This is the protocol for a review and there is no abstract. The objectives are as follows:
To assess the effects of different types of structured versus routine family planning counselling techniques for women (or less commonly, men) on contraceptive choice, initiation and compliance as primary outcomes.
Mistimed, unplanned or unwanted pregnancy is known as unintended pregnancy and is a public health concern. In 2008, the global rate of unintended pregnancy was 55 per 1000 women aged 15 to 44, of which 26 per 1000 ended in abortion (Singh 2010). It is estimated that 41% of the 208 million pregnancies that occurred worldwide in 2008 were unintended, of which half resulted in induced abortions (Singh 2010). The proportion of all abortions that are unsafe has increased, from 44% in 1995 and 47% in 2003 to 49% in 2008 (Sedgh 2012).
The health and economic consequences of unintended pregnancy are significant. In a review entitled "The effects of unintended pregnancy on infant, child, and parental health", Gipson et al indicated that such pregnancies are associated with maternal mortality and morbidity such as depression during and after pregnancy, poor maternal mental health, increased risk of violence during pregnancy and a poor relationship between mother and child (Gipson 2008). Unintended pregnancies are also associated with low birth weight, inadequate breast feeding, child malnutrition and incomplete vaccination, as well as child mortality (Gipson 2008). An estimated 22 million unsafe abortions are performed each year, resulting in the death of an estimated 47,000 women and disabilities in an additional five million women (WHO 2011).
Unintended pregnancy has many causes, including underlying factors such as poor access to family planning services (Speidel 2008). Other causes of unintended pregnancy are inconsistent or incorrect use of contraceptive methods, discontinuation of contraceptive use due to problems with the method or non-use of contraceptives because of fear of side effects or poor understanding of the risk of pregnancy. Contraceptive failure is another, less common, cause (Singh 2010).
Description of the condition
Due to the high prevalence of unintended pregnancy and its potential impact on the health of mothers and children, prevention is critical. The prevention of unintended pregnancy is ideal for most couples, and it is one of the most important reproductive health goals for health policy-makers. Strategies for the prevention of unintended pregnancy include comprehensive and appropriate contraception and sexual education, availability of reproductive health services and increased access to a range of effective contraceptive methods (Trussell 2009). During family planning counselling, clients should be given adequate information in order for them to make an informed choice about a contraceptive method (WHO 2004). Information given to clients about contraceptive methods should include the relative effectiveness, correct use, common side effects, health risks and benefits, and signs and symptoms that would necessitate a return to the clinic (WHO 2004).
A Cochrane systematic review concluded that a combination of educational and contraceptive interventions could reduce unintended pregnancy among adolescent groups (Oringanje 2009). Many global, regional and national health organisations have implemented a variety of interventions to improve the quality of family planning counselling in order to address a wide range of factors related to unintended pregnancy, in particular the improvement of contraceptive use and compliance. Some investigators and health organisations have tried to improve family planning counselling by adding audio or visual materials to the content of the counselling process; this is known as 'structured counselling' (Johnson 2010; Martin 2003). However, evaluation studies of the effects of current strategies show inconsistent evidence of effectiveness. In this review we intend to elucidate which strategy works better for reducing unwanted pregnancy: structured contraceptive counselling or usual care.
Description of the intervention
Effective communication is essential to help family planning clients make informed decisions when they are faced with choosing between multiple contraceptive methods. However, family planning clients are frequently passive in communicating their needs and preferences (Kim 2001). Public health professionals, reproductive health providers and major health organisations such as World Health Organization (WHO) have introduced counselling interventions as a key element in family planning care, to improve contraceptive use and compliance in order to prevent unintended pregnancy (Landry 2008; WHO 2004).
Providing family planning counselling is now considered a standard component of reproductive health care. Efforts to link improved counselling with contraceptive use have been associated with the quality of care. Some studies have demonstrated that providing adequate information to clients about side effects during their counselling increases contraceptive continuation (Canto De Cetina 2001). A Cochrane review concluded that a combination of intensive counselling interventions and multiple personal communications between clients and providers may be needed to improve acceptability and the successful use of contraceptives (Halpern 2011). They reviewed the effects of all intensive counselling techniques, including group motivation, structured, peer or multi-component counselling, on adherence to and acceptability of hormonal methods of contraception (Halpern 2011).
Some approaches to counselling might be more effective than others. For instance, structured counselling has been designed to prevent unintended pregnancy. Any counselling consisting of audio and visual materials with standardised information is known as structured counselling, a definition which is used in this review (Langston 2010). Using a structure provides a framework for the counselling process, allowing the client to visualise and hear the information in order to progress through the stages towards an informed choice of a medically appropriate contraceptive that truly meets their needs. Structured counselling is standardised in that clients receive tailored and well-structured information on the effectiveness, use and possible side effects of contraceptive method(s). Another component of structured counselling is the opportunity for participants to ask questions and receive correct answers. Therefore, an interactive computer application used by a health care provider, who is available for questions afterwards, will be included in this review. Different types of structured counselling interventions have been introduced in recent years to improve the quality of care in counselling. For example, the Population Council introduced the 'Balanced Counselling Strategy (BCS)' (Martin 2003). A balanced counselling strategy combines an algorithm of family planning counselling with a set of job aids: cards and pamphlets on methods available to improve the quality of counselling. When providers have used both the algorithm and the job aids, the quality of counselling has improved (León 2003). Three job aids used in the BCS are: 1) a poster describing the new counselling model, with step by step guidance for the provider, 2) a set of 11 palm-sized cards, one per contraceptive method offered and 3) a set of 11 four-page pamphlets, describing each method. The BCS intervention has improved worker performance by minimising reliance on memory and promoting compliance with standards (León 2003). The BCS was developed and tested in Kenya, Bangladesh and South Africa and has been integrated into the national family planning programmes of many countries (León 2008).
Another structured counselling intervention developed by the WHO is called the 'Decision-Making Tool' (DMT) for family planning clients and providers (Johnson 2010). The DMT is designed to enhance the quality of care by improving the counselling process through better client-provider interactions, the provision of accurate information and by increasing informed choice. The DMT is essentially a generic, two-sided flip chart that providers use in their counselling discussions with family planning clients. Studies have shown that the DMT could improve health communication between provider and client (Kim 2007), and that it is useful both as a job aid for providers and as a decision aid for clients (Kim 2005). Field testing of the Decision-Making Tool was conducted in five countries by a team from the Johns Hopkins University/Center for Communication Programs and the WHO. It has been translated into nearly 20 languages and has been introduced in nearly 50 countries (Johnson 2010).
How the intervention might work
The designers of structured counselling believe that using audiovisual components and standard information, giving clients personalised and tailored information and helping them clarify their values regarding contraceptive benefits and risks will ultimately help them to choose a method that suits their circumstances and preferences (Johnson 2010). For counsellors, the structured process could help them to provide more complete information, improve their performance by reducing guesswork and promote compliance with standards (Kim 2007). Reproductive health providers in developing countries frequently receive limited training and supervision. Structured counselling may therefore be useful in low- and middle-income countries where access to education and hence literacy remains limited for many women.
Why it is important to do this review
There is currently uncertainty regarding the effects of structured counselling and hence a need for a rigorous review to elucidate this clearly. Given the high prevalence of unintended pregnancy and its potential impact on families, the necessity of contraceptive counselling in health systems and the need for resource efficiency in health care, a comprehensive summary of studies is needed to assess the effects of structured counselling on contraceptive choice, initiation, compliance and, ultimately, the prevention of unintended pregnancy.
To assess the effects of different types of structured versus routine family planning counselling techniques for women (or less commonly, men) on contraceptive choice, initiation and compliance as primary outcomes.
Criteria for considering studies for this review
Types of studies
Eligible studies will be all publications and project reports containing a comparison group, if they examine the effectiveness of structured versus routine family planning counselling approaches. We will therefore include all randomised controlled trials, including cluster-randomised trials, quasi-randomised trials and pre-post intervention studies. We will exclude all descriptive, case-control and cohort studies, where the study design is not interventional.
Types of participants
Eligible participants in the studies will be:
clients: women or men of reproductive age who are consumers or potential users of contraceptive methods (married or unmarried and of any socio-economic and educational level); and
providers of family planning services, including women and men (educated and qualified providers).
Types of interventions
Eligible counselling interventions will be as follows.
Counselling should have been carried out with women, men or both.
Contraception consultation could have been conducted in a clinical setting (public or private) or in the community (e.g. door-to-door consultations).
The provider should have conducted person-to-person communication with family planning client(s) or group counselling (we will exclude interactive computer-based applications that are not provided by a person because there is no opportunity for the participants to ask questions and receive answers).
The counselling package may include structured counselling based on the definition introduced by Langston, which includes standardised, non-directive, visual and/or audio components consisting of comprehensive information about contraceptive methods (including an overview, information about contraceptive choice, medical eligibility criteria, possible side effects, how to use, when to start and what to remember to allow the participant to use the method correctly) (Langston 2010). Examples of structured counselling include watching an educational video, using educational pamphlets or flip charts such as WHO's DMT, counselling leaflets and other audiovisual sets.
We will include studies that compare structured family planning counselling (i.e. counselling which has audio and/or visual components with standardised information about contraceptive methods) and routine care (i.e. any contraceptive delivery system with or without counselling that is routinely offered by the providers and does not include audio or visual components and standardised contraceptive information). We will exclude structured counselling interventions that do not clearly report all the criteria used in a structured approach (such as using audio and/or visual components and standardised information on contraceptive method(s)).
Types of outcome measures
The primary outcomes will be contraceptive choice (types), initiation (yes/no) and compliance (yes/no) (consisting of continuation and correct use). To be eligible, studies must report results compatible with the following outcomes.
Contraceptive method choice or initiation
Any contraceptive method (modern or traditional method)
A very effective contraceptive method (a long-acting, reversible method)
Discontinuation rate (first selected method and any very effective method) within three, six and 12 months
Switching to another contraceptive method within three, six and 12 months of use
Discontinuation rate, for any reason, within three, six and 12 months of contraceptive use
We will not consider any secondary outcomes.
Search methods for identification of studies
We will include all computerised databases from governmental and non-governmental agencies that are available to us in print or online, without any language restriction. We will translate papers that are not in English with the help of the Cochrane Fertility Regulation Group. The full search strategies, which are compatible with search strategy developed by the Cochrane Fertility Regulation Group, are shown in Appendix 1.
We will search the following computerised databases: Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE using PubMed, the Excerpta Medica database produced by Elsevier Science (EMBASE), Cumulative Index to Nursing and Allied Health (CINAHL), PMC using PubMed, POPLINE, LILACS, HealthSTAR, System for Information on Grey Literature in Europe (OpenSIGLE) and PsycINFO for studies comparing structured versus routine family planning counselling. We also will search the WHO International Clinical Trials Registry Platform (ICTRP) and ClinicalTrials.gov to find recent clinical trials. We will use the search strategies shown in Appendix 1 for each computerised database.
Searching other resources
We will handsearch the following journals:
Journal of Practical Obstetrics and Gynecology (1986 to current issue)
Reproduction and Contraception (1981 to current issue)
Journal of Reproductive Medicine (1992 to current issue)
Advances in Contraception (1998 to current issue)
Journal of Family Planning and Reproductive Health Care (1975 to 1997 completed; 1998 to current issue)
Contraception (1997 to current issue)
European Journal of Contraception and Reproductive Health Care (1996 to current issue)
Family Planning Perspectives (1969 to current issue)
Studies in Family Planning (1963 to current issue)
Population Reports (all series)
We will examine the articles listed in reviews and the references of the included studies for further study reports. We will also contact experts in the field of contraception from the World Health Organization (WHO)/Human Reproduction (HRP), FHI 360 and the Population Council for unpublished studies.
Data collection and analysis
Selection of studies
Two authors will independently select studies based on the inclusion criteria using the titles and abstracts retrieved by the searches. We will also assess studies by their design. If there is any disagreement between the first two review authors, we will obtain and separately evaluate the full-text paper. We will resolve persistent disagreement between the review authors about which studies to include by discussion and/or by involving the last review author, who is an expert in public health and the most experienced systematic review author. She will also randomly screen 10% of the studies to estimate the degree of disagreement. We will exclude irrelevant studies and those which do not present any of the predefined outcome measures. We will document reasons for exclusion. In the study selection process, each study (rather than each paper) will be the unit of interest in the review, so we will collate multiple reports of the same study.
Data extraction and management
Two review authors will independently extract data directly from the full papers and reports of eligible studies, as well as missing data received from contact authors of the original articles, using a special data extraction form. We will resolve any disagreement regarding data extraction by involving the last review author (SJ). Two authors will enter the abstracted data in to Review Manager 5 (RevMan 2012). We will pilot test the data extraction form, which will include as a minimum the following subsections:
General characteristics of the included studies: author, date of the study, language of paper, funding and setting (including country, state, region, community).
Participants: unit of randomisation (single clients, couples, clinics), contraceptive method, age, gender and other socio-demographic characteristics of the participants.
Methods: the quality of concealment of allocation of the study groups (whether sufficient, insufficient, unclear), type of trial (randomised controlled trials, including cluster-randomised trials, quasi-randomised trials and pre-post intervention studies), provider and outcome assessor blinding, duration of the study, extent of loss to follow-up, co-interventions and other potential confounders.
Interventions: nature, how the intervention was delivered to the study and control group (standard and structured versus routine family planning counselling), timing of the intervention (post-delivery, post-abortion, other situations), duration and length of follow-up.
Outcome measures and results: differences between intervention and control groups in terms of contraceptive method choice, initiation and compliance (primary outcomes).
Assessment of risk of bias in included studies
Two review authors will independently assess the methodological quality of eligible studies. We will calculate and report the level of agreement between the two authors. We will resolve any disagreement by discussion with a third review author.
We will assess the risk of bias using a domain-based evaluation as recommended by the Cochrane Handbook for Systematic Reviews of Interventions (Higgins 2011). We will consider factors such as study design, randomisation method (where applicable), allocation concealment, blinding and losses to follow-up. We will assess randomised and non-randomised studies using the same dimensions, which include selection bias (concerning comparability of groups, confounding and adjustment), performance bias (concerning the fidelity of the interventions and the quality of the information regarding who received which interventions, including blinding of participants and health care providers), detection bias (concerning unbiased and correct assessment of outcome, including blinding of assessors), attrition bias (concerning completeness of sample, follow-up and data) and reporting bias (concerning publication biases and selective reporting of results).
Measures of treatment effect
The outcomes listed in the Types of outcome measures are very diverse. We will calculate the effects of interventions using a risk ratio (RR) or the Mantel-Haenszel odds ratio (OR) with 95% confidence interval (CI), with a fixed-effect model for dichotomous variables. For continuous variables we will calculate a mean difference (MD) with 95% CI, with a fixed-effect model. For studies with more than 20% loss to follow-up, we will use sensitivity analysis based on rates of loss to follow-up (Schulz 2006).
Unit of analysis issues
We will conduct meta-analysis for pooled estimates, if the interventions are not diverse. We will follow the methods of combining groups and transforming outcome data outlined in the Cochrane Handbook for Systematic Reviews of Interventions in the case of cluster-randomised trials trials (Higgins 2011). For trials with multiple comparison groups, we will assess the relevant intervention groups or we will combine all relevant experimental interventions and control groups into a single relevant group, if possible.
Dealing with missing data
In case of missing data, we will contact the primary study investigators to request this. We will show all responses and data provided in the 'Characteristics of included studies' table. We will carry out the analysis according to the intention-to-treat (ITT) principle for those studies where information related to missing data is not available. Where we make any assumptions about missing data, we will report the potential impact in the 'Discussion' section of the review (Higgins 2011).
Assessment of heterogeneity
We will test the outcome data for heterogeneity using the I2 statistic, if the studies have combinable data. In cases where substantial heterogeneity is evident (I2 value exceeds 50%), we will employ a DerSimonian and Laird random-effects model to provide a more conservative estimate of effect (Higgins 2003).
If the interventions are very diverse, we will not conduct meta-analysis. We will therefore assess sources of heterogeneity without pooling the data and note any heterogeneity due to differences in study design and population.
Assessment of reporting biases
We will assess biases at the study level according to the Cochrane Handbook for Systematic Reviews of Interventions (Kirkham 2010). If there are a sufficient number of studies for any outcome, we will use a funnel plot to identify possible reporting biases.
We will select and use a data synthesis method based on the diversity of studies (heterogeneity) included in the review. If it is not possible to conduct meta-analysis due to a low number of eligible studies or high heterogeneity, we will only describe and summarise the characteristics and results of the studies. We will then assess the quality of evidence for this review and summarise this. We will consider included studies to be at low, high or unclear risk of bias for selection, performance, detection and attrition biases.
Subgroup analysis and investigation of heterogeneity
We will conduct subgroup analysis based on intervention type (for example, randomised controlled trials, quasi-randomised trials and pre-post intervention studies), structured counselling type, participant characteristics (for example, client sex), contraceptive type and study setting (private/public).
We will perform the following set of sensitivity analyses, if there are a sufficient number of trials:
repeating the analysis excluding unpublished or low-quality studies;
repeating the analysis excluding studies with no control group (pre-post intervention studies)
The authors are extremely grateful to members of the Cochrane Fertility Regulation Group, especially Dr. Anja Helmerhorst, Managing Editor and the great reviewers, who accepted the idea for this protocol and provided generous encouragement and advice.
Contributions of authors
Hamidreza Farrokh-Eslamlou: had the idea for the review, designed the protocol and developed the search strategy, and will select trials based on the inclusion criteria, evaluate the quality of the trials, extract data, conduct the analyses and write the review.
Siamak Aghlmand: will search for and assess articles.
Davoud Khorasani-Zavareh: assisted in preparing the protocol, and will extract data, conduct data analysis and assist in writing the review.
Sakineh Mohammad-Alizadeh Charandabi: will search for trials, help with data analysis and write the review.
Fatemeh Moghaddam-Tabrizi: will search for trials, select trials based on the inclusion criteria, help with data extraction and write the review.
Shayesteh Jahanfar: assisted in editing the protocol, and will resolve disagreements, help with the data analyses and edit the review.