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

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 rehabilit...

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Published in:	Journal of clinical epidemiology Vol. 114; pp. 108 - 117
Main Authors:	Negrini, Stefano, Arienti, Chiara, Pollet, Joel, Engkasan, Julia Patrick, Francisco, Gerard E., Frontera, Walter R., Galeri, Silvia, Gworys, Kamila, Kujawa, Jolanta, Mazlan, Mazlina, Rathore, Farooq A., Schillebeeckx, Fabienne, Kiekens, Carlotte, Bogaerts, Stijn, Rummens, Sofie, De Groef, An, Verheyden, Geert, Spriet, Ann, Van Assche, Dieter, Van Dijk, Margreet, Vrijsen, Bart, Staes, Blanche, Van Kerschaver, Griet, Note, Eline, Del Zotto, Elisabetta, Medici, Luca, Patelli, Paolo, Redolfi, Alessandra, Suhaimi, Anwar, Yang, Chung Tze, Fauzi, Aishah Ahmad, Chen, Lee Poh, Veradan, Parimalaganthi, Shaikh Mazran, Noor Shahaneem, Adnan, Saufiyah, Farrukh, Shazia, Qamar, Asma, Puzder, Anna, Kowalewska, Elżbieta, Gasztych, Jowita, Chrzanowska-Rydz, Marta, Redlicka, Justyna, Tomczak, Magdalena, Binder, Katarzyna, Micheo, William, Baerga, Luis, Sepulveda, Fernando, Lopez, Carmen, Ramos, Edwardo, Cotto, Luis, Rodriguez, Veronica, Chen, Jason, Korupolu, Radha, Kumar, Dharmendra, Kern, Marcia, Edenfield, Erin E.
Format:	Journal Article
Language:	English
Published:	United States Elsevier Inc 01-10-2019 Elsevier Limited
Subjects:	Applicability Check lists Checklist Clinical medicine Clinical trials Complex interventions Domains Epidemiology Humans Hypotheses Intervention Observer Variation Periodicals as Topic - statistics & numerical data Questionnaires Randomization Randomized Controlled Trials as Topic - statistics & numerical data RCTs Rehabilitation Rehabilitation - methods Rehabilitation - statistics & numerical data Reproducibility of Results Research Report - standards Studies Teams Puerto Rico Pakistan Belgium United States > US Poland Italy Malaysia Applicability Rehabilitation RCTs Complex interventions
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Summary:	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.
Bibliography:	ObjectType-Article-1 SourceType-Scholarly Journals-1 ObjectType-Feature-2 content type line 23
ISSN:	0895-4356 1878-5921
DOI:	10.1016/j.jclinepi.2019.06.008