Category: Statistics

JAMA Netw Open. 2022 Oct 3;5(10):e2236123. doi: 10.1001/jamanetworkopen.2022.36123.

ABSTRACT

IMPORTANCE: Patients with chronic kidney disease and type 2 diabetes have a higher risk of developing pneumonia as well as an increased risk of severe COVID-19-associated adverse events and mortality. Therefore, the anti-inflammatory effects of mineralocorticoid receptor antagonists via blockade of the mineralocorticoid receptor may alter the risk of pneumonia and COVID-19-associated adverse events in patients with chronic kidney disease and type 2 diabetes.

OBJECTIVE: To evaluate whether the selective, nonsteroidal mineralocorticoid receptor antagonist finerenone is associated with protection against pneumonia and COVID-19 adverse events in patients with type 2 diabetes and chronic kidney disease.

DESIGN, SETTING, AND PARTICIPANTS: This secondary analysis used patient-level data from FIDELITY, a prespecified pooled analysis of 2 multicenter, double-blind, placebo-controlled, event-driven, phase 3 randomized clinical trials: FIDELIO-DKD and FIGARO-DKD, conducted between September 2015 and February 2021. Patients in FIDELIO-DKD or FIGARO-DKD with type 2 diabetes and chronic kidney disease (urine albumin to creatine ratio, 30-5000 mg/g, estimated glomerular filtration rate ≥25 mL/min/1.73 m2) were assessed. Data were analyzed from May 15, 2021, to July 28, 2022.

EXPOSURE: Patients were randomized to finerenone (10 or 20 mg once daily) or matching placebo.

MAIN OUTCOMES AND MEASURES: The main outcomes were investigator-reported incidences of treatment-emergent infective pneumonia adverse events and serious adverse events (during and up to 3 days after treatment) and any COVID-19 adverse events.

RESULTS: Of 13 026 randomized patients (mean [SD] age, 64.8 [9.5] years; 9088 [69.8%] men), 12 999 were included in the FIDELITY safety population (6510 patients receiving finerenone; 6489 patients receiving placebo). Over a median (range) treatment duration of 2.6 (0-5.1) years, finerenone was consistently associated with reduced risk of pneumonia and serious pneumonia vs placebo. Overall, 307 patients (4.7%) treated with finerenone and 434 patients (6.7%) treated with placebo experienced pneumonia (hazard ratio [HR], 0.71; 95% CI, 0.64-0.79; P < .001). Serious pneumonia occurred in 171 patients (2.6%) treated with finerenone and 250 patients (3.9%) treated with placebo (HR, 0.69; 95% CI, 0.60-0.79; P < .001). Incidence proportions of COVID-19 adverse events were 86 patients (1.3%) in the finerenone group and 118 patients (1.8%) in the placebo group (HR, 0.73; 95% CI, 0.60-0.89; P = .002).

CONCLUSIONS AND RELEVANCE: These findings suggest that mineralocorticoid receptor blockade with finerenone was associated with protection against pneumonia and COVID-19 adverse events in patients with type 2 diabetes and chronic kidney disease. Further clinical studies may be warranted.

TRIAL REGISTRATION: ClinicalTrials.gov identifiers: FIDELIO-DKD: NCT02540993; FIGARO-DKD: NCT02545049.

PMID:36287567 | DOI:10.1001/jamanetworkopen.2022.36123

JAMA Netw Open. 2022 Oct 3;5(10):e2238655. doi: 10.1001/jamanetworkopen.2022.38655.

ABSTRACT

IMPORTANCE: In order to equitably improve the residency application process, it is essential to understand the problems we need to address.

OBJECTIVE: To determine how obstetrics and gynecology (OBGYN) applicants and faculty communicate applicants’ interest to residency programs, and how program directors report being influenced by these communications.

DESIGN, SETTING, AND PARTICIPANTS: This survey study was conducted with email surveys of OBGYN application stakeholders in 2022. Included participants were OBGYN applicants, clerkship directors, and residency program directors in medical education associations’ email listservs.

EXPOSURES: Surveys sent by the American Association of Medical Colleges, Association of Professors of Gynecology and Obstetrics, and Council on Resident Education in Obstetrics and Gynecology.

MAIN OUTCOMES AND MEASURES: Whether applicants themselves, or faculty on their behalf, communicated to residency programs, and the influence program directors reported placing on these communications for their decision-making. Descriptive statistics and χ2 tests were used to analyze differences.

RESULTS: A total 726 of 2781 applicants (26.1%) responded to the survey and were included in analysis (79 of 249 [31.7%] clerkship directors; 200 of 280 [71.4%] program directors). The self-reported racial and ethnic demographics of the 726 applicant respondents were 86 Asian (11.8%), 54 Black (7.4%), 41 Latinx (5.6%), 1 Native Hawaiian or Pacific Islander (0.1%), 369 White (52.2%), 45 with multiple racial identities (6.2%), and 91 (21.5%) preferring not to answer. The majority of applicants (590 [82.9%]) sent communications at some point in the application process. Applicants who identified as White (336 [88.7%]) or Asian (75 [87.2%]) were more likely than those who identified as Black (40 [74.1%]) or Latinx (33 [80.5%]) to reach out to programs (P = .02). There were also differences in type of medical school, with 377 of 427 MD applicants (88.3%), 109 of 125 DO applicants (87.2%), and 67 of 87 International Medical Graduate applicants (77.7%) reporting sending communications (P = .02). Approximately one-third (254 applicants [35.7%]) had faculty reach out to programs on their behalf. White (152 [40.1%]) and Asian (37 [43.0%]) applicants were more likely to have faculty reach out compared with Black (6 [11.1%]) and Latinx (12 [29.3%]) applicants (P = .01). Program directors reported that preinterview communications from faculty they knew (64 [32.2%]) and other program directors (25 [12.6%]) strongly influenced their decisions, and otherwise rarely reported that communications strongly influenced their decisions.

CONCLUSIONS AND RELEVANCE: The current state of communications may increase inequities in residency application processes; differences between faculty communications for applicants from different racial and ethnic backgrounds are particularly concerning given that program directors are more likely to weigh communications from faculty in their decision-making. A centralized, equitable means for applicants to signal their interest to programs is urgently needed.

PMID:36287561 | DOI:10.1001/jamanetworkopen.2022.38655

JAMA Surg. 2022 Oct 26. doi: 10.1001/jamasurg.2022.4883. Online ahead of print.

NO ABSTRACT

PMID:36287556 | DOI:10.1001/jamasurg.2022.4883

JAMA Surg. 2022 Oct 26. doi: 10.1001/jamasurg.2022.4886. Online ahead of print.

NO ABSTRACT

PMID:36287552 | DOI:10.1001/jamasurg.2022.4886

JAMA Surg. 2022 Oct 26. doi: 10.1001/jamasurg.2022.4907. Online ahead of print.

NO ABSTRACT

PMID:36287548 | DOI:10.1001/jamasurg.2022.4907

JAMA Surg. 2022 Oct 26. doi: 10.1001/jamasurg.2022.4889. Online ahead of print.

NO ABSTRACT

PMID:36287547 | DOI:10.1001/jamasurg.2022.4889

JAMA Surg. 2022 Oct 26. doi: 10.1001/jamasurg.2022.4898. Online ahead of print.

NO ABSTRACT

PMID:36287542 | DOI:10.1001/jamasurg.2022.4898

JAMA Dermatol. 2022 Oct 26. doi: 10.1001/jamadermatol.2022.3911. Online ahead of print.

ABSTRACT

IMPORTANCE: Acne and rosacea have substantial implications for quality of life, and it is therefore important to ensure the patient’s voice is being captured in pivotal randomized clinical trials (RCTs). Although patient-reported outcome measures (PROMs) are a valuable tool to capture the patient perspective, little is known about use of PROMs in RCTs on acne and rosacea.

OBJECTIVE: To characterize the use of PROMs in RCTs on acne and rosacea.

EVIDENCE REVIEW: A systematic literature search was conducted using the search terms acne vulgaris and rosacea in the following databases: MEDLINE through PubMed, Embase, Cochrane Central Register of Controlled Trials, and Cochrane Database of Systematic Reviews. A modified search hedge for RCTs from the McGill Library was applied. All phase 2, 3, and 4 RCTs published between December 31, 2011, through December 31, 2021, that evaluated the efficacy and safety of therapies for acne and rosacea vs any comparator were eligible for inclusion.

FINDINGS: A total of 2461 publications describing RCTs were identified, of which 206 RCTs met the inclusion criteria (163 trials [79%] on acne and 43 [21%] on rosacea). At least 1 PROM was used in 53% of trials (110) included; PROM use was more common in rosacea RCTs (67% [n = 29]) compared with acne RCTs (50% [n = 81]). At least 1 dermatology-specific (13% [n = 27]) or disease-specific (14% [n = 28]) PROM was included in the RCTs analyzed. Only 7% of trials (14) included a PROM as a primary outcome measure. There was no statistically significant increase in PROM inclusion over the study period (11 of 21 trials in 2011 vs 5 of 12 trials in 2021).

CONCLUSIONS AND RELEVANCE: In this systematic review, PROMs were included in approximately one-half of acne and rosacea RCTs performed over the study period. In addition, PROMs were rarely used as a primary outcome measure, and inclusion of PROMs has not increased substantially over the past 10 years. Increasing use of PROMs in RCTs can ensure that the patient’s perspective is captured during the development of new treatments for acne and rosacea.

PMID:36287541 | DOI:10.1001/jamadermatol.2022.3911

JAMA Surg. 2022 Oct 26. doi: 10.1001/jamasurg.2022.4904. Online ahead of print.

NO ABSTRACT

PMID:36287539 | DOI:10.1001/jamasurg.2022.4904

JAMA Psychiatry. 2022 Oct 26. doi: 10.1001/jamapsychiatry.2022.3475. Online ahead of print.

ABSTRACT

IMPORTANCE: Psychiatric disorders are common among autistic children and adults. Little is known about sex differences in psychiatric disorders and hospitalization in early adulthood.

OBJECTIVE: To examine sex differences in psychiatric diagnoses and hospitalizations in autistic compared with nonautistic young adults.

DESIGN, SETTING, AND PARTICIPANTS: This population-based cohort study assessed all individuals born in Sweden between 1985 and 1997. A total of 1 335 753 individuals, including 20 841 autistic individuals (7129 [34.2%] female individuals), were followed up from age 16 through 24 years between 2001 and 2013. Analysis took place between June 2021 and August 2022.

EXPOSURES: Autism was defined as having received at least 1 clinical diagnosis of autism based on the International Classification of Diseases.

MAIN OUTCOMES AND MEASURES: The cumulative incidence of 11 psychiatric diagnoses up until age 25 years was estimated, and birth year-standardized risk difference was used to compare autistic female and male individuals directly. Sex-specific birth year-adjusted hazard ratios (HRs) with 95% CIs were calculated using Cox regression. Analyses were repeated for inpatient diagnoses to assess psychiatric hospitalization.

RESULTS: Of 1 335 753 individuals included in this study, 650 314 (48.7%) were assigned female at birth. Autism was clinically diagnosed in 20 841 individuals (1.6%; 7129 [34.2%] female) with a mean (SD) age of 16.1 (5.1) years (17.0 [4.8] years in female individuals and 15.7 [5.2] years in male individuals) for the first recorded autism diagnosis. For most disorders, autistic female individuals were at higher risk for psychiatric diagnoses and hospitalizations. By age 25 years, 77 of 100 autistic female individuals and 62 of 100 autistic male individuals received at least 1 psychiatric diagnosis. Statistically significant standardized risk differences were observed between autistic female and male individuals for any psychiatric disorder (-0.18; 95% CI, -0.26 to -0.10) and specifically for anxiety, depressive, and sleep disorders. Risk differences were larger among autistic than nonautistic individuals. Compared with nonautistic same-sex individuals, autistic female individuals (HR range [95% CI], 3.17 [2.50-4.04.]-20.78 [18.48-23.37]) and male individuals (HR range [95% CI], 2.98 [2.75-3.23]-18.52 [17.07-20.08]) were both at increased risk for all psychiatric diagnoses. Any psychiatric hospitalization was statistically significantly more common in autistic female individuals (32 of 100) compared with autistic male individuals (19 of 100). However, both autistic female and male individuals had a higher relative risk for psychiatric hospitalization compared with nonautistic female and male individuals for all disorders (female individuals: HR range [95% CI], 5.55 [4.63-6.66]-26.30 [21.50-32.16]; male individuals: HR range [95% CI], 3.79 [3.22-4.45]-29.36 [24.04-35.87]).

CONCLUSIONS AND RELEVANCE: These findings highlight the need for profound mental health services among autistic young adults. Autistic female individuals, who experience more psychiatric difficulties at different levels of care, require increased clinical surveillance and support.

PMID:36287538 | DOI:10.1001/jamapsychiatry.2022.3475