Effects of ambient air pollution on obesity and ectopic fat deposition: a protocol for a systematic review and meta-analysis

Introduction
Globally, the prevalence of obesity tripled from 1975 to 2016. There is evidence that air pollution may contribute to the obesity epidemic through an increase in oxidative stress and inflammation of adipose tissue. However, the impact of air pollution on body weight at a population level remains inconclusive. This systematic review and meta-analysis will estimate the association of ambient air pollution with obesity, distribution of ectopic adipose tissue, and the incidence and prevalence of non-alcoholic fatty liver disease among adults.

Methods and analysis
The study will follow the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines for conduct and reporting. The search will include the following databases: Ovid Medline, Embase, PubMed, Web of Science and Latin America and the Caribbean Literature on Health Sciences, and will be supplemented by a grey literature search. Each article will be independently screened by two reviewers, and relevant data will be extracted independently and in duplicate. Study-specific estimates of associations and their 95% Confidence Intervals will be pooled using a DerSimonian and Laird random-effects model, implemented using the RevMan software. The I2 statistic will be used to assess interstudy heterogeneity. The confidence in the body of evidence will be assessed using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach.

Ethics and dissemination
As per institutional policy, ethical approval is not required for secondary data analysis. In addition to being published in a peer-reviewed journal and presented at conferences, the results of the meta-analysis will be shared with key stakeholders, health policymakers and healthcare professionals.

PROSPERO registration number
CRD42023423955.

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Developing a quality framework for community pharmacy: a systematic review of international literature

Objective
To identify the defining features of the quality of community pharmacy (CP) services and synthesise these into an evidence-based quality framework.

Design
Systematic review following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines.

Data sources
International research evidence (2005 onwards) identified from six electronic databases (Embase, PubMed, Scopus, CINAHL, Web of Science and PsycINFO) was reviewed systematically from October 2022 to January 2023. Search terms related to ‘community pharmacy’ and ‘quality’.

Eligibility criteria for selecting studies
Titles and abstracts were screened against inclusion or exclusion criteria, followed by full-text screening by at least two authors. Qualitative, quantitative and mixed-method studies relevant to quality in CP were included.

Data extraction and synthesis
A narrative synthesis was undertaken. Following narrative synthesis, a patient and public involvement event was held to further refine the quality framework.

Results
Following the title and abstract screening of 11 493 papers, a total of 81 studies (qualitative and quantitative) were included. Of the 81 included studies, 43 investigated quality dimensions and/or factors influencing CP service quality; 21 studies assessed patient satisfaction with and/or preferences for CP, and 17 studies reported the development and assessment of quality indicators, standards and guidelines for CPs, which can help define quality.
The quality framework emerging from the global literature consisted of six dimensions: person-centred care, access, environment, safety, competence and integration within local healthcare systems. Quality was defined as having timely and physical access to personalised care in a suitable environment that is safe and effective, with staff competent in the dispensing process and pharmacy professionals possessing clinical knowledge and diagnostic skills to assess and advise patients relative to pharmacists’ increasingly clinical roles.

Conclusion
The emerging framework could be used to measure and improve the quality of CP services. Further research and feasibility testing are needed to validate the framework according to the local healthcare context.

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Community engagement approaches for malaria prevention, control and elimination: a scoping review

Introduction
Globally malaria programmes have adopted approaches to community engagement (ACE) to design and deliver malaria interventions. This scoping review aimed to understand, map, and synthesise intervention activities guided by ACE and implemented by countries worldwide for the prevention, control and elimination of malaria.

Methods
Three databases (Web of Science, Proquest, and Medline) were searched for peer-reviewed, primary studies, published in English between 1 January 2000 and 31 December 2022. Advanced Google was used to search for grey literature. The five levels of the International Association for Public Participation were used to categorise ACE – (1) Inform, (2) Consult, (3) involve, (4) Collaborate, and (5) Co-lead. Intervention activities were categorised as health education (HE), and/or health services (HS), and/or environmental management (EM). Outcomes were collected as knowledge, attitude, behaviour, help-seeking, health and HS and environment. Enablers and barriers were identified. Malaria intervention phases were categorised as (1) prevention (P), or (2) control (C), or (3) prevention and control (PC) or prevention, control and elimination (PCE).

Results
Seventy-five studies were included in the review. Based on ACE levels, most studies were at the inform (n=37) and involve (n=26) level. HE (n=66) and HS (n=43) were the common intervention activities. HE informed communities about malaria, its prevention and vector control. EM activities were effective when complemented by HE. Community-based HS using locally recruited health workers was well-accepted by the community. Involvement of local leaders and collaboration with local stakeholders can be enablers for malaria intervention activities.

Conclusion
Involving local leaders and community groups in all stages of malaria prevention programmes is vital for successful interventions. Key elements of successful ACE, that is, consult, collaborate, and co-lead were under-represented in the literature and require attention. National programes must consult and collaborate with community stakeholders to develop ownership of the interventions and eventually co-lead them.

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Effect of eye-tracking-based attention training for patients with poststroke cognitive impairment: a study protocol for a prospective, single-blinded, single-centre, randomised controlled trial in China

Introduction
Poststroke cognitive impairment (PSCI) is a common dysfunction that places a great burden on patients who had stroke and their families. Approximately 46%–92% of stroke survivors experience some degree of attention problems after a stroke. Improving attention is considered the core of successfully improving cognitive function and reintegrating patients into daily life. Eye tracking technology provides real-time feedback and accurate monitoring of cognitive processing, and using this technology to introduce attention training may improve patient treatment outcomes. The main purpose of this study was to investigate whether eye-tracking-based attention training has a positive effect on patients with PSCI.

Methods and analysis
This study is a prospective randomised controlled trial. We will recruit 48 patients with PSCI referred to the Department of Rehabilitation Medicine at West China Hospital, Sichuan University, in Southwest China. The participants will be randomly distributed into two groups. Both groups will undergo conventional rehabilitation for 3 weeks, and the intervention group will receive 3 weeks of eye-tracking-based attention training (20–30 min/day). The primary outcome will be the patients’ cognitive function, measured by the Montreal Cognitive Assessment. The secondary outcomes will be the patients’ attention, independence of daily activities and event-related potential. These outcomes will be assessed at baseline, at the end of treatment (3 weeks) and at follow-up (1 month and 3 months after treatment). We will report the statistics and estimations using 95% CI.

Ethics and dissemination
This trial received ethics approval from the Ethics Committee on Biomedical Research, West China Hospital of Sichuan University (2023 review No. 258). The results from this study will be disseminated via academic publication.

Trial registration number
ChiCTR2300068727.

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Development of clinically meaningful quality indicators for contemporary lung cancer care, and piloting and evaluation in a retrospective cohort; experiences of the Embedding Research (and Evidence) in Cancer Healthcare (EnRICH) Program

Objectives
Lung cancer continues to be the most common cause of cancer-related death and the leading cause of morbidity and burden of disease across Australia. There is an ongoing need to identify and reduce unwarranted clinical variation that may contribute to these poor outcomes for patients with lung cancer. An Australian national strategy acknowledges clinical quality outcome data as a critical component of a continuously improving healthcare system but there is a need to ensure clinical quality indicators adequately measure evidence-based contemporary care, including novel and emerging treatments. This study aimed to develop a suite of lung cancer-specific, evidence-based, clinically acceptable quality indicators to measure quality of care and outcomes, and an associated comparative feedback dashboard to provide performance data to clinicians and hospital administrators.

Design
A multistage modified Delphi process was undertaken with a Clinical Advisory Group of multidisciplinary lung cancer specialists, with patient representation, to update and prioritise potential indicators of lung cancer care derived from a targeted review of published literature and reports from national and international lung cancer quality registries. Quality indicators were piloted and evaluated with multidisciplinary teams in a retrospective observational cohort study using clinical audit data from the Embedding Research (and Evidence) in Cancer Healthcare Program, a prospective clinical cohort of over 2000 patients with lung cancer diagnosed from May 2016 to October 2021.

Setting and participants
Six tertiary specialist cancer centres in metropolitan and regional New South Wales, Australia.

Results
From an initial 37 potential quality indicators, a final set of 10 indicators spanning diagnostic, treatment, quality of life and survival domains was agreed.

Conclusions
These indicators build on and update previously available measures of lung cancer care and outcomes in use by national and international lung cancer clinical quality registries which, to our knowledge, have not been recently updated to reflect the changing lung cancer treatment paradigm.

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Protocol for a scoping review to identify research reporting on eating disorders in minority ethnic populations in the UK, Canada, Australia and New Zealand

Introduction
Eating disorders (EDs) are common, severe and often life-threatening psychiatric conditions. Notwithstanding stereotypes, EDs affect individuals from all racial and ethnic backgrounds. However, despite similar and in some cases increased prevalence of disordered eating and EDs among minority ethnic groups, there appear to be disparities when it comes to ED diagnosis and treatment. To date, most of the existing literature exploring disordered eating and EDs among minority ethnic groups has been conducted in the USA. The present scoping review aims to examine the extent, range and nature of research activity into disordered eating and EDs in the UK, Canada, Australia and New Zealand providing a comprehensive overview of the existing literature. A special focus will be placed on studies exploring prevalence, access to care and treatment experiences.

Methods and analysis
The scoping review framework first outlined by Arksey and O’Malley and improved on by Levac et al was used to guide the development of this scoping review protocol. A detailed systematic search of relevant databases (Medline, EMBASE, PsycINFO, CINAHL and Web of Science) will be conducted. Relevant literature will also be identified from the reference lists of included studies. Two reviewers will independently screen titles and abstracts and full-texts against specified inclusion and exclusion criteria. A third reviewer will resolve disagreements if necessary. Relevant data will be extracted using a data charting form. Quantitative and qualitative summaries of extracted data will be provided.

Ethics and dissemination
No ethical approval is required for this study. Findings will be of benefit to researchers, clinicians and policy-makers by highlighting areas for future research and identifying ways to making ED treatment more accessible for individuals from all backgrounds. Findings will be disseminated via conferences, presentations and peer-reviewed journals.

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Tools for assessing quality of studies investigating health interventions using real-world data: a literature review and content analysis

Objectives
We aimed to identify existing appraisal tools for non-randomised studies of interventions (NRSIs) and to compare the criteria that the tools provide at the quality-item level.

Design
Literature review through three approaches: systematic search of journal articles, snowballing search of reviews on appraisal tools and grey literature search on websites of health technology assessment (HTA) agencies.

Data sources
Systematic search: Medline; Snowballing: starting from three articles (D’Andrea et al, Quigley et al and Faria et al); Grey literature: websites of European HTA agencies listed by the International Network of Agencies for Health Technology Assessment. Appraisal tools were searched through April 2022.

Eligibility criteria for selecting studies
We included a tool, if it addressed quality concerns of NRSIs and was published in English (unless from grey literature). A tool was excluded, if it was only for diagnostic, prognostic, qualitative or secondary studies.

Data extraction and synthesis
Two independent researchers searched, screened and reviewed all included studies and tools, summarised quality items and scored whether and to what extent a quality item was described by a tool, for either methodological quality or reporting.

Results
Forty-nine tools met inclusion criteria and were included for the content analysis. Concerns regarding the quality of NRSI were categorised into 4 domains and 26 items. The Research Triangle Institute Item Bank (RTI Item Bank) and STrengthening the Reporting of OBservational studies in Epidemiology (STROBE) were the most comprehensive tools for methodological quality and reporting, respectively, as they addressed (n=20; 17) and sufficiently described (n=18; 13) the highest number of items. However, none of the tools covered all items.

Conclusion
Most of the tools have their own strengths, but none of them could address all quality concerns relevant to NRSIs. Even the most comprehensive tools can be complemented by several items. We suggest decision-makers, researchers and tool developers consider the quality-item level heterogeneity, when selecting a tool or identifying a research gap.

OSF registration number
OSF registration DOI (https://doi.org/10.17605/OSF.IO/KCSGX).

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Which elements of hospital-based clinical decision support tools for the assessment and management of children with head injury can be adapted for use by paramedics in prehospital care? A systematic mapping review and narrative synthesis

Objective
Hospital-based clinical decision tools support clinician decision-making when a child presents to the emergency department with a head injury, particularly regarding CT scanning. However, there is no decision tool to support prehospital clinicians in deciding which head-injured children can safely remain at scene. This study aims to identify clinical decision tools, or constituent elements, which may be adapted for use in prehospital care.

Design
Systematic mapping review and narrative synthesis.

Data sources
Searches were conducted using MEDLINE, EMBASE, PsycINFO, CINAHL and AMED.

Eligibility criteria
Quantitative, qualitative, mixed-methods or systematic review research that included a clinical decision support tool for assessing and managing children with head injury.

Data extraction and synthesis
We systematically identified all in-hospital clinical decision support tools and extracted from these the clinical criteria used in decision-making. We complemented this with a narrative synthesis.

Results
Following de-duplication, 887 articles were identified. After screening titles and abstracts, 710 articles were excluded, leaving 177 full-text articles. Of these, 95 were excluded, yielding 82 studies. A further 14 studies were identified in the literature after cross-checking, totalling 96 analysed studies. 25 relevant in-hospital clinical decision tools were identified, encompassing 67 different clinical criteria, which were grouped into 18 categories.

Conclusion
Factors that should be considered for use in a clinical decision tool designed to support paramedics in the assessment and management of children with head injury are: signs of skull fracture; a large, boggy or non-frontal scalp haematoma neurological deficit; Glasgow Coma Score less than 15; prolonged or worsening headache; prolonged loss of consciousness; post-traumatic seizure; amnesia in older children; non-accidental injury; drug or alcohol use; and less than 1 year old. Clinical criteria that require further investigation include mechanism of injury, clotting impairment/anticoagulation, vertigo, length of time of unconsciousness and number of vomits.

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Social media and postsecondary student adoption of mental health labels: protocol for a scoping review

Introduction
Many postsecondary students use social media at an age when mental health issues often arise for the first time. On social media, students describe their mental states or social interactions using psychiatric language. This is a process of mental health labelling as opposed to receiving a formal diagnosis from a psychiatrist. Despite substantial literature on psychiatric labelling effects such as stigma, little research has addressed the mechanisms and effects of labelling through social media. Our objective is to summarise the existing evidence to address this gap.

Methods and analysis
This review includes articles in English published since 1995 on how postsecondary students interact with mental health labels in their use of social media. We will consider empirical studies and theses. The search strategy includes SCOPUS, PubMed, OVID MEDLINE (to access APA PsycINFO), Web of Science and ProQuest Global Dissertations and Theses. This scoping review follows the Preferred Reporting Items for Systematic Reviews and Meta-Analyses extensions for protocols and Scoping Reviews guidelines. The artificial intelligence application, Connected Papers, will assist in identifying additional references. The outcomes of interest are labelling by self or others and changes in self-concept and presentation associated with these labels. Two researchers will independently identify the included studies and extract data, solving disagreements with a third opinion. We will produce tables and narrative descriptions of the operationalisation and measurement methods of labelling and social media use, reported effects and uses of labelling, and explanatory mechanisms for the adoption of labels.

Ethics and dissemination
This literature review does not require ethics approval. The researchers will present their findings for publication in an open-access peer-reviewed journal and at student/scientific conferences. Potential knowledge users include university students, social media users, researchers, mental health professionals and on-campus mental health services.

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Patient symptoms, self-management, and unscheduled healthcare use during the first 6 months of targeted oral anticancer agent therapy: protocol for a mixed-methods US study

Introduction
Targeted oral anticancer agents (OAAs) are increasingly used to treat cancer, including haematological malignancies and ovarian cancer, but they can cause serious symptomatic side effects such as arrhythmias, hypertension, and hyperglycaemia. Unaddressed OAA symptoms or inadequately managed symptoms may also lead to unnecessary and unscheduled healthcare use that decreases patient quality of life and financially burdens both patients and the healthcare system. Limited information is available about patient symptoms, self-management behaviours, and use of healthcare services over time while taking targeted OAAs, but is needed to ensure successful OAA therapy. The primary objective is to understand patient experiences and behaviours on initiating targeted OAA, and elicit cancer care clinicians’ (ie, physicians, advanced practice practitioners, nurses, and pharmacists) perspectives on supporting patients during therapy. Study results will inform comprehensive and realistic interventions that minimise disruptions to therapy while maximising quality of life.

Methods and analysis
We will conduct a remote single-arm, convergent-parallel mixed-methods cohort study within a large academic medical centre. A minimum of 60 patients will be enrolled. Patients will complete several validated patient-reported outcome measures at six timepoints over 6 months. Mixed-effects logistic regression will be used to predict the primary binary outcome of unscheduled healthcare use by patient self-efficacy for symptom self-management. Semistructured interviews will be conducted with patients and clinicians and thematically analysed. Triangulated quantitative and qualitative results will be reported using cross-case comparison joint display.

Ethics and dissemination
This study protocol is approved by the Institutional Review Board of University of Michigan Medical School (IRBMED). Study results will be published in peer-reviewed journals, presented at conferences, and disseminated to study participants.

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Relationships between experimental task and questionnaire measures of reward/punishment sensitivity in attention-deficit/hyperactivity disorder (ADHD): protocol for a scoping review

Introduction
One of the purported underlying causal mechanisms of attention deficit hyperactivity disorder (ADHD) is altered motivational processes. Questionnaires have been used to identify the characteristics of reward and punishment sensitivity in individuals with ADHD. However, these questionnaires were initially developed to measure individual traits related to anxiety (inhibitory) and impulsivity (approach) tendencies or differences in pleasure-seeking. These reward and punishment sensitivity questionnaires are useful but might not capture all relevant aspects of altered motivational processes in ADHD. The proposed scoping review aims to: (1) examine which aspects of hypothesised altered reward and punishment sensitivity correspond to constructs measured by existing questionnaires, (2) characterise the relationships between ADHD symptomatology and reward and punishment sensitivity as measured by existing questionnaires and (3) evaluate the consistency between the altered reward and punishment sensitivity as measured by existing questionnaires and experimental task performance.

Methods and analysis
Reporting of the scoping review results will adhere to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses Extension for Scoping Reviews and the Joanna Briggs Methodology for Scoping Reviews. Published English-language literature was searched in three electronic databases (PubMed, Web of Science, APA PsycINFO) on 16 November 2023, with no restriction on the year of publication. Two researchers independently screened all identified titles/abstracts before proceeding to full-text review and additional handsearching of relevant studies. A narrative review and conclusions will be presented together with tables summarising the articles reviewed and the results organised by the three aims.

Ethics and dissemination
This study reviews existing publications with ethical approval in place. Therefore, ethical approval is not required. Review results will be disseminated through academic conferences and peer-reviewed manuscripts. Scoping review results will also inform future research to measure and identify altered motivational processes in ADHD.

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Correction: Cardiac involvement assessment in systemic sclerosis using speckle tracking echocardiography: a systematic review and meta-analysis

Qiao W, Bi W, Wang X, et al. Cardiac involvement assessment in systemic sclerosis using speckle tracking echocardiography: a systematic review and meta-analysis. BMJ Open. 2023;13:e063364. doi: 10.1136/bmjopen-2022-063364.
In this systematic review, an article on multiple sclerosis was mistakenly included.1 The authors have excluded this article and updated the results accordingly. None of the revised analyses change the conclusion.
The corrected version of the systematic review includes 30 articles. Table 1, figure 1, figure 2, figure 3 and figure 4 in the main text, figure S1, figure S2 and table 1 in supplemental file have been replaced with revised data. All affected data in the text have been replaced and the supplemental file has been revised.
For another article that reported a larger SD of GLS in the control group,2 the authors tried to exclude it and re-analyse, and the conclusion did not change.

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Assessment of quality of data submitted for NICE technology appraisals over two decades

Background
The National Institute for Health and Care Excellence (NICE) pioneered the Health Technology Assessment (HTA) processes and methodologies. Technology appraisals (TAs) focus on pharmaceutical products and clinical and economic data, which are presented by the product manufacturers to the NICE appraisal committee for decision-making. Uncertainty in data reduces the chance of a positive outcome from the HTA process or requires a higher discount.

Objective
To investigate the quality of clinical data (comparator, quality of life (QoL), randomised controlled trials (RCTs) and overall quality of evidence) submitted by the manufacturers to NICE.

Design
This retrospective evaluation analysed active TAs published between 2000 and 2019 (up to TA600).

Methods
For all TAs, we extracted data from the Assessment Group and Evidence Review Group reports and Final Appraisal Determinations on (1) the quality of submitted RCTs and (2) the overall quality of evidence submitted for decision-making. For single TAs, we also extracted data and its critique on QoL and comparators. Each category was scored for quality and analysed using descriptive statistics.

Results
409 TAs were analysed (multiple technology appraisals (MTA)=104, single technology appraisal (STA)=305). In two-thirds of TAs, the overall quality of evidence was either poor (n=224, 55%) or unacceptable (n=41, 10%). In 39% (n=119) of the STAs, the quality of comparative evidence was considered poor, and in 17% (n=51) unacceptable. In 44% (n=135) of STAs, the quality of QoL data was considered poor, 15% (n=47) unacceptable, 33% (n=102) acceptable and 7% (n=21) as good. Over 20 years of longitudinal analysis did not show improvements in the quality of evidence submitted to NICE.

Conclusion
We found that the primary components of clinical evidence influencing NICE’s decision-making framework were of poor quality. It is essential to continue to generate robust clinical data for premarket and postmarket introduction of medicines into clinical practice to ensure they deliver benefits to patients.

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Non-pharmacological therapies for pain management in paediatric intensive care units: a protocol for a scoping review

Introduction
In critically ill children, pain management is complex owing to cognitive development and the nature of hospitalisation in paediatric intensive therapy units. Although there are many protocols and guidelines for pain control via pharmacological interventions, non-pharmacological practices should also be explored and disseminated for their potential benefit.

Methods and analysis
A systematic literature search will be performed using the following databases: Academic Search Premier, Cumulative Index to Nursing and Allied Health Literature, Cochrane Library, Excerpta Medica Database, Virtual Health Library, Medical Literature Analysis and Retrieval System Online, ScienceDirect, Scopus, Web of Science Core Collection, Theses from Coordenacão de Aperfeicoamento de Pessoal de Nível Superior, Dart Europe, Open Access Theses and Dissertations and grey literature from Google Scholar. The research will consider quantitative and qualitative studies, mixed-method studies, systematic reviews, text articles, opinion articles, letters to editors and editorials in any language and from any database. The following will be eligible for inclusion: (1) newborns, infants, children and adolescents; and (2) non-pharmacological therapies used for pain in paediatric intensive care.

Ethics and dissemination
This study does not require ethical approval. The results of this research will be disseminated through social media channels and podcasts about pain in children.

Trial registration number
This protocol has been registered with the Open Science Framework (DOI 10.17605/OSF.IO/DZHKT).

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