Left Atrial Appendage Occlusion Versus Direct Oral Anticoagulants in the Prevention of Ischaemic Stroke in Patients with Atrial Fibrillation.

Introduction Existing randomised controlled trials assessing the safety and efficacy of left atrial appendage occlusion (LAAO) in atrial fibrillation (AF) were of relatively small sample size, or included patients who could receive oral anticoagulant treatment after device implantation. We compared the outcomes of patients with newly diagnosed AF who received percutaneous LAAO or direct oral anticoagulants (DOAC) treatment, in a large population from a global federated health network (TriNetX). Methods Patients with AF treated with percutaneous LAAO were matched with those treated with DOAC between 1st December 2010 and 1st October 2018. Outcomes were all-cause mortality, ischaemic stroke and intracranial haemorrhage (ICH) at 5 years. Results We included 200 patients with AF, who received either LAAO or DOAC. The risk of all-cause mortality, ischaemic stroke and ICH at 5 years was not significantly different between the two groups (Risk Ratio [RR] for all-cause mortality: 1.52, 95% confidence interval (CI): 0.97- 2.38, RR for ischaemic stroke: 1.09, 95% CI: 0.51- 2.36, and RR for ICH: 1.0, 95% CI: 0.44- 2.30). Conclusion Patients newly diagnosed with AF, eligible for DOAC, showed similar 5-year risk of death, ischemic stroke, and ICH when comparing those who underwent percutaneous LAAO to those receiving DOAC. Future randomised controlled trials are needed to confirm the findings and advise changes in guidelines.

Moderate weight change following diabetes diagnosis and 10 year incidence of cardiovascular disease and mortality.

AIMS/HYPOTHESIS: Adults with type 2 diabetes are at high risk of developing cardiovascular disease (CVD). Evidence of the impact of weight loss on incidence of CVD events among adults with diabetes is sparse and conflicting. We assessed weight change in the year following diabetes diagnosis and estimated associations with 10 year incidence of CVD events and all-cause mortality. METHODS: In a cohort analysis among 725 adults with screen-detected diabetes enrolled in the Anglo-Danish-Dutch Study of Intensive Treatment in People with Screen-Detected Diabetes in Primary Care (ADDITION)-Cambridge trial, we estimated HRs for weight change in the year following diabetes diagnosis and 10 year incidence of CVD (n = 99) and all-cause mortality (n = 95) using Cox proportional hazards regression. We used linear regression to estimate associations between weight loss and CVD risk factors. Models were adjusted for age, sex, baseline BMI, smoking, occupational socioeconomic status, cardio-protective medication use and treatment group. RESULTS: Loss of ≥5% body weight in the year following diabetes diagnosis was associated with improvements in HbA1c and blood lipids and a lower hazard of CVD at 10 years compared with maintaining weight (HR 0.52 [95% CI 0.32, 0.86]). The associations between weight gain vs weight maintenance and CVD (HR 0.41 [95% CI 0.15, 1.11]) and mortality (HR 1.63 [95% CI 0.83, 3.19]) were less clear. CONCLUSIONS/INTERPRETATION: Among adults with screen-detected diabetes, loss of ≥5% body weight during the year after diagnosis was associated with a lower hazard of CVD events compared with maintaining weight. These results support the hypothesis that moderate weight loss may yield substantial long-term CVD reduction, and may be an achievable target outside of specialist-led behavioural treatment programmes.

Hepatitis A immunisation in persons not previously exposed to hepatitis A.

This review is withdrawn because it is outdated. A new review is to be published by the end of 2019.

Impact of metformin on cardiovascular disease: a meta-analysis of randomised trials among people with type 2 diabetes.

AIMS/HYPOTHESIS: Metformin is the most-prescribed oral medication to lower blood glucose worldwide. Yet previous systematic reviews have raised doubts about its effectiveness in reducing risk of cardiovascular disease, the most costly complication of type 2 diabetes. We aimed to systematically identify and pool randomised trials reporting cardiovascular outcomes in which the effect of metformin was 'isolated' through comparison to diet, lifestyle or placebo. METHODS: We performed an electronic literature search of MEDLINE, EMBASE and the Cochrane Library. We also manually screened the reference lists of previous meta-analyses of trials of metformin identified through a MEDLINE search. We included randomised controlled trials of adults with type 2 diabetes comparing any dose and preparation of oral metformin with no intervention, placebo or a lifestyle intervention and reporting mortality or a cardiovascular outcome. RESULTS: We included ten articles reporting 13 trials (including a total of 2079 individuals with type 2 diabetes allocated to metformin and a similar number to comparison groups) of which only four compared metformin with placebo and collected data on cardiovascular outcomes. Participants were mainly white, aged ≤65 years, overweight/obese and with poor glycaemic control. Summary estimates were based on a small number of events: 416 myocardial infarctions/ischaemic heart disease events in seven studies and 111 strokes in four studies. The UK Prospective Diabetes Study (UKPDS) contributed the majority of data to the summary estimates, with weights ranging from 52.3% for myocardial infarction to 70.5% for stroke. All outcomes, with the exception of stroke, favoured metformin, with limited heterogeneity between studies, but none achieved statistical significance. Effect sizes (Mantel-Haenszel RR) were: all-cause mortality 0.96 (95% CI 0.84, 1.09); cardiovascular death 0.97 (95% CI 0.80, 1.16); myocardial infarction 0.89 (95% CI 0.75, 1.06); stroke 1.04 (95% CI 0.73, 1.48); and peripheral vascular disease 0.81 (95% CI 0.50, 1.31). CONCLUSIONS/INTERPRETATION: There remains uncertainty about whether metformin reduces risk of cardiovascular disease among patients with type 2 diabetes, for whom it is the recommended first-line drug. Although this is mainly due to absence of evidence, it is unlikely that a definitive placebo-controlled cardiovascular endpoint trial among people with diabetes will be forthcoming. Alternative approaches to reduce the uncertainty include the use of electronic health records in long-term pragmatic evaluations, inclusion of metformin in factorial trials, publication of cardiovascular outcome data from adverse event reporting in trials of metformin and a cardiovascular endpoint trial of metformin among people without diabetes.

The ecology of medical care on an isolated island in Okinawa, Japan: a retrospective open cohort study.

BACKGROUND: We aimed to describe the ecology of medical care on an isolated island with limited access to secondary care, and to evaluate the gatekeeping function of the island's primary care clinic through comparison with a previous nationwide survey. METHODS: We conducted this retrospective, open cohort study on Iheya, an isolated island in Okinawa Prefecture that has one primary care clinic. We considered Iheya as unique location in which to examine the role of primary care in Japan. Participants were patients who visited the island's clinic between February 1, 2013 and January 31, 2014. We calculated the number of visits to the clinic and referrals to off-island medical facilities using electronic medical records. We also compared data for Iheya with a nationwide survey conducted in 2003. RESULTS: Iheya had 1314 inhabitants in 2013. Of the 5682 visits to the clinic in the 1-year study period, 290 people were referred to off-island medical institutions. There were 64 referrals to emergency departments; of these, 57 people were admitted to hospital. The rate of visits to the clinic per month per 1000 inhabitants was 360.4 visits (95% confidence interval: 351.0-369.7). Of these, 18.4 (16.3-20.5) were referred off-island, with 4.1 (3.1-5.1) referrals to emergency departments and 3.6 (2.6-4.6) hospitalizations. Despite the high incidence of visits to the primary care clinic, the rates of hospital-based outpatient clinic visits, emergency department visits, and hospitalizations were lower than rates reported in a previous Japanese study. CONCLUSIONS: This suggests that several dimensions of primary care, its gatekeeping function in particular, are likely to play important roles in this geographical setting.

Interventions to increase or decrease the length of primary care physicians' consultation.

BACKGROUND: Observational studies have shown differences in process and outcome between the consultations of primary care physicians whose average consultation lengths differ. These differences may be due to self selection. This is the first update of the original review. OBJECTIVES: To assess the effects of interventions to alter the length of primary care physicians' consultations. SEARCH METHODS: We searched the following electronic databases until 4 January 2016: the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, EMBASE, ClinicalTrials.gov, and World Health Organization International Clinical Trials Registry Platform (WHO ICTRP). SELECTION CRITERIA: Randomised controlled trials and non-randomised controlled trials of interventions to alter the length of primary care physicians' consultations. DATA COLLECTION AND ANALYSIS: Two review authors independently extracted data and assessed the risk of bias of included studies using agreed criteria and resolved disagreements by discussion. We attempted to contact authors of primary studies with missing data. Given the heterogeneity of studies, we did not conduct a meta-analysis. We assessed the certainty of the evidence for the most important outcomes using the GRADE approach and have presented the results in a narrative summary. MAIN RESULTS: Five studies met the inclusion criteria. All were conducted in the UK, and tested short-term changes in the consultation time allocated to each patient. Overall, our confidence in the results was very low; most studies had a high risk of bias, particularly due to non-random allocation of participants and the absence of data on participants' characteristics and small sample sizes. We are uncertain whether altering appointment length increases primary care consultation length, number of referrals and investigations, prescriptions, or patient satisfaction based on very low-certainty evidence. None of the studies reported on the effects of altering the length of consultation on resources used. AUTHORS' CONCLUSIONS: We did not find sufficient evidence to support or refute a policy of altering the lengths of primary care physicians' consultations. It is possible that these findings may change if high-quality trials are reported in the future. Further trials are needed that focus on health outcomes and cost-effectiveness.

Pharmacological agents for the prevention of vestibular migraine.

BACKGROUND: Vestibular migraine is a common cause of episodic vertigo. Many preventive treatments have been proposed for this condition, including calcium antagonists, beta-blockers, antidepressants, anticonvulsants, selective 5-HT1 agonists, serotonin antagonists and non-steroidal anti-inflammatory drugs (NSAIDs). OBJECTIVES: To assess the effects of pharmacological agents for the prevention of vestibular migraine. SEARCH METHODS: The Cochrane Ear, Nose and Throat Disorders Group (CENTDG) Trials Search Co-ordinator searched the CENTDG Trials Register; Central Register of Controlled Trials (CENTRAL 2015, Issue 5); PubMed; EMBASE; CINAHL; Web of Science; Clinicaltrials.gov; ICTRP and additional sources for published and unpublished trials. The date of the search was 5 June 2015. SELECTION CRITERIA: Randomised controlled trials (RCTs) in adults (over 18 years) with a diagnosis of vestibular migraine orprobable vestibular migraine according to the Bárány Society/International Headache Society (IHS) criteria, treated in any setting, comparing pharmacological treatments used in the prevention of vestibular migraine, including beta-blockers, calcium antagonists, anticonvulsants, antidepressants, serotonin antagonists and non-steroidal anti-inflammatory drugs (NSAIDs) against placebo or no treatment. DATA COLLECTION AND ANALYSIS: We used the standard methodological procedures expected by The Cochrane Collaboration. MAIN RESULTS: Our literature search identified 558 reports, however only 11 were sufficiently relevant for further assessment. We excluded two studies because they did not use the IHS diagnostic criteria for vestibular migraine. We excluded a further eight studies for various reasons related to their design (e.g. lack of placebo or no treatment comparator), aim (e.g. treatment of vestibular migraine rather than prevention) or conduct (e.g. early termination). We identified one ongoing study comparing metoprolol to placebo. The results of this study are awaited; recruitment of the last patient is expected by the end of 2016. AUTHORS' CONCLUSIONS: We found no evidence from RCTs to answer the question set out in the review objectives. This review has identified the need for well-designed randomised controlled trials to answer questions about the efficacy of current and new treatments.

Colchicine for pericarditis.

BACKGROUND: Pericarditis is the inflammation of the pericardium, the membranous sac surrounding the heart. Recurrent pericarditis is the most common complication of acute pericarditis, causing severe and disabling chest pains. Recurrent pericarditis affects one in three patients with acute pericarditis within the first 18 months. Colchicine has been suggested to be beneficial in preventing recurrent pericarditis. OBJECTIVES: To review all randomised controlled trials (RCTs) that assess the effects of colchicine alone or combined, compared to any other intervention to prevent further recurrences of pericarditis, in people with acute or recurrent pericarditis. SEARCH METHODS: We searched the following bibliographic databases on 4 August 2014: Cochrane Central Register of Controlled Trials (CENTRAL, Issue 7 of 12, 2014 on The Cochrane Library), MEDLINE (OVID, 1946 to July week 4, 2014), EMBASE (OVID, 1947 to 2014 week 31), and the Conference Proceedings Citation Index - Science on Web of Science (Thomson Reuters) 1990 to 1 Aug 2014. We did not apply any language or time restrictions. SELECTION CRITERIA: RCTs of people with acute or recurrent pericarditis who are receiving colchicine compared to any other treatment, in order to prevent recurrences. DATA COLLECTION AND ANALYSIS: Two review authors independently selected trials for inclusion, extracted data and assessed the risk of bias. The first primary outcome was the time to recurrence, measured by calculating the hazard ratios (HRs). The second primary outcome was the adverse effects of colchicine. Secondary outcomes were the rate of recurrences at 6, 12 and 18 months, and symptom relief. MAIN RESULTS: We included four RCTs, involving 564 participants in this review. We compared the effects of colchicine in addition to a non-steroidal anti-inflammatory drug (NSAID) such as ibuprofen, aspirin or indomethacin to the effects of the NSAID alone. Two comparable trials studied the effects of colchicine in 204 participants with recurrent pericarditis and two trials studied 360 people with acute pericarditis. All trials had a moderate quality for the primary outcomes. We identified two on-going trials; one of these trials examines acute pericarditis and the other assesses recurrent pericarditis.There was moderate quality evidence that colchicine reduces episodes of pericarditis in people with recurrent pericarditis over 18 months follow-up (HR 0.37; 95% confidence interval (CI) 0.24 to 0.58). It is expected that at 18 months, the number needed to treat (NNT) is 4. In people with acute pericarditis, there was moderate quality evidence that colchicine reduces recurrence (HR 0.40; 95% CI 0.27 to 0.61) at 18 months follow-up. Colchicine led to a greater chance of symptom relief at 72 hours (risk ratio (RR) 1.4; 95% CI 1.26 to 1.56; low quality evidence). Adverse effects were mainly gastrointestinal and included abdominal pain and diarrhoea. The pooled RR for adverse events was 1.26 (95% CI 0.75 to 2.12). While the number of people experiencing adverse effects was higher in the colchicine than the control groups (9% versus 7%), the quality of evidence was low owing to imprecision, and there was no statistically significant difference between the treatment groups (P = 0.42). There was moderate quality evidence that treatment with colchicine led to more people stopping treatment due to adverse events (RR 1.87; 95% CI 1.02 to 3.41). AUTHORS' CONCLUSIONS: Colchicine, as adjunctive therapy to NSAIDs, is effective in reducing the number of pericarditis recurrences in patients with recurrent pericarditis or acute pericarditis. However, evidence is based on a limited number of small trials. Patients with multiple resistant recurrences were not represented in any published or on-going trials, and it is these patients that are in the most need for treatment.

Workplace-based knowledge exchange programmes between academics, policy-makers and providers of healthcare: a qualitative study.

BACKGROUND: Workplace-based knowledge exchange programmes (WKEPs), such as job shadowing or secondments, offer potential for health and care providers, academics, and policy-makers to foster partnerships, develop local solutions and overcome key differences in practices. Yet opportunities for exchange can be hard to find and are poorly reported in the literature. OBJECTIVES: To understand the views of providers, academics and policy-makers regarding WKEPs, in particular, their motivations to participate in such exchanges and the perceived barriers and facilitators to participation. METHODS: A qualitative study involving semistructured interviews with 20 healthcare providers, academics and policy-makers in England. Rapid data collection and analysis techniques were employed. Interviews formed part of a wider scoping study that mapped the characteristics and existing literature related to WKEPs. RESULTS: Interviewees reported being motivated to develop, sponsor and/or participate in WKEPs with a clear purpose and defined outcomes that could demonstrate the value of the time out of work to their organisations. Perceived barriers included competitive application processes for national fellowships, a lack of knowing how to identify with whom to undertake an exchange (varying 'tribes'), and the burdens of time, costs and administration regarding arranging exchanges. WKEPs were reported to work best where there was a perceived sense of shared purpose, long-standing relationship and trust between organisations. Facilitators included existing confidentiality agreements and/or shared professional standards, as well as funding. CONCLUSION: WKEPs were reported to be valuable experiences but required significant organisational buy-in and cooperation to arrange and sustain. To benefit emerging partnerships, such as the new integrated care systems in England, more outcomes evaluations of existing WKEPs are needed, and research focused on overcoming barriers to participation, such as time and costs.

Atrial fibrillation and stroke: State-of-the-art and future directions.

Atrial fibrillation (AF) and stroke remain a major cause of morbidity and mortality. The two conditions shared common co-morbidities and risk factors. AF-related strokes are associated with worse clinical outcomes and higher mortality compared to non-AF-related. Early detection of AF is vital for prevention. While various scores have been developed to predict AF in such a high-risk group, they are yet to incorporated into clinical guidelines. Novel markers and predictors of AF including coronary and intracranial arterial calcification have also been studied. There are also ongoing debates on the management of acute stroke in patients with AF, and those who experienced breakthrough stroke while on oral anticoagulants. We provided an overview of the complex interplay between AF and stroke, as well as the treatment and secondary prevention of stroke in AF. We also comprehensively discussed the current evidence and the ongoing conundrums, and highlighted the future directions on the topic.

The time-efficiency principle: time as the key diagnostic strategy in primary care.

The test and retest opportunity afforded by reviewing a patient over time substantially increases the total gain in certainty when making a diagnosis in low-prevalence settings (the time-efficiency principle). This approach safely and efficiently reduces the number of patients who need to be formally tested in order to make a correct diagnosis for a person. Time, in terms of observed disease trajectory, provides a vital mechanism for achieving this task. It remains the best strategy for delivering near-optimal diagnoses in low-prevalence settings and should be used to its full advantage.

Gut feeling for the diagnosis of cancer in general practice: a diagnostic accuracy review.

OBJECTIVES: Diagnostic delay in cancer is a challenge in primary care. Although screening tests are effective in diagnosing some cancers such as breast, colorectal and cervical cancers, symptom-based cancer diagnosis is often difficult due to its low incidence in primary care and the influence of patient anxiety, doctor-patient relationship and psychosocial context. A general practitioner's gut feeling for cancer may play a role in the early diagnosis of cancer in primary care where diagnostic resources are limited. The aim of this study is to summarise existing evidence about the test accuracy of gut feeling (index test) in symptomatic adult patients presenting to general practice, compared with multidisciplinary team-confirmed diagnosis of cancer (reference standard). DESIGN: Diagnostic accuracy review following Cochrane methods was performed. DATA SOURCES: MEDLINE, EMBASE, Cochrane Library, the Database of Abstracts of Reviews of Effects and Medion databases. ELIGIBILITY CRITERIA: Cross-sectional, cohort and randomised studies of test accuracy that compared gut feeling (index test) with an appropriate cancer diagnosis (reference standard). No language or publication status restrictions were applied. We included all studies published before 25 March 2022. DATA EXTRACTION AND SYNTHESIS: Methodological quality was appraised, using Quality Assessment of Diagnostic Accuracy Studies 2 (QUADAS-2) criteria. Meta-analysis with hierarchical summary receiver operating characteristic (HSROC) models was used. RESULTS: Of 1286 potentially relevant studies identified, six met the inclusion criteria. For two of the six studies, data could not be extracted despite contacting authors. No studies satisfied all QUADAS-2 criteria. After meta-analysis of data from the remaining studies, the summary point of HSROC had a sensitivity of 0.40 (95% CI: 0.28, 0.53) and a specificity of 0.85 (95% CI: 0.75, 0.92). CONCLUSIONS: Gut feeling for cancer when used in symptomatic adult patients in general practice has a relatively low sensitivity and high specificity. When the prevalence of cancer in the symptomatic population presenting in general practice exceeds 1.15%, the performance of gut feeling reaches the National Institute for Health and Care Excellence 3% positive predictive value threshold for action, which recommends urgent access to specialist care and further investigations. The findings support the continued and expanded use of gut feeling items in referral pathways.

Current and future advances in practice: tendinopathies of the shoulder.

Tendinopathies of the shoulder are a burdensome problem. Current treatments include exercise, physical therapies, corticosteroid injections and surgery. However, the clinical outcomes from randomized controlled trials evaluating the effectiveness of these interventions are largely unremarkable. Given the apparent lack of progress in improving clinical outcomes for patients, it is appropriate to consider other avenues. Research has identified a link between lifestyle-related modifiable risk factors, including smoking, overweight and physical inactivity, and the onset and persistence of tendinopathies of the shoulder. Further research is required to understand whether addressing these factors results in better clinical outcomes for patients. Teachable moments and shared decision-making are concepts that could enable clinicians to integrate the assessment and management of these lifestyle factors. Given that these lifestyle factors also increase the risk of developing other common morbidities, including cardiovascular disease, an evolution of routine clinical care in this way could represent an important step forwards.

Hepatitis A immunisation in persons not previously exposed to hepatitis A.

BACKGROUND: In many parts of the world, hepatitis A infection represents a significant cause of morbidity and socio-economic loss. Whilst hepatitis A vaccines have the potential to prevent disease, the degree of protection afforded against clinical outcomes and within different populations remains uncertain. There are two types of hepatitis A virus (HAV) vaccine, inactivated and live attenuated. It is important to determine the efficacy and safety for both vaccine types. OBJECTIVES: To determine the clinical protective efficacy, sero-protective efficacy, and safety and harms of hepatitis A vaccination in persons not previously exposed to hepatitis A. SEARCH METHODS: We searched The Cochrane Hepato-Biliary Group Controlled Trials Register, The Cochrane Central Register of Controlled Trials (CENTRAL) in The Cochrane Library, MEDLINE, EMBASE, Science Citation Index Expanded, and China National Knowledge Infrastructure (CNKI) up to November 2011. SELECTION CRITERIA: Randomised clinical trials comparing HAV vaccine with placebo, no intervention, or appropriate control vaccines in participants of all ages. DATA COLLECTION AND ANALYSIS: Data extraction and risk of bias assessment were undertaken by two authors and verified by a third author. Where required, authors contacted investigators to obtain missing data. The primary outcome was the occurrence of clinically apparent hepatitis A (infectious hepatitis). The secondary outcomes were lack of sero-protective anti-HAV immunoglobulin G (IgG), and number and types of adverse events. Results were presented as relative risks (RR) with 95% confidence intervals (CI). Dichotomous outcomes were reported as risk ratio (RR) with 95% confidence interval (CI), using intention-to-treat analysis. We conducted assessment of risk of bias to evaluate the risk of systematic errors (bias) and trial sequential analyses to estimate the risk of random errors (the play of chance). MAIN RESULTS: We included a total of 11 clinical studies, of which only three were considered to have low risk of bias; two were quasi-randomised studies in which we only addressed harms. Nine randomised trials with 732,380 participants addressed the primary outcome of clinically confirmed hepatitis A. Of these, four trials assessed the inactivated hepatitis A vaccine (41,690 participants) and five trials assessed the live attenuated hepatitis A vaccine (690,690 participants). In the three randomised trials with low risk of bias (all assessing inactivated vaccine), clinically apparent hepatitis A occurred in 9/20,684 (0.04%) versus 92/20,746 (0.44%) participants in the HAV vaccine and control groups respectively (RR 0.09, 95% CI 0.03 to 0.30). In all nine randomised trials, clinically apparent hepatitis A occurred in 31/375,726 (0.01%) versus 505/356,654 (0.18%) participants in the HAV vaccine and control groups respectively (RR 0.09, 95% CI 0.05 to 0.17). These results were supported by trial sequential analyses. Subgroup analyses confirmed the clinical effectiveness of both inactivated hepatitis A vaccines (RR 0.09, 95% CI 0.03 to 0.30) and live attenuated hepatitis A vaccines (RR 0.07, 95% CI 0.03 to 0.17) on clinically confirmed hepatitis A. Inactivated hepatitis A vaccines had a significant effect on reducing the lack of sero-protection (less than 20 mIU/L) (RR 0.01, 95% CI 0.00 to 0.03). No trial reported on a sero-protective threshold less than 10 mIU/L. The risk of both non-serious local and systemic adverse events was comparable to placebo for the inactivated HAV vaccines. There were insufficient data to draw conclusions on adverse events for the live attenuated HAV vaccine. AUTHORS' CONCLUSIONS: Hepatitis A vaccines are effective for pre-exposure prophylaxis of hepatitis A in susceptible individuals. This review demonstrated significant protection for at least two years with the inactivated HAV vaccine and at least five years with the live attenuated HAV vaccine. There was evidence to support the safety of the inactivated hepatitis A vaccine. More high quality evidence is required to determine the safety of live attenuated vaccines.

Psychometric and biomedical outcomes of glycated haemoglobin target-setting in adults with type 1 and type 2 diabetes: Protocol for a mixed-methods parallel-group randomised feasibility study.

BACKGROUND: The disease burden of diabetes can have wide-ranging implications on patients' psychological well-being and health-related quality of life. Glycated haemoglobin targets are commonly used to guide patient management in diabetes to reduce the future risk of developing diabetes complications, but little is known of the psychological impact of glycated haemoglobin target-setting. This protocol describes a study to determine the feasibility of evaluating psychological outcomes when setting explicit glycated haemoglobin targets in people with diabetes. METHODS: This single-centre randomised feasibility study will follow a mixed-methods approach across four sub-studies. In sub-study A, eligible adults (aged 18 and over) with type 1 or type 2 diabetes will complete baseline validated psychometric questionnaires evaluating health-related quality of life (EuroQoL-5D-5L), diabetes-related distress (Problem Areas In Diabetes), self-care (Summary of Diabetes Self-Care Activities), well-being (Well-Being Quetionnaire-12) and diabetes-related psychosocial self-efficacy (Diabetes Empowerment Scale-Long Form). Participants will be randomised to receive explicit glycated haemoglobin intervention targets 5mmol/mol above or below current glycated haemoglobin readings. Rates of eligibility, recruitment, retention and questionnaire response rate will be measured. Psychometric outcomes will be re-evaluated 3-months post-intervention. Sub-studies B and C will use qualitative semi-structured interviews to evaluate experiences, views and opinions of diabetes patients and healthcare professionals in relation to the acceptability of study processes, the use of glycated haemoglobin targets, the impact of diabetes on psychological well-being and, in sub-study D, barriers to participation in diabetes research. DISCUSSION: This mixed-methods study aims to provide a novel insight into the psychological implications of glycated haemoglobin target-setting for people with diabetes in secondary care, alongside testing the feasibility of undertaking a larger project of this nature. TRIAL REGISTRATION: The study is registered with the ISRCTN (registration number: 12461724; date registered: 11th June 2021). Protocol version: 2.0.5, 26th February 2021.

The individualisation of glycaemic targets in response to patient characteristics in type 2 diabetes: a scoping review.

BACKGROUND: Evidence and guidelines increasingly support an individualised approach to care for people with type 2 diabetes and individualisation of glycaemic targets in response to patient factors. METHODS: We undertook a scoping review of the literature for evidence of factors impacting upon glycated haemoglobin target individualisation in adults with type 2 diabetes. Data were analysed thematically with the themes inductively derived from article review. FINDINGS: Evidence suggests that presence of cardiovascular disease, hypoglycaemia unawareness, severe hypoglycaemia, limited life expectancy, advanced age, long diabetes duration, frailty, cognitive impairment, disability, extensive comorbidity, diabetes distress and patient preference should inform the setting of glycaemic targets. CONCLUSION: The management of people with diabetes is complex. In clinical practice, many patients will have a variety of factors that should be considered when personalising their care. Approaches to personalised care and glycaemic treatment targets should be undertaken as part of a shared decision-making process between physician and patient. Use of electronic records might enable greater efficiency and more widespread use of personalised care plans for people with diabetes.

Digital maturity and its determinants in General Practice: A cross-sectional study in 20 countries.

Background: The extent to which digital technologies are employed to promote the delivery of high-quality healthcare is known as Digital Maturity. Individual and systemic digital maturity are both necessary to ensure a successful, scalable and sustainable digital transformation in healthcare. However, digital maturity in primary care has been scarcely evaluated. Objectives: This study assessed the digital maturity in General Practice (GP) globally and evaluated its association with participants' demographic characteristics, practice characteristics and features of Electronic Health Records (EHRs) use. Methods: GPs across 20 countries completed an online questionnaire between June and September 2020. Demographic data, practice characteristics, and features of EHRs use were collected. Digital maturity was evaluated through a framework based on usage, resources and abilities (divided in this study in its collective and individual components), interoperability, general evaluation methods and impact of digital technologies. Each dimension was rated as 1 or 0. The digital maturity score was calculated as the sum of the six dimensions and ranged between 0 to 6 (maximum digital maturity). Multivariable linear regression was used to model the total score, while multivariable logistic regression was used to model the probability of meeting each dimension of the score. Results: One thousand six hundred GPs (61% female, 68% Europeans) participated. GPs had a median digital maturity of 4 (P25-P75: 3-5). Positive associations with digital maturity were found with: male gender [B = 0.18 (95% CI 0.01; 0.36)], use of EHRs for longer periods [B = 0.45 (95% CI 0.35; 0.54)] and higher frequencies of access to EHRs [B = 0.33 (95% CI 0.17; 0.48)]. Practicing in a rural setting was negatively associated with digital maturity [B = -0.25 (95%CI -0.43; -0.08)]. Usage (90%) was the most acknowledged dimension while interoperability (47%) and use of best practice general evaluation methods (28%) were the least. Shorter durations of EHRs use were negatively associated with all digital maturity dimensions (aOR from 0.09 to 0.77). Conclusion: Our study demonstrated notable factors that impact digital maturity and exposed discrepancies in digital transformation across healthcare settings. It provides guidance for policymakers to develop more efficacious interventions to hasten the digital transformation of General Practice.

General practitioners' perceptions of using virtual primary care during the COVID-19 pandemic: An international cross-sectional survey study.

With the onset of COVID-19, general practitioners (GPs) and patients worldwide swiftly transitioned from face-to-face to digital remote consultations. There is a need to evaluate how this global shift has impacted patient care, healthcare providers, patient and carer experience, and health systems. We explored GPs' perspectives on the main benefits and challenges of using digital virtual care. GPs across 20 countries completed an online questionnaire between June-September 2020. GPs' perceptions of main barriers and challenges were explored using free-text questions. Thematic analysis was used to analyse the data. A total of 1,605 respondents participated in our survey. The benefits identified included reducing COVID-19 transmission risks, guaranteeing access and continuity of care, improved efficiency, faster access to care, improved convenience and communication with patients, greater work flexibility for providers, and hastening the digital transformation of primary care and accompanying legal frameworks. Main challenges included patients' preference for face-to-face consultations, digital exclusion, lack of physical examinations, clinical uncertainty, delays in diagnosis and treatment, overuse and misuse of digital virtual care, and unsuitability for certain types of consultations. Other challenges include the lack of formal guidance, higher workloads, remuneration issues, organisational culture, technical difficulties, implementation and financial issues, and regulatory weaknesses. At the frontline of care delivery, GPs can provide important insights on what worked well, why, and how during the pandemic. Lessons learned can be used to inform the adoption of improved virtual care solutions and support the long-term development of platforms that are more technologically robust and secure.

Perspectives on expert generalist practice among Japanese family doctor educators: a qualitative study.

BACKGROUND: Expert generalist practice (EGP) is increasingly being viewed as the defining expertise of generalist care. In Japan, several prominent family doctors consider it important and relevant in the Japanese context. However, no study has examined Japanese family doctor educators' perceptions of EGP. AIM: To explore Japanese family doctor educators' perceptions of EGP. DESIGN & SETTING: A qualitative study among family doctor educators in Japan. METHOD: Focus group interviews were conducted using a semi-structured interview guide following a short lecture on EGP. A qualitative description method was adopted and the framework method was used to conduct thematic analysis. RESULTS: Participants were 18 family medicine doctor educators, including 11 directors and six associate directors of family medicine training programmes. The results suggested that the concept of EGP was important and applicable to primary care in Japan. Participants' perceptions on EGP pertained to the following four areas: impact of EGP, triggers for EGP, enablers for EGP, and educational strategies for EGP. CONCLUSION: The concept of EGP may be useful in clinical practice in Japan, especially in complex patient care. A clearer framework for or description of EGP, and of non-traditional methods, such as ascetic practice and awareness of the self, were proposed as possible educational strategies.

Evaluation of a 'drop box' doorstep assessment service to aid remote assessments for COVID-19 in general practice.

The COVID-19 is an established threat whose clinical features and epidemiology continues to evolve. In an effort to contain the disease, the National Health Service has adopted a digital first approach in UK general practice resulting in a significant shift away from face-to-face consultations. Consequently, more consultations are being completed without obtaining objective recording of vital signs and face-to-face examination. Some regions have formed hot hubs to facilitate the review of suspected COVID-19 cases and keep their practice site 'clean' including the use of doorstep observations in avoiding the risk of face-to-face examination. To support the safe, effective and efficient remote assessment of suspected and confirmed patients with COVID-19, we established a doorstep assessment service to compliment telephone and video consultations. This allows physiological parameters such as temperature, pulse, blood pressure and oxygen saturation to be obtained to guide further triage. Quality improvement methods were used to integrate and optimise the doorstep assessment and measure the improvements made. The introduction of a doorstep assessment service increased the proportion of assessments for patients with suspected COVID-19 in routine care over weeks. At the same time we were able to dramatically reduce face-to-face assessment over a 6-week period by optimising through a range of measures including the introduction of a digital stethoscope. The majority of patients were managed by their own general practitioner following assessment supporting continuity of care. There were no adverse events during the period of observation; no staff absences related to COVID-19. Quality improvement methods have facilitated the successful integration of doorstep assessments into clinical care.