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Older adults undergoing major elective surgery experience significant emotional distress: insights into the surgical patient experience

Por: Dumon · K. R. · Rouhi · A. D. · Leon · S.

Commentary on: Kata A, Dillon EC, Christina Keny RN, et al.‘There’s So Much That They're Enduring’: Experiences of Older Adults Undergoing Major Elective Surgery. Ann Surg. Published online April 9, 2024. doi:10.1097/SLA.0000000000006293

Implications for practice and research

  • Routine psychosocial assessments for older adults may be implemented throughout the perioperative continuum to proactively identify emotional challenges and offer tailored support.

  • The effectiveness of integrated mental health and social support in improving surgical outcomes should be investigated in this vulnerable population, including longitudinal studies on mental health interventions.

  • Context

    Elderly patients, defined as adults aged 65 years and above, represent a growing segment of the surgical population.1 Despite numerous advances in surgical techniques and postoperative care, elderly patients face unique physical and psychological challenges that can exacerbate their risk of poor clinical outcomes.2 The recent study by Kata et al explores...

    Prevalence and factors associated with lower urinary tract symptoms suggestive of benign prostatic hyperplasia among men aged 50 years and above in Coimbatore district, Tamil Nadu, India: a community-based cross-sectional study

    Por: Pandi · B. N. S. · George · S. · Olickal · J. J. · Thankappan · K. R.
    Objectives

    To estimate the prevalence of lower urinary tract symptoms (LUTS) suggestive of benign prostatic hyperplasia (BPH) and to identify associated sociodemographic, lifestyle and comorbidity-related factors among men aged ≥50 years in a community setting.

    Design

    Community-based cross-sectional study.

    Setting

    Primary care and community settings in a district of southern India using multistage cluster sampling across urban and rural areas.

    Participants

    A total of 560 men aged ≥50 years were enrolled and completed the study. Participants were selected through multistage cluster sampling. Men with known alternative causes of LUTS (such as urinary tract infection, neurological disorders or prior prostate surgery) were excluded.

    Primary and secondary outcome measures

    The primary outcome was the prevalence of LUTS, suggestive of BPH, defined as an International Prostate Symptom Score (IPSS) ≥8. Secondary outcomes included the distribution of individual urinary symptoms, IPSS severity categories, quality-of-life scores and factors associated with LUTS. Outcomes were analysed using survey-weighted methods accounting for clustering and sampling weights.

    Results

    The survey-weighted mean (SD) IPSS score was 3.46 (2.64), with a median (IQR) of 3 (2-4). Most participants reported minimal urinary symptoms, including no incomplete emptying (82.1%), no urgency (81.4%), normal urinary stream (90.5%), and no straining (90.0%). Nocturia was common, with 43.6% waking once and 28.8% waking twice per night. Overall, 80.2% were mildly symptomatic, 10.1% moderately symptomatic and 0.4% severely symptomatic. The prevalence of LUTS suggestive of BPH was 10.32% (n=58; 95% CI 5.7 to 18.0). In survey-weighted multivariable Poisson regression, below-poverty-line status (adjusted prevalence ratio (APR) 4.13; 95% CI 1.38 to 12.41), physical inactivity (APR 2.89; 95% CI 1.81 to 4.63), diabetes mellitus (APR 2.58; 95% CI 1.26 to 5.30), cardiac disease (APR 3.27; 95% CI 1.67 to 6.41), and arthritis (APR 1.88; 95% CI 1.03 to 3.42) were independently associated with LUTS.

    Conclusions

    Approximately one in ten men aged ≥50 years had LUTS, suggestive of BPH. The findings indicate a higher prevalence of LUTS among men with socioeconomic disadvantage, physical inactivity and cardiometabolic comorbidities. Integrating symptom-based screening for LUTS into routine primary care and chronic disease follow-up may facilitate early identification and improve quality of life among older men. Further research is warranted to explore longitudinal relationships and alternative symptom thresholds in community populations.

    Hospitalisation, associated factors and out-of-pocket expenditure among patients with multimorbidity in Kerala, India: a cross-sectional study

    Por: Adhila · S. · Olickal · J. J. · Thankappan · K. R.
    Objectives

    To estimate the rate of hospitalisation, identify associated factors and assess out-of-pocket expenditure (OOPE) among adults with multimorbidity in Kerala, India.

    Design

    Community-based cross-sectional study.

    Setting

    Two districts of Kerala, representing different geographic regions of the state.

    Participants

    A total of 432 adults aged ≥30 years with multimorbidity were selected using multistage cluster sampling; 52.3% were women.

    Outcome measures

    Self-reported hospitalisation in the preceding 12 months and OOPE related to multimorbidity.

    Results

    Hospitalisation in the past year was reported by 26.62% of participants (n=115; 95% CI 22.5% to 31.1%). Among them, the majority (n=78, 67.83%) were admitted to government hospitals, and most hospital stays lasted

    Conclusion

    One in four adults with multimorbidity in Kerala reported hospitalisation. A significant proportion of OOPE was for drugs. These findings highlight the urgent need for targeted financial protection measures, equitable resource allocation and strengthening of primary care services to reduce avoidable hospitalisations and economic burden. The increase in hospitalisation among those with insurance coverage requires careful attention from policy makers. Regulation of drug prices may be required to reduce the financial burden imposed by drugs.

    Cognitive and physical exercise to improve outcomes after surgery (COPE-iOS) study: protocol for a randomised, controlled trial in the USA examining the efficacy of a combined cognitive and physical exercise programme performed before and after major surg

    Por: Rengel · K. F. · Archer · K. R. · Jackson · J. C. · Raman · R. · Orun · O. M. · Ellison · T. · Vanston · S. W. · Ervin · H. · Lauck · A. · Provin · M. · Pandharipande · P. P. · Hughes · C. G.
    Introduction

    Surgery and its resulting hospitalisation are associated with subsequent cognitive and functional decline. Interventions to reduce this decline have exhibited limited success. Prehabilitation is the process of enhancing capacity and reserve before an acute stressor to improve tolerance of the acute physiologic insult. Older adults requiring major surgery are an ideal population for prehabilitation. Prehabilitation exercise studies have mostly focused on physical training to improve physical outcomes after specific surgery types, and data on cognitive outcomes and in broader surgical populations are needed. Computerised cognitive training (CCT) has been shown to enhance memory, processing speed, attention and multitasking. Combining CCT with a physical exercise may be most effective in reducing cognitive and functional decline in older patients undergoing major surgery, but has yet to be evaluated.

    Methods and analysis

    The COgnitive and Physical Exercise to improve Outcomes after Surgery (COPE-iOS) study is a randomised, controlled, participant and assessor blinded clinical trial testing the hypothesis that a pragmatic programme combining CCT and physical exercise throughout the perioperative (ie, preoperative and postoperative) period will improve long-term cognitive and disability outcomes in older surgical patients at high risk for decline. The trial aims to randomise 250 patients who undergo major surgery for a treatment period of approximately 1 month prior to surgery and 3 months after surgery, with a follow-up period of 12 months after surgery. The primary outcome is global cognition at 3 months after surgery. Key secondary outcomes include global cognition at 12 months after surgery and disability in activities of daily living and depression at 3 and 12 months after surgery.

    Ethics and dissemination

    Trial protocol has been approved by Vanderbilt Human Research Protections Programme (#202496) and an independent Data Safety Monitoring Board. Results will be presented at scientific conferences and submitted for publication.

    Trial registration number

    ClinicalTrials.gov Registry NCT04889417.

    Advancing Strategies to Optimise the PerIopeRativE Management of PostOperative Nausea and Vomiting (ASPIRE-PONV) study: rationale and design for a sequential, repeated crossover trial

    Por: Stallings · E. G. · Wanderer · J. P. · Balavage · M. · Henson · C. P. · Fowler · L. · Eden · S. · Shotwell · M. S. · Gruss · C. · Neuhafen · K. R. · Gelfand · B. J. · Kertai · M. D. · for the ASPIRE-PONV Investigators
    Introduction

    This project, in adult surgical patients, will evaluate whether the creation of a customised checklist, driven by a clinical decision support tool, is able to improve anaesthesia providers’ adherence to consensus guidelines and standardised practice recommendations for the prevention of postoperative nausea and vomiting (PONV).

    Methods and analysis

    The intervention will be evaluated using a sequential, repeated crossover design at the institutional level, with designated washout, control and intervention periods. The surgical case will serve as the unit of analysis. The primary outcome is adherence to appropriate PONV prophylaxis administration guidelines. Secondary outcomes include the incidence of PONV and length of stay in the postanaesthesia care unit (PACU).

    Ethics and dissemination

    This protocol and statistical analysis plan provide an outline of the study design, primary and secondary end points and analytic approach. The Advancing Strategies to Optimise the PerIopeRativE Management of PostOperative Nausea and Vomiting trial has received approval from the Vanderbilt University Institutional Review Board (IRB: 250773). The results will be disseminated through peer-reviewed publications and presentations at national conferences. Findings from this trial will inform best practices for timely antiemetic prophylaxis, with the goal of reducing PONV incidence and shortening PACU stay.

    Trial registration number

    NCT07152249.

    Feasibility of a phase 3 partially randomised clinical trial to assess the safety and efficacy of paediatric praziquantel for schistosomiasis treatment in children aged 3 months to 6 years in endemic regions of Brazil: a pilot study

    Objective

    This study assessed the feasibility of implementing a phase 3 field-based clinical trial protocol to evaluate paediatric praziquantel (PED-PZQ) for the treatment of Schistosoma mansoni infection in children aged 3 months to 6 years in endemic areas of Brazil, focusing on operational aspects such as recruitment logistics, documentation management, investigational product handling and protocol adherence.

    Design

    Pilot and feasibility study for a phase 3 clinical trial, comprising two components: a randomised, open-label, parallel-group, two-arm trial and a single-arm trial.

    Setting

    Conde, Bahia, Brazil, from December 2024 to January 2025.

    Participants

    Two trials aim to screen 5774 participants from three rural areas in Bahia and three in Sergipe, states in northeastern Brazil, and enrol 403 children eligible for either randomisation or allocation. Trial 1 will randomise (1:1 ratio) 240 children aged 4–6 years into the PED-PZQ treatment arm or the standard praziquantel (PZQ) 1. Trial 2 will enrol 163 children aged 3 months to 3 years, all receiving PED-PZQ. Both trials are open label. Eligible participants shall meet age criteria, test positive for S. mansoni and fulfil other inclusion criteria. In the first recruiting centre, Conde (Bahia), it was estimated that 650 participants would need to be screened for trial 1 and 552 for trial 2, assuming schistosomiasis prevalence of 5% and 4%, respectively. This pilot study reports on the first 60 participants enrolled.

    Primary and secondary outcome measures

    The primary outcome of this pilot study is the feasibility of implementing the research protocol in a real-world field setting, focusing on key aspects such as study documentation challenges, participant safety, investigational medicinal product custody chain and protocol adherence. In addition to providing preliminary data on the parasitological cure rate, secondary outcomes include the prevalence of S. mansoni infection and the reduction in S. mansoni egg count (Kato-Katz method). Furthermore, the occurrence and severity of drug-related adverse events are monitored from drug administration to day 21 post-treatment, alongside changes in renal, hepatic and cardiac functions assessed through biochemical markers.

    Results

    A total of 60 participants were recruited, and 55 provided stool samples for screening. The pilot phase demonstrated the feasibility of implementing the clinical protocol under field conditions, with successful completion of all planned procedures and minimal protocol deviations. Operational challenges were identified mainly in documentation processes, participant recruitment and investigational product management and were addressed through preventive and corrective quality assurance actions. The experience also highlighted logistical and infrastructural barriers typical of field-based trials in remote endemic areas, which informed adjustments for the subsequent phase 3 study. Preliminary parasitological results indicated an overall S. mansoni prevalence of 9.1% (5/55), with 21% in trial 1 and 2.8% in trial 2. All infected participants met the eligibility criteria, received treatment and completed follow-up. Four achieved a parasitological cure, and one case of treatment failure was observed (trial 1, PZQ group). Two mild adverse events (diarrhoea) were reported, with no serious complications or clinically significant changes in biochemical parameters.

    Conclusions

    This pilot study demonstrated the feasibility of implementing a field-based phase 3 clinical trial protocol for PED-PZQ in endemic areas of Brazil. The findings confirm that the protocol can be successfully applied in primary care settings, despite operational challenges related to recruitment, logistics and documentation. The study also provided preliminary evidence supporting the safety and effectiveness of the paediatric formulation and highlighted the need to revise prevalence assumptions to improve future screening strategies. Overall, the experience offers valuable insights to guide the large-scale phase 3 trial and supports the incorporation of PED-PZQ into national schistosomiasis control policies.

    Trial registration number

    Brazilian Clinical Trials Registry; RBR-86kcy37.

    Are play and screen time associated with British preschoolers mental health? Cross-sectional findings from the British Preschool Childrens Play Survey

    Por: Hesketh · K. R. · Dodd · H. F.
    Objectives

    To investigate associations between adventurous play, outdoor play and screen time and mental health (MH) in British preschool-aged children.

    Design

    Cross-sectional.

    Setting

    A nationally representative sample of caregivers of 2–4 years old (n=1066) in England, Scotland and Wales (Britain), recruited through an online research data and analytics group (YouGov UK).

    Participants

    Caregivers of 1018 children provided valid complete-case data (age 2: n=298 (29%), age 3: n=365 (36%), age 4: n=355 (35%); female n=481 (47%); white: n=878 (81%)).

    Outcome measures

    Four outcomes, derived from parent-report questionnaires: internalising and externalising scores (using the Strengths and Difficulties Questionnaire) and positive and negative affect scores (using the Positive and Negative Affect Schedule for Children-P). Linear regression was used to explore associations between the three exposures (time (in hours per week) a child spent: (1) playing adventurously; and engaging in (2) educational screen time and (3) recreational screen time) and the four outcomes; interactions between play and screen time variables were also tested. Models were adjusted for child and parental demographic variables.

    Results

    For each additional hour per week a child engaged in adventurous play, they had lower internalising scores (–0.02 (–0.03 to –0.01)) and higher positive affect scores (0.04 (0.02 to 0.05)). More hours per day (vs

    Conclusion

    In British preschoolers, adventurous play is associated with better MH outcomes, whereas higher educational screen time was associated with poorer MH, indicating that adventurous play may benefit preschoolers’ MH or that preschoolers with better mental health are more likely to engage in adventurous play. Adventurous play may also offset possible negative associations with screen time.

    Prevalence and determinants of assistive device use among older adults in India: a cross-sectional analysis of a nationally representative survey

    Por: Ravi · R. · Olickal · J. J. · Adoor · A. · Sireesha · V. N. · Devasia · J. · Thankappan · K. R.
    Objectives

    To estimate the prevalence and identify the determinants of assistive device usage in daily life among older adults in India.

    Design

    Cross-sectional analysis of nationally representative survey data.

    Setting

    India

    Participants

    A total of 66 316 adults aged ≥45 years with complete information on assistive device use from Wave 1 of the Longitudinal Ageing Study in India, 2017–2018.

    Primary and secondary outcome measures

    The primary outcome was self-reported use of any assistive device, including visual, hearing, mobility or other assistive devices. There were no predefined secondary outcome measures. Sociodemographic and health-related variables were analysed as covariates to assess factors associated with assistive device use.

    Results

    The prevalence of assistive device use was 38.61% (95% CI: 37.73% to 39.50%). Use increased with age, from 34.48% among adults aged 45–59 years to 52.07% among those aged ≥75 years (adjusted prevalence ratios (aPR) 1.30; 95% CI: 1.25 to 1.35). Prevalence was higher among men (40.94%) than women (37.51%) (aPR 1.06; 95% CI: 1.03 to 1.09), among individuals with education above primary level (54.28%) compared with those with up to primary education (28.35%) (aPR 1.42; 95% CI: 1.36 to 1.48), and among urban residents (53.88%) vs rural residents (31.16%) (aPR 1.18; 95% CI: 1.14 to 1.22). A clear socioeconomic gradient was observed, with prevalence increasing from 27.65% in the poorest to 50.66% in the richest wealth quintile (aPR 1.32; 95% CI: 1.25 to 1.39). Assistive device use was higher among participants with chronic conditions (47.30%) than those without (28.16%) (aPR 1.15; 95% CI: 1.11 to 1.19) and was markedly higher among those with a prior eye or vision diagnosis (64.93%) compared with those without (14.61%) (aPR 3.94; 95% CI: 3.78 to 4.11). Among users, spectacles or contact lenses were most common (89.26%), followed by walking sticks or walkers (11.62%) and dentures (6.15%). State-level prevalence varied widely, ranging from 71.27% in Goa to 13.44% in Arunachal Pradesh.

    Conclusion

    Assistive device use was reported by less than half of Indian adults aged ≥45 years. The findings reveal clear socioeconomic and geographic inequities in access to assistive devices, with substantially lower use among older adults with less education, those in poorer wealth quintiles and rural residents. These disparities highlight the need for equity-focused interventions that improve accessibility to assistive devices, particularly for socially and economically disadvantaged groups and individuals with chronic conditions.

    Using real-world evidence to evaluate the long-term health and economic impact of the digital tool Grohealth W8Buddy supporting access to specialist weight management services: a protocol for a cohort observational study

    Por: Deo · P. S. · Grove · A. · Zhang · M. · Abrams · K. R. · Auguste · P. · Barber · T. M. · Gazeley · T. · Green · R. · Griffiths · F. · Hazlehurst · J. · Hee · S. W. · Kaura · A. · Mallipedhi · A. · OToole · S. · Panesar · A. · Parsons · N. · Scott · E. · Summers · C. · Thind · M. · Thorpe · M.
    Introduction

    Obesity affects over a quarter of the UK population and can lead to serious health issues. NHS Specialist Weight Management Services (WMS) offer treatments including lifestyle advice, psychological support and medications, but access and availability vary by region. Although around 4 million people could be eligible for NHS Specialist WMS annually, capacity is limited to 35 000, severely limiting overall access for those who need it. While digital technology has started to be used in WMS, more evidence is needed to confirm its long-term effectiveness, acceptability and cost-effectiveness. This study explores the use of Gro Health W8Buddy, a digital platform and app providing remote Specialist WMS. It aims to determine the long-term health benefits of remote WMS pathway Gro Health W8Buddy compared with standard NHS WMS delivered in hospitals, and to improve patients access to services.

    Methods and analysis

    The study is a real-world evaluation with observational data collection. We will recruit 450 study participants from four NHS specialist WMS who will choose either standard NHS WMS or the digital pathway Gro Health W8Buddy. Participants are being given the option to choose their pathway to generate real-world evidence. We will measure and analyse health outcomes including weight loss, time taken to be treated and cost-effectiveness, at 18 months and follow up at 24 months for later analysis (outside of this core funding). We will gather experiential data from patients and healthcare professionals through surveys, observation and interviews.

    Ethics and dissemination

    Ethical approval has been obtained from NHS Health Research Authority (HRA) and Health and Care Research Wales (HCRW) (Supplementary Figure 3) (REC reference: 25/EM/0147). Our findings will be disseminated through academic publications, conference presentations and stakeholder engagement.

    Trial registration

    ISRCTN89168871; Pre-results.

    Use of claims data to identify adverse events after colonoscopy in a randomised colorectal cancer screening trial in Norway: a cross-sectional study

    Por: Rognstad · O. B. · Botteri · E. · Hoff · G. · Bretthauer · M. · Nguyen · H. D. · Schult · A. L. · Holme · O. · Randel · K. R.
    Objectives

    Accurate identification of adverse events after colonoscopy is essential for quality assurance in colorectal cancer (CRC) screening. Review of medical records is labour intensive as adverse events are infrequent. The object of this study was to investigate the accuracy of claims data in identifying adverse events after colonoscopy in CRC screening.

    Design

    Cross-sectional, retrospective.

    Setting and participants

    Males and females aged 50–74 years were randomised to once-only sigmoidoscopy or biennial faecal immunochemical test in a CRC screening trial at two screening centres in Norway. Participants in the present study underwent follow-up colonoscopy from 2012 to April 2020 after initial positive screening test. We reviewed medical records for adverse events within 30 days following 11 205 colonoscopies.

    Primary and secondary outcome measures

    The primary outcome of the study was to assess the sensitivity of claims data from the Norwegian Patient Registry to identify lower gastrointestinal bleeding using emergency contact International Statistical Classification of Diseases and Related Health Problems 10th Revision diagnostic code sets under two definitions: a stringent definition (codes explicitly identifying bleeding) and a broad definition (including suggestive codes). Secondary outcome measures included the sensitivity to identify perforation using a stringent and a broad definition. Additionally, we assessed whether incorporating procedure codes and non-emergency contacts improved accuracy.

    Results

    87 cases of lower gastrointestinal bleeding and eight perforations were confirmed. Sensitivity for bleeding differed between the centres (p

    Conclusions

    Use of claims data underestimated adverse event rates following colonoscopy. Difference in coding practice across hospitals underscores the need for standardised reporting in screening programmes.

    Trial registration number

    NCT01538550.

    Multicentre prospective non-interventional study protocol for evaluating surgical strategies for Colorectal Resections and Postoperative Quality of Life in Retroperitoneal Sarcoma Patients Across German-Speaking Sarcoma Centres (COLOSARC-Q)

    Por: Hettler · M. · Scharpf · K. R. · Eich · A. · Albertsmeier · M. · Dupree · A. · Hetjens · S. · Harbrücker · M. · Menge · F. · Betzler · A. · Hohenberger · P. · Jakob · J.
    Introduction

    Retroperitoneal sarcomas (RPS) are rare and often large malignancies that frequently require extensive surgery for complete tumour removal. Resections of the colorectum are part of the standard resection, this way contributing to complication rates, including anastomotic leakage or obstruction. Surgical strategies for stoma formation and colorectal reconstruction remain poorly defined. The Colorectal Resections and Postoperative Quality of Life in Retroperitoneal Sarcoma Patients Across German-Speaking Sarcoma Centres (COLOSARC-Q) study aims to explore surgical procedures and health-related quality of life (HRQoL) in patients undergoing colorectal procedures during RPS surgery.

    Methods and analysis

    COLOSARC-Q is a prospective, multicentre, non-interventional study and will recruit 120 patients with primary RPS who undergo colorectal resection as part of sarcoma surgery in a sarcoma referral centre in Germany or Switzerland. HRQoL is assessed using standardised questionnaires (EORTC QLQ-C30, QLQ-CR29) as well as semi-structured interviews by psycho-oncology services and patient advocates. Data will be collected via an electronic Case Report Form, encompassing demographic, clinical, surgical and outcome-related information. All data will be centrally analysed. For the assessment of quality of life, a qualitative analysis with content and context analysis, as well as evaluation of the questionnaires according to a standardised scoring system, is planned. The primary aim is to evaluate surgical techniques for bowel resection and reconstruction and their influence on the further course of disease. Secondary endpoints assess postoperative complications as well as tumour-, patient- and treatment-related factors.

    Ethics and dissemination

    Ethical approval was granted by the Ethics Committee II of the University of Heidelberg (approval number 2024-562; 13 June 2024). The data protection review was approved by the data protection officer of the University of Heidelberg. Participation of other centres in the study requires local ethical approval. All patients will be required to sign an informed consent form. Results of primary and secondary endpoints will be published.

    Trial registration numbers

    NCT06943612; German Clinical Trials Registry (DRKS00034135).

    Parental experiences of congenital heart disease transition care highlight the need for family-centered approaches

    Por: Fox · K. R. · Garg · V.

    Commentary on: Lykkeberg B, Noergaard MW, Bjerrum M. Experiences and expectations of parents when young people with congenital heart disease transfer from pediatric to adult care: A qualitative systematic review. J Child Health Care. doi:10.1177/13674935241231024

    Implications for practice and research

  • To inform family-centred transition programmes, more high-quality qualitative research describing parental experiences should be conducted, particularly in non-European and low- and middle-income countries.

  • Congenital heart disease transition programmes should consider adopting a family-centred approach that incorporates informational and psychosocial support resources for parents.

  • Context

    A growing number of individuals born with congenital heart disease (CHD) are surviving well into adulthood, and a successful transition from paediatric to adult healthcare is essential for their long-term health. However, discontinuity in care is prevalent.1 Parents play an important role in the transition process and may impact transition-related outcomes,2 but their experiences and...

    PharmacoGENEtics in Youth Depression (GENE-YD) Study protocol: a pilot triple-blinded randomised controlled trial using pharmacogenetics to tailor antidepressant treatment in young Australians

    Por: Roberts · B. · Cooper · Z. · Miljevic · A. · Stanley · S. H. · Majda · B. T. · Collins · K. R. L. · Baltic · S. · Lindsey-Temple · S. E. · Akkari · P. A. · Hood · S. D. · Rodger · J.
    Background

    The prevalence of depression and mood disorders has been steadily rising in Australian youth, with a concomitant increase in antidepressant pharmacotherapy prescription rates. Yet, the tolerability and efficacy of antidepressant drugs in youth remain poor. Pharmacogenetic (PGx) testing, or the personalised and guided treatment of medication based on genetic data, has been suggested to improve the effectiveness and tolerability of antidepressants. However, limited studies have evaluated the utility of antidepressant PGx-guided treatment in adolescent and young adult populations. Thus, this pilot randomised controlled trial (RCT), the GENE-YD Study, will evaluate the feasibility for a large-scale RCT assessing the effect of PGx-guided antidepressant prescription vs treatment as usual in youth with major depressive disorder (MDD).

    Methods and analysis

    Eighty young people between 16 and 24 years of age and in the early stages of pharmacotherapy treatment for MDD will be recruited. Following initial screening, participants will be randomised on a 1:1 ratio to either the intervention or control study group. Participants in the intervention condition will have their treatment tailored based on their PGx profile. Participants randomised into the control group will have their prescription based on current best practice recommendations, or treatment as usual. Individuals will be assessed at drug prescription baseline and again 6 and 12 weeks following drug prescription. The primary outcome of the study will be to evaluate the feasibility and acceptability of the GENE-YD protocol. Specifically, this study will explore participation recruitment strategies and attrition to the study protocols to guide the recruitment processes of a large-scale RCT, along with participating satisfaction in overall study protocols. Secondary outcomes will inform the utility and variability of specific measures (eg, depression rating scales, quality of life measures and medication adherence scales) that may be scaled up for use in a future full-scale trial.

    Ethics and dissemination

    Ethics approval was granted by the Department of Health, Western Australia’s Human Research Ethics Committee (RGS0000006822) and recognised by the University of Western Australia’s Human Research Ethics Committee (2024/ET000685). All participants will be required to provide written informed consent. Results will be published in international peer-reviewed journals.

    Trial registration number

    ACTRN12624000760572.

    Cohort profile: the Maharashtra Anaemia Study 3 (MAS 3)--a maternal-child cohort study up to age 18 years in India

    Por: Benavente · M. T. · Geifman · N. · Bath · S. C. · Ahmadi · K. R. · Fogarty · A. W. · Marshall · C. · Ray · S. · Tata · L. J. · Yajnik · C. · Ahankari · A.
    Purpose

    The Maharashtra Anaemia Study 3 (MAS 3) aims to (1) Investigate the nutritional, environmental, and economic impacts on haemoglobin concentration/anaemia, (2) Identify the underlying micronutrient causes of anaemia and (3) Investigate the association between anaemia and physical and cognitive development of Indian children during their first 18 years of life. This paper introduces the MAS 3 cohort, which consists of data collected from the participants in the prospective Pune Maternal Nutrition Study from the antenatal period to children at 18 years of age (1996–2014) in the Maharashtra state, India.

    Participants

    Recruitment of 2466 married non-pregnant women, and their husbands, took place between June 1994 and April 1996 in six villages, approximately 50 km from Pune city in India. Women were followed up monthly to identify those who became pregnant. A total of 797 pregnant women were followed up for data collection at or near gestational week 18 and 28, with further data collection for women and children occurring within 72 hours of delivery, for both live and stillbirths. Of the 797 women, 710 were included in the MAS 3 cohort, and long-term follow-up of children occurred at 6 years, 12 years and 18 years of age.

    Findings to date

    In the MAS 3 cohort, most mothers (73%) were aged between 18 and 25 years at the time of their final prepregnancy visit (baseline), and half (55%) belonged to families of middle-upper socioeconomic status (SES). At the children’s baseline (birth) visit, children had a mean birth weight of 2630 g (SD: 376), with one third (31%) of low birth weight. At the 6-year, 12-year and 18-year follow-up visits, data were available for 706 (99%), 689 (97%) and 694 (98%) children.

    Future plans

    MAS 3 will be used to address a number of research objectives, including (1) Trends of haemoglobin and anaemia-related micronutrients from age 6 to 18 years, (2) Micronutrient causes of anaemia during childhood, (3) Prevalence and risk factors for maternal anaemia and childhood anaemia, (4) Impact of maternal anaemia on immediate birth outcomes and (5) Intergenerational risk factors associated with anaemia.

    Trends in cardiometabolic conditions and pregnancy outcomes: a retrospective cohort study in South-Eastern Melbourne

    Por: Belsti · Y. · Palmer · K. R. · Moran · L. J. · Rolnik · D. L. · Goldstein · R. · Mousa · A. · Enticott · J. · Teede · H. J.
    Objectives

    To examine trends in preconception and pregnancy cardiometabolic risk factors and conditions, pregnancy and birth complications, obstetric interventions, and the impact of COVID-19, and to forecast future disease burden.

    Design

    A multi-centre retrospective cohort study.

    Setting

    A large hospital network with three maternity hospitals serving ethnically diverse populations in Melbourne, Australia.

    Participants

    Pregnant women who gave birth between 2016 and 2022.

    Outcome measures

    Trends in cardiometabolic conditions, birth complications and obstetric interventions.

    Results

    Over 7 years, 63 232 women were included, of whom 40% were nulliparous, and 60.9% were born overseas from 167 countries. From 2016–2022, maternal age (30.2–31.3 years), obesity (21.0%–26.2%), gestational diabetes mellitus (GDM) (15.9%–28.1%) and caesarean delivery (28.5%–37.6%) increased, while average gestational weight gain, premature births and special care admissions declined from 12.6–11.6 kg, 6.3%–4.9% and 24.2%–14.1%, respectively; and was statistically significant (p

    Conclusions

    Prepregnancy and pregnancy cardiometabolic risk factors and conditions, pregnancy and birth complications, and obstetric interventions increased markedly over 7 years. Despite this, offspring complications, including special care admissions, stillbirths and prematurity, decreased, while pregnancy complications peaked during COVID-19. GDM is forecasted to increase to 43.0% by 2028, posing an unsustainable health and economic burden that necessitates urgent public health initiatives.

    Implementing relational continuity in general practice--understanding who needs it, when, to what extent, how and why: a realist review protocol

    Por: Tzortziou Brown · V. · Park · S. · Mahtani · K. R. · Taylor · S. · Owen-Boukra · E. C. · Taylor · J. · Richards · O. · Begum · S. · Wong · G.
    Introduction

    Relational continuity of care (RCC) refers to the sustained therapeutic relationship between a patient and a clinician, which fosters trust, enhances communication and facilitates the accumulation of knowledge about the patient. RCC is associated with enhanced patient outcomes, reduced hospital admissions, lower mortality rates, decreased healthcare costs and improved patient experience. Despite these benefits, reorganisations within the NHS and workforce challenges have led to an increased reliance on multidisciplinary and part-time working, resulting in fragmented care and a decline in RCC. Our study aims to explore who needs RCC, under what circumstances, to what extent and why, with the goal of informing optimal implementation strategies.

    Methods and analysis

    We will conduct a realist review to develop an evidence-based programme theory explaining the mechanisms underlying RCC, the populations that benefit most, the contextual factors influencing RCC and effective care models. Following Pawson’s five iterative stages, we will: (1) Locate existing theories, (2) Search for relevant evidence, (3) Select appropriate articles, (4) Extract and organise data and (5) Synthesise findings to draw conclusions. A stakeholder advisory group, comprising policymakers, healthcare professionals, public contributors and patients, will be engaged throughout the process. We will adhere to Realist And Meta-narrative Evidence Synthesis: Evolving Standards (RAMESES) for realist reviews to ensure methodological rigor.

    Dissemination and ethics

    Our findings will inform practical, evidence-based recommendations for optimising RCC within general practice. Outputs will include peer-reviewed publications, conference presentations, plain English summaries, social media infographics, a short video and end-of-study events. Collaborations with stakeholders and public involvement will ensure both accessibility and impact. Ethical approval is not required for this review.

    Prevalence of viral hepatitis in sub-Saharan Africa among the general population: an umbrella review of systematic reviews and meta-analyses

    Por: Sticher · J. S. · Csermak · K. R. · Otsyula · N. · Turkson · M. · Aubrun · E. · Oshagbemi · O. A.
    Objectives

    Hepatic impairment, especially hepatitis, is a growing public health concern in the general population globally. Viral hepatitis, a key driver of liver impairment, remains endemic in many countries across sub-Saharan Africa (SSA). We conducted an umbrella review to assess the prevalence of viral hepatitis among the general population in SSA.

    Design

    We conducted an umbrella review, using standardised methods to assess multiple systematic reviews and meta-analyses (SRMAs) on the prevalence of viral hepatitis.

    Data sources

    We systematically searched PubMed and Embase to retrieve systematic reviews published from 2013–2024.

    Eligibility criteria for selecting studies

    We retrieved systematic reviews published during 2013–2024 that examined the prevalence of viral hepatitis among the general population within SSA.

    Data extraction and synthesis

    Two independent reviewers used standardised methods to search, screen and identify included studies. We conducted an umbrella review, which was a comprehensive and systematic collation and assessment of SRMAs focused on the prevalence of viral hepatitis in SSA.

    Results

    The final analysis included 21 studies. Among these, one study focused on hepatitis A, 13 on hepatitis B, 10 on hepatitis C, 2 on hepatitis D and 1 on hepatitis E. Only one study reported the overall prevalence of hepatitis A and E in SSA as 90 200 and 46 860 per 100 000 population, respectively. Across SSA, hepatitis B exhibited a pooled prevalence ranging from 6000 to 18 900, while hepatitis C ranged from 720 to 7820 and hepatitis D from 50 to 28 990 per 100 000 population. Heterogeneity was high and ranged from I2=63.14% to 99%.

    Conclusion

    We present an umbrella review on viral hepatitis prevalence in SSA, providing an overall view of study quality, effect sizes, heterogeneity and bias across the search field. We found that the prevalence of viral hepatitis in many SSA countries is higher than the global estimate. However, these results are mainly based on seropositivity tests; nonetheless, the findings from this study provide an overarching picture of the burden of viral hepatitis within populations in SSA.

    Optical correction of hyperopia in school-aged children: a scoping review protocol

    Por: Srinivasan · G. · Kerber · K. L. · Liu · S.-H. · Manh · V. M. · Huang · K. · Williamson · A. · Sadhu · S. · Ollinger · M. C. · Tajbakhsh · Z. · Fisher · J. H. · Cheung · N. L. · Junge · J. · Chan · K. C. H. · Hussaindeen · J. R. · Simard · P. · Trast · K. R. · Morettin · C. E. · Krueger
    Introduction

    Prescribing patterns for hyperopia in children vary widely among eye care providers worldwide. This scoping review aims to identify and map the current literature on optical correction and catalogue outcomes reported, particularly in the domains of vision, vision-related functional outcomes and quality of life (QoL) in school-aged children with hyperopia.

    Methods and analysis

    This protocol was developed in accordance with the Joanna Briggs Institute’s Manual for Evidence Synthesis. We will include studies involving school-aged children with hyperopia without restrictions on sex, gender, race, ethnicity, type of optical correction, length of intervention, publication date or country of origin. We will include studies with internal or external comparison groups. We will exclude studies associated with myopia control treatments, ocular and visual pathway pathologies affecting vision or visual function. We will search Cochrane CENTRAL, Embase.com and PubMed. Examples of data to be extracted include population demographics, visual acuity, study-specific definitions for refractive error, treatment regimens for optical correction, vision and vision-related functional outcomes and QoL (general or vision-related) as quantified by validated instruments.

    Ethics and dissemination

    Informed consent and Institutional Review Board approval will not be required, as this scoping review will only use published data. The results from the scoping review will be disseminated by publication in a peer-reviewed scientific journal and at professional conferences.

    Athletes access to, attitudes towards and experiences of help-seeking for mental health: a scoping review

    Por: Brown · K. R. · Quinton · M. L. · Tidmarsh · G. · Cumming · J.
    Objectives

    Athletes have been found to experience a similar prevalence of mental health issues to non-athletes. However, they are subjected to a greater array of barriers to help-seeking for mental health, including sport-specific factors. This scoping review synthesised the literature on athletes’ access to, attitudes towards and experiences of help-seeking for mental health from formal (mental health professionals such as psychiatrists) and semiformal sources (those who are not mental health professionals but are a service provider such as a coach).

    Design

    The Joanna Briggs Institute framework and recommendations were used alongside the Preferred Reporting Items for Systematic Reviews and Meta-Analyses-Protocols checklist for scoping reviews. This scoping review was predominantly informed by Arksey and O’Malley’s framework for scoping reviews, supplemented by Levac et al’s additional recommendations. Rickwood and colleagues’ help-seeking frameworks informed the research question, inclusion/exclusion criteria and analysis.

    Data sources

    The search terms and synonyms of "athlete" AND "mental health" AND "help-seeking" were searched in PsychINFO, Embase, MEDLINE, APA PsychArticles Full Text, Web of Science Core Collection, Scopus, Sport Discus, CINAHL and Proquest (Education Database, Health & Medical Collection, Nursing & Allied Health database, Psychology Database, Public Health Database, Education Collection, and Medicine & Education). These searches were conducted at three time points between April 2022 and 2024.

    Eligibility criteria

    The inclusion and exclusion criteria were initially predetermined and specified in the protocol paper published in BMJ Open. Primary research articles, interventions and systematic reviews that referred to semiformal and formal sources of support were included.

    Data extraction and synthesis

    The lead reviewer (KRB) screened all titles and abstracts, and full texts, and extracted data from all included studies. A second reviewer was involved in screening and extracting 20%–30% of studies at each stage. Findings were synthesised descriptively (eg, study population, data collection method and location of studies) and by content (eg, access, attitudes and experiences, sources of support, use of theory and the validity of quantitative measures used).

    Results

    After screening 4954 titles and abstracts and 275 full texts in Covidence, 104 papers were included in the review. This comprised of 87 primary research articles, 13 interventions and 4 systematic reviews. Most of the primary articles and interventions were published in the USA (50%). 49.4% of the primary articles used quantitative methods, 34.5% used qualitative methods and 16.1% used mixed methods. Attitudes towards mental health help-seeking were investigated in 78.8% of the included studies, experiences of help-seeking in 53.8% and access to sources of support in 31.7% of studies. Of the primary articles and interventions, formal sources were investigated in 55% of studies, semiformal sources in 2% and both in 26% of studies.

    Conclusions

    This scoping review of 104 papers showed the benefit of using help-seeking frameworks to shape and analyse a review. Analysing the results using these frameworks provided a novel contribution to the literature, showing where the athlete help-seeking literature base is currently focused and identified gaps for further research. For example, there is a need for further research on athletes in less developed nations, more qualitative and mixed methods studies, and further research on athletes’ access to mental health support and their interactions with semiformal sources. The results have applied implications in public health and sport by highlighting the different factors that impact athlete help-seeking, and therefore areas where they require support.

    Assessment of adverse childhood experiences in women: a study of reliability and predictive validity of self-reporting versus medical records abstraction in an American population

    Por: Rocca · W. A. · Gazzuola Rocca · L. · Smith · C. Y. · Esterov · D. · Kapoor · E. · Geske · J. R. · Bailey · K. R. · Mielke · M. M. · Kantarci · K.
    Objective

    To study the reliability and validity of adverse childhood experiences (ACE) scores measured using a questionnaire versus abstraction of medical records, and to test whether the scores vary by history of bilateral oophorectomy, or by age and presence of anxiety or depressive symptoms at the time of questionnaire administration.

    Design

    The study involved a reliability component and a predictive validity component.

    Setting

    A population-based sample in Olmsted County, Minnesota, was derived from the Mayo Clinic Cohort Study of Oophorectomy and Aging-2.

    Participants

    We included 198 women who underwent premenopausal bilateral oophorectomy for a non-malignant indication between 1988 and 2007 and 174 referent women of the same age randomly sampled from the general population (total of 372 women). At a later time (median of 22.7 years later), the women were contacted and invited to self-administer the ACE questionnaire during an inperson visit. Independent of the visit, their medical records were abstracted for ACE by a physician.

    Interventions

    Questionnaire and abstraction-based ACE scores.

    Main outcome measures

    Agreement between the two ACE scores (reliability; weighted kappa statistics) and comparison of incidence of multimorbidity in women with ACE scores ≥1 vs 0 (predictive validity; survival analyses). Data were analysed in March and April 2024.

    Results

    The 372 women in the study had a median age of 65 years at the time of ACE questionnaire self-administration (IQR, 62–69). Questionnaire-based ACE scores showed moderate agreement with abstracted ACE scores (weighted kappa 0.44 (95% CI 0.34 to 0.54)). The cut-off score of ACE ≥1 showed an overall fair agreement between the two scores (kappa 0.33 (95% CI 0.24 to 0.43)). A comparison of the cumulative incidence of multimorbidity in women with an ACE score ≥1 versus women with ACE score of 0 yielded a HR of 1.13 (95% CI 1.00 to 1.27) for abstracted ACE and 1.13 (95% CI 1.01 to 1.27) for questionnaire-based ACE. The best predictive validity was for ACE measured by both methods combined (either or) with a HR of 1.29 (95% CI 1.13 to 1.46).

    Conclusions and relevance

    Questionnaire-based ACE scores have moderate agreement with medical records abstracted ACE scores. However, both sets of ACE scores are predictive of the accumulation of multimorbidity at older age and should be considered complementary.

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