Defining standards in colorectal optimisation: a Delphi study protocol to achieve international consensus on key standards for colorectal surgery prehabilitation

IntroductionPrehabilitation in colorectal surgery is evolving and may minimise postoperative morbidity and mortality. With many different healthcare professionals contributing to the prehabilitation literature, there is significant variation in reported primary endpoints that restricts comparison. In addition, there has been limited work on patient-related outcome measures suggesting that patients with colorectal cancer needs and issues are being overlooked. The Defining Standards in Colorectal Optimisation Study aims to achieve international consensus from all stakeholders on key standards to provide a framework for reporting future prehabilitation research.Methods and analysisA systematic review will identify key standards reported in trials of prehabilitation in colorectal surgery. Standards that are important to patients will be identified by a patient and public involvement (PPI) event. The longlist of standards generated from the systematic review and PPI event will be used to develop a three-round online Delphi process. This will engage all stakeholders (healthcare professionals and patients) both nationally and internationally. The results of the Delphi will be followed by a face-to-face interactive consensus meeting that will define the final standards for prehabilitation for elective colorectal surgery.Ethics and disseminationThe University of Glasgow College of Medical, Veterinary and Life Sciences Ethics Committee has approved this protocol, which is registered as a study (200190120) with the Core Outcome Measures in Effectiveness Trials Initiative. Publication of the standards developed by all stakeholders will increase the potential for comparative research that advances understanding of the clinical application of prehabilitation.PROSPERO registration numberCRD42019120381.

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Patient-centred outcomes for prehospital trauma trials: A systematic review and patient involvement exercise

Trauma ◽

10.1177/1460408618817912 ◽

2019 ◽

Vol 21 (4) ◽

pp. 259-271

Author(s):

James M Hancox ◽

Emma Toman ◽

Samantha J Brace-McDonnell ◽

David N Naumann

Keyword(s):

Quality Of Life ◽

Systematic Review ◽

Clinical Trials ◽

Length Of Stay ◽

Outcome Measures ◽

Public Involvement ◽

Major Trauma ◽

Patient And Public Involvement ◽

Trauma Survivors

Introduction Outcome measures are used in clinical trials to determine efficacy of interventions. We aimed to determine which outcome measures in prehospital major trauma trials have been reported in the literature, and which of these are most patient-centred. Methods A systematic review identified outcomes reported in prehospital clinical trials of major trauma patients. A search was undertaken using Medline, Embase, clinicaltrials.gov, Web of Science and Google Scholar. Data were summarised by dividing outcomes into common themes which were presented to a Patient and Public Involvement group consisting of trauma survivors and their relatives. This group ranked the categories of outcomes in order of most importance, and agreed consensus statements regarding these outcome measures. Results There were 27 eligible studies, including 9,537 patients. Outcome measures were divided into nine categories: quality of life; length of stay; mortality/survival; physiological parameters; fluid/blood product requirements; complications; health economics; safety and feasibility; and intervention success. Of these, mortality/survival was the most commonly reported category, but over multiple timescales. The Patient and Public Involvement group agreed that the most important category was quality of life, and that mortality/survival should only be reported if concurrently reported with longer term quality of life. Length of stay and health economics were not considered important. Conclusions Outcome measures in prehospital clinical trials in major trauma have been heterogeneous, inconsistent, and not necessarily patient-centred. Trauma survivors considered quality of life and mortality most important when combined. Consensus is required for consistent, patient-centred, outcome measures in order to investigate interventions of meaningful impact to patients.

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How to improve diversity in patient and public involvement

British Journal of Hospital Medicine ◽

10.12968/hmed.2021.0176 ◽

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.

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

BMJ ◽

10.1136/bmj.k4738 ◽

2018 ◽

pp. k4738 ◽

Cited By ~ 67

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.

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Long-term patient-related outcome measures of septoplasty: a systematic review

European Archives of Oto-Rhino-Laryngology ◽

10.1007/s00405-018-4874-y ◽

2018 ◽

Vol 275 (5) ◽

pp. 1039-1048 ◽

Cited By ~ 3

Author(s):

Chi Lap Nicholas Tsang ◽

Theresa Nguyen ◽

Torunn Sivesind ◽

Anders Cervin

Keyword(s):

Systematic Review ◽

Outcome Measures ◽

Patient Related Outcome

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ICON 2019—International Scientific Tendinopathy Symposium Consensus: There are nine core health-related domains for tendinopathy (CORE DOMAINS): Delphi study of healthcare professionals and patients

British Journal of Sports Medicine ◽

10.1136/bjsports-2019-100894 ◽

2019 ◽

Vol 54 (8) ◽

pp. 444-451 ◽

Cited By ~ 16

Author(s):

Bill Vicenzino ◽

Robert-Jan de Vos ◽

Hakan Alfredson ◽

Roald Bahr ◽

Jill L Cook ◽

...

Keyword(s):

Outcome Measures ◽

Delphi Study ◽

Online Survey ◽

Healthcare Professionals ◽

Sensory Modality ◽

Consensus Meeting ◽

Response Options ◽

Patient Rating ◽

Wide Range ◽

Health Related

BackgroundThe absence of any agreed-upon tendon health-related domains hampers advances in clinical tendinopathy research. This void means that researchers report a very wide range of outcome measures inconsistently. As a result, substantial synthesis/meta-analysis of tendon research findings is almost futile despite researchers publishing busily. We aimed to determine options for, and then define, core health-related domains for tendinopathy.MethodsWe conducted a Delphi study of healthcare professionals (HCP) and patients in a three-stage process. In stage 1, we extracted candidate domains from clinical trial reports and developed an online survey. Survey items took the form: ‘The ‘candidate domain’ is important enough to be included as a core health-related domain of tendinopathy’; response options were: agree, disagree, or unsure. In stage 2, we administered the online survey and reported the findings. Stage 3 consisted of discussions of the findings of the survey at the ICON (International Scientific Tendinopathy Symposium Consensus) meeting. We set 70% participant agreement as the level required for a domain to be considered ‘core’; similarly, 70% agreement was required for a domain to be relegated to ‘not core’ (see Results next).ResultsTwenty-eight HCP (92% of whom had >10 years of tendinopathy experience, 71% consulted >10 cases per month) and 32 patients completed the online survey. Fifteen HCP and two patients attended the consensus meeting. Of an original set of 24 candidate domains, the ICON group deemed nine domains to be core. These were: (1) patient rating of condition, (2) participation in life activities (day to day, work, sport), (3) pain on activity/loading, (4) function, (5) psychological factors, (6) physical function capacity, (7) disability, (8) quality of life and (9) pain over a specified time. Two of these (2, 6) were an amalgamation of five candidate domains. We agreed that seven other candidate domains were not core domains: range of motion, pain on clinician applied test, clinical examination, palpation, drop out, sensory modality pain and pain without other specification. We were undecided on the other five candidate domains of physical activity, structure, medication use, adverse effects and economic impact.ConclusionNine core domains for tendon research should guide reporting of outcomes in clinical trials. Further research should determine the best outcome measures for each specific tendinopathy (ie, core outcome sets).

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