Pathology of the long head of the biceps tendon (LHBT) frequently accompanies rotator cuff tears, with tenotomy and tenodesis often being used to address this pathology. While meta-analyses report comparable functional outcomes between these techniques, tenotomy is linked to higher rates of Popeye deformity, whereas tenodesis is more technically demanding and might involve extra material. A novel self-locking tenodesis technique aims to reduce deformity risk while being a simpler alternative to the conventional tenodesis procedure; however, comparative evidence is currently limited.

This single-centre, patient-blinded randomised controlled trial will enrol 100 patients aged ≥40 years with reparable, non-traumatic, full-thickness supraspinatus and/or infraspinatus and/or subscapularis tendon tears undergoing arthroscopic repair from January 2025 until January 2027. Key exclusion criteria include massive or irreparable tears, advanced glenohumeral osteoarthritis and prior shoulder surgery. Participants will be randomised to either 360 double lasso loop tenodesis or self-locking tenodesis. The primary outcome is the Constant score at 1 year, with a predefined non-inferiority margin of 10 points. Secondary outcomes include American Shoulder and Elbow Surgeons score, simple shoulder value score, LHB score, cosmetic appearance, pain scores and radiographic tendon migration. Statistical non-inferiority will be assessed using a one-sided t-test.

The study protocol received approval from the National Ethical Review Board in France (CPP Sud-Est V) and was registered at ClinicalTrials.gov. The results will be disseminated through publication in a peer-reviewed journal.

NCT06774820.

Functional constipation (FC) is prevalent among children and often persists despite standard pharmacological treatment with oral laxatives. Many parents turn to complementary therapies, including acupuncture, which has been shown to relieve symptoms in adults with FC. However, studies in children with FC are scarce and have important limitations. This study will evaluate the feasibility, safety and potential efficacy of acupuncture for children with FC.

Prospective, non-randomised, open-label pilot study in children with FC (6–18 years). Participants will undergo eight acupuncture sessions over 10 weeks. Concurrent pharmacological treatment with polyethylene glycol (≥0.2 g/kg/day) will continue as initiated prior to enrolment. The primary endpoint is feasibility, defined by an attrition rate of ≥70%. Secondary feasibility endpoints include consent rate, patient/parent satisfaction and personnel requirements. Safety will be assessed by systematic monitoring of adverse events. Efficacy endpoints include treatment success, defined as no longer meeting the Rome IV criteria for FC at the end of the intervention period, as well as defecation frequency, stool consistency, painful defecation, faecal incontinence frequency, abdominal pain, medication use and quality of life, based on a previously published core outcome set.

Ethical approval was provided by the Medical Ethics Committee of Amsterdam UMC (Netherlands; NL87083.018.24). Results will be published in peer-reviewed journals and presented to scientific and consumer audiences.

NCT06836362 and NL-OMON57236.

Gluteal tendon tears—frequently dubbed the ‘rotator cuff tears of the hip’—are a common but often underdiagnosed cause of lateral hip pain and abductor dysfunction, especially in middle-aged to older women. While both open and endoscopic repair techniques are used, current literature suggests similar functional outcomes but higher complication rates following open repair. However, evidence is mainly derived from small retrospective case series, and no randomised trials exist. This systematic review and multilevel meta-analysis aims to compare the efficacy, safety and complication profiles of endoscopic versus open gluteal tendon repair.

A comprehensive literature search will be conducted across PubMed, Embase, CENTRAL and Epistemonikos without language or date restrictions. Eligible studies include randomised controlled trials and observational studies reporting on open or endoscopic gluteal tendon repair. Primary outcomes will include pain, functional scores and complication rates. Risk of bias will be assessed using the RoB 2 tool for RCTs and ROBINS-I for non-randomised studies. A three-level random-effects meta-analysis will be performed using inverse variance weighting and Hartung-Knapp adjustments. Heterogeneity will be quantified using the I² statistic.

Ethical approval is not required for this secondary analysis of published data. Results will be disseminated via peer-reviewed publication and conference presentations.

The review will commence immediately after acceptance of this study protocol in BMJ Open. The systematic review and multilevel meta-analysis will be conducted as efficiently as possible, with anticipated completion approximately 3–6 months after initiation.

CRD420251088765

The currently available immunotherapies have failed to meet expectations in inducing durable responses in patients with advanced epithelial ovarian cancer (EOC). The low number of somatic missense mutations in EOC necessitates highly potent neoantigen-directed approaches. To this end, we have developed a novel dendritic cell (DC) product that consists of a specialised cross-presenting subset of DC, conventional DC type 1 (cDC1).

We will conduct the NEODOC study, an investigator-initiated first-in-human phase I/II trial. This study will assess the immunogenicity, safety and feasibility of a cDC1-based, autologous tumour lysate-loaded, DC product. 10 patients with previously untreated advanced EOC (stage IIIb-c, IVa or stage IVb if only supradiaphragmatic or inguinal lymph nodes

Ethical approval for this trial was granted by the Netherlands Central Committee on Research Involving Human Subjects. The results will be disseminated through publications in international, open-access scientific journals and presentations at scientific conferences.

NCT05773859; EUCT number 2024-512353-24-01.

High-intensity statin therapy is recommended as a first-line strategy for lowering low-density lipoprotein cholesterol (LDL-C) levels in patients with acute myocardial infarction (AMI). A combination of moderate-intensity statin and ezetimibe at an equivalent dose to high-intensity statin may achieve similar LDL-C reduction with fewer side effects. This study evaluates the long-term efficacy and safety of this approach, initiated following AMI, compared with high-intensity statin monotherapy.

The ROSUZET-AMI trial is a multicentre, prospective, open-label, randomised, non-inferiority trial. Patients with AMI who underwent percutaneous coronary intervention were randomised 1:1 to receive either moderate-intensity statin with ezetimibe (rosuvastatin 5 mg with ezetimibe 10 mg) or high-intensity statin monotherapy (rosuvastatin 20 mg). The primary endpoint is the composite of cardiovascular death, major coronary events (non-fatal myocardial infarction, documented unstable angina requiring hospitalisation and all coronary revascularisation events occurring at least 30 days after randomisation), or non-fatal stroke.

Ethics approval for this study was obtained from the Institutional Review Board of Seoul St. Mary’s Hospital (No. 2020-0424-0003). Informed consent is obtained from every participant before randomisation. The results of this study will be submitted for publication in international peer-reviewed journals, and the key findings will be presented at international scientific conferences.

NCT04499859.

Primary care electronic health records provide a rich source of information for inequalities research. However, the reliability and validity of the research derived from these records depend on the completeness and resolution of the codelists (ie, collections of medical terms/codes) used to identify populations of interest. The aim of this project was to develop comprehensive codelists for identifying people from ethnic minority groups, people with learning disabilities (LDs), people with severe mental illness (SMI) and people who are transgender.

We followed a three-stage process to define and extract relevant codelists. First, groups of interest were defined a priori. Next, relevant clinical codes, relating to the groups, were identified by searching Clinical Practice Research Datalink (CPRD) publications, codelist repositories and the CPRD Code Browser. Relevant codelists were extracted and merged according to group, and duplicates were removed. Finally, the remaining codes were reviewed by two general practitioners (GPs).

The curated codelists were compared using a representative sample in the UK. The frequencies of individuals identified using the curated codelists were assessed and compared with widely used alternative codelists.

Comprehensiveness was assessed in a representative CPRD population of 10 966 759 people.

After removal of duplicates and GP review, codelists were finalised with 325 unique codes for ethnicity, 558 for LD, 499 for SMI and 38 for transgender. Compared with comparator codelists, an additional 48 017 (76.6%), 52 953 (68.9%) and 508 (36.9%) people with LD, SMI or transgender code were identified. The proportions identified for ethnicity, meanwhile, were consistent with expectations for the UK (eg, 6.50% Asian, 2.66% black and 1.44% mixed).

The curated codelists are more sensitive than those widely used in practice and research. Discrepancies between national estimates and primary care records suggest potential record/retention issues. Resolving these requires further investigation and could lead to improved data quality for research.

To integrate the quantitative and qualitative data collected as part of the PEACH (Procalcitonin: Evaluation of Antibiotic use in COVID-19 Hospitalised patients) study, which evaluated whether procalcitonin (PCT) testing should be used to guide antibiotic prescribing and safely reduce antibiotic use among patients admitted to acute UK National Health Service (NHS) hospitals.

Triangulation to integrate quantitative and qualitative data.

Four data sources in 148 NHS hospitals in England and Wales including data from 6089 patients.

A triangulation protocol was used to integrate three quantitative data sources (survey, organisation-level data and patient-level data: data sources 1, 2 and 3) and one qualitative data source (clinician interviews: data source 4) collected as part of the PEACH study. Analysis of data sources initially took place independently, and then, key findings for each data source were added to a matrix. A series of interactive discussion meetings took place with quantitative, qualitative and clinical researchers, together with patient and public involvement (PPI) representatives, to group the key findings and produce seven statements relating to the study objectives. Each statement and the key findings related to that statement were considered alongside an assessment of whether there was agreement, partial agreement, dissonance or silence across all four data sources (convergence coding). The matrix was then interpreted to produce a narrative for each statement.

To explore whether PCT testing safely reduced antibiotic use during the first wave of the COVID-19 pandemic.

Seven statements were produced relating to the PEACH study objective. There was agreement across all four data sources for our first key statement, ‘During the first wave of the pandemic (01/02/2020-30/06/2020), PCT testing reduced antibiotic prescribing’. The second statement was related to this key statement, ‘During the first wave of the pandemic (01/02/2020-30/06/2020), PCT testing safely reduced antibiotic prescribing’. Partial agreement was found between data sources 3 (quantitative patient-level data) and 4 (qualitative clinician interviews). There were no data regarding safety from data sources 1 or 2 (quantitative survey and organisational-level data) to contribute to this statement. For statements three and four, ‘PCT was not used as a central factor influencing antibiotic prescribing’, and ‘PCT testing reduced antibiotic prescribing in the emergency department (ED)/acute medical unit (AMU),’ there was agreement between data source 2 (organisational-level data) and data source 4 (interviews with clinicians). The remaining two data sources (survey and patient-level data) contributed no data on this statement. For statement five, ‘PCT testing reduced antibiotic prescribing in the intensive care unit (ICU)’, there was disagreement between data sources 2 and 3 (organisational-level data and patient-level data) and data source 4 (clinician interviews). Data source 1 (survey) did not provide data on this statement. We therefore assigned dissonance to this statement. For statement six, ‘There were many barriers to implementing PCT testing during the first wave of COVID-19’, there was partial agreement between data source 1 (survey) and data source 4 (clinician interviews) and no data provided by the two remaining data sources (organisational-level data and patient-level data). For statement seven, ‘Local PCT guidelines/protocols were perceived to be valuable’, only data source 4 (clinician interviews) provided data. The clinicians expressed that guidelines were valuable, but as there was no data from the other three data sources, we assigned silence to this statement.

There was agreement between all four data sources on our key finding ‘during the first wave of the pandemic (01/02/2020-30/06/2020), PCT testing reduced antibiotic prescribing’. Data, methodological and investigator triangulation, and a transparent triangulation protocol give validity to this finding.

ISRCTN66682918.