bluuebunny/crossref_metadata_2025 huggingface dataset:
Development of ‘Core Outcome Sets’ for Meningioma in Clinical Studies (The COSMIC Project): protocol for two systematic literature reviews, eDelphi surveys and online consensus meetings
Authors: Millward Christopher P , Armstrong Terri S , Barrington Heather , Bell Sabrina , Brodbelt Andrew R , Bulbeck Helen , Crofton Anna , Dirven Linda , Georgious Theo , Grundy Paul L , Islim Abdurrahman I , Javadpour Mohsen , Keshwara Sumirat M , Koszdin Shelli D , Marson Anthony G , McDermott Michael W , Meling Torstein R , Oliver Kathy , Plaha Puneet , Preusser Matthias , Santarius Thomas , Srikandarajah Nisaharan , Taphoorn Martin J B , Turner Carole , Watts Colin , Weller Michael , Williamson Paula R , Zadeh Gelareh , Zamanipoor Najafabadi Amir H , Jenkinson Michael D
Published: May 2022

Introduction

Meningioma is the most common primary intracranial tumour in adults. The majority are non-malignant, but a proportion behave more aggressively. Incidental/minimally symptomatic meningioma are often managed by serial imaging. Symptomatic meningioma, those that threaten neurovascular structures, or demonstrate radiological growth, are usually resected as first-line management strategy. For patients in poor clinical condition, or with inoperable, residual or recurrent disease, radiotherapy is often used as primary or adjuvant treatment. Effective pharmacotherapy treatments do not currently exist. There is heterogeneity in the outcomes measured and reported in meningioma clinical studies. Two ‘Core Outcome Sets’ (COS) will be developed: (COSMIC: Intervention) for use in meningioma clinical effectiveness trials and (COSMIC: Observation) for use in clinical studies of incidental/untreated meningioma.

Methods and analysis

Two systematic literature reviews and trial registry searches will identify outcomes measured and reported in published and ongoing (1) meningioma clinical effectiveness trials, and (2) clinical studies of incidental/untreated meningioma. Outcomes include those that are clinician reported, patient reported, caregiver reported and based on objective tests (eg, neurocognitive tests), as well as measures of progression and survival. Outcomes will be deduplicated and categorised to generate two long lists. The two long lists will be prioritised through two, two-round, international, modified eDelphi surveys including patients with meningioma, healthcare professionals, researchers and those in caring/supporting roles. The two final COS will be ratified through two 1-day online consensus meetings, with representation from all stakeholder groups.

Ethics and dissemination

Institutional review board (University of Liverpool) approval was obtained for the conduct of this study. Participant eConsent will be obtained prior to participation in the eDelphi surveys and consensus meetings. The two systematic literature reviews and two final COS will be published and freely available.

Trial registration number

COMET study ID 1508
Enablers and barriers in upscaling telemonitoring across geographic boundaries: a scoping review
Authors: Gijsbers Harm , Feenstra Tim M , Eminovic Nina , van Dam Debora , Nurmohamed Shaikh Azam , van de Belt Tom , Schijven Marlies P
Published: May 2022

Introduction and objective

Telemonitoring is a method to monitor a person’s vital functions via their physiological data at distance, using technology. While pilot studies on the proposed benefits of telemonitoring show promising results, it appears challenging to implement telemonitoring on a larger scale. The aim of this scoping review is to identify the enablers and barriers for upscaling of telemonitoring across different settings and geographical boundaries in healthcare.

Methods

PubMed, Embase, Cinahl, Web of Science, ProQuest and IEEE databases were searched. Resulting outcomes were assessed by two independent reviewers. Studies were considered eligible if they focused on remote monitoring of patients’ vital functions and data was transmitted digitally. Using scoping review methodology, selected studies were systematically assessed on their factors of influence on upscaling of telemonitoring.

Results

A total of 2298 titles and abstracts were screened, and 19 articles were included for final analysis. This analysis revealed 89 relevant factors of influence: 26 were reported as enabler, 18 were reported as barrier and 45 factors were reported being both. The actual utilisation of telemonitoring varied widely across studies. The most frequently mentioned factors of influence are: resources such as costs or reimbursement, access or interface with electronic medical record and knowledge of frontline staff.

Conclusion

Successful upscaling of telemonitoring requires insight into its critical success factors, especially at an overarching national level. To future-proof and facilitate upscaling of telemonitoring, it is recommended to use this type of technology in usual care and to find means for reimbursement early on. A wide programme on change management, nationally or regionally coordinated, is key. Clear regulatory conditions and professional guidelines may further facilitate widespread adoption and use of telemonitoring. Future research should focus on converting the ‘enablers and barriers’ as identified by this review into a guideline supporting further nationwide upscaling of telemonitoring.
Factors that influence clinical trial participation by patients with cancer in Australia: a scoping review protocol
Authors: You Kyung Ha , Lwin Zarnie , Ahern Elizabeth , Wyld David , Roberts Natasha
Published: May 2022

Introduction

Clinical trials are the backbone of research. It is well recognised that patient participation in clinical trials can be influenced by a myriad of factors such as access to a clinical trial, restrictive trial eligibility criteria and perceptions held by patients or physicians about clinical trials. Australia is a key stakeholder in the global clinical trials sphere. This scoping review protocol aims to identify and map the current literature describing factors that influence clinical trial participation of patients with cancer, in Australia.

Methods and analyses

The Joanna Briggs Institute (JBI) methodology for scoping reviews will be used to conduct this review. Four electronic databases will be systematically searched for relevant published literature on this topic, as a collaborative process involving the lead investigator and a health science librarian. We will hand search of citations and reference lists of the included papers, and a grey literature search through Google scholar, Grey Literature Report, Web of Science Conference Proceedings. All published papers pertaining to patients diagnosed with solid organ or haematological malignancies will be included. Studies which did not involve patients from Australia will also be excluded. A customised data extraction tool will be pilot tested and refined, and subsequently two independent reviewers will perform data screening and extraction. Results will be collated and reported following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) extension for scoping reviews: PRISMA-Scoping Reviews. Quantitative data will be presented using descriptive statistics. Qualitative data will be synthesised using thematic analyses. This scoping review does not require ethical approval as the methodology focuses on analysing information from available published data.

Ethics and dissemination

Results will be disseminated to relevant stakeholders including consumers, clinicians, professional organisations and policy-makers through peer-reviewed publications and national and international conferences.
Induction of labour at 39 weeks versus expectant management in low-risk obese women: study protocol for a randomised controlled study
Authors: Krogh Lise Qvirin , Boie Sidsel , Henriksen Tine Brink , Thornton Jim , Fuglsang Jens , Glavind Julie
Published: May 2022

Introduction

Obesity is associated with many pregnancy complications, including both fetal macrosomia and prolonged labour. As a result, there is often also an increased risk of caesarean section. In other settings, labour induction near to term reduces adverse outcomes such as stillbirth and birth injury, without causing more caesarean deliveries. It has been suggested that induction will reduce adverse events in this setting too, but there have been no trials and the effect on caesarean section is unknown. The objective of this study is to compare induction of labour in gestational week 39 with expectant management on the risk of caesarean section in women with body mass index ≥30 kg/m2.

Methods and analysis

An open label randomised controlled multicentre trial are conducted at Danish delivery departments with an in-house neonatal intensive care unit. Recruitment started October 2020. A total of 1900 women with a prepregnancy body mass index ≥30 kg/m2 are randomised in a 1:1 ratio to either labour induction at 39 weeks and 0 to 3 days of gestation or to expectant management; that is, waiting for spontaneous labour onset or induction if medically indicated. The primary outcome is caesarean section. Data will be analysed according to intention-to-treat.

Ethics and dissemination

The Central Denmark Region Committee on Biomedical Research Ethics approved the study. The study is conducted in accordance with the ethical principles outlined in the latest version of the ‘Declaration of Helsinki’ and the ‘Guideline for Good Clinical Practice’ related to experiments on humans. The trial findings will be disseminated to participants, clinicians, commissioning groups and via peer-reviewed publications.

Trial registration number

NCT04603859.
Needs of patients with parkinsonism and their caregivers: a protocol for the PRIME-UK cross-sectional study
Authors: Tenison Emma , Lithander Fiona E , Smith Matthew D , Pendry-Brazier Danielle , Ben-Shlomo Yoav , Henderson Emily J
Published: May 2022

Introduction

People with parkinsonism are a highly heterogeneous group and the disease encompasses a spectrum of motor and non-motor symptoms which variably emerge and manifest across the disease course, fluctuate over time and negatively impact quality of life. While parkinsonism is not directly the result of ageing, it is a condition that mostly affects older people, who may also be living with frailty and multimorbidity. This study aims to describe the broad range of health needs for people with parkinsonism and their carers in relation to their symptomatology, disability, disease stage, comorbidities and sociodemographic characteristics.

Methods and analysis

In this single site cross-sectional study, people with parkinsonism will be sent a study information pack for themselves and their primary informal caregiver, if relevant. Data are collected via questionnaire, with additional support, if required, to maximise participation. A specific strategy has been developed to target and proactively recruit patients lacking capacity to consent, including those in residential care settings, with input from a personal consultee prior to completion of a bespoke questionnaire by a representative. Caregivers are also recruited to look at various health outcomes. Results will be displayed as descriptive statistics and regression models will be used to test simple associations and interactions.

Ethics and dissemination

This protocol was approved by the London—Brighton & Sussex Research Ethics Committee (REC reference 20/LO/0890). The results of this protocol will be disseminated through publication in an international peer-reviewed journal; presentation at academic meetings and conferences; and a lay summary uploaded to the PRIME-Parkinson website.

Trial registration number

ISRCTN11452969; Pre-results.
Projected impact of change in the percentage of energy from each NOVA group intake on cardiovascular disease mortality in Brazil: a modelling study
Authors: Vasconcelos Leitão Moreira Patricia , da Costa Pereira de Arruda Neta Adélia , Leite de Lima Ferreira Flávia Emília , de Araújo Jevuks Matheus , da Costa Louzada Maria Laura , Lira Formiga Cavalcanti de Lima Rafaela , Pinheiro de Toledo Vianna Rodrigo , Moreira da Silva Neto José , Colombet Zoe , O’Flaherty Martin
Published: May 2022

Objective

Estimate reductions in cardiovascular mortality achievable through improvement in nutrient intakes according to processing level (NOVA classification), that is, reducing consumption of culinary ingredients (G2), processed (G3) and ultra-processed foods (G4) while encouraging consumption of unprocessed and minimally processed foods (G1).

Design

Modelling study.

Setting

General adult population of Brazil.

Participants

Men and women aged 25 or more years (34 003) investigated in the Household Budget Survey 2017–2018, in the consumption data module.

Main outcome measures

We used the IMPACT Food Policy Model to estimate the reduction in deaths from cardiovascular diseases (CVD) up to 2048 in five scenarios with reductions in saturated fat, trans fat, salt and added sugar intakes resulting from changes in NOVA groups. (1) The optimistic scenario modelised an increase in the energy intake provided by G1 and a reduction in the energy intake from G2, G3 and G4, return to previous levels. (2) The minimal scenario modelised a 3.7% increase in the energy intake from G1, and a reduction in the energy intake from G4 to the 2008–2009 level. (3) The modest scenario only modelised a 25.0% reduction of the energy intake from G2 and G3. (4) The intermediary scenario modelised the minimal scenario plus a 25.0% reduction in the energy intake from G2. (5) Finally, the advanced scenario modelised the minimal scenario plus a 25.0% reduction in the energy intake from G2 and G3.

Results

Proposed changes in the optimistic scenario could prevent or delay 52.8% CVD-related deaths by 2048. Changes modelled in the minimal, modest, intermediary and advanced scenarios may result in a 10.1%, 28.4%, 31.4% and 38.6% reduction in 2048 CVD mortality, respectively.

Conclusions

Substantial health gains can be achieved by improving the diet, through plausible modifications aimed at the level of processing as a tool for Brazilian food policies.
Impact of cardiovascular evaluations and interventions on fall risk in older adults: a protocol for a scoping review and evidence map
Authors: Wang Liping , van Poelgeest Eveline P , Pronk Anouschka C , Daams Joost G , Leeflang Mariska M G , Hoekstra Alfons G , van der Velde Nathalie
Published: May 2022

Introduction

Cardiovascular disorders are increasingly recognised as important fall risk factors in older adults. Falls are a major public health problem in older adults, and therefore, effective interventions for reducing falls are essential for this population. Cardiovascular disease is a clinically relevant (but often overlooked) and potentially modifiable risk factor for falls. Literature describing the effects of cardiovascular assessments and treatments on fall prevention has generally focused on only one specific test or treatment. A comprehensive, comparative overview surrounding the effectiveness of available assessments and treatments on cardiovascular related fall risk is currently lacking.

Methods and analysis

A scoping review and evidence map will be conducted to summarise the available evidence regarding the (comparative) effectiveness of cardiovascular assessments and therapeutic interventions on reducing fall risk in older individuals. A systematic and comprehensive literature search will be performed in MEDLINE and Embase using the key components ‘older adults’, ‘cardiovascular evaluation’, ‘cardiovascular intervention’ and ‘falls’. Furthermore, we will create an evidence map to summarise the quantity and quality of currently available evidence identified in the scoping review. The evidence map will consider, but will not be limited to, observational studies, randomised controlled trials and reviews evaluating cardiovascular tests and treatments (vs controls) on fall risk in older adults.

Ethics and dissemination

The scoping review and evidence map will only include data that are publicly available and, therefore, ethical approval is not required. The results will be submitted for publication in a peer-reviewed journal and presented at scientific conferences.
Association between gut MIcrobiota, GROWth and Diet in peripubertal children from the TARGet Kids! cohort (The MiGrowD) study: protocol for studying gut microbiota at a community-based primary healthcare setting
Authors: Massara Paraskevi , Spiegel-Feld Carolyn , Hamilton Jill , Maguire Jonathon L , Birken Catherine , Bandsma Robert , Comelli Elena M
Published: May 2022

Introduction

The gut microbiota interacts with diet to affect body health throughout the life cycle. Critical periods of growth, such as infancy and puberty, are characterised by microbiota remodelling and changes in dietary habits. While the relationship between gut microbiota and growth in early life has been studied, our understanding of this relationship during puberty remains limited. Here, we describe the MIcrobiota, GROWth and Diet in peripubertal children (The MiGrowD) study, which aims to assess the tripartite growth-gut microbiota-diet relationship at puberty.

Methods and analysis

The MiGrowD study will be a cross-sectional, community-based study involving children 8–12 years participating in the TARGet Kids! cohort. TARGet Kids! is a primary healthcare practice-based research network in Canada. Children will be asked to provide a stool sample, complete two non-consecutive 24-hour dietary recalls and a pubertal self-assessment based on Tanner Stages. Anthropometry will also be conducted. The primary outcome is the association between gut microbiota composition and longitudinal growth from birth until entry into the study. Anthropometrics data from birth will be from the data collected prospectively through TARGet Kids!. Body mass index z-scores will be calculated according to WHO. The secondary outcome is the association between gut microbiota, diet and pubertal stage.

Ethics and dissemination

Ethics approval has been obtained by the Hospital for Sick Children and St. Michael’s Hospital—Unity Health, and the University of Toronto. Results will be disseminated in the public and academic sector, including participants, TARGet Kids! primary healthcare physicians teams, scientists via participation in the TARGet Kids! science and physician meetings, conferences and publications in peer-reviewed journals. The MiGrowD study results will help researchers understand the relationships underlying growth, gut microbiota and pubertal maturation in children.
Development of an intervention to improve informational continuity of care in older patients with polypharmacy at the interface between general practice and hospital care: protocol for a participatory qualitative study in Germany
Authors: Brueckle Maria-Sophie , Dinh Truc Sophia , Klein Astrid-Alexandra , Rietschel Lisa , Petermann Jenny , Brosse Franziska , Schulz-Rothe Sylvia , Gonzalez-Gonzalez Ana Isabel , Kramer Martin , Engler Jennifer , Mergenthal Karola , Muth Christiane , Voigt Karen , van den Akker Marjan
Published: May 2022

Introduction

Older patients with multimorbidity, polypharmacy and related complex care needs represent a growing proportion of the population and a challenge for healthcare systems. Particularly in transitional care (hospital admission and hospital discharge), medical errors, inappropriate treatment, patient concerns and lack of confidence in healthcare are major problems that may arise from a lack of information continuity. The aim of this study is to develop an intervention to improve informational continuity of care at the interface between general practice and hospital care.

Methods and analysis

A qualitative approach will be used to develop our participatory intervention. Overall, 32 semistructured interviews with relevant stakeholders will be conducted and analysed. The stakeholders will include healthcare professionals from the outpatient setting (general practitioners, healthcare assistants, ambulatory care nurses) and the inpatient setting (clinical doctors, nurses, pharmacists, clinical information scientists) as well as patients and informal caregivers. At a series of workshops based on the results of the stakeholder analyses, we aim to develop a participatory intervention that will then be implemented in a subsequent pilot study. The same stakeholder groups will be invited for participation in the workshops.

Ethics and dissemination

Ethical approval for this study was waived by the Ethics Committee of Goethe University Frankfurt because of the nature of the proposed study. Written informed consent will be obtained from all study participants prior to participation. Results will be tested in a pilot study and disseminated at (inter)national conferences and via publication in peer-reviewed journals.

Trial registation number

Clinical Trials Register: registration number DRKS00027649.
Progression of chronic pain and associated health-related quality of life and healthcare resource use over 5 years after total knee replacement: evidence from a cohort study
Authors: Cole Sophie , Kolovos Spyros , Soni Anushka , Delmestri Antonella , Sanchez-Santos Maria T , Judge Andrew , Arden Nigel K , Beswick Andrew David , Wylde Vikki , Gooberman-Hill Rachael , Pinedo-Villanueva Rafael
Published: May 2022

Objective

As part of the STAR Programme, a comprehensive study exploring long-term pain after surgery, we investigated how pain and function, health-related quality of life (HRQL), and healthcare resource use evolved over 5 years after total knee replacement (TKR) for those with and without chronic pain 1 year after their primary surgery.

Methods

We used data from the Clinical Outcomes in Arthroplasty Study prospective cohort study, which followed patients undergoing TKR from two English hospitals for 5 years. Chronic pain was defined using the Oxford Knee Score Pain Subscale (OKS-PS) where participants reporting a score of 14 or lower were classified as having chronic pain 1-year postsurgery. Pain and function were measured with the OKS, HRQL using the EuroQoL-5 Dimension, resource use from yearly questionnaires, and costs estimated from a healthcare system perspective. We analysed the changes in OKS-PS, HRQL and resource use over a 5-year follow-up period. Multiple imputation accounted for missing data.

Results

Chronic pain was reported in 70/552 operated knees (12.7%) 1 year after surgery. The chronic pain group had worse pain, function and HRQL presurgery and postsurgery than the non-chronic pain group. Those without chronic pain markedly improved right after surgery, then plateaued. Those with chronic pain improved slowly but steadily. Participants with chronic pain reported greater healthcare resource use and costs than those without, especially 1 year after surgery, and mostly from hospital readmissions. 64.7% of those in chronic pain recovered during the following 4 years, while 30.9% fluctuated in and out of chronic pain.

Conclusion

Although TKR is often highly beneficial, some patients experienced chronic pain postsurgery. Although many fluctuated in their pain levels and most recovered over time, identifying people most likely to have chronic pain and supporting their recovery would benefit patients and healthcare systems.
Randomised, double-blind, placebo-controlled, phase 2, superiority trial to demonstrate the effectiveness of faecal microbiota transplantation for selective intestinal decolonisation of patients colonised by carbapenemase-producing Klebsiella pneumoniae (KAPEDIS)
Authors: Pérez-Nadales Elena , Cano Ángela , Recio Manuel , Artacho María José , Guzmán-Puche Julia , Doblas Antonio , Vidal Elisa , Natera Clara , Martínez-Martínez Luis , Torre-Cisneros Julian , Castón Juan José
Published: May 2022

Introduction

Infections caused by carbapenemase-producing Enterobacterales are frequent and associated with high rates of mortality. Intestinal carriers are at increased risk of infection by these microorganisms. Decolonisation strategies with antibiotics have not obtained conclusive results. Faecal microbiota transplantation (FMT) could be an effective and safe strategy to decolonise intestinal carriers of KPC-producing Klebsiella pneumoniae (KPC-Kp) but this hypothesis needs evaluation in appropriate clinical trials.

Methods and analysis

The KAPEDIS trial is a single-centre, randomised, double-blind, placebo-controlled, phase 2, superiority clinical trial of FMT for eradication of intestinal colonisation by KPC-Kp. One hundred and twenty patients with rectal colonisation by KPC-Kp will be randomised 1:1 to receive encapsulated lyophilised FMT or placebo. The primary outcome is KPC-Kp eradication at 30 days. Secondary outcomes are: (1) frequency of adverse events; (2) changes in KPC-Kp relative load within the intestinal microbiota at 7, 30 and 90 days, estimated by real-time quantitative PCR analysis of rectal swab samples and (3) rates of persistent eradication, KPC-Kp infection and crude mortality at 90 days. Participants will be monitored for adverse effects throughout the intervention.

Ethics and dissemination

Ethical approval was obtained from Reina Sofía University Hospital Institutional Review Board (approval reference number: 2019-003808-13). Trial results will be published in peer-reviewed journals and disseminated at national and international conferences.

Trial registration number

NCT04760665.
Qualitative assessment of caregiver experiences when navigating childhood immunisation in urban communities in Sierra Leone
Authors: Jalloh Mohamed F , Patel Palak , Sutton Roberta , Kulkarni Shibani , Toure Mame , Wiley Kerrie , Sessay Tom , Lahuerta Maria
Published: May 2022

Objective

To gain in-depth understanding of the caregiver experience when navigating urban immunisation services for their children.

Design

An exploratory qualitative assessment comprising 16 in-depth interviews using an interpretative phenomenology approach.

Setting

Caregivers were purposively recruited from slums (n=8) and other urban communities (n=8) in the capital city of Sierra Leone.

Participants

Caregivers of children ages 6–36 months old who were fully vaccinated (n=8) or undervaccinated (n=8).

Results

Emotional enablers of vaccination were evident in caregivers’ sense of parental obligation to their children while also anticipating reciprocal benefits in children’s ability to take care of their parents later in life. Practical enablers were found in the diversity of immunisation reminders, information access, information trust, getting fathers more involved, positive experiences with health workers and postvaccination information sharing in the community. Underlying barriers to childhood vaccination were due to practical constraints such as overcrowding and long waiting times at the clinic, feeling disrespected by health workers, expecting to give money to health workers for free services and fear of serious vaccine side effects. To improve vaccination outcomes, caregivers desired more convenient and positive clinic experiences and deeper community engagement.

Conclusions

Health system interventions, community engagement and vaccination outreach need to be tailored for urban settings. Vaccine communication efforts may resonate more strongly with caregivers when vaccination is framed both around parental responsibilities to do the right thing for the child and the future benefits to the parent.
Do P2Y12 receptor inhibitors prescribed poststroke modify the risk of cognitive disorder or dementia? Protocol for a target trial using multiple national Swedish registries
Authors: Hinwood Madeleine , Nyberg Jenny , Leigh Lucy , Gustavsson Sara , Attia John , Oldmeadow Christopher , Ilicic Marina , Linden Thomas , Åberg N David , Levi Chris , Spratt Neil , Carey Leeanne M , Pollack Michael , Johnson Sarah J , Kuhn Georg Hans , Walker Frederick R , Nilsson Michael
Published: May 2022

Introduction

The target of a class of antiplatelet medicines, P2Y12R inhibitors, exists both on platelets and on brain immune cells (microglia). This protocol aims to describe a causal (based on a counterfactual model) approach for analysing whether P2Y12R inhibitors prescribed for secondary prevention poststroke may increase the risk of cognitive disorder or dementia via their actions on microglia, using real-world evidence.

Methods and analysis

This will be a cohort study nested within the Swedish National Health and Medical Registers, including all people with incident stroke from 2006 to 2016. We developed directed acyclic graphs to operationalise the causal research question considering potential time-independent and time-dependent confounding, using input from several experts. We developed a study protocol following the components of the target trial approach described by Hernan et al and describe the data structure that would be required in order to make a causal inference. We also describe the statistical approach required to derive the causal estimand associated with this important clinical question; that is, a time-to-event analysis for the development of cognitive disorder or dementia at 1, 2 and 5-year follow-up, based on approaches for competing events to account for the risk of all-cause mortality. Causal effect estimates and the precision in these estimates will be quantified.

Ethics and dissemination

This study has been approved by the Ethics Committee of the University of Gothenburg and Confidentiality Clearance at Statistics Sweden with Dnr 937-18, and an approved addendum with Dnr 2019-0157. The analysis and interpretation of the results will be heavily reliant on the structure, quality and potential for bias of the databases used. When we implement the protocol, we will consider and document any biases specific to the dataset and conduct appropriate sensitivity analyses. Findings will be disseminated to local stakeholders via conferences, and published in appropriate scientific journals.
Spatial scenery of congenital syphilis in Brazil between 2007 and 2018: an ecological study
Authors: Seabra Iaron , Ferreira Glenda Roberta Oliveira Naiff , Sorensen William , Oliveira Carmem , Parente Andressa Tavares , Gir Elucir , Reis Renata Karina , Ferrari Rosângela Aparecida Pimenta , Botelho Eliã
Published: May 2022

Objective

To analysis the epidemiological scenery of the congenital syphilis (CS) in Brazil employing spatial analysis techniques.

Design

Ecological study.

Settings

This study was conducted in Brazil

Sample

A total of 151 601 CS cases notified to the Diseases and Notification Information System from 2007 to 2018 from children aged 0–23 months and born from mothers living in Brazil were included in this study.

Primary outcome measures

The CS incidence rates were calculated by triad (2007–2010, 2011–2014 and 2015–2018) for all Brazilian municipalities following the Boxcox transformation to remove the discrepant values. The transformed rates were analysed through the spatial autocorrelation of Moran, Kernel density estimative and spatial scan.

Results

From 2007 to 2018, the CS incidence rates increased in all Brazilian regions. The CS spread towards the interior of Brazil, and a higher expansion was noticed between 2015 and 2018. The municipalities that were greatly affected by the CS were those having a high migration of people, such as the ones bordering other countries and the touristic cities. Recife, Campo Grande, Rio de Janeiro, Porto Alegre and Manaus were the capitals with the greatest spatial and spatiotemporal risk.

Conclusion

This study provides assistance to health authorities to fight CS in Brazil. More investment is necessary in prenatal care quality focusing on pregnant women and their partners to guarantee their full access to preventive resources against sexually transmitted infections.
Sero-prevalence of 19 infectious pathogens and associated factors among middle-aged and elderly Chinese adults: a cross-sectional study
Authors: Yao Pang , Millwood Iona , Kartsonaki Christiana , Mentzer Alexander J , Allen Naomi , Jeske Rima , Butt Julia , Guo Yu , Chen Yiping , Walters Robin , Lv Jun , Yu Canqing , Plummer Martyn , de Martel Catherine , Clifford Gary , LI Li-ming , Waterboer Tim , Yang Ling , Chen Zhengming
Published: May 2022

Objectives

To systematically assess the sero-prevalence and associated factors of major infectious pathogens in China, where there are high incidence rates of certain infection-related cancers.

Design

Cross-sectional study.

Setting

10 (5 urban, 5 rural) geographically diverse areas in China.

Participants

A subcohort of 2000 participants from the China Kadoorie Biobank.

Primary measures

Sero-prevalence of 19 pathogens using a custom-designed multiplex serology panel and associated factors.

Results

Of the 19 pathogens investigated, the mean number of sero-positive pathogens was 9.4 (SD 1.7), with 24.4% of participants being sero-positive for >10 pathogens. For individual pathogens, the sero-prevalence varied, being for example, 0.05% for HIV, 6.4% for human papillomavirus (HPV)-16, 53.5% for Helicobacter pylori (H. pylori) and 99.8% for Epstein-Barr virus . The sero-prevalence of human herpesviruses (HHV)-6, HHV-7 and HPV-16 was higher in women than men. Several pathogens showed a decreasing trend in sero-prevalence by birth cohort, including hepatitis B virus (HBV) (51.6% vs 38.7% in those born <1940 vs >1970), HPV-16 (11.4% vs 5.4%), HHV-2 (15.1% vs 8.1%), Chlamydia trachomatis (65.6% vs 28.8%) and Toxoplasma gondii (22.0% vs 9.0%). Across the 10 study areas, sero-prevalence varied twofold to fourfold for HBV (22.5% to 60.7%), HPV-16 (3.4% to 10.9%), H. pylori (16.2% to 71.1%) and C. trachomatis (32.5% to 66.5%). Participants with chronic liver diseases had >7-fold higher sero-positivity for HBV (OR=7.51; 95% CI 2.55 to 22.13).

Conclusions

Among Chinese adults, previous and current infections with certain pathogens were common and varied by area, sex and birth cohort. These infections may contribute to the burden of certain cancers and other non-communicable chronic diseases.
Prevalence and associated factors of overweight and obesity among primary school children: a cross-sectional study in Thanhhoa City, Vietnam
Authors: Le Giang Ba , Dinh Dai Xuan
Published: May 2022

Objective

To determine the prevalence and associated factors of overweight and obesity among primary school children (6–11 years old) in Thanhhoa city in 2021.

Design

Cross-sectional study.

Setting

Seven primary schools in Thanhhoa city, Vietnam.

Participants

782 children (and their parents).

Primary and secondary outcome measures

Two-stage cluster random sampling was used for selecting children and data were collected from January to February 2021. A self-administrated questionnaire was designed for children and their parents. Children’s height and weight were measured and body mass index (BMI)-for-age z-scores were computed using the WHO Anthro software V.1.0.4. Data were analysed using R software V.4.1.2. The associations between potential factors and childhood overweight/obesity were analysed through univariate and multivariate logistic regression analyses. Variables were selected using the Bayesian Model Averaging method.

Results

The prevalence of overweight/obesity among primary school children in Thanhhoa city was 35.93% (overweight 21.61% and obesity 14.32%). The proportion of overweight girls was nearly equal to that of boys (20.78% and 22.52%, respectively, p=0.6152) while the proportion of boys with obesity was four times as many as that of girls (23.86% and 5.62%, respectively, p<0.0001). Child’s sex was the factor significantly associated with childhood overweight/obesity. Boys had double the risk of being overweight/obese than girls (adjusted OR: aOR=2.48, p<0.0001). Other potential factors which may be associated with childhood overweight/obesity included mode of transport to school, the people living with the child, mother’s occupation, father’s education, eating confectionery, the total time of doing sports, and sedentary activities.

Conclusion

One in every three primary school children in Thanhhoa city were either overweight or obese. Parents, teachers and policy-makers can implement interventions in the aforementioned factors to reduce the rate of childhood obesity. In forthcoming years, longitudinal studies should be conducted to determine the causal relationships between potential factors and childhood overweight/obesity.
Effect of goal-directed mobilisation intervention compared with standard care on physical activity among medical inpatients: protocol for the GoMob-in randomised controlled trial
Authors: Liechti Fabian D , Heinzmann Jeannelle , Schmidt Leuenberger Joachim M , Limacher Andreas , Wertli Maria M , Verra Martin L
Published: May 2022

Introduction

Despite the fact that immobilisation is a major contributor to morbidity and mortality, patients hospitalised in general internal medicine (GIM) wards spend up to 50% of time in bed. Previous studies in selected patient populations showed increased mobility after implementation of goal-directed mobilisation (GDM). Due to the study design used so far, the degree of evidence is generally low. The effect of GDM on clinical outcomes and economically relevant indicators in patients hospitalised in GIM wards is currently unknown. This study aims to evaluate a GDM intervention compared to standard care on physical activity (de Morton Mobility Index, DEMMI) in medical inpatients.

Methods and analysis

GoMob-in is a randomised, controlled, open-label study with blinded outcome assessment. We plan to enrol 160 inpatients with indication for physiotherapy on GIM wards of a tertiary hospital in Bern, Switzerland. Adult patients newly hospitalised on GIM wards will be included in the study. The primary outcome will be the change in the DEMMI score between baseline and 5 days. Secondary outcomes are change of DEMMI (inclusion to hospital discharge), mobilisation time (inclusion to day 5, inclusion to discharge), in-hospital delirium episodes, number of in-hospital falls, length of stay, number of falls within 3 months, number of re-hospitalisations and all-cause mortality within 3 months, change in independence during activities of daily living, concerns of falling, and quality of life within 3 months and destination after 3 months. Patients in the intervention group will be attributed a regularly updated individual mobility goal level made visible for all stakeholders and get a short educational intervention on GDM.

Ethics and dissemination

This study has been approved by the responsible Ethics Board (Ethikkommission Bern/2020–02305). Written informed consent will be obtained from participants before study inclusion. Results will be published in open access policy peer-reviewed journals.

Trial registration number

NCT04760392.
Effects of mobile-based mindfulness meditation for mental health of nurses: a protocol for systematic review and meta-analysis
Authors: Chen Bin , Yang Ting , Tao Lin , Song Yuqing , Liu Ying , Wang Yan , Xiao Lei , Xu Changxia , Chen Hong
Published: May 2022

Introduction

Existing studies have shown that mobile-based mindfulness meditation (MMM) can have a certain impact on nurses’ mental health problems, but its specific effect and the effect on specific mental health problems such as stress, anxiety, depression, mindfulness, well-being and resilience are not clear.

Methods and analysis

This study protocol follows the Preferred Reporting Items for Systematic Review and Meta-analysis Protocols guidelines. Electronic search through PubMed, Web of Science, EBSCO, Cochrane Library, CINAHL, PsycINFO, ERIC, Embase and three Chinese databases namely CNKI, Wan Fang and Chinese Biology Medicine disc. The inclusion criteria follow the PICO principle, which is defined translate the question into a searchable and answerable question . P (patient/population): clinical characteristics of patients; I (intervention or exposure): treatment measures or exposure factors of concern; C (comparison): control measure.; O (outcome): outcome indicator of concern. Registered nurses, preregistered nurses, midwives and nursing students will all be included, studies using MMM as intervention to improve mental health of nurses, compared with waitlist controls or traditional methods groups, outcomes assessment of stress, anxiety, depression, mindfulness, well-being and resilience will meet the inclusion criteria. Studies designed randomised controlled trails (RCTs) of quasiexperimental and written in English or Chinese will be eligible. Search time was from inception of each database to July 2022. Two reviewers screen and assess studies for inclusion and extract data independently; any dispute will be settled through discussion. If the discussion still fails, the third author will make a decision. For RCT, risk of bias will be assessed using Cochrane risk-of-bias tool for randomised trials (RoB 2), and for non-RCT studies, risk of bias in non-randomised studies of interventions (ROBINS-I) tool will be performed. Meta-analysis will be performed using RevMan software if sufficient number of comparable studies are retrieved.

Ethics and dissemination

This is a study protocol of meta-analysis; no primary data will be collected, and no ethics assessment is required. The study results will be presented in a peer-reviewed scientific publication.

PROSPERO registration number

CRD42021277932.
Effectiveness of video consultations in type 1 diabetes patients treated with insulin pumps in the outpatient clinic: protocol for a randomised controlled trial
Authors: Schultz Anders Nikolai Ørsted , Christensen Robin , Bollig Georg , Kidholm Kristian , Brandt F
Published: May 2022

Introduction

The purpose of the study is to assess the effectiveness of video consultations in patients with type 1 diabetes mellitus (DM) treated with insulin pumps in the outpatient clinic.

Methods and analysis

A 52 weeks’ duration, open-label, randomised controlled trial will be conducted, enrolling 100 patients with type 1 DM currently treated with insulin pump.

Patients will be recruited from the diabetes outpatient clinic at Hospital of Southern Jutland, Department of internal medicine, Sønderborg. Participants will be randomised to either video consultations (experimental intervention) or standard care (control comparator). Participants in the video consultation group will follow their standard care treatment but will have all of their scheduled and non-scheduled appointments by video consultation. The control group will follow their standard care treatment as usual, having all their appointments at the outpatient centre. Primary outcome will be change from baseline of time in range (3.9–10.0 mmol/L).

Ethics and dissemination

The study has been approved by the Regional Committe on Health Research Ethics for Southern Denmark, S-20200039G Acadre 20/12922. We will present the results of the trial at international conferences as well as publish the results of the trial in (a) peer-reviewed scientific journal(s).

Trial registration number

NCT04612933.
Equity of timely access to liver and stomach cancer surgery for Indigenous patients in New Zealand: a national cohort study
Authors: Gurney Jason , Sarfati Diana , Stanley James , Kerrison Clarence , Koea Jonathan
Published: May 2022

Objectives

When combined, liver and stomach cancers are second only to lung cancer as the most common causes of cancer death for the indigenous Māori population of New Zealand—with Māori also experiencing substantial disparities in the likelihood of survival once diagnosed with these cancers. Since a key driver of this disparity in survival could be access to surgical treatment, we have used national-level data to examine surgical procedures performed on Māori patients with liver and stomach cancers and compared the likelihood and timing of access with the majority European population.

Design, participants and setting

We examined all cases of liver and stomach cancers diagnosed during 2007–2019 on the New Zealand Cancer Registry (liver cancer: 866 Māori, 2460 European; stomach cancer: 953 Māori, 3192 European) and linked these cases to all inpatient hospitalisations that occurred over this time to identify curative and palliative surgical procedures. As well as descriptive analysis, we compared the likelihood of access to a given procedure between Māori and Europeans, stratified by cancer and adjusted for confounding and mediating factors. Finally, we compared the timing of access to a given procedure between ethnic groups.

Results and conclusions

We found that (a) access to liver transplant for Māori is lower than for Europeans; (b) Māori with stomach cancer appear more likely to require the type of palliation consistent with gastric outlet obstruction; and (c) differential timing of first stomach cancer surgery between Māori and European patients. However, we may also be cautiously encouraged by the fact that differences in overall access to curative surgical treatment were either marginal (liver) or absent (stomach).
Developing a profile of activities of daily living for bipolar disorder: a systematic review protocol and meta-analysis
Authors: Aniserowicz Anna M , Safi Fatima , Colquhoun Heather , Stier J , Nowrouzi-Kia Behdin
Published: May 2022

Introduction

Bipolar disorder (BD) is a severe mental health disorder that affects 2% of the adult population. Individuals with this disorder are at a higher risk for morbidity and functional difficulties. They may also experience significant challenges in their activities of daily living (ADLs). This systematic review will identify all available studies that examine subsets of ADLs that impact individuals with BD.

Methods and analysis

MEDLINE, Embase, CINAHL and APA PsycINFO will be searched to identify observational studies that examined functioning, independence or performance across a variety of ADLs. Title and abstract, full-text screening and a risk of bias assessment will be conducted in duplicate. An overarching table that summarises the level of functioning across different ADLs or an ‘ADL profile’ will be developed, and if there are sufficient data, these will be separated based on the phases of BD, such as manic/hypomanic, depressed and euthymic.

Ethics and dissemination

As this systematic review uses information from previous literature, this review does not require ethics approval. This review will help identify the trends in daily activities that individuals struggle with and can help healthcare practitioners identify specific areas of need for support. We plan to disseminate the results in a peer-reviewed journal and conferences targeting occupational therapists and mental health clinicians.

PROSPERO registration number

CRD42021255089.