scholarly journals Quality of patient-reported outcome reporting across cancer randomized controlled trials according to the CONSORT patient-reported outcome extension: A pooled analysis of 557 trials

Cancer ◽  
2015 ◽  
Vol 121 (18) ◽  
pp. 3335-3342 ◽  
Author(s):  
Fabio Efficace ◽  
Peter Fayers ◽  
Andrea Pusic ◽  
Yeliz Cemal ◽  
Jane Yanagawa ◽  
...  
Keyword(s):  
Randomized Controlled Trials ◽  
Pooled Analysis ◽  
Patient Reported Outcome ◽  
Controlled Trials ◽  
Outcome Reporting ◽  
Randomized Controlled ◽  
Patient Reported

Impact of Blinding on Patient-Reported Outcome Differences Between Treatment Arms in Cancer Randomized Controlled Trials

2021 ◽  
Author(s):  
Fabio Efficace ◽  
David Cella ◽  
Neil K Aaronson ◽  
Melanie Calvert ◽  
Francesco Cottone ◽  
...  
Keyword(s):  
Randomized Controlled Trials ◽  
Experimental Treatment ◽  
Patient Reported Outcome ◽  
Controlled Trials ◽  
Open Label ◽  
Multivariable Logistic Regression Model ◽  
Randomized Controlled ◽  
Patient Reported ◽  
Independent Variable ◽  
Outcome Differences

Abstract Some concerns have been raised about potential bias in patient-reported outcome (PRO) results from open-label cancer randomized controlled trials (RCTs). We investigated if open-label trials favor the experimental treatment over the standard treatment more frequently than blinded trials. We also examined if the effect of blinding differs for distal vs more proximal PROs. We assessed 538 RCTs with a PRO endpoint conducted in the most prevalent cancers, of which 366 (68.0%) were open-label, 148 (27.5%) were blinded, and 24 (4.5%) were categorized as unclear. In our multivariable logistic regression model, we did not observe a statistically significant association of the independent variable treatment concealment (blinded vs open-label) on the dependent variable measuring the proportion of trials favoring the experimental treatment (adjusted odds ratio = 1.19, 95% confidence interval = 0.79 to 1.79; 2-sided P = .40). This was also the case when comparing distal and proximal PROs. Our findings provide novel evidence-based data that support the validity of PRO results from open-label cancer RCTs.

scholarly journals The Quality of Randomized Controlled Trials in High-impact Rheumatology Journals, 1998–2018

2020 ◽  
Vol 47 (9) ◽  
pp. 1446-1449
Author(s):  
Michael S. Putman ◽  
Ashley Harrison Ragle ◽  
Eric M. Ruderman
Keyword(s):  
Randomized Controlled Trials ◽  
Patient Reported Outcome Measures ◽  
High Impact ◽  
Controlled Trials ◽  
Industry Funding ◽  
Primary Analysis ◽  
Randomized Controlled ◽  
Patient Reported ◽  
Over Time

Objective.Well-designed randomized controlled trials (RCT) mitigate bias and confounding, but previous evaluations of rheumatology trials found high rates of methodological flaws. Outside of rheumatoid arthritis, no studies in the modern era have assessed the quality of rheumatology RCT over time or regarding industry funding.Methods.We identified all RCT published in 3 high-impact rheumatology journals from 1998, 2008, and 2018. Quality metrics derived from a modified Jadad scale were analyzed by year of publication and by funding source.Results.Ninety-six publications met inclusion criteria; 82 of these described the primary analysis of an RCT. Over time (1998–2008–2018), trials were less likely to adequately report dropouts and withdrawals (100% vs 82% vs 60%; p < 0.01) or include an active comparator (44% vs 12% vs 13%; p = 0.01). Later trials were more likely to evaluate biologic therapy (11% vs 38% vs 83%; p < 0.01) and report adequate randomization procedures (39% vs 29% vs 60%; p = 0.04). Seventy-nine percent of trials received industry funding. Industry-funded trials were more likely to report double-blinding (86% vs 53%; p < 0.01), patient-reported outcome measures (77% vs 41%; p < 0.01), and intention-to-treat analyses (86% vs 65%; p = 0.04).Conclusion.Industry-funded trials comprise the majority of RCT published in high-impact rheumatology journals and more frequently report metrics associated with RCT quality. RCT assessing active comparators and nonbiologic therapies have become less common in high-impact rheumatology journals.

scholarly journals Impact of onabotulinumtoxinA on quality of life and practical aspects of daily living: A pooled analysis of two randomized controlled trials

2015 ◽  
Vol 22 (12) ◽  
pp. 1131-1137 ◽  
Author(s):  
Karel Everaert ◽  
Jennifer Gruenenfelder ◽  
Heinrich Schulte‐Baukloh ◽  
Russell B Egerdie ◽  
Kristin Khalaf ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Randomized Controlled Trials ◽  
Daily Living ◽  
Pooled Analysis ◽  
Controlled Trials ◽  
Randomized Controlled

scholarly journals Investigating the impact of open label design on patient‐reported outcome results in prostate cancer randomized controlled trials

2020 ◽  
Vol 9 (20) ◽  
pp. 7363-7374
Author(s):  
Guillaume Mouillet ◽  
Fabio Efficace ◽  
Antoine Thiery‐Vuillemin ◽  
Emilie Charton ◽  
Mieke Van Hemelrijck ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Randomized Controlled Trials ◽  
Patient Reported Outcome ◽  
Controlled Trials ◽  
Open Label ◽  
Randomized Controlled ◽  
Patient Reported ◽  
The Impact

scholarly journals Factors in Randomized Controlled Trials Reported to Impact the Implementation of Patient-Reported Outcome Measures Into Routine Care: Protocol for a Systematic Review (Preprint)

2019 ◽  
Author(s):  
Natasha Anne Roberts ◽  
Kimberly Alexander ◽  
David Wyld ◽  
Monika Janda
Keyword(s):  
Systematic Review ◽  
Clinical Practice ◽  
Randomized Controlled Trials ◽  
Patient Reported Outcome Measures ◽  
Patient Reported Outcome ◽  
Controlled Trials ◽  
Evidence Based ◽  
Randomized Controlled ◽  
Patient Reported ◽  
Implementation Factors

BACKGROUND Patient-reported outcome measures (PROMs) are tools that enable patients to directly report their own assessments of well-being, or symptoms, in a structured and consistent way. Despite the usefulness of PROMs in optimizing health outcomes, their use in clinical practice is not routine. PROMs are complex to integrate into the clinical setting, with many elements potentially impacting on the success of implementation. For this reason, a protocol has been developed to guide a systematic review to collate information on implementation as presented in the randomized controlled trials (RCTs) to date. OBJECTIVE The primary objective of this systematic review is to identify and synthesize factors available from RCT data about the fidelity of PROM interventions in clinical practice. The secondary objective will be an assessment of how implementation factors impact fidelity outcomes. METHODS Preferred Reporting Items for Systematic Reviews and Meta-Analyses reporting standards will be followed. MEDLINE, EMBASE, and the Cumulative Index to Nursing and Allied Health Literature via OvidSP will be accessed using a defined search strategy. Grey literature and ClinicalTrials.gov will be reviewed for unpublished studies. Data extraction will be done to identify fidelity and factors impacting implementation, summarized using a narrative synthesis. An evidence-based implementation science framework will assist in identifying potential elements of importance and their effect on the process and outcomes of implementation. A meta-analysis to assess the impact of implementation factors will be attempted. A Cochrane risk of bias tool will be used. RESULTS This protocol has received funding, and searches of databases will commence at the end of May 2019. It is planned that this systematic review will be finalized for publication in (December) 2019. CONCLUSIONS Applying an implementation science evidence-based framework to the published literature may identify factors present in the data that impact on the implementation of PROMs into routine clinical care. This systematic review aims to improve understanding of how these factors impact the fidelity of this intervention, so that PROMs can be more effectively used in the care of patients. This systematic review can also offer more detailed information about the process and outcomes of successful implementation of PROMs.

scholarly journals Factors in Randomized Controlled Trials Reported to Impact the Implementation of Patient-Reported Outcome Measures Into Routine Care: Protocol for a Systematic Review

10.2196/14579 ◽  
2019 ◽  
Vol 8 (11) ◽  
pp. e14579
Author(s):  
Natasha Anne Roberts ◽  
Kimberly Alexander ◽  
David Wyld ◽  
Monika Janda
Keyword(s):  
Systematic Review ◽  
Clinical Practice ◽  
Randomized Controlled Trials ◽  
Patient Reported Outcome Measures ◽  
Patient Reported Outcome ◽  
Controlled Trials ◽  
Evidence Based ◽  
Randomized Controlled ◽  
Patient Reported ◽  
Implementation Factors

Background Patient-reported outcome measures (PROMs) are tools that enable patients to directly report their own assessments of well-being, or symptoms, in a structured and consistent way. Despite the usefulness of PROMs in optimizing health outcomes, their use in clinical practice is not routine. PROMs are complex to integrate into the clinical setting, with many elements potentially impacting on the success of implementation. For this reason, a protocol has been developed to guide a systematic review to collate information on implementation as presented in the randomized controlled trials (RCTs) to date. Objective The primary objective of this systematic review is to identify and synthesize factors available from RCT data about the fidelity of PROM interventions in clinical practice. The secondary objective will be an assessment of how implementation factors impact fidelity outcomes. Methods Preferred Reporting Items for Systematic Reviews and Meta-Analyses reporting standards will be followed. MEDLINE, EMBASE, and the Cumulative Index to Nursing and Allied Health Literature via OvidSP will be accessed using a defined search strategy. Grey literature and ClinicalTrials.gov will be reviewed for unpublished studies. Data extraction will be done to identify fidelity and factors impacting implementation, summarized using a narrative synthesis. An evidence-based implementation science framework will assist in identifying potential elements of importance and their effect on the process and outcomes of implementation. A meta-analysis to assess the impact of implementation factors will be attempted. A Cochrane risk of bias tool will be used. Results This protocol has received funding, and searches of databases will commence at the end of May 2019. It is planned that this systematic review will be finalized for publication in (December) 2019. Conclusions Applying an implementation science evidence-based framework to the published literature may identify factors present in the data that impact on the implementation of PROMs into routine clinical care. This systematic review aims to improve understanding of how these factors impact the fidelity of this intervention, so that PROMs can be more effectively used in the care of patients. This systematic review can also offer more detailed information about the process and outcomes of successful implementation of PROMs. International Registered Report Identifier (IRRID) PRR1-10.2196/14579

scholarly journals AB0766 ACCURACY OF PATIENT REPORTED OUTCOME REPORTING IN RANDOMIZED CONTROLLED TRIALS IN PSORIATIC ARTHRITIS

2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 1681.2-1681
Author(s):  
B. Frade-Sosa ◽  
A. Kerschbaumer ◽  
P. Studenic ◽  
E. Chwala ◽  
J. S. Smolen ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Clinical Trials ◽  
Psoriatic Arthritis ◽  
Randomized Controlled Trials ◽  
Well Being ◽  
Controlled Trials ◽  
Research Support ◽  
Randomized Controlled ◽  
Patient Reported

Background:Patient-reported outcomes (PROs) allow incorporating the patient’s perspective and health related quality of life (HRQoL) into shared decision making when choosing the optimal treatment strategy in patients suffering from psoriatic arthritis (PsA). PsA is a chronic inflammatory disease with heterogeneous manifestations with a range of symptoms, co-morbidities and reduced quality of life. International working groups (1) emphasized to integrate these outcomes as endpoints in clinical trials and as part of the core set of measures.Objectives:To evaluate the quality of PRO reporting in randomized clinical trials in PsA.Methods:We conducted a systematic literature review (PROSPERO ID 160930) searching PUBMED, MEDLINE and the Cochrane Library for publications (in English language) on randomized controlled trials investigating biological or targeted synthetic disease modifying drugs in adult PsA patients that included some PROs to evaluate the response to treatment. Two of the authors (BFS, AK) screened, selected and extracted the data of the trials that fulfilled inclusion criteria. Statistics were descriptive.Results:Of 1392 articles in total 880 were screened (512 duplicates); 92 were selected for detailed analysis with 48 finally analysed. 87% were primary publications were some patient-outcome measure were reported. The Health Assessment Questionnaire Disability Index (HAQ-DI) was reported in all RCTs (100%), while 70% of trials reported on the Short Form (36) Health Survey (SF36). Fatigue (FACIT-F) was reported in 29% of trials with different rates of articles published before and after the OMERACT working group recommendations (27% vs 50%) (1). Data on burden of psoriasis through the Dermatology Life Quality Index in 45%. Other PRO measurements to assess potentially affected health domains such as sleep disturbance, psychological disorders or well-being at work were reported only rarely.Conclusion:Our SLR shows that all trials report data on HAQ-DI. However, important domains as also emphasized by the OMERACT working group (1) are not routinely reported. Especially fatigue, included in 2016 as part of the OMERACT “Inner core” of the PsA Core Domain Set is only reported in about one quarter of studies, although 50% of studies published after 2016 report on fatigue. Data on emotional well-being, psychological status, productivity losses, and sleep disturbance remain rarely reported in PsA randomized controlled trials.References:[1]Orbai A, de Wit M, Mease P, et al International patient and physician consensus on a psoriatic arthritis core outcome set for clinical trials. Annals of the Rheumatic Diseases 2017;76:673-680.Acknowledgments:Acknowledgements: The author BFS had received an economic grant from the Spanish Society of Rheumatology (FER KERN-PHARMA Scholarships for Short stays: Plan for the promotion of research) and the Catalan Society of Rheumatology (BequesNovartis de formació per estades a l’estranger) for the research stay in Vienna (Austria).Disclosure of Interests:Beatriz Frade-Sosa Grant/research support from: FER KERN-PHARMA Scholarships for Short stays: Plan for the promotion of research. BequesNovartis de formació per estades a l’estranger, Andreas Kerschbaumer Paid instructor for: Celgene, Speakers bureau: Andreas Kerschbaumer has received lecture fees from Bristol-Myers Squibb, Gilead, Merck Sharp and Dohme and Pfizer., Paul Studenic Grant/research support from: Abbvie, Eva Chwala: None declared, Josef S. Smolen Grant/research support from: AbbVie, Eli Lilly, Janssen, Merck Sharp & Dohme, Pfizer, Roche – grant/research support, Consultant of: AbbVie, Amgen Inc., AstraZeneca, Astro, Celgene Corporation, Celtrion, Eli Lilly, Glaxo, ILTOO, Janssen, Medimmune, Merck Sharp & Dohme, Novartis, Pfizer, Roche, Samsung, Sanofi, UCB – consultant, Speakers bureau: AbbVie, Amgen Inc., AstraZeneca, Astro, Celgene Corporation, Celtrion, Eli Lilly, Glaxo, ILTOO, Janssen, Medimmune, Merck Sharp & Dohme, Novartis, Pfizer, Roche, Samsung, Sanofi, UCB – speaker, Daniel Aletaha Grant/research support from: AbbVie, Novartis, Roche, Consultant of: AbbVie, Amgen, Celgene, Lilly, Medac, Merck, Novartis, Pfizer, Roche, Sandoz, Sanofi Genzyme, Speakers bureau: AbbVie, Celgene, Lilly, Merck, Novartis, Pfizer, Sanofi Genzyme, UCB

Sign in / Sign up

Export Citation Format

Share Document