TY - JOUR
T1 - Reporting of rehabilitation intervention for low back pain in randomized controlled trials
T2 - Is the treatment fully replicable?
AU - Gianola, Silvia
AU - Castellini, Greta
AU - Agostini, Michela
AU - Bolotta, Rosa
AU - Corbetta, Davide
AU - Frigerio, Pamela
AU - Gasparini, Monica
AU - Gozzer, Paolo
AU - Guariento, Erica
AU - Li, Linda C.
AU - Pecoraro, Valentina
AU - Sirtori, Valeria
AU - Turolla, Andrea
AU - Andreano, Anita
AU - Moja, Lorenzo
PY - 2016/3/1
Y1 - 2016/3/1
N2 - Study Design. Methodological review of randomized controlled trials (RCTs). Objective. To assess the quality of reporting of rehabilitation interventions for mechanical low back pain (LBP) in published RCTs. Summary of Background Data. Reporting of interventions in RCTs often focused on the outcome value and failed to describe interventions adequately. Methods. We systematically searched for all RCTs in Cochrane systematic reviews on LBP published in the Cochrane Database of Systematic Reviews until December 2013. The description of rehabilitation interventions of each RCT was evaluated independently by 2 of the investigators, using an ad hoc checklist of 7 items. The primary outcome was the number of items reported in sufficient details to be replicable in a new RCT or in everyday practice. Results. We found 11 systematic reviews, including 220 eligible RCTs, on LBP. Of those, 185 RCTs were included. The median publication year was 1998 (I-III quartiles, 1990 to 2004). The most reported items were the characteristics of participants (91.3%; 95% confidence interval [CI], 87.3-95.4), the intervention providers (81.1%; 95% CI, 75.4-86.7), and the intervention schedule (69.7%; 95% CI, 63-76). Based on the description of the intervention, less than one fifth would be replicable clinically. The proportion of trials providing all essential information about the participants and interventions increased from 14% (n=7) in 1971 to 1980 to 20% (n=75) in 2001 to 2010. Conclusion. Despite the remarkable amount of energy spent producing RCTs in LBP rehabilitation, the majority of RCTs failed to report sufficient information that would allow the intervention to be replicated in clinical practice. Improving the quality of intervention description is urgently needed to better transfer research into rehabilitation practices.
AB - Study Design. Methodological review of randomized controlled trials (RCTs). Objective. To assess the quality of reporting of rehabilitation interventions for mechanical low back pain (LBP) in published RCTs. Summary of Background Data. Reporting of interventions in RCTs often focused on the outcome value and failed to describe interventions adequately. Methods. We systematically searched for all RCTs in Cochrane systematic reviews on LBP published in the Cochrane Database of Systematic Reviews until December 2013. The description of rehabilitation interventions of each RCT was evaluated independently by 2 of the investigators, using an ad hoc checklist of 7 items. The primary outcome was the number of items reported in sufficient details to be replicable in a new RCT or in everyday practice. Results. We found 11 systematic reviews, including 220 eligible RCTs, on LBP. Of those, 185 RCTs were included. The median publication year was 1998 (I-III quartiles, 1990 to 2004). The most reported items were the characteristics of participants (91.3%; 95% confidence interval [CI], 87.3-95.4), the intervention providers (81.1%; 95% CI, 75.4-86.7), and the intervention schedule (69.7%; 95% CI, 63-76). Based on the description of the intervention, less than one fifth would be replicable clinically. The proportion of trials providing all essential information about the participants and interventions increased from 14% (n=7) in 1971 to 1980 to 20% (n=75) in 2001 to 2010. Conclusion. Despite the remarkable amount of energy spent producing RCTs in LBP rehabilitation, the majority of RCTs failed to report sufficient information that would allow the intervention to be replicated in clinical practice. Improving the quality of intervention description is urgently needed to better transfer research into rehabilitation practices.
KW - data reporting
KW - decision making
KW - epidemiologic methods
KW - evidence-based practice
KW - healthcare providers
KW - intervention studies
KW - low back pain
KW - randomized controlled trials
KW - rehabilitation
KW - reproducibility of results
KW - systematic review
KW - therapeutics
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U2 - 10.1097/BRS.0000000000001290
DO - 10.1097/BRS.0000000000001290
M3 - Article
AN - SCOPUS:84958582068
VL - 41
SP - 412
EP - 418
JO - Spine
JF - Spine
SN - 0362-2436
IS - 5
ER -