DOCSLIB.ORG

The James Lind Alliance Guidebook

Total Page：16

File Type：pdf, Size：1020Kb

Download full-text PDF Read full-text
The James Lind Alliance Guidebook The James Lind Alliance Guidebook Version 5 Written by Katherine Cowan and Sandy Oliver www.JLAguidebook.org 0 Version 5 © James Lind Alliance (2013) Welcome to the James Lind Alliance Guidebook. The Guidebook provides step-by-step guidance to establishing Priority Setting Partnerships. These bring patients, their carers and clinicians together to identify and prioritise treatment uncertainties for research, using James Lind Alliance (JLA) methods. This is the printable version of the Guidebook. The Guidebook, along with its links and downloadable documents, is also available online at www.JLAguidebook.org. Contents Section 1: INTRODUCTION ...................................................................................................................................................... 4 About the Guidebook .......................................................................................................................................................... 4 Introduction .................................................................................................................................................................... 4 Who is the Guidebook aimed at? ................................................................................................................................... 5 Using the Guidebook ....................................................................................................................................................... 5 The James Lind Alliance .................................................................................................................................................. 6 Acknowledgements ......................................................................................................................................................... 7 Contact and feedback ..................................................................................................................................................... 7 About treatment uncertainties ........................................................................................................................................... 7 What are treatment uncertainties? ................................................................................................................................ 8 The UK Database of Uncertainties about the Effects of Treatments (UK DUETs) .......................................................... 8 Section 2: HOW TO ................................................................................................................................................................. 9 How to establish a priority setting partnership .................................................................................................................. 9 Overview of Priority Setting Partnerships ....................................................................................................................... 9 Who’s who in the Priority Setting Partnership? ....................................................................................................... 11 Setting up the steering group ....................................................................................................................................... 11 What does the steering group commit to? ............................................................................................................... 12 1 Version 5 © James Lind Alliance (2013) Planning to work with UK DUETs .............................................................................................................................. 12 Identifying partners....................................................................................................................................................... 13 Initial awareness meeting ......................................................................................................................................... 14 Affiliation ................................................................................................................................................................... 16 Declaration of interests ............................................................................................................................................. 16 Exclusions .................................................................................................................................................................. 16 Managing the partnership ............................................................................................................................................ 17 Managing values and perspectives ........................................................................................................................... 17 Working with patients ............................................................................................................................................... 18 Working with clinicians ............................................................................................................................................. 19 Maintaining involvement and commitment ............................................................................................................. 20 How to identify treatment uncertainties .......................................................................................................................... 21 Treatment uncertainties and the JLA process .............................................................................................................. 21 Gathering treatment uncertainties ............................................................................................................................... 21 Patient-identified uncertainties ................................................................................................................................ 23 Clinician-identified uncertainties .............................................................................................................................. 24 Existing literature ...................................................................................................................................................... 24 Consent ......................................................................................................................................................................... 25 Processing submitted uncertainties .............................................................................................................................. 25 Download the survey data ........................................................................................................................................ 26 Remove out-of-scope submissions ........................................................................................................................... 27 Categorise eligible submissions ................................................................................................................................ 27 Format the submissions ............................................................................................................................................ 28 Verify the uncertainties ............................................................................................................................................ 30 Prepare the long-list of uncertainties ....................................................................................................................... 34 Preparing uncertainties for import into UK DUETs ....................................................................................................... 35 How to prioritise uncertainties ......................................................................................................................................... 37 The principles of JLA priority setting ............................................................................................................................. 38 Interim priority setting .................................................................................................................................................. 38 Collating interim priorities ........................................................................................................................................ 39 Final priority setting ...................................................................................................................................................... 41 Description of a final priority setting workshop ....................................................................................................... 43 2 Version 5 © James Lind Alliance (2013) Final priority setting methods ................................................................................................................................... 46 Skills for setting research priorities ........................................................................................................................... 50 Transparency and fairness ............................................................................................................................................ 51 How to evaluate ................................................................................................................................................................ 51 Why evaluate?
Load more

Recommended publications
  • Final Roadmap: March 2015 2
    Final Roadmap: March 2015 2 Photo: ©Fotolia Grant agreement no. 282586 ROAMER: A roadmap for mental health research in Europe Coordination and Support Action Objective THEME [HEALTH.2011.3.3-4] Roadmap for Mental Health and Well-being Research in Europe Deliverable reference number and title: D11.4 Due date of deliverable: month 42 Actual submission date: 27/05/2015 Start date of project: October the 1st 2011 Duration: 42 months 2UJDQLVDWLRQQDPHRIOHDGEHQH¿FLDU\IRUWKLVGHOLYHUDEOH KCL - IOPPN / UNIMAN AUTHORS Prof. Til Wykes / Dr. Stefano Belli / Prof. Shôn Lewis (WP11) CIBERSAM-PSSJD Dr. Josep Maria Haro, Dr. Carla Obradors Tarragó (COORD) APPROVAL KCL - IOPPN / UNIMAN WORK-PACKAGE LEADER Prof. Til Wykes (WP11) CIBERSAM-PSSJD PROJECT COORDINATOR Dr. Josep Maria Haro (COORD) AUTHORISATION EUROPEAN PROJECT OFFICER Barbara Kerstiens COMMISSION Project co-funded by the European Commission within the Seventh Framework Programme (2007-2013) Dissemination Level(Please choose) PU Public X PP Restricted to other programme participants (including the Commission Services) RE 5HVWULFWHGWRDJURXSVSHFL¿HGE\WKHFRQVRUWLXP LQFOXGLQJWKH&RPPLVVLRQ6HUYLFHV CO &RQ¿GHQWLDORQO\IRUPHPEHUVRIWKHFRQVRUWLXP LQFOXGLQJWKH&RPPLVVLRQ6HUYLFHV Contents Contents ................................................................... 4 Partners.................................................................... 6 Executive Summary ......................................................... 8 1.Introduction ............................................................. 11 Structure
    [Show full text]
  • Hong Kong Principles
    1 The Hong Kong Principles for Assessing Researchers: 2 Fostering Research Integrity 3 4 David Moher1,2, Lex Bouter3,4, Sabine Kleinert5, Paul Glasziou6, Mai Har Sham7 5 Virginia Barbour8, Anne-Marie Coriat9, Nicole Foeger10, Ulrich Dirnagl11 6 7 1Centre for Journalology, Clinical Epidemiology Program, Ottawa Hospital Research Institute; 2School of 8 Epidemiology and Public Health, University of Ottawa, Ottawa, Canada; 3Department of Epidemiology 9 and Biostatistics, Amsterdam University Medical Centers, location VUmc; 4Department of Philosophy, 10 Faculty of Humanities, Vrije Universiteit, Amsterdam, The Netherlands; 5The Lancet, London Wall Office, 11 London, UK; 6Institute for Evidence-Based healthcare, Bond University, Gold Coast, Qld, Australia; and 12 7School of Biomedical Sciences, LKS Faculty of Medicine, The University of Hong Kong, Pokfulam, Hong 13 Kong SAR, China; 8Queensland University of Technology (QUT), Brisbane, Australia; 9Wellcome Trust, 14 London; 10Austrian Agency for Research Integrity, Vienna, Austria; 11Berlin Institute of Health, QUEST 15 Center for Transforming Biomedical Research, Berlin, Germany 16 17 David Moher: ORCID 0000-0003-2434-4206 18 Lex Bouter: ORCID 0000-0002-2659-5482 19 Sabine Kleinert: ORCID 0000-0001-7826-1188 20 Paul Glasziou: ORCID 0000-0001-7564-073X 21 Mai Har Sham: ORCID 0000-0003-1179-7839 22 Virginia Barbour: ORCID: 0000-0002-2358-2440 23 Anne-Marie Coriat: ORCID 0000-0003-2632-1745 24 Nicole Foeger: ORCID 0000-0001-7775-7325 25 Ulrich Dirnagl: ORCID 0000-0003-0755-6119 26 27 28 23rd November 2019 29 Abstract 30 31 The primary goal of research is to advance knowledge. For that knowledge to benefit research and 32 society, it must be trustworthy.
    [Show full text]
  • Randomised Trials in Context: Practical Problems and Social Aspects of Evidence-Based Medicine and Policy Warren Pearce1*, Sujatha Raman1 and Andrew Turner2
    Pearce et al. Trials (2015) 16:394 DOI 10.1186/s13063-015-0917-5 TRIALS REVIEW Open Access Randomised trials in context: practical problems and social aspects of evidence-based medicine and policy Warren Pearce1*, Sujatha Raman1 and Andrew Turner2 Abstract Randomised trials can provide excellent evidence of treatment benefit in medicine. Over the last 50 years, they have been cemented in the regulatory requirements for the approval of new treatments. Randomised trials make up a large and seemingly high-quality proportion of the medical evidence-base. However, it has also been acknowledged that a distorted evidence-base places a severe limitation on the practice of evidence-based medicine (EBM). We describe four important ways in which the evidence from randomised trials is limited or partial: the problem of applying results, the problem of bias in the conduct of randomised trials, the problem of conducting the wrong trials and the problem of conducting the right trials the wrong way. These problems are not intrinsic to the method of randomised trials or the EBM philosophy of evidence; nevertheless, they are genuine problems that undermine the evidence that randomised trials provide for decision-making and therefore undermine EBM in practice. Finally, we discuss the social dimensions of these problems and how they highlight the indispensable role of judgement when generating and using evidence for medicine. This is the paradox of randomised trial evidence: the trials open up expert judgment to scrutiny, but this scrutiny in turn requires further expertise. Background expertise to interpret and integrate research evidence Randomised trials can provide excellent evidence of with patient values is always contingent on social and treatment benefit in medicine.
    [Show full text]
  • 2012 January
    Affiliates Newsletter –January 2012 MESSAGE FROM THE CHAIR Dear colleague, Welcome to the first newsletter of 2012 – and a happy New Year to all our readers. 2012 is a watershed for us at the JLA: it will be the last full year of the JLA’s first phase of development. Over the past 18 months we have been planning for an important transition. During the 6 years of NIHR and MRC funding support received through the James Lind Initiative, we needed to show that the JLA concept held water and appeals to patients, carers and clinicians, and at least some elements of the medical research community. Due in no small part to the enthusiasm and overt support of you, our Affiliates, we have reached this stage, and, from March 2013, the JLA name and process will be taken over by our colleagues at the NIHR Evaluation, Trials and Studies Coordinating Centre (NETSCC) in Southampton. We are working on the detail for this migration now – but you can be certain that the key elements of what JLA offers will be maintained, and actually enhanced for broader application. Indeed, JLA’s new home could not be more logical, given that so many of the top ten uncertainties generated by JLA Priority Setting Partnerships end up with the Health Technology Assessment (HTA) programme (which falls within NETSCC), Over coming months we will keep you posted on developments. But rest assured that, in the meantime, our efforts with individual PSPs and our work to promote the importance of patient, carer and clinician involvement in research priority setting will continue unabated.
    [Show full text]
  • More Than a Top 10 Report
    More than a Top 10: How James Lind Alliance Priority Setting Partnerships transform research, people and organisations Kristina Staley, TwoCan Associates & Sally Crowe, Crowe Associates September 2019 About this project This project was funded by the National Institute for Health Research Biomedical Research Centre, Oxford grant BRC-1215-20008 to the Oxford University Hospitals NHS Foundation Trust and the University of Oxford. The views expressed are those of the authors and not necessarily those of the NIHR or the Department of Health and Social Care. About TwoCan Associates TwoCan Associates was established in 2004 and specialises in promoting and supporting patient and public involvement in health and social care research. TwoCan works with NHS and voluntary organisations to help clarify the purpose of involvement, to improve policy and practice, and develop meaningful and effective partnerships. The Director, Dr Kristina Staley, was joint lead on this project. Kristina has worked as an Information Specialist on several JLA PSPs and is familiar with the issues that arise in developing researchable questions from the Top 10’s. She carried out an early scoping study in 2008 for the JLA, to explore how public sector research funders make use of research priorities and the potential challenges they face. Further information available at: www.twocanassociates.co.uk About Crowe Associates Crowe Associates, established 20 years ago has a strong record of facilitation, consultation and project management in health and social care organisations and especially in patient and public involvement. Sally Crowe, the joint lead on this project, has partnered with NIHR, INVOLVE, research networks and many voluntary organisations over the years on aspects of public involvement in research.
    [Show full text]
  • Improving Translation by Identifying Evidence for More Human-Relevant Preclinical Strategies
    animals Conference Report Improving Translation by Identifying Evidence for More Human-Relevant Preclinical Strategies Merel Ritskes-Hoitinga 1,* , Cathalijn Leenaars 2,3 , Wouter Beumer 4, Tineke Coenen-de Roo 5, Frans Stafleu 6 and Franck L. B. Meijboom 2,6 1 SYRCLE, Department for Health Evidence (section HTA), Radboud Institute for Health Sciences, Radboud University Medical Centre, 6500 HB Nijmegen, The Netherlands 2 Unit Animals in Science and Society, Department of Population Health Sciences, Faculty of Veterinary Medicine, Utrecht University, 3508 TD Utrecht, The Netherlands; [email protected] (C.L.); [email protected] (F.L.B.M.) 3 Institute for Laboratory Animal Science, Hannover Medical School, 30625 Hannover, Germany 4 ProQR Therapeutics NV, 2333 CK Leiden, The Netherlands; [email protected] 5 Central Animal Facility, Leiden University Medical Centre, 2300 RC Leiden, The Netherlands; [email protected] 6 Ethics Institute, Faculty of Humanities, Utrecht University, 3508 TC Utrecht, The Netherlands; F.R.Stafl[email protected] * Correspondence: [email protected]; Tel.: +31-243-610-389 Received: 15 May 2020; Accepted: 8 July 2020; Published: 10 July 2020 Simple Summary: To develop new medical treatments, animal studies are used. However, there are questions and concerns about the usefulness of preclinical animal research. These so-called translational success rates vary between 0 and 100% and no clear relationship has been established with possible predictive factors such as animal species or field of research. This paper presents the main results of a conference that was organised in November 2019 as part of a research project that focuses on ways to improve predictability of translation from preclinical research to clinical studies.
    [Show full text]
  • Stakeholder Engagement in the MOSS Network 2020 Written by Roses Parker NIHR Network Support Fellow
    Version 1.0 March 2021 Stakeholder engagement in the MOSS Network 2020 Written by Roses Parker NIHR Network Support Fellow Stakeholder Engagement in the MOSS Network 2 Contents 1 Introduction 4 2 Stakeholder engagement in the MOSS Network 6 2.1 Back and Neck Group and Musculoskeletal Group 6 2.1.1 Observations of stakeholder engagement 6 2.1.2 Stakeholder engagement activities 6 2.2 Ear, Nose, and Throat Group 9 2.2.1 Observations of stakeholder engagement 9 2.2.2 Stakeholder engagement activities 10 2.3 Eyes and Vision Group 12 2.3.1 Observations of stakeholder engagement 12 2.3.2 Stakeholder engagement activities 12 2.4 Oral Health Group 15 2.4.1 Observations of stakeholder engagement 15 2.4.2 Stakeholder engagement activities 15 2.5 Pain, Palliative, and Supportive Care Group 16 2.5.1 Observations of stakeholder engagement 16 2.5.2 Stakeholder engagement activities 17 2.6 Skin Group 19 2.6.1 Observations of stakeholder engagement 19 2.6.2 Stakeholder engagement activities 19 2.7 Wounds Group 21 2.7.1 Observations of stakeholder engagement 21 2.7.2 Stakeholder engagement activities 22 3 Summary and themes 24 3.1 Benefits of stakeholder engagement 24 3.2 Capacity 24 3.2.1 Stakeholder engagement requires time 24 3.2.2 Stakeholder engagement requires knowledge 25 3.2.3 Stakeholder engagement requires funding 25 Stakeholder Engagement in the MOSS Network 3 3.3 Global reach 25 3.4 Authors as stakeholders 26 4 Conclusion 27 5 Appendix 28 5.1 Interview schedule 28 5.2 References 30 Stakeholder Engagement in the MOSS Network 4 1 Introduction Cochrane’s vision is “a world of improved health where decisions about health and health care are informed by high-quality, relevant and up-to-date synthesized research evidence”, its mission is “to promote evidence-informed health decision- making by producing high-quality, relevant, accessible systematic reviews and other synthesized research evidence”.
    [Show full text]
  • Wounds Research for Patient Benefit: a 5-Year Programme of Research
    PROGRAMME GRANTS FOR APPLIED RESEARCH VOLUME 4 ISSUE 13 AUGUST 2016 ISSN 2050-4322 Wounds research for patient benefit: a 5-year programme of research Nicky Cullum, Hannah Buckley, Jo Dumville, Jill Hall, Karen Lamb, Mary Madden, Richard Morley, Susan O’Meara, Pedro Saramago Goncalves, Marta Soares and Nikki Stubbs DOI 10.3310/pgfar04130 Wounds research for patient benefit: a 5-year programme of research Nicky Cullum,1* Hannah Buckley,2 Jo Dumville,1 Jill Hall,2 Karen Lamb,3 Mary Madden,2 Richard Morley,2 Susan O’Meara,2 Pedro Saramago Goncalves,4 Marta Soares4 and Nikki Stubbs3 1School of Nursing, Midwifery and Social Work, University of Manchester, Manchester, UK 2Department of Health Sciences, University of York, York, UK 3Leeds Community Healthcare NHS Trust, Leeds, UK 4Centre for Health Economics, University of York, York, UK *Corresponding author Declared competing interests of authors: none Published August 2016 DOI: 10.3310/pgfar04130 This report should be referenced as follows: Cullum N, Buckley H, Dumville J, Hall J, Lamb K, Madden M, et al. Wounds research for patient benefit: a 5-year programme of research. Programme Grants Appl Res 2016;4(13). Programme Grants for Applied Research ISSN 2050-4322 (Print) ISSN 2050-4330 (Online) This journal is a member of and subscribes to the principles of the Committee on Publication Ethics (COPE) (www.publicationethics.org/). Editorial contact: [email protected] The full PGfAR archive is freely available to view online at www.journalslibrary.nihr.ac.uk/pgfar. Print-on-demand copies can be purchased from the report pages of the NIHR Journals Library website: www.journalslibrary.nihr.ac.uk Criteria for inclusion in the Programme Grants for Applied Research journal Reports are published in Programme Grants for Applied Research (PGfAR) if (1) they have resulted from work for the PGfAR programme, and (2) they are of a sufficiently high scientific quality as assessed by the reviewers and editors.
    [Show full text]
  • Teenage and Young Adult Cancer: Research Priorities Research Priorities for Teenage and Young Adult Cancer
    Final report of the James Lind Alliance Priority Setting Partnership Teenage and Young Adult Cancer: research priorities Research Priorities for Teenage and Young Adult Cancer Final report of the James Lind Alliance Teenage and Young Top 10 research Adult Cancer Priority Setting priorities 1 What psychological support Partnership (TYA PSP) package improves psychological well-being, social functioning and mental health during and after treatment? Executive Summary 2 What interventions, including The Top 10 research priorities for teenage and young adult cancers as agreed at the final self-care, can reduce or reverse workshop of the Teenage and Young Adult Cancer Priority Setting Partnership are detailed adverse short and long term effects here. Following the national consultation, fourteen professionals, seven patients and four of cancer treatment? parents prioritised the final 30 questions identified as unanswered research questions by young people, carers, significant others, and professionals. During the workshop, questions 3 What are the best strategies to were considered, debated and deliberated throughout the day as the final list was named. improve access to clinical trials? The final questions reflect the breadth of the cancer experience for young people, from 4 What General Practitioner or early diagnosis through to targeted treatments based on the biology of disease; access to young person strategies, such clinical trials, psychosocial care, and support after treatment; impact of cancer on the wider as awareness campaigns and
    [Show full text]
  • Stan Lee's Lessons for The
    comment “The events at Gosport are probably less likely two decades on” DAVID OLIVER “There's always a third presence in the consultation—my computer” HELEN SALISBURY PLUS Sugar tax and lobbying by fizzy drink companies; hospital patients' boredom THE BOTTOM LINE Partha Kar Stan Lee’s lessons for the NHS ast month the world lost Stan Lee, the falter when it comes to delivery. In the X-Men series, great comic book creator. I was one of created in the 1960s to highlight prejudice against many who mourned his loss. As a child certain groups, “mutants” are accepted rather than I loved the colourful panels and stories shunned, and their capabilities are recognised. The of heroism in comic books, and as I’ve release of the Black Panther film in 2018 showed Lgrown older I’ve become aware of some important life many children that being a superhero wasn’t about lessons they’ve taught me. Those lessons—around being white—it was about their skills and qualities. management, leadership, and equality—are ever In terms of gender, studios aren’t merely paying lip more important as the NHS faces an uphill struggle to service to diversity when they give prominent female maintain staff morale. title roles to Wonder Woman or Captain Marvel: For one thing, comic books help us understand our these women are central figures who become leaders colleagues by creating vivid characters who personify because of their abilities. specific personality types. Personality types have been People say that life imitates art. The NHS would mapped, eruditely but controversially, by Myers- certainly be a better place if we could learn how to Briggs scores and other measures.
    [Show full text]
  • Identifying Research Priorities for Digital Technology in Mental Health Care: Results of the James Lind Alliance Priority Setting Partnership
    This is a repository copy of Identifying research priorities for digital technology in mental health care: results of the James Lind Alliance Priority Setting Partnership. White Rose Research Online URL for this paper: http://eprints.whiterose.ac.uk/139048/ Version: Accepted Version Article: Hollis, C., Sampson, S., Simons, L. et al. (11 more authors) (2018) Identifying research priorities for digital technology in mental health care: results of the James Lind Alliance Priority Setting Partnership. Lancet Psychiatry, 5 (10). pp. 845-854. ISSN 2215-0366 https://doi.org/10.1016/S2215-0366(18)30296-7 Article available under the terms of the CC-BY-NC-ND licence (https://creativecommons.org/licenses/by-nc-nd/4.0/). Reuse This article is distributed under the terms of the Creative Commons Attribution-NonCommercial-NoDerivs (CC BY-NC-ND) licence. This licence only allows you to download this work and share it with others as long as you credit the authors, but you can’t change the article in any way or use it commercially. More information and the full terms of the licence here: https://creativecommons.org/licenses/ Takedown If you consider content in White Rose Research Online to be in breach of UK law, please notify us by emailing [email protected] including the URL of the record and the reason for the withdrawal request. [email protected] https://eprints.whiterose.ac.uk/ Identifying research priorities for digital technology in mental healthcare Identifying research priorities for digital technology in mental healthcare: Results of the James Lind Alliance Priority Setting Partnership Prof.
    [Show full text]
  • A UK Priority Setting Partnership with the James Lind Alliance
    Open access Original research BMJ Open: first published as 10.1136/bmjopen-2019-030028 on 15 December 2019. Downloaded from Research priorities for the management of broken bones of the upper limb in people over 50: a UK priority setting partnership with the James Lind Alliance Warren J Sheehan ,1 Mark A Williams ,2 Zoe Paskins,3,4 Matthew L Costa,5 Miguel Antonio Fernandez ,1,6 Jenny Gould,7 Philip Bell,8 Liz Baird,9 Richard Grant,10 Patricia Ellis,11 Catherine White,12 Laura Arnel,1 Lauren Exell,1 Stephen Gwilym1 To cite: Sheehan WJ, ABSTRACT Strengths and limitations of this study Williams MA, Paskins Z, et al. Objective To determine research priorities for the Research priorities for the management of broken bones of the upper limb in ► This is the first time healthcare professionals have management of broken bones people over 50, which represent the shared priorities of the upper limb in people worked alongside patients and carers to set prior- of patients, their families, carers and healthcare over 50: a UK priority setting ities for upper limb fracture research using the es- professionals. partnership with the James tablished James Lind Alliance methodology. Design/setting A national (UK) research priority setting Lind Alliance. BMJ Open ► Survey responses were received from all over the partnership. 2019;9:e030028. doi:10.1136/ UK, with an even split of healthcare professionals Participants People aged 50 and over who have bmjopen-2019-030028 and members of the public (patients, carers, family experienced a fracture of the upper limb, carers involved Prepublication history and and friends).
    [Show full text]