Lessons learned from a multi-data source research collaboration: The mirabegron post-authorization safety study program.

Background: Many factors contribute to developing and conducting a successful multi-data source, non-interventional, post-authorization safety study (NI-PASS) for submission to multiple health authorities. Such studies are often large undertakings; evaluating and sharing lessons learned can provide useful insights to others considering similar studies.

Objectives: We discuss challenges and key methodological and organizational factors that led to the delivery of a successful post-marketing requirement (PMR)/PASS program investigating the risk of cardiovascular and cancer events among users of mirabegron, an oral medication for the treatment of overactive bladder.

Systematic Literature Review of Risk Factors for Poor Outcomes Among Adults With Respiratory Syncytial Virus Infection in High-Income Countries.

Unlabelled: Identification of risk factors for severe respiratory syncytial virus (RSV) disease in adults could facilitate their appropriate vaccine recommendations. We conducted a systematic literature review (last 10 years in PubMed/Embase) to identify quantitative estimates of risk factors for severe RSV infection outcomes in high-income countries. Severe outcomes from RSV infection included hospitalization, excess mortality, lower respiratory tract infection, or a composite measure: severe RSV, which included these outcomes and others, such as mechanical ventilation and extended hospital stay.

Validation of an ICD-10 case-finding algorithm for endometrial cancer in US insurance claims.

Purpose: To evaluate the positive predictive value (PPV) of an endometrial cancer case finding algorithm using International Classification of Disease 10th revision Clinical Modification (ICD-10-CM) diagnosis codes from US insurance claims for implementation in a planned post-marketing safety study. Two algorithm variants were evaluated.

Methods: Provisional incident endometrial cancer cases were identified from 2016 through 2020 among women aged ≥50 years.

Distribution of gestational age at birth by maternal and infant characteristics in U.S. birth certificate data: Informing gestational age assumptions when clinical estimates are not available.

Purpose: We aimed to describe the distribution of gestational age at birth (GAB) to inform the estimation of GAB when clinical or obstetric estimates are not available for perinatal pharmacoepidemiology studies.

Methods: We estimated GAB (median, mode, mean, and standard deviation) and percentage born at each gestational week in groups based on plurality and other variables for live births in CDC's U.S.

Surgical Management of Hidradenitis Suppurativa: Factors Associated with Postoperative Complications and Disease Recurrence.

Unlabelled: Hidradenitis suppurativa (HS) is a chronic inflammatory skin disorder. Treatment of HS remains challenging, and surgical procedures commonly follow attempts of conservative therapy. To date, a consensus regarding the optimal surgical technique has not been reached, and the implications of conservative therapy on future surgical outcomes have yet to be studied.