Cohort profile: COBLAnCE: a French prospective cohort to study prognostic and predictive factors in bladder cancer and to generate real-world data on treatment patterns, resource use and quality of life

Purpose
Bladder cancer is a complex disease with a wide range of outcomes. Clinicopathological factors only partially explain the variability between patients in prognosis and treatment response. There is a need for large cohorts collecting extensive data and biological samples to: (1) investigate gene-environment interactions, pathological/molecular classification and biomarker discovery; and (2) describe treatment patterns, outcomes, resource use and quality of life in a real-world setting.

Participants
COBLAnCE (COhort to study BLAdder CancEr) is a French national prospective cohort of patients with bladder cancer recruited between 2012 and 2018 and followed for 6 years. Data on patient and tumour characteristics, treatments, outcomes and biological samples are collected at enrolment and during the follow-up.

Findings to date
We describe the cohort at enrolment according to baseline surgery and tumour type. In total, 1800 patients were included: 1114 patients with non-muscle-invasive bladder cancer (NMIBC) and 76 patients with muscle-invasive bladder cancer (MIBC) had transurethral resection of a bladder tumour without cystectomy, and 610 patients with NMIBC or MIBC underwent cystectomy. Most patients had a solitary lesion (56.3%) without basement membrane invasion (71.7% of Ta and/or Tis). Half of the patients with cystectomy were stage ≤T2 and 60% had non-continent diversion. Surgery included local (n=298) or super-extended lymph node dissections (n=11) and prostate removal (n=492). Among women, 16.5% underwent cystectomy and 81.4% anterior pelvectomy.

Future plans
COBLAnCE will be used for long-term studies of bladder cancer with focus on clinicopathological factors and molecular markers. It will lead to a much-needed improvement in the understanding of the disease. The cohort provides valuable real-world data, enabling researchers to study various research questions, assess routine medical practices and guide medical decision-making.

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Dicembre 2023

Effectiveness of transcranial direct current stimulation (tDCS) as adjunctive treatment for chronic headache in adults with clinically stable systemic lupus erythematosus (SHADE): a randomised double-blind multiarm sham controlled clinical trial

Background
Chronic headache is a ‘silent’ neuropsychiatric systemic lupus erythematosus symptom with heterogeneous prevalence, potentially reaching 54.4%. It may reduce quality of life by increasing the likelihood of depression and sleep disturbance. While pharmacotherapy remains the first-line treatment, the current management is still challenging and needs other non-invasive modalities. An effective, tolerable and disease-specific treatment modality including transcranial direct current stimulation (tDCS) is considered to reduce the frequency of chronic headaches, including in SLE. Until recently, there was no standard protocol for tDCS in treating headaches.

Methods and analysis
SHADE is a single-centre randomised double-blind multiarm sham-controlled trial for adults with clinically stable SLE, chronic headaches and without history of traumatic brain injury, brain infection, stroke or brain tumour. Random allocation is conducted to 88 subjects into 3 treatment groups (administration at primary motor, primary sensory and dorsolateral prefrontal cortex) and control group in 1:1:1:1 ratio. The primary endpoint is reduced number of headache days after adjunctive tDCS. The secondary endpoints are reduced headache intensity, increased quality of life, increased sleep quality, decreased depression and reduced analgesics use. The outcome is measured monthly until 3-month postintervention using headache diary, 36-Item Short Form Survey, Chronic Headache Quality of Life Questionnaire, Pittsburgh Sleep Quality Index and Mini International Neuropsychiatry Interview version 10 (MINI ICD 10). Intention-to-treat analysis will be performed to determine the best tDCS electrode placement.

Ethics and dissemination
Ethical approval had been obtained from the local Institutional Review Board of Faculty of Medicine Universitas Indonesia. Results will be published through scientific relevant peer-reviewed journals.

Trial registration number
NCT05613582.

Leggi
Dicembre 2023

'Nothing About Us Without Us: exploring benefits and challenges of peer support for people with disability in peer support organisations – protocol paper for a qualitative coproduction project

Introduction
One in six people live with disability in Australia with higher levels of disability of people from diverse communities, such as those with culturally and linguistically diverse (CALD) backgrounds. In Australia, CALD refers to people from diverse ethnicity and cultures, nationalities, societal structures and religions that may or may not speak a language other than English. This study employs researchers with lived experience of disability and peer support to study the impact of peer support for people with disability, including people from CALD backgrounds, in two peer-led organisations in New South Wales (NSW) Australia.

Methods and analysis
This study uses participatory action research and inclusive research design with researchers with lived experience, having lived experience of disability and a peer in the disability community, leading the research.
Over three years, three different groups will be recruited through Community Disability Alliance Hunter (CDAH) and Diversity and Disability Alliance (DDAlliance): (1) peers with disability, (2) peer leaders with disability and (3) researchers with lived experience of disability and peer support. Data collection and creation methods include semistructured interviews, surveys and focus groups. Qualitative data will be analysed using thematic analysis through the lens of the researchers with lived experience.

Ethics and dissemination
Ethical approval was granted by the University of Newcastle Human Research Ethics Committee (Approval No: H-2021-0088). Dissemination includes peer-reviewed publications, presentations at local, national and international conferences and written reports for user-led organisations, disability service providers, disability agencies and people with disability.

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Dicembre 2023

British Society of Gastroenterology guidelines for the diagnosis and management of cholangiocarcinoma

These guidelines for the diagnosis and management of cholangiocarcinoma (CCA) were commissioned by the British Society of Gastroenterology liver section. The guideline writing committee included a multidisciplinary team of experts from various specialties involved in the management of CCA, as well as patient/public representatives from AMMF (the Cholangiocarcinoma Charity) and PSC Support. Quality of evidence is presented using the Appraisal of Guidelines for Research and Evaluation (AGREE II) format. The recommendations arising are to be used as guidance rather than as a strict protocol-based reference, as the management of patients with CCA is often complex and always requires individual patient-centred considerations.

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Dicembre 2023

Efficacy and safety of the Chaixiong Qiwei granule for tension-type headache: study protocol for a randomised controlled trial

Introduction
Tension-type headache (TTH) is the most prevalent headache disorder worldwide. Although current treatments for TTH are beneficial, they are not without adverse effects. Chaixiong Qiwei granule (CXQW) is an experienced prescription medicine for TTH management. This study will evaluate the efficacy and safety of CXQW for the treatment of TTH.

Methods and analysis
This study will be a multicentre, randomised, double-blind, placebo-controlled trial. A total of 148 eligible participants will be divided into the intervention (CXQW treatment) and control (placebo treatment) groups. The primary outcome will be the reduction in the number of headache days (headache-days reduction) within 9–12 weeks after randomisation, while secondary outcomes will include the number of headache days, headache intensity, responder rate, drug consumption for acute treatment, quality of life and symptoms related to traditional Chinese medicine use based on a symptom-observation table. This protocol describes the design of the randomised controlled trial.

Ethics and dissemination
The study design was approved by the Institutional Review Board of Human Research at Xiyuan Hospital, China Academy of Chinese Medical Sciences (No. 2020XLA030-2).

Trial registration number
ChiCTR2100042514.

Leggi
Novembre 2023

Critical Care Management of Patients After Cardiac Arrest: A Scientific Statement From the American Heart Association and Neurocritical Care Society

Circulation, Ahead of Print. The critical care management of patients after cardiac arrest is burdened by a lack of high-quality clinical studies and the resultant lack of high-certainty evidence. This results in limited practice guideline recommendations, which may lead to uncertainty and variability in management. Critical care management is crucial in patients after cardiac arrest and affects outcome. Although guidelines address some relevant topics (including temperature control and neurological prognostication of comatose survivors, 2 topics for which there are more robust clinical studies), many important subject areas have limited or nonexistent clinical studies, leading to the absence of guidelines or low-certainty evidence. The American Heart Association Emergency Cardiovascular Care Committee and the Neurocritical Care Society collaborated to address this gap by organizing an expert consensus panel and conference. Twenty-four experienced practitioners (including physicians, nurses, pharmacists, and a respiratory therapist) from multiple medical specialties, levels, institutions, and countries made up the panel. Topics were identified and prioritized by the panel and arranged by organ system to facilitate discussion, debate, and consensus building. Statements related to postarrest management were generated, and 80% agreement was required to approve a statement. Voting was anonymous and web based. Topics addressed include neurological, cardiac, pulmonary, hematological, infectious, gastrointestinal, endocrine, and general critical care management. Areas of uncertainty, areas for which no consensus was reached, and future research directions are also included. Until high-quality studies that inform practice guidelines in these areas are available, the expert panel consensus statements that are provided can advise clinicians on the critical care management of patients after cardiac arrest.

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Novembre 2023

Dietitian-led cluster randomised controlled trial on the effectiveness of mHealth education on health outcomes among pregnant women: a protocol paper

Introduction
Nutrition education is the cornerstone to maintain optimal pregnancy outcomes including gestational weight gain (GWG). Nevertheless, default for appointments is common and often lead to suboptimal achievement of GWG, accompanied with unfavourable maternal and child health outcomes. While mobile health (mHealth) usage is increasing and helps minimising barriers to clinic appointments among pregnant mothers, its effectiveness on health outcomes has been inconclusive. Therefore, this study aimed to address the gap between current knowledge and clinical care, by exploring the effectiveness of mHealth on GWG as the primary outcome, hoping to serve as a fundamental work to achieve optimal health outcomes with the improvement of secondary outcomes such as physical activity, psychosocial well-being, dietary intake, quality of life and sleep quality among pregnant mothers.

Methods and analysis
A total of 294 eligible participants will be recruited and allocated into 3 groups comprising of mHealth intervention alone, mHealth intervention integrated with personal medical nutrition therapy and a control group. Pretested structured questionnaires are used to obtain the respondents’ personal information, anthropometry data, prenatal knowledge, physical activity, psychosocial well-being, dietary intake, quality of life, sleep quality and GWG. There will be at least three time points of data collection, with all participants recruited during their first or second trimester will be followed up prospectively (after 3 months or/and after 6 months) until delivery. Generalised linear mixed models will be used to compare the mean changes of outcome measures over the entire study period between the three groups.

Ethics and dissemination
Ethical approvals were obtained from the ethics committee of human subjects research of Universiti Putra Malaysia (JKEUPM-2022-072) and medical research & ethics committee, Ministry of Health Malaysia: NMRR ID-22-00622-EPU(IIR). The results will be disseminated through journals and conferences targeting stakeholders involved in nutrition research.

Trial registration number
Clinicaltrial.gov ID: NCT05377151.

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Novembre 2023

Changes in alcohol consumption according to the duration of unemployment: prospective findings from the French CONSTANCES cohort

Objectives
To prospectively examine the association between the duration of unemployment among job seekers and changes in alcohol use in a year.

Design
A prospective study.

Setting
French population-based CONSTANCES cohort.

Participants
We selected 84 943 participants from the CONSTANCES cohort included between 2012 and 2019 who, at baseline and 1-year follow-up, were either employed or job-seeking.

Outcome measures
Multinomial logistic regression models computed the odds of reporting continuous no alcohol use, at-risk alcohol use, increased or decreased alcohol use compared with being continuously at low risk and according to employment status. The duration of unemployment was self-reported at baseline; thus, the employment status at 1-year follow-up was categorised as follows: (1) employed, (2) return to employment since less than a year, (3) unemployed for less than 1 year, (4) unemployed for 1 to 3 years and (5) unemployed for 3 years or more. Analyses were adjusted for age, gender, education, household monthly income, marital status, self-rated health, smoking status and depressive state.

Results
Compared with being continuously at low risk (ie, ≤10 drinks per week), the unemployment categories were associated in a dose-dependent manner with an increased likelihood of reporting continuous no alcohol use (OR: 1.74–2.50), being continuously at-risk (OR: 1.21–1.83), experiencing an increase in alcohol use (OR: 1.21–1.51) and a decrease in alcohol use (OR: 1.17–1.84).

Conclusion
Although our results suggested an association between the duration of unemployment and a decrease in alcohol use, they also revealed associations between at-risk and increased alcohol use. Thus, screening for alcohol use among unemployed job seekers must be reinforced, especially among those with long-term unemployment.

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Novembre 2023

Abstract 17750: Impact of Ventricular Assist Device Use on Pediatric Heart Transplant Outcomes in a Linked Cohort of the Advanced Cardiac Therapies Improving Outcomes Network (ACTION) and Pediatric Heart Transplant Society (PHTS) Databases

Circulation, Volume 148, Issue Suppl_1, Page A17750-A17750, November 6, 2023. Purpose:Pediatric ventricular assist devices (VAD) improve waitlist mortality. We aimed to compare outcomes after heart transplant (HT) based on pre-HT support in patients (pt)

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Novembre 2023