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.

Maternal mortality remains unacceptably high in sub-Saharan Africa with 533 maternal deaths per 100 000 live births, accounting for 68% of all maternal deaths worldwide. Most maternal deaths could be prevented by adequate maternal health service use. The study examined the effect of literacy status on maternal health services utilisation among reproductive-age women in Ethiopia.

A cross-sectional study.

Ethiopia.

A weighted sample of 3839 reproductive-age women who gave birth in the last 5 years preceding the survey and whose literacy status was measured were included in this study. The survey used a two-stage stratified cluster sampling technique.

This study used a dataset from the recent Ethiopia Mini Demographic and Health Surveys. We assessed the maternal health service utilisation among reproductive-age women. Multivariable logistic regression analyses were employed to assess the association between literacy status and maternal healthcare utilisation while controlling for other factors. Adjusted OR with a 95% CI was reported.

About 63.8% of reproductive-age women were illiterate. The prevalence of antenatal care (ANC) 1, ANC 4, skilled birth attendance and postnatal care (PNC) services utilisation was 74.9%, 43.5%, 51.9% and 32.0%, respectively. Literate women had significantly higher ANC 1, ANC 4, skilled birth attendance, and PNC services utilisation than illiterate women (p

Literate women had a significantly higher maternal healthcare services utilisation than illiterate, modified by sociodemographic and obstetric-related factors. Hence, wholehearted efforts should be directed towards educating and empowering women.

Our aim was to investigate the association between early environmental factors and the development of coeliac disease (CeD) in adolescents, recruited from a cohort nested in the Danish National Birth Cohort (DNBC).

The study was designed as a prospective cohort study, nested in DNBC

The Glutenfunen cohort comprises 1266 participants, nested in DNBC. All participants were screened for CeD, and in total, 28 cases of biopsy proven CeD were identified. Data about breastfeeding, timing of introduction to solid food in infancy, use of antibiotics, infections and symptoms were parentally reported prospectively at 6 months and 18 months, respectively. We estimated ORs and 95% CIs of CeD in adolescents using logistic regression analysis.

Viral croup reported at 18 months of age was associated with CeD in adolescents with an OR of 3.2 (95% CI: 1.2 to 8.7). Furthermore, otitis media also reported at 18 months of age was linked with CeD with an OR of 3.2 (95% CI: 1.5 to 7.3). We were not able to find any statistical associations between CeD and breastfeeding, frequency of infections, parentally reported use of antibiotic and timing of solid foods.

In this study, we present an overview of the relationship between early environmental factors and occurrence of CeD in adolescents. Our findings, despite limitations due to a limited number of cases of CeD, suggest a role of viral infections in the pathogenesis of CeD

Poverty may pose risks to child and adolescent mental health, but few studies have reported on this association among children and adolescents in low-income families in Norway.

Based on a sample participating in an intervention for low-income families in Norway, we report data from the survey administered at the start of the intervention. Mental health problems were measured using the Strengths and Difficulties Questionnaire (SDQ; self-report (SR) n = 148; parent/proxy-report (PR) n = 153, mean age = 10.8). Demographic and family characteristics were obtained from parent reported data. Results are presented by gender and migration background. Regression analysis was used to investigate the relative contribution of background factors to mental health symptoms. The distribution of scores is compared to UK norms.

Participants reported relatively high scores on the Strengths and Difficulties Questionnaire (SDQ) Total Difficulties Scale (parent/proxy-report, PR mean=10.7; self-report, SR mean=10.1). Participants with non-immigrant backgrounds scored considerably higher on the Total Difficulties Scale (PR mean difference=2.9; SR 5.3) and on most other domains measured with the SDQ compared with their peers with immigration backgrounds. Participants generally scored higher than or equal to UK norms.

Participants in the current study had many symptoms of mental health problems, with large differences between those with and without a migrant background. Interventions for low-income families should be based on detailed knowledge about differences in family risks, resources and needs.

During the last two decades, researchers and funders increasingly recognised the value of engaging patients and communities in research. Despite progress, community engagement remains challenging. There are few examples of successful participant engagement in governance of large-scale research programmes. Here we describe efforts to engage participants as partners in new governance roles in the All of Us Research Program, a precision medicine research initiative which intends to enrol at least one million participants. Using intentional, participant-centric engagement strategies, the All of Us Engagement Core recruited and integrated a diverse group of participants into governance roles including Steering and Executive Committees. Evaluation measures included a survey to assess Consortium Members’ readiness for participant engagement.

Over a 3-year period, all items on the survey increased (higher readiness). Of the 291 respondents to the 2021 survey, respondents most frequently agreed that participant perspectives are essential (100%), participants understand enough to contribute meaningfully (94%) and participants should be involved in setting goals (96%). Respondents least frequently agreed that participants should have an equal voice in Working Groups (75%), Steering Committee (69%) and Executive Committee (63%).

In conclusion, participants can be effectively integrated into large-scale research governance, which is associated with increased researcher readiness for engagement.