Exploring the experiences and perspectives of healthcare professionals, patients and caregivers toward serious illness conversations based on the Serious Illness Care Program is vital for improving communication with patients who are seriously ill, as has been shown in previous studies. However, few studies have carried out a systematic review to examine common themes, strengthen conclusions and identify gaps in the literature, the findings of which could help steer further research, policies and practice to improve more timely and person-centred conversations about the values and priorities of patients with serious illnesses. The objective of this qualitative meta-synthesis is to explore how healthcare professionals, patients and caregivers described their own experiences of the processes of serious illness communication through a secondary analysis of published qualitative data.

Meta-aggregation will be used to conduct a systematic review of qualitative studies. We conducted an initial search on 10 October 2023; papers published in English will be searched using electronic databases, including PubMed (MEDLINE), Web of Science, Embase, Ovid and CINAHL. Studies that satisfy the eligibility criteria will be evaluated for methodological quality using the Joanna Briggs Institute (JBI) Critical Appraisal Checklist for Qualitative Research. The meta-aggregative review will consist of the following: (1) extraction of findings of all included studies; (2) categorisation of the findings, with at least two findings per category; and (3) synthesis of one or more findings from at least two categories. Study eligibility screening, data extraction, analysis and JBI Critical Appraisal Checklist and Grading of Recommendations Assessment, Development and Evaluation-Confidence in the Evidence from Reviews of Qualitative research assessments will be undertaken independently by two authors.

Secondary data analysis of published literature does not require ethical approval. The results will be disseminated in peer-reviewed journals and presented in conference papers and elsewhere.

CRD42022330859.

To compare the modified strategy for the right-sided double-lumen tube (R-DLT) placement using a combination of CT measurements and flexible video bronchoscopy guidance with traditional bronchoscopy technique.

Double-blind, parallel randomised control trial at a tertiary care medical centre in China. 100 patients undergoing video-assisted thoracoscopic surgery and requiring R-DLT were randomly allocated to the control group and the intervention group.

The control group used the traditional bronchoscopy-guided technique. In the intervention group, the length and anteroposterior diameter of the right main bronchus (RMB) were measured on CT images to select the side and size of the Rüsch tube, and then a black depth marker was placed on the tube according to the difference between the length of the RMB and the bronchial cuff. Under the guidance of bronchoscopy, the depth marker should be placed parallel to the tracheal carina and a characteristic white line on the tube should be parallel to the midline of the tracheal carina.

The primary endpoint was the positioning of right upper lobe (RUL) ventilatory slot and RUL bronchial orifice. The secondary endpoints included intubation data and perioperative adverse events.

Compared with the control group, our modified strategy significantly increased the optimal and acceptable position rate (76% vs 98%, respectively; p

This study demonstrates the superiority of our strategy and provides a new viable method for R-DLT placement.

Chinese Clinical Trial Registry (ChiCTR1900021676).

Tuberculosis (TB) is a main concern of health care workers in sub-Saharan Africa. Healthcare workers have the potential to have contact with TB patients and are the main stakeholders in healthcare settings to implement TB infection control, and the poor practice of TB infection control may increase the risk of transmission of TB in healthcare settings. However, there is no consistent conclusion on the TB infection control practice among healthcare workers in Ethiopia. Thus, this study aimed to determine the pooled magnitude of TB infection control practice and associated factors among healthcare workers in Ethiopia.

This systematic review and meta-analysis will be done by following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guideline. The following databases will be used to search for articles: PubMed, Cochrane Library, Google Scholar and grey literatures. The quality of studies will be assessed using the Joanna Briggs Institute (JBI) critical appraisal checklist. The data from included studies will be extracted using Microsoft Excel V.2016, and the extracted data will be analysed using STATA V.16. Forest plot and I² statistics will be done for heterogeneity. A funnel plot and Egger’s regression test will be conducted to check for publication bias. Potential sources of bias will be identified by subgroup analysis and meta-regression. Any type of study design conducted in Ethiopia and in English language will be included.

Ethics approval is not required, and the findings will be published in peer-reviewed journal.

CRD42023393580.

Bronchiolitis is an acute viral infection of the lower respiratory tract. It is most commonly caused by respiratory syncytial virus. Being a common reason for hospitalisation, it affects 13–17% of all hospitalised children younger than 2 years. Only supportive therapy, including suctioning nasal secretions, water–electrolyte balance maintenance and oxygen supplementation when needed, is recommended. However, non-evidence-based diagnostic and therapeutic approaches, including the use of inhaled bronchodilators, nebulised epinephrine, and nebulised and systemic steroids, are common. The inhalation of 3% hypertonic saline is not recommended in bronchiolitis management. However, a recently published meta-analysis revealed that the inhalation of hypertonic saline can reduce the risk of hospitalisation for outpatients with bronchiolitis, while resulting in a shorter length of hospital stay and reduced severity of respiratory distress for inpatients, although the evidence is of low certainty. We aim to assess the efficacy of nebulised hypertonic saline for the treatment of children hospitalised with bronchiolitis.

This will be a randomised, double-blinded, parallel-group, controlled trial. Children younger than 2 years who are hospitalised due to bronchiolitis will be recruited from at least three paediatric departments in Poland. Bronchiolitis is defined as an apparent viral respiratory tract infection associated with airway obstruction that is manifested by at least one of following symptoms: tachypnoea, increased respiratory effort, crackles and/or wheezing. A total of 140 children will be randomised (1:1) to receive either hypertonic saline nebulisation (5 mL, three times a day) or normal saline at the same dose. The primary outcome measure will be the duration of hospitalisation.

The Bioethics Committee of the Lower Silesia Medical Chamber in Wroclaw approved the study protocol (4/PNDR/2023). Caregivers will receive oral and written information about the study and written informed consent will be obtained by the study physicians. The findings of the study will be submitted to a peer-reviewed journal, and abstracts will be submitted to relevant national and international conferences.

ClinicalTrials.gov Registry (NCT06069336).

Paediatric intensive care units (PICUs) survivors and their families often experience widespread morbidity and psychosocial consequences after discharge, known as post-intensive care syndrome in paediatrics (PICS-p). In Switzerland, more than 5000 children are admitted to PICUs each year, and despite the high survival rate, there are no data on post-PICU recovery. This study aims to investigate PICS in children and families and identify its associated factors.

This is a national, multicentre, longitudinal, observational study that includes PICU survivors, main family caregivers and siblings (n=1300) recruited from the eight Swiss accredited PICUs with follow-up at discharge, 1, 3 and 6 months after discharge from the PICU. Data will be collected on the domains of physical, emotional, social and cognitive health, as well as factors affecting the outcome related to demographics, clinical specification, PICU and family environment, as well as community and social resources. Structural equation models and growth mixture models will analyse the outcomes, and the heterogeneity of recovery that shed light on the diverse recovery experiences of children and their families. The study identifies risk and protective factors with a focus on the influence of social and familial resources. It will also explore the mutual impact of the child’s recovery and parent/sibling psychosocial health.

The protocol is approved by the CER-VD ethics committee. Participants will be provided with verbal and written explanations of the study, and their privacy and anonymity will be protected throughout the process. The results will be presented at local and international conferences.

Swiss ethics committees ID: 2022-02128, representing the eight cantons for both French and German-speaking parts of Switzerland.

Compensatory mouth breathing, caused by nasopharyngeal obstructive diseases, is the main cause of hyperdivergent mandibular retrognathia in children. Such deformities require effective growth guidance before pubertal growth peaks. The traditional mandibular advancement device, twin block (TB), can guide the forward development of the mandible. However, the side effect of increasing the vertical dimension of the lower facial third, worsens the facial profile of children with divergent growth trends. To solve this problem, a modified TB (LLTB) appliance was designed to control the vertical dimension by intruding incisors and inhibiting the elongation of posterior teeth during the advancement of the mandible, which could avoid the side effects of traditional appliances and effectively guide the growth of the mandible in a normal direction.

The study was designed as a single-centre, single-blind, randomised, parallel controlled trial. We aim to enrol 60 children aged 9–14 years with hyperdivergent skeletal class II malocclusion, using a 1:1 allocation ratio. The participants were will be randomly assigned to receive either the TB or LLTB treatment. The primary outcome will be a change in the angle of the mandibular plane relative to the anterior cranial base. The secondary outcomes will include changes in the sagittal maxillomandibular relation, occlusal plane, facial height, morphology of the mandible and upper airway width. Safety endpoints will also be evaluated.

Ethical approval was obtained from the ethics committee of Shanghai Stomatological Hospital. Both participants and their guardians will be fully informed of the study and sign an informed consent form before participating in the trial. The results will be publicly available in peer-reviewed scientific journals.

ChiCTR2000035882.

Child mortality rates remain high in sub-Saharan Africa, including Ethiopia. We are conducting a cluster randomised control trial in the Gondar zone of the Amhara region to determine the impact of pairing Orthodox priests with community health workers, known locally as the Health Development Army (HDA), on newborns’ nutritional status, early illness identification and treatment, and vaccination completeness.

Ensuring intervention efficacy with scientific rigour is essential, but there are often delays in adopting evidence into policy and programmes. Here, we present a protocol for conducting parallel implementation research alongside an efficacy study to understand intervention implementability and scalability. This will help develop a scale-up strategy for effective elements of the intervention to ensure rapid implementation at scale.

We will conduct a stakeholder analysis of key implementation stakeholders and readiness surveys to assess their readiness to scale up the intervention. We will conduct semistructured interviews and focus group discussions with stakeholders, including HDA members, health workers, Orthodox priests, and caregivers, to determine the core intervention elements that need to be scaled, barriers and facilitators to scaling up the intervention in diverse sociocultural settings, as well as the human and technical requirements for national and regional implementation. Finally, to determine the financial resources necessary for sustaining and scaling the intervention, we will conduct activity-based costing to estimate implementation costs from the provider’s perspective.

The study received approval from the University of Gondar Institutional Review Board (approval no: VP/RTT/05/1030/2022) and the University of Washington Human Subjects Division (approval no: STUDY00015369). Participants will consent to participate. Results will be disseminated through workshops with stakeholders, local community meetings, presentations at local and international conferences, and journal publications. The study will provide evidence for factors to consider in developing a scale-up strategy to integrate the intervention into routine health system practices.

The Gastric Alimetry platform offers a multimodal assessment of gastric function through body surface gastric mapping (BSGM) and concurrent symptom-tracking via a validated App. We aim to perform a longitudinal cohort study to examine the impact of Gastric Alimetry, and changes in clinical management on patient symptoms, quality of life and psychological health.

This is a prospective multicentre longitudinal observational cohort study of participants with chronic gastroduodenal symptoms. Consecutive participants undergoing Gastric Alimetry will be invited to participate. Quality of life will be assessed via EuroQol-5D and the Patient Assessment of Upper Gastrointestinal Disorders-Quality of Life score. Gastrointestinal symptoms will be assessed via the Patient Assessment of Upper Gastrointestinal Symptom Severity index, and the Gastroparesis Cardinal Symptom Index. Psychometrics will be assessed, including anxiety via the General Anxiety Disorder-7, perceived stress using the Perceived Stress Scale 4, and depression via the Patient Health Questionnaire 9. Clinical parameters including diagnoses, investigations and treatments (medication and procedures) will also be captured. Assessments will be made the week after the BSGM test, at 30 days, 90 days, 180 days and 360 days thereafter. The primary outcome is feasibility of longitudinal follow-up of a cohort that have undergone Gastric Alimetry testing; from which patients’ continuum of care can be characterised. Secondary outcomes include changes in patient-reported symptoms, quality of life and psychometrics (anxiety, stress and depression). Inferential causal analyses will be performed at the within patient level to explore causal associations between treatment changes and clinical outcomes. The impact of Gastric Alimetry on clinical management will also be captured.

The protocol has been approved in Aotearoa New Zealand by the Auckland Health Research Ethics Committee. Results will be submitted for conference presentation and peer-reviewed publication.

Dietary sodium intake represents a risk factor for cardiovascular disease and mortality. The study sought to analyse the sodium content of effervescent dietary supplements and drugs in Germany and the USA.

Comparative cross-sectional study.

The sodium content of 39 dietary supplement effervescent tablets available in Germany was measured in May and June 2022 using optical emission spectrometry with inductively coupled argon plasma. The sodium content of 33 common pharmacy-only effervescent tablets (over-the-counter (OTC) drugs) in Germany was obtained from the summary of product characteristics. We compared the sodium content of the measured German dietary supplement effervescent tablets to that of 51 dietary supplement effervescent tablets available in the USA (data: National Institutes of Health’s Dietary Supplement Label Database).

The measured sodium content in the German dietary supplements was 283.9±122.6 mg sodium/tablet, equivalent to 14±6% of the maximum recommended daily sodium intake (MRDSI). Vitamin products had the highest (378.3±112.8 mg, 19±6% of MRDSI), and calcium products had the lowest mean sodium content (170.4±113.2 mg, 9±6% of MRDSI). Vitamin products contained significantly more sodium than magnesium (378.3 mg vs 232.7 mg; p=0.004), calcium (378.3 mg vs 170.4 mg; p=0.006) and mineral products (378.3 mg vs 191.6 mg; p=0.048). The sodium content measured in products available in Germany was higher when compared with the declared sodium content on the label of the products sold in the USA (283.9 mg vs 190.0 mg; p

Effervescent tablets of nutritional supplements and OTC drugs contain high amounts of sodium, which often is not disclosed.

Attributing musculoskeletal (MSK) pain to normal and commonly occurring imaging findings, such as tendon, cartilage and spinal disc degeneration, has been shown to increase people’s fear of movement, reduce their optimism about recovery and increase healthcare costs. Interventions seeking to reduce the negative effects of MSK imaging reporting have had little effect. To understand the ineffectiveness of these interventions, this study seeks to scope their behavioural targets, intended mechanisms of action and theoretical underpinnings. This information alongside known barriers to helpful reporting can enable researchers to refine or create new more targeted interventions.

The scoping review will be conducted in accordance with the JBI methodology for scoping reviews and the Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews. Search terms will be devised by the research team. Searches of MEDLINE, EMBASE, CINAHL, AMED and PsycINFO from inception to current day will be performed. The review will include studies, which have developed or evaluated interventions targeting the reporting of MSK imaging. Studies targeting the diagnosis of serious causes of MSK pain will be excluded. Two independent authors will extract study participant data using predefined extraction templates and intervention details using the Template for Intervention Description and Replication checklist. Interventions will be coded and mapped to the technique, mechanism of action and behavioural target according to the Capability, Opportunity, Motivation-Behaviour (COM-B) model categories. Any explicit models or theories used to inform the selection of interventions will be extracted and coded. The study characteristics, behaviour change techniques identified, behavioural targets according to the COM-B and context specific theories within the studies will be presented in narrative and table form.

The information from this review will be used to inform an intervention design process seeking to improve the communication of imaging results. The results will also be disseminated through a peer-reviewed publication, conference presentations and stakeholder events.

A head and neck cancer (HNC) diagnosis significantly impacts a patient’s quality of life (QOL). Palliative care potentially improves their QOL. We will conduct a scoping review to identify existing knowledge about palliative care interventions for patients with HNC.

This scoping review was designed in accordance with the JBI Manual for Evidence Synthesis: Scoping Reviews and will be reported according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews. Our eligibility criteria follow the Population, Intervention, Comparison or Control, Outcomes and Study characteristics framework. The population is adult patients with locally advanced, metastatic, unresectable and/or recurrent HNC. We include peer-reviewed journal articles and articles in the press, in English, reporting on palliative care interventions with at least two of the eight National Consensus Project on Clinical Practice Guidelines for Quality Palliative Care domains; studies with and without comparators will be included. The outcomes are patient QOL (primary) and symptom severity, patients’ satisfaction with care, patients’ mood, advance care planning and place of death (secondary). We developed a search strategy across ten databases, to be searched from the inception to 11 September 2023: Medline ALL (Medline and EPub Ahead of Print and In-Process, In-Data-Review & Other Non-Indexed Citations), Cochrane Central Register of Controlled Trials, Cochrane Database of Systematic Reviews, Embase Classic+Embase, Emcare and PsycINFO all from the OvidSP platform; CINAHL from EBSCOhost, Scopus from Elsevier, Web of Science from Clarivate and Global Index Medicus from WHO. We will extract data using a piloted data form and analyse the data through descriptive statistics and thematic analysis.

Ethics approval is not needed for a scoping review. We will disseminate the findings to healthcare providers and policy-makers by publishing the results in a scientific journal.

Patient-reported outcome measures (PROMs) are useful for trauma registries interested in monitoring patient outcomes and trauma care quality. PROMs had not previously been collected by the New Zealand Trauma Registry (NZTR). More than 2500 New Zealanders are admitted to hospital for major trauma annually. The Trauma Outcomes Project (TOP) collected PROMs postinjury from three of New Zealand’s (NZ’s) major trauma regions. This cohort profile paper aims to provide a thorough description of preinjury and 6 month postinjury characteristics of the TOP cohort, including specifically for Māori (Indigenous population in Aotearoa me Te Waipounamu/NZ).

Between July 2019 and June 2020, 2533 NZ trauma patients were admitted to one of 22 hospitals nationwide for major trauma and included on the NZTR. TOP invited trauma patients (aged ≥16 years) to be interviewed from three regions; one region (Midlands) declined to participate. Interviews included questions about health-related quality of life, disability, injury recovery, healthcare access and household income adequacy.

TOP recruited 870 participants, including 119 Māori. At 6 months postinjury, most (85%) reported that the injury still affected them, 88% reported problems with≥1 of five EQ-5D-5L dimensions (eg, 75% reported problems with pain or discomfort, 71% reported problems with usual activities and 52% reported problems with mobility). Considerable disability (World Health Organization Disability Assessment Schedule, WHODAS II, score ≥10) was reported by 45% of participants. The prevalence of disability among Māori participants was 53%; for non-Māori it was 44%. Over a quarter of participants (28%) reported trouble accessing healthcare services for their injury. Participation in paid work decreased from 63% preinjury to 45% 6 months postinjury.

The 12 and 24 month postinjury data collection has recently been completed; analyses of 12 month outcomes are underway. There is potential for longer-term follow-up interviews with the existing cohort in future. TOP findings are intended to inform the National Trauma Network’s quality improvement processes. TOP will identify key aspects that aid in improving postinjury outcomes for people experiencing serious injury, including importantly for Māori.

Parkinson’s disease (PD) represents the fastest growing neurodegenerative disease with an increasing prevalence worldwide. It is characterised by complex motor and non-motor symptoms that lead to considerable disability. Specialised physiotherapy has been shown to benefit patients with PD. The Parkinson Netzwerk Therapie (PaNTher) was created to improve access to specialised physiotherapy tailored to care priorities of PD patients. This study aims to evaluate the effectiveness, acceptability and needs of the PaNTher network by neurologists and physiotherapists involved in the network in outpatient care.

This is a mixed-method, prospective, pragmatic non-randomised cohort study of parallel groups, with data collection taking place in Bavaria, Germany, between 2020 and 2024. Patients with PD insured by the Allgemeine Ortskrankenkasse Bayern (AOK Bayern) living in Bavaria will be recruited for study participation by network partners. Patients in the intervention group must reside in Munich or the surrounding area to ensure provision of specialised physiotherapy in close proximity to their place of residence. Controls receive care as usual. Six and 12 months after baseline, all patients receive a follow-up questionnaire. Mixed-effect regression models will be used to examine changes in impairment of activities of daily living and quality of life of patients with PD enrolled in the programme over time compared with usual care. Qualitative interviews will investigate the implementation processes and acceptability of the PaNTher network among neurologists and physiotherapists. The study is expected to show that the PaNTher network with an integrative care approach will improve the quality and effectiveness of the management and treatment of patients with PD.

The study has been approved by the ethics committee at the medical faculty of the Ludwig-Maximilians-University Munich (20-318). Results will be published in scientific, peer-reviewed journals and presented at national and international conferences.

Over 40% of US adults meet criteria for obesity, a major risk factor for chronic disease. Obesity disproportionately impacts populations that have been historically marginalised (eg, low socioeconomic status, rural, some racial/ethnic minority groups). Evidence-based interventions (EBIs) for weight management exist but reach less than 3% of eligible individuals. The aims of this pilot randomised controlled trial are to evaluate feasibility and acceptability of dissemination strategies designed to increase reach of EBIs for weight management.

This study is a two-phase, Sequential Multiple Assignment Randomized Trial, conducted with 200 Medicaid patients. In phase 1, patients will be individually randomised to single text message (TM1) or multiple text messages (TM+). Phase 2 is based on treatment response. Patients who enrol in the EBI within 12 weeks of exposure to phase 1 (ie, responders) receive no further interventions. Patients in TM1 who do not enrol in the EBI within 12 weeks of exposure (ie, TM1 non-responders) will be randomised to either TM1-Continued (ie, no further TM) or TM1 & MAPS (ie, no further TM, up to 2 Motivation And Problem Solving (MAPS) navigation calls) over the next 12 weeks. Patients in TM+ who do not enrol in the EBI (ie, TM+ non-responders) will be randomised to either TM+Continued (ie, monthly text messages) or TM+ & MAPS (ie, monthly text messages, plus up to 2 MAPS calls) over the next 12 weeks. Descriptive statistics will be used to characterise feasibility (eg, proportion of patients eligible, contacted and enrolled in the trial) and acceptability (eg, participant opt-out, participant engagement with dissemination strategies, EBI reach (ie, the proportion of participants who enrol in EBI), adherence, effectiveness).

Study protocol was approved by the University of Utah Institutional Review Board (#00139694). Results will be disseminated through study partners and peer-reviewed publications.

clinicaltrials.gov; NCT05666323.

To examine the associations of chronic kidney disease (CKD) with dynamic functional impairment among older Chinese adults.

This was a prospective longitudinal study.

Data were derived from the Chinese Longitudinal Healthy Longevity Study.

All adults aged ≥60 years were potentially eligible. This study included 2970 participants.

CKD was defined as an estimated glomerular filtration rate 2. Functional performances included instrumental activities of daily living (IADL) and basic activities of daily living (BADL), which were measured using six daily activities, including eating, dressing, transferring, using the toilet, bathing and continence, and eight daily activities, including visiting neighbours, shopping, cooking, washing clothes, walking 1 km, lifting 5 kg, crouching and standing up three times and taking public transportation, respectively.

This study included 2970 participants, including 988 (33.60%) participants with CKD. Participants with CKD had higher IADL scores than those without CKD (β=0.895, 95% CI: 0.761 to 1.029). Furthermore, there was a significant linear trend in the association of CKD severity with the IADL score (pβ=0.067, 95% CI: 0.017 to 0.118). However, only participants with moderate and advanced CKD had a higher BADL score (β=0.088 and 0.152, 95% CI: 0.006 to 0.171 and 0.019 to 0.286, respectively).

CKD was associated with worse functional impairment. Furthermore, there was a significant linear trend in the association of the severity of CKD with the IADL score. However, only participants with moderate and advanced CKD had higher BADL scores.

Successful antiviral therapy has transformed HIV infection into a chronic condition, where optimising quality of life (QoL) has become essential for successful lifelong treatment. Patient-reported outcome measures (PROMs) can signal potential physical and mental health problems related to QoL. This study aims to determine whether PROMs in routine clinical care improve quality of care as experienced by people with HIV (PWH).

We report the protocol of a multicentre longitudinal cohort studying PWH at Amsterdam University Medical Centres in the Netherlands. PROMs are offered annually to patients via the patient portal of the electronic health record. Domains include anxiety, depression, fatigue, sleep disturbances, social isolation, physical functioning, stigma, post-traumatic stress disorder, adherence, drug and alcohol use and screening questions for sexual health and issues related to finances, housing and migration status. Our intervention comprises (1) patients’ completion of PROMs, (2) discussion of PROMs scores during annual consultations and (3) documentation of follow-up actions in an individualised care plan, if indicated. The primary endpoint will be patient-experienced quality of care, measured by the Patient Assessment of Chronic Illness Care, Short Form (PACIC-S). Patients will provide measurements at baseline, year 1 and year 2. We will explore change over time in PACIC-S and PROMs scores and examine the sociodemographical and HIV-specific characteristics of subgroups of patients who participated in all or only part of the intervention to ascertain whether benefit has been achieved from our intervention in all subgroups.

Patients provide consent for the analysis of data collected as part of routine clinical care to the AIDS Therapy Evaluation in the Netherlands study (ATHENA) cohort through mechanisms described in Boender et al. Additional ethical approval for the analysis of these data is not required under the ATHENA cohort protocol. The results will be presented at national and international academic meetings and submitted to peer-reviewed journals for publication.

The epidemiological and demographic transitions are leading to a rising burden of multimorbidity (co-occurrence of two or more chronic conditions) worldwide. Evidence on the burden, determinants, consequences and care of multimorbidity in rural and urbanising India is limited, partly due to a lack of longitudinal and objectively measured data on chronic health conditions. We will conduct a mixed-methods study nested in the prospective Andhra Pradesh Children and Parents’ Study (APCAPS) cohort to develop a data resource for understanding the epidemiology of multimorbidity in rural and urbanising India and developing interventions to improve the prevention and care of multimorbidity.

We aim to recruit 2100 APCAPS cohort members aged 45+ who have clinical and lifestyle data collected during a previous cohort follow-up (2010–2012). We will screen for locally prevalent non-communicable, infectious and mental health conditions, alongside cognitive impairments, disabilities and frailty, using a combination of self-reported clinical diagnosis, symptom-based questionnaires, physical examinations and biochemical assays. We will conduct in-depth interviews with people with varying multimorbidity clusters, their informal carers and local healthcare providers. Deidentified data will be made available to external researchers.

The study has received approval from the ethics committees of the National Institute of Nutrition and Indian Institute of Public Health Hyderabad, India and the London School of Hygiene and Tropical Medicine, UK. Meta-data and data collection instruments will be published on the APCAPS website alongside details of existing APCAPS data and the data access process (www.lshtm.ac.uk/research/centres-projects-groups/apcaps).

This study was to investigate the colonisation rate of Group B Streptococcus (GBS) during pregnancy, and to evaluate the influence of GBS colonisation on pregnancy outcomes.

A retrospective cohort study.

Data of 47 380 pregnant women from 2016 to 2022 were collected from the Maternal and Child Health Hospital of Huadu District, Guangzhou City, China.

A total of 15 040 pregnant women were eligible for this study, of which 32 340 were excluded due to non-native pregnant women, in vitro fertilization infants, malformed fetuses, habitual abortion, abortions due to poor reproductive or obstetrical history, artificial insemination, umbilical cord torsion, and other diseases during pregnancy.

The incidence rates of GBS colonisation and premature delivery, fetal distress, premature rupture of membranes (PROM), low birth weight (LBW), abortion and stillbirth.

Of the 15 040 pregnant women included in this study, 1445 developed GBS colonisation, with a prevalence of 9.61% (95% CI, 9.15 to 10.09). Advanced maternal age (≥35 years) predisposed women to GBS colonisation, and the occurrence of GBS colonisation varied among different ethnic groups. Our data revealed that fetal distress, PROM and LBW were more common in pregnant women colonised with GBS than in pregnant women not colonised with GBS. The incidence for premature delivery, fetal distress, PROM and LBW in infants of pregnant women colonised with GBS was 41.0% (OR=1.410, 95% CI, 1.134 to 1.753), 282.5% (OR=3.825, 95% CI, 3.185 to 4.593), 14.9% (OR=1.149, 95% CI, 1.005 to 1.313), and 29.7% (OR=1.297, 95% CI, 1.010 to 1.664), respectively.

GBS colonisation was relatively low in pregnant women in Guangzhou. Women of advanced maternal age were more prone to GBS colonisation, and pregnant women colonised with GBS were more predisposed to fetal distress, PROM and LBW.

Head and neck cancer is the eighth most common cancer in the UK. Current standard of care treatment for patients with recurrent/metastatic squamous cell head and neck carcinoma (HNSCC) is platinum-based chemotherapy combined with the anti-epidermal growth factor receptor (anti-EGFR) monoclonal antibody, cetuximab. However, most patients will have poor median overall survival (OS) of 6–9 months despite treatment. HNSCC tumours exhibit an immune landscape poised to respond to immunotherapeutic approaches, with most tumours expressing the immunosuppressive receptor programmed death-ligand 1 (PD-L1). We undertook the current study to determine the safety and efficacy of avelumab, a monoclonal antibody targeting the interaction between PD-L1 and its receptor on cytotoxic T-cells, in combination with cetuximab.

This is a multi-centre, single-arm dose de-escalation phase II safety and efficacy study of avelumab combined with cetuximab; the study was to progress to a randomised phase II trial, however, the study will now complete after the safety run-in component. Up to 16 participants with histologically/cytologically recurrent/metastatic squamous cell carcinoma (including HNSCC) who have not received cetuximab previously will be recruited. All patients will receive 10 mg/kg avelumab and cetuximab (500, 400 or 300 mg/m² depending on the cohort open at time of registration) on days 1 and 15 of 4-week cycles for up to 1 year, (avelumab not given cycle 1 day 1). A modified continual reassessment method will be used to determine dose de-escalation. The primary objective is to establish the safety of the combination and to determine the optimum dose of cetuximab. Secondary objectives include assessing evidence of antitumour activity by evaluating response rates and disease control rates at 6 and 12 months as well as progression-free and OS.

Approval granted by City and East REC (18/LO/0021). Findings will be published in peer-reviewed journals and disseminated at conferences.

NCT03494322.