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1.  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
2.  Binge Drinking and Occupation, North Dakota, 2004–2005 
Preventing Chronic Disease  2007;4(4):A94.
Introduction
Binge drinking is a leading cause of preventable death and results in employee absenteeism and lost productivity. Knowledge about the prevalence of binge drinking among employees of different occupations is limited.
Methods
We assessed the prevalence of binge drinking (i.e., consuming five or more drinks per occasion during the previous 30 days) by primary occupation using data from the 2004–2005 North Dakota Behavioral Risk Factor Surveillance System. We used logistic regression to assess the association between binge drinking and primary occupation.
Results
Overall, 24.1% (95% confidence interval [CI], 22.5–25.7) of North Dakota workers reported binge drinking. The prevalence was highest among farm or ranch employees (45.3%; 95% CI, 28.3–63.4), food or drink servers (33.4%; 95% CI, 23.9–44.4), and farm or ranch owners (32.5%; 95% CI, 26.3–39.4). The prevalence was lowest among health care workers (13.2%; 95% CI, 10.3–16.8). Compared with health care workers, the adjusted odds of binge drinking were highest among farm or ranch employees (adjusted odds ratio [AOR], 2.2; 95% CI, 0.9–5.5), food or drink servers (AOR, 2.1; 95% CI, 1.1–4.0), and farm or ranch owners (AOR, 1.7; 95% CI, 1.1–2.6). Health insurance coverage was lowest among employees in occupations with the highest prevalence of binge drinking.
Conclusion
We found occupational differences in the prevalence of binge drinking among employees in North Dakota. Many occupational categories had a high prevalence of binge drinking. We recommend the implementation of both employer-sponsored and population-based interventions to reduce binge drinking among North Dakota workers, particularly because employees in occupations with the highest rates of binge drinking had the lowest rates of health insurance coverage.
PMCID: PMC2099292  PMID: 17875269
3.  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
4.  An Evidence-Based Multidisciplinary Practice Guideline to Reduce the Workload due to Lifting for Preventing Work-Related Low Back Pain 
We developed an evidence-based practice guideline to support occupational safety and health (OSH) professionals in assessing the risk due to lifting and in selecting effective preventive measures for low back pain (LBP) in the Netherlands. The guideline was developed at the request of the Dutch government by a project team of experts and OSH professionals in lifting and work-related LBP. The recommendations for risk assessment were based on the quality of instruments to assess the risk on LBP due to lifting. Recommendations for interventions were based on a systematic review of the effects of worker- and work directed interventions to reduce back load due to lifting. The quality of the evidence was rated as strong (A), moderate (B), limited (C) or based on consensus (D). Finally, eight experts and twenty-four OSH professionals commented on and evaluated the content and the feasibility of the preliminary guideline. For risk assessment we recommend loads heavier than 25 kg always to be considered a risk for LBP while loads less than 3 kg do not pose a risk. For loads between 3–25 kg, risk assessment shall be performed using the Manual handling Assessment Charts (MAC)-Tool or National Institute for Occupational Safety and Health (NIOSH) lifting equation. Effective work oriented interventions are patient lifting devices (Level A) and lifting devices for goods (Level C), optimizing working height (Level A) and reducing load mass (Level C). Ineffective work oriented preventive measures are regulations to ban lifting without proper alternatives (Level D). We do not recommend worker-oriented interventions but consider personal lift assist devices as promising (Level C). Ineffective worker-oriented preventive measures are training in lifting technique (Level A), use of back-belts (Level A) and pre-employment medical examinations (Level A). This multidisciplinary evidence-based practice guideline gives clear criteria whether an employee is at risk for LBP while lifting and provides an easy-reference for (in)effective risk reduction measures based on scientific evidence, experience, and consensus among OSH experts and practitioners.
doi:10.1186/2052-4374-26-16
PMCID: PMC4081511  PMID: 24999432
Back pain; Interventions; Occupational health care; Prevention; Surveillance; Practice guideline; Lifting
5.  VIP in construction: systematic development and evaluation of a multifaceted health programme aiming to improve physical activity levels and dietary patterns among construction workers 
BMC Public Health  2012;12:89.
Background
The prevalence of both overweight and musculoskeletal disorders (MSD) in the construction industry is high. Many interventions in the occupational setting aim at the prevention and reduction of these health problems, but it is still unclear how these programmes should be designed. To determine the effectiveness of interventions on these health outcomes randomised controlled trials (RCTs) are needed. The aim of this study is to systematically develop a tailored intervention for prevention and reduction of overweight and MSD among construction workers and to describe the evaluation study regarding its (cost-)effectiveness.
Methods/Design
The Intervention Mapping (IM) protocol was applied to develop and implement a tailored programme aimed at the prevention and reduction of overweight and MSD. The (cost-) effectiveness of the intervention programme will be evaluated using an RCT. Furthermore, a process evaluation will be conducted. The research population will consist of blue collar workers of a large construction company in the Netherlands.
Intervention
The intervention programme will be aimed at improving (vigorous) physical activity levels and healthy dietary behaviour and will consist of tailored information, face-to-face and telephone counselling, training instruction (a fitness "card" to be used for exercises), and materials designed for the intervention (overview of the company health promoting facilities, waist circumference measuring tape, pedometer, BMI card, calorie guide, recipes, and knowledge test).
Main study parameters/endpoints
The intervention effect on body weight and waist circumference (primary outcome measures), as well as on lifestyle behaviour, MSD, fitness, CVD risk indicators, and work-related outcomes (i.e. productivity, sick leave) (secondary outcome measures) will be assessed.
Discussion
The development of the VIP in construction intervention led to a health programme tailored to the needs of construction workers. This programme, if proven effective, can be directly implemented.
Trial registration
Netherlands Trial Register (NTR): NTR2095
doi:10.1186/1471-2458-12-89
PMCID: PMC3280176  PMID: 22289212
Obesity/overweight; Musculoskeletal disorders; RCT; Energy balance related behaviour; Physical activity; Dietary behaviour; Construction workers; Intervention mapping
6.  Tuberculosis among Health-Care Workers in Low- and Middle-Income Countries: A Systematic Review 
PLoS Medicine  2006;3(12):e494.
Background
The risk of transmission of Mycobacterium tuberculosis from patients to health-care workers (HCWs) is a neglected problem in many low- and middle-income countries (LMICs). Most health-care facilities in these countries lack resources to prevent nosocomial transmission of tuberculosis (TB).
Methods and Findings
We conducted a systematic review to summarize the evidence on the incidence and prevalence of latent TB infection (LTBI) and disease among HCWs in LMICs, and to evaluate the impact of various preventive strategies that have been attempted. To identify relevant studies, we searched electronic databases and journals, and contacted experts in the field. We identified 42 articles, consisting of 51 studies, and extracted data on incidence, prevalence, and risk factors for LTBI and disease among HCWs. The prevalence of LTBI among HCWs was, on average, 54% (range 33% to 79%). Estimates of the annual risk of LTBI ranged from 0.5% to 14.3%, and the annual incidence of TB disease in HCWs ranged from 69 to 5,780 per 100,000. The attributable risk for TB disease in HCWs, compared to the risk in the general population, ranged from 25 to 5,361 per 100,000 per year. A higher risk of acquiring TB disease was associated with certain work locations (inpatient TB facility, laboratory, internal medicine, and emergency facilities) and occupational categories (radiology technicians, patient attendants, nurses, ward attendants, paramedics, and clinical officers).
Conclusions
In summary, our review demonstrates that TB is a significant occupational problem among HCWs in LMICs. Available evidence reinforces the need to design and implement simple, effective, and affordable TB infection-control programs in health-care facilities in these countries.
A systematic review demonstrates that tuberculosis is an important occupational problem among health care workers in low and middle-income countries.
Editors' Summary
Background.
One third of the world's population is infected with Mycobacterium tuberculosis, the bacterium that causes tuberculosis (TB). In many people, the bug causes no health problems—it remains latent. But about 10% of infected people develop active, potentially fatal TB, often in their lungs. People with active pulmonary TB readily spread the infection to other people, including health-care workers (HCWs), in small airborne droplets produced when they cough or sneeze. In high-income countries such as the US, guidelines are in place to minimize the transmission of TB in health-care facilities. Administrative controls (for example, standard treatment plans for people with suspected or confirmed TB) aim to reduce the exposure of HCWs to people with TB. Environmental controls (for example, the use of special isolation rooms) aim to prevent the spread and to reduce the concentration of infectious droplets in the air. Finally, respiratory-protection controls (for example, personal respirators for nursing staff) aim to reduce the risk of infection when exposure to M. tuberculosis is unavoidably high. Together, these three layers of control have reduced the incidence of TB in HCWs (the number who catch TB annually) in high-income countries.
Why Was This Study Done?
But what about low- and middle-income countries (LMICs) where more than 90% of the world's cases of TB occur? Here, there is little money available to implement even low-cost strategies to reduce TB transmission in health-care facilities—so how important an occupational disease is TB in HCWs in these countries? In this study, the researchers have systematically reviewed published papers to find out the incidence and prevalence (how many people in a population have a specific disease) of active TB and latent TB infections (LTBIs) in HCWs in LMICs. They have also investigated whether any of the preventative strategies used in high-income countries have been shown to reduce the TB burden in HCWs in poorer countries.
What Did the Researchers Do and Find?
To identify studies on TB transmission to HCWs in LMICs, the researchers searched electronic databases and journals, and also contacted experts on TB transmission. They then extracted and analyzed the relevant data on TB incidence, prevalence, risk factors, and control measures. Averaged-out over the 51 identified studies, 54% of HCWs had LTBI. In most of the studies, increasing age and duration of employment in health-care facilities, indicating a longer cumulative exposure to infection, was associated with a higher prevalence of LTBI. The same trend was seen in a subgroup of medical and nursing students. After accounting for the incidence of TB in the relevant general population, the excess incidence of TB in the different studies that was attributable to being a HCW ranged from 25 to 5,361 cases per 100, 000 people per year. In addition, a higher risk of acquiring TB was associated with working in specific locations (for example, inpatient TB facilities or diagnostic laboratories) and with specific occupations, including nurses and radiology attendants; most of the health-care facilities examined in the published studies had no specific TB infection-control programs in place.
What Do These Findings Mean?
As with all systematic reviews, the accuracy of these findings may be limited by some aspects of the original studies, such as how the incidence of LTBI was measured. In addition, the possibility that the researchers missed some relevant published studies, or that only studies where there was a high incidence of TB in HCWs were published, may also affect the findings of this study. Nevertheless, they suggest that TB is an important occupational disease in HCWs in LMICs and that the HCWs most at risk of TB are those exposed to the most patients with TB. Reduction of that risk should be a high priority because occupational TB leads to the loss of essential, skilled HCWs. Unfortunately, there are few data available to indicate how this should be done. Thus, the researchers conclude, well-designed field studies are urgently needed to evaluate whether the TB-control measures that have reduced TB transmission to HCWs in high-income countries will work and be affordable in LMICs.
Additional Information.
Please access these Web sites via the online version of this summary at http://dx.doi.org/10.1371/journal.pmed.0030494.
• US National Institute of Allergy and Infectious Diseases patient fact sheet on tuberculosis
• US Centers for Disease Control and Prevention information for patients and professionals on tuberculosis
• MedlinePlus encyclopedia entry on tuberculosis
• NHS Direct Online, from the UK National Health Service, patient information on tuberculosis
• US National Institute for Occupational Health and Safety, information about tuberculosis for health-care workers
• American Lung Association information on tuberculosis and health-care workers
doi:10.1371/journal.pmed.0030494
PMCID: PMC1716189  PMID: 17194191
7.  Occupational Health Policies on Risk Assessment in Japan 
Safety and Health at Work  2010;1(1):19-28.
Industrial Safety and Health Law (ISH Law) of Japan requires abnormalities identified in evaluations of worker health and working environments are reported to occupational physicians, and employers are advised of measures to ensure appropriate accommodations in working environments and work procedures. Since the 1980s, notions of a risk assessment and occupational safety and health management system were expected to further prevent industrial accidents. In 2005, ISH Law stipulated workplace risk assessment using the wording "employers shall endeavor." Following the amendment, multiple documents and guidelines for risk assessment for different work procedures were developed. They require ISH Laws to be implemented fully and workplaces to plan and execute measures to reduce risks, ranking them from those addressing potential hazards to those requiring workers to wear protective articles. A governmental survey in 2005 found the performance of risk assessment was 20.4% and common reasons for not implementing risk assessments were lack of adequate personnel or knowledge. ISH Law specifies criminal penalties for both individuals and organizations. Moreover, under the Labor Contract Law promulgated in 2007, employers are obliged to make reasonable efforts to ensure employee health for foreseeable and avoidable risks. Therefore, enterprises neglecting even the non-binding provisions of guidelines are likely to suffer significant business impact if judged to be responsible for industrial accidents or occupational disease. To promote risk assessment, we must strengthen technical, financial, and physical support from public-service organizations, encourage the dissemination of good practices to reduce risks, and consider additional employer incentives, including relaxed mandatory regulations.
doi:10.5491/SHAW.2010.1.1.19
PMCID: PMC3430934  PMID: 22953159
Occupational health services; Health policy; Risk assessment; Risk management; Occupational health and safety management system
8.  Results from an Online Computer-Tailored Weight Management Intervention for Overweight Adults: Randomized Controlled Trial 
Background
Prevention of weight gain has been suggested as an important strategy in the prevention of obesity and people who are overweight are a specifically important group to target. Currently there is a lack of weight gain prevention interventions that can reach large numbers of people. Therefore, we developed an Internet-delivered, computer-tailored weight management intervention for overweight adults. The focus of the intervention was on making small (100 kcal per day), but sustained changes in dietary intake (DI) or physical activity (PA) behaviors in order to maintain current weight or achieve modest weight loss. Self-regulation theory was used as the basis of the intervention.
Objective
This study aims to evaluate the efficacy of the computer-tailored intervention in weight-related anthropometric measures (Body Mass Index, skin folds and waist circumference) and energy balance-related behaviors (physical activity; intake of fat, snacks and sweetened drinks) in a randomized controlled trial.
Methods
The tailored intervention (TI) was compared to a generic information website (GI). Participants were 539 overweight adults (mean age 47.8 years, mean Body Mass Index (BMI) 28.04, 30.9% male, 10.7% low educated) who where recruited among the general population and among employees from large companies by means of advertisements and flyers. Anthropometric measurements were measured by trained research assistants at baseline and 6-months post-intervention. DI and PA behaviors were assessed at baseline, 1-month and 6-month post-intervention, using self-reported questionnaires.
Results
Repeated measurement analyses showed that BMI remained stable over time and that there were no statistically significant differences between the study groups (BMI: TI=28.09, GI=27.61, P=.09). Similar results were found for waist circumference and skin fold thickness. Amount of physical activity increased and intake of fat, snacks and sweetened drinks decreased during the course of the study, but there were no differences between the study groups (eg, fat intake: TI=15.4, GI=15.9, P=.74). The first module of the tailored intervention was visited by almost all participants, but only 15% completed all four modules of the tailored intervention, while 46% completed the three modules of the general information intervention. The tailored intervention was considered more personally relevant (TI=3.20, GI=2.83, P=.001), containing more new information (TI=3.11, GI=2.73, P=.003) and having longer texts (TI=3.20, GI=3.07, P=.01), while there were no group differences on other process measures such as attractiveness and comprehensibility of the information (eg, attractive design: TI=3.22, GI=3.16, P=.58).
Conclusions
The online, computer-tailored weight management intervention resulted in changes in the desired direction, such as stabilization of weight and improvements in dietary intake, but the intervention was not more effective in preventing weight gain or modifying dietary and physical activity behaviors than generic information. A possible reason for the absence of intervention effects is sub-optimal use of the intervention and the self-regulation components. Further research is therefore needed to gain more insight into how the intervention and exposure to its contents can be improved.
Trial Registration
NTR1862; http://apps.who.int/trialsearch/trial.aspx?trialid=NTR1862
doi:10.2196/jmir.1901
PMCID: PMC3376515  PMID: 22417813
Prevention; Overweight; Adults; Randomized Controlled Trial; Physical activity; Dietary intake; BMI
9.  Individual and occupational risk factors for knee osteoarthritis – Study protocol of a case control study 
Background
Knee osteoarthritis (OA) is one of the frequent and functionally impairing disorders of the musculoskeletal system. In the literature, a number of occupational risk factors are discussed as being related to the development and progress of knee joint diseases, e.g. working in kneeling or squatting posture, lifting and carrying of heavy weights. The importance of the single risk factors and the possibility of prevention are currently under discussion. Besides the occupational factors, a number of individual risk factors are important, too. The distinction between work-related factors and individual factors is crucial in assessing the risk and in deriving preventive measures in occupational health. In existing studies, the occupational stress is determined mainly by surveys in employees and/or by making assumptions about individual occupations. Direct evaluation of occupational exposure has been performed only exceptionally.
The aim of the research project ArGon is the assessment of different occupational factors in relation to individual factors (e.g. constitutional factors, leisure time activities, sports), which might influence the development and/or progression of knee (OA). The project is designed as a case control study.
Methods/Design
To raise valid data about the physical stress associated with occupational and leisure time activities, patients with and without knee OA are questioned by means of a standardised questionnaire and an interview. The required sample size was estimated to 800 cases and an equal number of controls. The degree and localisation of the knee cartilage or joint damages in the cases are documented on the basis of radiological, arthroscopic and/or operative findings in a patient record. Furthermore, occupational exposure is analysed at selected workplaces. To evaluate the answers provided in the questionnaire, work analysis is performed.
Discussion
In this research project, specific information on the correlation of occupational and individual factors on the one hand and the current state of knee OA on the other will be analysed in order to describe preventive measures. In addition, information regarding a better evaluation of various forms of physical stress in different occupations will be available. This might lead to more effective prevention strategies.
doi:10.1186/1471-2474-9-26
PMCID: PMC2292715  PMID: 18302740
10.  Design of a RCT evaluating the (cost-) effectiveness of a lifestyle intervention for male construction workers at risk for cardiovascular disease: The Health under Construction study 
BMC Public Health  2008;8:1.
Background
Of all workers in Dutch construction industry, 20% has an elevated risk of cardiovascular disease (CVD). A major risk factor for CVD risk is an unhealthy lifestyle. The aim of our study is to design a lifestyle intervention for construction workers with an elevated CVD risk, and to evaluate its (cost-) effectiveness.
Methods/Design
In a RCT, 692 participants will be randomised to either the control or the intervention group. The control group will receive usual care. For the intervention group, a lifestyle intervention has been designed based on interviews and current literature. The intervention will last 6 months and will comprise 3 face-to-face and 4 telephone contacts, consisting of individual counselling aimed at increasing daily physical activity (PA) and improving dietary behaviour, and/or smoking cessation. Counselling will take place at the Occupational Health Service (OHS), and will be done according to motivational interviewing (MI). Additional written information about healthy lifestyle will also be provided to those in the intervention group. At baseline, after 6 and after 12 months, measurements will take place. Primary outcome variables will be the lifestyle behaviours of concern, i.e. daily PA, dietary intake, and smoking status. Secondary outcome variables will be body mass index (BMI), systolic and diastolic blood pressure, total and HDL blood cholesterol, Hba1c and cardio-respiratory fitness (CRF). Sickness absenteeism and cost-effectiveness will be assessed as well. Multilevel analysis will be performed to compare all outcome measures between the intervention group and the control group.
Discussion
By improving lifestyle, CVD risk may be lowered, yielding benefits for both employee and employer. If proven effective, this lifestyle intervention will be implemented on a larger scale within the Occupational Health Services in construction industry.
Trial registration
Current Controlled Trials ISRCTN60545588
doi:10.1186/1471-2458-8-1
PMCID: PMC2254612  PMID: 18173844
11.  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
12.  Work-related stress and psychosomatic medicine 
This article introduces key concepts of work-related stress relevant to the clinical and research fields of psychosomatic medicine. Stress is a term used to describe the body's physiological and/or psychological reaction to circumstances that require behavioral adjustment. According to the Japanese National Survey of Health, the most frequent stressors are work-related problems, followed by health-related and then financial problems. Conceptually, work-related stress includes a variety of conditions, such as overwork, unemployment or job insecurity, and lack of work-family balance. Job stress has been linked to a range of adverse physical and mental health outcomes, such as cardiovascular disease, insomnia, depression, and anxiety. Stressful working conditions can also impact employee well-being indirectly by directly contributing to negative health behaviors or by limiting an individual's ability to make positive changes to lifestyle behaviors, such as smoking and sedentary behavior. Over the past two decades, two major job stress models have dominated the occupational health literature: the job demand-control-support model and the effort-reward imbalance model. In both models, standardized questionnaires have been developed and frequently used to assess job stress. Unemployment has also been reported to be associated with increased mortality and morbidity, such as by cardiovascular disease, stroke, and suicide. During the past two decades, a trend toward more flexible labor markets has emerged in the private and public sectors of developed countries, and temporary employment arrangements have increased. Temporary workers often complain that they are more productive but receive less compensation than permanent workers. A significant body of research reveals that temporary workers have reported chronic work-related stress for years. The Japanese government has urged all employers to implement four approaches to comprehensive mind/body health care for stress management in the workplace: focusing on individuals, utilizing supervisory lines, enlisting company health care staff, and referring to medical resources outside the company. Good communications between occupational health practitioners and physicians in charge in hospitals/clinics help employees with psychosomatic distress to return to work, and it is critical for psychosomatic practitioners and researchers to understand the basic ideas of work-related stress from the viewpoint of occupational health.
doi:10.1186/1751-0759-4-4
PMCID: PMC2882896  PMID: 20504368
13.  Ethical considerations of worksite health promotion: an exploration of stakeholders’ views 
BMC Public Health  2014;14:458.
Background
Developing, implementing and evaluating worksite health promotion requires dealing with all stakeholders involved, such as employers, employees, occupational physicians, insurance companies, providers, labour unions and research and knowledge institutes. Although worksite health promotion is becoming more common, empirical research on ethical considerations of worksite health promotion is scarce.
Methods
We explored the views of stakeholders involved in worksite health promotion in focus group discussions and we described the ethical considerations that result from differences between these views. The focus group discussions were organised per stakeholder group. Data were analysed according to the constant comparison method.
Results
Our analyses show that although the definition of occupational health is the same for all stakeholders, namely ‘being able to perform your job’, there seem to be important differences in the views on what constitutes a risk factor to occupational health. According to the employees, risk factors to occupational health are prevailingly job-related. Labour unions agree with them, but other stakeholders, including the employer, particularly see employee-related issues such as lifestyle behaviour as risk factors to occupational health. The difference in definition of occupational health risk factors translates into the same categorisation of worksite health promotion; employee-related activities and work-related activities. The difference in conceptualisation of occupational health risk factors and worksite health promotion resonates in the way stakeholders understand ‘responsibility’ for lifestyle behaviour. Even though all stakeholders agree on whose responsibility lifestyle behaviour is, namely that of the employee, the meaning of ‘responsibility’ differs between employees, and employers. For employees, responsibility means autonomy, while for employers and other stakeholders, responsibility equals duty. This difference may in turn contribute to ambivalent relationships between stakeholders.
Conclusion
All stakeholders, including employees, should be given a voice in developing, implementing and evaluating worksite health promotion. Moreover, since stakeholders agree on lifestyle being the responsibility of the employee, but disagree on what this responsibility means (duty versus autonomy), it is of utmost importance to examine the discourse of stakeholders. This way, ambivalence in relationships between stakeholders could be prevented.
doi:10.1186/1471-2458-14-458
PMCID: PMC4047781  PMID: 24886339
Worksite health promotion; Ethics; Focus group discussion; Face-to-face interviews; Stakeholder analysis
14.  Perception of Occupational Risks and Practices of Self-protection from Infectious Diseases Among Workers in Contact with International Migrants at Hungary’s Border 
Objective: The purpose of the present study was to investigate employees’ self-assessments of their occupational risks and health awareness as well as their perception of preventive methods. We also aimed to collect data on employees’ perception of some selected alarming signs and symptoms that may encourage them to take further actions (such as separation and calling an ambulance).
Participants and methods: Between April and June 2013, an anonymous questionnaire survey was conducted with the participation of 70 employees working with migrants (both health-care and non-health-care staff) in 10 Hungarian settlements: 4 border crossing points along the eastern Schengen borderline, 3 asylum detention centers and 3 reception centers.
Results: Our results demonstrated an increased perception of certain biological and mental health hazards at work among those working with migrants: 63.7% of the health-care workers and even 37.3% of the non-health-care staff come into contact with human secretions (feces, urine, saliva) “frequently” or “sometimes”. Self-assessed awareness of the signs and symptoms of infectious diseases was poor: only 12.8% of participants evaluated their awareness as “good” or “very good”. Threat of verbal violence may be considered a common mental risk at work for participants: 35% “sometimes” or “frequently” and 5% “always” face verbal violence during their work. The most commonly used preventive measures against infectious diseases included the use of gloves, masks and disinfectants; these were generally available to 70 to 80% of the workers and properly applied.
Conclusions: Our results indicate considerable deficiencies in the participants’ preparedness in respect to their occupational health-related issues. Since it is essential for those having daily physical contact with migrants during their work to be properly informed about the occupational health hazards and consequences that may be associated with international migration, their training programs urgently require further development. More comprehensive knowledge may improve the preventive attitudes of employees, and conscious application of preventive measures may contribute to better public and occupation health safety.
doi:10.2185/jrm.2885
PMCID: PMC4310152  PMID: 25648905
occupational health; international migration; health hazards; questionnaire survey
15.  Design of a randomized controlled trial on the effects of Counseling of mental health problems by Occupational Physicians on return to work: the CO-OP-study 
BMC Public Health  2007;7:183.
Background
Mental health problems often lead to prolonged sick leave. In primary care, the usual approach towards these patients was the advice to take rest and not return to work before all complaints had disappeared. When complaints persist, these patients are often referred to psychologists from primary and specialized secondary care. As an alternative, ways have been sought to activate the Dutch occupational physician (OP) in primary care. Early 2000, the Dutch Association of Occupational Physicians (NVAB) published a guideline concerning the management by OPs of employees with mental health problems. The guideline received positive reactions from employees, employers and Dutch OPs. This manuscript describes the design of a study, which aims to assess the effects of the guideline, compared with usual care.
Methods/Design
In a randomized controlled trial (RCT), subjects in the intervention group were treated according to the guideline. The control group received usual care, with minimal involvement of the OP and easy access to a psychologist. Subjects were recruited from two Dutch police departments. The primary outcomes of the study are return to work and treatment satisfaction by the employee, employer, and OP. A secondary outcome is cost-effectiveness of the intervention, compared with usual care. Furthermore, prognostic measures are taken into account as potential confounders. A process evaluation will be done by means of performance indicators, based on the guideline.
Discussion
In this pragmatic trial, effectiveness instead of efficacy is studied. We will evaluate what is possible in real clinical practice, rather than under ideal circumstances. Many requirements for a high quality trial are being met. Results of this study will contribute to treatment options in occupational health practice for employees on sick leave due to mental health problems. Additionally, they may contribute to new and better-suited guidelines and stepped care. Results will become available during 2007.
Trial registration
Current Controlled Trials ISRCTN34887348
doi:10.1186/1471-2458-7-183
PMCID: PMC1976112  PMID: 17655758
16.  A qualitative study of the anticipated barriers and facilitators to the implementation of a lifestyle intervention in the dutch construction industry 
BMC Public Health  2014;14:1317.
Background
Lifestyle interventions have proven effective for lowering a cardiovascular risk profile by improving lifestyle behaviors, blood glucose and blood cholesterol levels. However, implementation of lifestyle interventions is often met with barriers. This qualitative study sought to determine anticipated barriers and facilitators to the nationwide implementation of an effective lifestyle intervention in the construction industry in the Netherlands.
Methods
Prior to implementation, focus groups were held with 8 lifestyle counselors and semi-structured interviews with 20 employees of the construction industry, 4 occupational physicians, 4 medical assistants, and 1 manager of an occupational health service. The transcripts were coded by two coders and analyzed by constant comparison.
Results
Hypothetical employee willingness to sign up for the intervention was facilitated by a high level of perceived risk, perceived added value of the intervention, and perceived social support. It was hampered by a preference for independence and perceived interference with their work. All professionals named a lack of time as an anticipated barrier to implementation. Lifestyle counselors suggested several strategies to improve the proficiency of their counseling technique, such as training in small groups and a continuous stream of employee referrals. Occupational physicians thought they would be hampered in screening employees and referring them to a lifestyle counselor by the perception that addressing employee lifestyles was not their task, and by a counter-productive relationship with other stakeholders. The manager addressed financial incentives and a good intervention fit with the current approach of the OHS.
Conclusion
The findings suggest that employees can be motivated to sign up for a lifestyle intervention by tailoring the implementation strategy to various subgroups within the target group. Occupational physicians can be motivated to refer employees for the intervention by making a referral personally and professionally rewarding.
Electronic supplementary material
The online version of this article (doi:10.1186/1471-2458-14-1317) contains supplementary material, which is available to authorized users.
doi:10.1186/1471-2458-14-1317
PMCID: PMC4326182  PMID: 25539630
Cardiovascular risk; Primary prevention; Occupational; Lifestyle intervention; Implementation; Barrier; Qualitative
17.  A multidisciplinary intervention to facilitate return to work in cancer patients: intervention protocol and design of a feasibility study 
BMJ Open  2012;2(4):e001321.
Introduction
Returning to work can be problematic for cancer survivors due to suboptimal workplace support, a heavy workload, decreased physical functioning and fatigue. The timely and permanent return to work (RtW) of cancer patients favourably influences quality of life and economic independence. Multidisciplinary interventions aimed at timely and enduring RtW are lacking. The objectives of this article are (1) to describe the protocol of an intervention aimed at RtW of cancer patients, comprising of counselling by an oncological occupational physician and supervised physical exercise in a clinical setting during treatment and (2) to present the design of the study aimed at evaluating the feasibility of this intervention.
Methods and analysis
The intervention comprises three counselling sessions with an oncological occupational physician and a 12-week moderate-to-high intensity physical exercise programme, starting at the onset of chemotherapy. The intervention is aimed at cancer patients treated with curative intent, aged 18–60 years, employed and on sick leave. It will take place in two large medical centres in the Netherlands. The feasibility of the intervention will be evaluated as follows: the number of sessions, topics discussed and exercises executed will be registered by care providers; patients' and care providers' opinions will be assessed by questionnaires and interviews, respectively; and the proportion of invited patients that participated will be calculated.
Ethics and dissemination
The study results will be used for optimising the intervention content and may serve as a foundation for future implementation. The Medical Ethics Committees of the Academic Medical Center and the participating medical centres approved the study protocol.
Article summary
Article focus
The goals of this article are to describe the protocol of an intervention aimed at RtW of cancer patients, comprising of counselling by an oncological occupational physician and supervised physical exercise in a clinical setting during treatment and to present the design of the study used to evaluate the feasibility of this intervention.
Key messages
Returning to work is problematic for cancer survivors due to, among other factors, suboptimal workplace support, a heavy workload, decreased physical functioning and fatigue.
Timely and enduring RtW may favourably influence quality of life and economic independence of cancer patients.
A multidisciplinary intervention for cancer patients consisting of counselling and physical exercise aimed at returning to work is warranted and must be evaluated for feasibility.
Strengths and limitations of this study
The intervention is innovative in its early onset, clinical setting and the fact that both work- and physical health-related determinants of RtW are targeted.
The feasibility of the intervention will be investigated thoroughly at the level of the patients and the care providers using qualitative and quantitative methods.
Only one occupational health professional will be involved in the intervention, and physical exercise will not be continued after chemotherapy treatment has concluded.
doi:10.1136/bmjopen-2012-001321
PMCID: PMC3400074  PMID: 22786950
18.  Short and long term effects of a lifestyle intervention for construction workers at risk for cardiovascular disease: a randomized controlled trial 
BMC Public Health  2011;11:836.
Background
The prevalence of overweight and elevated cardiovascular disease (CVD) risk among workers in the construction industry is relatively high. Improving lifestyle lowers CVD risk and may have work-related benefits. The purpose of the study was to evaluate the effects on physical activity (PA), diet, and smoking of a lifestyle intervention consisting of individual counseling among male workers in the construction industry with an elevated risk of cardiovascular disease (CVD).
Methods
In a randomized controlled trial including 816 male blue- and white-collar workers in the construction industry with an elevated risk of CVD, usual care was compared to a 6-month lifestyle intervention. The intervention consisted of individual counseling using motivational interviewing techniques, and was delivered by an occupational physician or occupational nurse. In three face to face and four telephone contacts, the participant's risk profile, personal determinants, and barriers for behavior change were discussed, and personal goals were set. Participants chose to aim at either diet and PA, or smoking. Data were collected at baseline and after six and 12 months, by means of a questionnaire. To analyse the data, linear and logistic regression analyses were performed.
Results
The intervention had a statistically significant beneficial effect on snack intake (β-1.9, 95%CI -3.7; -0.02) and fruit intake (β 1.7, 95%CI 0.6; 2.9) at 6 months. The effect on snack intake was sustained until 12 months; 6 months after the intervention had ended (β -1.9, 95%CI -3.6; -0.2). The intervention effects on leisure time PA and metabolic equivalent-minutes were not statistically significant. The beneficial effect on smoking was statistically significant at 6 (OR smoking 0.3, 95%CI 0.1;0.7), but not at 12 months (OR 0.8, 95%CI 0.4; 1.6).
Conclusions
Beneficial effects on smoking, fruit, and snack intake can be achieved by an individual-based lifestyle intervention among male construction workers with an elevated risk of CVD. Future research should be done on strategies to improve leisure time PA and on determinants of maintenance of changed behavior. Considering the rising prevalence of unhealthy lifestyle and CVD, especially in the aging population, implementation of this intervention in the occupational health care setting is recommended.
Trial registration
Current Controlled Trials ISRCTN60545588
doi:10.1186/1471-2458-11-836
PMCID: PMC3247875  PMID: 22040007
19.  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
20.  A trial of a job-specific workers' health surveillance program for construction workers: study protocol 
BMC Public Health  2011;11:743.
Background
Dutch construction workers are offered periodic health examinations. This care can be improved by tailoring this workers health surveillance (WHS) to the demands of the job and adjust the preventive actions to the specific health risks of a worker in a particular job. To improve the quality of the WHS for construction workers and stimulate relevant job-specific preventive actions by the occupational physician, we have developed a job-specific WHS. The job-specific WHS consists of modules assessing both physical and psychological requirements. The selected measurement instruments chosen, are based on their appropriateness to measure the workers' capacity and health requirements. They include a questionnaire and biometrical tests, and physical performance tests that measure physical functional capabilities. Furthermore, our job-specific WHS provides occupational physicians with a protocol to increase the worker-behavioural effectiveness of their counselling and to stimulate job-specific preventive actions. The objective of this paper is to describe and clarify our study to evaluate the behavioural effects of this job-specific WHS on workers and occupational physicians.
Methods/Design
The ongoing study of bricklayers and supervisors is a nonrandomised trial to compare the outcome of an intervention (job-specific WHS) group (n = 206) with that of a control (WHS) group (n = 206). The study includes a three-month follow-up. The primary outcome measure is the proportion of participants who have undertaken one or more of the preventive actions advised by their occupational physician in the three months after attending the WHS. A process evaluation will be carried out to determine context, reach, dose delivered, dose received, fidelity, and satisfaction. The present study is in accordance with the TREND Statement.
Discussion
This study will allow an evaluation of the behaviour of both the workers and occupational physician regarding the preventive actions undertaken by them within the scope of a job-specific WHS.
Trial registration
NTR3012
doi:10.1186/1471-2458-11-743
PMCID: PMC3192691  PMID: 21958019
21.  Rational Prescribing in Primary Care (RaPP): A Cluster Randomized Trial of a Tailored Intervention 
PLoS Medicine  2006;3(6):e134.
Background
A gap exists between evidence and practice regarding the management of cardiovascular risk factors. This gap could be narrowed if systematically developed clinical practice guidelines were effectively implemented in clinical practice. We evaluated the effects of a tailored intervention to support the implementation of systematically developed guidelines for the use of antihypertensive and cholesterol-lowering drugs for the primary prevention of cardiovascular disease.
Methods and Findings
We conducted a cluster-randomized trial comparing a tailored intervention to passive dissemination of guidelines in 146 general practices in two geographical areas in Norway. Each practice was randomized to either the tailored intervention (70 practices; 257 physicians) or control group (69 practices; 244 physicians). Patients started on medication for hypertension or hypercholesterolemia during the study period and all patients already on treatment that consulted their physician during the trial were included. A multifaceted intervention was tailored to address identified barriers to change. Key components were an educational outreach visit with audit and feedback, and computerized reminders linked to the medical record system. Pharmacists conducted the visits. Outcomes were measured for all eligible patients seen in the participating practices during 1 y before and after the intervention. The main outcomes were the proportions of (1) first-time prescriptions for hypertension where thiazides were prescribed, (2) patients assessed for cardiovascular risk before prescribing antihypertensive or cholesterol-lowering drugs, and (3) patients treated for hypertension or hypercholesterolemia for 3 mo or more who had achieved recommended treatment goals.
The intervention led to an increase in adherence to guideline recommendations on choice of antihypertensive drug. Thiazides were prescribed to 17% of patients in the intervention group versus 11% in the control group (relative risk 1.94; 95% confidence interval 1.49–2.49, adjusted for baseline differences and clustering effect). Little or no differences were found for risk assessment prior to prescribing and for achievement of treatment goals.
Conclusions
Our tailored intervention had a significant impact on prescribing of antihypertensive drugs, but was ineffective in improving the quality of other aspects of managing hypertension and hypercholesterolemia in primary care.
Editors' Summary
Background.
An important issue in health care is “getting research into practice,” in other words, making sure that, when evidence from research has established the best way to treat a disease, doctors actually use that approach with their patients. In reality, there is often a gap between evidence and practice.
  An example concerns the treatment of people who have high blood pressure (hypertension) and/or high cholesterol. These are common conditions, and both increase the risk of having a heart attack or a stroke. Research has shown that the risks can be lowered if patients with these conditions are given drugs that lower blood pressure (antihypertensives) and drugs that lower cholesterol. There are many types of these drugs now available. In many countries, the health authorities want family doctors (general practitioners) to make better use of these drugs. They want doctors to prescribe them to everyone who would benefit, using the type of drugs found to be most effective. When there is a choice of drugs that are equally effective, they want doctors to use the cheapest type. (In the case of antihypertensives, an older type, known as thiazides, is very effective and also very cheap, but many doctors prefer to give their patients newer, more expensive alternatives.) Health authorities have issued guidelines to doctors that address these issues. However, it is not easy to change prescribing practices, and research in several countries has shown that issuing guidelines has only limited effects.
Why Was This Study Done?
The researchers wanted—in two parts of Norway—to compare the effects on prescribing practices of what they called the “passive dissemination of guidelines” with a more active approach, where the use of the guidelines was strongly promoted and encouraged.
What Did the Researchers Do and Find?
They worked with 146 general practices. In half of them the guidelines were actively promoted. The remaining were regarded as a control group; they were given the guidelines but no special efforts were made to encourage their use. It was decided at random which practices would be in which group; this approach is called a randomized controlled trial. The methods used to actively promote use of the guidelines included personal visits to the practices by pharmacists and use of a computerized reminder system. Information was then collected on the number of patients who, when first treated for hypertension, were prescribed a thiazide. Other information collected included whether patients had been properly assessed for their level of risk (for strokes and heart attacks) before antihypertensive or cholesterol-lowering drugs were given. In addition, the researchers recorded whether the recommended targets for improvement in blood pressure and cholesterol level had been reached.
Only 11% of those patients visiting the control group of practices who should have been prescribed thiazides, according to the guidelines, actually received them. Of those seen by doctors in the practices where the guidelines were actively promoted, 17% received thiazides. According to statistical analysis, the increase achieved by active promotion is significant. Little or no differences were found for risk assessment prior to prescribing and for achievement of treatment goals.
What Do These Findings Mean?
Even in the active promotion group, the great majority of patients (83%) were still not receiving treatment according to the guidelines. However, active promotion of guidelines is more effective than simply issuing the guidelines by themselves. The study also demonstrates that it is very hard to change prescribing practices. The efforts made here to encourage the doctors to change were considerable, and although the results were significant, they were still disappointing. Also disappointing is the fact that achievement of treatment goals was no better in the active-promotion group. These issues are discussed further in a Perspective about this study (DOI: 10.1371/journal.pmed.0030229).
Additional Information.
Please access these Web sites via the online version of this summary at http://dx.doi.org/10.1371/journal.pmed.0030134.
• The Web site of the American Academy of Family Physicians has a page on heart disease
• The MedlinePlus Medical Encyclopedia's pages on heart diseases and vascular diseases
• Information from NHS Direct (UK National Health Service) about heart attack and stroke
• Another PLoS Medicine article has also addressed trends in thiazide prescribing
Passive dissemination of management guidelines for hypertension and hypercholesterolaemia was compared with active promotion. Active promotion led to significant improvement in antihypertensive prescribing but not other aspects of management.
doi:10.1371/journal.pmed.0030134
PMCID: PMC1472695  PMID: 16737346
22.  Promoting mental health in small-medium enterprises: An evaluation of the "Business in Mind" program 
BMC Public Health  2009;9:239.
Background
Workplace mental health promotion (WMHP) aims to prevent and effectively manage the social and economic costs of common mental illnesses such as depression. The mental health of managers and employees within small-medium enterprises (SMEs) is a neglected sector in occupational health research and practice, despite the fact that this sector is the most common work setting in most economies. The availability and propensity of SME staff to attend face-to-face training/therapy or workshop style interventions often seen in corporate or public sector work settings is a widely recognised problem. The 'Business in Mind' program employs a DVD mode of delivery that is convenient for SME managers, particularly those operating in regional and remote areas where internet delivery may not be optimal. The objective of the intervention program is to improve the mental health of SME managers, and examine whether employees of managers' whose mental health improves, report positive change in their psychosocial work environment. The mechanisms via which we aim to improve managers' mental health are through the development of their psychological capital (a higher order construct comprised of hope, self efficacy, resilience and optimism) and their skills and capacities for coping with work stress.
Methods/Design
The effectiveness of two versions of the program (self administered and telephone facilitated) will be assessed using a randomised trial with an active control condition (psychoeducation only). We aim to recruit a minimum of 249 managers and a sample of their employees. This design allows for 83 managers per group, as power analyses showed that this number would allow for attrition of 20% and still enable detection of an effect size of 0.5. The intervention will be implemented over a three month period and postal surveys will assess managers and employees in each group at baseline, intervention completion, and at 6 month follow up. The intervention groups (managers only) will also be assessed at 12 and 24 month follow-up to examine maintenance of effects. Primary outcomes are managers' levels of psychological capital (hope, resilience, self-efficacy and optimism), coping strategies, anxiety and depression symptoms, self-reported health, job satisfaction and job tension. Secondary outcomes are participating managers subordinates' perceptions of manager support, relational justice, emotional climate and job tension. In order to provide an economic evaluation of the intervention, both employees and manager rates of absenteeism and presenteeism will also be assessed.
Discussion
The intervention being trialled is expected to improve both primary and secondary outcomes. If proven efficacious, the intervention could be disseminated to reach a much larger proportion of the business community.
Trial registration
Current controlled trials ISRCTN 62853520
doi:10.1186/1471-2458-9-239
PMCID: PMC2714843  PMID: 19604351
23.  Empowering employees with chronic diseases; development of an intervention aimed at job retention and design of a randomised controlled trial 
Background
Persons with a chronic disease are less often employed than healthy persons. If employed, many of them experience problems at work. Therefore, we developed a training programme aimed at job retention. The objective of this paper is to describe this intervention and to present the design of a study to evaluate its effectiveness.
Development and description of intervention
A systematic review, a needs assessment and discussions with Dutch experts led to a pilot group training, tested in a pilot study. The evaluation resulted in the development of a seven-session group training combined with three individual counselling sessions. The training is based on an empowerment perspective that aims to help individuals enhance knowledge, skills and self-awareness. These advances are deemed necessary for problem solving in three stages: exploration and clarification of work related problems, communication at the workplace, and development and implementation of solutions. Seven themes are discussed and practised in the group sessions: 1) Consequences of a chronic disease in the workplace, 2) Insight into feelings and thoughts about having a chronic disease, 3) Communication in daily work situations, 4) Facilities for disabled employees and work disability legislation, 5) How to stand up for oneself, 6) A plan to solve problems, 7) Follow-up.
Methods
Participants are recruited via occupational health services, patient organisations, employers, and a yearly national conference on chronic diseases. They are eligible when they have a chronic physical medical condition, have a paid job, and experience problems at work. Workers on long-term, 100% sick leave that is expected to continue during the training are excluded. After filling in the baseline questionnaire, the participants are randomised to either the control or the intervention group. The control group will receive no care or care as usual. Post-test mail questionnaires will be sent after 4, 8, 12 and 24 months. Primary outcome measures are job retention, self efficacy, fatigue and work pleasure. Secondary outcome measures are work-related problems, sick leave, quality of life, acquired work accommodations, burnout, and several quality of work measures. A process evaluation will be conducted and satisfaction with the training, its components and the training methods will be assessed.
Discussion
Many employees with a chronic condition experience problems in performing tasks and in managing social relations at work. We developed an innovative intervention that addresses practical as well as psychosocial problems. The results of the study will be relevant for employees, employers, occupational health professionals and human resource professionals (HRM).
Trial registration
ISRCTN77240155
doi:10.1186/1472-6963-8-224
PMCID: PMC2614990  PMID: 18983652
24.  A Multifaceted Intervention to Implement Guidelines and Improve Admission Paediatric Care in Kenyan District Hospitals: A Cluster Randomised Trial 
PLoS Medicine  2011;8(4):e1001018.
Philip Ayieko and colleagues report the outcomes of a cluster-randomized trial carried out in eight Kenyan district hospitals evaluating the effects of a complex intervention involving improved training and supervision for clinicians. They found a higher performance of hospitals assigned to the complex intervention on a variety of process of care measures, as compared to those receiving the control intervention.
Background
In developing countries referral of severely ill children from primary care to district hospitals is common, but hospital care is often of poor quality. However, strategies to change multiple paediatric care practices in rural hospitals have rarely been evaluated.
Methods and Findings
This cluster randomized trial was conducted in eight rural Kenyan district hospitals, four of which were randomly assigned to a full intervention aimed at improving quality of clinical care (evidence-based guidelines, training, job aides, local facilitation, supervision, and face-to-face feedback; n = 4) and the remaining four to control intervention (guidelines, didactic training, job aides, and written feedback; n = 4). Prespecified structure, process, and outcome indicators were measured at baseline and during three and five 6-monthly surveys in control and intervention hospitals, respectively. Primary outcomes were process of care measures, assessed at 18 months postbaseline.
In both groups performance improved from baseline. Completion of admission assessment tasks was higher in intervention sites at 18 months (mean = 0.94 versus 0.65, adjusted difference 0.54 [95% confidence interval 0.05–0.29]). Uptake of guideline recommended therapeutic practices was also higher within intervention hospitals: adoption of once daily gentamicin (89.2% versus 74.4%; 17.1% [8.04%–26.1%]); loading dose quinine (91.9% versus 66.7%, 26.3% [−3.66% to 56.3%]); and adequate prescriptions of intravenous fluids for severe dehydration (67.2% versus 40.6%; 29.9% [10.9%–48.9%]). The proportion of children receiving inappropriate doses of drugs in intervention hospitals was lower (quinine dose >40 mg/kg/day; 1.0% versus 7.5%; −6.5% [−12.9% to 0.20%]), and inadequate gentamicin dose (2.2% versus 9.0%; −6.8% [−11.9% to −1.6%]).
Conclusions
Specific efforts are needed to improve hospital care in developing countries. A full, multifaceted intervention was associated with greater changes in practice spanning multiple, high mortality conditions in rural Kenyan hospitals than a partial intervention, providing one model for bridging the evidence to practice gap and improving admission care in similar settings.
Trial registration
Current Controlled Trials ISRCTN42996612
Please see later in the article for the Editors' Summary
Editors' Summary
Background
In 2008, nearly 10 million children died in early childhood. Nearly all these deaths were in low- and middle-income countries—half were in Africa. In Kenya, for example, 74 out every 1,000 children born died before they reached their fifth birthday. About half of all childhood (pediatric) deaths in developing countries are caused by pneumonia, diarrhea, and malaria. Deaths from these common diseases could be prevented if all sick children had access to quality health care in the community (“primary” health care provided by health centers, pharmacists, family doctors, and traditional healers) and in district hospitals (“secondary” health care). Unfortunately, primary health care facilities in developing countries often lack essential diagnostic capabilities and drugs, and pediatric hospital care is frequently inadequate with many deaths occurring soon after admission. Consequently, in 1996, as part of global efforts to reduce childhood illnesses and deaths, the World Health Organization (WHO) and the United Nations Children's Fund (UNICEF) introduced the Integrated Management of Childhood Illnesses (IMCI) strategy. This approach to child health focuses on the well-being of the whole child and aims to improve the case management skills of health care staff at all levels, health systems, and family and community health practices.
Why Was This Study Done?
The implementation of IMCI has been evaluated at the primary health care level, but its implementation in district hospitals has not been evaluated. So, for example, interventions designed to encourage the routine use of WHO disease-specific guidelines in rural pediatric hospitals have not been tested. In this cluster randomized trial, the researchers develop and test a multifaceted intervention designed to improve the implementation of treatment guidelines and admission pediatric care in district hospitals in Kenya. In a cluster randomized trial, groups of patients rather than individual patients are randomly assigned to receive alternative interventions and the outcomes in different “clusters” of patients are compared. In this trial, each cluster is a district hospital.
What Did the Researchers Do and Find?
The researchers randomly assigned eight Kenyan district hospitals to the “full” or “control” intervention, interventions that differed in intensity but that both included more strategies to promote implementation of best practice than are usually applied in Kenyan rural hospitals. The full intervention included provision of clinical practice guidelines and training in their use, six-monthly survey-based hospital assessments followed by face-to-face feedback of survey findings, 5.5 days training for health care workers, provision of job aids such as structured pediatric admission records, external supervision, and the identification of a local facilitator to promote guideline use and to provide on-site problem solving. The control intervention included the provision of clinical practice guidelines (without training in their use) and job aids, six-monthly surveys with written feedback, and a 1.5-day lecture-based seminar to explain the guidelines. The researchers compared the implementation of various processes of care (activities of patients and doctors undertaken to ensure delivery of care) in the intervention and control hospitals at baseline and 18 months later. The performance of both groups of hospitals improved during the trial but more markedly in the intervention hospitals than in the control hospitals. At 18 months, the completion of admission assessment tasks and the uptake of guideline-recommended clinical practices were both higher in the intervention hospitals than in the control hospitals. Moreover, a lower proportion of children received inappropriate doses of drugs such as quinine for malaria in the intervention hospitals than in the control hospitals.
What Do These Findings Mean?
These findings show that specific efforts are needed to improve pediatric care in rural Kenya and suggest that interventions that include more approaches to changing clinical practice may be more effective than interventions that include fewer approaches. These findings are limited by certain aspects of the trial design, such as the small number of participating hospitals, and may not be generalizable to other hospitals in Kenya or to hospitals in other developing countries. Thus, although these findings seem to suggest that efforts to implement and scale up improved secondary pediatric health care will need to include more than the production and dissemination of printed materials, further research including trials or evaluation of test programs are necessary before widespread adoption of any multifaceted approach (which will need to be tailored to local conditions and available resources) can be contemplated.
Additional Information
Please access these Web sites via the online version of this summary at http://dx.doi.org/10.1371/journal.pmed.1001018.
WHO provides information on efforts to reduce global child mortality and on Integrated Management of Childhood Illness (IMCI); the WHO pocket book “Hospital care for children contains guidelines for the management of common illnesses with limited resources (available in several languages)
UNICEF also provides information on efforts to reduce child mortality and detailed statistics on child mortality
The iDOC Africa Web site, which is dedicated to improving the delivery of hospital care for children and newborns in Africa, provides links to the clinical guidelines and other resources used in this study
doi:10.1371/journal.pmed.1001018
PMCID: PMC3071366  PMID: 21483712
25.  Web-based guided self-help for employees with depressive symptoms (Happy@Work): design of a randomized controlled trial 
BMC Psychiatry  2013;13:61.
Background
Depressive disorders are highly prevalent in the working population and are associated with excessive costs for both society and companies. Effective treatment for employees with depressive symptoms in occupational health care is limited. The purpose of this study is to investigate the effectiveness and cost-effectiveness of an indicated preventive web-based guided self-help course for employees with depressive symptoms.
Methods
The study is a two-arm randomized controlled trial comparing a web-based guided self-help course with care-as-usual. The self-help course consists of 6 weekly lessons. Weekly support will be provided by a coach via the website. Subjects in the care-as-usual group do not receive any treatment in addition to regular care. 200 white collar workers from several national and international companies in the Netherlands will be recruited via different methods such as banners on the company’s intranet, pamphlets and posters. Subjects will be included when they: have elevated depressive symptoms (score ≥16 on the Center for Epidemiologic Studies Depression scale), are 18 years of age or older, have access to the Internet and can be contacted via e-mail. Exclusion criteria are: partial or full work absenteeism, a legal labor dispute with the employer and receiving treatment from the company’s occupational health care at study entrance.
The primary outcome is depressive symptoms. Secondary outcomes include work absenteeism, work performance, burnout, anxiety, quality of life, health care use and production losses. Outcome data will be collected at 8 weeks, 6 months, and 12 months after baseline. Analyses will be based on the intention-to-treat principle. The cost-effectiveness analyses will be performed from a societal and a company’s perspective. A process evaluation will be conducted alongside the study.
Discussion
This study evaluates the effectiveness and cost-effectiveness of a web-based guided self-help course for employees with depressive symptoms. This study could stimulate the use of e-mental health interventions in the worksite setting.
Trial registration
Nederlands Trial Register (NTR): TC2993
doi:10.1186/1471-244X-13-61
PMCID: PMC3599070  PMID: 23418886
Internet; Depression; Absenteeism; Employees; Occupational therapy; Self-help; Cognitive therapy; Problem solving; Randomized trial.

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