Access to family resources by families living with schizophrenia: a qualitative study of primary care workers in urban Beijing, China

Objectives
This study aims to investigate the access to family resources by families living with schizophrenia from the perspective of primary care workers in Beijing, and provide evidence for appropriate and effective family resource coordination in primary care.

Design
Qualitative research using individual in-depth interviews to identify the access to family resources by families living with schizophrenia from the perspective of primary care workers.

Setting
This study was conducted from September to December 2021 in six urban community health service centres (CHSCs) in Beijing, China.

Participants
3 general practitioners and 10 mental health doctors selected by purposive sampling method from 6 CHSCs in urban Beijing were interviewed.

Results
Five themes emerged from the insights of the primary care workers: most family resources are non-targeted for families living with schizophrenia, the publicity of family resources is difficult, burdensome application process of family resources, limited available community-based treatment options and stigma hindering effective communication between families and society.

Conclusions
It is necessary to simplify the application process of family resources and provide primary care workers with systematic training regarding family resources. More family resources and improved public attitudes should be promoted for patients with schizophrenia and their caregivers.

Leggi
Settembre 2022

Evaluating the effect of short-course rifapentine-based regimens with or without enhanced behaviour-targeted treatment support on adherence and completion of treatment for latent tuberculosis infection among adults in the UK (RID-TB: Treat): protocol for an open-label, multicentre, randomised controlled trial

Introduction
The successful scale-up of a latent tuberculosis (TB) infection testing and treatment programme is essential to achieve TB elimination. However, poor adherence compromises its therapeutic effectiveness. Novel rifapentine-based regimens and treatment support based on behavioural science theory may improve treatment adherence and completion.

Methods and analysis
A pragmatic multicentre, open-label, randomised controlled trial assessing the effect of novel short-course rifapentine-based regimens for TB prevention and additional theory-based treatment support on treatment adherence against standard-of-care. Participants aged between 16 and 65 who are eligible to start TB preventive therapy will be recruited in England. 920 participants will be randomised to one of six arms with allocation ratio of 5:5:6:6:6:6: daily isoniazid +rifampicin for 3 months (3HR), routine treatment support (control); 3HR, additional treatment support; weekly isoniazid +rifapentine for 3 months (3HP), routine treatment support; weekly 3HP, additional treatment support ; daily isoniazid +rifapentine for 1 month (1HP), routine treatment support; daily 1HP, additional treatment support. Additional treatment support comprises reminders using an electronic pillbox, a short animation, and leaflets based on the perceptions and practicalities approach. The primary outcome is adequate treatment adherence, defined as taking ≥90% of allocated doses within the pre-specified treatment period, measured by electronic pillboxes. Secondary outcomes include safety and TB incidence within 12 months. We will conduct process evaluation of the trial interventions and assess intervention acceptability and fidelity and mechanisms for effect and estimate the cost-effectiveness of novel regimens. The protocol was developed with patient and public involvement, which will continue throughout the trial.

Ethics and dissemination
Ethics approval has been obtained from The National Health Service Health Research Authority (20/LO/1097). All participants will be required to provide written informed consent. We will share the results in peer-reviewed journals.

Trial registration number
EudraCT 2020-004444-29.

Leggi
Settembre 2022

Rationale and design for efficacy and safety evaluation of Bone-Anchored Maxillary Protraction (BAMP) for patients with unilateral cleft lip and palate with skeletal anterior crossbite: a single-arm, open-label, non-randomised prospective study protocol

Introduction
Bone-anchored maxillary protraction (BAMP) was devised recently as a method of direct maxillary protraction using anchor plates implanted in the maxilla and mandible without involving the teeth. Although several reports have described orthognathic effects of BAMP on patients with cleft lip and palate (CLP) with skeletal crossbite, none has described a study of Japanese patients with CLP or of BAMP treatment effects on speech in patients with CLP. This study, by performing BAMP treatment, and by evaluating speech function and skeletal and soft tissues, is intended to clarify BAMP efficacy and safety for patients with unilateral CLP (UCLP) who have skeletal crossbite.

Methods and analysis
This single-arm, open-label, non-randomised prospective study examines 20 patients with UCLP with skeletal crossbite (Wits appraisal ≤–5.0 mm). These 10–15 year-old participants had already undergone cheiloplasty, palatoplasty and bone grafting. The anchor plates are implanted in the zygomatic process in the maxilla and in the anterior part of the mandible. Two weeks after anchor plate implantation, maxillary protraction is started using elastics. Protraction is performed at 150 g per side at the start of protraction, 200 g per side from 1 month after the start of protraction and 250 g per side from 3 months after the start of protraction. The treatment period will be approximately 11/2 years. Pretreatment and post-treatment, cephalometric analysis, speech evaluation, nasopharyngeal closure function evaluation and facial soft tissue evaluation will be performed to ascertain the effects of BAMP on patients with UCLP.

Ethics and dissemination
Ethical approval for this study has been received from Tohoku Certificated Review Board of Tohoku University, Japan, CRB2200003. The approval number is 2021-34-2. The results of this research shall be presented at domestic and international academic conferences, and be published to peer-reviewed journals.

Trial registration number
jRCTs022210007.

Leggi
Settembre 2022

JAMA Oncology

JAMA Oncology is committed to publishing influential original research, opinions, and reviews that advance the science of oncology and improve the clinical care of patients with cancer.

Leggi
Settembre 2022

Impact on Mortality and Major Bleeding of Radial Versus Femoral Artery Access for Coronary Angiography or Percutaneous Coronary Intervention: a Meta-analysis of Individual Patient Data from Seven Multicenter Randomized Clinical Trials

Circulation, Ahead of Print. Background: In some randomized controlled trials (RCTs), transradial (TRA) compared with transfemoral access (TFA) was associated with lower mortality in coronary artery disease patients undergoing invasive management. We analyzed the effects of TRA versus TFA across multicenter RCTs and whether these associations are modified by patient or operator characteristics.Methods: We performed an individual patient data meta-analysis of multicenter RCTs comparing TRA versus TFA among patients undergoing coronary angiography with or without percutaneous coronary intervention (PCI) (PROSPERO; CRD42018109664). The primary outcome was all-cause mortality and the co-primary outcome was major bleeding at 30 days. The primary analysis was conducted by one-stage mixed-effects models based on the intention-to-treat cohort. The impact of access-site on mortality and major bleeding was further assessed by multivariable analysis. The relationship among access-site, bleeding, and mortality was investigated by natural effect model mediation analysis with multivariable adjustment.Results: A total of 21,600 patients (TRA=10,775 vs. TFA=10,825) from 7 RCTs were included. Median age was 63.9 years, 31.9% were female, 95% presented with acute coronary syndrome (ACS), and 75.2% underwent PCI. All-cause mortality (1.6% vs. 2.1%; HR 0.77, 95% CI 0.63-0.95, p=0.012) and major bleeding (1.5% vs. 2.7%; OR 0.55, 95% CI 0.45- 0.67, p

Leggi
Agosto 2022

Nimotuzumab plus induction chemotherapy followed by radiotherapy/concurrent chemoradiotherapy plus nimotuzumab for locally advanced nasopharyngeal carcinoma: protocol of a multicentre, open-label, single-arm, prospective phase II trial

Epidermal growth factor receptor (EGFR) is a therapeutic target in nasopharyngeal carcinoma (NPC). The optimal combined modality of optimal combined modality of anti-­EGFR monoclonal antibodies, induction chemotherapy (ICT), concurrent chemotherapy and radiotherapy for NPC remains poorly defined. None of previous studies have developed subsequent treatment strategies on the basis of stratification according to the efficacy following ICT plus anti-EGFR mAbs. This study aims to increase treatment intensity for patients with poor efficacy of ICT and reduce treatment toxicity for patients with favourable efficacy of ICT by assessing whether the efficacy of this treatment regimen is non-inferior to ICT plus concurrent chemoradiotherapy (historic controls).
Introduction

Methods and analysis
Pathology-confirmed WHO type II/III NPC patients at clinical stage III–IVA (eighth American Joint Committee on Cancer/Union for International Cancer Control staging system) will be included in the study. They will receive ICT plus nimotuzumab (NTZ), followed by radiotherapy plus NTZ or concurrent chemoradiotherapy plus NTZ (stratified based on the efficacy of ICT plus NTZ). The primary endpoint is 3-year failure-free survival rate; while the secondary endpoints are 3-year overall survival rate, distant metastasis-free survival rate and locoregional recurrence-free survival rate, and short-term remission rate of tumour and treatment toxicity.

Ethics and dissemination
The study protocol has been approved by the Ethics Committee of the Second Affiliated Hospital of Nanchang University. Our findings will be disseminated in a peer-reviewed journal. Implementation strategies are in place to ensure privacy and confidentiality of participants.

Trial registration number
ChiCTR2000041139.

Leggi
Agosto 2022

Correction: Multicentre, randomised, open-label, non-inferiority trial comparing the effectiveness and safety of ductal lavage versus oral corticosteroids for idiopathic granulomatous mastitis: a study protocol

Hu T, Li S, Huang H, et al., Multicentre, randomised, open-label, non-inferiority trial comparing the effectiveness and safety of ductal lavage versus oral corticosteroids for idiopathic granulomatous mastitis: a study protocol. BMJ Open 2010:10:e036643. doi: 10.1136/bmjopen-2019-036643
This article was previously published with below errors:
The phrase ‘four times a (per) day’ has been corrected as ‘qd’.
The spelling of the drug ‘meprednisone’ throughout the entire manuscript, has been corrected as ‘Methylprednisolone’.
The phrase ‘M-score of 1’ has been corrected as ‘M-score of

Leggi
Agosto 2022

Safety of surgical Treatment In severe primary Pontine haemorrhage Evacuation (STIPE): study protocol for a multi-centre, randomised, controlled, open-label trial

Introduction
Primary pontine haemorrhage (PPH) is the most devastating subtype of intracerebral haemorrhage and is associated with poor prognosis, especially for the severe patients. Although medical treatment (MT) is widely accepted, a large number of studies have shown surgical haematoma evacuation (HE) might dramatically reduce mortality and improve prognosis outcome in severe PPH (sPPH). However, evidence to clarify the safety of HE remains insufficient.

Methods and analysis
The Safety of surgical Treatment In severe primary Pontine haemorrhage Evacuation study is a multi-centre, randomised, controlled, open-label trial, conducted from January 2022 to November 2024 in 20 tertiary hospitals in China. A total of 64 patients with sPPH will be randomly assigned to MT or HE group. Eligible patients will receive the corresponding treatment according to the result of randomisation. The primary outcomes are related to the safety of surgery including rate of symptomatic rebleeding at 3 days and rate of mortality and intracranial infection at 30 days. The secondary outcomes are the neurological function indexes following up at 30 days, 90 days, 180 days and 365 days.

Ethics and dissemination
The clinical trial has been approved by the Biomedical Research Ethics Committee of West China Hospital of Sichuan University (unique identifiers: No. 2020-894). All results of the trial will be published in international peer-reviewed scientific journals and will be disseminated through scientific conferences. Academic dissertation will be published in a peer-reviewed journal.

Trial registration numbers
NCT04647162, ChiCTR2000039679.

Leggi
Agosto 2022

Cost analysis and cost-effectiveness of open versus laparoscopic versus robot-assisted versus transanal total mesorectal excision in patients with rectal cancer: a protocol for a systematic review

Introduction
Nowadays, most rectal tumours are treated open or minimally invasive, using laparoscopic, robot-assisted or transanal total mesorectal excision. However, insight into the total costs of these techniques is limited. Since all three techniques are currently being performed, including cost considerations in the choice of treatment technique may significantly impact future healthcare costs. Therefore, this systematic review aims to provide an overview of evidence regarding costs in patients with rectal cancer following open, laparoscopic, robot-assisted and transanal total mesorectal excision.

Methods and analysis
A systematic search will be conducted for papers between January 2000 and March 2022. Databases PubMed/MEDLINE, EMBASE, Scopus, Web of Science and Cochrane Library databases will be searched. Study selection, data extraction and quality assessment will be performed independently by four reviewers and discrepancies will be resolved through discussion. The Consensus Health Economic Criteria list will be used for assessing risk of bias. Total costs of the different techniques, consisting of but not limited to, theatre, in-hospital and postoperative costs, will be the primary outcome.

Ethics and dissemination
No ethical approval is required, as there is no collection of patient data at an individual level. Findings will be disseminated widely, through peer-reviewed publication and presentation at relevant national and international conferences.

Trial registration number
CRD42021261125.

Leggi
Agosto 2022

Cancer treatment decision-making among parents of paediatric oncology patients in Guatemala: a mixed-methods study

Objectives
To examine treatment decision-making priorities and experiences among parents of children with cancer in Guatemala.

Setting
This study was conducted at Guatemala’s National Pediatric Cancer Center in Guatemala City.

Participants
Spanish-speaking parents of paediatric patients (≤18 years of age) diagnosed with any form of cancer within the 8 weeks prior to study enrolment. The quantitative portion of this study included 100 parent participants; the qualitative component included 20 parents. Most participants were Catholic or Evangelical Spanish-speaking mothers.

Outcomes
Priorities and experiences of cancer treatment decision-making including decision-making role and experienced regret.

Results
A range of paediatric ages and cancer diagnoses were included. Most Guatemalan parents surveyed (70%) made decisions about their child’s cancer together and almost all (94%) without input from their community. Surveyed parents predominately preferred shared decision-making with their child’s oncologist (76%), however 69% agreed it was best not to be provided with many options. Two-thirds of surveyed parents (65%) held their preferred role in decision-making, with fathers more likely to hold their preferred role than mothers (p=0.02). A small number of parents (11%) experienced heightened decisional regret, which did not correlate with socio-demographic characteristics or preferred decision-making role. Qualitative results supported quantitative findings, demonstrating a decision-making process that emphasised trust and honesty.

Conclusions
Guatemalan parents preferred to make decisions with their medical team and appreciated providers who were honest and inclusive, but directive about decisions. This study reinforces the importance of the provider–parent relationship and encourages clinicians in all settings to ask about and honour each parent’s desired role in decision-making.

Leggi
Agosto 2022

How can equitable video visit access be delivered in primary care? A qualitative study among rural primary care teams and patients

Objective
The COVID-19 pandemic sparked exponential growth in video visit use in primary care. The rapid shift to virtual from in-person care exacerbated digital access disparities across racial groups and rural populations. Moving forward, it is critical to understand when and how to incorporate video visits equitably into primary care. We sought to develop a novel clinical algorithm to guide primary care clinics on how and when to employ video visits as part of care delivery.

Design
Qualitative data collection: one team member conducted all patient semistructured interviews and led all focus groups with four other team members taking notes during groups.

Setting
3 rural primary care clinics in the USA.

Participants
24 black veterans living in rural areas and three primary care teams caring for black veterans living in rural areas.

Primary and secondary outcome measures
Findings from semistructured interviews with patients and focus groups with primary care teams.

Results
Key issues around appropriate use of video visits for clinical teams included having adequate technical support, encouraging engagement during video visits and using video visits for appropriate clinical situations. Patients reported challenges with broadband access, inadequate equipment, concerns about the quality of video care, the importance of visit modality choice, and preferences for in-person care experience over virtual care. We developed an algorithm that requires input from both patients and their care team to assess fit for each clinical encounter.

Conclusions
Informed matching of patients and clinical situations to the right visit modality, along with individual patient technology support could reduce virtual access disparities.

Leggi
Agosto 2022