An aligned framework of actively collected and passively monitored clinical outcome assessments (COAs) for measure selection.

Regulators increasingly require clinical outcome assessment (COA) data for approval. COAs can be collected via questionnaires or digital health technologies (DHTs), yet no single resource provides a side-by-side comparison of tools that collect complementary or related COA measures. We propose how to align ontologies for actively collected and passively monitored COAs into a single framework to allow for rapid, evidence-based, and fit-for-purpose measure selection.

Recommendations to address respondent burden associated with patient-reported outcome assessment.

Patient-reported outcomes (PROs) are increasingly used in healthcare research to provide evidence of the benefits and risks of interventions from the patient perspective and to inform regulatory decisions and health policy. The use of PROs in clinical practice can facilitate symptom monitoring, tailor care to individual needs, aid clinical decision-making and inform value-based healthcare initiatives. Despite their benefits, there are concerns that the potential burden on respondents may reduce their willingness to complete PROs, with potential impact on the completeness and quality of the data for decision-making. We therefore conducted an initial literature review to generate a list of candidate recommendations aimed at reducing respondent burden. This was followed by a two-stage Delphi survey by an international multi-stakeholder group. A consensus meeting was held to finalize the recommendations. The final consensus statement includes 19 recommendations to address PRO respondent burden in healthcare research and clinical practice. If implemented, these recommendations may reduce PRO respondent burden.

Iran Quality of Care in Medicine Program (IQCAMP): Design and Outcomes.

BACKGROUND: Assessment of quality and cost of medical care has become a core health policy concern. We conducted a nationwide survey to assess these measures in Iran as a developing country. To present the protocol for the Iran Quality of Care in Medicine Program (IQCAMP) study, which estimates the quality, cost, and utilization of health services for seven diseases in Iran. METHODS: We selected eight provinces for this nationally representative short longitudinal survey. Interviewers from each province were trained comprehensively. The standard definition of seven high-burden conditions (acute myocardial infarction [MI], heart failure [HF], diabetes mellitus [DM], stroke, chronic obstructive pulmonary (COPD) disease, major depression, and end-stage renal disease [ESRD]) helped customize a protocol for disease identification. With a 3-month follow-up window, the participants answered pre-specified questions four times. The expert panels developed a questionnaire in four modules (demographics, health status, utilization, cost, and quality). The expert panel chose an inclusive set of quality indicators from the current literature for each condition. The design team specified the necessary elements in the survey to calculate the cost of care for each condition. The utilization assessment included various services, including hospital admissions, outpatient visits, and medication. RESULTS: Totally, 156 specialists and 78 trained nurses assisted with patient identification, recruitment, and interviewing. A total of 1666 patients participated in the study, and 1291 patients completed all four visits. CONCLUSION: The IQCAMP study was the first healthcare utilization, cost, and quality survey in Iran with a longitudinal data collection to represent the pattern, quantity, and quality of medical care provided for high-burden conditions.

Nurse practitioners' perception of temporary full practice authority during a COVID-19 surge: A qualitative study.

BACKGROUND: At the beginning of the COVID-19 pandemic in the United States, 22 state governors temporarily waived physician supervision of nurse practitioners to expand access to health care during the state of emergency. OBJECTIVE: We examined the nurse practitioner perception of the simultaneous scope of practice changes and the exigent pandemic demands during the initial COVID-19 surge in Massachusetts. METHODS: Qualitative descriptive design using content analysis of open-ended responses to a web-based survey of Massachusetts nurse practitioners conducted in May & June 2020. RESULTS: Survey response rate was 40.6 percent (N = 389). Content analysis identified four themes including: 1) State waivers enabled more control over practice and more expedited care, 2) State waiver did not change practice either because of pre-established independence or employers not changing policy, 3) Perception of nurse practitioner role as both versatile and disposable and 4) Telehealth increased access to care and created an autonomous setting. CONCLUSIONS: Although findings suggest fewer barriers in some areas, the temporary removal of state-level restrictions alone is not sufficient to achieve immediate full scope of practice for nurse practitioners. There is a need for regulatory frameworks that optimize the capacity of the advanced practice nursing workforce to respond to global health emergencies. US-based policymakers and healthcare organizations should revise outdated scope of practice policies and capitalize on telehealth technology to utilize the full extent of nurse practitioners. Likewise, nursing leaders should be a voice for nurse practitioners to more effectively and safely maximize the nurse practitioner contribution during emergency responses. In countries where the role is under development, regulators can leverage these findings to establish modernized nurse practitioner scope of practice policies from the outset.

Between a Rock and a Hard Place: How poverty and lack of agency affect HIV risk behaviors among married women in 25 African countries: A cross-sectional study.

BACKGROUND: Gender inequality and poverty exacerbate the burden of HIV/AIDS among women in Africa. AIDS awareness and educational campaigns have been inadequate in many countries and rates of HIV testing and adherence to condom use remains considerably low, especially among married women. We investigate whether higher HIV knowledge is equally effective in lowering risky behaviors among groups of women with different levels of wealth and agency. METHODS: Pooled data on 113 151 adult married women from Demographic and Health Surveys (DHS) in 25 African countries was used (2010 to 2016). Agency was defined as women's ability to refuse sex and ask her partner to use a condom, plus have a role in decision making in household spending and health-related issues. The lowest tertile of DHS wealth index defined poverty. Questions about HIV prevention and mother-to-child transmission were used to create a scale for knowledge (0-5). Use of condom, HIV testing, absence of sexually transmitted disease (STD), and having one partner were dependent variables. Regression models investigated the effect of agency and knowledge as predictors of behaviors. Separate additional models were run to measure associations of each behavior with knowledge scores on groups of women divided by agency and poverty. Analyses were adjusted for demographic factors, history of pregnancy, wife-beating attitude, and country dummies. RESULTS: Significantly higher risk and lower level of protective factors exist for poor women who lack agency. Knowledge had positive associations with a better score in behavior, higher rate of condom use and testing for HIV both among poor and not poor women. When examining compound effects of agency and poverty, absence of agency reduces the positive effect of knowledge on lowering STD rate and overall behavior score among poor women. It also nullifies the effect of knowledge on condom use in both wealth groups. CONCLUSION: Knowledge of HIV does not exert its potential protective effect when women live in poverty compounded with lack of agency. Success of anti-HIV programs should be tailored to dynamics of risk and sociocultural and economic context of target populations.

A mouse model for a partially inactive obesity-associated human MC3R variant.

We previously reported children homozygous for two MC3R sequence variants (C17A+G241A) have greater fat mass than controls. Here we show, using homozygous knock-in mouse models in which we replace murine Mc3r with wild-type human (MC3R(hWT/hWT)) and double-mutant (C17A+G241A) human (MC3R(hDM/hDM)) MC3R, that MC3R(hDM/hDM) have greater weight and fat mass, increased energy intake and feeding efficiency, but reduced length and fat-free mass compared with MC3R(hWT/hWT). MC3R(hDM/hDM) mice do not have increased adipose tissue inflammatory cell infiltration or greater expression of inflammatory markers despite their greater fat mass. Serum adiponectin levels are increased in MC3R(hDM/hDM) mice and MC3R(hDM/hDM) human subjects. MC3R(hDM/hDM) bone- and adipose tissue-derived mesenchymal stem cells (MSCs) differentiate into adipocytes that accumulate more triglyceride than MC3R(hWT/hWT) MSCs. MC3R(hDM/hDM) impacts nutrient partitioning to generate increased adipose tissue that appears metabolically healthy. These data confirm the importance of MC3R signalling in human metabolism and suggest a previously-unrecognized role for the MC3R in adipose tissue development.

Body mass index as a measure of percentage body fat prediction and excess adiposity diagnosis among Iranian adolescents.

BACKGROUND: Although various anthropometric methods are available for assessing body composition, these have not been compared in Iranian adolescents. The objective of the present study was to compare body mass index (BMI), waist circumference (WC), waist to hip ratio (WHR), waist to height ratio (WHtR) and sum of four skinfolds as predictors of percentage body fat (PBF) and diagnosis of excess adiposity in Iranian adolescents. METHODS: In this cross-sectional study, all anthropometric measurements were made in133 adolescents (65 boys and 68 girls), aged 10-18 years.PBF was determined using the bioelectrical impedance analysis method. Linear regression and receiver operating characteristic (ROC) analysis were used to analyze the data. Potential covariates including sex, age, and pubertal stage were adjusted. RESULTS: R(2)adj of models for BMI, WC, WHR, WHtR, and skinfolds were 0.67, 0.56, 0.19, 0.56, and 0.56, respectively (P < 0.001). The AUC value of BMI to differentiate between normal and obese adolescents was 0.92 (P < 0.001). The AUC of BMI was significantly higher than those of WC, WHR, and WHtR (P < 0.05). CONCLUSIONS: The performance of BMI is better than other anthropometric indices in predicting PBF and diagnosing excess adiposity in Iranian adolescents.

Performance of different definitions of metabolic syndrome for children and adolescents in a 6-year follow-up: Tehran Lipid and Glucose Study (TLGS).

AIM: To assess the utility of different definitions of the metabolic syndrome (MetS) in predicting adulthood MetS among Tehranian adolescents in a 6-year follow-up. METHODS: A random sample of 2645 adolescents was selected from the Tehran Lipid and Glucose Study (TLGS) in 1999-2001; MetS was assessed based on five definitions for adolescents. In 2005-2007, 572 age 18 years and over were assessed for MetS by NCEP ATP III adults' criteria. Sensitivity, specificity, and area under receiver operating curve for attaining adulthood MetS, obesity and overweight were calculated for each MetS definitions. RESULTS: The prevalence of adolescence MetS varied from 0.7+/-0.2 to 15.1+/-0.8% by different definitions in adolescents and 4.0+/-0.9% among adults. The highest area under curve for prediction of adulthood MetS pertained to the de Ferranti's definition (0.723), and for prediction of adulthood obesity and overweight were 0.723 and 0.606, respectively, for this definition. Kappa for agreement between these definitions was fair (0.195). CONCLUSIONS: Definition of MetS for adolescents showed a fair agreement with adult definition. Yet, a diagnosis of MetS in adolescents seems to be a good predictor of developing adulthood MetS within a short time.

Dietary patterns by reduced rank regression predicting changes in obesity indices in a cohort study: Tehran Lipid and Glucose Study.

OBJECTIVE: To examine the association between dietary patterns and obesity indices (BMI, WC, WHR) among Tehranian adults in a 6-year follow-up study. METHODS: Within frame of a cohort study in Tehran (mean follow up 6.6+/-0.9 years), 141 adults were recruited with: two 24 hour dietary recalls at the beginning, as well as obesity indices at the beginning and end of the study period. Dietary intakes were converted into grams of intakes of food items and categorized into 16 groups. Reduced rank regression analysis derived five patterns with total and polyunsaturated-to-saturated fat intake, cholesterol, fiber and calcium intake as response variables. Factors (dietary patterns) were generated retaining a corresponding factor loading > or = |0.17| on the food groups. Changes in obesity indices were scrutinized within quintiles of factor scores. RESULTS: There were high loadings on refined carbohydrates, whole grain, starchy vegetables, other vegetables, red and refined meat, saturated/trans fat, and egg for the first factor named "traditional". All obesity indices had increasing trend across quintiles of pattern score. The fifth pattern (namely egg pattern) had high loading for eggs, salty snacks, as well as fruits and dry fruits, and negative loadings for red and processed meat, saturated and trans fat, plant oils, and dairy products. This pattern showed increasing trends for WC and WHR after adjustment for potential confounders. Other patterns showed non-significant trends for obesity indices. CONCLUSIONS: The results were indicative of a traditional pattern which is dominated in the Tehran region and associated with increase in obesity indices.