Retrospective multi-center study of robotic-assisted cholecystectomy: after-hours surgery and business-hours surgery outcomes.

The effect of robotic-assisted cholecystectomy (RAC), when performed after hours, on perioperative outcomes has not been evaluated against outcomes achieved during normal business hours. Subjects 18-80 years old who underwent da Vinci robotic-assisted cholecystectomy from August 2018 to February 2021 were included. Baseline and 30-day perioperative outcomes were retrospectively and consecutively collected and analyzed. Inverse probability treatment weighting (IPTW) was performed to balance patient characteristics between groups. A weighted comparative analysis was followed. Outcomes from 505 patients (after hours, n = 169; business hours, n = 336) undergoing RAC across 5 U.S. medical institutions were analyzed. The higher rates of acute cholecystitis and gallbladder inflammation, gangrene, and intraoperative abnormalities in the after-hours group were associated with higher rates of urgent cases and longer operative times-but not increased complication rates-compared to the business-hours group. There were no significant differences in rates of intraoperative or postoperative complications, readmissions, or reoperations. Integrated da Vinci Firefly fluorescence imaging system was used extensively, and the critical view of safety was achieved in > 96% of cases in both groups. No conversions occurred in the after-hours group compared to four conversions in the business-hours group (p = 0.0266). After-hours patients had shorter outpatient lengths of stay. No mortalities were reported for either group (p = 0.0139). After-hours RAC with integrated da Vinci Firefly imaging performed by surgeons experienced in RAC is associated with similar or improved outcomes than the same procedures during business hours in terms of complications, conversions, readmissions, reoperations, and length of stay. ClinicalTrials.gov identifier: NCT04551820; August 5, 2020.

Personalized Multilevel Intervention for Improving Appropriate Use of Colorectal Cancer Screening in Older Adults: A Cluster Randomized Clinical Trial.

Importance: Despite guideline recommendations, clinicians do not systematically use prior screening or health history to guide colorectal cancer (CRC) screening decisions in older adults. Objective: To evaluate the effect of a personalized multilevel intervention on screening orders in older adults due for average-risk CRC screening. Design, Setting, and Participants: Interventional 2-group parallel unmasked cluster randomized clinical trial conducted from November 2015 to February 2019 at 2 US Department of Veterans Affairs (VA) facilities: 1 academic VA medical center and 1 of its connected outpatient clinics. Randomization at the primary care physician/clinician (PCP) level, stratified by study site and clinical full-time equivalency. Participants were 431 average-risk, screen-due US veterans aged 70 to 75 years attending a primary care visit. Data analysis was performed from August 2018 to August 2023. Intervention: The intervention group received a multilevel intervention including a decision-aid booklet with detailed information on screening benefits and harms, personalized for each participant based on age, sex, prior screening, and comorbidity. The control group received a multilevel intervention including a screening informational booklet. All participants received PCP education and system-level modifications to support personalized screening. Main Outcomes and Measures: The primary outcome was whether screening was ordered within 2 weeks of clinic visit. Secondary outcomes were concordance between screening orders and screening benefit and screening utilization within 6 months. Results: A total of 436 patients were consented, and 431 were analyzed across 67 PCPs. Patients had a mean (SD) age of 71.5 (1.7) years; 424 were male (98.4%); 374 were White (86.8%); 89 were college graduates (21.5%); and 351 (81.4%) had undergone prior screening. A total of 258 (59.9%) were randomized to intervention, and 173 (40.1%) to control. Screening orders were placed for 162 of 258 intervention patients (62.8%) vs 114 of 173 control patients (65.9%) (adjusted difference, -4.0 percentage points [pp]; 95% CI, -15.4 to 7.4 pp). In a prespecified interaction analysis, the proportion receiving orders was lower in the intervention group than in the control group for those in the lowest benefit quartile (59.4% vs 71.1%). In contrast, the proportion receiving orders was higher in the intervention group than in the control group for those in the highest benefit quartile (67.6% vs 52.2%) (interaction P = .049). Fewer intervention patients (106 of 256 [41.4%]) utilized screening overall at 6 months than controls (96 of 173 [55.9%]) (adjusted difference, -13.4 pp; 95% CI, -25.3 to -1.6 pp). Conclusions and Relevance: In this cluster randomized clinical trial, patients who were presented with personalized information about screening benefits and harms in the context of a multilevel intervention were more likely to receive screening orders concordant with benefit and were less likely to utilize screening. Trial Registration: ClinicalTrials.gov Identifier: NCT02027545.

Clinical Outcome and Utilization Profiles Among Latent Groups of High-Risk Patients: Moving from Segmentation Towards Intervention.

BACKGROUND: The ability of latent class models to identify clinically distinct groups among high-risk patients has been demonstrated, but it is unclear how healthcare data can inform group-specific intervention design. OBJECTIVE: Examine how utilization patterns across latent groups of high-risk patients provide actionable information to guide group-specific intervention design. DESIGN: Cohort study using data from 2012 to 2015. PATIENTS: Participants were 934,787 patients receiving primary care in the Veterans Health Administration, with predicted probability of 12-month hospitalization in the top 10th percentile during 2014. MAIN MEASURES: Patients were assigned to latent groups via mixture-item response theory models based on 28 chronic conditions. We modeled odds of all-cause mortality, hospitalizations, and 30-day re-hospitalizations by group membership. Detailed outpatient and inpatient utilization patterns were compared between groups. KEY RESULTS: A total of 764,257 (81.8%) of patients were matched with a comorbidity group. Groups were characterized by substance use disorders (14.0% of patients assigned), cardiometabolic conditions (25.7%), mental health conditions (17.6%), pain/arthritis (19.1%), cancer (15.3%), and liver disease (8.3%). One-year mortality ranged from 2.7% in the Mental Health group to 14.9% in the Cancer group, compared to 8.5% overall. In adjusted models, group assignment predicted significantly different odds of each outcome. Groups differed in their utilization of multiple types of care. For example, patients in the Pain group had the highest utilization of in-person primary care, with a mean (SD) of 5.3 (5.0) visits in the year of follow-up, while the Substance Use Disorder group had the lowest, with 3.9 (4.1) visits. The Substance Use Disorder group also had the highest rates of using services for housing instability (25.1%), followed by the Liver group (10.1%). CONCLUSIONS: Latent groups of high-risk patients had distinct hospitalization and utilization profiles, despite having comparable levels of predicted baseline risk. Utilization profiles pointed towards system-specific care needs that could inform tailored interventions.

Testing Practices, Interpretation, and Diagnostic Evaluation of Iron Deficiency Anemia by US Primary Care Physicians.

Importance: Recognition of iron deficiency anemia (IDA) is important to initiate timely evaluation for gastrointestinal tract cancer. Retrospective studies have reported delays in diagnostic evaluation of IDA as a common factor associated with delayed diagnosis of colorectal cancer. Objective: To assess how US primary care physicians (PCPs) approach testing for anemia, interpret iron laboratory studies, and refer patients with IDA for gastrointestinal endoscopy. Design, Setting, and Participants: This survey study, conducted in August 2019, included members of the American College of Physicians Internal Medicine Insiders Panel, a nationally representative group of American College of Physicians membership, who self-identified as PCPs. Participants completed a vignette-based survey to assess practices related to screening for anemia, interpretation of laboratory-based iron studies, and appropriate diagnostic evaluation of IDA. Main Outcomes and Measures: Descriptive statistics based on survey responses were evaluated for frequency of anemia screening, correct interpretation of iron laboratory studies, and proportion of patients with new-onset IDA referred for gastrointestinal tract evaluation. Results: Of 631 PCPs who received an invitation to participate in the survey, 356 (56.4%) responded and 31 (4.9%) were excluded, for an adjusted eligible sample size of 600, yielding 325 completed surveys (response rate, 54.2%). Of the 325 participants who completed surveys, 180 (55.4%) were men; age of participants was not assessed. The mean (SD) duration of clinical experience was 19.8 (11.2) years (range, 1.0-45.0 years). A total of 250 participants (76.9%) screened at least some patients for anemia. Interpretation of iron studies was least accurate in a scenario of a borderline low ferritin level (40 ng/mL) with low transferrin saturation (2%); 86 participants (26.5%) incorrectly responded that this scenario did not indicate IDA, and 239 (73.5%) correctly identified this scenario as IDA. Of 312 participants, 170 (54.5%) recommended bidirectional endoscopy (upper endoscopy and colonoscopy) for new IDA for women aged 65 years; of 305 respondents, 168 (55.1%) recommended bidirectional endoscopy for men aged 65 years. Conclusions and Relevance: In this survey study, US PCPs' self-reported testing practices for anemia suggest overuse of screening laboratory tests, misinterpretation of iron studies, and underuse of bidirectional endoscopy for evaluation of new-onset IDA. Both misinterpretation of iron studies and underuse of bidirectional endoscopy can lead to delayed diagnosis of gastrointestinal tract cancers and warrant additional interventions.

Type 2 Diabetes.

Type 2 diabetes is a prevalent illness that causes major vascular, renal, and neurologic complications. Prevention and treatment of diabetes and its complications are of paramount importance. Many new treatments have emerged over the past 5-10 years. Recent evidence shows that newer treatments may substantially reduce risk for cardiac and renal disease, suggesting that it may be necessary to change existing treatment paradigms. This review summarizes the evidence supporting diabetes prevention and treatment, focusing on aspects that are commonly in the purview of primary care physicians.

Which patients are persistently high-risk for hospitalization?

OBJECTIVES: Many healthcare systems use prediction models to estimate and manage patient-level probability of hospitalization. Patients identified as high-risk at one point in time may not, however, remain high-risk. We aimed to describe subgroups of patients with distinct longitudinal risk score patterns to inform interventions tailored to patients' needs. STUDY DESIGN: Retrospective national cohort study. METHODS: Using a previously validated prediction algorithm, we identified a cohort of 258,759 patients enrolled in the Veterans Health Administration (VHA) who were in the top 5% of risk for hospitalization within 90 days. During each of the following 24 months, patients were placed in 1 of 6 categories: death, hospitalized, no VHA care, persistently high-risk for hospitalization (≥10% probability), initially high-risk then persistently low-risk (<10% probability), and intermittently high-risk. We used multivariable logistic regression to identify characteristics predictive of being persistently high-risk through the last study month. RESULTS: After 2 years, 17.7% had died, 13.8% had remained persistently high-risk for hospitalization, 41.5% had become persistently low-risk, and 19.9% were intermittently high-risk. Predictors of being persistently high-risk included urban residence, chronic medical comorbidities, auditory and visual impairment, chronic pain, any cancer diagnosis, and social instability. CONCLUSIONS: Few patients who were high-risk for hospitalization at baseline remained so. Nonrandomized evaluations of interventions that identify patients based on a single high-risk score may spuriously appear to have positive effects. Clinical interventions may need to focus on individuals who are persistently high-risk.

Screening for Breast Cancer in Average-Risk Women: A Guidance Statement From the American College of Physicians.

Description: The purpose of this guidance statement is to provide advice to clinicians on breast cancer screening in average-risk women based on a review of existing guidelines and the evidence they include. Methods: This guidance statement is derived from an appraisal of selected guidelines from around the world that address breast cancer screening, as well as their included evidence. All national guidelines published in English between 1 January 2013 and 15 November 2017 in the National Guideline Clearinghouse or Guidelines International Network library were included. In addition, the authors selected other guidelines commonly used in clinical practice. Web sites associated with all selected guidelines were checked for updates on 10 December 2018. The AGREE II (Appraisal of Guidelines for Research and Evaluation II) instrument was used to evaluate the quality of guidelines. Target Audience and Patient Population: The target audience is all clinicians, and the target patient population is all asymptomatic women with average risk for breast cancer. Guidance Statement 1: In average-risk women aged 40 to 49 years, clinicians should discuss whether to screen for breast cancer with mammography before age 50 years. Discussion should include the potential benefits and harms and a woman's preferences. The potential harms outweigh the benefits in most women aged 40 to 49 years. Guidance Statement 2: In average-risk women aged 50 to 74 years, clinicians should offer screening for breast cancer with biennial mammography. Guidance Statement 3: In average-risk women aged 75 years or older or in women with a life expectancy of 10 years or less, clinicians should discontinue screening for breast cancer. Guidance Statement 4: In average-risk women of all ages, clinicians should not use clinical breast examination to screen for breast cancer.

Increased Cost With Use of Brand-Name Bowel Preparation by Patients With Medicare Part D From 2013 to 2015.

High-quality bowel preparation (prep) before colonoscopy is essential for the success of the procedure.1 Bowel preps should be safe, tolerable, efficacious, and allow for visualization of polyps 5 mm or larger.2 Full-volume (4 L) polyethylene glycol-3350 with electrolyte solution (PEG-ELS) has been considered a standard bowel prep regimen, with good safety and efficacy profiles, and is available as a generic.2.

Using item response theory with health system data to identify latent groups of patients with multiple health conditions.

A critical step toward tailoring effective interventions for heterogeneous and medically complex patients is to identify clinically meaningful subgroups on the basis of their comorbid conditions. We applied Item Response Theory (IRT), a potentially useful tool to identify clinically meaningful subgroups, to characterize phenotypes within a cohort of high-risk patients. This was a retrospective cohort study using 68,400 high-risk Veteran's Health Administration (VHA) patients. Thirty-one physical and mental health diagnosis indicators based on ICD-9 codes from patients' inpatient, outpatient VHA and VA-paid community care claims. Results revealed 6 distinct subgroups of high-risk patients were identified: substance use, complex mental health, complex diabetes, liver disease, cancer with cardiovascular disease, and cancer with mental health. Multinomial analyses showed that subgroups significantly differed on demographic and utilization variables which underscored the uniqueness of the groups. Using IRT models with clinical diagnoses from electronic health records permitted identification of diagnostic constellations among otherwise undifferentiated high-risk patients. Recognizing distinct patient profiles provides a framework from which insights into medical complexity of high-risk patients can be explored and effective interventions can be tailored.

Patient Attitudes Toward Individualized Recommendations to Stop Low-Value Colorectal Cancer Screening.

Importance: Guidelines for colorectal cancer (CRC) screening recommend an individualized approach in older adults that is informed by consideration of life expectancy and cancer risk. However, little is known about how patients perceive individualized screening recommendations. Objective: To assess veterans' attitudes toward and comfort with cessation of low-value CRC screening (defined as screening in a patient for whom the benefit is expected to be small based on quantitative estimates from hypothetical risk calculators). Design, Setting, and Participants: This survey study included patients older than 50 years who had undergone prior screening colonoscopy with normal results at the Veterans Affairs Ann Arbor Healthcare System. A total of 1500 surveys were mailed to potential participants from November 1, 2010, to January 1, 2012. Survey data were analyzed from January 1, 2016, to December 31, 2017. Main Outcomes and Measures: Response to the question, "If you personally had serious health problems that were likely to shorten your life and your doctor did not think screening would be of much benefit based on the calculator, how comfortable would you be with not getting any more screening colonoscopies?" Results: Of the 1500 surveys mailed, 85 were returned to sender, leaving 1415 potential respondents; 1054 of these respondents (median age range, 60-69 years; 884 [85.9%] white and 965 [94.2%] male) completed the survey (response rate, 74.5%). A total of 300 (28.7%) were not at all comfortable with cessation of low-value CRC screening, and 509 (49.3%) thought that age should never be used to decide when to stop screening. In addition, 332 (31.7%) thought it was not at all reasonable to use life expectancy calculators, and 255 (24.3%) thought it was not at all reasonable to use CRC risk calculators to guide these decisions. In ordered logistic regression analysis, factors associated with more comfort with screening cessation were (1) higher trust in physician (odds ratio [OR], 1.19; 95% CI, 1.07-1.32), (2) higher perceived health status (OR, 1.41; 95% CI, 1.23-1.61), and (3) higher barriers to screening (OR, 1.20; 95% CI, 1.11-1.30). Factors that were associated with less comfort with screening cessation included (1) greater perceived effectiveness of screening (OR, 0.86; 95% CI, 0.80-0.94) and (2) greater perceived threat of CRC (OR, 0.81; 95% CI, 0.73-0.89). Conclusions and Relevance: The findings suggest that many veterans have strong preferences against screening cessation even when given detailed information about why the benefit may be low. Efforts to tailor screening recommendations may be met by resistance unless they are accompanied by efforts to address underlying perceptions about the benefit of screening.

Overuse of Repeat Upper Endoscopy in the Veterans Health Administration: A Retrospective Analysis.

OBJECTIVES: Americans undergo ∼7 million esophagogastroduodenoscopies (EGDs) annually, and one-third of Medicare beneficiaries undergo a repeat EGD within 3 years. As many as 43% of these repeat EGDs are inappropriate. We aimed to determine the rate of repeat inappropriate EGD within the Veterans Health Administration (VHA), and identify factors associated with repeat EGD. METHODS: We conducted retrospective analyses of Veterans undergoing an index EGD at 159 VHA facilities between 1 January 2003 and 30 June 2007. We excluded Veterans without regular use of VHA for health care or 5 years of follow-up. Appropriateness of repeat EGDs was classified based on diagnostic and procedure codes into three categories: Likely Appropriate, Possible Overuse, and Probable Overuse. The proportion of repeat EGDs in each category was tabulated. Multilevel logistic regression was performed to estimate the impact of patient-level and site-level factors on the odds of repeat EGD. RESULTS: Of the 235,855 included Veterans, 85,690 (36.3%) underwent a repeat EGD within 5 years. Of the repeat EGDs, 42,412 (49.5%) were Likely Appropriate, 35,503 (41.4%) represented Possible Overuse, and 7,756 (9.1%) represented Probable Overuse. Patients with more frequent encounters with primary care providers and access to facilities performing EGD and with greater complexity of services were more likely to receive repeat EGD, regardless of whether the repeat EGD was appropriate or overuse. Women were slightly more likely to undergo repeat EGD in Probable Overuse situations. CONCLUSIONS: Overuse of repeat EGD is common in VHA despite the absence of financial incentives that promote overuse. Efforts are needed to better understand the motivations for overuse and barriers to appropriate use, and to promote appropriate use of repeat EGD.

Noninvasive Treatments for Acute, Subacute, and Chronic Low Back Pain: A Clinical Practice Guideline From the American College of Physicians.

Description: The American College of Physicians (ACP) developed this guideline to present the evidence and provide clinical recommendations on noninvasive treatment of low back pain. Methods: Using the ACP grading system, the committee based these recommendations on a systematic review of randomized, controlled trials and systematic reviews published through April 2015 on noninvasive pharmacologic and nonpharmacologic treatments for low back pain. Updated searches were performed through November 2016. Clinical outcomes evaluated included reduction or elimination of low back pain, improvement in back-specific and overall function, improvement in health-related quality of life, reduction in work disability and return to work, global improvement, number of back pain episodes or time between episodes, patient satisfaction, and adverse effects. Target Audience and Patient Population: The target audience for this guideline includes all clinicians, and the target patient population includes adults with acute, subacute, or chronic low back pain. Recommendation 1: Given that most patients with acute or subacute low back pain improve over time regardless of treatment, clinicians and patients should select nonpharmacologic treatment with superficial heat (moderate-quality evidence), massage, acupuncture, or spinal manipulation (low-quality evidence). If pharmacologic treatment is desired, clinicians and patients should select nonsteroidal anti-inflammatory drugs or skeletal muscle relaxants (moderate-quality evidence). (Grade: strong recommendation). Recommendation 2: For patients with chronic low back pain, clinicians and patients should initially select nonpharmacologic treatment with exercise, multidisciplinary rehabilitation, acupuncture, mindfulness-based stress reduction (moderate-quality evidence), tai chi, yoga, motor control exercise, progressive relaxation, electromyography biofeedback, low-level laser therapy, operant therapy, cognitive behavioral therapy, or spinal manipulation (low-quality evidence). (Grade: strong recommendation). Recommendation 3: In patients with chronic low back pain who have had an inadequate response to nonpharmacologic therapy, clinicians and patients should consider pharmacologic treatment with nonsteroidal anti-inflammatory drugs as first-line therapy, or tramadol or duloxetine as second-line therapy. Clinicians should only consider opioids as an option in patients who have failed the aforementioned treatments and only if the potential benefits outweigh the risks for individual patients and after a discussion of known risks and realistic benefits with patients. (Grade: weak recommendation, moderate-quality evidence).

Developing and Testing an Electronic Measure of Screening Colonoscopy Overuse in a Large Integrated Healthcare System.

BACKGROUND: Most existing performance measures focus on underuse of care, but there is growing interest in identifying and reducing overuse. OBJECTIVE: We aimed to develop a valid and reliable electronic performance measure of overuse of screening colonoscopy in the Veterans Affairs Health Care System (VA), and to quantify overuse in VA. DESIGN: This was a cross-sectional study with multiple cross-sections. SUBJECTS: U.S. Veterans who underwent screening colonoscopy between 2011 and 2013. MAIN MEASURES: Overuse of screening colonoscopy, using a validated electronic measure developed by an expert workgroup. KEY RESULTS: Compared to results obtained from manual record review, the electronic measure was highly specific (97 %) for overuse, but not sensitive (20 %). After exclusion of diagnostic and high-risk screening or surveillance procedures, the validated electronic measure identified 88,754 average-risk screening colonoscopies performed in VA during 2013. Of these, 20,530 (23 %) met the definition for probable (17 %) or possible (6 %) overuse. Substantial variation in colonoscopy overuse was noted between Veterans Integrated Care Networks (VISNs) and between facilities, with a nearly twofold difference between the maximum and minimum rates of overuse at the VISN level and a nearly eightfold difference at the facility level. Overuse at the VISN and facility level was relatively stable over time. CONCLUSIONS: Overuse of screening colonoscopy can be measured reliably and with high specificity using electronic data, and is common in a large integrated healthcare system. Overuse measures, such as those we have specified through a consensus workgroup process, could be combined with underuse measures to improve the appropriateness of colorectal cancer screening.

Adherence to Competing Strategies for Colorectal Cancer Screening Over 3 Years.

OBJECTIVES: We have shown that, in a randomized trial comparing adherence to different colorectal cancer (CRC) screening strategies, participants assigned to either fecal occult blood testing (FOBT) or given a choice between FOBT and colonoscopy had significantly higher adherence than those assigned to colonoscopy during the first year. However, how adherence to screening changes over time is unknown. METHODS: In this trial, 997 participants were cluster randomized to one of the three screening strategies: (i) FOBT, (ii) colonoscopy, or (iii) a choice between FOBT and colonoscopy. Research assistants helped participants to complete testing only in the first year. Adherence to screening was defined as completion of three FOBT cards in each of 3 years after enrollment or completion of colonoscopy within the first year of enrollment. The primary outcome was adherence to assigned strategy over 3 years. Additional outcomes included identification of sociodemographic factors associated with adherence. RESULTS: Participants assigned to annual FOBT completed screening at a significantly lower rate over 3 years (14%) than those assigned to colonoscopy (38%, P<0.001) or choice (42%, P<0.001); however, completion of any screening test fell precipitously, indicating the strong effect of patient navigation. In multivariable logistic regression analysis, being randomized to the choice or colonoscopy group, Chinese language, homosexuality, being married/partnered, and having a non-nurse practitioner primary care provider were independently associated with greater adherence to screening (P<0.01). CONCLUSIONS: In a 3-year follow-up of a randomized trial comparing competing CRC screening strategies, participants offered a choice between FOBT and colonoscopy continued to have relatively high adherence, whereas adherence in the FOBT group fell significantly below that of the choice and colonoscopy groups. Patient navigation is crucial to achieving adherence to CRC screening, and FOBT is especially vulnerable because of the need for annual testing.

Personalizing colonoscopy screening for elderly individuals based on screening history, cancer risk, and comorbidity status could increase cost effectiveness.

BACKGROUND & AIMS: Colorectal cancer (CRC) screening decisions for elderly individuals are often made primarily on the basis of age, whereas other factors that influence the effectiveness and cost effectiveness of screening are often not considered. We investigated the relative importance of factors that could be used to identify elderly individuals most likely to benefit from CRC screening and determined the maximum ages at which screening remains cost effective based on these factors. METHODS: We used a microsimulation model (Microsimulation Screening Analysis-Colon) calibrated to the incidence of CRC in the United States and the prevalence of adenomas reported in autopsy studies to determine the appropriate age at which to stop colonoscopy screening in 19,200 cohorts (of 10 million individuals), defined by sex, race, screening history, background risk for CRC, and comorbidity status. We applied a willingness-to-pay threshold of $100,000 per quality-adjusted life-year (QALY) gained. RESULTS: Less intensive screening history, higher background risk for CRC, and fewer comorbidities were associated with cost-effective screening at older ages. Sex and race had only a small effect on the appropriate age to stop screening. For some individuals likely to be screened in current practice (for example, 74-year-old white women with moderate comorbidities, half the average background risk for CRC, and negative findings from a screening colonoscopy 10 years previously), screening resulted in a loss of QALYs, rather than a gain. For some individuals unlikely to be screened in current practice (for example, 81-year-old black men with no comorbidities, an average background risk for CRC, and no previous screening), screening was highly cost effective. Although screening some previously screened, low-risk individuals was not cost effective even when they were 66 years old, screening some healthy, high-risk individuals remained cost effective until they reached the age of 88 years old. CONCLUSIONS: The current approach to CRC screening in elderly individuals, in which decisions are often based primarily on age, is inefficient, resulting in underuse of screening for some and overuse of screening for others. CRC screening could be more effective and cost effective if individual factors for each patient are considered.

The health system and population health implications of large-scale diabetes screening in India: a microsimulation model of alternative approaches.

BACKGROUND: Like a growing number of rapidly developing countries, India has begun to develop a system for large-scale community-based screening for diabetes. We sought to identify the implications of using alternative screening instruments to detect people with undiagnosed type 2 diabetes among diverse populations across India. METHODS AND FINDINGS: We developed and validated a microsimulation model that incorporated data from 58 studies from across the country into a nationally representative sample of Indians aged 25-65 y old. We estimated the diagnostic and health system implications of three major survey-based screening instruments and random glucometer-based screening. Of the 567 million Indians eligible for screening, depending on which of four screening approaches is utilized, between 158 and 306 million would be expected to screen as "high risk" for type 2 diabetes, and be referred for confirmatory testing. Between 26 million and 37 million of these people would be expected to meet international diagnostic criteria for diabetes, but between 126 million and 273 million would be "false positives." The ratio of false positives to true positives varied from 3.9 (when using random glucose screening) to 8.2 (when using a survey-based screening instrument) in our model. The cost per case found would be expected to be from US$5.28 (when using random glucose screening) to US$17.06 (when using a survey-based screening instrument), presenting a total cost of between US$169 and US$567 million. The major limitation of our analysis is its dependence on published cohort studies that are unlikely fully to capture the poorest and most rural areas of the country. Because these areas are thought to have the lowest diabetes prevalence, this may result in overestimation of the efficacy and health benefits of screening. CONCLUSIONS: Large-scale community-based screening is anticipated to produce a large number of false-positive results, particularly if using currently available survey-based screening instruments. Resource allocators should consider the health system burden of screening and confirmatory testing when instituting large-scale community-based screening for diabetes.

In the clinic. Type 2 diabetes.

This issue provides a clinical overview of Type 2 Diabetes focusing on prevention, diagnosis, treatment, practice improvement, and patient information. The content of In the Clinic is drawn from the clinical information and education resources of the American College of Physicians (ACP), including ACP Smart Medicine and MKSAP (Medical Knowledge and Self-Assessment Program). Annals of Internal Medicine editors develop In the Clinic from these primary sources in collaboration with the ACP's Medical Education and Publishing divisions and with the assistance of science writers and physician writers. Editorial consultants from ACP Smart Medicine and MKSAP provide expert review of the content. Readers who are interested in these primary resources for more detail can consult http://smartmedicine.acponline.org, http://mksap.acponline.org, and other resources referenced in each issue of In the Clinic.

Associations between depression and all-cause and cause-specific risk of death: a retrospective cohort study in the Veterans Health Administration.

OBJECTIVE: Depression may be associated with increased mortality risk, but there are substantial limitations to existing studies assessing this relationship. We sought to overcome limitations of existing studies by conducting a large, national, longitudinal study to assess the impact of depression on all-cause and cause-specific risk of death. METHODS: We used Cox regression models to estimate hazard ratios associated with baseline depression diagnosis (N=849,474) and three-year mortality among 5,078,082 patients treated in Veterans Health Administration (VHA) settings in fiscal year (FY) 2006. Cause of death was obtained from the National Death Index (NDI). RESULTS: Baseline depression was associated with 17% greater hazard of all-cause three-year mortality (95% CI hazard ratio [HR]: 1.15, 1.18) after adjusting for baseline patient demographic and clinical characteristics and VHA facility characteristics. Depression was associated with a higher hazard of three-year mortality from heart disease, respiratory illness, cerebrovascular disease, accidents, diabetes, nephritis, influenza, Alzheimer's disease, septicemia, suicide, Parkinson's disease, and hypertension. Depression was associated with a lower hazard of death from malignant neoplasm and liver disease. Depression was not associated with mortality due to assault. CONCLUSIONS: In addition to being associated with suicide and injury-related causes of death, depression is associated with increased risk of death from nearly all major medical causes, independent of multiple major risk factors. Findings highlight the need to better understand and prevent mortality seen with multiple medical disorders associated with depression.

A primer on clinical trial design.

A well-designed and executed clinical trial is the gold standard of evidence-based medicine. It is important for readers to understand the rationale for the study design, identify common pitfalls, and scrutinize limitations. Herein, we present a brief overview of types of designs used for clinical trials and discuss the use of appropriate end points, the selection of study participants, randomization, sample size calculation, blinding, and analysis of data. Finally, we emphasize the importance of accurate and transparent reporting. Our goal is to provide a primer for practicing urologists to enhance their understanding of the clinical trial literature.