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Co-creating a new Charter for equitable and inclusive co-creation: insights from an international forum of academic and lived experience experts

Por: Mulvale · G. · Moll · S. · Phoenix · M. · Buettgen · A. · Freeman · B. · Murray-Leung · L. · Micsinszki · S. K. · Mulalu · L. · Vrzovski · A. · Foisy · C.
Background

Co-creation approaches, such as co-design and co-production, aspire to power-sharing and collaboration between service providers and service users, recognising the specific insights each group can provide to improve health and other public services. However, an intentional focus on equity-based approaches grounded in lived experience and epistemic justice is required considering entrenched structural inequities between service-users and service-providers in public and institutional spaces where co-creation happens.

Objectives

This paper presents a Charter of tenets and principles to foster a new era of ‘Equity-based Co-Creation’ (EqCC).

Methods

The Charter is based on themes heard during an International Forum held in August 2022 in Ontario, Canada, where 48 lived experience experts and researchers were purposively invited to deliberate challenges and opportunities in advancing equity in the co-creation field.

Results

The Charter’s seven tenets—honouring worldviews, acknowledging ongoing and historical harms, operationalising inclusivity, establishing safer and brave spaces, valuing lived experiences, ‘being with’ and fostering trust, and cultivating an EqCC heartset/mindset—aim to promote intentional inclusion of participants with intersecting social positions and differing historic oppressions. This means honouring and foregrounding lived experiences of service users and communities experiencing ongoing structural oppression and socio-political alienation—Black, Indigenous and people of colour; disabled, Mad and Deaf communities, women, 2S/LGBTQIA+ communities, people perceived to be mentally ill and other minoritised groups—to address epistemic injustice in co-creation methodologies and practice, thereby providing opportunities to begin to dismantle intersecting systems of oppression and structural violence.

Conclusions

Each Charter tenet speaks to a multilayered, multidimensional process that is foundational to shifting paradigms about redesigning our health and social systems and changing our relational practices. Readers are encouraged to share their reactions to the Charter, their experiences implementing it in their own work, and to participate in a growing international EqCC community of practice.

Role of physical activity in the relationship between recovery from work and insomnia among early childhood education and care professionals: a cross-sectional study

Por: Karihtala · T. · Puttonen · S. · Valtonen · A. M. · Kautiainen · H. · Hopsu · L. · Heinonen · A.
Objectives

This study aimed to investigate the association between recovery from work and insomnia and the role of objectively measured leisure-time physical activity and occupational physical activity in this association.

Design

Cross-sectional.

Setting and participants

Study with female early childhood education and care professionals (N=224) in Finland was conducted between April 2017 and September 2018.

Methods

Recovery from work was measured with the Need for Recovery scale and insomnia with the Jenkins Sleep Scale. Physical activity was measured with an accelerometer for 7 days and analysed to represent leisure-time physical activity and occupational physical activity (min/day).

Results

Both Jenkins Sleep Scale and occupational physical activity significantly predicted Need for Recovery (β=0.29; 95% CI 0.17 to 0.42 and β=0.14; 95% CI 0.01 to 0.27, respectively). A low relationship was observed between the Need for Recovery and Jenkins Sleep Scale (r=0.32, 95% Cl 0.19 to 0.44). After categorising participants into four groups based on median splits of occupational and leisure-time physical activity, relationships between the Need for Recovery and Jenkins Sleep Scale were low to moderate in the high occupational physical activity and leisure time physical activity group (r=0.38, 95% Cl 0.14 to 0.61), and in the high occupational physical activity and low leisure-time physical activity group (r=0.40, 95% Cl 0.18 to 0.63).

Conclusion

Both insomnia and physical activity at work seem to be relevant in recovery from work. To enhance recovery, especially those involved in high physical activity at work, should seek methods to improve recovery, by incorporating activities that promote recuperation both during their workday and in their leisure time. Further research on the relevance of physical activity in recovery with longitudinal setting is warranted.

Trial registration number

NCT03854877.

REKOVER study protocol: a pRospective patient treatment rEgistry of tramadol and dexKetoprofen trometamol oral fixed-dose combination (SKUDEXA) in mOderate to seVere acutE pain in Real-world setting in Asia

Por: Ho · K. Y. · Gyanwali · B. · Dimayuga · C. · Eufemio · E. M. · Bernardo · E. · Raju · G. · Chong · K. W. · Waithayayothin · K. · Ona · L. · Castro · M. A. L. · Sawaddiruk · P. · Salvador · R. C. · Roohi · S. A. · Tangwiwat · S. · Wilairatana · V. · Oon · Z. H. · Gupta · A. · Nagrale · D.
Introduction

Satisfactory management of acute pain remains a major medical challenge despite the availability of multiple therapeutic options including the fixed-dose combination (FDC) drugs. Tramadol and dexketoprofen trometamol (TRAM/DKP) 75/25 mg FDC was launched in 2018 in Asia and is widely used in the management of moderate to severe acute pain. There are limited data on its effectiveness and safety in Asian patients, and therefore, a need to better understand its usage patterns in clinical practice. We aim to understand the usage pattern of TRAM/DKP FDC, its effectiveness and tolerability in patients with moderate to severe acute pain in Asia.

Methods and analysis

REKOVER is a phase-IV, multicountry, multicentre, prospective, real-world observational study. A total of 750 postsurgical and non-surgical patients (male and female, aged 18–80 years) will be recruited from 13 tertiary-care hospitals (15 sites) in Singapore, Thailand, the Philippines and Malaysia. All patients prescribed with TRAM/DKP FDC and willing to participate in the study will be enrolled. The recruitment duration for each site will be 6 months. The severity of pain will be collected using Numeric Pain Rating Scale through the treatment period from day 1 to day 5, while satisfaction with the treatment will be evaluated using Patient Global Evaluation Scale at the end of treatment. Any adverse event reported during the study duration will be recorded for safety analysis (up to day 6). The study data will be entered into the ClaimIt portal and mobile application (app) (ObvioHealth, USA). All the inpatient data will be entered into the portal by the study site and for outpatient it will be done by patients through an app.

Ethics and dissemination

The study has been approved by the local ethics committee from each study sites in Singapore, Thailand, the Philippines and Malaysia. Findings will be disseminated through local and global conference presentations, publications in peer-reviewed scientific journals and continuing medical education.

Finerenone cardiovascular and kidney outcomes by age and sex: FIDELITY post hoc analysis of two phase 3, multicentre, double-blind trials

Por: Bansal · S. · Canziani · M. E. F. · Birne · R. · Anker · S. D. · Bakris · G. L. · Filippatos · G. · Rossing · P. · Ruilope · L. M. · Farjat · A. E. · Kolkhof · P. · Lage · A. · Brinker · M. · Pitt · B.
Objectives

This study aimed to evaluate the efficacy and safety of finerenone, a selective, non-steroidal mineralocorticoid receptor antagonist, on cardiovascular and kidney outcomes by age and/or sex.

Design

FIDELITY post hoc analysis; median follow-up of 3 years.

Setting

FIDELITY: a prespecified analysis of the FIDELIO-DKD and FIGARO-DKD trials.

Participants

Adults with type 2 diabetes and chronic kidney disease receiving optimised renin–angiotensin system inhibitors (N=13 026).

Interventions

Randomised 1:1; finerenone or placebo.

Primary and secondary outcome measures

Cardiovascular (cardiovascular death, non-fatal myocardial infarction, non-fatal stroke or hospitalisation for heart failure (HHF)) and kidney (kidney failure, sustained ≥57% estimated glomerular filtration rate (eGFR) decline or renal death) composite outcomes.

Results

Mean age was 64.8 years; 45.2%, 40.1% and 14.7% were aged interaction=0.42) and sex categories (HR 0.86 (95% CI 0.77 to 0.96) (male), HR 0.89 (95% CI 0.35 to 2.27) (premenopausal female), HR 0.87 (95% CI 0.73 to 1.05) (postmenopausal female); Pinteraction=0.99). Effects on HHF reduction were not modified by age (Pinteraction=0.70) but appeared more pronounced in males (Pinteraction=0.02). Kidney events were reduced with finerenone versus placebo in age groups interaction=0.51). In sex subgroups, finerenone consistently reduced kidney events (Pinteraction=0.85). Finerenone reduced albuminuria and eGFR decline regardless of age and sex. Hyperkalaemia increased with finerenone, but discontinuation rates were

Conclusions

Finerenone improved cardiovascular and kidney composite outcomes with no significant heterogeneity between age and sex subgroups; however, the effect on HHF appeared more pronounced in males. Finerenone demonstrated a similar safety profile across age and sex subgroups.

Trial registration numbers

NCT02540993, NCT02545049.

What Matters to Aboriginal and Torres Strait Islander Youth (WM2Y): a study protocol to develop a national youth well-being measure

Por: Garvey · G. · Howard · K. · Garvey · D. · Dickson · M. · Howell · M. · Butler · T. L. · Cadet-James · Y. · Cunningham · J. · Bainbridge · R. · McGorry · P. · Williamson · A. · Anderson · K. M.
Introduction

Adolescents face challenges associated with unprecedented environmental, social and technological changes. The impacts of colonisation, intergenerational trauma, racism and socioeconomic disadvantage intensify these challenges for many Aboriginal and Torres Strait Islander adolescents. However, Aboriginal and Torres Strait Islander adolescents also have cultural, spiritual, family and community capital that fosters their well-being.

To date, little research has focused on understanding and appropriately measuring the well-being of Aboriginal and Torres Strait Islander adolescents, a pivotal factor in informing and guiding programmes and interventions that support them. This study will identify the domains of well-being and develop a new preference-based well-being measure based on the values and preferences of Aboriginal and Torres Strait Islander youth (aged 12–17 years).

Methods and analysis

This project will be conducted across three research phases: (1) qualitative exploration of well-being using PhotoYarning and yarns with adult mentors to develop candidate items; (2) Think Aloud study, quantitative survey, psychometric analysis, validity testing of candidate items and finalisation of the descriptive system; and (3) scoring development using a quantitative preference-based approach. A multinomial (conditional) logit framework will be used to analyse responses and generate a scoring algorithm for the new preference-based well-being measure.

Ethics and dissemination

Ethics approvals have been obtained from: the Human Research Ethics Committees for each state and territory where data are being collected, the institutions where the research is being conducted and from the relevant Departments of Education. The new well-being measure will have wide applicability and can be used in assessing the effectiveness of programmes and services. This new national measure will ensure benefit and positive impact through the ability to identify and measure the aspects of well-being important to and valued by Aboriginal and Torres Strait Islander youth. Results will be published in international peer-reviewed journals and presented at conferences, and summaries will be provided to the study partner organisations and other relevant organisations.

Talking in primary care (TIP): protocol for a cluster-randomised controlled trial in UK primary care to assess clinical and cost-effectiveness of communication skills e-learning for practitioners on patients musculoskeletal pain and enablement

Por: Bishop · F. L. · Cross · N. · Dewar-Haggart · R. · Teasdale · E. · Herbert · A. · Robinson · M. E. · Ridd · M. J. · Mallen · C. · Clarson · L. · Bostock · J. · Becque · T. · Stuart · B. · Garfield · K. · Morrison · L. · Pollet · S. · Vennik · J. · Atherton · H. · Howick · J. · Leydon · G. M
Introduction

Effective communication can help optimise healthcare interactions and patient outcomes. However, few interventions have been tested clinically, subjected to cost-effectiveness analysis or are sufficiently brief and well-described for implementation in primary care. This paper presents the protocol for determining the effectiveness and cost-effectiveness of a rigorously developed brief eLearning tool, EMPathicO, among patients with and without musculoskeletal pain.

Methods and analysis

A cluster randomised controlled trial in general practitioner (GP) surgeries in England and Wales serving patients from diverse geographic, socioeconomic and ethnic backgrounds. GP surgeries are randomised (1:1) to receive EMPathicO e-learning immediately, or at trial end. Eligible practitioners (eg, GPs, physiotherapists and nurse practitioners) are involved in managing primary care patients with musculoskeletal pain. Patient recruitment is managed by practice staff and researchers. Target recruitment is 840 adults with and 840 without musculoskeletal pain consulting face-to-face, by telephone or video. Patients complete web-based questionnaires at preconsultation baseline, 1 week and 1, 3 and 6 months later. There are two patient-reported primary outcomes: pain intensity and patient enablement. Cost-effectiveness is considered from the National Health Service and societal perspectives. Secondary and process measures include practitioner patterns of use of EMPathicO, practitioner-reported self-efficacy and intentions, patient-reported symptom severity, quality of life, satisfaction, perceptions of practitioner empathy and optimism, treatment expectancies, anxiety, depression and continuity of care. Purposive subsamples of patients, practitioners and practice staff take part in up to two qualitative, semistructured interviews.

Ethics approval and dissemination

Approved by the South Central Hampshire B Research Ethics Committee on 1 July 2022 and the Health Research Authority and Health and Care Research Wales on 6 July 2022 (REC reference 22/SC/0145; IRAS project ID 312208). Results will be disseminated via peer-reviewed academic publications, conference presentations and patient and practitioner outlets. If successful, EMPathicO could quickly be made available at a low cost to primary care practices across the country.

Trial registration number

ISRCTN18010240.

Evolution of the data and methods in real-world COVID-19 vaccine effectiveness studies on mortality: a scoping review protocol

Por: Stehlik · P. · Dowsett · C. · Camacho · X. · Falster · M. O. · Lim · R. · Nasreen · S. · Pratt · N. L. · Pearson · S.-A. · Henry · D.
Background

Early evidence on COVID-19 vaccine efficacy came from randomised trials. Many important questions subsequently about vaccine effectiveness (VE) have been addressed using real-world studies (RWS) and have informed most vaccination policies globally. As the questions about VE have evolved during the pandemic so have data, study design, and analytical choices. This scoping review aims to characterise this evolution and provide insights for future pandemic planning—specifically, what kinds of questions are asked at different stages of a pandemic, and what data infrastructure and methods are used?

Methods and analysis

We will identify relevant studies in the Johns Hopkins Bloomberg School of Public Health VIEW-hub database, which curates both published and preprint VE RWS identified from PubMed, Embase, Scopus, Web of Science, the WHO COVID Database, MMWR, Eurosurveillance, medRxiv, bioRxiv, SSRN, Europe PMC, Research Square, Knowledge Hub, and Google. We will include RWS of COVID-19 VE that reported COVID-19-specific or all-cause mortality (coded as ‘death’ in the ‘effectiveness studies’ data set).

Information on study characteristics; study context; data sources; design and analytic methods that address confounding will be extracted by single reviewer and checked for accuracy and discussed in a small group setting by methodological and analytic experts. A timeline mapping approach will be used to capture the evolution of this body of literature.

By describing the evolution of RWS of VE through the COVID-19 pandemic, we will help identify options for VE studies and inform policy makers on the minimal data and analytic infrastructure needed to support rapid RWS of VE in future pandemics and of healthcare strategies more broadly.

Ethics and dissemination

As data is in the public domain, ethical approval is not required. Findings of this study will be disseminated through peer-reviewed publications, conference presentations, and working-papers to policy makers.

Registration

https://doi.org/10.17605/OSF.IO/ZHDKR

Rituximab-combined anthracycline-free chemotherapy in newly diagnosed paediatric and adolescent patients with non-high-risk aggressive mature B cell lymphoma: protocol for a single-arm, open-label, multicentre, phase II study (the Japan Childrens Cancer G

Por: Sekimizu · M. · Fukano · R. · Koga · Y. · Mitsui · T. · Fujita · N. · Mori · T. · Hori · D. · Tanaka · M. · Ohki · K. · Iwafuchi · H. · Nakazawa · A. · Mori · T. · Kobayashi · R. · Hashimoto · H. · M. Saito · A. · Kamei · M. · on behalf of Lymphoma Committee of Japan Childrens Cancer G
Introduction

Children and adolescents with mature B cell non-Hodgkin lymphoma (B-NHL) are treated with short-intensive chemotherapy. The burden of short-term and long-term toxicity is highly relative to its high cure rate in good-risk patients. Although the addition of rituximab to standard lymphome Malin B (LMB) chemotherapy markedly prolongs event-free survival and overall survival in high-risk patients, the benefit of rituximab in good-risk patients remains to be elucidated. This clinical trial will examine whether the addition of rituximab eliminates anthracyclines in good-risk patients without compromising treatment outcomes.

Methods and analysis

We will perform a single-arm, open-label, multicentre phase II study. Low-risk (stage I – completely resected, stage II abdominal) and intermediate-risk (stages I and II – incompletely resected; stage II – resected, other than abdominal; stage III with LDH x upper limit of normal) patients with newly diagnosed B-NHL are eligible. Low-risk patients receive two courses of R-COM1P (rituximab, cyclophosphamide, vincristine, methotrexate, prednisolone and intrathecal methotrexate with hydrocortisone), and intermediate-risk patients receive COP (cyclophosphamide, vincristine, prednisolone and intrathecal methotrexate with hydrocortisone) followed by two courses each of R-COM3P and R-CYM (rituximab, cytarabine, methotrexate and intrathecal methotrexate with hydrocortisone). The primary endpoint is a 3-year event-free survival rate in paediatric patients (

Ethics and dissemination

This research was approved by the Certified Review Board at NHO Nagoya Medical Center (Nagoya, Japan) on 21 September 2021. Written informed consent is obtained from all patients and/or their guardians. The results of this study will be disseminated through peer-reviewed publications and conference presentations.

Study registration

Japan Registry of Clinical Trials, jRCTs041210104.

Systematic review of individual-level, community-level, and healthcare system-level factors contributing to socioeconomic differences in healthcare utilisation in OECD countries with universal health coverage

Por: Meulman · I. · Uiters · E. · Cloin · M. · Polder · J. · Stadhouders · N.
Objectives

Countries with universal health coverage (UHC) strive for equal access for equal needs without users getting into financial distress. However, differences in healthcare utilisation (HCU) between socioeconomic groups have been reported in countries with UHC. This systematic review provides an overview individual-level, community-level, and system-level factors contributing to socioeconomic status-related differences in HCU (SES differences in HCU).

Design

Systematic review following the Preferred Reporting Items for Systematic review and Meta-Analysis (PRISMA) guidelines. The review protocol was published in advance.

Data sources

Embase, PubMed, Web of Science, Scopus, Econlit, and PsycInfo were searched on 9 March 2021 and 9 November 2022.

Eligibility criteria

Studies that quantified the contribution of one or more factors to SES difference in HCU in OECD countries with UHC.

Data extraction and synthesis

Studies were screened for eligibility by two independent reviewers. Data were extracted using a predeveloped data-extraction form. Risk of bias (ROB) was assessed using a tailored version of Hoy’s ROB-tool. Findings were categorised according to level and a framework describing the pathway of HCU.

Results

Of the 7172 articles screened, 314 were included in the review. 64% of the studies adjusted for differences in health needs between socioeconomic groups. The contribution of sex (53%), age (48%), financial situation (25%), and education (22%) to SES differences in HCU were studied most frequently. For most factors, mixed results were found regarding the direction of the contribution to SES differences in HCU.

Conclusions

SES differences in HCU extensively correlated to factors besides health needs, suggesting that equal access for equal needs is not consistently accomplished. The contribution of factors seemed highly context dependent as no unequivocal patterns were found of how they contributed to SES differences in HCU. Most studies examined the contribution of individual-level factors to SES differences in HCU, leaving the influence of healthcare system-level characteristics relatively unexplored.

Socioeconomic inequalities in skilled attendance at birth and caesarean section rates in Myanmar 2015-2016: a cross-sectional study

Por: Show · K. L. · Maung · T. M. · Disney · G. · Bohren · M. A. · Lumbiganon · P. · Ngamjarus · C.
Objectives

This study aims to assess inequalities in skilled birth attendance and utilisation of caesarean section (CS) in Myanmar.

Study design

Cross-sectional study design.

Setting and population

We used secondary data from the Myanmar Demographic and Health Survey (2015–2016). Our outcome measures of skilled birth attendance and utilisation of CS were taken from the most recent birth of interviewed women. Absolute and relative inequalities across several sociodemographic characteristics were assessed and evaluated by calculating rate differences, rate ratio and concentration indexes.

Results

More than one-third (36%, 95% CI 32.5% to 39.4%) of women gave birth without a skilled birth attendant present at their most recent birth. 40.7% (95% CI 37.8% to 43.7%) gave birth in healthcare facilities, and the CS rate was 19.7% (95% CI 17.9% to 21.8%) for their most recent birth. The highest proportion of birth without a skilled provider was found in the hilly regions and rural residents, poorest and less educated women, and those with less than four antenatal care visits. Inequalities in birth without a skilled provider were observed across regions, place of residence, wealth quintile, education level and number of antenatal care taken. The highest rate of CS was found among plain regions and urban residents, richest women, more than secondary education, those with more than four antenatal care visits and in private health facilities. Inequalities in CS utilisation were observed across place of residence, wealth quintiles, education level, number of antenatal care taken and type of health facilities.

Conclusion

This study provides evidence regarding inequalities in maternal health service utilisation in Myanmar. Increasing maternal health service availability and accessibility, promoting quality of care and health education campaigns to increase maternal health services utilisation are recommended.

Barriers and facilitators to pressure ulcer prevention behaviours by older people living in their own homes and their lay carers: a qualitative study

Por: Roddis · J. · Dyson · J. · Woodhouse · M. · Devrell · A. · Oakley · K. · Cowdell · F.
Objective

To identify barriers and facilitators to pressure ulcer prevention behaviours in community-dwelling older people and their lay carers.

Design

Theoretically informed qualitative interviews with two-phase, deductive then inductive, thematic analysis.

Setting

The study was conducted in one geographical region in the UK, spanning several community National Health Service Trusts.

Participants

Community-dwelling older patients at risk of pressure ulcer development (n=10) and their lay carers (n=10).

Results

Six themes and subthemes were identified: (1) knowledge and beliefs about consequences (nature, source, timing and taboo); (2) social and professional role and influences (who does what, conflicting advice and disagreements); (3) motivation and priorities (competing self-care needs and carer physical ability); (4) memory; (5) emotion (carer exhaustion and isolation, carergiver role conflict and patient feelings) and (6) environment (human resource shortage and equipment).

Conclusions

There is minimal research in pressure ulcer prevention in community-dwelling older people. This study has robustly applied the theoretical domains framework to understanding barriers and facilitators to pressure ulcer prevention behaviours. Our findings will support co-design of strategies to promote preventative behaviours and are likely to be transferable to comparable healthcare systems nationally and internationally.

Geographical variation in perceptions, attitudes and barriers to mental health care-seeking across the UK: a cross-sectional study

Por: Wang · R. A. H. · Smittenaar · P. · Thomas · T. · Kamal · Z. · Kemp · H. · Sgaier · S. K.
Objectives

To examine the relative importance of the drivers of mental health care-seeking intention and how these, along with intention itself, are geographically distributed across integrated care systems (ICS) and health boards (HBs) in the UK. Also, to examine the degree of acceptance of virtual modes of care.

Design

Community-based cross-sectional survey.

Participants and setting

A national online survey of 17 309 adults between August and September 2021 recruited via a research technology company, Lucid. Sample size quotas were set to ensure coverage across the UK and match population distributions for gender, age and ethnicity. After exclusions, 16 835 participants remained (54% female, 89% white).

Main outcome measures

Care-seeking intention, using a continuous measure of likelihood and a categorical measure of estimated time to seek professional help for a future mental health difficulty.

Results

20.5% (95% CI 19.8% to 21.2%) reported that they would significantly delay or never seek mental healthcare, ranging from 8.3% to 25.7% across ICS/HBs. Multilevel regression analysis showed mental health knowledge was the most predictive of care-seeking intention, followed by attitudes towards others with mental illness and a combination of stigma, negative attitudes to treatment and instrumental barriers to accessing care. The model explained 17% of the variance. There was substantial geographical variation in prevalence of preclinical symptoms of depression and anxiety, attitudes to mental health, and barriers to care, leading to complex ICS/HB profiles. Remote and self-guided therapies did not pose as a major barrier to care with more than half of respondents likely or very likely to use them.

Conclusions

Our locally relevant and actionable findings suggest possible interventions that may improve care-seeking intention and indicate which of these interventions need to be geographically tailored to have maximal effect.

Efficacy and safety of moxibustion for ulcerative colitis: protocol for a systematic review and meta-analysis

Por: Li · Y. · Zhou · W. · Chen · W. · Deng · B. · You · J.
Introduction

Ulcerative colitis (UC) is a global chronic inflammatory bowel disease, and the poor efficacy of currently available pharmacological regimens makes the management of UC a great challenge. Moxibustion has shown great potential in the management of UC. However, its effectiveness and safety are still controversial. The purpose of this study is to synthesise the latest evidence regarding the clinical efficacy and safety of moxibustion for UC.

Methods and analysis

The Cochrane Library, PubMed, EMBASE, CNKI, Wanfang, VIP and SinoMed databases will be searched from inception to July 2023, to identify all randomised controlled trials with moxibustion for UC. The primary outcome will be clinical efficacy, as measured by validated scales. The serum inflammatory factor, colonoscopy results, quality of life, recurrence rate and adverse events will be the secondary outcomes. The Cochrane Risk of Bias 2.0 tool will be used to assess the methodological quality of each included trial. All data extraction will be carried out independently by two investigators. RevMan V.5.4 software will be used for data analysis and Cochran’s Q statistic and I2 test will be used to assess heterogeneity between studies. In addition, we will perform subgroup analyses, sensitivity analyses and publication bias if the available data are sufficient. The strength of evidence will be graded using the Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) system.

Ethics and dissemination

Ethics approval is not required for this review. Our findings will be published in a peer-reviewed journal.

PROSPERO registration number

CRD42023425481.

Home-based Intervention with Semaglutide Treatment of Neuroleptic-Related Prediabetes (HISTORI): protocol describing a prospective, randomised, placebo controlled and double-blinded multicentre trial

Por: Ganeshalingam · A. A. · Uhrenholt · N. G. · Arnfred · S. · Gaede · P. H. · Bilenberg · N. · Frystyk · J.
Introduction

Subjects with schizophrenia have a 2–3 fold higher mortality rate than the general population and a reduced life expectancy of 10–20 years. Approximately one-third of this excess mortality has been attributed to obesity-related type 2 diabetes (T2D) and to cardiovascular disease. Glucagon-like peptide-1 (GLP-1) analogues increase satiety and delay gastric emptying, thereby reducing food intake and weight. GLP-1 analogues also exert beneficial effects on cardiovascular outcomes in high-risk patients with T2D.

Our aim is to investigate whether 30 weeks add-on treatment with the GLP-1 analogue semaglutide can reduce HbA1c sufficiently to reverse pre-diabetes and the metabolic syndrome in overweight schizophrenic patients.

Methods and analysis

We will perform a 30 week, two-armed, multicentre, superiority, double-blinded, randomised trial investigating the effect of weekly injections of semaglutide versus placebo in mental health facilities in Region of Southern Denmark and Region of Zealand, Denmark. In total, 154 adults with schizophrenia spectrum disease, aged 18–60 years treated with second generation antipsychotic treatment, HbA1c 39–47 mmol/mol and body mass index >27 kg/m2 will be randomised to injections of 1.0 mg semaglutide or placebo. The primary outcome is changes in HbA1c. Secondary outcomes encompass metabolic measures, psychotic symptoms and quality of life. Exploratory outcomes encompass insulin sensitivity, cardiovascular risk profile, medication adherence, general well-being and physical activity.

Ethics and dissemination

This study will be carried out in accordance with the Declaration of Helsinki and Good Clinical Practice guidelines. This research has obtained approval from both the Danish Medicines Agency and The Regional Committees on Health Research Ethics for Southern Denmark.

Trial registration number

NCT05193578 European Clinical Trials Database Number (EudraCT) 2020-004374-22, Regional Ethical Committee number S-20200182.

Role of motivation and well-being indicators in interventions to improve well-being at work among primary care physicians: a systematic review

Por: Florez · A. · Villar-Hoz · E.
Objective

The well-being of primary care physicians (PCPs) has become an object of concern for governments due to staff shortages and high staff turnover. The objective of this study was to carry out a systematic review of individualised interventions aimed at improving the well-being of PCPs, which allowed us to determine (1) the type of interventions being carried out; (2) the well-being indicators being used and the instruments used to assess them; (3) the theories proposed to support the interventions and the mechanisms of action (MoA) put forward to explain the results obtained and (4) the role that individual motivation plays in the interventions to improve well-being among PCPs.

Design

Systematic review.

Eligibility criteria

Clinical trials on interventions aimed at improving the well-being of PCPs.

Information sources: a search of studies published between 2000 and 2022 was carried out in MEDLINE/PubMed, SCOPUS and Web of Science (WOS).

Results

From the search, 250 articles were retrieved. The two authors each reviewed the articles independently, duplicate articles and those that did not meet the inclusion criteria were discarded. A total of 14 studies that met the criteria were included: 6 randomised clinical trials, 4 controlled clinical trials and 4 unique cohorts, with a before-and-after assessment of the intervention, involving a total of 655 individuals participating in the interventions. A meta-analysis was not possible due to the heterogeneity of the studies.

Conclusions

The information evaluated is insufficient to accurately assess which outcomes are the best indicators of PCPs well-being or what role plays in the individual motivation in the results of the interventions. More studies need to be carried out on the subject to determine the MoA of the different interventions on the results and the motivation of the participating PCPs.

Multicentre, randomised, double-blind, placebo-controlled, proof of concept study of LSALT peptide as prevention of acute respiratory distress syndrome and acute kidney injury in patients infected with SARS-CoV-2 (COVID-19)

Por: Somayaji · R. · Luke · D. R. · Lau · A. · Guner · R. · Tabak · O. F. · Hepokoski · M. · Gardetto · N. · Conrad · S. A. · Kumar · S. D. · Ghosh · K. · Robbins · S. M. · Senger · D. L. · Sun · D. · Lim · R. K. S. · Liu · J. · Eser · F. · Karaali · R. · Tremblay · A. · Muruve · D.
Objective

Dipeptidase-1 (DPEP-1) is a recently discovered leucocyte adhesion receptor for neutrophils and monocytes in the lungs and kidneys and serves as a potential therapeutic target to attenuate inflammation in moderate-to-severe COVID-19. We aimed to evaluate the safety and efficacy of the DPEP-1 inhibitor, LSALT peptide, to prevent specific organ dysfunction in patients hospitalised with COVID-19.

Design

Phase 2a randomised, placebo-controlled, double-blinded, trial.

Setting

Hospitals in Canada, Turkey and the USA.

Participants

A total of 61 subjects with moderate-to-severe COVID-19.

Interventions

Randomisation to LSALT peptide 5 mg intravenously daily or placebo for up to 14 days.

Primary and secondary outcome measures

The primary endpoint was the proportion of subjects alive and free of respiratory failure and/or the need for renal replacement therapy (RRT). Numerous secondary and exploratory endpoints were assessed including ventilation-free days, and changes in kidney function or serum biomarkers.

Results

At 28 days, 27 (90.3%) and 28 (93.3%) of subjects in the placebo and LSALT groups were free of respiratory failure and the need for RRT (p=0.86). On days 14 and 28, the number of patients still requiring more intensive respiratory support (O2 ≥6 L/minute, non-invasive or invasive mechanical ventilation or extracorporeal membrane oxygenation) was 6 (19.4%) and 3 (9.7%) in the placebo group versus 2 (6.7%) and 2 (6.7%) in the LSALT group, respectively (p=0.14; p=0.67). Unadjusted analysis of ventilation-free days demonstrated 22.8 days for the LSALT group compared with 20.9 in the placebo group (p=0.4). LSALT-treated subjects had a significant reduction in the fold expression from baseline to end of treatment of serum CXCL10 compared with placebo (p=0.02). Treatment-emergent adverse events were similar between groups.

Conclusion

In a Phase 2 study, LSALT peptide was demonstrated to be safe and tolerated in patients hospitalised with moderate-to-severe COVID-19.

Trial registration number

NCT04402957.

Experiences, prevalence and drivers of disrespect and abuse of adolescents during facility-based childbirth in sub-Saharan Africa: a scoping review protocol

Por: Udho · S. · Clow · S. E.
Introduction

Adolescents are more likely to experience disrespect and abuse (D&A) by skilled health personnel during facility-based childbirth. However, research evidence on the experiences, prevalence and drivers of D&A of adolescents in childbirth is limited. We aim to establish research evidence on the experiences, prevalence and drivers of D&A of adolescents during facility-based childbirth in sub-Saharan Africa and identify gaps in the literature to inform future research.

Methods and analysis

The protocol is designed using Arksey and O’Malley’s methodological framework and will be reported following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews. We will systematically search to retrieve peer-reviewed articles published in English from 2011 to date in PubMed/Medline, EBSCOhost (Africa Wide Information, CINAHL, PsycINFO and SocINDEX), Web of Science (SciELO Citation Index and Web of Science Core Collection) and Scopus. Two independent reviewers will screen the references by titles, abstracts and full texts. Discrepancies in screening results will be resolved through discussions. Key elements of included studies will be charted using a predetermined tool. We will perform numerical analysis and synthesis of narrative accounts of the extent, nature and distribution of review studies.

Ethics and dissemination

No ethical approval is required since the scoping review will use openly available public data and information. Review findings will be disseminated at conferences and published in peer-reviewed journals. No protocol registration is required.

Application of generative language models to orthopaedic practice

Por: Caterson · J. · Ambler · O. · Cereceda-Monteoliva · N. · Horner · M. · Jones · A. · Poacher · A. T.
Objective

To explore whether large language models (LLMs) Generated Pre-trained Transformer (GPT)-3 and ChatGPT can write clinical letters and predict management plans for common orthopaedic scenarios.

Design

Fifteen scenarios were generated and ChatGPT and GPT-3 prompted to write clinical letters and separately generate management plans for identical scenarios with plans removed.

Main outcome measures

Letters were assessed for readability using the Readable Tool. Accuracy of letters and management plans were assessed by three independent orthopaedic surgery clinicians.

Results

Both models generated complete letters for all scenarios after single prompting. Readability was compared using Flesch-Kincade Grade Level (ChatGPT: 8.77 (SD 0.918); GPT-3: 8.47 (SD 0.982)), Flesch Readability Ease (ChatGPT: 58.2 (SD 4.00); GPT-3: 59.3 (SD 6.98)), Simple Measure of Gobbledygook (SMOG) Index (ChatGPT: 11.6 (SD 0.755); GPT-3: 11.4 (SD 1.01)), and reach (ChatGPT: 81.2%; GPT-3: 80.3%). ChatGPT produced more accurate letters (8.7/10 (SD 0.60) vs 7.3/10 (SD 1.41), p=0.024) and management plans (7.9/10 (SD 0.63) vs 6.8/10 (SD 1.06), p

Conclusions

This study shows that LLMs are effective for generation of clinical letters. With little prompting, they are readable and mostly accurate. However, they are not consistent, and include inappropriate omissions or insertions. Furthermore, management plans produced by LLMs are generic but often accurate. In the future, a healthcare specific language model trained on accurate and secure data could provide an excellent tool for increasing the efficiency of clinicians through summarisation of large volumes of data into a single clinical letter.

Effectiveness of a community-based multicomponent lifestyle intervention (the ADA programme) to improve the quality of life of French breast cancer survivors: protocol for a pragmatic cluster randomised trial and embedded qualitative study

Por: El-Khoury · F. · Mino · J.-C. · Deschamps · N. · Lopez · C. · Menvielle · G. · Dargent-Molina · P.
Introduction

Breast cancer survivors (BCSs) are often faced with multiple mental and physical sequelae and are at increased risk of emotional distress, degraded health-related quality of life (HRQoL), chronic pain and fatigue.

Physical activity is strongly associated with improved HRQoL and survival rates; however, adherence rates to recommendations for a healthy lifestyle are seldom satisfactory among BCSs. Also, few studies have examined the effectiveness of multicomponent and personalised interventions that integrate physical activity and motivational techniques to improve the HRQoL of BCS.

Method and analysis

"Activité physique adaptée Doublée d’un Accompagnement d’après cancer" (ADA) is an integrated programme of physical activity enriched with a dietary and supportive care approach targeting BCS in the early post-treatment phase. The effectiveness of the ADA intervention will be evaluated using a cluster randomised controlled trial design with two arms (ADA programme vs usual care; 1:1 ratio).

The ADA intervention aims to recruit 160 participants and will be implemented by Siel Bleu, a non-profit association specialised in health prevention via adapted physical activity. Measurements will be performed at baseline, 3, 6 and 12 months after the start of the intervention. The primary outcome will be participants’ HRQoL, at 12 months measured by the Functional Assessment of Chronic Illness Therapy-Fatigue global score. Secondary outcome will include participants’ physical, social, emotional and functional well-being. The effect of the intervention on physical activity level, motivation for physical activity, relation to food and self-efficacy will also be evaluated.

Ethics and dissemination

The study was approved by the ‘CPP Paris XI’ Institutional Review Board on 5 May 2022 (Ref no.: 21.04512.000048-22004). The study’s findings will be shared through various channels, including academic publications, simplified reports for wider audiences and active engagement with medical and institutional organisations as well as patients’ associations.

Trial registration number

NCT05658341.

Evaluating a rehabilitative intervention for substance-dependent patients with and without their accompanying children in Germany (KontextSucht): study protocol for a non-randomised trial

Por: Stullich · A. · Hoffmann · L. · Stephan · J. · Gehrmann · J. · Richter · M. · for the KontextSucht study group
Introduction

People suffering from substance use disorders often live in social contexts with children or are parents themselves. Addicted parents show specific substance-related problems while raising their children, which often leads to various lifelong consequences for the children. The German rehabilitative treatment system allows bringing children to inpatient treatment centres. This mixed-methods study evaluates a newly developed intervention, called ‘KontextSucht’ or ‘AddictionContext’, for parents in rehabilitation treatment centres concerning the effectiveness of the intervention in parenting and abstinence outcome.

Methods and analysis

The study uses a two-stage parallel mixed-methods design. A feasibility study (stage 1) and a benefit assessment (stage 2) will be conducted to evaluate the intervention. Both parts of the study will be carried out with qualitative and quantitative work packages. German-speaking parents of children 0–14 years will be included in this study. Qualitative data will be analysed using qualitative content analyses, whereas quantitative data will be analysed descriptively using regression analysis as well as linear mixed models.

Ethics and dissemination

All participants will receive detailed information on the study and sign informed consent before data collection. The research team has obtained the approval of the Ethical Review Committee at the Technical University of Munich in Germany and will follow all legislation rules regarding data protection. The study results will be published in peer-reviewed national and international journals. Furthermore, the study results will be included in an intervention manual distributed to treatment centres.

Trial registration number

DRKS00030950.

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