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The American Heart Association and the American Stroke Association recommend 15 measures to determine whether patients with acute ischemic stroke receive highquality care, but these recommendations do not identify measures that deliver higher value because they are more cost-effective. This study aimed to evaluate the health impact and cost-effectiveness of the measures. Visual Abstract. Prioritizing Quality Measures in Acute Stroke Care: The American Heart Association and the American Stroke Association recommend 15 measures to determine whether patients with acute ischemic stroke receive highquality care, but these recommendations do not identify measures that deliver higher value because they are more cost-effective. This study aimed to evaluate the health impact and cost-effectiveness of the measures. Background: The American Heart Association and American Stroke Association (AHA/ASA) endorsed 15 process measures for acute ischemic stroke (AIS) to improve the quality of care. Identifying the highest-value measures could reduce the administrative burden of quality measure adoption while retaining much of the value of quality improvement. Objective: To prioritize AHA/ASA-endorsed quality measures for AIS on the basis of health impact and cost-effectiveness. Design: Individual-based stroke simulation model. Data Sources: Published literature. Target Population: U.S. patients with incident AIS. Time Horizon: Lifetime. Perspective: Health care sector. Intervention: Current versus complete (100%) implementation at the population level of quality measures endorsed by the AHA/ASA with sufficient clinical evidence (10 of 15). Outcome Measures: Life-years, quality-adjusted life-years (QALYs), incremental cost-effectiveness ratios, and incremental net health benefits. Results of Base-Case Analysis: Discounted life-years gained from complete implementation would range from 472 (tobacco use counseling) to 34 688 (early carotid imaging) for an annual AIS patient cohort. All AIS quality measures were cost-saving or highly cost-effective by AHA standards (<$50 000 per QALY for high-value care). Early carotid imaging and intravenous tissue plasminogen activator contributed the largest fraction of the total potential value of quality improvement (measured as incremental net health benefit), accounting for 72% of the total value. The top 5 quality measures accounted for 92% of the total potential value. Results of Sensitivity Analysis: A web-based user interface allows for context-specific sensitivity and scenario analyses. Limitation: Correlations between quality measures were not incorporated. Conclusion: Substantial variation exists in the potential net benefit of quality improvement across AIS quality measures. Benefits were highly concentrated among 5 of 10 measures assessed. Our results can help providers and payers set priorities for quality improvement efforts and value-based payments in AIS care. Primary Funding Source: National Institute of Neurological Disorders and Stroke. [ABSTRACT FROM AUTHOR]

Aims: To examine the association between baseline glucose control and risk of COVID‐19 hospitalization and in‐hospital death among patients with diabetes. Methods: We performed a retrospective cohort study of adult patients in the INSIGHT Clinical Research Network with a diabetes diagnosis and haemoglobin A1c (HbA1c) measurement in the year prior to an index date of March 15, 2020. Patients were divided into four exposure groups based on their most recent HbA1c measurement (in mmol/mol): 39–46 (5.7%–6.4%), 48–57 (6.5%–7.4%), 58–85 (7.5%–9.9%), and ≥86 (10%). Time to COVID‐19 hospitalization was compared in the four groups in a propensity score‐weighted Cox proportional hazards model adjusting for potential confounders. Patients were followed until June 15, 2020. In‐hospital death was examined as a secondary outcome. Results: Of 168,803 patients who met inclusion criteria; 50,016 patients had baseline HbA1c 39–46 (5.7%–6.4%); 54,729 had HbA1c 48–57 (6.5–7.4%); 47,640 had HbA1c 58–85 (7.5^%–9.9%) and 16,418 had HbA1c ≥86 (10%). Compared with patients with HbA1c 48–57 (6.5%–7.4%), the risk of hospitalization was incrementally greater for those with HbA1c 58–85 (7.5%–9.9%) (adjusted hazard ratio [aHR] 1.19, 95% confidence interval [CI] 1.06–1.34) and HbA1c ≥86 (10%) (aHR 1.40, 95% CI 1.19–1.64). The risk of COVID‐19 in‐hospital death was increased only in patients with HbA1c 58–85 (7.5%–9.9%) (aHR 1.29, 95% CI 1.06, 1.61). Conclusions: Diabetes patients with high baseline HbA1c had a greater risk of COVID‐19 hospitalization, although association between HbA1c and in‐hospital death was less consistent. Preventive efforts for COVID‐19 should be focused on diabetes patients with poor glucose control. [ABSTRACT FROM AUTHOR]

Background: Metformin is the first-line treatment for type 2 diabetes mellitus. Observational studies show lower rates of use than would be expected from clinical guidelines. Objective: We undertook a qualitative study of barriers to metformin use from the patient and provider perspective. Design: Patient focus group, patient individual interviews, provider interviews, and chart review. Purposive sampling of patients and providers in New York State. Participants: Seven one-on-one patient interviews, one focus group with 13 patients, 10 provider interviews, and manual review of 1259 charts. Approach: Grounded theory. Results: Both providers and patients cited potential health benefits as strong reasons to take metformin and describe it as the first-line drug for diabetes. Patients and providers both cited gastrointestinal side effects as the primary barrier to metformin use. Patients described adapting to these side effects and taking metformin at a time that minimizes them. In contrast, providers emphasized dose titration and the use of extended-release formulation as tools for minimizing side effects but were uncertain about the effectiveness of these strategies. Conclusion: Metformin is positively viewed by patients and providers, but gastrointestinal side effects are a barrier to its use. There is some consensus on basic measures to improve its tolerability, but these measures are not consistently applied and lack evidence establishing their effectiveness. Pragmatic clinical trial research on optimal dose, formulation, and counseling for new metformin users should be considered. [ABSTRACT FROM AUTHOR]

Objectives Non-persistence may be a significant barrier to the use of metformin. Our objective was to assess reasons for metformin non-persistence, and whether initial metformin dosing or use of extended release (ER) formulations affect persistence to metformin therapy. Design Retrospective cohort study. Setting Electronic health record data from a network of urban academic practices. Participants The cohort was restricted to individuals receiving a metformin prescription between 2009/1/1 and 2015/9/31, under care for at least 6 months before the first prescription of metformin. The cohort was further restricted to patients with no evidence of any antihyperglycaemic agent use prior to the index date, an haemoglobin A1c measured within 1 month prior to or 1 week after the index date, at least 6 months of follow-up, and with the initial metformin prescription originating in either a general medicine or endocrinology clinic. Primary and secondary outcome measures The primary outcome measure was early non-persistence, as defined by the absence of further prescriptions for metformin after the first 90 days of follow-up. Results The final cohort consisted of 1259 eligible individuals. The overall rate of early non-persistence was 20.3%. Initial use of ER and low starting dose metformin were associated with significantly lower rates of reported side effects and non-persistence, but after multivariable analysis, only use of low starting doses was independently associated with improved persistence (adjusted OR 0.54, 95% CI 0.37 to 0.76, for comparison of 500 mg daily dose or less to all higher doses). Conclusions These data support the routine prescribing of low starting doses of metformin as a tool to improve persistence. In this study setting, many providers routinely used ER metformin as an initial treatment; while this practice may have benefits, it deserves more rigorous study to assess whether increased costs are justified. [ABSTRACT FROM AUTHOR]

Background: Failure of THA or TKA to meet a patient's expectations may result in patient disappointment and litigation. However, there is little evidence to suggest that surgeons can consistently anticipate which patients will benefit from those interventions.Questions/purposes: To determine the ability of surgeons to identify, in advance of surgery, patients who will benefit from THA or TKA and those who will not, where 'benefit' is defined as a clinically important improvement in a validated patient-reported outcomes score.Methods: In this prospective study, eight high-volume orthopaedic surgeons completed validated THA and TKA expectations questionnaires (score 0-100, 100 being the highest expectation) as part of preoperative assessment of all their patients scheduled for a THA or TKA and enrolled in the Hospital for Special Surgery institutional registry. Enrolled patients completed the WOMAC preoperatively and at 2 years. Successful outcomes were defined as achieving the minimum clinically important difference (MCID) in WOMAC pain and function subscales. Sensitivity, specificity, and receiver operating characteristic (ROC) curves were used to evaluate the ability of surgeons' expectation scores to identify patients likely to achieve the MCID on the WOMAC scale. Analyses were run separately for patients having THA and TKA. We enrolled 259 patients undergoing THA and 247 undergoing TKA, of whom 77% (n = 200) and 77% (n = 191) completed followup surveys 2 years after their procedures, respectively.Results: Surgeons' expectation scores effectively anticipated patients who would improve after THA, but they were no better than chance in identifying patients who would achieve the MCID on the WOMAC score 2 years after TKA. For patients having THA, the areas under the ROC curve were 0.67 (95% CI, 0.53-0.82; p = 0.02) and 0.74 (95% CI, 0.63-0.85; p < 0.01) for WOMAC function and pain outcomes, respectively, indicating good accuracy. Sensitivity and specificity were maximized on WOMAC pain and function scores (sensitivity = 0.69, specificity = 0.72, both for pain and function) at an expectations score of 83 or greater of 100. Surgeons' expectations were more accurate for patients who were men, who had a BMI less than 30 kg/m2, who had more than one comorbidity, and who were older than 65 years. For patients having TKA, surgeons' expectation scores were not better than chance for identifying those who would experience a clinically important improvement on the WOMAC scale (area under ROC curve: Function = 0.51, [95% CI, 0.42-0.61], p = 0.78; Pain = 0.51, [95% CI, 0.40-0.61], p = 0.92).Conclusions: Most patients having THA and TKA achieved the MCID improvement after surgery. However, the inability of surgeons' expectation scores to discriminate accurately between patients who benefit and those who do not among patients scheduled for THA who are young, with no comorbidities, and with elevated BMIs, and among all patients scheduled for TKA, calls for surgeons to spend more time with these patients to fully understand and address their needs and expectations. Using standardized assessment tools to compare surgeons' expectations and those of their patients may help focus the surgeon-patient discussion further, and address patients' expectations more effectively.Level Of Evidence: Level II, therapeutic study. [ABSTRACT FROM AUTHOR]

Background: Expert groups and national guidelines recommend individualized decision making about screening mammography for women in their 40s at low-to-average risk of breast cancer. We created Breast Screening Decisions (BSD), a personalized, web-based decision aid, to help women decide when to start and how often to have routine screening mammograms. We evaluated BSD in a large, prospective pilot trial of women and their clinicians.Methods: Women ages 40-49 were invited to use BSD before a scheduled preventive care visit. One month post-visit, users were asked about decisional conflict, knowledge, perceptions and worry about breast cancer and screening. They were also asked whether they had a screening mammogram since their visit, scheduled an appointment for a screening mammogram, or if they were planning to schedule an appointment within the next six months. Women who responded "no" to each of these successive questions were considered to have no plan for a screening mammogram within the next 6 months, unless they explicitly stated that they were unsure about screening mammography. Clinicians were surveyed regarding mammography discussions and perceived patient knowledge and anxiety.Results: Of 1,100 women invited to use BSD, 253 accessed the website, and 168 were eligible to participate in the pilot study. One-fifth had a family history of breast cancer, and at least 76% had any prior mammogram. At follow-up, 88% of BSD users reported discussing mammography at their visit, and 77% said they had a screening mammogram since the visit or that they made or were planning to make a screening mammogram appointment. The average decisional conflict score was 22.5, within the threshold for implementing decisions. Decisional conflict scores were lowest in women who said that they had or planned to have a mammogram (mean 21.4, 95% CI 18.3-24.6), higher in those who did not (mean 24.8, 95% CI 19.2-30.5), and highest in those who were unsure (mean 31.5, 95% CI 13.9-49.1). Most BSD users expressed accurate perceptions of their breast cancer risk and the benefits and limitations of screening.Conclusions: A web-based decision aid may support informed, individualized decisions about screening mammography and facilitate discussions about screening between women in their 40s and their clinicians. [ABSTRACT FROM AUTHOR]

Background: Individual informed consent from all participants is required for most randomized clinical trials (RCTs). However, some exceptions-for example, emergency research-are widely accepted.Methods: The literature on various approaches to randomization without consent (RWOC) has never been systematically reviewed. Our goal was to provide a survey and narrative synthesis of published proposals for RWOC. We focused on proposals to randomize at least some participants in a study without first obtaining consent to randomization. This definition included studies that omitted informed consent entirely, omitted informed consent for selected patients (e.g., the control group), obtained informed consent to research but not to randomization, or only obtained informed consent to randomization after random assignment had already occurred. It omitted oral and staged consent processes that still obtain consent to randomization from all participants before randomization occurs.Results: We identified ten different proposals for RWOC: two variants of cluster randomization, two variants of the Zelen design, consent to postponed information, two-stage randomized consent, cohort multiple RCT, emergency research, prompted optional randomization trials, and low-risk pragmatic RCTs without consent.Conclusion: Of all designs discussed here, only cluster randomized designs and emergency research are routinely used, with the justification that informed consent is infeasible in those settings. Other designs have raised concerns that they do not appropriately respect patient autonomy. Recent proposals have emphasized the importance for RWOC of demonstrating such respect through systematic patient engagement, transparency, and accountability, potentially in the context of learning health care systems. [ABSTRACT FROM AUTHOR]

Objective: Insurance expansion under the Affordable Care Act will amplify a projected 6-fold increase in total knee replacement (TKR) utilization by 2030 but will not fully address TKR disparities. Promoting appropriate use of TKR would help reduce disparities and improve outcomes. There are currently no validated appropriateness criteria (AC) for TKR in the US. We evaluated the performance of 2 non-US AC in a cohort of US TKR patients. Methods: AC1 was developed in Spain using the modified Delphi method with 624 patient scenarios. AC2 was developed in Canada using the overall Western Ontario and McMaster Universities Osteoarthritis Index score of >39 as the cutoff point for surgery. These criteria were applied to a random sample of TKR patients enrolled in our institutional registry. Preoperative clinical, radiographic, and patient-reported survey data were used in classifying patients. The rate of appropriateness was compared for the 2 AC. Inappropriate cases were further investigated to determine other mitigating factors beyond the criteria influencing the decision to operate. Results: In total, 508 TKR procedures were evaluated. All patients had osteoarthritic radiographic changes. On the basis of AC1, 7.7% of cases were classified as inappropriate and 11.6% uncertain. On the basis of AC2, 31.5% were classified as inappropriate. Only 4.7% of the cases were classified as inappropriate by both ACs; however, there was poor agreement between the 2 AC (κ = -0.08). Beyond the criteria, failure of nonsurgical treatment and clinically significant valgus/varus deformities influenced the decision for surgery. Conclusion: There was poor agreement between 2 validated AC for TKR when tested in a US population. Culturally specific AC are needed to promote rational use of TKR. [ABSTRACT FROM AUTHOR]

Background: Type II diabetes mellitus (DM) is one of the leading chronic diseases in Qatar as well as worldwide. However, the risk factors for DM in Qatar and their prevalence are not well understood. We conducted a case-control study with the specific aim of estimating, based on data from outpatients with DM in Qatar (cases) and outpatient/inpatient controls, the association between demographic/ lifestyle factors and DM. Methods: A total of 459 patients with DM from Hamad General Hospital (HGH) outpatient adult diabetes clinics, and 342 control patients from various outpatient clinics and inpatient departments within Hamad Medical Corporation (HMC) (years 2006-2008), were recruited. The association between risk factors and DM was evaluated using bivariate and multivariable logistic regression analyses. In addition to odds ratios (OR) and 95% confidence intervals (95% CI), we estimated the population attributable risk fractions for the DM demographic/lifestyle risk factors. Results: Qatari nationality was the strongest risk factor for DM (adjusted OR = 5.5; 95% CI = 3.5-8.6; p, 0.0001), followed by higher monthly income (defined as $3000 Qatari Riyals, adjusted OR = 5.1; 95% CI = 3.0-8.7; p,0.0001), age .65 years (adjusted OR = 3.3; 95% CI = 0.9-11.4; p = 0.06), male gender (adjusted OR = 2.9; 95% CI = 1.8-4.8; p, 0.0001), obesity (BMI $30, adjusted OR = 2.2; 95% CI = 1.5-3.2; p,0.0001), no college education (adjusted OR = 1.7; 95% CI = 1.2-2.6; p = 0.009), and no daily vigorous/moderate activity (adjusted OR = 1.5; 95% CI = 0.9-2.3; p = 0.12). Among Qatari nationals, obesity was found to be the main risk factor for DM (unadjusted OR = 3.0; 95% CI = 1.6-5.6;p,0.0001), followed by no college education (unadjusted OR = 2.7; 95% CI = 1.5-5.1; p = 0.001), while consanguinity did not appear to play a major role in predicting DM (unadjusted OR = 1.5; 95% CI = 0.8-2.8; p = 0.21). Our findings further suggested that eliminating obesity and improving access to education may reduce DM cases by up to one third for the population at large (31.7% and 26.8%, respectively) and up to half (46.9% and 49.3%, respectively) for Qatari nationals. Promoting physical activity may reduce the burden of DM by up to 9.4% for the population at large and up to 17.3% for Qatari nationals. Conclusions: Demographic/lifestyle factors appear to be the main risk factors for the high DM levels observed in Qatar, with a contribution that outweighs that of genetic risk factors. While further evaluation of DM risk factors among the Qatari population (as opposed to the resident population) is important and of interest, these findings highlight the need to focus short-term DM interventions on addressing demographic/lifestyle risk factors to achieve substantial and timely declines in DM levels. [ABSTRACT FROM AUTHOR]

Background Babesia microti is the leading reported cause of red blood cell ( RBC) transfusion-transmitted infection in the United States. Donor screening assays are in development. Study Design and Methods A decision analytic model estimated the cost-effectiveness of screening strategies for preventing transfusion-transmitted babesiosis ( TTB) in a hypothetical cohort of transfusion recipients in Babesia-endemic areas of the United States. Strategies included: 1) no screening; 2) Uniform Donor Health History Questionnaire ( UDHQ), 'status quo'; 3) recipient risk targeting using donor antibody and polymerase chain reaction ( PCR) screening; 4) universal endemic donor antibody screening; and 5) universal endemic donor antibody and PCR screening. Outcome measures were TTB cases averted, costs, quality-adjusted life-years ( QALYs), and incremental cost-effectiveness ratios ( ICERs; $/ QALY). We assumed a societal willingness to pay of $1 million/ QALY based on screening for other transfusion-transmitted infections. Results Compared to no screening, the UDHQ avoids 0.02 TTB cases per 100,000 RBC transfusions at an ICER of $160,000/ QALY whereas recipient risk-targeted strategy using antibody/ PCR avoids 1.62 TTB cases per 100,000 RBC transfusions at an ICER of $713,000/ QALY compared to the UDHQ. Universal endemic antibody screening avoids 3.39 cases at an ICER of $760,000/ QALY compared to the recipient risk-targeted strategy. Universal endemic antibody/ PCR screening avoids 3.60 cases and has an ICER of $8.8 million/ QALY compared to universal endemic antibody screening. Results are sensitive to blood donor Babesia prevalence, TTB transmission probability, screening test costs, risk and severity of TTB complications, and impact of babesiosis diagnosis on donor quality of life. Conclusion Antibody screening for Babesia in endemic regions is appropriate from an economic perspective based on the societal willingness to pay for preventing infectious threats to blood safety. [ABSTRACT FROM AUTHOR]

Context Implantable cardioverter-defibrillators (ICDs) have diffused rapidly into clinical practice with little evaluation of their real-world effectiveness. Objectives To determine the effect of the adoption of ICD on patient safety, particularly with respect to physician volume and early outcomes. Design Retrospective cohort of all ICD implantations in New York state from 1997 to 2006, with follow-up at 90 days and 1 year. Setting New York state non-federal hospital discharges in which an ICD was implanted during the admission. Patients were followed forward for 1 year for subsequent admissions. Patients New York state residents undergoing ICD implantation. Main outcome measures Effects of annual and career ICD implantation volume on 90-day complication, readmission, reprogramming, mortality and revision of the ICD within 1 year. Results This cohort (N¼38 992) represents a period of rapid adoption and implementation of this new technology, with frequency more than tripling between 1997 and 2006. We identified 6439 (16.5%) postimplantation complications and 1093 (2.8%) deaths within 90 days of implantation. The majority (73.4%) of physicians implanted one or fewer ICDs per year, and 11.0% of all implantations were performed by these very-low-volume operators. Patients treated by very-lowvolume operators were more likely to die (RR¼1.8, 95% CI 1.3 to 2.4) or experience cardiac complications (RR¼4.7, 95% CI 3.3 to 6.8) even after the adjustment for case mix compared to operators who frequently performed ICD implantation. Conclusions These findings suggest a need for safe and effective implementation strategies for new medical technologies, which minimize patient risk due to rapid diffusion among inexperienced providers and assure that the intended benefit can be maximised rapidly. [ABSTRACT FROM AUTHOR]

The article discusses a study of the use of optimal medical therapy (OMT) in patients with stable angina undergoing percutaneous coronary intervention (PCI) before and after publication of the Clinical Outcomes Utilizing Revascularization and Aggressive Drug Evaluation (COURAGE) study. The study involved patients in the National Cardiovascular Data Registry in the U.S. between September 1, 2005 and June 30, 2009. Majority of the patients who were receiving OMT before their PCI had more comorbidities. It cites the similarities in demographic and clinical characteristics of patients in the before and after COURAGE trial periods. Results show that almost a third of patients failed to receive OMT.

Background: National guidelines disagree on who should be screened for undiagnosed diabetes. No existing diabetes risk score is highly generalizable or widely followed. Objective: To develop a new diabetes screening score and compare it with other available screening instruments (Centers for Disease Control and Prevention, American Diabetes Association, and U.S. Preventive Services Task Force guidelines; 2 American Diabetes Association risk questionnaires; and the Rotterdam model). Design: Cross-sectional data. Setting: NHANES (National Health and Nutrition Examination Survey) 1999 to 2004 for model development and 2005 to 2006, plus a combined cohort of 2 community studies, ARIC (Atherosclerosis Risk in Communities) Study and CHS (Cardiovascular Health Study), for validation. Participants: U.S. adults aged 20 years or older. Measurements: A risk-scoring algorithm for undiagnosed diabetes, defined as fasting plasma glucose level of 7.0 mmol/L (126 mg/dL) or greater without known diabetes, was developed in the development data set. Logistic regression was used to determine which participant characteristics were independently associated with undiagnosed diabetes. The new algorithm and other methods were evaluated by standard diagnostic and feasibility measures. Results: Age, sex, family history of diabetes, history of hypertension, obesity, and physical activity were associated with undiagnosed diabetes. In NHANES (ARIC/CHS), the cut-point of 5 or more points selected 35% (40%) of persons for diabetes screening and yielded a sensitivity of 79% (72%), specificity of 67% (62%), positive predictive value of 10% (10%), and positive likelihood ratio of 2.39 (1.89). In contrast, the comparison scores yielded a sensitivity of 44% to 100%, specificity of 10% to 73%, positive predictive value of 5% to 8%, and positive likelihood ratio of 1.11 to 1.98. Limitation: Data during pregnancy were not available. Conclusion: This easy-to-implement diabetes screening score seems to demonstrate improvements over existing methods. Studies are needed to evaluate it in diverse populations in real-world settings. Primary Funding Source: Clinical and Translational Science Center at Weill Cornell Medical College. [ABSTRACT FROM AUTHOR]

The article discusses a retrospective cohort study on how cost and initial choice of formulation affect adherence and persistence to metformin therapy for type 2 diabetes. Highlights include the use of merged de-identified claims data from commercial insurance carriers in the U.S. from January 2012 to December 2016, the use of univariate statistics and logistic and linear regression to describe covariates, outcomes, and their association, and the adjusted link between persistence and cost.

OBJECTIVES: To estimate the cost-effectiveness from a societal perspective of a hip protector (HP) program over the remaining lifetime of individuals initially living at home. DESIGN: A state-transition Markov model considering outcomes of HP use in cohorts stratified by age, sex, and functional and residential status. Costs, transition probabilities, HP adherence, and efficacy were derived from published sources. SETTING: Community and nursing homes in the United States. PARTICIPANTS: Hypothetical cohort of individuals aged 65 and older without a hip fracture and initially living at home. INTERVENTION: HP program. MEASUREMENTS: Fractures, life years, and dollars saved, quality-adjusted life-years (QALYs), and incremental cost-effectiveness ratios (ICER). RESULTS: HP use prevented fractures and increased life expectancy in all cohorts. HP use saved costs and improved QALYs in women initiating HP use at age 80 and in men at age 85. In women initiating HP use at age 75, the HP ICER was $19,000/QALY. In men initiating HP use at age 80, HP use saved costs but slightly decreased QALYs. In younger cohorts, HP use was neither cost saving nor QALY improving. In sensitivity analyses, if there was no QALY loss from wearing a HP, the ICER was less than $50,000/QALY for all age and sex cohorts. If HP cost was reduced 50%, HP use was cost saving for women initiating HP use at age 75. In probabilistic sensitivity analyses, the HP ICER was less than $50,000/QALY in 68% of simulations for women initiating HP use at age 75 and 61% of simulations for men initiating at age 85. CONCLUSION: HP use saved costs and QALYs for older age cohorts of both sexes. Additional research on the quality-of-life effects and obstacles to wearing HP is warranted. [ABSTRACT FROM AUTHOR]

Objective: To examine the referral process to cardiac surgeons in order to explain racial disparities in access to high-quality cardiac surgeons.Data Sources/study Settings: All white and black Medicare fee-for-service patients undergoing coronary artery bypass graft (CABG) surgery in New York State during 1997-1999.Study Design: A retrospective analysis of referral patterns for white and black patients in relation to the quality of the cardiac surgeon, measured by the surgeon's risk-adjusted mortality rate (RAMR), and in relation to characteristics of the physician providing the majority of cardiac care before the surgery. The average RAMRs of the surgeons to whom different physicians referred patients were compared using t-tests and paired t-tests. A hierarchical multivariate regression model was estimated to test hypotheses about the effect of physicians' characteristics on referrals of blacks to low-quality surgeons.Data Extraction Method: Variables were constructed from Medicare claims.Principal Findings: The differential in surgeons' quality for white and black patients is partially due to the physician providing the majority of cardiac care before the surgery. There is both across- and within-physician variation in referrals. Of the physician characteristics investigated, only the number of black patients referred to CABG and the percent of all cardiac referrals to the same hospital decrease the difference in surgeons' quality between whites and blacks.Conclusions: Several different pathways lead blacks to cardiac surgeons of lower quality. Further research is needed to understand the causes and inform policies designed to minimize disparities in access to high-quality providers. [ABSTRACT FROM AUTHOR]

Objective. To examine the referral process to cardiac surgeons in order to explain racial disparities in access to high-quality cardiac surgeons. Data Sources/Study Settings. All white and black Medicare fee-for-service patients undergoing coronary artery bypass graft (CABG) surgery in New York State during 1997–1999. Study Design. A retrospective analysis of referral patterns for white and black patients in relation to the quality of the cardiac surgeon, measured by the surgeon's risk-adjusted mortality rate (RAMR), and in relation to characteristics of the physician providing the majority of cardiac care before the surgery. The average RAMRs of the surgeons to whom different physicians referred patients were compared using t-tests and paired t-tests. A hierarchical multivariate regression model was estimated to test hypotheses about the effect of physicians' characteristics on referrals of blacks to low-quality surgeons. Data Extraction Method. Variables were constructed from Medicare claims. Principal Findings. The differential in surgeons' quality for white and black patients is partially due to the physician providing the majority of cardiac care before the surgery. There is both across- and within-physician variation in referrals. Of the physician characteristics investigated, only the number of black patients referred to CABG and the percent of all cardiac referrals to the same hospital decrease the difference in surgeons' quality between whites and blacks. Conclusions. Several different pathways lead blacks to cardiac surgeons of lower quality. Further research is needed to understand the causes and inform policies designed to minimize disparities in access to high-quality providers. [ABSTRACT FROM AUTHOR]

Background: More than 6 million Americans have undiagnosed diabetes. Several national organizations endorse screening for diabetes by physicians, but actual practice is poorly understood. Our objectives were to measure the rate, the predictors and the results of glucose testing in primary care, including rates of follow-up for abnormal values. Methods: We conducted a retrospective cohort study of 301 randomly selected patients with no known diabetes who received care at a large academic general internal medicine practice in New York City. Using medical records, we collected patients' baseline characteristics in 1999 and followed patients through the end of 2002 for all glucose tests ordered. We used multivariate logistic regression to measure associations between diabetes risk factors and the odds of glucose testing. Results: Three-fourths of patients (78%) had at least 1 glucose test ordered. Patient age (=45 vs. <45 years), non-white ethnicity, family history of diabetes and having more primary care visits were each independently associated with having at least 1 glucose test ordered (p < 0.05), whereas hypertension and hyperlipidemia were not. Fewer than half of abnormal glucose values were followed up by the patients' physicians. Conclusion: Although screening for diabetes appears to be common and informed by diabetes risk factors, abnormal values are frequently not followed up. Interventions are needed to trigger identification and further evaluation of abnormal glucose tests. [ABSTRACT FROM AUTHOR]

Purpose – To assess the effect of diagnostic testing for coronary artery disease (CAD) on motivation for change, and on lifestyle change for patients with chest pain. Design/methodology/approach – This observational study followed patients with chest pain suggestive of CAD for three years. Constructs of autonomous and controlled motivation for lifestyle change, autonomous orientation, and autonomy support from self-determination theory were assessed. Self-reported tobacco use, physical activity, and diet were assessed at baseline and three years later. Physician rating of pre- and post-test probability of CAD were also assessed. CAD diagnosis was established after three years. Findings – Physicians' autonomy-supportive style and patients' autonomous orientations both predicted greater patient autonomous motivation, which in turn predicted improved diet, more exercise, and marginally less smoking. High probability of CAD also led patients to become more autonomously motivated for lifestyle change. Research limitations/implications – The observational nature of the study and the self-report measures of health behaviors preclude causal conclusions from this study. Findings from this study suggest that patient motivation and risk behavior are affected by results of cardiac testing, by physicians' support of autonomy, and by patients' personalities. Practical implications – Physicians may be effective in motivating behavior change around time of testing for CAD. Originality/value – The self-determination theory model for health behavior change accounted for change in patient health risk behavior change around the time of testing for CAD. Physicians and researchers might use these results to design and test interventions for practitioners to effectively motivate behavior change around the time of medical tests. [ABSTRACT FROM AUTHOR]

To estimate potential cost savings generated by a program of hip protectors in the nursing home from a Medicare perspective.A state-transition Markov model considering short-term and long-term outcomes of hip protectors for a hypothetical nursing home population, stratified by age, sex, and functional status. Costs, transition probabilities between health states, and estimates of hip protectors' effectiveness were derived from published secondary data.Nursing home facilities in the United States.Hypothetical cohort of permanent nursing home residents aged 65 and older without a previous hip fracture.Program of hip protectors reimbursed by Medicare.Number of fractures, life years, and dollars saved.Three pairs of hip protectors replaced annually would result in a weighted average lifetime absolute risk reduction for hip fracture of 8.5%, with net lifetime savings to Medicare of$223 per resident. When the annual cost of hip protectors is less than$151 per person, relative risk of fracture is less than or equal to 0.65 with hip protectors, or adherence is greater than 42%, hip protectors are cost saving to Medicare over a wide range of assumptions. Extrapolating these results to the estimated population of U.S. nursing home residents without a previous hip fracture, Medicare could save$136 million in the first year of a hip-protector reimbursement program.From a Medicare perspective, hip protectors are a cost-saving intervention in the nursing home setting when hip protector effectiveness is less than or equal to 0.65 over the remaining lifetime of subjects. [ABSTRACT FROM AUTHOR]

Study objectives: To develop and validate a model for estimating the risk of lung cancer death in current and former smokers. The model is intended for use in analyzing a population of subjects who are undergoing lung cancer screening or receiving lung cancer chemoprevention, to determine whether the intervention has altered lung cancer mortality. Design/setting/patients: Model derivation was based on analyses of the placebo arm of the Carotene and Retinol Efficacy Trial. Model validation was based on analyses of three other longitudinal cohorts. Measurements: Observed and predicted number of deaths due to lung cancer. Results: In internal validation, the model was highly concordant and well calibrated. In external validation, the model predictions were similar to what was observed in all of the validation analyses. The predicted and observed deaths within 6 years were very similar when assessed in the Johns Hopkins Hospital trial of chest radiography and sputum cytology screening (176 predicted, 184 observed, p = 0.53), the Memorial Sloan-Kettering Cancer Center trial of chest radiography and sputum cytology screening (108 predicted, 114 observed, p = 0.57), and the National Health and Nutrition Evaluation Survey part I (24 predicted, 21 observed, p = 0.52). Conclusions: The number of lung cancer deaths in a population of current or former smokers can be accurately predicted, making model-based evaluations of prevention and early detection interventions a useful adjunct to definitive randomized trials. We illustrate this potential use with a small example. [ABSTRACT FROM AUTHOR]

Objective: To determine the sensitivity and specificity of skin self-examination (SSE) to detect new and changing moles with and without the aid of baseline digital photographs in patients with dysplastic nevi. Design and Intervention: Patients had baseline digital photography and mole counts of their back, chest, and abdomen and were instructed to perform a baseline SSE. Print copies of the images were provided to the patient. Following the baseline examination, the appearance of existing moles was altered and new moles were created using cosmetic eyeliner. The number of moles altered and/or created totaled approximately 10% of each patients' absolute mole count. Setting and Patients: Fifty patients with 5 or more dysplastic nevi from the outpatient clinic at Memorial Sloan-Kettering Cancer Center, New York, NY. Main Outcome Measure: Skin self-examinations with and without access to the baseline photographs to identify the number of new and altered moles. Results: The sensitivity and specificity of SSE for detection of both altered and new moles without photography were 60.2% and 96.2%, respectively. Skin self-examination with photography yielded a sensitivity and specificity of 72.4% and 98.4%, respectively. The findings were similar when stratified by site (back vs chest or abdomen). The sensitivity and specificity for new moles were higher compared with altered moles. Conclusions: Access to baseline photography improved the diagnostic accuracy of SSE on the back and chest or abdomen and improved detection of changing and new moles. Our results suggest that baseline digital photography in tandem with SSE may be effective in improving the diagnostic accuracy of patients performing SSE. [ABSTRACT FROM AUTHOR]

Background: Bioterrorism using anthrax claimed five lives in the United States in 2001 and remains a potential public health threat. In the aftermath of a large-scale anthrax attack, mass screening to identify early inhalational anthrax may improve both the management of individual cases and the efficiency of health resource utilization.Purpose: To develop the evidence base for outpatient anthrax screening protocols by quantifying differences in clinical presentation between inhalational anthrax and common viral respiratory tract infections.Design: Review, compilation, and data extraction from English-language case reports of inhalational anthrax and epidemiologic studies of influenza and other viral respiratory infections.Data Sources: 13 reports of 28 cases of inhalational anthrax from 1920 to 2001 and 5 studies reporting on the clinical features of 2762 cases of influenza and 1932 cases of noninfluenza viral respiratory disease.Data Synthesis: Characterization of presenting clinical symptoms in anthrax and viral disease and calculation of likelihood ratios for the presence of selected clinical features.Results: Fever and cough do not reliably discriminate between inhalational anthrax and viral respiratory tract infection. Features suggestive of anthrax include the presence of nonheadache neurologic symptoms (positive likelihood ratio cannot be calculated), dyspnea (positive likelihood ratio, 5.3 [95% CI, 3.7 to 7.4]), nausea or vomiting (positive likelihood ratio, 5.1 [CI, 3.0 to 8.5]), and finding of any abnormality on lung auscultation (positive likelihood ratio, 8.1 [CI, 5.3 to 12.5]). In contrast, rhinorrhea (positive likelihood ratio, 0.2 [CI, 0.1 to 0.4]) and sore throat (positive likelihood ratio, 0.2 [CI, 0.1 to 0.5]) are more suggestive of viral respiratory tract infection.Conclusion: Inhalational anthrax has characteristic clinical features that are distinct from those seen in common viral respiratory tract infections. Screening protocols based on these features may improve rapid identification of patients with presumptive inhalational anthrax in the setting of a large-scale anthrax attack. [ABSTRACT FROM AUTHOR]

Background: Bioterrorism using anthrax claimed five lives in the United States in 2001 and remains a potential public health threat. In the aftermath of a large-scale anthrax attack, mass screening to identify early inhalational anthrax may improve both the management of individual cases and the efficiency of health resource utilization. Purpose: To develop the evidence base for outpatient anthrax screening protocols by quantifying differences in clinical presentation between inhalational anthrax and common viral respiratory tract infections. Design: Review, compilation, and data extraction from English-language case reports of inhalational anthrax and epidemiologic studies of influenza and other viral respiratory infections. Data Sources: 13 reports of 28 cases of inhalational anthrax from 1920 to 2001 and 5 studies reporting on the clinical features of 2762 cases of influenza and 1932 cases of noninfluenza viral respiratory disease. Data Synthesis: Characterization of presenting clinical symptoms in anthrax and viral disease and calculation of likelihood ratios for the presence of selected clinical features. Results: Fever and cough do not reliably discriminate between inhalational anthrax and viral respiratory tract infection. Features suggestive of anthrax include the presence of nonheadache neurologic symptoms (positive likelihood ratio cannot be calculated), dyspnea (positive likelihood ratio, 5.3 [95% CI, 3.7 to 7.4]), nausea or vomiting (positive likelihood ratio, 5.1 [CI, 3.0 to 8.5]), and finding of any abnormality on lung auscultation (positive likelihood ratio, 8.1 [CI, 5.3 to 12.5]). In contrast, rhinorrhea (positive likelihood ratio, 0.2 [CI, 0.1 to 0.4]) and sore throat (positive likelihood ratio, 0.2 [CI, 0.1 to 0.5]) are more suggestive of viral respiratory tract infection. Conclusion: Inhalational anthrax has characteristic clinical features that are distinct from those seen in common viral respiratory tract infections. [ABSTRACT FROM AUTHOR]

Background: Low-dose CT scan screening greatly improves the likelihood of detecting small nodules and, thus, of detecting lung cancer at a potentially more curable stage.Methods: To evaluate the cost-effectiveness of a single baseline low-dose CT scan for lung cancer screening in high-risk individuals, data from the Early Lung Cancer Action Project (ELCAP) was incorporated into a decision analysis model comparing low-dose CT scan screening of high-risk individuals (ie, those > or = 60 years with at least 10 pack-years of cigarette smoking and no other malignancies) to observation without screening. Cost-effectiveness was expressed as the incremental cost per year of life saved. The analysis adopted the perspectives of the health-care system. The probability of the different outcomes following the decision either to screen or not to screen an individual at risk was based on data from ELCAP and the Surveillance, Epidemiology, and End Results Registry or published data, respectively. The cost of the screening and treatment of patients with lung cancer was established based on data from the New York Presbyterian Hospital's financial system. The base-case analysis was conducted under the assumption of similar aggressiveness of screen-detected and incidentally discovered lung cancers and then was followed by multiple sensitivity analyses to relax these assumptions.Results: The incremental cost-effectiveness ratio of a single baseline low-dose CT scan was 2,500 US dollars per year of life saved. The base-case analysis showed that screening would be expected to increase survival by 0.1 year at an incremental cost of approximately 230 US dollars. Only when the likelihood of overdiagnosis was > 50% did the cost effectiveness ratio exceed 50,000 US dollars per year of life saved. The cost-effectiveness ratios were also relatively insensitive to estimates of the potential lead-time bias.Conclusions: A baseline low-dose CT scan for lung cancer screening is potentially highly cost-effective and compares favorably to the cost-effectiveness ratios of other screening programs. [ABSTRACT FROM AUTHOR]

Background: Low-dose CT scan screening greatly improves the likelihood of detecting small nodules and, thus, of detecting lung cancer at a potentially more curable stage. Methods: To evaluate the cost-effectiveness of a single baseline low-dose CT scan for lung cancer screening in high-risk individuals, data from the Early Lung Cancer Action Project (ELCAP) was incorporated into a decision analysis model comparing low-dose CT scan screening of high-risk individuals (ie, those ≥ 60 years with at least 10 pack-years of cigarette smoking and no other malignancies) to observation without screening. Cost-effectiveness was expressed as the incremental cost per year of life saved. The analysis adopted the perspectives of the health-care system. The probability of the different outcomes following the decision either to screen or not to screen an individual at risk was based on data from ELCAP and the Surveillance, Epidemiology, and End Results Registry or published data, respectively. The cost of the screening and treatment of patients with lung cancer was established based on data from the New York Presbyterian Hospital's financial system. The base-ease analysis was conducted under the assumption of similar aggressiveness of screen-detected and incidentally discovered lung cancers and then was followed by multiple sensitivity analyses to relax these assumptions. Results: The incremental cost-effectiveness ratio of a single baseline low-dose CT scan was $2,500 per year of life saved. The base-ease analysis showed that screening would be expected to increase survival by 0.1 year at an incremental cost of approximately $230. Only when the likelihood of overdiagnosis was > 50% did the cost effectiveness ratio exceed $50,000 per year of life saved. The cost-effectiveness ratios were also relatively insensitive to estimates of the potential lead-time bias. Conclusions: A baseline low-dose CT scan for lung cancer screening is potentially highly cost-effective and compares favorably to the cost-effectiveness ratios of other screening programs. [ABSTRACT FROM AUTHOR]

Objective: To evaluate the association between contracting practices of managed care organizations (MCOs) with cardiac surgeons and the quality of the cardiac surgeons.Data Sources/study Setting: The study included all cardiac surgeons offering coronary artery bypass graft (CABG) surgery and 78 percent of MCOs in New York State in 1998. Primary data: The MCOs' panel composition with respect to hospitals and cardiac surgeons. Secondary data: New York State (NYS) Cardiac Surgery Reports.Study Design: Statistical analyses of the probability of a contract between cardiac surgeons and MCOs conditional on the surgeon's risk-adjusted mortality rates (RAMR), outlier and low volume status, and controlling for other confounding variables, were performed.Principal Findings: Contract probability exhibited a tendency to decrease with RAMR, low volume and low-quality outlier status and to increase with high-quality outlier status. These effects were statistically significant for RAMR and high-quality outliers in Downstate and for low volume in Downstate and Upstate.Conclusions: In some, but not all cases, MCOs are seeking higher-quality providers. Further research is required to understand regional variability and the effect of market structure on the quality profile of MCOs. [ABSTRACT FROM AUTHOR]

Examines the role played by quality report cards in the contracting practices of health maintenance organizations in New York. Consideration for quality by managed care organizations (MCO) during cardiac surgeons; Low use of quality report cards by MCO; Recommendations for policy initiatives to increase the use of report cards.

Examines the accuracy of magnetic resonance imaging (MRI) in a patient population clinically suspected of having multiple sclerosis (MS). Double-dose, contrast-enhanced computed tomography (CT); Comparing the diagnostic accuracy of MRI and CT; Visualizing lesions; Insufficiency of the predictive value of a negative MRI result.

Offers information on a study that determined the necessary length of stay for patients admitted to the hospital with an exacerbation of chronic pulmonary disease. Data and methods used; Findings and conclusions.

Objective: To evaluate whether the patterns of inpatient care and patient characteristics have changed for patients undergoing a carotid endarterectomy across a group of academic medical centers from 1990 through 1995. If changes occurred, we investigated whether they had an impact on patient outcomes. Design: Retrospective evaluation of patients undergoing a carotid endarterectomy using a hospital discharge data set compiled by the Academic Medical Center Consortium. Setting: Ten academic medical centers. Patients: A total of 7019 hospital admissions for patients who had 1 carotid endarterectomy performed as a principal procedure from January 1990 to December 1995. Main Outcome Measures: Trends in patient demographics, comorbidities, length of stay, days in the intensive care unit, and inpatient cerebral arteriogram use were determined. Patient outcomes included inpatient mortality, discharge to an institution, 30-day readmission rate, and selected diagnoses (postoperative hemorrhage, infection, or seizure; acute myocardial infarction; or cranial nerve palsy) and postprocedure diagnostic tests (computed tomography and magnetic resonance imaging of the head and electroencephalogram) indicative of complications. Results: Over the 6-year study period, the number of carotid endarterectomies performed more than doubled and the percentage of hospital admissions for patients 65 years or older increased from 65% to 75%. The mean and median length of stay halved and the percentage of admissions with transfers to the intensive care unit decreased from 56% to 26% of cases. In addition, the percentage of cases with a cerebral arteriogram during the same admission but prior to the day of the carotid endarterectomy decreased from 52% to 27%. There were no trends in inpatient mortality, discharge to an institution, or 30-day readmission rate. There were no significant trends indicative of poorer quality of care as measured by the frequency of secondary diagnoses or post... [ABSTRACT FROM AUTHOR]

Decision-analytic methods can be valuable for targeting research in technology assessment. They can indicate whether further evaluation of a technology is warranted, and if so, which variables are key determinants of its clinical utility and cost-effectiveness. This approach was tested on a salient issue—whether magnetic resonance imaging (MR) should be used in evaluating patients with mild neurologic symptoms who might have multiple sclerosis (MS). The authors developed a decision-analytic model to assess the expected utility and costs associated with immediately using MR in this situation, compared with waiting for further symptoms to emerge before testing. Sensitivity analyses demonstrated that priorities for technology assessment research include estimating the value of information to patients in resolving uncertainty, evaluating the impact on patients of being labeled with a diagnosis of MS, and measuring the test characteristics of MR. Key words: cost-benefit analysis; multiple sclerosis; magnetic resonance imaging; decision analysis; Markov models. (Med Decis Making 1990;10:77-94) [ABSTRACT FROM PUBLISHER]

Combining medical decision theory and epidemiologic information, the authors have devel oped a strategy to assess diagnostic technologies. For any patient, patient utilities with new diagnostic information are compared with the preferred fallback action absent that diagnostic information. After determination of whether the expected value of diagnostic information (EVDI) justifies its cost, the method adds across the eligible population to determine whether the global EVDI justifies the technology's deployment, employing a screen (Hurdle 1) that assumes that the diagnostic device has perfect accuracy. This preliminary evaluation relies on published data on treatment efficacy, population probabilities of illness, etc., but not on new clinical trials. If the technology is not sufficiently cost-effective, even with this optimistic assumption, the strategy recommends against its use. Otherwise, the next step is Hurdle II, in which the critical clinical studies, identified by the decision-theory model, are undertaken. These commonly include measuring the actual diagnostic accuracy of a device, with which the cost-effectiveness is recalculated. These studies in general do not require randomized controlled trials. Key words: technology assessment; decision theory; diagnostic information. (Med Decis Making 8:279-289, 1988) [ABSTRACT FROM PUBLISHER]