Association of Chronic Diabetes with 42-Day Readmission after Delivery Hospitalization.

Objectives: To evaluate the impact of chronic diabetes on 42-day hospital readmission rates and hospitalization costs following hospital delivery discharge.

Methods: Using 2016-2019 data from the Hospital Cost and Utilization Project Nationwide Readmissions Database, we conducted a propensity score matched analysis comparing individuals with and without chronic diabetes. Given the strong relationship between severe maternal morbidity and readmission, we used an exact match for severe maternal morbidity during the delivery hospitalization.

Reproducibility of Equivocal HER2 In Situ Hybridization Groups 3 and 4, and Comparison With HER2 mRNA Expression: The Thin Line Between Amplified and Nonamplified Breast Cancers.

Context.—: Breast carcinomas (BCs) with equivocal HER2 (human epidermal growth factor receptor 2) immunohistochemistry are subjected to in situ hybridization (ISH) to assess HER2 copy numbers. Infrequently, dual-probe ISH also provides equivocal results, designated as ISH groups 2, 3, or 4.

Impact of the 2022 Infant Formula Shortage on Self-Reported Rates of Anxiety and Depression: Evidence from the Household Pulse Survey.

Purpose: To evaluate the impact of the 2022 infant formula shortage on self-reported anxiety and depression.

Background: The US national infant formula shortage of 2022 originated from supply chain disruptions triggered by the COVID-19 pandemic, and the shortage was further compounded by a recall of tainted formula products.

Methods: We used survey-weighted data from the Household Pulse Survey (HPS) to measure self-reported anxiety and depression among individuals with formula-fed infants less than 1 year of age.

Association of the COVID-19 Pandemic With Women, Infants, and Children (WIC) Receipt Among Pregnant Individuals: United States, 2016-2022.

To evaluate the effect of COVID-19 on Special Supplemental Nutrition Program for Women, Infants, and Children (WIC) receipt among pregnant individuals overall and by race/ethnicity. We measured changes in WIC receipt among Medicaid-covered births (n = 10 484 697) from the US National Center for Health Statistics Natality Files (2016-2022). Our interrupted time series logistic model included a continuous monthly variable, a binary post-COVID variable, and a continuous slope shift variable.

Predictive markers for pathological complete response (pCR) after neo-adjuvant chemotherapy in HER2-positive breast carcinoma.

Objectives: Patients with HER2-positive invasive breast cancer that is node-positive and/or larger than 3 cm are generally treated with neoadjuvant chemotherapy (NAC). We aimed to identify predictive markers for pathological complete response (pCR) after NAC in HER2-positive breast carcinoma.

Methods: Hematoxylin/eosin-stained slides of 43 HER2-positive breast carcinoma biopsies were histopathologically reviewed.

The Shared Ethical Responsibility of Medically and Non-medically Qualified Experts in Human Drug Development Teams.

The complexity of developing and applying increasingly sophisticated new medicinal products has led to the participation of many non-medically qualified scientists in multi-disciplinary non-clinical and clinical drug development teams world-wide. In this introductory paper to the "IFAPP International Ethics Framework for Pharmaceutical Physicians and Medicines Development Scientists" it is argued that all members of such multidisciplinary teams must share the scientific and ethical responsibilities since they all influence directly or indirectly both the outcome of the various phases of the medicines development projects and the safety of the research subjects involved. The participating medical practitioner retains the overriding responsibility and the final decision to stop a trial if the well-being of the research subjects is seriously endangered.

Fostering Competence in Medicines Development: The IFAPP Perspective.

IFAPP (International Federation of Associations of Pharmaceutical Physicians and Pharmaceutical Medicine) is a nonprofit organization with the mission to promote Pharmaceutical Medicine & Medicines Development (PM&MD) by enhancing the competencies and maintaining high research ethical standards of Pharmaceutical Physicians and other professionals involved in medicines development worldwide, leading to the availability and appropriate use of medicines for the benefit of patients and society. About 30 national professional associations related to PM&MD, involving 7000 professionals, are affiliated to IFAPP. Medicines development has traditionally been a challenging enterprise, with high risk, high investment, and potentially high returns in the lengthy and complex process of identifying a new chemical entity as a candidate for development and possibly succeeding in bringing it as a pharmaceutical product to the market.

Assessing the impact of dietary habits on health-related quality of life requires contextual measurement tools.

The increase of non-communicable diseases at all ages has fostered the general concern for sustaining population health worldwide. Unhealthy lifestyles and dietary habits impacting physical and psycho-social health are well known risk factors for developing life threatening diseases. Identifying the determinants of quality of life is an important task from a Public Health perspective.

Education and training for medicines development, regulation, and clinical research in emerging countries.

The aim of this satellite workshop held at the 17th World Congress of Basic and Clinical Pharmacology (WCP2014) was to discuss the needs, optimal methods and practical approaches for extending education and teaching of medicines development, regulation, and clinical research to Low and Middle Income Countries (LMICs). It was generally agreed that, for efficiently treating the rapidly growing number of patients suffering from non-communicable diseases, modern drug therapy has to become available more widely and with a shorter time lag in these countries. To achieve this goal many additional experts working in medicines development, regulation, and clinical research have to be trained in parallel.

Cost-effectiveness of prucalopride in the treatment of chronic constipation in the Netherlands.

Objective: To assess the cost-effectiveness of prucalopride vs. continued laxative treatment for chronic constipation in patients in the Netherlands in whom laxatives have failed to provide adequate relief.

Methods: A Markov model was developed to estimate the cost-effectiveness of prucalopride in patients with chronic constipation receiving standard laxative treatment from the perspective of Dutch payers in 2011.

Corrigendum: Core competencies for pharmaceutical physicians and drug development scientists.

[This corrects the article on p. 105 in vol. 4, PMID: 23986704.

Psychometric properties of PedsQL generic core scales for children with functional constipation in the Netherlands.

Objectives: The aim of the study was to evaluate the psychometric properties of the Dutch translation of the Pediatric Quality of Life Inventory version 4.0 Generic Core Scales (PedsQL) in children with functional constipation (FC).

Methods: The PedsQL was completed by children with FC ages 5 to 18 years and by the parents of children ages 2 to 18 years.

Core competencies for pharmaceutical physicians and drug development scientists.

Professional groups, such as IFAPP (International Federation of Pharmaceutical Physicians and Pharmaceutical Medicine), are expected to produce the defined core competencies to orient the discipline and the academic programs for the development of future competent professionals and to advance the profession. On the other hand, PharmaTrain, an Innovative Medicines Initiative project, has become the largest public-private partnership in biomedicine in the European Continent and aims to provide postgraduate courses that are designed to meet the needs of professionals working in medicines development. A working group was formed within IFAPP including representatives from PharmaTrain, academic institutions and national member associations, with special interest and experience on Quality Improvement through education.

Health economics and nutrition: a review of published evidence.

The relationship between nutrition and health-economic outcomes is important at both the individual and the societal level. While personal nutritional choices affect an individual's health condition, thus influencing productivity and economic contribution to society, nutrition interventions carried out by the state also have the potential to affect economic output in significant ways. This review summarizes studies of nutrition interventions in which health-related economic implications of the intervention have been addressed.

European initiative towards quality standards in education and training for discovery, development and use of medicines.

This position paper recommends a set of standards for quality assessment of continuing professional development (CPD) for medicines research and development (R&D). We have developed these standards to help us achieve the education and training goals of the Innovative Medicines Initiative (IMI; www.imi.

Economic evaluation of OROS hydromorphone for chronic pain: a Pan-European perspective.

Objectives: OROS hydromorphone (osmotic extended-release oral delivery system [OROS] hydromorphone) is a long-acting opioid analgesic, which is approved in Europe for the management of severe pain. The authors aimed to estimate the economic value of this product relative to other widely used oral opioids, including sustained-release morphine, extended-release (ER) oxycodone, and twice-daily (bid) hydromorphone.

Design: An adaptable, decision-analytic cost-utility model was developed.

Cost-utility analysis: current methodological issues and future perspectives.

The use of cost-effectiveness as final criterion in the reimbursement process for listing of new pharmaceuticals can be questioned from a scientific and policy point of view. There is a lack of consensus on main methodological issues and consequently we may question the appropriateness of the use of cost-effectiveness data in health care decision-making. Another concern is the appropriateness of the selection and use of an incremental cost-effectiveness threshold (Cost/QALY).

The cost utility of autologous chondrocytes implantation using ChondroCelect® in symptomatic knee cartilage lesions in Belgium.

Background: Knee cartilage lesions increase the risk of developing osteoarthritis (OA), and may eventually result in a total knee replacement (TKR). There is currently no consensus on the optimal treatment of cartilage lesions. ChondroCelect® (CC) is a cell-based therapy approved for use in autologous chondrocytes implantation (ACI) to treat symptomatic cartilage defects of the femoral condyle.

Psychometric evaluation of the functional assessment of HIV Infection (FAHI) questionnaire and its usefulness in clinical trials.

Purpose: To evaluate psychometric properties of the Functional Assessment of Human Immunodeficiency Virus Infection (FAHI) questionnaire, a 47-item disease-specific instrument evaluating Health-Related Quality of Life (HRQL) in human immunodeficiency virus (HIV)-infected patients.

Methods: Treatment-experienced HIV-infected patients from two clinical programmes (N = 565; N = 1,096) completed the FAHI at Baseline and after 24 weeks of treatment. Psychometric properties of the FAHI were assessed in both trial populations, including minimal important differences (MIDs) calculations.