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Abstract
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.
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.