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1.  Rationale, design and methods of the Study of Work and Pain (SWAP): a cluster randomised controlled trial testing the addition of a vocational advice service to best current primary care for patients with musculoskeletal pain (ISRCTN 52269669) 
Background
Musculoskeletal pain is a major contributor to short and long term work absence. Patients seek care from their general practitioner (GP) and yet GPs often feel ill-equipped to deal with work issues. Providing a vocational case management service in primary care, to support patients with musculoskeletal problems to remain at or return to work, is one potential solution but requires robust evaluation to test clinical and cost-effectiveness.
Methods/Design
This protocol describes a cluster randomised controlled trial, with linked qualitative interviews, to investigate the effect of introducing a vocational advice service into general practice, to provide a structured approach to managing work related issues in primary care patients with musculoskeletal pain who are absent from work or struggling to remain in work. General practices (n = 6) will be randomised to offer best current care or best current care plus a vocational advice service. Adults of working age who are absent from or struggling to remain in work due to a musculoskeletal pain problem will be invited to participate and 330 participants will be recruited. Data collection will be through patient completed questionnaires at baseline, 4 and 12 months. The primary outcome is self-reported work absence at 4 months. Incremental cost-utility analysis will be undertaken to calculate the cost per additional QALY gained and incremental net benefits. A linked interview study will explore the experiences of the vocational advice service from the perspectives of GPs, nurse practitioners (NPs), patients and vocational advisors.
Discussion
This paper presents the rationale, design, and methods of the Study of Work And Pain (SWAP) trial. The results of this trial will provide evidence to inform primary care practice and guide the development of services to provide support for musculoskeletal pain patients with work-related issues.
Trial registration
Current Controlled Trials ISRCTN52269669.
doi:10.1186/1471-2474-15-232
PMCID: PMC4114128  PMID: 25012813
Cluster randomised trial; Musculoskeletal pain; Primary care; Vocational advice; Case management; Work
2.  Evaluation of an internet-based aftercare program to improve vocational reintegration after inpatient medical rehabilitation: study protocol for a cluster-randomized controlled trial 
Trials  2013;14:26.
Background
Mental disorders are the main reasons for rising proportions of premature pension in most high-income countries. Although inpatient medical rehabilitation has increasingly targeted work-related stress, there is still a lack of studies on the transfer of work-specific interventions into work contexts. Therefore, we plan to evaluate an online aftercare program aiming to improve vocational reintegration after medical rehabilitation.
Methods
Vocationally strained patients (n = 800) aged between 18 and 59 years with private internet access are recruited in psychosomatic, orthopedic and cardiovascular rehabilitation clinics in Germany. During inpatient rehabilitation, participants in stress management group training are cluster-randomized to the intervention or control group. The intervention group (n = 400) is offered an internet-based aftercare with weekly writing tasks and therapeutic feedback, a patient forum, a self-test and relaxation exercises. The control group (n = 400) obtains regular e-mail reminders with links to publicly accessible information about stress management and coping. Assessments are conducted at the beginning of inpatient rehabilitation, the end of inpatient rehabilitation, the end of aftercare, and 9 months later. The primary outcome is a risk score for premature pension, measured by a screening questionnaire at follow-up. Secondary outcome measures include level of vocational stress, physical and mental health, and work capacity at follow-up.
Discussion
We expect the intervention group to stabilize the improvements achieved during inpatient rehabilitation concerning stress management and coping, resulting in an improved vocational reintegration. The study protocol demonstrates the features of internet-based aftercare in rehabilitation.
Trial registration
International Standard Randomised Controlled Trial Number Register (ISRCTN:ISRCTN33957202)
doi:10.1186/1745-6215-14-26
PMCID: PMC3598370  PMID: 23351836
Internet-based intervention; Medical rehabilitation; Premature pension; Rehabilitation aftercare; Stress management; Work disability; Work stress
3.  Intervention mapping for development of a participatory return-to-work intervention for temporary agency workers and unemployed workers sick-listed due to musculoskeletal disorders 
BMC Public Health  2009;9:216.
Background
In the past decade in activities aiming at return-to-work (RTW), there has been a growing awareness to change the focus from sickness and work disability to recovery and work ability. To date, this process in occupational health care (OHC) has mainly been directed towards employees. However, within the working population there are two vulnerable groups: temporary agency workers and unemployed workers, since they have no workplace/employer to return to, when sick-listed. For this group there is a need for tailored RTW strategies and interventions. Therefore, this paper aims to describe the structured and stepwise process of development, implementation and evaluation of a theory- and practise-based participatory RTW program for temporary agency workers and unemployed workers, sick-listed due to musculoskeletal disorders (MSD). This program is based on the already developed and cost-effective RTW program for employees, sick-listed due to low back pain.
Methods
The Intervention Mapping (IM) protocol was used to develop a tailor-made RTW program for temporary agency workers and unemployed workers, sick-listed due to MSD. The Attitude-Social influence-self-Efficacy (ASE) model was used as a theoretical framework for determinants of behaviour regarding RTW of the sick-listed worker and development of the intervention. To ensure participation and facilitate successful adoption and implementation, important stakeholders were involved in all steps of program development and implementation. Results of semi-structured interviews and 'fine-tuning' meetings were used to design the final participatory RTW program.
Results
A structured stepwise RTW program was developed, aimed at making a consensus-based RTW implementation plan. The new program starts with identifying obstacles for RTW, followed by a brainstorm session in which the sick-listed worker and the labour expert of the Social Security Agency (SSA) formulate solutions/possibilities for suitable (therapeutic) work. This process is guided by an independent RTW coordinator to achieve consensus. Based on the resulting RTW implementation plan, to create an actual RTW perspective, a vocational rehabilitation agency is assigned to find a matching (therapeutic) workplace. The cost-effectiveness of this participatory RTW program will be evaluated in a randomised controlled trial.
Conclusion
IM is a promising tool for the development of tailor-made OHC interventions for the vulnerable working population.
doi:10.1186/1471-2458-9-216
PMCID: PMC2718881  PMID: 19573229
4.  Efficacy of ‘Tailored Physical Activity’ or ‘Chronic Pain Self-Management Program’ on return to work for sick-listed citizens: design of a randomised controlled trial 
BMC Public Health  2013;13:66.
Background
Pain affects quality of life and can result in absence from work. Treatment and/or prevention strategies for musculoskeletal pain-related long-term sick leave are currently undertaken in several health sectors. Moreover, there are few evidence-based guidelines for such treatment and prevention. The aim of this study is to evaluate the efficacy of ‘Tailored Physical Activity’ or ‘Chronic Pain Self-Management Program’ for sick-listed citizens with pain in the back and/or the upper body.
Methods
This protocol describes the design of a parallel randomised controlled trial on the efficacy of ‘Tailored Physical Activity’ or a ‘Chronic Pain Self-management Program’ versus a reference group for sick-listed citizens with complaints of pain in the back or upper body. Participants will have been absent from work due to sick-listing for 3 to 9 weeks at the time of recruitment. All interventions will be performed at the ‘Health Care Center’ in the Sonderborg Municipality, and a minimum of 138 participants will be randomised into one of the three groups.
All participants will receive ‘Health Guidance’, a (1.5-hour) individualised dialogue focusing on improving ways of living, based on assessments of risk behavior, motivation for change, level of self-care and personal resources. In addition, the experimental groups will receive either ‘Tailored Physical Activity’ (three 50-minute sessions/week over 10 weeks) or ‘Chronic Pain Self-Management Program’ (2.5-hours per week over 6 weeks). The reference group will receive only ‘Health Guidance’.
The primary outcome is the participants’ sick-listed status at 3 and 12 months after baseline. The co-primary outcome is the time it takes to return to work. In addition, secondary outcomes include anthropometric measurements, functional capacity and self-reported number of sick days, musculoskeletal symptoms, general health, work ability, physical capacity, kinesiophobia, physical functional status, interpersonal problems and mental disorders.
Discussion
There are few evidence-based interventions for rehabilitation programmes assisting people with musculoskeletal pain-related work absence. This study will compare outcomes of interventions on return to work in order to increase the knowledge of evidence-based rehabilitation of sick-listed citizens to prevent long-term sick-leave and facilitate return to work.
Trial registration
The trial is registered in the ClinicalTrials.gov, number NCT01356784.
doi:10.1186/1471-2458-13-66
PMCID: PMC3558350  PMID: 23343386
‘Tailored Physical Activity’; ‘Chronic Pain Self-Management Program’; ‘Return to work’; ‘Musculoskeletal disorders’; Pain
5.  Enhancing return-to-work in cancer patients, development of an intervention and design of a randomised controlled trial 
BMC Cancer  2010;10:345.
Background
Compared to healthy controls, cancer patients have a higher risk of unemployment, which has negative social and economic impacts on the patients and on society at large. Therefore, return-to-work of cancer patients needs to be improved by way of an intervention. The objective is to describe the development and content of a work-directed intervention to enhance return-to-work in cancer patients and to explain the study design used for evaluating the effectiveness of the intervention.
Development and content of the intervention
The work-directed intervention has been developed based on a systematic literature review of work-directed interventions for cancer patients, factors reported by cancer survivors as helping or hindering their return-to-work, focus group and interview data for cancer patients, health care professionals, and supervisors, and vocational rehabilitation literature. The work-directed intervention consists of: 1) 4 meetings with a nurse at the treating hospital department to start early vocational rehabilitation, 2) 1 meeting with the participant, occupational physician, and supervisor to make a return-to-work plan, and 3) letters from the treating physician to the occupational physician to enhance communication.
Study design to evaluate the intervention
The treating physician or nurse recruits patients before the start of initial treatment. Patients are eligible when they have a primary diagnosis of cancer, will be treated with curative intent, are employed at the time of diagnosis, are on sick leave, and are between 18 and 60 years old. After the patients have given informed consent and have filled out a baseline questionnaire, they are randomised to either the control group or to the intervention group and receive either care as usual or the work-directed intervention, respectively. Primary outcomes are return-to-work and quality of life. The feasibility of the intervention and direct and indirect costs will be determined. Outcomes will be assessed by a questionnaire at baseline and at 6, 12, 18, and 24 months after baseline.
Discussion
This study will provide information about the effectiveness of a work-directed intervention for cancer patients. The intention is to implement the intervention in normal care if it has been shown effective.
Trial registration
NTR1658
doi:10.1186/1471-2407-10-345
PMCID: PMC2907345  PMID: 20594347
6.  Self-Management Support Interventions for Persons With Chronic Disease 
Background
Self-management support interventions such as the Stanford Chronic Disease Self-Management Program (CDSMP) are becoming more widespread in attempt to help individuals better self-manage chronic disease.
Objective
To systematically assess the clinical effectiveness of self-management support interventions for persons with chronic diseases.
Data Sources
A literature search was performed on January 15, 2012, using OVID MEDLINE, OVID MEDLINE In-Process and Other Non-Indexed Citations, OVID EMBASE, EBSCO Cumulative Index to Nursing & Allied Health Literature (CINAHL), the Wiley Cochrane Library, and the Centre for Reviews and Dissemination database for studies published between January 1, 2000, and January 15, 2012. A January 1, 2000, start date was used because the concept of non-disease-specific/general chronic disease self-management was first published only in 1999. Reference lists were examined for any additional relevant studies not identified through the search.
Review Methods
Randomized controlled trials (RCTs) comparing self-management support interventions for general chronic disease against usual care were included for analysis. Results of RCTs were pooled using a random-effects model with standardized mean difference as the summary statistic.
Results
Ten primary RCTs met the inclusion criteria (n = 6,074). Nine of these evaluated the Stanford CDSMP across various populations; results, therefore, focus on the CDSMP.
Health status outcomes: There was a small, statistically significant improvement in favour of CDSMP across most health status measures, including pain, disability, fatigue, depression, health distress, and self-rated health (GRADE quality low). There was no significant difference between modalities for dyspnea (GRADE quality very low). There was significant improvement in health-related quality of life according to the EuroQol 5-D in favour of CDSMP, but inconsistent findings across other quality-of-life measures.
Healthy behaviour outcomes: There was a small, statistically significant improvement in favour of CDSMP across all healthy behaviours, including aerobic exercise, cognitive symptom management, and communication with health care professionals (GRADE quality low).
Self-efficacy: There was a small, statistically significant improvement in self-efficacy in favour of CDSMP (GRADE quality low).
Health care utilization outcomes: There were no statistically significant differences between modalities with respect to visits with general practitioners, visits to the emergency department, days in hospital, or hospitalizations (GRADE quality very low).
All results were measured over the short term (median 6 months of follow-up).
Limitations
Trials generally did not appropriately report data according to intention-to-treat principles. Results therefore reflect “available case analyses,” including only those participants whose outcome status was recorded. For this reason, there is high uncertainty around point estimates.
Conclusions
The Stanford CDSMP led to statistically significant, albeit clinically minimal, short-term improvements across a number of health status measures (including some measures of health-related quality of life), healthy behaviours, and self-efficacy compared to usual care. However, there was no evidence to suggest that the CDSMP improved health care utilization. More research is needed to explore longer-term outcomes, the impact of self-management on clinical outcomes, and to better identify responders and non-responders.
Plain Language Summary
Self-management support interventions are becoming more common as a structured way of helping patients learn to better manage their chronic disease. To assess the effects of these support interventions, we looked at the results of 10 studies involving a total of 6,074 people with various chronic diseases, such as arthritis and chronic pain, chronic respiratory diseases, depression, diabetes, heart disease, and stroke. Most trials focused on a program called the Stanford Chronic Disease Self-Management Program (CDSMP). When compared to usual care, the CDSMP led to modest, short-term improvements in pain, disability, fatigue, depression, health distress, self-rated health, and health-related quality of life, but it is not possible to say whether these changes were clinically important. The CDSMP also increased how often people undertook aerobic exercise, how often they practiced stress/pain reduction techniques, and how often they communicated with their health care practitioners. The CDSMP did not reduce the number of primary care doctor visits, emergency department visits, the number of days in hospital, or the number of times people were hospitalized. In general, there was high uncertainty around the quality of the evidence, and more research is needed to better understand the effect of self-management support on long-term outcomes and on important clinical outcomes, as well as to better identify who could benefit most from self-management support interventions like the CDSMP.
PMCID: PMC3814807  PMID: 24194800
7.  Cost-effectiveness of a participatory return-to-work intervention for temporary agency workers and unemployed workers sick-listed due to musculoskeletal disorders: design of a randomised controlled trial 
Background
Within the working population there is a vulnerable group: workers without an employment contract and workers with a flexible labour market arrangement, e.g. temporary agency workers. In most cases, when sick-listed, these workers have no workplace/employer to return to. Also, for these workers access to occupational health care is limited or even absent in many countries. For this vulnerable working population there is a need for tailor-made occupational health care, including the presence of an actual return-to-work perspective. Therefore, a participatory return-to-work program has been developed based on a successful return-to-work intervention for workers, sick-listed due to low back pain.
The objective of this paper is to describe the design of a randomised controlled trial to study the (cost-)effectiveness of this newly developed participatory return-to-work program adapted for temporary agency workers and unemployed workers, sick-listed due to musculoskeletal disorders, compared to usual care.
Methods/Design
The design of this study is a randomised controlled trial with one year of follow-up. The study population consists of temporary agency workers and unemployed workers sick-listed between 2 and 8 weeks due to musculoskeletal disorders. The new return-to-work program is a stepwise program aimed at making a consensus-based return-to-work implementation plan with the possibility of a (therapeutic) workplace to return-to-work. Outcomes are measured at baseline, 3, 6, 9 and 12 months. The primary outcome measure is duration of the sickness benefit period after the first day of reporting sick. Secondary outcome measures are: time until first return-to-work, total number of days of sickness benefit during follow-up; functional status; intensity of musculoskeletal pain; pain coping; and attitude, social influence and self-efficacy determinants. Cost-benefit is evaluated from an insurer's perspective. A process evaluation is part of this study.
Discussion
For sick-listed workers without an employment contract there can be gained a lot by improving occupational health care, including return-to-work guidance, and by minimising the 'labour market handicap' by creating a return-to-work perspective. In addition, reduction of sickness absence and work disability, i.e. a reduction of disability claims, may result in substantial benefits for the Dutch Social Security System.
Trial registration
Trial registration number: NTR1047.
doi:10.1186/1471-2474-11-60
PMCID: PMC2858719  PMID: 20346183
8.  Multidisciplinary rehabilitation for chronic low back pain: systematic review 
BMJ : British Medical Journal  2001;322(7301):1511-1516.
Objective
To assess the effect of multidisciplinary biopsychosocial rehabilitation on clinically relevant outcomes in patients with chronic low back pain.
Design
Systematic literature review of randomised controlled trials.
Participants
A total of 1964 patients with disabling low back pain for more than three months.
Main outcome measures
Pain, function, employment, quality of life, and global assessments.
Results
Ten trials reported on a total of 12 randomised comparisons of multidisciplinary treatment and a control condition. There was strong evidence that intensive multidisciplinary biopsychosocial rehabilitation with functional restoration improves function when compared with inpatient or outpatient non-multidisciplinary treatments. There was moderate evidence that intensive multidisciplinary biopsychosocial rehabilitation with functional restoration reduces pain when compared with outpatient non-multidisciplinary rehabilitation or usual care. There was contradictory evidence regarding vocational outcomes of intensive multidisciplinary biopsychosocial intervention. Some trials reported improvements in work readiness, but others showed no significant reduction in sickness leaves. Less intensive outpatient psychophysical treatments did not improve pain, function, or vocational outcomes when compared with non-multidisciplinary outpatient therapy or usual care. Few trials reported effects on quality of life or global assessments.
Conclusions
The reviewed trials provide evidence that intensive multidisciplinary biopsychosocial rehabilitation with functional restoration reduces pain and improves function in patients with chronic low back pain. Less intensive interventions did not show improvements in clinically relevant outcomes.
What is already known on this topicDisabling chronic pain is regarded as the result of interrelating physical, psychological, and social or occupational factors requiring multidisciplinary interventionTwo previous systematic reviews of multidisciplinary rehabilitation for chronic pain were open to bias and did not include any of the randomised controlled trials now availableWhat this study addsIntensive, daily biopsychosocial rehabilitation with a functional restoration approach improves pain and function in chronic low back painLess intensive interventions did not show improvements in clinically relevant outcomesIt is unclear whether the improvements are worth the cost of these intensive treatments
PMCID: PMC33389  PMID: 11420271
9.  A Participatory Return-to-Work Program for Temporary Agency Workers and Unemployed Workers Sick-Listed Due to Musculoskeletal Disorders: a Process Evaluation Alongside a Randomized Controlled Trial 
Introduction Beside (cost-)effectiveness, the feasibility of an intervention is important for successful implementation in daily practice. This study concerns the process evaluation of a newly developed participatory return-to-work (RTW) program for workers without an employment contract, sick-listed due to musculoskeletal disorders. The program consisted of a stepwise process, guided by an independent RTW coordinator, aimed at making a consensus-based RTW plan with the possibility of a temporary (therapeutic) workplace. The aims of this study were to describe the reach and extent of implementation of the new program, the satisfaction and experiences of all stakeholders, and the perceived barriers and facilitators for implementation of the program in daily practice. Methods Temporary agency workers and unemployed workers, sick-listed for 2–8 weeks due to musculoskeletal disorders were eligible for this study. Data were collected from the workers; their insurance physicians and labour experts at the Dutch Social Security Agency; RTW coordinators; and case managers from participating vocational rehabilitation agencies. Data collection took place using professionals’ reports, standardized matrices, questionnaires at baseline and at 3-month follow-up, and group interviews with the professionals. Results Of the 79 workers who were allocated to the participatory RTW program group, 72 workers actually started with the intervention. Overall, implementation of the program was performed according to protocol. However, offering of suitable temporary workplaces was delayed with 44.5 days. Results showed satisfaction with the RTW coordinator among the workers and three quarters of the labour experts experienced a minor or major contribution of the presence of the RTW coordinator. Several barriers for implementation were identified, such as the administrative time-investment, unclear information about the program, no timely offering of temporary (therapeutic) workplaces, and the need for additional support in case of complex health problems. Conclusions This study indicates overall feasibility for implementation of the participatory RTW program in daily practice. However, to overcome important barriers, more attention should be paid to improve timely offering of suitable temporary workplaces, to describe more clearly the program goals and the professional’s roles, and to offer additional support for workers suffering from complex multi-causal health problems. Trial registration NTR1047.
doi:10.1007/s10926-011-9314-4
PMCID: PMC3274681  PMID: 21656252
Feasibility; Implementation; Return to work; Occupational health care; Vocational rehabilitation; Worker without employment contract
10.  Pulmonary Rehabilitation for Patients With Chronic Pulmonary Disease (COPD) 
Executive Summary
In July 2010, the Medical Advisory Secretariat (MAS) began work on a Chronic Obstructive Pulmonary Disease (COPD) evidentiary framework, an evidence-based review of the literature surrounding treatment strategies for patients with COPD. This project emerged from a request by the Health System Strategy Division of the Ministry of Health and Long-Term Care that MAS provide them with an evidentiary platform on the effectiveness and cost-effectiveness of COPD interventions.
After an initial review of health technology assessments and systematic reviews of COPD literature, and consultation with experts, MAS identified the following topics for analysis: vaccinations (influenza and pneumococcal), smoking cessation, multidisciplinary care, pulmonary rehabilitation, long-term oxygen therapy, noninvasive positive pressure ventilation for acute and chronic respiratory failure, hospital-at-home for acute exacerbations of COPD, and telehealth (including telemonitoring and telephone support). Evidence-based analyses were prepared for each of these topics. For each technology, an economic analysis was also completed where appropriate. In addition, a review of the qualitative literature on patient, caregiver, and provider perspectives on living and dying with COPD was conducted, as were reviews of the qualitative literature on each of the technologies included in these analyses.
The Chronic Obstructive Pulmonary Disease Mega-Analysis series is made up of the following reports, which can be publicly accessed at the MAS website at: http://www.hqontario.ca/en/mas/mas_ohtas_mn.html.
Chronic Obstructive Pulmonary Disease (COPD) Evidentiary Framework
Influenza and Pneumococcal Vaccinations for Patients With Chronic Obstructive Pulmonary Disease (COPD): An Evidence-Based Analysis
Smoking Cessation for Patients With Chronic Obstructive Pulmonary Disease (COPD): An Evidence-Based Analysis
Community-Based Multidisciplinary Care for Patients With Stable Chronic Obstructive Pulmonary Disease (COPD): An Evidence-Based Analysis
Pulmonary Rehabilitation for Patients With Chronic Obstructive Pulmonary Disease (COPD): An Evidence-Based Analysis
Long-term Oxygen Therapy for Patients With Chronic Obstructive Pulmonary Disease (COPD): An Evidence-Based Analysis
Noninvasive Positive Pressure Ventilation for Acute Respiratory Failure Patients With Chronic Obstructive Pulmonary Disease (COPD): An Evidence-Based Analysis
Noninvasive Positive Pressure Ventilation for Chronic Respiratory Failure Patients With Stable Chronic Obstructive Pulmonary Disease (COPD): An Evidence-Based Analysis
Hospital-at-Home Programs for Patients With Acute Exacerbations of Chronic Obstructive Pulmonary Disease (COPD): An Evidence-Based Analysis
Home Telehealth for Patients With Chronic Obstructive Pulmonary Disease (COPD): An Evidence-Based Analysis
Cost-Effectiveness of Interventions for Chronic Obstructive Pulmonary Disease Using an Ontario Policy Model
Experiences of Living and Dying With COPD: A Systematic Review and Synthesis of the Qualitative Empirical Literature
For more information on the qualitative review, please contact Mita Giacomini at: http://fhs.mcmaster.ca/ceb/faculty member_giacomini.htm.
For more information on the economic analysis, please visit the PATH website: http://www.path-hta.ca/About-Us/Contact-Us.aspx.
The Toronto Health Economics and Technology Assessment (THETA) collaborative has produced an associated report on patient preference for mechanical ventilation. For more information, please visit the THETA website: http://theta.utoronto.ca/static/contact.
Objective
The objective of this evidence-based review was to determine the effectiveness and cost-effectiveness of pulmonary rehabilitation in the management of chronic obstructive pulmonary disease (COPD).
Technology
Pulmonary rehabilitation refers to a multidisciplinary program of care for patients with chronic respiratory impairment that is individually tailored and designed to optimize physical and social performance and autonomy. Exercise training is the cornerstone of pulmonary rehabilitation programs, though they may also include components such as patient education and psychological support. Pulmonary rehabilitation is recommended as the standard of care in the treatment and rehabilitation of patients with COPD who remain symptomatic despite treatment with bronchodilators.
For the purpose of this review, the Medical Advisory Secretariat focused on pulmonary rehabilitation programs as defined by the Cochrane Collaboration—that is, any inpatient, outpatient, or home-based rehabilitation program lasting at least 4 weeks that includes exercise therapy with or without any form of education and/or psychological support delivered to patients with exercise limitations attributable to COPD.
Research Questions
What is the effectiveness and cost-effectiveness of pulmonary rehabilitation compared with usual care (UC) for patients with stable COPD?
Does early pulmonary rehabilitation (within 1 month of hospital discharge) in patients who had an acute exacerbation of COPD improve outcomes compared with UC (or no rehabilitation)?
Do maintenance or postrehabilitation programs for patients with COPD who have completed a pulmonary rehabilitation program improve outcomes compared with UC?
Research Methods
Literature Search
Search Strategy
For Research Questions 1and 2, a literature search was performed on August 10, 2010 for studies published from January 1, 2004 to July 31, 2010. For Research Question 3, a literature search was performed on February 3, 2011 for studies published from January 1, 2000 to February 3, 2011. Abstracts were reviewed by a single reviewer and, for those studies meeting the eligibility criteria, full-text articles were obtained. Reference lists and health technology assessment websites were also examined for any additional relevant studies not identified through the systematic search.
Inclusion Criteria
Research questions 1 and 2:
published between January 1, 2004 and July 31, 2010
randomized controlled trials, systematic reviews, and meta-analyses
COPD study population
studies comparing pulmonary rehabilitation with UC (no pulmonary rehabilitation)
duration of pulmonary rehabilitation program ≥ 6 weeks
pulmonary rehabilitation program had to include at minimum exercise training
Research question 3:
published between January 1, 2000 and February 3, 2011
randomized controlled trials, systematic reviews, and meta-analyses
COPD study population
studies comparing a maintenance or postrehabilitation program with UC (standard follow-up)
duration of pulmonary rehabilitation program ≥ 6 weeks
initial pulmonary rehabilitation program had to include at minimum exercise training
Exclusion Criteria
Research questions 1, 2, and 3:
grey literature
duplicate publications
non-English language publications
study population ≤ 18 years of age
studies conducted in a palliative population
studies that did not report primary outcome of interest
Additional exclusion criteria for research question 3:
studies with ≤ 2 sessions/visits per month
Outcomes of Interest
The primary outcomes of interest for the stable COPD population were exercise capacity and health-related quality of life (HRQOL). For the COPD population following an exacerbation, the primary outcomes of interest were hospital readmissions and HRQOL. The primary outcomes of interest for the COPD population undertaking maintenance programs were functional exercise capacity and HRQOL.
Quality of Evidence
The quality of each included study was assessed taking into consideration allocation concealment, randomization, blinding, power/sample size, withdrawals/dropouts, and intention-to-treat analyses.
The quality of the body of evidence was assessed as high, moderate, low, or very low according to the GRADE Working Group criteria. The following definitions of quality were used in grading the quality of the evidence:
Summary of Findings
Research Question 1: Effect of Pulmonary Rehabilitation on Outcomes in Stable COPD
Seventeen randomized controlled trials met the inclusion criteria and were included in this review.
The following conclusions are based on moderate quality of evidence.
Pulmonary rehabilitation including at least 4 weeks of exercise training leads to clinically and statistically significant improvements in HRQOL in patients with COPD.1
Pulmonary rehabilitation also leads to a clinically and statistically significant improvement in functional exercise capacity2 (weighted mean difference, 54.83 m; 95% confidence interval, 35.63–74.03; P < 0.001).
Research Question 2: Effect of Pulmonary Rehabilitation on Outcomes Following an Acute Exacerbation of COPD
Five randomized controlled trials met the inclusion criteria and are included in this review. The following conclusion is based on moderate quality of evidence.
Pulmonary rehabilitation (within 1 month of hospital discharge) after acute exacerbation significantly reduces hospital readmissions (relative risk, 0.50; 95% confidence interval, 0.33–0.77; P = 0.001) and leads to a statistically and clinically significant improvement in HRQOL.3
Research Question 3: Effect of Pulmonary Rehabilitation Maintenance Programs on COPD Outcomes
Three randomized controlled trials met the inclusion criteria and are included in this review. The conclusions are based on a low quality of evidence and must therefore be considered with caution.
Maintenance programs have a nonsignificant effect on HRQOL and hospitalizations.
Maintenance programs have a statistically but not clinically significant effect on exercise capacity (P = 0.01). When subgrouped by intensity and quality of study, maintenance programs have a statistically and marginally clinically significant effect on exercise capacity.
PMCID: PMC3384375  PMID: 23074434
11.  Vocational rehabilitation for people with severe mental illness 
Background
Unemployment rates are high amongst people with severe mental illness, yet surveys show that most want to work. Vocational rehabilitation services exist to help mentally ill people find work. Traditionally, these services have offered a period of preparation (Pre-vocational Training), before trying to place clients in competitive (i.e. open) employment. More recently, some services have begun placing clients in competitive employment immediately whilst providing on-the-job support (Supported Employment). It is unclear which approach is most effective.
Objectives
To assess the effects of Pre-vocational Training and Supported Employment (for people with severe mental illness) against each other and against standard care (in hospital or community). In addition, to assess the effects of: (a) special varieties of Pre-vocational Training (Clubhouse model) and Supported Employment (Individual Placement and Support model); and (b) techniques for enhancing either approach, for example payment or psychological intervention.
Search methods
Searches were undertaken of CINAHL (1982-1998), The Cochrane Library (Issue 2, 1999), EMBASE (1980-1998), MEDLINE (1966-1998) and PsycLIT (1887-1998). Reference lists of eligible studies and reviews were inspected and researchers in the field were approached to identify unpublished studies.
Selection criteria
Randomised controlled trials of approaches to vocational rehabilitation for people with severe mental illness.
Data collection and analysis
Included trials were reliably selected by a team of two raters. Data were extracted separately by two reviewers and cross-checked. Authors of trials were contacted for additional information. Relative risks (RR) and 95% confidence intervals (CI) of homogeneous dichotomous data were calculated. A random effects model was used for heterogeneous dichotomous data. Continuous data were presented in tables (there were insufficient continuous data for formal meta-analysis). A sensitivity analysis was performed, excluding poorer quality trials.
Main results
Eighteen randomised controlled trials of reasonable quality were identified. The main finding was that on the primary outcome (number in competitive employment) Supported Employment was significantly more effective than Pre-vocational Training; for example, at 18 months 34% of people in Supported Employment were employed versus 12% in Pre-vocational Training (RR random effects (unemployment) 0.76 95% CI 0.64 to 0.89, NNT 4.5). Clients in Supported Employment also earned more and worked more hours per month than those in Pre-vocational Training. There was no evidence that Pre-vocational Training was more effective in helping clients to obtain competitive employment than standard community care.
Authors’ conclusions
Supported employment is more effective than Pre-vocational Training in helping severely mentally ill people to obtain competitive employment. There is no clear evidence that Pre-vocational Training is effective.
doi:10.1002/14651858.CD003080
PMCID: PMC4170889  PMID: 11406069
*Rehabilitation, Vocational; Employment; Mental Disorders [*rehabilitation]; Randomized Controlled Trials as Topic; Humans
12.  Return to work of breast cancer survivors: a systematic review of intervention studies 
BMC Cancer  2009;9:117.
Background
Breast cancer management has improved dramatically in the past three decades and as a result, a population of working age women is breast cancer survivor. Interventions for breast cancer survivors have shown improvements in quality of life and in physical and psychological states. In contrast, efforts aimed at stimulating re-employment and return-to-work interventions for breast cancer survivors have not kept pace. The objective of this review was to study the effects and characteristics of intervention studies on breast cancer survivors in which the outcome was return to work.
Methods
The Cochrane Controlled Trials Register (The Cochrane Library, Issue 4, 2006), Medline, Ovid, EMBASE and PsychInfo were systematically searched for studies conducted between 1970 to February 2007. Intervention studies for female breast cancer survivors that were focused on return to work were included.
Results
Our search strategy identified 5219 studies. Four studies out of 100 potentially relevant abstracts were selected and included 46–317 employed women who had had mastectomy, adjuvant therapy and rehabilitation, with the outcome return to work. The intervention programs focused on improvement of physical, psychological and social recovery. Although a substantial percentage (between 75% to 85%) of patients included in these studies returned to work after rehabilitation, it is not clear whether this proportion would have been lower for patients without counseling or exercise, or any other interventions, as three out of four studies did not include a comparison group.
Conclusion
The most important finding of this review is the lack of methodologically sound intervention studies on breast cancer survivors with the outcome return to work. Using evidence from qualitative and observational studies on cancer and the good results of intervention studies on return to work programs and vocational rehabilitation, return to work interventions for breast cancer survivors should be further developed and evaluated.
doi:10.1186/1471-2407-9-117
PMCID: PMC2678275  PMID: 19383123
13.  Vocational rehabilitation services for patients with cancer: design of a feasibility study incorporating a pilot randomised controlled trial among women with breast cancer following surgery 
Trials  2011;12:89.
Background
Due to improvements in cancer survival the number of people of working age living with cancer across Europe is likely to increase. UK governments have made commitments to reduce the number of working days lost to ill-health and to improve access to vocational rehabilitation (VR) services. Return to work for people with cancer has been identified as a priority. However, there are few services to support people to remain in or return to work after cancer and no associated trials to assess their impact. A pilot randomised controlled trial among women with breast cancer has been designed to assess the feasibility of a larger definitive trial of VR services for people with cancer.
Methods
Patients are being recruited from three clinical sites in two Scottish National Health Service (NHS) Boards for 6 months. Eligible patients are all women who are: (1) aged between 18 and 65 years; (2) in paid employment or self-employed; (3) living or working in Lothian or Tayside, Scotland, UK; (4) diagnosed with an invasive breast cancer tumour; (5) treated first with surgery. Patients are randomly allocated to receive referral to a VR service or usual care, which involves no formal employment support. The primary outcome measure is self-reported sickness absence in the first 6 months following surgery. Secondary outcome measures include changes in quality of life (FACT-B), fatigue (FACIT-Fatigue) and employment status between baseline and 6- and 12-months post-surgery. A post-trial evaluation will be conducted to assess the acceptability of the intervention among participants and the feasibility of a larger, more definitive, trial with patients with lung and prostate cancer.
Discussion
To our knowledge this is the first study to determine the feasibility of a randomised controlled trial of the effectiveness of VR services to enable people with cancer to remain in or return to employment. The study will provide evidence to assess the relevance and feasibility of a larger future trial involving patients with breast, prostate or lung cancer and inform the development of appropriate VR services for people living with cancer.
Trial Registration
ISRCTN: ISRCTN29666484
Registration date: 07/10/10; Randomisation of first patient: 03/12/10
doi:10.1186/1745-6215-12-89
PMCID: PMC3076250  PMID: 21450089
14.  Return to work of workers without a permanent employment contract, sick-listed due to a common mental disorder: design of a randomised controlled trial 
BMC Public Health  2014;14:594.
Background
Workers without a permanent employment contract represent a vulnerable group within the working population. Mental disorders are a major cause of sickness absence within this group. Common mental disorders are stress-related, depressive and anxiety disorders. To date, little attention has been paid to effective return to work interventions for this type of sick-listed workers. Therefore, a participatory supportive return to work program has been developed. It combines elements of a participatory return to work program, integrated care and direct placement in a competitive job.
The objective of this paper is to describe the design of a randomised controlled trial to evaluate the cost-effectiveness of this program compared to care as usual.
Methods/Design
The cost-effectiveness of the participatory supportive return to work program will be examined in a randomised controlled trial with a follow-up of twelve months.
The program strongly involves the sick-listed worker in the identification of obstacles for return to work and possible solutions, resulting in a consensus based action plan. This plan will be used as a starting point for the search of suitable competitive employment with support of a rehabilitation agency. During this process the insurance physician of the sick-listed worker contacts other caregivers to promote integrated care.
Workers eligible to participate in this study have no permanent employment contract, have applied for a sickness benefit at the Dutch Social Security Agency and are sick-listed between two and fourteen weeks due to mental health problems.
The primary outcome measure is the duration until first sustainable return to work in a competitive job. Outcomes are measured at baseline and after three, six, nine and twelve months.
Discussion
If the participatory supportive return to work program proves to be cost-effective, the social security system, the sick-listed worker and society as a whole will benefit. A cost-effective return to work program will lead to a reduction of costs related to sickness absence. For the sick-listed worker a cost-effective program results in earlier sustainable return to work, which can be associated with both social and health benefits.
Trial registration
The trial registration number and date is NTR3563, August 7, 2012.
doi:10.1186/1471-2458-14-594
PMCID: PMC4061521  PMID: 24919561
Return to work; Intervention; Sickness absence; Common mental disorders; Unemployed workers; Temporary agency workers; Fixed-term contract workers; Vulnerable workers; Occupational health care; Social security; Randomised controlled trial
15.  Workers Who Stay at Work Despite Chronic Nonspecific Musculoskeletal Pain: Do They Differ from Workers with Sick Leave? 
Purpose Most workers with chronic nonspecific musculoskeletal pain (CMP) do not take sick leave, nor consult a health care professional or search vocational rehabilitation. Yet, the knowledge of many researchers, clinicians and policy makers is largely based on people with CMP who discontinue work. The aim of this study was to explore characteristics of workers who stay at work despite CMP, and to compare these with sick-listed workers with CMP following vocational rehabilitation. Methods The clinical characteristics of workers who stay at work despite CMP (n = 119) and sick-listed workers who follow vocational rehabilitation (n = 122) were described and the differences between these groups were assessed. Logistic regression analysis was used to assess differences between the groups and to determine which variables predicted group status. Results Workers who stayed at work despite CMP reported significantly lower levels of fear avoidance (OR = 0.94), pain catastrophizing (OR = 0.93), perceived workload (OR = 0.93), and higher pain acceptance (OR = 1.11), life control (OR = 1.62) and pain self-efficacy (OR = 1.09) compared to sick-listed workers following rehabilitation, even after controlling for confounders. The groups did not differ on physical activity level, active coping and work satisfaction. Group status was predicted best by pain intensity, duration of pain, pain acceptance, perceived workload, mental health, and psychological distress (area under the receiver operating characteristic curve = 0.91, 95% CI = 0.87–0.95). Conclusions A wide range of characteristics of workers who stay at work despite CMP were explored. Relevant differences from sick-listed workers with CMP were observed in all domains of the bio-psycho-social model. Six main predictors were identified that best discriminate between both groups.
doi:10.1007/s10926-012-9360-6
PMCID: PMC3484275  PMID: 22454300
Staying at work; Vocational rehabilitation; Musculoskeletal disorders; Chronic pain; Work participation
16.  Management of occupational back pain: the Sherbrooke model. Results of a pilot and feasibility study. 
OBJECTIVES--The aim was to combat occurrence of chronic occupational back pain. METHODS--A multidisciplinary model to manage back pain that includes both clinical and ergonomic approaches has been developed. Early detection, early clinical and ergonomic evaluations, and early active treatment make up the cornerstone of management. Detection of cases starts after four weeks of absence from work. An ergonomic intervention is implemented at six weeks. A medical specialist is involved at eight weeks. If return to work is not possible after 12 weeks, a functional recovery therapy followed by a therapeutic return to work is implemented. A multidisciplinary team decides if return to original or modified work is possible or if vocational rehabilitation is necessary. This model has been implemented by the investigators in the Sherbrooke (Quebec, Canada) area, and is presently being evaluated through a randomised trial in 31 industrial settlements (about 20,000 workers). A cluster randomisation of industries and workers will allow separate testing of ergonomic and clinical interventions. RESULTS--One year after implementation, 31 of 35 of the eligible industrial sites participated in the study and 79 of 88 of the eligible workers affected by recent back pain had agreed to participate. Ergonomic and clinical interventions have been implemented as planned. Only three workers dropped out. Hence this global clinical and ergonomic management programme has been shown to be feasible in a general population. CONCLUSION--A global management programme of back pain joining ergonomic and clinical intervention with a multidisciplinary approach has not been tested yet. Linking these two strategies in a same multidisciplinary team represents a systemic approach to this multifactorial ailment. During the first year of this trial we did not find any conflict between these two interventions from the employer's or worker's point of view.
PMCID: PMC1128053  PMID: 7951791
17.  Effects of nurse-led motivational interviewing of patients with chronic musculoskeletal pain in preparation of rehabilitation treatment (PREPARE) on societal participation, attendance level, and cost-effectiveness: study protocol for a randomized controlled trial 
Trials  2013;14:90.
Background
Non-adherence and drop-out are major problems in pain rehabilitation. For patients with various health problems, motivational interviewing (MI) has shown promising effects to tackle these problems. In chronic pain patients, the effectiveness of MI is however unknown. Therefore, a MI-based pre-pain rehabilitation intervention (MIP) addressing motivation, expectations, and beliefs has been developed to prepare eligible patients for rehabilitation treatment.
Methods/design
Study design: A parallel randomized controlled trial including two interventions: a motivational interviewing pre-pain rehabilitation intervention (MIP) and a usual care (UC) control arm. Follow-up will be 6 months after completion of rehabilitation treatment.
Study population: One hundred and sixty (n = 80 per arm) patients with chronic non-specific musculoskeletal pain visiting an outpatient rehabilitation department, who are eligible to participate in an outpatient cognitive behavioral pain rehabilitation program.
Intervention: MIP consists of two sessions to prepare and motivate the patient for pain rehabilitation treatment and its bio psychosocial approach. UC consists of information and education about the etiology and the general rehabilitation approach of chronic pain. Both the MIP and UC contain two sessions of 45 to 60 minutes each.
Objective: The aim of the current study is to evaluate the effectiveness of MIP compared to UC in terms of an increase in the long-term level of societal participation and decrease of drop-out during rehabilitation treatment.
Main study endpoints: Primary outcome is the change in level of participation (according to the ICF-definition: ‘involvement in a life situation’) 6 months after completion of rehabilitation treatment. Secondary outcomes are adherence and treatment drop-out, disability, pain intensity, self-reported main complaints, (pain-specific) self-efficacy, motivation, and quality of life. Costs are calculated including the costs of the pre-treatment intervention, productivity losses, and healthcare utilization. Potential moderators and active ingredients of MI are explored. For the process evaluation, parameters such as MI fidelity, feasibility, and experiences are explored.
Discussion
The results of this study will provide evidence on the effectiveness of this MI-based pre-treatment in pain rehabilitation. Furthermore, a cost-effectiveness analysis and exploration of moderating and working mechanisms of MI and an extensive process evaluation takes place.
Trial registration
Nederlands trial register NTR3065
doi:10.1186/1745-6215-14-90
PMCID: PMC3655830  PMID: 23548195
Motivational interviewing; Motivation; Adherence; Design article; Drop-outs; Working mechanism; Mediators/moderators; Societal participation
18.  “Employment and arthritis: making it work” a randomized controlled trial evaluating an online program to help people with inflammatory arthritis maintain employment (study protocol) 
Background
Arthritis and musculoskeletal conditions are the leading cause of long-term work disability (WD), an outcome with a major impact on quality of life and a high cost to society. The importance of decreased at-work productivity has also recently been recognized. Despite the importance of these problems, few interventions have been developed to reduce the impact of arthritis on employment. We have developed a novel intervention called “Making It Work”, a program to help people with inflammatory arthritis (IA) deal with employment issues, prevent WD and improve at-work productivity. After favorable results in a proof-of-concept study, we converted the program to a web-based format for broader dissemination and improved accessibility. The objectives of this study are: 1) to evaluate in a randomized controlled trial (RCT) the effectiveness of the program at preventing work cessation and improving at-work productivity; 2) to perform a cost-utility analysis of the intervention.
Methods/Design
526 participants with IA will be recruited from British Columbia, Alberta, and Ontario in Canada. The intervention consists of a) 5 online group sessions; b) 5 web-based e-learning modules; c) consultations with an occupational therapist for an ergonomic work assessment and a vocational rehabilitation counselor. Questionnaires will be administered online at baseline and every 6 months to collect information about demographics, disease measures, costs, work-related risk factors for WD, quality of life, and work outcomes. Primary outcomes include at-work productivity and time to work cessation of > 6 months for any reason. Secondary outcomes include temporary work cessation, number of days missed from work per year, reduction in hours worked per week, quality adjusted life year for the cost utility analysis, and changes from baseline in employment risk factors. Analysis of Variance will evaluate the intervention’s effect on at-work productivity, and multivariable Cox regression models will estimate the risk of work cessation associated with the intervention after controlling for risk factors for WD and other important predictors imbalanced at baseline.
Discussion
This program fills an important gap in arthritis health services and addresses an important and costly problem. Knowledge gained from the RCT will be useful to health care professionals, policy planners and arthritis stakeholders.
Trial registration
ClinicalTrials.gov NCT01852851; registered April 13, 2012; first participant randomized on July 6, 2013.
doi:10.1186/1472-6947-14-59
PMCID: PMC4123503  PMID: 25043631
Inflammatory arthritis; Employment; Worker productivity; Work disability; eLearning program; Self-management; Ergonomics; Vocational counselling; Health education; Health promotion
19.  Work, Recovery, and Comorbidity in Schizophrenia: A Randomized Controlled Trial of Cognitive Remediation 
Schizophrenia Bulletin  2009;35(2):319-335.
Employment is central to the concept of recovery in severe mental illness. However, common comorbid conditions present significant obstacles to consumers seeking employment and benefiting from vocational rehabilitation. We review research on the effects of three common comorbid conditions on work and response to vocational rehabilitation, including cognitive impairment, substance abuse, and medical conditions, followed by research on vocational rehabilitation. We then present the results of a randomized controlled trial evaluating the effects of adding cognitive remediation to a vocational rehabilitation program compared with vocational rehabilitation alone in 34 consumers with severe mental illness. Consumers who received both cognitive remediation and vocational rehabilitation demonstrated significantly greater improvements on a cognitive battery over 3 months than those who received vocational rehabilitation alone and had better work outcomes over the 2-year follow-up period. Substance abuse was associated with worse employment outcomes, but did not interact with treatment group, whereas medical comorbidity was not related to work outcomes. More research is warranted to evaluate the interactions between substance abuse and medical comorbidity with vocational rehabilitation and cognitive remediation.
doi:10.1093/schbul/sbn182
PMCID: PMC2659315  PMID: 19269925
recovery; vocational rehabilitation; medical comorbidities; substance abuse; severe mental illness; cognitive remediation
20.  Long-term follow-up of disability pensioners having musculoskeletal disorders 
BMC Public Health  2009;9:407.
Background
Previously we have conducted a randomised controlled trial (RCT) to evaluate the effect of a brief cognitive behavioural program with a vocational approach aiming to return disability pensioners with back pain to work, as compared to no intervention. One year after the intervention, 10 participants (22%) who received the program and 5 (11%) in the control group reported to have entered a return to work process. The aims of this study were to evaluate long-term effects of the intervention, and compare this effect to 2 reference populations not participating in the original trial.
Methods
Three groups of disability pensioners were investigated: 1) Disability pensioners having back pain (n = 89) previously participating in the RCT (randomized to either a brief cognitive behavioural intervention or to a control group), 2) 342 disability pensioners having back pain, but refusing to participate in the study and 3) 449 disability pensioners having other musculoskeletal disorders than back pain. Primary outcome was return to work, defined as a reduction in payment of disability pension.
Results
Only 2 of 89 (2.3%) participants from the RCT had reduced disability pension at 3-years follow-up, both from the control group. None of the participants that had been in a process of returning to work after 1 year had actually gained employment at 3-years follow-up. In the 2 groups not participating in the previous RCT, only 4 (1.2%) and 8 (1.6%) had returned to work after 3 years respectively.
Conclusion
The number of pensioners who returned to work was negligible in all groups regardless of having participated in a cognitive behavioural intervention or not.
doi:10.1186/1471-2458-9-407
PMCID: PMC2777167  PMID: 19903333
21.  Developing stroke-specific vocational rehabilitation: a soft systems analysis of current service provision 
Disability and Rehabilitation  2013;36(5):409-417.
Purpose:
This study aimed to clarify the existing service provision of stroke-specific vocational rehabilitation (VR) in one English county, in order to facilitate future service development.
Method:
Using soft systems methodology, services in Health, Social Care, Department of Work and Pensions, the voluntary and private sectors, which were identified as supporting return to work after stroke, were mapped using a mixed-methodology approach.
Results:
A lack of a sanctioned VR pathway meant access to support relied on brokered provision and tacit knowledge. The timing of an intervention was complex and there was a substantial degree of unmet need for mild stroke patients. VR was seen as “non-essential” due to competing commissioning priorities. Service providers from all sectors lacked training and cross-sector partnerships were tenuous and provider roles unclear.
Conclusions:
Stroke-specific VR should be delivered by an integrated, cross-sector multi-disciplinary team and integrated commissioning between health and other sectors is necessary. Although early intervention is important, support later on in the recovery process is also necessary. Service providers need adequate training to meet the needs of stroke survivors wishing to return to work and better awareness of best practice guidelines. Business cases which demonstrate the efficacy and cost-effectiveness of VR are vital.
Implications for Rehabilitation
The timeliness of a vocational rehabilitation (VR) intervention is complex; services need to be responsive to the changing needs of the stroke survivor throughout their recovery process and have better mechanisms to ensure re-entry into the stroke pathway is possible.
Return to work is a recognised health outcome; health services need to develop better mechanisms for interagency/cross sector working and liaison with employers and not assume that VR is beyond their remit. Therapists and non-health service providers should receive sufficient training to meet the needs of stroke survivors wishing to return to work. Rehabilitation teams must decide how to implement national guidance within existing resources and what training is needed to deploy SSVR.
The lack of a sanctioned pathway results in disorganised and patchy provision of VR for stroke survivors; mild stroke patients can fall through the net and receive little or no support. The journey back to work commences at the point of stroke. Mechanisms for identifying acute stroke survivors who were working at onset and for assessing the impact of the stroke on their work need to be put in place. The entire MDT has a role to play. In the absence of a VR specialist, even patients without obvious disability should be referred for ongoing rehabilitation with detailed work assessment and signposted to employment specialists e.g. disability employment advisors EARLY after stroke.
Health-based VR interventions can influence work return and job retention. However, therapists must routinely measure work outcomes to inform their business case and be encouraged to demonstrate these outcomes to local commissioners. Commissioners should consider emerging evidence of early VR interventions on reduced length of stay, health and social care resource use and the wider health benefits of maintaining employment.
doi:10.3109/09638288.2013.793410
PMCID: PMC3971737  PMID: 23692389
Mapping; soft systems analysis; stroke; vocational rehabilitation
22.  Home Telehealth for Patients With Chronic Obstructive Pulmonary Disease (COPD) 
Executive Summary
In July 2010, the Medical Advisory Secretariat (MAS) began work on a Chronic Obstructive Pulmonary Disease (COPD) evidentiary framework, an evidence-based review of the literature surrounding treatment strategies for patients with COPD. This project emerged from a request by the Health System Strategy Division of the Ministry of Health and Long-Term Care that MAS provide them with an evidentiary platform on the effectiveness and cost-effectiveness of COPD interventions.
After an initial review of health technology assessments and systematic reviews of COPD literature, and consultation with experts, MAS identified the following topics for analysis: vaccinations (influenza and pneumococcal), smoking cessation, multidisciplinary care, pulmonary rehabilitation, long-term oxygen therapy, noninvasive positive pressure ventilation for acute and chronic respiratory failure, hospital-at-home for acute exacerbations of COPD, and telehealth (including telemonitoring and telephone support). Evidence-based analyses were prepared for each of these topics. For each technology, an economic analysis was also completed where appropriate. In addition, a review of the qualitative literature on patient, caregiver, and provider perspectives on living and dying with COPD was conducted, as were reviews of the qualitative literature on each of the technologies included in these analyses.
The Chronic Obstructive Pulmonary Disease Mega-Analysis series is made up of the following reports, which can be publicly accessed at the MAS website at: http://www.hqontario.ca/en/mas/mas_ohtas_mn.html.
Chronic Obstructive Pulmonary Disease (COPD) Evidentiary Framework
Influenza and Pneumococcal Vaccinations for Patients With Chronic Obstructive Pulmonary Disease (COPD): An Evidence-Based Analysis
Smoking Cessation for Patients With Chronic Obstructive Pulmonary Disease (COPD): An Evidence-Based Analysis
Community-Based Multidisciplinary Care for Patients With Stable Chronic Obstructive Pulmonary Disease (COPD): An Evidence-Based Analysis
Pulmonary Rehabilitation for Patients With Chronic Obstructive Pulmonary Disease (COPD): An Evidence-Based Analysis
Long-term Oxygen Therapy for Patients With Chronic Obstructive Pulmonary Disease (COPD): An Evidence-Based Analysis
Noninvasive Positive Pressure Ventilation for Acute Respiratory Failure Patients With Chronic Obstructive Pulmonary Disease (COPD): An Evidence-Based Analysis
Noninvasive Positive Pressure Ventilation for Chronic Respiratory Failure Patients With Stable Chronic Obstructive Pulmonary Disease (COPD): An Evidence-Based Analysis
Hospital-at-Home Programs for Patients With Acute Exacerbations of Chronic Obstructive Pulmonary Disease (COPD): An Evidence-Based Analysis
Home Telehealth for Patients With Chronic Obstructive Pulmonary Disease (COPD): An Evidence-Based Analysis
Cost-Effectiveness of Interventions for Chronic Obstructive Pulmonary Disease Using an Ontario Policy Model
Experiences of Living and Dying With COPD: A Systematic Review and Synthesis of the Qualitative Empirical Literature
For more information on the qualitative review, please contact Mita Giacomini at: http://fhs.mcmaster.ca/ceb/faculty_member_giacomini.htm.
For more information on the economic analysis, please visit the PATH website: http://www.path-hta.ca/About-Us/Contact-Us.aspx.
The Toronto Health Economics and Technology Assessment (THETA) collaborative has produced an associated report on patient preference for mechanical ventilation. For more information, please visit the THETA website: http://theta.utoronto.ca/static/contact.
Objective
The objective of this analysis was to conduct an evidence-based assessment of home telehealth technologies for patients with chronic obstructive pulmonary disease (COPD) in order to inform recommendations regarding the access and provision of these services in Ontario. This analysis was one of several analyses undertaken to evaluate interventions for COPD. The perspective of this assessment was that of the Ontario Ministry of Health and Long-Term Care, a provincial payer of medically necessary health care services.
Clinical Need: Condition and Target Population
Canada is facing an increase in chronic respiratory diseases due in part to its aging demographic. The projected increase in COPD will put a strain on health care payers and providers. There is therefore an increasing demand for telehealth services that improve access to health care services while maintaining or improving quality and equality of care. Many telehealth technologies however are in the early stages of development or diffusion and thus require study to define their application and potential harms or benefits. The Medical Advisory Secretariat (MAS) therefore sought to evaluate telehealth technologies for COPD.
Technology
Telemedicine (or telehealth) refers to using advanced information and communication technologies and electronic medical devices to support the delivery of clinical care, professional education, and health-related administrative services.
Generally there are 4 broad functions of home telehealth interventions for COPD:
to monitor vital signs or biological health data (e.g., oxygen saturation),
to monitor symptoms, medication, or other non-biologic endpoints (e.g., exercise adherence),
to provide information (education) and/or other support services (such as reminders to exercise or positive reinforcement), and
to establish a communication link between patient and provider.
These functions often require distinct technologies, although some devices can perform a number of these diverse functions. For the purposes of this review, MAS focused on home telemonitoring and telephone only support technologies.
Telemonitoring (or remote monitoring) refers to the use of medical devices to remotely collect a patient’s vital signs and/or other biologic health data and the transmission of those data to a monitoring station for interpretation by a health care provider.
Telephone only support refers to disease/disorder management support provided by a health care provider to a patient who is at home via telephone or videoconferencing technology in the absence of transmission of patient biologic data.
Research Questions
What is the effectiveness, cost-effectiveness, and safety of home telemonitoring compared with usual care for patients with COPD?
What is the effectiveness, cost-effectiveness, and safety of telephone only support programs compared with usual care for patients with COPD?
Research Methods
Literature Search
Search Strategy
A literature search was performed on November 3, 2010 using OVID MEDLINE, MEDLINE In-Process and Other Non-Indexed Citations, EMBASE, the Cumulative Index to Nursing & Allied Health Literature (CINAHL), the Cochrane Library, and the International Agency for Health Technology Assessment (INAHTA) for studies published from January 1, 2000 until November 3, 2010. Abstracts were reviewed by a single reviewer and, for those studies meeting the eligibility criteria, full-text articles were obtained. Reference lists were also examined for any additional relevant studies not identified through the search. Articles with unknown eligibility were reviewed with a second clinical epidemiologist, and then a group of epidemiologists until consensus was established. The quality of evidence was assessed as high, moderate, low, or very low according to GRADE methodology.
Inclusion Criteria – Question #1
frequent transmission of a patient’s physiological data collected at home and without a health care professional physically present to health care professionals for routine monitoring through the use of a communication technology;
monitoring combined with a coordinated management and feedback system based on transmitted data;
telemonitoring as a key component of the intervention (subjective determination);
usual care as provided by the usual care provider for the control group;
randomized controlled trials (RCTs), controlled clinical trials (CCTs), systematic reviews, and/or meta-analyses;
published between January 1, 2000 and November 3, 2010.
Inclusion Criteria – Question #2
scheduled or frequent contact between patient and a health care professional via telephone or videoconferencing technology in the absence of transmission of patient physiological data;
monitoring combined with a coordinated management and feedback system based on transmitted data;
telephone support as a key component of the intervention (subjective determination);
usual care as provided by the usual care provider for the control group;
RCTs, CCTs, systematic reviews, and/or meta-analyses;
published between January 1, 2000 and November 3, 2010.
Exclusion Criteria
published in a language other than English;
intervention group (and not control) receiving some form of home visits by a medical professional, typically a nurse (i.e., telenursing) beyond initial technology set-up and education, to collect physiological data, or to somehow manage or treat the patient;
not recording patient or health system outcomes (e.g., technical reports testing accuracy, reliability or other development-related outcomes of a device, acceptability/feasibility studies, etc.);
not using an independent control group that received usual care (e.g., studies employing historical or periodic controls).
Outcomes of Interest
hospitalizations (primary outcome)
mortality
emergency department visits
length of stay
quality of life
other […]
Subgroup Analyses (a priori)
length of intervention (primary)
severity of COPD (primary)
Quality of Evidence
The quality of evidence assigned to individual studies was determined using a modified CONSORT Statement Checklist for Randomized Controlled Trials. (1) The CONSORT Statement was adapted to include 3 additional quality measures: the adequacy of control group description, significant differential loss to follow-up between groups, and greater than or equal to 30% study attrition. Individual study quality was defined based on total scores according to the CONSORT Statement checklist: very low (0 to < 40%), low (≥ 40 to < 60%), moderate (≥ 60 to < 80%), and high (≥ 80 to 100%).
The quality of the body of evidence was assessed as high, moderate, low, or very low according to the GRADE Working Group criteria. The following definitions of quality were used in grading the quality of the evidence:
Summary of Findings
Six publications, representing 5 independent trials, met the eligibility criteria for Research Question #1. Three trials were RCTs reported across 4 publications, whereby patients were randomized to home telemonitoring or usual care, and 2 trials were CCTs, whereby patients or health care centers were nonrandomly assigned to intervention or usual care.
A total of 310 participants were studied across the 5 included trials. The mean age of study participants in the included trials ranged from 61.2 to 74.5 years for the intervention group and 61.1 to 74.5 years for the usual care group. The percentage of men ranged from 40% to 64% in the intervention group and 46% to 72% in the control group.
All 5 trials were performed in a moderate to severe COPD patient population. Three trials initiated the intervention following discharge from hospital. One trial initiated the intervention following a pulmonary rehabilitation program. The final trial initiated the intervention during management of patients at an outpatient clinic.
Four of the 5 trials included oxygen saturation (i.e., pulse oximetry) as one of the biological patient parameters being monitored. Additional parameters monitored included forced expiratory volume in one second, peak expiratory flow, and temperature.
There was considerable clinical heterogeneity between trials in study design, methods, and intervention/control. In relation to the telemonitoring intervention, 3 of the 5 included studies used an electronic health hub that performed multiple functions beyond the monitoring of biological parameters. One study used only a pulse oximeter device alone with modem capabilities. Finally, in 1 study, patients measured and then forwarded biological data to a nurse during a televideo consultation. Usual care varied considerably between studies.
Only one trial met the eligibility criteria for Research Question #2. The included trial was an RCT that randomized 60 patients to nurse telephone follow-up or usual care (no telephone follow-up). Participants were recruited from the medical department of an acute-care hospital in Hong Kong and began receiving follow-up after discharge from the hospital with a diagnosis of COPD (no severity restriction). The intervention itself consisted of only two 10-to 20-minute telephone calls, once between days 3 to 7 and once between days 14 to 20, involving a structured, individualized educational and supportive programme led by a nurse that focused on 3 components: assessment, management options, and evaluation.
Regarding Research Question #1:
Low to very low quality evidence (according to GRADE) finds non-significant effects or conflicting effects (of significant or non-significant benefit) for all outcomes examined when comparing home telemonitoring to usual care.
There is a trend towards significant increase in time free of hospitalization and use of other health care services with home telemonitoring, but these findings need to be confirmed further in randomized trials of high quality.
There is severe clinical heterogeneity between studies that limits summary conclusions.
The economic impact of home telemonitoring is uncertain and requires further study.
Home telemonitoring is largely dependent on local information technologies, infrastructure, and personnel, and thus the generalizability of external findings may be low. Jurisdictions wishing to replicate home telemonitoring interventions should likely test those interventions within their jurisdictional framework before adoption, or should focus on home-grown interventions that are subjected to appropriate evaluation and proven effective.
Regarding Research Question #2:
Low quality evidence finds significant benefit in favour of telephone-only support for self-efficacy and emergency department visits when compared to usual care, but non-significant results for hospitalizations and hospital length of stay.
There are very serious issues with the generalizability of the evidence and thus additional research is required.
PMCID: PMC3384362  PMID: 23074421
23.  Case management vocational rehabilitation for women with breast cancer after surgery: a feasibility study incorporating a pilot randomised controlled trial 
Trials  2013;14:175.
Background
There is a paucity of methodologically robust vocational rehabilitation (VR) intervention trials. This study assessed the feasibility and acceptability of a VR trial of women with breast cancer to inform the development of a larger interventional study.
Methods
Women were recruited in Scotland and randomised to either a case management VR service or to usual care. Data were collected on eligibility, recruitment and attrition rates to assess trial feasibility, and interviews conducted to determine trial acceptability. Sick leave days (primary outcome) were self-reported via postal questionnaire every 4 weeks during the first 6 months post-surgery and at 12 months. Secondary outcome measures were change in employment pattern, quality of life and fatigue.
Results
Of the 1,114 women assessed for eligibility, 163 (15%) were eligible. The main reason for ineligibility was age (>65 years, n = 637, 67%). Of those eligible, 111 (68%) received study information, of which 23 (21%) consented to participate in the study. Data for 18 (78%) women were analysed (intervention: n = 7; control: n = 11). Participants in the intervention group reported, on average, 53 fewer days of sick leave over the first 6 months post-surgery than those in the control group; however, this difference was not statistically significant (p = 0.122; 95% confidence interval −15.8, 122.0). No statistically significant differences were found for secondary outcomes. Interviews with trial participants indicated that trial procedures, including recruitment, randomisation and research instruments, were acceptable.
Conclusions
Conducting a pragmatic trial of effectiveness of a VR intervention among cancer survivors is both feasible and acceptable, but more research about the exact components of a VR intervention and choice of outcomes to measure effectiveness is required. VR to assist breast cancer patients in the return to work process is an important component of cancer survivorship plans.
Trial registration
ISRCTN29666484
doi:10.1186/1745-6215-14-175
PMCID: PMC3698180  PMID: 23768153
Cancer survivor; Breast cancer; Vocational rehabilitation; Work; Employment; Sickness absence
24.  Occupational rehabilitation programs for musculoskeletal pain and common mental health disorders: study protocol of a randomized controlled trial 
BMC Public Health  2014;14:368.
Background
Long-term sick leave has considerably negative impact on the individual and society. Hence, the need to identify effective occupational rehabilitation programs is pressing. In Norway, group based occupational rehabilitation programs merging patients with different diagnoses have existed for many years, but no rigorous evaluation has been performed. The described randomized controlled trial aims primarily to compare two structured multicomponent inpatient rehabilitation programs, differing in length and content, with a comparative cognitive intervention. Secondarily the two inpatient programs will be compared with each other, and with a usual care reference group.
Methods/design
The study is designed as a randomized controlled trial with parallel groups. The Social Security Office performs monthly extractions of sick listed individuals aged 18–60 years, on sick leave 2–12 months, with sick leave status 50% - 100% due to musculoskeletal, mental or unspecific disorders. Sick-listed persons are randomized twice: 1) to receive one of two invitations to participate in the study or not receive an invitation, where the latter “untouched” control group will be monitored for future sick leave in the National Social Security Register, and 2) after inclusion, to a Long or Short inpatient multicomponent rehabilitation program (depending on which invitation was sent) or an outpatient cognitive behavioral therapy group comparative program. The Long program consists of 3 ½ weeks with full rehabilitation days. The Short program consists of 4 + 4 full days, separated by two weeks, in which a workplace visit will be performed if desirable. Three areas of rehabilitation are targeted: mental training, physical training and work-related problem solving. The primary outcome is number of sick leave days. Secondary outcomes include time until full sustainable return to work, health related quality of life, health related behavior, functional status, somatic and mental health, and perceptions of work. In addition, health economic evaluation will be performed, and the implementation of the interventions, expectations and experiences of users and service providers will be investigated with different qualitative methods.
Trial registration
ClinicalTrials.gov: NCT01926574.
doi:10.1186/1471-2458-14-368
PMCID: PMC3996166  PMID: 24735616
Absenteeism; Occupational health; Rehabilitation; Return to work; Cognitive behavior therapy; Exercise musculoskeletal diseases
25.  Physical functioning after occupational rehabilitation and returning to work among employees with chronic musculoskeletal pain and comorbid depressive symptoms 
Background
The aim of this investigation was to assess whether measures of physical functioning after multidisciplinary rehabilitation are associated with return to work among individuals with chronic musculoskeletal pain conditions and comorbid depressive symptoms.
Methods
Included were 92 employees with chronic musculoskeletal disorders who had participated in a 57- week multidisciplinary rehabilitation program. Their ages ranged from 25–59 years. The Hospital Anxiety and Depression Scale was used to assess depressive symptoms. Different aspects of physical functioning (muscle strength, mobility, endurance capacity, and balance) were measured with single-item visual analog scales, and physical fitness was measured with the validated COOP/WONCA charts. Being on “active work strategies,” such as receiving rehabilitation benefit/vocational rehabilitation or being reported partly or completely fit, was defined as “on their way into/in work”. Cross-sectional associations were measured using logistic regression models, estimating odds ratio with 95% confidence intervals.
Results
There were no differences between the “on their way into/in work” group (n=70) and the “on their way out/out of work” group (n=22) regarding age, sex, or levels of anxiety or pain. Surprisingly, regression analyses showed that those with higher levels of physical functioning had significantly lower odds of returning to work.
Conclusion
The findings of an inverse relationship between self-reported physical function and returning to work in this sample illustrate that the return-to-work process among employees with chronic musculoskeletal pain and comorbid depressive symptoms is multifactorial and influenced by factors other than physical functioning at the individual level. Further research, especially longitudinal studies, is needed to assess the occupational trajectories among employees with chronic musculoskeletal pain and comorbid depressive symptoms after participation in a multidisciplinary rehabilitation program.
doi:10.2147/JMDH.S55828
PMCID: PMC3904812  PMID: 24489473
chronic musculoskeletal pain; multidisciplinary rehabilitation; physical functioning; depression; return to work

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