Showing papers in "JAMA Internal Medicine in 2006"
TL;DR: In this article, a 7-item anxiety scale (GAD-7) had good reliability, as well as criterion, construct, factorial, and procedural validity, and increasing scores on the scale were strongly associated with multiple domains of functional impairment.
Abstract: Background Generalized anxiety disorder (GAD) is one of the most common mental disorders; however, there is no brief clinical measure for assessing GAD. The objective of this study was to develop a brief self-report scale to identify probable cases of GAD and evaluate its reliability and validity. Methods A criterion-standard study was performed in 15 primary care clinics in the United States from November 2004 through June 2005. Of a total of 2740 adult patients completing a study questionnaire, 965 patients had a telephone interview with a mental health professional within 1 week. For criterion and construct validity, GAD self-report scale diagnoses were compared with independent diagnoses made by mental health professionals; functional status measures; disability days; and health care use. Results A 7-item anxiety scale (GAD-7) had good reliability, as well as criterion, construct, factorial, and procedural validity. A cut point was identified that optimized sensitivity (89%) and specificity (82%). Increasing scores on the scale were strongly associated with multiple domains of functional impairment (all 6 Medical Outcomes Study Short-Form General Health Survey scales and disability days). Although GAD and depression symptoms frequently co-occurred, factor analysis confirmed them as distinct dimensions. Moreover, GAD and depression symptoms had differing but independent effects on functional impairment and disability. There was good agreement between self-report and interviewer-administered versions of the scale. Conclusion The GAD-7 is a valid and efficient tool for screening for GAD and assessing its severity in clinical practice and research.
15,911 citations
TL;DR: Coaching chronically ill older patients and their caregivers to ensure that their needs are met during care transitions may reduce the rates of subsequent rehospitalization.
Abstract: Background Patients with complex care needs who require care across different health care settings are vulnerable to experiencing serious quality problems. A care transitions intervention designed to encourage patients and their caregivers to assert a more active role during care transitions may reduce rehospitalization rates. Methods Randomized controlled trial. Between September 1, 2002, and August 31, 2003, patients were identified at the time of hospitalization and were randomized to receive the intervention or usual care. The setting was a large integrated delivery system located in Colorado. Subjects (N = 750) included community-dwelling adults 65 years or older admitted to the study hospital with 1 of 11 selected conditions. Intervention patients received (1) tools to promote cross-site communication, (2) encouragement to take a more active role in their care and to assert their pREFERENCES, and (3) continuity across settings and guidance from a “transition coach.” Rates of rehospitalization were measured at 30, 90, and 180 days. Results Intervention patients had lower rehospitalization rates at 30 days (8.3 vs 11.9, P = .048) and at 90 days (16.7 vs 22.5, P = .04) than control subjects. Intervention patients had lower rehospitalization rates for the same condition that precipitated the index hospitalization at 90 days (5.3 vs 9.8, P = .04) and at 180 days (8.6 vs 13.9, P = .046) than controls. The mean hospital costs were lower for intervention patients ($2058) vs controls ($2546) at 180 days (log-transformed P = .049). Conclusion Coaching chronically ill older patients and their caregivers to ensure that their needs are met during care transitions may reduce the rates of subsequent rehospitalization. Trial Registration clinicaltrials.gov Identifier:NCT00244491
1,843 citations
TL;DR: Collaborative care is more effective than standard care in improving depression outcomes in the short and longer terms.
Abstract: Background Depression is common in primary care but is suboptimally managed. Collaborative care, that is, structured care involving a greater role of nonmedical specialists to augment primary care, has emerged as a potentially effective candidate intervention to improve quality of primary care and patient outcomes. Methods To quantify the short-term and longer-term effectiveness of collaborative care compared with standard care and to understand mechanisms of action by exploring between-study heterogeneity, we conducted a systematic review of randomized controlled trials that compared collaborative care with usual primary care in patients with depression. We searched MEDLINE (from the beginning of 1966), EMBASE (from the beginning of 1980), CINAHL (from the beginning of 1980), PsycINFO (from the beginning of 1980), the Cochrane Library (from the beginning of 1966), and DARE (Database of Abstracts of Reviews of Effectiveness) (from the beginning of 1985) databases from study inception to February 6, 2006. Results We found 37 randomized studies including 12 355 patients with depression receiving primary care. Random effects meta-analysis showed that depression outcomes were improved at 6 months (standardized mean difference, 0.25; 95% confidence interval, 0.18-0.32), and evidence of longer-term benefit was found for up to 5 years (standardized mean difference, 0.15; 95% confidence interval, 0.001-0.31). When exploring determinants of effectiveness, effect size was directly related to medication compliance and to the professional background and method of supervision of case managers. The addition of brief psychotherapy did not substantially improve outcome, nor did increased numbers of sessions. Cumulative meta-analysis showed that sufficient evidence had emerged by 2000 to demonstrate the statistically significant benefit of collaborative care. Conclusions Collaborative care is more effective than standard care in improving depression outcomes in the short and longer terms. Future research needs to address the implementation of collaborative care, particularly in settings other than the United States.
1,192 citations
TL;DR: For some types of cancer, the incidence of venous thromboembolism was sufficiently high to warrant prospective clinical trials of primary thromboprophylaxis and was highest among patients initially diagnosed with metastatic-stage disease.
Abstract: Background: The incidence of venous thromboembolism after diagnosis of specific cancers and the effect of thromboembolism on survival are not well defined. Methods: The California Cancer Registry was linked to the California Patient Discharge Data Set to determine the incidence of venous thromboembolism among cancer cases diagnosed between 1993 and 1995. The incidence and timing of thromboembolism within 1 and 2 years of cancer diagnosis and the risk factors associated with thromboembolism and death were determined. Results: Among 235 149 cancer cases, 3775 (1.6%) were diagnosed with venous thromboembolism within 2 years, 463 (12%) at the time cancer was diagnosed and 3312 (88%) subsequently. In risk-adjusted models, metastatic disease at the time of diagnosis was the strongest predictor of thromboembolism. Expressed as events per 100 patient-years, the highest incidence of thromboembolism occurred during the first year of follow-up among cases with metastatic-stage pancreatic (20.0), stomach (10.7), bladder (7.9), uterine (6.4), renal (6.0), and lung (5.0) cancer. Adjusting for age, race, and stage, diagnosis of thromboembolism was a significant predictor of decreased survival during the first year for all cancer types (hazard ratios, 1.6-4.2; P Conclusions: The incidence of venous thromboembolism varied with cancer type and was highest among patients initially diagnosed with metastatic-stage disease. The incidence rate of thromboembolism decreased over time. Diagnosis of thromboembolism during the first year of follow-up was a significant predictor of death for most cancer types and stages analyzed. For some types of cancer, the incidence of thromboembolism was sufficiently high to warrant prospective clinical trials of primary thromboprophylaxis.
1,142 citations
TL;DR: A strong association between immunodeficiency and risk of liver-related death was found and long-term follow-up is required to investigate whether clinically significant treatment-associated liver- related mortality will develop.
Abstract: Background An increasing proportion of deaths among human immunodeficiency virus (HIV)-infected persons with access to combination antiretroviral therapy (cART) are due to complications of liver diseases. Methods We investigated the frequency of and risk factors associated with liver-related deaths in the Data Collection on Adverse Events of Anti-HIV Drugs study, which prospectively evaluated 76 893 person-years of follow-up in 23 441 HIV-infected persons. Multivariable Poisson regression analyses identified factors associated with liver-related, AIDS-related, and other causes of death. Results There were 1246 deaths (5.3%; 1.6 per 100 person-years); 14.5% were from liver-related causes. Of these, 16.9% had active hepatitis B virus (HBV), 66.1% had hepatitis C virus (HCV), and 7.1% had dual viral hepatitis co-infections. Predictors of liver-related deaths were latest CD4 cell count (adjusted relative rate [RR], 16.1; 95% confidence interval [CI], 8.1-31.7 for or =500/microL), age (RR, 1.3; 95% CI, 1.2-1.4 per 5 years older), intravenous drug use (RR, 2.0; 95% CI, 1.2-3.4), HCV infection (RR, 6.7; 95% CI, 4.0-11.2), and active HBV infection (RR, 3.7; 95% CI, 2.4-5.9). Univariable analyses showed no relationship between cumulative years patients were receiving cART and liver-related death (RR, 1.00; 95% CI, 0.93-1.07). Adjustment for the most recent CD4 cell count and patient characteristics resulted in an increased risk of liver-related mortality per year of mono or dual antiretroviral therapy before cART (RR, 1.09; 95% CI, 1.02-1.16; P = .008) and per year of cART (RR, 1.11; 95% CI, 1.02-1.21; P = .02). Conclusions Liver-related death was the most frequent cause of non-AIDS-related death. We found a strong association between immunodeficiency and risk of liver-related death. Longer follow-up is required to investigate whether clinically significant treatment-associated liver-related mortality will develop.
1,141 citations
Journal Article•
TL;DR: In this article, the authors conducted a systematic review of randomized controlled trials that compared collaborative care with usual primary care in patients with depression and found that collaborative care is more effective than standard care in improving depression outcomes in the short and longer terms.
Abstract: Background: Depression is common in primary care but is suboptimally managed. Collaborative care, that is, structured care involving a greater role of nonmedical specialists to augment primary care, has emerged as a potentially effective candidate intervention to improve quality of primary care and patient outcomes. Methods: To quantify the short-term and longer-term effectiveness of collaborative care compared with standard care and to understand mechanisms of action by exploring between-study heterogeneity, we conducted a systematic review of randomized controlled trials that compared collaborative care with usual primary care in patients with depression. We searched MEDLINE (from the beginning of 1966), EMBASE (from the beginning of 1980), CINAHL (from the beginning of 1980), PsycINFO (from the beginning of 1980), the Cochrane Library (from the beginning of 1966), and DARE (Database of Abstracts of Reviews of Effectiveness) (from the beginning of 1985) databases from study inception to February 6, 2006. Results: We found 37 randomized studies including 12 355 patients with depression receiving primary care. Random effects meta-analysis showed that depression outcomes were improved at 6 months (standardized mean difference, 0.25;95% confidence interval, 0.18-0.32), and evidence of longer-term benefit was found for up to 5 years (standardized mean difference, 0.15; 95% confidence interval, 0.001-0.31). When exploring determinants of effectiveness, effect size was directly related to medication compliance and to the professional background and method of supervision of case managers. The addition of brief psychotherapy did not substantially improve outcome, nor did increased numbers of sessions. Cumulative meta-analysis showed that sufficient evidence had emerged by 2000 to demonstrate the statistically significant benefit of collaborative care. Conclusions: Collaborative care is more effective than standard care in improving depression outcomes in the short and longer terms. Future research needs to address the implementation of collaborative care, particularly in settings other than the United States.
1,074 citations
TL;DR: Medication nonadherence is prevalent among patients with diabetes mellitus and is associated with adverse outcomes, and interventions are needed to increase medication adherence so that patients can realize the full benefit of prescribed therapies.
Abstract: Background Medication nonadherence may reduce the effectiveness of therapies. To our knowledge, the association between medication nonadherence and mortality remains unexplored outside the context of clinical trials. Methods A retrospective cohort study of 11 532 patients with diabetes mellitus in a managed care organization. Medication adherence was calculated as the proportion of days covered for filled prescriptions of oral hypoglycemics, antihypertensives, and statin medications. The primary outcomes of interest were all-cause hospitalization and all-cause mortality. Multivariable regression analyses were performed to assess the independent association between medication adherence and outcomes. Results Nonadherent patients (proportion of days covered, P P P P Conclusions Medication nonadherence is prevalent among patients with diabetes mellitus and is associated with adverse outcomes. Interventions are needed to increase medication adherence so that patients can realize the full benefit of prescribed therapies.
1,041 citations
TL;DR: In this paper, the authors used the Cochrane Collaboration search strategy to identify trials comparing the effects of low-carbohydrate diets without restriction of energy intake vs low-fat diets in individuals with a body mass index (calculated as weight in kilograms divided by the square of height in meters).
Abstract: Background Low-carbohydrate diets have become increasingly popular for weight loss. However, evidence from individual trials about benefits and risks of these diets to achieve weight loss and modify cardiovascular risk factors is preliminary. Methods We used the Cochrane Collaboration search strategy to identify trials comparing the effects of low-carbohydrate diets without restriction of energy intake vs low-fat diets in individuals with a body mass index (calculated as weight in kilograms divided by the square of height in meters) of at least 25. Included trials had to report changes in body weight in intention-to-treat analysis and to have a follow-up of at least 6 months. Two reviewers independently assessed trial eligibility and quality of randomized controlled trials. Results Five trials including a total of 447 individuals fulfilled our inclusion criteria. After 6 months, individuals assigned to low-carbohydrate diets had lost more weight than individuals randomized to low-fat diets (weighted mean difference, –3.3 kg; 95% confidence interval [CI], −5.3 to −1.4 kg). This difference was no longer obvious after 12 months (weighted mean difference, −1.0 kg; 95% CI, −3.5 to 1.5 kg). There were no differences in blood pressure. Triglyceride and high-density lipoprotein cholesterol values changed more favorably in individuals assigned to low-carbohydrate diets (after 6 months, for triglycerides, weighted mean difference, −22.1 mg/dL [−0.25 mmol/L]; 95% CI, −38.1 to −5.3 mg/dL [−0.43 to −0.06 mmol/L]; and for high-density lipoprotein cholesterol, weighted mean difference, 4.6 mg/dL [0.12 mmol/L]; 95% CI, 1.5-8.1 mg/dL [0.04-0.21 mmol/L]), but total cholesterol and low-density lipoprotein cholesterol values changed more favorably in individuals assigned to low-fat diets (weighted mean difference in low-density lipoprotein cholesterol after 6 months, 5.4 mg/dL [0.14 mmol/L]; 95% CI, 1.2-10.1 mg/dL [0.03-0.26 mmol/L]). Conclusions Low-carbohydrate, non–energy-restricted diets appear to be at least as effective as low-fat, energy-restricted diets in inducing weight loss for up to 1 year. However, potential favorable changes in triglyceride and high-density lipoprotein cholesterol values should be weighed against potential unfavorable changes in low-density lipoprotein cholesterol values when low-carbohydrate diets to induce weight loss are considered.
938 citations
TL;DR: Findings indicate potential windows of alcohol intake that may confer a net beneficial effect of moderate drinking, at least in terms of survival, while confirming the hazards of excess drinking.
Abstract: Results: A J-shaped relationship between alcohol and total mortality was confirmed in adjusted studies, in both men and women. Consumption of alcohol, up to 4 drinks per day in men and 2 drinks per day in women, was inversely associated with total mortality, maximum protection being 18% in women (99% confidence interval, 13%-22%) and 17% in men (99% confidence interval, 15%-19%). Higher doses of alcohol were associated with increased mortality. The inverse association in women disappeared at doses lower than in men. When adjusted and unadjusted data were compared, the maximum protection was only reduced from 19% to 16%. The degree of association in men was lower in the United States than in Europe. Conclusions: Low levels of alcohol intake (1-2 drinks per day for women and 2-4 drinks per day for men) are inversely associated with total mortality in both men and women. Our findings, while confirming the hazards of excess drinking, indicate potential windows of alcohol intake that may confer a net beneficial effect of moderate drinking, at least in terms of survival. Arch Intern Med. 2006;166:2437-2445
897 citations
TL;DR: Frailty among older persons is a dynamic process, characterized by frequent transitions between frailty states over time, and ample opportunity for the prevention and remediation of frailty is suggested.
Abstract: Background: Little is known about the natural course of frailty. We performed a prospective study to determine the transition rates between frailty states and to evaluate the effect of the preceding frailty state on subsequent frailty transitions. Methods: We studied 754 community-living persons, aged 70 years or older, who were nondisabled in 4 essential activities of daily living. Frailty, assessed every 18 months for 54 months, was defined on the basis of weight loss, exhaustion, low physical activity, muscle weakness, and slow walking speed. Participants were classified as frail if they met 3 or more of these criteria, as prefrail if they met 1 or 2 of the criteria, and as nonfrail if they met none of the criteria. Results: Of the 754 participants, 434 (57.6%) had at least 1 transition between any 2 of the 3 frailty states during 54 months. The rates were 36.8%, 21.5%, and 9.2% for 1, 2, and 3 transitions, respectively. During the 18-month intervals, transitions to states of greater frailty were more common (rates up to 43.3%) than transitions to states of lesser frailty (rates up to 23.0%), and the probability of transitioning from being frail to nonfrail was very low (rates, 0%-0.9%), even during an extended period. The likelihood of transitioning between frailty states was highly dependent on one's preceding frailty state. Conclusions: Frailty among older persons is a dynamic process, characterized by frequent transitions between frailty states over time. Our findings suggest ample opportunity for the prevention and remediation of frailty.
884 citations
TL;DR: The addition of clinical pharmacist services in the care of inpatients generally resulted in improved care, with no evidence of harm, and future studies should include multiple sites, larger sample sizes, reproducible interventions, and identification of patient-specific factors that lead to improved outcomes.
Abstract: Background The role of clinical pharmacists in the care of hospitalized patients has evolved over time, with increased emphasis on collaborative care and patient interaction. The purpose of this review was to evaluate the published literature on the effects of interventions by clinical pharmacists on processes and outcomes of care in hospitalized adults. Methods Peer-reviewed, English-language articles were identified from January 1, 1985, through April 30, 2005. Three independent assessors evaluated 343 citations. Inpatient pharmacist interventions were selected if they included a control group and objective patient-specific health outcomes; type of intervention, study design, and outcomes such as adverse drug events, medication appropriateness, and resource use were abstracted. Results Thirty-six studies met inclusion criteria, including 10 evaluating pharmacists' participation on rounds, 11 medication reconciliation studies, and 15 on drug-specific pharmacist services. Adverse drug events, adverse drug reactions, or medication errors were reduced in 7 of 12 trials that included these outcomes. Medication adherence, knowledge, and appropriateness improved in 7 of 11 studies, while there was shortened hospital length of stay in 9 of 17 trials. No intervention led to worse clinical outcomes and only 1 reported higher health care use. Improvements in both inpatient and outpatient outcome measurements were observed. Conclusions The addition of clinical pharmacist services in the care of inpatients generally resulted in improved care, with no evidence of harm. Interacting with the health care team on patient rounds, interviewing patients, reconciling medications, and providing patient discharge counseling and follow-up all resulted in improved outcomes. Future studies should include multiple sites, larger sample sizes, reproducible interventions, and identification of patient-specific factors that lead to improved outcomes.
TL;DR: Data undermine the claim that reliance on surrogates is justified by their ability to predict incapacitated patients' treatment preferences and should assess whether reliance on patient-designated and next-of-kin surrogates offers patients and/or their families benefits that are independent of the accuracy of surrogates' decisions.
Abstract: Background Clinicians currently rely on patient-designated and next-of-kin surrogates to make end-of-life treatment decisions for incapacitated patients. Surrogates are instructed to use the substituted judgment standard, which directs them to make the treatment decision that the patient would have made if he or she were capacitated. However, commentators have questioned the accuracy with which surrogates predict patients' treatment pREFERENCES. Methods A systematic literature search was conducted using PubMed, the Cochrane Library, and manuscript REFERENCES, to identify published studies that provide empirical data on how accurately surrogates predict patients' treatment pREFERENCES and on the efficacy of commonly proposed methods to improve surrogate accuracy. Two of us (D.I.S. and D.W.) reviewed all articles and extracted data on the hypothetical scenarios used to assess surrogate accuracy and the percentage of agreement between patients and surrogates. Results The search identified 16 eligible studies, involving 151 hypothetical scenarios and 2595 surrogate-patient pairs, which collectively analyzed 19 526 patient-surrogate paired responses. Overall, surrogates predicted patients' treatment pREFERENCES with 68% accuracy. Neither patient designation of surrogates nor prior discussion of patients' treatment pREFERENCES improved surrogates' predictive accuracy. Conclusions Patient-designated and next-of-kin surrogates incorrectly predict patients' end-of-life treatment pREFERENCES in one third of cases. These data undermine the claim that reliance on surrogates is justified by their ability to predict incapacitated patients' treatment pREFERENCES. Future studies should assess whether other mechanisms might predict patients' end-of-life treatment pREFERENCES more accurately. Also, they should assess whether reliance on patient-designated and next-of-kin surrogates offers patients and/or their families benefits that are independent of the accuracy of surrogates' decisions.
TL;DR: High prevalence of clinical MRSA strains with elevated vancomycin MIC (2 microg/mL) requires aggressive empirical vancomYcin dosing to achieve a trough greater than 15 microg /mL, and Combination or alternative therapy should be considered for invasive infections caused by these strains.
Abstract: Background Vancomycin hydrochloride treatment failure for infections caused by susceptible methicillin-resistant Staphylococcus aureus (MRSA) strains with high minimum inhibitory concentration (MIC) has prompted recent guidelines to recommend a higher vancomycin target trough of 15 to 20 μg/mL. Methods A prospective cohort study of adult patients infected with MRSA was performed to determine the distribution of vancomycin MIC and treatment outcomes with vancomycin doses targeting an unbound trough of at least 4 times the MIC. The microbiology laboratory computer records were used to identify all patients from whom MRSA was isolated from August 1, 2004, through June 30, 2005. Primary outcome measures were clinical response, mortality, and nephrotoxicity. Patients were placed into subgroups based on target trough attainment and high vs low vancomycin MIC (≥2 vs Results Of the 95 patients in the study, 51 (54%) were infected with high-MIC strains and had pneumonia (77%) and/or bacteremia. An initial response rate of 74% was achieved if the target trough was attained irrespective of MIC. However, despite achieving the target trough, the high-MIC group had lower end-of-treatment responses (24/39 [62%] vs 34/40 [85%]; P = .02) and higher infection-related mortality (11/51 [24%] vs 4/44 [10%]; P =.16) compared with the low-MIC group. High MIC ( P = .03) and Acute Physiology and Chronic Health Evaluation II score ( P = .009) were independent predictors of poor response in multivariate analysis. Nephrotoxicity occurred only in the high-trough group (11/63 [12%]), significantly predicted by concomitant therapy with other nephrotoxic agents. Conclusions High prevalence of clinical MRSA strains with elevated vancomycin MIC (2 μg/mL) requires aggressive empirical vancomycin dosing to achieve a trough greater than 15 μg/mL. Combination or alternative therapy should be considered for invasive infections caused by these strains.
TL;DR: Pharmacist medication review, patient counseling, and telephone follow-up were associated with a lower rate of preventable ADEs 30 days after hospital discharge, and medication discrepancies before and after discharge were common targets of intervention.
Abstract: Background Hospitalization and subsequent discharge home often involve discontinuity of care, multiple changes in medication regimens, and inadequate patient education, which can lead to adverse drug events (ADEs) and avoidable health care utilization. Our objectives were to identify drug-related problems during and after hospitalization and to determine the effect of patient counseling and follow-up by pharmacists on preventable ADEs. Methods We conducted a randomized trial of 178 patients being discharged home from the general medicine service at a large teaching hospital. Patients in the intervention group received pharmacist counseling at discharge and a follow-up telephone call 3 to 5 days later. Interventions focused on clarifying medication regimens; reviewing indications, directions, and potential side effects of medications; screening for barriers to adherence and early side effects; and providing patient counseling and/or physician feedback when appropriate. The primary outcome was rate of preventable ADEs. Results Pharmacists observed the following drug-related problems in the intervention group: unexplained discrepancies between patients' preadmission medication regimens and discharge medication orders in 49% of patients, unexplained discrepancies between discharge medication lists and postdischarge regimens in 29% of patients, and medication nonadherence in 23%. Comparing trial outcomes 30 days after discharge, preventable ADEs were detected in 11% of patients in the control group and 1% of patients in the intervention group ( P = .01). No differences were found between groups in total ADEs or total health care utilization. Conclusions Pharmacist medication review, patient counseling, and telephone follow-up were associated with a lower rate of preventable ADEs 30 days after hospital discharge. Medication discrepancies before and after discharge were common targets of intervention.
TL;DR: Sleep loss induces a functional alteration of the monocyte proinflammatory cytokine response, which alters molecular processes that drive cellular immune activation and induce inflammatory cytokines; mapping the dynamics of sleep loss on molecular signaling pathways has implications for understanding the role of sleep in altering immune cell physiologic characteristics.
Abstract: Background Inflammation is associated with increased risk of cardiovascular disorders, arthritis, diabetes mellitus, and mortality. The effects of sleep loss on the cellular and genomic mechanisms that contribute to inflammatory cytokine activity are not known. Methods In 30 healthy adults, monocyte intracellular proinflammatory cytokine production was repeatedly assessed during the day across 3 baseline periods and after partial sleep deprivation (awake from 11PMto 3AM). We analyzed the impact of sleep loss on transcription of proinflammatory cytokine genes and used DNA microarray analyses to characterize candidate transcription-control pathways that might mediate the effects of sleep loss on leukocyte gene expression. Results In the morning after a night of sleep loss, monocyte production of interleukin 6 and tumor necrosis factor α was significantly greater compared with morning levels following uninterrupted sleep. In addition, sleep loss induced a more than 3-fold increase in transcription of interleukin 6 messenger RNA and a 2-fold increase in tumor necrosis factor α messenger RNA. Bioinformatics analyses suggested that the inflammatory response was mediated by the nuclear factor κB inflammatory signaling system as well as through classic hormone and growth factor response pathways. Conclusions Sleep loss induces a functional alteration of the monocyte proinflammatory cytokine response. A modest amount of sleep loss also alters molecular processes that drive cellular immune activation and induce inflammatory cytokines; mapping the dynamics of sleep loss on molecular signaling pathways has implications for understanding the role of sleep in altering immune cell physiologic characteristics. Interventions that target sleep might constitute new strategies to constrain inflammation with effects on inflammatory disease risk.
TL;DR: Off-label medication use is common in outpatient care, and most occurs without scientific support, so efforts should be made to scrutinize underevaluated off-label prescribing that compromises patient safety or represents wasteful medication use.
Abstract: Background:UnlikemedicinesprescribedforFoodand DrugAdministration–approvedindications,off-labeluses may lack rigorous scientific scrutiny. Despite concerns aboutpatientsafetyandcoststothehealthcaresystem,little is known about the frequency of off-label drug use or the degree of scientific evidence supporting this practice. Methods: We used nationally representative data from the 2001 IMS Health National Disease and Therapeutic Index (NDTI) to define prescribing patterns by diagnosis for 160 commonly prescribed drugs. Each reported drug-diagnosis combination was identified as Food andDrugAdministration–approved,off-labelwithstrong scientific support, or off-label with limited or no scientific support. Outcome measures included (1) the proportion of uses that were off-label and (2) the proportion of off-label uses supported by strong scientific evidence. Multivariate analyses were used to identify drug-specific characteristics predictive of increased off-label use. Results: In 2001, there were an estimated 150 million (95%confidenceinterval,127-173million)off-labelmentions (21% of overall use) among the sampled medications. Off-label use was most common among cardiac medications(46%,excludingantihyperlipidemicandantihypertensiveagents)andanticonvulsants(46%),whereas gabapentin(83%)andamitriptylinehydrochloride(81%) had the greatest proportion of off-label use among specificmedications.Mostoff-labeldrugmentions(73%;95% confidence interval, 61%-84%) had little or no scientific support. Although several functional classes were associatedwithincreasedoff-labeluse(P.05),fewotherdrug characteristics predicted off-label prescription. Conclusions:Off-labelmedicationuseiscommoninoutpatient care, and most occurs without scientific support. Efforts should be made to scrutinize underevaluatedoff-labelprescribingthatcompromisespatientsafety or represents wasteful medication use. Arch Intern Med. 2006;166:1021-1026
TL;DR: The need to improve the transition of care from the hospital to outpatient setting to ensure that patients continue to take evidence-based medications that have mortality benefit is suggested.
Abstract: Background: Nonadherence to medications is common, but the determinants and consequences are poorly defined. The objectives of this study were to identify patient and myocardial infarction (MI) treatment factors associated with medication therapy discontinuation and to assess the impact of medication discontinuation 1 month after MI on 12-month mortality. Methods: This was a multicenter prospective cohort of patients with MI enrolled in the Prospective Registry Evaluating Myocardial Infarction: Event and Recovery study.Theoutcomeswereuseofaspirin,-blockers,and statins at 1 month after MI hospitalization among patients discharged with all 3 medications as well as 12month mortality. Results: Of 1521 patients discharged with all 3 medications,184discontinueduseofall3medications,56discontinued use of 2 medications, 272 discontinued use of 1 medication, and 1009 continued taking all 3 medications at 1 month. In multivariable analyses, patients not graduating from high school (odds ratio [OR], 1.76; 95%confidenceinterval[CI],1.20-2.60)weremorelikely to discontinue use of all medications. The effect of increasing age on medication therapy discontinuation was greater for females (OR, 1.77; 95% CI, 1.34-2.34) than males (OR, 1.23; 95% CI, 1.02-1.47). Patients who discontinued use of all medications at 1 month had lower 1-yearsurvival(88.5%vs97.7%;log-rankP.001)comparedwithpatientswhocontinuedtotake1ormoremedication(s). In multivariable survival analysis, medication therapy discontinuation was independently associated with higher mortality (hazards ratio, 3.81; 95% CI, 1.887.72). Results were consistent when evaluating discontinuation of use of aspirin, -blockers, and statins separately.
TL;DR: In this cross-sectional study of volunteers with type 2 diabetes, sleep duration and quality were significant predictors of HbA1c, a key marker of glycemic control.
Abstract: Background Evidence from laboratory and epidemiologic studies suggests that decreased sleep duration or quality may increase diabetes risk We examined whether short or poor sleep is associated with glycemic control in African Americans with type 2 diabetes mellitus Methods We conducted a cross-sectional study of volunteers with type 2 diabetes interviewed at the University of Chicago Hospitals, Chicago, Ill The final analysis included 161 participants Glycemic control was assessed by hemoglobin A 1c (HbA 1c ) level obtained from medical charts Sleep quality was assessed using the Pittsburgh Sleep Quality Index (PSQI) Perceived sleep debt was calculated as the difference between preferred and actual weekday sleep duration Results The mean ± SD sleep duration was 60 ± 16 hours, and 71% of the participants were classified as having poor quality sleep (PSQI score >5) We excluded patients with sleep frequently disrupted by pain (n = 39) In patients without diabetic complications, glycemic control was associated with perceived sleep debt but not PSQI score The predicted increase in HbA 1c level for a perceived sleep debt of 3 hours per night was 11% above the median In patients with at least 1 complication, HbA 1c level was associated with PSQI score but not perceived sleep debt The predicted increase in HbA 1c level for a 5-point increase in PSQI was 19% above the median Conclusions In our sample, sleep duration and quality were significant predictors of HbA 1c , a key marker of glycemic control Combined with existing evidence linking sleep loss to increased diabetes risk, these data suggest that optimizing sleep duration and quality should be tested as an intervention to improve glucose control in patients with type 2 diabetes
George Washington University1, University of California, San Diego2, Harvard University3, University of Pittsburgh4, University of Tennessee Health Science Center5, Wayne State University6, Fred Hutchinson Cancer Research Center7, University of Washington8, University of California, Irvine9, University of Massachusetts Medical School10, Brown University11, Rutgers University12, University of Miami13
TL;DR: Conjugated equine estrogens provided no overall protection against myocardial infarction or coronary death in generally healthy postmenopausal women during a 7-year period of use.
Abstract: Background In recent randomized trials, conjugated equine estrogens (CEE) with continuous medroxyprogesterone acetate provided no protection against coronary heart disease in postmenopausal women and may have increased cardiac risk. These trials did not address the role of unopposed estrogen for coronary protection. Methods A total of 10 739 women aged 50 to 79 years at baseline (mean age, 63.6 years) who had previously undergone hysterectomy were randomized to receive CEE, 0.625 mg/d, or placebo at 40 US clinical centers beginning in 1993. The trial was terminated early after 6.8 years of follow-up (planned duration, 8.5 years). This report includes final, centrally adjudicated results for the primary efficacy outcome (myocardial infarction or coronary death), secondary coronary outcomes, and subgroup analyses. Results During the active intervention period, 201 coronary events were confirmed among women assigned to receive CEE compared with 217 events among women assigned to receive placebo (hazard ratio, 0.95; nominal 95% confidence interval, 0.79-1.16). Among women aged 50 to 59 years at baseline, the hazard ratio for the primary outcome was 0.63 (nominal 95% confidence interval, 0.36-1.08). In that age group, coronary revascularization was less frequent among women assigned to receive CEE (hazard ratio, 0.55; nominal 95% confidence interval, 0.35-0.86), as were several composite outcomes, which included the primary outcome and coronary revascularization (hazard ratio, 0.66; nominal 95% confidence interval, 0.44-0.97). Conclusions Conjugated equine estrogens provided no overall protection against myocardial infarction or coronary death in generally healthy postmenopausal women during a 7-year period of use. There was a suggestion of lower coronary heart disease risk with CEE among women 50 to 59 years of age at baseline.
TL;DR: A meta-analysis of qualitative studies found repeated inquiry about partner violence was seen as appropriate by women who were at later stages of an abusive relationship and a wish from women for responses from health care professionals that were nonjudgmental, nondirective, and individually tailored.
Abstract: Background The appropriate response of health care professionals to intimate partner violence is still a matter of debate. This article reports a meta-analysis of qualitative studies that answers 2 questions: (1) How do women with histories of intimate partner violence perceive the responses of health care professionals? and (2) How do women with histories of intimate partner violence want their health care providers to respond to disclosures of abuse? Methods Multiple databases were searched from their start to July 1, 2004. Searches were complemented with citation tracking and contact with researchers. Inclusion criteria included a qualitative design, women 15 years or older with experience of intimate partner violence, and English language. Two reviewers independently applied criteria and extracted data. Findings from the primary studies were combined using a qualitative meta-analysis. Results Twenty-nine articles reporting 25 studies (847 participants) were included. The emerging constructs were largely consistent across studies and did not vary by study quality. We ordered constructs by the temporal structure of consultations with health care professionals: before the abuse is discussed, at disclosure, and the immediate and further responses of the health care professional. Key constructs included a wish from women for responses from health care professionals that were nonjudgmental, nondirective, and individually tailored, with an appreciation of the complexity of partner violence. Repeated inquiry about partner violence was seen as appropriate by women who were at later stages of an abusive relationship. Conclusion Women’s perceptions of appropriate and inappropriate responses partly depended on the context of the consultation, their own readiness to address the issue, and the nature of the relationship between the woman and the health care professional.
TL;DR: Admission to a room previously occupied by an MRSA-positive patient or a VRE- positive patient significantly increased the odds of acquisition for MRSA and VRE, and this route of transmission was a minor contributor to overall transmission.
Abstract: Background Environmental contamination with methicillin-resistant Staphylococcus aureus (MRSA) and vancomycin-resistant enterococci (VRE) occurs during the care of patients harboring these organisms and may increase the risk of transmission to subsequent room occupants. Methods Twenty-month retrospective cohort study of patients admitted to 8 intensive care units performing routine admission and weekly screening for MRSA and VRE. We assessed the relative odds of acquisition among patients admitted to rooms in which the most recent occupants were MRSA positive or VRE positive, compared with patients admitted to other rooms. Results Of 11 528 intensive care unit room stays, 10 151 occupants were eligible to acquire MRSA, and 10 349 were eligible to acquire VRE. Among patients whose prior room occupant was MRSA positive, 3.9% acquired MRSA, compared with 2.9% of patients whose prior room occupant was MRSA negative (adjusted odds ratio, 1.4; P = .04). VRE, Among patients whose prior room occupant was VRE positive, these values were 4.5% and 2.8% respectively (adjusted odds ratio, 1.4; P = .02). These excess risks accounted for 5.1% of all incident MRSA cases and 6.8% of all incident VRE cases, with a population attributable risk among exposed patients of less than 2% for either organism. Acquisition was significantly associated with longer post–intensive care unit length of stay. Conclusions Admission to a room previously occupied by an MRSA-positive patient or a VRE-positive patient significantly increased the odds of acquisition for MRSA and VRE. However, this route of transmission was a minor contributor to overall transmission. The effect of current cleaning practices in reducing the risk to the observed levels and the potential for further reduction are unknown.
TL;DR: Patients with DM drawn from the general Japanese population may be at increased risk of total cancer and of cancer in specific sites.
Abstract: Background: An association between diabetes melli- tus (DM) and cancer has long been speculated, but no conclusive evidence has been obtained. Methods: We prospectively examined the association between a history of DM and subsequent risk of cancer in the Japan Public Health Center-Based Prospective Study.Atotalof97771generalJapanesepersons(46548 men and 51223 women) aged 40 to 69 years who re- creas (n=118 (16 with DM); HR, 1.85; 95% CI, 1.07- 3.20), and kidney (n=99 (13 with DM); HR, 1.92; 95% CI, 1.06-3.46). We also observed a moderately in- creased risk of colon cancer (n=491 (46 with DM); HR, 1.36;95%CI,1.00-1.85)andofstomachcancerwithbor- derlinesignificance(n=977(87withDM);HR,1.23;95% CI, 0.98-1.54). In women, a borderline significant in- creaseinriskwasobservedfortheincidenceoftotalcan- cer (n=2555 (104 with DM); HR, 1.21; 95% CI, 0.99- 1.47), while statistical significance was observed for the incidence of stomach cancer (n=362 (20 with DM); HR, 1.61; 95% CI, 1.02-2.54) and liver cancer (n=120 (10 with DM); HR, 1.94; 95% CI, 1.00-3.73) and borderline significancewasobservedfortheincidenceofovariancan- cer (n=74 (5 with DM); HR, 2.42; 95% CI, 0.96-6.09). Conclusion: Patients with DM drawn from the general Japanesepopulationmaybeatincreasedriskoftotalcan- cer and of cancer in specific sites. Arch Intern Med. 2006;166:1871-1877
TL;DR: In this paper, the authors applied an evidence-based approach to determine the efficacy of lifestyle measures for patients with gastroesophageal reflux disease (GERD) management.
Abstract: Lifestyle modifications are first-line therapy for patients with gastroesophageal reflux disease (GERD). We applied an evidence-based approach to determine the efficacy of lifestyle measures for GERD management. We used PubMed and Ovid to perform a search of the literature published between 1975 and 2004 using the key words heartburn, GERD, smoking, alcohol, obesity, weight loss, caffeine or coffee, citrus, chocolate, spicy food, head of bed elevation, and late-evening meal. Each study was reviewed by 2 reviewers who assigned one of the following ratings: evidence A, randomized clinical trials; evidence B, cohort or case-control studies; evidence C, case reports or flawed clinical trials; evidence D, investigator experience; or evidence E, insufficient information. We screened 2039 studies and identified 100 that were relevant. Only 16 clinical trials examined the impact on GERD (by change in symptoms, esophageal pH variables, or lower esophageal sphincter pressure) of the lifestyle measure. Although there was physiologic evidence that exposure to tobacco, alcohol, chocolate, and high-fat meals decreases lower esophageal sphincter pressure, there was no published evidence of the efficacy of dietary measures. Neither tobacco nor alcohol cessation was associated with improvement in esophageal pH profiles or symptoms (evidence B). Head of bed elevation and left lateral decubitus position improved the overall time that the esophageal pH was less than 4.0 (evidence B). Weight loss improved pH profiles and symptoms (evidence B). Weight loss and head of bed elevation are effective lifestyle interventions for GERD. There is no evidence supporting an improvement in GERD measures after cessation of tobacco, alcohol, or other dietary interventions.
TL;DR: Examination of 31-year trends in CVD risk factors by annual income and educational levels among US adults found education- and income-related disparities have worsened for smoking, and increases in diabetes prevalence have occurred primarily among persons with a lower socioeconomic status.
Abstract: Background It is unknown whether the previously recognized disparities in cardiovascular disease (CVD) risk factors related to annual income and educational level have diminished, persisted, or worsened in recent decades. The objective of this study was to examine 31-year trends in CVD risk factors by annual income and educational levels among US adults. Methods Four cross-sectional national surveys were used: National Health and Nutrition Examination Survey I (1971-1974), II (1976-1980), III (1988-1994), and 1999-2002. The main outcome measure was prevalence of high cholesterol (≥240 mg/dL [≥6.2 mmol/L]), high blood pressure (140/90 mm Hg), smoking, and diabetes mellitus. Results Between 1971 and 2002, the prevalence of all CVD risk factors, except diabetes, decreased in all income and education groups, but there has been little reduction in income- and education-related disparities in CVD risk factors and few improvements during the past 10 years. The prevalence of high blood pressure declined by about half in all income and education groups, ranging from 30.3% to 40.6% in 1971-1974 and 16.4% in 1999-2002, with the greatest reduction among those in the lowest income quartile and those with less than a high school education (18.0 and 15.9 percentage points, respectively). High cholesterol prevalence also declined in all groups and ranged from 28.8% to 32.4% in 1971-1974 and 15.3% to 22.0% in 1999-2002, with the largest decline (15.9 percentage points) among people with the highest incomes. Education- and income-related disparities in smoking widened considerably, because there were large declines in smoking prevalence among people with high incomes and education (from about 33% in 1971-1974 to about 14%-17% in 1999-2002) but only marginal reductions among those with low incomes and education (about 6–percentage point decline). Diabetes prevalence increased most among persons with low incomes and education. Conclusions Despite the general success in reducing CVD risk factors in the US population, not all segments of society are benefiting equally and improvements may have slowed. Education- and income-related disparities have worsened for smoking, and increases in diabetes prevalence have occurred primarily among persons with a lower socioeconomic status. Diabetes prevention and smoking prevention and cessation programs need to specifically target persons of lower income and education.
TL;DR: Low testosterone levels were associated with increased mortality in male veterans and after adjusting for age, medical morbidity, and other clinical covariates, low testosterone levels continued to be associated with elevated mortality.
Abstract: Background:Lowserumtestosteroneisacommoncondition in aging associated with decreased muscle mass andinsulinresistance.Thisstudyevaluatedwhetherlow testosterone levels are a risk factor for mortality in male veterans. Methods: We used a clinical database to identify men older than 40 years with repeated testosterone levels obtained from October 1, 1994, to December 31, 1999, and without diagnosed prostate cancer. A low testosterone level was a total testosterone level of less than 250 ng/dL (8.7 nmol/L) or a free testosterone level of less than 0.75 ng/dL (0.03 nmol/L). Men were classified as having a low testosterone level (166 [19.3%]), an equivocal testosterone level (equal number of low and normal levels) (240 [28.0%]), or a normal testosterone level (452 [52.7%]). The risk for all-cause mortality was estimated using Cox proportional hazards regression models, adjustingfordemographicandclinicalcovariatesoverafollow-up of up to 8 years. Results: Mortality in men with normal testosterone levelswas20.1%(95%confidenceinterval[CI],16.2%-24.1%) vs24.6%(95%CI,19.2%-30.0%)inmenwithequivocaltestosteronelevelsand34.9%(95%CI,28.5%-41.4%)inmen withlowtestosteronelevels.Afteradjustingforage,medical morbidity, and other clinical covariates, low testosterone levels continued to be associated with increased mortality(hazardratio,1.88;95%CI,1.34-2.63;P.001)while equivocal testosterone levels were not significantly differentfromnormaltestosteronelevels(hazardratio,1.38;95% CI,0.99%-1.92%;P=.06).Inasensitivityanalysis,menwho diedwithinthefirstyear(50[5.8%])wereexcludedtominimize the effect of acute illness, and low testosterone levels continued to be associated with elevated mortality. Conclusions: Low testosterone levels were associated with increased mortality in male veterans. Further prospective studies are needed to examine the association between low testosterone levels and mortality. Arch Intern Med. 2006;166:1660-1665
TL;DR: In this paper, the efficacy of acupuncture compared with minimal acupuncture and with no acupuncture in patients with chronic low back pain was investigated in 30 outpatient centers, where patients were randomized to treatment with acupuncture, minimal acupuncture (superficial needling at nonacupuncture points), or a waiting list control.
Abstract: BACKGROUND: Acupuncture is widely used by patients with low back pain, although its effectiveness is unclear. We investigated the efficacy of acupuncture compared with minimal acupuncture and with no acupuncture in patients with chronic low back pain. METHODS: Patients were randomized to treatment with acupuncture, minimal acupuncture (superficial needling at nonacupuncture points), or a waiting list control. Acupuncture and minimal acupuncture were administered by specialized acupuncture physicians in 30 outpatient centers, and consisted of 12 sessions per patient over 8 weeks. Patients completed standardized questionnaires at baseline and at 8, 26, and 52 weeks after randomization. The primary outcome variable was the change in low back pain intensity from baseline to the end of week 8, as determined on a visual analog scale (range, 0-100 mm). RESULTS: A total of 298 patients (67.8% female; mean +/- SD age, 59 +/- 9 years) were included. Between baseline and week 8, pain intensity decreased by a mean +/- SD of 28.7 +/- 30.3 mm in the acupuncture group, 23.6 +/- 31.0 mm in the minimal acupuncture group, and 6.9 +/- 22.0 mm in the waiting list group. The difference for the acupuncture vs minimal acupuncture group was 5.1 mm (95% confidence interval, -3.7 to 13.9 mm; P = .26), and the difference for the acupuncture vs waiting list group was 21.7 mm (95% confidence interval, 13.9-30.0 mm; P<.001). Also, at 26 (P=.96) and 52 (P=.61) weeks, pain did not differ significantly between the acupuncture and the minimal acupuncture groups. CONCLUSION: Acupuncture was more effective in improving pain than no acupuncture treatment in patients with chronic low back pain, whereas there were no significant differences between acupuncture and minimal acupuncture.
TL;DR: In this paper, the authors examined whether calcium supplementation decreases clinical fracture risk in elderly women and its mechanism of action and concluded that supplementing with calcium carbonate tablets supplying 1200 mg/d is ineffective as a public health intervention in preventing clinical fractures in the ambulatory elderly population owing to poor long-term compliance, but it is effective in those patients who are compliant.
Abstract: Background: Increased dietary calcium intake has been proposed as a population-based public health intervention to prevent osteoporotic fractures. We have examined whether calcium supplementation decreases clinical fracture risk in elderly women and its mechanism of action. Methods: Five-year, double-blind, placebo-controlled study of 1460 women recruited from the population and older than 70 years (mean age, 75 years) who were randomized to receive calcium carbonate, 600 mg twice per day, or identical placebo. The primary end points included clinical incident osteoporotic fractures, vertebral deformity, and adverse events ascertained in 5 years. Bone structure was also measured using dual x-ray absorptiometry of the hip and whole body, quantitative ultrasonography of the heel, and peripheral quantitative computed tomography of the distal radius. Results: Among our patients, 16.1% sustained 1 or more clinical osteoporotic fractures. In the intention-to-treat analysis, calcium supplementation did not significantly reduce fracture risk (hazard ratio, 0.87; 95% confidence interval, 0.67-1.12). However, 830 patients (56.8%) who took 80% or more of their tablets (calcium or placebo) per year had reduced fracture incidence in the calcium compared with the placebo groups (10.2% vs 15.4%; hazard ratio, 0.66; 95% confidence interval, 0.45-0.97). Calciumtreated patients had improved quantitative ultrasonography findings of the heel, femoral neck and whole-body dual x-ray absorptiometry data, and bone strength compared with placebo-treated patients. Of the 92 000 adverse events recorded, constipation was the only event increased by the treatment (calcium group, 13.4%; placebo group, 9.1%). Conclusion: Supplementation with calcium carbonate tablets supplying 1200 mg/d is ineffective as a public health intervention in preventing clinical fractures in the ambulatory elderly population owing to poor long-term compliance, but it is effective in those patients who are compliant. Arch Intern Med. 2006;166:869-875
TL;DR: All 3 imaging techniques, ie, TEE, helical CT, and MRI, yield clinically equally reliable diagnostic values for confirming or ruling out thoracic aortic dissection.
Abstract: Background Patients with suspected thoracic aortic dissection require early and accurate diagnosis. Aortography has been replaced by less invasive imaging techniques including transesophageal echocardiography (TEE), helical computed tomography (CT), and magnetic resonance imaging (MRI); however, accuracies have varied from trial to trial, and which imaging technique should be applied to which risk population remains unclear. We systematically reviewed the diagnostic accuracy of these imaging techniques in patients with suspected thoracic aortic dissection. Methods Published English-language reports on the diagnosis of thoracic aortic dissection by TEE, helical CT, or MRI were identified from electronic databases. Sensitivity, specificity, and positive and negative likelihood ratios were pooled in a random-effects model. Results Sixteen studies involving a total of 1139 patients were selected. Pooled sensitivity (98%-100%) and specificity (95%-98%) were comparable between imaging techniques. The pooled positive likelihood ratio appeared to be higher for MRI (positive likelihood ratio, 25.3; 95% confidence interval, 11.1-57.1) than for TEE (14.1; 6.0-33.2) or helical CT (13.9; 4.2-46.0). If a patient had shown a 50% pretest probability of thoracic aortic dissection (high risk), he or she had a 93% to 96% posttest probability of thoracic aortic dissection following a positive result of each imaging test. If a patient had a 5% pretest probability of thoracic aortic dissection (low risk), he or she had a 0.1% to 0.3% posttest probability of thoracic aortic dissection following a negative result of each imaging test. Conclusion All 3 imaging techniques, ie, TEE, helical CT, and MRI, yield clinically equally reliable diagnostic values for confirming or ruling out thoracic aortic dissection.
TL;DR: In a cohort of elderly men, cocoa intake is inversely associated with blood pressure and 15-year cardiovascular and all-cause mortality.
Abstract: Background: Small, short-term, intervention studies indicate that cocoa-containing foods improve endothelial function and reduce blood pressure. We studied whether habitual cocoa intake was cross-sectionally related to blood pressure and prospectively related with cardiovascular mortality. Methods: Data used were of 470 elderly men participating in the Zutphen Elderly Study and free of chronic diseases at baseline. Blood pressure was measured at baseline and 5 years later, and causes of death were ascertained during 15 years of follow-up. Habitual food consumption was assessed by the cross-check dietary history method in 1985, 1990, and 1995. Cocoa intake was estimated from the consumption of cocoa-containing foods. Results: One third of the men did not use cocoa at baseline. The median cocoa intake among users was 2.11 g/d. After adjustment, the mean systolic blood pressure in the highest tertile of cocoa intake was 3.7 mm Hg lower (95% confidence interval [CI], ?7.1 to ?0.3 mm Hg; P = .03 for trend) and the mean diastolic blood pressure was 2.1 mm Hg lower (95% CI, ?4.0 to ?0.2 mm Hg; P = .03 for trend) compared with the lowest tertile. During follow-up, 314 men died, 152 of cardiovascular diseases. Compared with the lowest tertile of cocoa intake, the adjusted relative risk for men in the highest tertile was 0.50 (95% CI, 0.32-0.78; P = .004 for trend) for cardiovascular mortality and 0.53 (95% CI, 0.39-0.72; P <.001) for all-cause mortality. Conclusion: In a cohort of elderly men, cocoa intake is inversely associated with blood pressure and 15-year cardiovascular and all-cause mortality
TL;DR: Providing automated computer-tailored feedback in an Internet weight loss program was as effective as human e-mail counseling at 3 months, and further research is needed to improve the efficacy of automatedComputer-automated feedback as a population-based weight loss approach.
Abstract: Background Several studies have shown that e-mail counseling improves weight loss achieved in self-directed Internet programs. Computer-tailored feedback offers a population-based alternative to human e-mail counseling. Methods One hundred ninety-two adults, aged 49.2 ± 9.8 years, having a body mass index (calculated as weight in kilograms divided by height in meters squared) of 32.7 ± 3.5, were randomized to 1 of 3 Internet treatment groups: No counseling, computer-automated feedback, or human e-mail counseling. All participants received 1 weight loss group session, coupons for meal replacements, and access to an interactive Web site. The human e-mail counseling and computer-automated feedback groups also had access to an electronic diary and message board. The human e-mail counseling group received weekly e-mail feedback from a counselor, and the computer-automated feedback group received automated, tailored messages. Results Retention was 82% at 3 months and 80% at 6 months for all 3 groups. At 3 months, completers in both the computer-automated feedback (−5.3 ± 4.2 kg) and human e-mail counseling (−6.1 ± 3.9 kg) groups had significantly greater weight losses compared with the no counseling group (−2.8 ± 3.5 kg) and these groups did not differ from each other. At 6 months, weight losses were significantly greater in the human e-mail counseling group (−7.3 ± 6.2 kg) than in the computer-automated feedback (−4.9 ± 5.9 kg) or no counseling (−2.6 ± 5.7 kg) groups. Intent-to-treat analyses using single or multiple imputation techniques showed the same pattern of significance. Conclusions Providing automated computer-tailored feedback in an Internet weight loss program was as effective as human e-mail counseling at 3 months. Further research is needed to improve the efficacy of automated computer-tailored feedback as a population-based weight loss approach. Trial Registration clinicaltrials.gov Identifier:NCT00200304.