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Temporal trends in use of tests in UK primary care, 2000-15: retrospective analysis of 250 million tests
Objectives To assess the temporal change in test use in UK primary care and to identify tests with the greatest increase in use. Design Retrospective cohort study. Setting UK primary care. Participants All patients registered to UK General Practices in the Clinical Practice Research Datalink, 2000/1 to 2015/16. Main outcome measures Temporal trends in test use, and crude and age and sex standardised rates of total test use and of 44 specific tests. Results 262 974 099 tests were analysed over 71 436 331 person years. Age and sex adjusted use increased by 8.5% annually (95% confidence interval 7.6% to 9.4%); from 14 869 tests per 10 000 person years in 2000/1 to 49 267 in 2015/16, a 3.3-fold increase. Patients in 2015/16 had on average five tests per year, compared with 1.5 in 2000/1. Test use also increased statistically significantly across all age groups, in both sexes, across all test types (laboratory, imaging, and miscellaneous), and 40 of the 44 tests that were studied specifically. Conclusion Total test use has increased markedly over time, in both sexes, and across all age groups, test types (laboratory, imaging, and miscellaneous) and for 40 of 44 tests specifically studied. Of the patients who underwent at least one test annually, the proportion who had more than one test increased significantly over time.
Oral hormone pregnancy tests and the risks of congenital malformations: a systematic review and meta-analysis
Background: Oral hormone pregnancy tests (HPTs), such as Primodos, containing ethinylestradiol and high doses of norethisterone, were given to over a million women from 1958 to 1978, when Primodos was withdrawn from the market because of concerns about possible teratogenicity. We aimed to study the association between maternal exposure to oral HPTs and congenital malformations. Methods: We have performed a systematic review and meta-analysis of case-control and cohort studies that included data from pregnant women and were exposed to oral HPTs within the estimated first three months of pregnancy, if compared with a relevant control group. We used random-effects meta-analysis and assessed the quality of each study using the Newcastle–Ottawa Scale for non-randomized studies. Results: We found 16 case control studies and 10 prospective cohort studies, together including 71 330 women, of whom 4209 were exposed to HPTs. Exposure to oral HPTs was associated with a 40% increased risk of all congenital malformations: pooled odds ratio (OR) = 1.40 (95% CI 1.18 to 1.66; P<0.0001; I2 = 0%). Exposure to HPTs was associated with an increased risk of congenital heart malformations: pooled OR = 1.89 (95% CI 1.32 to 2.72; P = 0.0006; I2=0%); nervous system malformations OR = 2.98 (95% CI 1.32 to 6.76; P = 0.0109 I2 = 78%); gastrointestinal malformations, OR = 4.50 (95% CI 0.63 to 32.20; P = 0.13; I2 = 54%); musculoskeletal malformations, OR = 2.24 (95% CI 1.23 to 4.08; P= 0.009; I2 = 0%); the VACTERL syndrome (Vertebral defects, Anal atresia, Cardiovascular anomalies, Tracheoesophageal fistula, Esophageal atresia, Renal anomalies, and Limb defects), OR = 7.47 (95% CI 2.92 to 19.07; P < 0.0001; I2 = 0%). Conclusions: This systematic review and meta-analysis shows that use of oral HPTs in pregnancy is associated with increased risks of congenital malformations.
Non-pharmacological interventions for depression/anxiety in older adults with physical comorbidities affecting functioning: systematic review and meta-analysis
Objective: To review the effectiveness of non-pharmacological interventions in older adults with depression or anxiety and comorbidities affecting functioning. Design: Systematic review and meta-analysis of randomized controlled trials, including searches of 10 databases (inception-Jul 2017). Setting: Home/community. Participants: People aged 60 and over experiencing functional difficulties from physical or cognitive comorbidities and have symptoms or a diagnosis of depression and/or anxiety. Interventions: Non-pharmacological interventions targeted at depression/anxiety. Measurements: We extracted outcome data on depressive symptoms, quality of life, functioning, and service use. We used random effects meta-analysis to pool study data where possible. Two authors assessed the risk of bias using the Cochrane Risk of Bias tool. Results: We identified 14 eligible trials including 2099 randomized participants and two subgroup analyses. Problem-solving therapy (PST) reduced short-term clinician-rated depressive symptoms (n = 5 trials, mean difference in Hamilton Depression Rating Scale score −4.94 [95% CI −7.90 to −1.98]) but not remission, with limited evidence for effects on functioning and quality of life. There was limited high-quality evidence for other intervention types. Collaborative care did not appear to affect depressive symptoms, functioning, or quality of life; and had mixed evidence for effects upon remission. No intervention consistently affected service use, but trials were limited by small sample sizes and short follow-up periods. No anxiety interventions were identified. Conclusion: PST may reduce depressive symptoms post-intervention in older people with depression and functional impairments. Collaborative care appears to have few effects in this population. Future research needs to assess cost-effectiveness, long-term outcomes, and anxiety interventions for this population.
Understanding the impact of delegated home visiting services accessed via general practice by community-dwelling patients: a realist review protocol
Introduction: In western countries, early visiting services (EVS) have been proposed as a recent intervention to reduce both general practitioner workload and hospital admissions among housebound individuals experiencing a healthcare need within the community. EVS involves the delegation of the patient home visits to other staff groups such as paramedics or nursing staff. However, the principles of organising this care are unknown and it remains unclear how different contexts, such as patient conditions and the processes of organising EVS influence care outcomes. A review has been designed to understand how EVS are enacted and, specifically, who benefits, why, how and when in order to provide further insight into the design and delivery of EVS. Methods and analysis: The purpose of this review is to produce findings that provide explanations of how and why EVS contexts influence their associated outcomes. Evidence on EVS will be consolidated through realist review—a theory-driven approach to evidence synthesis. A realist approach is needed as EVS is a complex intervention. What EVS achieve is likely to vary for different individuals and contexts. We expect to synthesise a range of relevant data such as qualitative, quantitative and mixed-method research in the following stages: devising an initial programme theory, searching evidence, selecting appropriate documents, extracting data, synthesising and refining the programme theory.
Population‐calibrated multiple imputation for a binary/categorical covariate in categorical regression models
Multiple imputation (MI) has become popular for analyses with missing data in medical research. The standard implementation of MI is based on the assumption of data being missing at random (MAR). However, for missing data generated by missing not at random mechanisms, MI performed assuming MAR might not be satisfactory. For an incomplete variable in a given data set, its corresponding population marginal distribution might also be available in an external data source. We show how this information can be readily utilised in the imputation model to calibrate inference to the population by incorporating an appropriately calculated offset termed the “calibrated‐δ adjustment.” We describe the derivation of this offset from the population distribution of the incomplete variable and show how, in applications, it can be used to closely (and often exactly) match the post‐imputation distribution to the population level. Through analytic and simulation studies, we show that our proposed calibrated‐δ adjustment MI method can give the same inference as standard MI when data are MAR, and can produce more accurate inference under two general missing not at random missingness mechanisms. The method is used to impute missing ethnicity data in a type 2 diabetes prevalence case study using UK primary care electronic health records, where it results in scientifically relevant changes in inference for non‐White ethnic groups compared with standard MI. Calibrated‐δ adjustment MI represents a pragmatic approach for utilising available population‐level information in a sensitivity analysis to explore potential departures from the MAR assumption.
Barriers to a software reminder system for risk assessment of stroke in atrial fibrillation: a process evaluation of a cluster randomised trial in general practice
Background: Oral anticoagulants reduce the risk of stroke in patients with atrial fibrillation (AF), but are underused. AURAS-AF (AUtomated Risk Assessment for Stroke in AF) is a software tool designed to identify eligible patients and promote discussions within consultations about initiating anticoagulants. Aim: To investigate the implementation of the software in UK general practice. Design and setting: Process evaluation involving 23 practices randomly allocated to use AURAS-AF during a cluster randomised trial. Method: An initial invitation to discuss anticoagulation was followed by screen reminders appearing during consultations until a decision had been made. The reminders required responses, giving reasons for cases where an anticoagulant was not initiated. Qualitative interviews with clinicians and patients explored acceptability and usability. Results: In a sample of 476 patients eligible for the invitation letter, only 159 (33.4%) were considered suitable for invitation by their GPs. Reasons given were frequently based on frailty, and risk of falls or haemorrhage. Of those invited, 35 (22%) started an anticoagulant (7.4% of those originally identified). A total of 1695 main-screen reminders occurred in 940 patients. In 883 instances, the decision was taken not to initiate and a range of reasons offered. Interviews with 15 patients and seven clinicians indicated that the intervention was acceptable, though the issue of disruptive screen reminders was raised. Conclusion: Automated risk assessment for stroke in atrial fibrillation and prompting during consultations are feasible and generally acceptable, but did not overcome concerns about frailty and risk of haemorrhage as barriers to anticoagulant uptake.
A multi-modal recruitment strategy using social media and internet-mediated methods to recruit a multidisciplinary, international sample of clinicians to an online research study
Challenges exist in recruiting an international sample of clinicians and researchers to an online survey. Traditional recruitment methods remain relevant but issues such as narrow geographical reach, high cost and time intensity limit what can be achieved when aiming to recruit an international, multi-disciplinary sample. Internet-mediated and social media approaches to recruitment and engagement offer new, untested ways of capitalizing upon existing professional networks. Objective: To develop, use and appraise a multi-modal recruitment strategy for an online, international survey regarding the management of shoulder pain. Methods: Traditional recruitment methods were combined with internet-mediated recruitment methods to form a multi-modal recruitment strategy. An overview of the development of this three-month recruitment strategy is provided and the value and role of each strand of the recruitment strategy discussed. Results: In response to the multi-modal recruitment strategy, data was received from 565 clinicians and researchers from 31 countries (64% UK). Complete data was received from 387 respondents with no demographic differences between respondents who completed, and those who started but did not complete the survey. Over 30% of responses were received within 1 week, 50% within 4 weeks and 81% within 8 weeks. Conclusions: This study shows the acceptability and international, multidisciplinary reach of a low cost multi-modal recruitment strategy for an online survey of international clinicians and researchers. Incorporating the use of social media proved to be an effective, time and resource-efficient recruitment strategy for this online survey and appeared to enhance clinician engagement. A multimodal recruitment strategy is worthy of consideration for future online surveys of clinicians and researchers.
Restructuring physical micro-environments to reduce the demand for meat: a systematic review and qualitative comparative analysis
Background Reducing meat consumption could help to protect the natural environment and promote population health. Interventions restructuring physical micro-environments might help to change habitual behaviour. We synthesised the scientific evidence pertaining to whether, and which, interventions restructuring physical micro-environments effectively reduce the demand for meat. Methods We did a systematic review of quantitative studies evaluating the effectiveness of interventions restructuring physical micro-environments to reduce the demand for meat. We identified relevant records by searching six electronic databases (CAB Abstracts, Embase, PsycINFO, Science Citation Index, MEDLINE, and Dissertations & Theses) on Aug 31, 2017, contacting experts, screening publicly accessible online resources, and searching references. We included studies that evaluated the effectiveness of interventions restructuring physical micro-environments to reduce the demand for meat, defined as the actual or intended consumption, purchase, or selection of meat in real or virtual environments. We extracted data pertaining to the study samples, the interventions, and meat demand at the follow-up closest to intervention completion and at the longest follow-up, with the former representing our primary outcome. We synthesised data narratively and did a qualitative comparative analysis to identify configurations of intervention characteristics associated with, and those not found to be associated with, significant reductions in meat demand. Our Systematic Review is registered with PROSPERO, number CRD42017081532. Results Of 10 733 titles and abstracts screened for eligibility, we assessed 60 full papers and included 14 papers reporting on 18 studies with 22 intervention conditions. Three interventions reducing the portion size of meat servings reduced meat consumption in randomised trials. Three interventions providing meat alternatives with supporting educational material were associated with reduced meat demand in pre-post design studies. Three of four interventions altering the sensory properties (eg, visual presentation) of meat or meat alternatives at point of purchase reduced meat demand in randomised trials. Four interventions repositioning meat products to be less prominent at point of purchase were associated with lower meat demand, but only two such interventions reached statistical significance in a randomised trial and a multiple treatment reversal design. Only one of five interventions manipulating the description of meat or meat alternatives at point of purchase was associated with lower meat demand in a multiple treatment reversal design. Evidence from randomised trials evaluating a pricing intervention or interventions restructuring several aspects of micro-environments was too scarce or inconsistent to be conclusive. The results from our qualitative comparative analysis supported the findings of this narrative synthesis. Interpretation Some interventions restructuring physical micro-environments could help to promote lower demand for meat. Interventions reducing portion sizes of meat servings, providing meat alternatives, or changing the sensory properties of meat and meat alternatives at point of purchase offered the most promise in the context of experimental studies.
Depression, depressive symptoms and treatments in women who have recently given birth: UK cohort study
Objectives: To investigate how depression is recognised in the year after child birth and treatment given in clinical practice. Design: Cohort study based on UK primary care electronic health records. Setting: Primary care. Participants: Women who have given live birth between 2000 and 2013. Outcomes: Prevalence of postnatal depression, depression diagnoses, depressive symptoms, antidepressant and non-pharmacological treatment within a year after birth. Results: Of 206 517 women, 23 623 (11%) had a record of depressive diagnosis or symptoms in the year after delivery and more than one in eight women received antidepressant treatment. Recording and treatment peaked 6–8 weeks after delivery. Initiation of selective serotonin reuptake inhibitors (SSRI) treatment has become earlier in the more recent years. Thus, the initiation rate of SSRI treatment per 100 pregnancies (95% CI) at 8 weeks were 2.6 (2.5 to 2.8) in 2000–2004, increasing to 3.0 (2.9 to 3.1) in 2005–2009 and 3.8 (3.6 to 3.9) in 2010–2013. The overall rate of initiation of SSRI within the year after delivery, however, has not changed noticeably. A third of the women had at least one record suggestive of depression at any time prior to delivery and of these one in four received SSRI treatment in the year after delivery. Younger women were most likely to have records of depression and depressive symptoms. (Relative risk for postnatal depression: age 15–19: 1.92 (1.76 to 2.10), age 20–24: 1.49 (1.39 to 1.59) versus age 30–34). The risk of depression, postnatal depression and depressive symptoms increased with increasing social deprivation. Conclusions: More than 1 in 10 women had electronic health records indicating depression diagnoses or depressive symptoms within a year after delivery and more than one in eight women received antidepressant treatment in this period. Women aged below 30 and from the most deprived areas were at highest risk of depression and most likely to receive antidepressant treatment.
Developing an implementation strategy for a digital health intervention: an example in routine healthcare
Background: Evidence on how to implement new interventions into complex healthcare environments is often poorly reported and indexed, reducing its potential to inform initiatives to improve healthcare services. Using the implementation of a digital intervention within routine National Health Service (NHS) practice, we provide an example of how to develop a theoretically based implementation plan and how to report it transparently. In doing so we also highlight some of the challenges to implementation in routine healthcare. Methods: The implemented intervention was HeLP-Diabetes, a digital self-management programme for people with Type 2 Diabetes, which was effective in improving diabetes control. The target setting for the implementation was an inner city London Clinical Commissioning Group in the NHS comprised of 34 general practices. HeLP-Diabetes was designed to be offered to patients as part of routine diabetes care across England. Evidence synthesis, engagement of local stakeholders, a theory of implementation (Normalization Process Theory), feedback, qualitative interviews and usage data were used to develop an implementation plan. Results: A new implementation plan was developed to implement HeLP-Diabetes within routine practice. Individual component strategies were selected and developed informed by Normalization Process Theory. These strategies included: engagement of local opinion leaders, provision of educational materials, educational visits, educational meetings, audit and feedback and reminders. Additional strategies were introduced iteratively to address barriers that arose during the implementation. Barriers largely related to difficulties in allocating resources to implement the intervention within routine care. Conclusion: This paper provides a worked example of implementing a digital health intervention. The learning from this work can inform others undertaking the work of planning and executing implementation activities in routine healthcare. Of particular importance is: the selection of appropriate theory to guide the implementation process and selection of strategies; ensuring that enough attention is paid to planning implementation; and a flexible approach that allows response to emerging barriers.
Synthesizing Qualitative Data Sets to Improve the Design of Trials and Complex Health Interventions: A Worked Example
Qualitative researchers are increasingly reanalyzing and synthesizing data sets from different studies, and this method has now been used across trials to inform trial methodology and delivery. Despite this work, however, limited guidance exists about how this method should be employed. This article details an example in which interview data collected during three primary care depression trials were brought together to explore trial participants’ study and treatment journeys. It details the process involved and the decisions made. It also presents findings from this synthesis to illustrate how this method can be used to inform the development of future trials and complex interventions, through raising questions about how researchers currently define and design treatment arms and indicating what factors may improve or hinder participants’ engagement with their allocated treatment.
OPtimising Treatment for MIld Systolic hypertension in the Elderly (OPTiMISE): protocol for a randomised controlled non-inferiority trial
Introduction: Recent evidence suggests that larger blood pressure reductions and multiple antihypertensive drugs may be harmful in older people, particularly frail individuals with polypharmacy and multimorbidity. However, there is a lack of evidence to support deprescribing of antihypertensives, which limits the practice of medication reduction in routine clinical care. The aim of this trial is to examine whether antihypertensive medication reduction is possible in older patients without significant changes in blood pressure control at follow-up. Methods and analysis: This trial will use a primary care-based, open-label, randomised controlled trial design. A total of 540 participants will be recruited, aged ≥80 years, with systolic blood pressure <150 mm Hg and receiving ≥2 antihypertensive medications. Participants will have no compelling indication for medication continuation and will be considered to potentially benefit from medication reduction due to existing polypharmacy, comorbidity and frailty. Following a baseline appointment, individuals will be randomised to a strategy of medication reduction (intervention) with optional self-monitoring or usual care (control). Those in the intervention group will have one antihypertensive medication stopped. The primary outcome will be to determine if a reduction in medication can achieve a proportion of participants with clinically safe blood pressure levels at 12-week follow-up (defined as a systolic blood pressure <150 mm Hg), which is non-inferior (within 10%) to that achieved by the usual care group. Qualitative interviews will be used to understand the barriers and facilitators to medication reduction. The study will use economic modelling to predict the long-term effects of any observed changes in blood pressure and quality of life. Ethics and dissemination: The protocol, informed consent form, participant information sheet and all other participant facing material have been approved by the Research Ethics Committee (South Central—Oxford A; ref 16/SC/0628), Medicines and Healthcare products Regulatory Agency (ref 21584/0371/001–0001), host institution(s) and Health Research Authority. All research outputs will be published in peer-reviewed journals and presented at national and international conferences.
Synthesizing Qualitative Data Sets to Improve the Design of Trials and Complex Health Interventions: A Worked Example
Qualitative researchers are increasingly reanalyzing and synthesizing data sets from different studies, and this method has now been used across trials to inform trial methodology and delivery. Despite this work, however, limited guidance exists about how this method should be employed. This article details an example in which interview data collected during three primary care depression trials were brought together to explore trial participants’ study and treatment journeys. It details the process involved and the decisions made. It also presents findings from this synthesis to illustrate how this method can be used to inform the development of future trials and complex interventions, through raising questions about how researchers currently define and design treatment arms and indicating what factors may improve or hinder participants’ engagement with their allocated treatment.
Poisoning substances taken by young people: a population-based cohort study
Background Globally, poisonings account for most medically-attended self-harm. Recent data on poisoning substances are lacking, but are needed to inform self-harm prevention. Aim To assess poisoning substance patterns and trends among 10–24-year-olds across England Design and setting Open cohort study of 1 736 527 young people, using linked Clinical Practice Research Datalink, Hospital Episode Statistics, and Office for National Statistics mortality data, from 1998 to 2014. Method Poisoning substances were identified by ICD-10 or Read Codes. Incidence rates and adjusted incidence rate ratios (aIRR) were calculated for poisoning substances by age, sex, index of multiple deprivation, and calendar year. Results In total, 40 333 poisoning episodes were identified, with 57.8% specifying the substances involved. The most common substances were paracetamol (39.8%), alcohol (32.7%), non-steroidal anti-inflammatory drugs (NSAIDs) (11.6%), antidepressants (10.2%), and opioids (7.6%). Poisoning rates were highest at ages 16–18 years for females and 19–24 years for males. Opioid poisonings increased fivefold from 1998–2014 (females: aIRR 5.30, 95% confidence interval (CI) = 4.08 to 6.89; males: aIRR 5.11, 95% CI = 3.37 to 7.76), antidepressant poisonings three-to fourfold (females: aIRR 3.91, 95% CI = 3.18 to 4.80, males: aIRR 2.70, 95% CI = 2.04 to 3.58), aspirin/NSAID poisonings threefold (females: aIRR 2.84, 95% CI = 2.40 to 3.36, males: aIRR 2.76, 95% CI = 2.05 to 3.72) and paracetamol poisonings threefold in females (aIRR 2.87, 95% CI = 2.58 to 3.20). Across all substances poisoning incidence was higher in more disadvantaged groups, with the strongest gradient for opioid poisonings among males (aIRR 3.46, 95% CI = 2.24 to 5.36). Conclusion It is important that GPs raise awareness with families of the substances young people use to self-harm, especially the common use of over-the-counter medications. Quantities of medication prescribed to young people at risk of self-harm and their families should be limited, particularly analgesics and antidepressants.
Patient understanding of two commonly used patient reported outcome measures for primary care: a cognitive interview study
Background: Standardised generic patient-reported outcome measures (PROMs) which measure health status are often unresponsive to change in primary care. Alternative formats, which have been used to increase responsiveness, include individualised PROMs (in which respondents specify the outcomes of interest in their own words) and transitional PROMs (in which respondents directly rate change over a period). The objective of this study was to test qualitatively, through cognitive interviews, two PROMs, one using each respective format. Methods: The individualised PROM selected was the Measure Yourself Medical Outcomes Profile (MYMOP). The transitional PROM was the Patient Enablement Instrument (PEI). Twenty patients who had recently attended the GP were interviewed while completing the questionnaires. Interview data was analysed using a modification of Tourangeau’s model of cognitive processing: comprehension, response, recall and face validity. Results: Patients found the PEI simple to complete, but for some it lacked face validity. The transitional scale was sometimes confused with a status scale and was problematic in situations when the relevant GP appointment was part of a longer episode of care. Some patients reported a high enablement score despite verbally reporting low enablement but high regard for their GP, which suggested hypothesis-guessing. The interpretation of the PEI items was inconsistent between patients. MYMOP was more difficult for patients to complete, but had greater face validity than the PEI. The scale used was open to response-shift: some patients suggested they would recalibrate their definition of the scale endpoints as their illness and expectations changed. Conclusions: The study provides information for both users of PEI/MYMOP and developers of individualised and transitional questionnaires. Users should heed the recommendation that MYMOP should be interview-administered, and this is likely to apply to other individualised scales. The PEI is open to hypothesis-guessing and may lack face-validity for a longer episode of care (e.g. in patients with chronic conditions). Developers should be cognisant that transitional scales can be inconsistently completed: some patients forget during completion that they are measuring change from baseline. Although generic questionnaires require the content to be more general than do disease-specific questionnaires, developers should avoid questions which allow broad and varied interpretations.
Frailty trajectories to identify end of life: alongitudinal population-based study
Background:Timely recognition of the end of life allows patients to discuss preferences and make advance plans,and clinicians to introduce appropriate care. We examined changes in frailty over 1 year, with the aim of identifyingtrajectories that could indicate where an individual is at increased risk of all-cause mortality and may requirepalliative care.Methods:Electronic health records from 13,149 adults (cases) age 75 and over who died during a 1-year period(1 January 2015 to 1 January 2016) were age, sex and general practice matched to 13,149 individuals with no recordof death over the same period (controls). Monthly frailty scores were obtained for 1 year prior to death for cases, andfrom 1 January 2015 to 1 January 2016 for controls using the electronic frailty index (eFI; a cumulative deficit measureof frailty, available in most English primary care electronic health records, and ranging in value from 0 to 1). Latentgrowth mixture models were used to investigate longitudinal patterns of change and associated impact on mortality.Cases were reweighted to the population level for tests of diagnostic accuracy.Results:Three distinct frailty trajectories were identified. Rapidly rising frailty (initial increase of 0.022 eFI per monthbefore slowing from a baseline eFI of 0.21) was associated with a 180% increase in mortality (OR 2.84, 95% CI 2.34–3.45)for 2.2% of the sample. Moderately increasing frailty (eFI increase of 0.007 per month, with baseline of 0.26) wasassociated with a 65% increase in mortality (OR 1.65, 95% CI 1.54–1.76) for 21.2% of the sample. The largest (76.6%)class was stable frailty (eFI increase of 0.001 from a baseline of 0.26). When cases were reweighted to population level,rapidly rising frailty had 99.1% specificity and 3.2% sensitivity (positive predictive value 19.8%, negative predictive value93.3%) for predicting individual risk of mortality.Conclusions:People aged over 75 with frailty who are at highest risk of death have a distinctive frailty trajectory in thelast 12 months of life, with a rapid initial rise from a low baseline, followed by a plateau. Routine measurement of frailtycan be useful to support clinicians to identify people with frailty who are potential candidates for palliative care, andallow time for intervention.
The utility of long-term blood pressure variability for cardiovascular risk prediction in primary care
Objectives: Blood pressure (BP) is a long-established risk factor for cardiovascular disease (CVD). SBP is used in all widely used cardiovascular risk scores for clinical decision-making. Recently, within-person BP variability has been shown to be a major predictor of CVD. We investigated whether cardiovascular risk scores could be improved by incorporating BP variability with standard risk factors. Methods: We used cohort data on patients aged 40–74 on 1 January 2005, from English general practices contributing to the Clinical Practice Research Datalink, a research database derived from electronic health records. Data were linked to hospital episodes and mortality data. SBP variability independent of the mean was calculated across up to six clinic visits. We divided data geographically into derivation and validation data sets. In the derivation data set, we developed a reference model, incorporating risk factors used in previous scores and an index model, incorporating the same factors and BP variability. We calculated model validation statistics in the validation data set including calibration ratio and c-statistic. Results: In the derivation data set, BP variability was associated with CVD, independently of other risk factors (P = 0.005). However, in the validation data set, both models had similar c-statistic (0.7415 and 0.7419, respectively), R 2 (31.8 and 32.0, respectively) and calibration ratio (0.938 and 0.940, respectively). Conclusion: The association of BP variability with CVD is statistically significant in a large data set but does not substantially improve the performance of a cardiovascular risk score.
Defining acute flares in knee osteoarthritis: a systematic review
Objective: To identify and critically synthesise definitions of acute flares in knee osteoarthritis (OA) reported in the medical literature. Design: Systematic review and narrative synthesis. We searched Medline, EMBASE, Web of science and six other electronic databases (inception to July 2017) for original articles and conference abstracts reporting a definition of acute flare (or synonym) in humans with knee OA. There were no restrictions by language or study design (apart from iatrogenic-induced flare-ups, eg, injection-induced). Data extraction comprised: definition, pain scale used, flare duration or withdrawal period, associated symptoms, definition rationale, terminology (eg, exacerbation or flare), baseline OA severity, age, gender, sample size and study design. Results: Sixty-nine articles were included (46 flare design trials, 17 observational studies, 6 other designs; sample sizes: 15–6085). Domains used to define flares included: worsening of signs and symptoms (61 studies, 27 different measurement tools), specifically increased pain intensity; minimum pain threshold at baseline (44 studies); minimum duration (7 studies, range 8–48 hours); speed of onset (2 studies, defined as ‘sudden’ or ‘quick’); requirement for increased medication (2 studies). No definitions included activity interference. Conclusions: The concept of OA flare appears in the medical literature but most often in the context of flare design trials (pain increases observed after stopping usual treatment). Key domains, used to define acute events in other chronic conditions, appear relevant to OA flare and could provide the basis for consensus on a single, agreed definition of ‘naturally occurring’ OA flares for research and clinical application.
From substance to process: A meta-ethnographic review of how healthcare professionals and patients understand placebos and their effects in primary care
Research suggests that a ‘placebo’ can improve conditions common in primary care including pain, depression and irritable bowel syndrome. However, disagreement persists over the definition and clinical relevance of placebo treatments. We conducted a meta-ethnographic, mixed-research systematic review to explore how healthcare professionals and patients understand placebos and their effects in primary care. We conducted systematic literature searches of five databases – augmented by reference chaining, key author searches and expert opinion – related to views on placebos, placebo effects and placebo use in primary care. From a total of 34 eligible quantitative, qualitative and mixed-methods articles reporting findings from 28 studies, 21 were related to healthcare professionals’ views, 11 were related to patients’ views and two were related to both groups. In the studies under review, healthcare professionals reported using placebos at markedly different frequencies. This was highly influenced by how placebos were defined in the studies. Both healthcare professionals and patients predominantly defined placebos as material substances such as ‘inert’ pills, despite this definition being inconsistent with current scientific thinking. However, healthcare professionals also, but less prevalently, defined placebos in a different way: as contextual processes. This better concurs with modern placebo definitions, which focus on context, ritual, meaning and enactivism. However, given the enduring ubiquity of substance definitions, for both healthcare professionals and patients, we question the practical, clinical validity of stretching the term ‘placebo’ towards its modern iteration. To produce ‘placebo effects’, therefore, primary healthcare professionals may be better off abandoning placebo terminology altogether.
The tip of the iceberg: finding patients with heart failure with preserved ejection fraction in primary care. An observational study
Background: Heart failure with preserved ejection fraction (HFpEF) is under-identified in primary care. Aim: The aim of this study was to determine what information is available in patients’ primary care practice records that would identify patients with HFpEF. Design & setting: Record review in two practices in east of England. Method: Practices completed a case report form on each patient on the heart failure register and sent anonymised echocardiography reports on patients with an ejection fraction (EF) >50%. Reports were reviewed and data analysed using SPSS (version 25). Results: One hundred and forty-eight patients on the heart failure registers with mean age 77 +12 years were reviewed. Fifty-three patients (36%) had possible HFpEF based on available information. These patients were older and multimorbid, with a high prevalence of overweight and obesity. Confirmation of diagnosis was not possible as recommended HFpEF diagnostic information (natriuretic peptides, echocardiogram parameters of structural heart disease and diastolic function) was widely inconsistent or absent in these patients. Conclusion: Without correct identification of HFpEF, patient management may be suboptimal or inappropriate, and lack the needed focus on comorbidities and lifestyle that can improve patient outcomes. This study describes in detail the characteristics of many of the patients who probably have HFpEF in a real-world sample, and the improvements and diagnostic information required to better identify them. Identifying more than the tip of the iceberg that is the HFpEF population will allow the improvement of the quality of their management, the prevention of ineffective health care, and the recruitment of patients into research.