Dataset Information

Patient-Reported Outcomes in Cardiovascular Trials.

ABSTRACT: Patient-reported outcomes (PROs) are reports of a person's health status that provide a global perspective of patient well-being. PROs can be classified into 4 primary domains: global, mental, physical, and social health. In this descriptive review, we focus on how PROs can be used in cardiac clinical trials, with an emphasis on cardiac surgical trials for patients with coronary heart disease and heart failure. We also highlight ongoing challenges and provide specific suggestions and novel opportunities to advance cardiac clinical trials. Current challenges include the long-term measurement of PROs in clinical trials beyond 1 year, inconsistency in the choice of the outcome measures among studies, and the lack of measurement of PROs across multiple domains. Opportunities for advancement include measuring PROs using consumer health informatics tools, including returning information back to participants in formats that they can understand using visualization. Future opportunities include quantifying cohort-specific minimal clinically important differences for PROs.

SUBMITTER: Masterson Creber R

PROVIDER: S-EPMC8487900 | biostudies-literature | 2021 Sep

REPOSITORIES: biostudies-literature

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Patient-Reported Outcomes in Cardiovascular Trials.

Masterson Creber Ruth R Spadaccio Cristiano C Dimagli Arnaldo A Myers Annie A Taylor Brittany B Fremes Stephen S

The Canadian journal of cardiology 20210508 9

Patient-reported outcomes (PROs) are reports of a person's health status that provide a global perspective of patient well-being. PROs can be classified into 4 primary domains: global, mental, physical, and social health. In this descriptive review, we focus on how PROs can be used in cardiac clinical trials, with an emphasis on cardiac surgical trials for patients with coronary heart disease and heart failure. We also highlight ongoing challenges and provide specific suggestions and novel oppor ...[more]

PMID: 33974992

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Project description:ObjectivesTo systematically assess the type of outcomes selected and the prevalence of patient reported outcomes in contemporary cardiovascular trials and to quantify any misuse or underuse of patient reported outcomes using a specially developed tool that would allow estimation of the relevance of such outcomes to clinical decision making.DesignSystematic review.Data sourcesMedline and Embase.Study selectionRandomised controlled trials of the treatment for or prevention of cardiovascular disease published in 10 leading general medical and cardiology journals from January 2005 to December 2008.ResultsPrimary outcomes were patient important (death, morbidity, or patient reported outcomes) in only 93 of 413 trials (23%, SE 2%), whereas another 92 (22%, SE 2%) combined these outcomes with other less important ones into a composite. Sixty five trials (16%; SE 2%) used at least one instrument to measure patient reported outcomes, mostly in trials where such information would have been important or crucial for clinical decision making (52 trials). Patient reported outcomes were judged to be of little incremental value to a large number of, mostly explanatory, cardiovascular trials (152 trials). However, many trials in which patient reported outcomes would have been important or crucial for clinical decision making did not report such outcomes (122 of 174 trials, 70%). These included several trials that primarily aimed to improve symptoms or functional status, trials that tested interventions with a considerable potential for causing harm (mainly bleeding) that were not meaningfully measured, and trials with composite outcomes that were dominated by outcomes of questionable importance to patients.ConclusionsDespite a continued rise in the reporting of patient reported outcomes with no evidence for their misuse in more recent cardiovascular trials, they seem to be still underused once their relevance to clinical decision making has been taken into account. This was largely explained by inappropriate use of composite outcomes and inadequate measurement of harms.

Project description:BackgroundLymphoma treatment can lead to long-term consequences such as fatigue, infertility and organ damage. In clinical trials, survival outcomes, clinical response and toxicity are extensively reported while the assessment of treatment on quality of life (QoL) and symptoms is often lacking.ObjectiveWe evaluated the use and frequency of patient-reported outcome (PRO) instruments used in randomized controlled trials (RCTs) for Hodgkin lymphoma (HL) and their consistency of reporting.MethodsMEDLINE, CENTRAL and trial registries for RCTs investigating HL were systematically searched from 01/01/2016 to 31/05/2022. Following trial selection, trial, patient characteristics and outcome data on the use of PRO measures (PROMs) and reporting of PROs using a pre-defined extraction form were extracted. To assess reporting consistency, trial registries, protocols and publications were compared.ResultsWe identified 4,222 records. Following screening, a total of 317 reports were eligible for full-text evaluation. One hundred sixty-six reports of 51 ongoing/completed trials were included, of which 41% of trials were completed and 49% were ongoing based on registry entries. Full-text or abstract were available for 33 trials. Seventy percent of trials were conducted in the newly diagnosed disease setting, the majority with advanced HL. In 32 trials with published follow-up data, the median follow-up was 5.2 years. Eighteen (35%) completed/ongoing trials had mentioned PRO assessment in registry entries, protocol or publications. Twelve trials (67%) had published results and only 6 trials (50%) reported on PROs in part with the exception of 1 trial where PROs were evaluated as secondary/exploratory outcome. The most referenced global PROM was the EORTC-QLQ-C30 (12 studies), the EQ-5D (3 studies) and the FACT-Neurotoxicity (3 studies). FACT-Lymphoma, a disease-specific PROM for non-HL was mentioned in one ongoing trial. None of the trials referenced the EORTC QLQ-HL27, another disease-specific PROM developed specifically for HL patient's QoL assessment.DiscussionsOnly one-third of RCTs in HL report PROs as an outcome and only half present the outcome in subsequent publications, showcasing the underreporting of PROs in trials. Disease-specific PROMs are underutilized in the assessment of QoL in HL patients. Guidance on the assessment of PROs is needed to inform on comprehensive outcomes important to patients.Systematic review registrationhttps://www.crd.york.ac.uk/PROSPERO/display_record.php?RecordID=391552, identifier CRD42023391552.

Project description:Background Atherosclerotic cardiovascular disease ( ASCVD ) accounts for approximately one third of deaths in women. Although there is an established relationship between positive patient experiences, health-related quality of life, and improved health outcomes, little is known about gender differences in patient-reported outcomes among ASCVD patients. We therefore compared gender differences in patient-centered outcomes among individuals with ASCVD . Methods and Results Data from the 2006 to 2015 Medical Expenditure Panel Survey, a nationally representative US sample, were used for this study. Adults ?18 years with a diagnosis of ASCVD , ascertained by International Classification of Diseases, Ninth Revision ( ICD-9) codes and/or self-reported data, were included. Linear and logistic regression were used to compare self-reported patient experience, perception of health, and health-related quality of life by gender. Models adjusted for demographics, socioeconomic status, and comorbidities. There were 21 353 participants included, with >10 000 (47%-weighted) of the participants being women, representing ?11 million female adults with ASCVD nationwide. Compared with men, women with ASCVD were more likely to experience poor patient-provider communication (odds ratio 1.25 [95% confidence interval 1.11-1.41]), lower healthcare satisfaction (1.12 [1.02-1.24]), poor perception of health status (1.15 [1.04-1.28]), and lower health-related quality of life scores. Women with ASCVD also had lower use of aspirin and statins, and greater odds of ?2 Emergency Department visits/y. Conclusions Women with ASCVD were more likely to report poorer patient experience, lower health-related quality of life, and poorer perception of their health when compared with men. These findings have important public health implications and require more research towards understanding the gender-specific differences in healthcare quality, delivery, and ultimately health outcomes among individuals with ASCVD .

Dataset Information

Patient-Reported Outcomes in Cardiovascular Trials.

Publications

Patient-Reported Outcomes in Cardiovascular Trials.

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