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Association between non-registration of chronic kidney disease and mortality and cardiovascular outcome: a time-to-event analysis of retrospective primary care data

Por: Van den Wyngaert · I. · Mamouris · P. · Ali · E. A. · Vaes · B. · Van Pottelbergh · G.
Objective

Patients with impaired kidney function and increased albuminuria are at risk of developing cardiovascular disease (CVD). Previous research has revealed that a substantial proportion of patients with chronic kidney disease (CKD) do not get a registered diagnosis in the electronic health record of the general practitioner. The aim of this study was to investigate the association between non-registration of CKD and all-cause mortality and cardiovascular outcome.

Design and setting

A retrospective study in primary care.

Methods

The analyses were carried out in the INTEGO database, a general practice-based morbidity registration network in Flanders, Belgium. The study used INTEGO data from the year 2018 for all patients ≥18 years old, including 10 551 patients. To assess the risk of mortality and CVD, a time-to-event analysis was performed. Cox proportional hazard model was used to evaluate the association between non-registration and incidence of all-cause mortality and cardiovascular events with mortality as a competing risk. Subgroup analyses were performed for estimated glomerular filtration rate stages (3A, 3B, 4 and 5). Multiple imputation was done following the methodology of Mamouris et al.

Results

Mortality was higher in patients with non-registered CKD compared with patients with registered CKD (HR 1.29, 95% CI 1.19 to 1.41). Non-registration of CKD was not associated with an increased risk for the development of CVD (HR 0.92, 95% CI 0.77 to 1.11).

Conclusion

An association between non-registration and all-cause mortality was identified, although no such association was apparent for CVD.

Exploring community participation in vectorborne disease control in Southeast Asia: a scoping review protocol

Por: Naserrudin · N. A. · Adhikari · B. · Culleton · R. · Hod · R. · Saffree Jeffree · M. · Ahmed · K. · Hassan · M. R.
Introduction

Vector borne diseases (VBDs) present significant public health challenges in Southeast Asia (SEA), and the increasing number of cases threatens vulnerable communities. Inadequate vector control and management have been linked to the spread of VBDs. To address these issues, community participation has been proposed as a promising approach to enhance health programmes and control of VBDs. This article outlines a protocol for a scoping review of the published literature on community-participation approaches to control VBDs in the SEA region. The primary research question is ‘How does community participation complement the control of VBDs in SEA?’ This review aims to provide an overview of various approaches and identify barriers and facilitators to effective implementation.

Methods and analysis

The research questions will guide the scoping review. In stage 1, peer-reviewed publications from PubMed, Web of Science and Scopus will be searched using predefined search terms related to community-based approaches and VBDs in the SEA region, English, Indonesian and Malay published between 2012 and 2022. In stage 2, the references from relevant articles will be screened for eligibility. In stage 3, eligible articles will be charted in Microsoft Excel to facilitate the review process, and studies will be characterised based on the investigated diseases; this review will also highlight the methodological context of these studies. In stage 4, a thematic analysis will be conducted to derive meaningful findings from the dataset relevant to the research inquiry, followed by writing the results in stage 5. This scoping review aims to be the first to explore community participation in VBD control in the SEA population, providing valuable insights for future research and stakeholders involved in disease control.

Ethics and dissemination

This scoping review does not require ethical approval because the methodology synthesises information from available articles. This review is planned for dissemination in academic journals, conference presentations and shared with stakeholders as part of knowledge sharing among those involved in VBD control.

Utilising a 'Community of Practice to support pharmacists to work in residential aged care: protocol for a longitudinal evaluation

Por: Lee · K. · Etherton-Beer · C. · Johnson · J. · Lobo · E. · Wang · K. · Ailabouni · N. · Mavaddat · N. · Clifford · R. M. · Page · A. T.
Introduction

A Community of Practice is briefly defined as a group of people with a shared interest in a given area of practice who work collaboratively to grow collective knowledge. Communities of Practice have been used to facilitate knowledge exchange and improve evidence-based practice. Knowledge translation within the residential aged care sector is lacking, with barriers such as inadequate staffing and knowledge gaps commonly cited. In Australia, a Federal inquiry into residential aged care practices led to a recommendation to embed pharmacists within residential aged care facilities. Onsite practice in aged care is a new role for pharmacists in Australia. Thus, support is needed to enable pharmacists to practice in this role.

The primary aim is to evaluate the processes and outcomes of a Community of Practice designed to support pharmacists to work in aged care.

Methods and analysis

A longitudinal, single-group, pretest–post-test design in which the intervention is a Community of Practice. The Community of Practice will be established and made available for 3 years to all Australian pharmacists interested in, new to or established in aged care roles. The Community of Practice will be hosted on online discussion platforms, with additional virtual meetings and annual symposia. The following data will be collected from all members of the Community of Practice: self-evaluation of the processes and outcomes of the Community of Practice (via the CoPeval scale) and confidence in evidence-based practice (EPIC scale), collected via online questionnaires annually; and discussion platform usage statistics and discussion transcripts. A subset of members will be invited to participate in annual semi-structured individual interviews.

Data from the online questionnaire will be analysed descriptively. Discussion transcripts will be analysed using topic modelling and content analysis to identify the common topics discussed and their frequencies. Qualitative data from individual interviews will be thematically analysed to explore perceptions and experiences with the intervention for information/knowledge exchange, impact on practice, and sharing/promoting/implementing evidence-based practice.

Ethics and dissemination

Human ethics approval has been granted by the University of Western Australia’s Human Ethics Committee (2023/ET000000). No personal information will be included in any publications and reports to funding bodies.

Findings will be disseminated to all members of the Community of Practice, professional organisations, social and mass media, peer-review journals, research and professional conferences and annual reports to the funding body.

Impact evaluation of a cash-plus programme for children with disabilities in the Xiengkhouang Province in Lao PDR: study protocol for a non-randomised controlled trial

Por: Banks · L. M. · Soukkhaphone · B. · Scherer · N. · Siengsounthone · L. · Carew · M. T. · Shakespeare · T. · Chen · S. · Davey · C. · Goyal · D. · Zinke-Allmang · A. · Kuper · H. · Chanthakoumane · K.
Introduction

More than 170 countries have implemented disability-targeted social protection programmes, although few have been rigorously evaluated. Consequently, a non-randomised controlled trial is being conducted of a pilot ‘cash-plus’ programme implemented by UNICEF Laos and the Laos government for children with disabilities in the Xiengkhouang Province in Laos. The intervention combines a regular cash transfer with provision of assistive devices and access for caregivers to a family support programme.

Methods and analysis

The non-randomised controlled trial will involve 350 children with disabilities across 3 districts identified by programme implementers as eligible for the programme (intervention arm). Implementers have also identified approximately 180 children with disabilities in neighbouring districts, who would otherwise meet eligibility criteria but do not live in the project areas (control arm). The trial will assess the impact of the programme on child well-being (primary outcome), as well as household poverty, caregiver quality of life and time use (secondary outcomes). Baseline data are being collected May–October 2023, with endline 24 months later. Analysis will be intention to treat. A complementary process evaluation will explore the implementation, acceptability of the programme, challenges and enablers to its delivery and mechanisms of impact.

Ethics and dissemination

The study has received ethical approval from the London School of Hygiene and Tropical Medicine and the National Ethics Committee for Health Research in Laos. Informed consent and assent will be taken by trained data collectors. Data will be collected and stored on a secure, encrypted server and its use will follow a detailed data management plan. Findings will be disseminated in academic journals and in short briefs for policy and programmatic actors, and in online and in-person events.

Trial registration number

ISRCTN80603476.

Analgesia for the treatment of acute pancreatitis: a protocol for a systematic review and network meta-analysis

Por: Subramani · S. S. · Berg · A. C. · Kral · L. A. · Murad · M. H. · Smith · A. · Phillips · A. E. · Yadav · D. · Uc · A. · Imdad · A.
Introduction

Gastrointestinal hospitalisations in the USA cause over US$130 billion in expenditures, and acute pancreatitis is a leading cause of these hospitalisations. Adequate pain control is one of the primary treatment goals for acute pancreatitis. Though opioids are commonly used for analgesia in these patients, there have been concerns about short-term and long-term side effects of using opioids. Recently, non-opioid medications have been studied to treat pain in patients with acute pancreatitis. This systematic review and network meta-analysis aims to assess the comparative efficacy of analgesic medication for non-severe, acute pancreatitis.

Methods and analysis

We will search multiple electronic databases for randomised controlled trials that study pain management in patients with non-severe, acute pancreatitis. The intervention will be any analgesic for acute pancreatitis in the hospital setting. The comparison group will be patients who received a placebo or other active interventions for pain management. The primary outcomes of interest include pain scores and the need for supplementary analgesia. The secondary outcomes will be serious adverse events, local complications, progression to severe pancreatitis, transfer to the intensive care unit, length of hospitalisation, time to start enteral feeds, 30-day all-cause mortality and Quality of Life Scale scores. If sufficient homogeneity exists among included studies, the findings will be pooled using a traditional pairwise and network meta-analysis. The risk of bias in randomised control trials will be evaluated using the Cochrane Risk of Bias Tool 2.0. The Grading of Recommendations, Assessment, Development, and Evaluation approach will be used to report the certainty of evidence.

Ethics and dissemination

This systematic review will not involve direct contact with human subjects. The findings of this review will be published in a peer-reviewed journal. They will give healthcare providers a better awareness of the optimal analgesic medication for pain treatment in non-severe, acute pancreatitis.

Understanding the impact of a residential housing program for people living with HIV/AIDS: results from a realist evaluation

Por: Ali · A. · Groot · G. · April · M. · MacPhee · M. · Witham · S. · Alimezelli · H. · Carr · T.
Background

In Canada, the Public Health Agency surveillance of new HIV cases has demonstrated annual increasing rates since 2020. The rates of new HIV cases are highest in the province of Saskatchewan.

Objectives

The aim of the project was to conduct a resident-oriented realist evaluation of an innovative supportive housing programme, Sanctum, for people living with HIV/AIDS who also face social care issues, such as homelessness. This project took place in Saskatchewan, a province that is seeking innovative approaches to improve quality of life and HIV/AIDS management for its citizens. Our evaluation addressed how and why participants were successful (or not) within the Sanctum programme.

Design and setting

Sanctum is a housing programme located in an inner-city location within the province of Saskatchewan. A unique component of this evaluation was the inclusion of an individual with lived experience, a resident partner, as a member of the research team.

Participants

11 recent Sanctum graduates, seven men and four women, were recruited for client partner-led in-depth, semistructured interviews.

Interventions

Prior to the evaluation, we developed a realist programme theory with potential causal explanations, known as context-mechanism-outcomes (CMO) configurations. Interview data from the evaluation and ongoing discussions with Sanctum board members and our resident partner were used to test, refine and validate the final programme theory and CMO configurations.

Results

CMO configurations at the micro (individual), meso (interpersonal) and macro (community) levels complement the over-arching programme theory. Key findings were the importance of Sanctum’s harm reduction philosophy, accompanied by a non-judgmental and patient-oriented approach. Participants were supported to reduce risky behaviour, improve self-care management and develop healthier relationships within a ‘safe’ home-like setting. Underlying mechanisms that contributed to participants’ success in the programme included: intrinsic motivation, self-worth, belongingness, empowerment and self-efficacy. Evidence-informed recommendations are offered to support Sanctum-like programme development for individuals with holistic health needs related to HIV/AIDS diagnoses and lack of access to necessary social determinants of health.

Conclusions

Stigma associated with HIV/AIDS and living circumstances, such as homelessness, were successfully addressed using harm reduction principles and judgement-free approaches within a family-like environment.

Cost-effectiveness of a complex continuum of care intervention targeting women and children: protocol for an economic evaluation of the Bukhali trial in South Africa

Por: Palmer · T. · Leiva Granados · R. · Draper · C. · Norris · S. A. · Batura · N.
Introduction

As nearly two-thirds of women presenting at their first antenatal visit are either overweight or obese in urban South Africa, the preconception period is an opportunity to optimise health and offset transgenerational risk of both obesity and non-communicable diseases. This protocol describes the planned economic evaluation of an individually randomised controlled trial of a complex continuum of care intervention targeting women and children in Soweto, South Africa (Bukhali trial).

Methods and analysis

The economic evaluation of the Bukhali trial will be conducted as a within-trial analysis from both provider and societal perspectives. Incremental costs and health outcomes of the continuum of care intervention will be compared with standard care. The economic impact on implementing agencies (programme costs), healthcare providers, participants and their households will be estimated. Incremental cost-effectiveness ratios (ICERs) will be calculated in terms of cost per case of child adiposity at age years averted. Additionally, ICERs will also be reported in terms of cost per quality-adjusted life year gained. If Bukhali demonstrates effectiveness, we will employ a decision analytical model to examine the cost-effectiveness of the intervention over a child’s lifetime. A Markov model will be used to estimate long-term health benefits, healthcare costs and cost-effectiveness. Probabilistic sensitivity analyses will be conducted to explore uncertainty and ensure robust results. An analysis will be conducted to assess the equity impact of the intervention, by comparing intervention impact within quintiles of socioeconomic status.

Ethics and dissemination

The Bukhali trial economic evaluation has ethical approval from the Human Ethics Research Committee of the University of the Witwatersrand, Johannesburg, South Africa (M240162). The results of the economic evaluation will be disseminated in a peer-reviewed journal and presented at a relevant international conference.

Trial registration number

Pan African Clinical Trials Registry (PACTR201903750173871; https://pactr.samrc.ac.za).

Interdisciplinary research approach based on a mixed-methods design to explore patient altruism at the end of life: a study protocol

Por: Bernard · M. · Gamondi · C. · Sterie · A.-C. · Larkin · P. J. · Jox · R. · Borasio · G. D.
Introduction

In the end of life context, patients are often seen as somewhat passive recipients of care provided by health professionals and relatives, with little opportunity to be perceived as autonomous and active agents. Since studies show a very high prevalence of altruistic dispositions in palliative care patients, we strive to investigate the concept of patient altruism in a set of six interdisciplinary studies by considering three settings: (1) in the general palliative context—by studying to what extent patient altruism is associated with essential psychological outcomes of palliative care (subproject 1a), how altruism is understood by patients (subproject 1b) and how altruism expressed by patients is experienced by palliative care nurses (subproject 1c); (2) in two concrete decision-making contexts—advance care planning (subproject 2a) and assisted suicide (subproject 2b); and (3) through verbal and non-verbal patient communication in palliative care settings (subproject 3).

Methods and analysis

Subproject 1a: a cross-sectional study using validated and standardised questionnaires. Subprojects 1b and 1c: a constructivist grounded theory method aiming at developing a novel theory from semistructured interviews in both patients and nurses. Subproject 2a: a thematic analysis based on (1) audio-recordings of advance care planning encounters and (2) follow-up semidirective interviews with patients and their relatives. Subproject 2b: a qualitative study based on thematic analysis of interviews with patients actively pursuing assisted suicide and one of their relatives.Subproject 3: a conversation analysis based on audio and video-recorded interactions in two settings: (1) palliative inpatient unit and (2) advance care planning discussions.

Ethics and dissemination

The study project was approved by the Ethics Committees of the Canton of Vaud, Bern and Ticino (no: 2023-00088). In addition to participation in national and international conferences, each project will be the subject of two scientific publications in peer-reviewed journals. Additional publications will be realised according to result triangulation between projects. A symposium opened to professionals, patients and the public will be organised in Switzerland at the end of the project.

Hungarian general practice paediatricians antibiotic prescribing behaviour for suspected respiratory tract infections: a qualitative study

Por: Babarczy · B. · Hajdu · A. · Benko · R. · Matuz · M. · Papp · R. · Antoniou · P. · Kandelaki · K. · Lo Fo Wong · D. · Warsi · S. K.
Objectives

Inappropriate antibiotic prescribing is a major cause of antimicrobial resistance (AMR). The aim of this study was to explore paediatric general practitioners’ (GP Peds) antibiotic prescription practice in suspected respiratory tract infections (RTIs), using the capability–opportunity–motivation–behaviour framework.

Design

The design is a qualitative study based on individual, semistructured telephone or virtual interviews.

Setting

Paediatric general practice in Hungary. We applied stratified maximum variation sampling to cover the categories of age, sex and geographical location of participants.

Participants

We interviewed 22 GP Peds. Nine were male and 13 were female: 2 of them were less than 40 years old, 14 were between 40 and 60 years, and 6 were above 60 years. 10 worked in low-antibiotic prescription areas, 5 in areas with medium levels of antibiotic prescription, 3 in high-antibiotic prescription areas, and 4 in and around the capital city.

Results

Study participants had varying antibiotic prescription preferences. Personal experience and physical examination play a central role in GP Peds’ diagnostic and treatment practice. Participants emphasised the need to treat children in their entirety, taking their personal medical record, social background and sometimes parents’ preferences into account, besides the acute clinical manifestation of RTI. Most respondents were confident they apply the most effective therapy even if, in some cases, this meant prescribing medicines with a higher chance of contributing to the development of AMR. Some participants felt antibiotic prescription frequency has decreased in recent years.

Conclusions

Our findings suggest that a more prudent attitude toward antibiotic prescribing may have become more common but also highlight relevant gaps in both physicians’ and public knowledge of antibiotics and AMR. To reinforce awareness and close remaining gaps, Hungary should adopt its national AMR National Action Plan and further increase its efforts towards active professional communication and feedback for primary care physicians.

Tobacco policies and changes in the tendency of smoking cessation in cigarette users in Chile: a longitudinal cross-sectional study

Objective

To assess the impact of tobacco control regulations and policy implementation on smoking cessation tendencies in cigarette users born between 1982 and 1991 in Chile.

Design

Longitudinal cross-sectional study.

Setting

National level.

Participants

Data from the National Survey of Drug Consumption (Service of Prevention and Rehabilitation for Drug and Alcohol Consumption). A pseudo-cohort of smokers born between 1982 and 1991 (N=17 905) was tracked from 2002 to 2016.

Primary and secondary outcomes measures

Primary outcome was the tendency to cease smoking conceptualised as the report of using cigarettes 1 month or more ago relative to using cigarettes in the last 30 days. The main exposure variable was the Tobacco Policy Index—tracking tobacco policy changes over time. Logistic regression, controlling for various factors, was applied.

Results

Models suggested a 14% increase in the smoking cessation tendency of individuals using cigarettes 1 month or more ago relative to those using cigarettes in the last 30 days (OR 1.14, CI 95% CI 1.10 to 1.19) for each point increment in the Tobacco Policy index.

Conclusions

Our study contributes to documenting a positive impact of the implementation of interventions considered in the MPOWER strategy in the progression of smoking cessation tendencies in smokers born between 1982 and 1991 in Chile.

Study protocol for two randomised controlled trials evaluating the effects of Cerclage in the reduction of extreme preterm birth and perinatal mortality in twin pregnancies with a short cervix or dilatation: the TWIN Cerclage studies

Por: van Gils · L. · de Boer · M. A. · Bosmans · J. · Duijnhoven · R. · Schoenmakers · S. · Derks · J. B. · Prins · J. R. · Al-Nasiry · S. · Lutke Holzik · M. · Lopriore · E. · van Drongelen · J. · Knol · M. H. · van Laar · J. O. E. H. · Jacquemyn · Y. · van Holsbeke · C. · Dehaene · I. · L
Introduction

Twin pregnancies have a high risk of extreme preterm birth (PTB) at less than 28 weeks of gestation, which is associated with increased risk of neonatal morbidity and mortality. Currently there is a lack of effective treatments for women with a twin pregnancy and a short cervix or cervical dilatation. A possible effective surgical method to reduce extreme PTB in twin pregnancies with an asymptomatic short cervix or dilatation at midpregnancy is the placement of a vaginal cerclage.

Methods and analysis

We designed two multicentre randomised trials involving eight hospitals in the Netherlands (sites in other countries may be added at a later date). Women older than 16 years with a twin pregnancy at

Ethics and dissemination

This study has been approved by the Research Ethics Committees in the Netherlands on 3/30/2023. Participants will be required to sign an informed consent form. The results will be presented at conferences and published in a peer-reviewed journal. Participants will be informed about the results.

Trial registration number

ClinicalTrials.gov, NCT05968794.

SurLym trial: study protocol for a multicentre pragmatic randomised controlled trial on the added value of reconstructive lymphatic surgery to decongestive lymphatic therapy for the treatment of lymphoedema

Por: Devoogdt · N. · De Vrieze · T. · Heroes · A.-K. · Bechter-Hugl · B. · Fieuws · S. · Godderis · L. · Segers · K. · Maleux · G. · Deltombe · T. · Frippiat · J. · Servaes · M. · Berners · A. · Fosseprez · P. · Krug · B. · Kayser · F. · Falticeanu · A. · Randon · C. · Monten · C. · Van Landuyt
Introduction

Lymphoedema is a chronic condition caused by lymphatic insufficiency. It leads to swelling of the limb/midline region and an increased risk of infection. Lymphoedema is often associated with mental and physical problems limiting quality of life. The first choice of treatment is a conservative treatment, consisting of exercises, skin care, lymph drainage and compression. Reconstructive lymphatic surgery is also often performed, that is, lymphovenous anastomoses, lymph node transfer or a combination. However, robust evidence on the effectiveness of reconstructive lymphatic surgery is missing. Therefore, the objective of this trial is to investigate the added value of reconstructive lymphatic surgery to the conservative treatment in patients with lymphoedema.

Methods and analysis

A multicentre randomised controlled and pragmatic trial was started in March 2022 in three Belgian university hospitals. 90 patients with arm lymphoedema and 90 patients with leg lymphoedema will be included. All patients are randomised between conservative treatment alone (control group) or conservative treatment with reconstructive lymphatic surgery (intervention group). Assessments are performed at baseline and at 1, 3, 6, 12, 18, 24 and 36 months. The primary outcome is lymphoedema-specific quality of life at 18 months. Key secondary outcomes are limb volume and duration of wearing the compression garment at 18 months. The approach of reconstructive lymphatic surgery is based on presurgical investigations including clinical examination, lymphofluoroscopy, lymphoscintigraphy, lymph MRI or CT angiography (if needed). All patients receive conservative treatment during 36 months, which is applied by the patient’s own physical therapist and by the patient self. From months 7 to 12, the hours a day of wearing the compression garment are gradually decreased.

Ethics and dissemination

The study has been approved by the ethical committees of University Hospitals Leuven, Ghent University Hospital and CHU UCL Namur. Results will be disseminated via peer-reviewed journals and presentations.

Trial registration number

NCT05064176

What recovery domains are important following a total knee replacement? A qualitative, interview-based study

Por: Khatri · C. · Dhaif · F. · Ellard · D. · Rodrigues · J. N. · Underwood · M. · Mitchell · P. · Metcalfe · A.
Objectives

To explore people’s views of recovery from total knee replacement (TKR) and which recovery domains they felt were important.

Design

Semi-structured interviews exploring the views of individuals about to undergo or who have undergone TKR. A constant-comparative approach with thematic analysis was used to identify themes. The process of sampling, collecting data and analysis were continuous and iterative throughout the study, with interviews ceasing once thematic saturation was achieved.

Setting

Tertiary care centre.

Participants

A purposive sample was used to account for variables including pre, early or late postoperative status.

Results

12 participants were interviewed, 4 who were preoperative, 4 early postoperative and 4 late postoperative. Themes of pain, function, fear of complications, awareness of the artificial knee joint and return to work were identified. Subthemes of balancing acute and chronic pain were identified.

Conclusions

The results of this interview-based study identify pain and function, in particular mobility, that were universally important to those undergoing TKR. Surgeons should consider exploring these domains when taking informed consent to enhance shared decision-making. Researchers should consider these recovery domains when designing interventional studies.

Effectiveness and cost-effectiveness of community-based directly observed treatment (DOT) versus health facility-based DOT of tuberculosis in Africa: protocol for a systematic review and meta-analysis

Por: Baye · T. · Kassaw · A. T. · Gebrie · D. · Girmaw · F. · Ashagrie · G.
Background

Tuberculosis (TB) remains a significant global health challenge, especially prevalent in the WHO African region. The WHO’s End TB Strategy emphasises effective treatment approaches such as directly observed therapy (DOT), yet the optimal implementation of DOT, whether through health facility-based (HF DOT) or community-based (CB DOT) approaches, remains uncertain.

Objective

To conduct a systematic comparison of the effectiveness and cost-effectiveness of Community-Based Directly Observed Treatment (CB DOT) versus Health Facility-Based Directly Observed Treatment (HF DOT) for tuberculosis (TB) treatment in African settings.

Methods

We will conduct a systematic review and meta-analysis following Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols guidelines. We will search PubMed, Embase, Web of Science, Scopus and the Cochrane Library for articles published up to 30 March 2023, without date restrictions. Eligible studies must be full economic evaluations conducted in African countries, comparing CB DOT to HF DOT regarding treatment outcomes and costs. Exclusion criteria include non-English, non-peer-reviewed or studies lacking caregiver involvement in CB DOT, health facility-based DOT comparison, direct comparability between CB DOT and HF DOT, significant selection bias or non-economic evaluations. Data extraction will be performed independently by reviewers, and meta-analyses will use STATA software. To pool the data, a random-effect model will be applied, and quality assessment of the studies will be conducted.

Ethics and dissemination

Ethical approval is not required as the study will use previously published articles available publicly. Findings will be presented at international and national conferences and published in open-access, peer-reviewed journals.

PROSPERO registration number

CRD42023443260.

Interventions to promote medical student well-being: an overview of systematic reviews

Por: Bennett-Weston · A. · Keshtkar · L. · Jones · M. · Sanders · C. · Lewis · C. · Nockels · K. · Solomon · J. · Howick · J.
Objective

To conduct an overview of systematic reviews that explore the effectiveness of interventions to enhance medical student well-being.

Design

Overview of systematic reviews.

Data sources

The Cochrane Library of Systematic Reviews, MEDLINE, APA PsychInfo, CINAHL and Scopus were searched from database inception until 31 May 2023 to identify systematic reviews of interventions to enhance medical student well-being. Ancestry searching and citation chasing were also conducted.

Data extraction and synthesis

The Assessing the Methodological Quality of Systematic Reviews V.2 tool was used to appraise the quality of the included reviews. A narrative synthesis was conducted, and the evidence of effectiveness for each intervention was rated.

Results

13 reviews (with 94 independent studies and 17 616 students) were included. The reviews covered individual-level and curriculum-level interventions. Individual interventions included mindfulness (n=12), hypnosis (n=6), mental health programmes (n=7), yoga (n=4), cognitive and behavioural interventions (n=1), mind-sound technology (n=1), music-based interventions (n=1), omega-3 supplementation (n=1), electroacupuncture (n=1) and osteopathic manipulative treatment (n=1). The curriculum-level interventions included pass/fail grading (n=4), problem-based curriculum (n=2) and multicomponent curriculum reform (n=2). Most interventions were not supported by sufficient evidence to establish effectiveness. Eleven reviews were rated as having ‘critically low’ quality, and two reviews were rated as having ‘low’ quality.

Conclusions

Individual-level interventions (mindfulness and mental health programmes) and curriculum-level interventions (pass/fail grading) can improve medical student well-being. These conclusions should be tempered by the low quality of the evidence. Further high-quality research is required to explore additional effective interventions to enhance medical student well-being and the most efficient ways to implement and combine these for maximum benefit.

'Its just my knee: a qualitative study investigating the process of reframing and young athletes perceived quality of life between anterior cruciate ligament injury and surgery

Por: Marmura · H. · Bryant · D. · Getgood · A. · Webster · F.
Objectives

To understand the factors influencing young athletes’ perceptions of quality of life (QOL) following an anterior cruciate ligament (ACL) rupture, prior to reconstructive surgery.

Design

Qualitative descriptive study using semi-structured interviews and thematic analysis of data.

Setting

Tertiary sports medicine clinic with patients recruited from the practices of three specialist orthopaedic surgeons.

Participants

Twenty athletes aged 14–25 provided consent to participate in the study and completed interviews prior to their ACL reconstruction surgery. Participants were eligible to participate if they were scheduled to undergo ACL reconstruction, were 25 years of age or younger, identified as athletes (participated in any level of organised sport), could communicate in English and agreed to be audio recorded. Participants were not eligible if they had experienced a multiligament injury or fracture.

Results

Young athletes shared common factors that made up their QOL; social connections and support, sport, health, and independence. However, participants’ perceptions of their current QOL were quite variable (13–95/100 on a Visual Analogue Scale). Participants who were able to reframe their injury experience by shifting focus to the positive or unaffected aspects of their lives tended to have more favourable perceptions of their QOL than participants who shifted focus to the losses associated with injury.

Conclusions

Young athletes who have experienced an ACL injury define their QOL based on social support, sport, health and independence. Individual processes of adaptation and cognitive reframing in response to an ACL injury may exert a greater influence on postinjury QOL than the physical ramifications of the injury itself. Understanding individual perceptions may help target potential interventions or supports to enhance athletes’ adaptation to injury.

Cognitive stimulation for people with dementia in nursing homes: a protocol for a feasibility study examining a new 24/7 approach (CogStim24)

Por: Folkerts · A.-K. · Seven · U. S. · Guicheteau · J. · N Dichter · M. · Hellmich · M. · Köpke · S. · Kalbe · E.
Introduction

Based on the available evidence, cognitive stimulation is recommended as an intervention for people with dementia (PwD). Currently, cognitive stimulation is regularly offered as a group programme in care facilities. However, some residents, such as those who are bedridden, cannot participate. Furthermore, group programmes were not feasible during the pandemic. A concept that accompanies everyday life and enables cognitive stimulation in everyday communication (ie, ‘24/7’) has been missing. Therefore, this feasibility study aims to (1) assess the feasibility of a new continuous 24/7 cognitive stimulation programme (CogStim24) based on a process evaluation and (2) examine the possible effects of CogStim24 on the primary outcome of global cognition in PwD and further PwD-related and staff-related outcomes.

Methods and analysis

The complex CogStim24 programme is developed to be conducted as an everyday intervention during routine care including cognitively stimulating techniques, such as reminiscence therapy, multisensory stimulation and physical activity. In this unblinded single-arm study with pre-assessments and post-assessments, four nursing homes with a total of N=20 nursing and care staff will participate in an 11-week CogStim24 training programme. The intervention will be conducted to N=60 PwD. Neuropsychological assessments will be conducted pre-staff and post-staff training, as well as after a 6-week implementation phase. A process evaluation will be performed.

Ethics and dissemination

Ethics approval was obtained from the ethics committee of the Faculty of Medicine of the University of Cologne, Cologne, Germany. Although cognitive stimulation is known to be effective for enhancing global cognition and quality of life in PwD, it is currently undersupplied to PwD. Therefore, CogStim24 has the potential to reach many more PwD. This study has the potential to serve as a basis for a large multicentre cluster randomised controlled trial. An interdisciplinarity team and mixed-methods approach will help generate information on the practicality and mechanisms of impact of CogStim24. This is important for the further development of the intervention and for facilitating its implementation. The study results will be disseminated via presentations at scientific conferences and meetings for healthcare professionals and PwD and their relatives. Several manuscripts presenting results of the different study parts will be published in peer-reviewed journals.

Trial registration number

DRKS00024381.

Evaluation of adherence to pharmacological treatments by undocumented migrants with chronic diseases: a 10-year retrospective cohort study

Por: Fiorini · G. · Pellegrini · G. · Franchi · M. · Rigamonti · A. E. · Marazzi · N. · Sartorio · A. · Corrao · G. · Cella · S. G.
Objectives

To investigate the time course of medication adherence and some of the factors involved in this process in undocumented migrants with chronic diseases.

Design

Retrospective cohort study.

Setting

A big non-governmental organisation in Milano, Italy, giving medical assistance to undocumented migrants.

Participants

1918 patients, 998 females and 920 males, with at least one chronic condition (diabetes, cardiovascular diseases (CVDs), mental health disorders) seen over a period of 10 years (2011–2020). Their mean age was 49.2±13 years.

Results

Adherence to medications decreased over 1 year in all patients. This was more evident during the first 2 months of treatment. Patients on only one medication were less adherent than those on more than one medication; at 6 months the percentage of patients with high adherence was 33% vs 57% (p

Conclusions

Interventions to increase medication adherence of undocumented migrants with chronic diseases are necessary, particularly in the first 2 months after beginning treatment. These should be aimed at people-centred care and include more outpatient consultations. Educational interventions should especially be taken into consideration for patients on monotherapy.

Medical researchers perceptions regarding research evaluation: a web-based survey in Japan

Por: Minoura · A. · Shimada · Y. · Kuwahara · K. · Kondo · M. · Fukushima · H. · Sugiyama · T.
Objectives

Japanese medical academia continues to depend on quantitative indicators, contrary to the general trend in research evaluation. To understand this situation better and facilitate discussion, this study aimed to examine how Japanese medical researchers perceive quantitative indicators and qualitative factors of research evaluation and their differences by the researchers’ characteristics.

Design

We employed a web-based cross-sectional survey and distributed the self-administered questionnaire to academic society members via the Japanese Association of Medical Sciences.

Participants

We received 3139 valid responses representing Japanese medical researchers in any medical research field (basic, clinical and social medicine).

Outcomes

The subjective importance of quantitative indicators and qualitative factors in evaluating researchers (eg, the journal impact factor (IF) or the originality of the research topic) was assessed on a four-point scale, with 1 indicating ‘especially important’ and 4 indicating ‘not important’. The attitude towards various opinions in quantitative and qualitative research evaluation (eg, the possibility of research misconduct or susceptibility to unconscious bias) was also evaluated on a four-point scale, ranging from 1, ‘strongly agree’, to 4, ‘completely disagree’.

Results

Notably, 67.4% of the medical researchers, particularly men, younger and basic medicine researchers, responded that the journal IF was important in researcher evaluation. Most researchers (88.8%) agreed that some important studies do not get properly evaluated in research evaluation using quantitative indicators. The respondents perceived quantitative indicators as possibly leading to misconduct, especially in basic medicine (strongly agree—basic, 22.7%; clinical, 11.7%; and social, 16.1%). According to the research fields, researchers consider different qualitative factors, such as the originality of the research topic (especially important—basic, 46.2%; social, 39.1%; and clinical, 32.0%) and the contribution to solving clinical and social problems (especially important—basic, 30.4%; clinical, 41.0%; and social, 52.0%), as important. Older researchers tended to believe that qualitative research evaluation was unaffected by unconscious bias.

Conclusion

Despite recommendations from the Declaration on Research Assessment and the Leiden Manifesto to de-emphasise quantitative indicators, this study found that Japanese medical researchers have actually tended to prioritise the journal IF and other quantitative indicators based on English-language publications in their research evaluation. Therefore, constantly reviewing the research evaluation methods while respecting the viewpoints of researchers from different research fields, generations and genders is crucial.

Use of artificial intelligence in obstetric and gynaecological diagnostics: a protocol for a systematic review and meta-analysis

Por: Chaurasia · A. · Curry · G. · Zhao · Y. · Dawoodbhoy · F. · Green · J. · Vaninetti · M. · Shah · N. · Greer · O.
Introduction

Emerging developments in applications of artificial intelligence (AI) in healthcare offer the opportunity to improve diagnostic capabilities in obstetrics and gynaecology (O&G), ensuring early detection of pathology, optimal management and improving survival. Consensus on a robust AI healthcare framework is crucial for standardising protocols that promote data privacy and transparency, minimise bias, and ensure patient safety. Here, we describe the study protocol for a systematic review and meta-analysis to evaluate current applications of AI in O&G diagnostics with consideration of reporting standards used and their ethical implications. This protocol is written following the Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols (PRISMA-P) 2015 checklist.

Methods and analysis

The study objective is to explore the current application of AI in O&G diagnostics and assess the reporting standards used in these studies. Electronic bibliographic databases MEDLINE, EMBASE and Cochrane will be searched. Study selection, data extraction and subsequent narrative synthesis and meta-analyses will be carried out following the PRISMA-P guidelines. Included papers will be English-language full-text articles from May 2015 to March 2024, which provide original data, as AI has been redefined in recent literature. Papers must use AI as the predictive method, focusing on improving O&G diagnostic outcomes.

We will evaluate the reporting standards including the risk of bias, lack of transparency and consider the ethical implications and potential harm to patients. Outcome measures will involve assessing the included studies against gold-standard criteria for robustness of model development (Transparent Reporting of a multivariable prediction model for Individual Prognosis Or Diagnosis, model predictive performance, model risk of bias and applicability (Prediction model Risk Of Bias Assessment Tool and study reporting (Consolidated Standards of Reporting Trials-AI) guidance.

Ethics and dissemination

Ethical approval is not required for this systematic review. Findings will be shared through peer-reviewed publications.There will be no patient or public involvement in this study.

PROSPERO registration number

CRD42022357024.

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