随机对照试验中腰痛康复干预的报告：该治疗方法是否完全可重复？

Reporting of Rehabilitation Intervention for Low Back Pain in Randomized Controlled Trials: Is the Treatment Fully Replicable?

作者信息

Gianola Silvia, Castellini Greta, Agostini Michela, Bolotta Rosa, Corbetta Davide, Frigerio Pamela, Gasparini Monica, Gozzer Paolo, Guariento Erica, Li Linda C, Pecoraro Valentina, Sirtori Valeria, Turolla Andrea, Andreano Anita, Moja Lorenzo

机构信息

*Center of Biostatistics for Clinical Epidemiology, Department of Health Science, University of Milano-Bicocca, Monza, Italy†Clinical Epidemiology Unit, I.R.C.C.S. Orthopedic Institute Galeazzi, Milan, Italy‡University of Milano, Milan, Italy§Laboratory of Kinematics and Robotics. I.R.C.C.S. Fondazione Ospedale San Camillo, Venezia, Italy¶Service of Physiotherapy, National Institute of Injury Insurance, Milan, Italy||Unit of Functional Recovery, Ospedale San Raffaele, Milan, Italy**Spinal Cord Unit, Niguarda Ca' Granda Hospital, Milan, Italy††Department of rehabilitation, Asl Biella, Italy‡‡APSS Tn, Villa Igea, Trento, Italy§§La Quiete casa di cura S.r.l, Varese, Italy¶¶Department of Physical Therapy, University of British Columbia, Vancouver, British Columbia, Canada||||Arthritis Research Centre of Canada, Vancouver, British Columbia, Canada***Department of Biomedical Sciences for Health, University of Milan, Milan, Italy.

出版信息

Spine (Phila Pa 1976). 2016 Mar;41(5):412-8. doi: 10.1097/BRS.0000000000001290.

DOI:10.1097/BRS.0000000000001290

PMID:26926164

Abstract

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.

LEVEL OF EVIDENCE

摘要

研究设计

随机对照试验（RCTs）的方法学综述。

目的

评估已发表的随机对照试验中机械性下腰痛（LBP）康复干预措施的报告质量。

背景数据总结

随机对照试验中干预措施的报告通常侧重于结果值，而未能充分描述干预措施。

方法

我们系统检索了截至2013年12月在Cochrane系统评价数据库中发表的关于下腰痛的Cochrane系统评价中的所有随机对照试验。由2名研究人员使用一份包含7项内容的特设清单，对每个随机对照试验的康复干预措施描述进行独立评估。主要结果是报告的详细程度足以在新的随机对照试验或日常实践中重复实施的项目数量。

结果

我们发现了11项关于下腰痛的系统评价，包括220项符合条件的随机对照试验。其中，纳入了185项随机对照试验。中位发表年份为1998年（第一至第三四分位数，1990年至2004年）。报告最多的项目是参与者特征（91.3%；95%置信区间[CI]，87.3 - 95.4）、干预提供者（81.1%；95%CI，75.4 - 86.7）和干预时间表（69.7%；95%CI，63 - 76）。根据干预措施的描述，临床上可重复实施的不到五分之一。提供关于参与者和干预措施所有基本信息的试验比例从1971年至1980年的14%（n = 7）增加到2001年至2010年的20%（n = 75）。