Introduction: High-quality randomised controlled trials (RCTs) provide the most reliable evidence on the comparative efficacy of new medicines. However, non-randomised studies (NRS) are increasingly recognised as a source of insights into the real-world performance of novel therapeutic products, particularly when traditional RCTs are impractical or lack generalisability. This means there is a growing need for synthesising evidence from RCTs and NRS in healthcare decision making, particularly given recent developments such as innovative study designs, digital technologies and linked databases across countries. Crucially, however, no formal framework exists to guide the integration of these data types. Objectives and Methods: To address this gap, we used a mixed methods approach (review of existing guidance, methodological papers, Delphi survey) to develop guidance for researchers and healthcare decision-makers on when and how to best combine evidence from NRS and RCTs to improve transparency and build confidence in the resulting summary effect estimates. Results: Our framework comprises seven steps on guiding the integration and interpretation of evidence from NRS and RCTs and we offer recommendations on the most appropriate statistical approaches based on three main analytical scenarios in healthcare decision making (specifically, ‘high-bar evidence’ when RCTs are the preferred source of evidence, ‘medium,’ and ‘low’ when NRS is the main source of inference). Conclusion: Our framework augments existing guidance on assessing the quality of NRS and their compatibility with RCTs for evidence synthesis, while also highlighting potential challenges in implementing it. This manuscript received endorsement from the International Society for Pharmacoepidemiology.

Respiratory infections among older adults in long-term care facilities (LTCFs) are a major global concern, yet a rigorous systematic synthesis of the literature on the burden of respiratory infections in the LTCF setting is lacking. To address the critical need for evidence regarding the global burden of respiratory infections in LTCFs, we assessed the burden of respiratory infections in LTCFs through a systematic review of the published literature. We identified articles published between April 1964 and March 2019 through searches of PubMed (MEDLINE), EMBASE, and the Cochrane Library. Experimental and observational studies published in English that included adults aged ≥60 residing in LTCFs who were unvaccinated (to identify the natural infection burden), and that reported measures of occurrence for influenza, respiratory syncytial virus (RSV), or pneumonia were included. Disagreements about article inclusion were discussed and articles were included based on consensus. Data on study design, population, and findings were extracted from each article. Findings were synthesized qualitatively. A total of 1451 articles were screened for eligibility, 345 were selected for full-text review, and 26 were included. Study population mean ages ranged from 70.8 to 90.1 years. Three (12%) studies reported influenza estimates, 7 (27%) RSV, and 16 (62%) pneumonia. Eighteen (69%) studies reported incidence estimates, 7 (27%) prevalence estimates, and 1 (4%) both. Seven (27%) studies reported outbreaks. Respiratory infection incidence estimates ranged from 1.1 to 85.2% and prevalence estimates ranging from 1.4 to 55.8%. Influenza incidences ranged from 5.9 to 85.2%. RSV incidence proportions ranged from 1.1 to 13.5%. Pneumonia prevalence proportions ranged from 1.4 to 55.8% while incidence proportions ranged from 4.8 to 41.2%. The reported incidence and prevalence estimates of respiratory infections among older LTCF residents varied widely between published studies. The wide range of estimates offers little useful guidance for decision-making to decrease respiratory infection burden. Large, well-designed epidemiologic studies are therefore still necessary to credibly quantify the burden of respiratory infections among older adults in LTCFs, which will ultimately help inform future surveillance and intervention efforts.

BACKGROUND/OBJECTIVES: Guideline‐based management of cardiovascular disease often involves prescribing multiple medications, which contributes to polypharmacy and risk for adverse drug events in older adults. Deprescribing is a potential strategy to mitigate these risks. We sought to characterize and compare clinician perspectives regarding deprescribing cardiovascular medications across three specialties. DESIGN: National cross‐sectional survey. SETTING: Ambulatory. PARTICIPANTS: Random sample of geriatricians, general internists, and cardiologists from the American College of Physicians. MEASUREMENTS: Electronic survey assessing clinical practice of deprescribing cardiovascular medications, reasons and barriers to deprescribing, and choice of medications to deprescribe in hypothetical clinical cases. RESULTS: In each specialty, 750 physicians were surveyed, with a response rate of 26% for geriatricians, 26% for general internists, and 12% for cardiologists. Over 80% of respondents within each specialty reported that they had recently considered deprescribing a cardiovascular medication. Adverse drug reactions were the most common reason for deprescribing for all specialties. Geriatricians also commonly reported deprescribing in the setting of limited life expectancy. Barriers to deprescribing were shared across specialties and included concerns about interfering with other physicians' treatment plans and patient reluctance. In hypothetical cases, over 90% of physicians in each specialty chose to deprescribe when patients experienced adverse drug reactions. Geriatricians were most likely and cardiologists were least likely to consider deprescribing cardiovascular medications in cases of limited life expectancy (all P < .001), such as recurrent metastatic cancer (84% of geriatricians, 68% of general internists, and 45% of cardiologists), Alzheimer dementia (92% of geriatricians, 81% of general internists, and 59% of cardiologists), or significant functional impairment (83% of geriatricians, 68% of general internists, and 45% of cardiologists). CONCLUSIONS: While barriers to deprescribing cardiovascular medications are shared across specialties, reasons for deprescribing, especially in the setting of limited life expectancy, varied. Implementing deprescribing will require improved processes for both physician‐physician and physician‐patient communication. J Am Geriatr Soc 68:78–86, 2019

After acute myocardial infarction (AMI), β-blockers are a mainstay of guideline-recommended care for adults.^1,2 Randomized trials in middle-aged and young-old adults (ie, aged 65-75 years) show that treatment with β-blockers after AMI reduces mortality by 25% to 30%.^3-5 Multiple observational studies have found a similar level of mortality reduction in adults 85 years or older and in those with functional impairment or multiple chronic conditions.^6-9

Hip fractures are associated with significant morbidity and mortality in the nursing home. Our objective was to describe the incidence rate (IR) of hip fracture according to age, sex, and race in a nationwide sample of long-stay nursing home residents. Using 2007–2010 Medicare claims data linked with the Minimum Data Set, we identified 892,837 long-stay residents (≥100 days in the same nursing facility) between May 1, 2007 and April 30, 2008. Hip fractures were defined using Part A diagnostic codes (ICD-9). Residents were followed from the date they became a long-stay resident until the first event of death, discharge, hip fracture, or 2 years of follow-up. Mean age was 84 years (range 65–113 years), and 74.5% were women. 83.9% were white and 12.0% were black. The overall IR of hip fracture was 2.3/100 person years. The IR was similar in men and women across age groups. The IR of hip fracture was highest in Native Americans aged 85 years or older (3.7/100 person years), in whites (2.6/100 person years), and during the first 100 days of institutionalization (2.7/100 person years). IRs of hip fracture were lowest in blacks (1.3/100 person years). In nursing home residents surviving 100 days or more in a facility, the incidence of hip fracture is high, particularly among older white, Native American, and newly admitted residents. This is the first nationwide study to provide sex- and age-specific estimates among U.S. nursing home residents, and it underscores the magnitude of the problem.

Strategies used to predict fracture in community-dwellers may not be useful in the nursing home (NH). Our objective was to develop and validate a model (Fracture Risk Assessment in Long-term Care [FRAiL]) to predict the 2-year risk of hip fracture in NH residents using readily available clinical characteristics. The derivation cohort consisted of 419,668 residents between May 1, 2007 and April 30, 2008 in fee-for service Medicare. Hip fractures were identified using Part A diagnostic codes. Resident characteristics were obtained using the Minimum Data Set and Part D claims. Multivariable competing risk regression was used to model 2-year risk of hip fracture. We validated the model in a remaining 1/3 sample (n = 209,834) and in a separate cohort in 2011 (n = 858,636). Mean age was 84 years (range 65–113 years) and 74.5% were female. During 1.8 years mean follow-up, 14,553 residents (3.5%) experienced a hip fracture. Fifteen characteristics in the final model were associated with an increased risk of hip fracture including dementia severity, ability to transfer and walk independently, prior falls, wandering, and diabetes. In the derivation sample, the concordance index was 0.69 in men and 0.71 in women. Calibration was excellent. Results were similar in the internal and external validation samples. The FRAiL model was developed specifically to identify NH residents at greatest risk for hip fracture, and it identifies a different pattern of risk factors compared with community models. This practical model could be used to screen NH residents for fracture risk and to target intervention strategies.