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

Trauma ◽  
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.

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

BMJ Open ◽  
2021 ◽  
Vol 11 (3) ◽  
pp. e047235
Author(s):  
Iona Pearson ◽  
Sue Blackwell ◽  
Rebecca Fish ◽  
Sarah Daniels ◽  
Malcolm West ◽  
...  
Keyword(s):  
Systematic Review ◽  
Colorectal Surgery ◽  
Outcome Measures ◽  
Delphi Study ◽  
Public Involvement ◽  
Healthcare Professionals ◽  
Patient And Public Involvement ◽  
International Consensus ◽  
Elective Colorectal Surgery ◽  
Patient Related Outcome

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.

Trends in Hidradenitis Suppurativa Disease Severity and Quality of Life Outcome Measures: A Systematic Review (Preprint)

2021 ◽  
Author(s):  
Jalal Maghfour ◽  
Torunn Elise Sivesind ◽  
Cory A. Dunnick ◽  
Robert Paul Dellavalle
Keyword(s):  
Quality Of Life ◽  
Systematic Review ◽  
Disease Severity ◽  
Outcome Measures ◽  
Hidradenitis Suppurativa ◽  
Life Quality ◽  
Clinical Score ◽  
Validity And Reliability ◽  
Patient Reported

BACKGROUND While there has been an increase in the number of randomized, controlled trials (RCTs) evaluating treatment efficacy for HS, instrument measurements of disease severity and quality of life (QoL) are varied, making compilation of data and comparison between studies a challenge for clinicians. OBJECTIVE The aim of this review is to evaluate trends in disease severity scales and patient reported outcome measures used in RCTs assessing treatment interventions among HS patients. METHODS A primary systematic literature review was conducted in August 2020. PubMed/MEDLINE, Embase, Web of Science, and Cochrane databases were used to identify all articles published from January 1964 to July 2020. The study was prospectively registered with PROSPERO (ID: 209582). Twenty-five articles were included in the systematic review. RESULTS Sartorius and modified Sartorius scores (n=8), and Hidradenitis Suppurativa Clinical score (HiSCs) (n=8) were the most commonly used instruments for disease severity. Participants’ pain, followed by Dermatology Life Quality Index (DLQI), were the most common QoL measures used in the reviewed studies. CONCLUSIONS Heterogeneity of data characterizing both the validity and reliability of existing outcome measures hinders interpretation and translation of the results from RCTs into clinical practice. Many of the QoL measures identified were not specific to HS and may not be representative of all factors impacting patients.

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.

scholarly journals Reporting of Quality of Life in Clinical Trials of Biologics for Plaque Psoriasis: A Systematic Review

2018 ◽  
Vol 2 (5) ◽  
Author(s):  
Giselle Prado ◽  
Anna J Nichols ◽  
Mercedes Florez-White ◽  
Francisco Kerdel
Keyword(s):  
Quality Of Life ◽  
Systematic Review ◽  
Clinical Trials ◽  
Plaque Psoriasis ◽  
Dermatology Life Quality Index ◽  
Quality Index ◽  
Life Quality ◽  
Risk Of Bias ◽  
The Mean

Background: Psoriasis is a chronic remitting and relapsing skin disease. For many patients, improved quality of life (QoL) is as important as clinical improvement of lesions.Objective: To review reporting of Dermatology Life Quality Index (DLQI) in randomized controlled trials (RCTs) of biologics for adult patients with plaque psoriasis.Methods: A systematic review was conducted in 4 databases for RCTs that measured DLQI at baseline and endpoint. A data collection form was created for collecting study variables. Risk of bias was assessed using the Cochrane risk of bias tool.Results: Thirty-four RCTs enrolling 16,784 patients were included. Complete baseline and final mean DLQI data was retrieved for 24 studies (70.6%). The mean DLQI at baseline was reported in 79.4% of RCTs. The median at baseline was reported in 14.7% of RCTs. The mean DLQI at endpoint was reported in 23.5% of RCTs and the median DLQI at endpoint was reported in 5.9% of RCTs. The mean change in DLQI was reported in 64.7% of RCTs.Conclusions: DLQI was measured in most clinical trials assessing the efficacy of biologics for psoriasis. Studies did not adhere to uniform standards in publishing results, making analysis of the impact on DLQI challenging.Key Words: plaque psoriasis, quality of life, Dermatology Life Quality Index, Systematic Review, biologic therapy

scholarly journals Patient Reported Outcome Measures Assessing Health-Related Quality Of Life in Dupuytren´S Disease: A Systematic Review

2020 ◽  
Vol 5 (01) ◽  
Author(s):  
Diego Gómez Herrero ◽  
Rafael Sanjuan-Cerveró ◽  
Pedro Vazquez-Ferreiro ◽  
Francisco Javier Carrera-Hueso ◽  
Marina Sáez-Belló ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Systematic Review ◽  
Outcome Measures ◽  
Patient Reported Outcome Measures ◽  
Measurement Properties ◽  
Health Related Quality ◽  
Patient Reported ◽  
Related Quality ◽  
Health Related

Objective: The objective of this study is to carry out a systematic review of the outcome measures reported by the patient that are used to measure the quality of life of patients with Dupuytren´s disease (DD), assessing their relevance and effectiveness. Methods: A systematic literature search was carried out in the PubMed®, Web of Sciencie®, SciELO®, EMBASE®, Google Scholar® and Cochrane® databases. We searched for peer-reviewed articles evaluating health related quality of life (HR-QoL) in patients with DD diagnosed and/or treated until April 1, 2017, for English or Spanish language. The following keywords were used: “Dupuytren´s disease (MeSH)” AND “health related quality of life (MeSH)”. The documents were eligible for inclusion if they described data on the HR-QoL domains in relation to diagnosis or treatment of DD after a revision process by two independent authors. The checklist (STROBE) was used to evaluate the quality of the works. Results: From 352 identified articles were finally selected 26 studies in the systematic review, mostly European. A total of nine outcomes measures specifically reported by the patient were identified: DASH (used in 13 of the 26 selected studies), Quick-DASH (8/26), MHQ (7/26), briefMHQ (1/26), URAM (4/26), POS-HAND/ARM (1/26), SDSS (1/26), DDSP (1/26) and CHFS (1/26) questionnaires. We analyze their quantitative results to evaluate the effectiveness and evaluate the methodological quality of the studies on the measurement properties of the results reported by patients related to health. Conclusion: More work is urgently needed in these areas before we can reach a consensus on which instrument is the best to assess functional deterioration and improvement in patients with DD.

scholarly journals Evaluating measures of quality of life in adult scoliosis: a protocol for a systematic review and narrative synthesis

2021 ◽  
Vol 10 (1) ◽  
Author(s):  
James E. Archer ◽  
Charles Baird ◽  
Adrian Gardner ◽  
Alison B. Rushton ◽  
Nicola R. Heneghan
Keyword(s):  
Quality Of Life ◽  
Systematic Review ◽  
Outcome Measures ◽  
Study Design ◽  
Systematic Reviews ◽  
Primary Outcome ◽  
Adult Scoliosis ◽  
Measurement Properties ◽  
Narrative Synthesis

Abstract Background Adult scoliosis represents a distinct subgroup of scoliosis patients for whom the diagnosis can have a large impact on their health-related quality of life (HR-QOL). Therefore, HR-QOL patient-reported outcome measures (PROMs) are essential to assess disease progression and the impact of interventions. The objective of this systematic review is to evaluate the measurement properties of HR-QOL PROMs in adult scoliosis patients. Methods We will conduct a literature search, from their inception onwards, of multiple electronic databases including AMED, CINAHL, EMBASE, Medline, PsychINFO and PubMed. The searches will be performed in two stages. For both stages of the search, participants will be aged 18 and over with a diagnosis of scoliosis. The primary outcome of interest in the stage one searches will be studies which use PROMs to investigate HR-QOL as defined by the Core Outcome Measures in Effectiveness Trials (COMET) taxonomy, the secondary outcome will be to assess the frequency of use of the various PROMs. In stage two, the primary outcome of interest will be studies which assess the measurement properties of the HR-QOL PROMs identified in stage one. No specific measurement property will be given priority. No planned secondary outcomes have been identified but will be reported if discovered. In stage one, the only restriction on study design will be the exclusion of systematic reviews. In Stage two the only restriction on study design will be the exclusion of full-text articles not available in the English language. Two reviewers will independently screen all citations and abstract data. Potential conflicts will be resolved through discussion. The study methodological quality (or risk of bias) will be appraised using the Consensus-based Standards for the selection of Health Measurement Instruments (COSMIN) checklist. The overall strength of the body of evidence will then be assessed using the Grading of Recommendations, Assessment, Development and Evaluation (GRADE) approach. A narrative synthesis will be provided with information presented in the main text and tables to summarise and explain the characteristics and findings of the included studies. The narrative synthesis will explore the evidence for currently used PROMs in adult scoliosis patients and any areas that require further study. Discussion The review will help clinicians and researchers identify a HR-QOL PROM for use in patients with adult scoliosis. Findings from the review will be published and disseminated through a peer-reviewed journal and conference presentations. Systematic review registration This systematic review has been registered with the International Prospective Register of Systematic Reviews (PROSPERO), reference number: CRD42020219437

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