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Obesity is a chronic and complex disease affecting millions of people worldwide. Currently, there is no standard definition of success for the management of obesity. We set out to complete a synthesis of clinical practice guidelines for obesity management for adult populations, aiming to provide both a quantitative descriptive and qualitative analysis of definitions of success in clinical practice guidelines. An electronic search retrieved 4477 references. Sixteen clinical practice guidelines were included after screening and full-text review. We coded definitions of success 147 times across the included guidelines. No standard or explicit definition of success was identified in the guidelines but rather success was implicitly defined. We developed three themes describing how success was defined in the clinical practice guidelines: Knowledge-based decision making; management of expectations; and the perception of control. The review reinforced that success is an inherently subjective and complex concept. Defining success is limited by existing studies that focus on weight loss and would benefit from additional research on different outcomes. Equally, the relationship between people living with obesity and their clinicians should be further explored to understand how defining success is controlled, discussed and framed in a clinical setting.
\n \n\n \n \nBackground: Adherence to the Dietary Approaches to Stop Hypertension (DASH) diet enhances potassium intake and reduces sodium intake and blood pressure (BP), but the underlying metabolic pathways are unclear. Objectives: Among free-living populations, we delineated metabolic signatures associated with the DASH diet adherence, 24-hour urinary sodium and potassium excretions, and the potential metabolic pathways involved. Methods: We used 24-hour urinary metabolic profiling by proton nuclear magnetic resonance spectroscopy to characterize the metabolic signatures associated with the DASH dietary pattern score (DASH score) and 24-hour excretion of sodium and potassium among participants in the United States (n = 2164) and United Kingdom (n = 496) enrolled in the International Study of Macro- and Micronutrients and Blood Pressure (INTERMAP). Multiple linear regression and cross-tabulation analyses were used to investigate the DASH-BP relation and its modulation by sodium and potassium. Potential pathways associated with DASH adherence, sodium and potassium excretion, and BP were identified using mediation analyses and metabolic reaction networks. Results: Adherence to the DASH diet was associated with urinary potassium excretion (correlation coefficient, r = 0.42; P < 0.0001). In multivariable regression analyses, a 5-point higher DASH score (range, 7 to 35) was associated with a lower systolic BP by 1.35 mmHg (95% CI, -1.95 to -0.80 mmHg; P = 1.2 \u00d7 10-5); control of the model for potassium but not sodium attenuated the DASH-BP relation. Two common metabolites (hippurate and citrate) mediated the potassium-BP and DASH-BP relationships, while 5 metabolites (succinate, alanine, S-methyl cysteine sulfoxide, 4-hydroxyhippurate, and phenylacetylglutamine) were found to be specific to the DASH-BP relation. Conclusions: Greater adherence to the DASH diet is associated with lower BP and higher potassium intake across levels of sodium intake. The DASH diet recommends greater intake of fruits, vegetables, and other potassium-rich foods that may replace sodium-rich processed foods and thereby influence BP through overlapping metabolic pathways. Possible DASH-specific pathways are speculated but confirmation requires further study. INTERMAP is registered as NCT00005271 at www.clinicaltrials.gov.
\n \n\n \n \nBACKGROUND: Digital weight management interventions (DWMIs) have the potential to support existing specialist weight management services (SWMS) in the National Health Service (NHS) to increase access to treatment for people living with obesity and type 2 diabetes. At present, there is limited real-world evidence and long-term outcomes on the potential effectiveness of DWMIs to support such services. OBJECTIVE: This study aimed to examine real-world data to evaluate the impact of Second Nature's 12-month DWMI for patients living with obesity with or without type 2 diabetes, referred from NHS primary care services, on sustained weight loss over a 2-year period. METHODS: Retrospective data were extracted in August 2023 for participants who participated in the program between January 1, 2017, and January 8, 2021. Eligible participants were adults with a BMI \u226535 kg/m2, with or without type 2 diabetes. The primary outcomes were weight change in kilograms and percentage weight change at 2 years. Secondary outcomes were weight loss at 1 year, program engagement, and the proportion of participants who achieved >5% and >10% weight loss. Differences in weight loss between baseline and the 1- and 2-year follow-up points were compared using paired 2-tailed t tests. Linear regression models were used to examine whether participants' ethnicity, indices of multiple deprivation, presence of type 2 diabetes, or program engagement were associated with weight loss at 1 year or 2 years. RESULTS: A total of 1130 participants with a mean baseline BMI of 46.3 (SD 31.6) kg/m2 were included in the analysis. Of these participants, 65% (740/1130) were female (mean age 49.9, SD 12.0 years), 18.1% (205/339) were from Black, Asian, mixed, or other ethnicities, and 78.2% (884/1130) had type 2 diabetes. A total of 281 (24.9%) participants recorded weight readings at 2 years from baseline, with a mean weight loss of 13.8 kg (SD 14.2 kg; P
\n \n\n \n \nBackground: Digital weight management interventions have the potential to increase access to novel pharmacotherapy for people living with obesity. At present, there is limited real-world evidence on the effectiveness, feasibility, and acceptability of this type of intervention. Objective: This retrospective service evaluation examines real-world data to evaluate the preliminary impact of Second Nature\u2019s 24-month, remotely delivered, semaglutide-supported weight management intervention for adults living with obesity at 12 weeks. Methods: Retrospective data were extracted in October 2023 for participants who started the intervention between June 8, 2023, and July 22, 2023. The primary outcomes were weight change (kg) and percentage of weight change at 12 weeks. The secondary outcomes were the proportion of participants who achieved \u22655% and \u226510% weight loss and the feasibility and acceptability of this type of intervention. Descriptive statistics were used to evaluate the baseline characteristics, retention, engagement, prevalence of side effects, and weight change. A paired 2-tailed t test was used to determine the significance of weight change. Content analysis was used to analyze the free-text questionnaire responses. Results: A total of 113 participants with a mean baseline BMI of 38.4 kg/m2 (SD 7.3) were included in the analysis (n=102, 90.4% women, mean age 46.6, SD 11.1 years). Over 12 weeks, 23% (n=26) of participants withdrew from the intervention. A total of 70.8% (n=80) of participants provided weight data at 12 weeks. The average weight loss observed over this 12-week period was 6.5 (SD 4.4) kg (P
\n \n\n \n \nBackground: Goal setting aids health-related behavior changes; however, the influence of different types of goals on weight loss remains unclear. Objective: We aimed to investigate the association of 3 aspects of goal setting with weight and program dropout over a 24-week period. Methods: This study was a prospective longitudinal analysis of participants in a 12-week digital behavioral weight loss program. Weight and engagement data for eligible participants (N=36,794) were extracted from the database. Eligible participants were adults in the United Kingdom who had enrolled in the program, had a BMI \u226525 kg/m2, and a weight reading recorded at baseline. Three aspects of goal setting were self-reported at enrollment: weight loss motivation (appearance, health, fitness, or self-efficacy), overall goal preference (low, medium, or high), and percentage weight loss goal (<5%, 5%-10%, or >10%). Weight was measured at 4, 12, and 24 weeks. Mixed models for repeated measures were used to explore the association between goals and weight across the 24-week period. To measure sustained weight change, the primary outcome was weight at 24 weeks. We explored dropout rates over the 24-week period by goal and whether engagement mediated the association between goals and weight loss. Results: Of the 36,794 participants (mean 46.7, SD 11.1 years; 33,902/36,794, 92.14% female) included in the cohort, 13.09% (n=4818) reported weight at 24 weeks. Most participants set goals of 5%-10% weight loss (23,629/36,794, 64.22%), but setting goals for >10% was associated with greater weight loss (mean difference 5.21 kg, 95% CI 5.01-5.41; P10% were less likely to drop out compared with 5%-10% goals (odds ratio [OR] 0.40, 95% CI 0.38-0.42; P
\n \n\n \n \nObjective: The objective of this study was to investigate whether pausing a weight loss program for a defined period of time could enhance weight loss and reduce attrition. Methods: Five databases and two trial registries were searched from inception to July 2023. Randomized-controlled trials of adults with overweight and/or obesity were included if they compared planned-pause interventions with continuous energy restriction (CER), usual care, or a minimal intervention. To be included, the weight loss intervention must have incorporated a pause of at least 1 week. Pooled mean differences for weight change and risk ratios for attrition were calculated using random-effects meta-analyses. Results: Nine intervention arms (N = 796 participants, 77% female) were included. Pooled results did not detect a significant difference in weight change between planned pauses and CER interventions at the end of the active intervention at a median 26 weeks (planned pauses vs. CER mean: \u22127.09 vs. \u22127.0 kg; mean difference: \u22120.09 kg; 95% CI: \u22121.10 to 0.93) or at final follow-up at a median 52 weeks (planned pauses vs. CER mean: \u22126.91 vs. \u22126.19 kg; mean difference: \u22120.72 kg; 95% CI: \u22122.92 to 1.48). There was no difference in attrition between planned pauses and CER interventions at the end of the active intervention (risk ratio: 1.20, 95% CI: 0.82 to 1.75) or at final follow-up (risk ratio: 1.04, 95% CI: 0.89 to 1.22). Conclusions: Planned pauses were consistently found to be no more or less effective than CER for weight loss or attrition.
\n \n\n \n \nBackground: Healthcare system data (HSD) are increasingly used in clinical trials, augmenting or replacing traditional methods of collecting outcome data. This study, PRIMORANT, set out to identify, in the UK context, issues to be considered before the decision to use HSD for outcome data in a clinical trial is finalised, a methodological question prioritised by the clinical trials community. Methods: The PRIMORANT study had three phases. First, an initial workshop was held to scope the issues faced by trialists when considering whether to use HSDs for trial outcomes. Second, a consultation exercise was undertaken with clinical trials unit (CTU) staff, trialists, methodologists, clinicians, funding panels and data providers. Third, a final discussion workshop was held, at which the results of the consultation were fed back, case studies presented, and issues considered in small breakout groups. Results: Key topics included in the consultation process were the validity of outcome data, timeliness of data capture, internal pilots, data-sharing, practical issues, and decision-making. A majority of consultation respondents (n = 78, 95%) considered the development of guidance for trialists to be feasible. Guidance was developed following the discussion workshop, for the five broad areas of terminology, feasibility, internal pilots, onward data sharing, and data archiving. Conclusions: We provide guidance to inform decisions about whether or not to use HSDs for outcomes, and if so, to assist trialists in working with registries and other HSD providers to improve the design and delivery of trials.
\n \n\n \n \nObjectivesTo conduct a systematic review of studies externally validating the ADNEX (Assessment of Different Neoplasias in the adnexa) model for diagnosis of ovarian cancer and to present a meta-analysis of its performance.DesignSystematic review and meta-analysis of external validation studiesData sourcesMedline, Embase, Web of Science, Scopus, and Europe PMC, from 15 October 2014 to 15 May 2023.Eligibility criteria for selecting studiesAll external validation studies of the performance of ADNEX, with any study design and any study population of patients with an adnexal mass. Two independent reviewers extracted the data. Disagreements were resolved by discussion. Reporting quality of the studies was scored with the TRIPOD (Transparent Reporting of a multivariable prediction model for Individual Prognosis Or Diagnosis) reporting guideline, and methodological conduct and risk of bias with PROBAST (Prediction model Risk Of Bias Assessment Tool). Random effects meta-analysis of the area under the receiver operating characteristic curve (AUC), sensitivity and specificity at the 10% risk of malignancy threshold, and net benefit and relative utility at the 10% risk of malignancy threshold were performed.Results47 studies (17\u2009007 tumours) were included, with a median study sample size of 261 (range 24-4905). On average, 61% of TRIPOD items were reported. Handling of missing data, justification of sample size, and model calibration were rarely described. 91% of validations were at high risk of bias, mainly because of the unexplained exclusion of incomplete cases, small sample size, or no assessment of calibration. The summary AUC to distinguish benign from malignant tumours in patients who underwent surgery was 0.93 (95% confidence interval 0.92 to 0.94, 95% prediction interval 0.85 to 0.98) for ADNEX with the serum biomarker, cancer antigen 125 (CA125), as a predictor (9202 tumours, 43 centres, 18 countries, and 21 studies) and 0.93 (95% confidence interval 0.91 to 0.94, 95% prediction interval 0.85 to 0.98) for ADNEX without CA125 (6309 tumours, 31 centres, 13 countries, and 12 studies). The estimated probability that the model has use clinically in a new centre was 95% (with CA125) and 91% (without CA125). When restricting analysis to studies with a low risk of bias, summary AUC values were 0.93 (with CA125) and 0.91 (without CA125), and estimated probabilities that the model has use clinically were 89% (with CA125) and 87% (without CA125).ConclusionsThe results of the meta-analysis indicated that ADNEX performed well in distinguishing between benign and malignant tumours in populations from different countries and settings, regardless of whether the serum biomarker, CA125, was used as a predictor. A key limitation was that calibration was rarely assessed.Systematic review registrationPROSPERO CRD42022373182.
\n \n\n \n \nWh\u0101nau Pakari is a healthy lifestyle assessment and intervention programme for children and adolescents with obesity in Taranaki (Aotearoa/New Zealand), which, in this region, replaced the nationally funded Green Prescription Active Families (GRxAF) programme. We compared national referral rates from the GRxAF programme (age 5\u201315 years) and the B4 School Check (B4SC, a national preschool health and development assessment) with referral rates in Taranaki from Wh\u0101nau Pakari. We retrospectively analysed 5 years of clinical data (2010\u20132015), comparing referral rates before, during, and after the Wh\u0101nau Pakari clinical trial, which was embedded within the programme. We also surveyed programme referrers and stakeholders about their experiences of Wh\u0101nau Pakari, analysing their responses using a multiple-methods framework. After the Wh\u0101nau Pakari trial commenced, Taranaki GRxAF referral rates increased markedly (2.3 pretrial to 7.2 per 1000 person-years), while NZ rates were largely unchanged (1.8\u20131.9 per 1000 person-years) (p < 0.0001 for differences during the trial). Post-trial, Taranaki GRxAF referral rates remained higher irrespective of ethnicity, being 1.8 to 3.2 times the national rates (p < 0.001). Taranaki B4SC referrals for obesity were nearly complete at 99% in the last trial year and 100% post-trial, compared with national rates threefold lower (31% and 32%, respectively; p < 0.0001), with Taranaki referral rates for extreme obesity sustained at 80% and exceeding national rates for both periods (58% and 62%, respectively; p < 0.01). Notably, a referral was 50% more likely for referrers who attended a Wh\u0101nau Pakari training half-day (RR = 1.51; p = 0.009). Stakeholders credited the success of Wh\u0101nau Pakari to its multidisciplinary team, family-centred approach, and home-based assessments. However, they highlighted challenges such as navigating multidisciplinary collaboration, engaging with families with complex needs, and shifting conventional healthcare practices. Given its favourable referral trends and stakeholder endorsement, Wh\u0101nau Pakari appears to be a viable contemporary model for an accessible and culturally appropriate intervention on a national and potentially international scale.
\n \n\n \n \nNeuroendocrine tumours (NET) of the small bowel present significant clinical challenges, such as their rate of metastasis at initial presentation, common multifocality and understaging even with gold standard imaging. Here, we present a case of a high-risk surgical patient with a complex medical history initially presenting as an acute abdomen due to an incarcerated incisional hernia.Hewas found at emergency laparotomy to have three small NET deposits in a 30-cm segment of incarcerated ileum which was resected. Postoperative morphological and functional imaging and biochemical markers were unremarkable, but due to clinical suspicion for undetected residual tumour bulk given the non-systematic palpation of the entire small bowel at initial operation, underwent re-operation where a further 70 cm of ileum was found to harbour multiple tumour deposits (n=25) and was resected. There was no surgical morbidity and the patient remains tumour-free at 9-month follow-up.
\n \n\n \n \nAbstract\nBackground\nThe multidimensional and dynamically complex process of ageing presents key challenges to economic evaluation of geriatric interventions, including: (1) accounting for indirect, long-term effects of a geriatric shock such as a fall; (2) incorporating a wide range of societal, non-health outcomes such as informal caregiver burden; and (3) accounting for heterogeneity within the demographic group. Measures of frailty aim to capture the multidimensional and syndromic nature of geriatric health. Using a case study of community-based falls prevention, this article explores how incorporating a multivariate frailty index in a decision model can help address the above key challenges.\n\nMethods\nA conceptual structure of the relationship between geriatric shocks and frailty was developed. This included three key associations involving frailty: (A) the shock-frailty feedback loop; (B) the secondary effects of shock via frailty; and (C) association between frailty and intervention access. A case study of economic modelling of community-based falls prevention for older persons aged 60\u2009+\u2009was used to show how parameterising these associations contributed to addressing the above three challenges. The English Longitudinal Study of Ageing (ELSA) was the main data source for parameterisation. A new 52-item multivariate frailty index was generated from ELSA. The main statistical methods were multivariate logistic and linear regressions. Estimated regression coefficients were inputted into a discrete individual simulation with annual cycles to calculate the continuous variable value or probability of binary event given individuals\u2019 characteristics.\n\nResults\nAll three conceptual associations, in their parameterised forms, contributed to addressing challenge (1). Specifically, by worsening the frailty progression, falls incidence in the model increased the risk of falling in subsequent cycles and indirectly impacted the trajectories and levels of EQ-5D-3\u00a0L, mortality risk, and comorbidity care costs. Intervention access was positively associated with frailty such that the greater access to falls prevention by frailer individuals dampened the falls-frailty feedback loop. Association (B) concerning the secondary effects of falls via frailty was central to addressing challenge (2). Using this association, the model was able to estimate how falls prevention generated via its impact on frailty paid and unpaid productivity gains, out-of-pocket care expenditure reduction, and informal caregiving cost reduction. For challenge (3), frailty captured the variations within demographic groups of key model outcomes including EQ-5D-3\u00a0L, QALY, and all-cause care costs. Frailty itself was shown to have a social gradient such that it mediated socially inequitable distributions of frailty-associated outcomes.\n\nConclusion\nThe frailty-based conceptual structure and parameterisation methods significantly improved upon the methods previously employed by falls prevention models to address the key challenges for geriatric economic evaluation. The conceptual structure is applicable to other geriatric and non-geriatric intervention areas and should inform the data selection and statistical methods to parameterise structurally valid economic models of geriatric interventions.\n
\n \n\n \n \nWe argue that editorial independence, through robust practice of publication ethics and research integrity, promotes good science and prevents bad science. We elucidate the concept of research integrity, and then discuss the dimensions of editorial independence. Best practice guidelines exist, but compliance with these guidelines varies. Therefore, we make recommendations for protecting and strengthening editorial independence.
\n \n\n \n \nBACKGROUND: Enduring ethnic inequalities exist in mental healthcare. The COVID-19 pandemic has widened these. AIMS: To explore stakeholder perspectives on how the COVID-19 pandemic has increased ethnic inequalities in mental healthcare. METHOD: A qualitative interview study of four areas in England with 34 patients, 15 carers and 39 mental health professionals from National Health Service (NHS) and community organisations (July 2021 to July 2022). Framework analysis was used to develop a logic model of inter-relationships between pre-pandemic barriers and COVID-19 impacts. RESULTS: Impacts were largely similar across sites, with some small variations (e.g. positive service impacts of higher ethnic diversity in area 2). Pre-pandemic barriers at individual level included mistrust and thus avoidance of services and at a service level included the dominance of a monocultural model, leading to poor communication, disengagement and alienation. During the pandemic remote service delivery, closure of community organisations and media scapegoating exacerbated existing barriers by worsening alienation and communication barriers, fuelling prejudice and division, and increasing mistrust in services. Some minority ethnic patients reported positive developments, experiencing empowerment through self-determination and creative activities. CONCLUSIONS: During the COVID-19 pandemic some patients showed resilience and developed adaptations that could be nurtured by services. However, there has been a reduction in the availability of group-specific NHS and third-sector services in the community, exacerbating pre-existing barriers. As these developments are likely to have long-term consequences for minority ethnic groups' engagement with mental healthcare, they need to be addressed as a priority by the NHS and its partners.
\n \n\n \n \nBackground The workload and wellbeing of support staff in general practice has been critically understudied. This includes reception, secretarial and administrative workers who are critical in the daily practice function. Currently, only reception staff are mentioned in the evidence base on general practice working conditions, and all support staff are excluded from studies about the impact of the pandemic on healthcare workers\u2019 work and wellbeing. Aim To outline the unique work support staff do, the additional burden it places on them, and how the symphony of crises in 2020\u20132023 compounded those burdens. Additionally, to provide practical advice for practice leaders on how to support staff wellbeing through developing a relational and psychologically safe working environment. Methods These findings are drawn from qualitative research (case studies built through observations, interviews and focus groups) conducted in 2022\u20132023. Results Through theoretically informed analysis, we found that support staff do specialist intersectional guiding work to support patients, other staff, and the practice as a whole. We define this as lay translation, specialist-lay translation, and occupational translation. Under crises, the volume of this work grows, complexifies, and becomes more fragmented. Relational and supportive teams were more able to adapt to these challenges. Discussion Support staff should be recognised and enabled to perform these specialised roles. Therefore, we provide a set of recommendations for practice leaders to consider integrating into their own workplaces.
\n \n\n \n \nPurpose: Preclinical studies support a protective role for omega-3 fatty acids (FAs) on diabetic retinopathy (DR), but these observations have not been confirmed in randomized trials. We present randomized evidence for the effects of omega-3 FAs on DR outcomes. Design: A substudy of the A Study of Cardiovascular Events iN Diabetes (ASCEND) double-blind, randomized, placebo-controlled trial of 1 g omega-3 fatty acids (containing 460 mg eicosapentaenoic acid and 380 mg docosahexaenoic acid) daily for the primary prevention of serious cardiovascular events, in 15 480 UK adults at least 40 years of age, with diabetes. Participants: Fifteen thousand four hundred eighty adults at least 40 years of age from the United Kingdom with diabetes from the ASCEND cohort. Methods: Linkage to electronic National Health Service Diabetic Eye Screening Programme records in England and Wales and confirmation of participant-reported eye events via medical record review. Log-rank and stratified log-rank methods were used for intention-to-treat analyses of time until the main outcomes of interest. Main Outcome Measures: The primary efficacy endpoint was time to the first postrandomization recording of referable disease, a composite of referable retinopathy (R2 or R3a/s) or referable maculopathy (M1) based on the grading criteria defined by the United Kingdom National Screening Committee. Secondary and tertiary outcomes included the referable disease outcome stratified by the severity of DR at baseline, any progression in retinopathy grade, and incident diabetic maculopathy. Results: Linkage data were obtained for 7360 participants (48% of those who were randomized in ASCEND). During their mean follow-up of 6.5 years, 548 participants (14.8%) had a referable disease event in the omega-3 FAs group, compared with 513 participants (13.9%) in the placebo group (rate ratio, 1.07; 95% confidence interval, 0.95\u20131.20; P = 0.29). There were no statistically significant between-group differences in the proportion of events for either of the secondary or tertiary outcomes. Conclusions: Representing the largest prospective test of its kind to date, these data exclude any clinically meaningful benefits of 1 g daily omega-3 FAs on DR. Financial Disclosure(s): Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.
\n \n\n \n \nBackground: Reporting of domestic violence and abuse (DVA) increased globally during the pandemic. General Practice has a central role in identifying and supporting those affected by DVA. Pandemic associated changes in UK primary care included remote initial contacts with primary care and predominantly remote consulting. This paper explores general practice\u2019s adaptation to DVA care during the COVID-19 pandemic. Methods: Remote semi-structured interviews were conducted by telephone with staff from six localities in England and Wales where the Identification and Referral to Improve Safety (IRIS) primary care DVA programme is commissioned. We conducted interviews between April 2021 and February 2022 with three practice managers, three reception and administrative staff, eight general practice clinicians and seven specialist DVA staff. Patient and public involvement and engagement (PPI&E) advisers with lived experience of DVA guided the project. Together we developed recommendations for primary care teams based on our findings. Results: We present our findings within four themes, representing primary care adaptations in delivering DVA care:\u00a01. Making general practice accessible for DVA care: staff adapted telephone triaging processes for appointments and promoted availability of DVA support online. 2. General practice team-working to identify DVA: practices developed new approaches of collaboration, including whole team adaptations to information processing and communication 3. Adapting to remote consultations about DVA: teams were required to adapt to challenges including concerns about safety, privacy, and developing trust remotely. 4. Experiences of onward referrals for specialist DVA support: support from specialist services was effective and largely unchanged during the pandemic. Conclusions: Disruption caused by pandemic restrictions revealed how team dynamics and interactions before, during and after clinical consultations contribute to identifying and supporting patients experiencing DVA. Remote assessment complicates access to and delivery of DVA care. This has implications for all primary and secondary care settings, within the NHS and internationally, which are vital to consider in both practice and policy.
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