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Cohort profile: Worldwide Collaboration on OsteoArthritis prediCtion for the Hip (World COACH) - an international consortium of prospective cohort studies with individual participant data on hip osteoarthritis

Por: van Buuren · M. M. A. · Riedstra · N. S. · van den Berg · M. A. · Boel · F. D. E. M. · Ahedi · H. · Arbabi · V. · Arden · N. K. · Bierma-Zeinstra · S. M. A. · Boer · C. G. · Cicuttini · F. · Cootes · T. F. · Crossley · K. · Felson · D. · Gielis · W. P. · Heerey · J. · Jones · G. · Kluz
Purpose

Hip osteoarthritis (OA) is a major cause of pain and disability worldwide. Lack of effective therapies may reflect poor knowledge on its aetiology and risk factors, and result in the management of end-stage hip OA with costly joint replacement. The Worldwide Collaboration on OsteoArthritis prediCtion for the Hip (World COACH) consortium was established to pool and harmonise individual participant data from prospective cohort studies. The consortium aims to better understand determinants and risk factors for the development and progression of hip OA, to optimise and automate methods for (imaging) analysis, and to develop a personalised prediction model for hip OA.

Participants

World COACH aimed to include participants of prospective cohort studies with ≥200 participants, that have hip imaging data available from at least 2 time points at least 4 years apart. All individual participant data, including clinical data, imaging (data), biochemical markers, questionnaires and genetic data, were collected and pooled into a single, individual-level database.

Findings to date

World COACH currently consists of 9 cohorts, with 38 021 participants aged 18–80 years at baseline. Overall, 71% of the participants were women and mean baseline age was 65.3±8.6 years. Over 34 000 participants had baseline pelvic radiographs available, and over 22 000 had an additional pelvic radiograph after 8–12 years of follow-up. Even longer radiographic follow-up (15–25 years) is available for over 6000 of these participants.

Future plans

The World COACH consortium offers unique opportunities for studies on the relationship between determinants/risk factors and the development or progression of hip OA, by using harmonised data on clinical findings, imaging, biomarkers, genetics and lifestyle. This provides a unique opportunity to develop a personalised hip OA risk prediction model and to optimise methods for imaging analysis of the hip.

Building CapaCITY/E for sustainable transportation: protocol for an implementation science research program in healthy cities

Por: Winters · M. · Fuller · D. · Cloutier · M.-S. · Harris · M. A. · Howard · A. · Kestens · Y. · Kirk · S. · Macpherson · A. · Moore · S. · Rothman · L. · Shareck · M. · Tomasone · J. R. · Laberee · K. · Stephens · Z. P. · Sones · M. · Ayton · D. · Batomen · B. · Bell · S. · Collins · P. · Diab
Introduction

Improving sustainable transportation options will help cities tackle growing challenges related to population health, congestion, climate change and inequity. Interventions supporting active transportation face many practical and political hurdles. Implementation science aims to understand how interventions or policies arise, how they can be translated to new contexts or scales and who benefits. Sustainable transportation interventions are complex, and existing implementation science frameworks may not be suitable. To apply and adapt implementation science for healthy cities, we have launched our mixed-methods research programme, CapaCITY/É. We aim to understand how, why and for whom sustainable transportation interventions are successful and when they are not.

Methods and analysis

Across nine Canadian municipalities and the State of Victoria (Australia), our research will focus on two types of sustainable transportation interventions: all ages and abilities bicycle networks and motor vehicle speed management interventions. We will (1) document the implementation process and outcomes of both types of sustainable transportation interventions; (2) examine equity, health and mobility impacts of these interventions; (3) advance implementation science by developing a novel sustainable transportation implementation science framework and (4) develop tools for scaling up and scaling out sustainable transportation interventions. Training activities will develop interdisciplinary scholars and practitioners able to work at the nexus of academia and sustainable cities.

Ethics and dissemination

This study received approval from the Simon Fraser University Office of Ethics Research (H22-03469). A Knowledge Mobilization Hub will coordinate dissemination of findings via a website; presentations to academic, community organisations and practitioner audiences; and through peer-reviewed articles.

Cost of SARS-CoV-2 self-test distribution programmes by different modalities: a micro-costing study in five countries (Brazil, Georgia, Malaysia, Ethiopia and the Philippines)

Por: Hansen · M. A. · Lekodeba · N. A. · Chevalier · J. M. · Ockhuisen · T. · del Rey-Puech · P. · Marban-Castro · E. · Martinez-Perez · G. Z. · Shilton · S. · Radzi Abu Hassan · M. · Getia · V. · Weinert-Mizuschima · C. · Tenorio Bezerra · M. I. · Chala · L. · Leong · R. · Peregino · R.
Objective

Diagnostic testing is an important tool to combat the COVID-19 pandemic, yet access to and uptake of testing vary widely 3 years into the pandemic. The WHO recommends the use of COVID-19 self-testing as an option to help expand testing access. We aimed to calculate the cost of providing COVID-19 self-testing across countries and distribution modalities.

Design

We estimated economic costs from the provider perspective to calculate the total cost and the cost per self-test kit distributed for three scenarios that differed by costing period (pilot, annual), the number of tests distributed (actual, planned, scaled assuming an epidemic peak) and self-test kit costs (pilot purchase price, 50% reduction).

Setting

We used data collected between August and December 2022 in Brazil, Georgia, Malaysia, Ethiopia and the Philippines from pilot implementation studies designed to provide COVID-19 self-tests in a variety of settings—namely, workplace and healthcare facilities.

Results

Across all five countries, 173 000 kits were distributed during pilot implementation with the cost/test distributed ranging from $2.44 to $12.78. The cost/self-test kit distributed was lowest in the scenario that assumed implementation over a longer period (year), with higher test demand (peak) and a test kit price reduction of 50% ($1.04–3.07). Across all countries and scenarios, test procurement occupied the greatest proportion of costs: 58–87% for countries with off-site self-testing (outside the workplace, for example, home) and 15–50% for countries with on-site self-testing (at the workplace). Staffing was the next key cost driver, particularly for distribution modalities that had on-site self-testing (29–35%) versus off-site self-testing (7–27%).

Conclusions

Our results indicate that it is likely to cost between $2.44 and $12.78 per test to distribute COVID-19 self-tests across common settings in five heterogeneous countries. Cost-effectiveness analyses using these results will allow policymakers to make informed decisions on optimally scaling up COVID-19 self-test distribution programmes across diverse settings and evolving needs.

Aspirin versus metformin in pregnancies at high risk of preterm pre-eclampsia in China (AVERT): protocol for a multicentre, double-blind, 3-arm randomised controlled trial

Por: Liu · J. · Shen · L. · Nguyen-Hoang · L. · Zhou · Q. · Wang · C. C. · Lu · X. · Sahota · D. · Chong · K. C. · Ying · H. · Gu · W. · Zhou · R. · Yang · H. · Jiang · Y. · Chen · D. · Li · X. · Poon · L.
Introduction

Pre-eclampsia (PE) affects about 5% of Chinese pregnant women and is a major cause of maternal and perinatal morbidity and mortality. The first trimester screening model developed by the Fetal Medicine Foundation, which uses the Bayes theorem to combine maternal characteristics and medical history together with measurements of biomarkers, has been proven to be effective and has superior screening performance to that of the traditional risk factor-based approach for the prediction of PE. Prophylactic use of low-dose aspirin in women at risk for PE has resulted in a lower incidence of preterm-PE. However, there is no consensus on the preferred aspirin dosage for the prevention of preterm-PE. Evidence has also suggested that metformin has the potential benefit in preventing PE in pregnant women who are at high risk of the disorder.

Method and analysis

We present a protocol (V.2.0, date 17 March 2022) for the AVERT trial, which is a multicentre, double-blinded, 3-arm randomised controlled trial (RCT) that uses an effective PE screening programme to explore the optimal dosage of aspirin and the role of metformin for the prevention of PE among high-risk pregnant women in China. We intend to recruit 66 000 singleton pregnancies without treatment of low-dose aspirin and metformin at 11–13 weeks’ gestation and all eligible women attending for their first trimester routine scan will be invited to undergo screening for preterm-PE by the combination of maternal factors, mean arterial pressure and placental growth factor. Women found to be at high risk of developing preterm-PE will be invited to take part in the RCT. This study will compare the incidence of preterm-PE with delivery at

Ethics and dissemination

Ethical approval for the study was obtained from the Joint Chinese University of Hong Kong–New Territories East Cluster Clinical Research Ethics Committee (CREC Ref. No. 2021.406) in Hong Kong and the Ethics Committee of each participating hospital in Mainland China. The study is registered at ClinicalTrials.gov. The results of the AVERT trial will be disseminated at international academic conferences and published in high-impact factor journals.

Trial registration number

NCT05580523.

Colchicine for the treatment of patients with COVID-19: an updated systematic review and meta-analysis of randomised controlled trials

Por: Cheema · H. A. · Jafar · U. · Shahid · A. · Masood · W. · Usman · M. · Hermis · A. H. · Naseem · M. A. · Sahra · S. · Sah · R. · Lee · K. Y.
Objectives

We conducted an updated systematic review and meta-analysis to investigate the effect of colchicine treatment on clinical outcomes in patients with COVID-19.

Design

Systematic review and meta-analysis.

Data sources

We searched PubMed, Embase, the Cochrane Library, medRxiv and ClinicalTrials.gov from inception to January 2023.

Eligibility criteria

All randomised controlled trials (RCTs) that investigated the efficacy of colchicine treatment in patients with COVID-19 as compared with placebo or standard of care were included. There were no language restrictions. Studies that used colchicine prophylactically were excluded.

Data extraction and synthesis

We extracted all information relating to the study characteristics, such as author names, location, study population, details of intervention and comparator groups, and our outcomes of interest. We conducted our meta-analysis by using RevMan V.5.4 with risk ratio (RR) and mean difference as the effect measures.

Results

We included 23 RCTs (28 249 participants) in this systematic review. Colchicine did not decrease the risk of mortality (RR 0.99; 95% CI 0.93 to 1.05; I2=0%; 20 RCTs, 25 824 participants), with the results being consistent among both hospitalised and non-hospitalised patients. There were no significant differences between the colchicine and control groups in other relevant clinical outcomes, including the incidence of mechanical ventilation (RR 0.75; 95% CI 0.48 to 1.18; p=0.22; I2=40%; 8 RCTs, 13 262 participants), intensive care unit admission (RR 0.77; 95% CI 0.49 to 1.22; p=0.27; I2=0%; 6 RCTs, 961 participants) and hospital admission (RR 0.74; 95% CI 0.48 to 1.16; p=0.19; I2=70%; 3 RCTs, 8572 participants).

Conclusions

The results of this meta-analysis do not support the use of colchicine as a treatment for reducing the risk of mortality or improving other relevant clinical outcomes in patients with COVID-19. However, RCTs investigating early treatment with colchicine (within 5 days of symptom onset or in patients with early-stage disease) are needed to fully elucidate the potential benefits of colchicine in this patient population.

PROSPERO registration number

CRD42022369850.

Linking genetic counseling communication skills to patient outcomes and experiences using a community-engagement and provider-engagement approach: research protocol for the GC-PRO mixed methods sequential explanatory study

Por: Fisher · E. R. · Cragun · D. · Dedrick · R. F. · Lumpkins · C. Y. · Ramirez · M. · Kaphingst · K. A. · Petersen · A. · MacFarlane · I. M. · Redlinger-Grosse · K. · Shire · A. · Culhane-Pera · K. A. · Zierhut · H. A.
Introduction

In over 50 years since the genetic counseling (GC) profession began, a systematic study of GC communication skills and patient-reported outcomes in actual sessions across multiple clinical specialties has never been conducted. To optimize GC quality and improve efficiency of care, the field must first be able to comprehensively measure GC skills and determine which skills are most critical to achieving positive patient experiences and outcomes. This study aims to characterise GC communication skills using a novel and pragmatic measure and link variations in communication skills to patient-reported outcomes, across clinical specialties and with patients from diverse backgrounds in the USA. Our community-engagement and provider-engagement approach is crucial to develop recommendations for quality, culturally informed GC care, which are greatly needed to improve GC practice.

Methods and analysis

A mixed methods, sequential explanatory design will be used to collect and analyze: audio-recorded GC sessions in cancer, cardiac, and prenatal/reproductive genetic indications; pre-visit and post-visit quantitative surveys capturing patient experiences and outcomes and post-visit qualitative interview data. A novel, practical checklist will measure GC communication skills. Coincidence analysis will identify patterns of GC skills that are consistent with high scores on patient-reported measures. Two-level, multilevel models will be used to evaluate how GC communication skills and other session/patient characteristics predict patient-reported outcomes. Four community advisory boards (CABs) and a genetic counselor advisory board will inform the study design and analysis.

Ethics and dissemination

This study has been approved by the single Institutional Review Board of the University of Minnesota. This research poses no greater than minimal risk to participants. Results from this study will be shared through national and international conferences and through community-based dissemination as guided by the study’s CABs. A lay summary will also be disseminated to all participants.

De-imFAR phase II project: a study protocol for a cluster randomised implementation trial to evaluate the effectiveness of de-implementation strategies to reduce low-value statin prescribing in the primary prevention of cardiovascular disease

Por: Sanchez · A. · Pijoan · J. I. · Sainz de Rozas · R. · Lekue · I. · San Vicente · R. · Quindimil · J. A. · Rotaeche · R. · Etxeberria · A. · Mozo · C. · Martinez-Cengotitabengoa · M. · Monge · M. · Gomez-Ramirez · C. · Samper · R. · Ogueta Lana · M. · Celorrio · S. · Merino-Inda · N.
Introduction

This study aims to reduce potentially inappropriate prescribing (PIP) of statins and foster healthy lifestyle promotion in cardiovascular disease (CVD) primary prevention in low-risk patients. To this end, we will compare the effectiveness and feasibility of several de-implementation strategies developed following the structured design process of the Behaviour Change Wheel targeting key determinants of the clinical decision-making process in CVD prevention.

Methods and analysis

A cluster randomised implementation trial, with an additional control group, will be launched, involving family physicians (FPs) from 13 Integrated Healthcare Organisations (IHOs) of Osakidetza-Basque Health Service with non-zero incidence rates of PIP of statins in 2021. All FPs will be exposed to a non-reflective decision assistance strategy based on reminders and decision support tools. Additionally, FPs from two of the IHOs will be randomly assigned to one of two increasingly intensive de-implementation strategies: adding a decision information strategy based on knowledge dissemination and a reflective decision structure strategy through audit/feedback. The target population comprises women aged 45–74 years and men aged 40–74 years with moderately elevated cholesterol levels but no diagnosed CVD and low cardiovascular risk (REGICOR

Ethics and dissemination

The study was approved by the Basque Country Clinical Research Ethics Committee and was registered in ClinicalTrials.gov (NCT04022850). Results will be disseminated in scientific peer-reviewed journals.

Trial registration number

NCT04022850.

Effect of platelet‐rich plasma combined with negative pressure wound therapy in treating patients with chronic wounds: A meta‐analysis

Abstract

A meta-analysis was conducted to comprehensively explore the effects of platelet-rich plasma (PRP) combined with negative pressure wound therapy (NPWT) in treating patients with chronic wounds. Computer searches were conducted, from database infection to November 2023, in EMBASE, Google Scholar, Cochrane Library, PubMed, Wanfang and China National Knowledge Infrastructure databases for randomized controlled trials (RCTs) on the use of PRP combined with NPWT technology for treating chronic wounds. Two researchers independently screened the literature, extracted data and conducted quality assessments according to the inclusion and exclusion criteria. Stata 17.0 software was employed for data analysis. Overall, 18 RCTs involving 1294 patients with chronic wounds were included. The analysis revealed that, compared with NPWT alone, the use of PRP combined with NPWT technology significantly improved the healing rate (odds ratios [OR] = 1.92, 95% confidence intervals [CIs]: 1.43–2.58, p < 0.001) and total effective rate (OR = 1.31, 95% CI: 1.23–1.39, p < 0.001), and also significantly shortened the healing time of the wound (standardized mean difference = −2.01, 95% CI: −2.58 to −1.45, p < 0.001). This study indicates that the treatment of chronic wounds with PRP combined with NPWT technology can significantly enhance clinical repair effectiveness and accelerate wound healing, with a high healing rate, and is worth further promotion and practice.

Meta‐analysis comparing different ultrasound detection methods to accurately assess wound healing and scar formation after caesarean section

Abstract

The accurate assessment of wound healing post-caesarean section, especially in twin pregnancies, remains a pivotal concern in obstetrics, given its implications for maternal health and recovery. Traditional methods, including conventional abdominal ultrasonography (CU), have been challenged by the advent of transvaginal ultrasonography (TU), offering potentially enhanced sensitivity and specificity. This meta-analysis directly compares the efficacy of TU and CU in evaluating wound healing and scar formation, crucial for optimizing postoperative care. Results indicate that TU is associated with significantly better outcomes in wound healing, demonstrated by lower REEDA scores (SMD = −20.56, 95% CI: [−27.34.20, −13.77], p < 0.01), and in scar formation reduction, evidenced by lower Manchester Scar Scale scores (SMD = −25.18, 95% CI: [−29.98, −20.39], p < 0.01). These findings underscore the potential of integrating TU into routine post-caesarean evaluation protocols to enhance care quality and patient recovery.

Skin closUre in carPal tunnEl Release (SUPER): protocol for a blinded randomised controlled trial comparing absorbable and non-absorbable sutures in carpal tunnel release

Por: Savolainen · A. · Nietosvaara · Y. · Sirola · J. · Hytönen · M. · Reito · A. · Heikkinen · N. · Räisänen · M. P.
Introduction

Carpal tunnel syndrome is a common disorder affecting a substantial portion of the general population. Surgical intervention is often deemed necessary, with the median nerve release being one of the most frequent operations. Optimising all the aspects of this procedure can enhance patient satisfaction with the treatment.

Methods and analysis

We aim to determine the differences in the aesthetic outcome of the scar as well as the pain experienced during the healing process between the use of absorbable and non-absorbable sutures. The primary outcome measure will be the patients’ subjective satisfaction with the aesthetic appearance of the scar 1 year after the operation. Secondary outcomes will include a similar evaluation of the aesthetics performed by a blinded outcome assessor, as well as pain experienced by the patients during the 2 weeks postoperatively. The severity and improvement of the patients’ symptoms will also be measured by a Finnish version of the Boston Carpal Tunnel Questionnaire. Costs will be evaluated for both groups. Safety of the wound closure will be followed and reported.

Ethics and dissemination

This protocol was approved by the Research Ethics Committee of the Northern Savo Hospital District (2319/2021). The trial will be conducted in accordance with the principles of Good Clinical Practice and the Declaration of Helsinki. The results will be disseminated through publication in peer-reviewed journals.

Trial registration number

NCT05503719.

Comparative analysis of antibodies to four major periodontal bacteria in respiratory diseases: a cohort study

Por: Lund Haheim · A. L. · Olsen · I. · Thelle · D. S. · Ronningen · K. S.
Objectives

To make a descriptive comparison of antibodies to four major periodontal bacteria and their relation to the respiratory diseases asthma and bronchitis/emphysema, and to cancer incidence.

Methods

The serum of a random sample of men with no history of cancer incidence (n=621) was analysed by the ELISA method for antibody levels of four periodontal bacteria; the anaerobes of the so-called red complex Tannerella forsythia (TF), Porphyromonas gingivalis (PG), and Treponema denticola (TD), and the facultative anaerobe Aggregatibacter actinomycetemcomitans (AA). The antibody readings were divided into quartiles and the distribution of cases of the relevant diseases as compared with the non-cases. Comparisons of the quartile distributions were by the Pearson 2 test. Data and serum from the Oslo II study of Norwegian men from 2000 were used. The ELISA analyses were performed on thawed frozen serum. Cancer data from 17.5 years of follow-up were provided by the Norwegian Cancer Registry.

Results

In all, 52 men had reported asthma and 23 men had bronchitis/emphysema at the health screening. Results on cancer incidence are given for all respiratory cancers, n=23, and bronchi and lung cancers separately, n=18. Stratified analyses were performed for the four endpoints showing significant association with low levels of TD antibodies for bronchitis; p=0.035. Both TF and TD were significant for low levels of antibodies among daily smokers; p=0.030 for TF and p

Conclusion

A low level of TD was associated with bronchitis/emphysema compared with the rest of the cohort. In the total study sample, low levels of antibodies to both TF and TD were associated with daily smoking.

Protocol for an independent patient data meta-analysis of prophylactic mesh placement for incisional hernia prevention after abdominal aortic aneurysm surgery: a collaborative European Hernia Society project (I-PREVENT-AAA)

Por: van den Berg · R. · den Hartog · F. P. J. · Bali · C. · Matsagkas · M. · Bevis · P. M. · Earnshaw · J. J. · Debus · E. S. · Honig · S. · Berrevoet · F. · Detry · O. · Stabilini · C. · Muysoms · F. · Tanis · P. J. · European Hernia Society Prophylactic mesh study group collaborato
Introduction

Incisional hernia (IH) is a prevalent and potentially dangerous complication of abdominal surgery, especially in high-risk groups. Mesh reinforcement of the abdominal wall has been studied as a potential intervention to prevent IHs. Randomised controlled trials (RCTs) have demonstrated that prophylactic mesh reinforcement after abdominal surgery, in general, is effective and safe. In patients with abdominal aortic aneurysm (AAA), prophylactic mesh reinforcement after open repair has not yet been recommended in official guidelines, because of relatively small sample sizes in individual trials. Furthermore, the identification of subgroups that benefit most from prophylactic mesh placement requires larger patient numbers. Our primary aim is to evaluate the efficacy and effectiveness of the use of a prophylactic mesh after open AAA surgery to prevent IH by performing an individual patient data meta-analysis (IPDMA). Secondary aims include the evaluation of postoperative complications, pain and quality of life, and the identification of potential subgroups that benefit most from prophylactic mesh reinforcement.

Methods and analysis

We will conduct a systematic review to identify RCTs that study prophylactic mesh placement after open AAA surgery. Cochrane Central Register of Controlled Trials, MEDLINE Ovid, Embase, Web of Science Core Collection and Google Scholar will be searched from the date of inception onwards. RCTs must directly compare primary sutured closure with mesh closure in adult patients who undergo open AAA surgery. Lead authors of eligible studies will be asked to share individual participant data (IPD). The risk of bias (ROB) for each included study will be assessed using the Cochrane ROB tool. An IPDMA will be performed to evaluate the efficacy, with the IH rate as the primary outcome. Any signs of heterogeneity will be evaluated by Forest plots. Time-to-event analyses are performed using Cox regression analysis to evaluate risk factors.

Ethics and dissemination

No new data will be collected in this study. We will adhere to institutional, national and international regulations regarding the secure and confidential sharing of IPD, addressing ethics as indicated. We will disseminate findings via international conferences, open-source publications in peer-reviewed journals and summaries posted online.

PROSPERO registration number

CRD42022347881.

Functional therapy and adenotonsillectomy clinical trial for class II malocclusion (FACT-II): protocol for a randomised controlled trial

Por: Guo · F. · Lv · C. · Tang · B. · Lin · L. · Zhang · C. · Zheng · J. · Zhao · T. · He · H.
Introduction

Class II malocclusion with mandibular retrognathia is a common complication of paediatric obstructive sleep apnoea (OSA), often accompanied by transverse maxillary deficiency. In early orthodontic treatment, a twin block (TB) is a regular functional appliance for correcting this malocclusion. For paediatric OSA, the most common risk factor is adenotonsillar hypertrophy (AHT). Untreated AHT may lead to the persistence and worsening of obstructive sleep-disordered breathing traits, including habitual mouth breathing. Additionally, the clockwise mandibular rotation associated with AHT-induced pharyngeal crowding can undermine the effectiveness and stability of TB treatment. Adenotonsillectomy (T&A) is currently the first-line treatment for paediatric OSA. This proposed trial will investigate the impact of T&A surgery timing on the efficacy and stability of TB functional treatment in children with class II mandibular retrognathia and ATH.

Methods and analysis

This will be a single-centre, parallel-group, superiority randomised controlled trial with participants randomised to intervention (T&A followed by TB treatment) or control arms (TB treatment followed by T&A) in a 1:1 ratio. A total of 40 patients aged 8–14 years, diagnosed with class II mandibular retrognathia and co-existing ATH-induced OSA, and indicated for both T&A surgery and TB treatment, will be recruited at the School and Hospital of Stomatology, Wuhan University. The primary outcomes will be the changes in the apnoea-hypopnoea index and the point A-nasion-point B angle from baseline to postorthodontic treatment between the two groups. Secondary outcomes will include other dental, skeletal, upper airway and soft tissue changes, as well as subjective sleep-related and oral-related quality of life. Outcome changes within each group and between groups will be analysed.

Ethics and dissemination

This study is approved by the Ethics Committee of the School and Hospital of Stomatology, Wuhan University (no. 2022-D07). The research findings will be faithfully disseminated through scientific conferences or published articles.

Trial registration number

ChiCTR2200061703 (https://www.chictr.org.cn).

Multicentre double-blind randomised placebo-controlled trial evaluating the efficacy of the meningococcal B vaccine, 4CMenB (Bexsero), against Neisseria gonorrhoeae infection in men who have sex with men: the GoGoVax study protocol

Por: Seib · K. L. · Donovan · B. · Thng · C. · Lewis · D. A. · McNulty · A. · Fairley · C. K. · Yeung · B. · Jin · F. · Fraser · D. · Bavinton · B. R. · Law · M. · Chen · M. Y. · Chow · E. P. F. · Whiley · D. M. · Mackie · B. · Jennings · M. P. · Jennison · A. V. · Lahra · M. M. · Grulich · A. E
Introduction

Gonorrhoea, the sexually transmissible infection caused by Neisseria gonorrhoeae, has a substantial impact on sexual and reproductive health globally with an estimated 82 million new infections each year worldwide. N. gonorrhoeae antimicrobial resistance continues to escalate, and disease control is largely reliant on effective therapy as there is no proven effective gonococcal vaccine available. However, there is increasing evidence from observational cohort studies that the serogroup B meningococcal vaccine four-component meningitis B vaccine (4CMenB) (Bexsero), licensed to prevent invasive disease caused by Neisseria meningitidis, may provide cross-protection against the closely related bacterium N. gonorrhoeae. This study will evaluate the efficacy of 4CMenB against N. gonorrhoeae infection in men (cis and trans), transwomen and non-binary people who have sex with men (hereafter referred to as GBM+).

Methods and analysis

This is a double-blind, randomised placebo-controlled trial in GBM+, either HIV-negative on pre-exposure prophylaxis against HIV or living with HIV (CD4 count >350 cells/mm3), who have had a diagnosis of gonorrhoea or infectious syphilis in the last 18 months (a key characteristic associated with a high risk of N. gonorrhoeae infection). Participants are randomised 1:1 to receive two doses of 4CMenB or placebo 3 months apart. Participants have 3-monthly visits over 24 months, which include testing for N. gonorrhoeae and other sexually transmissible infections, collection of demographics, sexual behaviour risks and antibiotic use, and collection of research samples for analysis of N. gonorrhoeae-specific systemic and mucosal immune responses. The primary outcome is the incidence of the first episode of N. gonorrhoeae infection, as determined by nucleic acid amplification tests, post month 4. Additional outcomes consider the incidence of symptomatic or asymptomatic N. gonorrhoeae infection at different anatomical sites (ie, urogenital, anorectum or oropharynx), incidence by N. gonorrhoeae genotype and antimicrobial resistance phenotype, and level and functional activity of N. gonorrhoeae-specific antibodies.

Ethics and dissemination

Ethical approval was obtained from the St Vincent’s Hospital Human Research Ethics Committee, St Vincent’s Hospital Sydney, NSW, Australia (ref: 2020/ETH01084). Results will be disseminated in peer-reviewed journals and via presentation at national and international conferences.

Trial registration number

NCT04415424.

Identifying carers in general practice (STATUS QUO): a multicentre, cross-sectional study in England

Por: Lawton · S. · Mallen · C. · Hussain · Z. · Bajpai · R. · Muller · S. · Holmstrom · C. · Jinks · C. · Helliwell · T.
Objectives

To determine General Practice (GP) recording of carer status and the number of patients self-identifying as carers, while self-completing an automated check-in screen prior to a GP consultation.

Design

A descriptive cross-sectional study.

Setting

11 GPs in the West Midlands, England. Recruitment commenced in September 2019 and concluded in January 2020.

Participants

All patients aged 10 years and over, self-completing an automated check-in screen, were invited to participate during a 3-week recruitment period.

Primary and secondary outcome measures

The current coding of carers at participating GPs and the number of patients identifying themselves as a carer were primary outcome measures. Secondary outcome measures included the number of responses attained from automated check-in screens as a research data collection tool and whether carers felt supported in their carer role.

Results

80.3% (n=9301) of patients self-completing an automated check-in screen participated in QUantifying the identification Of carers in general practice (STATUS QUO Study) (62.6% (n=5822) female, mean age 52.9 years (10–98 years, SD=20.3)). Prior to recruitment, the clinical code used to denote a carer was identified in 2.7% (n=2739) of medical records across the participating GPs.

10.1% (n=936) of participants identified themselves as a carer. They reported feeling supported with their own health and social care needs: always 19.3% (n=150), a lot of the time 13.2% (n=102), some of the time 40.8% (n=317) and never 26.7% (n=207).

Conclusions

Many more participants self-identified as a carer than were recorded on participating GP lists. Improvements in the recording of the population’s caring status need to be actioned, to ensure that supportive implementation strategies for carers are effectively received. Using automated check-in facilities for research continues to provide high participation rates.

Cost-effectiveness of a radio intervention to stimulate early childhood development: protocol for an economic evaluation of the SUNRISE trial in Burkina Faso

Por: Palmer · T. · Clare · A. · Fearon · P. · Head · R. · Hill · Z. · Kagone · B. · Kirkwood · B. · Manu · A. · Skordis · J. · on behalf of the SUNRISE team
Introduction

Approximately 250 million children under 5 years of age are at risk of poor development in low-income and middle-income countries. However, existing early childhood development (ECD) interventions can be expensive, labour intensive and challenging to deliver at scale. Mass media may offer an alternative approach to ECD intervention. This protocol describes the planned economic evaluation of a cluster-randomised controlled trial of a radio campaign promoting responsive caregiving and opportunities for early learning during the first 3 years of life in rural Burkina Faso (SUNRISE trial).

Methods and analysis

The economic evaluation of the SUNRISE trial will be conducted as a within-trial analysis from the provider’s perspective. Incremental costs and health outcomes of the radio campaign will be compared with standard broadcasting (ie, ‘do nothing’ comparator). All costs associated with creating and broadcasting the radio campaign during intervention start-up and implementation will be captured. The cost per child under 3 years old reached by the intervention will be calculated. Incremental cost-effectiveness ratios will be calculated for the trial’s primary outcome (ie, incremental cost per SD of cognitive gain). A cost-consequence analysis will also be presented, whereby all relevant costs and outcomes are tabulated. Finally, an analysis will be conducted to assess the equity impact of the intervention.

Ethics and dissemination

The SUNRISE trial has ethical approval from the ethics committees of the Ministry of Health, Burkina Faso, University College London and the London School of Hygiene and Tropical Medicine. The results of the economic evaluation will be disseminated in a peer-reviewed journal and presented at a relevant international conference.

Trial registration number

The SUNRISE trial was registered with ClinicalTrials.gov on 19 April 2019 (identifier: NCT05335395).

Professionals perspectives on interventions to reduce problematic alcohol use in older adults: a realist evaluation of working elements

Por: van den Bulck · F. A. E. · Knijff · R. · Crutzen · R. · van de Mheen · D. · Bovens · R. H. L. M. · Stutterheim · S. E. · Van de Goor · I. · Rozema · A. D.
Objectives

This study set out to understand how (which elements), in what context and why (which mechanisms) interventions are successful in reducing (problematic) alcohol use among older adults, from the perspective of professionals providing these interventions.

Design

Guided by a realist evaluation approach, an existing initial programme theory (IPT) on working elements in alcohol interventions was evaluated by conducting semistructured interviews with professionals.

Setting and participants

These professionals (N=20) provide interventions across several contexts: with or without practitioner involvement; in-person or not and in an individual or group setting. Data were coded and links between contexts, elements, mechanisms and outcomes were sought for to confirm, refute or refine the IPT.

Results

From the perspective of professionals, there are several general working elements in interventions for older adults: (1) pointing out risks and consequences of drinking behaviour; (2) paying attention to abstinence; (3) promoting contact with peers; (4) providing personalised content and (5) providing support. We also found context-specific working elements: (1) providing personalised conversations and motivational interviewing with practitioners; (2) ensuring safety, trust and a sense of connection and a location nearby home or a location that people are familiar with in person and (3) sharing experiences and tips in group interventions. Furthermore, the mechanisms awareness and accessible and low threshold participation were important contributors to positive intervention outcomes.

Conclusion

In addition to the IPT, our findings emphasise the need for social contact and support, personalised content, and strong relationships (both between client and practitioner, and client and peers) in interventions for older adults.

Real-world data evaluating Guys rapid diagnostic clinic as an alternate pathway for patients with FIT levels below 10

Por: Monroy-Iglesias · M. J. · Martin · S. · Cargaleiro · C. · Jones · G. · Steward · L. · Murtagh · C. · Bruno · F. · Millwaters · J. · Schizas · A. · Watson · H. · Haire · A. · Haire · K. · Moss · C. L. · Russell · B. · Srirajaskanthan · R. · Van Hemelrijck · M. · Dolly · S.
Objective

To analyse the effectiveness of rapid diagnostic clinics (RDCs) as an alternative pathway for patients with concerning symptoms and a faecal immunochemical test (FIT) result

Design

A retrospective and prospective cohort study.

Setting

GSTT RDC, one of England’s largest single-centre RDCs. Sociodemographic and clinical characteristics of FIT

Participants

Patients with an FIT result

Results

A total of 1299 patients with an FIT

Conclusion

This study demonstrates the effectiveness of RDCs as an alternate pathway for FIT

How do people living with obesity who use obesity services perceive healthcare professionals representation of the disease on social media? An interpretative phenomenological analysis

Por: Maher · S. · McHugh · J. · Crotty · M. · Birney · S. · OConnell · J. · Finucane · F. · Spooner · M.
Objectives

The objective of this study was to explore how people living with obesity who use obesity services perceive healthcare professionals’ (HCPs) online representation of the disease on social media. By exploring their perspective, we aimed to develop a framework to inform good practice around social media use for HCPs.

Design

This was a qualitative study using a phenomenological framework. Following in-depth semi-structured interviews, analysis was undertaken to identify superordinate themes relating to how HCPs portray living with obesity online.

Setting

Patient advocacy organisation (The Irish Coalition for People Living with Obesity) and three clinical sites offering obesity treatment in Ireland.

Participants

15 adult participants comprising of 12 women and 3 men who use social media and are living with obesity and who use obesity services.

Results

Three key themes of how people living with obesity who use obesity services perceive HCP’s online representation of the disease. (1) Negative experiences of HCPs—participants describe encountering weight stigma and bias on social media from HCPs that they characterised as simplistic and outdated conceptualisations. These engender shame, fear and anger. (2) Positive experience of HCPs—participants report social media allows HCPs to educate and inform public perception of obesity. Positive online experiences lead to feelings of inclusion, understanding and encouragement. (3) Expectations of HCPs—qualifications, professional titles and academic association affected the perceived trustworthiness of information and its impact on readers. Participants feel there is a duty of care for HCPs in obesity medicine to advocate and be active online to provide accurate medical information.

Conclusion

HCP’s use of social media has a powerful impact on people with obesity who use healthcare and obesity services. Social media is a key tool in obesity awareness and education. We propose the ‘3E’ framework—Empower, Evidence-Based and Educate and be educated to guide HCPs’ social media use.

Chronic disease prevention and screening outcomes for patients with and without financial difficulty: a secondary analysis of the BETTER WISE cluster randomised controlled trial

Por: Aubrey-Bassler · K. · Patel · D. · Fernandes · C. · Lofters · A. K. · Campbell-Scherer · D. · Meaney · C. · Moineddin · R. · Wong · T. · Pinto · A. D. · Shea-Budgell · M. · McBrien · K. · Grunfeld · E. · Manca · D. P.
Objective

Building on Existing Tools To improvE chronic disease pRevention and screening in primary care Wellness of cancer survIvorS and patiEnts (BETTER WISE) was designed to assess the effectiveness of a cancer and chronic disease prevention and screening (CCDPS) programme. Here, we compare outcomes in participants living with and without financial difficulty.

Design

Secondary analysis of a cluster-randomised controlled trial.

Setting

Patients of 59 physicians from 13 clinics enrolled between September 2018 and August 2019.

Participants

596 of 1005 trial participants who responded to a financial difficulty screening question at enrolment.

Intervention

1-hour CCDPS visit versus usual care.

Outcome measures

Eligibility for a possible 24 CCDPS actions was assessed at baseline and the primary outcome was the percentage of eligible items that were completed at 12-month follow-up. We also compared the change in response to the financial difficulty screening question between baseline and follow-up.

Results

55 of 265 participants (20.7%) in the control group and 69 of 331 participants (20.8%) in the intervention group reported living with financial difficulty. The primary outcome was 29% (95% CI 26% to 33%) for intervention and 23% (95% CI 21% to 26%) for control participants without financial difficulty (p=0.01). Intervention and control participants with financial difficulty scored 28% (95% CI 24% to 32%) and 32% (95% CI 27% to 38%), respectively (p=0.14). In participants who responded to the financial difficulty question at both time points (n=302), there was a net decrease in the percentage of participants who reported financial difficulty between baseline (21%) and follow-up (12%, p

Conclusion

The BETTER intervention improved uptake of CCDPS manoeuvres in participants without financial difficulty, but not in those living with financial difficulty. Improving CCDPS for people living with financial difficulty may require a different clinical approach or that social determinants be addressed concurrently with clinical and lifestyle needs or both.

Trial registration number

ISRCTN21333761.

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