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Systematic review of enriched-enrolment randomised-withdrawal trial designs in chronic pain : a new framework for design and reporting
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Moore, R., Wiffen, P. J., Eccleston, C., Derry, S., Baron, R. (Richard), Bell, R. F., Furlan, A. D. , Gilron, I. , Haroutounian, S., Katz, N. P., Lipman, A. G., Morley, S., Peloso, P. M. , Quessy, S. N., Seers, Kate, Strassels, S. A. and Straube, S. (2015) Systematic review of enriched-enrolment randomised-withdrawal trial designs in chronic pain : a new framework for design and reporting. Pain, 156 (8). pp. 1382-1395. doi:10.1097/j.pain.0000000000000088 ISSN 0304-3959.
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Official URL: http://www.ncbi.nlm.nih.gov/pubmed/25985142
Abstract
Enriched-enrolment randomised-withdrawal (EERW) pain trials select, before randomisation, patients who respond by demonstrating a predetermined degree of pain relief and acceptance of adverse events. There is uncertainty over the value of this design. We report a systematic review of EERW trials in chronic non-cancer pain together with a critical appraisal of methods and potential biases in the methods used and recommendations for the design and reporting of future EERW trials. Electronic and other searches found 25 EERW trials published between 1995 and June 2014, involving 5669 patients in a randomised withdrawal phase comparing drug to placebo; 13 (median 107 patients) had a randomised withdrawal phase of six weeks or less, and 12 (median 334) lasted 12-26 weeks. Risks of bias included short duration, inadequate outcome definition, incomplete outcome data reporting, small size, and inadequate dose tapering on randomisation to placebo. Active treatment was usually better than placebo (22/25 trials).This review reduces the uncertainty around the value of EERW trials in pain. If properly designed, conducted, and reported, they are feasible and useful for making decisions about pain therapies. Shorter, small studies can be explanatory; longer, larger studies can inform practice. Current evidence is inadequate for valid comparisons in outcome between EERW and classical trials, though no gross differences were found. This systematic review provides a framework for assessing potential biases and the value of the EERW trials, and for the design of future studies by making recommendations for the conduct and reporting of EERW trials.
| Item Type: | Journal Article | ||||
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| Subjects: | R Medicine > RM Therapeutics. Pharmacology | ||||
| Divisions: | Faculty of Science, Engineering and Medicine > Medicine > Warwick Medical School > Health Sciences Faculty of Science, Engineering and Medicine > Medicine > Warwick Medical School > Health Sciences > Warwick Research in Nursing > Royal College of Nursing Research Institute (RCN) (- July 2017) Faculty of Science, Engineering and Medicine > Medicine > Warwick Medical School |
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| Library of Congress Subject Headings (LCSH): | Analgesia , Analgesics, Placebos (Medicine), Drugs -- Side effects | ||||
| Journal or Publication Title: | Pain | ||||
| Publisher: | Elsevier BV | ||||
| ISSN: | 0304-3959 | ||||
| Official Date: | August 2015 | ||||
| Dates: |
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| Volume: | 156 | ||||
| Number: | 8 | ||||
| Page Range: | pp. 1382-1395 | ||||
| DOI: | 10.1097/j.pain.0000000000000088 | ||||
| Status: | Peer Reviewed | ||||
| Publication Status: | Published | ||||
| Access rights to Published version: | Restricted or Subscription Access |
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