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Music intervention associated with improved quality of life in patients with breast cancer after mastectomy

Por: Amadi · G. P. · Fenton · J. J.

Commentary on: Chuang C, Chen C: Effects of music intervention on quality of life, anxiety and fatigue among patients with breast cancer: a randomized controlled trial, Oncol Nurs Forum, 2024;51(5):467-482.

Implications for practice and research

  • Music intervention may improve perceived quality of life in patients who have recently received a mastectomy for breast cancer.

  • High-quality research is needed to determine whether and how music intervention can help patients during cancer treatment.

  • Context

    Music intervention is a complementary treatment that aims to ameliorate symptoms related to a medical condition. Music intervention is distinct from music therapy in that it is a solo listening experience rather than an active or therapist-guided session. Music intervention is thought to be a low-risk and convenient treatment with potentially positive effects on patients with breast cancer as measured by self-assessed symptom or quality of life scores or pain treatment...

    Psychosocial risk screening in the inpatient care of physically ill patients: study protocol for a feasibility study

    Por: Feder · S. C. · Simsek · Z. · Simon · J. J. · Hartmann · M. · Bruns · B. · Bugaj · T. J. · Hoch · J. · Dugas · M. · Friederich · H.-C.
    Background

    The length of hospital stay for patients with physical illnesses is longer for those with mental health comorbidity, particularly in the presence of severe physical multimorbidity. Integrating psychosocial risk screening at hospital admission, with a subsequent care pathway, could address psychosomatic and social care needs early and reduce length of stay. However, implementation may be hindered by organisational factors such as increased staff workload and timely integration into existing processes. In addition, patient factors such as low acceptance of screening and follow-up may affect uptake. This pilot study aims to assess the feasibility of implementing this integrated approach to screening and follow-up in preparation for a confirmatory trial.

    Methods

    The present study is a single centre, randomised feasibility study conducted on a pilot ward. Patients will be enrolled and assigned to the intervention or the control group. Only the intervention group will receive tablet-based psychosocial risk screening conducted by ward physicians or medical students in their practical year. If the psychosomatic screening is positive and the patient agrees, he or she is referred to the psychosomatic consultation service. If the social service screening is positive, the patient will be seen by a social worker. The main objective of this study is to assess the feasibility of conducting a full-sized confirmatory trial. An informed consent rate of 30% of eligible patients is set as the feasibility criterion. A study period of 4 months is planned for the feasibility study. The feasibility study will be analysed using descriptive statistics.

    Ethics and dissemination

    The study protocol was approved by the Ethics Committee of the Medical Faculty of Heidelberg University (S-301/2024) on 24 May 2024. The results of this feasibility study will be published in a peer-reviewed journal.

    Trial registration number

    NCT06651164.

    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.

    Osteoporosis treatment gap and prescribing patterns in Ireland: a cross-sectional analysis of the DXA HIP project

    Por: Carey · J. J. · Brennan · A. · Armstrong · C. · Heaney · F. · Dempsey · A. · Egan · R. · Gorham · K. · Yang · L. · DXA MAP · Erjiang · Wang · Whelan · OSullivan · Silke · Yu · Dempsey · Fitzgerald
    Objectives

    Previous studies suggest Ireland has the smallest osteoporosis treatment in Europe and very little inappropriate prescribing, in contrast to our experience. In this study, we examine the osteoporosis treatment gap in Ireland by assessing the prevalence of appropriate and inappropriate prescribing in 2 subgroups of the Irish dual-energy X-ray absorptiometry (DXA) Health Informatics Prediction (HIP) Project. Treatment eligibility was defined using established intervention thresholds, including prior fracture, femoral-neck T-score ≤–2.5, glucocorticoid use, or Fracture Risk Assessment Tool (FRAX) major osteoporotic fracture risk ≥20% or hip fracture risk ≥3%.

    Design

    Secondary cross-sectional analysis of a subgroup of the DXA HIP Project Cohort.

    Setting

    3 hospitals in the West of Ireland. DXA referrals come from primary care providers, hospital consultants and the osteoporosis service.

    Participants

    5564 participants of a previously described convenience cohort including: (i) 3474 subjects referred for a DXA scan, and (ii) 2090 patients who completed a DXA scan.

    Results

    82.4% were female with a mean age of 66.6 years, 59.6% of whom had a prior fracture. Prescribing data of calcium and vitamin D were available for 3738 (67.2%) subjects, and osteoporosis medication for 4157 (74.7%) subjects. Prescribing information was available for more than 99% of the DXA group, but just over 50% of the referral group. When examined in aggregate, the treatment gap is 6% for calcium and vitamin D and 38% for osteoporosis medication, in line with prior publications. However, among those with prescribing information and at least one indication for treatment, only 58.3% were prescribed calcium and vitamin D and 39.1% an osteoporosis medication. Furthermore, among patients without a clear indication for treatment, 50.6% were prescribed calcium and vitamin D, and 32.5% an osteoporosis medication.

    Conclusions

    These data suggest the majority of patients with osteoporosis or at high risk of fracture in Ireland today do not receive appropriate osteoporosis treatment, while inappropriate prescribing is substantial. These findings suggest that the true treatment gap in Ireland is substantially larger than aggregate estimates imply.

    Public versus private clinical radiography training in Lagos State, Nigeria: a comparative cross-sectional survey of associations with graduate self-perceived competence and practice readiness

    Por: Udo · E. O. · Emordi · O. R. · Kalu · E. I. · Enebeli · U. U. · Uzochukwu · B. · Kalu · F. A. · Igwe · P. C. · Kalu · J. J. · Kalu · B. O. · Cherima · Y. J. · Nwokenna · U. S. · Hassan · R. K. · Amadi · A. N.
    Objectives

    To compare clinical radiography training experiences (structure, resources, participation, feedback) and self-perceived competence/practice readiness between public and private radiography centres in Lagos State, Nigeria.

    Design

    Comparative cross-sectional survey design from August to October 2025 using a validated self-administered questionnaire distributed in person during departmental seminars and clinical debriefings at University of Lagos-affiliated centres.

    Setting

    Centre-based settings at public and private radiodiagnostic centres.

    Participants

    A total of 260 final-year students and recent graduates, 130 each from public and private radiodiagnostic centres. Inclusion criteria included: age ≥18 years, with ≥6 months clinical exposure, from centres affiliated to the University of Lagos. All participants completed the self-administered questionnaire. There were no interventions.

    Primary and secondary outcome measures

    The primary outcome was the self-perceived competence/practice readiness, and the secondary was participation, extent and feedback mechanisms, measured as planned without protocol deviations. All variables were measured using validated items in the questionnaire.

    Results

    Private centres significantly outperformed public centres in hands-on practice and feedback, with higher self-perceived competence (mean 35.6±5.7 vs 32.8±6.4; p=0.001). There were no significant differences in training structure (p=0.78). Public centres reported higher patient loads (86.2% vs 68.5%; p=0.001) but lower equipment availability (47.7% vs 72.3%; p

    Conclusions

    Private centres were associated with higher self-perceived competence and readiness, better resources and feedback, while public centres offered greater patient volumes. Hybrid placements and targeted infrastructure investment are recommended to help address disparities in perceived readiness.

    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.

    Patiromer utility as an adjunct treatment in patients needing urgent hyperkalaemia management (PLATINUM): a randomised controlled trial in the emergency department

    Por: Rafique · Z. · Safdar · B. · Duanmu · Y. · Boone · S. · Meltzer · A. · Bischof · J. J. · Robinson · D. · Budden · J. · Budd · J. · Quinn · C. M. · Milliet · C. · Singer · A. J. · Soto · K. · Peacock · F.
    Objectives

    Hyperkalaemia (HK) is common in the emergency department (ED) and can cause life-threatening arrhythmias. Patiromer is a potassium binder whose role in acute HK management is uncertain; therefore, we investigated the efficacy and safety of patiromer as an adjunct to the standard of care treatment of HK in the ED.

    Design

    A prospective, randomised, double-blind, placebo-controlled study.

    Setting

    16 ED sites across the USA.

    Participants

    Patients aged ≥18 years treated at a participating ED who were found to have serum potassium ≥5.8 mEq/L.

    Interventions

    Participants were randomised 1:1 to standard combination therapy (25 g intravenous dextrose, 5 units intravenous insulin and 10 mg albuterol) with either patiromer or placebo. The initial dose was given within 1 hour of the potassium result, and the second dose 24 hours later.

    Primary and secondary outcome measures

    The primary endpoint was net clinical benefit (NCB) at 6 hours, defined as the change in number of potassium-lowering interventions minus change in serum potassium. Adverse events (AEs) were also recorded.

    Results

    The study was terminated early and did not reach the prespecified sample size. Overall, 111 patients (53 patiromer and 58 placebo) were analysed. Mean (SD) age was 61.34 (15.21) years, 34% were female, 48% white and 22.5% received chronic haemodialysis. Mean baseline potassium was 6.5 mmol/L. NCB at 6 hours was similar between patiromer and placebo (–0.6 vs –0.4; p=0.44). Potassium levels at 2, 4 and 6 hours were similar between the groups (5.50 vs 5.70, 5.45 vs 5.65, 5.50 vs 5.60; patiromer and placebo (all p>0.05)). The number of interventions per patient was similar (p>0.05) between groups at each time point. The proportion of patients experiencing AEs was not significant between the patiromer and placebo groups (16.98% vs 32.76%; p=0.08).

    Conclusions

    No differences in efficacy were reported in this study, which was underpowered to detect statistical efficacy of patiromer over placebo.

    Trial registration number

    NCT04443608.

    STRATUM-OS: first step in the development and validation of the STRATUM tool based on multimodal data processing to assist surgery in patients affected by intra-axial brain tumours - observational study protocol

    Por: Fabelo · H. · Ramallo-Farina · Y. · Morera · J. · Pineiro · J. F. · Lagares · A. · Jimenez-Roldan · L. · Burström · G. · Garcia-Bello · M. A. · Garcia-Perez · L. · Falero · R. · Gonzalez · M. · Duque · S. · Rodriguez-Jimenez · C. · Hernandez · M. · Delgado-Sanchez · J. J. · Paredes
    Introduction

    Integrated digital diagnostics can support complex surgeries in many anatomic sites, and brain tumour surgery represents one of the most complex cases. Neurosurgeons face several challenges during brain tumour surgeries, such as differentiating critical tissue from brain tumour margins. To overcome these challenges, the STRATUM project will develop a 3D decision support tool for brain surgery guidance and diagnostics based on multimodal data processing, including hyperspectral imaging, integrated as a point-of-care computing tool in neurosurgical workflows. This paper reports the protocol for the development and technical validation of the STRATUM tool.

    Methods and analysis

    This international multicentre, prospective, open, observational cohort study, STRATUM-OS (study: 28 months, pre-recruitment: 2 months, recruitment: 20 months, follow-up: 6 months), with no control group, will collect data from 320 patients undergoing standard neurosurgical procedures to: (1) develop and technically validate the STRATUM tool and (2) collect the outcome measures for comparing the standard procedure versus the standard procedure plus the use of the STRATUM tool during surgery in a subsequent historically controlled non-randomised clinical trial.

    Ethics and dissemination

    The protocol was approved by the participant ethics committees. Results will be disseminated in scientific conferences and peer-reviewed journals.

    Trial registration number

    NCT07036783.

    Laparoscopic bariatric surgery versus any non-surgical intervention for adolescents or adults with obesity: protocol for a systematic review with meta-analysis and trial sequential analysis of randomised clinical trials

    Por: Duun · O. · Dichman · M.-L. · Lindschou · J. · Scragg · J. · Petersen · J. J. · Nyvold Bojsen-Moller · K. · Jebb · S. A. · Gluud · C. · Dirksen · C.
    Introduction

    The number of people living with obesity is increasing rapidly worldwide, and the WHO estimates approximately 5 million deaths yearly from non-communicable diseases related to elevated body mass index (BMI). The most effective treatment for weight loss is bariatric surgery, but due to the associated risks and the need for lifelong care, this is not a viable treatment for every patient. With the advent of gut-hormone-based medications to treat obesity, the effectiveness of non-surgical treatment is approaching that of surgical interventions. We therefore aim to investigate the beneficial and harmful effects of laparoscopic bariatric surgery versus any non-surgical treatment.

    Methods and analysis

    We will conduct a systematic review with meta-analysis applying our eight-step procedure to assess thresholds for clinical significance and trial sequential analysis to mitigate the risk of random errors. To identify relevant trials, we will search for both published and unpublished trials, without any language restriction, in major medical databases (CENTRAL, MEDLINE, EMBASE, LILACS, SCI-EXPANDED and CPCI-S) and trial registries. The date range covered by the search is from database inception until final search date—within 3 months prior to submission of final results manuscript. Two review authors will independently screen references, extract data and perform risk-of-bias assessment using the Cochrane Risk of Bias Tool 2 and the Grading of Recommendations, Assessment, Development and Evaluations. We will include randomised clinical trials comparing laparoscopic surgery currently in use with any non-surgical comparator in adults or adolescents with BMI >30 kg/m2. Quasi-randomised studies or non-randomised studies will not be included. Our critical outcomes are all-cause mortality, serious adverse events and quality of life, and our important outcomes are major cardiovascular events, weight at follow-up, physical function and glycaemic control. In addition, we have two explorative outcomes: metabolic syndrome or Z-score and reported incident of alcohol abuse or other addictive disorder or self-inflicted harm.

    Ethics and dissemination

    This review will collect and perform secondary analysis of data from publicly available sources and ethical approval is therefore not required. The findings will be published in peer-reviewed journals and presented at relevant scientific conferences. We will strive to publish with open access. Awareness will be made through social media platforms. This review aims to help clinicians in identifying best practices in the wide-spanning field of obesity treatment.

    PROSPERO registration number

    CRD420251135341.

    Development of a resilience assessment tool for cardiac care pathways in Europe: a mixed-methods study

    Por: V Carvalho · A. S. · Brito Fernandes · O. · Piek · J. J. · Mauri · J. · Sanz Escartin · A. · Wijns · W. · Klazinga · N. · Kringos · D.
    Objectives

    To develop a resilience assessment tool for cardiac care pathways in Europe, informed by stakeholder insights on the impact of COVID-19, emerging innovations and recommendations to enhance resilience.

    Design

    Mixed-methods study comprising three phases: (1) survey among European cardiac care providers; (2) five multistakeholder focus groups and (3) participatory tool development. Quantitative data were analysed using descriptive statistics, and qualitative data were analysed thematically.

    Setting

    The survey targeted cardiology professionals from the 27 European Union Member States and Ukraine who worked during the COVID-19 pandemic. Focus group participants were purposefully sampled to represent clinical, organisational and policy perspectives.

    Participants

    A total of 177 survey respondents and 40 informants in focus groups.

    Results

    Six key resilience dimensions of cardiac care pathways were identified: workforce, organisation of care delivery, governance and trust, communication and cooperation, medical devices and products, and data collection and use. Staff shortages and infrastructure capacity were key challenges during the pandemic. The most frequent measures were the reallocation of health staff (75%; n=133) and repurposing infrastructures (38%; n=32). Participants discussed the six resilience dimensions around a total of 17 subdimensions and 39 recommended actions to enhance resilience were identified. The resulting resilience assessment tool included four components: (1) mapping a context-specific cardiac care pathway; (2) stakeholder identification critical to participate in collective self-assessment; (3) a preparedness checklist generating a visual heat map and (4) a resource toolkit.

    Conclusions

    The resilience assessment tool offers step-by-step guidance to strengthening cardiac care pathways across six key resilience dimensions, supported by actionable recommendations. The tool enables the identification of context-specific vulnerabilities and improvement priorities, thereby supporting healthcare professionals and policymakers in enhancing preparedness and ensuring care continuity before, during and after crises. Its implementation is currently being piloted in European hospitals to evaluate and refine its practical applicability.

    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.

    Decisional needs among patients and physicians in the treatment of chronic myeloid leukaemia: a qualitative analysis in the Netherlands

    Por: Mingels · S. · Cloots · M. J. J. · Smit · Y. · Blijlevens · N. M. A. · Posthuma · E. F. M. · Dekker · A. L. A. J. · Fijten · R. R. R. · Wener · E. · Kromkamp · C. C. G.
    Objective

    Treatment advancements in chronic myeloid leukaemia (CML) have made the disease manageable but carry significant risk of side effects. Bridging information gaps between patients and physicians through shared decision-making (SDM) is increasingly favoured, yet understanding treatment complexities remains a challenge. This study sought to identify decisional and informational needs of both patients and physicians in CML care.

    Design

    A qualitative study using semi-structured interviews was conducted to investigate the opinions, attitudes and preferences of both patients with chronic myeloid leukaemia and physicians.

    Setting

    Patients and physicians were recruited through the Dutch CMyLife platform, an initiative of haematologists, patients and patient organisations. They were provided with the participant information and invited to participate if interested.

    Participants

    A total of 15 interviews (n=10 patients, n=5 physicians) were conducted between April and October 2023.

    Primary and secondary outcome measures

    A pre-defined interview guide was developed based on the Decisional Needs Assessment questionnaire. Interview transcripts were thematically analysed.

    Results

    Eight themes and 28 sub-themes were observed, highlighting patient needs, treatment choices and informational preferences. Patients emphasised the importance of understanding medication options and side effects, while physicians stressed the necessity of delivering up-to-date and comprehensible information. Almost all participants had experienced professionals making the treatment decision, without patient involvement, especially when initiating treatment. Some patients expressed too little information and missed partnership with professionals at treatment onset. Peer support, decision-making dynamics and the role of caregivers were also significant considerations.

    Conclusions

    Both shared and distinct perspectives on CML treatment decision-making between patients and physicians were revealed, underscoring the complexity of decisional needs in CML management. The findings emphasise the importance of patient-centred care, SDM and tailored communication strategies to optimise patient outcomes and satisfaction. Improved communication and evidence-based decision-making tools can significantly impact patient well-being. Further research and interventions are necessary to address the challenges in decision-making processes in CML care.

    Chinese caregivers preferences and predicted uptake of HPV vaccination: a study protocol for two discrete choice experiments

    Por: Fang · H. · Mu · J. · Chow · E. P. · Ong · J. J. · Wu · D. · Zhang · Y.
    Introduction

    Human papillomavirus (HPV) vaccines have been introduced in the Chinese market since 2016. However, the HPV vaccine coverage is still remarkably low among adolescent girls in China. This study will employ discrete choice experiments (DCEs) to elicit the preferences of Chinese caregivers for HPV vaccine-related profile characteristics and service delivery methods for adolescent girls.

    Methods

    Two DCEs will be conducted with caregivers of girls aged 9–18 in China. The first DCE will focus on caregivers’ preferences regarding the HPV vaccine-related profile for girls aged 9–18, with potential attributes including level of protection against cervical cancer, level of protection against genital warts, risk of severe side effects, number of dose(s), place of manufacture, waiting time and cost for one dose. The second DCE will assess Chinese caregivers’ preferences for vaccination service delivery methods, with the potential attributes including source of recommendation, information channel, message framing, how to make an appointment, location for receiving the vaccine and incentives. A total of 300 participants will be recruited to complete the DCEs. We will summarise the key socio-demographic characteristics of participants and use latent class and mixed logit models to assess preferences and preference heterogeneity in HPV vaccination services.

    Ethical and dissemination

    Ethical approval was obtained from the Research and Ethics Committee at Nanjing Medical University. Findings from this study will be disseminated widely to relevant stakeholders via scheduled meetings, webinars, presentations at conferences and in peer-reviewed journal manuscripts.

    PeRsonalIsed MEdicine in Rheumatoid Arthritis (PRIMERA) trial: a multicentre, open-label, randomised controlled trial comparing routine care with a tailor-made approach

    Por: Dag · H. H. · Looijen · A. E. M. · Vonkeman · H. E. · Willemze · A. · Korswagen · L.-A. · Padmos · R. C. · van Gaalen · F. A. · Tchetverikov · I. · van der Kaap · J. H. · Veris-van Dieren · J. J. · Riyazi · N. · Spierings · J. · van der Helm-van Mil · A. H. M. · de Jong · P. H. P.
    Introduction

    Rheumatoid arthritis (RA) is a heterogeneous disease, which current treatment guidelines insufficiently accommodate, as they predominantly emphasise the suppression of disease activity. However, a step towards personalised medicine is preferred to further optimise treatment and requires homogeneous subgroups with similarities in pathophysiological mechanisms and treatment responses. Prior research has already demonstrated notable differences in the pathophysiology of patients with autoantibody-positive and autoantibody-negative RA, as well as differences in treatment responses, which may serve as a strong basis for personalised medicine. Additionally, there is evidence suggesting that an early treatment response is indicative of future courses. Based on these findings, we designed a personalised medicine trial in RA that compares the effectiveness and cost-effectiveness of a tailor-made approach with routine care.

    Methods and analysis

    The PeRsonalIsed Medicine in RA (PRIMERA) trial is a multicentre, open-label, randomised controlled trial that includes 300 adult patients with newly diagnosed, DMARD-naïve RA, according to 2010 American College of Rheumatology/EULAR criteria. Patients are randomised into either routine care or a tailor-made approach. Both management approaches use a treat-to-target strategy, aiming for low disease activity (LDA, Disease Activity Score using 44 joints (DAS) ≤2.4). In routine care, initial treatment consists of methotrexate along with a single intramuscular dose of glucocorticoids (GCs) and treatment can be intensified after 3, 7 and 10 months if LDA is not reached. Conversely, initial treatment in the tailor-made approach depends on the presence of autoantibodies, with patients with autoantibody-positive and autoantibody-negative RA starting with hydroxychloroquine or methotrexate together with a single intramuscular dose of GCs, respectively. Medication intensifications will be allowed at months 1, 3, 4, 7 and 10. Intensifications at months 1 and 4 depend on whether patients have an early sufficient response to GCs and targeted synthetic disease-modifying antirheumatic drugs (tsDMARDs), respectively. The tailor-made approach is superior to routine care if no more biological DMARDs (bDMARDs) or tsDMARDs are used after 10 months of treatment, while the mean DAS over time is lower. Our primary outcome is the proportional difference in bDMARD or tsDMARD usage after 10 months of treatment between routine care and the tailor-made approach. Secondary outcomes are DAS over time, time to achieve LDA, cost-effectiveness and patient-reported outcome measurements over time.

    Ethics and dissemination

    Ethical approval has been granted by Erasmus MC Medical Ethics Review Committee (MEC-2020-0825). The results will be disseminated through peer-review journals and medical congresses.

    Trial registration number

    ISRCTN16170070.

    Cervical high-risk human papillomavirus infection and its associated risk factors: a community-based cross-sectional study in hard-to-reach areas in Bangladesh

    Por: Nazrul · N. · Rahman · A. · de Fouw · M. · Campbell · C. · Koot · J. · Kulsum · M. U. · Ahmed · M. S. · Haider · S. S. · Hossain · M. A. · Islam · K. M. · Nessa · A. · Amrin · M. · Stekelenburg · J. · Beltman · J. J.
    Objectives

    This study aimed to determine the prevalence of cervical high-risk human papillomavirus (hrHPV) in a community-based setting and its risk factors association in women living in hard-to-reach areas in Bangladesh.

    Design

    A cross-sectional study

    Setting

    The study was carried out in six subdistricts, located in hard-to-reach and climate-impacted regions of Bangladesh.

    Participants

    A total of 8000 married women aged 30–60 years were invited for screening. Women who were unable to give consent, were pregnant or had a hysterectomy with removal of the cervix, previous screening less than 5 years, or treatment of the cervix or had symptoms of potential cervical cancer were excluded.

    Interventions

    A community-based hrHPV self-collected screening for cervical cancer was conducted from June 2022 to July 2023.

    Main outcome measures

    Prevalence of cervical hrHPV and risk factor association.

    Results

    11 127 women were eligible for screening; 7850 women submitted hrHPV self-swabs, 7828 valid HPV test results were reported and 164 women (2.1%) tested hrHPV positive. Women living in the North were 2.1 times more likely to be hrHPV positive compared with women living in the South (adjusted OR (AOR)=2.1, 95% CI: 1.5 to 3.8, p=0.023) and widowed women were 3.0 times more likely to be hrHPV positive than married women (AOR=3.0, 95% CI: 1.7 to 5.3, p=0.001). Another risk factor associated with testing hrHPV positive was the use of hormonal contraceptives for 5 years and above (AOR=7.0, 95% CI: 2.0 to 24.4, p=0.002).

    Conclusion

    The study identified a low overall prevalence of hrHPV infection (2.1%) among women in hard-to-reach areas in Bangladesh, with some regional variations. Higher prevalence was observed in widowed compared with married women and among women reporting more than 5 years of hormonal contraceptive use. This study shows no evidence of particularly high-risk groups in hard-to-reach areas in Bangladesh. The findings support the feasibility of implementing a nationwide hr-HPV-based self-sampling strategy as a viable approach to reach WHO targets for reducing the burden of cervical cancer. Recommendation for policymakers to support future research to identify hrHPV prevalence among women in comparable groups in other geographically remote areas in Bangladesh.

    Trial registration number

    NCT05234112.

    Associations between oral health behaviours, oral health, salivary biomarkers and clinical phenotype in individuals with alcohol use disorder: protocol for a longitudinal observational study

    Por: Maki · K. A. · Xu · S. · Wallen · G. R. · Gerrard · C. · Sung · C. · Papneja · S. · Tuason · R. T. S. · Ramchandani · V. A. · Diazgranados · N. · Barb · J. J.
    Introduction

    Binge drinking in the previous month was reported in 23.5% of US adults, and 28.1 million adults met criteria for Alcohol Use Disorder (AUD) in 2023. Individuals with AUD face increased risks of oral health problems, including caries, periodontal disease and mucosal lesions. Poor oral hygiene, nutrition and dental care all contribute to these conditions, but individuals with AUD are often under-represented in oral health surveys. Understanding relationships between oral health behaviours, attitudes and general health is crucial for designing future interventions. This pilot aims to explore the relationship between oral and systemic health in subjects with AUD, focusing on oral health behaviours, salivary biomarkers and clinical phenotype, including systemic biomarkers of inflammation, to inform future research on oral–systemic interactions in AUD.

    Methods and analysis

    This protocol has two parts. Part 1 involves cognitive interviews to assess the content validity and interpretability of the Oral Health Behaviours Assessment (OHBA) questionnaire. Part 2 will collect biological and behavioural data from treatment-seeking patients with AUD and matched controls (age, sex and smoking status), including saliva, blood, dental exams, and health behaviour and symptom measures. Inpatients with AUD will provide biospecimens and answer symptom severity questionnaires at admission and again at the dental exam visit (7–12 days later), while controls will provide a single set of measures at their dental exam visit. Oral health will be assessed through structured dental and periodontal examinations, radiographs and validated questionnaires (including the OHBA). Additional data will include alcohol use history, psychiatric and medical history assessments, dietary recall, and measures of stress, sleep and mood to capture potential moderators of oral–systemic relationships. Biomarkers of inflammation and stress will be quantified from saliva and blood using immunoassays. Primary outcomes will compare oral health, salivary biomarkers and clinical measures between AUD and controls, while secondary outcomes will evaluate within-subject changes in patients with AUD during inpatient treatment and early abstinence.

    Ethics and dissemination

    This clinical protocol was approved by the National Institutes of Health Institutional Review Board (IRB #002005). Prior to enrolling, participants will be informed of the study purpose, risks and benefits, and study procedures, and evaluated for understanding prior to signing consent. Part 1 of the protocol is currently active and recruiting participants for cognitive interviews. The study findings will be disseminated through journals and conferences related to addiction medicine, psychology, immunology, neuroscience and dentistry. We expect the results of the pilot study will inform future research on oral health and salivary bioscience while also providing treatment-seeking patients with AUD targeted information on the importance of oral health behaviours for maintaining oral and systemic health.

    Trial registration number

    NCT06684483; preresults.

    Navigating cardiac rehabilitation in the virtual era: patient perspectives and program adaptations in the course of COVID-19

    Por: Su · J. J. · Batalik · L.

    Commentary on: Vanzella LM, Cotie LM, Flores-Hukom M, Marzolini S, Konidis R, Ghisi GLM. Patients' Perceptions of Hybrid and Virtual-Only Care Models During the Cardiac Rehabilitation Patient Journey: A Qualitative Study. J Cardiovasc Nurs. Published online January 5, 2024.

    Implications for practice and research

  • The use of theoretical models integrating well-recognised techniques (eg, goal setting, action planning, telemonitoring, individual assessment/tailoring) to guide virtual cardiac rehabilitation (CR) is essential.

  • Apart from teleconferencing, using advanced wearable devices, analytics and artificial intelligence techniques may improve personalised exercise and educational content capacity of future virtual CR studies.

  • Context

    Cardiac rehabilitation (CR) is a recommended treatment for patients with cardiovascular disease (CVDs), given the rising number of cardiac incidents due to ageing population and modern lifestyles.1 To improve accessibility and follow-up support for optimal health, e-platforms are increasingly being used. Virtual CR uses technology-based methods such...

    Microsimulation modelling to predict the burden of CKD and the cost-effectiveness of timely CKD screening in Belgium: results from the Inside CKD study

    Por: Vadia · R. · Vandendriessche · E. · Mahieu · E. · Meeus · G. · Van Pottelbergh · G. · Jouret · F. · Retat · L. · Card-Gowers · J. · Jadoul · M. · Vankeirsbilck · A. · Garcia Sanchez · J. J.
    Objectives

    Inside CKD aims to assess the burden of chronic kidney disease (CKD) and the cost-effectiveness of screening programmes in Belgium.

    Design

    Microsimulation-based modelling.

    Setting

    Data derived from national statistics and key literature from Belgium.

    Participants

    Virtual populations of ≥10 million individuals, representative of Belgian populations of interest, were generated based on published data and cycled through the Inside CKD model. Baseline input data included age, estimated glomerular filtration rate (eGFR), urine albumin-creatinine ratio (UACR) and CKD status.

    Primary outcome measures

    Outcomes included the clinical and economic burden of CKD during 2022–2027 and the cost-effectiveness of two different CKD screening programmes (one UACR measurement and two eGFR measurements or only two eGFR measurements, followed by renin-angiotensin-aldosterone system inhibitor treatment in newly diagnosed eligible patients). The economic burden estimation included patients diagnosed with CKD stages 3–5; the screening cost-effectiveness estimation included patients aged ≥45 years with no CKD diagnosis and high-risk subgroups (with cardiovascular disease, hypertension, type 2 diabetes or aged ≥65 years).

    Results

    Between 2022 and 2027, CKD prevalence is estimated to remain stable and substantial at approximately 1.66 million, with 69.9% undiagnosed. The total healthcare cost of patients diagnosed with CKD is expected to remain stable at approximately 2.15 billion per year. The one UACR, two eGFR measurement screening programme was cost-effective in all populations, with an incremental cost-effectiveness ratio of 3623 per quality-adjusted life year (QALY) gained in those aged ≥45 years, well below the estimated willingness-to-pay threshold of 43 839 per QALY gained.

    Conclusions

    Without changes to current practice, the disease burden of CKD in Belgium is predicted to remain substantial over the next few years. This highlights the need for timely diagnosis of CKD and demonstrates that, in line with guideline recommendations, implementing a CKD screening programme involving UACR and eGFR measurements followed by treatment would be cost-effective.

    Organising maternal and newborn care in high-income countries: a scoping review of organisational elements and their association with outcomes

    Por: Liebregts · J. · Goodarzi · B. · Valentijn · P. · Downe · S. · Erwich · J. J. · Burchell · G. · Batenburg · R. · de Jonge · A. · Verhoeven · C. J. M. · VOICE Study Group · Burzynska · de Graaf · van Heemstra · Rippen · Koster · van der Voort · Kaiser · Fransen · Berks · Haga · Vermo
    Introduction

    Countries face challenges in maternal and newborn care (MNC) regarding costs, workforce and sustainability. Organising integrated care is increasingly seen as a way to address these challenges. The evidence on the optimal organisation of integrated MNC in order to improve outcomes is limited.

    Objectives

    (1) To study associations between organisational elements of integrated care and maternal and neonatal health outcomes, experiences of women and professionals, healthcare costs and care processes and (2) to examine how the different dimensions of integrated care, as defined by the Rainbow Model of Integrated Care, are reflected in the literature addressing these organisational elements.

    Results

    We included 288 papers and identified 23 organisational elements, grouped into 6 categories: personal continuity of care; interventions to improve interdisciplinary collaboration and coordination; care by a midwife; alternative payment models (non-fee-for-service); place of birth outside the obstetric unit and woman-centred care. Personal continuity, care by a midwife and births outside obstetric units were most consistently associated with improved maternal and newborn outcomes, positive experiences for women and professionals and potential cost savings, particularly where well-coordinated multidisciplinary care was established. Positive professional experiences of collaboration depended on clear roles, mutual trust and respectful interdisciplinary behaviour. Evidence on collaboration interventions and alternative payment models was inconclusive. Most studies emphasised clinical and professional aspects rather than organisational integration, with implementation barriers linked to prevailing biomedical system orientations.

    Conclusions

    Although the literature provides substantial evidence of organisational elements that contribute to improved outcomes, a significant gap remains in understanding how to overcome the barriers in sustainable implementation of these elements within healthcare systems. Interpreted through a systems and transition science lens, these findings suggest that strengthening integrated maternity care requires system-level changes aligning with WHO policy directions towards midwifery models of person-centred care.

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