Publications by authors named "Ann McMahon"

Aims: (1) Identify and characterise the nursing contribution to impact case studies submitted to Research Excellence Framework (REF) 2021 across all Units of Assessment and compare this to those submitted to REF 2014; (2) Identify and characterise those impact case studies of relevance to nursing that did not include a nurse in the research team; (3) Compare the characteristics of impact case studies identified in Aim 2 with those that did include a nurse in the research team.

Design: Desk-based analysis of REF2021 published data.

Methods: We searched the REF2021 impact database with the term nurs* then sorted case studies into categories representing the involvement of nurses on the research team.

View Article and Find Full Text PDF

We conducted retrospective public health surveillance using data from 2006 to 2016 in seven integrated delivery systems from FDA's Sentinel System. We identified pediatric hypertensive patients by clinical and claims-based definitions and compared demographics, baseline profiles and follow-up time profiles. Among 3,757,803 pediatric patients aged 3 to 17 years, we identified 781,722 children and 551,246 teens with at least three blood pressure measures over 36-months.

View Article and Find Full Text PDF

Purpose: Given limited information available on real-world data (RWD) sources with pediatric populations, this study describes features of globally available RWD sources for pediatric pharmacoepidemiologic research.

Methods: An online questionnaire about pediatric RWD sources and their attributes and capabilities was completed by members and affiliates of the International Society for Pharmacoepidemiology and representatives of nominated databases. All responses were verified by database representatives and summarized.

View Article and Find Full Text PDF

To streamline drug development, the United States Food and Drug Administration (FDA) can consider the extrapolation of adult efficacy data to children when the disease and drug effects are sufficiently similar. This study explored whether the relationship between drug exposure and response for selected drugs in systemic lupus erythematosus (SLE) was sufficiently similar to support a consideration of the extrapolation of adult efficacy data to children of ≥5 years of age. An exposure-response analysis of drugs used to treat SLE was conducted using published exposure versus response and efficacy versus time data.

View Article and Find Full Text PDF

This cross-sectional study investigates the use of real-world data and real-world evidence in informing medicine efficacy in pediatric literature.

View Article and Find Full Text PDF

Pediatric safety evaluations are an essential part of a pediatric drug development program. Communication of the results of these safety evaluations is primarily accomplished by labeling of the drug either during the initial pediatric drug development program, or during the postmarketing period after drug approval for pediatric patients. During drug development, the dose-adverse drug event (ADE) relationship is an important part of the evaluation, but a consideration for pediatric ADEs that are unrelated to drug dosage must be maintained.

View Article and Find Full Text PDF

Objective: This scoping review mapped studies using real-world data (RWD) to measure pediatric safety and effectiveness of vaccines administered to pregnant women.

Introduction: In the US, two vaccines are recommended for all pregnant women to prevent illness in the infant: inactivated influenza vaccine (recommended since 2004), and the combined tetanus-diphtheria-acellular pertussis (Tdap) vaccine (recommended since 2013). This scoping review maps the studies conducted to date that address questions about pediatric safety and effectiveness of vaccines administered during pregnancy and provides a knowledge base for evaluating the use of RWD to study this issue.

View Article and Find Full Text PDF

Objective: This scoping review aims to map studies using real-world data (RWD) to measure pediatric safety and effectiveness of vaccines administered to pregnant women.

Introduction: In the United States, two vaccines are recommended for all pregnant women to prevent illness in the infant: inactivated influenza vaccine (recommended since 2004) and the combined tetanus-diphtheria-acellular pertussis (Tdap) vaccine (recommended since 2013). Because of the ethical constraints in conducting randomized clinical trials to measure the effects on the infant, there is great interest in using electronic health care data or administrative claims data to study the effects of maternal immunization on the infant's health, and it is anticipated that such studies may be submitted to support regulatory decision-making.

View Article and Find Full Text PDF

Background: The promise of real-world evidence (RWE) is especially relevant to pediatrics, where medicines prescribed for children are often used without evidence derived from randomized clinical trials.

Objectives: The aim of this systematic review was to describe the state of RWE in pediatrics by identifying observational studies published during 2016 that used RWE to assess medication safety or effectiveness in children.

Methods: An electronic search of PubMed was combined with an extended search of references within systematic reviews and expert suggestions.

View Article and Find Full Text PDF