by regional family development nurse to assess suitability. Community leaders/self promoting individuals were generally excluded.
TRAINING: four weeks of training, during which the concepts of the programme are explained. Community mothers also meet, exchange ideas and explore ways of delivering the programme.
PATIENTS: First time mothers with infant <1 year old. In the control group mean age=23.1 years and in the intervention group mean age=24.1 years. 56% were single; 17% (control) to 29% (intervention) employed; 12% social class I, II, IIINM; 88% social class IIIM,IV,V; 40% live in private hosuing; 60% live in local authority housing; 42% of fathers employed.
TOTAL=262; INTERVENTION=141; CONTROL=121.
InterventionsOBJECTIVE: to deliver a child development programme (early reading as a child, language development, cognitive development through play) to disadvantaged mothers.
INTERVENTION: non professional community mothers.
CONTROL: no intervention.
MODE OF DELIVERY: one volunteer mother supports 5 to 15 first time parents with guidance on health/development. After training, each community mother works under the guidance of a family development nurse, who serves as a resource person, confidante, and monitor.
CONSUMER INVOLVEMENT IN DESIGN/DEVELOPMENT/DELIVERY: not described.
ORGANISATIONAL BASE OF THE INTERVENTION: based upon the principles inherent in the Early Childhood Development Unit in the University of Bristol.
GEOGRAPHICAL SETTING: urban Ireland.
HEALTH CARE SETTING: home.
OutcomesHEALTH CARE BEHAVIOURS: immunizations, dietry nutrition intake, number of mothers who read to their children, the extent to which mothers use nursery rhyme and song with their children.
HEALTH STATUS AND WELL BEING: mother's self esteem, relative risk of having an accident, mother's feeling in year since child was born, hospital admissions.
LENGTH OF FOLLOW UP: one year.
Notes 
Risk of bias
BiasAuthors' judgementSupport for judgement
Allocation concealment?Low riskA - Adequate

Kidane 2000

MethodsCluster RCT
ParticipantsLHW: mother coordinators chosen by neighborhood groups of 10-44 households.
TRAINING: 2 months of malaria specific training from Malaria Control Program (MCP) including how to teach neighborhood mothers to recognize symptoms of malaria in children <5 years; give appropriate course of treatment; recognize adverse drug reactions, share chloroquine appropriately.
PATIENTS: children <5 years and their mothers.
TOTAL=13677 children in 24 tabias; INTERVENTION=6383 children in 12 tabias; CONTROL=7294 children in 12 tabias.
InterventionsOBJECTIVE: to recognize malaria symptoms in children <5 years old, give appropriate course of treatment, recognize adverse drug reactions and share chloroquine appropriately.
INTERVENTION: mother coordinators deliver malaria specific services as well as keep check on births/deaths and have information on where to refer sick children.
CONTROL: coordinators but no malaria specific services.
MODE OF DELIVERY: mother coordinators were supplied with drugs for distribution to all households and were responsible for monitoring/replenishing drugs (using pictorial treatment charts to calculate dosage by age). They refered children for further treatment if no improvement in 48 hours.
CONSUMER INVOLVEMENT IN DESIGN/DEVELOPMENT/DELIVERY: households within the villages selected their mother coordinators.
ORGANISATIONAL BASE OF THE INTERVENTION: Malaria Control Program (MCP), organised by the department of health.
GEOGRAPHICAL SETTING: rural Ethiopia.
HEALTH CARE SETTING: home.
OutcomesHEALTH STATUS AND WELL BEING: mortality rate in children <5 years old, number of possible malaria deaths in children <5 years old.
LENGTH OF FOLLOW UP: one year after intervention.
Notes 
Risk of bias
BiasAuthors' judgementSupport for judgement
Allocation concealment?Low riskA - Adequate

Komaroff 1974

MethodsRCT
ParticipantsLHW: physician assistants who had completed high school; none had past work experience of consequence in the health field. Selected for their apparent sensitivity, poise and warmth. Intelligence, willingness and ability to perform repetitive tasks and dexterity.
TRAINING: 4 weeks concentrating on protocol skills and psychological aspects of patient care, using a training manual on the pathophysiology of hypertension and diabetes.
PATIENTS: diabetes and hypertension patients. Many of the hypertensive patients were also diabetic. Patients included those considered "suitable" for protocol management by a physician.The "typical patient" was poor, black, 55 years old women, requiring insulin.
TOTAL=137; INTERVENTION=84; CONTROL=53
InterventionsOBJECTIVE: to make more efficient the care of patients already diagnosed with hypertension or diabetes.
INTERVENTION: health care assistants.
CONTROL: normal physician care.
MODE OF DELIVERY: assistants took patient history; conducted a limited physical examination; ordered lab tests (all guided by computer protocol); encouraged patients to reveal additional symptoms and recorded additional clinical observations. Patients usually saw the same health assistant and each session lasted an average of 25 minutes. Physicians assessed the performance of LHW in the application of the protocols with real patients.
CONSUMER INVOLVEMENT IN DESIGN/DEVELOPMENT/DELIVERY: not described.
ORGANISATIONAL BASE OF THE INTERVENTION: physician clinical practices.
GEOGRAPHICAL SETTING: urban U.S.A.
HEALTH CARE SETTING: primary care facility.
OutcomesCONSULTATION PROCESS: physician acceptance.
UTILIZATION OF LHW: physician visit saving.
CONSUMER SATISFACTION WITH CARE: patient acceptance.
HEALTH STATUS AND WELL BEING: serum glucose levels; blood pressure.
LENGTH OF FOLLOW UP: assessments made at following patient visit.
Notes 
Risk of bias
BiasAuthors' judgementSupport for judgement
Allocation concealment?Unclear riskB - Unclear

Krieger 1999

MethodsRCT
ParticipantsLHW: community health workers who were generally Black (12/14) and all came from low-income neighborhoods similar to intervention site.
TRAINING: 100 hours of training on hypertension; the cardiovascular system; risk factors for cardiovascular disease; community resources; research methods; stress management; and alcohol and other drugs. They were also certified as blood pressure measurement specialists.
PATIENTS: mainly middle aged, Black, male, poor and unlikely to have received education beyond high school.
TOTAL=421: INTERVENTION=209; CONTROL=212.
InterventionsOBJECTIVE: to improve the medical follow up (screening and referral for treatment) of people with elevated blood pressure.
INTERVENTION: community health workers assisted referral to blood pressure treatment services.
CONTROL: no intervention.
MODE OF DELIVERY: community health workers conducted blood pressure (BP) measurements at social service agencies, food banks, shops, shelters, libraries etc. Persons with elevated BP were detected. Those randomized to CHW were then provided with the following services: (1) referral to medical care and, if necessary, assistance in locating a provider; (2) an appointment, or telephone follow-up with clients who preferred to make their own appointment to check that this had been made; (3) an appointment reminder letter; (4) follow-up to determine whether the appointment was kept; (5) a new appointment for each missed appointment (6) assistance in reducing barriers to care through referral to community transportation, child care or other services. Contact activities were monitored with a computerised tracking system.
CONSUMER INVOLVEMENT IN DESIGN/DEVELOPMENT/DELIVERY: not described.
ORGANISATIONAL BASE OF THE INTERVENTION: not described.
GEOGRAPHICAL SETTING: urban U.S.A.
HEALTH CARE SETTING: primary care facility and community.
OutcomesHEALTH CARE BEHAVIOURS: completion of follow up appointment with health care professional (HCP).
LENGTH OF FOLLOW UP: 3 months after enrolment.
Notes 
Risk of bias
BiasAuthors' judgementSupport for judgement
Allocation concealment?Low riskA - Adequate

Krieger 2000

MethodsRCT
ParticipantsLHW: peer to peer outreach volunteers were predominantly African-American senior centre members.
TRAINING: 4 hours training including role play sessions.
PATIENTS: participants were aged >65 years and resident in targeted ZIP code areas. Ethnically diverse; most low income; most had no complete college.
TOTAL=1246; INTERVENTION=622; CONTROL=624
InterventionsOBJECTIVE: to encourage immunization against influenza and pneumonia.
INTERVENTION: Peer to peer outreach volunteers.
CONTROL: no intervention.
MODE OF DELIVERY: each volunteer contacted 20-25 intervention group participants and used script to encourage immunization of defaulters (receipt of immunization/address barriers to immunization); mailing of educational material. Intervention lasted for 6 weeks. If volunteer could not reach participant after 5 attempts then alternative contact person phoned. Volunteers were assisted by an on site project coordinator.
CONSUMER INVOLVEMENT IN DESIGN/DEVELOPMENT/DELIVERY: volunteers were predominantly senior citizens.
ORGANISATIONAL BASE OF THE INTERVENTION: not described.
GEOGRAPHICAL SETTING: urban U.S.A.
HEALTH CARE SETTING: home.
OutcomesHEALTH CARE BEHAVIOURS: influenza and pneumococcal immunization.
COST: cost and cost effectiveness.
OTHER: change in knowledge, perceived barriers to immunization, appraisal of the intervention.
LENGTH OF FOLLOW UP: three months after intervention.
Notes 
Risk of bias
BiasAuthors' judgementSupport for judgement
Allocation concealment?Unclear riskB - Unclear

Lapham 1995

MethodsRCT
ParticipantsLHW: recovering alcoholics/addicts with at least one year of sobriety.
TRAINING: not described.
PATIENTS: homeless persons with alcohol related problems. Median age = 37 years (range 18-67); 87% male; non-Hispanic whites had "somewhat higher education levels". Almost half of the participants identified their profession as "skilled labour"; 25% were clerical workers or semi- to unskilled labourers. 49% unemployed over previous 12 months. Those with dependent children, serious mental illness or organic brain syndrome were not considered eligible.
TOTAL=469; INTERVENTION 1=161; INTERVENTION 2=164; INTERVENTION 3=92; CONTROL=52.
InterventionsOBJECTIVE: to encourage positive group interactions and peer group support systems to assist recovering addicts/alcoholics.
INTERVENTION 1: case management; substance abuse counseling services; 4 months of transitional housing.
INTERVENTION 2: 4 months of transitional housing.
INTERVENTION 3: 4 months of housing.
MODE OF DELIVERY: case manager and volunteer staff performed therapy/provided education orientated groups, staff transitional housing, provided peer support. The expectation was that participants, with assistance from residence managers, will become motivated to develop group support systems within their respective housing units.
CONSUMER INVOLVEMENT IN DESIGN/DEVELOPMENT/DELIVERY: volunteers were recovering addicts/alcoholics with at least one year sobriety.
ORGANISATIONAL BASE OF THE INTERVENTION: care homes organised by the H&ART project.
GEOGRAPHICAL SETTING: urban U.S.A.
HEALTH CARE SETTING: transitional housing.
OutcomesHEALTH CARE BEHAVIOURS: study attrition.
HEALTH STATUS AND WELL BEING: drug and alcohol use.
LENGTH OF FOLLOW UP: 10 months after intervention.
Notes 
Risk of bias
BiasAuthors' judgementSupport for judgement
Allocation concealment?Low riskA - Adequate

Leigh 1999

MethodsRCT
ParticipantsLHW: 69 volunteers recruited through community advertising.
TRAINING: after initial screening, three training sessions and then a second interview and 2 psychometric tests before signing a 4 month contract.
PATIENTS: chronic alcoholics with a mean age of 30-40 years.
TOTAL=106; INTERVENTION=52; CONTROL=54.
InterventionsOBJECTIVE: to support recovering alcoholics attending therapy.
INTERVENTION: volunteer aides.
CONTROL: no intervention.
MODE OF DELIVERY: volunteers attended all but client's first treatment session and spent 4-6 hours with each client, each week, in the community. Attempt made to match clients/volunteers on age, sex, educational background. At each session volunteer and client reported on shared activities, planned for future ones and discussed with the therapist best way to achieve client's goals. Volunteer and client agreed to meet each other in the community to work on these goals. Clients could spend part of their session alone with the therapist if they so requested.
CONSUMER INVOLVEMENT IN DESIGN/DEVELOPMENT/DELIVERY: not described.
ORGANISATIONAL BASE OF THE INTERVENTION: not described.
GEOGRAPHICAL SETTING: urban Canada.
HEALTH CARE SETTING: community.
OutcomesHEALTH CARE BEHAVIOURS: mean number of drinking days per month, medium number of weeks attended.
HEALTH STATUS AND WELL BEING: physical health, emotional function.
LENGTH OF FOLLOW UP: 12 months post intervention.
Notes 
Risk of bias
BiasAuthors' judgementSupport for judgement
Allocation concealment?Unclear riskB - Unclear

Lin 1997

MethodsCluster RCT
ParticipantsLHW: 24 volunteers selected from the community.
TRAINING: volunteers received a 2 day training course from the staff of a local Health Station (clinic). This training included how to measure blood pressure and body weight and the required knowledge related to hypertension and cardiovascular complications.
PATIENTS: some participants were diagnosed with hypertension but others had no specific health problems. Average age was approximately 60 years; 47% were male; 85% were married and approximately 12% widowed or divorced, 40% illiterate and 40% had elementary school education; 40-47% were farmers and fisherman, approximately 20% housewives, 15-19% unemployed, 9-19% businessmen or laborers.
TOTAL=1102; INTERVENTION=582; CONTROL=520.
InterventionsOBJECTIVE: to improve the follow-up and education of consumers with regard to blood pressure and healthy lifestyle.
INTERVENTION: volunteer home visits.
CONTROL: no intervention.
MODE OF DELIVERY: During home visits, the volunteers measured blood pressure and body weight; conveyed health information related to hypertension, regular blood pressure checks, weight reduction, reduction of alcohol consumption, and physical exercise; encouraged compliance with antihypertensive drug therapy, where appropriate.
CONSUMER INVOLVEMENT IN DESIGN/DEVELOPMENT/DELIVERY: not described.
ORGANISATIONAL BASE OF THE INTERVENTION: local health station and local Health Promotion Committee.
GEOGRAPHICAL SETTING: rural Taiwan.
HEALTH CARE SETTING: home.
OutcomesHEALTH CARE BEHAVIOURS: hypertension related knowledge and behaviour.
HEALTH STATUS AND WELL BEING: blood pressure.
LENGTH OF FOLLOW UP: 6 months after intervention.
Notes 
Risk of bias
BiasAuthors' judgementSupport for judgement
Allocation concealment?Low riskA - Adequate

McNeil 1995

MethodsRCT
ParticipantsLHW: nonprofessional volunteers who were undergraduate students in psychology, often organized by local church, community or senior groups.
TRAINING: not described.
PATIENTS: older persons with mild depression. 26 females and 4 females with mean age = 72.5 years; mean education level = 9.2 years.
30% were married; 10% single, divorced or separated. SES was evenly distributed between laborer/homemaker, clerical worker/small business owner, manager/professional.
TOTAL=30.
InterventionsOBJECTIVE: to relieve depression in older persons.
INTERVENTION 1: accompanied walking.
INTERVENTION 2: conversation.
CONTROL: no intervention.
MODE OF DELIVERY: accompanied walking demonstrated positive effects of aerobic exercise/well being of the elderly, mobility, urine control, balance, exercise endurance. Twice per week, and one alone for 20 minutes. Increase to 40 minutes later. Conversation with OP twice weekly visits for 20 minutes. Increase to 40 minutes.
CONSUMER INVOLVEMENT IN DESIGN/DEVELOPMENT/DELIVERY: not described.
ORGANISATIONAL BASE OF THE INTERVENTION: not described.
GEOGRAPHICAL SETTING: urban Canada.
HEALTH CARE SETTING: home.
OutcomesHEALTH STATUS AND WELL BEING: subjective health, psychological well being, depression, psychological symptoms score, somatic symptoms score, aerobic capacity.
LENGTH OF FOLLOW UP: 6 weeks after intervention.
Notes 
Risk of bias
BiasAuthors' judgementSupport for judgement
Allocation concealment?Low riskA - Adequate

Morrell 2000

MethodsRCT
ParticipantsLHW: not described.
TRAINING: National vocational qualification (level 2) postnatal care award, endorsement units for domiciliary care award and competence in the care of young children through an 8 week training programme.
PATIENTS: women >17 years old who delivered live baby. Mean age was approximately 28 years.
TOTAL=623; INTERVENTION=311; CONTROL=312.
InterventionsOBJECTIVE: to provide practical and emotional post-natal support for mothers, including help in gaining confidence in caring for baby and reinforcement of midwifery advice on infant feeding.
INTERVENTION: community post natal support workers.
CONTROL: no intervention.
MODE OF DELIVERY: the intervention group were offered 10 visits from a support worker for up to 3 hours per day in the first 28 postnatal days. Most women received 6 visits and 15% received 10 visits. The length of visits ranged from 10-375 minutes. Time was spent on: housework (38%); talking with the mother (23%); dealing with the baby (9%); dealing with other siblings (8%); bottle feeding (7%); talking about the baby (6%); discussing breast feeding (3%).
CONSUMER INVOLVEMENT IN DESIGN/DEVELOPMENT/DELIVERY: not described.
ORGANISATIONAL BASE OF THE INTERVENTION: not described.
GEOGRAPHICAL SETTING: urban U.K.
HEALTH CARE SETTING: home.
OutcomesCONSUMER SATISFACTION WITH CARE: consumer satisfaction with midwife, health visitor and general practioner.
HEALTH STATUS AND WELL BEING: general health perception, depression, social support, breastfeeding rates.
COST: NHS costs, use of social services, personal expenditure.
LENGTH OF FOLLOW UP: 6 months after intervention.
Notes 
Risk of bias
BiasAuthors' judgementSupport for judgement
Allocation concealment?Low riskA - Adequate

Morrow 1999

MethodsCluster RCT
ParticipantsLHW: counselors who previously worked for Instituto National de la Nutrician as field data collectors, lived in the study neighbourhood, were aged 25-30 years, had a high-school education and a commitment to breastfeeding, although did not necessarily have previous personal breastfeeding experience.
TRAINING: peer counselors were trained and supervised by staff of La Leche League of Mexico and the physician study coordinator, who was also trained in lactation management. The peer-counsellor training consisted of 1 week of classes, 2 months in lactation clinics and with mother-to-mother support groups, and 1 day of observation and demonstration by visiting experts. Peer counselors also practiced in a non-study neighbourhood for 6 months before the trial and refined the content of messages and their problem solving skills.
PATIENTS: all women residing in the periurban study area. Majority had primary or no schooling and were married. Few (7-15%) were employed outside the home. 27% of mothers were primiparous and 31% gave birth by caesarian section.
TOTAL=130; INTERVENTION 1=44; INTERVENTION 2=52; CONTROL=34.
InterventionsOBJECTIVE: to promote breastfeeding among pregnant and lactating women.
INTERVENTION 1: six home visits.
INTERVENTION 2: three home visits.
CONTROL: no home visits.
MODE OF DELIVERY: Home visits to pregnant women focused on the benefits of exclusive breastfeeding; basic lactation anatomy and physiology; infant positioning; common myths; typical problems and solutions; and preparation for birth. Postpartum visits focused on establishing a healthy breastfeeding pattern; addressing maternal concerns; and providing information and social support.
CONSUMER INVOLVEMENT IN DESIGN/DEVELOPMENT/DELIVERY: not described.
ORGANISATIONAL BASE OF THE INTERVENTION: support provided by staff of La Leche League, Mexico.
GEOGRAPHICAL SETTING: informal urban Mexico.
HEALTH CARE SETTING: home.
OutcomesCONSUMER SATISFACTION WITH CARE: maternal satisfaction.
HEALTH CARE BEHAVIOURS: exclusive breastfeeding in previous week at 2 weeks and 3 months, practice of exclusive breastfeeding at all five measurement times, duration of any breastfeeding, incidence of diarrhoea in children >3 months of age.
LENGTH OF FOLLOW UP: up to 3 months post partum.
Notes 
Risk of bias
BiasAuthors' judgementSupport for judgement
Allocation concealment?Low riskA - Adequate

Mtango 1986

MethodsCluster RCT
ParticipantsLHW: village health workers.
TRAINING: courses on Acute Respiratory Infections (ARI).
PATIENTS: 18% of children in villages in Bagamoya District were aged <5 years, predominantly Muslim and mainly of Bantu descent. The district's economic base is mainly agricultural, income per capita is among lowest in Tanzania.
TOTAL=16126 (YEAR 1); 19014 (YEAR 2); INTERVENTION=8028 (YEAR 1); 9099 (YEAR 2); CONTROL=8098 (YEAR 1); 9915 (YEAR 2).
InterventionsOBJECTIVE: to improve diagnosis, referral and treatment of ARI.
INTERVENTION: village health workers (VHW).
CONTROL: no intervention.
MODE OF DELIVERY: utilization of VHWs to include higher levels of primary care by visiting each household with child <5 years every 6-8 weeks, giving health education to mothers about childhood symptoms/signs of ARI, treating pneumonia immediately with Cotrimoxazole and referring severe cases to nest higher level of care.
CONSUMER INVOLVEMENT IN DESIGN/DEVELOPMENT/DELIVERY: not described.
ORGANISATIONAL BASE OF THE INTERVENTION: not described.
GEOGRAPHICAL SETTING: rural Tanzania.
HEALTH CARE SETTING: home.
OutcomesHEALTH STATUS AND WELL BEING: mortality rate for children <5 years of age.
LENGTH OF FOLLOW UP: 2 years.
Notes 
Risk of bias
BiasAuthors' judgementSupport for judgement
Allocation concealment?Low riskA - Adequate

Nielsen 1972

MethodsRCT
ParticipantsLHW: employees of commercial home aide service given no previous special training.
TRAINING: not described.
PATIENTS: older persons discharged from hospital. All were 60 years of age or older (median age=74) and 2/3 were female.
TOTAL=100; INTERVENTION=50; CONTROL=50.
InterventionsOBJECTIVE: geriatric rehabilitation.
INTERVENTION: home aide service.
CONTROL: no intervention.
MODE OF DELIVERY: home aide service was orientated towards helping the older person carry out the tasks that he would ordinarily do for himself if he were able, or that a family member, if he had one, might do for him. These tasks included house cleaning, meal planning, grocery shopping, bathing, dressing and exercising assistance, escort services, reading to and writing for older participants. The home aides were supervised by mature and experienced paraprofessional workers who were in turn supervised and directed by a social worker and a nurse.
CONSUMER INVOLVEMENT IN DESIGN/DEVELOPMENT/DELIVERY: not described.
ORGANISATIONAL BASE OF THE INTERVENTION: commercial home aide service.
GEOGRAPHICAL SETTING: urban U.S.A.
HEALTH CARE SETTING: home.
OutcomesCONSUMER SATISFACTION WITH CARE: self assessed/evaluator assessed contentment score.
HEALTH CARE BEHAVIOURS: number of admissions/days spent in short and long stay institutions.
HEALTH STATUS AND WELL BEING: mortality.
LENGTH OF FOLLOW UP: one year.
Notes 
Risk of bias
BiasAuthors' judgementSupport for judgement
Allocation concealment?Low riskA - Adequate

Olds 2002

MethodsRCT
ParticipantsLHW: paraprofessional home visitors were required to have high school education but excluded if they had college preparation in the helping disciplines or a bachelor's degree in any discipline as well as strong people skills. Preference was given to those who had previously worked in human services agencies.
TRAINING: one month intensive training. Volunteers then served 2 families in a pilot program to gain experience with the model and performed regular in service training to cover aspects of MCH/development.
PATIENTS: low income women from from 21 antepartum clinics in the Denver metropolitan area, who had no previous live births and who qualified for Medicaid or had no private health insurance. Mean age=19.76 years; 84% of whom were unmarried; had a mean=11 years education; no previous live births; qualified for Medicaid/no private insurance.
TOTAL=735; INTERVENTION 1=245; INTERVENTION 2=235; CONTROL=255.
InterventionsOBJECTIVE: child and maternal health promotion to 1) improve maternal/fetal health during pregnancy; 2) improve health/development of child by helping parents provide more competent care; 3) enhance parent's personal development, planning future pregnancies, further education and find work.
INTERVENTION 1: paraprofessional home visits.
INTERVENTION 2: nurse home visits.
CONTROL: no intervention.
MODE OF DELIVERY: each visitor managed a case load of 25 families. There were 2 supervisors for 10 visitors. 3/10 visitors left the study and replacements were hired. Paraprofessionals completed approximately 6.3 home visits during pregnancy and 16 visits during infancy. By the end of the program 48% of the paraprofessional visited families had discontinued the program.
CONSUMER INVOLVEMENT IN DESIGN/DEVELOPMENT/DELIVERY: not described.
ORGANISATIONAL BASE OF THE INTERVENTION: not described.
GEOGRAPHICAL SETTING: urban U.S.A.
HEALTH CARE SETTING: home.
OutcomesCONSULTATION PROCESS MEASURES: length of visit, family members participating, % time devoted to different progress areas, attempted visits not completed.
UTILIZATION OF LHW: program drop out, relationship continuity.
CONSUMER SATISFACTION WITH CARE: mother's rating of helping relationship.
COST: cost of program or 2 or 5 years service per family.
HEALTH CARE BEHAVIOURS: number/timing of subsequent pregnancies, mother-infant interaction, use of psychoactive substances, use of nicotine, marijuana or cocaine, change in tobacco use.
HEALTH STATUS AND WELL BEING: child emotional, mental and behavioural development, language development.
LENGTH OF FOLLOW UP: up to 24 months.
Notes 
Risk of bias
BiasAuthors' judgementSupport for judgement
Allocation concealment?Low riskA - Adequate

Ramadas 2003

MethodsCluster RCT
ParticipantsLHW: health workers were biology or social science graduates.
TRAINING: 3 month training period organized by the Community Oncology Division of the Regional Cancer Centre (RCC). Taught oral cancer theory including risk factors, natural history, diagnosis, treatment, audio/visual prognosis; trained in field. Control HWs also trained (2 for each panchayath) but not in oral screening techniques.
PATIENTS: residents of Kerala who were all over 35 years old.
TOTAL=153708; INTERVENTION=78969; CONTROL=74739.
InterventionsOBJECTIVE: to reduce oral cancer mortality through screening.
INTERVENTION: health workers delivered a variety of services including oral cancer screening.
CONTROL: health worker delivered a variety of services but did not screen for oral cancer.
MODE OF DELIVERY: during home visits health workers conducted oral examination and recorded weight, blood pressure and respiratory peak flow measurement; enumerated households and record all their residents; interviewed eligible subjects with respect to socio-demographic factors, personal habits, diet and medical history. Recorded information on structured form; measured height, weight, blood pressure, respiratory peak flow; conducted oral/visual inspection to identify anatomic lesions, benign lesions, leukoplakia, oral sub mucous fibrosis and oral cancer.
CONSUMER INVOLVEMENT IN DESIGN/DEVELOPMENT/DELIVERY: not described.
ORGANISATIONAL BASE OF THE INTERVENTION: Community Oncology Division of the Regional Cancer Centre (RCC).
GEOGRAPHICAL SETTING: rural India.
HEALTH CARE SETTING: home.
OutcomesHEALTH STATUS AND WELL BEING: number of incident oral cancers, number of deaths among oral cancer patients.
OTHER: program sensitivity, specificity and positive predictive value.
LENGTH OF FOLLOW UP: 1995-2002.
Notes 
Risk of bias
BiasAuthors' judgementSupport for judgement
Allocation concealment?Unclear riskB - Unclear

Schuler 2000

MethodsRCT
ParticipantsLHW: lay visitors were two middle aged African-American women who had previous experience of making home visits and were familiar with the community where the mothers lived.
TRAINING: trained to persue HELP at Home (Hawaii Early Learning Profile, 1991).
PATIENTS: women with mean age=27 years. 97.7-100% unemployed; 91.7-96.4% single.
TOTAL=171; INTERVENTION=84; CONTROL=87.
InterventionsOBJECTIVE: to increase maternal empowerment and infant development.
INTERVENTION: home visitors.
CONTROL: no intervention.
MODE OF DELIVERY: home visitors delivered a developmentally orientated intervention based on program used by IHDP, providing information on drug use/treatment to increase maternal empowerment and infant development. Home visitors modeled behavior/activity on a sheet. Weekly visits in the first 6 months (mean=8.9) of mean length=30.1 mins
CONSUMER INVOLVEMENT IN DESIGN/DEVELOPMENT/DELIVERY: not described.
ORGANISATIONAL BASE OF THE INTERVENTION: not described.
GEOGRAPHICAL SETTING: urban U.S.A.
HEALTH CARE SETTING: home.
OutcomesHEALTH CARE BEHAVIOURS: cocaine/heroin, marijuana, alcohol use.
HEALTH STATUS AND WELL BEING: mother infant interaction (maternal responsiveness and infant warmth).
LENGTH OF FOLLOW UP: 6 months post intervention.
Notes 
Risk of bias
BiasAuthors' judgementSupport for judgement
Allocation concealment?Low riskA - Adequate

Siegel 1980

MethodsRCT
ParticipantsLHW: paraprofessional infant care workers.
TRAINING: 200 hours of pre-service training including 3 months of multi-method classroom learning experiences and field work during last month of training . Began with orientation to research project then covered mother-infant attachment, child care/development, importance of play/stimulation, special needs of mothers/infants, use of community resources, skills in relating to mothers. Continuous supervision provided by project field director who had a degree in child development. Public health nurses participated in training and served as continuing resources to infant care workers, the relationship was facilitated by the health department
PATIENTS: women in third trimester of pregnancy who received care at public prenatal clinic.
TOTAL=202; INTERVENTION 1=47; INTERVENTION 2=50; INTERVENTION 3=53; CONTROL=52.
InterventionsOBJECTIVE: to promote mother's involvement with children and support mothers coping with situational stresses.
INTERVENTION 1: home visits and extended contact in hospital.
INTERVENTION 2: extended contact in hospital only.
INTERVENTION 3: home visits only.
CONTROL: normal hospital care (approximately 2 ½ hours of routine contact per day).
MODE OF DELIVERY: infant care workers first visited mothers in hospital then made 9 visits during first 3 months of infant's life. Hospital contact consisted of at least 45 mins during first three hours after delivery and then at least 5 additional hours each day during hospital stay. During first 6 months of intervention workers met as a group with field director for three hours twice a week (once a week after 6 months).
CONSUMER INVOLVEMENT IN DESIGN/DEVELOPMENT/DELIVERY: not described.
ORGANISATIONAL BASE OF THE INTERVENTION: not described.
GEOGRAPHICAL SETTING: urban U.S.A.
HEALTH CARE SETTING: home.
OutcomesHEALTH CARE BEHAVIOURS: acceptance, interaction/stimulation, consoling, infant positive/negative behaviour.
HEALTH STATUS AND WELL BEING: reports of child abuse and neglect.
OTHER: health care utilization by infants.
LENGTH OF FOLLOW UP: up to 12 months.
Notes 
Risk of bias
BiasAuthors' judgementSupport for judgement
Allocation concealment?Low riskA - Adequate

Silver 1997

MethodsRCT
ParticipantsLHW: 3 lay counselors were were recruited through advertisements in neighborhood newspapers. They were all women who had raised children with ongoing health conditions. Further selection of counselors occurred, but no information provided on how this occurred.
TRAINING: 40 hour training programme focusing on listening, reflection and communication skills and on the issues that mothers of children with ongoing conditions experience. A second intensive training programme covered home visiting, coordinating schedules and how to describe the programme to participants. 10 women received 40 hour training program. 6 proceeded to further training and 3 women accepted jobs as lay interveners.
PATIENTS: mothers and children with a variety of ongoing health conditions.Mothers had an average age of approximately 34 years; one-third were high school graduates, one-third had attended some college and 20% had less than high school education; approximately 40% of mothers were employed; just under half of families were on welfare. Children had an average age of approximately 7 years; on average had been diagnosed for 5 years; both parents were present in fewer than half of households.
TOTAL=265; INTERVENTION=183; CONTROL=182.
InterventionsOBJECTIVE: to provide social support and increased access to relevant information, services and knowledgeable advisors for mothers of children with ongoing health conditions.
INTERVENTION: support and information from lay counselors.
CONTROL: no intervention.
MODE OF DELIVERY: through face-to-face home meetings and biweekly telephone calls and group activities the project attempted to 1. Link mothers with community support/resources; 2. Share information about child health/behavior; 3. Enhance maternal confidence in parenting; 4. Provide source of emotional support; 5. Help identify support among mothers' naturally occurring network of friends/family. Lay intervenors worked approximately 21 hours per week and were supervised by a clinical psychologist and a social worker.
'CONSUMER INVOLVEMENT IN DESIGN/DEVELOPMENT/DELIVERY: social support provided by mothers with older children who had previously suffered from on going health conditions
ORGANISATIONAL BASE OF THE INTERVENTION: not described.
GEOGRAPHICAL SETTING: urban U.S.A.
HEALTH CARE SETTING: home and community.
OutcomesUTILIZATION OF LHW: program participation.
HEALTH STATUS AND WELL BEING: children's illness related functional impairment, stressful life events.
OTHER: maternal capacity to provide care.
LENGTH OF FOLLOW UP: 12 months after intervention.
Notes 
Risk of bias
BiasAuthors' judgementSupport for judgement
Allocation concealment?Low riskA - Adequate

Sung 1997

MethodsRCT
ParticipantsLHW: 20 para-professional home visitors had experience of working in community as self-help support group leader for NBWHP.
TRAINING: 10 weeks in interviewing and health education topics.
PATIENTS: inner city, low income, African-American women who were recruited from public/senior citizen housing projects, inner-city business settings and by referrals from a health orientated, self help organization.
TOTAL=221; INTERVENTION=163; CONTROL=158.
InterventionsOBJECTIVE: to promote breast/cervical screening among inner city African-American women.
INTERVENTION: culturally sensitive home education program about cancer prevention.
CONTROL: no intervention.
MODE OF DELIVERY: women were interviewed using a standard questionnaire and then LHWs visited homes of intervention group. 2 home visits one month apart and booster session 2 months later. The second sessions included 1)Information about breast and cervical cancer screening procedures and video; 2)Information about reproductive health and printed materials. The intervention was delivered over 11 weeks.
CONSUMER INVOLVEMENT IN DESIGN/DEVELOPMENT/DELIVERY: not described.
ORGANISATIONAL BASE OF THE INTERVENTION: the National Cancer Institute (NCI) supported the study.
GEOGRAPHICAL SETTING: urban U.S.A.
HEALTH CARE SETTING: home.
OutcomesHEALTH CARE BEHAVIOURS: change in screening uptake for pap smear, breast self examination, breast clinical examination, mammography.
LENGTH OF FOLLOW UP: 6 months post intervention.
Notes 
Risk of bias
BiasAuthors' judgementSupport for judgement
Allocation concealment?Unclear riskB - Unclear

Tudiver 1992

MethodsRCT
ParticipantsLHW: volunteers from the gay community.
TRAINING: volunteer training was an intensive one-day session on group process and the curriculum for the programme.
PATIENTS: gay and bisexual men with a mean age of 32 years (range 14-72); 97% first language English; 83% had some college or university education; 88% were employed; 18% had annual earnings >$40000. 72% had lived in Canada all their lives
TOTAL=626; INTERVENTION 1=252; INTERVENTION 2=111; CONTROL=263.
InterventionsOBJECTIVE: to promote AIDS reduction strategies.
INTERVENTION 1: volunteer led group eduaction seesions.
INTERVENTION 2: professional led group education sessions.
CONTROL: no intervention.
MODE OF DELIVERY: volunteers led highly structured 3 hour education session in one of the participants homes for 8-12 gay and bisexual men on AIDS risk reduction. Each pair of volunteers led several different sessions. These included (1) introduction and goal setting (2) establishment of group rapport (3) the impact of AIDS on individuals and the community (4) safer sex guidelines and risk clarification (5) condom demonstration (6) difficulties with safer sex practices (7) sexual scenario role-play (8) safer sex fantasies and scenarios.
CONSUMER INVOLVEMENT IN DESIGN/DEVELOPMENT/DELIVERY: volunteers were from the gay community.
ORGANISATIONAL BASE OF THE INTERVENTION: not described.
GEOGRAPHICAL SETTING: urban Canada.
HEALTH CARE SETTING: home.
OutcomesHEALTH CARE BEHAVIOURS: knowledge of AIDS risk score, knowledge of risk score for anal intercourse, impulse control awareness, condom efficacy, sexual practices.
LENGTH OF FOLLOW UP: 3 months after intervention.
NotesIntervention 2 does not appear to have a lay health worker componant but we are awaiting confirmation from the authors.
Risk of bias
BiasAuthors' judgementSupport for judgement
Allocation concealment?Unclear riskB - Unclear

Von Korff 1998

MethodsRCT
ParticipantsLHW: 8 lay leaders who had experienced chronic/recurrent back pain and were willing and able to lead groups according to a highly structured protocol.
TRAINING: 2 days of formal training by one of the co-authors (KL).
PATIENTS: patients aged 25-70 with back pain who were largely well educated, employed full-time or part-time, married and white with a mean age =50 years.
TOTAL=255; INTERVENTION=129; CONTROL=126.
InterventionsOBJECTIVE: to assist patients with chronic back pain with methods of self care regarding exercise programs, posture, etc.
INTERVENTION: weekly education classes on self help methods for treating back pain.
CONTROL: consumers received a commercial book on back pain care.
MODE OF DELIVERY: volunteers led four 2-hour classes, held once a week totaling 16 hours of patient education (information and problem solving skills) and supplemented by written information and video-tapes. Classes aimed to teach skills in appropriate pacing of exercise and activity, positive and negative self talk in managing back pain, handling of flare-ups and working with health providers. The classes were conducted according to a fully structured protocol. Self-care materials developed for this study were provided to study participants at the end of the first class session. These materials included a book and two professionally produced videotapes: a 40-minute videotape on back pain self-management and a 25-minute videotape demonstrating exercises. Intervention subjects who did not attend any of the group sessions were not given these educational materials. There were 2 volunteers to 10-15 patients.
CONSUMER INVOLVEMENT IN DESIGN/DEVELOPMENT/DELIVERY: trainers were patients who had recurrent or chronic back pain.
ORGANISATIONAL BASE OF THE INTERVENTION: not described.
GEOGRAPHICAL SETTING: urban U.S.A.
HEALTH CARE SETTING: primary care facility.
OutcomesHEALTH STATUS AND WELL BEING: pain intensity and interference, disability rating, mental health.
OTHER: attitudes towards back pain self care, back pain worries.
LENGTH OF FOLLOW UP: up to 12 months after intervention.
Notes 
Risk of bias
BiasAuthors' judgementSupport for judgement
Allocation concealment?Low riskA - Adequate

Voorhees 1996

MethodsCluster RCT
ParticipantsLHW: 29 smoking cessation lay volunteers.
TRAINING: a 4 session training programme in understanding smoking behaviour, nicotine addiction and the process of withdrawal. They were also trained to assist people through individual and small group methods
PATIENTS: smokers with an average age of approximately 46 years; 68-75% female; 67-81% had more than 12 years of education; 74-78% belonged to Baptist churches.
TOTAL=340; INTERVENTION (FOLLOWED UP)=199; CONTROL (FOLLOWED UP)=93;
InterventionsOBJECTIVE: to encourage smokers to quit smoking.
INTERVENTION: culturally specific smoking cessation strategies.
CONTROL: smoking cessation pamphlet.
MODE OF DELIVERY: smoking cessation strategies included assisting registration, carbon monoxide measurement, administration of questionnaires used to assess smoking prevalence, diabetes and coronary disease risk. There were also one to four pastoral sermons on smoking; testimony during church services from individuals going through the quit process; baseline and follow-up health fairs, including voluntary health assessment.
CONSUMER INVOLVEMENT IN DESIGN/DEVELOPMENT/DELIVERY: not described.
ORGANISATIONAL BASE OF THE INTERVENTION: Baptist churches.
GEOGRAPHICAL SETTING: urban U.S.A.
HEALTH CARE SETTING: church facilities.
OutcomesHEALTH CARE BEHAVIOURS: quit rate among smokers, shifts in stages change among smokers.
LENGTH OF FOLLOW: one year after baseline.
NotesFurther additional materials were provided to the intervention group. These included "One day at a time" book of devotions to assist smokers; Stop Smoking inspirational audiotape; smoking cessation specialist's manual.
Risk of bias
BiasAuthors' judgementSupport for judgement
Allocation concealment?Low riskA - Adequate

Wan 1980

MethodsRCT
ParticipantsLHW: homemakers.
TRAINING: no details given of training or support.
PATIENTS: the elderly who might otherwise need long term care. 48% over the age of 75. Mixed gender with 80% of sample being classified as White. About ¼ of sample lived alone. Over half were severely dependent.
TOTAL=1871; INTERVENTION 1=307 (CONTROL=323); INTERVENTION 2=194 (CONTROL=190); INTERVENTION 3=59 (CONTROL=80).
InterventionsOBJECTIVE: to provide day care and homemaker services for the elderly.
INTERVENTION 1: homemaker services.
INTERVENTION 2: day care services.
INTERVENTION 3: both homemaker and day care services.
CONTROL: no services for all three interventions.
MODE OF DELIVERY: homemaker services included cooking, cleaning, laundry, ironing, assistance with activities such as eating, walking, dressing, bathing etc, shopping, health care management, accompanying the patient to the health services, assisting visiting health professionals. Day care services included nursing, social services, meals, transportation, patient activities, occupational therapy, speech therapy, eye, ear and podiatric therapy.
CONSUMER INVOLVEMENT IN DESIGN/DEVELOPMENT/DELIVERY: not described.
ORGANISATIONAL BASE OF THE INTERVENTION: not described.
GEOGRAPHICAL SETTING: urban U.S.A.
HEALTH CARE SETTING: home and primary care facility/community.
OutcomesHEALTH STATUS AND WELL BEING: activites of daily living, mental health status, contentment, activity scale, mortality.
LENGTH OF FOLLOW UP: 12 months.
Notes 
Risk of bias
BiasAuthors' judgementSupport for judgement
Allocation concealment?Low riskA - Adequate

Weinberger 1989

MethodsRCT
ParticipantsLHW: 21 non medical personel.
TRAINING: not described.
PATIENTS: osteoarthritis patients from the Regenstrief Medical Record System with a mean age=62.3 years; 87.7% were women; 23.2% were currently married; average years of education =9.3; 65.6% reported annual family incomes below US$6000.
TOTAL=439; INTERVENTION 1=109; INTERVENTION 2=109; INTERVENTION 3=109; CONTROL=112.
InterventionsOBJECTIVE: to improve the treatment of patients with osteoarthritis.
INTERVENTION 1: telephone contact.
INTERVENTION 2: clinic contact.
INTERVENTION 3: telephone and clinic contact.
CONTROL: regular treatment.
MODE OF DELIVERY: telephone group - called monthly except when called one week before scheduled clinic visit to remind patients of appointment. Schedule then shifted to return to monthly calls. Clinic group - intervention interview delivered at all scheduled visits to GMP. At each contact interview, the following items were discussed. 1) Problems with joint pain; 2) Medications (i.e. compliance, whether the supply was sufficient to last until the next appointment); 3) Gastrointestinal and other symptoms; 4) Presence of early warning signs for hypertension, heart disease, diabetes and chronic obstructive pulmonary disease; 5) Date of the next scheduled outpatient visit; 6) An established mechanism whereby patients could telephone a physician during evenings and weekends; 7) Barriers to keeping appointments.
CONSUMER INVOLVEMENT IN DESIGN/DEVELOPMENT/DELIVERY: not described.
ORGANISATIONAL BASE OF CARE: Regenstrief Medical Record System.
GEOGRAPHICAL SETTING: urban U.S.A.
HEALTH CARE SETTING: home and primary care facility.
OutcomesUTILIZATION OF LHW: mean number of contacts between patients and LHWs.
CONSUMER SATISFACTION WITH CARE: Rand Corporation satisfaction with health care scale.
HEALTH CARE BEHAVIOURS: compliance with medication over preceding week.
HEALTH STATUS AND WELL BEING: arthritis impact measurement including psychological health, physical health and pain scores, Philedelphia Geriatric Centre Morale Scale.
OTHER: perceived availability of social support.
LENGTH OF FOLLOW UP: 11 months after enrolment.
Notes 
Risk of bias
BiasAuthors' judgementSupport for judgement
Allocation concealment?Low riskA - Adequate

Wertz 1986

MethodsRCT
ParticipantsLHW: volunteers friends/familiy members of patients with no previous experience in health care.
TRAINING: volunteers received 6-10 hours training weekly for 12 weeks: information on aphasia, observing treatment of aphasia on videotape, practicing techniques to use. Speech pathologist trained the home therapist volunteers and developed treatment programs they administered.
PATIENTS: aphasic patient 2-24 weeks after stroke who were75 years or younger and could read/write in English.
TOTAL=121; INTERVENTION 1=38; INTERVENTION 2=43; CONTROL=40.
InterventionsOBJECTIVE: to provide home treatment for aphasic patients.
INTERVENTION 1: treatment in clinic following stroke.
INTERVENTION 2: treatment at home following stroke.
CONTROL: no treatment in first 12 weeks following stroke.
MODE OF DELIVERY: LHWs administered programs of stimulus response designed by speech therapists. Individual programs were customized by speech therapist to the patient's needs and each patient received 8-10 hours of treatment. Every 2 weeks volunteer-patient pairs were videoed and approach was discussed by therapist after she had reviewed tape.
CONSUMER INVOLVEMENT IN DESIGN/DEVELOPMENT/DELIVERY: consumer's family/friends selected to deliver the intervention.
ORGANISATIONAL BASE OF THE INTERVENTION: not described.
GEOGRAPHICAL SETTING: urban U.S.A.
HEALTH CARE SETTING: home and primary care facility (clinic).
OutcomesHEALTH STATUS AND WELL BEING: comprehension, reading, writing and speaking ability.
LENGTH OF FOLLOW UP: up to 24 weeks post intervention.
Notes 
Risk of bias
BiasAuthors' judgementSupport for judgement
Allocation concealment?Low riskA - Adequate

Williams 1992

MethodsRCT
ParticipantsLHW: health visitor assistants (HVA).
TRAINING: not described.
PATIENTS: aged >75 years who were discharged from hospital during study and returned to their own/relatives houses but did not require district nursing.
TOTAL=470; INTERVENTION=231; CONTROL=239.
InterventionsOBJECTIVE: to provide support and treatment to elderly patients in the year following discharge from hospital.
INTERVENTION: health visitor assistants.
CONTROL: no intervention.
MODE OF DELIVERY: HVAs visited consumers following discharge from hospital according to the following schedule - 2 x 2 weeks following discharge
3 x monthly visits; 3 x 2 monthly visits (8 visits per year). They initiated actions including medication; heating; housing; mobility; sight; hearing; eating; sleeping; incontinence; mental state; loneliness; shopping; cooking; cleaning; laundry; appearance; feet; aids and appliances; financial benefits and carer relief; counseling support or advice. They were supported by a community based registered general nurse.
CONSUMER INVOLVEMENT IN DESIGN/DEVELOPMENT/DELIVERY: not described.
ORGANISATIONAL BASE OF THE INTERVENTION: not described.
GEOGRAPHICAL SETTING: urban U.K.
HEALTH CARE SETTING: home.
OutcomesCONSULTATION PROCESS: number of patients who had full 8 visits, recorded actions at each visit.
HEALTH STATUS AND WELL BEING: physical status, disability level, mental status.
OTHER: discharge from hospital, home circumstances, informal support, use of social and nursing services, need for help from social services, need for information on financial benefits.
LENGTH OF FOLLOW UP: one year after discharge from hospital.
Notes 
Risk of bias
BiasAuthors' judgementSupport for judgement
Allocation concealment?Low riskA - Adequate

Zwarenstein 2000

MethodsRCT
ParticipantsLHW: many of the lay health workers (LHW) were previous TB patients, or had TB in the family.
TRAINING: 5 mornings of interactive health promotion education. The rationale was that the process of training the LHW volunteers would increase knowledge of the disease in the community.
PATIENTS: pulmonary tuberculosis patients of whom 49% <35 years of age; 58% male; 69% single; 89% living in formal housing; 11% employed; 22% had >11 years of schooling.
TOTAL=156; INTERVENTION 1=54; INTERVENTION 2=44; CONTROL=58.
InterventionsOBJECTIVE: to improve tuberculosis (TB) treatment outcomes for pulmonary TB.
INTERVENTION 1: observation of TB treatment taking by lay health workers.
INTERVENTION 2: self observed TB treatment taking.
CONTROL: nurse observed TB treatment taking at a clinic
MODE OF DELIVERY: LHW supervises the daily dose of anti-tuberculosis medication. The TB patient came to the LHW's house each day, and the LHW administered the medication from the supplies that they held. They then monitored this on a compliance record. If the patient missed a day's treatment, the LHW visited the patient's home. If the LHW could not solve the problem, a staff member of the managing NGO visited the patient.
CONSUMER INVOLVEMENT IN DESIGN/DEVELOPMENT/DELIVERY: many LHWs were previous TB patients who family members of TB patients.
ORGANISATIONAL BASE OF THE INTERVENTION: SANTA, a TB NGO.
GEOGRAPHICAL SETTING: urban South Africa.
HEALTH CARE SETTING: home.
OutcomesHEALTH STATUS AND WELL BEING: successful TB treatment completion (patients cured and patients completely cured), successful treatment in new patients, sucecssful treatment in recurrent patients, successful treatment in female patients, successful treatment in male patients.
LENGTH OF TREATMENT: 6 months.
Notes 
Risk of bias
BiasAuthors' judgementSupport for judgement
Allocation concealment?Low riskA - Adequate

Characteristics of excluded studies [ordered by study ID]

StudyReason for exclusion
Akram 1997Not a RCT
Anderson 1998Not a RCT
Andresen 1992Review article
Arlotti 1998Not a RCT
Armstrong 1999Not a RCT
Ashworth 1992Education programme delivered in schools
Assar 2000Study compares two types of LHW
Ayele 1993Not an RCT, view as a CBA. Both groups intervention and control have CHA
Bailey 1996Not an RCT, not an CHW. This study compared 2 ways of training LHW
Bang 1993Controlled field study
Bang 1994Field trial
Bang 1999Not a RCT
Berry 1991Not a RCT
Bester 1991Descriptive study not an RCT.
Bhattacharya 1988Quasi randomization, ? systematic. Not CHW intervention. Training for mothers and family members.
Bird 1998Not a RCT.
Boucher 1987Not a RCT or LHW
Brennan 1991RCT but not aCHW
Brook 1989Not a RCT
Brownstein 1992Review article
Bullough 1989Both groups have CHW involement
Chamberlain 2001Study compares two types of LHW
Charles 1974Not a RCT or LWH study
Chen 1999RCT but not LHW
Christopher 1990Not a RCT
Corrado 2000Not a RCT
Cox 1998Not a LHW study
Dalby 2000Not a LHW study
Davies-Adetugbo 1997Controlled before and after
Davis 1994Not a RCT
Delacollette 1996Not a RCT.
Dennis 1997Not LHW study
DiCenso 1997Not LHW study
Dick 1997Not a RCT
DiClemente 1989Intervention delivered by teachers
Durand 1992Not a RCT
Durlak 1981NOT a RCT
Gerson 1976RCT but nor a LHW project
Goodburn 2000Not a RCT
Graham 2002School based, teacher led intervention
Grande 1999RCT but not CHW
Gray 1980Professional staff who administer the intervention
Greenwood 1989Not LHW study
Gunnell 2000Randomized but not CHW intervention.
Gupta 1992Not a LHW studt
Haider 1997Not a RCT
Hamalainen 1992Formal education setting
Hampson 1980RCT not a LHW project
Havas 1991Not a RCT
Heikens 1993RCT but not CHW. Both groups provided with care.
Heins 1987Not a RCT
Helgeson 2001Not LHW study
Hernandez 2000RCT but not CHW.
Hill 1999Not LHW study
Hill 2000Not a RCT
Hodnett 1989Not LHWs but midwives in training to become professional
Hughes 1992RCT but not a CHW.
Jepson 1999RCT but not a CHW
Jessop 1991Not LHW study
Johansson 1999Not LHW study
Johnstone 2000RCT but not an CHW
Kaag 1996Not LHW study
Kamolratanakul 1999Within intervention arm allocation to LHW or professional supervision was not random
Kent 1997Not a RCT
Kidorf 1997Not a RCT
King 1991Not LHW study
Kitzman 2000Not LHW study
Kules 1995Not a RCT
Kumar 1998Controlled field study
Larson 1980Not RCT, visits by undergraduate students
Lasater 1996Not LHW study
Lefeber 1997Not a RCT
Lin,T 1997Controlled before and after
Lindsay 1993Not a RCT
Linn 1977Institutionalised professional care
Mallams 1982Patient support group intervention
Mandelblatt 1996Not a RCT
Margolis 1998Not a RCT
May 1986Not a RCT
Mc Farlane 1997Not a RCT
McCosker 1997Not a RCT
McCurren 1999Insitutionalised care
McInnes 2000This study is a CCT not a RCT
Menendez 1994Not LHW study
Menendez,CStudy measuring effectivness
Mercier 1992Not a RCT or a LHW project
Moongtui 2000Not LHW study
Mowles 1982Not a RCT
Muijen 1992RCT but not a LHW project
Nations 1997Not a RCT
Neittaanmaki 1980Not a RCT
Newcomer 1999RCT but not a LHW intervention.
Newell 1993Not an RCT
Nikodem 2001Institutionalised care
Pai 1982Used trained nurses
Pai 1983Not a LHW project
Paulson 1999Not a RCT
Radentz,W.HTested the use of an audiovisual health education program
Rettig,B 1986Not LHW study
Robinson 1988RCT but both groups have CHW's. Family caregivers intervention is training to CHW
Rotheram-Borus 1991Not a RCT
Rubenstein 1978Not a RCT
Samman 1999Not LHW study
Saylor 1983Not a RCT
Scarano 1987Not a RCT
Schafer 1998Controlled before and after
Schardin 1994Not a RCT
Searle 1999RCT but not a LHW project
Shaughnessy 1996Not a RCT
Shaw 1999Not a RCT
Small 1987Comparison of two types of LHW
Smith 2000Not LHW study
Smith, JB 2000Not a RCT
Spiby 1999Not a RCT
Stephens 1996Not a RCT
Stephenson 1998Health education intervention administered in schools
Stewart 1999Not a RCT
Strawczynski 1973Not a LHW project
Stricklin 2000Not a LHW, not a RCT
Sullivan 1999Not LHW study
Susser 1998Not a LHW project
Terefe 1993RCT but both groups have CHW involvement. The intervention was husband involvement
Teri 1999Not a RCT
Tessaro 1997Not a LHW study
Thomas 1985Intervention delivered by public health nurses or health education teachers
Thouw 1992Not a RCT
Tinetti 1993RCT but not CHW
Tinetti 1999Not LHW study
Toobert 2000Not LHW study
Townsend 1976Not LHW
Tramarin 1992Not LHW study
Tuckman 1994Not a RCT
Tudiver, F 1992RCT but not a LHW study
Uphold 2000Not a LHW project or a RCT
Victora 1994Not LHW study
Walraven 1995Not LHW study
Walton 1993RCT but not CHW
Wanlass 1983Not LHW study
Watts 1995Review article; not LHW study
Weiler 1993Not an RCT or LHW study
Weinberger 1988Not LHW study
Wenger 1992Not LHW study
Weuve 2000Randomized but probably not CHW intervention. Both groups had family caregivers
Williams, EI 1992Not LHW study
Wolf 1985Intervention used Visiting Nurse Association

Ancillary