Quality of descriptions of rehabilitation interventions in low back pain: a review of published randomized controlled trials

Article type
Authors
Gianola S1, Castellini G2, Agostini M3, Bolotta R4, Corbetta D5, Frigerio P6, Gasparini M7, Gozzer P8, Guariento E9, Li LC10, Pecoraro V9, Sirtori V5, Turolla A11, Moja L12
1Center of Biostatistics for Clinical Epidemiology, Department of Health Science, University of Milano-Bicocca, Monza, Clinical Epidemiology Unit, I.R.C.C.S. Orthopedic Institute Galeazzi, Milan, Italy
2University of Milano, Milan, Italy
3 Laboratory of Kinematics and Robotics. I.R.C.C.S. Fondazione Ospedale San Camillo, Venezia, Italy
4Servizio di Fisioterapia Inail, Milano , Italy
5Unit of Functional Recovery, Fondazione Centro San Raffaele del Monte Tabor, Milan, Italy
6Spinal Cord Unit, Niguarda Ca’ Granda Hospital, Milan, Italy
7Department of rehabilitation, Asl Biella, Italy
8APSS Tn, Villa Igea, Trento, Italy
9 IRCCS Galeazzi Orthopaedic Institute, Italy
10Department of Physical Therapy, University of British Columbia, Vancouver, British Columbia, Arthritis Research Centre of Canada, Vancouver, British Columbia, Canada
11Laboratory of Kinematics and Robotics. I.R.C.C.S. Fondazione Ospedale San Camillo, Venezia, Italy
12Department of Biomedical Sciences for Health, University of Milan, Clinical Epidemiology Unit, I.R.C.C.S. Orthopedic Institute Galeazzi, Milan, Italy
Abstract
Background:
Published reports of randomized controlled trials (RCTs) often focus on the results, thereby failing to adequately describe the characteristics of the interventions studied. The findings of these reports are of little use as they cannot be replicated in real-life settings.

Objectives:
We aimed to assess the quality of descriptions provided for low back pain rehabilitation interventions in RCTs.

Methods:
We systematically searched for all RCTs considered eligible in Cochrane Systematic Rviews (SRs) published (full-text) on The Cochrane Database of Systematic Reviews in February 2013, focusing on the evaluation of rehabilitation interventions for mechanical low back pain. Two authors independently evaluated through an ad hoc checklist the quality of descriptions of rehabilitation interventions. The primary outcome was the proportion of items considered to be able to be fully replicated based on the reported information.

Results:
Across 11 SRs, 185 RCTs were included (median (IRQ) of publication year 1998 (1990 - 2004)). Less than one fifth (17,8%) of the RCTs were able to be replicated. Most RCTs (49,7 %) did not report key information, compromising the trials’ ability to be replicated; another one fifth (17,3%) of RCTs gave insufficient descriptions of interventions. Who provides and who receives the intervention were the most commonly reported items in the description of interventions (91% and 81%, respectively) while materials and procedure were less reported (48% and 43%, respectively). Over time, the reporting of intervention descriptions improved.

Conclusions:
Despite the remarkable amount of effort spent on conducting RCTs to compare the effectiveness of rehabilitation approaches for low back pain, a large proportion of trials failed to report key information to allow for the repetition of the intervention. This is likely to hinder practical application of the research findings.