scholarly journals ‘Give Us The Tools!’: development of knowledge transfer tools to support the involvement of patient partners in the development of clinical trial protocols with patient-reported outcomes (PROs), in accordance with SPIRIT-PRO Extension

BMJ Open ◽  
2021 ◽  
Vol 11 (6) ◽  
pp. e046450
Author(s):  
Samantha Cruz Rivera ◽  
Richard Stephens ◽  
Rebecca Mercieca-Bebber ◽  
Ameeta Retzer ◽  
Claudia Rutherford ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Public Involvement ◽  
Patient And Public Involvement ◽  
Patient Reported Outcome ◽  
Flow Diagram ◽  
Additional Patient ◽  
The Public ◽  
Patient Reported ◽  
Trial Protocols ◽  
User Friendly

Objectives(a) To adapt the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT)-patient-reported outcome (PRO) Extension guidance to a user-friendly format for patient partners and (b) to codesign a web-based tool to support the dissemination and uptake of the SPIRIT-PRO Extension by patient partners.DesignA 1-day patient and public involvement session.ParticipantsSeven patient partners.MethodsA patient partner produced an initial lay summary of the SPIRIT-PRO guideline and a glossary. We held a 1-day PPI session in November 2019 at the University of Birmingham. Five patient partners discussed the draft lay summary, agreed on the final wording, codesigned and agreed the final content for both tools. Two additional patient partners were involved in writing the manuscript. The study compiled with INVOLVE guidelines and was reported according to the Guidance for Reporting Involvement of Patients and the Public 2 checklist.ResultsTwo user-friendly tools were developed to help patients and members of the public be involved in the codesign of clinical trials collecting PROs. The first tool presents a lay version of the SPIRIT-PRO Extension guidance. The second depicts the most relevant points, identified by the patient partners, of the guidance through an interactive flow diagram.ConclusionsThese tools have the potential to support the involvement of patient partners in making informed contributions to the development of PRO aspects of clinical trial protocols, in accordance with the SPIRIT-PRO Extension guidelines. The involvement of patient partners ensured the tools focused on issues most relevant to them.

scholarly journals Systematic Evaluation of the Patient-Reported Outcome (PRO) Content of Clinical Trial Protocols

PLoS ONE ◽  
2014 ◽  
Vol 9 (10) ◽  
pp. e110229 ◽  
Author(s):  
Derek Kyte ◽  
Helen Duffy ◽  
Benjamin Fletcher ◽  
Adrian Gheorghe ◽  
Rebecca Mercieca-Bebber ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Patient Reported Outcome ◽  
Systematic Evaluation ◽  
Patient Reported ◽  
Trial Protocols

scholarly journals Patient and public involvement prior to trial initiation: lessons learnt for rapid partnership in the COVID-19 era

2021 ◽  
Vol 7 (1) ◽  
Author(s):  
Zahra Jamal ◽  
◽  
Alexander Perkins ◽  
Christopher Allen ◽  
Richard Evans ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Research Ethics ◽  
Public Involvement ◽  
Ethics Committees ◽  
Patient And Public Involvement ◽  
Research Ethics Committees ◽  
The Public ◽  
Clinical Trials Unit ◽  
The Uk

Plain English summary Patient and Public Involvement (PPI) describes the active involvement of patients and the public in the research process. Through PPI, patients and members of the public are increasingly involved in the design and conduct of clinical trials. PPI has been shown to improve the quality and relevance of research. During the COVID-19 pandemic, clinical trials have been playing a vital role in helping us find ways to prevent and treat the infection and improve our understanding of the virus. It is important that patients and the public are actively involved in deciding how COVID-19 research is carried out. Unfortunately, Research Ethics Committees in the UK have seen far less PPI for COVID-19 research studies compared with research before the pandemic. A key reason for this is that research is being designed much faster than normal and researchers may feel they do not have time to properly involve patients and the public. In this paper, we share our experiences of PPI for a COVID-19 clinical trial. We show that it is possible to rapidly involve patients and the public in COVID-19 clinical trials. We also explain how the design of the clinical trial was changed in response to feedback from public contributors. Lastly, we discuss the wider learning from this process which might be useful for researchers planning PPI activities for COVID-19 clinical trials in the future. Abstract Background: Clinical trials are playing a critical role in the global public health response to the COVID-19 pandemic. Despite the increasing recognition of the value of PPI in clinical trials, just 22% of the COVID-19 research proposals reviewed by Research Ethics Committees in the UK at the start of the pandemic reported PPI. There is a perception that PPI might result in delays in delivering research and therefore delays in obtaining important results. In this paper, we report our experience of rapid PPI for a COVID-19 clinical trial. Methods: RAPID-19 is a COVID-19 clinical trial which was planned to be submitted for fast-track ethics review in the United Kingdom. During the development of the trial protocol, the PPI Panel at the London School of Hygiene & Tropical Medicine Clinical Trials Unit was involved in the design of the study. The meeting with the PPI Panel lasted just over 1 h and was conducted by teleconference. Results: Although we only had a short period of time to explore the study with the PPI Panel, we were able to gain valuable insight into how the trial would be perceived by potential trial participants. Substantive changes were made to the trial to improve the acceptability of the research without compromising the study timelines. Having access to public contributors with relevant lived experience is an important resource for a Clinical Trials Unit and is critical for rapid PPI. The move to remote working due to lockdown required virtual discussions which helped to overcome some of the barriers to organising face-to-face meetings at short notice. Conclusions: PPI for clinical trials can be conducted in a time-efficient manner within the pressured environment of a pandemic. Involving PPI contributors at an early stage in protocol development maximised the opportunity to shape and influence the trial as well as limited potential delays which could occur if changes to the protocol had to be made at a later stage.

scholarly journals The role of response domain and scale label in the quantitative interpretation of patient-reported outcome measure response options

2021 ◽  
Author(s):  
Tessa Peasgood ◽  
Jen-Yu Chang ◽  
Robina Mir ◽  
Clara Mukuria ◽  
Philip A. Powell
Keyword(s):  
First Language ◽  
Patient Reported Outcome Measures ◽  
Patient Reported Outcome ◽  
Response Options ◽  
The Public ◽  
Online Panel ◽  
Patient Reported ◽  
Common Response ◽  
Chi Squared

Abstract Purpose Uncertainties exist in how respondents interpret response options in patient-reported outcome measures (PROMs), particularly across different domains and for different scale labels. The current study assessed how respondents quantitatively interpret common response options. Methods Members of the general public were recruited to this study via an online panel, stratified by age, gender, and having English as a first language. Participants completed background questions and were randomised to answer questions on one of three domains (i.e. loneliness (negatively phrased), happiness or activities (positively phrased)). Participants were asked to provide quantitative interpretations of response options (e.g. how many times per week is equal to “often”) and to order several common response options (e.g. occasionally, sometimes) on a 0–100 slider scale. Chi-squared tests and regression analyses were used to assess whether response options were interpreted consistently across domains and respondent characteristics. Results Data from 1377 participants were analysed. There was general consistency in quantifying the number of times over the last 7 days to which each response option referred. Response options were consistently assigned a lower value in the loneliness than happiness and activities domains. Individual differences, such as age and English as a second language, explained some significant variation in responses, but less than domain. Conclusion Members of the public quantify common response options in a similar way, but their quantification is not equivalent across domains or every type of respondent. Recommendations for the use of certain scale labels over others in PROM development are provided.

How to improve diversity in patient and public involvement

2021 ◽  
pp. 1-8
Author(s):  
Rebecca Golenya ◽  
George D Chloros ◽  
Michalis Panteli ◽  
Peter V Giannoudis ◽  
Anthony Howard
Keyword(s):  
Lived Experiences ◽  
Public Involvement ◽  
Healthcare Professionals ◽  
Patient And Public Involvement ◽  
Future Research ◽  
Barriers To Participation ◽  
The Public ◽  
Common Barriers ◽  
Quality Of Research

Patient and public involvement involves ascertaining the opinions of and collaborating with patients and members of the public to holistically improve the quality of research. Patient and public involvement provides patients with a platform to use and share their lived experiences. This allows healthcare professionals to gain a deeper appreciation of the patient's perspective, which enables future research to be more patient centred and tailored to patients' requirements. Patient and public involvement aims to broadly encapsulate the opinions of the public, so ensuring diversity is recommended. This article provides a practical framework to increase diversity and engage hard-to-reach demographics in patient and public involvement. It highlights some common barriers to participation and methods for overcoming this, describes sampling frameworks and provides examples of how these have been adopted in practice.

scholarly journals Impact of patient and public involvement on enrolment and retention in clinical trials: systematic review and meta-analysis

BMJ ◽  
2018 ◽  
pp. k4738 ◽  
Author(s):  
Joanna C Crocker ◽  
Ignacio Ricci-Cabello ◽  
Adwoa Parker ◽  
Jennifer A Hirst ◽  
Alan Chant ◽  
...  
Keyword(s):  
Systematic Review ◽  
Clinical Trial ◽  
Clinical Trials ◽  
Lived Experience ◽  
Odds Ratio ◽  
Public Involvement ◽  
Meta Analysis ◽  
Patient And Public Involvement ◽  
Retention Rates ◽  
The Impact

AbstractObjectiveTo investigate the impact of patient and public involvement (PPI) on rates of enrolment and retention in clinical trials and explore how this varies with the context and nature of PPI.DesignSystematic review and meta-analysis.Data sourcesTen electronic databases, including Medline, INVOLVE Evidence Library, and clinical trial registries.Eligibility criteriaExperimental and observational studies quantitatively evaluating the impact of a PPI intervention, compared with no intervention or non-PPI intervention(s), on participant enrolment and/or retention rates in a clinical trial or trials. PPI interventions could include additional non-PPI components inseparable from the PPI (for example, other stakeholder involvement).Data extraction and analysisTwo independent reviewers extracted data on enrolment and retention rates, as well as on the context and characteristics of PPI intervention, and assessed risk of bias. Random effects meta-analyses were used to determine the average effect of PPI interventions on enrolment and retention in clinical trials: main analysis including randomised studies only, secondary analysis adding non-randomised studies, and several exploratory subgroup and sensitivity analyses.Results26 studies were included in the review; 19 were eligible for enrolment meta-analysis and five for retention meta-analysis. Various PPI interventions were identified with different degrees of involvement, different numbers and types of people involved, and input at different stages of the trial process. On average, PPI interventions modestly but significantly increased the odds of participant enrolment in the main analysis (odds ratio 1.16, 95% confidence interval and prediction interval 1.01 to 1.34). Non-PPI components of interventions may have contributed to this effect. In exploratory subgroup analyses, the involvement of people with lived experience of the condition under study was significantly associated with improved enrolment (odds ratio 3.14v1.07; P=0.02). The findings for retention were inconclusive owing to the paucity of eligible studies (odds ratio 1.16, 95% confidence interval 0.33 to 4.14), for main analysis).ConclusionsThese findings add weight to the case for PPI in clinical trials by indicating that it is likely to improve enrolment of participants, especially if it includes people with lived experience of the health condition under study. Further research is needed to assess which types of PPI work best in particular contexts, the cost effectiveness of PPI, the impact of PPI at earlier stages of trial design, and the impact of PPI interventions specifically targeting retention.Systematic review registrationPROSPERO CRD42016043808.

Patient-Reported Outcome following Metal-On-Metal Resurfacing of the Hip and Total Hip Replacement

2009 ◽  
Vol 19 (3) ◽  
pp. 245-250 ◽  
Author(s):  
David P. Hall ◽  
Del Srikantharajah ◽  
Raimond E. Anakwe ◽  
Paul Gaston ◽  
Colin R. Howie
Keyword(s):  
Total Hip Replacement ◽  
Hip Replacement ◽  
Short Form ◽  
Length Of Hospital Stay ◽  
Multivariate Regression Analysis ◽  
Hip Resurfacing ◽  
Patient Reported Outcome ◽  
Additional Patient ◽  
Total Hip ◽  
Patient Reported

Patient-reported outcome and satisfaction scores have become increasingly important in evaluating successful surgery. This case-matched control study compared patient-reported outcome and satisfaction data following hip resurfacing and total hip arthroplasty. Thirty-three consecutive patients selected for hip resurfacing were compared with 99 patients undergoing cemented total hip replacement (THR), matched for age, sex and pathology. Participants completed a Short-Form 12 Health Survey (SF-12) and Oxford Hip Score questionnaire preoperatively and 6 months post operatively with an additional patient satisfaction questionnaire. There was no difference in length of hospital stay. While both groups reported improved outcome scores, multivariate regression analysis did not demonstrate any significant benefit for one group over the other. Both groups reported high levels of satisfaction, which tended to be better in patients undergoing hip resurfacing.

scholarly journals Patient and public involvement and engagement: Practice case study with reflections and learnings from a small rural district general hospital

2021 ◽  
Vol 5 (2) ◽  
Author(s):  
Zoë A. Sheppard ◽  
Sarah Williams ◽  
Richard Lawson ◽  
Kim Appleby
Keyword(s):  
General Hospital ◽  
Public Involvement ◽  
District General Hospital ◽  
Patient And Public Involvement ◽  
Rural District ◽  
Relevant Research ◽  
The Public ◽  
Research Volunteers ◽  
Large Groups

The notion of patient and public involvement and engagement (PPIE) in research has been around for some time, and it is considered essential to ensure high-quality relevant research that is shared and that will make a difference. This case study of practice aims to share the PPIE practice from Dorset County Hospital NHS Foundation Trust, a small rural district general hospital. It describes the process of recruiting patients and members of the public as research volunteers, as well as the plethora of engagement and involvement activities with which they have been involved to date. This is followed by a reflection on the process and an overview of plans for the future, highlighting key challenges as well as learnings. A dedicated role to support/oversee PPIE activities is recommended to coordinate large groups of research volunteers, as well as to monitor the important impact of their input, which is considerable. Increasing diversity and access to under-served groups, and embedding the research volunteer role within the wider clinical research team, are also highlighted as fundamental challenges, as well as opportunities to make the most from this valuable resource. The case study of practice puts forward a recommendation to all research departments to embed PPIE in all of the work that they do.

scholarly journals Single postoperative infusion of zoledronic acid to improve patient-reported outcome after hip or knee replacement: study protocol for a randomised, controlled, double-blinded clinical trial

BMJ Open ◽  
2020 ◽  
Vol 10 (9) ◽  
pp. e040985
Author(s):  
Jonathan Brandt ◽  
Håkan Ledin ◽  
Jonas Ranstam ◽  
Ewa Roos ◽  
Per Aspenberg ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Zoledronic Acid ◽  
Knee Replacement ◽  
Knee Prosthesis ◽  
Patient Reported Outcome ◽  
Ethical Review ◽  
Outcome Score ◽  
Patient Reported ◽  
Double Blinded ◽  
Improve Patient

IntroductionIn Sweden, roughly 3000 patients are reoperated each year due to pain and loss of function related to a loosened hip or knee prosthesis. These reoperations are strenuous for the patient, technically demanding and costly for the healthcare system. Any such reoperation that can be prevented would be of great benefit. Bisphosphonates are drugs that inhibit osteoclast function. Several clinical trials suggest that bisphosphonates lead to improved implant fixation and one small study even indicates better functional outcome. Furthermore, in epidemiological studies, bisphosphonates have been shown to decrease the rate of revision for aseptic loosening by half. Thus, there are several indirect indications that bisphosphonates could improve patient-reported outcome, but no firm evidence.Methods and analysisThis is a pragmatic randomised, placebo-controlled, double-blinded, academic clinical trial of a single postoperative dose of zoledronic acid, in patients younger than 80 years undergoing primary total hip or knee replacement for osteoarthritis. Participants will be recruited from two orthopaedic departments. All surgeries will be performed, and study drugs given at Motala Hospital, Sweden. The primary endpoint is to investigate between-group differences in the Hip dysfunction and Osteoarthritis Outcome Score and the Knee injury and Osteoarthritis Outcome Score at 3-year follow-up. Secondary outcomes will be investigated at 1 year, 3 years and 6 years, and stratified for hip and knee implants. These secondary endpoints are supportive, exploratory or explanatory. A total of 1000 patients will be included in the study.Ethics and disseminationThe study has been approved by the Regional Ethical Review Board in Linköping (DNR 2015/286-31). The study will be reported in accordance with the Consolidated Standards of Reporting Trials statement for pharmacological trials. The results will be submitted for publication in peer-reviewed academic journals and disseminated to patient organisations and the media.Trial registration numberEudraCT: No 2015-001200-55; Pre-results.

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