Randomized controlled trials (RCTs) in rehabilitation research

Session: 

Oral session: Knowledge translation and communicating evidence (3)

Date: 

Sunday 16 September 2018 - 16:50 to 17:00

Location: 

Pentland Auditorium

All authors in correct order:

Meyer T1, Levack W2, Negrini S3, Gimigliano F4, Arienti C5, Rathore F6, Malmivaara A7
1 School of Public Health, Bielefeld University, Germany
2 University of Otago, Wellington, New Zealand
3 University of Brescia, Italy
4 Department of Mental and Physical Health and Preventive Medicine at Università degli Studi della Campania “Luigi Vanvitelli”, Napoli, Italy
5 Department of Biomedical Sciences and Translational Medicine, University of Brescia, Italy
6 Bahria University Medical and Dental College, Karachi, Pakistan
7 Centre for Health and Social Economics, Helsinki, Finland
Presenting author and contact person

Presenting author:

Thorsten Meyer

Contact person:

Thorsten Meyer
Abstract text
Background: The emergence of evidence-based medicine and standards of high quality clinical research have thoroughly changed the field of rehabilitation. However, there has been considerable discussion on how widely randomized controlled trials (RCTs) can cover issues of knowledge translation within rehabilitation.
Objectives: Due to the pivotal role of this controversy for Cochrane Rehabilitation, we aimed to: a) describe and discuss pros and cons of RCTs in rehabilitation research and b) discuss future needs for advancing methodology of effectiveness research in rehabilitation.
Methods: We conducted a conceptual review of papers that analyse or discuss pros and cons of RCTs. We set up a literature search aiming to cover a range of arguments to reach analytic generalizability. We asked experts in the field for additional input based on published arguments. We describe pros and cons, and analyze them by means of a thematic analysis.
Results: Discussions relate to which study questions different types of RCTs are able to answer, strengths and limitations of internal validity of RCTs, and generalizability of evidence from RCTs to practice. We found unjustified or weak arguments against the application of RCTs, e.g. critique of including homogeneous or excluding heterogeneous populations, which is not a function of an RCT, but of appropriate inclusion/exclusion criteria, or critique of conducting RCTs primarily in centres of excellence. Substantial arguments against the use of RCTs relate to the complexity of rehabilitation interventions, which makes the outcome of a study difficult to interpret because of a number of potential causal and interacting factors. Additionally, there is the problem that for rehabilitation the goals of interventions have to be individually tailored and related to the person’s living environment to be meaningful, which challenges standardized methods of outcome assessment.
Conclusions: RCTs fulfil a valuable role in rehabilitation research. However, their limitations in practice should be addressed and principle limitations should facilitate the development or adjustment of alternative study designs to provide useful evidence for rehabilitation practice.
Patient or healthcare consumer involvement: Patient groups for which the interventions are conducted should be involved in the development of RCTs and other study designs.

Relevance to patients and consumers: 

Patients or consumers are interested in health care that is based on best evidence. In rehabilitation, RCTs might prove to be relevant only to specific types of health care interventions. The problems related to complex interventions may be underestimated if inappropriate evaluating methods are used. Also, patients or consumers should be involved in developing or adapting alternative study designs as well as knowledge translation to rehabilitation practice.