Literature DB >> 32922778

Successful and unsuccessful recruitment and retainment strategies in a UK multicentre drug trial for a rare chronic pain condition which performed above target.

Jatinder Bisla1, Gareth Ambler2, Bernhard Frank3, Sumit Gulati3, Poppy Hocken4,5, Mairi James6, Joanna Kelly1, Jocelyn Keshet-Price7, Candy McCabe4,5,8, Deborah McGylnn6, Nick Padfield9, David Pang9, Gill Pout7, Mark Sanders7, Mick Serpell6, Nicholas Shenker10, Karim Shoukrey11, Samuel Wesley9, Margaret Weston11, Beverly White-Alao1, Lynne Wyatt3, Caroline Murphy1, Andreas Goebel12.   

Abstract

INTRODUCTION: Recruitment into trials in rare chronic pain conditions can be challenging, so such trials consequently are underpowered or fail.
METHODS: Drawing from our experience in conducting, to date, the largest academic trial in a rare chronic pain condition, complex regional pain syndrome, we have identified recruitment and retention strategies for successful trial conduct.
RESULTS: We present 13 strategies grouped across the categories of 'setting the recruitment rate', 'networking', 'patient information', 'trial management' and 'patient retention'. Moreover, six recruitment risks are also discussed. A conservative recruitment estimate, based on audits of newly referred patients to the trial centres without taking into account availability of 'old' patients or recruitment from outside centres, and assuming a 55% patient refusal rate yielded accurate numbers.
CONCLUSION: Appreciation of these identified recruitment challenges and opportunities may contribute to supporting prospective investigators when they design clinical trials for chronic pain patient population groups where it has been historically difficult to conduct high-quality and robust clinical trials. © The British Pain Society 2019.

Entities:  

Keywords:  Chronic pain; complex regional pain syndromes; intractable; musculoskeletal pain; pain; pain clinics; pain management; pain perception; pain threshold; postoperative

Year:  2019        PMID: 32922778      PMCID: PMC7453479          DOI: 10.1177/2049463719893399

Source DB:  PubMed          Journal:  Br J Pain        ISSN: 2049-4637


  15 in total

1.  AASAP: a program to increase recruitment and retention in clinical trials.

Authors:  Lawrence Fisher; Danielle Hessler; Diana Naranjo; William Polonsky
Journal:  Patient Educ Couns       Date:  2011-08-09

2.  Clinical trials: the challenge of recruitment and retention of participants.

Authors:  Raisa B Gul; Parveen A Ali
Journal:  J Clin Nurs       Date:  2010-01       Impact factor: 3.036

3.  Safety and efficacy of a Nav1.7 selective sodium channel blocker in patients with trigeminal neuralgia: a double-blind, placebo-controlled, randomised withdrawal phase 2a trial.

Authors:  Joanna M Zakrzewska; Joanne Palmer; Valerie Morisset; Gerard Mp Giblin; Mark Obermann; Dominik A Ettlin; Giorgio Cruccu; Lars Bendtsen; Mark Estacion; Dominique Derjean; Stephen G Waxman; Gary Layton; Kevin Gunn; Simon Tate
Journal:  Lancet Neurol       Date:  2017-02-17       Impact factor: 44.182

Review 4.  Research design considerations for confirmatory chronic pain clinical trials: IMMPACT recommendations.

Authors:  Robert H Dworkin; Dennis C Turk; Sarah Peirce-Sandner; Ralf Baron; Nicholas Bellamy; Laurie B Burke; Amy Chappell; Kevin Chartier; Charles S Cleeland; Ann Costello; Penney Cowan; Rozalina Dimitrova; Susan Ellenberg; John T Farrar; Jacqueline A French; Ian Gilron; Sharon Hertz; Alejandro R Jadad; Gary W Jay; Jarkko Kalliomäki; Nathaniel P Katz; Robert D Kerns; Donald C Manning; Michael P McDermott; Patrick J McGrath; Arvind Narayana; Linda Porter; Steve Quessy; Bob A Rappaport; Christine Rauschkolb; Bryce B Reeve; Thomas Rhodes; Cristina Sampaio; David M Simpson; Joseph W Stauffer; Gerold Stucki; Jeffrey Tobias; Richard E White; James Witter
Journal:  Pain       Date:  2010-03-06       Impact factor: 6.961

5.  Direct Health Care Cost and Work Incapacity Related to Complex Regional Pain Syndrome in Switzerland: A Retrospective Analysis from 2008 to 2015.

Authors:  Stefan Markus Scholz-Odermatt; François Luthi; Maria Monika Wertli; Florian Brunner
Journal:  Pain Med       Date:  2019-08-01       Impact factor: 3.750

6.  Health-related quality of life in chronic refractory reflex sympathetic dystrophy (complex regional pain syndrome type I).

Authors:  M A Kemler; H C de Vet
Journal:  J Pain Symptom Manage       Date:  2000-07       Impact factor: 3.612

7.  Intravenous immunoglobulin treatment of the complex regional pain syndrome: a randomized trial.

Authors:  Andreas Goebel; Andrew Baranowski; Konrad Maurer; Artemis Ghiai; Candy McCabe; Gareth Ambler
Journal:  Ann Intern Med       Date:  2010-02-02       Impact factor: 25.391

8.  Validation of proposed diagnostic criteria (the "Budapest Criteria") for Complex Regional Pain Syndrome.

Authors:  R Norman Harden; Stephen Bruehl; Roberto S G M Perez; Frank Birklein; Johan Marinus; Christian Maihofner; Timothy Lubenow; Asokumar Buvanendran; Sean Mackey; Joseph Graciosa; Mila Mogilevski; Christopher Ramsden; Melissa Chont; Jean-Jacques Vatine
Journal:  Pain       Date:  2010-05-20       Impact factor: 6.961

9.  Low-dose intravenous immunoglobulin treatment for complex regional pain syndrome (LIPS): study protocol for a randomized controlled trial.

Authors:  Andreas Goebel; Nicholas Shenker; Nick Padfield; Karim Shoukrey; Candida McCabe; Mick Serpell; Mark Sanders; Caroline Murphy; Amaka Ejibe; Holly Milligan; Joanna Kelly; Gareth Ambler
Journal:  Trials       Date:  2014-10-24       Impact factor: 2.279

10.  Challenges recruiting to a proof-of-concept pharmaceutical trial for a rare disease: the trigeminal neuralgia experience.

Authors:  Joanna M Zakrzewska; Joanne Palmer; Lars Bendtsen; Giulia Di Stefano; Dominik A Ettlin; Stine Maarbjerg; Mark Obermann; Valerie Morisset; Deb Steiner; Simon Tate; Giorgio Cruccu
Journal:  Trials       Date:  2018-12-27       Impact factor: 2.279

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  2 in total

Review 1.  Denying the Truth Does Not Change the Facts: A Systematic Analysis of Pseudoscientific Denial of Complex Regional Pain Syndrome.

Authors:  K D Bharwani; A B Kersten; A L Stone; F Birklein; S Bruehl; M Dirckx; P D Drummond; J Gierthmühlen; A Goebel; L Knudsen; F J P M Huygen
Journal:  J Pain Res       Date:  2021-10-27       Impact factor: 3.133

2.  Strategies to improve retention in randomised trials.

Authors:  Katie Gillies; Anna Kearney; Ciara Keenan; Shaun Treweek; Jemma Hudson; Valerie C Brueton; Thomas Conway; Andrew Hunter; Louise Murphy; Peter J Carr; Greta Rait; Paul Manson; Magaly Aceves-Martins
Journal:  Cochrane Database Syst Rev       Date:  2021-03-06
  2 in total

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