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☐ ☆ ✇ BMJ Open

Cohort profile: The Trauma Outcomes Project, a prospective study of New Zealanders experiencing major trauma

Por: Owen · H. E. · Wyeth · E. H. · Maclennan · B. · Barson · D. · McBride · P. · Gabbe · B. J. · Civil · I. · Derrett · S. — Noviembre 27th 2023 at 17:08
Purpose

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).

Participants

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.

Findings to date

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.

Future plans

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.

☐ ☆ ✇ BMJ Open

Implementation and the effects of a Parkinson Network Therapy (PaNTher) on activities of daily living and health-related quality of life in Parkinsons disease patients: study protocol of an mixed-method observational cohort study in outpatient care

Por: Loidl · V. · Ziegler · K. · Hoppmann · D. · Wagner · C. · Fietzek · U. M. · Ceballos-Baumann · A. O. · Grill · E. — Noviembre 27th 2023 at 17:08
Introduction

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.

Methods and analysis

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.

Ethics and dissemination

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.

☐ ☆ ✇ BMJ Open

Correction: Efficacy of an innovative Herbst appliance with TADs for patients with hyperdivergent class II malocclusion: study protocol for a randomised controlled trial

— Noviembre 27th 2023 at 17:08

Wang Y, Xu Y, Gong Z, et al. Efficacy of an innovative Herbst appliance with TADs for patients with hyperdivergent class II malocclusion: study protocol for a randomised controlled trial. BMJ Open 2023;13:e071840. doi: 10.1136/bmjopen-2023-071840

One funding project of this paper was inadvertently omitted and should be included in the funding statement. The updated Funding statement is as follows:

This research was supported by the Shanghai Commission of Science and Technology (No. 20Y11904100), Shanghai Municipal Health Commission (No.20224Y0391), Clinical Research Plan of Shanghai Stomatological Hospital (No. SSDC-2020-CXTD -A04), Shanghai Science and Technology Commission Sailing Program (No.20YF1442400) and Shanghai Stomatological Hospital Science and Technology Talents Project (SHH-2022-YJ-B02).

☐ ☆ ✇ BMJ Open

Increasing the reach of evidence-based interventions for weight management and diabetes prevention among Medicaid patients: study protocol for a pilot Sequential Multiple Assignment Randomised Trial

Por: Schlechter · C. R. · Del Fiol · G. · Jones · D. R. · Orleans · B. · Gibson · B. · Nahum-Shani · I. · Maxfield · E. · Locke · A. · Cornia · R. · Bradshaw · R. · Wirth · J. · Jaggers · S. J. · Lam · C. Y. · Wetter · D. W. — Noviembre 27th 2023 at 17:08
Introduction

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.

Methods and analysis

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).

Ethics and dissemination

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

Trial registration number

clinicaltrials.gov; NCT05666323.

☐ ☆ ✇ BMJ Open

Chronic kidney disease and functional impairment in a longitudinal study of older adults in China

Por: Duan · X. · Wang · L. · Wei · W. · Wang · Z. · Zhang · X. · Liu · J. · Ding · D. — Noviembre 27th 2023 at 17:08
Objectives

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

Design

This was a prospective longitudinal study.

Setting

Data were derived from the Chinese Longitudinal Healthy Longevity Study.

Participants

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

Primary outcome measures

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.

Results

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).

Conclusions

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.

☐ ☆ ✇ BMJ Open

Optimising HIV care using information obtained from PROMs: protocol for an observational study

Por: Moody · K. · Nieuwkerk · P. T. · Bedert · M. · Nellen · J. F. · Weijsenfeld · A. · Sigaloff · K. C. E. · Laan · L. · Bruins · C. · van Oers · H. · Haverman · L. · Geerlings · S. E. · Van der Valk · M. — Noviembre 27th 2023 at 17:08
Introduction

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).

Methods and analysis

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.

Ethics and dissemination

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.

☐ ☆ ✇ BMJ Open

Burden, determinants, consequences and care of multimorbidity in rural and urbanising Telangana, India: protocol for a mixed-methods study within the APCAPS cohort

Por: Lieber · J. · Banjara · S. K. · Mallinson · P. A. C. · Mahajan · H. · Bhogadi · S. · Addanki · S. · Birk · N. · Song · W. · Shah · A. S. · Kurmi · O. · Iyer · G. · Kamalakannan · S. · Kishore Galla · R. · Sadanand · S. · Dasi · T. · Kulkarni · B. · Kinra · S. — Noviembre 27th 2023 at 17:08
Introduction

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.

Methods and analysis

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.

Ethics and dissemination

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).

☐ ☆ ✇ BMJ Open

Colonisation of Group B Streptococcus and its effects on pregnancy outcomes in pregnant women in Guangzhou, China: a retrospective study

Por: Liu · Y. · Liu · W. · Zhuang · G. · Liu · W. · Qiu · C. — Noviembre 27th 2023 at 17:08
Objectives

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.

Design

A retrospective cohort study.

Setting

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.

Participants

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.

Primary outcome measures

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

Results

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.

Conclusions

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.

☐ ☆ ✇ BMJ Open

Protocol for the EACH trial: a multicentre phase II study evaluating the safety and antitumour activity of the combination of avelumab, an anti-PD-L1 agent, and cetuximab, as any line treatment for patients with recurrent/metastatic head and neck squamous

Por: Ng · K. · Metcalf · R. · Sacco · J. · Kong · A. · Wheeler · G. · Forsyth · S. · Bhat · R. · Ward · J. · Ensell · L. · Lowe · H. · Spanswick · V. · Hartley · J. · White · L. · Lloyd-Dehler · E. · Forster · M. — Noviembre 27th 2023 at 17:08
Introduction

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.

Methods and analysis

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.

Ethics and dissemination

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

Trial registration number

NCT03494322.

☐ ☆ ✇ BMJ Open

Effect of womens literacy status on maternal healthcare services utilisation in Ethiopia: a stratified analysis of the 2019 mini Ethiopian Demographic and Health Survey

Por: Handebo · S. · Demie · T. G. · Gessese · G. T. · Woldeamanuel · B. T. · Biratu · T. D. — Noviembre 27th 2023 at 17:08
Objectives

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.

Design

A cross-sectional study.

Settings

Ethiopia.

Participants

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.

Primary and secondary outcome measures

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.

Results

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

Conclusion

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.

☐ ☆ ✇ BMJ Open

Early environmental risk factors and coeliac disease in adolescents: a population-based cohort study in Denmark

Por: Crawley · C. · Sander · S. D. · Nohr · E. A. · Nybo Andersen · A.-M. · Husby · S. — Noviembre 27th 2023 at 17:08
Objectives

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).

Design

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

Participants

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.

Results

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.

Conclusion

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

☐ ☆ ✇ BMJ Open

Self-reported and parent-reported mental health in children from low-income families in Agder, Norway: results from baseline measurements of New Patterns project participants

Por: Boe · T. · Ostojic · H. A. · Haraldstad · K. · Abildsnes · E. · Wilson · P. · Vigsnes · K. · Molland · E. — Noviembre 27th 2023 at 17:08
Background

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.

Methods

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.

Results

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.

Conclusion

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.

☐ ☆ ✇ BMJ Open

Integrating participants as partners in research governance and operations: an approach from the All of Us Research Program Engagement Core

Por: Hammack-Aviran · C. · Fair · A. M. · Aldrich · M. · Richmond · J. · Carpenter · S. M. · Watson · K. S. · Cohn · E. G. · Wilkins · C. H. — Noviembre 27th 2023 at 17:08
Objectives

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.

Results

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%).

Conclusion

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

☐ ☆ ✇ BMJ Open

COVID-19 anxiety and related factors amid adjusted epidemic prevention policies: a cross-sectional study on patients with late-life depression in China

Por: Wu · J. · Qiu · L. · Xiong · W. · Shen · Y. · Li · J. · Wu · J. · Zhou · Q. — Noviembre 24th 2023 at 17:10
Objectives

To explore the prevalence and associated factors of COVID-19 anxiety in patients with late-life depression (LLD) during the adjustment of epidemic prevention policies in China.

Design

Cross-sectional study.

Setting

The data analysed in this study were collected from seven regions in China between November 2022 and January 2023.

Participants

A total of 1205 patients with LLD (aged 60–78 years) participated in the survey. They completed a social demographic assessment and the Chinese version of the five-point Coronavirus Anxiety Scale (CAS).

Primary outcome measures

The primary outcome was the anxiety level of the participants. Patients were categorised into two groups based on their anxiety levels, one with anxiety and one without, according to CAS scores.

Results

The prevalence of COVID-19 anxiety in depressed older adults was 47.3%. Regression analysis revealed that the average COVID-19 anxiety score was significantly higher among females (AOR: 2.177, 95% CI 1.201 to 3.947), widowed individuals (AOR: 3.015, 95% CI 1.379 to 6.591), patients residing at a distance from healthcare facilities (AOR: 3.765, 95% CI 1.906 to 7.438), and those who frequently experienced worry (AOR: 1.984, 95% CI 1.111 to 3.543). Conversely, the anxiety score was significantly lower among divorced individuals (AOR: 0.491, 95% CI 0.245 to 0.988), those aged 70 years and above (AOR: 0.117, 95% CI 0.064 to 0.213), patients without difficulty obtaining medication (AOR: 0.027, 95% CI 0.007 to 0.097), those living with family members (AOR: 0.080, 95% CI 0.022 to 0.282) or in nursing homes compared with those living alone (AOR: 0.019, 95% CI 0.004 to 0.087).

Conclusion

Women with LLD who are widowed, live far from healthcare facilities, and are prone to excessive worry are more likely to experience anxiety. It is advisable to implement appropriate preventive measures and provide psychosocial support programmes for this vulnerable group during the COVID-19 pandemic.

☐ ☆ ✇ BMJ Open

Protocol for the PATHOME study: a cohort study on urban societal development and the ecology of enteric disease transmission among infants, domestic animals and the environment

Por: Baker · K. K. · Simiyu · S. · Busienei · P. · Gutema · F. D. · Okoth · B. · Agira · J. · Amondi · C. S. · Ziraba · A. · Kapanka · A. G. · Osinuga · A. · Ouma · C. · Sewell · D. K. · Gaire · S. · Tumwebaze · I. K. · Mberu · B. — Noviembre 24th 2023 at 17:10
Introduction

Global morbidity from enteric infections and diarrhoea remains high in children in low-income and middle-income countries, despite significant investment over recent decades in health systems and water and sanitation infrastructure. Other types of societal development may be required to reduce disease burden. Ecological research on the influence of household and neighbourhood societal development on pathogen transmission dynamics between humans, animals and the environment could identify more effective strategies for preventing enteric infections.

Methods and analysis

The ‘enteric pathome’—that is, the communities of viral, bacterial and parasitic pathogens transmitted from human and animal faeces through the environment is taxonomically complex in high burden settings. This integrated cohort-exposure assessment study leverages natural socioeconomic spectrums of development to study how pathome complexity is influenced by household and neighbourhood infrastructure and hygiene conditions. We are enrolling under 12-month-old children in low-income and middle-income neighbourhoods of two Kenyan cities (Nairobi and Kisumu) into a ‘short-cohort’ study involving repeat testing of child faeces for enteric pathogens. A mid-study exposure assessment documenting infrastructural, behavioural, spatial, climate, environmental and zoonotic factors characterises pathogen exposure pathways in household and neighbourhood settings. These data will be used to inform and validate statistical and agent-based models (ABM) that identify individual or combined intervention strategies for reducing multipathogen transmission between humans, animals and environment in urban Kenya.

Ethics and dissemination

The protocols for human subjects’ research were approved by Institutional Review Boards at the University of Iowa (ID-202004606) and AMREF Health Africa (ID-ESRC P887/2020), and a national permit was obtained from the Kenya National Commission for Science Technology and Innovation (ID# P/21/8441). The study was registered on Clinicaltrials.gov (Identifier: NCT05322655) and is in pre-results stage. Protocols for research on animals were approved by the University of Iowa Animal Care and Use Committee (ID 0042302).

☐ ☆ ✇ BMJ Open

Non-pharmacological interventions for patients with psoriasis: a scoping review

Por: Zhang · X.-j. · Lin · J. · Feng · L. · Ou · M. · Gong · F.-q. — Noviembre 24th 2023 at 17:10
Objectives

Healthcare ultimately aims to eradicate diseases and restore normality to people’s lives. However, until this is achieved for every person, there is a need to support and assist patients with psoriasis using non-pharmacological interventions. These ‘adjuvant’ approaches have received little attention, whereas dermatologists and researchers strive for better pharmacological therapy. Here, we aimed to perform a scoping review to identify and catalogue non-pharmacological interventions for patients with psoriasis.

Design

A scoping review.

Setting

All healthcare settings.

Search strategy

EMBASE, PubMed, CINAHL, PsycINFO and Scopus databases were searched from their inception to June 2022. Irrespective of the study type, the studies included non-pharmacological interventions for patients with psoriasis. This theme was extracted from the included articles. Two reviewers independently screened and analysed the data.

Results

From 1322 initial records, 71 studies were identified and analysed. Non-pharmacological interventions for patients with psoriasis include two levels: organisational and individual. The organisational non-pharmacological interventions included the nationwide healthcare model (PsPSP, ProvenCare, German PsoHealth and Psoriasis Network, IMPROVE model and PsoWell clinic), innovative teledermatology models (mHealth app, electronic Targeted Intervention for Psoriasis study and therapist-guided internet-based cognitive and behavioural treatments) and multidisciplinary interventions. The individual non-pharmacological interventions included educational interventions (therapeutic patient education, psychoeducational intervention and self-management education), psychosocial interventions (cognitive and behavioural treatments, self-help and peer-to-peer support programmes) and others (happify and motivational interviewing-based training).

Conclusions

Based on previous literature, a nationwide healthcare model protocol was constructed for patients with psoriasis. This provided the direction for developing a new psoriasis healthcare model and a basis for summarising the non-pharmacological interventions for patients with psoriasis, which helps them adjust to changes in the skin disease.

☐ ☆ ✇ BMJ Open

Solutions to Enhance Health with Alternative Treatments (SEHAT) protocol: a double-blinded randomised controlled trial for gut microbiota-targeted treatment of severe acute malnutrition using rice bran in ready-to-use therapeutic foods in Indonesia

Por: Weber · A. M. · Barbazza · S. · Fauzi · M. D. · Rachmadewi · A. · Zuhrina · R. · Putri · F. K. · Campos Ponce · M. · Hoeven · M. v. d. · Rimbawan · R. · Nasution · Z. · Giriwono · P. E. · Wieringa · F. T. · Soekarjo · D. D. · Ryan · E. P. — Noviembre 24th 2023 at 17:10
Introduction

Current formulations of ready-to-use therapeutic foods (RUTFs) to treat severe acute malnutrition (SAM) in children focus on nutrient density and quantity. Less attention is given to foods targeting gut microbiota metabolism and mucosal barrier functions. Heat-stabilised rice bran contains essential nutrients, prebiotics, vitamins and unique phytochemicals that have demonstrated favourable bioactivity to modulate gut microbiota composition and mucosal immunity. This study seeks to examine the impact of RUTF with rice bran on the microbiota during SAM treatment, recovery and post-treatment growth outcomes in Jember, Indonesia. Findings are expected to provide insights into rice bran as a novel food ingredient to improve SAM treatment outcomes.

Methods and analysis

A total of 200 children aged 6–59 months with uncomplicated SAM (weight-for-height z-scores (WHZ)

Ethics and dissemination

The findings of this trial will be submitted to peer-reviewed journals and will be presented at relevant conferences. Ethics approval obtained from the Medical and Health Research Ethical Committee at the Faculty of Medicine, Public Health and Nursing, Universitas Gadjah Madain Yogyakarta Ref. No.: KE/FK/0546/EC/2022 and KE/FK/0703/EC/2023 and from Colorado State University IRB#1823, OHRP FWA00000647.

Trial registration number

NCT05319717.

☐ ☆ ✇ BMJ Open

Epidemiological transition: a historical analysis of immigration patterns by country of origin (1861-1986) related to circulatory system diseases and all-cause mortality in twentieth-century Australia

Por: Kelleher · C. C. · Kelly · G. E. · Segurado · R. · Briody · J. · Sellers · A. M. · McCalman · J. — Noviembre 24th 2023 at 17:10
Background and objectives

Circulatory system disease (CSD) patterns vary over time and between countries, related to lifestyle risk factors, associated in turn with socioeconomic circumstances. Current global CSD epidemics in developing economies are similar in scale to those observed previously in the USA and Australasia. Australia exhibits an important macroeconomic phenomenon as a rapidly transitioning economy with high immigration throughout the nineteenth and twentieth centuries. We wished to examine how that historical immigration related to CSD patterns subsequently.

Methods and setting

We provide a novel empirical analysis employing census-derived place of birth by age bracket and sex from 1891 to 1986, in order to map patterns of immigration against CSD mortality rates from 1907 onwards. Age-specific generalised additive models for both CSD mortality in the general population, and all-cause mortality for the foreign-born (FB) only, from 1910 to 1980 were also devised for both males and females.

Results

The percentage of FB fell from 32% in 1891 to 9.8% in 1947. Rates of CSD rose consistently, particularly from the 1940s onwards, peaked in the 1960s, then declined sharply in the 1980s and showed a strong period effect across age groups and genders. The main effects of age and census year and their interaction were highly statistically significant for CSD mortality for males (p

Conclusions

We argue our empirical calculations, supported by historical and socioepidemiological evidence, employing immigration patterns as a proxy for epidemiological transition, affirm the life course hypothesis that both early life circumstances and later life lifestyle drive CSD patterns.

☐ ☆ ✇ BMJ Open

Assessment of health literacy in patients with polycystic ovary syndrome and its relationship with health behaviours: a cross-sectional study

Por: Liu · Y. · Guo · Y. · Yan · X. · Ding · R. · Tan · H. · Wang · Y. · Wang · X. · Wang · L. — Noviembre 24th 2023 at 17:10
Objective

Healthy behaviours are important for people with polycystic ovary syndrome (PCOS). However, adopting and maintaining lifestyle changes involves a complex set of behavioural changes, which most patients fail to adhere to. The current research on health literacy, which includes individual and social skills needed in health self-management, in patients with PCOS is limited. Therefore, this study aimed to explore health literacy, health behaviours and the relationship between the two to expand research on PCOS management.

Design

Cross-sectional study.

Setting

A gynaecological outpatient clinic.

Participants

A total of 286 patients with PCOS (≥18 years, diagnosed via Rotterdam criteria, able to self-report and give informed consent) were recruited from March to June 2022.

Outcome measures

Health literacy and health behaviours in patients with PCOS were assessed using the Health Literacy Management Scale and the Health Promoting Lifestyle Profile (Chinese version). Multiple logistic regression was used to analyse the factors influencing health literacy, and linear regression to assess the relationship between health literacy and health behaviours, with an F-significance test; p

Results

Overall, most patients with PCOS had insufficient health literacy (55.9%). The influencing factors of health literacy in patients with PCOS were age (β=0.154, p

Conclusion

The positive correlation between health literacy and health behaviour in patients with PCOS indicates that promoting health literacy in future treatment and management of PCOS may be beneficial.

☐ ☆ ✇ BMJ Open

IC3 protocol: a longitudinal observational study of cognition after stroke using novel digital health technology

Por: Gruia · D.-C. · Trender · W. · Hellyer · P. · Banerjee · S. · Kwan · J. · Zetterberg · H. · Hampshire · A. · Geranmayeh · F. — Noviembre 24th 2023 at 17:10
Introduction

Stroke is a major cause of death and disability worldwide, frequently resulting in persistent cognitive deficits among survivors. These deficits negatively impact recovery and therapy engagement, and their treatment is consistently rated as high priority by stakeholders and clinicians. Although clinical guidelines endorse cognitive screening for poststroke management, there is currently no gold-standard approach for identifying cognitive deficits after stroke, and clinical stroke services lack the capacity for long-term cognitive monitoring and care. Currently, available assessment tools are either not stroke-specific, not in-depth or lack scalability, leading to heterogeneity in patient assessments.

Methods and analysis

To address these challenges, a cost-effective, scalable and comprehensive screening tool is needed to provide a stroke-specific assessment of cognition. The current study presents such a novel digital tool, the Imperial Comprehensive Cognitive Assessment in Cerebrovascular Disease (IC3), designed to detect both domain-general and domain-specific cognitive deficits in patients after stroke with minimal input from a health professional. To ensure its reliability, we will use multiple validation approaches, and aim to recruit a large normative sample of age-matched, gender-matched and education-matched UK-based controls. Moreover, the IC3 assessment will be integrated within a larger prospective observational longitudinal clinical trial, where poststroke cognition will be examined in tandem with brain imaging and blood biomarkers to identify novel multimodal biomarkers of recovery after stroke. This study will enable deeper cognitive phenotyping of patients at a large scale, while identifying those with highest risk of progressive cognitive decline, as well as those with greatest potential for recovery.

Ethics and dissemination

This study has been approved by South West—Frenchay Research Ethics Committee (IRAS 299333) and authorised by the UK’s Health Research Authority. Results from the study will be disseminated at conferences and within peer-reviewed journals.

Trial registration number

NCT05885295. Stage: Pre-results.

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