Disclosure. I have no conflict of interest with respect to this talk. I am on the formulary committee for a large insurance company.

Transcription

1 CHOOSING WISELY FOR VULNERABLE ELDERS DECEMBER 11, 2014 TOM FINUCANE Disclosure I have no conflict of interest with respect to this talk. I am on the formulary committee for a large insurance company. An initiative of the ABIM Foundation Choosing Wisely aims to promote conversations between physicians and patients to help patients choose care that is: Evidence based Not duplicative Low risk Truly necessary 1

2 The Choosing Wisely Campaign Several specialty societies were asked to create a list of Things Physicians and Patients Should Question To date, 56 societies have released lists, some of them releasing a second or third list Consumer Reports has joined the ABIM Foundation to disseminate and promote the Choosing Wisely campaign AGS Final Five 1 Don t recommend percutaneous feeding tubes in patients with advanced dementia; instead offer assisted oral feeding. 2 Don t use antipsychotics as first choice to treat behavioral and psychological symptoms of dementia. 3 Avoid using medications to achieve hemoglobin A1c <7.5% in most adults age 65 and older; moderate control is generally better. 4 Don t use benzodiazepines or other sedative hypnotics in older adults as first choice for insomnia, agitation or delirium. 5 Don t use antimicrobials to treat bacteriuria in older adults unless specific urinary tract symptoms are present. AGS Final Five List Don t prescribe cholinesterase inhibitors for dementia without periodic assessment for perceived cognitive benefits and adverse gastrointestinal effects. Don t recommend screening for breast or colorectal cancer, or prostate cancer (with the PSA test) without considering life expectancy and the risks of testing, overdiagnosis and overtreatment. Avoid using prescription appetite stimulants or high calorie supplements for treatment of anorexia or cachexia in older adults; instead, optimize social supports, provide feeding assistance, and clarify patient goals and expectations. 9 Don t prescribe a medication without conducting a drug regimen review. 10 Avoid physical restraints to manage behavioral symptoms of hospitalized older adults with delirium. 2

3 1 Choosing Wisely : Tube Feeding Patients with Advanced Dementia Don t recommend percutaneous feeding tubes in patients with advanced dementia; instead offer assisted oral feeding. Case Study An elder with advanced dementia, bedfast and non communicative Feeding is progressively more difficult Coughing when fed. Two recent pneumonias. Eating little, losing weight A new bedsore. Serum albumin 2.8 gm/dl. Tube feeding Wouldn t it make sense to place a feeding tube: to prevent recurrent aspiration? to provide adequate food and water? 3

4 Aspiration Definition Prevalence Aspiration pneumonia Definition Mendelson s syndrome Contaminated oral secretions Aspiration pneumonia and PEG There is no reason a priori to expect that a feeding tube will reduce the risk of aspiration pneumonia in these patients There are reasons to worry it might make things worse No paper containing data suggests that tube feeding reduces pneumonia risk. Percutaneous feeding tubes in patients with advanced dementia: there are no RCTs Aspiration pneumonia No reason a priori to expect benefit No data to suggest benefit Harm is possible 4

5 PEG and nutritional outcomes Survival Pressure ulcers Infection Urine, lung, skin, viral Function Suffering Choosing Wisely : Antipsychotics 2 Don t use antipsychotics as first choice to treat behavioral and psychological symptoms of dementia. Choosing Wisely : Hemoglobin A1c Targets in Diabetes Mellitus 3 Avoid using medications to achieve hemoglobin A1c <7.5% in most adults age 65 and older; moderate control is generally better. 5

6 Diabetes kills more Americans every year than AIDS and breast cancer combined 0 %20Sean/FastFacts%20March% pdf Diabetes caused 1.3 million deaths in 2008, and the global prevalence of diabetes was estimated to be 9%. idity/cvd_text/en/ Overall, the risk for death among people with diabetes is about twice that of people of similar age but without diabetes. 1.htm#10 6

7 2013 Cochrane collaboration review What was the risk ratio for all cause mortality when the Cochrane Collaboration compared intensive with conventional glycemic control? (28 RCTs comprising 35,000 pts)? 1.00 Hemmingsen As compared with standard therapy, the use of intensive therapy to target normal glycated hemoglobin levels for 3.5 years increased mortality and did not significantly reduce major cardiovascular events. These findings identify a previously unrecognized harm of intensive glucose lowering in highrisk patients with type 2 diabetes. ACCORD NEJM Intensive glucose control in patients with poorly controlled type 2 diabetes had no significant effect on the rates of major cardiovascular events, death, or microvascular complications with the exception of progression of albuminuria (P = 0.01) VADT NEJM 7

8 A strategy of intensive glucose control, involving gliclazide (modified release) and other drugs as required, that lowered the glycated hemoglobin value to 6.5% yielded a 10% relative reduction in the combined outcome of major macrovascular and microvascular events, primarily as a consequence of a 21% relative reduction in nephropathy ADVANCE NEJM ADVANCE Combined endpoint; 5 yrs: 18.1 vs 20% Microvascular: 9.4 vs 10.9 (Nephropathy: 4.1 vs 5.2) Chance of no albuminuria at 5 years? 95% vs 96% No difference in Major macrovascular events Death from cardiovascular causes Death from any cause Mean age of subjects (yrs) ADVANCE 66 ACCORD 62 VADT 60 UKPDS 53 UGDP 52 Steno 2 55 UGDP 52 8

9 Survival as a function of HbA1C in people with Type 2 DM: a retrospective cohort study. Currie CJ Lancet 6 Feb. 10 (Mean age 64) Although still limited, early evidence suggests that metformin is associated with a lower risk of cancer and that exogenous insulin is associated with an increased cancer risk. Diabetes and cancer: A consensus report. Giovanucci

10 Far too large a section of the treatment of disease is today controlled by the big manufacturing pharmacists, who have enslaved us in a plausible pseudoscience. Osler, 1909 Choosing Wisely : Benzodiazepines 4 Don t use benzodiazepines or other sedative hypnotics in older adults as first choice for insomnia, agitation or delirium. Choosing Wisely : Antimicrobials to Treat Bacteriuria in Older Adults 5 Don t use antimicrobials to treat bacteriuria in older adults unless specific urinary tract symptoms are present. 10

11 Asymptomatic bacteriuria (ASB) Asymptomatic bacteriuria, or asymptomatic urinary infection, is isolation of a specified quantitative count of bacteria in an appropriately collected urine specimen obtained from a person without symptoms or signs referable to urinary infection Nicolle Clin Infect Dis 2005 ASB is common in older adults Population ASB Rates Community women >70 11% 16% Community men >70 4% 19% Long term care overall 15% 50% LTC men 15% 40% LTC women 25% 50% Chronic indwelling catheter 100% ASB in older adults is benign Increased risk of infection, but not related to bacteriuria No long term increased risk of hypertension No long term increased risk of renal failure Survival differences are similar when controlling for other functional and clinical factors Nordenstram GR, et. al. N Engl J Med. 1986;314:

12 Treating ASB in older adults 5 randomized controlled trials conducted with community dwelling and institutionalized elders show no benefit in mortality, infectious morbidity, or incontinence when asymptomatic bacteriuria is treated with antibiotics. McKenzie, Am J Med 2014 Do treat ASB prior to invasive urologic procedures in older adults Bacteremia occurs in 60% of bacteriuric patients undergoing TURP Clinical evidence of sepsis in 6% 10% NNT to prevent septicemia: Urologic interventions with a high probability of mucosal bleeding should be considered a risk Nicolle Clin Infect Dis Choosing Wisely : Cholinesterase Inhibitors 6 Don t prescribe cholinesterase inhibitors for dementia without periodic assessment for perceived cognitive benefits and adverse gastrointestinal effects. 12

13 Evidence based practice center statement ChEIs can improve global cognitive function in AD. The average effects of changes in cognitive functioning observed in trials are small, and the clinical importance of population benefits is probably negligible when commonly accepted thresholds are used. Lin JS Ann Intern Med No significant differences were seen between donepezil and placebo in behavioural and psychological symptoms, carer psychopathology, formal care costs, unpaid caregiver time, adverse events or deaths, or between 5mg and 10 mg donepezil. Courtney Lancet 2004 Disease stabilization? Why would anybody think that? 13

14 Disease stabilization? No significant benefits were seen with donepezil compared with placebo in institutionalisations (42% vs. 44% at 3 years; p=0.4) or progression of disability (58% vs. 59% at 3 years; p=0.4). Courtney Lancet 2004 Disease stabilization? Evidence is insufficient to support the use of pharmaceutical agents or dietary supplements to prevent cognitive decline or Alzheimer s disease. Preventing AD and cognitive decline df What about disease stabilization? 14

15 What about disease stabilization? Despite intensive laboratory and clinical research over three decades, an effective treatment to delay the onset and progression of Alzheimer's disease is not at hand. Selkoe Science 2012 What about disease stabilization? I don t think so. Think about the biological plausiblity. Strength of AGS CW recommendation Wiggle room in language: Leaves prescribers free to prescribe Does not define periodic Leaves estimate of benefit to prescriber s perception Says consider discontinuing if no benefit after 12 weeks 15

16 Choosing Wisely : Cancer Screening 7 Don t recommend screening for breast or colorectal cancer, nor prostate cancer (with the PSA test) without considering life expectancy and the risks of testing, overdiagnosis and overtreatment. Guidelines American Urological Association 2013: PSA screening is not recommended in men with life expectancy less than years USPSTF 2008: Benefits of colorectal cancer screening take at least 7 years National Cancer Institute: Women with life expectancy <5 years have little to gain from breast cancer screening There s an app for this! eprognosis: Cancer screening Available for iphone/ipad for free on App Store Asks users to input data to calculate life expectancy Compares life expectancy to time to benefit (10 years) for cancer screening 16

17 Choosing Wisely : Appetite Stimulants 8 Avoid using prescription appetite stimulants or high calorie supplements for treatment of anorexia or cachexia in older adults; instead, optimize social supports, provide feeding assistance, and clarify patient goals and expectations. Unintentional weight loss Unintentional weight loss is a common experience in old age Annual incidence of approximately 13% in elderly veterans living in the community* Prevalence estimates as high as 27% in highrisk free living frail elderly receiving community services**. Incidence as high as 48% in older nursing home residents*** 21 st century orexigenics Controversial for a long time More robust evidence base Additional clinical study Meaningful systematic reviews Little or modest benefit Risk to benefit profiles concerning 17

18 Time to stop using megestrol acetate for unintentional weight loss Clinical effect Clinical impact MA improves appetite NNT = 4 MA has a small effect on weight gain NNT = 12 MA does NOT improve quality of life MA increases VTE risk NNH = 2 55 MA increases risk of dying NNH = 23 Dronabinol Orally active cannabinoid FDA approved for anorexia with weight loss in AIDS Evidence for positive effects in patients with HIV/AIDS is limited and may be the effects of bias Longer term data, and data showing a benefit in terms of survival, are lacking Not a very geriatric friendly medication Mirtazapine Atypical antidepressant Increased appetite and weight gain are side effects 17% increase in appetite and 10% increase in weight Most weight gain takes place in the first 4 8 weeks No evidence of weight gain in absence of depression* Weight gain not clearly superior compared with other antidepressants** **J Amer Geriatr Soc. 2002;50: *Cochrane Database Syst Rev. 2011;12:CD

19 Some of the fringe players Cyproheptadine Makes the 2012 Beers Criteria List Highly anticholinergic, greater risk of confusion, dry mouth, constipation, and other anticholinergic side effects Little evidence that it actually works as an orexigenic Eicosapentaenoic acid Little evidence that it works as an orexigenic Not studied in elderly Anabolic steroids Little evidence that they work in late life or advanced progressive illness Not studied in the elderly Oral liquid nutrition supplements A multibillion dollar expense to healthcare Main ingredients Water Sucrose (sugar) Corn syrup (more sugar) Maltdextrin (less sweet sugar) Few oils, proteins (whey and soy), multivitamin Liquid candy bar with vitamins Distraction from real food? Oral liquid supplement vs real food Boost Ensure Low fat yogurt and orange Serving size 8 oz 8 oz 8 oz + 1 orange Calories Fiber 0 g < 1 g 3 g 1 st two ingredients Water Corn syrup solids Water Corn syrup Low fat milk Milk solids Cost (San Diego 1999) $1.40 $1.43 $1.09 Taste Best =1 to Worst =

20 What can be done? Bolster feeding support in those experiencing increased dependency in eating Eliminate dietary restrictions Eliminate drugs that impair appetite, taste Eliminate drugs that dry the mouth, impair attention or cause movement disorders Make meal time and place more pleasant Choosing Wisely : Drug Regimen Review 9 Don t prescribe a medication without conducting a drug regimen review. 20

21 Choosing Wisely : Restraints 10 Avoid physical restraints to manage behavioral symptoms of hospitalized older adults with delirium Rationale Physical restraint use in hospitalized older adults is associated with: Increased delirium severity/agitation Pressure ulcers Infections Discomfort Increased risk of serious injury Death Restraint use and falls Restraints (including bilateral side rails) have not been shown to lower risk of falls 1 3 Restraint reduction practices have not resulted in increased fall rates in hospitalized older adults in general 4 or in older adults with delirium 5 21

22 Choosing Wisely For more information, visit In summary Eat food. Not too much. Mostly plants. Stay as physically active as you are able. Have company. Be company. If drugs are given for symptoms, stop them if the symptom doesn t improve. If drugs are given for a disease, be sure they do more good than harm. Above all, do no harm 22