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A discursive exploration of public perspectives on placebos and their effects
There is increasing evidence that placebos could be effective in clinical practice. However, knowledge of public perspectives on placebos is underdeveloped. We conducted a discourse analysis of internet comments on news articles related to placebos, aiming to improve this knowledge for clinicians and researchers. We developed two discursive constructs of the placebo. The dominant construct of the ‘placebo pill’ informs a paradoxical understanding of placebos that closes down treatment. The less-prevalent counter-discursive construct of the ‘treatment process’ frames placebos as potentially viable within modern evidence-based medicine. We discuss the opportunities and challenges of this alternative understanding of placebos.
Health indicator recording in UK primary care electronic health records: key implications for handling missing data
Background: Clinical databases are increasingly used for health research; many of them capture information on common health indicators including height, weight, blood pressure, cholesterol level, smoking status, and alcohol consumption. However, these are often not recorded on a regular basis; missing data are ubiquitous. We described the recording of health indicators in UK primary care and evaluated key implications for handling missing data. Methods: We examined the recording of health indicators in The Health Improvement Network (THIN) UK primary care database over time, by demographic variables (age and sex) and chronic diseases (diabetes, myocardial infarction, and stroke). Using weight as an example, we fitted linear and logistic regression models to examine the associations of weight measurements and the probability of having weight recorded with individuals’ demographic characteristics and chronic diseases. Results: In total, 6,345,851 individuals aged 18–99 years contributed data to THIN between 2000 and 2015. Women aged 18–65 years were more likely than men of the same age to have health indicators recorded; this gap narrowed after age 65. About 60–80% of individuals had their height, weight, blood pressure, smoking status, and alcohol consumption recorded during the first year of registration. In the years following registration, these proportions fell to 10%–40%. Individuals with chronic diseases were more likely to have health indicators recorded, particularly after the introduction of a General Practitioner incentive scheme. Individuals’ demographic characteristics and chronic diseases were associated with both observed weight measurements and missingness in weight. Conclusion: Missing data in common health indicators will affect statistical analysis in health research studies. A single analysis of primary care data using the available information alone may be misleading. Multiple imputation of missing values accounting for demographic characteristics and disease status is recommended but should be considered and implemented carefully. Sensitivity analysis exploring alternative assumptions for missing data should also be evaluated.
Women’s views on lifestyle changes to reduce the risk of developing Type 2 diabetes after gestational diabetes: a systematic review,qualitative synthesis and recommendations for practice
Aims To synthesize systematically the literature that focuses on the views of women with a history of gestational diabetes on reducing their risk of developing diabetes postpartum through lifestyle and behaviour changes. Methods We identified qualitative studies that examined the views of women with a history of gestational diabetes towards healthy eating and physical activity, Type 2 diabetes risk management or their experience of a diabetes prevention programme, and conducted a thematic synthesis to develop descriptive and then analytical themes. We evaluated the quality of each study and the confidence that we had in its findings using the Critical Appraisal Skills Programmes criteria and the Grading of Recommendations Assessment, Development and Evaluation‐Confidence in Evidence from Reviews of Qualitative Research. Results We included 21 articles after screening 23 160 citations and 129 full texts. We identified six themes of interacting influences on postpartum behaviour: role as mother and priorities; social support; demands of life; personal preferences and experiences; risk perception and information; and finances and resources (plus preferred format of interventions). These factors inhibited many women from addressing their own health, while they motivated others to persevere. We also developed 20 recommendations, most with high or moderate confidence, for effective promotion of healthy lifestyles in this population. Conclusions Many factors hinder healthy lifestyles after gestational diabetes, yet how women interpret them can motivate or prevent changes that reduce diabetes risk. As our recommendations emphasize, women's experiences and needs should be considered when designing strategies to promote healthier lifestyles in this population.
Patients’ understanding of cellulitis and views about how best to prevent recurrent episodes: mixed‐methods study in primary and secondary care
Background: Cellulitis is a common painful infection of the skin and underlying tissues that recurs in approximately one‐third of cases. The only proven strategy to reduce the risk of recurrence is long‐term, low‐dose antibiotics. Given current concerns about antibiotic resistance and the pressure to reduce antibiotic prescribing, other prevention strategies are needed. Objectives: To explore patients’ views about cellulitis and different ways of preventing recurrent episodes. Methods: Adults aged ≥ 18 years with a history of first‐episode or recurrent cellulitis were invited through primary care, hospitals and advertising to complete a survey, take part in an interview or both. Results: Thirty interviews were conducted between August 2016 and July 2017. Two hundred and forty surveys were completed (response rate 17%). Triangulation of quantitative and qualitative data showed that people who have had cellulitis have wide‐ranging beliefs about what can cause cellulitis and are often unaware of risk of recurrence or potential strategies to prevent recurrence. Enhanced foot hygiene, applying emollients daily, exercise and losing weight were more popular potential strategies than the use of compression stockings or long‐term antibiotics. Participants expressed caution about long‐term oral antibiotics, particularly those who had experienced only one episode of cellulitis. Conclusions: People who have had cellulitis are keen to know about possible ways to prevent further episodes. Enhanced foot hygiene, applying emollients daily, exercise and losing weight were generally viewed to be more acceptable, feasible strategies than compression or antibiotics, but further research is needed to explore uptake and effectiveness in practice.
Stop smoking practitioner consensus on barriers and facilitators to smoking cessation in pregnancy and how to address these: A modified Delphi survey
Introduction: Pregnant women can experience barriers and facilitators towards achieving smoking cessation. We sought consensus from smoking cessation practitioners on how influential pre-identified barriers and facilitators can be on pregnant women's smoking behaviour, and how difficult these might be to manage. Suggestions for techniques that could help overcome the barriers or enhance the facilitators were elicited and consensus sought on the appropriateness for their use in practice. Methods: Forty-four practitioners who provided cessation support to pregnant women completed a three-round modified Delphi survey. Round one sought consensus on the ‘influence’ and ‘difficulty’ of the barriers and facilitators, and gathered respondents' suggestions on ways to address these. Rounds two and three sought further consensus on the barriers and facilitators and on ‘appropriateness’ of the respondent-suggested techniques. The techniques were coded for behaviour change techniques (BCTs) content using existing taxonomies. Results: Barriers and facilitators considered to be the most important mainly related to the influence of significant others and the women's motivation & self-efficacy. Having a supportive partner was considered the most influential, whereas lack of support from partner was the only barrier that reached consensus as being difficult to manage. Barriers relating to social norms were also considered influential, however these received poor coverage of respondent-suggested techniques. Those considered the easiest to address mainly related to aspects of cessation support, including misconceptions surrounding the use of nicotine replacement therapy (NRT). Barriers and facilitators relating to the women's motivation & self-efficacy, such as the want to protect the baby, were also considered as being particularly easy to address. Fifty of the 54 respondent-suggested techniques reached consensus as being appropriate. Those considered the most appropriate ranged from providing support early, giving correct information on NRT, highlighting risks and benefits and reinforcing motivating beliefs. Thirty-three BCTs were identified from the respondent-suggested techniques. ‘Social support (unspecified)’, ‘Tailor interactions appropriately’ and ‘Problem solving’ were the most frequently coded BCTs. Conclusions: Involving partners in quit attempts was advocated. Existing support could be potentially improved by establishing appropriate ways to address barriers relating to pregnant smokers' ‘social norms’. In general, providing consistent and motivating support seemed favourable.
Persistent unexplained physical symptoms: a prospective longitudinal cohort study in UK primary care
Background Unexplained physical symptoms (UPS) are extremely common among primary care attenders, but little is known about their longer-term outcome. Aim To investigate the persistence of somatic symptoms at 6 months among a cohort with multiple UPS, and identify prognostic factors associated with worsening symptom scores. Design and setting Prospective longitudinal cohort study involving adults attending UK general practice in North and Central London between January and December 2013. Method Consecutive adults attending nine general practices were screened to identify those with at least three UPS. Eligible participants completed measures of symptom severity (measured using the Patient Health Questionnaire Somatic Symptom Module [PHQ-15]), physical and mental wellbeing, and past health and social history, and were followed up after 6 months. Multivariable linear regression analysis was conducted to identify prognostic factors associated with the primary outcome: somatic symptom severity. Results Overall, 245/294 (83%) provided 6-month outcome data. Of these, 135/245 (55%) reported still having UPS, 103/245 (42%) had symptoms still under investigation, and only 26/245 (11%) reported complete symptom resolution. Being female, higher baseline somatic symptom severity, poorer physical functioning, experience of childhood physical abuse, and perception of poor financial wellbeing were significantly associated with higher somatic symptom severity scores at 6 months. Conclusion This study has shown that at 6 months few participants had complete resolution of unexplained somatic symptoms. GPs should be made aware of the likelihood of UPS persisting, and the factors that make this more likely, to inform decision making and care planning. There is a need to develop prognostic tools that can predict the risk of poor outcome
Benefits and harms of pregabalin in the management of neuropathic pain: a rapid review and meta-analysis of randomised clinical trials
Objective: To assess the benefits and harms of pregabalin in the management of neuropathic pain. Design: Rapid review and meta-analysis of phase III, randomised, placebo-controlled trials. Participants: Adults aged 18 years and above with neuropathic pain defined according to the International Association for the Study of Pain criteria. Interventions: Pregabalin or placebo. Primary and secondary outcome measures: Our primary outcomes were pain (as measured using validated scales) and adverse events. Our secondary outcomes were sleep disturbance, quality of life, Patient Global Impression of Change, Clinician Global Impression scale, anxiety and depression scores, overall discontinuations and discontinuations because of adverse events. Results: We included 28 trials comprising 6087 participants. The neuropathic pain conditions studied were diabetic peripheral neuropathy, postherpetic neuralgia, herpes zoster, sciatica (radicular pain), poststroke pain and spinal cord injury-related pain. Patients who took pregabalin reported significant reductions in pain (numerical rating scale (NRS)) compared with placebo (standardised mean difference (SMD) −0.49 (95% CI −0.66 to −0.32, p<0.00001), very low quality evidence). Pregabalin significantly reduced sleep interference scores (NRS) compared with placebo (SMD −0.38 (95% CI −0.50 to −0.26, p<0.00001), moderate quality evidence. Pregabalin significantly increased the risk of adverse events compared with placebo (RR 1.33 (95% CI 1.23 to 1.44, p<0.00001, low quality evidence)). The risks of experiencing weight gain, somnolence, dizziness, peripheral oedema, fatigue, visual disturbances, ataxia, non-peripheral oedema, vertigo and euphoria were significantly increased with pregabalin. Pregabalin was significantly more likely than placebo to lead to discontinuation of the drug because of adverse events (RR 1.91 (95% CI 1.54 to 2.37, p<0.00001), low quality evidence). Conclusion: Pregabalin has beneficial effects on some symptoms of neuropathic pain. However, its use significantly increases the risk of a number of adverse events and discontinuation due to adverse events. The quality of the evidence from journal publications is low.
Use of hormone replacement therapy and risk of venous thromboembolism: nested case-control studies using the QResearch and CPRD databases
Objective To assess the association between risk of venous thromboembolism and use of different types of hormone replacement therapy. Design Two nested case-control studies. Setting UK general practices contributing to the QResearch or Clinical Practice Research Datalink (CPRD) databases, and linked to hospital, mortality, and social deprivation data. Participants 80 396 women aged 40-79 with a primary diagnosis of venous thromboembolism between 1998 and 2017, matched by age, general practice, and index date to 391 494 female controls. Main outcome measures Venous thromboembolism recorded on general practice, mortality, or hospital records. Odds ratios were adjusted for demographics, smoking status, alcohol consumption, comorbidities, recent medical events, and other prescribed drugs. Results Overall, 5795 (7.2%) women who had venous thromboembolism and 21 670 (5.5%) controls had been exposed to hormone replacement therapy within 90 days before the index date. Of these two groups, 4915 (85%)and 16 938 (78%) women used oral therapy, respectively, which was associated with a significantly increased risk of venous thromboembolism compared with no exposure (adjusted odds ratio 1.58, 95% confidence interval 1.52 to 1.64), for both oestrogen only preparations (1.40, 1.32 to 1.48) and combined preparations (1.73, 1.65 to 1.81). Estradiolhad a lower risk than conjugated equine oestrogen for oestrogen only preparations (0.85, 0.76 to 0.95) and combined preparations (0.83, 0.76 to 0.91). Compared with no exposure, conjugated equine oestrogen with medroxyprogesterone acetate had the highest risk (2.10, 1.92 to 2.31), and estradiol with dydrogesterone had the lowest risk (1.18, 0.98 to 1.42). Transdermal preparations were not associated with risk of venous thromboembolism, which was consistent for different regimens (overall adjusted odds ratio 0.93, 95% confidence interval 0.87 to 1.01). Conclusions In the present study, transdermal treatment was the safest type of hormone replacement therapy when risk of venous thromboembolism was assessed. Transdermal treatment appears to be underused, with the overwhelming preference still for oral preparations.
Synthesis of researcher reported strategies to recruit adults of ethnic minorities to clinical trials in the United Kingdom: A systematic review
Background: People from ethnic minorities are reported to have higher rates of physical illness (diabetes and ischemic heart disease) and mental disorders. Disparities relate not just to diagnosis, but also to care pathways and treatment outcomes. Despite this, they are underrepresented in clinical research. This reduces the generalisability of research findings across multi ethnic populations and hinders the development of accessible services. Researchers often face difficulties in recruiting ethnic minority participants to clinical research due to low levels of cultural competence and limited resources. There are few published trials focusing on ethnic minorities in the UK and we need to understand what recruitment strategies have already been implemented and recommended when recruiting ethnic participants. This will help researchers in applying these lessons to future clinical trials. Method: To identify strategies for recruiting ethnic minorities to clinical trials in the UK a systematic review of published randomised controlled trials (RCT) exclusively targeting ethnic minorities was conducted. Multiple databases were searched by combining the terms “ethnic minorities”, “randomised controlled trials” and “United Kingdom”. Data was extracted on recruitment strategies described by each RCT and then themes were created. Results: Twenty-one included RCT's identified various strategies to recruit ethnic communities to clinical trials. These have been described under three overarching themes; adaptation of screening and outcome measures, culturally specific recruitment training and recruitment processes. Conclusion: The review highlighted that researchers employed limited strategies to enhance the recruitment level. The full extent of the use of strategies was not described well in the publications. There is a need for wider training and support for the trialist to enhance and build up recruitment skills to facilitate the recruitment of ethnic minorities to clinical trials.
Factors prospectively associated with physical activity and dietary related outcomes in people with severe mental illness: A systematic review of longitudinal studies
Understanding factors that contribute towards physical activity and diet outcomes are important for health improvement in people with severe mental illness. Cross-sectional findings on factors associated with diet and physical activity outcomes provide limited information on what predicts changes or long-term outcomes in lifestyle behaviours in people with severe mental illness. A systematic review was therefore conducted to identify prospective studies with quantitative data on baseline factors associated with follow-up diet or physical activity related outcomes. MEDLINE, EMBASE, PsycINFO, CINAHL Plus and grey literature databases were searched from inception to March 2018. From 6921 studies, 5 were eligible for physical activity related outcomes and 2 for diet related outcomes. The follow-up duration was 4 weeks to 24 months and participants were mostly diagnosed with schizophrenia. Older age was commonly related to better physical activity related outcomes, whilst higher negative symptoms were related to poorer-related outcomes. Physical activity intentions and gender were unrelated to physical activity outcomes. There was a lack of data on factors influencing dietary outcomes. Although there were some common factors predictive of physical activity including older age and negative symptoms, more high-quality research is needed to determine the effect of sociodemographic, mental health, social, clinical, lifestyle and other factors on both physical activity and dietary outcomes.
Nasal balloon autoinflation for glue ear in primary care: a qualitative interview study
Background: Nasal balloon autoinflation is an effective, non-surgical treatment for symptomatic children with glue ear, although uptake is variable and evidence about acceptability and feasibility is limited. Aim: To explore parent and healthcare professional views and experiences of nasal balloon autoinflation for children with glue ear in primary care. Design and setting: Qualitative study using semi-structured interviews with a maximum-variety sample of parents, GPs, and practice nurses. The study took place between February 2013 and September 2014. Method: Semi-structured face-to-face and telephone interviews were audiorecorded, transcribed verbatim, and analysed using inductive thematic analysis. Results: In all, 14 parents, 31 GPs, and 19 nurses were included in the study. Parents described the nasal balloon as a natural, holistic treatment that was both acceptable and appealing to children. GPs and nurses perceived the method to be a low-cost, low-risk strategy, applicable to the primary care setting. Good instruction and demonstration ensured children mastered the technique and engaged with the treatment, but uncertainties were raised about training provision and potential impact on the GP consultation. Making nasal balloon autoinflation part of a child’s daily routine enhances compliance, but difficulties can arise if children are unwell or refuse to cooperate. Conclusion: Nasal balloon autoinflation is an acceptable, low-cost treatment option for children with glue ear in primary care. Provision of educational materials and demonstration of the method are likely to promote uptake and compliance. Wider use of the nasal balloon has the potential to enhance early management, and may help to fill the management gap arising from forthcoming changes to care pathways.
Development and piloting of a highly tailored digital intervention to support adherence to antihypertensive medications as an adjunct to primary care consultations
Objectives: This paper describes the systematic development and piloting of a highly tailored text and voice message intervention to increase adherence to medication in primary care. Methods: Following the Medical Research Council guidance, this paper describes (a) the systematic development of the theoretical framework, based on review of theories and meta-analyses of effectiveness; (b) the systematic development of the delivery mode, intervention content and implementation procedures, based on consultations, face-to-face interviews, think-aloud protocols, focus groups, systematic reviews, patient and public involvement/engagement input, intervention pre-test; and (c) the piloting of the intervention, based on a 1-month intervention; and follow-up assessment including interviews and questionnaires. The mixed-methods analysis combined findings from the parallel studies complementarily. Results: intervention development suggested the target behaviour of the intervention should be the tablets taken at a regular time of the day. It recommended that patients could be more receptive to intervention content when they initiate medication taking or they change prescription plan; and more emphasis is needed to patients’ consent process. Intervention piloting suggested high intervention engagement with, and fidelity of, the intervention content; which included a combination of behaviour change techniques, and was highly tailored to patients’ beliefs and prescription plan. Patients reported that the intervention content increased awareness about the necessity to take and maintain adherent to medication, reinforced social support and habit formation, and reminded them to take medication as prescribed. Conclusion: Tailored automated text and voice message interventions are feasible ways to improve medication adherence as an adjunct to primary care.
The elicitation and management of multiple health concerns in GP consultations
Objective: To describe the nature of patient concerns and to explore if, when and how they are addressed by GPs in the UK. Methods: Detailed coding and descriptive analysis of 185 video recordings from the EPaC study (Elicitation of Patient Concerns, EPaC) Results: An average of 2.1 concerns were raised per consultation and the most common concerns were musculoskeletal, administrative (e.g. test results and medication related issues), and skin symptoms. GPs who had been trained as part of the EPaC intervention to solicit for additional concerns in the opening phase of the consultation did so 92.6% of the time. In contrast, those in the control arm did so only 7% of the time. However, the particular formulation of the GP soliciting question does not seem to be associated with the likelihood of the patient volunteering an additional concern. Conclusions: GP consultations are complex encounters in which multiple concerns are dealt with across a wide range of disease areas. GPs can be trained to solicit for problems/concerns early in the consultation. Practice implications: Soliciting for additional concerns is not routinely done. But very brief training can substantially help in eliciting concerns early in the consultation, which may help with organising the consultation.
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.