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Background The aim was to estimate the prevalence of frailty and relative contribution of physical/balance, nutritive, cognitive and sensory frailty to important adverse health states (falls, physical activity levels, outdoor mobility, problems in self-care or usual activities, and lack of energy or accomplishment) in an English cohort by age and sex. Methods Analysis of baseline data from a cohort of 9803 community-dwelling participants in a clinical trial. The sample was drawn from a random selection of all people aged 70 or more registered with 63 general practices across England. Data were collected by postal questionnaire. Frailty was measured with the Strawbridge questionnaire. We used cross sectional, multivariate logistic regression to estimate the association between frailty domains and known correlates and adjusted for age. Some models were stratified by sex. Results Mean age of participants was 78 years (sd 5.7), range 70 to 101 and 47.5% (4653/9803) were men. The prevalence of overall frailty was 20.7% (2005/9671) and there was no difference in prevalence by sex (Odds Ratio 0.98; 95% Confidence Interval 0.89 to 1.08). Sensory frailty was the most common and this was reported by more men (1823/4586) than women (1469/5056; Odds Ratio for sensory frailty 0.62, 95% Confidence Interval 0.57 to 0.68). Men were less likely than women to have physical or nutritive frailty. Physical frailty had the strongest independent associations with adverse health states. However, sensory frailty was independently associated with falls, less frequent walking, problems in self-care and usual activities, lack of energy and accomplishment. Conclusions Physical frailty was more strongly associated with adverse health states, but sensory frailty was much more common. The health gain from intervention for sensory frailty in England is likely to be substantial, particularly for older men. Sensory frailty should be explored further as an important target of intervention to improve health outcomes for older people both at clinical and population level. Trial registration ISRCTN71002650.

Additional file 1. Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) 2013 Checklist: recommended items to address in a clinical trial protocol and related documents*.

Background People with chronic obstructive pulmonary disease (COPD) are at increased risk of depression and anxiety, which greatly reduces their quality of life and is associated with worse outcomes; but these psychological co-morbidities are under-recognised and undertreated in COPD patients. Pulmonary rehabilitation (PR) improves mood for up to 6 months but health practitioners under-refer, and patients commonly fail to attend/complete PR. Research suggests that complex non-pharmacological interventions, including both psychological and exercise components, may reduce anxiety and depression in COPD. We have developed a tailored, cognitive behavioural approach (CBA) intervention for patients with COPD and co-morbid anxiety and/or depression (‘TANDEM’), which precedes and optimises the benefits of currently offered PR. We hypothesise that such a psychological intervention, delivered by supervised, trained respiratory healthcare professionals, will improve mood in patients with mild to moderate anxiety and/or depression and encourage uptake and completion of PR. Methods We will conduct a multi-centre, pragmatic, randomised controlled trial of the TANDEM intervention compared to usual care across the Midlands, London, the South East and Bristol, UK. We will train healthcare professionals familiar with COPD to deliver the manualised, tailored, face-to-face, one-to-one intervention weekly for 6–8 weeks. We will recruit 430 participants from primary, community and secondary care with confirmed COPD and moderate to very severe airflow limitation, who are eligible for assessment for PR, and who screen positive for symptoms of mild/moderate depression and/or anxiety using the Hospital Anxiety and Depression scale (HADS). Participants will be randomised 1.25:1 (intervention: usual care). The co-primary outcomes are the HADS anxiety and depression subscale scores at 6 months; participants will be followed up to 12 months. Secondary outcomes include uptake and completion of PR and healthcare resource use. There will be a parallel process evaluation and a health economic evaluation. Discussion The TANDEM intervention has the potential to optimise the unrealised synergy between a psychological intervention and PR. The CBA sessions will precede PR and target individuals’ cognitions, behaviours and symptoms associated with anxiety and depression to decrease psychological morbidity and increase effective self-management amongst patients with COPD. Trial registration ISRCTN, ID: ISRCTN59537391. Registered on 20 March 2017. Protocol version 6.0, 22 April 2018.

Additional file 2. Family members’ focus group guide; questions based on knowledge of antimicrobial resistance, usual practice, views on the algorithm. (DOCX 30 kb)

Additional file 1. SPIRIT 2013 Checklist: Recommended items to address in a clinical trial protocol and related documents*.

Additional file 1. Available and matched placement details. Description: Table detailing placements that were available, including title, type of provider, details of the role, and which placements were filled.

Additional file 1. Care home staff focus group guide; questions based on knowledge of antimicrobial resistance, usual practice, views on the algorithm, and how data might be collected in the study.

Additional file 3. GP interview guide; questions based on usual practice, views on the algorithm.

Background or aim Despite guidelines and the International Classification of Headache Disorders (ICHD-III beta) criteria, the diagnosis of common chronic headache disorders can be challenging for non-expert clinicians. The aim of the review was to identify headache classification tools that could be used by a non-expert clinician to classify common chronic disorders in primary care. Methods We conducted a systematic literature review of studies validating diagnostic and classification headache tools published between Jan 1988 and June 2016 from key databases: MEDLINE, ASSIA, Embase, Web of Knowledge and PsycINFO. Quality assessment was assessed using items of the Quality of Diagnostic Accuracy Studies (QUADAS-2). Results The search identified 38 papers reporting the validation of 30 tools designed to diagnose, classify or screen for headache disorders; nine for multiple headache types, and 21 for one headache type only. We did not identify a tool validated in a primary care that can be used by a non-expert clinician to classify common chronic headache disorders and screen for primary headaches other than migraine and tension-type headache in primary care. Conclusions Despite the availability of many headache classification tools we propose the need for a tool that could support primary care clinicians in diagnosing and managing chronic headache disorders within primary care, and allow more targeted referral to headache specialists.

Low back pain (LBP) varies over time. Consumers, clinicians and researchers use various terms to describe fluctuations of LBP symptoms. Although "flare" is commonly used to describe symptom fluctuation, there is no consensus on how it is defined. This study aimed to obtain consensus for a LBP flare definition using a mixed-method approach. Step 1 involved derivation of a preliminary candidate flare definition based on thematic analysis of consumers' views in consultation with an expert consumer writer. In Step 2, a workshop was conducted to incorporate perspectives of LBP experts into the preliminary flare definition, which resulted in two alternative LBP flare definitions. Step 3 refined the definition using a two-round Delphi consensus process with experts in musculoskeletal conditions. The definition favoured by experts was further tested with individuals with LBP in Step 4, using the definition in three scenarios. This multiphase study produced a LBP flare definition that distinguishes it from other LBP fluctuations, represents views of consumers, involves expert consensus, and is understandable by consumers in clinical and research contexts: "A flare-up is a worsening of your condition that lasts from hours to weeks that is difficult to tolerate and generally impacts your usual activities and/or emotions". Perspective: A multiphase processes produced a low back pain (LBP) flare definition that distinguishes it from other LBP fluctuations, involves expert consensus and represents consumers' views.

Figure S1 and Table S6. Parameter distributions. (PDF 176 kb)

Voting results from the consensus conference pleanary session. (DOCX 30 kb)

Additional file 1 General expressions for B and var(B) for K−1 early outcomes. Expressions B and var(B) for unequal group sizes for two early outcomes. R code for the worked example.