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 language | English |
|---|---|
| Pages (from-to) | 108-117 |
| Number of pages | 10 |
| Journal | Journal of Clinical Epidemiology |
| Volume | 114 |
| DOIs | |
| Publication status | Published - Oct 1 2019 |
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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 journal › Article
}
TY - JOUR
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
UR - http://www.scopus.com/inward/record.url?scp=85068928719&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85068928719&partnerID=8YFLogxK
U2 - 10.1016/j.jclinepi.2019.06.008
DO - 10.1016/j.jclinepi.2019.06.008
M3 - Article
C2 - 31220570
AN - SCOPUS:85068928719
VL - 114
SP - 108
EP - 117
JO - Journal of Clinical Epidemiology
JF - Journal of Clinical Epidemiology
SN - 0895-4356
ER -