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Safety and feasibility of a real-time electronic heart team decision-making approach in patients with complex coronary artery disease: a protocol for a randomised controlled trial (EHEART trial)

Por: Su · X. · Ma · H. · Lin · S. · Dou · K. · Zheng · Z.
Introduction

The implementation of a heart team still faces many challenges which may be facilitated with advanced communication technology. There is a knowledge gap to support the use of an electronic real-time heart team decision-making approach based on communication technology in the real clinical practice and evaluate its safety and feasibility in patients with complex coronary artery disease (CAD).

Methods and analysis

The EHEART (Electronic HEArt team with Real-Time decision-making) trial is a prospective, multicentre, two-arm, randomised controlled trial that will randomise 490 patients with complex CAD to either an electronic real-time heart team group or conventional heart team group. For patients allocated to the real-time electronic group, heart team meetings will be initiated during the coronary angiography and guided by a supporting system based on communication technology to help with information synchronisation, real-time communication between specialists, meeting process recording and assistance and joint decision-making with patients’ families. The primary and safety endpoint is a composite of all-cause death, myocardial infarction, stroke, revascularisation or re-angina hospital admission at 1 year. The primary secondary outcome is the time interval from the coronary angiography to the final treatment, which is the major indicator of feasibility. We will also compare the practical feasibility from the specialist’s and patient’s perspectives (for example, specialist’s workload and patient’s decision results) between the two groups.

Ethics and dissemination

The study was approved by the Institutional Review Board (IRB) of Fuwai Hospital (no. 2022-1749). Informed consent will be obtained from all participants. The results of this trial will be disseminated through manuscript publication and national/international conferences, and reported in the trial registry entry.

Trial registration number

ClinicalTrials.gov Registry (NCT05514210).

Exploring the challenges of public health nurses in the management of infertility in Northern Ghana: a qualitative descriptive study

Por: Kuug · A. K. · Sindiwe · J. · Jardien-Baboo · S.
Objective

To explore the challenges public health nurses (PNHs) face in managing infertility in rural settings of the Talensi and Nabdam districts in the Upper East Region of Ghana.

Design

The study adopted a qualitative descriptive design approach where PHNs who worked in rural settings were interviewed using a semistructured interview guide. Thematic analysis was employed to analyse the data.

Setting

Primary healthcare setting in the Upper East Region of Ghana.

Participants

The study participants were 15 PHNs working in primary health centres with a mean age of 36.9 years (SD=6.40).

Results

This study revealed that couples with infertility issues face challenges in seeking care for their condition. The challenges expressed by the participants that affect individual and couples’ access to infertility care were (1) lack of material and human resources, (2) lack of specialists and guides for infertility treatment and (3) inadequate and inconsiderate communication.

Conclusion

This study provides evidence of the challenges experienced by PHNs in managing infertility among couples. Adequate measures are therefore required to ameliorate these challenges to improve care provision for couples with infertility.

Social determinants of alcohol-related traumatic injury in young adults: a scoping review protocol

Por: Goodon · H. · Czyrnyj · C. · Comaskey · B. · Gawaziuk · J. · Logsetty · S. · Spiwak · R.
Introduction

Limited research examines alcohol-related injury in the context of social determinants of health (SDoH) to guide effective intervention and prevention programmes. SDoH are non-medical factors that impact health such as income, housing and childhood environment. This scoping review aims to explore the role SDoH in childhood have in alcohol-related injury in young adults.

Methods and analysis

The scoping review process will be guided by the methodology framework of Arksey and O’Malley and the Preferred Reporting Items for Systematic Reviews and Meta-analysis Protocols Extension for Scoping Reviews Guidelines (PRISMA-ScR). The PubMed and SCOPUS databases will be systematically searched. Studies of various designs and methodologies (published in English since 1 January 2000) that examine certain SDoH of interest in relation to alcohol-related injury in adults aged 18–25 years old will be considered for inclusion in this review. Two reviewers will screen all articles identified from the databases independently. Titles and abstracts will be reviewed based on the initial search and included if eligibility criteria are met. Duplicate articles will be removed and full texts will be examined to create a final list of included studies. Any disagreements on the inclusion of any articles will be resolved through discussion and consultation with a third reviewer if necessary.

Ethics and dissemination

As this research does not involve human subjects, ethics approval is not required. The results of this study will be summarised quantitatively through numerical counts and qualitatively through a narrative synthesis. The results from this review will address an important literature gap and inform the development of targeted prevention programmes for alcohol-related injury.

Registration number

This protocol is registered with Open Science Framework (https://doi.org/10.17605/OSF.IO/MYEXA).

Communication between consultants providing advice and referring physicians: a scoping review

Por: Muftah · A. · Stempien · J. · Goodridge · D. · Watson · E. · Oyedokun · T.
Objective

Communication during consultations between referring and consultant physicians is often cited as a source of adverse events, medical error and professional incivility. While existing literature focuses on the role of referring physicians, few studies acknowledge the role of consultant physicians in enhancing communication during consultations. This scoping review aims to identify and synthesise available recommendations to enhance the communication practices of consultants during real-time consultations.

Design

A scoping review was conducted and reported in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews.

Data sources

Medline, EMBASE and PsycINFO databases were searched from inception to August 2022.

Eligibility criteria for selecting studies

English-language publications which describe recommendations, strategies or frameworks to improve the communication practices of consultant physicians during real-time consultations with referring physicians.

Data extraction and synthesis

The search strategy included the following concepts: consultation, physician, communication, interprofessional relations and best practice. Two authors independently performed each phase of title and abstract screening, full-text review and data extraction. Discrepancies were resolved by a third author. Extracted data were iteratively analysed and summarised thematically.

Results

Sixteen publications met the inclusion criteria. Synthesis of available recommendations identified organisation, expertise and interpersonal skills as three overarching and interconnected dimensions of communication demonstrated by consultants during effective consultations. Twelve studies identified interpersonal skills as being critical in alleviating the widespread professional incivility that is reported during consultations. Existing recommendations to improve the communication practices of consultants are limited as they lack standardised interventions and fail to comprehensively address all three elements identified in this review.

Conclusion

This scoping review synthesises available recommendations to improve the communication practices of consultant physicians during real-time consultations. An opportunity exists to develop communication tools or educational interventions based on the findings of this review to enhance interphysician consultation encounters.

Comparative survey among paediatricians, nurses and health information technicians on ethics implementation knowledge of and attitude towards social experiments based on medical artificial intelligence at childrens hospitals in Shanghai: a cross-sectional

Por: Wang · Y. · Fu · W. · Gu · Y. · Fang · W. · Zhang · Y. · Jin · C. · Yin · J. · Wang · W. · Xu · H. · Ge · X. · Ye · C. · Tang · L. · Fang · J. · Wang · D. · Su · L. · Wang · J. · Zhang · X. · Feng · R.
Objectives

Implementing ethics is crucial to prevent harm and promote widespread benefits in social experiments based on medical artificial intelligence (MAI). However, insufficient information is available concerning this within the paediatric healthcare sector. We aimed to conduct a comparative survey among paediatricians, nurses and health information technicians regarding ethics implementation knowledge of and attitude towards MAI social experiments at children’s hospitals in Shanghai.

Design and setting

A cross-sectional electronic questionnaire was administered from 1 July 2022 to 31 July 2022, at tertiary children’s hospitals in Shanghai.

Participants

All the eligible individuals were recruited. The inclusion criteria were as follows: (1) should be a paediatrician, nurse and health information technician, (2) should have been engaged in or currently participating in social experiments based on MAI, and (3) voluntary participation in the survey.

Primary outcome

Ethics implementation knowledge of and attitude to MAI social experiments among paediatricians, nurses and health information technicians.

Results

There were 137 paediatricians, 135 nurses and 60 health information technicians who responded to the questionnaire at tertiary children’s hospitals. 2.4–9.6% of participants were familiar with ethics implementation knowledge of MAI social experiments. 31.9–86.1% of participants held an ‘agree’ ethics implementation attitude. Health information technicians accounted for the highest proportion of the participants who were familiar with the knowledge of implementing ethics, and paediatricians or nurses accounted for the highest proportion among those who held ‘agree’ attitudes.

Conclusions

There is a significant knowledge gap and variations in attitudes among paediatricians, nurses and health information technicians, which underscore the urgent need for individualised education and training programmes to enhance MAI ethics implementation in paediatric healthcare.

Using SUpported Motivational InTerviewing (SUMIT) to increase physical activity for people with knee osteoarthritis: a pilot, feasibility randomised controlled trial

Por: Bell · E. C. · O'Halloran · P. · Wallis · J. A. · Crossley · K. M. · Gibbs · A. J. · Lee · A. · Jennings · S. · Barton · C. J.
Objective

The objective of this study was to determine the feasibility and effectiveness of using SUpported Motivational InTerviewing (SUMIT) to increase physical activity in people with knee osteoarthritis (KOA).

Design

Randomised controlled trial.

Setting

We recruited people who had completed Good Life with osteoArthritis Denmark (GLA:D) from private, public and community settings in Victoria, Australia.

Interventions

Participants were randomised participants to receive SUMIT or usual care. SUMIT comprised five motivational interviewing sessions targeting physical activity over 10 weeks, and access to a multimedia web-based platform.

Participants

Thirty-two participants were recruited (17 SUMIT, 15 control) including 22 females (69%).

Outcome measures

Feasibility outcomes included recruitment rate, adherence to motivational interviewing, ActivPAL wear and drop-out rate. Effect sizes (ESs) were calculated for daily steps, stepping time, time with cadence >100 steps per minute, time in bouts >1 min; 6 min walk distance, Knee Osteoarthritis Outcome Score (KOOS) subscales (pain, symptoms, function, sport and recreation, and quality of life (QoL)), Euroqual, systolic blood pressure, body mass index, waist circumference, 30 s chair stand test and walking speed during 40 m walk test.

Results

All feasibility criteria were achieved, with 32/63 eligible participants recruited over seven months; with all participants adhering to all motivational interviewing calls and achieving sufficient ActivPAL wear time, and only two drop-outs (6%).

12/15 outcome measures showed at least a small effect (ES>0.2) favouring the SUMIT group, including daily time with cadence >100 steps per minute (ES=0.43). Two outcomes, walking speed (ES= 0.97) and KOOS QoL (ES=0.81), showed a large effect (ES>0.8).

Conclusion

SUMIT is feasible in people with knee osteoarthritis. Potential benefits included more time spent walking at moderate intensity, faster walking speeds and better QoL.

Trial registration number

ACTRN12621000267853.

Telenursing practice in the care of surgical cancer patients: a scoping review protocol

Por: Mozer · C. A. d. N. · Goncalves · J. d. C. · dos Santos · L. S. · Furieri · L. B. · Fioresi · M.
Introduction

Telenursing is a component of telehealth that occurs when nurses use information and communication technologies to provide care and nursing services remotely. To understand how telenursing services in surgical oncology patients can be better implemented, it is important that the success models are collected and studied. Therefore, the general objective is to develop the scoping review protocol for the survey of existing evidence on the practice of oncological perioperative telenursing.

Methods and analysis

The scoping review will be conducted following the scoping review directions of the Joanna Briggs Institute with the use of the Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for scoping reviews checklist for the review report. The databases that will be used for these searches will be: MEDLINE (PubMed), EMBASE, CINAHL, SCOPUS, Web of Science and Virtual Health Library. To search for grey literature, Google Scholar, WorldWideScience and Global ETD Search will be used. Primary studies, observational or experimental, published in any year or language will be considered. For the selection and extraction of data, two independent reviewers will read the title, summary and full text using the Rayyan software and a form prepared by the authors. The data to be extracted are related to the characterisation of the study (study design, country and year of publication) and details of the telenursing programme (surgery or surgical specialty, perioperative period, tools used, organisation and operation, outcome indicators and treatment methods and content in telenursing). Among others, the difficulties and potentialities for the development or implementation of telenursing will also be extracted, as the main result of the study.

Ethics and dissemination

The study does not require ethical approval as it will use previously published research data. The results will be shared in journals and scientific events and may be used for the development and implementation of oncological perioperative telenursing programmes.

Exploring the outcomes of research engagement using the observation method in an online setting

Por: Marshall · D. A. · Suryaprakash · N. · Lavallee · D. C. · Barker · K. L. · Mackean · G. · Zelinsky · S. · McCarron · T. L. · Santana · M. J. · Moayyedi · P. · Bryan · S.
Objective

The objective of this study was to explore the outcomes of research engagement (patient engagement, PE) in the context of qualitative research.

Design

We observed engagement in two groups comprised of patients, clinicians and researchers tasked with conducting a qualitative preference exploration project in inflammatory bowel disease. One group was led by a patient research partner (PLG, partner led group) and the other by an academic researcher (RLG, researcher led group). A semistructured guide and a set of critical outcomes of research engagement were used as a framework to ground our analysis.

Setting

The study was conducted online.

Participants

Patient research partners (n=5), researchers (n=5) and clinicians (n=4) participated in this study.

Main outcome measures

Transcripts of meetings, descriptive and reflective observation data of engagement during meetings and email correspondence between group members were analysed to identify the outcomes of PE.

Results

Both projects were patient-centred, collaborative, meaningful, rigorous, adaptable, ethical, legitimate, understandable, feasible, timely and sustainable. Patient research partners (PRPs) in both groups wore dual hats as patients and researchers and influenced project decisions wearing both hats. They took on advisory and operational roles. Collaboration seemed easier in the PLG than in the RLG. The RLG PRPs spent more time than their counterparts in the PLG sharing their experience with biologics and helping their group identify a meaningful project question. A formal literature review informed the design, project materials and analysis in the RLG, while the formal review informed the project materials and analysis in the PLG. A PRP in the RLG and the PLG lead leveraged personal connections to facilitate recruitment. The outcomes of both projects were meaningful to all members of the groups.

Conclusions

Our findings show that engagement of PRPs in research has a positive influence on the project design and delivery in the context of qualitative research in both the patient-led and researcher-led group.

Synergistic effect of Tai Chi and transcranial direct current stimulation on memory function in patients with mild cognitive impairment: study protocol for a 2x2 factorial randomised controlled trial

Por: Wu · M. · Liu · H. · Huang · J. · Liu · W. · Liu · Z. · Xu · Y.
Introduction

Interventions at the mild cognitive impairment (MCI) stage prevent or delay the progression of cognitive decline. In recent years, several studies have shown that physical exercise combined with transcranial direct current stimulation (tDCS) effectively delays the disease and promotes cognitive recovery in patients with MCI. This study aims to determine whether Tai Chi (TC) combined with tDCS can significantly improve memory in patients with MCI compared with TC or tDCS alone.

Methods and analysis

This clinical trial will use a 2x2 factorial design, enrolling 128 community-dwelling MCI patients, randomly categorised into four groups: TC, tDCS, TC combined with tDCS and the health education group. Outcome measures will include the Chinese Wechsler Memory Scale-Revised, Auditory Verbal Learning Test and Rey-Osterrieth Complex Figure Test. All assessments will be conducted at baseline and 3 months after the intervention. All analyses will use intention-to-treat or per-protocol methods.

Ethics and dissemination

Ethics approval was obtained from the Ethics Committee of the Affiliated Rehabilitation Hospital of the Fujian University of Traditional Chinese Medicine (2022KY-002–01). The results of the study will be disseminated through peer-reviewed publications and at scientific conferences.

Trial registration number

ChiCTR2200059316.

Organisation and delivery of supportive services for patients with prostate cancer in the National Health Service in England and Wales: a national cross-sectional hospital survey and latent class analysis

Por: Dodkins · J. · Cook · A. · Morris · M. · Nossiter · J. · Prust · S. · Waller · S. · van der Meulen · J. · Aggarwal · A. · Clarke · N. · Payne · H. A.
Objectives

We assessed how often National Health Service (NHS) hospitals reported that they had specific supportive services for patients with prostate cancer available onsite, including nursing support, sexual function and urinary continence services, psychological and genetic counselling, and oncogeriatric services. We identified groups of hospitals with similar patterns of supportive services.

Design/setting

We conducted an organisational survey in 2021 of all NHS hospitals providing prostate cancer services in England and Wales. Latent class analysis grouped hospitals with similar patterns of supportive services.

Results

In 138 hospitals, an advanced prostate cancer nurse was available in 125 hospitals (90.6%), 107 (77.5%) had a clinical nurse specialist (CNS) attending all clinics, 103 (75.7%) had sexual function services, 111 (81.6%) had continence services and 93 (69.4%) psychological counselling. The availability of genetic counselling (41 hospitals, 30.6%) and oncogeriatric services (15 hospitals, 11.0%) was lower. The hospitals could be divided into three groups. The first and largest group of 85 hospitals provided the most comprehensive supportive services onsite: all hospitals had a CNS attending all clinics, 84 (98.8%) sexual function services and 73 (85.9%) continence services. A key characteristic of the second group of 31 hospitals was that none had a CNS attending all clinics. A key characteristic of the third group of 22 hospitals was that none had sexual function services available. The hospitals in the largest group were more likely to run joint clinics (p

Conclusions

There is considerable variation in supportive services for prostate cancer available onsite in NHS hospitals in England and Wales. Availability of genetic counselling and oncogeriatric services is low. The different patterns of supportive services among hospitals demonstrate that initiatives to improve the availability of the entire range of supportive services to all patients should be carefully targeted.

Are pharmacists on the front lines of the opioid epidemic? A cross-sectional study of the practices and competencies of community and hospital pharmacists in Punjab, Pakistan

Por: Mubarak · N. · Zahid · T. · Rana · F. R. · Ijaz · U.-E.-B. · Shabbir · A. · Manzoor · M. · Khan · N. · Arif · M. · Naeem · M. M. · Kanwal · S. · Saif-ur-Rehman · N. · Zin · C. S. · Mahmood · K. · Asgher · J. · Elnaem · M. H.
Introduction

Countries are grappling with a rapidly worsening upsurge in the opioid-related overdose deaths, misuse and abuse. There is a dearth of data in Pakistan regarding the practices and competencies of pharmacists in handling opioid-related issues.

Study design

A cross-sectional study, conducted across Punjab, Pakistan.

Method

The study deployed a validated survey to evaluate the competencies and practices of the community and hospital pharmacists.

Results

504 community pharmacists and 279 hospital pharmacists participated in the survey with an overall response rate of 85.5%. Almost half of the respondents ‘never’ or ‘sometimes’ made clinical notes in a journal or dispensing software to monitor ongoing opioid use. Generally, pharmacists were reluctant to collaborate with physicians or notify police regarding the abuse/misuse of opioids. Hospital pharmacists achieved significantly higher mean competency scores than chain and independent community pharmacists (p

Conclusion

Both community and hospital pharmacists hold significant positions and potential to contribute meaningfully to the mitigation of harms and risks associated with opioids. Nevertheless, this study underscores notable deficiencies in the competence of pharmacists, whether in hospital or community settings in Punjab, concerning various aspects related to the dispensing and utilisation of opioids. It also highlights the pressing need for the development of strategies aimed at improving several practice areas including the documentation, the quality of patient counselling, the effectiveness of reporting mechanisms for opioid abuse and the stringent enforcement of regulatory policies to curtail opioid misuse. Thus, to mitigate the opioid epidemic in Pakistan, it is imperative to institute opioid stewardship initiatives aimed at rectifying the competency and procedural deficiencies within the pharmacist workforce.

Patients experience of accessing healthcare for obesity in Peninsular Malaysia: a qualitative descriptive study

Por: Yunus · N. A. · Russell · G. · Muhamad · R. · Sturgiss · E. A.
Objective

To explore patients’ experiences accessing healthcare for obesity and their perceived behaviour changes following the care.

Design

Using a descriptive qualitative research approach informed by Levesque’s framework of access to healthcare, we conducted phone interviews in the Malaysian language, which were audio-recorded and transcribed verbatim. Data were analysed inductively using a reflexive thematic analysis approach.

Setting

Primary care clinics in five states in Peninsular Malaysia.

Participants

Adult patients with obesity receiving face-to-face care for obesity from healthcare providers in Peninsular Malaysia.

Results

We interviewed 22 participants aged 24–62, with the majority being female (77%), Malay (95%), married (73%) and with tertiary education (82%). Most participants attended obesity management services at public primary care clinics. We identified five themes: (1) moving from perceiving the need to seeking obesity care is a non-linear process for patients, (2) providers’ words can inspire patients to change, (3) patients’ needs and preferences are not adequately addressed in current obesity care, (4) over-focusing on weight by patients and healthcare providers can lead to self-blame and loss of hope for patients and (5) obesity healthcare can have consequences beyond weight loss.

Conclusion

Patients lack the self-regulatory skills to continue their lifestyle changes and struggle with self-blame and hopelessness. Over-focusing on weight by patients and obesity healthcare increase patients’ self-stigmatisation. While provider-initiated weight discussions and engaging and personalised consultation provide the initial step towards weight management, obesity healthcare could be enhanced by behavioural support and patient education on the complexity of obesity. Further considerations could be given to shifting from a weight-centric to a more holistic health-centred approach in obesity healthcare.

Maternal serum levels of prokineticin-1 related to pregnancy complications and metformin use in women with polycystic ovary syndrome: a post hoc analysis of two prospective, randomised, placebo-controlled trials

Por: Ujvari · D. · Trouva · A. · Hirschberg · A. L. · Vanky · E.
Objective

Serum prokineticin-1 (s-PROK1) in the second and third trimester of pregnancy is positively correlated to preeclampsia, intrauterine growth restriction (IUGR) and preterm delivery. Women with polycystic ovary syndrome (PCOS) are prone to these adverse pregnancy outcomes. However, the contribution of PROK1 to the development of pregnancy complications and the effect of metformin and hyperandrogenism on s-PROK1 in PCOS have not been studied previously.

Design

This work is a post hoc analysis of two prospective, randomised, placebo-controlled trials.

Setting

Pregnant women with PCOS were included from 11 study centres in Norway.

Participants

From 313 women, 264 participated in the present study after exclusions due to dropouts or insufficient serum samples.

Intervention

Women with PCOS were randomly administered with metformin or placebo, from first trimester to delivery.

Primary and secondary outcome measures

s-PROK1 was analysed using ELISA at gestational week 19 and related to pregnancy complications, fasting insulin levels, homoeostatic model assessment for insulin resistance (HOMA-IR), testosterone, or androstenedione levels, metformin use, PCOS phenotype and hyperandrogenism.

Results

Maternal s-PROK1 in the second trimester did not predict pregnancy-induced hypertension, pre-eclampsia or late miscarriage/preterm delivery in women with PCOS. However, s-PROK1 was lower in women who used metformin before inclusion, both in those randomised to metformin and to placebo, compared with those who did not. s-PROK1 was also lower in those who used metformin both at conception and during pregnancy compared with those who used metformin from inclusion or did not use metformin at all. s-PROK1 was lower in hyperandrogenic compared with normo-androgenic women with PCOS.

Conclusions

Maternal s-PROK1 in the second trimester did not predict pregnancy complications in PCOS. Those who used metformin at conception and/or during pregnancy had lower s-PROK1. PCOS women with hyperandrogenism exhibited lower s-PROK1 compared with normo-adrogenic phenotypes.

Trial registration number

NCT03259919 and NCT00159536.

Early 6 months usage of single anTiplAtelet OR anTicoAgulant followed by single antiplatelet after transcatheter aortic valve replacement: protocol for a multicentre, open-label, randomised controlled clinical trial

Por: Hu · X. · Xu · H. · Wang · C. · Wang · Y. · Wang · Y. · Zhou · D. · Zhu · Q. · Xu · K. · Yang · J. · Zhang · H. · Jiang · N. · Zhang · J. · Fang · Z. · Fu · G. · Guo · Y. · Li · Y. · Wang · M. · Feng · D. · Niu · G. · Zhang · E. · Chen · Y. · Ye · Y. · Wu · Y.
Introduction

The strategy for initiating antithrombotic therapy to prevent bioprosthetic valve thrombosis (BPVT) after transcatheter aortic valve replacement (TAVR) remains uncertain. There is still lacking evidence on the efficacy and safety of early 6 months usage of single-antiplatelet therapy (SAPT) or oral anticoagulant (OAC) after TAVR in patients without anticoagulant indications.

Methods and analysis

This is a multicentre, randomised controlled, open-label trial, and 650 patients undergoing TAVR from 13 top TAVR centres in China will be recruited. Each eligible participant will be randomly assigned to two groups (1:1 ratio) as (1) SAPT (aspirin 75–100 mg for 6 months) group or (2) OAC group (warfarin, therapeutic international normalised ratio at 1.8–2.5 for 6 months), both followed by sequential aspirin 75–100 mg for 6 months. Participants in both groups will be invited for three follow-up visits of 1, 6 and 12 months after discharge. We will use both the net clinical benefit endpoint (composite of all-cause mortality, myocardial infarction, stroke/transient ischaemic attacks, peripheral artery thrombosis, intracardiac thrombosis and major bleeding and disabling or life-threatening bleeding) and the BPVT endpoint evaluated by four-dimensional CT as our primary endpoints. P value of

Ethics and dissemination

The present study was approved by the Institutional Review Boards at Fuwai Hospital, National Center for Cardiovascular Diseases of China (Approval No. 2023-1947). All patients will be informed of the details of the study and will sign an informed consent prior to inclusion in the study. Results of this study will be published in a peer-reviewed journal.

Trial registration number

NCT05375474.

Perceived value and benefits of the Community Paramedicine at Clinic (CP@clinic) programme: a descriptive qualitative study

Por: Marzanek · F. · Nair · K. · Ziesmann · A. · Paramalingam · A. · Pirrie · M. · Angeles · R. · Agarwal · G.
Objectives

Community Paramedicine (CP) is increasingly being used to provide chronic disease management for vulnerable populations in the community. CP@clinic took place in social housing buildings to support cardiovascular health and diabetes management for older adults. The purpose of this study was to examine participant perceptions of their experience with CP@clinic as well as potential ongoing programme benefits.

Design

This descriptive qualitative study used focus groups to understand resident experiences of the CP@clinic programme. Groups were facilitated by experienced moderators using a semistructured guide. An inductive coding approach was used with at least two researchers taking part in each step of the analysis process.

Setting

Community-based social housing buildings in Ontario, Canada.

Participants

Forty-one participants from four CP@clinic sites took part in a focus group. Convenience sampling was used with anyone having taken part in a CP@clinic session being eligible to attend the focus group.

Results

Analysis yielded six themes across two broad areas: timely access to health information and services, support to achieve personal health goals, better understanding of healthcare system (Personal Benefits); and sense of community, comfortable and familiar place to talk about health, facilitated communication between healthcare professionals (Programme Structure). Participants experienced discernible health changes that motivated their participation. CP@clinic was viewed as a programme that created connections within the building and outside of it. Participants were enthusiastic for the continuation of the programme and appreciated the consistent support to meet their health goals.

Conclusions

CP@clinic was successful in creating a supportive and friendly environment to facilitate health behavioural changes. Ongoing implementation of CP@clinic would allow residents to continue to build their chronic disease management knowledge and skills.

Trial registration number

Trial registration number: NCT02152891, Clinicaltrials.gov.

Initial prescriptions and medication switches of biological products: an analysis of prescription pathways and determinants in the Swiss healthcare setting

Por: Wirth · K. · Boes · S. · Näpflin · M. · Huber · C. · Blozik · E.
Objectives

Biological products have contributed to extraordinary advances in disease treatments over the last decade. However, the cost-saving potential of imitator products, so-called biosimilars, is still under-researched in Switzerland. This study aims to assess biosimilars’ prescriptions at treatment initiation and their determinants, as well as biological therapy switches.

Design

The study included all patients who had at least one biosimilar available on the market at the time when they were prescribed a biological product. We analysed longitudinal data for biosimilar prescriptions in Switzerland using descriptive statistics and logistic regression to quantify the associations with individual, pharmaceutical and provider-related variables.

Setting

The analysis is based on de-identified claims data of patients with mandatory health insurance at Helsana, one of the Swiss health insurance companies with a substantial enrollee base in mandatory health insurance.

Participants

Overall, 18 953 patients receiving at least one biological product between 2016 and 2021 were identified.

Outcome measures

We differentiated between initial prescriptions and follow-up prescriptions. Our regression focused on initial prescriptions due to evidence indicating that patients tend to follow the medication prescribed at therapy initiation.

Results

Although biosimilars’ market share was low (28.6%), the number of prescriptions has increased (from 1016 in 2016 to 6976 in 2021). Few patients with medication switches (n=1492, 8.5%) were detected. Increased relative price difference (difference in the price of available biosimilars relative to price of corresponding reference product) was associated with decreased probability of biosimilar prescriptions, whereas male sex, an increase of available imitator drugs on the market, larger packaging sizes, and prescriptions from specialists or physicians in outpatient settings were associated with increased biosimilar use.

Conclusion

The low number of biosimilar prescriptions, despite the proliferating biosimilar market, indicates a high potential for biosimilar diffusion. The findings indicate that patients typically adhere to the therapy options initially chosen and are less inclined to make changes following the initiation of treatment. Our research highlights the need for awareness initiatives to improve understanding among patients and physicians, enabling informed, shared decision-making about biosimilar prescriptions.

Clinical Observation, Management and Function Of low back pain Relief Therapies (COMFORT): A cluster randomised controlled trial protocol

Por: Abdel Shaheed · C. · Ivers · R. · Vizza · L. · McLachlan · A. · Kelly · P. J. · Blyth · F. · Stanaway · F. · Clare · P. J. · Thompson · R. · Lung · T. · Degenhardt · L. · Reid · S. · Martin · B. · Wright · M. · Osman · R. · French · S. · McCaffery · K. · Campbell · G. · Jenkins · H. · Mathie
Introduction

Low back pain (LBP) is commonly treated with opioid analgesics despite evidence that these medicines provide minimal or no benefit for LBP and have an established profile of harms. International guidelines discourage or urge caution with the use of opioids for back pain; however, doctors and patients lack practical strategies to help them implement the guidelines. This trial will evaluate a multifaceted intervention to support general practitioners (GPs) and their patients with LBP implement the recommendations in the latest opioid prescribing guidelines.

Methods and analysis

This is a cluster randomised controlled trial that will evaluate the effect of educational outreach visits to GPs promoting opioid stewardship alongside non-pharmacological interventions including heat wrap and patient education about the possible harms and benefits of opioids, on GP prescribing of opioids medicines dispensed. At least 40 general practices will be randomised in a 1:1 ratio to either the intervention or control (no outreach visits; GP provides usual care). A total of 410 patient–participants (205 in each arm) who have been prescribed an opioid for LBP will be enrolled via participating general practices. Follow-up of patient–participants will occur over a 1-year period. The primary outcome will be the cumulative dose of opioid dispensed that was prescribed by study GPs over 1 year from the enrolment visit (in morphine milligram equivalent dose). Secondary outcomes include prescription of opioid medicines, benzodiazepines, gabapentinoids, non-steroidal anti-inflammatory drugs by study GPs or any GP, health services utilisation and patient-reported outcomes such as pain, quality of life and adverse events. Analysis will be by intention to treat, with a health economics analysis also planned.

Ethics and dissemination

The trial received ethics approval from The University of Sydney Human Research Ethics Committee (2022/511). The results will be disseminated via publications in journals, media and conference presentations.

Trial registration number

ACTRN12622001505796.

Evaluating the impact of COVID-19 pandemic-related home confinement on the refractive error of school-aged children in Germany: a cross-sectional study based on data from 414 eye care professional centres

Por: Sanz Diez · P. · Ohlendorf · A. · Barraza-Bernal · M. J. · Kratzer · T. · Wahl · S.
Objective

This study aimed at evaluating refractive changes in German school-aged children before and after the COVID-19 pandemic.

Design

Cross-sectional study.

Setting

414 eye care professional centres from Germany.

Participants

Refractive data from 59 926 German children aged 6–15 years were examined over a 7-year period (2015–2021).

Primary and secondary outcome measures

Spherical equivalent refraction was assessed as a function of year, age and gender. The refractive values concerning 2020 and 2021 were compared with those assigned to prior years (2015–2019).

Results

The refractive data associated with 2020 and 2021 showed a myopic refractive shift of approximately –0.20D compared with the 2015–2019 range. The refractive change was statistically considerable in the 6 to 11-year range (p

Conclusion

Disruption of normal lifestyle due to pandemic-related home confinement appears to lead to a myopic refractive shift in children aged 6–11 years in Germany. The greater effect observed at younger ages seems to emphasise the importance of refractive development in this age group.

Sustainable development goals and multisectoral collaborations for child health in Cambodia: a qualitative interview study with key child health stakeholders

Por: Hellden · D. · Sok · S. · Chea · T. · Nordenstedt · H. · Kuruvilla · S. · Alvesson · H. M. · Alfven · T.
Objectives

Multisectoral collaboration highlighted as key in delivering on the Sustainable Development Goals (SDGs), but still little is known on how to move from rhetoric to action. Cambodia has made remarkable progress on child health over the last decades with multisectoral collaborations being a key success factor. However, it is not known how country stakeholders perceive child health in the context of the SDGs or multisectoral collaborations for child health in Cambodia.

Design, settings and participants

Through purposive sampling, we conducted semistructured interviews with 29 key child health stakeholders from a range of government and non-governmental organisations in Cambodia. Guided by framework analysis, themes, subthemes and categories were derived.

Results

We found that the adoption of the SDGs led to increased possibility for action and higher ambitions for child health in Cambodia, while simultaneously establishing child health as a multisectoral issue among key child stakeholders. There seems to be a discrepancy between the desired step-by-step theory of conducting multisectoral collaboration and the real-world complexities including funding and power dynamics that heavily influence the process of collaboration. Identified success factors for multisectoral collaborations included having clear responsibilities, leadership from all and trust among stakeholders while the major obstacle found was lack of sustainable funding.

Conclusion

The findings from this in-depth multistakeholder study can inform policy-makers and practitioners in other countries on the theoretical and practical process as well as influencing aspects that shape multisectoral collaborations in general and for child health specifically. This is vital if multisectoral collaborations are to be successfully leveraged to accelerate the work towards achieving better child health in the era of the SDGs.

Association of body fat distribution with all-cause and cardiovascular mortality in US adults: a secondary analysis using NHANES

Por: Li · F. · Wang · Z. · Li · S. · Liu · W. · Li · Y. · Jiang · C. · Tian · Y. · Cui · W. · Zhang · X. · Zhang · J. · Xu · Y.
Objective

To investigate the association of fat and lean mass in specific regions with all-cause and cardiovascular-related mortality.

Design

Population based cohort study.

Setting

US National Health and Nutrition Examination Survey (2003–2006 and 2011–2018).

Participants

22 652 US adults aged 20 years or older.

Exposures

Fat and lean mass in specific regions obtained from the whole-body dual-energy X-ray absorptiometry.

Main outcome measures

All-cause and cardiovascular-related mortality.

Results

During a median of 83 months of follow-up, 1432 deaths were identified. Associations between body composition metrics and mortality risks were evident above specific thresholds. For all-cause mortality, Android fat mass showed elevated HRs above 2.46 kg (HR: 1.17, 95% CI 1.02 to 1.34), while Android lean mass (ALM) had similar trends above 2.75 kg (HR: 1.17, 95% CI 1.03 to 1.33), and Android total mass above 5.75 kg (HR: 1.08, 95% CI 1.01 to 1.16). Conversely, lower HRs were observed below certain thresholds: Gynoid fat mass (GFM) below 3.71 kg (HR: 0.72, 95% CI 0.56 to 0.93), Gynoid lean mass below 6.44 kg (HR: 0.77, 95% CI 0.64 to 0.92), and Gynoid total mass below 11.78 kg (HR: 0.76, 95% CI 0.70 to 0.84). Notably, below 0.722 kg, the HR of visceral adipose tissue mass (VATM) was 1.25 (95% CI 1.04 to 1.48) for all-cause mortality, and above 3.18 kg, the HR of total abdominal fat mass was 2.41 (95% CI 1.15 to 5.05). Cardiovascular-related mortality exhibited associations as well, particularly for Android fat mass (AFM) above 1.78 kg (HR: 1.22, 95% CI 1.01 to 1.47) and below 7.16 kg (HR: 0.50, 95% CI 0.36 to 0.69). HRs varied for Gynoid total mass below and above 10.98 kg (HRs: 0.70, 95% CI 0.54 to 0.93, and 1.12, 95% CI 1.02 to 1.23). Android per cent fat, subcutaneous fat mass (SFM), AFM/GFM, and VATM/SFM were not statistically associated with all-cause mortality. Android per cent fat, Gynoid per cent fat, AFM/GFM, and VATM/SFM were not statistically associated with cardiovascular-related mortality. Conicity index showed that the ALM/GLM had the highest performance for all-cause and cardiovascular-related mortality with AUCs of 0.785, and 0.746, respectively.

Conclusions

The relationship between fat or lean mass and all-cause mortality varies by region. Fat mass was positively correlated with cardiovascular mortality, regardless of the region in which they located. ALM/GLM might be a better predictor of all-cause and cardiovascular-related mortality than other body components or body mass index.

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