Background Frailty, a state of increased vulnerability to adverse health outcomes, is important in diabetes management. We aimed to quantify the prevalence of frailty in people with diabetes, and to summarise the association between frailty and generic outcomes (eg, mortality) and diabetes-specific outcomes (eg, hypoglycaemia). Methods In this systematic review and study-level meta-analysis, we searched MEDLINE, Embase, and Web of Science for observational studies published between Jan 1, 2001 (the year of the original publication of the Fried frailty phenotype), to Nov 26, 2019. We included studies that assessed and quantified frailty in adults with diabetes, aged 18 years and older; and excluded conference abstracts, grey literature, and studies not published in English. Data from eligible studies were extracted using a piloted data extraction form. Our primary outcome was the prevalence of frailty in people with diabetes. Secondary outcomes were incidence of frailty and generic and diabetes-specific outcomes. Data were assessed by random-effects meta-analysis where possible and by narrative synthesis where populations were too heterogeneous to allow meta-analysis. This study is registered with PROSPERO, CRD42020163109. Findings Of the 3038 studies we identified, 118 studies using 20 different frailty measures were eligible for inclusion (n=1 375 373). The most commonly used measures of frailty were the frailty phenotype (69 [58%] of 118 studies), frailty (16 [14%]), and FRAIL scale (10 [8%]). Studies were heterogenous in setting (88 studies were community-based, 18 were outpatient-based, ten were inpatient-based, and two were based in residential care facilities), demographics, and inclusion criteria; therefore, we could not do a meta-analysis for the primary outcome and instead summarised prevalence data using a narrative synthesis. Median community frailty prevalence using frailty phenotype was 13% (IQR 9-21). Frailty was consistently associated with mortality in 13 (93%) of 14 studies assessing this outcome (pooled hazard ratio 1•51 [95% CI 1•30-1•76]), with hospital admission in seven (100%) of seven, and with disability in five (100%) of five studies. Frailty was associated with hypoglycaemia events in one study (<1%), microvascular and macrovascular complications in nine (82%) of 11 studies assessing complications, lower quality of life in three (100%) of three studies assessing quality of life, and cognitive impairment in three (100%) of three studies assessing cognitive impairment. 13 (11%) of 118 studies assessed glycated haemoglobin finding no consistent relationship with frailty. Interpretation The identification and assessment of frailty should become a routine aspect of diabetes care. The relationship between frailty and glycaemia, and the effect of frailty in specific groups (eg, middle-aged [aged <65 years] people and people in low-income and lower-middle-income countries) needs to be better understood to enable diabetes guidelines to be tailored to individuals with frailty. Funding Medical Rese...

Background Representativeness of antihypertensive drug trials is uncertain, as many trials recruit few or no older people. Some trials specifically recruit older participants to address this. Here, we assess the representativeness of trials focusing on older people by comparing the rates of serious adverse events in these trials with the rates in trials of a general adult population (ie, standard trials), and comparing these findings to the rate of hospitalisations and deaths in people with hypertension starting a similar treatment in routine clinical practice.Methods For this observational study, we identified randomised controlled trials (phase 2/3, 3, or 4) of reninangiotensin-aldosterone system (RAAS) drugs for hypertension registered from 1999 onwards with ClinicalTrials.gov. Serious adverse events are routinely included in trial reports and are predominantly accounted for by all-cause hospitalisations and deaths. We compared serious adverse event rates in older-people trials (minimum inclusion age ≥60 years) and standard trials (minimum inclusion age <60 years) using Poisson regression models adjusted for trial characteristics (drug type, comparison type, phase, and outcome type). We identified a community cohort of 56 036 adults with hypertension commencing similar drugs to obtain an expected rate of emergency or urgent hospitalisations or deaths, and compared this rate to observed serious adverse event rates in each trial, adjusted for age and sex. For standard trials and for older-people trials, we calculated the standardised ratio of the expected to the observed rate of serious adverse events using Poisson regression models. FindingsWe included 110 trials, of which 11 (10%) were older-people trials and 99 (90%) were standard trials. Olderpeople trials had a higher rate of serious adverse events than did standard trials (median events per person per year 0•18 [IQR 0•12-0•29] vs 0•11 [0•08-0•18]; adjusted incidence rate ratio 1•76 [95% CI 1•01-3•03]). The hospitalisation and death rate in the community for those taking RAAS antihypertensives was much greater than the rate of serious adverse events reported in standard trials (standardised ratio [SR] 4•23, 95% CI 3•51-5•09) and olderpeople trials (4•76, 2•89-7•86), adjusting for age and sex. The magnitude of risk increase for serious adverse events in community patients taking RAAS did not differ when comparing older-people and standard trials (ratio of SRs 1•13, 95% CI 0•66-1•92).Interpretation Trials report substantially fewer serious adverse events than expected from rates of hospitalisations and deaths among similar-aged people receiving equivalent treatments in the community. Serious adverse event rates might be a useful metric to assess trial representativeness. Clinicians should be cautious when applying trial recommendations to older people, even when trials focus on older participants.Funding Wellcome Trust, Medical Research Council.

Background: General Practice (GP) websites are an increasingly important point of interaction, but their readability is largely unexplored. 1 in 4 adults struggle with basic literacy, and there is a socioeconomic gradient. Readable content is a prerequisite to promote health literacy. Aim: To assess GP website readability by analysing text and design factors, and to assess whether practices adapted their website text to the likely literacy levels of their populations. Design and setting: All GP websites across Scotland. Method: Text was extracted from five webpages per website and eight text readability factors were measured including Flesch Reading Ease and Flesch-Kincaid Grade Level. The relationship between readability and the Scottish Index of Multiple Deprivation (SIMD) measure of a practice population’s level of deprivation was assessed. Ten design factors contributing to readability and accessibility were scored. Results: 86% (813/941) of practices had a website. 22.9% (874/3823) of webpages were written at or below the government-recommended reading level for online content (9-14 years old), and 77.1% (2949/3823) had a higher reading age. 80.5% (3077/3823) of webpages were above the recommended level for easy-to-understand ‘Plain English.’ There was no significant association between webpage reading age and SIMD. Only 6.7% (51/764) of the websites achieved all design and accessibility recommendations. Conclusion: Straightforward changes to practice websites could improve readability and promote health literacy, but will require resources and support. Failure to provide accessible websites may inadvertently contribute to the widening of health inequalities. This is increasingly important as the move to online services accelerates.

IntroductionDiabetes mellitus is common and growing in prevalence, and an increasing proportion of people with diabetes are living to older age. Frailty is, therefore, becoming an important concept in diabetes. Frailty is associated with older age and describes a state of increased susceptibility to decompensation in response to physiological stress. A range of measures have been used to quantify frailty. This systematic review aims to identify measures used to quantify frailty in people with diabetes (any type); to summarise the prevalence of frailty in diabetes; and to describe the relationship between frailty and adverse clinical outcomes in people with diabetes.Methods and analysisThree electronic databases (Medline, Embase and Web of Science) will be searched from 2000 to November 2019 and supplemented by citation searching of relevant articles and hand searching of reference lists. Two reviewers will independently review titles, abstracts and full texts. Inclusion criteria include: (1) adults with any type of diabetes mellitus; (2) quantify frailty using any validated frailty measure; (3) report the prevalence of frailty and/or the association between frailty and clinical outcomes in people with diabetes; (4) studies that assess generic (eg, mortality, hospital admission and falls) or diabetes-specific outcomes (eg, hypoglycaemic episodes, cardiovascular events, diabetic nephropathy and diabetic retinopathy); (5) cross-sectional and longitudinal observational studies. Study quality will be assessed using the Newcastle–Ottawa Scale for observational studies. Clinical and methodological heterogeneity will be assessed, and a random effects meta-analysis performed if appropriate. Otherwise, a narrative synthesis will be performed.Ethics and disseminationThis manuscript describes the protocol for a systematic review of observational studies and does not require ethical approval.PROSPERO registration numberCRD42020163109.

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