Finding, testing and demonstrating efficacy of new treatments for stroke recovery is a multifaceted challenge. We believe that to advance the field, neurorehabilitation trials need a conceptually rigorous starting framework. An essential first step is to agree on definitions of sensorimotor recovery and on measures consistent with these definitions. Such standardization would allow pooling of participant data across studies and institutions aiding meta-analyses of completed trials, more detailed exploration of recovery profiles of our patients and the generation of new hypotheses. Here, we present the results of a consensus meeting about measurement standards and patient characteristics that we suggest should be collected in all future stroke recovery trials. Recommendations are made considering time post stroke and are aligned with the international classification of functioning and disability. A strong case is made for addition of kinematic and kinetic movement quantification. Further work is being undertaken by our group to form consensus on clinical predictors and pre-stroke clinical data that should be collected, as well as recommendations for additional outcome measurement tools. To improve stroke recovery trials, we urge the research community to consider adopting our recommendations in their trial design.
Protocol: http://wso.sagepub.com/content/11/4/454
Gert Kwakkel, Natasha A Lannin, Karen Borschmann, Coralie English, Myzoon Ali, Leonid Churilov, Gustavo Saposnik, Carolee Winstein, Erwin EH van Wegen, Steven L Wolf, John W Krakauer, Julie Bernhardt
Professor Julie Bernhardt is chair of the SRRR organising committee and co-chair of "Measurement in Clinical Trials" working group.
Professor Gert Kwakkel is chair of the "Measurement in Clinical Trials" working party.
Disease Category: Neurology, Rehabilitation
Disease Name: Stroke
Age Range: 18 - 105
Sex: Either
Nature of Intervention: Rehabilitation
- Clinical experts
- Governmental agencies
- Journal editors
- Methodologists
- Researchers
- Service providers
- Statisticians
- COS for clinical trials or clinical research
- Consensus conference
- Semi structured discussion
- Survey
The first stage in the process was identification of (potentially multiple) desirable criteria to be used for assessing alternative outcome measures and the relative importance of this criteria. The second stage involved individual decision-makers to rank order the measures according to every criterion, and the final stage was to aggregate the individual rank order lists into the whole group rank order list. The first two stages draw on “value focussed thinking” work by Ralph Keeney {www.hup.harvard.edu/catalog.php?isbn=9780674931985} and “Decision Aids for Selection Problems” monograph by David Olson {http://link.springer.com/book/10.1007%2F978-1-4612-3982-6}, while the third stage is based on the work by Utley et al (2007) “A consensus process for identifying a prioritised list of study questions” published in Health Care Management Science {http://www.ncbi.nlm.nih.gov/pubmed/17323658}
The proposed approach is different to the Delphi process