Longitudinal randomised controlled trials in rehabilitation post-stroke: a systematic review on the quality of reporting and use of baseline outcome values

Abstract

Background: The World Health Organisation stresses the need to collect high quality longitudinal data on rehabilitation and to improve the comparability between studies. This implies using all the information available and transparent reporting. We therefore investigated the quality of reported or planned randomised controlled trials on rehabilitation post-stroke with a repeated measure of physical functioning, provided recommendations on the presentation of results using regression parameters, and focused on the difficulties of adjustment for baseline outcome measures.

Setting-up a clinical trial: Some methodological recommendations

“…According to the World Health Organization (WHO (World Health Organization), 2011), longitudinal studies play a fundamental role for the understanding of the ''dynamics of disability'', especially when considering studies in the field of rehabilitative interventions. However, a recent systematic review pointed out that, taking into account RCTs in post-stroke rehabilitation, only 39% of the studies performed longitudinal analysis of data, whether the 52% ignored the longitudinal nature of data (Sauzet, Kleine, Menzel-Begemann, & Exner, 2015). Moreover, 95% of RCTs published in top medical journals show different levels of missing data (Ashbeck & Bell, 2016).…”

“…In that sense, the longitudinal nature of data should always be considered into repeated measures analysis and the intervention effect over the follow-up should always be reported. This could be achieved by mean of statistical methods like mixed models (Sauzet et al, 2015). In this perspective, also epidemiological studies and related time series analyses, using temporal and spectral methods, should be considered as a keen instrument to be included as a toolkit in clinical sciences.…”

Data in longitudinal randomised controlled trials in cancer pain: is there any loss of the information available in the data? Results of a systematic literature review and guideline for reporting

“…Such differences are to be seen in the presence of inhomogeneous patient groups, i.e. patients with high and patients with low pain scores at baseline [ 11 , 18 ].…”

Evidence-Based Stroke Rehabilitation

“…Outcome can be measured by: morbidity, mortality, impairment, hospitalization, functional consequences, and quality of life. The insufficient number of randomized studies for rehabilitation of different diseases was mentioned in the Report of Disability published by the World Health organization [19].…”

“…The most prominent aspects with improvement are: locomotion, mobility, self-care, and sphincter control. Communication and social cognition are improved to a smaller rate [19,20].…”