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


Journal

Journal of clinical epidemiology
ISSN: 1878-5921
Titre abrégé: J Clin Epidemiol
Pays: United States
ID NLM: 8801383

Informations de publication

Date de publication:
10 2019
Historique:
received: 09 04 2019
revised: 27 05 2019
accepted: 11 06 2019
pubmed: 21 6 2019
medline: 22 5 2020
entrez: 21 6 2019
Statut: ppublish

Résumé

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). 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. 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). 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.

Identifiants

pubmed: 31220570
pii: S0895-4356(19)30315-4
doi: 10.1016/j.jclinepi.2019.06.008
pii:
doi:

Types de publication

Journal Article Research Support, Non-U.S. Gov't

Langues

eng

Sous-ensembles de citation

IM

Pagination

108-117

Investigateurs

Stijn Bogaerts (S)
Sofie Rummens (S)
An De Groef (A)
Geert Verheyden (G)
Ann Spriet (A)
Dieter Van Assche (D)
Margreet Van Dijk (M)
Bart Vrijsen (B)
Blanche Staes (B)
Griet Van Kerschaver (G)
Eline Note (E)
Elisabetta Del Zotto (E)
Luca Medici (L)
Paolo Patelli (P)
Alessandra Redolfi (A)
Anwar Suhaimi (A)
Chung Tze Yang (CT)
Aishah Ahmad Fauzi (AA)
Lee Poh Chen (LP)
Parimalaganthi Veradan (P)
Noor Shahaneem Shaikh Mazran (NS)
Saufiyah Adnan (S)
Shazia Farrukh (S)
Asma Qamar (A)
Anna Puzder (A)
Elżbieta Kowalewska (E)
Jowita Gasztych (J)
Marta Chrzanowska-Rydz (M)
Justyna Redlicka (J)
Magdalena Tomczak (M)
Katarzyna Binder (K)
William Micheo (W)
Luis Baerga (L)
Fernando Sepulveda (F)
Carmen Lopez (C)
Edwardo Ramos (E)
Luis Cotto (L)
Veronica Rodriguez (V)
Jason Chen (J)
Radha Korupolu (R)
Dharmendra Kumar (D)
Marcia Kern (M)
Erin E Edenfield (EE)

Informations de copyright

Copyright © 2019 Elsevier Inc. All rights reserved.

Auteurs

Stefano Negrini (S)

Department of Clinical and Experimental Sciences, University of Brescia, Brescia, Italy; IRCCS Fondazione Don Carlo Gnocchi, Milan, Italy.

Chiara Arienti (C)

IRCCS Fondazione Don Carlo Gnocchi, Milan, Italy.

Joel Pollet (J)

IRCCS Fondazione Don Carlo Gnocchi, Milan, Italy. Electronic address: joel.pollet.ft@gmail.com.

Julia Patrick Engkasan (JP)

Department of Rehabilitation Medicine, Faculty of Medicine, University of Malaya, Kuala Lumpur, Malaysia.

Gerard E Francisco (GE)

The Neuro-Recovery Research Center, TIRR Memorial Hermann, Houston, TX, USA.

Walter R Frontera (WR)

Department of Physical Medicine, Rehabilitation, and Sports Medicine, University of Puerto Rico School of Medicine, San Juan, Puerto Rico.

Silvia Galeri (S)

IRCCS Fondazione Don Carlo Gnocchi, Milan, Italy.

Kamila Gworys (K)

Department of PRM, Medical University of Lodz, Lodz, Poland.

Jolanta Kujawa (J)

Department of PRM, Medical University of Lodz, Lodz, Poland.

Mazlina Mazlan (M)

Department of Rehabilitation Medicine, Faculty of Medicine, University of Malaya, Kuala Lumpur, Malaysia.

Farooq A Rathore (FA)

Department of Rehabilitation Medicine, PNS Shifa Hospital, Karachi, Sindh, Pakistan.

Fabienne Schillebeeckx (F)

Physical and Rehabilitation Medicine, University Hospitals, Leuven, Belgium - Department of Development and Regeneration, KU Leuven, Leuven, Belgium.

Carlotte Kiekens (C)

Physical and Rehabilitation Medicine, University Hospitals, Leuven, Belgium - Department of Development and Regeneration, KU Leuven, Leuven, Belgium.

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