Knowledge, practice and attitudes regarding substance use disorder treatment and harm reduction strategies among pharmacists: a scoping review protocol

Introduction
Pharmacists provide a spectrum of services and comprehensive medication management for patients with substance use disorders (SUDs) with many providing timely and increased access to care for patients. Prior studies have evaluated other healthcare professionals’ attitudes, knowledge and practice in regard to SUD treatment and harm reduction services. However, no reviews to date summarise the available literature on the attitudes, knowledge and practice in regard to SUD treatment and harm reduction services from the pharmacist perspective. This scoping review aims to systematically map the extent, range and nature of available evidence and identify and describe gaps in knowledge, practice and attitudes towards SUD treatment among pharmacists with the goal of providing information for meaningful integration of pharmacists into SUD care.

Methods and analysis
We will use the framework proposed by Arksey and O’Malley (2005) updated with recommendations by Levac et al (2010) and the Joanna Briggs Institute (2020). The protocol is registered via Open Science Framework (https://osf.io/92dek). We will search for peer-reviewed literature containing empirical evidence investigating SUD treatment or harm reduction with outcomes pertaining to the knowledge, practice or attitudes of pharmacists. Findings will be guided and assessed by research objectives and summarised using descriptive statistics and thematically for quantitative and qualitative findings, respectively. This review will be conducted and reported in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses for Scoping Reviews.

Ethics and dissemination
Our findings will provide crucial information and support for future interventions and programmes which aim to meaningfully integrate pharmacists into SUD care. We will disseminate findings at conferences and publish in a peer-reviewed journal. In addition, we will integrate feedback on search strategy, data extraction and our dissemination approach from multidisciplinary collaborators including those within our team’s institution and outside experts with clinical or administrative knowledge in SUD care.

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Effects of vitamin D levels during pregnancy on prematurity: a systematic review protocol

Introduction
Prematurity is an urgent public health problem worldwide. Recent studies associate maternal hypovitaminosis D during pregnancy with an increased risk of prematurity. However, the evidence on this association remains inconclusive, and there is lack of consensus in the literature. The exact mechanism by which low vitamin D levels may increase the risk of preterm birth is not yet fully understood. Nevertheless, it is known that vitamin D may play a role in maintaining a healthy pregnancy by regulating inflammation and immunomodulation by acting on the maternal and fetal immune systems. Inflammation and immune dysregulation are both associated with preterm birth, and low vitamin D levels may exacerbate these processes. The results of this review may have important implications for clinical practice and public health policy, particularly regarding vitamin D supplementation during pregnancy.

Methods and analysis
A systematic review of the literature will be conducted. The search will be performed in electronic databases: CINAHL; MEDLINE; Cochrane Central Register of Controlled Trials; Cochrane Library; Academic Search Complete; Information Science and Technology Abstracts; MedicLatina; SCOPUS; PubMed; and Google Scholar, with the chronological range of January 2018 to November 2022. The search strategy will include the following Medical Subject Headings or similar terms: ‘Vitamin D’; ‘25-hydroxyvitamin D’; ‘Hypovitaminosis D’; ‘Pregnancy’; ‘Pregnant women’; ‘Expectant mother’; ‘Prematurity’; ‘Premature birth’; ‘Premature delivery’; ‘Preterm birth’; and ‘Preterm labour’. This review will include quantitative primary studies, both experimental (clinical trials) and observational (cohort, cross-sectional, and case–control). The quality of each selected study and the results obtained will be assessed by two reviewers separately, using the Cochrane risk of bias tool for evaluating randomised clinical trials or the Newcastle Ottawa Scale for non-randomised studies, following the respective checklist. In case of disagreement, a third reviewer will be consulted.

Ethics and dissemination
This study does not involve human subjects and therefore does not require ethics approval. The results will be disseminated through publication in a peer-reviewed scientific journal and through conference presentations. All changes made to the protocol will be registered in PROSPERO, with information on the nature and justification for the changes made.

PROSPERO registration number
CRD42022303901.

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Investigating the efficacy and safety of olanzapine prophylaxis for opioid-induced nausea and vomiting (JORTC-PAL20): a study protocol for an open-label, single-arm exploratory study

Introduction
In opioid therapy for cancer pain, opioid-induced nausea and vomiting (OINV) occur in 20%–40% of patients during initial opioid treatment or increasing opioid doses. OINV result in failure to achieve pain relief due to poor opioid adherence. Therefore, antiemetics are used to prevent OINV, but their efficacy and safety in this context have not yet been fully elucidated. Olanzapine is a promising antiemetic for the prophylaxis of chemotherapy-induced nausea and vomiting.

Methods and analysis
This single-arm, single-centre exploratory study will evaluate the prophylactic antiemetic efficacy and safety of 5 mg olanzapine in patients with cancer pain who are withholding initial regular opioid therapy. Thirty-five patients will be enrolled. The primary endpoint is the proportion of patients achieving complete control (CC) of OINV during 5 days of opioid treatment. CC was defined as the absence of emetic episodes, no need for rescue medication to treat nausea, and minimal or no nausea (3 or less on an 11-point categorical scale). Secondary endpoints include the complete response, defined as no emetic episodes and no use of rescue medication during the overall assessment period, the time from opioid initiation to first emetic episode, the time from opioid initiation to first rescue antiemetic administration, and adverse events graded by Patient-Reported Outcome (PRO) Common Terminology Criteria for Adverse Events (CTCAE) version 1.0 and CTCAE version 5.0.

Ethics and dissemination
This study protocol was approved by National Cancer Center Hospital Certified Review Board. The results will be used as preliminary data to conduct a validation study.

Trial registration number
Japan Registry of Clinical Trials (jRCT) jRCTs031220008.

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Health economic evaluations of preventative care for perinatal anxiety and associated disorders: a rapid review

Objectives
Perinatal mental health problems affect one in five women and cost the UK £8.1 billion for every year of births, with 72% of this cost due to the long-term impact on the child. We conducted a rapid review of health economic evaluations of preventative care for perinatal anxiety and associated disorders.

Design
This study adopted a rapid review approach, using principles of the standard systematic review process to generate quality evidence. This methodology features a systematic database search, Preferred Reporting Items for Systematic Reviews and Meta-Analyses diagram, screening of evidence, data extraction, critical appraisal and narrative synthesis.

Data sources
PubMed, Cumulative Index to Nursing and Allied Health Literature, Cochrane Library, Applied Social Sciences Index and Abstracts, PsycINFO and MEDLINE.

Eligibility criteria for selecting studies
Studies that evaluated the costs and cost-effectiveness of preventative care for perinatal anxiety and associated disorders carried out within the National Health Service and similar healthcare systems.

Data extraction and synthesis
A minimum of two independent reviewers used standardised methods to search, screen, critically appraise and synthesise included studies.

Results
The results indicate a lack of economic evaluation specifically for perinatal anxiety, with most studies focusing on postnatal depression (PND). Interventions to prevent postnatal mental health problems are cost-effective. Modelling studies have also been conducted, which suggest that treating PND with counselling would be cost-effective.

Conclusion
The costs of not intervening in maternal mental health outweigh the costs of preventative interventions. Preventative measures such as screening and counselling for maternal mental health are shown to be cost-effective interventions to improve outcomes for women and children.

PROSPERO registration number
CRD42022347859.

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Effectiveness, barriers and facilitating factors of strategies for active delabelling of patients with penicillin allergy labels: a systematic review protocol

Introduction
Up to 15% of adult patients in the clinical setting report to be allergic to penicillin. However, in most cases, penicillin allergy is not confirmed. Due to the negative aspects associated with erroneous penicillin allergy, the implementation of active delabelling processes for penicillin allergy is an important part of antibiotic stewardship programmes. Depending on the clinical setting, different factors need to be considered during implementation. This review examines the effectiveness of different delabelling interventions and summarises components and structures that facilitate, support or constrain structured penicillin allergy delabelling.

Methods and analysis
This review will adhere to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses. The databases MEDLINE (via PubMed), EMBASE and Cochrane Library were searched for studies reporting on any intervention to identify, assess or rule out uncertain penicillin allergy. To improve completeness, two further databases are also searched for grey literature. Study design, intervention type, professional groups involved, effectiveness, limitations, barriers, facilitating factors, clinical setting and associated regulatory factors will be extracted and analysed. In addition, exclusion criteria for participation in the delabelling intervention and criteria for not delabelling penicillin allergy will be summarised. In case of failed protocols, these are highlighted and quantitatively analysed if possible. Two independent reviewers will perform the screening process and data extraction. Discordant decisions will be resolved through review by a third reviewer. Bias assessment of the individual studies will be performed using the Newcastle Ottawa Scale.

Ethics and dissemination
Because individual patient-related data are not analysed, an ethical approval is not required. The review will be published in a peer-reviewed scientific journal.

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Improving safety and preventing falls using an evidence-based, front-line staff huddling practice: protocol for a pragmatic trial to increase quality of care in State Veterans Homes

Introduction
Falls in nursing homes are a major cause for decreases in residents’ quality of life and overall health. This study aims to reduce resident falls by implementing the LOCK Falls Programme, an evidence-based quality improvement intervention. The LOCK Falls Programme involves the entire front-line care team in (1) focusing on evidence of positive change, (2) collecting data through systematic observation and (3) facilitating communication and coordination of care through the practice of front-line staff huddles.

Methods and analysis
The study protocol describes a mixed-methods, 4-year hybrid (type 2) effectiveness-implementation study in State Veterans Homes in the USA. The study uses a pragmatic stepped-wedge randomised trial design and employs relational coordination theory and the Reach, Effectiveness, Adoption, Implementation and Maintenance framework to guide implementation and evaluation. A total of eight State Veterans Homes will participate and data will be collected over an 18-month period. Administrative data inclusive of all clinical assessments and Minimum Data Set assessments for Veterans with a State Veterans Home admission or stay during the study period will be collected (8480 residents total). The primary outcome is a resident having any fall. The primary analysis will be a partial intention-to-treat analysis using the rate of participants experiencing any fall. A staff survey (n=1200) and qualitative interviews with residents (n=80) and staff (n=400) will also be conducted. This research seeks to systematically address known barriers to nursing home quality improvement efforts associated with reducing falls.

Ethics and dissemination
This study is approved by the Central Institutional Review Board (#167059-11). All participants will be recruited voluntarily and will sign informed consent as required. Collection, assessment and managing of solicited and spontaneously reported adverse events, including required protocol alterations, will be communicated and approved directly with the Central Institutional Review Board, the data safety monitoring board and the Office of Research and Development. Study results will be disseminated through peer-reviewed publications and conference presentations at the Academy Health Annual Research Meeting, the Gerontological Society of America Annual Scientific Meeting and the American Geriatrics Society Annual Meeting. Key stakeholders will also help disseminate lessons learnt.

Trial registration number
NCT05906095.

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Assessing caregiver burden in advanced kidney disease: protocol for a systematic review of the measurement properties of instruments and tools

Introduction
Caregiver burden is a significant issue in the care of patients with advanced kidney disease. Its assessment is crucial for evaluating the needs of caregivers and for the development of interventions to support them. Several instruments have been developed to measure caregiver burden in these patients. However, the measurement properties of these instruments have not been systematically reviewed.

Methods and analysis
This systematic review will include a comprehensive search of databases including PubMed, CINAHL, Embase, Cochrane Library, SCOPUS and Web of Science by using keywords and MeSH terms to identify relevant studies starting from each database inception to 1 January 2024 and covering papers in English. The search strategy will combine relevant keywords and database-specific subject headings related to the following concepts: (1) caregivers, (2) burden, stress, distress, (3) chronic kidney disease, end-stage kidney disease, dialysis. Reference lists of eligible articles will also be hand searched. We will include quantitative and qualitative studies evaluating measurement properties of instruments assessing caregiver burden in caregivers of adult patients (aged ≥18 years). Data will be extracted from the selected studies and analysed using the COnsensus-based Standards for the selection of health Measurement INstruments checklist as the study quality assessment tool. Subsequently, the van der Vleuten utility index will be used to critique and categorise the instruments. A narrative that synthesises the utility of all instruments will be presented along with recommendations for the selection of instruments depending on specific clinical contexts. This systematic review will provide an overview of the measurement properties of available instruments, including discussion on reliability, validity and responsiveness. Results from the review may give rise to the subsequent development of most appropriate instrument that could be applied to the assessment of caregiver burden in advanced kidney disease.

Ethics and dissemination
Ethics approval is not required as this study will merely synthesise data from published studies. The results will be disseminated through peer-reviewed publications as well as conference presentations.

PROSPERO registration number
CRD42023433906.

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Tobacco use and behaviour among South African adolescents and young adults: systematic review and meta-analysis

Objective
Tobacco use, particularly the initiation of smoking during adolescence and young adulthood, represents a significant public health concern in South Africa. This study aims to conduct a comprehensive review of published literature about tobacco use and behaviour among adolescents and young adults and to determine an aggregated prevalence estimate of tobacco use within this demographic.

Design
Systematic review and meta-analysis.

Data sources
PubMed/MEDLINE, EMBASE, Cochrane Library, Scopus and Google Scholar were searched from 1 January 2000 through 31 October 2023.

Eligibility criteria
Studies were eligible for inclusion if they were cross-sectional studies conducted in South Africa and measured the prevalence and determinants of tobacco use among adolescents and young adults aged 12–24 years.

Data extraction and synthesis
Two reviewers independently extracted information for each article and saved it into an Excel spreadsheet. Risk of bias analysis was conducted using the Risk of Bias Assessment Tool for non-randomised studies. The methodology quality of each selected study was evaluated using the Joanna Briggs Institute checklist. The heterogeneity of prevalence estimates was assessed using I2 statistic (random-effects DerSimonian-Laid approach).

Results
Out of 73 articles identified, 12 articles were included in the analysis. The pooled prevalence of current tobacco use among South African adolescents and young adults was estimated to be 22%. The pooled prevalence of tobacco use among school dropouts, university students and secondary school learners was 51%, 20% and 16%, respectively. Stratifying using gender, boys (26%) were two times more likely to use tobacco than girls (13%).

Conclusion
The elevated occurrence of tobacco usage among South African adolescents and young adults is a relevant public health concern. There is a need for more population-based prevalence studies at a national level to estimate the burden of tobacco use in South Africa.

PROSPERO registration number
CRD42023428369.

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Prevalence of alcohol use and associated factors since COVID-19 among school-going adolescents within the Southern African Development Community: a systematic review protocol

Introduction
The COVID-19 pandemic has significantly shaped the global landscape and impacted various aspects of individuals’ lives, especially the behaviour of school-going adolescents regarding substance use. Among these substances, alcohol is the most predominant substance, particularly among school-going adolescents, who also are highly susceptible to harmful alcohol use, such as poor academic performance, psychiatric disorders and disrupted social lives. This review will synthesise the known prevalence estimates and associated factors of alcohol use among school-going adolescents in the Southern African Development Community (SADC) since the COVID-19 pandemic.

Methods and analysis
We will perform a systematic review in line with the Cochrane Handbook for Systematic Reviews. We will systematically search for selected global databases (ScienceDirect, EbscoHost, PsycINFO and PubMed) and regional electronic databases (African Index Medicus, Sabinet and African Journals OnLine). Peer-reviewed literature published between 11 March 2020 and 10 March 2024 will be considered for eligibility without language restriction. All 16 countries of the SADC region will be included in the review. The Mixed-Methods Appraisal Tool checklist for quality appraisal will be used to appraise the methodological quality of the included studies. Depending on the level of heterogeneity, prevalence estimates will be pooled in a meta-analysis; narrative synthesis will be applied to describe the reported associated factors of alcohol use.

Ethics and dissemination
We will not seek ethical approval from an institutional review board since the study will not involve gathering data directly from individual school-going adolescents, nor will it violate their privacy. When completed, the full report of this review will be submitted to a journal for peer-reviewed publication; the key findings will be presented at local and international conferences with a partial or full focus on (adolescent) alcohol (mis)use.

PROSPERO registration number
CRD42023452765.

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Review of Evaluation and Treatment of Knee Pain—Reply

In Reply We appreciate Dr Misseri and colleagues’ interest in our Review article. They raise a relevant point about RFA as a potential treatment option for managing knee osteoarthritis pain. Research on this topic has mostly been published in anesthesiology and pain medicine journals, likely because specialist pain management physicians usually perform this procedure. Few studies about RFA have been published in rheumatology, orthopedic, and osteoarthritis journals, at least until very recently.

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RNA Therapeutics for the Cardiovascular System

Circulation, Volume 149, Issue 9, Page 707-716, February 27, 2024. RNA therapeutics hold significant promise in the treatment of cardiovascular diseases. RNAs are biologically diverse and functionally specific and can be used for gain- or loss-of-function purposes. The effectiveness of mRNA-based vaccines in the recent COVID-19 pandemic has undoubtedly proven the benefits of an RNA-based approach. RNA-based therapies are becoming more common as a treatment modality for cardiovascular disease. This is most evident in hypertension where several small interfering RNA–based drugs have proven to be effective in managing high blood pressure in several clinical trials. As befits a rapidly burgeoning field, there is significant interest in other classes of RNA. Revascularization of the infarcted heart through an mRNA drug is under clinical investigation. mRNA technology may provide the platform for the expression of paracrine factors for myocardial protection and regeneration. Emergent technologies on the basis of microRNAs and gene editing are tackling complex diseases in a novel fashion. RNA-based gene editing offers hope of permanent cures for monogenic cardiovascular diseases, and long-term control of complex diseases such as essential hypertension, as well. Likewise, microRNAs are proving effective in regenerating cardiac muscle. The aim of this review is to provide an overview of the current landscape of RNA-based therapies for the treatment of cardiovascular disease. The review describes the large number of RNA molecules that exist with a discussion of the clinical development of each RNA type. In addition, the review also presents a number of avenues for future development.

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Design and rationale of the Post-Intensive Care Syndrome – paediatrics (PICS-p) Longitudinal Cohort Study

Introduction
As paediatric intensive care unit (PICU) mortality declines, there is growing recognition of the morbidity experienced by children surviving critical illness and their families. A comprehensive understanding of the adverse physical, cognitive, emotional and social sequelae common to PICU survivors is limited, however, and the trajectory of recovery and risk factors for morbidity remain unknown.

Methods and analysis
The Post-Intensive Care Syndrome – paediatrics Longitudinal Cohort Study will evaluate child and family outcomes over 2 years following PICU discharge and identify child and clinical factors associated with impaired outcomes. We will enrol 750 children from 30 US PICUs during their first PICU hospitalisation, including 500 case participants experiencing ≥3 days of intensive care that include critical care therapies (eg, mechanical ventilation, vasoactive infusions) and 250 age-matched, sex-matched and medical complexity-matched control participants experiencing a single night in the PICU with no intensive care therapies. Children, parents and siblings will complete surveys about health-related quality of life, physical function, cognitive status, emotional health and peer and family relationships at multiple time points from baseline recall through 2 years post-PICU discharge. We will compare outcomes and recovery trajectories of case participants to control participants, identify risk factors associated with poor outcomes and determine the emotional and social health consequences of paediatric critical illness on parents and siblings.

Ethics and dissemination
This study has received ethical approval from the University of Pennsylvania Institutional Review Board (protocol #843844). Our overall objective is to characterise the ongoing impact of paediatric critical illness to guide development of interventions that optimise outcomes among children surviving critical illness and their families. Findings will be presented at key disciplinary meetings and in peer-reviewed publications at fixed data points. Published manuscripts will be added to our public study website to ensure findings are available to families, clinicians and researchers.

Trials registration number
NCT04967365.

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Voice disorder recognition using machine learning: a scoping review protocol

Introduction
Over the past decade, several machine learning (ML) algorithms have been investigated to assess their efficacy in detecting voice disorders. Literature indicates that ML algorithms can detect voice disorders with high accuracy. This suggests that ML has the potential to assist clinicians in the analysis and treatment outcome evaluation of voice disorders. However, despite numerous research studies, none of the algorithms have been sufficiently reliable to be used in clinical settings. Through this review, we aim to identify critical issues that have inhibited the use of ML algorithms in clinical settings by identifying standard audio tasks, acoustic features, processing algorithms and environmental factors that affect the efficacy of those algorithms.

Methods
We will search the following databases: Web of Science, Scopus, Compendex, CINAHL, Medline, IEEE Explore and Embase. Our search strategy has been developed with the assistance of the university library staff to accommodate the different syntactical requirements. The literature search will include the period between 2013 and 2023, and will be confined to articles published in English. We will exclude editorials, ongoing studies and working papers. The selection, extraction and analysis of the search data will be conducted using the ‘Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for scoping reviews’ system. The same system will also be used for the synthesis of the results.

Ethics and dissemination
This scoping review does not require ethics approval as the review solely consists of peer-reviewed publications. The findings will be presented in peer-reviewed publications related to voice pathology.

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