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 ‘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 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.

scholarly journals Systematic Evaluation of Patient-Reported Outcome Protocol Content and Reporting in Cancer Trials

2019 ◽  
Vol 111 (11) ◽  
pp. 1170-1178 ◽  
Author(s):  
Derek Kyte ◽  
Ameeta Retzer ◽  
Khaled Ahmed ◽  
Thomas Keeley ◽  
Jo Armes ◽  
...  
Keyword(s):  
Patient Reported Outcomes ◽  
Reporting Quality ◽  
Patient Reported Outcome ◽  
Systematic Evaluation ◽  
Patient Reported ◽  
Informed Treatment ◽  
Cancer Trials ◽  
Consort Pro ◽  
Do So

Abstract Background Patient-reported outcomes (PROs) are captured within cancer trials to help future patients and their clinicians make more informed treatment decisions. However, variability in standards of PRO trial design and reporting threaten the validity of these endpoints for application in clinical practice. Methods We systematically investigated a cohort of randomized controlled cancer trials that included a primary or secondary PRO. For each trial, an evaluation of protocol and reporting quality was undertaken using standard checklists. General patterns of reporting where also explored. Results Protocols (101 sourced, 44.3%) included a mean (SD) of 10 (4) of 33 (range = 2–19) PRO protocol checklist items. Recommended items frequently omitted included the rationale and objectives underpinning PRO collection and approaches to minimize/address missing PRO data. Of 160 trials with published results, 61 (38.1%, 95% confidence interval = 30.6% to 45.7%) failed to include their PRO findings in any publication (mean 6.43-year follow-up); these trials included 49 568 participants. Although two-thirds of included trials published PRO findings, reporting standards were often inadequate according to international guidelines (mean [SD] inclusion of 3 [3] of 14 [range = 0–11]) CONSORT PRO Extension checklist items). More than one-half of trials publishing PRO results in a secondary publication (12 of 22, 54.5%) took 4 or more years to do so following trial closure, with eight (36.4%) taking 5–8 years and one trial publishing after 14 years. Conclusions PRO protocol content is frequently inadequate, and nonreporting of PRO findings is widespread, meaning patient-important information may not be available to benefit patients, clinicians, and regulators. Even where PRO data are published, there is often considerable delay and reporting quality is suboptimal. This study presents key recommendations to enhance the likelihood of successful delivery of PROs in the future.

scholarly journals Patient-reported outcomes in the RELIGHT clinical trial of ranibizumab in diabetic macular oedema

2019 ◽  
Vol 4 (1) ◽  
pp. e000226 ◽  
Author(s):  
Usha Chakravarthy ◽  
Ian Pearce ◽  
Sanjiv Banerjee ◽  
Benjamin J L Burton ◽  
Louise Downey ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Macular Oedema ◽  
Statistical Significance ◽  
Diabetic Macular Oedema ◽  
Patient Reported Outcome ◽  
Macular Disease ◽  
Patient Reported ◽  
The Status ◽  
Visual Function Questionnaire ◽  
Composite Scores

Background/aimsThe RELIGHT clinical trial used an individualised treatment regimen of ranibizumab to treat diabetic macular oedema (DMO). We report findings from two patient-reported outcome instruments.MethodsThe National Eye Institute Visual Function Questionnaire (NEI-VFQ) was administered before starting treatment (M0) and at M6, 12 and 18. The Macular Disease Society Treatment Satisfaction Questionnaire (MacTSQ) was administered 1 month after treatment start (M1) and at M6, 12 and 18. Relationships between best-corrected visual acuity (BCVA) in the study eye (SE) and the status of the eye at baseline (as better or worse eye by BCVA) and the two instrument measures were investigated.ResultsBCVA in the SE correlated strongly with the NEI-VFQ composite scores and the majority of the subscales but not with the MacTSQ subscales. Statistically significant improvements were observed in the majority of the subscales of the NEI-VFQ at M6, 12 and 18. For the MacTSQ, improvements between baseline M6, 12 and 18 were seen for subscale 1 but only reached statistical significance at M12. In subscale 2, the changes in mean scores were statistically significant at all timepoints.ConclusionsAlthough ranibizumab treatment in DMO over an 18-month period resulted in improvements in visual functioning and patient satisfaction, no correlation was found between the instruments used to measure these outcomes. Our finding of a lack of correlation between BCVA and the MacTSQ suggests the presence of psychophysical factors not measured by traditional means.

The Psoriasis Symptom Inventory: An Effective Patient-reported Outcome Measure of Psoriasis Severity

2015 ◽  
Vol 42 (6) ◽  
pp. 1034-1036 ◽  
Author(s):  
Philip J. Mease
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Clinical Practice ◽  
Severity Index ◽  
Patient Reported Outcome ◽  
Measurement Instruments ◽  
Symptom Inventory ◽  
Clinical Registries ◽  
Patient Reported ◽  
Psoriasis Severity

There is a need for simple, practical, and reliable measurement instruments for use in clinical trials, registries, and clinical practice to assess psoriasis severity and the change in symptoms with treatment. The Psoriasis Area and Severity Index (PASI) is the standard measure of psoriasis used in clinical trials, but it is rarely used in clinical practice and it is not readily used in clinical registries because of its complexity. The Physician Static Global Assessment score is a simpler measure also used in clinical trials and less frequently in registries and practice, but like the PASI, it requires some degree of experience to score. The Psoriasis Symptom Inventory (PSI) was developed as a simple measure to enable patients to self-score psoriasis severity. It has been demonstrated to be reliable and discriminative, and it correlated with the PASI score in a psoriasis clinical trial. It also was recently validated to assess psoriasis in a psoriatic arthritis (PsA) clinical trial. The PSI may be a useful and practical measure of psoriasis severity in psoriasis and PsA clinical trials, registries, and in clinical practice.

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