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Annual Review of the LTC Literature October 1 st , 2011

Annual Review of the LTC Literature October 1 st , 2011. Dr. Robert Wells, MD, CMD Chief Medical Officer for Extended Care Physicians, PA. Chocolate Consumption Is Associated with Reduced Risk for Adverse CV Outcomes.

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Annual Review of the LTC Literature October 1 st , 2011

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  1. Annual Review of the LTC LiteratureOctober 1st, 2011 Dr. Robert Wells, MD, CMD Chief Medical Officer for Extended Care Physicians, PA

  2. Chocolate Consumption Is Associated with Reduced Risk for Adverse CV Outcomes People who ate chocolate more than five times a week had lower risks for any cardiovascular disease and stroke. But Alas Comment: In this study, high overall consumption of chocolate was associated with reduced risk for any CV disease and stroke. The results, however, do not prove causality. Furthermore, excessive consumption of sugar-laden chocolate confections is unhealthy. In the absence of results of randomized trials comparing chocolate with placebo (in which few people would likely participate), chocolate should be enjoyed in moderation. BMJ 2011 Aug 29; 343:d4488.

  3. A Little Hand Hygiene Goes a Long Way Does hand washing really reduce the incidence of gastrointestinal (GI) and respiratory illnesses in the community, and, if so, by how much? Which is better: alcohol-based hand sanitizers, nonantibacterial (plain) soap, or antibacterial soap? Am J Public Health2008 Aug; 98:1372.

  4. Education plus use of nonantibacterial soap (6 studies) significantly reduced the risk for GI illness by 39% and for respiratory illness (1 study) by 51%, compared with control conditions, but had no significant effect in the two studies that combined the two outcomes. In two studies, use of antibacterial soaps did not offer an advantage over plain soap for either illness. Although alcohol-based hand sanitizer plus education did not reduce the risk for either illness alone, this strategy showed a protective effect in the three studies that combined the two outcomes (21% reduction). In two studies, benzalkonium chloride–based hand sanitizer significantly reduced the risk for GI and respiratory illnesses alone and the two outcomes combined by about 40%.

  5. Therapeutic Potential of Oral Factor Xa Inhibitors “Venous thromboembolism is the third leading cause of cardiovascular death, after myocardial infarction and stroke. Total hip or knee arthroplasty is the procedure with the highest risk of venous thromboembolism. The oral factor Xa inhibitors represent a major advance in the prevention and treatment of thromboembolic disease. Factor Xa is strategically positioned at the juncture of the intrinsic and extrinsic coagulation pathways proximal to thrombin.”

  6. “It is conceivable that the oral factor Xa inhibitors, as compared with warfarin, will prove to be safer in clinical practice because they are administered in fixed doses, do not interfere with diet, and have fewer interactions with other drugs. The reversibility of the drugs’ effects and the ability to measure the anticoagulant effect in specific situations will continue to be highly desirable features and will help to allay physicians’ concerns.” Elaine M. Hylek, M.D., M.P.H. N Engl J Med 363;26 , december 23, 2010

  7. A Revolution in VTE Prophylaxis Lassen MR et al. Apixaban versus enoxaparin for thromboprophylaxis after hip replacement. N Engl J Med 2010 Dec 23; 363:2487. Hylek E. Oral factor Xa inhibitors — Warfarin auld langsyne? N Engl J Med 2010 Dec 23; 363:2559. Published inJournal Watch Hospital MedicineDecember 22, 2010

  8. Apixaban versus enoxaparin for thromboprophylaxis after hip replacement. N Engl J Med 2010 Dec 23; 363:2487.

  9. A double-blind study of VTE prophylaxis after hip replacement; 5400 patients were randomized to receive apixaban (2.5 mg orally twice daily, initiated 12–24 hours postoperatively) or enoxaparin(40 mg subcutaneously every 24 hours, initiated 12 hours before surgery) for 35 days. • Apixaban was significantly more effective than enoxaparin for preventing the primary endpoint (asymptomatic or symptomatic deep venous thrombosis, nonfatal pulmonary embolism, or death; 1.4% vs. 3.9%), without excess risk for bleeding. Apixaban also was more effective than enoxaparin for preventing majorVTE events. The number needed to treat (NNT) to prevent 1 primary endpoint was 40, and the NNT to prevent 1 major VTE event was about 150.

  10. Apixabanappears to be more effective then enoxaparin for VTE prophylaxis after total hip replacement. This class of drugs could transform how VTE is prevented and treated. The current lack of an antidote and the higher cost are barriers to use but are not insurmountable. It's more a matter of when, not if, these drugs will revolutionize care.

  11. Oral Rivaroxaban for Symptomatic Venous ThromboembolismN Engl J Med 2010 Dec 23; 363:2559. The study of rivaroxaban for acute DVT included 3449 patients: 1731 given rivaroxaban and 1718 given enoxaparin plus a vitamin K antagonist. Rivaroxaban had noninferior efficacy with respect to the primary outcome (36 events [2.1%], vs. 51 events with enoxaparin–vitamin K antagonist [3.0%]; hazard ratio, 0.68; 95% confidence interval [CI], 0.44 to 1.04; P<0.001).

  12. The principal safety outcome occurred in 8.1% of the patients in each group. In the continued-treatment study, which included 602 patients in the rivaroxaban group and 594 in the placebo group, rivaroxaban had superior efficacy (8 events [1.3%], vs. 42 with placebo [7.1%]; hazard ratio, 0.18; 95% CI, 0.09 to 0.39; P<0.001). Four patients in the rivaroxaban group had nonfatal major bleeding (0.7%), versus none in the placebo group (P = 0.11).

  13. “A New Era for Anticoagulation in AtrialFibrillation” Editorial by Jessica L. Mega, M.D., M.P.H. N Engl J Med 2011; 365:1052-1054 September 15, 2011

  14. Apixaban versus Warfarin in Patients with Atrial Fibrillation Granger and colleagues report the impressive primary results of the Apixaban for Reduction in Stroke and Other Thromboembolic Events in Atrial Fibrillation trial (ARISTOTLE; ClinicalTrials.gov number, NCT00412984) N Engl J Med 2011; 365:981-992September 15, 2011

  15. A total of 18,201 subjects with atrial fibrillation and at least one additional risk factor for stroke were enrolled in the trial and were randomly assigned to receive the direct factor Xa inhibitor apixaban (at a dose of 5 mg twice daily) or warfarin (target international normalized ratio [INR], 2.0 to 3.0). The trial was designed to test whether apixaban was noninferior to warfarin with respect to efficacy. The investigators found that apixaban was not only noninferior to warfarin, but actually superior, reducing the risk of stroke or systemic embolism by 21% and the risk of major bleeding by 31%. In predefined hierarchical testing, apixaban, as compared with warfarin, also reduced the risk of death from any cause by 11%.

  16. Rivaroxaban versus Warfarin in NonvalvularAtrial FibrillationN Engl J Med 2011; 365:883-891September 8, 2011 BACKGROUND The use of warfarin reduces the rate of ischemic stroke in patients with atrial fibrillation but requires frequent monitoring and dose adjustment. Rivaroxaban, an oral factor Xa inhibitor, may provide more consistent and predictable anticoagulation than warfarin. METHODS In a double-blind trial, we randomly assigned 14,264 patients with nonvalvularatrial fibrillation who were at increased risk for stroke to receive either rivaroxaban (at a daily dose of 20 mg) or dose-adjusted warfarin. The per-protocol, as-treated primary analysis was designed to determine whether rivaroxaban was noninferior to warfarin for the primary end point of stroke or systemic embolism.

  17. RESULTS In the primary analysis, the primary end point occurred in 188 patients in the rivaroxaban group (1.7% per year) and in 241 in the warfarin group (2.2% per year) (hazard ratio in the rivaroxaban group, 0.79; 95% confidence interval [CI], 0.66 to 0.96; P<0.001 for noninferiority). In the intention-to-treat analysis, the primary end point occurred in 269 patients in the rivaroxaban group (2.1% per year) and in 306 patients in the warfarin group (2.4% per year) (hazard ratio, 0.88; 95% CI, 0.74 to 1.03; P<0.001 for noninferiority; P=0.12 for superiority). Major and nonmajor clinically relevant bleeding occurred in 1475 patients in the rivaroxaban group (14.9% per year) and in 1449 in the warfarin group (14.5% per year) (hazard ratio, 1.03; 95% CI, 0.96 to 1.11; P=0.44), with significant reductions in intracranial hemorrhage (0.5% vs. 0.7%, P=0.02) and fatal bleeding (0.2% vs. 0.5%, P=0.003) in the rivaroxaban group.

  18. Are Antidepressants Ineffective for Depression in Dementia Patients?

  19. Sertraline or mirtazapine for depression in dementia (HTA-SADD): a randomised, multicentre, double-blind, placebo-controlled trial OBJECTIVES: To determine the efficacy of antidepressants in people with depression and dementia. DESIGN: A systematic review and meta-analysis based on a literature search of Medline and Cochrane Trials Registry for acute-phase, double-blind, placebo-controlled, parallel design, random-assignment trials of antidepressants marketed in the United States.

  20. Findings: Decreases in depression scores at 13 weeks did not differ between 111 controls and 107 participants allocated to receive sertraline (mean difference 1·17, 95% CI –0·23 to 2·58; p=0·10) or mirtazapine (0·01, –1·37 to 1·38; p=0·99), or between participants in the mirtazapine and sertraline groups (1·16, –0·25 to 2·57; p=0·11); these findings persisted to 39 weeks. Fewer controls had adverse reactions (29 of 111 [26%]) than did participants in the sertraline group (46 of 107, 43%; p=0·010) or mirtazapine group (44 of 108, 41%; p=0·031), and fewer serious adverse events rated as severe (p=0·003). Five patients in every group died by week 39. Interpretation: Because of the absence of benefit compared with placebo and increased risk of adverse events, the present practice of use of these antidepressants, with usual care, for first-line treatment of depression in Alzheimer’s disease should be reconsidered. The lancet Vol 378 July 30, 201

  21. A Systematic Review and Meta-Analysis of Placebo-ControlledAntidepressant Studies in People with Depressionand Dementia OBJECTIVES: To determine the efficacy of antidepressants in people with depression and dementia. DESIGN: A systematic review and meta-analysis based on a literature search of Medline and Cochrane Trials Registry for acute-phase, double-blind, placebo-controlled, parallel design, random-assignment trials of antidepressants marketed in the United States.

  22. CONCLUSION: The evidence for antidepressant treatment of people with depression and dementia, although suggestive, does not confirm efficacy. All of the trials were significantly underpowered to detect differences, resulting in inconclusive findings. Variable trial methods, co-morbid conditions, and differences in antidepressants employed further confounded findings. J Am Geriatr Soc 59:577–585, 2011.

  23. Comparative Effectiveness and Safety of Medications for Type 2Diabetes: An Update Including New Drugs and 2-Drug Combinations Purpose: To summarize the benefits and harms of metformin, second-generation sulfonylureas, thiazolidinediones, meglitinides, dipeptidyl peptidase-4 (DPP-4) inhibitors, and glucagon-like peptide-1 receptor agonists, as monotherapy and in combination, to treat adults with type 2 diabetes

  24. Data Synthesis: Evidence on long-term clinical outcomes (all-cause mortality, cardiovascular disease, nephropathy, and neuropathy) was of low strength or insufficient. Most medications decreased the hemoglobin A1c level by about 1 percentage point and most 2-drug combinations produced similar reductions. Metformin was more efficacious than the DPP-4 inhibitors, and compared with thiazolidinediones or sulfonylureas, the mean differences in body weight were about 2.5 kg. Metformin decreased low-density lipoprotein cholesterol levels compared with pioglitazone, sulfonylureas, and DPP-4 inhibitors. Sulfonylureas had a 4-fold higher risk for mild or moderate hypoglycemia than metformin alone and, in combination with metformin, had more than a 5-fold increased risk compared with metformin plus thiazolidinediones. Thiazolidinediones increased risk for congestive heart failure compared with sulfonylureas and increased risk for bone fractures compared with metformin. Diarrhea occurred more often with metformin than with thiazolidinediones.

  25. Conclusion: Evidence supports metformin as a first-line agent to treat type 2 diabetes. Most 2-drug combinations similarly reduce hemoglobin A1c levels, but some increased risk for hypoglycemia and other adverse events. Ann Intern Med. 2011;154:602-613.

  26. Association of Hospitalist Care With Medical Utilization AfterDischarge: Evidence of Cost Shift From a Cohort Study Background: Hospitalist care has grown rapidly, in part because it is associated with decreased length of stay and hospital costs. No national studies examining the effect of hospitalist care on hospital costs or on medical utilization and costs after discharge have been done. Objective: To assess the relationship of hospitalist care with hospital length of stay, hospital charges, and medical utilization and Medicare costs after discharge.

  27. Results: In propensity score analysis, hospital length of stay was 0.64 day less among patients receiving hospitalist care. Hospital charges were $282 lower, whereas Medicare costs in the 30 days after discharge were $332 higher (P 0.001 for both). Patients cared for by hospitalists were less likely to be discharged to home (odds ratio, 0.82 [95% CI, 0.78 to 0.86]) and were more likely to have emergency department visits (odds ratio, 1.18 [CI, 1.12 to 1.24]) and readmissions (odds ratio, 1.08 [CI, 1.02 to 1.14]) after discharge. They also had fewer visits with their primary care physician and more nursing facility visits after discharge. Conclusion: Decreased length of stay and hospital costs associated with hospitalist care are offset by higher medical utilization and costs after discharge. Ann Intern Med. 2011;155:152-159.

  28. Complications and Mortality After Percutaneous Endoscopic Gastrostomy in Geriatrics: A Prospective Multicenter Observational Trial Background Generally, the high short-term mortality after percutaneous endoscopic gastrostomy (PEG) in geriatric patients is attributed to the severity of their underlying diseases. However, the procedure-related mortality in this group is unknown. Methods This prospective multicenter observational study gathered information about 197 geriatric patients treated with PEG insertion, including the indication for PEG insertion and the prevalence of postprocedure complications and analyzed how these factors related to mortality.

  29. Results Dysphagia (64%) and insufficient food intake (76%) were the most frequent indications for PEG insertion. Severe complications after PEG insertion occurred in 9.6% of patients. Mortality was 9.6% in hospital, as well as 18.4% at 1 month. Six months after PEG placement, with 81 patients lost to follow-up, mortality was 51.9%. Hospital mortality was significantly higher in patients with severe complications caused by PEG insertion (47.4% vs 5.6%; P < .001). A regression analysis that corrected for confounding factors revealed that severe complications in general (HR 6.9; 95% CI: 2.6–18.1; P < .001), peritonitis (HR 33.1; 95% CI: 3.7–293.2; P = .002), and severe wound infections (HR 6.9; 95% CI: 1.9–24.9; P = .003) were each independently associated with hospital mortality. Considering the prevalence of procedure-related complications and their association with early mortality after PEG insertion, the procedure-related mortality rate in geriatric patients was at least 2% in this study. Conclusion Although the prevalence of complications after PEG in this study of multimorbid geriatric patients is within the expected range, the procedure-related mortality is higher than expected. jamda.2011.07.010

  30. Physician Consultation, Multidisciplinary Care, and 1-YearMortality in Medicare Recipients Hospitalized with Hip andLower Extremity Injuries OBJECTIVE: To determine whether routine surgeon consultation with medicine specialists and multidisciplinary care conferences are associated with lower 1-year mortality in older adults with hip and lower extremity injuries

  31. RESULTS: After adjusting for age, injury severity, comorbid conditions, trauma center status, and hospital annual volume of patients with hip fracture, the relative odds of dying in the year after injury for inpatients treated in settings with routine surgeon consultation with medical staff was 0.69 (95% CI 0.57–0.83) compared with patients not treated in such settings. Inpatient treatment in settings with routine multidisciplinary care conferences did not significantly affect the relative odds of dying in the year after injury. J Am Geriatr Soc 58:1835–1842, 2010.

  32. Does High-Quality Care Protect Against Litigation? Not much: Good nursing homes were sued only slightly less often than bad ones.

  33. Legal theory holds that personal-injury litigation serves a social purpose, improving overall medical care by punishing substandard practice. However, a correlation between bad care and litigation risk has been difficult to establish, either for individual practitioners or for institutions. Researchers tallied tort claims filed against 1465 nursing homes belonging to five large U.S. chains during 1998–2006. Overall, weak but significant inverse correlations were found between risk for being sued and 5 of 10 commonly accepted measures of quality care, including compliance with federal standards, staffing ratios, and clinical indicators such as rates of pressure ulcers and falls. These correlations persisted in low-litigation environments but vanished in high-litigation environments. Further, the actual numerical differences were quite small: The overall best nursing homes faced an estimated 40% annual risk for suit, while the worst faced a 47% annual risk. For specific clinical measures, the best-quality nursing homes had absolute litigation risks that were only 2%–7% lower than the worst.

  34. Comment: This thought-provoking study suggests that institutional litigation risk has little to do with overall quality of care. If confirmed, this finding casts doubt on many of the principles underlying modern medical care, including the now widely accepted premise that risk management and quality assurance are two sides of the same coin. Abigail Zuger, MD Journal Watch General MedicineApril 12, 2011 Relationship between quality of care and negligence litigation in nursing homes. N Engl J Med 2011 Mar 31; 364:1243

  35. The Risks and Benefits of Implementing Glycemic ControlGuidelines in Frail Older Adults with Diabetes Mellitus OBJECTIVES: To determine the hypo- and hyperglycemic outcomes associated with implementing the American Geriatrics Society (AGS) guideline for a glycosylated hemoglobin (HbA1c) level of less than 8% in frail older adults with diabetes mellitus (DM).

  36. RESULTS: Participants in the before, early, and late periods were similar in age, race and ethnicity, comorbidities, and functional dependence. Antihyperglycemic edication use was greater in the late period, with more participants using metformin (28% before, 42% late, Po.001) and insulin (23% before, 34% late, Po.001) and achieving the AGS glycemic target of HbA1c of less than 8% (74% before, 84% late, Po.001). Episodes of hyperglycemia (per 100 person-years) were dramatically lower in the late period (159 before, 46 late, Po.001), and episodes of hypoglycemia were similar (10.1 before, 9.3 late, P5.50). There were more episodes of severe hypoglycemia in the early period (1.1 before, 2.9 early, P5.03).

  37. CONCLUSION: Implementing the AGS glycemic control guideline for frail older adults led to fewer hyperglycemic episodes but more severe hypoglycemic episodes requiring ED visits in the early implementation period. Future glycemic control guideline implementation efforts should be coupled with close monitoring for severe hypoglycemia in the early guideline implementation period. J Am Geriatr Soc 59:666–672, 2011.

  38. Hospice Use and Outcomes in Nursing Home Residents withAdvanced Dementia OBJECTIVES: To identify characteristics of nursing home (NH) residents with advanced dementia and their healthcare proxies (HCPs) associated with hospice referral and to examine the association between hospice use and the treatment of pain and dyspnea and unmet needs during the last 7 days of life.

  39. RESULTS: Twenty-two percent of residents were referred to hospice. After multivariable adjustment, factors associated with hospice referral were nonwhite race, eating problems, HCP’s perception that the resident’s had less than 6 months to live, and better HCP mental health. Residents in hospice were more likely to receive scheduled opioids for pain (adjusted odds ratio (AOR)53.16; 95% confidence interval (95% CI)51.57–6.36) and oxygen, morphine, scopolamine, or hyoscyamine for dyspnea (AOR53.28, 95% CI51.37–7.86). HCPs of residents in hospice reported fewer unmet needs in all domains during the last 7 days of the residents’ life

  40. CONCLUSION: A minority of NH residents with advanced dementia received hospice care. Hospice recipients were more likely to received scheduled opioids for pain and symptomatic treatment for dyspnea and had fewer unmet needs at the end of life. J Am Geriatr Soc 58:2284–2291, 2010.

  41. Interventions to Reduce Hospitalizations from Nursing Homes:Evaluation of the INTERACT II Collaborative Quality Improvement Project A substantial proportion of hospitalizations of nursing home (NH) residents may be avoidable. Medicare payment reforms, such as bundled payments for episodes of care and value-based purchasing, will change incentives that favor hospitalization but could result in care quality problems if NHs lack the resources and training to identify and manage acute conditions proactively.

  42. Interventions to Reduce Acute Care Transfers (INTERACT) II is a quality improvement intervention that includes a set of tools and strategies designed to assist NH staff in early identification, assessment, communication, and documentation about changesin resident status.

  43. INTERACT II was evaluated in 25 NHs in three states in a 6-month quality improvement initiative that provided tools, on-site education, and teleconferences every 2 weeks facilitated by an experienced nurse practitioner. There was a 17% reduction in self-reported hospital admissions in these 25 NHs from the same 6-month period in the previous year. The group of 17 NHs rated as engaged in the initiative had a 24% reduction, compared with 6% in the group of eight NHs rated as not engaged and 3% in a comparison group of 11 NHs. The average cost of the 6-month implementation was $7,700 per NH. The projected savings to Medicare in a 100-bed NH were approximately $125,000 per year. J Am Geriatr Soc 59:745–753, 2011.

  44. Levothyroxine dose and risk of fractures in older adults: Nested case-control study Elders with hypothyroidism require lower doses of levothyroxine for replacement than do younger people. However, many elders are overtreated and, as a result, develop iatrogenic hyperthyroidism — a risk factor for fracture. In this case-control study, investigators assessed the effects of levothyroxine dose on fracture risk among 214,000 Canadians (age,  70; mean age, 82) who were prescribed levothyroxine between 2002 and 2007.

  45. When remote levothyroxine use (stopped >180 days before index date) was used for comparison, current use and recent past use (stopped within 15–180 days of index date) were associated with significantly elevated risks for fracture (odds ratios, 1.9 and 1.3, respectively) after adjustment for multiple confounders. Daily dose among current levothyroxine users also affected risk; when low doses of levothyroxine (<0.04 mg) were used for comparison, high doses (>0.09 mg) and medium doses (0.04–0.09 mg) were associated with significantly elevated risk for any fracture (ORs, 3.5 and 2.6, respectively). Results were similar for hip fracture alone and for both sexes. The findings remind us to monitor patients who are receiving levothyroxine and to avoid suppressed TSH levels, which indicate iatrogenic hyperthyroidism. BMJ 2011 Apr 28; 342:d2238.

  46. New Institute of Medicine Recommendations on Vitamin D Vitamin D is essential to human health. The main sources of this fat-soluble vitamin are dietary intake from foods and supplements, and cutaneous sun exposure. Despite vitamin D's importance, its normal levels, recommended daily allowance, and the spectrum of its health effects have been shrouded in controversy. Therefore, the U.S. and Canadian governments requested that the Institute of Medicine analyze existing information about vitamin D and update its viewpoints accordingly. A committee of 14 scientists reviewed more than 1000 studies and evaluated the opinions of experts in the field to prepare their report.

  47. Quality of Life in the ACCORD TrialIntensive glycemic control did not improve self-reported physical or mental health

  48. In the widely cited ACCORD randomized trial, 10,000 older patients with longstanding type 2 diabetes received either intensive glycemic control (target glycosylated hemoglobin [HbA1c]  6%) or standard control (target HbA1c, 7.0%–7.9%). Previously, the ACCORD researchers reported that intensive glycemic control did not prevent macrovascular or microvascular complications during 4 years of follow-up (JW Gen Med Jun 6 2008 and JW Gen Med Jul 13 2010). Now, the researchers report quality-of-life outcomes in a subset of 2000 patients (1000 each in the intensive and standard groups) who completed standardized questionnaires at baseline and at 1, 3, and 4 years. During the study, no clinically important differences between groups were noted in self-reported physical health, mental health, or effect of diabetes-related symptoms on functional status. Effect of intensive glycemic lowering on health-related quality of life in type 2 diabetes: ACCORD trial.Diabetes Care 2011 Apr; 34:807.

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