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☐ ☆ ✇ BMJ Open

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. — Abril 17th 2024 at 17:18
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.

☐ ☆ ✇ BMJ Open

Outcomes after cancer diagnosis in children and adult patients with congenital heart disease in Sweden: a registry-based cohort study

Por: Karazisi · C. · Dellborg · M. · Mellgren · K. · Giang · K. W. · Skoglund · K. · Eriksson · P. · Mandalenakis · Z. — Abril 17th 2024 at 17:18
Objective

Patients with congenital heart disease (CHD) have an increased cancer risk. The aim of this study was to determine cancer-related mortality in CHD patients compared with non-CHD controls, compare ages at cancer diagnosis and death, and explore the most fatal cancer diagnoses.

Design

Registry-based cohort study.

Setting and participants

CHD patients born between 1970 and 2017 were identified using Swedish Health Registers. Each was matched by birth year and sex with 10 non-CHD controls. Included were those born in Sweden with a cancer diagnosis.

Results

Cancer developed in 758 out of 67814 CHD patients (1.1%), with 139 deaths (18.3%)—of which 41 deaths occurred in patients with genetic syndromes. Cancer was the cause of death in 71.9% of cases. Across all CHD patients, cancer accounted for 1.8% of deaths. Excluding patients with genetic syndromes and transplant recipients, mortality risk between CHD patients with cancer and controls showed no significant difference (adjusted HR 1.17; 95% CI 0.93 to 1.49). CHD patients had a lower median age at cancer diagnosis—13.0 years (IQR 2.9–30.0) in CHD versus 24.6 years (IQR 8.6–35.1) in controls. Median age at death was 15.1 years (IQR 3.6–30.7) in CHD patients versus 18.5 years (IQR 6.1–32.7) in controls. The top three fatal cancer diagnoses were ill-defined, secondary and unspecified, eye and central nervous system tumours and haematological malignancies.

Conclusions

Cancer-related deaths constituted 1.8% of all mortalities across all CHD patients. Among CHD patients with cancer, 18.3% died, with cancer being the cause in 71.9% of cases. Although CHD patients have an increased cancer risk, their mortality risk post-diagnosis does not significantly differ from non-CHD patients after adjustements and exclusion of patients with genetic syndromes and transplant recipients. However, CHD patients with genetic syndromes and concurrent cancer appear to be a vulnerable group.

☐ ☆ ✇ BMJ Open

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. — Abril 17th 2024 at 17:18
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.

☐ ☆ ✇ BMJ Open

Randomised controlled, patient-blinded, multicentre, superiority trial to evaluate the efficacy of the line-attached sheath-type traction device for endoscopic submucosal dissection in patients with superficial gastric neoplasms

Por: Abe · H. · Sako · T. · Yamamoto · Y. · Ikeda · A. · Kawara · F. · Ose · T. · Takao · T. · Kitamura · Y. · Ariyoshi · R. · Morita · Y. · Ishida · T. · Ikegawa · T. · Ishida · R. · Yoshizaki · T. · Sakaguchi · H. · Toyonaga · T. · Kodama · Y. — Abril 17th 2024 at 17:18
Introduction

EndoTrac is a line-attached sheath-type traction device that enables us to control the direction and the force of traction during endoscopic submucosal dissection (ESD). The efficacy of EndoTrac for gastric ESD has not been fully verified.

Methods and analysis

The G-Trac study is a multicentre (nine general hospitals and two university hospitals in Japan) collaborative trial assessing the efficacy of EndoTrac for gastric ESDs. Patients with superficial gastric neoplasms will be enrolled and randomly assigned to undergo either conventional ESD or EndoTrac ESD. Allocation will be stratified according to tumour location, operator experience and tumour diameter at an allocation rate of 1:1. The type of endoknife used will be confirmed before randomisation. The primary outcome, procedure time, will be compared between the groups in both intention-to-treat and per-protocol analyses using the Wilcoxon rank sum test. The efficacy-related, safety-related and device-related outcomes will be assessed in the secondary analysis. The planned sample size of the 142 patients in the two groups will enable us to detect a difference with a power of 80% by using the Wilcoxon rank sum test, assuming an effect size of 0.54, asymptotic relative efficiency of 0.864 and a two-sided type 1 error rate of 5%.

Ethics and dissemination

This trial was approved by the certified review board of Kobe University (22 December 2022). The results from this trial will be disseminated through peer-review journals, presentations at national and international conferences, and data sharing with other researchers.

Trial registration number

jRCT1052220166.

☐ ☆ ✇ BMJ Open

Trends and determinants of clinical staff retention in the English NHS: a double retrospective cohort study

Por: Moscelli · G. · Nicodemo · C. · Sayli · M. · Mello · M. — Abril 17th 2024 at 00:31
Objectives

To investigate how demographic, contractual and organisational factors are related to the retention of hospital workers in the English NHS. The study will specifically examine the trends in age-retention profiles.

Design

A double retrospective cross-cohort study using administrative data on senior and specialty doctors, nurses and midwives who were included in the 2009 and 2014 payrolls of all English NHS hospital Trusts. These individuals were tracked over time until 2019 to examine the associations between sociodemographic characteristics and the retention of hospital workers in each cohort. Logistic regressions were estimated at the individual worker level to analyse the data. Additionally, a multilevel panel regression was performed using linked payroll-survey data to investigate the association between hospital organisation characteristics and the retention of clinical staff.

Setting

Secondary acute and mental healthcare NHS hospital Trusts in England.

Participants

70 777 senior doctors (specialty and specialist doctors and hospital consultants) aged 30–70, and a total of 448 568 between nurses and midwives of any grade aged 20–70, employed by English NHS Trusts.

Primary outcome measures

Employee retention, measured through binary indicators for stayers and NHS leavers, at 1-year and 5-year horizons.

Results

Minority doctors had lower 1-year retention rates in acute care than white doctors, while minority nurses and midwives saw higher retention. Part-time roles decreased retention for doctors but improved it for nurses. Fixed-term contracts negatively impacted both groups’ retention. Trends diverged for nurses and doctors from 2009 to 2014—nurses’ retention declined while doctors’ 5-year retention slightly rose. Engagement boosted retention among clinical staff under 51 years of age in acute care. For nurses over 50, addressing their feedback was positively associated with retention.

Conclusions

Demographic and contractual factors appear to be stronger predictors of hospital staff retention than organisational characteristics.

☐ ☆ ✇ BMJ Open

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. — Abril 16th 2024 at 18:01
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.

☐ ☆ ✇ BMJ Open

Missed nursing care and its associated factors in public hospitals of Bahir Dar City, Northwest Ethiopia: a cross-sectional study

Por: Abere · Y. · Biresaw · H. · Misganaw · M. · Netsere · B. · Adal · O. — Abril 16th 2024 at 18:01
Objectives

The aim of this study was to investigate the prevalence of missed nursing care and its associated factors among public hospitals in Bahir Dar City, Northwest Ethiopia.

Design

An institution-based cross-sectional study was conducted among 369 randomly selected nurses.

Setting

The study was conducted in primary and secondary-level public hospitals in Bahir Dar City.

Participants

Nurses who had worked in hospitals in Bahir Dar City were included.

Intervention

No intervention was needed in this study.

Primary and secondary outcome measures

A binary logistic regression model was used for statistical analysis. Statistical significance of the association between outcome variables and independent variables was declared at a p value of

Results

The prevalence of missed nursing care in this study was 46.3% (95% CI: 41.7% to 50.9%). The activities most frequently missed were physical examination (56.4%), patient discharge planning and teaching (50.9%), providing emotional support to the patient and family (50.8%), monitoring input and output (50.2%), assisting with patient ambulation (48.5%) and documentation (48%). Factors associated with missed nursing care include: male professionals (adjusted OR (AOR): 2.9, 95% CI: 1.8 to 4.8), those who had not received on-the-job training (AOR: 2.2, 95% CI: 1.4 to 3.6), those who worked full 24-hour shifts (AOR: 3.7, 95% CI: 2.0 to 6.5), those who were dissatisfied with the level of teamwork (AOR: 4.6, 95% CI: 2.8 to 7.6) and those who had an intention to leave the nursing profession (AOR: 1.8, 95% CI: 1.1 to 2.9). These factors were statistically associated with missed nursing care.

Conclusion

A significant proportion of nurses missed essential nursing care activities. Efforts should be made to enhance training, improve teamwork among nurses, provide stability and adjust work shifts to mitigate this issue.

☐ ☆ ✇ BMJ Open

Impact of supplementation with iron-folic acid (IFA) and vitamin D3 compared with IFA alone on haemoglobin levels in elderly people with mild-to-moderate anaemia: protocol for the double-blind, randomised, placebo-controlled Iron and vitamin D trial in El

Por: Ahamed · F. · Jaiswal · A. · Sahoo · S. · Ghosh · T. · Kaur · A. · Rehman · T. · Goswami · K. — Abril 16th 2024 at 18:01
Introduction

Anaemia in the elderly is often difficult to treat with iron supplementation alone as prevalence of anaemia of chronic disease (ACD) alone or mixed with iron-deficiency anaemia (IDA) is high in this age group. Hepcidin remains high in ACD, preventing utilisation of iron for heme synthesis. Vitamin D3 has shown hepcidin suppression activity in both in vitro and in vivo studies. As there is no study assessing the effect of iron–folic acid (IFA) with vitamin D3 on haemoglobin levels in the elderly in India, we want to conduct this study to estimate the impact of supplementation of a therapeutic package of IFA and vitamin D3 on haemoglobin levels in the elderly with mild-to-moderate anaemia in comparison with IFA only. The study will also assess the impact of the proposed intervention on ferritin, hepcidin, 25-hydroxyvitamin D, C reactive protein (CRP) and parathyroid hormone (PTH) levels.

Methods and analysis

This study is a community-based, double-blind, placebo-controlled, randomised trial. The study will be done in the Kalyani municipality area. Individuals aged ≥60 years with mild-to-moderate anaemia and normal vitamin D3 levels will be randomised into the intervention (IFA and vitamin D3 supplementation) group or the control group (IFA and olive oil as placebo). All medications will be self-administered. Follow-up will be done on a weekly basis for 12 weeks. The calculated sample size is 150 in each arm. Block randomisation will be done. The primary outcome is change in haemoglobin levels from baseline to 12 weeks. Secondary outcome is change in serum ferritin, 25-hydroxyvitamin D, hepcidin, CRP and PTH levels from baseline to 12 weeks.

Ethics and dissemination

Ethical approval from the Institutional Ethics Committee of All India Institute of Medical Sciences Kalyani has been obtained (IEC/AIIMS/Kalyani/Meeting/2022/03). Written informed consent will be obtained from each study participant. The trial results will be reported through publication in a reputable journal and disseminated through health talks within the communities.

Trial registration number

CTRI/2022/05/042775.

Protocol version

Version 1.0.

☐ ☆ ✇ BMJ Open

Modelling of physicians clinical information-seeking behaviour in Iran: a grounded theory study

Por: Daei · A. · Soleymani · M. R. · Zargham-Boroujeni · A. · Kelishadi · R. · Ashrafi-rizi · H. — Abril 16th 2024 at 18:01
Objectives

Exploring clinical information-seeking behaviour (CISB) and its associated factors contributes to its theoretical advancement and offers a valuable framework for addressing physicians’ information needs. This study delved into the dimensions, interactions, strategies and determinants of CISB among physicians at the point of care.

Design

A grounded theory study was developed based on Strauss and Corbin’s approach. Data were collected by semistructured interviews and then analysed through open, axial and selective coding.

Setting

The study was conducted at academic centres affiliated with Isfahan University of Medical Sciences.

Participants

This investigation involved recruiting 21 specialists and subspecialists from the academic centres.

Results

The findings revealed that physicians’ CISB encompassed multiple dimensions when addressing clinical inquiries. Seven principal themes emerged from the analysis: ‘clinical information needs’, ‘clinical question characteristics’, ‘clinical information resources’, ‘information usability’, ‘factors influencing information seeking’, ‘action/interaction encountering clinical questions’ and ‘consequences of CISB’. The core category identified in this study was ‘focused attention’.

Conclusions

The theoretical explanation demonstrated that the CISB process was interactive and dynamic. Various stimuli, including causal, contextual and intervening conditions, guide physicians in adopting information-seeking strategies and focusing on resolving clinical challenges. However, insufficient stimuli may hinder physicians’ engagement in CISB. Understanding CISB helps managers, policy-makers, clinical librarians and information system designers optimally implement several interventions, such as suitable training methods, reviewing monitoring and evaluating information systems, improving clinical decision support systems, electronic medical records and electronic health records, as well as monitoring and evaluating these systems. Such measures facilitate focused attention on clinical issues and promote CISB among physicians.

☐ ☆ ✇ BMJ Open

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. — Abril 16th 2024 at 18:01
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.

☐ ☆ ✇ BMJ Open

Predictive factors of clot propagation in patients with superficial venous thrombosis towards deep venous thrombosis and pulmonary embolism: a systematic review and meta-analysis

Por: van Royen · F. S.-A. · van Smeden · M. · van Doorn · S. · Rutten · F. H. · Geersing · G.-J. — Abril 16th 2024 at 18:01
Objective

A subset of patients with superficial venous thrombosis (SVT) experiences clot propagation towards deep venous thrombosis (DVT) and/or pulmonary embolism (PE). The aim of this systematic review is to identify all clinically relevant cross-sectional and prognostic factors for predicting thrombotic complications in patients with SVT.

Design

Systematic review.

Data sources

PubMed/MEDLINE and Embase were systematically searched until 3 March 2023.

Eligibility criteria

Original research studies with patients with SVT, DVT and/or PE as the outcome and presenting cross-sectional or prognostic predictive factors.

Data extraction and synthesis of results

The CHecklist for critical Appraisal and data extraction for systematic Reviews of prediction Modelling (CHARMS) checklist for prognostic factor studies was used for systematic extraction of study characteristics. Per identified predictive factor, relevant estimates of univariable and multivariable predictor—outcome associations were extracted, such as ORs and HRs. Estimates of association for the most frequently reported predictors were summarised in forest plots, and meta-analyses with heterogeneity were presented. The Quality in Prognosis Studies (QUIPS) tool was used for risk of bias assessment and Grading of Recommendations, Assessment, Development and Evaluations (GRADE) for assessing the certainty of evidence.

Results

Twenty-two studies were included (n=10 111 patients). The most reported predictive factors were high age, male sex, history of venous thromboembolism (VTE), absence of varicose veins and cancer. Pooled effect estimates were heterogenous and ranged from OR 3.12 (95% CI 1.75 to 5.59) for the cross-sectional predictor cancer to OR 0.92 (95% CI 0.56 to 1.53) for the prognostic predictor high age. The level of evidence was rated very low to low. Most studies were scored high or moderate risk of bias.

Conclusions

Although the pooled estimates of the predictors high age, male sex, history of VTE, cancer and absence of varicose veins showed predictive potential in isolation, variability in study designs, lack of multivariable adjustment and high risk of bias prevent firm conclusions. High-quality, multivariable studies are necessary to be able to identify individual SVT risk profiles.

PROSPERO registration number

CRD42021262819.

☐ ☆ ✇ BMJ Open

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 — Abril 16th 2024 at 18:01
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.

☐ ☆ ✇ BMJ Open

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. — Abril 16th 2024 at 18:01
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).

☐ ☆ ✇ BMJ Open

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 — Abril 16th 2024 at 18:01
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.

☐ ☆ ✇ BMJ Open

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. — Abril 16th 2024 at 18:01
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.

☐ ☆ ✇ BMJ Open

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 — Abril 16th 2024 at 18:01
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).

☐ ☆ ✇ BMJ Open

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. — Abril 16th 2024 at 08:27
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.

☐ ☆ ✇ BMJ Open

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. — Abril 16th 2024 at 08:27
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

☐ ☆ ✇ BMJ Open

Labour Care Guide implementation as a decision-making tool for monitoring labour among healthcare providers in Uganda: protocol for a mixed-methods study

Por: Mugyenyi · G. R. · Byamugisha · J. · Tumuhimbise · W. · Atukunda · E. · Yarine · F. T. — Abril 16th 2024 at 08:27
Introduction

The new WHO Labour Care Guide (LCG), also regarded as the ‘next-generation partograph’, is a core component of 2018 WHO consolidated guidelines on intrapartum care for positive childbirth experience. The Ugandan Ministry of Health is in the process of adopting the new WHO LCG with no local context-specific data to inform this transition. We will explore potential barriers and facilitators to healthcare providers’ (HCPs) sustained engagement in labour monitoring in Mbarara city, Southwestern Uganda, and use the data to refine the new WHO LCG and develop a suitable implementation strategy to effectively integrate LCG into routine maternity care in Uganda. We shall then assess effectiveness, validity and other preliminary implementation outcomes of using the new LCG in detecting prolonged labour.

Methods and analysis

The study will use a mixed-methods approach to identify key LCG user perspectives to refine and customise the WHO LCG among 120 HCPs and stakeholders involved in maternity care and labour monitoring within facilities in Southwestern Uganda. The refined prototype will be deployed and used to monitor labour in all 14 basic and comprehensive emergency obstetric and newborn care facilities in the study area. We will review labour outcomes of 520 patients monitored using the new LCG and compare these outcomes with a historical cohort of 520 patients monitored using the partograph. The main effectiveness outcome will be the proportion of women diagnosed with prolonged labour and/or obstructed labour.

Ethics and dissemination

Ethical approval was obtained from the Mbarara University of Science and Technology Research Ethics Committee (MUST-2023-808) and Uganda National Council for Science and Technology (HS2864ES). We shall obtain written informed consent from each participant. The results of this study will be published in international peer-reviewed journals and presented to the Ugandan Ministry of Health as policy briefs and at selected national/international conferences.

Trial registration number

NCT05979194.

☐ ☆ ✇ BMJ Open

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. — Abril 16th 2024 at 08:27
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.

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