Description of the condition
The World Health Organization (WHO) defines injury as "a bodily lesion at the organic level, resulting from acute exposure to energy in the work environment (mechanical, thermal, electrical, chemical or radiant) in amounts that exceed the threshold of physiological tolerance. In some cases (e.g. drowning, strangulation, freezing), the injury results from an insufficiency of a vital element" (Baker 1984). Among the various injuries, traumatic upper limb injuries frequently occur in mechanised industry when people interact with machines, at home, during transportation, and in recreation and sports activities (King 1992). Due to the complex physical arrangement, traumatic upper limb injuries often involve varying degrees of damage to, or even loss of, tissue such as the skin, tendons, nerves, blood vessels, bones, or the whole upper limb. Due to the multiple systems affected (that is musculoskeletal, vascular, nervous, or tendinous) in traumatic upper limb injuries, the resultant impairment is often devastating (Cooper 2007). Therefore, a comprehensive return-to-work (RTW) rehabilitation programme following traumatic upper limb injuries aims to enable resumption of participation in work and leisure activities (Blackmore 1992).
In Taiwan, traumatic upper limb injuries are the most frequent type of occupational injury and the major cause of functional impairment and work-related disability (accounting for 45% of 14,261 occupational injuries and 55.8% of occupational permanent disability benefits in 2010) (CLA 2011). In the UK, upper limb injuries were the most frequent type (47.3%) of non-fatal injury to employees in 2010 to 2011 (HSE 2012). In Australia, during the period 1 July 2002 to 30 June 2004, there were 16,712 cases (32%) of work-related hand and wrist injuries resulting in hospitalisation. In Victoria alone, 12,491 (32.7%) of emergency department presentations were work-related hand and wrist injuries over the two-year period (ASCC 2008). The incidence of upper extremity injury in the US was slightly lower. In 2010, about 25.1 % of nonfatal occupational injuries and illnesses with days away from work per 10,000 full-time workers were related to upper limb injuries (BLS 2010). Undoubtedly traumatic upper limb injuries cause considerable losses in working days and productivity (Ebel 2004). However, survivors of severe injuries can achieve a quality of life (QoL) comparable with the normal population after returning to their previous jobs (Post 2006). On the other hand the permanent dysfunction of limb injured workers not only limits their daily activities but also directly affects their outcomes in their RTW. For a worker with traumatic upper limb injuries, RTW plays an important role in economic productivity and regaining meaningfulness in life. Therefore, the goals of rehabilitation for patients with traumatic upper limb injuries should be functional independence and RTW.
Description of the intervention
A person's ability to work can be profoundly affected by their disease, disability, and a range of contextual factors. Rehabilitation medicine is integral to the process leading to going back to working life after illness or injury, but other rehabilitation disciplines are also essential. It is important to clarify what rehabilitation physicians or trainees in rehabilitation medicine need to know about vocational rehabilitation (VR).
VR is a process whereby those disadvantaged by illness or disability can be enabled to access, maintain, or return to employment. This applies to those with temporary and permanent impairments. Miscellaneous VR programmes are involved, in parallel, during the process of returning to the labour market after an injury. In this review, VR is defined as changes or interventions with the aim of facilitating a worker's employment after injury. These may include one or more of the following: education, follow-up by a case manager, occupational therapy, worksite visits, on-site management, vocational guidance, occupational health services, work hardening, work modification, job accommodation, work adjustments, work reintegration plans, or ergonomic interventions. VR deals mainly with rehabilitation on the basis of the International Classification of Functioning, Disability and Health (ICF)-level of 'participation' (WHO 2001).
Workers who have not returned to work within two to three months after injury are at high risk of disability and dropping out of the work arena completely (Frank 1996). Therefore, encouraging early RTW by intervening at the workplace may be an efficient way to minimise socioeconomic and personal consequences (Elders 2004).
How the intervention might work
VR targets promoting employment opportunities for the disabled. When a defect due to trauma affects functional capacity for work or employment, the need for VR should be considered (Gobelet 2006). There are various factors influencing RTW. The chance of RTW is higher among patients who have more positive factors such as younger age, male gender, higher education, white collar work, less injury severity, less disability, more self-efficacy, and better psychological or QoL condition (Chamberlain 2009). Factors may be personal or medical, and some are external influences, that is where the context is outside the individual such as activity, participation, and environmental factors in the International Classification of Functioning, Disability and Health (ICF), which are categorised in the ICF Environmental factors (WHO 2001).
Although the interventions of VR vary, their purpose is in general "to maximise the ability of an individual to return to meaningful employment" (BSRM 2000). In other words, the best rehabilitation practice in RTW enhances work and activity tolerance, prevents illness behaviour, and reduces pain and the effects of illness or disability (Gobelet 2006). Therefore, VR helps the injured people in mitigating work disability, accelerating return to meaningful employment, minimising workdays lost, increasing the productivity of injured workers, reducing premature retirement, and containing the welfare cost (Disler 2001).
Alhough the Association of British Insurers has suggested that functional and vocational rehabilitation for severe injuries should be administered after a medical plateau is reached (that is when the worker's medical condition has stabilised and further significant medical improvement is unlikely) (ABI & TUC 2002), early intervention (after sufficient time for healing of injured structures) and the patient's active involvement have been shown to decrease deconditioning (that is due to immobility, the decrease of physiological adaptation to normal conditions) and illness behaviour and foster higher RTW rates (ABI & TUC 2002). Early VR programmes are likely to increase both job and physical well-being and to decrease the need for a disability pension and sick leave. According to a review on the general effects of rehabilitation on unspecified disability by Kuoppala 2008, VR and multimodal medical treatment combined with VR increase the RTW risk ratio (RR) to 1.53 (95% confidence interval (CI) 1.42 to 2.00) and RR 1.5 (95% CI 0.93 to 2.41), respectively. Moreover, VR delivered to people at risk of job loss (but still employed) can delay job loss (Allaire 2003). In this respect, VR can improve patients' QoL and well-being as well as reduce loss of workforce.
Why it is important to do this review
Several VR programmes have been used for traumatic upper limb injuries without a critical appraisal of their benefits. Traditional rehabilitation has emphasised training to improve strength, endurance, sensory function, and range of motion. However, recent reviews have shown that various novel VR programmes are effective in enhancing RTW in workers with various diseases or conditions (Aas 2011; Arends 2012; de Boer 2011; Khan 2009; Schaafsma 2010; van Oostrom 2009). Yet only a few systematic reviews have examined the effectiveness of VR in enhancing early RTW. According to the systematic review by Franche 2005, there is moderate to strong evidence that five kinds of VR, including early contact by the workplace, work accommodation, contact between healthcare provider and workplace, an ergonomic worksite intervention, or the use of a RTW co-ordinator, can shorten the duration of work disability (Franche 2005). The van Oostrom 2009 review on the other hand focused on people with low back pain, recurrent musculoskeletal disorders, job stress, or chronic work-related upper extremities disorders. Other published Cochrane reviews have assessed the effectiveness of measures to improve RTW in a range of patient populations including those with brain injuries (Nair 2008), back pain (Schaafsma 2010), neck pain (Aas 2011), multiple sclerosis (Khan 2009), and cancer (de Boer 2011), which are all different from our target population of people with traumatic upper limb injuries. To date, no-one has used Cochrane methods to assess the effectiveness of VR interventions to enhance RTW for workers with traumatic upper limb injuries.
To assess the effects of VR in enhancing RTW of workers with traumatic upper limb injuries.
Criteria for considering studies for this review
Types of studies
We planned to include all randomised controlled trials (RCTs) that compared VR with an alternative (control) intervention such as standard rehabilitation or an incomplete form of VR intervention (such as with limited advice on RTW, referral information, or liaison with employer), or wait-list controls.
Types of participants
We planned to include trials where participants were working age adults (18 to 65 years) who had been in paid employment (employee or self-employed) at the time of sustaining an acute episode of traumatic upper limb injury involving any parts of the fingers, hand, wrist, forearm, elbow, or arm, regardless of injury type and mechanism. We excluded trials where participants suffered from a subacute or chronic upper limb injury for over three months.
When a study included workers with various kinds of injuries, we planned to include it if 50% or more of the participants had sustained upper limb injuries and the study authors reported separate analyses for participants with upper limb injuries.
We excluded studies where participants had cumulative trauma disorders or repetitive strain injuries such as tendonitis or tendosynovitis, epicondylitis, carpal tunnel syndrome, or the like. We also excluded studies where participants had coexisting injuries to the central nervous system (that is brain or spinal cord), or to internal organs.
Types of interventions
We planned to include any type of intervention with the aim of enhancing RTW. Interventions may have been carried out either with an individual or in a group, and in a clinical setting or in the community. Interventions could primarily focus on different factors which influence RTW, for example on coping (in psychological interventions), workplace adjustments (in vocational interventions), or physical exercises (in physical interventions). Interventions were divided into the following.
- Psychological: any type of psychological intervention such as counselling, education, training in coping skills, cognitive-behavioural interventions, and problem solving therapy (PST) undertaken by any qualified professional (such as a psychologist, social worker, or nurse).
- Vocational: any type of intervention focused on employment. Vocational interventions may be person-directed or work-directed. Person-directed vocational interventions are aimed at the patient and incorporate programmes which aim to encourage RTW, vocational rehabilitation, or occupational rehabilitation. Work-directed vocational interventions are aimed at the workplace and include workplace adjustments such as modified work hours, modified work tasks, or modified workplace, and improved communication with or between managers, colleagues, and health professionals.
- Physical: any type of physical training (such as functional capacity training, work hardening training), physical exercises (such as tendon exercises, nerve gliding exercises), or training of bodily functions (such as muscle strengthening, balance training, endurance training, sensory re-education, range of motion).
- Multifaceted: a combination of psychological, vocational, and physical interventions.
Where there were multiple intervention groups within a trial, we planned to conduct pairwise comparisons of an intervention versus no intervention, placebo, or another intervention.
Types of outcome measures
RTW included return to either full- or part-time employment, to the same or a reduced role, and to either the previous job or any new employment (Clay 2010). We planned to perform separate subgroup analyses of: return to the previous role (either under the same or a new employer), return to a reduced role (either under the same or a new employer), change from full-time to part-time employment, and change to a reduced pay employment. We planned to consider two types of RTW data:
• RTW measured as time-to-event data, such as number of days between reporting sick and any work resumption, or the number of days on sick leave during the follow-up period (Ebel 2004; MacKenzie 1998; MacKenzie 2006).
• Functional status: measures related to job demands or activities of daily living that are expressed in terms of 'can perform the task' or 'cannot perform the task' (Burke 1994; Pransky 2005; Soberg 2010).
Search methods for identification of studies
We searched the following electronic databases, from inception:
1. CISDOC, HSELINE, International Bibliographic, NIOSHTIC, NIOSHTIC-2, RILOSH (OSH update, searched on 10 December 2012);
2. Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library 2012, Issue 11) (November);
3. MEDLINE through PubMed (1946 to 15 November 2012);
4. EMBASE (1947 to 28 November 2012);
5. CINAHL (1937 to 5 May 2013);
6. PsycINFO (searched on 7 December 2012).
Searching other resources
In an effort to identify further published, unpublished, and ongoing studies, we:
- scanned the reference lists of relevant review articles and planned to scan the reference lists of included studies;
- contacted experts in the field of occupational health and safety;
- planned to write to the authors of included studies to obtain additional references, unpublished trials, and ongoing trials, or to obtain missing data not reported in the original publication.
We had no limitations on language, publication status, or date of publication.
Data collection and analysis
Selection of studies
Two authors (WHH and CCC) independently selected suitable studies for inclusion in this review by screening the titles and abstracts of studies identified from the electronic databases. If the title and abstract provided sufficient information to determine that the inclusion criteria were not met, we excluded the study. We further checked the full text of the study if the study could not be excluded with certainty. When the two authors disagreed about the inclusion of a study, we resolved disagreements by discussion. A third author (HLL) arbitrated when necessary. We listed the studies that could only be excluded after reading the full text and have provided the reasons for exclusion in the 'Characteristics of excluded studies' table.
Data extraction and management
We planned to extract and summarise details of included studies using a standardised data extraction form. Where studies had been published more than once, we planned to extract data from all reports and consider the one with the greatest amount of data as the primary reference. Two authors (WHH and CCC) planned to independently extract the following data:
- author, title, source of reference, country, and publication year;
- number and description of participants;
- intervention and comparison;
- concomitant interventions;
- who delivered the intervention;
- primary and secondary outcome data and methods of measurement;
- duration of follow-up.
Assessment of risk of bias in included studies
Two authors (WHH and CCC) planned to independently assess each included study using the Cochrane Collaboration tool for assessing risk of bias as described in the Cochrane Handbook for Systematic Reviews of Interventions (Higgins 2011). This tool addresses specific domains, namely random sequence generation, allocation concealment, blinding of participants and personnel, blinding of outcome assessment, incomplete outcome data, selective reporting, and other sources of biases (for example extreme baseline imbalance) (see Appendix 7 for details of the criteria). We planned to assess the blinding and completeness of the outcome data for each outcome separately and generate a 'Risk of bias' table for each included study. When the two authors disagreed about a particular judgment for the risk of bias, we planned to resolve disagreements by discussion and a third author (HLL) would arbitrate if necessary.
We planned to present the assessments of risk of bias in a summary figure to illustrate all of the judgments in a cross-tabulation of studies.
Measures of treatment effect
We planned to plot the results of each RCT as point estimates, such as risk ratios (RRs) for dichotomous outcomes, means and standard deviations (SDs) for continuous outcomes, or other types of data as reported by the authors of the studies. When the results could not be plotted, we planned to describe them in the 'Characteristics of included studies' table, or enter the data into 'Additional tables'.
We planned to plot time-to-event data as hazard ratios (HRs). If Kaplan-Meier curves were presented, we planned to extract the data from the graphs and calculate HRs according to the methods given in the Cochrane Handbook for Systematic Reviews of Interventions (Higgins 2011).
Unit of analysis issues
All observed participants in the intervention and control groups were the planned primary unit of analysis. For studies that employed a cluster-randomised design but did not make an allowance for the design effect, we planned to calculate the design effect based on a fairly large assumed intra-cluster correlation of 0.10. We based this assumption, by analogy, on studies about implementation research (Campbell 2001). We planned to follow the methods stated in the Cochrane Handbook for Systematic Reviews of Interventions (Higgins 2011) for the calculations.
Dealing with missing data
We planned to contact study authors to obtain missing data. Where we could not obtain missing data from study authors, we planned to judge the trials with incomplete outcome data according to the criteria recommended by the Cochrane Handbook for Systematic Reviews of Interventions (Higgins 2011). For example, if statistics were missing, such as SDs, we planned to calculate them from other available statistics such as P values.
Assessment of heterogeneity
We planned to assess clinical homogeneity based on similarity of population, intervention, outcomes, and follow-up. We planned to categorise study participants into jobs with high hand load, such as typing or lifting small objects, and into jobs with low upper limb load, such as in monitoring or receptionist work. Otherwise we planned to consider study populations as similar if the participants had been in paid employment when 50% or more of them had sustained an acute episode of traumatic upper limb injury involving any parts of the fingers, hand, wrist, forearm, elbow, or arm, regardless of injury type and mechanism, and regardless of occupation or type of work. We planned to consider interventions as similar if they fell into one of the predefined categories of interventions (as stated in the paragraph on criteria for including studies). We planned to consider the RTW outcomes and sick leave duration outcomes as similar. We planned to regard follow-up periods of less than three months, three months to one year, and more than one year as different. In addition, we planned to test for statistical heterogeneity by means of the Chi
Assessment of reporting biases
We planned to reduce the effects of reporting bias by including studies and not publications to avoid the introduction of duplicate data (that is two articles may represent duplicate publications of the same study). Following the Cho 2000 statement on redundant publications, we attempted to detect duplicate studies and, if more than one article reported on the same study, we planned to extract data only once. We prevented location bias by searching across multiple databases. We prevented language bias by not excluding any article based on language. We planned to assess publication bias with a funnel plot if at least 10 studies were available for the primary outcome and could be included in the funnel plot.
We planned to pool data from studies judged to be clinically homogeneous using RevMan 2012. If sufficient data were available, we planned to perform meta-analyses. When studies were statistically heterogeneous, we planned to use a random-effects model; otherwise we planned to use a fixed-effect model. When using the fixed-effect model, we planned to conduct a sensitivity analysis by using the random-effects model to test if there were differences in the results. We planned to include 95% CIs for all estimates. For the analysis of HRs, we planned to use the inverse variance method in RevMan 2012. For RTW outcomes we planned to deem time to RTW, the rate of RTW, and the number of days on sick leave sufficiently similar to be combined in a meta-analysis. We planned to use effect sizes to combine continuous and dichotomous RTW outcome data. We planned to use the mean number of days off work to calculate the effect size for the days on sick leave with the following formula: mean change difference over standard deviation (Håland 2002). For the HRs and rate ratios, we planned to take their natural logarithms and transform them into effect sizes as recommended in the Cochrane Handbook for Systematic Reviews of Interventions (Chinn 2000; Higgins 2011). We planned to use effect sizes and their standard errors as input in the meta-analysis using the generic inverse variance method. After meta-analysis, we planned to re-calculate a mean difference in time-to-RTW from the pooled effect size using the median SD of the included studies in the formula: pooled mean difference = pooled effect size x median SD.
We planned to use the GRADE approach as described in the Cochrane Handbook for Systematic Reviews of Interventions (Higgins 2011) and implemented in the GRADEPro 3.6 software (GRADEpro) to present the quality of evidence and 'Summary of findings' tables.
The downgrading of the quality of a body of evidence for a specific outcome would be based on five factors:
- limitations of study;
- indirectness of evidence;
- inconsistency of results;
- imprecision of results;
- publication bias.
The GRADE approach specifies four levels of quality (high, moderate, low, and very low) (van Tulder 2003).
Subgroup analysis and investigation of heterogeneity
We planned to perform subgroup analyses according to injury severity or body parts, setting, and quality of the study, because these variables could potentially affect the intervention effect estimates.
We planned to conduct a sensitivity analysis to test the robustness of our meta-analysis results by excluding studies judged to have a high risk of bias.
Description of studies
Results of the search
We identified a total of 332 records and assessed 15 as full text for eligibility for this review. See Figure 1 for a study flow diagram.
|Figure 1. Study flow diagram.|
None of the studies that we assessed for eligibility met our inclusion criteria.
We considered 15 studies potentially eligible and retrieved their full texts. However, all of them failed to meet the inclusion criteria and therefore we excluded them. We present descriptions of all 15 studies with the reasons why we excluded them in the Characteristics of excluded studies.
Risk of bias in included studies
We did not include any randomised controlled trials and so there was no risk of bias to assess.
Effects of interventions
We did not include any randomised controlled trials and so we did not conduct any analyses.
Summary of main results
We did not identify any RCTs addressing the efficacy of VR in enhancing RTW in workers with traumatic upper limb injuries. Most of the studies identified from the searches evaluated the effects of range of motion exercise and physical training to facilitate early RTW. A number of identified RCTs compared different policies of workplace accommodation, counselling, case management, or worksite visits for workers with chronic musculoskeletal problems of the upper extremities (Cheng 2007; Haahr 2005; Li 2006). There were also clinical trials comparing surgical intervention and medical rehabilitation (that is splinting, mobilising, or strengthening) for upper limb injuries during hospitalisation (Feehan 2004; Lubbert 2008; Unsworth-White 1994). Various VR programs have been developed to help workers who have sustained traumatic upper limb injury to return to the labour market. However, we found no high-level evidence to either support or refute the effects of VR in enhancing RTW in workers with traumatic upper limb injuries.
Overall completeness and applicability of evidence
The absence of randomised trials eligible for inclusion in this review illustrates that the evidence on VR for enhancing RTW in workers with traumatic upper limb injuries is unclear and incomplete. All of the studies that we retrieved in the searches had assessed the effects of different rehabilitation after immobilisation or enhancing range of motion strategies at acute medical stages, which we had pre-specified as exclusion criteria for this review.
Potential biases in the review process
We made every attempt to limit bias in the review process by ensuring a comprehensive search for potentially eligible studies. The authors' independent assessments of eligibility of studies for inclusion in this review minimised the potential for additional bias.
Agreements and disagreements with other studies or reviews
We found a systematic review of early prognostic factors for RTW following orthopaedic trauma (Clay 2010). This review used prospective and retrospective cohort studies and explored prognostic factors either at pre-injury or at the early post-injury phase. Two prospective studies that used survival analysis found that providing modified work (Seland 2006) and strong practical support (MacKenzie 1998) increased the likelihood of RTW, to 1.24 and 1.7 times respectively. However, none of the studies included in the Clay 2010 review assessed the effectiveness of VR intervention for acute orthopaedic injuries.
There are several RCTs focusing on the effects of rehabilitation intervention for adults with distal radial fractures. Their results have been pooled in a Cochrane systematic review by Handoll 2006. The types of rehabilitation interventions examined in these studies are limited to hand therapy or medical rehabilitation and no further VR programs have been arranged for patients with orthopaedic trauma.
Implications for practice
Despite a thorough search for evidence relating to the efficacy of VR for enhancing RTW in workers with traumatic upper limb injuries, we found no relevant randomised trials. This review therefore found no evidence on the effect of VR for enhancing RTW in workers with traumatic upper limb injuries.
Implications for research
VR programmes have been proposed to help injured people in mitigating work disability, accelerating return to meaningful employment, minimising workdays lost, increasing productivity, reducing premature retirement, and containing the welfare cost (Disler 2001). The fact that VR has been constantly provided as part of occupational health care despite a lack of high-quality evidence for its effectiveness in this population underlines the necessity for RCTs of this intervention.
Another way to fill the evidence gap is to make better use of RCTs of general rehabilitation measures which should also include RTW outcomes, preferably the number at work at end of follow-up or the time taken to return-to-work. The intervention should be well-described according to the elements that make up vocational rehabilitation. A careful process evaluation should show how well the intervention was implemented. Reporting should conform to the Consolidated Standards of Reporting Trials (CONSORT) statement (http://www.consortstatement.org), which will enable appraisal and interpretation of results and accurate judgments to be made about the risk of bias and the overall quality of the evidence.
We would like to thank Jos Verbeek, Jani Ruotsalainen, Risto Rautiainen, Wim van Veelen, Anneli Ojajärvi, and Leena Isotalo from the Cochrane Occupational Safety and Health Review Group for their extensive feedback, and Jani Ruotsalainen, Joey Kwong and Janet Wale for copy editing the text. We also thank Kaisa Neuvonen for her help in developing search strategies and executing searches.
Data and analyses
This review has no analyses.
Appendix 1. OSH update search strategy and results
Database: OSH update
Date run: 10.12.2012 (KN)
databases within OSH update: CISDOC, HSELINE, International Bibliographic, NIOSHTIC, NIOSHTIC-2, RILOSH
Appendix 2. CENTRAL search strategy and results
Date Run: 12/12/12 (KN)
Appendix 3. PubMed search strategy and results
Date run: 15.11.2012 (KN)
(("hand injuries"[MeSH Terms] OR hand injury[Text Word] OR hands injury[Text Word] OR hand injur*[Text Word] OR hands injur*[Text Word] OR "tendon injuries"[MeSH Terms] OR tendon injury[Text Word] OR tendon injur*[Text Word] OR "forearm injuries"[MeSH Terms] OR forearm injury[Text Word] OR forearm injur*[Text Word] OR forearms injur*[Text Word] OR "wrist injuries"[MeSH Terms] OR wrist injuries[Text Word] OR wrist injury[Text Word] OR wrist injur*[Text Word] OR wrists injur*[Text Word] OR "humeral fractures"[MeSH Terms] OR humeral fractures[Text Word] OR humeral fracture[Text Word] OR humeral fractur*[Text Word] OR humerus fracture[Text Word] OR humerus fractur*[Text Word] OR humeri fracture[Text Word] OR humeri fractur*[Text Word] OR "shoulder fractures"[MeSH Terms] OR shoulder fractures[Text Word] OR brachium fractur*[Text Word] OR brachial fractur*[Text Word] OR "radius fractures"[MeSH Terms] OR radius fractures[Text Word] OR radius fracture[Text Word] OR radius fractur*[Text Word] OR radii fractur*[Text Word] OR "ulna fractures"[MeSH Terms] OR ulna fractures[Text Word] OR ulna fracture[Text Word] OR ulna fractur*[Text Word] OR "Upper Extremity/injuries"[Mesh] OR upper extremity injury[Text Word] OR upper extremity injur*[Text Word] OR "finger injuries"[MeSH Terms] OR finger injuries[Text Word] OR finger injury[Text Word] OR finger injur*[Text Word] OR digit injury[Text Word] OR digit injur*[Text Word]) AND (("occupational medicine"[MeSH Terms] OR occupational medicine[Text Word] OR "occupational health"[MeSH Terms] OR occupational health[Text Word] OR "occupational health services"[MeSH Terms] OR occupational health services[Text Word] OR "rehabilitation"[Subheading] OR "rehabilitation"[MeSH Terms] OR rehabilitation[Text Word] OR "employment"[MeSH Terms] OR employment[Text Word] OR "work"[MeSH Terms] OR working[Text Word] OR "education"[Subheading] OR "educational status"[MeSH Terms] OR "education"[MeSH Terms] OR education[Text Word]) OR ("Rehabilitation, Vocational"[Mesh] OR "Counseling"[Mesh] OR "Vocational Guidance"[Mesh] OR work rehabilitation[Text Word] OR vocational*[Text Word] OR counseling*[Text Word] OR training*[Text Word] OR occupational rehabilitation*[Text Word] OR workplace intervention*[Text Word] OR workplace accommodation*[Text Word] OR workplace adjustment*[Text Word] OR modified-duty[Text Word] OR modified-duties[Text Word] OR modified work*[Text Word] OR case manager*[Text Word] OR work reintegration*[Text Word] OR work-site-visit*[Text Word] OR workplace vocational*[Text Word])) AND (("absenteeism"[MeSH Terms] OR absenteeism[Text Word] OR absenteeism*[Text Word] OR "sick leave"[MeSH Terms] OR sick leave[Text Word] OR sick leaves[Text Word] OR sickness leave[Text Word] OR Sickness absence[Text Word]) OR (return to work[Text Word] OR return-to-work[Text Word] OR "unemployment"[MeSH Terms] OR unemployment[Text Word] OR unemployed[Text Word] OR employability[Text Word] OR employable[Text Word] OR employee*[Text Word]) OR (disability management[Text Word] OR work ability[Text Word] OR work activity[Text Word] OR work disability[Text Word] OR work status[Text Word] OR work retention[Text Word] OR job retention[Text Word] OR workability[Text Word]))) AND (randomized controlled trial[pt] OR controlled clinical trial[pt] OR randomized[tiab] OR placebo[tiab] OR drug therapy[sh] OR randomly[tiab] OR trial[tiab] OR groups[tiab] NOT (animals[mh] NOT humans[mh]))
Appendix 4. EMBASE search strategy and results
Appendix 5. CINAHL search strategy and results
Data run: 05.05.2013
Appendix 6. PsycINFO search strategy and results
Database: PsycINFO (Ovid) 1967 to December Week 1/2012
Date run: 7.12.2012 (KN)
Appendix 7. Risk of bias assessment
1. Was the allocation sequence randomly generated?
Yes, low risk of bias
The investigators describe a random component in the sequence generation process such as: referring to a random number table; using a computer random number generator; coin tossing; shuffling cards or envelopes; throwing dice; drawing of lots.
No, high risk of bias
The investigators describe a non-random component in the sequence generation process. Usually, the description would involve some systematic, non-random approach, for example: sequence generated by odd or even date of birth; sequence generated by some rule based on date (or day) of admission; sequence generated by some rule based on hospital or clinic record number.
Insufficient information about the sequence generation process to permit judgement of 'Yes' or 'No'.
2. Was the treatment allocation adequately concealed?
Yes, low risk of bias
Participants and investigators enrolling participants could not foresee assignment because one of the following, or an equivalent method, was used to conceal allocation: central allocation (including telephone, web-based and pharmacy-controlled randomisation); sequentially-numbered drug containers of identical appearance; sequentially-numbered, opaque, sealed envelopes.
No, high risk of bias
Participants or investigators enrolling participants could possibly foresee assignments and thus introduce selection bias, such as allocation based on: using an open random allocation schedule (e.g. a list of random numbers); assignment envelopes were used without appropriate safeguards (e.g. if envelopes were unsealed or nonopaque or not sequentially numbered); alternation or rotation; date of birth; case record number; any other explicitly unconcealed procedure.
Insufficient information to permit judgment of 'Yes' or 'No'. This is usually the case if the method of concealment is not described or not described in sufficient detail to allow a definite judgment, for example if the use of assignment envelopes is described, but it remains unclear whether envelopes were sequentially numbered, opaque and sealed.
3. Blinding - was knowledge of the allocated interventions adequately prevented during the study?
Yes, low risk of bias
Any one of the following.
- No blinding, but the review authors judge that the outcome and the outcome measurement are not likely to be influenced by lack of blinding.
- Blinding of participants and key study personnel ensured, and unlikely that the blinding could have been broken.
- Either participants or some key study personnel were not blinded, but outcome assessment was blinded and the non-blinding of others unlikely to introduce bias.
No, high risk of bias
Any one of the following.
- No blinding or incomplete blinding, and the outcome or outcome measurement is likely to be influenced by lack of blinding.
- Blinding of key study participants and personnel attempted, but likely that the blinding could have been broken.
- Either participants or some key study personnel were not blinded, and the non-blinding of others likely to introduce bias.
Any one of the following.
- Insufficient information to permit judgement of 'Yes' or 'No'.
- The study did not address this outcome.
4. Were incomplete outcome data adequately addressed?
Yes, low risk of bias
Any one of the following.
- No missing outcome data.
- Reasons for missing outcome data unlikely to be related to true outcome (for survival data, censoring unlikely to be introducing bias).
- Missing outcome data balanced in numbers across intervention groups, with similar reasons for missing data across groups.
- For dichotomous outcome data, the proportion of missing outcomes compared with observed event risk not enough to have a clinically relevant impact on the intervention effect estimate.
- For continuous outcome data, plausible effect size (difference in means or standardised difference in means) among missing outcomes not enough to have a clinically relevant impact on observed effect size.
- Missing data have been imputed using appropriate methods.
No, high risk of bias
Any one of the following.
- Reason for missing outcome data likely to be related to true outcome, with either imbalance in numbers or reasons for missing data across intervention groups.
- For dichotomous outcome data, the proportion of missing outcomes compared with observed event risk enough to induce clinically relevant bias in intervention effect estimate.
- For continuous outcome data, plausible effect size (difference in means or standardised difference in means) among missing outcomes enough to induce clinically relevant bias in observed effect size.
- 'As-treated' analysis done with substantial departure of the intervention received from that assigned at randomisation.
- Potentially inappropriate application of simple imputation.
Any one of the following.
- Insufficient reporting of attrition/exclusions to permit judgement of 'Yes' or 'No' (e.g. number randomised not stated, no reasons for missing data provided).
- The study did not address this outcome.
5. Are reports of the study free of suggestion of selective outcome reporting?
Yes, low risk of bias
Any of the following.
- The study protocol is available and all of the study's pre-specified (primary and secondary) outcomes that are of interest in the review have been reported in the pre-specified way.
- The study protocol is not available but it is clear that the published reports include all expected outcomes, including those that were pre-specified (convincing text of this nature may be uncommon).
No, high risk of bias
Any one of the following.
- Not all of the study's pre-specified primary outcomes have been reported.
- One or more primary outcomes is reported using measurements, analysis methods or subsets of the data (e.g. subscales) that were not pre-specified.
- One or more reported primary outcomes were not pre-specified (unless clear justification for their reporting is provided, such as an unexpected adverse effect).
- One or more outcomes of interest in the review are reported incompletely so that they cannot be entered in a meta-analysis.
- The study report fails to include results for a key outcome that would be expected to have been reported for such a study.
Insufficient information to permit judgement of 'Yes' or 'No'. It is likely that the majority of studies will fall into this category.
6. Other sources of potential bias
Yes, low risk of bias
The study appears to be free of other sources of bias.
No, high risk of bias
There is at least one important risk of bias. For example, the study:
- had a potential source of bias related to the specific study design used; or
- stopped early due to some data-dependent process (including a formal-stopping rule); or
- had extreme baseline imbalance; or
- has been claimed to have been fraudulent; or
- had some other problem.
There may be a risk of bias, but there is either:
- insufficient information to assess whether an important risk of bias exists; or
- insufficient rationale or evidence that an identified problem will introduce bias.
Contributions of authors
WHH initiated and planned the review. WHH and HLL wrote the draft of the protocol. KKN provided related information for the traumatic upper limb injury background. CCC and HYC revised the protocol. WHH and HLL planned the search strategy. WHH and HLL undertook the search with the assistance of Trials Search Coordinator Kaisa Neuvonen from the editorial base of the Cochrane Occupational Safety and Health Review Group. WHH, CCC, and HLL participated in the decision-making process regarding inclusion and exclusion of trials. WHH, CCC, and HLL planned to participate in the data extraction and assessment of risk of bias of included studies. WHH is responsible for circulating progressive drafts of the review to all co-authors.
Declarations of interest
Sources of support
- Graduate Institute of Occupational Safety and Health (GIOSH), Kaohsiung Medical University, Taiwan.Motivational and free electronic database support for undertaking this review.
- Department of Physical Medicine and Rehabilitation, E-Da Hospital / I-Shou University, Taiwan.Salary and time to enable the author to perform this review.
- Department of Dermatology and Centre for Evidence-Based Medicine, Chang Gung Memorial Hospital-Chiayi, Chang Gung University College of Medicine, Taiwan.Salary and time to enable the author to perform this review.
- Center for Evidence-Based Medicine, Taipei Medical University, Taiwan.Salary and time to enable the author to perform this review.
- No sources of support supplied
Differences between protocol and review
Medical Subject Headings (MeSH)
MeSH check words