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Young men with an eating disorder are not getting the help and support they need because of a perceptions about a "women's illness", say researchers.
Multi-cancer early detection test in symptomatic patients referred for cancer investigation in England and Wales (SYMPLIFY): a large-scale, observational cohort study
Background: Analysis of circulating tumour DNA could stratify cancer risk in symptomatic patients. We aimed to evaluate the performance of a methylation-based multicancer early detection (MCED) diagnostic test in symptomatic patients referred from primary care. Methods: We did a multicentre, prospective, observational study at National Health Service (NHS) hospital sites in England and Wales. Participants aged 18 or older referred with non-specific symptoms or symptoms potentially due to gynaecological, lung, or upper or lower gastrointestinal cancers were included and gave a blood sample when they attended for urgent investigation. Participants were excluded if they had a history of or had received treatment for an invasive or haematological malignancy diagnosed within the preceding 3 years, were taking cytotoxic or demethylating agents that might interfere with the test, or had participated in another study of a GRAIL MCED test. Patients were followed until diagnostic resolution or up to 9 months. Cell-free DNA was isolated and the MCED test performed blinded to the clinical outcome. MCED predictions were compared with the diagnosis obtained by standard care to establish the primary outcomes of overall positive and negative predictive value, sensitivity, and specificity. Outcomes were assessed in participants with a valid MCED test result and diagnostic resolution. SYMPLIFY is registered with ISRCTN (ISRCTN10226380) and has completed follow-up at all sites. Findings: 6238 participants were recruited between July 7 and Nov 30, 2021, across 44 hospital sites. 387 were excluded due to staff being unable to draw blood, sample errors, participant withdrawal, or identification of ineligibility after enrolment. Of 5851 clinically evaluable participants, 376 had no MCED test result and 14 had no information as to final diagnosis, resulting in 5461 included in the final cohort for analysis with an evaluable MCED test result and diagnostic outcome (368 [6·7%] with a cancer diagnosis and 5093 [93·3%] without a cancer diagnosis). The median age of participants was 61·9 years (IQR 53·4–73·0), 3609 (66·1%) were female and 1852 (33·9%) were male. The MCED test detected a cancer signal in 323 cases, in whom 244 cancer was diagnosed, yielding a positive predictive value of 75·5% (95% CI 70·5–80·1), negative predictive value of 97·6% (97·1–98·0), sensitivity of 66·3% (61·2–71·1), and specificity of 98·4% (98·1–98·8). Sensitivity increased with increasing age and cancer stage, from 24·2% (95% CI 16·0–34·1) in stage I to 95·3% (88·5–98·7) in stage IV. For cases in which a cancer signal was detected among patients with cancer, the MCED test's prediction of the site of origin was accurate in 85·2% (95% CI 79·8–89·3) of cases. Sensitivity 80·4% (95% CI 66·1–90·6) and negative predictive value 99·1% (98·2–99·6) were highest for patients with symptoms mandating investigation for upper gastrointestinal cancer. Interpretation: This first large-scale prospective evaluation of an MCED diagnostic test in a symptomatic population demonstrates the feasibility of using an MCED test to assist clinicians with decisions regarding urgency and route of referral from primary care. Our data provide the basis for a prospective, interventional study in patients presenting to primary care with non-specific signs and symptoms. Funding: GRAIL Bio UK.
Phenotype execution and modeling architecture to support disease surveillance and real-world evidence studies: English sentinel network evaluation.
OBJECTIVE: To evaluate Phenotype Execution and Modelling Architecture (PhEMA), to express sharable phenotypes using Clinical Quality Language (CQL) and intensional Systematised Nomenclature of Medicine (SNOMED) Clinical Terms (CT) Fast Healthcare Interoperability Resources (FHIR) valuesets, for exemplar chronic disease, sociodemographic risk factor, and surveillance phenotypes. METHOD: We curated 3 phenotypes: Type 2 diabetes mellitus (T2DM), excessive alcohol use, and incident influenza-like illness (ILI) using CQL to define clinical and administrative logic. We defined our phenotypes with valuesets, using SNOMED's hierarchy and expression constraint language, and CQL, combining valuesets and adding temporal elements where needed. We compared the count of cases found using PhEMA with our existing approach using convenience datasets. We assessed our new approach against published desiderata for phenotypes. RESULTS: The T2DM phenotype could be defined as 2 intensionally defined SNOMED valuesets and a CQL script. It increased the prevalence from 7.2% to 7.3%. Excess alcohol phenotype was defined by valuesets that added qualitative clinical terms to the quantitative conceptual definitions we currently use; this change increased prevalence by 58%, from 1.2% to 1.9%. We created an ILI valueset with SNOMED concepts, adding a temporal element using CQL to differentiate new episodes. This increased the weekly incidence in our convenience sample (weeks 26-38) from 0.95 cases to 1.11 cases per 100 000 people. CONCLUSIONS: Phenotypes for surveillance and research can be described fully and comprehensibly using CQL and intensional FHIR valuesets. Our use case phenotypes identified a greater number of cases, whilst anticipated from excessive alcohol this was not for our other variable. This may have been due to our use of SNOMED CT hierarchy. Our new process fulfilled a greater number of phenotype desiderata than the one that we had used previously, mostly in the modeling domain. More work is needed to implement that sharing and warehousing domains.
General practitioners' perspectives on diagnostic tests for children: a qualitative interview study.
Background Most healthcare contacts for children in the UK occur in general practice. Diagnostic tests can be beneficial in narrowing differential diagnoses, however, there is substantial variation in the use of tests for children in general practice. Unwarranted variation in testing can lead to variation in quality of care and exacerbate health inequities. No prior study has tried to understand why variation in testing exists for children in general practice. Aim To explore GP perspectives on using diagnostic tests for children in primary care and the underlying drivers of variation. Design and setting Semi-structured interviews were conducted with GPs and trainee GPs in England. Methods We conducted interviews with 18 GPs and 2 trainees between April and June 2023. The interviews were transcribed and analysed thematically. Results GPs reflected that their approach to testing in children differed from adults; their threshold to test was higher, but the threshold to refer to specialists was lower. GPs' perceptions of test utility varied, including objective testing for asthma. Perceived drivers of variation in testing included: 1) intrinsic (clinician) factors relating to their risk tolerance and experience, and 2) extrinsic factors, including disease prevalence, parental concern and expectations of healthcare, workforce changes leading to fragmentation in care, time constraints and differences in guidelines. Conclusions The findings of this study identify actionable issues for clinicians, researchers, and policymakers to address gaps in education, evidence, and guidance, reduce unwarranted differences in test use and improve the quality of health care delivered to children in general practice.
The impact of low-energy total diet replacement with behavioural support for remission of type 2 diabetes on disordered eating (ARIADNE): Protocol for a non-inferiority randomised controlled trial
Introduction: The National Health Service (NHS) in England is currently piloting a weight loss programme for remission of newly diagnosed type 2 diabetes (T2D), where participants replace all food with low-energy nutritionally complete formula products for 12 weeks (total diet replacement, TDR) and receive behavioural support. In a clinical trial, this programme led to remission in nearly half the participants. However, this weight loss programme might also worsen disordered eating and prompt eating disorders in susceptible people. We aim to investigate if the TDR programme is non-inferior to standard care in terms of disordered eating in susceptible individuals. Methods: Fifty six people with newly diagnosed T2D, BMI ≥ 27 kg/m2, and medium to high scores of disordered eating based on the Eating Disorders Examination questionnaire (EDE-Q) will be randomised 1:1 to TDR receiving remote weekly/bi-weekly dietetic support or standard care. Participants will be re-assessed remotely at 1, 3, 4, 6, and 12 months. The primary outcome will be the between-group difference in the score of the EDE-Q. If the sample size can be expanded to 150, we will reduce the non-inferiority boundary. Weight, glycated haemoglobin (HbA1c), impairment from disordered eating, and distress will be secondary outcomes. Using the recorded consultations, we will evaluate the process in observed changes in eating behaviour and disordered eating. Conclusions: If TDR for T2D remission is deemed non-inferior to standard care, more people may enrol and benefit from T2D remission. If TDR exacerbates disordered eating, screening may reduce unintended harm. Trial Registration: NCT05744232 (ClinicalTrials.gov, prospectively registered).
The association between disability and mortality: a mixed-methods study.
BACKGROUND: Globally, 1·3 billion people have a disability and are more likely to experience poor health than the general population. However, little is known about the mortality or life expectancy gaps experienced by people with disabilities. We aimed to undertake a systematic review and meta-analysis of the association between disability and mortality, compare these findings to the evidence on the association of impairment types and mortality, and model the estimated life expectancy gap experienced by people with disabilities. METHODS: We did a mixed-methods study, which included a systematic review and meta-analysis, umbrella review, and life expectancy modelling. For the systematic review and meta-analysis, we searched MEDLINE, Global Health, PsycINFO, and Embase for studies published in English between Jan 1, 2007, and June 7, 2023, investigating the association of mortality and disability. We included prospective and retrospective cohort studies and randomised controlled trials with a baseline assessment of disability and a longitudinal assessment of all-cause mortality or cause-specific mortality. Two reviewers independently assessed study eligibility, extracted the data, and assessed risk of bias. We did a random-effects meta-analysis to calculate a pooled estimate of the mortality rate ratio for people with disabilities compared with those without disabilities. We did an umbrella review of meta-analyses examining the association between different impairment types and mortality. We used life table modelling to translate the mortality rate ratio into an estimate of the life expectancy gap between people with disabilities and the general population. The systematic review and meta-analysis is registered with PROSPERO, CRD42023433374. FINDINGS: Our search identified 3731 articles, of which 42 studies were included in the systematic review. The meta-analysis included 31 studies. Pooled estimates showed that all-cause mortality was 2·24 times (95% CI 1·84-2·72) higher in people with disabilities than among people without disabilities, although heterogeneity between the studies was high (τ2=0·28, I2=100%). Modelling indicated a median gap in life expectancy of 13·8 years (95% CI 13·1-14·5) by disability status. Cause-specific mortality was also higher for people with disabilities, including for cancer, COVID-19, cardiovascular disease, and suicide. The umbrella review identified nine meta-analyses, which showed consistently elevated mortality rates among people with different impairment types. INTERPRETATION: Mortality inequities experienced by people with disabilities necessitate health system changes and efforts to address inclusion and the social determinants of health. FUNDING: National Institute for Health and Care Research, Rhodes Scholarship, Indonesia Endowment Funds for Education, Foreign, Commonwealth and Development Office (Programme for Evidence to Inform Disability Action), and the Arts and Humanities Research Council.
Building disability-inclusive health systems
Health systems often fail people with disabilities, which might contribute to their shorter life expectancy and poorer health outcomes than people without disabilities. This Review provides an overview of the existing evidence on health inequities faced by people with disabilities and describes existing approaches to making health systems disability inclusive. Our Review documents a broad range of health-care inequities for people with disabilities (eg, lower levels of cancer screening), which probably contribute towards health differentials. We identified 90 good practice examples that illustrate current strategies to reduce inequalities. Implementing such strategies could help to ensure that health systems can expect, accept, and connect people with disabilities worldwide, deliver on their right to health, and achieve health for all.
Type 2 diabetes prevention policy and practice: a multimethod qualitative study exploring the perspectives of patients, clinicians, and policy makers
Introduction There are broadly two approaches to type 2 diabetes prevention. ‘Population’ approaches which target structural influences, and ‘high-risk’ approaches which focus on identifying individuals at risk of type 2 diabetes and encouraging lifestyle change. There is a paucity of evidence on how people respond to pre-diabetes and evaluations of high-risk approaches have shown limited effects in women, deprived and diverse groups. Despite this, there is relatively little focus on the structural drivers of ill health. Aims To understand the impact of pre-diabetes policies from different stakeholder perspectives. Objectives 1. Explore the perspective of primary care teams; how they deliver the pre-diabetes diagnosis and manage the condition. 2. Explore what pre-diabetes means to people and how this influences their lifestyle choices. 3. Explore policymakers’ perspectives and understand why individualist health promotion policies dominate the policy agenda. Methods 1. Three focus groups with primary care practice teams. 2. In depth case studies with people diagnosed with pre-diabetes. 3. Semi-structured interviews with commissioners and policymakers. A thematic analysis was undertaken applying critical social science perspectives; Bourdieu’s Theory of Practice and Shiffman and Smith’s framework for determining political priorities to the data. Findings Pre-diabetes was largely framed as a biomedical diagnosis by all participant groups. GP practices and policymakers were tasked with individual-level monitoring with little power to address population-level influences due to the distribution of funding and power. Participants with pre-diabetes whose social-cultural backgrounds did not align with health promotion messages reported difficulties changing lifestyles. Disrupting social norms posed risks to social positioning, cultural belonging and relationship building. This risk was greater than a future type 2 diabetes risk. Structural influences determined whether participants could eat well and exercise. Conclusion Type 2 diabetes prevention strategies reflect our strongly neoliberal political context, placing the responsibility on individuals to reduce their type 2 diabetes risk with limited emphasis on addressing structural influences on health. Individuals who sustain lifestyle change, are those whose ‘habitus’ aligns with these interventions, have the capital to enact change, and live in communities which facilitate health promoting practices.
Competing Benefits and Competing Hazards: The Benefit to Harm Balance in Individual Patients in Rational Therapeutics
For any therapeutic intervention in an individual, there is a balance between the potential benefits and the possible harms. The extent to which the benefits are desirable in a given condition depends on the efficacy of the intervention, the chance of obtaining it and the seriousness and intensity of the condition. The extent to which the harms are undesirable depends on the nature of the hazard that can lead to harm, the chance that the harm will occur and its seriousness and intensity. Rational therapeutic decisions require clinicians to consider competing courses of action, with potential benefits of different desirability and potential harms of different undesirability. They also have a duty to explain to the patient, for the contemplated interventions, both the possible benefits and the potential harms that the patient may consider significant. In an individual patient, it is necessary to consider (a) the probabilities of benefit from both intervention and non-intervention and (b) the probabilities of harm from both intervention and non-intervention. However, there are several potential problems. Here, we consider how failure to distinguish maximum benefits from probable benefits, or hazards (potential harms) from probable harms, and failure to consider all the competing probabilities may lead to imperfect therapeutic decisions. We also briefly discuss methods to assess the benefit to harm balance.
Impact of coordinated care on adherence to antihypertensive medicines among adults experiencing polypharmacy in Australia
Background: Adherence to antihypertensives is key for blood pressure control. Most people with hypertension have several comorbidities and require multiple medicines, leading to complex care pathways. Strategies for coordinating medicine use can improve adherence, but cumulative benefits of multiple strategies are unknown. Methods: Using dispensing claims for a 10% sample of eligible Australians, we identified adult users of antihypertensives during July 2018–June 2019 who experienced polypharmacy (≥5 unique medicines). We measured medicine use reflecting coordinated medicine management in 3 months before and including first observed dispensing, including: use of simple regimens for each cardiovascular medicine; prescriber continuity; and coordination of dispensings at the pharmacy. We measured adherence (proportion of days covered) to antihypertensive medicines in the following 12 months, and used logistic regression to assess independent associations and interactions of adherence with these measures of care. Results: We identified 202 708 people, of which two-thirds (66.6%) had simple cardiovascular medicine regimens (one tablet per day for each medicine), two-thirds (63.3%) were prescribed >75% of medicines from the same prescriber, and two-thirds (65.5%) filled >50% of their medicine on the same day. One-third (28.4%) of people experienced all three measures of coordinated care. Although all measures were significantly associated with higher adherence, adherence was greatest among people experiencing all three measures (odds ratio = 1.63; 95% confidence interval: 1.55–1.72). This interaction was driven primarily by effects of prescriber continuity and dispensing coordination. Conclusions: Coordinating both prescribing and dispensing of medicines can improve adherence to antihypertensives, which supports strategies consolidating both prescribing and supply of patients’ medicines.
Predicting the risk of pancreatic cancer in adults with new-onset diabetes: development and internal–external validation of a clinical risk prediction model
Background: The National Institute for Health and Care Excellence (NICE) recommends that people aged 60+ years with newly diagnosed diabetes and weight loss undergo abdominal imaging to assess for pancreatic cancer. More nuanced stratification could lead to enrichment of these referral pathways. Methods: Population-based cohort study of adults aged 30–85 years at type 2 diabetes diagnosis (2010–2021) using the QResearch primary care database in England linked to secondary care data, the national cancer registry and mortality registers. Clinical prediction models were developed to estimate risks of pancreatic cancer diagnosis within 2 years and evaluated using internal–external cross-validation. Results: Seven hundred and sixty-seven of 253,766 individuals were diagnosed with pancreatic cancer within 2 years. Models included age, sex, BMI, prior venous thromboembolism, digoxin prescription, HbA1c, ALT, creatinine, haemoglobin, platelet count; and the presence of abdominal pain, weight loss, jaundice, heartburn, indigestion or nausea (previous 6 months). The Cox model had the highest discrimination (Harrell’s C-index 0.802 (95% CI: 0.797–0.817)), the highest clinical utility, and was well calibrated. The model’s highest 1% of predicted risks captured 12.51% of pancreatic cancer cases. NICE guidance had 3.95% sensitivity. Discussion: A new prediction model could have clinical utility in identifying individuals with recent onset diabetes suitable for fast-track abdominal imaging.
Evaluating video and hybrid group consultations in general practice: mixed-methods, participatory study protocol (TOGETHER 2)
Background General practice is facing an unprecedented challenge in managing the consequences of the pandemic. In the midst of a policy drive to balance remote and in-person service provision, substantial workload pressures remain, together with increasing prevalence of long-term conditions, and declining staff numbers and morale. To address these challenges, some practices in the UK have been delivering video and hybrid group consultations (VHGCs). Despite positive initial findings and enthusiasm, there are still gaps in our understanding of the influence VHGCs have on patient experience, healthcare utilisation, quality, safety, equity and affordability. Objectives To generate an in-depth understanding of VHGCs for chronic conditions in general practice, surface assumptions and sociotechnical dynamics, inform practice and extend theorisation. Methods Mixed-methods, multi-site research study using co-design and participatory methods, from qualitative, quantitative and cost-related perspectives. WP1 includes a national, cross-sectional survey on VHGC provision across the UK. In WP2 we will engage patients and general practice staff in co-design workshops to develop VHGC models with emphasis on digital inclusion and equity. In WP3 we will carry out a mixed-methods process evaluation in up to 10 GP practices across England (5 sites already running VHGCs and 5 comparison sites). Qualitative methods will include interviews, focus groups and ethnographic observation to examine the experiences of patients, carers, clinical and non-clinical NHS staff, commissioners and policy-makers. Quantitative methods will examine the impact of VHGCs on healthcare utilisation in primary and secondary care, patient satisfaction, engagement and activation. We will also assess value for money of group and individual care models from a health economics perspective. Conclusions We aim to develop transferable learning on sociotechnical change in healthcare delivery, using VHGCs as an exemplar of technology-supported innovation. Findings will also inform the design of a future study.
Personal and organisational health literacy in the non-specific symptom pathway for cancer: An ethnographic study.
INTRODUCTION: People being investigated for cancer face a wealth of complex information. Non-specific symptom pathways (NSS) were implemented in the United Kingdom in 2017 to address the needs of patients experiencing symptoms such as weight loss, fatigue or general practitioner 'gut feeling', who did not have streamlined pathways for cancer investigation. This study aimed to explore the health literacy skills needed by patients being investigated for cancer in NSS pathways. METHODS: This study employed ethnographic methods across four hospitals in England, including interviews, patient shadowing and clinical care observations, to examine NSS pathways for cancer diagnosis. We recruited 27 patients who were shadowed and interviewed during their care. We also interviewed 27 professionals. The analysis focused on patient communication and understanding, drawing on the concepts of personal and organisational health literacy. RESULTS: Our analysis derived six themes highlighting the considerable informational demands of the NSS pathway. Patients were required to understand complex blood tests and investigations in primary care and often did not understand why they were referred. The NSS pathway itself was difficult to understand with only a minority of patients appreciating that multiple organs were being investigated for cancer. The process of progressing through the pathway was also difficult to understand, particularly around who was making decisions and what would happen next. The results of investigations were complex, often including incidental findings. Patients whose persistent symptoms were not explained were often unsure of what to do following discharge. CONCLUSION: We have identified several potential missed opportunities for organisations to support patient understanding of NSS pathways which could lead to inappropriate help-seeking post-discharge. Patients' difficulties in comprehending previous investigations and findings could result in delays, overtesting or inadequately targeted investigations, hindering the effective use of their medical history. Third, patients' limited understanding of their investigations and results may impede their ability to engage in patient safety by reporting potential care errors. PATIENT OR PUBLIC CONTRIBUTION: Patient, public, clinical and policy representatives contributed to developing the research objectives through a series of meetings and individual conversations in preparation for the study. We have held several events in which patients and the public have had an opportunity to give feedback about our results, such as local interest groups in North London and academic conferences. A clinical contributor (J.-A. M.) was involved in data analysis and writing the manuscript.
Diagnostic yield from symptomatic gastroscopy in the UK: British Society of Gastroenterology analysis using data from the National Endoscopy Database.
OBJECTIVE: This national analysis aimed to calculate the diagnostic yield from gastroscopy for common symptoms, guiding improved resource utilisation. DESIGN: A cross-sectional study was conducted of diagnostic gastroscopies between 1 March 2019 and 29 February 2020 using the UK National Endoscopy Database. Mixed-effect logistic regression models were used, incorporating random (endoscopist) and fixed (symptoms, age and sex) effects on two dependent variables (endoscopic cancer; Barrett's oesophagus (BO) diagnosis). Adjusted positive predictive values (aPPVs) were calculated. RESULTS: 382 370 diagnostic gastroscopies were analysed; 30.4% were performed in patients aged <50 and 57.7% on female patients. The overall unadjusted PPV for cancer was 1.0% (males 1.7%; females 0.6%, p<0.01). Other major pathology was found in 9.1% of procedures, whereas 89.9% reported only normal findings or minor pathology (92.5% in females; 94.6% in patients <50).Highest cancer aPPVs were reached in the over 50s (1.3%), in those with dysphagia (3.0%) or weight loss plus another symptom (1.4%). Cancer aPPVs for all other symptoms were below 1%, and for those under 50, remained below 1% regardless of symptom. Overall, 73.7% of gastroscopies were carried out in patient groups where aPPV cancer was <1%.The overall unadjusted PPV for BO was 4.1% (males 6.1%; females 2.7%, p<0.01). The aPPV for BO for reflux was 5.8% and ranged from 3.2% to 4.0% for other symptoms. CONCLUSIONS: Cancer yield was highest in elderly male patients, and those over 50 with dysphagia. Three-quarters of all gastroscopies were performed on patients whose cancer risk was <1%, suggesting inefficient resource utilisation.