Clinical replicability of rehabilitation interventions in randomized controlled trials reported in main journals is inadequate

Negrini, Stefano and Arienti, Chiara and Pollet, Joel and Engkasan, Julia Patrick and Francisco, Gerard E. and Frontera, Walter R. and Galeri, Silvia and Gworys, Kamila and Kujawa, Jolanta and Mazlan, Mazlina and Rathore, Farooq A. and Schillebeeckx, Fabienne and Kiekens, Carlotte and Bogaerts, Stijn and Rummens, Sofie and De Groef, An and Verheyden, Geert and Spriet, Ann and Van Assche, Dieter and Van Dijk, Margreet and Vrijsen, Bart and Staes, Blanche and Van Kerschaver, Griet and Note, Eline and Del Zotto, Elisabetta and Medici, Luca and Patelli, Paolo and Redolfi, Alessandra and Suhaimi, Anwar and Chung, Tze Yang and Fauzi, Aishah Ahmad and Lee, Poh Chen and Veradan, Parimalaganthi and Shaikh Mazran, Noor Shahaneem and Adnan, Saufiyah and Farrukh, Shazia and Qamar, Asma and Puzder, Anna and Kowalewska, Elżbieta and Gasztych, Jowita and Chrzanowska-Rydz, Marta and Redlicka, Justyna and Tomczak, Magdalena and Binder, Katarzyna and Micheo, William and Baerga, Luis and Sepulveda, Fernando and Lopez, Carmen and Ramos, Edwardo and Cotto, Luis and Rodriguez, Veronica and Chen, Jason and Korupolu, Radha and Kumar, Dharmendra and Kern, Marcia and Edenfield, Erin E. (2019) Clinical replicability of rehabilitation interventions in randomized controlled trials reported in main journals is inadequate. Journal of Clinical Epidemiology, 114. pp. 108-117. ISSN 0895-4356, DOI

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Objective: The objective of this study was to study if randomized controlled trials (RCTs) in rehabilitation (a field where complex interventions prevail) published in main journals include all the details needed to replicate the intervention in clinical practice (clinical replicability). Study Design and Setting: Forty-seven rehabilitation clinicians of 5 professions from 7 teams (Belgium, Italy, Malaysia, Pakistan, Poland, Puerto Rico, the USA) reviewed 76 RCTs published by main rehabilitation journals exploring 14 domains chosen through consensus and piloting. Results: The response rate was 99%. Inter-rater agreement was moderate/good. All clinicians considered unanimously 12 (16%) RCTs clinically replicable and none not replicable. At least one “absent” information was found by all participants in 60 RCTs (79%), and by a minimum of 85% in the remaining 16 (21%). Information considered to be less well described (8–19% “perfect” information) included two providers (skills, experience) and two delivery (cautions, relationships) items. The best described (50–79% “perfect”) were the classic methodological items included in CONSORT (descending order: participants, materials, procedures, setting, and intervention). Conclusion: Clinical replicability must be considered in RCTs reporting, particularly for complex interventions. Classical methodological checklists such as CONSORT are not enough, and also Template for Intervention Description and Clinical replication do not cover all the requirements. This study supports the need for field-specific checklists. © 2019 Elsevier Inc.

Item Type: Article
Uncontrolled Keywords: RCTs; Applicability; Complex interventions; Rehabilitation
Subjects: R Medicine
Divisions: Faculty of Medicine
Depositing User: Ms. Juhaida Abd Rahim
Date Deposited: 20 Feb 2020 02:44
Last Modified: 20 Feb 2020 02:44

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