Evidence map›Paper›PMID 31399456›Full record

ArticleBMJ open2019

Testing a support programme for opioid reduction for people with chronic non-malignant pain: the I-WOTCH randomised controlled trial protocol.

Harbinder K Sandhu, Charles Abraham, Sharisse Alleyne, Shyam Balasubramanian, Lauren Betteley, Katie Booth, Dawn Carnes, Andrea D Furlan, Kirstie Haywood, Cynthia Paola Iglesias Urrutia and 14 more

Open access · goldAbstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in BMJ open, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 12 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
12citing papers in PubMed, 2 pooled it
2.2field-weighted citation impact, top 13% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

12 citing papers in PubMed, 2 syntheses or guidelines pooled it, 17 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Trial
  4. Trial
  5. Trial
  6. Trial
  7. Article
  8. Article
  9. Article
  10. Article
  11. Article
  12. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

24 authors at 8 institutions in 3 countries.

Harbinder K SandhuWarwick Clinical Trials Unit, Warwick Medical School, University of Warwick, Coventry, UK.
Charles AbrahamSchool of Psychological Sciences, Faculty of Medicine, Dentistry and Health Sciences, University of Melbourne, Melbourne, Australia.
Sharisse AlleyneWarwick Clinical Trials Unit, Warwick Medical School, University of Warwick, Coventry, UK.
Shyam BalasubramanianDepartment of Anaesthesia and Pain Medicine, University Hospital Coventry and Warwickshire NHS Trust, Coventry, UK.
Lauren BetteleyWarwick Clinical Trials Unit, Warwick Medical School, University of Warwick, Coventry, UK.
Katie BoothWarwick Clinical Trials Unit, Warwick Medical School, University of Warwick, Coventry, UK.
Dawn CarnesCentre for Primary Care and Public Health, Blizard Institute, Barts and The London School of Medicine and Dentistry, Queen Mary University of London, London, UK.
Andrea D FurlanToronto Rehabilitation Institute, University Health Network, Toronto, Canada.ORCID 0000-0001-6138-8510
Kirstie HaywoodDivision of Health Sciences, Warwick Medical School, University of Warwick, Coventry, UK.
Cynthia Paola Iglesias UrrutiaDepartment of Health Sciences, University of York, York, UK.
Ranjit LallWarwick Clinical Trials Unit, Warwick Medical School, University of Warwick, Coventry, UK.
Andrea MancaCentre for Health Economics, University of York, York, UK.
Dipesh MistryWarwick Clinical Trials Unit, Warwick Medical School, University of Warwick, Coventry, UK.
Vivien P NicholsWarwick Clinical Trials Unit, Warwick Medical School, University of Warwick, Coventry, UK.ORCID 0000-0002-3372-1395
Jennifer NoyesDepartment of Pain Medicine, The James Cook University Hospital, Middlesbrough, UK.
Anisur RahmanCentre for Rheumatology Research, University College London, London, UK.
Kate SeersWarwick Research in Nursing, Warwick Medical School, University of Warwick, Coventry, UK.
Jane ShawDepartment of Pain Medicine, The James Cook University Hospital, Middlesbrough, UK.
Nicole K Y TangDepartment of Psychology, University of Warwick, Coventry, UK.
Stephanie TaylorCentre for Primary Care and Public Health, Blizard Institute, Barts and The London School of Medicine and Dentistry, Queen Mary University of London, London, UK.
Colin TysallUniversity/User Teaching and Research Action Partnership, University of Warwick, Coventry, UK.
Martin UnderwoodWarwick Clinical Trials Unit, Warwick Medical School, University of Warwick, Coventry, UK.
Emma J WithersWarwick Clinical Trials Unit, Warwick Medical School, University of Warwick, Coventry, UK.
Sam EldabeDepartment of Pain Medicine, The James Cook University Hospital, Middlesbrough, UK.
University of Warwick · GBJames Cook University Hospital · GBQueen Mary University of London · GBUniversity of York · GBThe University of Melbourne · AUUniversity College London · GBUniversity Health Network · CAUniversity Hospital Coventry · GB

Funding

Department of Health HTA/14/224/04
6 · The paper itself

Abstract

introductionChronic non-malignant pain has a major impact on the well-being, mood and productivity of those affected. Opioids are increasingly prescribed to manage this type of pain, but with a risk of other disabling symptoms, when their effectiveness has been questioned. This trial is designed to implement and evaluate a patient-centred intervention targeting withdrawal of strong opioids in people with chronic pain. METHODS AND ANALYSIS: A pragmatic, multicentre, randomised controlled trial will assess the clinical and cost-effectiveness of a group-based multicomponent intervention combined with individualised clinical facilitator led support for the management of chronic non-malignant pain against the control intervention (self-help booklet and relaxation compact disc). An embedded process evaluation will examine fidelity of delivery and investigate experiences of the intervention. The two primary outcomes are activities of daily living (measured by Patient-Reported Outcomes Measurement Information System Pain Interference Short Form (8A)) and opioid use. The secondary outcomes are pain severity, quality of life, sleep quality, self-efficacy, adverse events and National Health Service (NHS) healthcare resource use. Participants are followed up at 4, 8 and 12 months, with a primary endpoint of 12 months. Between-group differences will indicate effectiveness; we are looking for a difference of 3.5 points on our pain interference outcome (scale 40 to 77). We will undertake an NHS perspective cost-effectiveness analysis using quality adjusted life years. ETHICS AND DISSEMINATION: Full approval was given by Yorkshire & The Humber - South Yorkshire Research Ethics Committee on 13 September, 2016 (16/YH/0325). Appropriate local approvals were sought for each area in which recruitment was undertaken. The current protocol version is 1.6 date 19 December 2018. Publication of results in peer- reviewed journals will inform the scientific and clinical community. We will disseminate results to patient participants and study facilitators in a study newsletter as well as a lay summary of results on the study website. TRIAL REGISTRATION NUMBER: ISRCTN49470934; Pre-results.

Indexed as

Activities of Daily LivingAnalgesics, OpioidChronic PainCost-Benefit AnalysisHealth ResourcesHumansMulticenter Studies as TopicPain ManagementPain MeasurementPatient Reported Outcome MeasuresPragmatic Clinical Trials as TopicQuality of LifeRandomized Controlled Trials as TopicResearch DesignSelf EfficacySleepAnalgesics, Opioidbehavioural interventionschronic non-malignant painopioidsprocess evaluationRCTself-managementtapering

Identifiers

PMID31399456
PMCPMC6701652
OpenAlexW2967666812

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.