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Relationship Between Enrolling Country Income Level and Patient Profile, Protocol Completion, and Trial End Points.

ABSTRACT: BACKGROUND:Globalization of clinical trials fosters inclusion of higher and lower income countries, but the influence of enrolling country income level on heart failure trial performance is unclear. This study sought to evaluate associations between enrolling country income level, acute heart failure patient profile, protocol completion, and trial end points. METHODS AND RESULTS:The ASCEND-HF (Acute Study of Clinical Effectiveness of Nesiritide in Decompensated Heart Failure) trial included 7141 patients with acute heart failure from 30 countries. Country income data in gross national income per capita in current US dollars from the year 2007 (ie, the year trial enrollment began) were abstracted from the World Bank. Patients were grouped by enrolling country income level (ie, high [>$11 455], upper middle [$3706-$11 455], lower middle [$936-$3705], and low [<$936]). Income data were available for 29 (97%) countries (N=7064). There were 3996 (57%), 1518 (21%), and 1550 (22%) patients from high-income, upper-middle-income, and lower-middle-income countries, respectively. There were no patients from low-income countries. Patients from lower-middle-income countries tended to be younger with fewer comorbidities and lower utilization of guideline-directed therapies. Rates of adverse events (13.8%) and protocol noncompletion (4.9%) during 180-day follow-up were highest among high-income countries (all P <0.01). After adjustment for race, geographic region, and clinical characteristics, compared with lower-middle-income countries, enrollment from higher income countries was associated with increased 30-day mortality or rehospitalization (high income: odds ratio, 1.70; 95% CI, 1.02-2.85; upper-middle-income: odds ratio, 2.16; 95% CI, 1.23-3.81), driven by higher rates of rehospitalization. Mortality was similar at 30 and 180 days. The association between higher country income and the 30-day composite end point was similar across geographic regions, with exception of Latin America ( P for interaction, 0.03). CONCLUSIONS:In this global acute heart failure trial, patients from higher income countries had lower rates of protocol completion, higher rates of adverse events, and similar mortality rates. After adjustment for race, geographic region, and clinical factors, enrollment from a higher income country was associated with worse clinical outcomes, driven by higher rates of rehospitalization. Variation in enrolling country income level may influence study end points and trial performance independent of geographic region. CLINICAL TRIAL REGISTRATION:URL: https://www.clinicaltrials.gov . Unique identifier: NCT00475852.

SUBMITTER: Greene SJ

PROVIDER: S-EPMC6208149 | biostudies-literature | 2018 Oct

REPOSITORIES: biostudies-literature

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Relationship Between Enrolling Country Income Level and Patient Profile, Protocol Completion, and Trial End Points.

Greene Stephen J SJ Hernandez Adrian F AF Sun Jie-Lena JL Butler Javed J Armstrong Paul W PW Ezekowitz Justin A JA Zannad Faiez F Ferreira João Pedro JP Coles Adrian A Metra Marco M Voors Adriaan A AA Califf Robert M RM O'Connor Christopher M CM Mentz Robert J RJ

Circulation. Cardiovascular quality and outcomes 20181001 10

<h4>Background</h4>Globalization of clinical trials fosters inclusion of higher and lower income countries, but the influence of enrolling country income level on heart failure trial performance is unclear. This study sought to evaluate associations between enrolling country income level, acute heart failure patient profile, protocol completion, and trial end points.<h4>Methods and results</h4>The ASCEND-HF (Acute Study of Clinical Effectiveness of Nesiritide in Decompensated Heart Failure) tria ...[more]

PMID: 30354576

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Project description:BackgroundThe rapid development and rollout of COVID-19 vaccines helped reduce the pandemic's mortality burden. The vaccine rollout, however, has been uneven; it is well known that vaccination rates tend to be lower in lower income countries. Vaccine uptake, however, ultimately depends on the willingness of individuals to get vaccinated. If vaccine confidence is low, then uptake will be low, regardless of country income level. We investigated the impact on country-level COVID-19 vaccination rates of both national income and vaccine hesitancy.MethodsWe estimated a linear regression model of COVID-19 vaccine uptake across 145 countries; this cross-sectional model was estimated at each of four time points: 6, 12, 18, and 24 months after the onset of global vaccine distribution. Vaccine uptake reflects the percentage of the population that had completed their primary vaccination series at the time point. Covariates include per capita GDP, an estimate of the percentage of country residents who strongly disagreed that vaccines are safe, and a variety of control variables. Next, we estimated these models of vaccine uptake by country income (countries below, and above the international median per capita GDP) to examine whether the impact of vaccine hesitancy varies by country income.ResultsWe find that GDP per capita has a pronounced impact on vaccine uptake at 6 months after global rollout. After controlling for other factors, there was a 22 percentage point difference in vaccination rates between the top 20% and the bottom 20% of countries ranked by per capita GDP; this difference grew to 38% by 12 months. The deleterious impact of distrust of vaccine safety on vaccine uptake became apparent by 12 months and then increased over time. At 24 months, there was a 17% difference in vaccination rates between the top 20% and the bottom 20% of countries ranked by distrust. The income stratified models reveal that the deleterious impact of vaccine distrust on vaccine uptake at 12 and 24 months is particularly evident in lower income countries.ConclusionsOur study highlights the important role of both national income and vaccine hesitancy in determining COVID-19 vaccine uptake globally. There is a need to increase the supply and distribution of pandemic vaccines to lower-income countries, and to take measures to improve vaccine confidence in these countries.

Project description:BackgroundIn 2020, the Global Cancer Observatory reported 280,000 cases of childhood cancer worldwide, with a higher burden of disease and mortality rates in low- and middle-income countries. In 2022, the National Institute of Health reported 1708 new cases of childhood cancer in Colombia and an overall survival rate of approximately 55%. The aim of this study is to compare outcomes in children with cancer in the hospital setting during the last 72 h of life who received concurrent Pediatric Palliative Care (PPC) versus oncology care alone.MethodsAn observational descriptive study was conducted between January 2013 and June 2022 in a center for pediatric patients with oncological diagnoses. In 2017, the PPC team was created. Patients between 28 days and 17 years of age who were hospitalized at least 72 h before death were included. A retrospective review of the medical records of patients in the last 72 h of life was performed. Two cohorts were established: oncology-alone group received exclusive management by oncology, and oncology and PPC received concurrent oncology and PPC management since the diagnosis.ResultsWe evaluated 257 medical records of deceased pediatric patients with cancer diagnoses. For the first cohort (2013-2017), 136 patients were included; for the second cohort (2018 and 2022), 121 patients were evaluated. The most frequent diagnosis was leukemia [47.1% (n = 121)]. No significant difference was found in either group between dyspnea, pain, and seizures. Dyspnea was the most frequent symptom in both groups. Agitation and anxiety were reported more frequently in children from the oncology-alone group (22.1% and 13.2%, respectively). The oncology and PPC group received more psychology and social work consultation (94.2% and 70.2% vs. 84.6 and 54.4% in the oncology alone group) and had a higher percentage of advance care planning (79.3% vs. 62.5% in the oncology alone group).ConclusionsThis retrospective study highlights that PPC at the end of life (EoL) offers a holistic approach to the physical and psychosocial symptoms experienced by children with cancer; these patients received more comfort through symptom management and less aggressive treatment at the EoL. The availability of a PPC team may contribute to improvements in the quality of end-of-life care.Trial registrationretrospectively registered.

Project description:ImportanceMetabolic and bariatric surgery (MBS) is an effective and safe treatment for obesity and its comorbidities, but less than 50% of those who are eligible and referred for MBS complete the procedure. The patient-physician relationship could be a decisive factor in the decision to complete MBS; however, this relationship has not been explored, particularly among racially and ethnically diverse populations.ObjectiveTo examine the association between patient-reported satisfaction with their patient-physician relationship and MBS completion by self-reported racial and ethnic group.Design, setting, and participantsThis prospective cohort study included 408 patients who were referred to a bariatric surgeon or obesity medicine program between July 24, 2019, and May 19, 2022.ExposurePatient satisfaction with their physician was measured by 7 dimensions (general satisfaction, technical quality, interpersonal manner, communication, financial aspects, time spent with physician, and accessibility and convenience) using the Patient Satisfaction Questionnaire Short Form.Main outcomes and measuresCompletion status for MBS (yes or no).ResultsA total of 408 patients (mean [SD] age, 47.3 [11.6] years; among 366 with data available, 317 [86.6%] women and 49 [13.4%] men) were included in the study. Of 363 patients with data available on race and ethnicity, 66 were Hispanic/Latinx (18.2%), 136 (37.5%) were non-Hispanic Black, 146 (40.2%) were non-Hispanic White, and 15 (4.1%) were other race or ethnicity. A total of 124 patients (30.4%) completed MBS. Overall, the mean (SD) patient satisfaction score was significantly greater in MBS completers vs noncompleters (3.86 [0.56] vs 3.61 [0.64]; P < .001). Multivariable logistic regression analysis showed technical quality was the most significant factor for MBS completion (adjusted odds ratio [aOR], 1.99 [95% CI, 1.24-3.19]), followed by communication (aOR, 1.78 [95% CI, 1.16-2.72]) and accessibility and convenience (aOR, 1.61 [95% CI, 1.03-2.53]). The interaction between racial and ethnic groups and patient satisfaction was not significant (eg, mean [SD] score for Hispanic/Latinx completers, 3.95 [0.55] vs 3.77 [0.60] for non-Hispanic White completers; P = .46 for interaction).Conclusions and relevanceThese findings suggest that there is an association between patient satisfaction with the patient-physician relationship and the decision to complete MBS regardless of race and ethnicity. These findings have important implications for strategies to improve the proportion of qualified patients who complete MBS to achieve improved health outcomes.

Project description:BackgroundThe recent Lancet Commission on Legal Determinants of Global Health argues that governance can provide the framework for achieving sustainable development goals. Even though over 90% of fatal road traffic injuries occur in low- and middle-income countries (LMICs) primarily affecting motorcyclists, the utility of helmet laws outside of high-income settings has not been well characterized. We sought to evaluate the differences in outcomes of mandatory motorcycle helmet legislation and determine whether these varied across country income levels.Methods and findingsA systematic review and meta-analysis were completed using the PRISMA checklist. A search for relevant articles was conducted using the PubMed, Embase, and Web of Science databases from January 1, 1990 to August 8, 2021. Studies were included if they evaluated helmet usage, mortality from motorcycle crash, or traumatic brain injury (TBI) incidence, with and without enactment of a mandatory helmet law as the intervention. The Newcastle-Ottawa Scale (NOS) was used to rate study quality and funnel plots, and Begg's and Egger's tests were used to assess for small study bias. Pooled odds ratios (ORs) and their 95% confidence intervals (CIs) were stratified by high-income countries (HICs) versus LMICs using the random-effects model. Twenty-five articles were included in the final analysis encompassing a total study population of 31,949,418 people. There were 17 retrospective cohort studies, 2 prospective cohort studies, 1 case-control study, and 5 pre-post design studies. There were 16 studies from HICs and 9 from LMICs. The median NOS score was 6 with a range of 4 to 9. All studies demonstrated higher odds of helmet usage after implementation of helmet law; however, the results were statistically significantly greater in HICs (OR: 53.5; 95% CI: 28.4; 100.7) than in LMICs (OR: 4.82; 95% CI: 3.58; 6.49), p-value comparing both strata < 0.0001. There were significantly lower odds of motorcycle fatalities after enactment of helmet legislation (OR: 0.71; 95% CI: 0.61; 0.83) with no significant difference by income classification, p-value: 0.27. Odds of TBI were statistically significantly lower in HICs (OR: 0.61, 95% CI 0.54 to 0.69) than in LMICs (0.79, 95% CI 0.72 to 0.86) after enactment of law (p-value: 0.0001). Limitations of this study include variability in the methodologies and data sources in the studies included in the meta-analysis as well as the lack of available literature from the lowest income countries or from the African WHO region, in which helmet laws are least commonly present.ConclusionsIn this study, we observed that mandatory helmet laws had substantial public health benefits in all income contexts, but some outcomes were diminished in LMIC settings where additional measures such as public education and law enforcement might play critical roles.

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Relationship Between Enrolling Country Income Level and Patient Profile, Protocol Completion, and Trial End Points.

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Relationship Between Enrolling Country Income Level and Patient Profile, Protocol Completion, and Trial End Points.

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