Core Outcome Measures in Effectiveness Trials

Development of a Core Outcome Set for Work Participation (COS-WP)

General Information

Summary:
In the field of insurance medicine and occupational health ‘work participation’ is frequently used as an umbrella term. Several outcomes are linked to ‘work participation’ as a concept and the instruments to measure these outcomes differ. Lack of standardization in outcome measurement and reporting greatly hinders the synthesis of research and, consequently, hampers decision making at the cost of the best possible treatment and social medical guidance for workers.

In a pilot review we found great variability among work participation outcomes reported in RCTs identified in seven Cochrane Reviews in the field of occupational health. The outcomes in these reviews include return to work (RTW), sick leave, absenteeism, work status, functional status, productivity, or work functioning. Further, outcomes were measured at different follow up times; definitions or cut-off points for RTW or sick leave varied; diverse statistics were included; and different sources to measure work participation were used. The authors of these Cochrane reviews recommend a uniform assessment of work participation outcomes and outcome measurement instruments, the use of explicit definitions and cut-off points, definition of minimal clinical important differences, and better validation of measurements instruments.

The variation in outcomes and measurements highlights the need for a Core Outcome Set for Work Participation (COS-WP) which is relevant within the field of occupational health and insurance medicine. A set of consistent definitions on key constructs and outcomes may improve the understanding of the outcomes that matter to the stakeholders, address the complexity of outcomes such as return to work, and help to understand the dynamic process in measuring these outcomes.

Starting mid-2018, the Coronel Institute of Occupational Health of the Amsterdam UMC, Academic Medical Center in Amsterdam will start a 4-year international collaborative project to develop a COS for work participation. Part of this 4-year project will be a PhD project. During the development of a COS we will use the methods advocated by COMET (www.comet-initiative.org) and COSMIN (www.cosmin.nl). By means of three systematic reviews on the topic of work participation, a survey among international experts / stakeholders in the field of occupational health/insurance medicine, a focus group study and a Delphi study to reach consensus among experts / stakeholders we aim to seek consensus on the core outcomes and the most suitable outcome measurement instruments. We also plan to perform two projects on dissemination/ implementation and knowledge transfer and evaluate these.

We call on the international community of practitioners, clients and researchers in occupational health and insurance medicine to help us join forces for the development of such a COS. To date, several partners support this initiative including the Amsterdam Public Health (APH) COS focus group, Cochrane Insurance Medicine (CIM) and Cochrane Work. The project will result in a universally applicable and broadly agreed COS for work participation that should be used when conducting RCTs and systematic reviews so that we can achieve the best possible treatment and social medical guidance for our clients.



Contributors:
Project leader and contact:

Dr. Jan L. Hoving; Amsterdam UMC, Academic Medical Center, University of Amsterdam, Coronel Institute of Occupational Health, Amsterdam Public Health research institute, Amsterdam, NL. J.l.Hoving@amc.uva.nl; +31-(0)20-5665339

Project team:

1. Margarita Ravinskaya (PhD Student on COS-WP project); Amsterdam UMC, Academic Medical Center, University of Amsterdam, Coronel Institute of Occupational Health, Amsterdam Public Health research institute, Amsterdam, NL

2. Dr. Cecilia A.C. Prinsen; Amsterdam UMC, VU University Medical Centre, Department of Epidemiology and Biostatistics, Amsterdam Public Health Research Institute, Amsterdam, NL

3. Dr. Jos H. Verbeek; Finish Institute of Occupational Health, Cochrane Work, Kuopio, FIN

4. Prof. Dr. Regina Kunz; Academic Unit EbIM, Evidence Based Insurance Medicine, Department of Clinical Research, University of Basel, SZ

5. Dr. Miranda Langendam, Amsterdam UMC, Academic Medical Center, University of Amsterdam, Department of Clinical Epidemiology, Biostatistics and Bioinformatics, Amsterdam Public Health research institute, NL

6. Prof. Carel Hulshof, Amsterdam UMC, Academic Medical Center, University of Amsterdam, Coronel Institute of Occupational Health, Amsterdam Public Health research institute, Amsterdam, NL

Further Study Information

Current Stage:
Ongoing
Date:
August 2018 - August 2022
Funding source(s):
Amsterdam UMC, Academic Medical Center, University of Amsterdam, Coronel Institute of Occupational Health, Amsterdam Public Health research institute

Health Area

Disease Category
Other

Disease Name
N/A

Target Population

Age Range
18 - 65

Sex
Either


Nature / type of Intervention
Other

Method(s)

Consensus meeting
Delphi process
Focus group(s)
Interview
Literature review
Survey
Systematic review

During the development of a COS we will use the methods advocated by COMET (www.comet-initiative.org) and COSMIN (www.cosmin.nl). By means of three systematic reviews on the topic of work participation, a survey among international experts / stakeholders in the field of occupational health/insurance medicine, a focus group study and a Delphi study to reach consensus among experts / stakeholders we aim to seek consensus on the core outcomes and the most suitable outcome measurement instruments. We also plan to perform two projects on dissemination/ implementation and knowledge transfer and evaluate these.


Stakeholders Involved

Clinical experts
Epidemiologists
Journal editors
Methodologists
Patient/ support group representatives
Policy makers
Researchers

Study Type

COS for clinical trials or clinical research

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