Infectious Diseases Data Observatory (IDDO) Visceral Leishmaniasis Library of Clinical Therapeutic Studies: A Protocol for a Living Systematic Review of Clinical Studies

Introduction: Visceral Leishmaniasis (VL) is a vector-borne disease caused by protozoan parasites of the genus Leishmania. The disease is endemic in parts of South Asia, East Africa, South America and the Mediterranean region, with an estimated 50,000 to 90,000 cases occurring annually. A living systematic review of existing scientific literature is proposed to identify clinical drug efficacy studies against VL, conducted following the Preferred Reporting Items for Systematic-Reviews and Meta-Analyses (PRISMA) guidelines. Methods and analysis: The proposed living systematic review builds on a previous systematic review first carried out in 2016, and the current protocol is designed to capture any published or registered VL clinical study from Nov-2021 onwards. The following databases will be searched by a medical librarian: PubMed, Ovid Embase, Scopus, Web of Science Core Collection, Cochrane Central Register of Controlled Trials, clinicaltrials.gov, WHO ICTRP, as well as IMEMR, IMSEAR, and LILACS from the WHO Global Index Medicus. The systematic review will consider both randomised and non-randomised interventional studies, including single-armed studies. Ethics and dissemination: A database of eligible studies, including study characteristics, is openly available (https://www.iddo.org/tool/vl-surveyor) and will be continually updated every six months. All findings will be published in a peer reviewed journal.PROSPERO registration number: CRD42021284622

P.078 Clinical Milestones in PSP and MSA may be Appropriate Triggers for Palliative Care Intervention

Background: Progressive supranuclear palsy (PSP) and multiple system atrophy (MSA) are progressive neurodegenerative disorders with complex symptom burden and unpredictable disease trajectories. The ideal timing of palliative care interventions is uncertain given the variable natural history of both diseases. Methods: A systematic review was conducted to identify publications investigating predictors of survival in PSP and MSA. A medical librarian assisted to ensure comprehensive search strategy. Relevant literature on palliative care in PSP and MSA was also reviewed. Results from both searches were qualitatively combined in order to suggest triggers for targeted palliative care throughout the disease trajectory. Results: ‘Milestones’ are well documented and clinically relevant disease points that prompt further care. Important milestones include: frequent falls, cognitive impairment, unintelligible speech, severe dysphagia, wheelchair dependence, urinary catheterisation, and nursing home placement. PSP-Richardson syndrome accumulates milestones earlier than PSP-Parkinsonism or MSA. Many PSP patients already have falls and cognitive impairment at the time of diagnosis. Time from milestone to death is variable. Conclusions: Milestones can be used to trace disease progression and help predict survival. Clinical milestones are likely to be important triggers for targeted palliative care interventions including the early incorporation of a palliative approach to care or referral to specialised palliative care services.

Trajectory research in children on the autism spectrum: a scoping review protocol

IntroductionLongitudinal trajectory methods, featuring outcome assessments at three or more time points, are increasingly being used as appropriate approaches to understand developmental pathways of people on the autism spectrum across the lifespan. Understanding the scope of this rapidly expanding body of research can help inform future trajectory studies and identify areas for potential meta-analysis as well as key evidence gaps. We present the protocol for a scoping review whose objective is to identify and summarise the scope of research that uses a longitudinal trajectory study design to examine development in children diagnosed with autism. Specifically, we will identify outcome domains and age intervals that have been well characterised, areas where further research is needed and the historical use of various longitudinal trajectory analytical approaches.Methods and analysisWe outline the methods for the proposed scoping review according to the framework outlined by Arksey and O’Malley, with subsequent clarifications and enhancements by other authors. Using a search strategy developed by a medical librarian, we will search six databases for relevant publications. Titles and abstracts will be screened in duplicate, followed by full-text screening. Data extraction fields developed predominantly a priori from a set of guiding subquestions will be used to chart relevant data. The findings will include quantitative aggregate summaries, narrative summaries, and appraisal of trajectory studies according to our methodological subquestions. We will consult autistic self-advocate and parent–caregiver stakeholders to facilitate interpretation of the findings.Ethics and disseminationResearch ethics approval is not required for this scoping review. The results will be presented to researcher, care professional, policy-maker and stakeholder audiences at local and international conferences, other dissemination activities and published in a peer-reviewed journal.

Habit and Routine Interventions with Emerging Adults with Diabetes: An Integrative Review

Although theoretical and empirical writings on habits and routines are a promising body of science to guide interventions, little is known about such interventions among emerging adults with type 1 diabetes. Thus, an integrative review was conducted to describe interventions in relation to habits and routines, their influence on outcomes, and users’ perspectives. A medical librarian conducted a search. Teams screened titles, abstracts, and articles based upon predefined criteria. Evidence from the final 11 articles was synthesized. A minority of investigators explicitly articulated habits and routines theoretical underpinnings as part of the interventions. However, text messaging or feedback via technology used in other interventions could be implicitly linked to habits and routines. For the most part, these interventions positively influenced diabetes self-management-related behaviors and health outcomes. In general, the interventions were perceived positively by users. Future research is advocated using habit and routine theoretical underpinnings to guide interventions.

Infection-associated biofilms and statins: protocol for systematic review

IntroductionOwing to their propensity for being associated with infections, biofilms have become a focus in infectious disease research. There is evidence suggesting that statins, which are commonly used for prevention of cardiovascular disease, may prevent biofilm-associated infections, but this association has not been well-understood.Methods and analysisThis systematic review protocol will include six database searches from their inception to 20 August 2020. A medical librarian will conduct the searches in PubMed, EMBASE, Web of Science, CINAHL, LILACS and CENTRAL, without any limits. Bibliographies of selected articles, previously published reviews and high-yield journals that publish on statins and/or biofilms will be searched to identify additional articles. The screening and data extraction will be conducted by two independent reviewers using DistillerSR. All included papers will also be evaluated for quality using Cochrane Risk of Bias Assessment tool, and we will examine for publication bias. If there are two or more studies with quantitative estimates that can be combined, we will conduct a meta-analysis after assessing for heterogeneity. We will report all findings according to the Preferred Reporting Items for Systematic reviews and Analyses-P framework.Ethics and disseminationThere are conflicting results on the effect of statins on biofilm-associated infections. The rise of antibiotic resistance in medical settings warrants a deeper understanding of this association, especially if statins can be used as a novel antibiotic. The findings of this review will assess the association between statin use and biofilm-associated infection to inform future medical practice. No formal ethical review is required for this protocol. All findings will be published in a peer-reviewed journal.PROSPERO registration numberCRD42020193985.

Ethical considerations for research involving pregnant women living with HIV and their young children: a systematic review of the empiric literature and discussion

Background The proper and ethical inclusion of PWLHIV and their young children in research is paramount to ensure valid evidence is generated to optimize treatment and care. Little empirical data exists to inform ethical considerations deemed most critical to these populations. Our study aimed to systematically review the empiric literature regarding ethical considerations for research participation of PWLHIV and their young children. Methods We conducted this systematic review in partnership with a medical librarian. A search strategy was designed and performed within the following electronic databases: Ovid MEDLINE, Embase and CINAHL. We screened titles and abstracts using the following inclusion criteria: (1) a study population of PWLHIV or children under 5 years of age; and (2) collection of qualitative or quantitative data regarding ethics of research participation. Excluded were reviews, commentaries, policy statements, clinical care-related ethics concerns, abstracts, case studies, or studies unrelated to HIV research. Studies were appraised for quality, data were extracted, and studies were qualitatively analyzed using a principle-based ethical framework within the Belmont Report. Results Of the 7470 titles identified, 538 full-text articles were reviewed for eligibility and only three articles met full criteria for inclusion within this review. While we allowed for inclusion of studies involving young children born to mothers with HIV, only articles focused on PWLHIV were identified. Within the results of these studies, four themes emerged: (1) adequacy of informed consent; (2) consideration of paternal involvement; (3) balancing risks; and (4) access to research and treatment. A strength of this review is that it included perspectives of international research investigators, community leaders, and male partners. However, only two studies collected empiric data from PWLHIV regarding their experiences participating in research Conclusion Researchers and funding agencies should be aware of these considerations and appreciate the value of and critical need for formative research to ensure clinical trials involving PWLHIV promote ethical, well-informed research participation and, ultimately, improve care outcomes. More research is needed to create a comprehensive ethical framework for researchers when conducting studies with PWLHIV.

Scoping review protocol: the use of telemedicine in providing opioid agonist treatment and related psychosocial supports

IntroductionThe global opioid-related disease burden is significant. Opioid agonist treatment (OAT) can be effective in reducing illicit opioid use and fatal overdose, and improving multiple health and social outcomes. Despite evidence for its effectiveness, there are significant deficits in OAT globally. COVID-19 has required rapid adaptation of remote models of healthcare. Telemedicine is not used routinely in OAT, and little is known about the current levels of use and effectiveness. The objective of this review is to describe models of telemedicine and their efficacy.Methods and analysisThis scoping review uses the review methodology described by Arksey and O’Malley and adapted by Levac et al. The search strategy developed by the medical librarian at the Irish College of General Practitioners in conjunction with the research team will involve five databases (PubMed, EMBASE, the Cochrane Library, PsycInfo and OpenGrey) and the hand searching of reference lists. A limited initial search of two databases will be completed to refine search terms, followed by a second comprehensive search using newly refined search terms of all databases and finally hand searching references of included studies. To be included, studies must report on remote ways of providing OAT (including assessment, induction and monitoring) or related psychosocial support; be published in English after 2010. Two researchers will independently screen titles, abstracts and full-text articles considered for inclusion. Data will be extracted onto an agreed template and will undergo a descriptive analysis of the contextual or process-oriented data and simple quantitative analysis using descriptive statistics.Ethics and disseminationResearch ethics approval is not required for this scoping review. The results of this scoping review will inform the development of a national remote model of OAT. The results will be published in peer-reviewed journals and presented at relevant conferences.

Information Quality Assessment Framework for Online Dementia Care Resources

Persons with dementia and caregivers can benefit from online resources. The quality and accessibility of these resources, however, can vary. We present work on the Information Quality Framework for Online Dementia Care Resources. To develop the framework, we first empirically examine resources being retrieved with query terms developed with a medical librarian. Searching one of the possible keyword combinations related to living with dementia on Google “Alzheimer AND financial planning” returned 18,900,000 results. Among the top 13 results on the first page of the search results, six were websites of government or non-profit organizations, four were for-profit companies, and three were advertisements. Out of eight unique organizations and companies, two provided support through online communities, but only one is active. The next steps include developing systematic ways to evaluate the credibility and accuracy of these resources, and search and test broader topics of dementia care resources online.