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. 2020 Nov 1;72(4):382-393.
doi: 10.3138/ptc-2018-0117.

Generalizability of Results from Randomized Controlled Trials in Post-Stroke Physiotherapy

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Generalizability of Results from Randomized Controlled Trials in Post-Stroke Physiotherapy

Matteo Paci et al. Physiother Can. .

Abstract

Purpose: The randomized controlled trial (RCT) is considered a reliable experimental design, able to detect the effect of an intervention. However, a criticism frequently levelled at RCTs by clinicians is their lack of generalizability. This study aimed to evaluate the generalizability of findings from RCTs of physiotherapy interventions for individuals with stroke. Method: A sample of RCTs of physiotherapy interventions after stroke indexed in the PEDro database was selected, and the reported inclusion and exclusion criteria were analyzed. Results: We reviewed 100 articles, which included 7,366 participants (41.6% women, with a mean weighted age of 65.5 years). The most frequent criteria for exclusion were comorbidity (83%), cognitive impairments (69%), communication skills (55%), recurrent stroke (53%), low functional level (47%) and being elderly (25%). Conclusions: A variety of cohorts of individuals who have had a stroke are excluded from RCTs published in the field of physiotherapy. Because they represent a substantial proportion of the real-world population with stroke, and consequently treated in clinical practice, more vulnerable cohorts of participants should be included in RCTs.

Objectif : l’essai aléatoire et contrôlé (EAC) est considéré comme une méthodologie expérimentale fiable, en mesure de déterminer l’effet d’une intervention. Cependant, les cliniciens en critiquent souvent l’absence de généralisabilité. La présente étude visait à évaluer la généralisabilité des résultats des EAC sur des interventions de recherche en physiothérapie auprès de personnes ayant subi un accident vasculaire cérébral (AVC). Méthodologie : les auteurs ont sélectionné un échantillon d’EAC sur des interventions de physiothérapie après un AVC indexées dans la base de données PEDro. Ils ont analysé les critères d’inclusion et d’exclusion déclarés. Résultats : les auteurs ont examiné 100 articles, qui incluaient 7 366 participants (41,6 % de femmes, d’un âge moyen pondéré de 65,5 ans). Les critères d’exclusion les plus fréquents étaient la comorbidité (83 %), les déficiences cognitives (69 %), les aptitudes à la communication (55 %), les AVC récurrents (53 %), un faible niveau fonctionnel (47 %) et le fait d’être âgé (25 %). Conclusion : diverses cohortes de personnes qui ont subi un AVC sont exclues des EAC publiés en physiothérapie. Puisqu’elles représentent une forte proportion de la population de personnes qui subissent un AVC en situation réelle et qui sont ensuite traitées en pratique clinique, il faudrait inclure plus de cohortes de participants vulnérables dans les EAC.

Keywords: accident vasculaire cérébral; rehabilitation; reproducibility of results; reproductibilité des résultats; réadaptation; stroke.

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Figures

Figure 1
Figure 1
Flow chart of study selection.
Figure 2
Figure 2
Number of included trials by year of publication.
Figure 3
Figure 3
PEDro scores of included trials.

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