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1.  Cost effectiveness of a multi-stage return to work program for workers on sick leave due to low back pain, design of a population based controlled trial [ISRCTN60233560] 
Background
To describe the design of a population based randomized controlled trial (RCT), including a cost-effectiveness analysis, comparing participative ergonomics interventions between 2–8 weeks of sick leave and Graded Activity after 8 weeks of sick leave with usual care, in occupational back pain management.
Methods
Design
An RCT and cost-effectiveness evaluation in employees sick-listed for a period of 2 to 6 weeks due to low back pain. Interventions used are 1. Communication between general practitioner and occupational physician plus Participative Ergonomics protocol performed by an ergonomist. 2. Graded Activity based on cognitive behavioural principles by a physiotherapist. 3. Usual care, provided by an occupational physician according to the Dutch guidelines for the occupational health management of workers with low back pain. The primary outcome measure is return to work. Secondary outcome measures are pain intensity, functional status and general improvement. Intermediate variables are kinesiophobia and pain coping. The cost-effectiveness analysis includes the direct and indirect costs due to low back pain. The outcome measures are assessed before randomization (after 2–6 weeks on sick leave) and 12 weeks, 26 weeks and 52 weeks after first day of sick leave.
Discussion
The combination of these interventions has been subject of earlier research in Canada. The results of the current RCT will: 1. crossvalidate the Canadian findings in an different sociocultural environment; 2. add to the cost-effectiveness on treatment options for workers in the sub acute phase of low back pain. Results might lead to alterations of existing (inter)national guidelines.
doi:10.1186/1471-2474-4-26
PMCID: PMC317323  PMID: 14629775
Low back pain; Graded Activity; Participative Ergonomics; Return to work; Randomized Controlled Trial; Cost-effectiveness; Occupational health
2.  Prevention of recurrent sickness absence among employees with common mental disorders: design of a cluster-randomised controlled trial with cost-benefit and effectiveness evaluation 
BMC Public Health  2010;10:132.
Background
Common mental disorders, such as depression, anxiety disorder, and adjustment disorder, have emerged as a major public and occupational health problem in many countries. These disorders can have severe consequences such as absenteeism and work disability. Different interventions have been developed to improve the return-to-work of employees with common mental disorders, but still a large proportion of employees experiences health and work problems after their return-to-work. For this reason, the SHARP-at work intervention is developed to prevent a relapse of sickness absence among employees who have returned to work after a period of sickness absence because of common mental disorders. We aim to evaluate the effectiveness, cost-benefit and process of the intervention compared to care as usual.
Methods/Design
The study is designed as a cluster-randomised controlled trial with randomisation at the level of the occupational physician. Employees who have returned to work after a period of sickness absence because of a common mental disorder are included in the study. Employees in the intervention group will receive the SHARP-at work intervention. The intervention focusses on active guidance of employees by occupational physicians during the first weeks of work after sickness absence. Employees in the control group will receive care as usual. Outcomes will be assessed at baseline and at 3, 6, and 12 months follow-up. The primary outcome is cumulative recurrent sickness absence days. Secondary outcome measures are mental health, work functioning, and coping. Adherence to the protocol, communication between stakeholders, and satisfaction with the treatment are the process measures assessed in both study groups. Cost-benefit is calculated from a societal perspective. Finally, prognostic factors for a relapse of sickness absence are investigated.
Discussion
This study goes beyond return-to-work by focussing on the prevention of recurrent sickness absence. The study incorporates not only outcomes on sickness absence and mental health but also on health-related work functioning. The results of this study can contribute to a further development of practice guidelines and the promotion of sustainable work participation.
Trial registration
NTR1963
doi:10.1186/1471-2458-10-132
PMCID: PMC2841673  PMID: 20230606
3.  Effectiveness and cost-effectiveness of an exposure-based return-to-work programme for patients on sick leave due to common mental disorders: design of a cluster-randomized controlled trial 
BMC Public Health  2009;9:140.
Background
To reduce the duration of sick leave and loss of productivity due to common mental disorders (CMDs), we developed a return-to-work programme to be provided by occupational physicians (OPs) based on the principles of exposure in vivo (RTW-E programme). This study evaluates this programme's effectiveness and cost-effectiveness by comparing it with care as usual (CAU). The three research questions we have are: 1) Is an RTW-E programme more effective in reducing the sick leave of employees with common mental disorders, compared with care as usual? 2) Is an RTW-E programme more effective in reducing sick leave for employees with anxiety disorders compared with employees with other common mental disorders? 3) From a societal perspective, is an RTW-E programme cost-effective compared with care as usual?
Methods/design
This study was designed as a pragmatic cluster-randomized controlled trial with a one-year follow-up and randomization on the level of OPs. We aimed for 60 OPs in order to include 200 patients. Patients in the intervention group received the RTW-E programme. Patients in the control group received care as usual. Eligible patients had been on sick leave due to common mental disorders for at least two weeks and no longer than eight weeks. As primary outcome measures, we calculated the time until full return to work and the duration of sick leave. Secondary outcome measures were time until partial return to work, prevalence rate of sick leave at 3, 6, 9, and 12 months' follow-up, and scores of symptoms of distress, anxiety, depression, somatization, and fatigue; work capacity; perceived working conditions; self-efficacy for return to work; coping behaviour; avoidance behaviour; patient satisfaction; and work adaptations. As process measures, we used indices of compliance with the intervention in the intervention group and employee-supervisor communication in both groups. Economic costs were calculated from a societal perspective. The total costs consisted of the costs of consuming health care, costs of production loss due to sick leave and reduced productivity, and out-of-pocket costs of patients for travelling to their OP.
Discussion
The results will be published in 2009. The strengths and weaknesses of the study protocol are discussed.
Trial registration
ISRCTN72643128
doi:10.1186/1471-2458-9-140
PMCID: PMC2689200  PMID: 19439084
4.  Improving return-to-work after childbirth: design of the Mom@Work study, a randomised controlled trial and cohort study 
BMC Public Health  2007;7:43.
Background
Many women suffer from health problems after giving birth, which can lead to sick leave. About 30% of Dutch workers are on sick leave after maternity leave. Structural contact of supervisors with employees on maternity leave, supported by early medical advice of occupational physicians, may increase the chances of return-to-work after maternity leave. In addition, to understand the process of sick leave and return-to-work after childbirth it is important to gain insight into which factors hinder return-to-work after childbirth, as well, as which prognostic factors lead to the development of postpartum health complaints. In this paper, the design of the Mom@Work study is described.
Methods
The Mom@Work study is simultaneously a randomised controlled trial and a cohort study. Pregnant women working for at least 12 hours a week at one of the 15 participating companies are eligible to participate. The supervisors of these pregnant employees are randomised at 35 weeks pregnancy into the intervention group or control group. During maternity leave, supervisors in the intervention group contact their employee six weeks after delivery using a structured interview. When employees do not expect to return to their jobs at the end of their scheduled maternity leave due to health problems, the supervisor offers early support of the occupational physician. Supervisors in the control group have no structural contact with their employees during maternity leave. Measurements take place at 30 weeks pregnancy and at 6, 12, 24 and 52 weeks postpartum. In addition, cost data are collected. For the RCT, primary outcome measures are sick leave and return-to-work, and secondary outcome measures are costs, health, satisfaction with intervention and global feelings of recovery. Outcome measures for the cohort are pregnancy-related pelvic girdle pain, fatigue and depression. Finally, a number of prognostic factors for return-to-work and for the development of complaints will be measured.
Discussion
The Mom@Work study will provide important information about return-to-work of employees after giving birth. Results will give insight in prognosis of postpartum sick leave and complaints. Also, the role of supervisors and occupational physicians in successful return-to-work after childbirth will be clarified.
doi:10.1186/1471-2458-7-43
PMCID: PMC1851952  PMID: 17394629
5.  Faster return to work after psychiatric consultation for sicklisted employees with common mental disorders compared to care as usual. A randomized clinical trial 
Introduction
Return to work (RTW) of employees on sick leave for common mental disorders may require a multidisciplinary approach. This article aims to assess time to RTW after a psychiatric consultation providing treatment advice to the occupational physician (OP) for employees on sick leave for common mental disorders in the occupational health (OH) setting, compared to care as usual (CAU).
Methods
Cluster randomized clinical trial evaluating patients of 12 OPs receiving consultation by a psychiatrist, compared to CAU delivered by 12 OPs in the control group. 60 patients suffering from common mental disorders and ≥ six weeks sicklisted were included. Follow up three and six months after inclusion. Primary outcome measure was time to RTW. Intention- to-treat multilevel analysis and a survival analysis were performed to evaluate time to RTW in both groups.
Results
In CAU, referral was the main intervention. Both groups improved in terms of symptom severity and quality of life, but time to RTW was significantly shorter in the psychiatric consultation group. At three months follow up, 58% of the psychiatric consultation group had full RTW versus 44% of the control group, a significant finding (P = 0.0093). Survival analysis showed 68 days earlier RTW after intervention in the psychiatric consultation group (P = 0.078) compared to CAU.
Conclusion
Psychiatric consultation for employees on sick leave in the OH setting improves time to RTW in patients with common mental disorders as compared to CAU. In further research, focus should be on early intervention in patients with common mental disorders on short sick leave duration. Psychiatric consultation might be particularly promising for improvement of RTW in those patients.
Trial registration number
ISRCTN: 86722376
PMCID: PMC2938286  PMID: 20856601
psychiatric consultation; mental disorders; RCT; sickness absence; major depressive disorder; anxiety disorder; somatoform disorder
6.  Effectiveness of guideline-based care by occupational physicians on the return-to-work of workers with common mental disorders: design of a cluster-randomised controlled trial 
BMC Public Health  2013;13:193.
Background
Sickness absence due to common mental disorders (such as depression, anxiety disorder, adjustment disorder) is a problem in many Western countries. Long-term sickness absence leads to substantial societal and financial costs. In workers with common mental disorders, sickness absence costs are much higher than medical costs. In the Netherlands, a practice guideline was developed that promotes an activating approach of the occupational physician to establish faster return-to-work by enhancing the problem-solving capacity of workers, especially in relation to their work environment. Studies on this guideline indicate a promising association between guideline adherence and a shortened sick leave duration, but also minimal adherence to the guideline by occupational physicians. Therefore, this study evaluates the effect of guideline-based care on the full return-to-work of workers who are sick listed due to common mental disorders.
Methods/design
This is a two-armed cluster-randomised controlled trial with randomisation at the occupational physician level. During one year, occupational physicians in the intervention group receive innovative training to improve their guideline-based care whereas occupational physicians in the control group provide care as usual. A total of 232 workers, sick listed due to common mental disorders and counselled by participating occupational physicians, will be included. Data are collected via the registration system of the occupational health service, and by questionnaires at baseline and at 3, 6 and 12 months. The primary outcome is time to full return-to-work. Secondary outcomes are partial return-to-work, total number of sick leave days, symptoms, and workability. Personal and work characteristics are the prognostic measures. Additional measures are coping, self-efficacy, remoralization, personal experiences, satisfaction with consultations with the occupational physician and with contact with the supervisor, experiences and behaviour of the supervisor, and the extent of guideline adherence.
Discussion
If the results show that guideline-based care in fact leads to faster and sustainable return-to-work, this study will contribute to lowering personal, societal and financial costs.
Trial registration
ISRCTN86605310
doi:10.1186/1471-2458-13-193
PMCID: PMC3599838  PMID: 23496948
Common mental disorders; Sick leave; Return-to-work; Occupational health service; Occupational physicians; Guideline adherence; Guideline-based care
7.  Cost-effectiveness of a workplace intervention for sick-listed employees with common mental disorders: design of a randomized controlled trial 
BMC Public Health  2008;8:12.
Background
Considering the high costs of sick leave and the consequences of sick leave for employees, an early return-to-work of employees with mental disorders is very important. Therefore, a workplace intervention is developed based on a successful return-to-work intervention for employees with low back pain. The objective of this paper is to present the design of a randomized controlled trial evaluating the cost-effectiveness of the workplace intervention compared with usual care for sick-listed employees with common mental disorders.
Methods
The study is designed as a randomized controlled trial with a follow-up of one year. Employees eligible for this study are on sick leave for 2 to 8 weeks with common mental disorders. The workplace intervention will be compared with usual care. The workplace intervention is a stepwise approach that aims to reach consensus about a return-to-work plan by active participation and strong commitment of both the sick-listed employee and the supervisor. Outcomes will be assessed at baseline, 3, 6, 9 and 12 months. The primary outcome of this study is lasting return-to-work, which will be acquired from continuous registration systems of the companies after the follow-up. Secondary outcomes are total number of days of sick leave during the follow-up, severity of common mental disorders, coping style, job content, and attitude, social influence, and self-efficacy determinants. Cost-effectiveness will be evaluated from the societal perspective. A process evaluation will also be conducted.
Discussion
Return-to-work is difficult to discuss in the workplace for sick-listed employees with mental disorders and their supervisors. Therefore, this intervention offers a unique opportunity for the sick-listed employee and the supervisor to discuss barriers for return-to-work. Results of this study will possibly contribute to improvement of disability management for sick-listed employees with common mental disorders. Results will become available in 2009.
Trial registration
ISRCTN92307123
doi:10.1186/1471-2458-8-12
PMCID: PMC2254399  PMID: 18194525
8.  Effectiveness of a minimal psychological intervention to reduce mild to moderate depression and chronic fatigue in a working population: the design of a randomized controlled trial 
BMC Public Health  2013;13:129.
Background
In a working population, common mental complaints like depressed mood and chronic fatigue are highly prevalent and often result in further deterioration of mental health and consequently absence from work. In a large occupational health setting, we will evaluate the (cost-) effectiveness of a Minimal Psychological Intervention (MPI), in reducing symptoms of depression and chronic fatigue in a working population. The MPI is also evaluated regarding its appreciation by worker, nurse, and occupational health physician (process evaluation). The tailor-made intervention is administered by nurses, who are trained in the principles of cognitive behavioural therapy and self-management.
Methods/design
The presented WoPaCoM study (Work Participation of Workers with Common Mental complaints) is a two-armed randomized controlled trial, comparing MPI with usual care. A total number of 124 workers suffering from (chronic) mental fatigue or mild to moderate depression will be included. A stratified and block randomization will be applied, stratifying by customer organisation, income, and gender, using a block size of four. It will include a baseline measurement and subsequently follow up measurements after 4, 6 and 12 months. The primary outcome measures are symptoms of either fatigue (using the Checklist Individual Strength) and/or depression (using the Beck Depression Inventory) and secondary outcome measures include sickness absence, self efficacy, costs and quality of life. Analysis will include both univariate and multivariate techniques and data will be analysed according to the intention to treat principle.
Discussion
Patient recruitment in an occupational setting proves to be complicated and time consuming. Shift work for instance proved to be an obstacle for making appointments for consultation with the nurse. Furthermore, economic developments might have created job insecurity which negatively influenced participation in the study, with workers being anxious to be detected as having psychological problems. Additionally, long-term follow-up in a working population is time-consuming and continuously engages occupational health staff and administrative personnel to control the process of data gathering. However, if the intervention proves to be effective, occupational medicine will have a manageable option for treatment of workers who are at risk of loss of productivity or sickness absence.
Trial registration
Nederlands Trialregister NTR3162
doi:10.1186/1471-2458-13-129
PMCID: PMC3579682  PMID: 23402525
9.  Multidisciplinary outpatient care program for patients with chronic low back pain: design of a randomized controlled trial and cost-effectiveness study [ISRCTN28478651] 
BMC Public Health  2007;7:254.
Background
Chronic low back pain (LBP) is a major public and occupational health problem, which is associated with very high costs. Although medical costs for chronic LBP are high, most costs are related to productivity losses due to sick leave. In general, the prognosis for return to work (RTW) is good but a minority of patients will be absent long-term from work. Research shows that work related problems are associated with an increase in seeking medical care and sick leave. Usual medical care of patients is however, not specifically aimed at RTW.
The objective is to present the design of a randomized controlled trial, i.e. the BRIDGE-study, evaluating the effectiveness in improving RTW and cost-effectiveness of a multidisciplinary outpatient care program situated in both primary and outpatient care setting compared with usual clinical medical care for patients with chronic LBP.
Methods/Design
The design is a randomized controlled trial with an economic evaluation alongside. The study population consists of patients with chronic LBP who are completely or partially sick listed and visit an outpatient clinic of one of the participating hospitals in Amsterdam (the Netherlands). Two interventions will be compared. 1. a multidisciplinary outpatient care program consisting of a workplace intervention based on participatory ergonomics, and a graded activity program using cognitive behavioural principles. 2. usual care provided by the medical specialist, the occupational physician, the patient's general practitioner and allied health professionals. The primary outcome measure is sick leave duration until full RTW. Sick leave duration is measured monthly by self-report during one year. Data on sick leave during one-year follow-up are also requested form the employers. Secondary outcome measures are pain intensity, functional status, pain coping, patient satisfaction and quality of life. Outcome measures are assessed before randomization and 3, 6, and 12 months later. All statistical analysis will be performed according to the intension-to-treat principle.
Discussion
Usual care of primary and outpatient health services isn't directly aimed at RTW, therefor it is desirable to look for care which is aimed at RTW. Research shows that several occupational interventions in primary care are aimed at RTW. They have shown a significant reduction of sick leave for employee with LBP. If a comparable reduction of sick leave duration of patients with chronic LBP of who attend an outpatient clinic can be achieved, such reductions will be obviously substantial for the Netherlands and will have a considerable impact.
Trial registration
ISRCTN28478651
doi:10.1186/1471-2458-7-254
PMCID: PMC2174473  PMID: 17883853
10.  Intensive group training protocol versus guideline physiotherapy for patients with chronic low back pain: a randomised controlled trial 
European Spine Journal  2008;17(9):1193-1200.
Intensive group training using principles of graded activity has been proven to be effective in occupational care for workers with chronic low back pain. Objective of the study was to compare the effects of an intensive group training protocol aimed at returning to normal daily activities and guideline physiotherapy for primary care patients with non-specific chronic low back pain. The study was designed as pragmatic randomised controlled trial with a setup of 105 primary care physiotherapists in 49 practices and 114 patients with non-specific low back pain of more than 12 weeks duration participated in the study. In the intensive group training protocol exercise therapy, back school and operant-conditioning behavioural principles are combined. Patients were treated during 10 individual sessions along 20 group sessions. Usual care consisted of physiotherapy according to the Dutch guidelines for Low Back Pain. Main outcome measures were functional disability (Roland Morris disability questionnaire), pain intensity, perceived recovery and sick leave because of low back pain assessed at baseline and after 6, 13, 26 and 52 weeks. Both an intention-to-treat analysis and a per-protocol analysis were performed. Multilevel analysis did not show significant differences between both treatment groups on any outcome measures during the complete follow-up period, with one exception. After 26 weeks the protocol group showed more reduction in pain intensity than the guideline group, but this difference was absent after 52 weeks. We finally conclude that an intensive group training protocol was not more effective than usual physiotherapy for chronic low back pain.
doi:10.1007/s00586-008-0718-6
PMCID: PMC2527421  PMID: 18663487
Low back pain; Physiotherapy; Randomized controlled trial; Graded activity; Group training
11.  A Cluster-Randomised Trial Evaluating an Intervention for Patients with Stress-Related Mental Disorders and Sick Leave in Primary Care 
PLoS Clinical Trials  2007;2(6):e26.
Objective:
Mental health problems often affect functioning to such an extent that they result in sick leave. The worldwide reported prevalence of mental health problems in the working population is 10%–18%. In developed countries, mental health problems are one of the main grounds for receiving disability benefits. In up to 90% of cases the cause is stress-related, and health-care utilisation is mainly restricted to primary care. The aim of this study was to assess the effectiveness of our Minimal Intervention for Stress-related mental disorders with Sick leave (MISS) in primary care, which is intended to reduce sick leave and prevent chronicity of symptoms.
Design:
Cluster-randomised controlled educational trial.
Setting:
Primary health-care practices in the Amsterdam area, The Netherlands.
Participants:
A total of 433 patients (MISS n = 227, usual care [UC] n = 206) with sick leave and self-reported elevated level of distress.
Interventions:
Forty-six primary care physicians were randomised to either receive training in the MISS or to provide UC. Eligible patients were screened by mail.
Outcome Measures:
The primary outcome measure was duration of sick leave until lasting full return to work. The secondary outcomes were levels of self-reported distress, depression, anxiety, and somatisation.
Results:
No superior effect of the MISS was found on duration of sick leave (hazard ratio 1.06, 95% confidence interval 0.87–1.29) nor on severity of self-reported symptoms.
Conclusions:
We found no evidence that the MISS is more effective than UC in our study sample of distressed patients. Continuing research should focus on the potential beneficial effects of the MISS; we need to investigate which elements of the intervention might be useful and which elements should be adjusted to make the MISS effective.
Editorial Commentary
Background: People who take sick leave from work as a result of mental health problems very often report that the cause is stress-related. Although stress-related sick leave imposes a significant burden on individuals and economies, few evidence-based therapies exist to prevent sick leave in people who are experiencing stress-related mental health problems. The researchers carrying out this study wanted to evaluate the effectiveness of an intervention for stress-related mental health disorders amongst people who had been on sick leave for less than three months. The intervention involved short training sessions for primary health-care practitioners, during which the practitioners were taught how to diagnose stress-related problems; how to provide information to patients and encourage their recovery and active return to work; and how to give advice and monitor patients' recovery. The researchers carried out a cluster-randomized trial evaluating this training program, in which 46 primary care practitioners were assigned by chance to receive either the training program or to practice usual care. Over the course of the trial, 433 patients with elevated levels of distress and sick leave were included in the study, 227 of whom were treated by practitioners receiving the training program and 206 of whom received usual care. These patients were followed up for 12 months and the primary outcome studied in the trial was the length of sick leave taken until full return to work. Secondary outcome measures included patients' reports of distress, depression, and other symptoms as recorded using specific questionnaires.
What the trial shows: In the trial, data on the primary outcome measure was available for 87% of the patients treated by practitioners receiving the training intervention and 84% of the patients receiving usual care. When these outcomes were analyzed, there was no evidence of a benefit of the training program on amount of sick leave taken. Over the course of the study, the severity of patients' self-reported symptoms fell in both groups, but there was no significant difference in symptom severity between the two groups of patients. A subgroup analysis suggested that more practitioners in the intervention group recognized patients as having stress-related mental health problems. Among the group of patients who were diagnosed as having stress-related mental health problems, those who were treated by practitioners in the intervention group seemed to return to work slightly more quickly than those in the usual care group. However, it is not easy to interpret the findings of this secondary analysis.
Strengths and limitations: Strengths of this study include the procedures for cluster randomization, in which primary care practitioners were randomized, rather than patients. This process ensures that only patients assigned to the intervention arm receive the benefits of the intervention, and avoids “contamination” between intervention and control groups. A further strength includes the blinding of researchers who were collecting data to the intervention that each practitioner had received. The findings of the study, however, are difficult to interpret. No effect of the training intervention was found on the study's primary outcome measure; it is possible that the training intervention does indeed have some benefit, but the benefit may not have been found in this particular trial because of the inclusion of patients with a very wide range of problems; in addition the practitioners may have not had the time or ability to apply what they learnt in the training program.
Contribution to the evidence: Very little evidence exists regarding the effects of training interventions for improving care of patients with stress-related mental health problems. The findings of this trial support those of another study carried out in a primary care setting, which found that training interventions do not seem to reduce length of sick leave. However, another study carried out in an occupational health-care setting, in which patients included in the trial had been recognised as having stress-related mental disorders, did find some benefit of an intervention program.
doi:10.1371/journal.pctr.0020026
PMCID: PMC1885369  PMID: 17549228
12.  Effectiveness of adjuvant occupational therapy in employees with depression: design of a randomized controlled trial 
BMC Public Health  2010;10:558.
Background
Major depressive disorder is among the medical conditions with the highest negative impact on work outcome. However, little is known regarding evidence-based interventions targeting the improvement of work outcomes in depressed employees. In this paper, the design of a randomized controlled trial is presented in order to evaluate the effectiveness of adjuvant occupational therapy in employees with depression. This occupational intervention is based on an earlier intervention, which was designed and proven effective by our research group, and is the only intervention to date that specifically targets work outcome in depressed employees.
Methods/Design
In a two-arm randomized controlled trial, a total of 117 participants are randomized to either 'care as usual' or ' care as usual' with the addition of occupational therapy. Patients included in the study are employees who are absent from work due to depression for at least 25% of their contract hours, and who have a possibility of returning to their own or a new job. The occupational intervention consists of six individual sessions, eight group sessions and a work-place visit over a 16-week period. By increasing exposure to the working environment, and by stimulating communication between employer and employee, the occupational intervention aims to enhance self-efficacy and the acquisition of more adaptive coping strategies. Assessments take place at baseline, and at 6, 12, and 18-month follow-ups. Primary outcome measure is work participation (hours of absenteeism and time until work resumption). Secondary outcome measures are work functioning, symptomatology, health-related quality of life, and neurocognitive functioning. In addition, cost-effectiveness is evaluated from a societal perspective. Finally, mechanisms of change (intermediate outcomes) and potential patient-treatment matching variables are investigated.
Discussion
This study hopes to provide valuable knowledge regarding an intervention to treat depression, one of the most common and debilitating diseases of our time. If our intervention is proven (cost-) effective, the personal, economic, and health benefits for both patients and employers are far-reaching.
Trial registration number
NTR2057
doi:10.1186/1471-2458-10-558
PMCID: PMC2946299  PMID: 20849619
13.  Perceived Impeding Factors for Return-to-Work after Long-Term Sickness Absence Due to Major Depressive Disorder: A Concept Mapping Approach 
PLoS ONE  2014;9(1):e85038.
Objective
The purpose of the present study was to explore various stakeholder perspectives regarding factors that impede return-to-work (RTW) after long-term sickness absence related to major depressive disorder (MDD).
Methods
Concept mapping was used to explore employees', supervisors' and occupational physicians' perspectives on these impeding factors.
Results
Nine perceived themes, grouped in three meta-clusters were found that might impede RTW: Person, (personality / coping problems, symptoms of depression and comorbid (health) problems, employee feels misunderstood, and resuming work too soon), Work (troublesome work situation, too little support at work, and too little guidance at work) and Healthcare (insufficient mental healthcare and insufficient care from occupational physician). All stakeholders regarded personality/coping problems and symptoms of depression as the most important impeding theme. In addition, supervisors emphasized the importance of mental healthcare underestimating the importance of the work environment, while occupational physicians stressed the importance of the lack of safety and support in the work environment.
Conclusions
In addition to the reduction of symptoms, more attention is needed on coping with depressive symptoms and personality problems in the work environment support in the work environment and for RTW in mental healthcare, to prevent long term sickness absence.
doi:10.1371/journal.pone.0085038
PMCID: PMC3893138  PMID: 24454786
14.  Recurrence of Medically Certified Sickness Absence According to Diagnosis: A Sickness Absence Register Study 
Introduction Sickness absence is a major public health problem. Research on sickness absence focuses on interventions aimed at expediting return to work. However, we need to know more about sustaining employees at work after return to work. Therefore, this study investigated the recurrence of sickness absence according to diagnosis. Methods We analyzed the registered sickness absence data of 137,172 employees working for the Dutch Post and Telecom. Episodes of sickness absence were medically certified, according to the ICD-10 classification of diseases, by an occupational physician. The incidence density (ID) and recurrence density (RD) of medically certified absences were calculated per 1,000 person-years in each ICD-10 category. Results Sickness absence due to musculoskeletal disorders had the highest recurrence (RD = 118.7 per 1,000 person-years), followed by recurrence of sickness absence due to mental disorders (RD = 80.4 per 1,000 person-years). The median time to recurrent sickness absence due to musculoskeletal disorders was 409 days after the index episode. Recurrences of sickness absence due to musculoskeletal disorders accounted for 37% of the total number of recurrent sickness absence days. For recurrences of sickness absence due to mental disorders this was 328 days and 21%, respectively. Unskilled employees with a short duration (<5 years) of employment had a higher risk of recurrent sickness absence. Conclusions Interventions to expedite return to work of employees sick-listed due to musculoskeletal or mental disorders should also aim at reducing recurrence of sickness absence in order to sustain employees at work.
doi:10.1007/s10926-009-9226-8
PMCID: PMC2832874  PMID: 20052523
Absenteeism; Sickness absence; Epidemiology; Recurrence of sickness absence
15.  Reducing patients’ suicide ideation through training mental health teams in the application of the Dutch multidisciplinary practice guideline on assessment and treatment of suicidal behavior: study protocol of a randomized controlled trial 
Trials  2013;14:372.
Background
To strengthen suicide prevention skills in mental health care in The Netherlands, multidisciplinary teams throughout the country are trained in the application of the new Dutch guideline on the assessment and treatment of suicidal behavior. Previous studies have shown beneficial effects of additional efforts for guideline implementation on professionals’ attitude, knowledge, and skills. However, the effects on patients are equally important, but are rarely measured. The main objective of this study is to examine whether patients of multidisciplinary teams who are trained in guideline application show greater recovery from suicide ideation than patients of untrained teams.
Methods/Design
This is a multicentre cluster randomized controlled trial (RCT), in which multidisciplinary teams from mental health care institutions are matched in pairs, and randomly allocated to either the experimental or control condition. In the experimental condition, next to the usual dissemination of the guideline (internet, newsletter, books, publications, and congresses), teams will be trained in the application of the guideline via a 1-day small interactive group training program supported by e-learning modules. In the control condition, no additional actions next to usual dissemination of the guideline will be undertaken.
Assessments at patient level will start when the experimental teams are trained. Assessments will take place upon admission and after 3 months, or earlier if the patient is discharged. The primary outcome is suicide ideation. Secondary outcomes are non-fatal suicide attempts, level of treatment satisfaction, and societal costs. Both a cost-effectiveness and cost-utility analysis will be performed. The effects of the intervention will be examined in multilevel models.
Discussion
The strengths of this study are the size of the study, RCT design, training of complete multidisciplinary teams, and the willingness of both management and staff to participate.
Trial registration
Netherlands trial register: NTR3092
doi:10.1186/1745-6215-14-372
PMCID: PMC3826515  PMID: 24195781
Suicide prevention; Suicidal behavior; Guideline application; Implementation; Cost-effectiveness; Cost-utility; Multicentre; E-learning; Train-the-trainer; Professionals
16.  The Mental Vitality @ Work study: design of a randomized controlled trial on the effect of a workers' health surveillance mental module for nurses and allied health professionals 
BMC Public Health  2011;11:290.
Background
Employees in health care service are at high risk for developing mental health complaints. The effects of mental health complaints on work can have serious consequences for the quality of care provided by these workers. To help health service workers remain healthy and productive, preventive actions are necessary. A Workers' Health Surveillance (WHS) mental module may be an effective strategy to monitor and promote good (mental) health and work performance. The objective of this paper is to describe the design of a three arm cluster randomized controlled trial on the effectiveness of a WHS mental module for nurses and allied health professionals. Two strategies for this WHS mental module will be compared along with data from a control group. Additionally, the cost effectiveness of the approaches will be evaluated from a societal perspective.
Methods
The study is designed as a cluster randomized controlled trial consisting of three arms (two intervention groups, 1 control group) with randomization at ward level. The study population consists of 86 departments in one Dutch academic medical center with a total of 1731 nurses and allied health professionals. At baseline, after three months and after six months of follow-up, outcomes will be assessed by online questionnaires. In both intervention arms, participants will complete a screening to detect problems in mental health and work functioning and receive feedback on their screening results. In cases of impairments in mental health or work functioning in the first intervention arm, a consultation with an occupational physician will be offered. The second intervention arm offers a choice of self-help e-mental health interventions, which will be tailored based on each individual's mental health state and work functioning. The primary outcomes will be help-seeking behavior and work functioning. Secondary outcomes will be mental health and wellbeing. Furthermore, cost-effectiveness in both intervention arms will be assessed, and a process evaluation will be performed.
Discussion
When it is proven effective compared to a control group, a WHS mental module for nurses and allied health professionals could be implemented and used on a regular basis by occupational health services in hospitals to improve employees' mental health and work functioning.
Trial Registration
NTR2786
doi:10.1186/1471-2458-11-290
PMCID: PMC3112124  PMID: 21569282
17.  Improving the application of a practice guideline for the assessment and treatment of suicidal behavior by training the full staff of psychiatric departments via an e-learning supported Train-the-Trainer program: study protocol for a randomized controlled trial 
Trials  2013;14:9.
Background
In 2012, in The Netherlands a multidisciplinary practice guideline for the assessment and treatment of suicidal behavior was issued. The release of guidelines often fails to change professional behavior due to multiple barriers. Structured implementation may improve adherence to guidelines. This article describes the design of a study measuring the effect of an e-learning supported Train-the-Trainer program aiming at the training of the full staff of departments in the application of the guideline. We hypothesize that both professionals and departments will benefit from the program.
Method
In a multicenter cluster randomized controlled trial, 43 psychiatric departments spread over 10 regional mental health institutions throughout The Netherlands will be clustered in pairs with respect to the most prevalent diagnostic category of patients and average duration of treatment. Pair members are randomly allocated to either the experimental or the control condition. In the experimental condition, the full staff of departments, that is, all registered nurses, psychologists, physicians and psychiatrists (n = 532, 21 departments) will be trained in the application of the guideline, in a one-day small interactive group Train-the-Trainer program. The program is supported by a 60-minute e-learning module with video vignettes of suicidal patients and additional instruction. In the control condition (22 departments, 404 professionals), the guideline shall be disseminated in the traditional way: through manuals, books, conferences, internet, reviews and so on. The effectiveness of the program will be assessed at the level of both health care professionals and departments.
Discussion
We aim to demonstrate the effect of training of the full staff of departments with an e-learning supported Train-the-Trainer program in the application of a new clinical guideline. Strengths of the study are the natural setting, the training of full staff, the random allocation to the conditions, the large scale of the study and the willingness of both staff and management to participate in the study.
Trial registration
Dutch trial register: NTR3092
doi:10.1186/1745-6215-14-9
PMCID: PMC3551842  PMID: 23302322
Guideline; Implementation; Suicide prevention; Train-the-trainer; E-learning; Healthcare professionals
18.  Health complaints and working conditions experienced in relation to work and age. 
OBJECTIVES--The main objective is to describe the potential health and work problems of the aging employees in the Dutch working population. In this way, we can identify groups at extra risk of specific health problems. METHODS--In The Netherlands, occupational health services gather questionnaire data about work and health as part of periodical occupational health surveys (POHSs). These data from the POHSs of complaints about health and working conditions, aggregated into occupational groups and age categories, are used to provide indications for groups at extra risk of specific health problems. These problems are assessed by overviews of the relation between age and complaints about health and working conditions. RESULTS--Almost all of the health questions show an increase in health complaints with increasing age. White collar workers, especially the high grade white collar workers, usually have lower complaint percentages on health questions than blue collar workers. Female employees have relatively high complaint percentages on the health questions. Differences between occupational groups in the complaints about work and working conditions reflect the differences in work demands and exposure. The relation between age and work complaints is generally inconsistent and weak. The complaint percentages on work questions of female employees tend to be equal to or lower than those of the male employees. CONCLUSIONS--The absence of a clear increase of work complaints with advancing age in the presence of a decrease in health and working capacity may be explained by a selective turnover in the working population, especially in demanding occupations. To enhance the work participation of older employees it may be necessary to reduce the work demands and to increase decision latitude.
PMCID: PMC1128404  PMID: 8563858
19.  The effectiveness of two occupational health intervention programmes in reducing sickness absence among employees at risk. Two randomised controlled trials 
Objectives:
To evaluate the effectiveness of two occupational health intervention programmes, both compared with usual care.
Methods:
Based on a health survey, 1341 employees (88% males) in construction, service and maintenance work were classified into three groups: “low risk” (n = 386), “intermediate risk” (n = 537) and “high risk” (n = 418) of sickness absence. Two separate randomised trials were performed in the groups “high risk” and “intermediate risk”, respectively. Those high risk subjects that were allocated to the intervention group (n = 209) were invited to occupational health service for a consultation. The intervention included, if appropriate, a referral to specialist treatment. Among the intermediate risk employees those in the intervention group (n = 268) were invited to call a phone advice centre. In both trials the control group received usual occupational health care. The primary outcome was sickness absence during a 12-month follow-up (register data).
Results:
The high risk group, representing 31% of the cohort, accounted for 62% of sickness absence days. In the trial for the high risk group the mean sickness absence was 30 days in the usual care group and 19 days in the intervention group; the mean difference was 11 days (95% CI 1 to 20 days). In the trial for the intermediate risk group the mean sickness absence was 7 days in both arms (95% CI of the mean difference –2.3 to 2.4 days).
Conclusions:
The identification of high risk of work disability was successful. The occupational health intervention was effective in controlling work loss to a degree that is likely to be economically advantageous within the high risk group. The phone advice intervention for the intermediate risk group was not effective in controlling work loss primarily due to poor adherence.
doi:10.1136/oem.2007.032706
PMCID: PMC2564865  PMID: 17681994
20.  Design of a trial-based economic evaluation on the cost-effectiveness of employability interventions among work disabled employees or employees at risk of work disability: The CASE-study 
BMC Public Health  2012;12:43.
Background
In the Netherlands, absenteeism and reduced productivity due to work disability lead to high yearly costs reaching almost 5% of the gross national product. To reduce the economic burden of sick leave and reduced productivity, different employability interventions for work-disabled employees or employees at risk of work disability have been developed. Within this study, called 'CASE-study' (Cost-effectiveness Analysis of Sustainable Employability), five different employability interventions directed at work disabled employees with divergent health complaints will be analysed on their effectiveness and cost-effectiveness. This paper describes a consistent and transparent methodological design to do so.
Methods/design
Per employability intervention 142 participants are needed whereof approximately 66 participants receiving the intervention will be compared with 66 participants receiving usual care. Based on the intervention-specific characteristics, a randomized control trial or a quasi-experiment with match-criteria will be conducted. Notwithstanding the study design, eligible participants will be employees aged 18 to 63, working at least 12 h per week, and at risk of work disability, or already work-disabled due to medical restrictions. The primary outcome will be the duration of sick leave. Secondary outcomes are health status and quality of life. Outcomes will be assessed at baseline and then 6, 12 and 18 months later. Economic costs will consist of healthcare costs and cost of lost production due to work disability, and will be evaluated from a societal perspective.
Discussion
The CASE-study is the first to conduct economic evaluations of multiple different employability interventions based on a similar methodological framework. The cost-effectiveness results for every employability intervention will be published in 2014, but the methods, strengths and weaknesses of the study protocol are discussed in this paper. To contribute to treatment options in occupational health practice and enable the development of guidelines on how to conduct economic evaluation better suited to this field; this paper provides an important first step.
Trial registration
Four trials involved in the CASE-study are registered with the Netherlands Trial Registry: Care for Work (NTR2886), Health and Motion (NTR3111), Guidance to Excel in Return to Work (NTR3151), Care for Companies/Second Care (NTR3136).
doi:10.1186/1471-2458-12-43
PMCID: PMC3273437  PMID: 22257557
Economic evaluation; Cost effectiveness; Employability; Return-to-Work; Work disability
21.  A Randomized Trial Using Computerized Decision Support to Improve Treatment of Major Depression in Primary Care 
OBJECTIVE
To examine whether feedback and treatment advice for depression presented to primary care physicians (PCPs) via an electronic medical record (EMR) system can potentially improve clinical outcomes and care processes for patients with major depression.
DESIGN
Randomized controlled trial.
SETTING
Academically affiliated primary care practice in Pittsburgh, PA.
PATIENTS
Two hundred primary care patients with major depression on the Primary Care Evaluation of Mental Disorders (PRIME-MD) and who met all protocol-eligibility criteria.
INTERVENTION
PCPs were randomly assigned to 1 of 3 levels of exposure to EMR feedback of guideline-based treatment advice for depression: “active care” (AC), “passive care” (PC), or “usual care” (UC).
MEASUREMENTS AND MAIN RESULTS
Patients' 3- and 6-month Hamilton Rating Scale for Depression (HRS-D) score and chart review of PCP reports of depression care in the 6 months following the depression diagnosis. Only 22% of patients recovered from their depressive episode at 6 months (HRS-D ≤7). Patients' mean HRS-D score decreased regardless of their PCPs' guideline-exposure condition (20.4 to 14.2 from baseline to 6-month follow-up; P < .001). However, neither continuous (HRS-D ≤7: 22% AC, 23% PC, 22% UC; P = .8) nor categorical measures of recovery (P = .2) differed by EMR exposure condition upon follow-up. Care processes for depression were also similar by PCP assignment despite exposure to repeated reminders of the depression diagnosis and treatment advice (e.g., depression mentioned in ≥3 contacts with usual PCP at 6 months: 31% AC, 31% PC, 18% UC; P = .09 and antidepressant medication suggested/prescribed or baseline regimen modified at 6 months: 59% AC, 57% PC, 52% UC; P = .3).
CONCLUSIONS
Screening for major depression, electronically informing PCPs of the diagnosis, and then exposing them to evidence-based treatment recommendations for depression via EMR has little differential impact on patients' 3- or 6-month clinical outcomes or on process measures consistent with high-quality depression care.
doi:10.1046/j.1525-1497.2002.10421.x
PMCID: PMC1495078  PMID: 12133139
major depression; PRIME-MD; primary care; electronic medical records; clinical practice guidelines; intervention
22.  Cost-effectiveness of a vocational enablement protocol for employees with hearing impairment; design of a randomized controlled trial 
BMC Public Health  2012;12:151.
Background
Hearing impairment at the workplace, and the resulting psychosocial problems are a major health problem with substantial costs for employees, companies, and society. Therefore, it is important to develop interventions to support hearing impaired employees. The objective of this article is to describe the design of a randomized controlled trial evaluating the (cost-) effectiveness of a Vocational Enablement Protocol (VEP) compared with usual care.
Methods/Design
Participants will be selected with the 'Hearing and Distress Screener'. The study population will consist of 160 hearing impaired employees. The VEP intervention group will be compared with usual care. The VEP integrated care programme consists of a multidisciplinary assessment of auditory function, work demands, and personal characteristics. The goal of the intervention is to facilitate participation in work. The primary outcome measure of the study is 'need for recovery after work'. Secondary outcome measures are coping with hearing impairment, distress, self-efficacy, psychosocial workload, job control, general health status, sick leave, work productivity, and health care use. Outcome measures will be assessed by questionnaires at baseline, and 3, 6, 9, and 12 months after baseline. The economic evaluation will be performed from both a societal and a company perspective. A process evaluation will also be performed.
Discussion
Interventions addressing occupational difficulties of hearing impaired employees are rare but highly needed. If the VEP integrated care programme proves to be (cost-) effective, the intervention can have an impact on the well-being of hearing impaired employees, and thereby, on the costs for the company as well for the society.
Trial registration
Netherlands Trial Register (NTR): NTR2782
doi:10.1186/1471-2458-12-151
PMCID: PMC3306742  PMID: 22380920
Hearing loss; 'Need for recovery after work'; Economic evaluation; Psychosocial problems; Occupational physician; Integrated care; Intervention
23.  Effectiveness of early part-time sick leave in musculoskeletal disorders 
Background
The importance of staying active instead of bed rest has been acknowledged in the management of musculoskeletal disorders (MSDs). This emphasizes the potential benefits of adjusting work to fit the employee's remaining work ability. Despite part-time sick leave being an official option in many countries, its effectiveness has not been studied yet. We have designed a randomized controlled study to assess the health effects of early part-time sick leave compared to conventional full-day sick leave. Our hypothesis is that if work time is temporarily reduced and work load adjusted at the early stages of disability, employees with MSDs will have less disability days and faster return to regular work duties than employees on a conventional sick leave.
Methods/Design
The study population will consist of 600 employees, who seek medical advice from an occupational physician due to musculoskeletal pain. The inclusion requires that they have not been on a sick leave for longer than 14 days prior to the visit. Based on the physician's judgement, the severity of the symptoms must indicate a need for conventional sick leave, but the employee is considered to be able to work part-time without any additional risk. Half of the employees are randomly allocated to part-time sick leave group and their work time is reduced by 40–60%, whereas in the control group work load is totally eliminated with conventional sick leave. The main outcomes are the number of days from the initial visit to return to regular work activities, and the total number of sick leave days during 12 and 24 months of follow-up. The costs and benefits as well as the feasibility of early part-time sick leave will also be evaluated.
Conclusion
This is the first randomised trial to our knowledge on the effectiveness of early part-time sick leave compared to conventional full-time sick leave in the management of MSDs. The data collection continues until 2011, but preliminary results on the feasibility of part-time sick leave will be available already in 2008. The increased knowledge will assist in better decision making process regarding the management of disability related to MSDs.
Trial Registration
International Standard Randomised Controlled Trial Number Register, register number ISRCTN30911719
doi:10.1186/1471-2474-9-23
PMCID: PMC2267790  PMID: 18294405
24.  A self-management program for employees with complaints of the arm, neck, or shoulder (CANS): study protocol for a randomized controlled trial 
Trials  2013;14:258.
Background
Complaints of the arm, neck, or shoulder (CANS) have a multifactorial origin and cause considerable work problems, including decreased work productivity, sickness absence, and, ultimately, job loss. There is a need for intervention programs for people with CANS. Self-management is an approach used in chronic disease care to improve self-efficacy and wellness behaviors to facilitate participants to make informed choices and carry them out. This study will evaluate the effectiveness of a self-management program (including ehealth) and compare it to usual care among employees with chronic CANS (lasting >3 months).
Methods/design
This is a randomized controlled trial in which 142 participants will be recruited and randomized (with pre-stratification) to either the intervention group (IG) or control group (CG). The IG will participate in a self-management program consisting of six group sessions and an ehealth module. The CG is allowed to use all usual care available. The primary outcome of the study is the self-reported disability of arm, shoulder, and hand, measured with the Disabilities of the Arm, Shoulder and Hand questionnaire (DASH). Secondary outcomes include: absenteeism, pain in the previous week, quality of life, catastrophizing pain, self-efficacy, workstyle, presenteeism, fatigue, the use of usual care, and limitations experienced on the job. Data are collected at baseline and at 3, 6, and 12 months follow-up.
Discussion
Following the process of intervention mapping we developed a self-management program to suit and alleviate the problems and needs of employees with CANS. A strength of the study is that our intervention is specifically tailored to match the needs of employees with CANS. The study also has some potential weaknesses (for example, use of co-interventions, combination of group sessions and ehealth, self-reporting of data and possible contamination, Hawthorne effect, and recall or information bias) which are discussed.
Trial registration
The trial is registered with the Dutch Trial Register (http://www.trialregister.nlNTR3816): (January 2013). The first participant was randomized in September 2012.
doi:10.1186/1745-6215-14-258
PMCID: PMC3751728  PMID: 23958154
CANS; RSI; RCT; Self-management; ehealth
25.  A new combined strategy to implement a community occupational therapy intervention: designing a cluster randomized controlled trial 
BMC Geriatrics  2011;11:13.
Background
Even effective interventions for people with dementia and their caregivers require specific implementation efforts. A pilot study showed that the highly effective community occupational therapy in dementia (COTiD) program was not implemented optimally due to various barriers. To decrease these barriers and make implementation of the program more effective a combined implementation (CI) strategy was developed. In our study we will compare the effectiveness of this CI strategy with the usual educational (ED) strategy.
Methods
In this cluster randomized, single-blinded, controlled trial, each cluster consists of at least two occupational therapists, a manager, and a physician working at Dutch healthcare organizations that deliver community occupational therapy. Forty-five clusters, stratified by healthcare setting (nursing home, hospital, mental health service), have been allocated randomly to either the intervention group (CI strategy) or the control group (ED strategy). The study population consists of the professionals included in each cluster and community-dwelling people with dementia and their caregivers. The primary outcome measures are the use of community OT, the adherence of OTs to the COTiD program, and the cost effectiveness of implementing the COTiD program in outpatient care. Secondary outcome measures are patient and caregiver outcomes and knowledge of managers, physicians and OTs about the COTiD program.
Discussion
Implementation research is fairly new in the field of occupational therapy, making this a unique study. This study does not only evaluate the effects of the CI-strategy on professionals, but also the effects of professionals' degree of implementation on client and caregiver outcomes.
Clinical trials registration
NCT01117285
doi:10.1186/1471-2318-11-13
PMCID: PMC3078849  PMID: 21450063

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