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Objectives: Traditional methods for medical device post-market surveillance often fail to accurately account for operator learning effects, leading to biased assessments of device safety. These methods struggle with non-linearity, complex learning curves, and time-varying covariates, such as physician experience. To address these limitations, we sought to develop a machine learning (ML) framework to detect and adjust for operator learning effects., Materials and Methods: A gradient-boosted decision tree ML method was used to analyze synthetic datasets that replicate the complexity of clinical scenarios involving high-risk medical devices. We designed this process to detect learning effects using a risk-adjusted cumulative sum method, quantify the excess adverse event rate attributable to operator inexperience, and adjust for these alongside patient factors in evaluating device safety signals. To maintain integrity, we employed blinding between data generation and analysis teams. Synthetic data used underlying distributions and patient feature correlations based on clinical data from the Department of Veterans Affairs between 2005 and 2012. We generated 2494 synthetic datasets with widely varying characteristics including number of patient features, operators and institutions, and the operator learning form. Each dataset contained a hypothetical study device, Device B, and a reference device, Device A. We evaluated accuracy in identifying learning effects and identifying and estimating the strength of the device safety signal. Our approach also evaluated different clinically relevant thresholds for safety signal detection., Results: Our framework accurately identified the presence or absence of learning effects in 93.6% of datasets and correctly determined device safety signals in 93.4% of cases. The estimated device odds ratios' 95% confidence intervals were accurately aligned with the specified ratios in 94.7% of datasets. In contrast, a comparative model excluding operator learning effects significantly underperformed in detecting device signals and in accuracy. Notably, our framework achieved 100% specificity for clinically relevant safety signal thresholds, although sensitivity varied with the threshold applied., Discussion: A machine learning framework, tailored for the complexities of post-market device evaluation, may provide superior performance compared to standard parametric techniques when operator learning is present., Conclusion: Demonstrating the capacity of ML to overcome complex evaluative challenges, our framework addresses the limitations of traditional statistical methods in current post-market surveillance processes. By offering a reliable means to detect and adjust for learning effects, it may significantly improve medical device safety evaluation., (© The Author(s) 2024. Published by Oxford University Press on behalf of the American Medical Informatics Association. All rights reserved. For permissions, please email: journals.permissions@oup.com.)

Aim: To estimate the minimally important difference (MID) in change in National Eye Institute Visual Function Questionnaire-25 (VFQ-25) composite score using methods aligned with patient perception., Methods: Retrospective analysis of prospectively collected data from adults with primary angle closure or primary angle closure glaucoma enrolled in the Effectiveness, in Angle-closure Glaucoma, of Lens Extraction study. We included data from 335 participants with patient reported visual function (VFQ-25) and health status measured by the EQ-5D-3L over 36 months. We used the recommended anchor-based methods (receiver operating characteristic (ROC), predictive modelling and mean change) to determine the MID of the VFQ-25. EQ-5D-3L anchor change was defined as none (<0.065); minimal (0.065≤EQ-5D-3L change ≤0.075 points) and greater change (>0.075 points)., Results: Mean baseline VFQ-25 score was 87.6 (SD 11.8). Estimated MIDs in the change in VFQ-25 scores (95% CI) were 10.5 (1.9 to 19.2); 3.9 (-2.3 to 10.1); 5.8 (1.9 to 7.2) and 8.1 (1.7 to 14.8) for the 'within-patient', 'between-patient' change, ROC and predictive modelling anchor methods respectively. Excluding estimates from the methodologically weaker 'within-patient' method, the MID of a change in VFQ-25 composite score is 5.8 (median value)., Conclusions: Estimates of the MID using multiple methods assist in the interpretation of the VFQ scores. In the context of early glaucoma related visual disability, a change score of around six points on the VFQ-25 is likely to be important to patients. Further confirmatory research is required. Studies comparing changes in patient-reported outcome measure scores with a global measure of patients' perceived change are required., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2022. No commercial re-use. See rights and permissions. Published by BMJ.)

(1) Background: The aim of this systematic review was to compare the cost-effectiveness of two follow-up methods (face-to-face and telemedicine) used in dermatology in the last ten years. (2) Methods: A search for articles that included economic analyses was conducted in August 2021 in the databases PubMed, Medline, Scielo and Scopus using the following keywords: "Cost-Benefit Analysis", "Dermatology", "Telemedicine", "Primary Health Care", as well as other search terms and following the PICOS eligibility criteria. (3) Results: Three clinical trials and five observational studies were analyzed, providing information for approximately 16,539 patients (including four cost-minimization or saving analyses, three cost-effectiveness analyses, and one cost-utility analysis) in Europe and the United States. They describe the follow-up procedures in each of the cases and measure and analyze the direct and indirect costs and effectiveness. All the articles indicate that teledermatology lowers costs and proves satisfactory to both patients and professionals. (4) Conclusions: Although it has been found that follow-up via teledermatology can be more efficient than traditional hospital follow-up, more work is needed to establish evaluation protocols and procedures that measure key variables more equally and demonstrate the quality of the evidence of said studies.

When patented, brand-name antibiotics lose market exclusivity, generics typically enter the market at lower prices, which may increase consumption of the drug. To examine the effect of generic market entry on antibiotic consumption in the United States, we conducted an interrupted time series analysis of the change in the number of prescriptions per month for antibiotics for which at least one generic entered the US market between 2000 and 2012. Data were acquired from the IQVIA Xponent database. Thirteen antibiotics were analyzed. Here, we show that one year after generic entry, the number of prescriptions increased for five antibiotics (5 to 406%)-aztreonam, cefpodoxime, ciprofloxacin, levofloxacin, ofloxacin-and decreased for one drug: cefdinir. These changes were sustained two years after. Cefprozil, cefuroxime axetil and clarithromycin had significant increases in trend, but no significant level changes. No consistent pattern for antibiotic use following generic entry in the United States was observed.

Aim: To explore the experiences of Victorian foster and kinship carers in accessing health services for children in their care and to quantify the frequency of potential barriers to health care., Methods: On-line survey co-designed with the Foster Care Association of Victoria measuring carer-reported health service engagement by a child/young person in their care, ease of service access, time to receiving Medicare number and out-of-pocket health-related costs. A total of 239 foster and 51 kinship carers were recruited through email and social media by carer support agencies., Results: In total, 90% of children/young people had engaged with a general practitioner. Most had engaged with dental (75%), paediatric (72%), optometry (61%) and audiology (54%) services. Mental health services were most likely to be needed but not yet received. Neither carer education nor socio-economic status was associated with likelihood of service engagement. Carers reported that it was hardest to get appointments with mental health and paediatric services. Twenty-seven percent had waited to see a health service because of delays in carers receiving their Medicare number. Sixty percent of carers had paid out-of-pocket for health services; 78% of these had not been reimbursed., Conclusion: Victorian foster and kinship carers report high health service use for children and young people in their care. Mental health services were the hardest to access with the largest gap between identified need and service use. Timely access to Medicare numbers and financial support are barriers to access that could be addressed. The development of integrated paediatric health care and clinicians co-located with child protection could also assist., (© 2020 Paediatrics and Child Health Division (The Royal Australasian College of Physicians).)

Background: Emergency risk communication is a critical component in emergency planning and response. It has been recognised as significant for planning for and responding to public health emergencies. While there is a growing body of guidelines and frameworks on emergency risk communication, it remains a relatively new field. There has also been limited attention on how emergency risk communication is being performed in public health organisations, such as acute hospitals, and what the associated challenges are. This article seeks to examine the perception of crisis and emergency risk communication in an acute hospital in response to COVID-19 pandemic in Singapore and to identify its associated enablers and barriers., Methods: A 13-item Crisis and Emergency Risk Communication (CERC) Survey, based on the US Centers for Disease and Control (CDC) CERC framework, was developed and administered to hospital staff during February 24-28, 2020. The survey also included an open-ended question to solicit feedback on areas of CERC in need of improvement. Chi-square test was used for analysis of survey data. Thematic analysis was performed on qualitative feedback., Results: Of the 1154 participants who responded to the survey, most (94.1%) reported that regular hospital updates on COVID-19 were understandable and actionable. Many (92.5%) stated that accurate, concise and timely information helped to keep them safe. A majority (92.3%) of them were clear about the hospital's response to the COVID-19 situation, and 79.4% of the respondents reported that the hospital had been able to understand their challenges and address their concerns. Sociodemographic characteristics, such as occupation, age, marital status, work experience, gender, and staff's primary work location influenced the responses to hospital CERC. Local leaders within the hospital would need support to better communicate and translate hospital updates in response to COVID-19 to actionable plans for their staff. Better communication in executing resource utilization plans, expressing more empathy and care for their staff, and enhancing communication channels, such as through the use of secure text messaging rather than emails would be important., Conclusion: CERC is relevant and important in the hospital setting to managing COVID-19 and should be considered concurrently with hospital emergency response domains.

This paper is the second of two reviews that seek to stimulate debate on new and neglected avenues in oral health research. The first commissioned narrative review, "Inclusion oral health: Advancing a theoretical framework for policy, research and practice", published in February 2020, explored social exclusion, othering and intersectionality. In it, we argued that people who experience social exclusion face a "triple threat": they are separated from mainstream society, stigmatized by the dental profession, and severed from wider health and social care systems because of the disconnection between oral health and general health. We proposed a definition of inclusion oral health and a theoretical framework to advance the policy, research and practice agenda. This second review delves further into the concept of intersectionality, arguing that individuals who are socially excluded experience multiple forms of discrimination, stigma and disadvantage that reflect intersecting social identities. We first provide a theoretical and historical overview of intersectionality, rooted in Black feminist ideologies in the United States. Our working definition of intersectionality, requiring the simultaneous appreciation of multiple social identities, an examination of power and inequality, and a recognition of changing social contexts, then sets the scene for examining existing applications of intersectionality in oral health research. A critique of the sparse application of intersectionality in oral health research highlights missed opportunities and shortcomings related to paradigmatic and epistemological differences, a lack of robust theoretically engaged quantitative and mixed methods research, and a failure to sufficiently consider power from an intersectionality perspective. The final section proposes a framework to guide future oral health research that embraces an intersectionality agenda consisting of descriptive research to deepen our understanding of intersectionality, and transformative research to tackle social injustice and inequities through participatory research and co-production., (© 2020 The Authors. Community Dentistry and Oral Epidemiology published by John Wiley & Sons Ltd.)

Aim: To compare the costs of community-based food allergy model of care (intervention cohort, IC) with a tertiary-hospital, specialist allergy clinic model of care (control cohort, CC)., Methods: In this pragmatic controlled trial, children (aged 0-12 years) newly referred to the allergy clinic at Melbourne's Royal Children's Hospital with suspected/known food allergy to three or fewer foods were allocated to see either a community-based paediatrician, trained via online webinars and web-based clinical decision support tools for food allergy diagnosis and management, or a hospital allergist. Per-patient costs to the health-care system and out-of-pocket costs to families seen within 12 months (clinician time, allergy tests and medicare billing) were compared between the two models of care., Results: At 12 months, 54/181 (30%) CC families had been seen in the allergy clinic and 93/115 (81%) of the IC families who chose to see a community paediatrician had been seen. In an intention-to-treat analysis (ITT), health-care system costs per IC patient were higher than the costs per CC patient (mean cost $333 versus $319, respectively; mean difference $14, 95% Confidence Interval (CI) -97 to 118, P = 0.81). Total out-of-pocket costs to family were $129 in the IC compared with $89 in the CC (mean difference $40, 95% CI $4-$77, P = 0.03)., Conclusions: A community-based model of care for simple food allergy showed that costs to the health-care system were similar between the community model and hospital care but did not show reduced out-of-pocket costs to the families 12-months post-enrolment., (© 2020 Paediatrics and Child Health Division (The Royal Australasian College of Physicians).)

Objective: Aspects of antineutrophil cytoplasmic antibodies-associated vasculitis (AAV) prioritized by patients with AAV were described using the International Classification of Function, Disability, and Health (ICF)., Methods: Items identified during 14 individual interviews were incorporated into an ICF-based questionnaire administered to participants of 2 vasculitis patient symposia: 36 in the United Kingdom and 63 in the United States., Results: Categories identified as at least "moderately relevant" by ≥ 5% of subjects included 44 body functions, 14 body structures, 35 activities and participation, 31 environmental factors, and 38 personal factors., Conclusion: Identified categories differ from those identified by the current Outcome Measures in Rheumatology (OMERACT) core set and those prioritized by vasculitis experts.

Background and Objectives: We investigated whether the recent growth in home dialysis use was proportional among all racial/ethnic groups and also whether there were changes in racial/ethnic differences in home dialysis outcomes., Design, Setting, Participants, & Measurements: This observational cohort study of US Renal Data System patients initiating dialysis from 2005 to 2013 used logistic regression to estimate racial/ethnic differences in home dialysis initiation over time, and used competing risk models to assess temporal changes in racial/ethnic differences in home dialysis outcomes, specifically: ( 1 ) transfer to in-center hemodialysis (HD), ( 2 ) mortality, and ( 3 ) transplantation., Results: Of the 523,526 patients initiating dialysis from 2005 to 2013, 55% were white, 28% black, 13% Hispanic, and 4% Asian. In the earliest era (2005-2007), 8.0% of white patients initiated dialysis with home modalities, as did a similar proportion of Asians (9.2%; adjusted odds ratio [aOR], 0.95; 95% confidence interval [95% CI], 0.86 to 1.05), whereas lower proportions of black [5.2%; aOR, 0.71; 95% CI, 0.66 to 0.76] and Hispanic (5.7%; aOR, 0.83; 95% CI, 0.86 to 0.93) patients did so. Over time, home dialysis use increased in all groups and racial/ethnic differences decreased (2011-2013: 10.6% of whites, 8.3% of blacks [aOR, 0.81; 95% CI, 0.77 to 0.85], 9.6% of Hispanics [aOR, 0.94; 95% CI, 0.86 to 1.00], 14.2% of Asians [aOR, 1.04; 95% CI, 0.86 to 1.12]). Compared with white patients, the risk of transferring to in-center HD was higher in blacks, similar in Hispanics, and lower in Asians; these differences remained stable over time. The mortality rate was lower for minority patients than for white patients; this difference increased over time. Transplantation rates were lower for blacks and similar for Hispanics and Asians; over time, the difference in transplantation rates between blacks and Hispanics versus whites increased., Conclusions: From 2005 to 2013, as home dialysis use increased, racial/ethnic differences in initiating home dialysis narrowed, without worsening rates of death or transfer to in-center HD in minority patients, as compared with white patients., (Copyright © 2019 by the American Society of Nephrology.)

Purpose: The aim of the present study was to describe antipsychotic utilization patterns among patients with schizophrenic disorder in Italy, Spain, the UK, and the USA., Methods: A retrospective cohort study was conducted. Patients aged 15 and over with schizophrenic disorder were identified in the Caserta claims database (Italy), the Valencia electronic medical record (EMR) database (Spain), in The Health Improvement Network EMR database (UK), and in databases of publicly and privately insured populations in the United States (US)., Results: The frequency of first-generation or second-generation antipsychotic use and of long-acting or other formulations was described. Persistence to antipsychotics was estimated. Overall, 1,403,240 patients with schizophrenic disorder having a total of 765,573 new antipsychotic treatment episodes were identified. The median follow-up time ranged from 0.8 (IQR 0.2-1.9) years in the US commercially-insured population to 1.2 (IQR 0.1-1.7) years in the Spanish population. Second-generation antipsychotics were more frequently used than first-generation antipsychotics in all countries (on average, from 64.4% in the UK to 87% in US): the use of this class increased over time in Italy, Spain, and US (Medicaid). The use of long-acting formulations was heterogeneous across countries, but generally much lower than other formulations. Persistence to antipsychotic treatment at 1 year was low in all countries, ranging from 40 in Spain to 30% in Italy., Conclusions: Antipsychotic utilization was heterogeneous among persons with schizophrenic disorder. Nevertheless, low persistence was an issue in all the countries, as less than half of the patients continued their treatment beyond 1 year.

Objectives: To provide recommendations for the selection of comparators for randomized controlled trials of health-related behavioral interventions., Study Design and Setting: The National Institutes of Health Office of Behavioral and Social Science Research convened an expert panel to critically review the literature on control or comparison groups for behavioral trials and to develop strategies for improving comparator choices and for resolving controversies and disagreements about comparators., Results: The panel developed a Pragmatic Model for Comparator Selection in Health-Related Behavioral Trials. The model indicates that the optimal comparator is the one that best serves the primary purpose of the trial but that the optimal comparator's limitations and barriers to its use must also be taken into account., Conclusion: We developed best practice recommendations for the selection of comparators for health-related behavioral trials. Use of the Pragmatic Model for Comparator Selection in Health-Related Behavioral Trials can improve the comparator selection process and help resolve disagreements about comparator choices., (Copyright © 2019 Elsevier Inc. All rights reserved.)

Competing Interests: Competing interests: We have read and understood BMJ policy on declaration of interests and declare the following: SKJ reports grants and personal fees from AstraZeneca, Bayer, Boston Scientific, and Abbott; and grants from Jansen and Ted Med Co, outside the submitted work. RJM reports grants and personal fees from Amgen, Novartis, Merck, and Luitpold; grants from AstraZeneca, GSK, and Bayer; and personal fees from Boehringer Ingelheim during the conduct of the study. EP reports personal fees from UCB Pharma, Eisai Inc, GW Pharma, Mylan, Livanova, Sun Pharma, Sanofi, Takeda, and Medichem; and other from Wiley and Elsevier, outside the submitted work. The Health Services Research Unit, University of Aberdeen, receives core funding from the chief scientist office of the Scottish Government Health Directorates. FRR is a recipient of the NOW Spinoza award.

In this study, we assessed the psychometric properties of the Spanish Patient-Reported Outcomes Measurement Information System (PROMIS) Depression in an adult population-representative sample from Spain (n = 1,503). We tested unidimensionality and local independence item response theory (IRT) assumptions with confirmatory factor and bifactor models under the exploratory structural equations modeling framework. We evaluated item monotonicity assumption with Mokken scaling analysis. We calibrated the items with an IRT-graded response model and assessed score reliability and test information, and evidence of validity with regard to scores on external measures. To examine differential item functioning by age, sex, education, and country (United States vs. Spain, N = 2,271), we used ordinal logistic regression. Results support compliance with IRT assumptions. We found few signs of differential item functioning: Only one item showed country differential functioning between the United States (n = 768) and Spain, with minimal impact on the overall score. Information values were equivalent to reliabilities over 0.90 from -1 (low depression) to +4 SD (high depression) around the population score mean. Evidence of validity in relation to concurrent measures was supported by the expected correlation pattern with external variables of depression, but higher than expected correlations with anxiety were found. Results indicate that the Spanish version of PROMIS Depression is adequate for assessing and monitoring depression levels in the general population and that PROMIS Depression is especially suitable for cross-national comparisons. (PsycINFO Database Record (c) 2019 APA, all rights reserved).

An analysis of the adoption of secondary preventive behaviors is significant in regions with disparities in mammography use and breast cancer survival. Therefore, we determined the cognitive factors and the degree to which they differentiate stages of change in mammography among Mexican women. We also compared the decisional balance performance at Mexico, Switzerland, South Korea, and the USA. A cross-sectional study was designed for women in the stages of precontemplation (n = 240), contemplation (n = 243), action (n = 205), maintenance (n = 311), and relapse (n = 348). We only considered those ≥40 years with no cancer history. We measured the pros, cons, and self-efficacy, among other components. The decisional balance was estimated, and the result was transformed into T-scores. Odds ratios (OR) and 95% confidence intervals (CI) were estimated with multinomial logistic regression using precontemplation as the reference group. The decisional balance distinguished stages partially: in contemplation, the OR was 1.26 (95%CI 1.08, 1.47) and in maintenance, 1.34 (95%CI 1.13, 1.59); in action and relapse, the statistical significance was marginal (p < 0.10). The decisional balance T-score performance registered variations among countries. Additionally, the effect of self-efficacy progressively ascended from contemplation to action and maintenance (OR = 1.29 [95%CI 1.05, 1.58], 1.53 [95%CI 1.20, 1.96], and 2.48 [95%CI 1.82, 3.39], respectively). Furthermore, risk perception and severity did not have an effect on stages of change among Mexican women. Recognition of what provokes action in a population is a key factor in the efficacy of screening programs. Variations among countries highlight the necessity for importance of investigating cognitive determinants for mammography in specific areas.

Background: This study examined the influence of migration status, nativity and country of residence on joint associations of physical activity (PA) and sedentary behavior (SB) in anthropometric indicators of Mexicans and Mexican-Americans living in the US and in Mexico., Methods: We examined data from two large national surveys, the National Health and Nutrition Examination Survey from the US (NHANES, 2011⁻2012) and Mexico (ENSANUT, 2012). Using self-reported minutes of moderate to vigorous physical activity and SB, we calculated four categories for analyses. Anthropometric measures consisted of body mass index (BMI) and waist circumference (WC). We used data of migration status, nativity and country of residence. Linear regression models examined how joint categories of PA and SB were associated with BMI and WC according to migration status, nativity and country of residence, controlling for health risk behaviors., Results: Analyses showed that even among those in the category with the lowest risk behavior, &ldquo;physically active and low sedentary&rdquo;, there were differences in BMI and WC by migration status, nativity and country of residence. Within this lower risk category, Mexican immigrants living in the US had the greatest association with high BMI, while US-born Mexican-Americans living in the US had the highest WC values when compared with the group of Mexicans living in Mexico., Conclusions: Joint categories of PA and SB were associated with BMI and WC by migration status, nativity and country of residence among populations with Mexican ethnicity.

Patients often have lower (white coat effect) or higher (masked effect) ambulatory/home blood pressure readings compared with clinic measurements, resulting in misdiagnosis of hypertension. The present study assessed whether blood pressure and patient characteristics from a single clinic visit can accurately predict the difference between ambulatory/home and clinic blood pressure readings (the home-clinic difference). A linear regression model predicting the home-clinic blood pressure difference was derived in 2 data sets measuring automated clinic and ambulatory/home blood pressure (n=991) using candidate predictors identified from a literature review. The model was validated in 4 further data sets (n=1172) using area under the receiver operator characteristic curve analysis. A masked effect was associated with male sex, a positive clinic blood pressure change (difference between consecutive measurements during a single visit), and a diagnosis of hypertension. Increasing age, clinic blood pressure level, and pulse pressure were associated with a white coat effect. The model showed good calibration across data sets (Pearson correlation, 0.48-0.80) and performed well-predicting ambulatory hypertension (area under the receiver operator characteristic curve, 0.75; 95% confidence interval, 0.72-0.79 [systolic]; 0.87; 0.85-0.89 [diastolic]). Used as a triaging tool for ambulatory monitoring, the model improved classification of a patient's blood pressure status compared with other guideline recommended approaches (93% [92% to 95%] classified correctly; United States, 73% [70% to 75%]; Canada, 74% [71% to 77%]; United Kingdom, 78% [76% to 81%]). This study demonstrates that patient characteristics from a single clinic visit can accurately predict a patient's ambulatory blood pressure. Usage of this prediction tool for triaging of ambulatory monitoring could result in more accurate diagnosis of hypertension and hence more appropriate treatment., (© 2016 The Authors.)

The Patient-Centered Outcomes Research Institute, known as PCORI, was established by Congress as part of the Affordable Care Act (ACA) to promote evidence-based treatment. Provisions of the ACA prohibit the use of a cost-effectiveness analysis threshold and quality-adjusted life-years (QALYs) in PCORI comparative effectiveness studies, which has been understood as a prohibition on support for PCORI's conducting conventional cost-effectiveness analyses. This constraint complicates evidence-based choices where incremental improvements in outcomes are achieved at increased costs of care. How frequently this limitation inhibits efficient cost containment, also a goal of the ACA, depends on how often more effective treatment is not cost-effective relative to less effective treatment. We examined the largest database of studies of comparisons of effectiveness and cost-effectiveness to see how often there is disagreement between the more effective treatment and the cost-effective treatment, for various thresholds that may define good value. We found that under the benchmark assumption, disagreement between the two types of analyses occurs in 19 percent of cases. Disagreement is more likely to occur if a treatment intervention is musculoskeletal and less likely to occur if it is surgical or involves secondary prevention, or if the study was funded by a pharmaceutical company., (Project HOPE—The People-to-People Health Foundation, Inc.)

Background: Although current osteoporosis management guidelines recommend use of pharmacologic treatment after hip fracture, the care of such patients has been suboptimal. The objective of this cross-national study was to quantify the use of and adherence to osteoporosis medication after hip fracture in 3 countries with different healthcare systems—the United States, Korea, and Spain., Methods: In 3 cohorts of patients aged ≥65 years hospitalized for hip fracture, we calculated the proportion receiving ≥1 osteoporosis drug after discharge. Adherence to osteoporosis treatment was measured as the proportion of days covered (PDC) during the first year after the hip fracture., Results: We identified 86,202 patients with a hip fracture: 4704 (US Medicare), 6700 (US commercial), 57,631 (Korea), and 17,167 (Spain). The mean age was 77-83 years, and 74%-78% were women. In the year before the index hip fracture, 16%-18% were taking an osteoporosis medication. Within 3 months after the index hip fracture, 11% (US Medicare), 13% (US commercial), 39% (Korea), and 25% (Spain) of patients filled ≥1 prescription for osteoporosis medication. For those who filled ≥1 prescriptions for an osteoporosis medication, the mean PDC in the year after the fracture was 0.70 (US Medicare), 0.67 (US commercial), 0.43 (Korea), and 0.66 (Spain)., Conclusions: Regardless of differences in healthcare delivery systems and medication reimbursement plans, the use of osteoporosis medications for the secondary prevention of osteoporotic fracture was low. Adherence to osteoporosis treatment was also suboptimal, with the PDC <0.70 in all 3 countries., (Copyright © 2015 Elsevier Inc. All rights reserved.)

Objectives: To describe our experience with the implementation and refinement of an enhanced recovery programme (ERP) for radical cystectomy (RC) and urinary diversion. To assess the impact on length of stay (LOS), complication and readmission rates., Patients and Methods: In all, 165 consecutive patients undergoing open RC (ORC) and urinary diversion between January 2008 and April 2013 were entered into an ERP. A retrospective case note review was undertaken. Outcomes recorded included LOS, time to mobilisation, complication rates within the first 30 days (Clavien-Dindo classification) and readmissions., Results: All patients were successfully entered into the ERP. As enhanced recovery principles became embedded in the unit, LOS reduced from a mean of 14 days over the initial year of the ERP to a mean of 9.2 days. The complication rate was 6.6% for Clavien ≥3, and 43.5% for Clavien ≤2. The 30-day mortality rate was 1.2%. The 30-day readmission rate was 13.9%. In the most contemporary subset of 52 patients: the median time after ORC to sit out of bed, mobilise and open bowels was day 1, 2 and 6, respectively., Conclusions: The ERP described for patients undergoing ORC appears to be safe. Benefits include early feeding, mobilisation and hospital discharge. The ERP will continue to develop with the incorporation of advancing evidence and technology, in particular the introduction of robot-assisted RC., (© 2013 The Authors. BJU International © 2013 BJU International.)

Cardiovascular disease is a leading cause of death of women around the world. Diet, exercise, smoking cessation, and blood pressure control are all recognized as key elements of preventing cardiovascular disease. Infant feeding has received less attention, but the studies reviewed here indicate that lactation may also play an important role in determining women's future risk of heart disease. A growing body of literature indicates that mothers who prematurely discontinue lactation face increased risk of visceral adiposity, hypertension, hyperlipidemia, diabetes, and subclinical cardiovascular disease, as well as cardiovascular morbidity and mortality. Breastfeeding is not always easy, but neither is dieting, exercise, smoking cessation, or treating hypertension. In order to effectively fight heart disease, efforts are needed to promote all aspects of a healthy lifestyle, which for women includes breastfeeding their babies.

Objective: To assess face validity, construct validity and the training benefits of a virtual reality TURP simulator., Method: 11 novices (no TURP experience) and 7 experts (>200 TURP's) completed a virtual reality median lobe prostate resection task on the TURPsim™ (Simbionix USA Corp., Cleveland, OH). Performance indicators (percentage of prostate resected (PR), percentage of capsular resection (CR) and time diathermy loop active without tissue contact (TAWC) were recorded via the TURPsim™ and compared between novices and experts to assess construct validity. Verbal comments provided by experts following task completion were used to assess face validity. Repeated attempts of the task by the novices were analysed to assess the training benefits of the TURPsim™., Results: Experts resected a significantly greater percentage of prostate per minute (p < 0.01) and had significantly less active diathermy time without tissue contact (p < 0.01) than novices. After practice, novices were able to perform the simulation more effectively, with significant improvement in all measured parameters. Improvement in performance was noted in novices following repetitive training, as evidenced by improved TAWC scores that were not significantly different from the expert group (p = 0.18)., Conclusions: This study has established face and construct validity for the TURPsim™. The potential benefit in using this tool to train novices has also been demonstrated., (Copyright © 2012 Surgical Associates Ltd. Published by Elsevier Ltd. All rights reserved.)

Objectives: Health status instruments, which measure the subjective functioning and well-being of respondents, are increasingly being used in international, multi-centre trials of new treatments. If the results of such trials in different countries are to be pooled, it is vitally important for researchers to know how comparable the instruments are across cultures. In this study, we evaluated the response rate, data quality, score reliability and scaling assumptions of the 30-item Endometriosis Health Profile (EHP-30) in the USA., Methods: Data were obtained from a multi-centre study which recruited 225 patients from 43 clinic sites in the United States of America. It was a randomised, evaluator-blinded, Phase III study. In the evaluation of the EHP-30 reported here, the two groups (Depot Medroxyprogesterone Acetate [DMPA] and Leuprolide Acetate [LA]) are combined, and analyses are based on the data gained at baseline. Questionnaires were self-completed by patients when they visited the clinics., Results: Data completeness was very high, with 97.33% of respondents completing all of the items on the EHP-30. Furthermore, there were no more than a maximum of two missing responses for any given item. No floor and ceiling effects were found for any of the dimensions of the questionnaire. Internal consistency reliability was high for all dimensions (alpha ranged from 0.84 to 0.91). The psychometric properties of the instrument, outlined in the development of the UK version, are supported in the American context., Conclusions: The data presented here suggest that the EHP-30 is a valid and reliable measure that can be appropriately and meaningfully used in studies that include respondents from the USA.

This paper identifies naturally occurring lifestyle and self-care practices in managing type 2 diabetes mellitus that are associated with good glycemic control. In-depth, qualitative interviews were conducted in Guadalajara, Mexico, with 31 matched pairs of good and poor control diabetic patients (n=62), who were matched on their duration of disease and use of medications. While many themes were listed by both groups, a comparison of the responses indicated that themes of daily exercise with a preference for walking, eating beef and milk rather than chicken and fish, economic issues, and emotional issues distinguished poor-control patients. Good-control patients were more likely to have a negative reaction to their initial diagnosis, take a more comprehensive approach to control, eat only two meals a day (plus snacks), use noncaloric beverages to satisfy desires for more food, and know what their blood sugar levels should be.

Context: Few studies and no international comparisons have examined the impact of multiple chronic conditions on populations using a comprehensive health-related quality of life (HRQL) questionnaire., Objective: The impact of common chronic conditions on HRQL among the general populations of eight countries was assessed., Design: Cross-sectional mail and interview surveys were conducted., Participants and Setting: Sample representatives of the adult general population of eight countries (Denmark, France, Germany, Italy, Japan, The Netherlands, Norway and the United States) were evaluated. Sample sizes ranged from 2031 to 4084., Main Outcome Measures: Self-reported prevalence of chronic conditions (including allergies, arthritis, congestive heart failure, chronic lung disease, hypertension, diabetes, and ischemic heart disease), sociodemographic data and the SF-36 Health Survey were obtained. The SF-36 scale and summary scores were estimated for individuals with and without selected chronic conditions and compared across countries using multivariate linear regression analyses. Adjustments were made for age, gender, marital status, education and the mode of SF-36 administration., Results: More than half (55.1%) of the pooled sample reported at least one chronic condition, and 30.2% had more than one. Hypertension, allergies and arthritis were the most frequently reported conditions. The effect of ischemic heart disease on many of the physical health scales was noteworthy, as was the impact of diabetes on general health, or arthritis on bodily pain scale scores. Arthritis, chronic lung disease and congestive heart failure were the conditions with a higher impact on SF-36 physical summary score, whereas for hypertension and allergies, HRQL impact was low (comparing with a typical person without chronic conditions, deviation scores were around -4 points for the first group and -1 for the second). Differences between chronic conditions in terms of their impact on SF-36 mental summary score were low (deviation scores ranged between -1 and -2)., Conclusions: Arthritis has the highest HRQL impact in the general population of the countries studied due to the combination of a high deviation score on physical scales and a high frequency. Impact of chronic conditions on HRQL was similar roughly across countries, despite important variation in prevalence. The use of HRQL measures such as the SF-36 should be useful to better characterize the global burden of disease.

Background and Objectives: Health status measures, used to measure the subjective functioning and well-being of respondents, are increasingly being used in trials of treatments that are undertaken in a variety of countries. To assess comparability of results gained from such cross-cultural studies, it is important for researchers to know the comparability of instruments across cultures. One measure widely used in cross-cultural studies is the Parkinson's Disease Questionnaire (PDQ-39). We evaluated response rate, data quality, score reliability, and scaling assumptions of the instrument in the United States, Canada, Spain, Italy, and Japan., Methods: Our data were gained from the Global Parkinson's Disease Survey, a cross-national survey, in which the PDQ-39 was interviewer administered to respondents., Results: Our data suggest that the PDQ-39 is, for the most part, a valid and reliable measure that can be appropriately and meaningfully used in cross-cultural studies. However, one of the dimensions of the measure, Social Support, may not be sufficiently reliable to be used as a primary endpoint in trials., Conclusion: The PDQ-39 seems to be sufficiently robust to be used in trials and surveys in cross-cultural studies.

Background: Adjuvant tamoxifen is recommended for all women with estrogen receptor-positive breast carcinoma without regard for age. We investigated age-dependent variations in adjuvant tamoxifen prescription patterns in a cohort of women 80 years of age and older., Methods: We studied 92 women diagnosed at four U.S. sites with primary, early-stage breast carcinoma. Each woman consented to a medical record review and participated in two telephone interviews. We compared the proportion of tamoxifen prescriptions received by women 85-92 years of age with those received by women 80-84 years of age. Relative risks (RR) and 95% confidence intervals (95% CI) were generated using generalized estimating equations. Confounding by demographic, disease, and treatment characteristics was assessed., Results: Before adjustment, patients 85-92 years of age were 28% less likely to receive a tamoxifen prescription compared with patients 80-84 years of age (RR = 0.72, 95% CI 0.57-0.91). In this sample, patients not prescribed tamoxifen had substantially more comorbidity. After adjusting the crude finding for comorbidity, the RR was 0.74 (95% CI 0.58-0.93). In addition, the oldest patients and those not prescribed tamoxifen were significantly less likely to be married or have living children. After adjusting the crude finding for these two factors, the RR was 0.75 (95% CI 0.59-0.95). There was no confounding by the other demographic, disease, or treatment covariates assessed., Conclusion: Given the increasing longevity of the oldest old, undertreatment with adjuvant tamoxifen may put older breast carcinoma patients at an increased risk of disease recurrence and breast carcinoma mortality., (Copyright 2002 American Cancer Society.DOI 10.1002/cncr.10985)

Background: Continuing controversy surrounds screening mammography, particularly for women 40 to 49 years of age. Newspapers are potentially important sources of information on this topic, but it is not known whether they provide well-founded and objective information and recommendations., Objective: To examine how screening mammography is reported in newspapers., Design: Cross-sectional descriptive study., Setting: 6 top-circulation U.S. newspapers, 1990 to 1997., Measurements: Number of articles about screening mammography, issues covered by the articles, information sources, content and sources of quotes, recommendations cited in articles, and presentation of risks and benefits., Results: The most common theme of newspaper articles about mammography was screening for women 40 to 49 years of age. Thirty-one percent of the articles presented information without citing a source or justification. Quotes and recommendations in the articles were approximately twice as likely to support as to express reservations about mammography for women aged 40 to 49 years. Recommendations changed little over time and rarely reflected changes in recommendations of national organizations. Of the 102 articles describing the benefits of mammography, 95% expressed them in relative terms and 11% expressed them in absolute terms., Conclusions: Newspapers tended to overrepresent support for screening mammography for women aged 40 to 49 years. Reports would have been improved by identification of all sources for information cited, less reliance on relatively few sources, and discussion of benefits in absolute as well as relative terms. Medical journalism may benefit from identification of standards similar to those used for reporting medical research.

Policy makers and continuing educators often face difficult decisions about which educational and quality assurance interventions to provide. Where possible, such decisions are best informed by rigorous evidence, such as that provided by systematic reviews. The Cochrane Collaboration is an international organization that aims to help people make well-informed decisions about health care by preparing, maintaining, and ensuring the accessibility of systematic reviews of the benefits and risks of health care interventions. International collaborative review groups prepare Cochrane reviews for publication in The Cochrane Library, a collection of databases available on CD-ROM and the World Wide Web and updated quarterly. The Cochrane Effective Practice and Organization of Care Group (EPOC) aims to prepare and maintain systematic reviews of professional, financial, organizational, and regulatory interventions that are designed to improve professional practice and the delivery of effective health services. EPOC has 17 reviews and 20 protocols published in Issue 3, 2000, of the Cochrane Library, with further protocols in development. We also have undertaken an overview of previously published systematic reviews of professional behavior change strategies. Our specialized register contains details of over 1,800 studies that fall within the group's scope. Systematic reviews provide a valuable source of information for policy makers and educators involved in planning continuing education and quality assurance initiatives and organizational change. EPOC will attempt to keep the Journal of Continuing Education in the Health Professions informed on an ongoing basis about new systematic reviews that it produces in the area of continuing medical education and quality assurance.

Background: Reducing length of hospital stay (LOS) is a policy aim for many health care systems and is thought to indicate efficiency., Methods: A MedLine search was undertaken for articles relating to 'LOS', 'early discharge' or 'patient discharge' between 1983 and 1997 and a selective search was undertaken for material published before 1983., Results: Routine data showed that there were variations in LOS between countries, regions and hospitals. The trends in LOS showed a decrease over time in all regions. Research consistently fails to show an adverse effect on health outcomes of reducing LOS, but there may nevertheless be an ethical or moral minimum LOS. Two recent examples illustrate this. There has been an outcry at some ultrashort stays, for example 'drive-through mastectomy' and 'lunchtime abortion' and these are discussed in the review., Conclusions: There are a number of reasons for the perceived lack of relationship between LOS and health outcomes. Clearly reducing days of care at the low-intensity end of a hospital stay may not necessarily affect health outcomes. There is a case to be made for tailoring care more exactly to an individual's needs by looking at the actual components of care rather than the place of care--within or outside hospital walls.

Objectives: To investigate the evidence for the existence of gender bias (defined as care provided independently of clinical need) in the use of specialist services by critically appraising the literature., Methods: A computer-assisted search of the bibliographic databases PubMed, Medline, EMBASE, Healthstar and Social Science Citation Index for English language papers published from 1966 until May 1999. In addition, four journals were handsearched and the reference lists of identified papers were explored. Retrospective studies were only used when there were insufficient prospective studies., Results: One hundred and thirty-eight studies were identified covering five major topics: coronary artery disease; renal transplantation; human immunodeficiency virus (HIV) and acquired immune deficiency syndrome (AIDS); mental illness; and other (mainly invasive) procedures. The majority (94) examined coronary artery disease. It appears that men are more likely to undergo non-invasive investigations than women, but that subsequent investigation and treatment shows no clear evidence of gender differences. Men are more likely to undergo renal transplantation and, for those with HIV and AIDS, to receive azidothymidine (zidovudine, AZT) than women. There are some indications that disparities in favour of men also occur for those suffering from cardiac arrhythmias and cerebrovascular disease, and for those undergoing vascular surgery, hip replacement and heart transplantation. In contrast, women are more likely to undergo liver transplantation and cataract surgery. Mental health services may be provided differently for men and women. All these findings are limited by a lack of accurate denominator information and insufficient ability to adjust for prognostic factors., Conclusions: Differences in health care use can be due to demand factors (e.g. differences in the prevalence and severity of disease or in patient preferences), supply factors (particularly clinical judgement), or both. There is a need to examine these explanations thoroughly for gender inequalities in order to ensure that equity (lack of bias) is achieved. There is also a need for higher quality studies if differences are to be attributed conclusively to bias or not.

Objective: To assess the impact on the process and the outcomes of care of feeding back information on perceived health status to health care professionals in clinical practice., Design: Systematic review of controlled trials., Data Identification: Search in electronic databases (MEDLINE 1966-1997), manual searches, and requests to experts in the field., Data Analysis: Differences between intervention and control group were considered in process of care (use of health services, diagnosis, and treatment), patient outcomes (health status), and patient satisfaction. In a subgroup of 13 interventions that dealt with the provision of feedback about the patient's mental health, the impact on the process of care was subjected to meta-analysis., Results: We identified 21 studies that satisfied the selection criteria. Eleven of 20 (55%) found significant differences (P <0.05) in at least 1 of the process indicators in favor of the intervention group. Of 11 trials that assessed patient outcomes, only 4 (36%) detected significant improvements. A similar trend but lower percentages were observed among the 8 interventions that provided general health status information. Eleven interventions that evaluated feedback information about the patient's mental health status showed a higher rate of diagnosis in the intervention group (combined odds ratio [OR]=1.91; 95% confidence interval [CI] 1.28 to 2.83). Seven of 9 studies evaluating treatment failed to show an effect on this indicator (combined OR=1.15; 95% CI 0.76 to 1.75)., Conclusions: The provision of feedback on perceived health status to health professionals seems to have an effect on the process of care but not on patient functional or health status. This is especially true with regard to mental health status information. Nevertheless, there is still need for a more through evaluation of this type of intervention.

High up on the agenda of the World Trade Organisation (WTO) is the privatisation of education, health, welfare, social housing and transport. The WTO's aim is to extend the free market in the provision of traditional public services. Governments in Europe and the US link the expansion of trade in public services to economic success, and with the backing of powerful medico-pharmaceutical, insurance, and service corporations, the race is on to capture the share of gross domestic product that governments currently spend on public services. They will open domestic European services and domestic markets to global competition by government procurement agreements, dispute-settlement procedures, and the investment rules of global financial institutions. The UK has already set up the necessary mechanisms: the introduction of private-sector accounting rules to public services; the funding of public-sector investment via private-public partnerships or the private finance initiative; and the change to capitation funding streams, which allows the substitution of private for public funds and services. We explain the implications of these changes for European public-health-care systems and the threat they pose to universal coverage, solidarity through risk-pooling, equity, comprehensive care, and democratic accountability.

Recent data have shown differences between Spain and the United States in the prevalence of reported disability among community elderly. Differences in reporting functional capacity by culture may contribute to these observed differences. The purpose of this study was to estimate the agreement between self-report of disability and performance-based measures for some basic mobility tasks in the community-dwelling elderly of a Mediterranean country. Interviews containing questions about difficulty for walking and rising from a chair, and performance-based measures (walking speed and chair stand tests) were carried out in 626 individuals aged 72 years and older in Barcelona, Spain. Kappa statistics were calculated, and logistic regression models were constructed to identify possible factors associated with under- and overreporting functional capacity. Moderate kappas (0.41-0.55) were found between self-report and performance-based measures. Patients who rated their health as "poor or very poor" were less likely to underreport disability (adjusted odds ratio (OR) = 0.2, 0.4) but more likely to overreport it (adjusted OR = 23.4, 9.9). No significant agreement differences by sex or informant source were found. These findings suggest that Spanish elderly self-report functional capacity accurately and that, contrary to previous results among US elderly, the direction of the observed disagreement is not systematic.

Objectives: Patient-based health status measures have an important role to play in the assessment of health care outcomes. Among these measures, global assessments increasingly have been used, although the understanding of the performance of these indicators and the determinants of patients responses is underdeveloped. In this study, the performance of a single-item global indicator of visual function in cataract patients of four international settings was compared., Methods: Visual acuity and ocular comorbidity was assessed by patients' ophthalmologist using Snellen-type charts in patients referred for a first cataract surgery in the United States, Manitoba (Canada), Denmark, and Barcelona (Spain). Patients also were interviewed by telephone and asked to report overall trouble with vision on a single-item indicator ("great deal," "moderate," "a little," "none") and to complete the Visual Functioning Index (VF-14), a scale of visual function ranging from 0 (worst function) to 100 (best level of function), along with other questions including the degree the patient was bothered by symptoms as measured by the Cataract Symptom Score (CSS). A total of 1,407 patients completed the clinical examination and the preoperative interview., Results: Distribution of overall trouble with vision varied across the sites, with the proportion of patients reporting a great deal of trouble ranging from 21.7% to 37.9%. In all sites, patients reporting more trouble with vision tended to show a poorer age-adjusted and sex-adjusted visual acuity. The proportion of patients reporting great deal of trouble with vision was higher in the groups with worse visual acuity (P < 0.001). In multivariate analysis, after controlling for clinical and sociodemographic factors, the patients from Manitoba (OR = 0.32, 95% CI = 0.20, 0.51) and those from Barcelona (OR = 0.33, 95% CI = 0.20, 0.56) were less likely to report a great deal of trouble with their vision (P < 0.01) than the Danish and US patients. No such differences were found among the US patients from three sites., Conclusions: There is international variation in the self-reporting of global vision-related functional capacity that is not explained by clinical or sociodemographic factors, which may be because of cultural differences. International comparisons of patient-based health outcomes should not rely only on single-item indicators until there is convincing evidence of their cross-cultural equivalence.

We conducted a telephone survey of patients in a university-based medical practice to determine if there was a difference across payer class in patients' willingness to have supervised housestaff physicians function as their primary care providers. Overall, commercial managed care patients were more likely to object to seeing housestaff physicians than were Medicaid or Medicare patients (50% vs 32% or 23%, respectively). However, prior outpatient care by a resident physician significantly increased patient willingness to be cared for by a resident. This effect of prior care by a resident was noted in the managed care as well as the Medicaid and Medicare populations. Although there may have been self-selection, our data demonstrate that a significant proportion of managed care patients who have had residents as their primary care providers are amenable to continuing this practice.

Many reports on guidelines for investigation describe either the guidelines themselves or their implementation. Implicitly these assume that there has been general agreement about the guidelines, whereas there may be uncertainty about the appropriateness of a particular investigation in a given situation. We report the use of a technique for developing guidelines which explicitly seeks to identify areas of agreement and disagreement, and focuses on the reasons that particular decisions were made and the causes of disagreement.