Background The geographic representation of investigators and participants in heart failure (HF) randomized clinical trials (RCTs) may not reflect the global burden of disease. Aims We assessed the geographic diversity of RCT leaders and explored associations with geographic representation of enrolled participants among impactful HF RCTs. Methods and Results We searched MEDLINE, EMBASE, and CINAHL for HF RCTs published in journals with impact factor ≥10 between January 2000 and June 2020. We used the Jonckheere-Terpstra test to assess temporal trends and multivariable logistic regression models to explore associations between predictors and outcomes. There were 414 eligible RCTs. Only 80 of 828 trial leaders (9.7%; 95% CI: 7.8% to 11.8%), and 453 of 4656 collaborators (9.7%; 95% CI: 8.8% to 10.6%) were from outside Europe and North America, with no change in temporal trends and greater disparities in large RCTs. The adjusted odds of trial leadership outside Europe and North America were lower with industry funding (aOR: 0.33; 95% CI: 0.15 to 0.75; P = 0.008). Among 157,416 participants in whom geography was reported, only 14.5% (95% CI: 14.3% to 14.7%) were enrolled outside Europe and North America, but odds of enrolment were ten-fold greater with trial leadership outside Europe and North America (aOR: 10.0; 95% CI 5.6–19.0; P < 0.001). Conclusions Regions disproportionately burdened with HF are under-represented in HF trial leadership, collaboration, and enrolment. RCT leadership outside Europe and North America is independently associated with participant enrolment in under-represented regions. Increasing research capacity outside Europe and North America could enhance trial diversity and generalizability.

Background: Heart failure has a disproportionate burden on patients who are Black, Indigenous, and people of color (BIPOC), but not much is known about representation of these groups in randomized controlled trials (RCTs). We explored temporal trends in and RCT factors associated with the reporting of race and ethnicity data and the enrollment of BIPOC in heart failure RCTs. Methods: We searched MEDLINE, EMBASE, and CINAHL for heart failure RCTs published in journals with an impact factor ≥10 between January 1, 2000 and June 17, 2020. We used the Cochran-Armitage and Jonchkeere-Terpstra tests to examine temporal trends, and multivariable regression to assess the association between trial characteristics and outcomes. Results: Of 414 RCTs meeting inclusion criteria, only 157 (37.9% [95% CI, 33.2%–2.8%]) reported race and ethnicity data. Among 158 200 participants in these 157 RCTs, 29 512 (18.7% [95% CI, 18.5%–18.9%]) were BIPOC. There was a temporal increase in reporting of race and ethnicity data (29.5% in 2000–2003 to 54.7% in 2016–2020, P <0.001) and in enrollment of BIPOC (14.4% in 2000–2003 to 22.2% in 2016–2020, P =0.038). Trial leadership by a woman was independently associated with twice the odds of reporting race and ethnicity data (odds ratio, 2.0 [95% CI, 1.1–3.8]; P =0.028) and an 8.4% increase (95% CI, 1.9%–15.0%; P =0.013) in BIPOC enrollment. Conclusions: A minority of heart failure RCTs reported race and ethnicity data, and among these, BIPOC were under-enrolled relative to disease distribution. Both reporting of race and ethnicity as well as enrollment of BIPOC increased between 2000 and 2020. After multivariable adjustment, trials led by women had greater odds of reporting race and ethnicity and enrolling BIPOC. REGISTRATION: URL: https://www.crd.york.ac.uk/PROSPERO/ ; Unique identifier: CRD42021237497.

Purpose To determine the efect of early MPFL reconstruction versus rehabilitation on the rate of recurrent patellar dislocations and functional outcomes in skeletally mature patients with traumatic, irst-time patellar dislocation. Methods Three online databases MEDLINE, PubMed and EMBASE were searched from database inception (1946, 1966, and 1974, respectively) to August 20th, 2021 for literature addressing the management of patients sustaining acute irsttime patellar dislocations. Data on redislocation rates, functional outcomes using the Kujala score, and complication rates were recorded. A meta-analysis was used to pool the mean postoperative Kujala score, as well as calculate the proportion of patients sustaining redislocation episodes using a random efects model. Quality assessment of included studies was performed for all included studies using the MINORS and Detsky scores. Results A total of 19 studies and 1,165 patients were included in this review. The pooled mean redislocation rate in 14 studies comprising 734 patients in the rehabilitation group was 30% (95% CI 25-36%, I 2 = 67%). Moreover, the pooled mean redislocation rate in 5 studies comprising 318 patients undergoing early MPFL reconstruction was 7% (95% CI 2-17%, I 2 = 70%). The pooled mean postoperative Kujala anterior knee pain score in 7 studies comprising 332 patients in the rehabilitation group was 81 (95% CI 78-85, I 2 = 78%), compared to a score of 87 (95% CI 85-89, I 2 = 0%, Fig. 4) in 3 studies comprising 54 patients in the reconstruction group. Conclusion Management of acute irst-time patellar dislocations with MPFL reconstruction resulted in a lower rate of redislocation of 7% in the reconstruction group vs 30% in the rehabilitation group and a higher Kujala score compared to the rehabilitation group. The information this review provides will help surgeons guide their decision to choose early MPFL reconstruction versus rehabilitation when treating patients with irst-time patellar dislocations and may guide future studies on the topic. Level of evidence IV.

Background Patient‐reported outcomes (PROs) are important measures of treatment response in heart failure. We assessed temporal trends in and factors associated with inclusion of PROs in heart failure randomized controlled trials (RCTs). Methods and Results We searched MEDLINE, Embase, and CINAHL for studies published between January 2000 and July 2020 in journals with an impact factor ≥10. We assessed temporal trends using the Jonckheere‐Terpstra test and conducted multivariable logistic regression to explore trial characteristics associated with PRO inclusion. We assessed the quality of PRO reporting using the Consolidated Standards of Reporting Trials (CONSORT) PRO extension. Of 417 RCTs included, PROs were reported in 226 (54.2%; 95% CI, 49.3%–59.1%), with increased reporting between 2000 and 2020 ( P <0.001). The odds of PRO inclusion were greater in RCTs that were published in recent years (adjusted odds ratio [aOR] per year, 1.08; 95% CI, 1.04–1.12; P <0.001), multicenter (aOR, 1.89; 95% CI, 1.03–3.46; P =0.040), medium‐sized (aOR, 2.35; 95% CI, 1.26–4.40; P =0.008), coordinated in Central and South America (aOR, 5.93; 95% CI, 1.14–30.97; P =0.035), and tested health service (aOR, 3.12; 95% CI, 1.49–6.55; P =0.003), device/surgical (aOR, 6.66; 95% CI, 3.15–14.05; P <0.001), or exercise (aOR, 4.66; 95% CI, 1.81–12.00; P =0.001) interventions. RCTs reported a median of 4 (interquartile interval , 3–6) of a possible of 11 CONSORT PRO items. Conclusions Just over half of all heart failure RCTs published in high impact factor journals between 2000 and 2020 included PROs, with increased inclusion of PROs over time. Trials that were large, tested pharmaceutical interventions, and coordinated in North America / Europe had lower adjusted odds of reporting PROs relative to other trials. The quality of PRO reporting was modest.

Hospital at home versus routine hospitalization for acute heart failure: A survey of patients' preferences,