+ Site Statistics
+ Search Articles
+ PDF Full Text Service
How our service works
Request PDF Full Text
+ Follow Us
Follow on Facebook
Follow on Twitter
Follow on LinkedIn
+ Subscribe to Site Feeds
Most Shared
PDF Full Text
+ Translate
+ Recently Requested

Non-compliance with randomised allocation and missing outcome data in randomised controlled trials evaluating surgical interventions: a systematic review



Non-compliance with randomised allocation and missing outcome data in randomised controlled trials evaluating surgical interventions: a systematic review



Bmc Research Notes 8: 403



Randomised controlled trials are widely acknowledged as the gold standard in medical research although their validity can be undermined by non-compliance with the randomly allocated treatment and missing data. Due to the nature of the intervention, surgical trials face particular threat to compliance and data collection. For example, ineligibility for the intervention may only become apparent once the operation has commenced. It is unclear how such cases are reported and handled. The objective was to assess non-compliance and missing data in reports of trials of surgical interventions. Searches for reports of trials involving at least one surgical procedure and published in 2010 were carried out in the Medical Literature Analysis and Retrieval System Online (MEDLINE(®)). Data on missing data, non-compliance and methods of handling missing data were extracted from full texts. Descriptive data analyses were carried out on the data. Forty-five (55%) studies reported non-compliance with treatment allocation and 52 (63%) reported primary outcome missing data. The median levels of non-compliance and missing data were 2% [IQR (0, 5), range (0-29)] and 6% [IQR (0, 15), range (0-57)], respectively. Fifty-two (63%) studies analysed as randomised, 17 (21%) analysed per protocol and 3 (4%) analysed as treated. Complete case analysis was the most common method used to deal with missing data, 35/52 (67%). The reporting of non-compliance to allocation and the handling of missing data were typically suboptimal. There is still room for improvement on the use of the CONSORT statement particularly in accounting for study participants. Transparency in reporting would facilitate evidence synthesis.

Please choose payment method:






(PDF emailed within 0-6 h: $19.90)

Accession: 058414625

Download citation: RISBibTeXText

PMID: 26336099

DOI: 10.1186/s13104-015-1364-9


Related references

A systematic review of outcome and outcome-measure reporting in randomised trials evaluating surgical interventions for anterior-compartment vaginal prolapse: a call to action to develop a core outcome set. International Urogynecology Journal 29(12): 1727-1745, 2018

Compliance with Sport Injury Prevention Interventions in Randomised Controlled Trials: A Systematic Review. Sports Medicine 46(8): 1125-1139, 2016

The Effect of Perioperative E-Health Interventions on the Postoperative Course: A Systematic Review of Randomised and Non-Randomised Controlled Trials. Plos one 11(7): E0158612, 2016

Psychosocial interventions in perimenopausal and postmenopausal women: a systematic review of randomised and non-randomised trials and non-controlled studies. Maturitas 77(2): 93, 2014

Treatment of missing data in follow-up studies of randomised controlled trials: A systematic review of the literature. Clinical Trials 14(4): 387-395, 2017

Applicability and generalisability of published results of randomised controlled trials and non-randomised studies evaluating four orthopaedic procedures: methodological systematic review. Bmj 339: B4538, 2009

Evaluation of Quality Assessment Tools for Non-Randomised Controlled Trials Assessing Surgical Interventions: A Systematic Review of Systematic Reviews. Value in Health 18(7): A722, 2015

A systematic review of randomised controlled trials evaluating the use of patient-reported outcome measures (PROMs). Quality of Life Research 28(3): 567-592, 2019

A systematic review of randomised controlled trials in rheumatoid arthritis: the reporting and handling of missing data in composite outcomes. Trials 17(1): 272, 2016

Systematic review of randomised controlled trials of interventions for painful shoulder: selection criteria, outcome assessment, and efficacy. BMJ 316(7128): 354-360, 1998

Outcome reporting across randomised controlled trials evaluating therapeutic interventions for pre-eclampsia. Bjog 124(12): 1829-1839, 2017

Evaluation of interventions for informed consent for randomised controlled trials (ELICIT): protocol for a systematic review of the literature and identification of a core outcome set using a Delphi survey. Trials 16: 484, 2015

Long term maintenance of weight loss with non-surgical interventions in obese adults: systematic review and meta-analyses of randomised controlled trials. Bmj 348: G2646, 2014

Choice of primary outcomes in randomised trials and systematic reviews evaluating interventions for preterm birth prevention: a systematic review. Bjog 121(10): 1188-94; Discussion 1195-6, 2014

Statistical analysis of patient-reported outcome data in randomised controlled trials of locally advanced and metastatic breast cancer: a systematic review. Lancet. Oncology 19(9): E459-E469, 2018