FreshRSS

🔒
❌ Acerca de FreshRSS
Hay nuevos artículos disponibles. Pincha para refrescar la página.
AnteayerBMJ Open

Implementation of an intervention aimed at deprescribing benzodiazepines in a large US healthcare system using patient education materials: a pre/post-observational study with a control group

Por: Le · T. M. · Campbell · S. · Andraos · A. · Ahlmark · P. · Hoang · H. · Isserman · S. · Goldzweig · C. L. · Mays · A. M. · Bradley · K. · Keller · M. S.
Objectives

Long-term benzodiazepine use is common despite known risks. In the original Eliminating Medications Through Patient Ownership of End Results (EMPOWER) Study set in Canada, patient education led to increased rates of benzodiazepine cessation. We aimed to determine the effectiveness of implementing an adapted EMPOWER quality improvement (QI) initiative in a US-based healthcare system.

Design

We used a pre–post design with a non-randomised control group.

Setting

A network of primary care clinics.

Participants

Patients with ≥60 days’ supply of benzodiazepines in 6 months and ≥1 risk factor (≥65 years of age, a concurrent high-risk medication prescribed or a diazepam equivalent daily dose ≥10) were eligible.

Intervention

In March 2022, we engaged 22 primary care physicians (PCPs), and 308 of their patients were mailed an educational brochure, physician letter and flyer detailing benzodiazepine risks; the control group included 4 PCPs and 291 of their patients.

Primary and secondary measures

The primary measure was benzodiazepine cessation by 9 months. We used logistic regression and a generalised estimating equations approach to control for clustering by PCP, adjusting for demographics, frailty, number of risk factors, and diagnoses of arthritis, depression, diabetes, falls, and pain.

Results

Patients in the intervention and control groups were comparable across most covariates; however, a greater proportion of intervention patients had pain-related diagnoses and depression. By 9 months, 26% of intervention patients (81 of 308) had discontinued benzodiazepines, compared with 17% (49 of 291) of control patients. Intervention patients had 1.73 greater odds of benzodiazepine discontinuation compared with controls (95% CI: 1.09, 2.75, p=0.02). The unadjusted number needed to treat was 10.5 (95% CI: 6.30, 34.92) and the absolute risk reduction was 0.095 (95% CI: 0.03 to 0.16).

Conclusions

Results from this non-randomised QI initiative indicate that patient education programmes using the EMPOWER brochures have the potential to promote cessation of benzodiazepines in primary care.

Gendered gaps to tuberculosis prevention and care in Kenya: a political economy analysis study

Por: Abdullahi · L. H. · Oketch · S. · Komen · H. · Mbithi · I. · Millington · K. · Mulupi · S. · Chakaya · J. · Zulu · E. M.
Background

Tuberculosis (TB) remains a public health concern in Kenya despite the massive global efforts towards ending TB. The impediments to TB prevention and care efforts include poor health systems, resource limitations and other sociopolitical contexts that inform policy and implementation. Notably, TB cases are much higher in men than women. Therefore, the political economy analysis (PEA) study provides in-depth contexts and understanding of the gender gaps to access and successful treatment for TB infection.

Design

PEA adopts a qualitative, in-depth approach through key informant interviews (KII) and documentary analysis.

Setting and participants

The KIIs were distributed among government entities, academia, non-state actors and community TB groups from Kenya.

Results

The themes identified were mapped onto the applied PEA analysis framework domains. The contextual and institutional issues included gender concerns related to the disconnect between TB policies and gender inclusion aspects, such as low prioritisation for TB programmes, limited use of evidence to inform decisions and poor health system structures. The broad barriers influencing the social contexts for TB programmes were social stigma and cultural norms such as traditional interventions that negatively impact health-seeking behaviours. The themes around the economic situation were poverty and unemployment, food insecurity and malnutrition. The political context centred around the systemic and governance gaps in the health system from the national and devolved health functions.

Conclusion

Broad contextual factors identified from the PEA widen the disparity in targeted gender efforts toward men. Following the development of effective TB policies and strategies, it is essential to have well-planned gendered responsive interventions with a clear implementation plan and monitoring system to enhance access to TB prevention and care.

Experiences and resultant care gaps among women with HIV in Canada: concept mapping the Canadian HIV Womens Sexual and Reproductive Health Cohort Study (CHIWOS) findings

Por: Medeiros · P. · Koebel · J. · Yu · A. · Kazemi · M. · Nicholson · V. · Frank · P. · Persad · Y. · O'Brien · N. · Bertozzi · B. · Smith · S. · Ndung'u · M. · Fraleigh · A. · Gagnier · B. · Cardinal · C. · Webster · K. · Sanchez · M. · Lee · M. · Lacombe-Duncan · A. · Logie · C. H. · Gormley
Objectives

The community-based, longitudinal, Canadian HIV Women’s Sexual and Reproductive Health Cohort Study (CHIWOS) explored the experiences of women with HIV in Canada over the past decade. CHIWOS’ high-impact publications document significant gaps in the provision of healthcare to women with HIV. We used concept mapping to analyse and present a summary of CHIWOS findings on women’s experiences navigating these gaps.

Design

Concept mapping procedures were performed in two steps between June 2019 and March 2021. First, two reviewers (AY and PM) independently reviewed CHIWOS manuscripts and conference abstracts written before 1 August 2019 to identify main themes and generate individual concept maps. Next, the preliminary results were presented to national experts, including women with HIV, to consolidate findings into visuals summarising the experiences and care gaps of women with HIV in CHIWOS.

Setting

British Columbia, Ontario and Quebec, Canada.

Participants

A total of 18 individual CHIWOS team members participated in this study including six lead investigators of CHIWOS and 12 community researchers.

Results

Overall, a total of 60 peer-reviewed manuscripts and conference abstracts met the inclusion criteria. Using concept mapping, themes were generated and structured through online meetings. In total, six composite concept maps were co-developed: quality of life, HIV care, psychosocial and mental health, sexual health, reproductive health, and trans women’s health. Two summary diagrams were created encompassing the concept map themes, one for all women and one specific to trans women with HIV. Through our analysis, resilience, social support, positive healthy actions and women-centred HIV care were highlighted as strengths leading to well-being for women with HIV.

Conclusions

Concept mapping resulted in a composite summary of 60 peer-reviewed CHIWOS publications. This activity allows for priority setting to optimise care and well-being for women with HIV.

Characteristics and treatment for severe postpartum haemorrhage in different midwifery hospitals in one district of Beijing in China: an institution-based, retrospective cohort study

Por: Yang · Y. · Shao · Y. · Chen · H. · Guo · X. · Liang · Y. · Wang · Y. · Zhao · Y.
Objective

To identify the characteristics and treatment approaches for patients with severe postpartum haemorrhage (SPPH) in various midwifery institutions in one district in Beijing, especially those without identifiable antenatal PPH high-risk factors, to improve regional SPPH rescue capacity.

Design

Retrospective cohort study.

Setting

This study was conducted at 9 tertiary-level hospitals and 10 secondary-level hospitals in Haidian district of Beijing from January 2019 to December 2022.

Participants

The major inclusion criterion was SPPH with blood loss ≥1500 mL or needing a packed blood product transfusion ≥1000 mL within 24 hours after birth. A total of 324 mothers with SPPH were reported to the Regional Obstetric Quality Control Office from 19 midwifery hospitals.

Outcome measures

The pregnancy characteristics collected included age at delivery, gestational weeks at delivery, height, parity, delivery mode, antenatal PPH high-risk factors, aetiology of PPH, bleeding amount, PPH complications, transfusion volume and PPH management. SPPH characteristics were compared between two levels of midwifery hospitals and their association with antenatal PPH high-risk factors was determined.

Results

SPPH was observed in 324 mothers out of 106 697 mothers in the 4 years. There were 74.4% and 23.9% cases of SPPH without detectable antenatal PPH high-risk factors in secondary and tertiary midwifery hospitals, respectively. Primary uterine atony was the leading cause of SPPH in secondary midwifery hospitals, whereas placental-associated disorders were the leading causes in tertiary institutions. Rates of red blood cell transfusion over 10 units, unscheduled returns to the operating room and adverse PPH complications were higher in patients without antenatal PPH high-risk factors. Secondary hospitals had significantly higher rates of trauma compared with tertiary institutions.

Conclusion

Examining SPPH cases at various institutional levels offers a more comprehensive view of regional SPPH management and enhances targeted training in this area.

Internet-delivered transdiagnostic psychological treatments for individuals with depression, anxiety or both: a systematic review with meta-analysis of randomised controlled trials

Por: Kolaas · K. · Berman · A. H. · Hedman-Lagerlöf · E. · Lindsäter · E. · Hybelius · J. · Axelsson · E.
Objective

Depression and anxiety are major public health problems. This study evaluated the effects of internet-delivered transdiagnostic psychological treatments for individuals with depression, anxiety, or both.

Design

Systematic review with meta-analysis.

Data sources

Medline (Ovid), Cochrane Library (Wiley), the Web of Science Core Collection (Clarivate), and PsycInfo (EBSCO) were searched on 24 May 2021, with an update on 6 February 2023.

Eligibility criteria

Randomised controlled trials of internet-delivered transdiagnostic psychological treatments, open to both participants with primary depression and participants with primary anxiety. This review concerned all treatment frameworks, both guided and unguided formats and all age groups.

Data extraction and synthesis

In random-effects meta-analysis, we estimated pooled effects on depression symptoms and anxiety in terms of Hedges’ g with 95% CIs. Absolute and relative heterogeneity was quantified as the 2 and I 2.

Results

We included 57 trials with 21 795 participants. Nine trials (16%) recruited exclusively from routine care, and three (5%) delivered treatment via video. For adults, large within-group reductions were seen in depression (g=0.90; 95% CI 0.81 to 0.99) and anxiety (g=0.87; 95% CI 0.78 to 0.96). Compared with rudimentary passive controls, the added effects were moderate (depression: g=0.52; 95% CI 0.42 to 0.63; anxiety: g=0.45; 95% CI 0.34 to 0.56) and larger in trials that required all participants to meet full diagnostic criteria for depression or an anxiety disorder. Compared with attention/engagement controls, the added effects were small (depression: g=0.30; 95% CI 0.07 to 0.53; anxiety: g=0.21; 95% CI 0.01 to 0.42). Heterogeneity was substantial, and the certainty of the evidence was very low. Two trials concerned adolescents and reported mixed results. One trial concerned older adults and reported promising results.

Conclusion

Internet-delivered transdiagnostic treatments for depression and anxiety show small-to-moderate added effects, varying by control condition. Research is needed regarding routine care, the video format, children and adolescents and older adults.

PROSPERO registration number

CRD42021243172.

Measurement properties of the Mental Health Literacy Scale (MHLS) validation studies: a systematic review protocol

Por: ElKhalil · R. · AlMekkawi · M. · O'Connor · M. · Sherif · M. · Masuadi · E. · Ahmed · L. A. · Al-Rifai · R. H. · Belfakir · M. · Bayoumi · R. · Elbarazi · I.
Introduction

Mental Health Literacy (MHL) is important for improving mental health and reducing inequities in treatment. The Mental Health Literacy Scale (MHLS) is a valid and reliable assessment tool for MHL. This systematic review will examine and compare the measurement properties of the MHLS in different languages, enabling academics, clinicians and policymakers to make informed judgements regarding its use in assessments.

Methods and analysis

The review will adhere to the COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) methodology for systematic reviews of patient-reported outcome measures and the Joanna Briggs Institute (JBI) Manual for Evidence Synthesis and will be presented following the Preferred Reporting Items for Systematic reviews and Meta-Analysis 2020 checklist. The review will be conducted in four stages, including an initial search confined to PubMed, a search of electronic scientific databases PsycINFO, CINAHL, Scopus, MEDLINE, Embase (Elsevier), PubMed (NLM) and ERIC, an examination of the reference lists of all papers to locate relevant publications and finally contacting the MHLS original author to identify validation studies that the searches will not retrieve. These phases will assist us in locating studies that evaluate the measurement properties of MHLS across various populations, demographics and contexts. The search will focus on articles published in English between May 2015 and December 2023. The methodological quality of the studies will be evaluated using the COSMIN Risk of Bias checklist, and a comprehensive qualitative and quantitative data synthesis will be performed.

Ethics and dissemination

Ethics approval is not required. The publication will be in peer-reviewed journals and presented at national and international conferences.

PROSPERO registration number

CRD42023430924.

Efficacy of electro-acupuncture versus sham acupuncture for diabetic peripheral neuropathy: study protocol for a three-armed randomised controlled trial

Por: Zhuang · R. · Xiong · Z. · Yan · S. · Zhang · H. · Dong · Q. · Liu · W. · Miao · J. · Zhuo · Y. · Fan · X. · Zhang · W. · Wang · X. · Liu · L. · Cao · J. · Zhang · T. · Hao · C. · Huang · X. · Jiang · L.
Introduction

Specific treatment for diabetic peripheral neuropathy (DPN) is still lacking, and acupuncture may relieve the symptoms. We intend to investigate the efficacy and safety of electro-acupuncture (EA) in alleviating symptoms associated with DPN in diabetes.

Methods and analysis

This multicentre, three-armed, participant- and assessor-blind, randomised, sham-controlled trial will recruit 240 eligible participants from four hospitals in China and will randomly assign (1:1:1) them to EA, sham acupuncture (SA) or usual care (UC) group. Participants in the EA and SA groups willl receive either 24-session EA or SA treatment over 8 weeks, followed by an 8-week follow-up period, while participants in the UC group will be followed up for 16 weeks. The primary outcome of this trial is the change in DPN symptoms from baseline to week 8, as rated by using the Total Symptom Score. The scale assesses four symptoms: pain, burning, paraesthesia and numbness, by evaluating the frequency and severity of each. All results will be analysed with the intention-to-treat population.

Ethics and dissemination

The protocol has been approved by the Ethics Committee of the Beijing University of Chinese Medicine (Identifier: 2022BZYLL0509). Every participant will be informed of detailed information about the study before signing informed consent. The results of this trial will be published in a peer-reviewed journal.

Trial registration number

ChiCTR2200061408.

Quality measures of virtual care in ambulatory healthcare environments: a scoping review

Por: Petrie · S. · Laur · C. · Rios · P. · Suarez · A. · Makanjuola · O. · Burke · E. · Bhattacharyya · O. · Mukerji · G.
Objectives

Delivery of virtual care increased throughout the COVID-19 pandemic and persisted after physical distancing measures ended. However, little is known about how to measure the quality of virtual care, as current measures focus on in-person care and may not apply to a virtual context. This scoping review aims to understand the connections between virtual care modalities used with ambulatory patient populations and quality measures across the Quintuple Aim (provider experience, patient experience, per capita cost, population health and health equity).

Design

Virtual care was considered any interaction between patients and/or their circle of care occurring remotely using any form of information technology. Five databases (MEDLINE, Embase, PsycInfo, Cochrane Library, JBI) and grey literature sources (11 websites, 3 search engines) were searched from 2015 to June 2021 and again in August 2022 for publications that analysed virtual care in ambulatory settings. Indicators were extracted, double-coded into the Quintuple Aim framework; patient and provider experience indicators were further categorised based on the National Academy of Medicine quality framework (safety, effectiveness, patient-centredness, timeliness, efficiency and equity). Sustainability was added to capture the potential for continued use of virtual care.

Results

13 504 citations were double-screened resulting in 631 full-text articles, 66 of which were included. Common modalities included video or audio visits (n=43), remote monitoring (n=11) and mobile applications (n=11). The most common quality indicators were related to patient experience (n=58 articles), followed by provider experience (n=25 articles), population health outcomes (n=23 articles) and health system costs (n=19 articles).

Conclusions

The connections between virtual care modalities and quality domains identified here can inform clinicians, administrators and other decision-makers how to monitor the quality of virtual care and provide insights into gaps in current quality measures. The next steps include the development of a balanced scorecard of virtual care quality indicators for ambulatory settings to inform quality improvement.

Protocol for a randomised controlled trial: optimisation of perioperative analgesia protocol for uniportal video-assisted thoracoscopic surgery

Por: Wang · L. F. · Feng · H. X. · Shi · Y. H. · Li · Y. · Zheng · M. T. · Bu · T. · Zhang · Z. R.
Introduction

Postoperative pain after thoracic surgery impairs patients’ quality of life and increases the incidence of respiratory complications. Optimised analgesia strategies include minimally invasive incisions, regional analgesia and early chest tube removal. However, little is known about the optimal analgesic regimen for uniportal video-assisted thoracoscopic surgery (uVATS).

Methods and analysis

We will conduct a single-centre, prospective, single-blind, randomised trial. The effects of postoperative analgesia will be tested using thoracic paravertebral block (PVB) in combination with patient-controlled intravenous analgesia (PVB+PCIA), erector spinae plane block (ESPB) in combination with patient-controlled intravenous analgesia (ESPB+PCIA) or PCIA alone; 102 patients undergoing uVATS will be enrolled in this study. Patients will be randomly assigned to the PVB group (30 mL of 0.33% ropivacaine with dexamethasone), ESPB group (40 mL of 0.25% ropivacaine with dexamethasone) or control groups. PCIA with sufentanil will be administered to all patients after surgery. The primary outcome will be total opioid consumption after surgery. Secondary outcomes include postoperative pain score; postoperative chronic pain at rest and during coughing; sensations of touch and pain in the chest wall, non-opioid analgesic consumption; length of stay; ambulation time, the total cost of hospitalisation and long-term postoperative analgesia. Adverse reactions to analgesics and adverse events related to the regional blocks will also be recorded. The statisticians will be blinded to the group allocation. Comparison of the continuous data among the three groups will be performed using a one-way analysis of variance to assess differences among the means.

Ethics and dissemination

The results will be published in patient education courses, academic conferences and peer-reviewed journals.

Trial registration number

NCT06016777.

Alcohol use among in-school adolescents in Sierra Leone

Por: Osborne · A. · Aboagye · R. G. · Olorunsaiye · C. Z. · James · P. B. · Bangura · C. · Seidu · A.-A. · Kangbai · J. B. · Ahinkorah · B. O.
Objective

To examine the prevalence of alcohol use and its associated factors among in-school adolescents in Sierra Leone.

Design

Data for the study was sourced from the 2017 Sierra Leone Global School-Based Student Health Survey, a nationally representative survey conducted among in-school adolescents aged 10–19 years using a multistage sampling methodology. Percentages were used to present the prevalence of alcohol use among in-school adolescents. Multivariable binary logistic regression analysis was performed to examine the factors associated with alcohol use among in-school adolescents. The results were presented using adjusted odds ratios (aOR) with their respective 95% confidence interval (CI).

Setting

Sierra Leone.

Participants

A weighted sample of 1730 in-school adolescents in Sierra Leone.

Outcome measure

Current alcohol use.

Results

The prevalence of alcohol use among in-school adolescents was 10.7% (7.3, 15.3). In-school adolescents in senior secondary schools were more likely to use alcohol compared with those in junior secondary school (aOR=2.13; 95% CI 1.37, 3.30). The odds of alcohol use was higher among in-school adolescents who were truant at school relative to those who were not (aOR=2.24; 95% CI 1.54, 3.26). Also, in-school adolescents who were bullied (aOR=1.85; 95% CI 1.24, 2.76), ever engaged in sexual intercourse (aOR=2.06; 95% CI 1.39, 3.06), and used marijuana (aOR=3.36; 95% CI 1.72, 6.53) were more likely to use alcohol compared with those who were not. However, in-school adolescents who reported that their parents understood their problems (aOR=0.52; 95% CI 0.33, 0.82) had a lower likelihood of consuming alcohol.

Conclusion

Our study has shown that alcohol use is prevalent among in-school adolescents in Sierra Leone. Grade level, experiences of being bullied, history of sexual intercourse, truancy at school, and previous use of marijuana were the factors influencing alcohol use among in-school adolescents. The findings emphasise the necessity of creating school-based health interventions in Sierra Leone that can effectively identify in-school adolescents potentially vulnerable to alcohol-related issues. Also, existing policies and programmes aimed at reducing alcohol use among in-school adolescents need to be strengthened.

Prospective diagnostic accuracy study of history taking and physical examination for adults with vertigo in general practice: study protocol

Por: Ross · A. · Leemeyer · A.-M. R. · Bruintjes · T. D. · Cals · J. W. L. · Bronstein · A. · van Leeuwen · R. B. · Lissenberg-Witte · B. · van Vugt · V. A. · Rutgers · S. · Maarsingh · O. R.
Introduction

Vertigo is a prevalent and burdensome symptom. More than 80% of patients with vertigo are primarily treated by their general practitioner (GP) and are never referred to a medical specialist. Despite this therapeutic responsibility, the GP’s diagnostic toolkit has serious limitations. All recommended tests lack empirical evidence, because a diagnostic accuracy study on vestibular disorders (‘How well does test x discriminate between patients with or without target condition y?’) has never been performed in general practice. The VERtigo DIagnosis study aims to fill this gap.

Methods and analysis

We will perform a diagnostic accuracy study on vertigo of primary vestibular origin in general practice to assess the discriminative ability of history taking and physical examination. We will compare all index tests with a respective reference standard. We will focus on five target conditions that account for more than 95% of vertigo diagnoses in general practice: (1) benign paroxysmal positional vertigo, (2) vestibular neuritis, (3) Ménière’s disease, (4) vestibular migraine (VM) and (5) central causes other than VM. As these five target conditions have a different pathophysiology and lack one generally accepted gold standard, we will use consensus diagnosis as a construct reference standard. Data for each patient, including history, physical examination and additional tests as recommended by experts in an international Delphi procedure, will be recorded on a standardised form and independently reviewed by a neurologist and otorhinolaryngologist. For each patient, the reviewers have to decide about the presence/absence of each target condition. We will calculate sensitivity, specificity, predictive values, likelihood ratios and diagnostic ORs, followed by decision rules for each target condition.

Ethics and dissemination

The study obtained approval from the Vrije Universiteit Medical Center Medical Ethical Review Committee (reference: 2022.0817—NL83111.029.22). We will publish our findings in peer-reviewed international journals.

Trial registration number

ISRCTN97250704.

Effectiveness of an anti-inflammatory diet versus low-fat diet for knee osteoarthritis: the FEAST randomised controlled trial protocol

Por: Law · L. · Heerey · J. L. · Devlin · B. L. · Brukner · P. · Kemp · J. L. · Attanayake · A. · Hulett · M. D. · De Livera · A. · Mosler · A. B. · Morris · H. G. · White · N. P. · Culvenor · A. G.
Introduction

Chronic inflammation plays a key role in knee osteoarthritis pathophysiology and increases risk of comorbidities, yet most interventions do not typically target inflammation. Our study will investigate if an anti-inflammatory dietary programme is superior to a standard care low-fat dietary programme for improving knee pain, function and quality-of-life in people with knee osteoarthritis.

Methods and analysis

The eFEct of an Anti-inflammatory diet for knee oSTeoarthritis study is a parallel-group, assessor-blinded, superiority randomised controlled trial. Following baseline assessment, 144 participants aged 45–85 years with symptomatic knee osteoarthritis will be randomly allocated to one of two treatment groups (1:1 ratio). Participants randomised to the anti-inflammatory dietary programme will receive six dietary consultations over 12 weeks (two in-person and four phone/videoconference) and additional educational and behaviour change resources. The consultations and resources emphasise nutrient-dense minimally processed anti-inflammatory foods and discourage proinflammatory processed foods. Participants randomised to the standard care low-fat dietary programme will receive three dietary consultations over 12 weeks (two in-person and one phone/videoconference) consisting of healthy eating advice and education based on the Australian Dietary Guidelines, reflecting usual care in Australia. Adherence will be assessed with 3-day food diaries. Outcomes are assessed at 12 weeks and 6 months. The primary outcome will be change from baseline to 12 weeks in the mean score on four Knee injury and Osteoarthritis Outcome Score (KOOS4) subscales: knee pain, symptoms, function in daily activities and knee-related quality of life. Secondary outcomes include change in individual KOOS subscale scores, patient-perceived improvement, health-related quality of life, body mass and composition using dual-energy X-ray absorptiometry, inflammatory (high-sensitivity C reactive protein, interleukins, tumour necrosis factor-α) and metabolic blood biomarkers (glucose, glycated haemoglobin (HbA1c), insulin, liver function, lipids), lower-limb function and physical activity.

Ethics and dissemination

The study has received ethics approval from La Trobe University Human Ethics Committee. Results will be presented in peer-reviewed journals and at international conferences.

Trial registration number

ACTRN12622000440729.

Association between proton pump inhibitors and risk of hepatic encephalopathy in patients undergoing transjugular intrahepatic portosystemic shunt: a protocol for a systematic review and meta-analysis

Por: Su · Y. · Chen · Y. · Zheng · J. · Yao · C.
Introduction

Hepatic encephalopathy (HE) is a major complication of acute liver failure, cirrhosis and transjugular intrahepatic portosystemic shunt (TIPS) placement. Its clinical manifestations range from mild cognitive deficits to coma. Furthermore, HE is a financial burden to a patient’s family and significantly affects the patient’s quality of life. In clinical practice, proton pump inhibitors (PPIs) are widely used for the treatment of HE. The use of PPIs is associated with an increased risk of post-TIPS HE; however, findings on the risk relationship between PPIs and post-TIPS HE are inconsistent. Therefore, a systematic evaluation of the relationship is needed to further provide valid evidence for the rational use of PPIs in patients who undergo TIPS.

Methods and analysis

PubMed, Web of Science, Cochrane Library and Embase will be searched extensively for relevant information. Information from 1 July 2023 to 31 July 2023 in these databases will be included. Primary outcomes will be the use of PPIs and incidence of HE after TIPS; secondary outcomes will be survival, dose dependence and adverse events. This meta-analysis will be reported in accordance with the 50 Preferred Reporting Items for Systematic Reviews and Meta-Analyses 2020. The risk of bias, heterogeneity and quality of evidence of the included studies will be evaluated prior to the data analysis. All data will be analysed using Review Manager (V.5.4.1) and Stata (V.17.0) statistical software.

Ethics and dissemination

Ethical approval will not be necessary for this review and meta-analysis. The results of the study will be published in a peer-reviewed journal.

PROSPERO registration number

CRD42022359208.

Protocol for a construct and clinical validation study of MyCog Mobile: a remote smartphone-based cognitive screener for older adults

Por: Young · S. R. · McManus Dworak · E. · Byrne · G. J. · Jones · C. M. · Yoshino Benavente · J. · Yao · L. · Curtis · L. M. · Varela Diaz · M. · Gershon · R. · Wolf · M. · Nowinski · C.
Introduction

Annual cognitive screening in older adults is essential for early detection of cognitive impairment, yet primary care settings face time constraints that present barriers to routine screening. A remote cognitive screener completed on a patient’s personal smartphone before a visit has the potential to save primary care clinics time, encourage broader screening practices and increase early detection of cognitive decline. MyCog Mobile is a promising new remote smartphone-based cognitive screening app for primary care settings. We propose a combined construct and clinical validation study of MyCog Mobile.

Methods and analysis

We will recruit a total sample of 300 adult participants aged 65 years and older. A subsample of 200 healthy adult participants and a subsample of 100 adults with a cognitive impairment diagnosis (ie, dementia, mild cognitive impairment, cognitive deficits or other memory loss) will be recruited from the general population and specialty memory care centres, respectively. To evaluate the construct validity of MyCog Mobile, the healthy control sample will self-administer MyCog Mobile on study-provided smartphones and be administered a battery of gold-standard neuropsychological assessments. We will compare correlations between performance on MyCog Mobile and measures of similar and dissimilar constructs to evaluate convergent and discriminant validity. To assess clinical validity, participants in the clinical sample will self-administer MyCog Mobile on a smartphone and be administered a Mini-Cog screener and these data will be combined with the healthy control sample. We will then apply several supervised model types to determine the best predictors of cognitive impairment within the sample. Area under the receiver operating characteristic curve, accuracy, sensitivity and specificity will be the primary performance metrics for clinical validity.

Ethics and dissemination

The Institutional Review Board at Northwestern University (STU00214921) approved this study protocol. Results will be published in peer-reviewed journals and summaries provided to the study’s funders.

Head impact differences in blind football between Rio 2016 and Tokyo 2020 Paralympic Games: video-based observational study

Por: Tsutsumi · S. · Sasadai · J. · Maeda · N. · Tamura · Y. · Nagao · T. · Watanabe · T. · Arima · S. · Kaneda · K. · Yoshimi · M. · Mizuta · R. · Ishihara · H. · Shimizu · R. · Fukui · K. · Tashiro · T. · Komiya · M. · Suzuki · A. · Urabe · Y.
Objective

In Tokyo 2020 Paralympic Games, there were the rule and goal size changes at the blind football competition. This study aimed to compare the scoring and head impact characteristics during blind football competition between the Rio 2016 and Tokyo 2020 Paralympic Games using the official videos.

Design

Video-based observational study.

Participants

In total, 36 blind football (men’s football 5-a-side) game videos were obtained from the official International Paralympic Committee.

Primary and secondary outcome measures

Head impact was defined as the sudden contact of any object with the head. Videos were analysed to assess the number of scores and head impacts along with their corresponding details (ie, round, playing phase, scoring situation, impact situation, occurrence area, impact object, head impact site, fall and foul).

Results

The total number of goals scored at the Tokyo 2020 Paralympic Games was nearly double that at the Rio 2016 Paralympic Games. Regarding head impacts, a total of 2036 cases (Rio 2016, n=1105; Tokyo 2020, n=931) were evaluated. Significant differences were observed in head impact characteristics between the Rio 2016 and Tokyo 2020 Paralympic Games among seven outcomes (round, scoring situation, impact situation, occurrence area, impact object, site of head impact and fall).

Conclusions

Compared with the Rio 2016 Paralympic Games, the Tokyo 2020 Paralympic Games showed an increase in the number of points scored and different head impact characteristics.

Information needs on type 1 diabetes mellitus (T1DM) and its management in children and adolescents: a qualitative study

Por: Muhammed Elamin · S. · Muhamad Arshad · N. F. · Md Redzuan · A. · Abdul Aziz · S. A. · Hong · J. · Chua · X. Y. · Bin-Abbas · B. S. · Alsagheir · A. · Mohamed Shah · N.
Objective

The objective of this study is to explore the information needs related to insulin therapy in children and adolescents with type 1 diabetes mellitus (T1DM) from the children’s perspectives as well as their caregivers.

Design

Qualitative study; semistructured interviews. To identify emerging themes relating to information needs, open coding and thematic analysis were employed.

Setting

Participants were recruited from a tertiary care children’s hospital in Kuala Lumpur, Malaysia and a specialist hospital in Riyadh, Saudi Arabia.

Participants

Thirty one children with a mean age of 11.5 years (SD=1.9) and their caregivers were interviewed. Seventeen participants were from Malaysia and 14 were from Saudi Arabia.

Results

Four themes of information emerged from the interviews, including information related to (1) hypoglycaemia and hyperglycaemia, (2) insulin therapy, (3) injection technique and (4) other information needs pertaining to continuous glucose monitoring, access to peer groups and future advances in insulin therapy.

Conclusion

This study provided valuable insights into the information needs related to T1DM and insulin therapy among children and adolescents with T1DM that should be considered by stakeholders in the development of age-appropriate education materials. Such materials will assist children and adolescents to better manage their life-long T1DM condition from adolescence until adulthood.

Preoperative pancreatic stent placement before the enucleation of insulinoma located in the head and neck of the pancreas in proximity to the main pancreatic duct: study protocol for a multicentre randomised clinical trial in Chinese tertiary medical cent

Por: Gao · R. · Yin · B. · Jin · J. · Tian · X. · Zhang · Y. · Wei · J. · Cao · F. · Wang · Z. · Ma · Z. · Wang · M. · Gou · S. · Cong · L. · Xu · Q. · Wu · W. · Zhao · Y.
Introduction

The surgical intervention approach to insulinomas in proximity to the main pancreatic duct remains controversial. Standard pancreatic resection is recommended by several guidelines; however, enucleation (EN) still attracts surgeons with less risk of late exocrine/endocrine insufficiency, despite a higher postoperative pancreatic fistula (POPF) rate. Recently, the efficacy and safety of preoperative pancreatic stent placement before the EN have been demonstrated. Thus, a multicentre open-label study is being conducted to evaluate the efficacy and safety of stent placement in improving the outcome of EN of insulinomas in proximity to the main pancreatic duct.

Methods and analysis

This is a prospective, randomised, open-label, superiority clinical trial conducted at multiple tertiary centres in China. The major eligibility criterion is the presence of insulinoma located in the head and neck of the pancreas in proximity (≤2 mm) to the main pancreatic duct. Blocked randomisation will be performed to allocate patients into the stent EN group and the direct EN group. Patients in the stent EN group will go through stent placement by the endoscopist within 24 hours before the EN surgery, whereas other patients will receive EN surgery directly. The primary outcome is the assessment of the superiority of stent placement in reducing POPF rate measured by the International Study Group of Pancreatic Surgery standard. Both interventions will be performed in an inpatient setting and regular follow-up will be performed. The primary outcome (POPF rate) will be tested for superiority with the X2 test. The difference in secondary outcomes between the two groups will be analysed using appropriate tests.

Ethics and dissemination

The study has been approved by the Peking Union Medical College Hospital Institutional Review Board (K23C0195), Ruijin Hospital Ethics Committee (2023-314), Peking University First Hospital Ethics Committee (2024033-001), Institutional Review Board of Xuanwu Hospital of Capital Medical University (2023223-002), Ethics Committee of the First Affiliated Hospital of Xi’an Jiaotong University (XJTU1AF2023LSK-473), Institutional Review Board of Tongji Medical College Tongji Hospital (TJ-IRB202402059), Ethics Committee of Tongji Medical College Union Hospital (2023-0929) and Shanghai Cancer Center Institutional Review Board (2309282-16). The results of the study will be published in an international peer-reviewed journal.

Trial registration number

NCT05523778.

Real-world treatment patterns and clinical outcomes from a retrospective chart review study of patients with recurrent or advanced endometrial cancer who progressed following prior systemic therapy in Europe

Por: Zhang · J. · Kelkar · S. S. · Prabhu · V. S. · Qiao · Y. · Grall · V. · Miles · N. · Marth · C.
Objective

To evaluate real-world treatment patterns and clinical outcomes in recurrent/advanced endometrial cancer patients who progressed following prior systemic therapy in clinical practice in Europe.

Design

Endometrial Cancer Health Outcomes-Europe (ECHO-EU) is a retrospective patient chart review study.

Setting

ECHO-EU is a multicentre study conducted in the UK, Germany, Italy, France and Spain.

Participants

Patients with recurrent/advanced endometrial cancer who progressed between 1 July 2016 and 30 June 2019 following prior first-line systemic therapy were eligible and data were collected until last available follow-up through November 2021.

Primary and secondary outcome measures

Data collected included patient demographics, clinical and treatment characteristics, and clinical outcomes. Kaplan-Meier analyses were performed since initiation of second-line therapy to estimate time to treatment discontinuation, real-world progression-free survival (rwPFS) and overall survival (OS).

Results

A total of 475 patients were included from EU5 countries. Median age was 69 years at advanced endometrial cancer diagnosis, 78.7% had stage IIIB–IV disease, 45.9% had Eastern Cooperative Oncology Group status ≥2 at second-line therapy initiation. In second line, a majority of patients initiated either non-platinum-based chemotherapy (55.6%) or endocrine therapy (16.2%). Physician-reported real-world overall response rate (classified as complete or partial response) to second-line therapy was 34.5%, median rwPFS was 7.4 months (95% CI 6.2 to 8.0) and median OS was 11.0 months (95% CI 9.9 to 12.3).

Conclusions

Patients had poor clinical outcomes with a median OS of

Mental health inequalities, challenges and support needs during COVID-19: a qualitative study of 14-to-25-year-olds in London

Por: Lee · J. · Wong · K. K.-Y.
Objectives

The impact of the COVID-19 pandemic on adolescent’s mental health and relationships has received growing attention, yet the challenges and support needs of adolescents living in existing deprivation are not well understood. The current qualitative study, part of a broader project cocreating mental health and life-skill workshops with young people, documents adolescents’ lived experience and support needs 4 years on from the COVID-19 pandemic.

Design

20 semi-structured interviews and 6 focus groups were transcribed and thematically analysed in NVivo V.12 to inform codesigned workshops to support adolescents’ needs.

Setting

Islington borough in North London, United Kingdom.

Participants

20 adolescents aged 14–25 years (mean=18.3; 60% female, 60% white) from Islington with a history of difficulties (eg, mental health, deprivation, court order) were referred by Islington local authority teams to our study.

Results

Thematic analyses revealed eight themes on adolescents’ COVID-19 experiences and five associated suggestions on ‘support needs’: health challenges and support; relationships and support; routines and support; educational challenges and learning support; inequality and support; distrust; loss of opportunities and grief.

Conclusions

In our qualitative study, adolescents spoke of positive reflections, challenges, and need for support 4 years on from the COVID-19 pandemic. Many adolescents shared their lived experiences for the first time with someone else and wished they would have the space and time to acknowledge this period of loss. Adolescents living with existing inequality and deprivation before the pandemic have reported sustained and exacerbated impacts during the pandemic, hence coproduced support for adolescents should be a priority.

Supplements for cognitive ability in patients with mild cognitive impairment or Alzheimers disease: a protocol for systematic review and network meta-analysis of randomised controlled trials

Por: Zhang · X.-Y. · Li · Y.-Q. · Yin · Z.-H. · Bao · Q.-N. · Xia · M.-Z. · Chen · Z.-H. · Zhong · W.-Q. · Wu · K.-X. · Yao · J. · Liang · F.-R.
Introduction

Considering the increasing incidence of Alzheimer’s disease (AD) and mild cognitive impairment (MCI) worldwide, there is an urgent need to identify efficacious, safe and convenient treatments. Numerous investigations have been conducted on the use of supplements in this domain, with oral supplementation emerging as a viable therapeutic approach for AD or MCI. Nevertheless, given the multitude of available supplements, it becomes imperative to identify the optimal treatment regimen.

Methods and analysis

Eight academic databases and three clinical trial registries will be searched from their inception to 1 June 2023. To identify randomised controlled trials investigating the effects of supplements on patients with AD or MCI, two independent reviewers (X-YZ and Y-QL) will extract relevant information from eligible articles, while the risk of bias in the included studies will be assessed using the Rob 2.0 tool developed by the Cochrane Collaboration. The primary outcome of interest is the overall cognitive function. Pair-wise meta-analysis will be conducted using RevMan V.5.3, while network meta-analysis will be carried out using Stata 17.0 and ADDIS 1.16.8. Heterogeneity test, data synthesis and subgroup analysis will be performed if necessary. The GRADE system will be employed to assess the quality of evidence. This study is scheduled to commence on 1 June 2023 and conclude on 1 October 2023.

Ethics and dissemination

Ethics approval is not required for systematic review and network meta-analysis. The results will be submitted to a peer-reviewed journal or at a conference.

Trial registration number

PROSPERO (CRD42023414700).

❌