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UK Chiari 1 Study: protocol for a prospective, observational, multicentre study

Introduction

Chiari 1 malformation (CM1) is a structural abnormality of the hindbrain characterised by the descent of the cerebellar tonsils through the foramen magnum. The management of patients with CM1 remains contentious since there are currently no UK or international guidelines for clinicians. We therefore propose a collaborative, prospective, multicentre study on the investigation, management and outcome of CM1 in the UK: the UK Chiari 1 Study (UKC1S). Our primary objective is to determine the health-related quality of life (HRQoL) in patients with a new diagnosis of CM1 managed either conservatively or surgically at 12 months of follow-up. We also aim to: (A) determine HRQoL 12 months following surgery; (B) measure complications 12 months following surgery; (C) determine the natural history of patients with CM1 treated conservatively without surgery; (D) determine the radiological correlates of presenting symptoms, signs and outcomes; and (E) determine the scope and variation within UK practice in referral patterns, patient pathways, investigations and surgical decisions.

Methods and analysis

The UKC1S will be a prospective, multicentre and observational study that will follow the British Neurosurgical Trainee Research Collaborative model of collaborative research. Patients will be recruited after attending their first neurosurgical outpatient clinic appointment. Follow-up data will be collected from all patients at 12 months from baseline regardless of whether they are treated surgically or not. A further 12-month postoperative follow-up timepoint will be added for patients treated with decompressive surgery. The study is expected to last three years.

Ethics and dissemination

The UKC1S received a favourable ethical opinion from the East Midlands Leicester South Research Ethics Committee (REC reference: 20/EM/0053; IRAS 269739) and the Health Research Authority. The results of the study will be published in peer-reviewed medical journals, presented at scientific conferences, shared with collaborating sites and shared with participant patients if they so wish.

Policy changes and the screening, diagnosis and treatment of drug-resistant tuberculosis patients from 2015 to 2018 in Zhejiang Province, China: a retrospective cohort study

Por: Jiang · W. · Peng · Y. · Wang · X. · Elbers · C. · Tang · S. · Huang · F. · Chen · B. · Cobelens · F.
Objectives

To examine changes in the screening, diagnosis, treatment and management of drug-resistant tuberculosis (DRTB) patients, and investigate the impacts of DRTB-related policies on patients of different demographic and socioeconomic characteristics.

Design

A retrospective cohort study using registry data, plus a survey on DRTB-related policies.

Setting

All prefecture-level Centres for Disease Control in Zhejiang Province, China.

Main outcome measures

Alongside the care cascade, we examined: (1) reported number of presumptive DRTB patients; (2) percentage of presumptive patients with drug susceptibility testing (DST) records; (3) percentage of DRTB/rifampicin-resistant (RR) patients registered; (4) percentage of RR/multidrug-resistant TB (MDRTB) patients that received anti-DRTB treatment; and (5) percentage of RR/MDRTB patients cured/completed treatment among those treated. Multivariate logistic regressions were conducted to explore the impacts of DRTB policies after adjusting for other factors.

Results

The number of reported presumptive DRTB patients and the percentage with DST records largely increased during 2015–2018, and the percentage of registered patients who received anti-DRTB treatment also increased from 59.0% to 86.5%. Patients under the policies of equipping GeneXpert plus expanded criteria for DST had a higher likelihood of being registered compared with no GeneXpert (adjusted OR (aOR)=2.57, 95% CI: 1.20 to 5.51), while for treatment initiation the association was only significant when further expanding the registration criteria (aOR=2.38, 95% CI: 1.19 to 4.79). Patients with registered residence inside Zhejiang were more likely to be registered (aOR=1.96, 95% CI: 1.52 to 2.52), treated (aOR=3.83, 95% CI: 2.78 to 5.28) and complete treatment (aOR=1.92, 95% CI: 1.03 to 3.59) compared with those outside.

Conclusion

The policy changes on DST and registration have effectively improved DRTB case finding and care. Nevertheless, challenges remain in servicing vulnerable groups such as migrants and improving equity in the access to TB care. Future policies should provide comprehensive support for migrants to complete treatment at their current place of residence.

Development of the Prevent for Work questionnaire (P4Wq) for assessment of musculoskeletal risk in the workplace: part 1--literature review and domains selection

Por: Langella · F. · Christensen · S. W. M. · Palsson · T. S. · Hogh · M. · Gagni · N. · Bellosta-Lopez · P. · Christiansen · D. H. · Delle Chiaie · M. · Domenech-Garcia · V. · Johnston · V. · Szeto · G. P. Y. · Villafane · J. H. · Herrero · P. · Berjano · P.
Objective

This study aims to define appropriate domains and items for the development of a self-administered questionnaire to assess the risk of developing work-related musculoskeletal disorder (WMSD) and the risk of its progression to chronicity.

Design

Literature review and survey study.

Setting and participants

A literature review and a two-round interview with 15 experts in musculoskeletal pain were performed to identify the available domains for WMSD assessment.

Interventions and outcome

To ensure quality, only validated questionnaires were included for the Delphi process. A three-round Delphi method, with three round steps, was used to select the most pertinent and relevant domains and items.

Results

Nine questionnaires were identified through the expert discussion and literature review, comprising 38 candidate domains and 504 items. In the first round of the Delphi group, 17 domains reached more than 70% agreement and were selected. In the second round, 10 domains were rejected, while 11 were selected to complete the pool of domains. In the third and final round, 89 items belonging to 28 domains were defined as significant to develop a WMSDs risk assessment questionnaire.

Conclusions

No specific risk assessment questionnaires for WMSDs were identified from the literature. WMSD risk of presence and chronicity can be defined by an assessment tool based on the biopsychosocial model and the fear-avoidance components of chronic pain. The present study provides the formulation and operationalisation of the constructs in domains and items needed for developing and validating the questionnaire.

Effects of an optimised approach to home-based respiratory care in individuals with amyotrophic lateral sclerosis: a study protocol for a randomised controlled trial

Por: Pondofe · K. · Fregonezi · G. A. F. · Brito · O. · Dourado Junior · M. E. · Torres-Castro · R. · Resqueti · V. R.
Introduction

This study aims to investigate the effects of an optimal home-based respiratory care protocol in individuals with amyotrophic lateral sclerosis (ALS).

Methods and analysis

This is a randomised, blinded controlled trial involving patients diagnosed with ALS, both sexes, age between 18 and 80 years. Patients will be randomly allocated into the conventional respiratory care (CRC) group and the optimised respiratory care home-based (ORC) group. Primary outcomes will be peak cough flow, the number of exacerbations and ALS Functional Rating Scale Revised. Secondary outcomes will include chest wall volumes, maximal respiratory pressures, sniff nasal inspiratory pressure, nasal expiratory pressure and forced vital capacity (FVC), forced expiratory volume in the 1st second (FEV1) and FEV1/FVC. The CRC group will receive educational information about respiratory care at the clinic. The ORC group will receive conventional care and home-based care. The clinical status of all individuals will be monitored weekly through telephone calls. A 6-month intervention is planned, the outcomes will be assessed every 3 months and 3 and 6 months follow-up after final evaluation. The primary and secondary results will be described as average or median for continuous variables and absolute and relative frequencies for qualitative variables. Treatment effects or differences between the outcomes (baseline, 3 months and 6 months) of the study groups will be analysed using an analysis of variance. The level of significance will be set as p≤0.05.

Ethics and dissemination

The research ethics committee approved the study. It is expected to evaluate respiratory function in patients with ALS in the short, medium and long terms with home-based care protocol applied. The disease’s rapid progression is a limitation for performing a long-term clinical study.

Trial registration number

RBR-3z23ts; Pre-results.

Factors associated with mobile phone usage to access maternal and child healthcare among women of urban slums in Dhaka, Bangladesh: a cross-sectional study

Por: Mistry · S. K. · Akter · F. · Yadav · U. N. · Hossain · M. B. · Sichel · A. · Labrique · A. B. · Storisteanu · D. M. L.
Introduction

With the acute shortage of human resources and infrastructure, mobile phones can be a critical tool for accessing health services and strengthening health systems in Bangladesh. Yet, there is a scarcity of evidence on the use of mobile phones in this context for accessing health services. In this study, we sought to explore the current use of mobile phones for accessing maternal and child healthcare and its determinants among recently delivered women in urban slums of Bangladesh.

Methods

The data were collected through interviewing 800 recently delivered women from eight slums of Dhaka city of Bangladesh during May and June 2018. The study followed a cross-sectional design and a two-stage cluster random sampling procedure was followed. A pretested structured questionnaire was employed to collect information. Chi square tests were performed for descriptive analyses and a multilevel binary logistic regression model was executed to explore the determinants of mobile phone usage for accessing maternal and childcare among the participants.

Results

Overall, 73.8% of study participants used mobile phones for accessing maternal and child healthcare. After adjusting for potential confounders, participants’ age, husband’s occupation, sex of household head, women’s ownership of mobile phones and household wealth status were found to be significantly associated with higher odds of using mobile phones to access maternal and child healthcare.

Conclusion

The study highlighted the possibility of implementing large-scale mobile health (mHealth) interventions in slum settlements for accessing maternal and child healthcare and is a sustainable mitigation strategy for the acute health worker crisis in Bangladesh. The findings of this study are particularly crucial for policymakers and practitioners while they revise the health policy to incorporate mHealth interventions as highlighted in the recently initiated Digital Health Strategy of Bangladesh.

Study protocol for You.Mind!: boosting first-line mental health care for YOUngsters suffering from chronic conditions with mindfulness: a randomised staggered within-subjects design

Por: Kock · M. · Van Hoecke · E. · Raes · F. · Van der Gucht · K.
Introduction

Adolescents with chronic conditions often experience high levels of stress, anxiety and depression, and reduced quality of life. Mindfulness-based interventions (MBIs) have been found to improve emotional distress in clinical and non-clinical populations and are a promising technique to support adolescents with chronic conditions in managing their symptoms and ultimately enhance their quality of life.

Methods and analysis

To test the effects of an MBI on emotional distress and quality of life and delineate the underlying mechanisms, the You.Mind! study uses a randomised staggered within-subjects design. Thirty adolescents with a chronic condition will be randomised to a baseline phase of 14–28 days followed by an MBI, consisting of four online group sessions and online support spread over 8 weeks. Outcomes will be assessed by short, repeated measurements throughout the baseline, intervention and follow-up phases and by standardised questionnaires and experience sampling measures before randomisation, at postintervention and at 3-months follow-up. Analysis will be based on general linear modelling and multilevel mixed-effects modelling.

Ethics and dissemination

Ethical approval was obtained from the Ethics Committee Research UZ/KU Leuven and the Ethics Committee of Ghent University Hospital and Ghent University (S63485). Results will be disseminated through presentations at public lectures, scientific institutions and meetings, and through publication in peer-reviewed journals.

Trial registration number

NCT04359563.

CoCo20 protocol: a pilot longitudinal follow-up study about the psychiatric outcomes in a paediatric population and their families during and after the stay-at-home related to coronavirus pandemic (COVID-19)

Por: Gindt · M. · Fernandez · A. · Richez · A. · Nachon · O. · Battista · M. · Askenazy · F.
Introduction

In the context of a viral outbreak and the stay-at-home measures, a significant increase in psychological distress, such as stress or fear behaviours, has previously been reported in adult and paediatric population. Children and adolescents seem to be particularly at risk of developing psychiatric disorders during and after the stay-at-home but evidences are lacking. The main objective of this article is to present the methodology of Coronavirus Confinement 2020 (CoCo20) Study, which aims to assess the impact of the coronavirus pandemic (COVID-19) and stay-at-home on the development of psychiatric disorders, including post-traumatic stress disorder (PTSD), in children and adolescents.

Methods and analysis

We describe a longitudinal and multicentre study in the paediatric population during and after stay-at-home related to COVID-19 pandemic. Inclusions started on 30 March 2020 for 6 months. This study is proposed to all consecutive paediatric outpatients consulting during and after stay-at-home related to COVID-19 pandemic in medical–psychological centres and in a paediatric psychotrauma centre and/or calling the emergency COVID-19 hotline. We perform standardised and internationally validated psychiatric assessments (Diagnosis Infant and Preschool Assessment, Kiddie Schedule for Affective Disorders and Schizophrenia—Present and Lifetime Version) together with anxiety, attention deficit hyperactivity disorder, PTSD, parenting stress and somatic symptoms scales during five visits (baseline, 1 week after baseline, 1 month after baseline, 1 week after the end of the containment and 1 month after the end of the containment) in patients and their families enrolled during the containment and during three visits in case of enrolment after the containment. The inclusion period will end in 30 November 2020.

Ethics and dissemination

The protocol has been approved by the Ethics Committee of Cote d’Azur University « CERNI » (number 2020-59). All patients and their legal caregivers provide a written informed consent on enrolment in the study. We will submit the results of the study to relevant journals and offer national and international presentations. This study will enable better characterisation of the impact of the stay-at-home (related to COVID-19 pandemic) on the mental health of children and adolescents.

Trial registration number

NCT04498416.

Self-reported health and smoking status, and body mass index: a case-control comparison based on GEN SCRIP (GENetics of SChizophRenia In Pakistan) data

Por: Ayub · M. · Arsalan · A. · Khan · S.-u.-D. A. · Bajwa · S. · Hussain · F. · Umar · M. · Khizar · B. · Sibtain · M. · Butt · A. · Mukhtar-Ul-Haq · M. · Dogar · I. A. · Ansari · M. A. · Shafiq · S. · Tariq · M. · Hussain · M. I. · Nasar · A. · Mustafa · A. B. · Taj · R. · Rehman · R. U. · Rajp
Introduction

Individuals with schizophrenia are at a high risk of physical health comorbidities and premature mortality. Cardiovascular and metabolic causes are an important contributor. There are gaps in monitoring, documenting and managing these physical health comorbidities. Because of their condition, patients themselves may not be aware of these comorbidities and may not be able to follow a lifestyle that prevents and manages the complications. In many low-income and middle-income countries including Pakistan, the bulk of the burden of care for those struggling with schizophrenia falls on the families.

Objectives

To determine the rate of self-reported physical health disorders and risk factors, like body mass index (BMI) and smoking, associated with cardiovascular and metabolic disorders in cases of schizophrenia compared with a group of mentally healthy controls.

Design

A case-controlled, cross-sectional multicentre study of patients with schizophrenia in Pakistan.

Settings

Multiple data collection sites across the country for patients, that is, public and private psychiatric OPDs (out patient departments), specialised psychiatric care facilities, and psychiatric wards of teaching and district level hospitals. Healthy controls were enrolled from the community.

Participants

We report a total of 6838 participants’ data with (N 3411 (49.9%)) cases of schizophrenia compared with a group of healthy controls (N 3427 (50.1%)).

Results

BMI (OR 0.98 (CI 0.97 to 0.99), p=0.0025), and the rate of smoking is higher in patients with schizophrenia than in controls. Problems with vision (OR 0.13 (0.08 to 0.2), joint pain (OR 0.18 (0.07 to 0.44)) and high cholesterol (OR 0.13 (0.05 to 0.35)) have higher reported prevalence in controls. The cases describe more physical health disorders in the category ‘other’ (OR 4.65 (3.01 to 7.18)). This captures residual disorders not listed in the questionnaire.

Conclusions

Participants with schizophrenia in comparison with controls report more disorders. The access in the ‘other’ category may be a reflection of undiagnosed disorders.

Prevalence and risk factors of adverse birth outcomes in the Pacific Island region: a scoping review protocol

Por: Kaforau · L. S. K. · Tessema · G. A. · Jancey · J. · Dhamrait · G. K. · Bugoro · H. · Pereira · G. F.
Introduction

Fetal growth restriction, preterm birth, low birth weight and stillbirth are adverse birth outcomes that are prevalent in low-income and middle-income settings such as the Pacific Island region. It is widely accepted that the excess burden of adverse birth outcomes is attributable to socioeconomic and environmental factors that predispose families to excess risk. Our review seeks to determine the prevalence of adverse birth outcomes in the Pacific Island region and to identify the risk factors of adverse birth outcomes in the Pacific Island region.

Methods

This scoping review will follow the five-staged Arksey and O’Malley’s framework and consultation with Solomon Islands’ health stakeholders. A preliminary literature review was undertaken to understand the scope of the review. We will use Medical Subject Heading and keyword terms for adverse birth outcomes to search CINAHL, Medline, Scopus, ProQuest and Springer Link databases for articles published from 1 January 2000. The subsequent searches will be undertaken via Google Scholar and the internet browser to world health organisation and regional health organisations for published and unpublished reports on non-indexed studies. All articles retrieved will be managed with EndNote software. Eligible studies will be screened using Preferred Reporting Items for Systematic Reviews and Meta-Analyses flow chart for final selection. In the charting phase, we will extract the data into Excel spreadsheets. The results will be presented as numerical and thematic summaries that map risk factors and prevalence to the population and cultures of the Pacific Island region.

Ethics and dissemination

Formal ethical approval is not required as primary or administrative data will not be collected. However, we will seek ethics approval for the stakeholder consultation from the Research Office of Curtin University and the Solomon Islands. The findings of this study will be published in peer-reviewed journals and presented in national and regional conferences and disseminated to stakeholders.

Ethics approval

There will be no direct contact with human or patients in the case of the scoping review; therefore, no ethics will be required. However, we will seek ethical approval from the Research Ethics Office of Curtin University and the Health Research and Ethics Committee in the Solomon Islands for stakeholder consultation. Dissemination will be made through regional conferences and publication in peer-reviewed journals.

Cross-sectional seroprevalence study of antibody to Bordetella pertussis toxin in western Saudi Arabia: is there a need for a vaccine booster dose for adolescents and young adults?

Por: Farahat · F. · Althaqafi · A. · Al-Amri · A. · Alsaedi · A. · Abouremsh · M. · Alshamrani · M.
Objectives

The present study was conducted to estimate the seroprevalence of antibody to pertussis toxin among adult populations in western Saudi Arabia.

Design

A cross-sectional study.

Setting

King Abdulaziz Medical City, Jeddah, western Saudi Arabia. A tertiary care teaching hospital.

Participants

A total of 1200 participants (400 healthcare workers, 400 military recruits and 400 blood donors) were included. The majority were male (79.3%), and the mean (±SD) age was 27.2 (±6.7) years old.

Interventions

The study included the analysis of serum blood samples using commercial ELISA. A consecutive sampling technique was applied.

Primary outcome measures

Seropositivity of antipertussis toxin immunoglobulin G (anti-PT IgG) ≥62.5 IU/mL.

Results

Antibody titres ≥62.5 IU/mL, indicating exposure to Bordetella pertussis infection within the last year, were identified in 12.0% (95% CI 10.2% to 14.0%) of the participants. Titres ≥125 IU/mL, suggesting recent infection, were detected in 3.5% (95% CI 2.5% to 4.7%). Seroprevalence of positive IgG antibody titres (≥62.5 IU/mL) was highest among the healthcare workers (HCWs) (14%), then the military recruits (13.5%) and blood donors (8.5%; p=0.03). The multivariate regression analysis showed association between participants group (HCWs and military), male gender and younger age (

Conclusions

High pertussis seropositivity was associated with participants’ occupation (ie, healthcare workers and military recruits), and anti-PT IgG titre was negatively correlated with age. A substantial deficiency in pertussis reporting in Saudi Arabia has been suggested, with potential increased risk to the most vulnerable populations (ie, infants and elderly). Enhancing the booster dose of pertussis vaccine for adolescents and adults is crucial to minimise the burden of pertussis.

Knowledge, attitude and psychological status of patients living with hepatitis C in five provinces in China: a cross-sectional survey

Por: Zhao · T.-S. · Jin · C. · Wang · Y. · Cui · F.
Objective

This study investigated the knowledge, attitudes and psychological status of hepatitis C virus (HCV)-positive patients through a cross-sectional survey to provide scientific strategies for improving their treatment compliance and quality of life.

Setting

The research was conducted in nine hospitals in five provincial administrative regions in China, namely Inner Mongolia, Jilin, Beijing, Hebei and Sichuan.

Participants

A total of 457 patients were recruited for this study and 409 patients were included in the final analysis. The participants were 215 men and 194 women, with an average age of 59 years.

Primary and secondary outcome measures

The primary outcomes were scores on scales assessing knowledge, attitudes and psychological status. The secondary outcomes were transmission of HCV, preference regarding the mode in which information about HCV was provided and factors affecting treatment.

Results

Blood transfusion was the most common route of HCV transmission (42.7%), followed by surgery (15.9%) and blood donation/sale (8.7%). The misunderstanding of HCV and negative attitudes towards other HCV-positive patients were relatively common among HCV-positive patients and were more pronounced among rural and ethnic minority populations. HCV-positive patients were generally categorised as possibly having symptoms of depression. Patients with negative attitudes were more likely to have symptoms of depression (OR=0.6, 95% CI 0.4 to 0.8).

Conclusions

HCV-positive patients had a poor understanding of HCV and a negative attitude towards other HCV-positive patients. It is very important to develop effective health education strategies to improve the knowledge, attitudes and mental health of HCV-positive patients and enhance treatment compliance.

Community-centred interventions for improving public mental health among adults from ethnic minority populations in the UK: a scoping review

Por: Baskin · C. · Zijlstra · G. · McGrath · M. · Lee · C. · Duncan · F. H. · Oliver · E. J. · Osborn · D. · Dykxhoorn · J. · Kaner · E. F. S. · LaFortune · L. · Walters · K. R. · Kirkbride · J. · Gnani · S.
Objectives

Undertake a scoping review to determine the effectiveness of community-centred interventions designed to improve the mental health and well-being of adults from ethnic minority groups in the UK.

Methods

We searched six electronic academic databases for studies published between January 1990 and September 2019: Medline, Embase, PsychINFO, Scopus, CINAHL and Cochrane. For intervention description and data extraction we used the Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews checklist and Template for Intervention Description and Replication guide. Quality was assessed using Cochrane risk of bias tools. Grey literature results were deemed beyond the scope of this review due to the large number of interventions and lack of available outcomes data.

Results

Of 4501 studies, 7 met the eligibility criteria of UK-based community interventions targeting mental health in adults from ethnic minority populations: four randomised controlled trials, one pre/post-pilot study, one cross-sectional study and one ethnographic study. Interventions included therapy-style sessions, peer-support groups, educational materials, gym access and a family services programme. Common components included a focus on tackling social isolation, using lay health workers from within the community, signposting and overcoming structural barriers to access. Four studies reported a statistically significant positive effect on mental health outcomes and six were appraised as having a high risk of bias. Study populations were ethnically heterogeneous and targeted people mainly from South Asia. No studies examined interventions targeting men.

Conclusions

There is a paucity of high-quality evidence regarding community-centred interventions focused on improving public mental health among ethnic minority groups. Decision makers need scientific evidence to inform effective approaches to mitigating health disparities. Our next steps are to map promising community activities and interventions that are currently being provided to help identify emerging evidence.

Discrepancies in self-reported financial conflicts of interest disclosures by physicians: a systematic review

Por: Taheri · C. · Kirubarajan · A. · Li · X. · Lam · A. C. L. · Taheri · S. · Olivieri · N. F.
Background

There is a high prevalence of financial conflicts of interest (COI) between physicians and industry.

Objectives

To conduct a systematic review with meta-analysis examining the completeness of self-reported financial COI disclosures by physicians, and identify factors associated with non-disclosure.

Data sources

MEDLINE, Embase and PsycINFO were searched for eligible studies up to April 2020 and supplemented with material identified in the references and citing articles.

Data extraction and synthesis

Data were independently abstracted by two authors. Data synthesis was performed via systematic review of eligible studies and random-effects meta-analysis.

Main outcomes and measures

The proportion of discrepancies between physician self-reported disclosures and objective payment data was the main outcome. The proportion of discrepant funds and factors associated with non-disclosure were also examined.

Results

40 studies were included. The pooled proportion of COI discrepancies at the article level was 81% (range: 54%–98%; 95% CI 72% to 89%), 79% at the payment level (range: 71%–89%; 95% CI 67% to 89%), 93% at the authorship level (range: 71%–100%; 95% CI 79% to 100%) and 66% at the author level (range: 8%–99%; 95% CI 48% to 78%). The proportion of funds discrepant was 33% (range: 2%–77%; 95% CI 12% to 58%). There was high heterogeneity between studies across all five analyses (I2=94%–99%). Most undisclosed COI were related to food and beverage, or travel and lodging. While the most common explanation for failure to disclose was perceived irrelevance, a median of 45% of non-disclosed payments were directly or indirectly related to the work. A smaller monetary amount was the most common factor associated with nondisclosure.

Conclusions

Physician self-reports of financial COI are highly discrepant with objective data sources reporting payments from industry. Stronger policies are required to reduce reliance on physician self-reporting of financial COI and address non-compliance.

Economic evaluation of a novel community-based diabetes care model in rural Mexico: a cost and cost-effectiveness study

Por: Duan · K. I. · Rodriguez Garza · F. · Flores · H. · Palazuelos · D. · Maza · J. · Martinez-Juarez · L. A. · Elliott · P. F. · Moreno Lazaro · E. · Enriquez Rios · N. · Nigenda · G. · Palazuelos · L. · McBain · R. K.
Objectives

Diabetes is the leading cause of disability-adjusted life years in Mexico, and cost-effective care models are needed to address the epidemic. We sought to evaluate the cost and cost-effectiveness of a novel community-based model of diabetes care in rural Mexico, compared with usual care.

Design

We performed time-driven activity-based costing to estimate annualised costs associated with typical diabetes care in Chiapas, Mexico, as well as a novel diabetes care model known as Compañeros En Salud Programa de Enfermedades Crónicas (CESPEC). We conducted Markov chain analysis to estimate the cost-effectiveness of CESPEC compared with usual care from a societal perspective. We used patient outcomes from CESPEC in 2016, as well as secondary data from existing literature.

Setting

Rural primary care clinics in Chiapas, Mexico.

Participants

Adults with diabetes.

Interventions

CESPEC is a novel, comprehensive, diabetes care model that integrates community health workers, provider education, supply chain management and active case finding.

Outcome measure

The primary outcome was the incremental cost-effectiveness of CESPEC compared with care as usual, per quality-adjusted life year (QALY) gained, expressed in 2016 US dollars.

Results

The economic cost of the CESPEC diabetes model was US$144 per patient per year, compared with US$125 for diabetes care as usual. However, CESPEC care was associated with 0.13 additional years of health-adjusted life expectancy compared with usual care and 0.02 additional years in the first 5 years of treatment. This translated to an incremental cost-effectiveness ratio (ICER) of US$2981 per QALY gained over a patient’s lifetime and an ICER of US$10 444 over the first 5 years. Findings were robust to multiple sensitivity analyses.

Conclusions

CESPEC is a cost-effective, community-based model of diabetes care for patients in rural Mexico. Given the high prevalence and significant morbidity associated with diabetes in Mexico and other countries in Central America, this model should be considered for broader scale up and evaluation.

Physiotherapist-led treatment for femoroacetabular impingement syndrome (the PhysioFIRST study): a protocol for a participant and assessor-blinded randomised controlled trial

Por: Kemp · J. L. · Johnston · R. T. R. · Coburn · S. L. · Jones · D. M. · Schache · A. G. · Mentiplay · B. F. · King · M. G. · Scholes · M. J. · De Oliveira Silva · D. · Smith · A. · McPhail · S. M. · Crossley · K. M.
Introduction

This double-blind, randomised controlled trial (RCT) aims to estimate the effect of a physiotherapist-led intervention with targeted strengthening compared with a physiotherapist-led intervention with standardised stretching, on hip-related quality of life (QOL) or perceived improvement at 6 months in people with femoroacetabular impingement (FAI) syndrome. We hypothesise that at 6 months, targeted strengthening physiotherapist-led treatment will be associated with greater improvements in hip-related QOL or greater patient-perceived global improvement when compared with standardised stretching physiotherapist-led treatment.

Methods and analysis

We will recruit 164 participants with FAI syndrome who will be randomised into one of the two intervention groups, both receiving one-on-one treatment with the physiotherapist over 6 months. The targeted strengthening physiotherapist-led treatment group will receive a personalised exercise therapy and education programme. The standardised stretching physiotherapist-led treatment group will receive standardised stretching and personalised education programme. Primary outcomes are change in hip-related QOL using International Hip Outcome Tool-33 and patient-perceived global improvement. Secondary outcomes include cost-effectiveness, muscle strength, range of motion, functional task performance, biomechanics, hip cartilage structure and physical activity levels. Statistical analyses will make comparisons between both treatment groups by intention to treat, with all randomised participants included in analyses, regardless of protocol adherence. Linear mixed models (with baseline value as a covariate and treatment condition as a fixed factor) will be used to evaluate the treatment effect and 95% CI at primary end-point (6 months).

Ethics and dissemination

The study protocol was approved (La Trobe University Human Ethics Committee (HEC17-080)) and prospectively registered with the Australian New Zealand Clinical Trials Registry. The findings of this RCT will be disseminated through peer reviewed scientific journals and conferences. Patients were involved in study development and will receive a short summary following the completion of the RCT.

Trial registration number

ACTRN12617001350314

Sociodemographic differences in self-reported exposure to high fat, salt and sugar food and drink advertising: a cross-sectional analysis of 2019 UK panel data

Por: Yau · A. · Adams · J. · Boyland · E. J. · Burgoine · T. · Cornelsen · L. · de Vocht · F. · Egan · M. · Er · V. · Lake · A. A. · Lock · K. · Mytton · O. · Petticrew · M. · Thompson · C. · White · M. · Cummins · S.
Objectives

To explore sociodemographic differences in exposure to advertising for foods and drinks high in fat, salt and sugar (HFSS) and whether exposure is associated with body mass index (BMI).

Design

Cross-sectional survey.

Setting

UK.

Participants

1552 adults recruited to the Kantar Fast Moving Consumer Goods panel for London and the North of England.

Outcome measures

Self-reported advertising exposure stratified by product/service advertised (processed HFSS foods; sugary drinks; sugary cereals; sweet snacks; fast food or digital food delivery services) and advertising setting (traditional; digital; recreational; functional or transport); BMI and sociodemographic characteristics.

Results

Overall, 84.7% of participants reported exposure to HFSS advertising in the past 7 days. Participants in the middle (vs high) socioeconomic group had higher odds of overall self-reported exposure (OR 1.48; 95% CI 1.06 to 2.07). Participants in the low (vs high) socioeconomic group had higher odds of reporting exposure to advertising for three of five product categories (ORs ranging from 1.41 to 1.67), advertising for digital food delivery services (OR 1.47; 95% CI 1.05 to 2.05), traditional advertising (OR 1.44; 95% CI 1.00 to 2.08) and digital advertising (OR 1.50; 95% CI 1.06 to 2.14). Younger adults (18–34 years vs ≥65 years) had higher odds of reporting exposure to advertising for digital food delivery services (OR 2.08; 95% CI 1.20 to 3.59), digital advertising (OR 3.93; 95% CI 2.18 to 7.08) and advertising across transport networks (OR 1.96; 95% CI 1.11 to 3.48). Exposure to advertising for digital food delivery services (OR 1.40; 95% CI 1.05 to 1.88), digital advertising (OR 1.80; 95% CI 1.33 to 2.44) and advertising in recreational environments (OR 1.46; 95% CI 1.02 to 2.09) was associated with increased odds of obesity.

Conclusions

Exposure to less healthy product advertising was prevalent, with adults in lower socioeconomic groups and younger adults more likely to report exposure. Broader restrictions may be needed to reduce sociodemographic differences in exposure to less healthy product advertising.

Virtual reality-based relaxation for enhancement of perioperative well-being and quality of life: protocol for a randomised pilot trial

Por: Schrempf · M. C. · Petzold · J. Q. · Vachon · H. · Petersen · M. A. · Gutschon · J. · Wolf · S. · Sommer · F. · Murnauer · M. · Anthuber · M.
Introduction

Patients with cancer undergoing surgery often suffer from reduced quality of life and various forms of distress. Untreated distress can negatively affect coping resources as well as surgical and oncological outcomes. A virtual reality-based stress reduction intervention may increase quality of life and well-being and reduce distress in the perioperative phase for patients with cancer. This pilot trial aims to explore the feasibility of the proposed intervention, assess patient acceptability and obtain estimates of effect to provide data for sample size calculations.

Methods and analysis

Patients with colorectal cancer and liver metastasis undergoing elective surgery will be recruited for this single-centre, randomised pilot trial with a three-arm design. A total of 54 participants will be randomised at 1:1:1 ratio to one of two intervention groups or a control receiving standard treatment. Those randomised to an intervention group will either receive perioperative virtual reality-based stress reduction exercises twice daily or listen to classical music twice daily. Primary feasibility outcomes are number and proportions of participants recruited, screened, consented and randomised. Furthermore, adherence to the intervention, compliance with the completion of the quality of life questionnaires and feasibility of implementing the trial procedures will be assessed. Secondary clinical outcomes are measurements of the effectiveness of the interventions to inform sample size calculations.

Ethics and dissemination

The study protocol, the patient information and the informed consent form have been approved by the ethics committee of the Ludwigs-Maximilians-University, Munich, Germany (Reference Number: 19–915). Study findings will be submitted for publication in peer-reviewed journals.

Trial registration number

DRKS00020909.

Outcomes of out-of-hospital cardiac arrest in Beijing: a 5-year cross-sectional study

Por: Shao · F. · Li · H. · Ma · S. · Li · D. · Li · C.
Objective

The purpose of this study was to assess the trends in outcomes of out-of-hospital cardiac arrest (OHCA) in Beijing over 5 years.

Design

Cross-sectional study.

Methods

Adult patients with OHCA of all aetiologies who were treated by the Beijing emergency medical service (EMS) between January 2013 and December 2017 were analysed. Data were collected using the Utstein Style. Cases were followed up for 1 year. Descriptive statistics were used to characterise the sample and logistic regression was performed.

Results

Overall, 5016 patients with OHCA underwent attempted resuscitation by the EMS in urban areas of Beijing during the study period. Survival to hospital discharge was 1.2% in 2013 and 1.6% in 2017 (adjusted rate ratio=1.0, p for trend=0.60). Survival to admission and neurological outcome at discharge did not significantly improve from 2013 to 2017. Patient characteristics and the aetiology and location of cardiac arrest were consistent, but there was a decrease in the initial shockable rhythm (from 6.5% to 5.6%) over the 5 years. The rate of bystander cardiopulmonary resuscitation (CPR) increased steadily over the years (from 10.4% to 19.4%).

Conclusion

Survival after OHCA in urban areas of Beijing did not improve significantly over 5 years, with long-term survival being unchanged, although the rate of bystander CPR increased steadily, which enhanced the outcomes of patients who underwent bystander CPR.

Prevalence and coprevalence of modifiable risk factors for upper digestive tract cancer among residents aged 40-69 years in Yangzhong city, China: a cross-sectional study

Por: Feng · X. · Hua · Z.-L. · Zhou · Q. · Shi · A.-W. · Song · T.-Q. · Qian · D.-F. · Chen · R. · Wang · G.-Q. · Wei · W.-Q. · Zhou · J.-Y. · Wang · J.-J. · Shao · G. · Wang · X.
Objectives

To describe the prevalence of modifiable risk factors for upper digestive tract cancer (UDTC) and its coprevalence, and investigate relevant influencing factors of modifiable UDTC risk factors coprevalence among residents aged 40–69 years in Yangzhong city, China.

Design

Cross-sectional study.

Participants

A total of 21 175 participants aged 40–69 years were enrolled in the study. 1962 subjects were excluded due to missing age, marital status or some other selected information. Eventually, 19 213 participants were available for the present analysis.

Main outcomes measures

Prevalence and coprevalence of eight modifiable UDTC risk factors (overweight or obesity, current smoking, excessive alcohol consumption, insufficient vegetables intake, insufficient fruit intake and the consumption of pickled, fried and hot food) were analysed.

Results

The prevalence of overweight/obesity, current smoking, excessive alcohol consumption, insufficient vegetables intake, insufficient fruit intake and the consumption of pickled, fried and hot food in this study was 45.3%, 24.1%, 16.2%, 66.1%, 94.5%, 68.1%, 36.0% and 88.4%, respectively. Nearly all (99.9%) participants showed one or more UDTC risk factors, 98.6% of the participants showed at least two risk factors, 92.2% of the participants had at least three risk factors and 69.7% of the participants had four or more risk factors. Multivariate logistic regression analysis revealed that men, younger age, single, higher education, higher annual family income and smaller household size were more likely to present modifiable UDTC risk factors coprevalence.

Conclusions

The prevalence and coprevalence of modifiable UDTC risk factors are high among participants in Yangzhong city. Extra attention must be paid to these groups who are susceptible to risk factors coprevalence during screening progress. Relative departments also need to make significant public health programmes that aim to decrease modifiable UDTC risk factors coprevalence among residents aged 40–69 years from high-risk areas of UDTC.

Processes of care and survival associated with treatment in specialist teenage and young adult cancer centres: results from the BRIGHTLIGHT cohort study

Por: Fern · L. A. · Taylor · R. M. · Barber · J. · Alvarez-Galvez · J. · Feltbower · R. · Lea · S. · Martins · A. · Morris · S. · Hooker · L. · Gibson · F. · Raine · R. · Stark · D. P. · Whelan · J.
Objective

Survival gains in teenagers and young adults (TYA) are reported to be lower than children and adults for some cancers. Place of care is implicated, influencing access to specialist TYA professionals and research.

Consequently, age-appropriate specialist cancer care is advocated for TYA although systematic investigation of associated outcomes is lacking. In England, age-appropriate care is delivered through 13 Principal Treatment Centres (TYA-PTC). BRIGHTLIGHT is the national evaluation of TYA cancer services to examine outcomes associated with differing places and levels of care. We aimed to examine the association between exposure to TYA-PTC care, survival and documentation of clinical processes of care.

Design

Prospective cohort study.

Setting

109 National Health Service (NHS) hospitals across England.

Participants

1114 TYA, aged 13–24, newly diagnosed with cancer between 2012 and 2014.

Intervention

Participants were assigned a TYA-PTC category dependent on the proportion of care delivered in a TYA-PTC in the first year after diagnosis: all care in a TYA-PTC (ALL-TYA-PTC, n=270), no care in a TYA-PTC (NO-TYA-PTC, n=359), and some care in a TYA-PTC with additional care in a children’s/adult unit (SOME-TYA-PTC, n=419).

Primary outcome

Data were collected on documented processes indicative of age-appropriate care using clinical report forms, and survival through linkage to NHS databases.

Results

TYA receiving NO-TYA-PTC care were less likely to have documentation of molecular diagnosis, be reviewed by a children’s or TYA multidisciplinary team, be assessed by supportive care services or have a fertility discussion. There was no significant difference in survival according to category of care. There was weak evidence that the association between care category and survival differed by age (p=0.08) with higher HRs for those over 19 receiving ALL or SOME-TYA-PTC compared with NO-TYA-PTC.

Conclusion

TYA-PTC care was associated with better documentation of clinical processes associated with age-appropriate care but not improved survival.

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