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

REREP study participants

Research output: Contribution to journalArticle

3 Citations (Scopus)

Abstract

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.

Original languageEnglish
Pages (from-to)108-117
Number of pages10
JournalJournal of Clinical Epidemiology
Volume114
DOIs
Publication statusPublished - Oct 1 2019

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Rehabilitation
Randomized Controlled Trials
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Puerto Rico
Belgium
Malaysia
Pakistan
Poland
Italy

Keywords

  • Applicability
  • Complex interventions
  • RCTs
  • Rehabilitation

ASJC Scopus subject areas

  • Epidemiology

Cite this

Clinical replicability of rehabilitation interventions in randomized controlled trials reported in main journals is inadequate. / REREP study participants.

In: Journal of Clinical Epidemiology, Vol. 114, 01.10.2019, p. 108-117.

Research output: Contribution to journalArticle

@article{96519ef237c048c5baa4e02b42d746ac,
title = "Clinical replicability of rehabilitation interventions in randomized controlled trials reported in main journals is inadequate",
abstract = "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.",
keywords = "Applicability, Complex interventions, RCTs, Rehabilitation",
author = "{REREP study participants} and Stefano Negrini and Chiara Arienti and Joel Pollet and Engkasan, {Julia Patrick} and Francisco, {Gerard E.} and Frontera, {Walter R.} and Silvia Galeri and Kamila Gworys and Jolanta Kujawa and Mazlina Mazlan and Rathore, {Farooq A.} and Fabienne Schillebeeckx and Carlotte Kiekens and Stijn Bogaerts and Sofie Rummens and {De Groef}, An and Geert Verheyden and Ann Spriet and {Van Assche}, Dieter and {Van Dijk}, Margreet and Bart Vrijsen and Blanche Staes and {Van Kerschaver}, Griet and Eline Note and {Del Zotto}, Elisabetta and Luca Medici and Paolo Patelli and Alessandra Redolfi and Anwar Suhaimi and Yang, {Chung Tze} and Fauzi, {Aishah Ahmad} and Chen, {Lee Poh} and Parimalaganthi Veradan and {Shaikh Mazran}, {Noor Shahaneem} and Saufiyah Adnan and Shazia Farrukh and Asma Qamar and Anna Puzder and Elżbieta Kowalewska and Jowita Gasztych and Marta Chrzanowska-Rydz and Justyna Redlicka and Magdalena Tomczak and Katarzyna Binder and William Micheo and Luis Baerga and Fernando Sepulveda and Carmen Lopez and Edwardo Ramos and Luis Cotto",
year = "2019",
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journal = "Journal of Clinical Epidemiology",
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T1 - Clinical replicability of rehabilitation interventions in randomized controlled trials reported in main journals is inadequate

AU - REREP study participants

AU - Negrini, Stefano

AU - Arienti, Chiara

AU - Pollet, Joel

AU - Engkasan, Julia Patrick

AU - Francisco, Gerard E.

AU - Frontera, Walter R.

AU - Galeri, Silvia

AU - Gworys, Kamila

AU - Kujawa, Jolanta

AU - Mazlan, Mazlina

AU - Rathore, Farooq A.

AU - Schillebeeckx, Fabienne

AU - Kiekens, Carlotte

AU - Bogaerts, Stijn

AU - Rummens, Sofie

AU - De Groef, An

AU - Verheyden, Geert

AU - Spriet, Ann

AU - Van Assche, Dieter

AU - Van Dijk, Margreet

AU - Vrijsen, Bart

AU - Staes, Blanche

AU - Van Kerschaver, Griet

AU - Note, Eline

AU - Del Zotto, Elisabetta

AU - Medici, Luca

AU - Patelli, Paolo

AU - Redolfi, Alessandra

AU - Suhaimi, Anwar

AU - Yang, Chung Tze

AU - Fauzi, Aishah Ahmad

AU - Chen, Lee Poh

AU - Veradan, Parimalaganthi

AU - Shaikh Mazran, Noor Shahaneem

AU - Adnan, Saufiyah

AU - Farrukh, Shazia

AU - Qamar, Asma

AU - Puzder, Anna

AU - Kowalewska, Elżbieta

AU - Gasztych, Jowita

AU - Chrzanowska-Rydz, Marta

AU - Redlicka, Justyna

AU - Tomczak, Magdalena

AU - Binder, Katarzyna

AU - Micheo, William

AU - Baerga, Luis

AU - Sepulveda, Fernando

AU - Lopez, Carmen

AU - Ramos, Edwardo

AU - Cotto, Luis

PY - 2019/10/1

Y1 - 2019/10/1

N2 - 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.

AB - 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.

KW - Applicability

KW - Complex interventions

KW - RCTs

KW - Rehabilitation

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U2 - 10.1016/j.jclinepi.2019.06.008

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JO - Journal of Clinical Epidemiology

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