Glucagon-like peptide-1 receptor agonists as add-on therapy to basal insulin in patients with type 2 diabetes: a systematic review The effects of multidimensional exercise on functional decline, urinary incontinence, and fear of falling in community-dwelling elderly women with multiple symptoms of geriatric syndrome: a randomized controlled and 6-month follow-up trial. Hemoglobin A1c Targets for Glycemic Control With Pharmacologic Therapy for Nonpregnant Adults With Type 2 Diabetes Mellitus: A Guidance Statement Update From the American College of Physicians Pharmacologic Therapy for Type 2 Diabetes: Synopsis of the 2017 American Diabetes Association Standards of Medical Care in Diabetes Evaluation of a web-based tool in screening for medication-related problems in community-dwelling older adults. AMERICAN ASSOCIATION OF CLINICAL ENDOCRINOLOGISTS AND AMERICAN COLLEGE OF ENDOCRINOLOGY COMPREHENSIVE CLINICAL PRACTICE GUIDELINES FOR MEDICAL CARE OF PATIENTS WITH OBESITY. Diabetes in Older Adults Glucagon-like peptide-1 receptor agonist therapeutics for total diabetes management: assessment of composite end-points Synopsis of the 2017 U.S. Department of Veterans Affairs/U.S. Department of Defense Clinical Practice Guideline: Management of Type 2 Diabetes Mellitus The Promoting Effective Advance Care for Elders (PEACE) randomized pilot study: theoretical framework and study design. The Quality of Medical Care Provided to Vulnerable Community-Dwelling Older Patients Quality Indicators for the Management of Urinary Incontinence in Vulnerable Community-Dwelling Elders Consensus and update on the definition of on-treatment platelet reactivity to adenosine diphosphate associated with ischemia and bleeding. Off-Loading the Diabetic Foot for Ulcer Prevention and Healing Cumulative deficit model of geriatric assessment to predict the postoperative outcomes of older patients with solid abdominal cancer. An in-home preventive assessment program for independent older adults: a randomized controlled trial. Management of hyperglycemia in hospitalized patients in non-critical care setting: an endocrine society clinical practice guideline. The design of the Dutch EASYcare study: a randomised controlled trial on the effectiveness of a problem-based community intervention model for frail elderly people [NCT00105378] Assessment of Barriers to Improve Diabetes Management in Older Adults Assessing Care of Vulnerable Elders: ACOVE Project Overview A randomized clinical trial of outpatient comprehensive geriatric assessment coupled with an intervention to increase adherence to recommendations. Cost-Effectiveness and Population Impact of Statins for Primary Prevention in Adults Aged 75 Years or Older in the United States Canadian Thoracic Society 2012 guideline update: diagnosis and management of asthma in preschoolers, children and adults.
The prevalence of obesity and diabetes continues to rise in the US . Glucagon-like peptide-1 receptor agonist ( GLP-1RA ) is an effective treatment option for type 2 diabetes mellitus ( T2DM ) that promotes weight loss . Common and effective treatment options added to metformin therapy ( basal insulin , sulfonylureas , and pioglitazone ) contribute to weight gain , which makes the addition of GLP-1RAs advantageous . Exenatide was the first agent in this class and has recently been approved for use in combination with insulin glargine by the US Food and Drug Administration and the European Medicines Agency . Until recently , there was a lack of data examining basal insulin combined with these agents . The main purpose of this article is to review the prospect i ve interventional data on the safety and efficacy of GLP-1RAs ( exenatide , liraglutide , albiglutide , lixisenatide ) combined with basal insulin therapy in nonpregnant adults with T2DM . Data bases search ed were PubMed , Cochrane Central Register of Controlled Trials and the Data base of Systematic Review s ( inception to January 2012 ) . Abstract s presented at relevant diabetes and endocrine meetings from 2009 to 2011 were also review ed , as were reference lists of identified publications . A total of five studies met the criteria and were included in the review . Data from these studies demonstrated that this combination therapy offers advantages for the treatment of diabetes , such as additional lowering of A1c without major risk for hypoglycemia , lower basal insulin requirements , decreased postpr and ial glucose levels ( with or without fasting plasma glucose decreases ) , and weight loss , or at the very least , less weight gain . However , the gastrointestinal side effects and high cost of these agents may limit their use . This review demonstrates that adding a GLP-1RA to an existing basal insulin regimen is a reasonable treatment strategy in nonpregnant adult patients with T2DM This study assessed the effects of multidimensional exercises on functional decline , urinary incontinence , and fear of falling in community-dwelling Japanese elderly women with multiple symptoms of geriatric syndrome ( MSGS ) . Sixty-one participants were r and omly assigned either to an intervention ( n=31 ) or to a control group ( n=30 ) . For 3-month period , the intervention group received multidimensional exercise , twice a week , aim ing to increase the muscle strength , walking ability , and pelvic floor muscle ( PFM ) . Outcome variables were measured at baseline , and after intervention and follow-up . The functional decline of the intervention group decreased from 50.0 % at baseline to 16.7 % after intervention and follow-up ( Q=16.67 , p<0.001 ) . For urinary incontinence , the intervention group decreased from 66.7 % at baseline to 23.3 % after intervention and 40.0 % at follow-up ( Q=13.56 , p=0.001 ) , whereas the control group showed no improvement . Intervention group showed greater and significant decrease in the score of MSGS compared to control group ( F=12.66 , p=0.001 ) . Within the subjects that showed improvement to normal status of MSGS , a significantly higher proportion demonstrated increased maximum walking speed at follow-up ( Q=6.50 , p=0.039 ) . These results suggest that multidimensional exercise is an effective strategy for reducing geriatric syndromes in elderly population . An increase in walking ability may contribute to the improvement of MSGS Diabetes mellitus is a leading cause of death in the United States and is associated with microvascular and macrovascular complications . Approximately 29.1 million persons , or 9.3 % of the U.S. population , have type 2 diabetes ( 1 ) . In 2012 , the total direct and indirect costs associated with diabetes in the United States were $ 245 billion ( 1 ) . Markedly elevated glucose levels can result in subacute symptoms , such as polyuria , polydipsia , weight loss , and dehydration . Over time , the metabolic derangements associated with diabetes may lead to vision loss , painful neuropathy or sensory loss , foot ulcers , amputations , myocardial infa rct ions , strokes , and end-stage renal disease . Lowering blood glucose may decrease risk for complications , but lowering strategies come with harms , patient burden , and costs . Blood glucose can be measured in various ways , including the hemoglobin A1c ( HbA1c ; also called glycosylated or glycated hemoglobin ) level , which approximates average blood glucose control over about 3 months . As with all laboratory tests , HbA1c measurements are associated with variability ( 2 ) and can vary further with race and ethnicity ( 35 ) . Guidelines have historically recommended initiation or intensification of pharmacologic therapy to achieve specific HbA1c targets , depending on the population in question . The ideal target that optimally balances benefits and harms remains uncertain . Guidance Statement Focus and Target Population The purpose of this American College of Physicians ( ACP ) guidance statement is to critically review the available guidelines from various organizations and the evidence included therein to assist clinicians in making decisions about targets when using pharmacologic therapy in adults with type 2 diabetes . Recent data suggesting that newer agents reduce cardiovascular morbidity and mortality in high-risk patients with type 2 diabetes have prompted calls for a fundamental shift in diabetes management . Some anticipate that treatment decisions will eventually be based more on cardiovascular risk than achievement of specific HbA1c targets , analogous to recent changes in lipid management . However , for the foreseeable future , glycemic targets will continue to influence management decisions by front-line clinicians ( 6 ) . This statement focuses on the benefits and harms of targeting lower versus higher HbA1c levels and does not cover use of specific medications outside of their use to achieve HbA1c targets . The intended audience is all clinicians , and the target population is nonpregnant adults with type 2 diabetes . Methods The Clinical Guidelines Committee ( CGC ) of ACP develops guidance statements on topics where several conflicting guidelines are available . We provide clinicians with a rigorous review of the guidelines and the evidence they include . We then adopt the clinical recommendations if we agree with their evaluation of benefits and harms or adapt them if changes are needed based on our assessment of the recommendations and evidence . Data Sources and Guideline Selection We search ed the National Guideline Clearinghouse and the Guidelines International Network library ( May 2017 ) for guidelines on recommended HbA1c targets in the treatment of type 2 diabetes in nonpregnant outpatient adults . We included guidelines that were developed by national organizations , were published in English , and targeted the correct population . We review ed titles and abstract s and excluded guidelines that were modified or adapted from other organizations or addressed specific population s ( such as pregnant women or patients with kidney disease ) . Our search yielded guidelines from the National Institute for Health and Care Excellence ( NICE ) ( 7 ) and the Institute for Clinical Systems Improvement ( ICSI ) ( 8) . On the basis of the knowledge and expertise of ACP CGC members , we also selected the following 4 guidelines not identified in either data base at the time of the search but commonly used in clinical practice : the American Association of Clinical Endocrinologists and American College of Endocrinology ( AACE/ACE ) guideline ( 9 ) , the American Diabetes Association ( ADA ) guideline ( 10 ) , the Scottish Intercollegiate Guidelines Network ( SIGN ) guideline ( 11 ) , and the U.S. Department of Veterans Affairs and Department of Defense ( VA/DoD ) guideline ( 12 ) . Quality Assessment Six co authors independently review ed and assessed each guideline using the AGREE II ( Appraisal of Guidelines for Research and Evaluation II ) instrument ( 13 ) . This instrument asks 23 questions in the following 6 domains : scope and purpose , stakeholder involvement , rigor of development , clarity of presentation , applicability , and editorial independence . The authors scored each guideline independently , and the scores were compared ( Appendix Figure and Appendix Table 1 ) . Authors then provided a summary determination of whether they would recommend this guideline for use by recording yes , no , or yes with modifications . Appendix Figure . Mean AGREE II scores for items in each domain across the 6 review ers . Each question was rated on a Likert scale with a minimum of 1 point and a maximum of 7 points . The scores were averaged for each of the 6 review ers . Error bars represent calculated st and ard deviation . AACE/ACE = American Association of Clinical Endocrinologists and American College of Endocrinology ; ADA = American Diabetes Association ; AGREE II = Appraisal of Guidelines for Research and Evaluation II ; GDG = guideline development group ; ICSI = Institute for Clinical Systems Improvement ; NICE = National Institute for Health and Care Excellence ; SIGN = Scottish Intercollegiate Guidelines Network ; VA/DoD = U.S. Department of Veterans Affairs and Department of Defense . Appendix Table 1 . Scaled AGREE II Domain Scores for Each Guideline and Overall Assessment Peer Review The draft guidance statement was peer- review ed through Annals of Internal Medicine and was posted online for comments from ACP Regents and Governors , who represent ACP members at the regional level . The final guidance statement incorporated comments from peer review ers and ACP Regents and Governors . Public Panel Review The development of this guidance statement also included perspectives , values , and preferences of 2 CGC members who represent the public and a 7-member public panel . Summary of Evaluated Guidelines Using the AGREE II Instrument We review ed and rated 6 guidelines ( AACE/ACE [ 9 ] , ADA [ 10 ] , ICSI [ 8 ] , NICE [ 7 ] , SIGN [ 11 ] , and VA/DoD [ 12 ] ) , focusing solely on sections addressing HbA1c targets in patients with type 2 diabetes . Appendix Table 1 shows the detailed scaled domain scores and average quality ratings for each guideline , and the Appendix Figure shows average AGREE II scores for each item in each of the 6 domains . The fundamental difference between high- and low-scoring guidelines was methodology . The 2 lowest-scoring guidelines , AACE/ACE and ADA , scored lowest on stakeholder involvement , applicability , editorial independence , and scientific rigor . A systematic review is the backbone for any trustworthy guideline , but some guidelines might not be based on a systematic review or may not have made the review publicly available ( 14 , 15 ) . Several factors were important in considering guideline quality . For example , although many guidelines described benefits , adverse effects , and the strength and limitations of evidence or linked the evidence to the recommendation , they often inadequately described how they had considered or weighted these factors in developing the final recommendations . The guidelines frequently relied on selective reporting of studies or outcomes and focused on relative versus absolute effects and asymptomatic surrogate measures rather than patient-centered health outcomes . All of the review ed guidelines recommend individualizing HbA1c targets on the basis of patient characteristics , such as comorbid conditions and risk for hypoglycemia ( Appendix ) . The ADA and SIGN guidelines recommend a target of 7 % for the general population , whereas AACE/ACE recommends 6.5 % ( if it can be achieved safely ) . The NICE guideline specifies 6.5 % or 7 % , depending on the patient 's treatment regimen . Both ICSI and VA/DoD recommend target ranges . The ICSI guideline recommends less than 7 % to less than 8 % based on patient factors , whereas the VA/DoD recommends the following target ranges based on life expectancy and comorbid conditions : 6 % to 7 % for patients with a life expectancy greater than 10 to 15 years and no or mild microvascular complications ; 7 % to 8.5 % for those with established microvascular or macrovascular disease , comorbid conditions , or a life expectancy of 5 to 10 years ; and 8 % to 9 % for those with a life expectancy less than 5 years , significant comorbid conditions , advanced complications of diabetes , or difficulties in self-management attributable to mental status , disability , or other factors ( 12 ) . All guidelines recognize that HbA1c targets can be higher in patients with comorbid conditions and limited life expectancy . We looked into the evidence presented in these guidelines , specifically 5 large , long-term r and omized trials with a treat-to-target strategy and corresponding reports on extended follow-up ( 1623 ) . We summarize below the individual studies and result ing benefits and harms . Note that recent studies evaluating the effectiveness and safety of several newer diabetes drugs ( for example , recently approved sodiumglucose cotransporter-2 inhibitors , dipeptidyl peptidase-4 inhibitors , and glucagon-like peptide-1 receptor agonists ) were not considered in guideline sections pertaining to HbA1c targets because these studies were not design ed to evaluate treat-to-target strategies . Therefore , their findings are not described here . Benefits and Harms of Lower HbA1c Targets : Evidence From Clinical Trials Five large , long-term r and omized controlled trials investigated intensive ( achieved HbA1c levels , 6.3 % to 7.4 % ) versus less intensive ( achieved HbA1c levels , 7.3 % to 8.4 % ) The American Diabetes Association ( ADA ) first released its St and ards of Medical Care in Diabetes for health professionals in 1989 . These practice guidelines provide an extensive set of evidence -based recommendations that are up date d annually for the diagnosis and management of patients with diabetes . The 2017 St and ards cover all aspects of patient care ( 1 ) ; this guideline synopsis focuses on pharmacologic approaches for patients with type 2 diabetes . Guideline Development and Evidence Grading To develop the 2017 St and ards , the ADA Professional Practice Committee , which comprises physicians , adult and pediatric endocrinologists , diabetes educators , registered dietitians , epidemiologists , and public health experts , systematic ally search ed MEDLINE from 1 January 2016 ( date of last previous search ) to November 2016 . The committee revised recommendations based on the new evidence or , in some cases , to clarify prior ones or match the strength of the wording to the strength of the evidence . It also solicited feedback from the larger clinical community . The recommendations are rated as A , B , C , or E. Those with an A rating are based on large , well- design ed , multicenter clinical trials or high- quality meta-analyses . Recommendations with lower- quality evidence may be equally important and are based on well-conducted cohort studies ( B rating ) or uncontrolled studies ( C rating ) . Those assigned an E rating are consensus recommendations for which there is no evidence from clinical trials , in which clinical trials may be impractical , or in which there is conflicting evidence . The ADA funds development of the St and ards from its general revenues with no industry support or involvement . Details on the methodology , information about the committee members and their conflict-of-interest disclosures , and the complete St and ards can be downloaded at professional.diabetes.org/annals . Pharmacologic Therapy for Type 2 Diabetes : Recommendations Metformin , if not contraindicated and if tolerated , is the preferred initial pharmacologic agent for the treatment of type 2 diabetes ( A rating ) . Long-term use of metformin may be associated with biochemical vitamin B12 deficiency , and periodic measurement of vitamin B12 levels should be considered in patients treated with metformin , especially those with anemia or peripheral neuropathy ( B rating ) . Providers should consider initiating insulin therapy ( with or without additional agents ) in patients with newly diagnosed type 2 diabetes who are symptomatic , have a hemoglobin A1c ( HbA1c ) level of 10 % or greater , or have a blood glucose level of 16.7 mmol/L ( 300 mg/dL ) or greater ( E rating ) . If noninsulin monotherapy at the maximum tolerated dose does not achieve or maintain the HbA1c target after 3 months , adding a second oral agent , a glucagon-like peptide-1 (GLP-1)receptor agonist , or basal insulin should be considered ( A rating ) . For patients with type 2 diabetes who are not achieving glycemic goals , insulin therapy should be instituted without delay ( B rating ) . A patient-centered approach should be used to guide the choice of pharmacologic agents ( E rating ) . Initial Treatment Approach : Metformin Metformin monotherapy should be initiated at the time of diagnosis of type 2 diabetes for most patients unless there are contraindications . It is effective , safe , and inexpensive and may reduce the risk for cardiovascular events and death ( 2 ) . A large meta- analysis ( 3 ) supports the use of metformin monotherapy as first-line therapy . It may be safely used in patients with an estimated glomerular filtration rate as low as 30 mL/min/1.73 m2 ( 4 ) ; the U.S. label of metformin was recently revised to reflect its safety in patients with an estimated glomerular filtration rate of 30 mL/min/1.73 m2 or greater ( 5 ) . Gastrointestinal side effects are common in patients receiving metformin . In the authors ' experience , these side effects can be reduced if metformin monotherapy is started at a dose of 500 mg once or twice daily with food and titrated gradually to the maximum effective dose ( 2 g/d ) . Patients should be advised to stop taking their medication if they experience nausea , vomiting , or dehydration . The Diabetes Prevention Program Outcomes Study found that long-term users of metformin may develop vitamin B12 deficiency . Periodic testing of vitamin B12 levels should be considered in metformin users , especially those with anemia or peripheral neuropathy ( 6 ) . Using Pharmacotherapies Other Than or in Addition to Metformin If the patient does not tolerate or has a contraindication to metformin , another option should be considered . The ADA/European Association for the Study of Diabetes position statement ( 7 ) recommends a patient-centered approach , including assessment of efficacy , hypoglycemia risk , effect on weight , side effects , cost , and patient preferences . A table detailing characteristics of all available glucose-lowering agents in the United States that may guide individualized treatment choices is available in section 8 of the St and ards ( 8) . Tables 1 and 2 depict the costs of antihyperglycemic agents that were extracted from the Red Book ( 9 ) . With so many choices , patients and providers should be able to find a mutually agreeable treatment option . Table 1 . Median Monthly Cost of Maximum Approved Daily Dose of Noninsulin Glucose-Lowering Agents in the United States * Table 2 . Median Cost of Insulins  in the United States , Calculated as the AWP per 1000 Units of Specified Dosage Form/Product * For patients with an HbA1c level of 9 % or greater who are not acutely symptomatic , initiation of dual combination therapy ( Figure 1 ) should be considered to more quickly achieve the target HbA1c level . If the patient has a r and om glucose level of 16.7 mmol/L ( 300 mg/dL ) or greater or an HbA1c level of 10 % or greater and has acute symptoms of polyuria , polydipsia , or weight loss , combination therapy that includes insulin should be considered ( Figure 2 ) . Figure 1 . Antihyperglycemic therapy for type 2 diabetes : general recommendations . The order in the chart was determined by historical availability and the route of administration , with injectables to the right ; it is not meant to denote any specific preference . Potential sequences of antihyperglycemic therapy for patients with type 2 diabetes are displayed , with the usual transition moving vertically from top to bottom ( although horizontal movement within therapy stages is also possible , depending on the circumstances ) . Adapted with permission from Inzucchi and colleagues ( 7 ) . DPP-4-i= dipeptidyl peptidase-4 inhibitor ; GI= gastrointestinal ; GLP-1-RA= glucagon-like peptide-1receptor agonist ; GU= genitourinary ; HbA1c= hemoglobin A1c ; HF= heart failure ; SGLT-2-i= sodiumglucose contransporter-2 inhibitor . * See Dieuzeide and colleagues ( 21 ) for description of efficacy and cost categorizations . Usually a basal insulin ( such as neutral protamine Hagedorn , glargine , detemir , or degludec ) . Figure 2 . Combination injectable therapy for type 2 diabetes . Adapted with permission from Inzucchi and colleagues ( 7 ) . GLP-1-RA= glucagon-like peptide-1receptor agonist ; HbA1c= hemoglobin A1c ; SMBG= self-monitored blood glucose . Assessing Response and Deciding to Intensify Therapy Providers should assess whether the HbA1c target has been achieved within approximately 3 months of therapy initiation ( Figure 1 ) ; if it has not , therapy should be intensified ( Figure 2 ) . They should use shared decision making and a patient-centered approach when selecting a second agent . Potential combination therapies include a sulfonylurea , thiazolidinedione , dipeptidyl peptidase-4 ( DPP-4 ) inhibitor , sodiumglucose contransporter-2 ( SGLT-2 ) inhibitor , GLP-1receptor agonist , or basal insulin . Insulin should also be considered as part of any combination regimen for patients with severe hyperglycemia , especially if symptoms or catabolic features ( such as weight loss or ketosis ) are present . Patients should be reassessed within 3 months for achievement of the HbA1c target . Recent Evidence From Cardiovascular Outcomes Trials Major cardiovascular outcomes trials have studied patients with type 2 diabetes and established cardiovascular disease , including EMPA-REG ( Empagliflozin Cardiovascular Outcome Event Trial in Type 2 Diabetes Mellitus Patients ) ( 10 ) and the LEADER ( Liraglutide Effect and Action in Diabetes : Evaluation of Cardiovascular Outcome Results ) trial ( 11 ) . These 2 studies found that , compared with placebo and st and ard treatment , empagliflozin and liraglutide reduced composite outcomes for myocardial infa rct ion , stroke , and cardiovascular death in population s in which most , if not all , patients had established atherosclerotic cardiovascular disease . Whether other agents in the same class as empagliflozin and liraglutide have similar benefits , and whether the treatments benefit patients at lower risk for cardiovascular disease , is unknown . Cardiovascular outcomes trial data for the DPP-4 inhibitors sitagliptin ( 12 ) , saxagliptin ( 13 ) , and alogliptin ( 14 ) showed no statistically significant differences in rates of major cardiovascular events between treatment and placebo groups . Recent Warnings About Pharmacotherapies In May 2015 , the U.S. Food and Drug Administration ( FDA ) issued a warning that SGLT-2 inhibitors may lead to ketoacidosis in the absence of significant hyperglycemia ( termed euglycemic diabetic ketoacidosis ) . Patients who develop symptoms of ketoacidosis  , which may include dyspnea , nausea , vomiting , and abdominal pain  , should stop taking SGLT-2 inhibitors and immediately seek medical attention ( 15 ) . In April 2016 , the FDA also warned that the DPP-4 inhibitors saxagliptin and alogliptin may increase the risk for heart failure , especially in patients with preexisting heart failure or renal impairment ( 16 ) . Insulin Therapy Diabetes is a progressive condition , and many patients with type 2 diabetes eventually require and benefit from insulin therapy . Early patient education about expected disease progression OBJECTIVE The primary objective was to evaluate the effectiveness of a Web-based program , Monitor-Rx , in identifying older adults at risk for drug-related geriatric syndromes or inappropriate medicines . DESIGN This prospect i ve pilot study compared medication related risks generated by the Web-based program with those identified by a certified geriatric pharmacist ( CGP ) . SETTING Wisconsin-based community pharmacy serving primarily older adults . PARTICIPANTS 29 community-dwelling older adults ( mean age : 81.6 years , mean daily medications : 11.7 ) . INTERVENTIONS Each participant received a complete medication history , including self-identified geriatric syndromes . Each participant 's demographic information and medications were entered into Monitor-Rx and concurrently review ed by a CGP . MAIN OUTCOME MEASURES Number of potentially inappropriate medications ( PIMs ) , anticholinergic medicines , and identified geriatric syndromes . RESULTS All participants were identified as at risk for falls by Monitor-Rx and the CGP . Significant medication-related risks identified were urinary incontinence , cognition/memory , nutrition , and dental care . Monitor-Rx identified more participants at risk for geriatric syndromes than the CGP ; however , PIMs were identified more frequently by the CGP . Twenty-six participants self-identified at least one geriatric syndrome . Prevalence of anticholinergic use was more than 75 % . CONCLUSIONS In the participants screened , Monitor-Rx was successful at identifying those with a high risk of drug-related geriatric syndromes . An interview was also important to clarify use of the PIM and to identify whether at-risk participants were actually experiencing the drug related geriatric syndromes . Use of the Web-based tool does not supplant the experience of a well-trained geriatric pharmacist and the professional judgment that comes with that experience OBJECTIVE Development of these guidelines is m and ated by the American Association of Clinical Endocrinologists ( AACE ) Board of Directors and the American College of Endocrinology ( ACE ) Board of Trustees and adheres to published AACE protocol s for the st and ardized production of clinical practice guidelines ( CPGs ) . METHODS Recommendations are based on diligent review of clinical evidence with transparent incorporation of subjective factors . RESULTS There are 9 broad clinical questions with 123 recommendation numbers that include 160 specific statements ( 85 [ 53.1 % ] strong [ Grade A ] ; 48 [ 30.0 % ] intermediate [ Grade B ] , and 11 [ 6.9 % ] weak [ Grade C ] , with 16 [ 10.0 % ] based on expert opinion [ Grade D ] ) that build a comprehensive medical care plan for obesity . There were 133 ( 83.1 % ) statements based on strong ( best evidence level [ BEL ] 1 = 79 [ 49.4 % ] ) or intermediate ( BEL 2 = 54 [ 33.7 % ] ) levels of scientific substantiation . There were 34 ( 23.6 % ) evidence -based recommendation grade s ( Grade s A-C = 144 ) that were adjusted based on subjective factors . Among the 1,790 reference citations used in this CPG , 524 ( 29.3 % ) were based on strong ( evidence level [ EL ] 1 ) , 605 ( 33.8 % ) were based on intermediate ( EL 2 ) , and 308 ( 17.2 % ) were based on weak ( EL 3 ) scientific studies , with 353 ( 19.7 % ) based on review s and opinions ( EL 4 ) . CONCLUSION The final recommendations recognize that obesity is a complex , adiposity-based chronic disease , where management targets both weight-related complications and adiposity to improve overall health and quality of life . The detailed evidence -based recommendations allow for nuanced clinical decision-making that addresses real-world medical care of patients with obesity , including screening , diagnosis , evaluation , selection of therapy , treatment goals , and individualization of care . The goal is to facilitate high- quality care of patients with obesity and provide a rational , scientific approach to management that optimizes health outcomes and safety . ABBREVIATIONS A1C = hemoglobin A1c AACE = American Association of Clinical Endocrinologists ACE = American College of Endocrinology ACSM = American College of Sports Medicine ADA = American Diabetes Association ADAPT = Arthritis , Diet , and Activity Promotion Trial ADHD = attention-deficit hyperactivity disorder AHA = American Heart Association AHEAD = Action for Health in Diabetes AHI = apnea-hypopnea index ALT = alanine aminotransferase AMA = American Medical Association ARB = angiotensin receptor blocker ART = assisted reproductive technology AUC = area under the curve BDI = Beck Depression Inventory BED = binge eating disorder BEL = best evidence level BLOOM = Behavioral Modification and Lorcaserin for Overweight and Obesity Management BLOSSOM = Behavioral Modification and Lorcaserin Second Study for Obesity Management BMI = body mass index BP = blood pressure C-SSRS = Columbia Suicidality Severity Rating Scale CAD = coronary artery disease CARDIA = Coronary Artery Risk Development in Young Adults CBT = cognitive behavioral therapy CCO = Consensus Conference on Obesity CHF = congestive heart failure CHO = carbohydrate CI = confidence interval COR-I = Contrave Obesity Research I CPG = clinical practice guideline CV = cardiovascular CVD = cardiovascular disease DASH = Dietary Approaches to Stop Hypertension DBP = diastolic blood pressure DEXA = dual-energy X-ray absorptiometry DPP = Diabetes Prevention Program DSE = diabetes support and education EL = evidence level ED  = erectile dysfunction  ER = extended release EWL = excess weight loss FDA = Food and Drug Administration FDG = 18F-fluorodeoxyglucose GABA = gamma-aminobutyric acid GERD = gastroesophageal reflux disease GI = gastrointestinal GLP-1 = glucagon-like peptide 1 HADS = Hospital Anxiety and Depression Scale HDL-c = high-density lipoprotein cholesterol HR = hazard ratio HTN = hypertension HUNT = Nord-Trøndelag Health Study ICSI = intracytoplasmic sperm injection IFG = impaired fasting glucose IGT = impaired glucose tolerance ILI = intensive lifestyle intervention IVF = in vitro fertilization LAGB = laparoscopic adjustable gastric b and ing LDL-c = low-density lipoprotein cholesterol LES = lower esophageal sphincter LSG = laparoscopic sleeve gastrectomy LV = left ventricle LVH = left ventricular hypertrophy LVBG = laparoscopic vertical b and ed gastroplasty MACE = major adverse cardiovascular events MAOI = monoamine oxidase inhibitor MI = myocardial infa rct ion MN RCT = meta- analysis of non-r and omized prospect i ve or case-controlled trials MRI = magnetic resonance imaging MUFA = monounsaturated fatty acid NAFLD = nonalcoholic fatty liver disease NASH = nonalcoholic steatohepatitis NES = night eating syndrome NHANES = National Health and Nutrition Examination Surveys NHLBI = National Heart , Lung , and Blood Institute NHS = Nurses ' Health Study NICE = National Institute for Health and Care Excellence OA = osteoarthritis OGTT = oral glucose tolerance test OR = odds ratio OSA = obstructive sleep apnea PHQ-9 = Patient Health Question naire PCOS = polycystic ovary syndrome PCP = primary care physician POMC = pro-opiomelanocortin POWER = Practice -Based Opportunities for Weight Reduction PPI = proton pump inhibitor PRIDE = Program to Reduce Incontinence by Diet and Exercise PSA = prostate specific antigen QOL = quality of life RA = receptor agonist RCT = r and omized controlled trial ROC = receiver operator characteristic RR = relative risk RYGB = Roux-en-Y gastric bypass  SAD = sagittal abdominal diameter SBP = systolic blood pressure SCOUT = Sibutramine Cardiovascular Outcome Trial SG = sleeve gastrectomy SHBG = sex hormonebinding globulin SIEDY = Structured Interview on Erectile Dysfunction SNRI = serotonin-norepinephrine reuptake inhibitors SOS = Swedish Obese Subjects SS = surveillance study SSRI = selective serotonin reuptake inhibitors STORM = Sibutramine Trial on Obesity Reduction and Maintenance TCA = tricyclic antidepressant TONE = Trial of Nonpharmacologic Intervention in the Elderly TOS = The Obesity Society T2DM = type 2 diabetes mellitus UKPDS = United Kingdom Prospect i ve Diabetes Study U.S = United States VAT = visceral adipose tissue VLDL = very low-density lipoprotein WC = waist circumference WHO = World Health Organization WHR = waist-hip ratio WHtR = waist-to-height ratio WMD = weighted mean difference WOMAC = Western Ontario and McMaster Universities osteoarthritis index XENDOS = XEnical in the Prevention of Diabetes in Obese Subjects More than 25 % of the U.S. population aged ≥65 years has diabetes ( 1 ) , and the aging of the overall population is a significant driver of the diabetes epidemic . Although the burden of diabetes is often described in terms of its impact on working-age adults , diabetes in older adults is linked to higher mortality , reduced functional status , and increased risk of institutionalization ( 2 ) . Older adults with diabetes are at substantial risk for both acute and chronic microvascular and cardiovascular complications of the disease . Despite having the highest prevalence of diabetes of any age-group , older persons and /or those with multiple comorbidities have often been excluded from r and omized controlled trials of treatments— and treatment targets — for diabetes and its associated conditions . Heterogeneity of health status of older adults ( even within an age range ) and the dearth of evidence from clinical trials present challenges to determining st and ard intervention strategies that fit all older adults . To address these issues , the American Diabetes Association ( ADA ) convened a Consensus Development Conference on Diabetes and Older Adults ( defined as those aged ≥65 years ) in February 2012 . Following a series of scientific presentations by experts in the field , the writing group independently developed this consensus report to address the following questions : 1 . What is the epidemiology and pathogenesis of diabetes in older adults ? 2 . What is the evidence for preventing and treating diabetes and its common comorbidities in older adults ? 3 . What current guidelines exist for treating diabetes in older adults ? 4 . What issues need to be considered in individualizing treatment recommendations for older adults ? 5 . What are consensus recommendations for treating older adults with or at risk for diabetes ? 6 . How can gaps in the evidence best be filled ? According to the most recent surveillance data , the prevalence of diabetes among U.S. adults aged ≥65 years varies from 22 to 33 % , depending on the diagnostic criteria Abstract Assessment of the benefits of anti-diabetic drugs for type 2 diabetes requires analysis of composite end-points , taking HbA1c , bodyweight , hypoglycemia and other metabolic parameters into consideration ; continuous , optimal glycemic control as well as bodyweight , blood pressure and lipid levels are critical to prevent micro- and macro-vascular complications . Glucagon-like peptide-1 receptor agonists ( GLP-1RAs ) are now established as an important total treatment strategy for type 2 diabetes , exerting glucose-lowering effects with little hypoglycemia risk and also ameliorating bodyweight , blood pressure and lipid levels , which are therapeutic targets for prevention of complications of the disease . The available data strongly suggest only beneficial effects of GLP-1RAs ; however , long-term evaluation of the relevant composite end-points including health-related quality of life and cost-effectiveness remain to be investigated in adequately powered , prospect i ve , controlled clinical trials . In the meantime , healthcare professionals need to be scrupulously attentive for potential , rare adverse events in patients using GLP-1RAs Diabetes is the leading cause of major complications , such as end-stage renal disease and lower extremity amputations , and is a significant contributor to ischemic heart disease , stroke , peripheral vascular disease , and vision loss ( 1 ) . There has been increasing acceptance of the importance of individualizing glycemic management and assessment of risk for adverse events , especially hypoglycemia ( 26 ) . This is of great importance for all patients , especially older adults ( aged 65 years ) with comorbid conditions . In 2013 , 12.0 million older adults in the United States had diabetes , comprising 40 % of the 30.2 million persons with the disease ( 7 ) . Older adults account for an estimated 60 % to 70 % of the U.S. Department of Veterans Affairs ( VA ) and U.S. Department of Defense ( DoD ) diabetic population ( largely retirees ) ( VA/DoD. Unpublished data ) . These considerations make safe and effective diabetes management a policy priority for health care providers ( physicians , nurses , dietitians , and pharmacists ) and policymakers in both the VA and the DoD. The 2017 VA/DoD Clinical Practice Guideline ( CPG ) for the Management of Type 2 Diabetes Mellitus in Primary Care offers health care providers an evidence -based framework to evaluate , treat , and manage persons with type 2 diabetes  mellitus in the context of their individual needs and preferences ( 8) . The current article is a summary of key CPG recommendations , which was developed with multiple stakeholders to ensure representation by a broad spectrum of clinicians . It provides practice recommendations for the care of patients with diabetes , with an emphasis on shared decision making . Guideline Development and Review Process These recommendations were developed using methods established by the VA/DoD Evidence -Based Practice Work Group ( EBPWG ) ( 9 ) , which are aligned with st and ards for trustworthy guidelines ( 10 ) . The EBPWG and the U.S. Army Medical Comm and selected guideline panel cochairs ( 1 each from the VA and the DoD ) . The cochairs then selected a multidisciplinary panel of practicing clinician stakeholders , including primary care physicians ( family and internal medicine ) , endocrinologists , medical nutritionists , pharmacists , diabetes educators , and nurse practitioners . At the start of the CPG development process and at other key points throughout , all members were required to su bmi t disclosure statements for potential conflicts of interest in the previous 24 months . Verbal affirmations of no conflicts were used during meetings throughout the development process . The project team was also subject to r and om Web-based surveillance ( for example , ProPublica ) . The VA/DoD contracted with The Lewin Group , a third party with expertise in clinical practice guideline development , to facilitate meetings . The guideline panel , in collaboration with the ECRI Institute , developed 9 key questions using the PICOTS ( population , intervention , comparator , outcomes , timing of outcomes measurement , and setting ) format . A systematic search of the peer- review ed literature from January 2009 through March 2016 was conducted to find evidence relevant to the key questions that focused on r and omized trials , systematic review s , and meta-analyses of fair or better quality . One key question was up date d through 14 June 2016 . The search methods and results are detailed in the full guideline ( 8) . The guideline panel rated recommendations by using the GRADE ( Grading of Recommendations Assessment , Development and Evaluation ) method ( 11 ) . The guideline panel focused on developing new and up date d recommendations using the evidence review for the key questions . The panel also considered , without a complete review of the relevant evidence , the current applicability of recommendations that were included in the 2010 CPG . As part of the development process , a patient focus group was also convened to better underst and the perspectives of patients receiving diabetes treatment in the VA and the DoD. Five patients were included , consistent with the requirements of the federal Paperwork Reduction Act . All patients had type 2 diabetes and were veterans receiving care in the VA . The focus group explored knowledge of treatment options , views on the delivery of care , patients ' needs and preferences , and the effect of diabetes on their lives . Important concepts that emerged from the focus group were shared with the panel and informed guideline development . It was acknowledged that this convenience sample may not be representative of all VA and DoD patients receiving treatment for type 2 diabetes . The draft guideline was sent to more than 15 expert review ers inside and outside the federal sector . Comments were review ed and , where appropriate , were incorporated into the final guideline based on panel consensus . The VA/DoD EBPWG approved the final document on 3 April 2017 and released it on 17 April 2017 . Recommendations are presented in the Table , and an algorithm for establishing a personalized glycemic goal and treatment plan is presented in the Figure . Key recommendations are review ed in this article . Table . Summary of Recommendations From the 2017 VA/DoD CPG on the Management of Type 2 Diabetes Mellitus Figure . Algorithmic approach to evaluating glycemic control risk factors , setting a personalized glycemic control target range , providing self-management ( including lifestyle and nutrition ) education , and initiating or reevaluating medication therapy . Recommendations Provide Patient-Centered Care and Incorporate Shared Decision Making The CPG strongly encourages clinicians to incorporate shared decision making and partner with their patients . Shared decision making is the process by which the patient and family , in conjunction with the care provider , reach an agreement about a plan of care and treatment . Key principles include readiness of the patient and family , tools with underst and able information about the benefits and harms of all options , and strategies to identify and incorporate patient preferences . Patients can not effectively participate in care and shared decision making unless they underst and diabetes and how they can be involved in planning and carrying out the jointly developed care plan . Shared decision making reinforces a trusted therapeutic relationship and increases patient satisfaction and treatment buy-in with regard to the methods used to reach a particular goal or treatment plan ( 1214 ) . It should be used not only for patients with stable glycemic control but also to assist those who are not able or willing to make lifestyle changes and decisions that affect their diabetes at any time during the course of treatment . At a minimum , shared decision making should be included at the time of diagnosis , during difficulties with management , and at times of transition or development of complications ( 14 ) . Benefits include greater knowledge of medications ( 13 ) and underst and ing of risks ( 14 ) . In addition , patient-centered care and shared decision making together may decrease patient anxiety , increase trust in clinicians ( 15 ) , and improve treatment adherence ( 16 ) . Family involvement should be considered if appropriate , especially in older adults ( 17 ) . Patient information should be culturally appropriate ; underst and able and actionable by people with limited literacy skills ; and accessible to those with physical , sensory , or learning needs ( 18 ) . As part of the patient-centered care approach to diabetes management , clinicians should explore with the patient the outcomes of previous opportunities for shared decision making , their ability to self-manage , prior efforts to change health behaviors , past treatment experiences ( including reasons for discontinuing treatment ) , and relevant clinical outcomes . In actively sharing decisions , they should involve the patient in prioritizing problems to be addressed and setting specific goals regardless of the setting or level of care . Assess Patient Characteristics and Nonglycemic Factors When Interpreting Results of Hemoglobin A1c , Fructosamine , and Other Glycemic Biomarker Testing Many factors affect measurement of hemoglobin A1c ( HbA1c ) besides the level of glycemia ( 19 ) . Because HbA1c level depends on the duration of erythrocyte exposure to glucose , conditions that alter erythrocyte life span affect the measured level of HbA1c ( 20 , 21 ) . Iron deficiency anemia , which prolongs erythrocyte life span and exposes the cell to glucose for a longer period , is associated with falsely elevated HbA1c levels ( 22 ) . In contrast , conditions that shorten erythrocyte life span ( such as hemolytic anemia ) may result in falsely low HbA1c levels . Various other conditions , such as chronic kidney disease , may alter HbA1c measurement . Hemoglobin variants can result in falsely elevated or falsely lowered HbA1c levels , depending on the assay used ( 2325 ) . In addition , oral hypoglycemic agents ( metformin or sulfonylureas ) may alter the relationship between blood glucose and HbA1c levels , although the clinical significance is unclear ( 26 ) . There are also racial/ethnic differences in HbA1c levels for a given level of glycemia . A previous study found that African Americans with prediabetes ( 27 ) had HbA1c values that were 0.4 % higher than among white persons ; those who were within 3 years of diagnosis ( 28 ) also had higher HbA1c values than white persons for any measure of glycemia . This difference can not be explained by measured differences in glycemia , clinical factors known to affect HbA1c measurement , or sociodemographic factors ( 27 , 28 ) . Therefore , it is recommended that a new diagnosis of diabetes be based on a confirmatory fasting blood glucose level of at least 7.0 mmol/L ( 126 mg/dL ) if the initial HbA1c value is 6.5 % to 6.9 % . How and where the HbA1c level is measured can also affect results because of intralaboratory variation ( variation in test accuracy and precision ) and interlaboratory variation ( variation related to use of different test methods ) . A single HbA1c measurement , even from a Practice guidelines are available for hospice and palliative medicine specialists and geriatricians . However , these guidelines do not adequately address the needs of patients who straddle the 2 specialties : homebound chronically ill patients . The purpose of this article is to describe the theoretical basis for the Promoting Effective Advance Care for Elders ( PEACE ) r and omized pilot study . PEACE is an ongoing 2-group r and omized pilot study ( n=80 ) to test an in-home interdisciplinary care management intervention that combines palliative care approaches to symptom management , psychosocial and emotional support , and advance care planning with geriatric medicine approaches to optimizing function and addressing polypharmacy . The population comprises new enrollees into PASSPORT , Ohio 's community-based , long-term care Medicaid waiver program . All PASSPORT enrollees have geriatric/palliative care crossover needs because they are nursing home eligible . The intervention is based on Wagner 's Chronic Care Model and includes comprehensive interdisciplinary care management for these low-income frail elders with chronic illnesses , uses evidence -based protocol s , emphasizes patient activation , and integrates with community-based long-term care and other community agencies . Our model , with its st and ardized , evidence -based medical and psychosocial intervention protocol s , will transport easily to other sites that are interested in optimizing outcomes for community-based , chronically ill older adults Context Many Americans 65 years of age and older are at risk for functional decline , yet we know little about the quality of care for geriatric conditions . Contribution This study used a 13-item survey about functional status to evaluate the care of 420 people 65 years of age and older whom the investigators identified as vulnerable to functional decline .  Quality of care was highly variable from condition to condition but was generally better for general medical conditions , such as diabetes , than for geriatric conditions , such as incontinence . Implication s Efforts to improve care for vulnerable elders should focus on the geriatric conditions that profoundly influence functional status . The Editors The quality of care among patients 65 years of age and older has not been extensively investigated , and most existing studies have focused on general adult medical conditions . This is surprising , considering that more than 40 % of all medical expenditures are for persons 65 years of age and older ( 1 ) . The most comprehensive study to date of quality of care among older patients evaluated 24 process indicators among U.S. Medicare beneficiaries in all 50 states between 1997 and 1999 ( 2 ) . Care for acute myocardial infa rct ion , heart failure , stroke , and pneumonia was evaluated by using inpatient medical records . Pneumonia , breast cancer , and diabetes indicators were evaluated by using survey and Medicare cl aims data . The investigators found that the percentage of patients receiving appropriate care varied widely by measure and state . Several other studies of older patients evaluated cardiovascular conditions , diabetes , or aspects of preventive care and medication use ( 3 - 10 ) . No study , however , has assessed the quality of medical care provided for geriatric conditions that profoundly affect the lives of vulnerable older patients . Furthermore , surveys find that older persons often prioritize function and comfort over disease treatment and prolongation of life ( 11 ) . Quality -of-care measurement for older patients that examines only a few conditions and only indicators aim ed at prolonging life yields an incomplete assessment because it ignores other conditions and aspects of care that are of equal or even greater importance to older patients . For this reason , we developed a  quality assessment system  that assesses more conditions . Together , these conditions account for a majority of all of the care older patients receive ( 12 ) and include several geriatric syndromes . We used this quality assessment system to evaluate the care provided to a sample of vulnerable elders at increased risk for death or functional decline . Methods The Assessing Care of Vulnerable Elders ( ACOVE ) project developed and applied a quality assessment system for vulnerable older persons . The assessment system aim ed to develop quality indicators ( QIs ) that cover the spectrum of care for these patients . Indicators were implemented by using medical record abstract ion and patient interview . The ACOVE Quality -of-Care Assessment System The ACOVE investigators developed a system of QIs to cover the most important conditions vulnerable elders encounter in all care venues . This system focused on processes ( care behaviors ) rather than outcomes for 2 reasons . First , although most agree that outcomes should be adjusted for risk when quality is measured , there is little consensus regarding the best severity measurement system ( 13 ) . Second , measurement of processes of care is thought to be a more direct assessment of quality than measurement of outcomes ( 14 ) . The process measures were selected to represent the various domains of care : screening and prevention , diagnosis , treatment , and follow-up . The development of the assessment system was guided by a Policy Advisory Committee , which helped to direct the focus toward practical applications , and by a Clinical Committee , which provided clinical expertise for development and monitored the assembly of the QIs into a comprehensive system ( 15 ) . The methods for selecting conditions and developing the QIs have been described in detail elsewhere ( 12 , 16 ) . In brief , the Clinical Committee used the criteria of prevalence , impact , effectiveness of prevention or treatment , need for quality improvement , feasibility of measurement , and geriatric niche in a formal group rating process to identify 22 target conditions for quality improvement ( 12 ) . For each of the 22 conditions , we developed a set of  evidence -based QIs  for vulnerable elders using a combination of systematic review s and expert judgment ( 16 ) . Of 420 proposed QIs , the 2 expert panels , the Clinical Committee , and the American College of Physicians Task Force on Aging accepted 236 as valid indicators ; these were assembled into the ACOVE QI set ( 17 ) . The 236 QIs covered the domains of care as follows : Sixty-one ( 26 % ) focused on screening and prevention , 50 ( 21 % ) focused on diagnosis , 84 ( 36 % ) focused on treatment , and 41 ( 17 % ) focused on follow-up and continuity of care . Examples of ACOVE QIs for each condition are presented in Table 1 . Table 1 . Examples of Assessing Care of Vulnerable Elders Quality Indicators Patients and Data Collection Using the ACOVE QI set , we assessed care provided to seniors who were enrolled in 2 managed care organizations . These patients were defined as vulnerable on the basis of self-report or proxy report on a brief , 13-item screening survey ( Vulnerable Elders-13 [ VE-13 ] Survey [ 18 ] ) . Vulnerable elders , identified by this function-based survey , are community-dwelling persons 65 years of age and older who have 4 times the risk for functional decline or death over the next 2 years compared with individuals not identified as vulnerable ( 18 ) . Each managed care organization , 1 in the northeastern United States and the other in the southwestern United States , had more than 20 000 elderly enrollees and contracted with a network of providers to deliver care . Eligibility criteria included continuous enrollment in the managed care organization for at least 13 months and no out-of-plan care or active treatment for malignant conditions ( excluding nonmelanoma skin cancer ) during this period . A r and om sample of 3207 community-dwelling elderly adults was drawn from eligible persons in each managed care organization by using a r and om-number generator . Vulnerable elders were identified by using the VE-13 Survey as part of a telephone interview . Patients who did not speak English were not eligible to participate . The R AND Institutional Review Board approved the study protocol . Medical Record Review Using administrative data , we identified all inpatient and outpatient medical care received by study participants during the 13-month period of 1 July 1998 to 31 July 1999 . Medical records were requested from primary care and specialist providers ( including eye care and mental health providers ) , acute care hospitals , skilled-nursing facilities , home health agencies , and facilities providing outpatient services ( for example , physical therapy ) . Identifying information of patients and providers was removed from the medical records . Trained nurses with previous experience in quality assessment performed medical record abstract ion . Abstract ors were provided with written abstract ion guidelines and real-time consultation with a senior nurse review er . The abstract or considered all of a patient 's records when assessing whether he or she was eligible for and received the indicated care processes . In other words , information on eligibility for a QI could have been derived from 1 record ( such as an outpatient note ) while the care process was delivered and documented in another setting ( for example , inpatient medical record ) . If the care process was performed in the defined time interval , care was scored as complying with the QI . The senior nurse review er also assessed each completed medical record abstract ion . Physicians review ed QIs that required a more detailed level of clinical assessment . Examples include whether the elements of a delirium evaluation had been completed or whether an adequate intervention was performed for hyperlipidemia . An ophthalmologist evaluated selected data elements addressing vision care . Ten percent of all records were re abstract ed to evaluate reliability of the abstract ion process . Exact agreement on QI eligibility and score was 95 % . ( For details of abstract or preparation and abstract ion material s , see the Appendix . ) Quality -of-Care Interview A quality -of-care interview was conducted to ask study participants ( or , if participants were incapable of responding , their proxies ) about aspects of their care that might not be captured in the medical record ( for example , physicianpatient counseling ) . On the basis of conditions and medications reported during the interview , patients were asked about specific processes of care they had received . Patients were also asked about care preferences that might affect the applicability of QIs . In addition , the interview included demographic questions and functional status items . The quality -of-care interview was conducted by telephone between August and October 2000 and required , on average , 44 minutes to complete . Statistical Analysis Of the 236 QIs , we were able to evaluate 207 using chart abstract ion ( n = 185 [ 89 % ] ) or interview ( n = 22 [ 11 % ] ) . Interview was used to score  QIs  for data elements that we did not collect from the medical record . A QI was scored for a patient if he or she satisfied the IF statement of the QI and thus was eligible to receive the specified care process ( Table 1 ) . A score of 1 was awarded if the care process was carried out , and a score of 0 was assigned if it was not . For QIs that included several triggering events , a score between 0 and 1 was possible . If the medical record indicated that the patient declined the care process , the QI was considered to be passed ( the care was credited in both the numerator and the denominator of the indicator score ) . On the other h and , if the patient had a The prevalence of urinary incontinence in noninstitutionalized persons older than 60 years of age is 15 % to 35 % ; of these , 25 % to 30 % have frequent episodes of urinary incontinence ( 1 ) . The significance of urinary incontinence may vary from minimal to severe , with extreme activity limitation and social isolation . For example , several reports have linked urinary incontinence in community-dwelling elders with falls and depression ( 2 , 3 ) . Urinary incontinence also imposes significant psychosocial distress on family , friends , and caregivers ( 1 ) . Urinary incontinence is even more prevalent in the nursing home than in the community . In nursing homes , however , urinary incontinence is known to be very treatable with assisted toileting programs ( 4 ) . Nursing home residents are older and frailer than community-dwelling elders and have caregivers available 24 hours per day . As a result , major differences exist in how incontinence can be assessed and treated in the nursing home compared with the community . This paper describes  incontinence quality indicators  that can be applied to vulnerable community-dwelling elders who may be treated across the spectrum of care , from primary care physicians to surgical specialists . Methods The methods for developing these quality indicators , including literature review and expert panel consideration , are detailed in a preceding paper ( 5 ) . For urinary incontinence , the structured literature review identified 4153 titles , from which abstract s and articles relevant to this report were identified . On the basis of the literature and the authors ' expertise , 16 potential quality indicators were proposed . Results Of the 16 potential quality indicators , 9 were judged valid by the expert panel ( see the quality indicators ) , 2 were merged into other indicators , and 5 were not accepted . The panel also suggested an additional indicator . The literature review s that support each of the indicators judged to be valid by the expert panel process are summarized below . Quality Indicators 1 and 2 Initial Evaluation : Detection of Incontinence ALL vulnerable elders should have documentation of the presence or absence of urinary incontinence during the initial evaluation . ALL vulnerable elders should have annual documentation of the presence or absence of urinary incontinence BECAUSE urinary incontinence is prevalent in older adults , has a high psychological impact , is often neglected , is associated with a large practice variation , has a high monetary cost , and is reasonably responsive to directed treatment . Supporting Evidence . Despite the high prevalence of urinary incontinence and its influence on both mood and functional status , primary care providers do not consistently inquire about it and patients do not report it . Patients frequently are embarrassed , consider it to be an inevitable fact of aging , or have low expectations for treatment ( 1 ) . Because providers often lack knowledge about the evaluation and management of urinary incontinence , they fail to elicit its presence ( 1 ) . Older geriatric patients , and male patients in general , are even less likely to be screened for urinary incontinence than are younger geriatric patients and women ( 6 ) . This discrepancy leads to substantial variation in the identification , assessment , and management of urinary incontinence . While no direct evidence shows that routine inquiry about urinary incontinence will lead to increased detection and treatment or improved outcomes , achieving these goals is likely to be more difficult without increased vigilance on the part of the health care provider . No data support or refute the interval at which inquiry should be performed . Quality Indicators 3 , 4 , and 5 : Targeted Evaluation Targeted History IF a vulnerable elder has new urinary incontinence that persists for more than 1 month or urinary incontinence at the time of a new evaluation , THEN a targeted history should be obtained that documents each of the following : 1 ) characteristics of voiding , 2 ) ability to get to the toilet , 3 ) previous treatment for urinary incontinence , 4 ) importance of the problem to the patient , and 5 ) mental status BECAUSE this information is necessary for the appropriate diagnosis and treatment of urinary incontinence . Targeted Physical Examination IF a vulnerable elder has new urinary incontinence that persists for more than 1 month or urinary incontinence at the time of a new evaluation , THEN a targeted physical examination should be performed that documents 1 ) a rectal examination and 2 ) a genital system examination ( including a pelvic examination for women ) BECAUSE information obtained from these examinations is necessary for the appropriate diagnosis and treatment of urinary incontinence . Diagnostic Tests IF a vulnerable elder has new urinary incontinence that persists for more than 1 month or urinary incontinence at the time of a new evaluation , THEN a dipstick urinalysis and post-void residual should be obtained BECAUSE information obtained from these studies is necessary for the appropriate diagnosis and treatment of urinary incontinence . Supporting Evidence . These indicators are based on clinical practice algorithms that are advocated by the Agency for Health Care Policy and Research ( AHCPR ) ( now the Agency for Healthcare Research and Quality ) and others ( 1 , 7 , 8) . They are the product of expert consensus but have not been tested prospect ively . Few prospect i ve studies of clinical algorithms for urinary incontinence in older adult patients have been conducted or published , and those that have been published focused on diagnostic accuracy rather than treatment outcomes . With aging , the pathophysiology of urinary incontinence becomes more complex and often has more than one contributory cause ( 9 ) . Urodynamic testing detects abnormalities even in healthy , asymptomatic older adults ( 10 , 11 ) . Therefore , a focused evaluation is necessary to determine the relevant diagnosis . Although the clinical history of urinary incontinence may be nonspecific , it is often valuable . Most patients with stress incontinence symptoms have true stress urinary incontinence , and many persons with symptoms of urgency or urge urinary incontinence have detrusor instability ( 1215 ) . Likewise , the physical examination may help identify the cause of urinary incontinence . The goals of physical examination also include identifying other medical conditions , such as reversible factors that may trigger or contribute to urinary incontinence , and assessing pelvic floor deficits that may warrant surgical correction . No studies were identified that directly assessed the utility of physical examination in the evaluation of urinary incontinence . However , several studies have identified reversible causes of urinary incontinence as a result of evaluations that included a physical examination . In one study evaluating the cause of  urinary incontinence in 100 women referred to an incontinence clinic ( mean age , 74.6 years ) , 17 patients had a urinary tract infection and 8 patients had fecal impaction  , both of which are easily treatable causes of urinary incontinence ( 16 ) . The fact that infection was identified in so many residents supports the importance of screening for symptoms of infection , such as a burning sensation . In a study of institutionalized and noninstitutionalized persons ( mean age , 80.2 years ) referred to an incontinence clinic for persistent urinary incontinence , 7 of 264 ( 3 % ) had reversible causes identified and successfully treated after a history , physical examination , and limited laboratory testing ( 17 ) . Evaluation of reversible causes should screen for medications that can affect urine production or bladder or sphincter function ( for example , diuretics , anticholinergic medications , opiates , and -adrenergic medications ) . Despite the value of the history and the examination , signs and symptoms of urinary retention may be unreliable in elderly persons ( 1719 ) . Unsuspected obstruction or underactive detrusor are not uncommon , and the high prevalence of detrusor hyperactivity with impaired bladder contractility involving risk for retention with medication or impaction makes monitoring for urinary retention in these patients especially important ( 9 , 20 ) . An elevated amount of post-void residual urine is especially common in older patients . In one study , post-void residual urine exceeding 100 mL was found in 28 % of both men and women older than 65 years of age who had urinary incontinence and were referred to a urology clinic ( 21 ) . Pelvic ultrasonography or straight catheterization may be used to measure the post-void residual urine content , but ultrasonography is safer in elderly men . Quality Indicator 6 Discuss Treatment Options for Urinary Incontinence IF a vulnerable elder has new urinary incontinence or urinary incontinence at the time of a new evaluation , THEN treatment options should be discussed BECAUSE urinary incontinence frequently remains untreated despite the availability of many effective treatment options . Supporting Evidence . Absorbent pads and garments are too often used as a first-line treatment for urinary incontinence ( 1 ) . The widespread use of these products is reflected in the growth of the market for disposable pads and adult diapers from $ 99 million in 1972 to $ 496 million in 1987 ( 1 ) . One practice guideline recommends the use of such absorbent products only as an adjunct to other therapy during the evaluation period and for long-term care of patients with chronic intractable urinary incontinence ( 1 ) . However , diapers should not be the first-line treatment for incontinence , and vulnerable elders with incontinence should be made aware of alternative treatments . The treatment options that might be discussed include pharmacologic treatments , electrical stimulation , and behavioral therapy . The effectiveness and relative lack of side effects of pharmacologic treatments have been documented for most types of incontinence ( 2225 ) . The evidence for efficacy of Dual antiplatelet therapy with aspirin and a P2Y12 receptor blocker is a key strategy to reduce platelet reactivity and to prevent thrombotic events in patients treated with percutaneous coronary intervention . In an earlier consensus document , we proposed cutoff values for high on-treatment platelet reactivity to adenosine diphosphate ( ADP ) associated with post-percutaneous coronary intervention ischemic events for various platelet function tests ( PFTs ) . Up date d American and European practice guidelines have issued a Class IIb recommendation for PFT to facilitate the choice of P2Y12 receptor inhibitor in selected high-risk patients treated with percutaneous coronary intervention , although routine testing is not recommended ( Class III ) . Accumulated data from large studies underscore the importance of high on-treatment platelet reactivity to ADP as a prognostic risk factor . Recent prospect i ve r and omized trials of PFT did not demonstrate clinical benefit , thus question ing whether treatment modification based on the results of current PFT platforms can actually influence outcomes . However , there are major limitations associated with these r and omized trials . In addition , recent data suggest that low on-treatment platelet reactivity to ADP is associated with a higher risk of bleeding . Therefore , a therapeutic window concept has been proposed for P2Y12 inhibitor therapy . In this up date d consensus document , we review the available evidence addressing the relation of platelet reactivity to thrombotic and bleeding events . In addition , we propose cutoff values for high and low on-treatment platelet reactivity to ADP that might be used in future investigations of personalized antiplatelet therapy Retrospective and prospect i ve studies have shown that elevated plantar pressure is a causative factor in the development of many plantar ulcers in diabetic patients and that ulceration is often a precursor of lower-extremity amputation . Herein , we review the evidence that relieving areas of elevated plantar pressure ( off-loading ) can prevent and heal plantar ulceration . There is no consensus in the literature concerning the role of off-loading through footwear in the primary or secondary prevention of ulcers . This is likely due to the diversity of intervention and control conditions tested , the lack of information about off-loading efficacy of the footwear used , and the absence of a target pressure threshold for off-loading .  Uncomplicated plantar ulcers  should heal in 6 to 8 weeks with adequate off-loading . Total-contact casts and other nonremovable devices are most effective because they eliminate the problem of nonadherence to recommendations for using a removable device . Conventional or st and ard therapeutic footwear is not effective in ulcer healing . Recent US and European surveys show that there is a large discrepancy between guidelines and clinical practice in off-loading diabetic foot ulcers . Many clinics continue to use methods that are known to be ineffective or that have not been proved to be effective while ignoring methods that have demonstrated efficacy . A variety of strategies are proposed to address this situation , notably the adoption and implementation of recently established international guidelines , which are evidence based and specific , by professional societies in the United States and Europe . Such an approach would improve the often poor current expectations for healing diabetic plantar ulcers OBJECTIVE The geriatric assessment ( GA ) has proven to be of great value for clinicians treating older patients . However , a clear consensus on the optimal set of GA instruments is lacking , particularly for surgical patients . Therefore , the aim of this prospect i ve study was to compare the prevalence of frailty , depending on the number of incorporated GA domains , and to evaluate its accuracy in predicting postoperative outcome . MATERIAL S AND METHODS Seventy-five patients aged 65 years and older , qualified for abdominal surgery due to solid cancer , were enrolled . The GA included a wide variety of vali date d tools that evaluate functional , mobility , nutritional , co-morbidity , polypharmacy , and psychosocial domains .  RESULTS Depending on the number of incorporated GA domains the frequency of frailty was 23 - 97 % . The cumulative score rather than individual components of the GA , turned out to be an independent risk factor of 30-day postoperative morbidity . In predicting 30-day " any " and " major " morbidities , the area under the curve was 0.67 - 0.72 and 0.70 - 0.82 ( model including the severity of the surgery ) vs. 0.57 - 0.66 and 0.50 - 0.65 ( model not including the severity of the surgery ) , respectively . CONCLUSION The number of incorporated GA domains has a great influence on the prevalence of frailty and on adequate surgical risk assessment . The summary deficit score based on Pre-operative Assessment of Cancer in the Elderly ( PACE ) or the GA consisting of functional , mobility , cognitive , depression , nutritional , co-morbidity , polypharmacy , and social support assessment domains can predict 30-day postoperative morbidity . However , only models with addition of the severity of surgery show moderate to good predictive value OBJECTIVE To evaluate the effectiveness of in-home geriatric assessment s as a means of providing preventive health care and improving health and functional status of community-living elderly veterans . DESIGN R and omized controlled trial with 1-year follow-up . SETTING Home visits performed in a suburb of Los Angeles . PARTICIPANTS Community-living veterans 70 years and older not currently receiving health care at the Sepulveda VA Medical Center ( n = 131 intervention ; 123 controls ) . INTERVENTION A home visit by a physician 's assistant or nurse , to screen for medical , functional and psychosocial problems , followed by a letter describing findings and recommendations , and follow-up visits by trained volunteers at 4-month intervals for 1 year . Controls received only telephone interviews at 4-month intervals to collect outcome data . MEASUREMENTS Compliance with recommendations was studied for the intervention group . Outcome comparisons between the two groups included : mortality , medication usage , functional status , immunization rates , and nursing home and hospital utilization . MAIN RESULTS A mean of four new or suboptimally treated problems was identified for intervention subjects . Subjects complied with 76 % of recommendations to see a physician or initiate a specific health practice . At 12-month follow-up , intervention subjects had significantly increased their immunization rates ( P < 0.001 ) and had a significantly increased likelihood of having a primary care physician ( P < 0.05 ) . Twelve-month functional status ( IADL ) scores were significantly higher for intervention subjects than for controls ; intervention subjects maintained their functional status , while controls experienced significant decline during the follow-up year ( P < 0.05 ) . Non-prescription drug use increased significantly among controls , but not among intervention subjects ( P < 0.05 ) . CONCLUSIONS A brief geriatric screening assessment performed in the home can detect unrecognized and treatable problems , even among relatively healthy older adults . The use of trained volunteers is a feasible strategy for providing health education and follow-up contacts . These results support the concept that preventive gerontological approaches can help maintain important aspects of health and function OBJECTIVE The aim was to formulate practice guidelines on the management of  hyperglycemia in hospitalized patients in the non-critical care setting . PARTICIPANTS The Task Force was composed of a chair , selected by the Clinical Guidelines Subcommittee of The Endocrine Society , six additional experts , and a method ologist . EVIDENCE This evidence -based guideline was developed using the Grading of Recommendations , Assessment , Development , and Evaluation ( GRADE ) system to describe both the strength of recommendations and the quality of evidence . CONSENSUS PROCESS One group meeting , several conference calls , and e-mail communications enabled consensus . Endocrine Society members , American Diabetes Association , American Heart Association , American Association of Diabetes Educators , European Society of Endocrinology , and the Society of Hospital Medicine review ed and commented on preliminary drafts of this guideline . CONCLUSIONS Hyperglycemia is a common , serious , and costly health care problem in hospitalized patients . Observational and r and omized controlled studies indicate that improvement in glycemic control results in lower rates of hospital complications in general medicine and surgery patients . Implementing a st and ardized sc insulin order set promoting the use of scheduled basal and nutritional insulin therapy is a key intervention in the inpatient management of diabetes . We provide recommendations for practical , achievable , and safe glycemic targets and describe protocol s , procedures , and system improvements required to facilitate the achievement of glycemic goals in patients with hyperglycemia and diabetes admitted in non-critical care setting Background Because of their complex clinical presentations and needs frail elderly people require another approach than people who age without many complications . Several inpatient geriatric health services have proven effectiveness in frail persons . However , the wish to live independently and policies that promote independent living as an answer to population aging call for community intervention models for frail elderly people . Maybe models such as preventive home visits , comprehensive geriatric assessment , and intermediate care qualify , but their efficacy is controversial , especially in frail elderly persons living in the community . With the Dutch EASYcare Study Geriatric Intervention Programme ( DGIP ) we developed a model to study effectiveness of problem based community intervention models in frail elderly people . Methods / Design DGIP is a community intervention model for frail elderly persons where the GP refers elderly patients with a problem in cognition , mood , behaviour , mobility , and nutrition . A geriatric specialist nurse applies a guideline -based intervention with a limited number of follow up visits . The intervention starts with the application of the EASYcare instrument for geriatric screening . The EASYcare  instrument  assesses ( instrumental ) activities of daily life , cognition , mood , and includes a goal setting item . During the intervention the nurse regularly consults the referring GP and a geriatrician . Effects on functional performance ( Groningen Activity Restriction Scale ) , health related quality of life ( MOS-20 ) , and carer burden ( Zarit Burden Interview ) are studied in an observer blinded r and omised controlled trial . 151 participants were r and omised over two treatment arms – DGIP and regular care – using pseudo cluster r and omisation . We are currently performing the follow up visits . These visits are planned three and six months after inclusion . Process measures and cost measures will be recorded . Intention to treat analyses will focus on post intervention differences between treatment groups . Discussion The design of a trial evaluating the effects of a community intervention model for frail elderly people was presented . The problem-based participant selection procedure satisfied ; few patients that the GP referred did not meet our eligibility criteria . The use of st and ard terminology makes detailed insight into the contents of our intervention possible using terminology others can underst and well OBJECTIVE To evaluate whether assessment of barriers to self-care and strategies to cope with these barriers in older adults with diabetes is superior to usual care with attention control . The American Diabetes Association guidelines recommend the assessment of age-specific barriers . However , the effect of such strategy on outcomes is unknown . RESEARCH DESIGN AND METHODS We r and omized 100 subjects aged ≥69 years with poorly controlled diabetes ( A1C > 8 % ) in two groups . A geriatric diabetes team assessed barriers and developed strategies to help patients cope with barriers for an intervention group . The control group received equal amounts of attention time . The active intervention was performed for the first 6 months , followed by a “ no-contact ” period . Outcome measures included A1C , Tinetti test , 6-min walk test ( 6MWT ) , self-care frequency , and diabetes-related distress . RESULTS We assessed 100 patients ( age 75 ± 5 years , duration 21 ± 13 years , 68 % type 2 diabetes , 89 % on insulin ) over 12 months . After the active period , A1C decreased by −0.45 % in the intervention group vs. −0.31 % in the control group . At 12 months , A1C decreased further in the intervention group by −0.21 % vs. 0 % in control group ( linear mixed-model , P < 0.03 ) . The intervention group showed additional benefits in scores on measures of self-care ( Self-Care Inventory-R ) , gait and balance ( Tinetti ) , and endurance ( 6MWT ) compared with the control group . Diabetes-related distress improved in both groups . CONCLUSIONS Only attention between clinic visits lowers diabetes-related distress in older adults . However , communication with an educator cognizant of patients ’ barriers improves glycemic control and self-care frequency , maintains functionality , and lowers distress in this population Civilization and modern medicine now allow an unprecedented number of people to survive to old age . Not only has the definition of old evolved , but the aims of medical care for the elderly have progressed far beyond survival to maximizing functional and cognitive status , improving quality of life , and preserving productivity . Although many health problems in older age can be prevented or postponed by medical interventions , the quality of medical care for older persons remains largely unexamined . Previous work on quality -of-care measurement has focused on specific diseases or aspects of care , and in some cases targeted only a slice of the older population ( 16 ) . Such targeted approaches may not present a fair picture of overall quality and may lead to unintended incentives ( gaming the system ) ( 7 ) . Although broad systems of quality -of-care evaluation are less susceptible to gaming , they seldom include quality indicators focused on aspects of care important to older sick persons ( 8 , 9 ) . Substantial variation in preferences may make quality of care for older adults particularly difficult to measure . For example , older adults do not consistently prefer care that prolongs life , particularly if this care occurs at the expense of comfort . Furthermore , many ill , older adults can not advocate for themselves and may have no family members or friends to do so on their behalf . Thus , objective measures of the care they receive are particularly important . The Assessing Care of Vulnerable Elders ( ACOVE ) project endeavored to develop a comprehensive set of  quality - assessment tools for ill older persons . Because ill older persons constitute a heterogeneous cohort that is not easily delineated , we created a system to identify high-risk , community-dwelling individuals and targeted the most important clinical conditions affecting them . Specifically , our goals for this project were the following : 1 . Develop a definition of vulnerable elders that delineates a group of community-living persons 65 years of age and older who are at high risk for death or functional decline , and develop a system to identify them . 2 . Identify important medical conditions that affect vulnerable elders and for which effective methods of prevention or management exist . 3 . Develop a set of evidence -based , quality -of-care indicators that are relevant to vulnerable elders using systematic literature review s , expert opinion , and the guidance of expert groups and stakeholders . 4 . Design a chart abstract ion tool , interview instrument , and administrative data analytic methods to implement the quality -of-care indicator system . Project Structure : Advisory Boards To make the ACOVE tools as clinical ly useful as possible and to enhance their value to those who may use them , two advisory committees oversaw the project . The Clinical Committee directed the definition of the target population and identified the target conditions . It also review ed the full set of quality indicators assembled by the expert panels ( see the Methods paper ) . The Policy Advisory Committee directed the structure of the quality indicator system and the measurement approach . This committee review ed the sampling system , considered the value of a community surveybased sample versus a sample drawn from administrative data , advised the project on methods of data collection , and advocated the use of process measures rather than outcomes .Project Overview The Appendix lists the members and institutional affiliations of the Clinical Committee and the Policy Advisory Committee and ACOVE investigators and staff . Definition and Selection of the Patient Sample We termed our target sample vulnerable elders . With the assistance of the Clinical Committee , we defined vulnerable elders as persons 65 years of age and older who are at increased risk for death or functional decline . We considered several methods of identifying a community-based sample for measurement , including use of administrative data and survey sampling . The Policy Advisory Committee advised against using a sampling method based solely on administrative data because , by definition , using utilization data to define health status and disease burden disproportionately sample s persons with higher utilization of health services and may not identify persons who are undertreated or underdiagnosed . We selected a survey method that would identify vulnerable elders regardless of the amount of health care they used and that would be versatile for use across venues and health insurance systems . Using the Medicare Current Beneficiary Survey , we determined that functional status is a more important predictor of death and functional decline than are specific clinical conditions . A parsimonious set of factors that could be asked about in a brief interview , including age , self-rated health , and functional disabilities and limitations , predicted functional decline and death . Using these factors , we developed a scoring system that identified 32 % of a nationally representative sample as vulnerable : This group had more than four times the risk for death or functional decline over a 2-year period compared to the lower-scoring majority of the sample ( 10 ) . When we applied this definition to a r and om sample of persons 65 years of age and older enrolled in managed care plans , 21 % of elders were classified as vulnerable . Target Conditions for Assessing Quality of Care We selected the target conditions for quality -of-care assessment using literature review s and a formal group-judgment process . Target conditions were conceptualized as prevalent , important to health status and quality of life , having outcomes affected by medical care , feasible to measure , and geriatric . The Clinical Committee used these criteria to select 21 diseases , geriatric syndromes , physiologic impairments , and clinical situations ( see the Methods article for a list of these 21 conditions ) . The Policy Advisory Committee added a 22nd condition , continuity and coordination of care . According to national survey estimates , the prevalence of the selected conditions ranged from 10 % to 50 % among community-dwelling elders . These conditions accounted for at least 43 % of acute hospital admissions and 33 % of office visits for persons 65 years of age and older . The process of selecting the conditions is discussed in detail elsewhere ( 11 ) . Developing  Quality -of-Care Indicators  for Vulnerable Elders Clinical experts developed potential quality indicators for each target condition using existing guidelines and clinical opinion . Indicators covered the domains of prevention , diagnosis , treatment , and follow-up . Structured literature review s were then performed to assess the evidence supporting a link between the proposed processes of care and improved outcomes in older adults . We subsequently presented the proposed quality indicators and the literature syntheses to panels of experts in geriatric care and medical specialists . These expert panels considered the indicators ' validity and feasibility . On the basis of the panels ' ratings and a comprehensive review of the set by the Clinical Committee , we developed a set of 236  quality indicators  covering the 22 conditions . The Methods article describes this process in detail . This set of indicators was review ed and modified by the American College of PhysiciansAmerican Society of Internal Medicine ( ACPASIM ) Task Force on Aging . The full set of quality indicators with the literature substantiation for 11 of the conditions constitute the remainder of this supplement . A review of the accepted quality indicators reveals their decidedly geriatric nature . Many of them focus on the transfer of information between the health care provider and the patient or patient 's proxy . In addition to disease management , the indicators pay attention to detecting classically underidentified conditions , such as depression , dementia , and functional impairment . Consideration of proportionate care , informed consent , and end-of-life issues permeates the set . Implementing the Quality Indicators We developed instruments to implement the quality indicators using information collected from three sources : the medical record , a patient ( or , if necessary , proxy ) interview , and administrative data . Medical records include all inpatient and outpatient care over a 1-year period . The interview is design ed to be conducted by telephone with the patient to identify aspects of care that are not well captured in the medical record . The  quality indicators  presented here are currently undergoing feasibility testing in two managed care plans . Scoring the quality indicators accounts for clinical circumstances , patient preferences , and patient prognosis . The scoring of each quality indicator accounts for these factors at the following five levels : 1 . Any chart documentation indicating that a care process does not apply to the patient excludes application of this indicator to the patient . 2 . Any care process that is contraindicated because of comorbidity , allergy , or intolerance ( such as contraindications to medication ) excludes application of the indicator to the patient . 3 . If an indicator states that a care process should be offered to a patient , this indicator is satisfied if the care process occurs , if the medical record ( or patient interview ) indicates that the patient rejected the care process , or if the medical record ( or patient interview ) documents that the care process was offered to the patient . 4 . If the medical record contains documentation or if during an interview a patient states that he or she would not want , under any circumstances , to be hospitalized , then the 11 indicators that would require hospitalization do not apply . Similarly , a preference not to accept surgery would exclude from application to that patient the 9 indicators that prescribe surgery or procedures that would lead to surgery . 5 . If a patient has advanced dementia or a chart-documented poor prognosis ( expected survival < 6 months ) , then BACKGROUND Although comprehensive geriatric assessment ( CGA ) has been demonstrated to confer health benefits in some setting s , its value in outpatient or office setting s is uncertain . OBJECTIVE To assess the effectiveness of outpatient CGA consultation coupled with an adherence intervention on 15-month health outcomes . DESIGN A r and omized controlled trial . SETTING Community-based sites . PATIENTS 363 community-dwelling older persons who had failed a screen for at least one of four conditions ( falls , urinary incontinence , depressive symptoms , or functional impairment ) INTERVENTION A single outpatient CGA consultation coupled with an intervention to improve primary care physician and patient adherence with CGA recommendations . MEASUREMENTS Medical Outcomes Study Short Form-36 ( MOS SF-36 ) , restricted activity and bed days , Physical Performance Test , NIA lower-extremity battery . RESULTS In complete case analysis ( excluding the five control group subjects who died during the follow-up period ) , the adjusted difference in change scores ( 4.69 points ) for physical functioning between treatment and control groups indicated a significant benefit of treatment ( P = .021 ) . Similar benefits were demonstrated for number of restricted activity days and MOS SF-36 energy/fatigue , social functioning , and physical health summary scales . In analyses assigning scores of 0 to those who died , these benefits were greater , and significant benefits for the Physical Performance Test and MOS SF-36 emotional/well being , pain , and mental health summary scales were also demonstrated . CONCLUSIONS A single outpatient comprehensive geriatric assessment coupled with an adherence intervention can prevent functional and health-related quality -of-life decline among community-dwelling older persons who have specific geriatric conditions Editors ' Notes Context Clinical guidelines provide conflicting recommendations about whether to prescribe statins in persons aged 75 years or older for primary prevention of unwanted cardiovascular outcomes . Contribution This study used information from clinical trials to model the tradeoffs between benefits and harms and found that using  statins  in all persons aged 75 to 94 years would prevent new myocardial infa rct ions and deaths from coronary heart disease at an acceptable cost . Caution Small increases in the frequency or severity of harms would negate the benefits . Implication Additional research is warranted to better underst and the tradeoffs between benefits and harms in this age group . Statins are commonly used in adults aged 75 years or older ( 1 ) . Despite their widespread use , evidence for their effectiveness for primary prevention in elderly adults is unclear , and guidelines for their use in this population are inconsistent . The recently published American College of Cardiology/American Heart Association ( ACC/AHA ) Guideline on the Treatment of Blood Cholesterol to Reduce Atherosclerotic Cardiovascular Risk in Adults gave limited recommendations for statin use for primary prevention in adults aged 75 years or older ( 2 ) , noting that few data were available to indicate an atherosclerotic cardiovascular disease event reduction benefit in primary prevention among individuals > 75 years of age who do not have clinical year atherosclerotic cardiovascular disease , and suggesting that comorbid conditions , safety , and priorities of care are recommended for joint provider and patient decision making . The American Medical Directors Association , a professional group of long-term care providers , recommended that statins not be routinely prescribed in adults aged 70 years or older as part of the American Board of Internal Medicine Choosing Wisely campaign ( 3 ) . This recommendation was based on the lack of an association between high cholesterol levels and outcomes in older adults as well as the potential for an increased risk for statin-related adverse events , including cognitive impairment , falls , neuropathy , and muscle damage ( 3 ) . The variation in these treatment recommendations reflects uncertainty about the balance between the benefits and risks of statin use in older adults compared with younger adults as well as the more limited evidence base in this population . Adults aged 75 years or older have been underrepresented in trials of statins for primary prevention , so the effectiveness of statins is less clear in this population . Results from observational studies suggest that the associations between low-density lipoprotein ( LDL ) cholesterol levels and outcomes are attenuated in older adults ( 47 ) . Although the baseline risk for cardiovascular disease is increased in older adults , their life expectancy is shorter and their risks for competing mortality are greater . Finally , there has been concern about geriatric-specific adverse effects , especially functional limitation due to muscle pain , weakness , and mild cognitive impairment ( 816 ) . In the presence of uncertainty about the riskbenefit tradeoff , computer simulations can provide estimates of the potential benefits of various treatment strategies as well as the costs and potential risk for harms . We evaluated the population benefit and cost-effectiveness of statins in persons aged 75 years or older without a history of cardiovascular disease in the United States . This investigation was conducted using the Cardiovascular Disease Policy Model ( CVDPM ) , a Markov model of the U.S. population ( 17 ) . We simulated the impact of statins for primary prevention based on treatment of the high-risk groups identified by the ACC/AHA guidelines , the associated costs , and potential harms that could offset the potential cardiovascular benefits in the U.S. population of adults aged 75 to 94 years over the next 10 years . Methods The Model The CVDPM is an established state-transition ( Markov ) model of the incidence , prevalence , mortality , and cost of CHD and stroke in U.S. residents aged 35 to 94 years ( 17 ) . The present study was limited to adults aged 75 to 94 years . The model comprises 3 components . First , the demographic-epidemiologic submodel estimates the incidence of coronary heart disease ( CHD ) ( cardiac arrest , myocardial infa rct ion [ MI ] , angina , or CHD death ) , ischemic stroke , and death from other causes on the basis of age , sex , systolic blood pressure , smoking , high-density lipoprotein and LDL cholesterol levels , diabetes , body mass index , and statin use . Second , the bridge submodel characterizes the initial CHD or stroke event and related events in the subsequent 30 days . Third , the disease-history submodel predicts the number of subsequent CHD and stroke events , revascularization procedures , and deaths among patients with cardiovascular disease , stratified according to age , sex , and history of cardiovascular disease events . In addition , persons may exit the model at any stage through a non-CHD , nonstroke mortality function , allowing for competing risk . Modifiable components of the model include population distributions , risk factor levels , risk factor coefficients , event rates , case-fatality rates , costs , and disability adjustments ( 17 ) . Costs for stroke requiring hospitalization , CHD , and acute stroke rehabilitation were estimated using California hospital data ( 18 ) and were deflated using costcharge ratios and the ratio of the U.S. national average costs to the California average ( 19 , 20 ) . Age- and sex-specific background health care costs were estimated using national data ( 21 ) . All model costs were inflated to 2014 costs by using the medical component of the Consumer Price Index ( 22 ) . All disability weights associated with the CHD and stroke event states were based on the Global Burden of Disease Study ( 23 , 24 ) . Additional details are provided in the Appendix . Simulation Inputs We modeled the effect of statins on LDL cholesterol level based on PROSPER ( Prospect i ve Study of Pravastatin in the Elderly at Risk of Vascular Disease ) , a r and omized , placebo-controlled trial of 5804 men and women aged 70 to 82 years ( 25 ) . In that trial , the mean reduction in LDL cholesterol level was 34 % for participants with an average initial level of 147 mg/dL , consistent with the estimated effect of a moderate-dose statin in the 2013 ACC/AHA guideline ( 2 ) . We included 3 estimates for the effectiveness of a decrease in LDL cholesterol level on events . The primary estimates were derived by extrapolating the age-stratified effect sizes of a 1.0-mmol/L reduction in LDL cholesterol level from the Cholesterol Treatment Trialists ' meta- analysis ( 26 ) . We fit a regression line to the 3 age strata reported in that analysis ( 60 years , > 60 to 70 years , and > 70 years ) to estimate the effect sizes at ages 80 and 90 years . In a sensitivity analysis , we used a high estimate based on the age-pooled estimate of effect of a 1.0-mmol/L reduction in LDL cholesterol level on major coronary events in the meta- analysis . We used a low estimate based on the effect size from PROSPER for primary prevention ( 25 ) . Statin costs were derived from the National Average Drug Acquisition Cost ( NADAC ) data base ( 27 ) . Our primary cost estimate ( $ 5.59 for a 30-day supply ) was the average of the NADAC costs for the 4 moderate-dose statins that are available in generic form : atorvastatin , 10 mg ; simvastatin , 20 mg ; pravastatin , 40 mg ; and lovastatin , 40 mg . This cost estimate was $ 5.00 when indexed to 2010 dollars based on the medical component of the Consumer Price Index ( 22 ) . In addition , we used a low cost estimate of $ 4 per month , based on the price of generic statins from multiple discount retailers ( such as Walmart , Target , and Walgreens ) . For a high cost estimate , we used $ 30 for a 30-day supply ; the low and high cost estimates have been used similarly in other contemporary cost-effectiveness analyses ( 28 , 29 ) . Adults aged 65 years or older use a median of 4 medications ; therefore , we estimated the cost of an additional 0.25 physician visit per year for statin use , assuming that medication management could be covered in 1 visit ( 30 , 31 ) . We estimated 1 lipid panel per year for monitoring ( 32 ) . Event rates for myopathy and hemorrhagic stroke were estimated as 0.001 per statin-year of use , based on the ACC/AHA guideline statement ( 2 ) . Although many major and minor adverse effects have been reported to be associated with statin use , we focused on 2 that are important to geriatric population s and that have generated concern in the scientific literature : functional limitation due to muscle pain and weakness , and mild cognitive impairment ( 816 ) . Both are prevalent in older adults and can have a substantial effect on quality of life and the ability to live independently . A recent review of late-life activity limitations in the United States reported data on participants in 5 nationally representative surveys . The prevalence of limitations in activities of daily living was 27 % in adults aged 75 to 84 years and 45 % in those aged 85 years or older ( 33 ) . The population -weighted average of these estimates is 32 % for adults aged 75 to 94 years . Widely varying prevalence estimates for mild cognitive impairment have been reported due to the differential measures of this condition and the differences between population s. A recent review reported prevalence of mild cognitive impairment of 19 % to 28 % in studies of older U.S. adults ; we used the average of the 4 U.S. studies , which was 25 % ( 34 ) . Disability-adjusted life-years for the corresponding states were calculated as 1 minus the disability weights reported in the Global Burden of Disease Study ( 24 ) . Because the statin-associated relative risk for these adverse effects is uncertain , we assumed no elevated risk for these adverse effects in our base-case scenario . The goal of this investigation was not to evaluate the strength of the literature regarding the presence of these adverse BACKGROUND In 2010 , the Canadian Thoracic Society ( CTS ) published a Consensus Summary for the diagnosis and management of asthma in children six years of age and older , and adults , including an up date d Asthma Management Continuum . The CTS Asthma Clinical Assembly subsequently began a formal clinical practice guideline up date process , focusing , in this first iteration , on topics of controversy and ⁄or gaps in the previous guidelines . METHODS Four clinical questions were identified as a focus for the up date d guideline : the role of noninvasive measurements of airway inflammation for the adjustment of anti-inflammatory therapy ; the initiation of adjunct therapy to inhaled corticosteroids ( ICS ) for uncontrolled asthma ; the role of a single inhaler of an ICS⁄long-acting beta(2)-agonist combination as a reliever , and as a reliever and a controller ; and the escalation of controller medication for acute loss of asthma control as part of a self-management action plan . The expert panel followed an adaptation process to identify and appraise existing guidelines on the specified topics . In addition , literature search es were performed to identify relevant systematic review s and r and omized controlled trials . The panel formally assessed and grade d the evidence , and made 34 recommendations . RESULTS The up date d guideline recommendations outline a role for inclusion of assessment of sputum eosinophils , in addition to st and ard measures of asthma control , to guide adjustment of controller therapy in adults with moderate to severe asthma . Appraisal of the evidence regarding which adjunct controller therapy to add to ICS and at what ICS dose to begin adjunct therapy in children and adults with poor asthma control supported the 2010 CTS Consensus Summary recommendations . New recommendations for the adjustment of controller medication within written action plans are provided . Finally , priority areas for future research were identified . CONCLUSIONS The present clinical practice guideline is the first up date of the CTS Asthma Guidelines following the Canadian Respiratory Guidelines Committee 's new guideline development process . Tools and strategies to support guideline implementation will be developed and the CTS will continue to regularly provide up date s reflecting new evidence
Telemedicine interventions can improve communication and connection between older patients and their providers , and improve glycemic control .
Summary A systematic review confirmed the efficacy and safety of metformin as first-line therapy of type 2 diabetes in the older adult , but multiple reports highlighted the risk for vitamin B12 deficiency .
R and omized controlled trials showed the efficacy and safety of antihyperglycemic agents in the elderly , including some with longer duration and lesser risk for hypoglycemia .
R and omized clinical trials showed cardiovascular protection with SGLT-2i ( empagliflozin , canagliflozin ) and GLP-1RA ( liraglutide , semaglutide ) .
Purpose of Review The current approach to diabetes in the elderly incorporates components from the comprehensive geriatric approach .
The most up date d guidelines from the American Diabetes Association reflect influence from the consensus made in 2012 with the American Geriatrics Society .
Notably , the framework included the evaluation for geriatric syndromes ( falls and urinary incontinence ) , functional and cognitive abilities .
The goal for this review is to provide an up date d summary of treatment strategies for community-dwelling older adults .
Recent Findings Findings on cardiovascular protection with sodium-glucose co-transporter 2 inhibitors ( SGLT-2i ) and some glucagon-like peptide 1 receptor agonists ( GLP-1RA ) support their use for older patients with diabetes .
Functional medicine concepts can offer additional adjuvant strategies to support the therapeutic interventions and management of diabetes in the elderly .
The most current guidelines recommend addressing for geriatric syndromes , physical and cognitive function in the elderly , in order to individualize targets and therapeutic strategies .