Relationship between long-acting reversible contraception and acne in a cohort of adolescents and young adults.

BACKGROUND: The use of progestin-only long-acting reversible contraception (LARC) may be a risk factor for acne. Few studies have focused primarily on the effects of hormonal LARC on the development or exacerbation of acne in adolescents and young adults. We sought to understand the incidence and management of acne following hormonal LARC insertion in this adolescent/young adult population. METHODS: A secondary data analysis was conducted of prospectively collected quality improvement (QI) data from the Adolescent Medicine LARC Collaborative. Subjects were evaluated by clinicians in adolescent medicine clinics at participating study sites, and acne severity was documented using a standardized recording instrument and scale. Descriptive statistics were reported as frequencies and percentages for categorical variables or mean and standard deviation (SD) for continuous variables. We compared demographic and clinical characteristics by those who had worsening acne, accounting for site inter-correlation using Cochran-Mantel-Haenszel chi-square tests for categorical variables and linear generalized estimating equation (GEE) regression for continuous variables. RESULTS: Of 1319 subjects who completed LARC insertion, 28.5% (376/1319) experienced worsening acne following use of progestin-only LARC. Acne was a contributing factor to LARC removal in only 3% (40/1319), and the sole reason for removal in 0.4% (5/1319) of all subjects. As this was a secondary analysis of prospectively collected QI data, limitations of this study include incomplete or inaccurate documentation of acne severity. Moreover, LARC insertions without follow-up/removal visits or with only follow-up/removal within 8 weeks of insertion were excluded from our study, which may also bias results. CONCLUSIONS: Adolescents and young adults seeking progestin-only LARC should be counseled about the potential for developing acne or experiencing a worsening of existing acne during LARC use. However, acne was not a common reason for LARC discontinuation.

Characteristics and use of patient-reported outcomes of clinical trials for high-risk neurological medical devices that received FDA premarket approval from 2001 to 2022.

Neurological medical devices have revolutionized the management of neurological disorders, providing diagnostic, therapeutic, and monitoring solutions. High-risk neurological devices, such as deep brain stimulation and neurostimulators, offer groundbreaking treatments, emphasizing patient benefits while considering risks. To gain FDA approval, high-risk Class III devices necessitate premarket approval (PMA) applications with pivotal clinical trials, often assessing patient-reported outcomes (PROs). This article analyzes FDA-approved high-risk neurological devices from 2001 to 2022 via the PMA pathway. It explores device characteristics and pivotal clinical trials, and PRO incorporation. Of the 23 identified devices, pain neurology devices (30.4 %) predominated. All devices were therapeutic, with varying study designs. Pain neurology devices notably emphasized PRO endpoints as expected. This study underscores the significance of PROs in assessing device efficacy and safety, offering insights into regulatory processes and patient-centered care in neurological disorder management.

Delays to care in infantile epileptic spasms syndrome: Racial and ethnic inequities.

OBJECTIVE: Non-Hispanic (NH) Black children are less likely to receive a standard treatment course for infantile epileptic spasms syndrome (IESS) than White/NH children at pediatric tertiary care epilepsy centers in the United States. However, if inequities exist in time to diagnosis is unknown. Diagnostic delays as little as 1 week can be associated with worse developmental outcomes. METHODS: Diagnostic delays were evaluated in a retrospective cohort of 100 children with new onset IESS between January 2019 and May 2022. RESULTS: Children with Black, Indigenous, and People of Color (BIPOC) caregivers were more likely to experience clinically significant delays in referral from first provider to neurologist, when compared to White/NH children, even after controlling for other demographic and clinical variables (odds ratio = 4.98, confidence interval = 1.24-19.94, p = .023). SIGNIFICANCE: Disproportionate diagnostic delays place BIPOC children at risk of adverse developmental and epilepsy outcomes. Further interventional prospective and qualitative studies are needed to address inequities in care.

Continuation rates of hormonal intrauterine devices in adolescents and young adults when placed for contraceptive and non-contraceptive indications.

OBJECTIVE: This study aimed to estimate and compare continuation rates of hormonal intrauterine devices (IUDs) when placed for contraceptive or menstrual management indications in adolescents and young adults. STUDY DESIGN: We conducted a secondary analysis of a prospectively collected database of all hormonal IUD insertions from January 1, 2017 through December 31, 2020, with at least 1-year follow-up, across four Adolescent Medicine practices. IUD insertions without known indication were excluded. RESULTS: A total of 936 IUD insertions were attempted, 45% for contraception only, 18% for menstrual management only, and 37% for both indications. Insertion was successful in 868 (93%) attempts, and success did not differ by indication (p = 0.74). The mean age at insertion was 18.9 years (SD = 2.4 years), with no difference by indication. Of the completed insertions, 650 (75%) had at least one follow-up during the data analysis period. Excluding those without follow-up, the overall continuation rates were 77% at 1 year, 66% at 2 years, and 54% at 3 years. While continuation rates did not differ by indication at 1 year, at 3 years, continuation was highest among those who sought the device for menstrual management only (contraception = 53%, menstrual = 57%, both = 53%, p < 0.01) Malposition was rare (4.0%), as was device expulsion (2.5%), and these did not differ by indication. CONCLUSION: IUD continuation rates were high among adolescents and young adults and did not significantly differ when placed for contraceptive or non-contraceptive indication in the first year of use. IMPLICATIONS: Adolescents and young adults may seek the hormonal IUD for contraception and/or menstrual management. Our study found that IUD continuation rates were high at 1 year regardless of the indication for utilization.

Long-acting reversible contraception in gender-diverse adolescents and young adults: Outcomes from a multisite collaborative.

OBJECTIVES: This study aimed to describe the clinical experience of gender-diverse adolescents and young adults receiving long-acting reversible contraception (LARC). STUDY DESIGN: This was a secondary analysis of prospectively collected quality improvement data among gender-diverse adolescents and young adults receiving LARC in four adolescent medicine clinics. RESULTS: Most attempted insertions (59/63) were successful. A majority (54%) chose LARC for both contraception and menstrual management. Pelvic pain/cramping and unsatisfactory bleeding were reported side effects. One known expulsion and six known LARC removals occurred. CONCLUSIONS: Gender-diverse adolescents and young adults had high rates of successful LARC insertion and demonstrated a side effect profile similar to a broader adolescent and young adult population seeking LARC care. IMPLICATIONS: LARC is an important and well-tolerated method of menstrual management and contracention in gender-diverse adolescents and young adults, although more investigation is needed to understand how gender-affirming testosterone therapy may impact the LARC experience in this population.

Mimics of Pediatric Small Vessel Primary Angiitis of the Central Nervous System.

OBJECTIVE: Small vessel primary angiitis of the central nervous system is a rare and often severe disease characterized by central nervous system-restricted inflammatory vasculitis on histopathology. Diagnosis requires brain biopsy for confirmation and is suggested prior to starting immunotherapy when feasible. However, emerging evidence suggests that other neuroinflammatory conditions may have a clinical and radiographic phenotype that mimics small vessel primary angiitis, at times with overlapping pathologic features as well. Such diagnoses, including myelin oligodendrocyte glycoprotein antibody-associated disease and central nervous system-restricted hemophagocytic lymphohistiocytosis, can be non-invasively diagnosed with serum antibody or genetic testing that would prompt different monitoring and treatment paradigms. To determine the ultimate diagnosis of patients who were suspected prior to biopsy to have small vessel primary angiitis, we reviewed the clinical, radiographic, and pathological features of a cohort of patients at a single center undergoing brain biopsy for non-oncologic indications. METHODS: Clinical data were retrospectively extracted from the medical record. Pathology and neuroimaging review was conducted. RESULTS: We identified 21 patients over a 19-year time-period, of whom 14 (66.7%) were ultimately diagnosed with entities other than small vessel primary angiitis that would have obviated the need for brain biopsy. Diagnoses included anti-myelin oligodendrocyte glycoprotein antibody associated disease (n = 9), central nervous system-restricted hemophagocytic lymphohistiocytosis (n = 3), anti-GABAA receptor encephalitis (n = 1), and Aicardi-Goutières syndrome (n = 1). INTERPRETATION: This study highlights the importance of pursuing now readily available non-invasive testing for mimicking diagnoses before performing a brain biopsy for suspected small vessel primary angiitis of the central nervous system. ANN NEUROL 2023;93:109-119.