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Rationale: The definition of the lower limit of normal (LLN) of spirometric variables is not well established. Objectives: To investigate the relationship between spirometric abnormalities defined with different thresholds of the LLN and clinical outcomes and to explore the possibility of using different LLN thresholds according to the pretest probability of disease. Methods: We studied the associations between prebronchodilator spirometric abnormalities (forced expiratory volume in the first second [FEV 1 ] < LLN, forced vital capacity [FVC] < LLN, airflow obstruction, spirometric restriction) defined with different thresholds of the LLN (10th, 5th, 2.5th, 1st percentile) and multiple outcomes (prevalence of spirometric abnormalities, respiratory symptoms, all-cause and respiratory mortality) in 26,091 30- to 46-year-old men who participated in a general population survey in Norway in 1988-1990 and were followed for 26 years. Analyses were performed with both local and Global Lung Function Initiative (GLI)-2012 reference equations, stratified by pretest risk (presence or absence of respiratory symptoms), and adjusted for age, body mass index, smoking, and education. Results: In the total population, the prevalence of airflow obstruction was 11.6% with GLI-LLN10, 11.0% with Local-LLN5, 6.1% with GLI-LLN5, 7.6% with Local-LLN2.5, and 3.5% with GLI-LLN2.5. The prevalence of spirometric restriction was 5.9% with GLI-LLN10, 5.2% with Local-LLN5, and 2.8% with GLI-LLN5. Increasingly lower thresholds of the LLN were associated with increasingly higher odds of respiratory symptoms and hazard of mortality for all spirometric abnormalities with both reference equations. Spirometric abnormalities defined with Local-LLN2.5 in asymptomatic subjects were associated with lower hazard of all-cause mortality (hazard ratio [HR], 1.50; 95% confidence interval [CI], 1.15-1.95 for FEV 1  < LLN) than those defined with Local-LLN5 in the general population (HR, 1.67; 95% CI, 1.50-1.87 for FEV 1  < LLN) and symptomatic subjects (HR, 1.67; 95% CI, 1.46-1.91 for FEV 1  < LLN). Overall, the prevalence of spirometric abnormalities and associations with outcomes obtained with Local-LLN5 were comparable to those obtained with GLI-LLN10 and those obtained with Local-LLN2.5 to GLI-LLN5. Conclusions: There is a relationship between statistically based thresholds of the LLN of spirometric variables and clinical outcomes. Different thresholds of the LLN may be used in different risk subgroups of subjects, but the choice of the threshold needs to be evaluated together with the choice of reference equations.

Importance: Hemorrhage is the most common cause of preventable death after injury. Most deaths occur early, in the prehospital phase of care., Objective: To establish whether prehospital zone 1 (supraceliac) partial resuscitative endovascular balloon occlusion of the aorta (Z1 P-REBOA) can be achieved in the resuscitation of adult trauma patients at risk of cardiac arrest and death due to exsanguination., Design, Setting, and Participants: This was a prospective observational cohort study (Idea, Development, Exploration, Assessment and Long-term follow-up [IDEAL] 2A design) with recruitment from June 2020 to March 2022 and follow-up until discharge from hospital, death, or 90 days evaluating a physician-led and physician-delivered, urban prehospital trauma service in the Greater London area. Trauma patients aged 16 years and older with suspected exsanguinating subdiaphragmatic hemorrhage, recent or imminent hypovolemic traumatic cardiac arrest (TCA) were included. Those with unsurvivable injuries or who were pregnant were excluded. Of 2960 individuals attended by the service during the study period, 16 were included in the study., Exposures: ZI REBOA or P-REBOA., Main Outcomes and Measures: The main outcome was the proportion of patients in whom Z1 REBOA and Z1 P-REBOA were achieved. Clinical end points included systolic blood pressure (SBP) response to Z1 REBOA, mortality rate (1 hour, 3 hours, 24 hours, or 30 days postinjury), and survival to hospital discharge., Results: Femoral arterial access for Z1 REBOA was attempted in 16 patients (median [range] age, 30 [17-76] years; 14 [81%] male; median [IQR] Injury Severity Score, 50 [39-57]). In 2 patients with successful arterial access, REBOA was not attempted due to improvement in clinical condition. In the other 14 patients (8 [57%] of whom were in traumatic cardiac arrest [TCA]), 11 successfully underwent cannulation and had aortic balloons inflated in Z1. The 3 individuals in whom cannulation was unsuccessful were in TCA (failure rate = 3/14 [21%]). Median (IQR) pre-REBOA SBP in the 11 individuals for whom cannulation was successful (5 [46%] in TCA) was 47 (33-52) mm Hg. Z1 REBOA plus P-REBOA was associated with a significant improvement in BP (median [IQR] SBP at emergency department arrival, 101 [77-107] mm Hg; 0 of 10 patients were in TCA at arrival). The median group-level improvement in SBP from the pre-REBOA value was 52 (95% CI, 42-77) mm Hg (P < .004). P-REBOA was feasible in 8 individuals (8/11 [73%]) and occurred spontaneously in 4 of these. The 1- and 3-hour postinjury mortality rate was 9% (1/11), 24-hour mortality was 27% (3/11), and 30-day mortality was 82% (9/11). Survival to hospital discharge was 18% (2/11). Both survivors underwent early Z1 P-REBOA., Conclusions and Relevance: In this study, prehospital Z1 P-REBOA is feasible and may enable early survival, but with a significant incidence of late death., Trial Registration: ClinicalTrials.gov Identifier: NCT04145271.

Background: Randomised controlled trials (RCTs) are typically designed to determine beneficial intervention effects. In addition, an important aspect of every trial is to collect data on any potential harmful effects, with the aim of ensuring that the benefit-risk balance is appropriate. The language used by trialists to describe these potential harmful effects is inconsistent. In pharmacological trials, researchers collect adverse events; when a causal relationship is suspected adverse events are further classified as adverse reactions. Academic researchers have moved to collectively refer to these as harm outcomes; the pharmaceutical industry refer to these events as safety outcomes. In trials of complex interventions, phrases such as unintended consequences or effects are used. With the inconsistent use of terminology by researchers and the potential benefits to be gained from harmonising communications, we sought public opinion on terminology used to describe harmful effects and how these outcomes are communicated in the scientific literature, as well as in public facing material on medications., Methods: We held two in-person public involvement meetings with public partners, in London and Aberdeen in 2023. Both meetings followed a pre-specified format. We provided a background to the topic including the information researchers collect on potential harms in clinical trials and shared examples on how this information gets presented in practice. We then discussed public partners' perspectives on terminology used and communication of intervention harm in academic journals and in public facing materials. A summary of these discussions and the main topics raised by public partners are presented., Results: Public partners endorsed the use of different terms for different situations, preferring the use of 'side-effect' across all contexts and reserving the use of 'harm' to indicate more severe events. Generally, public partners were happy with the type of information presented in public facing materials but discussions revealed that presentation of information on public NHS websites led to misconceptions about harm., Conclusion: This work provides a starting point on preferred terminology by patients and the public to describe potential harmful intervention effects. Whilst researchers have tried to seek agreement, public partners endorsed use of different terms for different situations. We highlight some key areas for improvement in public facing materials that are necessary to avoid miscommunication and incorrect perception of harm., (© 2024. The Author(s).)

Background: Preserved ratio impaired spirometry (PRISm) and restrictive spirometric pattern (RSP) are often considered interchangeable in identifying restrictive impairment in spirometry., Research Question: Do PRISm and RSP have different individual associations with risk factors, morbidity, and mortality?, Study Design and Methods: In a cross-sectional and longitudinal study, including 26,091 Norwegian general population men (30 to 46 years of age), we explored the association of PRISm and RSP with smoking habits, BMI, education, respiratory symptoms, self-reported cardiopulmonary disease, and mortality after 26 years of follow-up. PRISm was defined as FEV 1 /FVC ≥ lower limit of normal (LLN) and FEV 1  < LLN, and RSP was defined as FEV 1 /FVC ≥ LLN and FVC < LLN. We compared the associations of PRISm and RSP to airflow obstruction and normal spirometry, both as mutually (PRISm alone, RSP alone) and nonmutually exclusive (PRISm, RSP) categories, adjusting for age, BMI, smoking, and education. We also conducted sensitivity analyses using Global Initiative for Chronic Obstructive Lung Disease criteria to define spirometric abnormalities., Results: The prevalence of the mutually exclusive spirometric patterns was as follows: normal 82.4%, obstruction 11.0%, PRISm alone 1.4%, RSP alone 1.7%, and PRISm + RSP 3.5%. PRISm alone patients were frequently obese (11.2%), had active or previous tobacco use, commonly reporting cough, phlegm, wheeze, asthma, and bronchitis. RSP alone patients were both obese (14.6%) and underweight (2.9%), with increased breathlessness, but similar smoking habits to patients with normal spirometry. The prevalence of heart disease was 4.6% in PRISm alone, 2.7% in RSP alone, and 1.6% in obstruction. With normal spirometry as a reference, RSP alone had increased all-cause (hazard ratio [HR], 1.57; 95% CI, 1.21-2.04), cardiovascular (HR, 1.48; 95% CI, 0.88-2.48), diabetes (HR, 6.43; 95% CI, 1.88-21.97), and cancer (excluding lung) mortality (HR, 1.51; 95% CI, 0.95-2.42). PRISm alone had increased respiratory disease mortality (HR, 4.00; 95% CI, 1.22-13.16). Patients with PRISm + RSP had intermediate characteristics and the worst prognosis. Findings were overall confirmed with nonmutually exclusive categories and Global Initiative for Chronic Obstructive Lung Disease criteria., Interpretation: PRISm and RSP are spirometric patterns with distinct risk factors, morbidity, and mortality, which should be differentiated in future studies., Competing Interests: Financial/Nonfinancial Disclosures The authors have reported to CHEST the following: L. C. and R. N. report funding from AstraZeneca, outside the submitted work. K. S. reports fees from UCB Pharma and MSD, outside the submitted work. None declared (A. J., A. G.)., (Copyright © 2024 The Author(s). Published by Elsevier Inc. All rights reserved.)

Background: Digital technologies have impacted health care delivery globally, and are increasingly being deployed in clinical practice. However, there is limited research on patients' expectations of doctors' clinical competencies when using digital health care technologies (DHTs) in medical care. Understanding these expectations can reveal competency gaps, enhance patient confidence, and contribute to digital innovation initiatives., Objective: This study explores patients' perceptions of doctors' use of DHTs in clinical care. Using Singapore as a case study, it examines patients' expectations regarding doctors' communication, diagnosis, and treatment skills when using telemedicine, health apps, wearable devices, electronic health records, and artificial intelligence., Methods: Findings were drawn from individual semistructured interviews with patients from outpatient clinics. Participants were recruited using purposive sampling. Data were analyzed qualitatively using thematic analysis., Results: Twenty-five participants from different backgrounds and with various chronic conditions participated in the study. They expected doctors to be adept in handling medical data from apps and wearable devices. For telemedicine, participants expected a level of assessment of their medical conditions akin to in-person consultations. In addition, they valued doctors recognizing when a physical examination was necessary. Interestingly, eye contact was appreciated but deemed nonessential by participants across all age bands when electronic health records were used, as they valued the doctor's efficiency more than eye contact. Nonetheless, participants emphasized the need for empathy throughout the clinical encounter regardless of DHT use. Furthermore, younger participants had a greater expectation for DHT use among doctors compared to older ones, who preferred DHTs as a complement rather than a replacement for clinical skills. The former expected doctors to be knowledgeable about the algorithms, principles, and purposes of DHTs such as artificial intelligence technologies to better assist them in diagnosis and treatment., Conclusions: By identifying patients' expectations of doctors amid increasing health care digitalization, this study highlights that while basic clinical skills remain crucial in the digital age, the role of clinicians needs to evolve with the introduction of DHTs. It has also provided insights into how DHTs can be integrated effectively into clinical settings, aligning with patients' expectations and preferences. Overall, the findings offer a framework for high-income countries to harness DHTs in enhancing health care delivery in the digital era., (©Humairah Zainal, Xin Xiao Hui, Julian Thumboo, Warren Fong, Fong Kok Yong. Originally published in JMIR Human Factors (https://humanfactors.jmir.org), 27.08.2024.)

Background: Understanding diagnostic capacities is essential to addressing healthcare provision and inequity, particularly in low-income and middle-income countries. This study used routine data to assess trends in rapid diagnostic test (RDT) reporting, supplies and unmet needs across national and 47 subnational (county) levels in Kenya., Methods: We extracted facility-level RDT data for 19 tests (2018-2020) from the Kenya District Health Information System, linked to 13 373 geocoded facilities. Data quality was assessed for reporting completeness (ratio of reports received against those expected), reporting patterns and outliers. Supply assessment covered 12 RDTs reported by at least 50% of the reporting facilities (n=5251), with missing values imputed considering reporting trends. Supply was computed by aggregating the number of tests reported per facility. Due to data limitations, demand was indirectly estimated using healthcare-seeking rates (HIV, malaria) and using population data for venereal disease research laboratory test (VDRL), with unmet need computed as the difference between supply and demand., Results: Reporting completeness was under 40% across all counties, with RDT-specific reporting ranging from 9.6% to 89.6%. Malaria RDTs showed the highest annual test volumes (6.3-8.0 million) while rheumatoid factor was the lowest (0.5-0.7 million). Demand for RDTs varied from 2.5 to 11.5 million tests, with unmet needs between 1.2 and 3.5 million. Notably, malaria testing and unmet needs were highest in Turkana County, as well as the western and coastal regions. HIV testing was concentrated in the western and central regions, with decreasing unmet needs from 2018 to 2020. VDRL testing showed high volumes and unmet needs in Nairobi and select counties, with minimal yearly variation., Conclusion: RDTs are crucial in enhancing diagnostic accessibility, yet their utilisation varies significantly by region. These findings underscore the need for targeted interventions to close testing gaps and improve data reporting completeness. Addressing these disparities is vital for equitably enhancing diagnostic services nationwide., Competing Interests: Competing interests: EO serves on the AstraZeneca Vaccine & Immune Therapies Effectiveness Evidence Scientific Advisory Committee (VEE-SAC)., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY. Published by BMJ.)

Objective: This umbrella review synthesises evidence on the methods used to recruit and retain ethnically diverse participants and report and analyse variables related to ethnic diversity in randomised controlled trials., Design: Umbrella review., Data Sources: Ovid MEDLINE, Ovid Embase, CINAHL, PsycINFO and Cochrane and Campbell Libraries for review papers published between 1 January 2010 and 13 May 2024., Eligibility Criteria: English language systematic reviews focusing on inclusion and reporting of ethnicity variables. Methodological quality was assessed using the AMSTAR 2 tool., Results: Sixty-two systematic reviews were included. Findings point to limited representation and reporting of ethnic diversity in trials. Recruitment strategies commonly reported by the reviews were community engagement, advertisement, face-to-face recruitment, cultural targeting, clinical referral, community presentation, use of technology, incentives and research partnership with communities. Retention strategies highlighted by the reviews included frequent follow-ups on participants to check how they are doing in the study, provision of incentives, use of tailored approaches and culturally appropriate interventions. The findings point to a limited focus on the analysis of variables relevant to ethnic diversity in trials even when they are reported in trials., Conclusion: Significant improvements are required in enhancing the recruitment and retention of ethnically diverse participants in trials as well as analysis and reporting of variables relating to diversity in clinical trials., Prospero Registration Number: CRD42022325241., Competing Interests: Competing interests: BB has received funds from the Australian National Health and Medical Research Council for projects related to dementia, ethnicity and ageing. HG works for COUCH Health, which undertakes research commissioned by the pharmaceutical, academic and charity sectors. No COUCH Health clients participated in the collection, analysis or interpretation of the data for the RECONSIDER Project. None of the other authors have any conflicts of interest to declare., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY. Published by BMJ.)

Unsettled infant behaviours are highly prevalent in the postnatal period and constitute a significant proportion of visits to healthcare services. Unsettled infant behaviours can be highly distressing for parents and are identified as a significant risk factor for postnatal depression. Understanding parents' experiences is paramount to reducing the gap between consumer expectations and service delivery. This study employed a qualitative descriptive approach to explore parents' experiences seeking healthcare advice for their infant with unsettled behaviours. Semi-structured interviews were conducted with 20 mothers. Inductive thematic analysis yielded two overarching themes: (1) 'the journey for answers', consisting of five sub-themes, and (2) 'parents' knowledge and behaviours', consisting of six sub-themes. Despite some positive interactions with healthcare services, mothers generally spoke negatively of their overall experience seeking answers and receiving care for their infant, and they felt the healthcare services they attended were not equipped to meet their needs. To address the gap between service delivery and consumer expectations, mothers relied on online communities for advice and emotional support. The findings of this study highlight several discrepancies between mothers' expectations and service delivery in the context of unsettled infant behaviours, and this paper makes recommendations to address identified shortcomings in approaches to care., Competing Interests: Declaration of conflicting interestsThe author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

Introduction: Understanding genetic contributors to sarcopenia (age-related loss of muscle strength and mass) is key to finding effective therapies. Variants of the bradykinin receptor 2 (BDKRB2) have been linked to athletic and muscle performance. The rs1799722-9 and rs5810761 T alleles have been shown to be overrepresented in endurance athletes, possibly due to increased transcriptional rates of the receptor. These variants have been rarely studied in older people or people with sarcopenia., Methods: We performed a post hoc sub-study of the Leucine and ACE (LACE) inhibitor trial, which enrolled 145 participants aged ≥70 years with low grip strength and low gait speed. Participants' blood samples were genotyped for rs179972 using TaqMan and rs5810761 by amplification through Hotstar Taq. Genotypes were compared with outcomes of physical performance and body composition measures., Results: Data from 136 individuals were included in the analysis. For rs1799722 the genotype frequency (TT: 17, CC: 48, CT: 71) remained in Hardy-Weinberg Equilibrium (HWE p = 0.248). There was no difference between the genotypes for six-Minute Walk Distance (6MWD) or Short Physical Performance Battery (SPPB). Men with the TT genotype had a significantly greater 6MWD than other genotypes (TT 400m vs CT 310m vs CC 314m, p = 0.027), and greater leg muscle mass (TT 17.59kg vs CT 15.04kg vs CC 15.65kg, p = 0.007). For rs5810761, the genotype frequency (-9-9: 31, +9+9: 43, -9+9: 60) remained in HWE (p = 0.269). The +9+9 genotype was associated with a significant change in SPPB score at 12 months (-9-9 0 vs -9+9 0 vs +9+9-1, p<0.001), suggesting an improvement. In men, the -9-9 genotype was associated with lower arm fat (-9-9 2.39kg vs -9+9 2.72kg vs +9+9 2.76kg, p = 0.019)., Conclusion: In men, the rs1799722 TT genotype was associated with longer 6MWD and greater leg muscle mass, while the rs5810761 -9-9 genotype was associated with lower arm fat mass., Competing Interests: The authors have declared that no competing interests exist., (Copyright: © 2024 Shrestha et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.)

Background: Glaucoma is a chronic disease of the optic nerve and a leading cause of severe visual loss in the UK. Once patients have been diagnosed, they need regular monitoring at hospital eye services. Recent advances in technology mean patients with glaucoma can now monitor their disease at home. This could be more convenient for patients and potentially reduce costs and increase capacity for the NHS. However, it is uncertain whether self-monitoring would be acceptable or possible for patients with glaucoma., Objectives: The objectives were to: identify which patients are most appropriate for home monitoring; understand views of key stakeholders (patients, clinicians, researchers) on whether home glaucoma monitoring is feasible and acceptable; develop a conceptual framework for the economic evaluation of home glaucoma monitoring; and explore the need for and provide evidence on the design of a future study to evaluate the clinical and cost-effectiveness of digital technologies for home monitoring of glaucoma., Design: In-home Tracking of glaucoma: Reliability, Acceptability, and Cost (I-TRAC) was a multiphase mixed-methods feasibility study with key components informed by theoretical and conceptual frameworks., Setting: Expert glaucoma specialists in the UK recruited through professional glaucoma societies; study site staff and patient participants recruited through three UK hospital eye services (England, Scotland, Northern Ireland); and UK research teams recruited though existing networks., Intervention: Home tonometer that measures intraocular pressure and a tablet computer with a visual function application. Patients were asked to use the technology weekly for 12 weeks., Results: Forty-two patients were recruited. Retention and completion of follow-up procedures was successful, with 95% ( n = 40) completing the 3-month follow-up clinic visits. Adherence to the interventions was generally high [adherence to both devices (i.e. ≥ 80% adherence) was 55%]. Overall, patients and healthcare professionals were cautiously optimistic about the acceptability of digital technologies for home monitoring of patients with glaucoma. While most clinicians were supportive of the potential advantages glaucoma home monitoring could offer, concerns about the technologies (e.g. reliability and potential to miss disease progression) and how they would fit into routine care need to be addressed. Additionally, clarity is required on defining the ideal population for this intervention. Plans for how to evaluate value for money in a future study were also identified. However, the study also highlighted several unknowns relating to core components of a future evaluative study that require addressing before progression to a definitive effectiveness trial., Limitations: The main limitation relates to our sample and its generalisability, for example, the over-representation of educated persons of white ethnicity who were generally experienced with technology and research motivated., Conclusions: The In-home Tracking of glaucoma: Reliability, Acceptability, and Cost study has demonstrated 'cautious optimism' when considering patients' and healthcare professionals' views on the acceptability of digital technologies for home monitoring of patients with glaucoma. However, the study also highlighted several unknowns relating to the research question and design of a future evaluative study that require addressing before progression to a randomised controlled trial., Future Work: Further research is required to determine the appropriate population (i.e. low vs. high risk of progression) and further refine the intervention components and delivery for planning of future evaluation studies., Study Registration: This study is registered as Research Registry #6213., Funding: This award was funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme (NIHR award ref: NIHR129248) and is published in full in Health Technology Assessment ; Vol. 28, No. 44. See the NIHR Funding and Awards website for further award information.

Background: Low levels of testosterone cause male hypogonadism, which is associated with sexual dysfunction, tiredness and reduced muscle strength and quality of life. Testosterone replacement therapy is commonly used for ameliorating symptoms of male hypogonadism, but there is uncertainty about the magnitude of its effects and its cardiovascular and cerebrovascular safety., Aims of the Research: The primary aim was to evaluate the safety of testosterone replacement therapy. We also assessed the clinical and cost-effectiveness of testosterone replacement therapy for men with male hypogonadism, and the existing qualitative evidence on men's experience and acceptability of testosterone replacement therapy., Design: Evidence synthesis and individual participant data meta-analysis of effectiveness and safety, qualitative evidence synthesis and model-based cost-utility analysis., Data Sources: Major electronic databases were searched from 1992 to February 2021 and were restricted to English-language publications., Methods: We conducted a systematic review with meta-analysis of individual participant data according to current methodological standards. Evidence was considered from placebo-controlled randomised controlled trials assessing the effects of any formulation of testosterone replacement therapy in men with male hypogonadism. Primary outcomes were mortality and cardiovascular and cerebrovascular events. Data were extracted by one reviewer and cross-checked by a second reviewer. The risk of bias was assessed using the Cochrane Risk of Bias tool. We performed one-stage meta-analyses using the acquired individual participant data and two-stage meta-analyses to integrate the individual participant data with data extracted from eligible studies that did not provide individual participant data. A decision-analytic Markov model was developed to evaluate the cost per quality-adjusted life-years of the use of testosterone replacement therapy in cohorts of patients of different starting ages., Results: We identified 35 trials (5601 randomised participants). Of these, 17 trials (3431 participants) provided individual participant data. There were too few deaths to assess mortality. There was no difference between the testosterone replacement therapy group (120/1601, 7.5%) and placebo group (110/1519, 7.2%) in the incidence of cardiovascular and/or cerebrovascular events (13 studies, odds ratio 1.07, 95% confidence interval 0.81 to 1.42; p  = 0.62). Testosterone replacement therapy improved quality of life and sexual function in almost all patient subgroups. In the testosterone replacement therapy group, serum testosterone was higher while serum cholesterol, triglycerides, haemoglobin and haematocrit were all lower. We identified several themes from five qualitative studies showing how symptoms of low testosterone affect men's lives and their experience of treatment. The cost-effectiveness of testosterone replacement therapy was dependent on whether uncertain effects on all-cause mortality were included in the model, and on the approach used to estimate the health state utility increment associated with testosterone replacement therapy, which might have been driven by improvements in symptoms such as sexual dysfunction and low mood., Limitations: A meaningful evaluation of mortality was hampered by the limited number of defined events. Definition and reporting of cardiovascular and cerebrovascular events and methods for testosterone measurement varied across trials., Conclusions: Our findings do not support a relationship between testosterone replacement therapy and cardiovascular/cerebrovascular events in the short-to-medium term. Testosterone replacement therapy improves sexual function and quality of life without adverse effects on blood pressure, serum lipids or glycaemic markers., Future Work: Rigorous long-term evidence assessing the safety of testosterone replacement therapy and subgroups most benefiting from treatment is needed., Study Registration: The study is registered as PROSPERO CRD42018111005., Funding: This award was funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme (NIHR award ref: 17/68/01) and is published in full in Health Technology Assessment ; Vol. 28, No. 43. See the NIHR Funding and Awards website for further award information.

Background: Local authorities need to find new ways of collecting and using data on social care users' experiences to improve service design and quality. Here we draw on and adapt an approach used in the healthcare improvement field, accelerated experience-based co-design, to see if it can be translated to social care. We use loneliness support as our exemplar., Objectives: To understand how loneliness is understood and experienced by members of the public and characterised by social care and voluntary sector staff; to identify service improvements around loneliness support; to explore whether accelerated experience-based co-design is effective in social care; and to produce new resources for publication on Socialcaretalk.org., Design and Methods: Discovery phase: in-depth interviews with a diverse sample of people in terms of demographic characteristics with experience of loneliness, and 20 social care and voluntary staff who provided loneliness support. Production of a catalyst film from the public interview data set. Co-design phase: exploring whether the accelerated experience-based co-design approach is effective in one local authority area via a series of three workshops to agree shared priorities for improving loneliness support (one workshop for staff, another for people with experience of local loneliness support, and a third, joint workshop), followed by 7-monthly meetings by two co-design groups to work on priority improvements. A process evaluation of the co-design phase was conducted using interviews, ethnographic observation, questionnaires and other written material., Results: Accelerated experience-based co-design demonstrated strong potential for use in social care. Diverse experiences of participants and fuzzy boundaries around social care compared to health care widened the scope of what could be considered a service improvement priority. Co-design groups focused on supporting people to return to pre-pandemic activities and developing a vulnerable passenger 'gold standard' award for taxi drivers. This work generated short-term 'wins' and longer-term legacies. Participants felt empowered by the process and prospect of change, and local lead organisations committed to take the work forward., Conclusions: Using an exemplar, loneliness support, that does not correspond to a single pathway allowed us to comprehensively explore the use of accelerated experience-based co-design, and we found it can be adapted for use in social care. We produced recommendations for the future use of the approach in social care which include identifying people or organisations who could have responsibility for implementing improvements, and allowing time for coalition-building, developing trusted relationships and understanding different perspectives., Limitations: COVID-19 temporarily affected the capacity of the local authority Project Lead to set up the intervention. Pandemic work pressures led to smaller numbers of participating staff and had a knock-on effect on recruitment. Staff turnover within Doncaster Council created further challenges., Future Work: Exploring the approach using a single pathway, such as assessing eligibility for care and support, could add additional insights into its transferability to social care., Trial Registration: This trial is registered as Current Controlled Trials ISRCTN98646409., Funding: This award was funded by the National Institute for Health and Care Research (NIHR) Health and Social Care Delivery Research programme (NIHR award ref: NIHR128616) and is published in full in Health and Social Care Delivery Research; Vol. 12, No. 27. See the NIHR Funding and Awards website for further award information.

Objectives: To assess the feasibility of estimating an EQ-5D-5L value set using a small study design in cancer patients and to compare the EQ-5D-5L values based on the preferences of cancer patients with those of the general public., Methods: Patients with clinically diagnosed cancers were recruited from two hospitals in Shanghai, China. In face-to-face interviews using the EQ-PVT survey, health states were valued by cancer patients using both cTTO and DCE methods. cTTO data was modelled alone or jointly with DCE data. Forty-eight models using different model specifications (cross-attribute level effect [CALE] and additive models), random/fixed effects model assumptions, data heteroscedasticity and censoring were estimated. The best performed model was identified in terms of monotonicity of estimated model coefficients and out-of-sample prediction accuracy., Results: Data collected from 221 cancer patients who participated in the study were included. The hybrid CALE model using both TTO and DCE data performed best in terms of prediction accuracy (Lin's concordance coefficient = 0.989; root mean squared error = 0.058) and suggested that pain/discomfort and anxiety/depression were the most undesirable health problems. Compared to values based on general Chinese public's health preferences, the values based on cancer patients' preferences were much higher and lower for health states characterized by extreme mobility problems and severe/extreme pain or discomfort, respectively., Conclusion: This study demonstrated the feasibility of using a small design to develop EQ-5D-5L value sets based on cancer patients' health preferences. Since there were signs of differences between preferences of patients and general population, it may be valuable to develop patient-specific value sets and use them in clinical decision making and economic evaluations., (© 2023. The Author(s), under exclusive licence to Springer-Verlag GmbH Germany, part of Springer Nature.)

Background: For cancer screening programmes to be effective in early detection it is important that those invited can access screening services and understand the benefits of participation. A better understanding of the factors that matter to potential participants of cancer screening programmes can assist in developing strategies to increase current uptake., Methods: We conducted an overview of systematic reviews to answer the question: What factors influence the uptake of cancer screening services (breast, bowel and cervical) in high-income countries? A thematic approach supported by tabular summaries and qualitative heat maps was used to categorize factors, described as 'barriers' or 'facilitators'., Results: A total of 41 systematic reviews met the criteria for inclusion. The barrier with the greatest number of 'hot spots' across all three screening programmes was a fear of the unknown regarding a possible diagnosis of cancer or abnormal screening results, followed closely by a general lack of knowledge surrounding cancer screening programmes. The greatest collective facilitator to uptake was recommendation by a healthcare provider to attend screening., Conclusion: Across all factors 'trust' and 'building trusted relationships' can be seen as integral to the success of cancer screening programmes and must be reflective of collaborative efforts to mitigate barriers and enhance facilitators to uptake. There is future scope to consider interventions that (i) increase demand for screening services, (ii) reduce barriers to uptake of services and/or (iii) are relevant to the healthcare system and those providing services., (© The Author(s) 2024. Published by Oxford University Press on behalf of the European Public Health Association.)

Background and Aims: Ustekinumab (UST) is an effective biologic for treatment of inflammatory bowel disease (IBD). However, some patients treated with UST have suboptimal clinical response with standard dosing. The aims of this study were to determine the effectiveness of UST dose intensification (DI), identify factors associated with DI, cumulative incidence of DI and persistence of UST among treated patients., Methods: Clinical data of patients with Crohn's disease (CD) and ulcerative colitis (UC) who received UST from September 2017 to October 2022 in Singapore General Hospital were collected. Primary outcome was defined as achieving corticosteroid-free clinical remission, biochemical remission, endoscopic healing and/or transmural healing (CD). Statistical analysis was performed to identify factors, which are predictive of UST DI and effectiveness of UST DI., Results: Forty-two patients (34 CD and 8 UC) underwent UST DI to either 6-weekly (n = 19, 45.2%) or 4-weekly (n = 23, 35.9%) and the median time to intensification was 31.1 weeks (17.8-65.7). Presence of perianal disease in CD (HR 4.9; 1.47-16.4) was associated with DI. After DI, 16 (38%) patients achieved primary outcome by week 52. The overall drug persistence rates at 1 year and 2 years were 75.7% (95% CI 62.9-84.6) and 63.5% (95% CI 49.9-74.3), respectively., Conclusion: Two third of IBD patients underwent DI while on UST treatment and the median time to DI was about 6 months after induction. CD patients with perianal disease is more likely to undergo DI. More than one third of dose-intensified patients achieved remission by week 52., (© 2024 Journal of Gastroenterology and Hepatology Foundation and John Wiley & Sons Australia, Ltd.)

Background: Peripheral artery disease is a common condition caused by narrowing/blockage of the arteries, resulting in reduced blood supply. Peripheral artery disease is associated with an increased risk of vascular complications, but early treatment reduces mortality and morbidity. Leg ulcers are long-lasting wounds, usually treated by compression therapy. Compression therapy is not suitable for people with peripheral artery disease, as it can affect the arterial blood supply. In clinical practice, people with peripheral artery disease are identified by measurement of the ankle-brachial pressure index using a sphygmomanometer and manual Doppler device. However, this method can be uncomfortable for people with leg ulcers and automated devices have been proposed as a more acceptable alternative. The objective of this appraisal was to summarise the clinical and cost-effectiveness evidence on the use of automated devices to detect peripheral artery disease in people with leg ulcers., Methods: ., Clinical Effectiveness: To identify reports of relevant studies, we searched major electronic databases and scrutinised the information supplied by the manufacturers of the automated devices under investigation. Due to the lack of evidence on people with leg ulcers, we considered evidence from studies of any design assessing automated devices versus an acceptable reference device in any population receiving ankle-brachial pressure index assessment. We summarised information on diagnostic accuracy of the automated devices and level of agreement with the reference device. For each device, when data permit, we pooled data across studies by conducting random-effects meta-analyses using a Hierarchical Summary Receiving Operating Characteristics model., Cost-Effectiveness: An economic model comprising a decision tree (24 weeks) and Markov models to capture lifetime costs and quality-adjusted life-years associated with venous, arterial and mixed aetiology disease in leg ulcer patients. Analyses were conducted from a United Kingdom National Health Service and Personal Social Services perspective. Costs and quality-adjusted life-years were discounted at 3.5% per year. Deterministic and several probabilistic analyses were used to capture uncertainty surrounding a range of optimistic and pessimistic assumptions about the impact of automated tests on health outcomes (ulcer healing and requirement for invasive management of arterial disease)., Results: ., Clinical Effectiveness: From the 116 records retrieved by the electronic searches, we included 24 studies evaluating five devices (BlueDop Vascular Expert, BOSO ABI-System 100, Dopplex Ability, MESI ankle-brachial pressure index MD and WatchBP Office ABI). Two studies assessing people with leg ulcers found that automated devices often gave higher ankle-brachial pressure index readings than manual Doppler (underestimation of arterial disease). In the 22 studies involving people without leg ulcers, automated devices generally demonstrated good specificity and moderate specificity. Meta-analysis of 12 studies showed a pooled sensitivity of 64% (95% confidence interval 57% to 71%) and a pooled specificity of 96% (95% confidence interval 92% to 98%) for detection of peripheral artery disease., Cost-Effectiveness: Automated devices cost less than manual Doppler to deliver. However, increased risks of invasive treatment requirements for inappropriately compressed arterial/mixed ulcers due to false-negative results, and increased healing times due to delayed compression of false-positive test results mean that in most scenarios manual Doppler was less costly and had slightly higher quality-adjusted life-years than automated devices. Results are highly uncertain, dependent on many assumptions and should be interpreted cautiously., Limitations and Conclusions: The limited evidence identified for each automated device, especially in people with leg ulcers, and its clinical heterogeneity precludes any firm conclusions on the diagnostic performance and cost-effectiveness of these devices in clinical practice., Study Registration: This study is registered as PROSPERO CRD42022327588., Funding: This award was funded by the National Institute for Health and Care Research (NIHR) Evidence Synthesis programme (NIHR award ref: NIHR135478) and is published in full in Health Technology Assessment ; Vol. 28, No. 37. See the NIHR Funding and Awards website for further award information.

Background and Objectives: The burden of disease for Australian children from non-acute conditions is growing; however, little is known about how well prevocational training experiences prepare trainee doctors. This study examines the confidence of general practice registrars in managing paediatric consultations in primary care and whether confidence varies by prevocational training type., Method: This was a cross-sectional national survey of Australian general practice registrars that measured confidence in managing paediatric primary care presentations., Results: Respondents reported feeling confident (65%) or very confident (8%) in managing paediatrics in primary care, with higher confidence for those more advanced in their training or with greater exposure to paediatrics during prevocational training. Regression models showed registrars were more likely to report higher confidence when managing acute versus non-acute presentations., Discussion: Although most registrars reported confidence in managing paediatric presentations, confidence levels were notably lower for non-acute conditions and when prevocational training experiences included limited exposure to paediatric patients.

While the world recovers from the COVID-19 pandemic, another outbreak of contagious disease remains the most likely future risk to public safety. Now is therefore the time to equip health authorities with effective tools to ensure they are operationally prepared for future events. We propose a direct approach to obtain reliable nearly instantaneous time-varying reproduction numbers for contagious diseases, using only the number of infected individuals as input and utilising the dynamics of the susceptible-infected-recovered (SIR) model. Our approach is based on a multivariate nonlinear regression model simultaneously assessing parameters describing the transmission and recovery rate as a function of the SIR model. Shortly after start of a pandemic, our approach enables estimation of daily reproduction numbers. It avoids numerous sources of additional variation and provides a generic tool for monitoring the instantaneous reproduction numbers. We use Norwegian COVID-19 data as case study and demonstrate that our results are well aligned with changes in the number of infected individuals and the change points following policy interventions. Our estimated reproduction numbers are notably less volatile, provide more credible short-time predictions for the number of infected individuals, and are thus clearly favorable compared with the results obtained by two other popular approaches used for monitoring a pandemic. The proposed approach contributes to increased preparedness to future pandemics of contagious diseases, as it can be used as a simple yet powerful tool to monitor the pandemics, provide short-term predictions, and thus support decision making regarding timely and targeted control measures.

Background: This study aims to assess the impact of safety footwear (SF) on workers concerning foot-related problems, especially regarding discomfort, foot pain, and skin lesions., Methods: A literature search of PubMed, Embase, Scopus, and Cochrane databases was performed according to PRISMA guidelines. Studies reporting foot-related problems in workers wearing SF were included. Exclusion criteria included non-English papers, reviews, laboratory and animal studies, expert opinions, letters to the editor, and grey literature. The quality assessment was performed using the Newcastle-Ottawa Scale. Descriptive statistic was used to present data., Result: The initial search results yielded 483 articles; 7 articles were included in the review process. Despite the extensive variety of SF, all studies consistently reported symptomatic discomfort and pain. The discomfort factors included heat, sweating, heaviness, and footwear flexibility, with primary issues in the toes, toecaps, or metatarsal-toe crease region. The pain prevalence ranged from 42.3% to 60.8% in various anatomical regions. Irritant Contact Dermatitis was the most common (97.9%) foot dermatosis, but other foot lesions were reported: dry skin (30.2%), calluses (30%), hard nails (28%), corns (27%), and blisters., Conclusions: Current SFs are designed to comply with safety regulations but are influenced by the frequent occurrence of discomfort and foot problems. The literature review identified weaknesses in certain design features. Recommendations have been proposed to improve SF development. These include addressing issues such as the selection of specific types and designs of SF based on task performance and the working environment, footwear weight, and breathable materials for moisture permeation. Considerations should also encompass distinct sizing for an optimal fit, insole application, especially for prolonged standing users, and education programs to prevent foot-related issues.

Introduction: Fluid overload is a known complication in patients with diabetes mellitus, particularly those with cardiovascular and/or chronic kidney disease (CKD). This study investigates the impact of fluid overload on healthcare utilisation and its association with diabetes-related complications., Method: Electronic medical records from the SingHealth Diabetes Registry (2013-2022) were analysed. Hospitalisations due to fluid overload were identified using International Classification of Diseases, 10th Revision (ICD-10) discharge codes. Trends were examined using Joinpoint regression, and associations were assessed with generalised estimating equation models., Results: Over a period of 10 years, 259,607 individuals treated at primary care clinics and tertiary hospitals were studied. The incidence of fluid overload-related hospitalisations decreased from 2.99% (n=2778) in 2013 to 2.18% (n=2617) in 2017. However, this incidence increased from 2.42% (n=3091) in 2018 to 3.71% (n=5103) in 2022. The strongest associations for fluid overload-related hospitalisation were found with CKD stages G5 (odds ratio [OR] 6.61, 95% confidence interval [CI] 6.26-6.99), G4 (OR 5.55, 95% CI 5.26-5.86) and G3b (OR 3.18, 95% CI 3.02-3.35), as well as with ischaemic heart disease (OR 3.97, 95% CI 3.84-4.11), acute myocardial infarction (OR 3.07, 95% CI 2.97-3.18) and hypertension (OR 3.90, 95% CI 3.45-4.41). Additionally, the prevalence of stage G5 CKD among patients with fluid overload increased between 2018 and 2022., Conclusion: Our study revealed a significant increase in fluid overload-related hospitalisations and extended lengths of stay, likely driven by severe CKD. This underscores an urgent need for initiatives aimed at slowing CKD progression and reducing fluid overload-related hospitalisations in diabetes patients., Competing Interests: All authors declare no relevant conflict of interest and no financial interest in this manuscript.

Introduction: Reasons for using and stopping the use of e-cigarettes and their associations with transitions in nicotine product use are relatively unknown in countries with e-cigarette bans, such as Mexico., Methods: Data comes from an open cohort of people who smoke in Mexico, surveyed every 4 months from November 2018 to November 2021. Those who smoked and used e-cigarettes at time t (n=904 individuals, 1653 observations) were categorised at 4-month follow-up (t+1): (1) continued 'dual use', (2) exclusive smoking, (3) exclusive use of e-cigarettes or neither product. For people who formerly used e-cigarettes at time t (n=332 individuals, 372 observations), follow-up categories were: (1) continued exclusive smoking; (2) re-initiated e-cigarette use. Multinomial and logistic models regressed follow-up status (ref=status at time t) on reasons for using or stopping e-cigarette use, respectively, at time t, adjusting for covariates., Results: The most prevalent reasons for current e-cigarette use were 'they were less harmful to others' (40.5%) and 'enjoyable' (39.0%). Those who reported using e-cigarettes because they were less harmful to others (Adjusted Relative Risk Ratio (ARRR)=0.67), more enjoyable (ARRR=0.52), could help them to quit smoking (ARRR=0.65), or to control weight (ARRR=0.46) were less likely to return to exclusively smoking. Among people who formerly used e-cigarettes, lack of satisfaction was the primary reason for stopping e-cigarette use (32%) and those who reported this were less likely to start using e-cigarettes again at follow-up (Adjusted Odds Ratio (AOR)=0.58)., Conclusions: Specific reasons for using and stopping e-cigarettes predict changes in smoking and e-cigarette use, and targeting these beliefs could promote desired behaviour changes., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2024. No commercial re-use. See rights and permissions. Published by BMJ.)

Background: There is sustained interest in understanding the perspectives of liver transplant recipients and living donors, with several qualitative studies shedding light on this emotionally charged subject. However, these studies have relied primarily on traditional semi-structured interviews, which, while valuable, come with inherent limitations. Consequently, there remains a gap in our comprehension of the broader public discourse surrounding living liver donation. This study aims to bridge this gap by delving into public conversations related to living liver donation through a qualitative analysis of Twitter (now X) posts, offering a fresh perspective on this critical issue., Methods: To compile a comprehensive dataset, we extracted original tweets containing the hashtags "#donateliver" OR "#liverdonor", all posted in English from January 1, 2012, to December 31, 2022. We then selected tweets from individual users whose Twitter (X) accounts featured authentic human names, ensuring the credibility of our data. Employing Braun and Clarke's reflexive thematic analysis approach, the study investigators read and analysed the included tweets, identifying two main themes and six subthemes. The Health Policy Triangle framework was applied to understand the roles of different stakeholders involved in the discourse and suggest areas for policy improvement., Results: A total of 361 unique tweets from individual users were analysed. The major theme that emerged was the persistent shortage of liver donors, underscoring the desperation faced by individuals in need of life-saving liver transplants and the urgency of addressing the organ shortage problem. The second theme delved into the experiences of liver donors post-surgery, shedding light on a variety of aspects related to the transplantation process, including the visibility of surgical scars, and the significance of returning to physical activity and exercise post-surgery., Conclusion: The multifaceted experiences of individuals involved in the transplantation process, both recipients and donors, should be further studied in our efforts to improve the critical shortage of liver donors., (© 2024. The Author(s).)

Aims: Maintaining continuity of care between doctors and patients is considered a fundamental aspect of quality in primary healthcare. In this study, we aim to examine continuity in Norway over time by computing two commonly used indicators of continuity: the St Leonard's Index of Continuity of Care (SLICC) and the Usual Provider of Care Index (UPC)., Method: We employ individual-level data, which covers all primary care consultations. This data includes the identities of each patient and physician, and we can identify each patient's regular general practitioner (GP). The SLICC is calculated as the share of consultations conducted by the patient's regular GP annually from 2006 to 2021. Additionally, we identify each patient's most visited physician and compute the UPC as the share of total consultations conducted by the most visited physician during the same period. Our analysis is conducted at the national level and stratified according to the level of centrality, differentiating between areas of high, moderate, and low centrality., Results: Our findings reveal that, at the national level, SLICC and UPC exhibit remarkable stability, reaching 64 and 71 percent, respectively, in 2021. However, there is significant geographical variation, with the least central areas experiencing less continuous healthcare (SLICC at 49 percent in 2021) than patients residing in more central areas (SLICC at 68 in 2021)., Conclusion: Our results demonstrate a high degree of continuity that has been stable over time. However, large geographical variations suggest that policymakers should strive to reduce geographical disparities in healthcare quality., Competing Interests: The authors have declared that no competing interests exist., (Copyright: © 2024 Delalic et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.)

Background: Sharing trial results with participants is a moral imperative, but too often does not happen in appropriate ways., Methods: We carried out semi-structured interviews with patients (n = 13) and site staff (n = 11), and surveyed 180 patients and 68 site staff who were part of the Show RESPECT study, which tested approaches to sharing results with participants in the context of the ICON8 ovarian cancer trial (ISRCTN10356387). Qualitative and free-text data were analysed thematically, and findings used to develop the SHOW RESPECT adaptable framework of considerations for planning how to share trial results with participants. This paper presents the framework, with illustrations drawn from the Show RESPECT study., Results: Our adaptable 'SHOW RESPECT' framework covers (1) Supporting and preparing trial participants to receive results, (2) HOw will the results reach participants?, (3) Who are the trial participants?, (4) REsults-what do they show?, (5) Special considerations, (6) Provider-who will share results with participants?, (7) Expertise and resources, (8) Communication tools and (9) Timing of sharing results. While the data upon which the framework is based come from a single trial, many of our findings are corroborated by findings from other studies in this area, supporting the transferability of our framework to trials beyond the UK ovarian cancer setting in which our work took place., Conclusions: This adaptable 'SHOW RESPECT' framework can guide researchers as they plan how to share aggregate trial results with participants. While our data are drawn from a single trial context, the findings from Show RESPECT illustrate how approaches to communication in a specific trial can influence patient and staff experiences of feedback of trial results. The framework generated from these findings can be adapted to fit different trial contexts and used by other researchers to plan the sharing of results with their own participants., Trial Registration: ISRCTN96189403. Registered on February 26, 2019. Show RESPECT was supported by the Medical Research Council (MC&#95;UU&#95;12023/24 and MC&#95;UU&#95;00004/08) and the NIHR CRN., (© 2024. The Author(s).)

Background: Amidst the escalating prevalence of glucose-related chronic diseases, the advancements, potential uses, and growing accessibility of continuous glucose monitors (CGM) have piqued the interest of healthcare providers, consumers, and health behaviour researchers. Yet, there is a paucity of literature characterising the use of CGM in behavioural intervention research. This scoping review aims to describe targeted populations, health behaviours, health-related outcomes, and CGM protocols in randomised controlled trials (RCTs) that employed CGM to support health behaviour change., Methods: We searched Ovid MEDLINE, Elsevier Embase, Cochrane Central Register of Controlled Trials, EBSCOhost PsycINFO, and ProQuest Dissertations & Theses Global from inception to January 2024 for RCTs of behavioural interventions conducted in adults that incorporated CGM-based biological feedback. Citation searching was also performed. The review protocol was registered ( https://doi.org/10.17605/OSF.IO/SJREA )., Findings: Collectively, 5389 citations were obtained from databases and citation searching, 3995 articles were screened, and 31 were deemed eligible and included in the review. Most studies (n = 20/31, 65%) included adults with type 2 diabetes and reported HbA1c as an outcome (n = 29/31, 94%). CGM was most commonly used in interventions to target changes in diet (n = 27/31, 87%) and/or physical activity (n = 16/31, 52%). 42% (n = 13/31) of studies provided prospective CGM-based guidance on diet or activity, while 61% (n = 19/31) included retrospective CGM-based guidance. CGM data was typically unblinded (n = 24/31, 77%) and CGM-based biological feedback was most often provided through the CGM and two-way communication (n = 12/31, 39%). Communication typically occurred in-person (n = 13/31, 42%) once per CGM wear (n = 13/31; 42%)., Conclusions: This scoping review reveals a predominant focus on diabetes in CGM-based interventions, pointing out a research gap in its wider application for behaviour change. Future research should expand the evidence base to support the use of CGM as a behaviour change tool and establish best practices for its implementation., Trial Registration: doi.org/10.17605/OSF.IO/SJREA., (© 2024. The Author(s).)

Importance: Effective weight loss interventions are needed for men with obesity., Objective: To determine whether an intervention that combined text messaging with financial incentives attained significant weight loss at the 12-month follow-up compared with the control group and whether an intervention of text messaging alone attained significant weight loss at the 12-month follow-up compared with the control group., Design, Setting, and Participants: An assessor-blinded randomized clinical trial conducted in Belfast, Bristol, and Glasgow areas in the UK. A total of 585 men with body mass index (BMI) of 30 or more were enrolled between July 2021 and May 2022. Final follow-up occurred June 2023., Interventions: Participants were randomly assigned to 12 months of behavioral focused text messages combined with financial incentives (n = 196), 12 months of behavioral focused text messages alone (n= 194), or a waiting list (control group; n= 195). The financial incentive consisted of a monetary reward that was lost if weight loss targets were not met. All participants received weight management information and a pedometer at baseline., Main Outcomes and Measures: The 2 primary comparisons were the 12-month comparison of within-participant weight change between the text messaging with financial incentive group and the control group and the comparison between the text messaging alone group and the control group (minimum clinically important difference, 3%). The P value defined for statistical significance was P < .025 for each comparison., Results: Of the 585 men (mean [SD] age, 50.7 [13.3] years; mean weight, 118.5 [19.9] kg; mean BMI, 37.7 [5.7]; 525 [90%] White), 227 (39%) lived in postal code areas with lower socioeconomic status, and 426 (73%) completed the 12-month follow-up. At the 12-month follow-up, compared with the control group, the mean percent weight change was significantly greater in the text messaging with financial incentive group (mean difference, -3.2%; 97.5% CI, -4.6% to -1.9%; P < .001) but was not significantly greater in the text messaging alone group (mean difference, -1.4%; 97.5% CI, -2.9% to 0.0, P = .05). The mean (SD) weight changes were -5.7 (7.4) kg for the text messaging with financial incentives group, -3.0 (7.5) kg for the text messaging alone group, and -1.5 (6.6) kg for the control group. The 12-month mean (SD) percentage weight changes from baseline were -4.8% (6.1%) for the text messaging with financial incentives group, -2.7% (6.3%) for text messaging alone group, and -1.3% (5.5%) for the control group. Of 366 adverse events reported, the most common were infections (83 [23%]). Of the 23 serious adverse events (6.3%), 12 (52%) occurred in the text messaging with financial incentives group, 5 (22%) in the texts messaging alone group, and 6 (26%) in the control group. None were considered related to participating in a trial group., Conclusion and Relevance: Among men with obesity, an intervention with text messaging with financial incentive significantly improved weight loss compared with a control group, whereas text messaging alone was not significantly better than the control condition. These findings support text messaging combined with financial incentives to attain weight loss in men with obesity., Trial Registration: isrctn.org Identifier: ISRCTN91974895.

Objective: The objective of this study was to identify factors associated with long-term opioid use and to assess the association between long-term use and death., Study Design: Retrospective cohort study combining several population-wide databases and covering a population of five million inhabitants, including all adults who were initiated on opioid treatment from 2014 to 2018 for non-cancer pain., Methods: We used logistic regression models to identify factors associated with chronic opioid use and carried out survival analyses using multivariable Cox regression modelling for all-cause mortality during follow-up using inverse probability of treatment weighting (IPTW) and propensity scores based on the probability of using opioids chronically., Results: Among 760,006 patients, 82,423 (10.85%) used opioids for 90 days or more after initiation. Initial therapy characteristics associated with higher risk for long-term use were initiating with long- and short-acting opioids (when compared to tramadol, odds ratio [OR]: 2.63, 95% confidence interval [CI]: 2.57, 2.69 and OR: 1.60, 95%CI: 1.46, 1.76, respectively), using higher daily doses (when compared to 50 morphine milligramme equivalent [MME] or less, prescribing 50 to 89 daily MME, OR: 1.76, 95%CI: 1.65, 1.87; 90 to 119 daily MME, OR: 2.44, 95%CI: 1.99, 3.01; and more than 120 daily MME, OR: 1.77, 95%CI: 1.64, 1.91), and overlapping with gabapentinoids (OR: 2.26, 95%CI: 2.20, 2.32), benzodiazepines (OR: 1.32, 95%CI: 1.30, 1.35), and antipsychotics (OR: 1.21, 95%CI: 1.16, 1.26). After IPTW, chronic opioid use was associated with higher risk of all-cause mortality when compared to short-term use (Hazard Ratio (HR): 1.37, 95%CI: 1.32, 1.42). Sensitivity analyses provided similar results., Conclusion: These findings may help healthcare managers to identify and address patients at higher risk of long-term use and riskier prescription patterns., (Copyright © 2024 The Authors. Published by Elsevier Ltd.. All rights reserved.)

Purpose: To determine whether primary trabeculectomy or medical treatment produces better outcomes in terms of quality of life (QoL), clinical effectiveness, and safety in patients with advanced glaucoma., Design: Multicenter randomized controlled trial., Participants: Between June 3, 2014, and May 31, 2017, 453 adults with newly diagnosed advanced open-angle glaucoma in at least 1 eye (Hodapp classification) were recruited from 27 secondary care glaucoma departments in the United Kingdom. Two hundred twenty-seven were allocated to trabeculectomy, and 226 were allocated medical management., Methods: Participants were randomized on a 1:1 basis to have either mitomycin C-augmented trabeculectomy or escalating medical management with intraocular pressure (IOP)-reducing drops as the primary intervention and were followed up for 5 years., Main Outcome Measures: The primary outcome was vision-specific QoL measured with the 25-item Visual Function Questionnaire (VFQ-25) at 5 years. Secondary outcomes were general health status, glaucoma-related QoL, clinical effectiveness (IOP, visual field, and visual acuity), and safety., Results: At 5 years, the mean ± standard deviation VFQ-25 scores in the trabeculectomy and medication arms were 83.3 ± 15.5 and 81.3 ± 17.5, respectively, and the mean difference was 1.01 (95% confidence interval [CI], -1.99 to 4.00; P = 0.51). The mean IOPs were 12.07 ± 5.18 mmHg and 14.76 ± 4.14 mmHg, respectively, and the mean difference was -2.56 (95% CI, -3.80 to -1.32; P < 0.001). Glaucoma severity measured with visual field mean deviation were -14.30 ± 7.14 dB and -16.74 ± 6.78 dB, respectively, with a mean difference of 1.87 (95% CI, 0.87-2.87 dB; P < 0.001). Safety events occurred in 115 (52.2%) of patients in the trabeculectomy arm and 124 (57.9%) of patients in the medication arm (relative risk, 0.92; 95% CI, 0.72-1.19; P = 0.54). Serious adverse events were rare., Conclusions: At 5 years, the Treatment of Advanced Glaucoma Study demonstrated that primary trabeculectomy surgery is more effective in lowering IOP and preventing disease progression than primary medical treatment in patients with advanced disease and has a similar safety profile., Financial Disclosure(s): Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article., (Copyright © 2024 American Academy of Ophthalmology. Published by Elsevier Inc. All rights reserved.)

School-based diabetes care is an important consideration for clinicians and families alike. This Discrete-Choice Experiment describes parental preference for enhanced psychosocial and activity-focused supports over academic supports for children with Type 1 diabetes in Australian primary and secondary schools., Competing Interests: Declaration of competing interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2024 Elsevier B.V. All rights reserved.)

Introduction: Second-degree perineal tears following vaginal birth are common and presumed to be of little clinical importance. However, the extent of damage to the perineal body varies widely, and there is reason to believe that larger second-degree tears may be associated with more pelvic floor symptoms, compared to lesser form. Therefore, the aim of this study was to assess differences in pelvic floor symptoms according to the severity of second-degree perineal tears up to 12 months post-partum, stratified by parity., Material and Methods: This was a prospective cohort study conducted at Akershus University Hospital, a tertiary referral hospital in Norway. The study sample consisted of 409 primiparas and 394 multiparas with vaginal births. Perineal tears were classified using the classification system recommended by the Royal College of Obstetricians and Gynecologists. Further, second-degree tears were subclassified as 2A, 2B, or 2C, depending on the percentage of damage to the perineal body. Episiotomies were analyzed as a separate group. Pelvic floor symptoms were assessed using the Karolinska Symptoms After Perineal Tear Inventory (KAPTAIN). A linear mixed model was estimated to assess the trend in pelvic floor symptom scores according to perineal tear category and stratified by parity. The primary and secondary outcome measures were the mean sum scores of the KAPTAIN-Inventory, measured in pregnancy (at 18 weeks of gestation), at 3- and 12 months post-partum, and the reported impact of genital discomfort on quality of life measured in pregnancy and at 12 months post-partum., Results: There were no significant differences in pelvic floor symptom scores over time, or at any timepoint, between no tear, first-degree tear, or second-degree tear subcategories, for primi-, and multiparas. Pelvic floor symptoms increased from pregnancy to 3 months post-partum and remained higher at 12 months post-partum compared to pregnancy in all perineal tear categories. Compared to primiparas, multiparas reported a significantly higher impact of genital discomfort on quality of life in pregnancy and at 12 months post-partum., Conclusions: There were no statistically significant differences in pelvic floor symptoms according to the severity of second-degree perineal tears., (© 2024 The Authors. Acta Obstetricia et Gynecologica Scandinavica published by John Wiley & Sons Ltd on behalf of Nordic Federation of Societies of Obstetrics and Gynecology (NFOG).)

Objective: The aim of the study was to identify groups of young adults with distinct longitudinal patterns of use of treatment for substance use disorders and mental health (MH) problems and to investigate potential explanatory factors for different patterns of treatment use over time, including sociodemographic factors., Methods: The sample consisted of 447 young adults aged 16-29 years who entered long-term residential substance use disorder treatment facilities in Norway from 2011 to 2016. In this study, we obtained data collected by the Norwegian Patient Registry and Statistics Norway. These data were linked with the electronic health record data of the substance use disorder treatment facilities from which the participants were recruited. Growth mixture modeling was performed. The identified groups were further compared using analysis of variance or χ 2 test., Results: Four groups of participants for total treatment use, substance use disorder treatment use, and MH treatment use were identified. Most participants from the overall sample were classified as members of a group characterized by a low and stable pattern of treatment use over time. A group with a high and stable pattern of treatment use was identified in total and MH treatment use. The proportion of participants with higher levels of substance use disorder treatment use at the end of the study period than at the beginning was larger (35%) than in the case of MH treatment use (14.2%). Younger age was associated with a decreasing pattern of MH treatment use and with an increasing pattern of substance use disorder treatment use over time. There were larger proportions of female participants in groups with a stable high use of MH treatment and in groups with an initially increasing trend of substance use disorder treatment use. Findings revealed that most participants across the identified groups were recipients of welfare benefits, had low educational attainment, and were not working., Conclusions: Results demonstrated significant variation in trajectories of treatment use among young adults with substance use disorder. Differences in treatment use could indicate differences in symptom severity and complexity. In this study, treatment use was associated with socioeconomic factors, sex, and age. Integrative approaches, including interagency and interdisciplinary collaboration, will often be necessary to sufficiently address the multidimensionality of substance use disorder.

Collaboration among healthcare providers is regarded as a promising method to improve care quality and patient outcomes with limited human and financial resources. In Norway, "hospital-at-home" refers to care given by teams from the hospital pediatric wards who provide treatment and care in the family's home. When children need home visits multiple times daily, the hospital-at-home often reaches out to municipality healthcare providers, asking them to share this task. We aimed to explore the collaboration between stakeholders to gain knowledge on matters concerning the transfer of pediatric competence between hospital and home-based care, and to gain insight into how to set up the service for children in the future. We conducted three focus group interviews. The results showed that managing hospital-at-home collaboratively came with various challenges concerning unclear responsibilities between hospitals and homecare services and several obstacles to setting up cooperation across service levels. Thus, positive collaboration experiences between hospital and homecare settings were shared. Formalizing this collaboration was considered important for future collaboration. Building competence and learning from and with each other ensures better conditions for success if the collaboration is organized and facilitated through agreements between the hospital and the municipalities.

Objective: The Mexican government has pursued multiple initiatives to improve healthcare coverage and financial protection. Yet, out-of-pocket health spending and use of private sector providers in Mexico remains high. In this paper, we sought to describe the characteristics of public and private healthcare users, describe recent visit quality across provider types, and to assess whether perceiving the public healthcare sector as poor quality is associated with private health sector use., Methods and Findings: We analyzed the cross-sectional People's Voice Survey conducted from December 2022 to January 2023. We used Chi-square tests to compare contextual, individual, and need-for-care factors and ratings of most recent visits between users of public (social security and other public providers) and private sector providers (stand-alone private providers and providers adjacent to pharmacies). We used a multivariable Poisson regression model to assess associations between low ratings of public healthcare sources and the use of private care. Among the 811 respondents with a healthcare visit in the past year, 31.2% used private sources. Private healthcare users were more educated and had higher incomes than public healthcare users. Quality of most recent visit was rated more highly in private providers (70.2% rating the visit as excellent or very good for stand-alone private providers and 54.3% for pharmacy-adjacent doctors) compared to social security (41.6%) and other public providers (46.6%). Those who perceived public health institutions as low quality had a higher probability of seeking private healthcare., Conclusion: Users rated public care visits poorly relative to private care; at the population level, perceptions of poor quality care may drive private care use and hence out-of-pocket costs. Improving public healthcare quality is necessary to ensure universal health coverage., Competing Interests: HHL is an academic Editor for PLOS Global Public Health. Other authors have declared no competing interests., (Copyright: © 2024 Doubova et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.)

Objectives: This study aimed to explore the acceptability, feasibility, usability, and preliminary effect of an electronic patient-reported outcome (ePRO) intervention for patients with breast cancer in Mexico., Design: We conducted a multimethod non-randomised pilot study. We used a pre-test/post-test design for quantitative assessment of the intervention's effect on patients' supportive care needs and quality of life. We conducted in-depth interviews (IDIs) with participants and healthcare workers to explore the intervention's benefits and barriers and understand its feasibility., Participants: 50 women aged 20-75 diagnosed with stage I-III breast cancer were enrolled within 2 weeks of starting neoadjuvant or adjuvant treatment with chemotherapy or radiotherapy. We excluded illiterate women and those with visual impairment, cognitive disability or severe depression. IDIs were conducted with 18 participants and 10 healthcare providers., Setting: Oncology services in three public hospitals of the Mexican Social Security Institute., Intervention: The ePRO intervention consisted of a responsive web application for weekly symptom reporting combined with proactive follow-up by nurses guided by predefined clinical algorithms for 6 weeks., Results: 50 women were enrolled out of 66 eligible patients approached (75.8%). All 50 completed the 4-week follow-up assessment (100% retention). Completion of the symptom registry declined from 100% in week 1 to 66% in week 6. Participants experienced decreases in supportive care needs and increased quality of life. The ePRO application was rated highly usable. Participants and health professionals both perceived intervention benefits. Drawbacks included poor fit for women receiving radiotherapy and challenges using the application for women with low digital literacy or experiencing severe symptoms., Conclusions: This pilot study provided evidence of the high usability and potential efficacy of a web-based ePRO intervention. We revised recruitment during the pilot to include multiple facilities, and we will further revise for the randomised trial to address barriers to successful ePRO implementation., Trial Registration Number: ClinicalTrials.gov ID: NCT05925257., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Background: Previous investigations of multiple sclerosis (MS)-related healthcare have focused on utilisation of specific individual health services (e.g. hospital care, office-based neurologists) by people with MS (PwMS). Meanwhile, little is known about possible patterns of utilisation across health services and their potential differences across patient characteristics., Objective: To comprehensively analyse and identify patterns of MS-related health service utilisation and detect patient characteristics explaining such patterns., Methods: In 2021, we invited all PwMS insured by the largest insurance company in Lower Saxony, Germany, to take part in an online survey. We merged respondents' survey and health insurance claims data. We analysed MS-related health service utilisation and defined individual characteristics for subgroup analyses based on Andersen's Behavioural Model. We executed non-parametric missing value imputation and conducted hierarchical clustering to find patterns in health service utilisation., Results: Of 6928 PwMS, 1935 responded to our survey and 1803 were included in the cluster analysis. We identified four distinct health service utilisation clusters: (1) regular users (n = 1130), (2) assistive care users (n = 443), (3) low users (n = 195) and (4) special services users (n = 35). Clusters differ by patient characteristics (e.g. age, impairment)., Conclusion: Our findings highlight the complexity of MS-related health service utilisation and provide relevant stakeholders with information allowing them to tailor healthcare planning according to utilisation patterns., Competing Interests: The authors declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: CT has received honoraria for consultation and expert testimony from Alexion Pharma Germany GmbH, and Roche Pharma GmbH. None of this interfered with the current report. PF has received speaker's fees and honoraria for advisory boards from Almirall, Bayer, Biogen Idec, BMS-Celgene, Coloplast, Genzyme, GW Pharma, Hexal, Janssen-Cilag, Novartis, Merck, Roche, Sanofi, Stadapharm and Teva. AS has no personal pecuniary interests to disclose, other than being the lead of the German MS Registry, which receives (project) funding from a range of public and corporate sponsors, recently including The German Innovation Fund (G-BA), The German Retirement Insurance, The German MS Trust, The German MS Society, Biogen GmbH, BristolMyersSquibb, Merck Health care Germany GmbH, Novartis Pharma GmbH and Roche Pharma AG. None resulted in a conflict of interest. The remaining authors declare that there is no conflict of interest., (© The Author(s), 2024.)

Background: Evidence indicates that trial participants often struggle to understand participant information leaflets (PILs) for clinical trials, including the concept of randomisation. We analysed the language used to describe randomisation in PILs and determine the most understandable and acceptable description through public and participant feedback., Methods: We collected 280 PILs/informed consent forms and one video animation from clinical research facilities/clinical trial units in Ireland and the UK. We extracted text on how randomisation was described, plus trial characteristics. We conducted content analysis to group the randomisation phrases inductively. We then excluded phrases that appeared more than once or were very similar to others. The final list of randomisation phrases was then presented to an online panel of participants and the public. Panel members were asked to rate each phrase on a 5-point Likert scale in terms of their understanding of the phrase, confidence in their understanding and acceptability of the phrase., Results: Two hundred and eighty PILs and the transcribed text from one video animation represented 229 ongoing or concluded trials. The pragmatic content analysis generated five inductive categories: (1) explanation of why randomisation is required in trials; (2) synonyms for randomisation; (3) comparative randomisation phrases; (4) elaborative phrases for randomisation (5) and phrases that describe the process of randomisation. We had 48 unique phrases, which were shared with 73 participants and members of the public. Phrases that were well understood were not necessarily acceptable. Participants understood, but disliked, comparative phrases that referenced gambling, e.g. toss of a coin, like a lottery, roll of a die. They also disliked phrases that attributed decision-making to computers or automated systems. Participants liked plain language descriptions of what randomisation is and those that did not use comparative phrases., Conclusions: Potential trial participants are clear on their likes and dislikes when it comes to describing randomisation in PILs. We make five recommendations for practice., (© 2024. The Author(s).)

Background: People with multiple and persistent physical symptoms have impaired quality of life and poor experiences of health care. We aimed to evaluate the effectiveness of a community-based symptom-clinic intervention in people with multiple and persistent physical symptoms, hypothesising that this symptoms clinic plus usual care would be superior to usual care only., Methods: The Multiple Symptoms Study 3 was a pragmatic, multicentre, parallel-group, individually randomised controlled trial conducted in 108 general practices in the UK National Health Service in four regions of England between Dec 6, 2018, and June 30, 2023. Participants were individually randomised (1:1) to the symptom-clinic intervention plus usual care or to usual care only via a computer-generated, pseudo-random list stratified by trial centre. Allocation was done by the trial statistician and concealed with a centralised, web-based randomisation system; masking participants was not possible due to the nature of the intervention. The symptom-clinic intervention was a sequence of up to four medical consultations that aimed to elicit a detailed clinical history, fully hear and validate the participant, offer rational explanations for symptoms, and assist the participant to develop ways of managing their symptoms; it was delivered by general practitioners with an extended role. The primary outcome was Patient Health Questionnaire-15 (PHQ-15) score 52 weeks after randomisation, analysed by intention to treat. The trial is registered on the ISRCTN registry (ISRCTN57050216)., Findings: 354 participants were randomly assigned; 178 (50%) were assigned to receive the community-based symptoms clinic plus usual care and 176 (50%) were assigned to receive usual care only. At the primary-outcome point of 52 weeks, PHQ-15 scores were 14·1 (SD 3·7) in the group receiving usual care and 12·2 (4·5) in the group receiving the intervention. The adjusted between-group difference of -1·82 (95% CI -2·67 to -0·97) was statistically significantly in favour of the intervention group (p<0·0001). There were 39 adverse events in the group receiving usual care and 36 adverse events in the group receiving the intervention. There were no statistically significant between-group differences in the proportion of participants who had non-serious adverse events (-0·03, 95% CI -0·11 to 0·05) or serious adverse events (0·02, -0·02 to 0·07). No serious adverse event was deemed to be related to the trial intervention., Interpretation: Our symptom-clinic intervention, which focused on explaining persistent symptoms to participants in order to support self-management, led to sustained improvement in multiple and persistent physical symptoms., Funding: UK National Institute for Health and Care Research., Competing Interests: Declaration of interests CB has received publisher royalties from Wiley. JD was a member of the Health and Social Care Delivery Research Board for the UK National Institute for Health and Care Research. All other authors declare no competing interests., (Copyright © 2024 The Author(s). Published by Elsevier Ltd. This is an Open Access article under the CC BY 4.0 license. Published by Elsevier Ltd.. All rights reserved.)

Background: Retaining participants in randomised controlled trials (RCTs) is challenging and trial teams are often required to use strategies to ensure retention or improve it. Other than monetary incentives, there is no requirement to disclose the use of retention strategies to the participant. Additionally, not all retention strategies are developed at the planning stage, i.e. post-funding during protocol development, but some protocols include strategies for participant retention as retention is considered and planned for early in the trial planning stage. It is yet unknown if these plans are communicated in the corresponding participant information leaflets (PILs). The purpose of our study was to determine if PILs communicate plans to promote participant retention and, if so, are these outlined in the corresponding trial protocol., Methods: Ninety-two adult PILs and their 90 corresponding protocols from Clinical Trial Units (CTUs) in the UK were analysed. Directed (deductive) content analysis was used to analyse the participant retention text from the PILs. Data were presented using a narrative summary and frequencies where appropriate., Results: Plans to promote participant retention were communicated in 81.5% (n = 75/92) of PILs. Fifty-seven percent (n = 43/75) of PILs communicated plans to use "combined strategies" to promote participant retention. The most common individual retention strategy was telling the participants that data collection for the trial would be scheduled during routine care visits (16%; n = 12/75 PILs). The importance of retention and the impact that missing or deleted data (deleting data collected prior to withdrawal) has on the ability to answer the research question were explained in 6.5% (n = 6/92) and 5.4% (n = 5/92) of PILs respectively. Out of the 59 PILs and 58 matching protocols that both communicated plans to use strategies to promote participant retention, 18.6% (n = 11/59) communicated the same information, the remaining 81.4% (n = 48/59) of PILs either only partially communicated (45.8%; n = 27/59) the same information or did not communicate the same information (35.6%; n = 21/59) as the protocol with regard to the retention strategy(ies)., Conclusion: Retention strategies are frequently communicated to potential trial participants in PILs; however, the information provided often differs from the content in the corresponding protocol. Participant retention considerations are best done at the planning stage of the trial and we encourage trial teams to be consistent in the communication of these strategies in both the protocol and PIL., (© 2024. The Author(s).)

Background: Geriatric assessment and management (GAM) improve outcomes in older patients with cancer treated with surgery or chemotherapy. It is unclear whether GAM may provide better function and quality of life (QoL), or be cost-effective, in a radiotherapy (RT) setting., Methods: In this Norwegian cluster-randomised controlled pilot study, we assessed the impact of a GAM intervention involving specialist and primary health services. It was initiated in-hospital at the start of RT by assessing somatic and mental health, function, and social situation, followed by individually adapted management plans and systematic follow-up in the municipalities until 8 weeks after the end of RT, managed by municipal nurses as patients' care coordinators. Thirty-two municipal/city districts were 1:1 randomised to intervention or conventional care. Patients with cancer ≥ 65 years, referred for RT, were enrolled irrespective of cancer type, treatment intent, and frailty status, and followed the allocation of their residential district. The primary outcome was physical function measured by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (QLQ-C30). Secondary outcomes were overall quality of life (QoL), physical performance, use and costs of health services. Analyses followed the intention-to-treat principle. Study registration at ClinicalTrials.gov ID NCT03881137., Results: We included 178 patients, 89 in each group with comparable age (mean 74.1), sex (female 38.2%), and Edmonton Frail Scale scores (mean 3.4 [scale 0-17], scores 0-3 [fit] in 57%). More intervention patients received curative RT (76.4 vs 61.8%), had higher irradiation doses (mean 54.1 vs 45.5 Gy), and longer lasting RT (mean 4.4 vs 3.6 weeks). The primary outcome was completed by 91% (intervention) vs 88% (control) of patients. No significant differences between groups on predefined outcomes were observed. GAM costs represented 3% of health service costs for the intervention group during the study period., Conclusions: In this heterogeneous cohort of older patients receiving RT, the majority was fit. We found no impact of the intervention on patient-centred outcomes or the cost of health services. Targeting a more homogeneous group of only pre-frail and frail patients is strongly recommended in future studies needed to clarify the role and organisation of GAM in RT settings., (© 2024. The Author(s).)

Aim: To explore the experience of second victim symptoms and adverse outcomes among nurses working in public healthcare institutions; understand the preferred components of a structured support programme; and explore the barriers to accessing existing support strategies., Background: The second victim phenomenon is experienced by nurses during patient-related adverse events, requiring further exploration., Methods: A mixed-methods design. Second Victim Experience and Support Tool and semi-structured individual interviews were used among nurses involved in adverse events that occurred from January 2022 to April 2023. Descriptive statistics was used to describe sociodemographic characteristics and survey responses. Thematic analysis was used to analyse qualitative data., Results: Nurses (n = 12) experienced second victim-related physical, psychological and professional distress (58.3% to 83.3%) within one month after the event. Nurses continued to experience second victim-related distress (58.3%) three months after and turnover intentions (58.4%). Having a respected peer to discuss what happened was the most desired component of a support programme (75.0%). Five qualitative themes: (i) whirlwind of immediate emotions, (ii) lasting impact of adverse events, (iii) organisational barriers, (iv) coping resources at organisational level and (v) positive individual coping strategies., Discussion: Nurses experienced immediate and profound distress, highlighting the pervasive and distressing nature of the second victim phenomenon., Conclusion: It is critical to recognise the second victim phenomenon and improve organisational climate to provide adequate support to affected nurses., Implications for Nursing and Health Policy: Organisations can establish a structured second victim support system, allowing nurses to seek emotional aid during the occurrence of adverse events. Establishing national policies as guidelines for organisations to refer to, raise awareness of the second victim phenomenon, and provide a standardised approach for identification and intervention for affected nurses., (© 2024 International Council of Nurses.)

Background: Asynchronous outpatient patient-to-provider communication is expanding in UK health care, requiring evaluation. During the pandemic, Aberdeen Royal Infirmary in Scotland expanded its outpatient asynchronous consultation service from dermatology (deployed in May 2020) to gastroenterology and pain management clinics., Objective: We conducted a mixed methods study using staff, patient, and public perspectives and National Health Service (NHS) numerical data to obtain a rounded picture of innovation as it happened., Methods: Focus groups (3 web-based and 1 face-to-face; n=22) assessed public readiness for this service, and 14 interviews with staff focused on service design and delivery. The service's effects were examined using NHS Grampian service use data, a patient satisfaction survey (n=66), and 6 follow-up patient interviews. Survey responses were descriptively analyzed. Demographics, acceptability, nonattendance rates, and appointment outcomes of users were compared across levels of area deprivation in which they live and medical specialties. Interviews and focus groups underwent theory-informed thematic analysis., Results: Staff anticipated a simple technical system transfer from dermatology to other receptive medical specialties, but despite a favorable setting and organizational assistance, it was complicated. Key implementation difficulties included pandemic-induced technical integration delays, misalignment with existing administrative processes, and discontinuity in project management. The pain management clinic began asynchronous consultations (digital appointments) in December 2021, followed by the gastroenterology clinic in February 2022. Staff quickly learned how to explain and use this service. It was thought to function better for pain management as it fitted preexisting practices. From May to September 2022, the dermatology (adult and pediatric), gastroenterology, and pain management clinics offered 1709 appointments to a range of patients (n=1417). Digital appointments reduced travel by an estimated 44,712 miles (~71,956.81 km) compared to the face-to-face mode. The deprivation profile of people who chose to use this service closely mirrored that of NHS Grampian's population overall. There was no evidence that deprivation impacted whether digital appointment users subsequently received treatment. Only 18% (12/66) of survey respondents were unhappy or very unhappy with being offered a digital appointment. The benefits mentioned included better access, convenience, decreased travel and waiting time, information sharing, and clinical flexibility. Overall, patients, the public, and staff recognized its potential as an NHS service but highlighted informed choice and flexibility. Better communication-including the use of the term assessment instead of appointment-may increase patient acceptance., Conclusions: Asynchronous pain management and gastroenterology consultations are viable and acceptable. Implementing this service is easiest when existing administrative processes face minimal disruption, although continuous support is needed. This study can inform practical strategies for supporting staff in adopting asynchronous consultations (eg, preparing for nonlinearity and addressing task issues). Patients need clear explanations and access to technical support, along with varied consultation options, to ensure digital inclusion., (©Magdalena Rzewuska Díaz, Louise Locock, Andrew Keen, Mike Melvin, Anthony Myhill, Craig Ramsay. Originally published in the Journal of Medical Internet Research (https://www.jmir.org), 04.06.2024.)

The use of seclusion to manage conflict behaviours in psychiatric inpatient settings is increasingly viewed as an intervention of last resort. Many protocols have, thus, been developed to reduce the practice. We conducted a systematic review to determine the effectiveness of protocols to reduce seclusion on process outcomes (e.g., seclusion, restraint), patient outcomes (e.g., injuries, aggressive incidents, satisfaction), and staff outcomes (e.g., injuries, satisfaction). We searched Medline, Embase, the Cochrane Register of Clinical Trials, PsycINFO, CINAHL, cairn.info, and ClinicalTrials.gov for protocols to reduce seclusion practices for adult patients on inpatient mental health units (from inception to September 6, 2022). We summarised and categorised reported elements of the protocols designed to reduce seclusion using the Behaviour Change Wheel Intervention Functions and resources needed to implement the protocol in psychiatric units. We assessed risk of bias and determined certainty of evidence using GRADE. Forty-eight reports addressed five approaches to reduce seclusion: hospital/unit restructuring (N = 4), staff education/training (N = 3), sensory modulation rooms (N = 7), risk assessment and management protocols (N = 7), and comprehensive/mixed interventions (N = 22; N = 6 without empirical data). The relationship between the various protocols and outcomes was mixed. Psychiatric units that implement architecturally positive designs, sensory rooms, the Brøset Violence Checklist, and various multi-component comprehensive interventions may reduce seclusion events, though our certainty in these findings is low due to studies' methodological limitations. Future research and practice may benefit from standardised reporting of process and outcome measures and analyses that account for confounders., (© 2024 John Wiley & Sons Australia, Ltd. This article has been contributed to by U.S. Government employees and their work is in the public domain in the USA.)

Objective: The aim of this study was to examine the validity, reliability and responsiveness of common generic paediatric health-related quality of life (HRQoL) instruments in children and adolescents with mental health challenges., Methods: Participants were a subset of the Australian Paediatric Multi-Instrument Comparison (P-MIC) study and comprised 1013 children aged 4-18 years with attention-deficit/hyperactivity disorder (ADHD) (n = 533), or anxiety and/or depression (n = 480). Participants completed an online survey including a range of generic paediatric HRQoL instruments (PedsQL, EQ-5D-Y-3L, EQ-5D-Y-5L, CHU9D) and mental health symptom measures (SDQ, SWAN, RCADS-25). A subset of participants also completed the HUI3 and AQoL-6D. The psychometric performance of each HRQoL instrument was assessed regarding acceptability/feasibility; floor/ceiling effects; convergent validity; known-group validity; responsiveness and test-retest reliability., Results: The PedsQL, CHU9D, EQ-5D-Y-3L and EQ-5D-Y-5L showed similarly good performance for acceptability/feasibility, known-group validity and convergent validity. The CHU9D and PedsQL showed no floor or ceiling effects and fair-good test-retest reliability. Test-retest reliability was lower for the EQ-5D-Y-3L and EQ-5D-Y-5L. The EQ-5D-Y-3L showed the highest ceiling effects, but was the top performing instrument alongside the CHU9D on responsiveness to improvements in health status, followed by the PedsQL. The AQoL-6D and HUI3 showed good acceptability/feasibility, no floor or ceiling effects, and good convergent validity, yet poorer performance on known-group validity. Responsiveness and test-retest reliability were not able to be assessed for these two instruments. In subgroup analyses, performance was similar for all instruments for acceptability/feasibility, known-group and convergent validity, however, relative strengths and weaknesses for each instrument were noted for ceiling effects, responsiveness and test-retest reliability. In sensitivity analyses using utility scores, performance regarding known-group and convergent validity worsened slightly for the EQ-5D-Y-3L and CHU9D, though improved slightly for the HUI3 and AQoL-6D., Conclusions: While each instrument showed strong performance in some areas, careful consideration of the choice of instrument is advised, as this may differ dependent on the intended use of the instrument, and the age, gender and type of mental health condition of the population in which the instrument is being used., Trial Registration: ANZCTR-ACTRN12621000657820., (© 2024. The Author(s).)

Objective: College students have high rates of mental health problems and low rates of treatment. Although sociodemographic disparities in student mental health treatment seeking have been reported, findings have not been synthesized and quantified. The extent to which differences in perceived need for treatment contribute to overall disparities remains unclear., Methods: A systematic search of PubMed, PsycInfo, and Embase was conducted. Studies published between 2007 and 2022 were included if they reported treatment rates among college students with mental health problems, stratified by sex, gender, race-ethnicity, sexual orientation, student type, student year, or student status. Random-effects models were used to calculate pooled prevalence ratios (PRs) of having a perceived need for treatment and of receiving treatment for each sociodemographic subgroup., Results: Twenty-one studies qualified for inclusion. Among students experiencing mental health problems, consistent and significant sociodemographic differences were identified in perceived need for treatment and treatment receipt. Students from racial-ethnic minority groups (in particular, Asian students [PR=0.49]) and international students (PR=0.63) reported lower rates of treatment receipt than White students and domestic students, respectively. Students identifying as female (sex) or as women (gender) (combined PR=1.33) reported higher rates of treatment receipt than students identifying as male or as men. Differences in perceived need appeared to contribute to some disparities; in particular, students identifying as male or as men reported considerably lower rates of perceived need than students identifying as female or as women., Conclusions: Findings highlight the need for policy makers to address barriers throughout the treatment-seeking pathway and to tailor efforts to student subgroups to reduce treatment disparities., Competing Interests: Dr. Kessler has served as a consultant for Cambridge Health Alliance, Holmusk, Mass General Brigham, RallyPoint Networks, and Sage Therapeutics and reports having stock options in Cerebral, Mirah, PYM, Roga Sciences, and Verisense Health. The other authors report no financial relationships with commercial interests.

Introduction: Over a fifth of pregnant women are living with multiple long-term health conditions, which is associated with increased risks of adverse outcomes for mothers and infants. While there are many examples of research exploring individuals' experiences and care pathways for pregnancy with a single health condition, evidence relating to multiple health conditions is limited. This study aimed to explore experiences and care of women with multiple long-term health conditions around the time of pregnancy., Methods: Semistructured interviews were conducted between March 2022 and May 2023 with women with multiple long-term health conditions who were at least 28 weeks pregnant or had had a baby in the last 2 years, and healthcare professionals with experience of caring for these women. Participants were recruited from across the United Kingdom. Data were analysed using thematic analysis., Results: Fifty-seven women and 51 healthcare professionals participated. Five themes were identified. Women with long-term health conditions and professionals recognised that it takes a team to avoid inconsistent care and communication, for example, medication management. Often, women were required to take a care navigation role to link up their healthcare providers. Women described mixed experiences regarding care for their multiple identities and the whole person. Postnatally, women and professionals recognised a downgrade in care, particularly for women's long-term health conditions. Some professionals detailed the importance of engaging with women's knowledge, and recognising their own professional boundaries of expertise. Many participants described difficulties in providing informational continuity and subsequent impacts on care. Specifically, the setup of care systems made it difficult for everyone to access necessary information, especially when care involved multiple sites., Conclusion: Pregnant women with long-term health conditions can experience a substantial burden of responsibility to maintain communication with their care team, often feeling vulnerable, patronised, and let down by a lack of acknowledgement of their expertise. These results will be used to inform the content of coproduction workshops aimed at developing a list of care recommendations for affected women. It will also inform future interventional studies aimed at improving outcomes for these women and their babies., Patient or Public Contribution: Our Patient and Public Involvement group were involved in the design of the study and the analysis and interpretation of the data, and a public study investigator was part of the author group., (© 2024 The Author(s). Health Expectations published by John Wiley & Sons Ltd.)

Introduction: Patients with intestinal failure (IF) are often dependent on PN for provision of calories and nutrients for survival. Similar to chronic intestinal failure (CIF) patients, those who have AIF are also at risk of IFALD, which is a poorly understood but potentially fatal condition. The local incidence of IFALD amongst AIF patients is not known., Objectives: The primary objective of this study was to determine the incidence of IFALD in AIF patients on short-term PN. Secondary objectives were to analyse patient and PN risk factors of IFALD, and clinical outcomes of length of stay (LOS) and inpatient mortality., Design: This was a retrospective cross-sectional cohort study of hospitalised adult patients with AIF prescribed with short-term PN. All adult patients aged 21 years and above who received PN for at least 5 consecutive days and had normal liver function tests (LFTs) at the time of PN initiation were included in this study., Results: A total of 171 patients were enrolled in this study, with 77 (45%) having deranged LFTs at the end of PN therapy and categorised under the IFLAD group. The patient cohort was predominantly male (92 [54%]) and had a median age of 68 years (IQR 59-76). Patients with IFALD at the end of PN therapy had higher diabetes prevalence (36% vs 26%, p = 0.2) and were on PN for a longer duration (median [IQR]: 12 [8-17] vs 8 [6-15] days, p = 0.003) than those without IFALD. There were no significant differences in patient and PN characteristics between the IFLAD and non-IFALD group. The multivariable models showed that the IFALD cohort had longer hospital stays (HR 0.90, 95% CI 0.65-1.23) and lower odds of inpatient death (OR 0.75, 95% CI 0.12-4.60), though both findings are not statistically significant (p = 0.5, 0.7)., Conclusion: In this study, IFALD is a common phenomenon in AIF and the incidence was found to be an estimated 50% amongst patients on short-term PN with similar clinical outcomes between the two groups., Competing Interests: Declaration of competing interest The authors do not have any declaration of interest to disclose with regards to the writing of this manuscript and its content., (Copyright © 2024 European Society for Clinical Nutrition and Metabolism. Published by Elsevier Ltd. All rights reserved.)

Background: We evaluated first-line treatment of metastatic microsatellite-stable colorectal cancer with short-course oxaliplatin-based chemotherapy alternating with immune checkpoint blockade., Methods: Patients were randomly assigned to chemotherapy (the FLOX regimen; control group) or alternating two cycles each of FLOX and nivolumab (experimental group). Radiographic response assessment was done every eight weeks with progression-free survival (PFS) as the primary endpoint. Cox proportional-hazards regression models estimated associations between PFS and relevant variables. A post hoc analysis explored C-reactive protein as signal of responsiveness to immune checkpoint blockade., Results: Eighty patients were randomised and 38 in each group received treatment. PFS was comparable-control group: median 9.2 months (95% confidence interval (CI), 6.3-12.7); experimental group: median 9.2 months (95% CI, 4.5-15.0). The adjusted Cox model revealed that experimental-group subjects aged ≥60 had significantly lowered progression risk (p = 0.021) with hazard ratio 0.17 (95% CI, 0.04-0.76). Experimental-group patients with C-reactive protein <5.0 mg/L when starting nivolumab (n = 17) reached median PFS 15.8 months (95% CI, 7.8-23.7). One-sixth of experimental-group cases (all KRAS/BRAF-mutant) achieved complete response., Conclusions: The investigational regimen did not improve the primary outcome for the intention-to-treat population but might benefit small subgroups of patients with previously untreated, metastatic microsatellite-stable colorectal cancer., Trial Registration: ClinicalTrials.gov number, NCT03388190 (02/01/2018)., (© 2024. The Author(s).)