scholarly journals The extent to which off-patent registered prescription medicines are used for off-label indications in Australia: A scoping review

PLoS ONE ◽  
2021 ◽  
Vol 16 (12) ◽  
pp. e0261022
Author(s):  
Katrina Howe ◽  
Siobhan Bourke ◽  
Lloyd Sansom

Aim The aim of this scoping review was to determine the extent of off-patent prescription medicine use beyond registered indications in various Australian clinical settings. Method The review followed the Joanna Briggs Institute approach and reported using PRISMA Extension for Scoping Reviews. Online databases were used to identify published literature about off-patent registered prescription medicines used for off-label indications in Australian public hospital, community and primary healthcare settings. In addition, empirical data from the Queensland and the South Australian state-wide medicine formularies were screened for the same medication/off-label indication dyads identified in the literature, and other locally approved uses. Results Overall, fourteen studies were included, conducted in public hospitals (n = 11), palliative care units (n = 2) and the community setting (n = 1). There were 213 reports extracted from the literature describing off-patent registered prescription medicines used for off-label indications, representing 128 unique medication/off-label indication dyads and 32 different medicines. Of these, just five medication/off-label indication dyads were approved for use on both the Queensland and South Australian state-wide medicine formularies, with 12 others only approved for use in Queensland and 16 others only approved for use in South Australia. Further examination of these state-wide formularies demonstrated that the use of off-patent registered prescription medicines beyond registered indications is more extensive than has been reported to date in the literature. There were 28 additional medication/off-label indication dyads approved on the Queensland state-wide medicine formulary and 14 such examples approved for use in South Australia. Of these, just two medication/off-label indication dyads were approved for use on both formularies. Conclusion The extent to which off-patent registered prescription medicines have been repurposed in clinical settings for off-label indications in Australia is greater than previously reported in the literature. Usage and funded availability of certain medication/off-label indication dyads, varies across Australia. These results further expose the two tiered system of medicines regulation in Australia, and its impact on equity of access to medicines. Further research is required to support policy change to encourage submission of registration updates for off-patent prescription medicines.

2021 ◽  
Author(s):  
Hwayeon Danielle Shin ◽  
Juveria Zaheer ◽  
Terri Rodak ◽  
John Torous ◽  
Gillian Strudwick

IntroductionThere is a surplus of Information and Communication Technology (ICT)-based interventions for suicide prevention. However, it is unclear which of these ICT-based interventions for suicide prevention have been implemented in clinical settings. Furthermore, evidence shows that implementation strategies have often been mismatched to existing barriers. In response, the authors recognize the critical need for prospectively assessing the barriers and facilitators and then strategically developing implementation strategies. This review is part of a multi-phase project to develop and test tailored implementation strategies for mobile app-based suicide prevention in clinical settings. The overall objective of this scoping review is to identify and characterize ICT-based interventions for all levels of suicide prevention in clinical settings. Additionally, this review will identify and characterize the barriers and facilitators to implementing these ICT-based interventions as well as reported measures and outcomes. The findings will directly inform the subsequent phase to maximize implementation and inform future efforts for implementing other types of ICT-based interventions related to suicide prevention in clinical settings.Methods and analysis This review will adhere to the methods described by the Joanna Briggs Institute for conducting scoping reviews. The reporting will follow the Preferred Reporting Items for Systematic Reviews and Meta-Analysis extension for scoping reviews checklist. The following databases will be searched: Medline, PsycInfo, Embase, CINAHL, Web of Science, and LISTA. Two reviewers will independently screen the articles and extract data using a standardised data collection tool. Then, authors will characterize extracted data using frameworks, typology, and taxonomies to address the proposed review questions. Ethics and disseminationEthics approval is not required for this scoping review. Authors will share the results in a peer-reviewed, open access publication, and conference presentations. Furthermore, the findings will be shared with relevant health organizations through lay language summaries and informal presentations.


2021 ◽  
Author(s):  
Camille Guinemer ◽  
Martin Boeker ◽  
Bjoern Weiss ◽  
Akira-Sebastian Poncette ◽  
Daniel Fuerstenau ◽  
...  

BACKGROUND The role of telemedicine in intensive care has been increasing steadily. Tele ICU interventions are varied and can be employed in different levels of treatment, often with direct implications for the intensive care processes. While a significant body of primary and secondary literature has been published on the topic, there is a need for broadening the understanding of the organizational factors influencing the effectiveness of telemedical interventions in the ICU. OBJECTIVE This scoping review aims to provide a map of existing evidence on tele ICU interventions, focusing on the analysis of the implementation context and identifying areas for further technological research. METHODS A research protocol outlining the method has been published in JMIR Research Protocols. This review follows the PRISMA extension for scoping reviews (PRISMA-ScR). A core research team was assembled to provide feedback and discuss findings. RESULTS We were able to characterize the context of tele ICU studies and identify three use cases for tele ICU interventions. The first use case is Extending Coverage, which describes interventions aimed at extending the availability of intensive care capabilities. The second use case is Improving Compliance, which includes interventions targeted at improving patient safety, intensive care best practices and quality of care. The third use case, Facilitating Transfer, describes telemedicine interventions targeted toward the management of patient transfers to or from the ICU. CONCLUSIONS The benefits of tele ICU interventions have been well documented for centralized systems aimed at extending critical care capabilities in community setting and improving care compliance in tertiary hospitals. No strong evidence has been found on the reduction of patient transfers following tele ICU intervention. INTERNATIONAL REGISTERED REPORT RR2-10.2196/19695


2020 ◽  
Author(s):  
Abdulrahman Takiddin ◽  
Jens Schneider ◽  
Yin Yang ◽  
Alaa Abd-Alrazaq ◽  
Mowafa Househ

BACKGROUND Skin cancer is the most common cancer type affecting humans. Traditional skin cancer diagnosis methods are costly, require a professional physician, and take time. Hence, to aid in diagnosing skin cancer, Artificial Intelligence (AI) tools are being used, including shallow and deep machine learning-based techniques that are trained to detect and classify skin cancer using computer algorithms and deep neural networks. OBJECTIVE The aim of this study is to identify and group the different types of AI-based technologies used to detect and classify skin cancer. The study also examines the reliability of the selected papers by studying the correlation between the dataset size and number of diagnostic classes with the performance metrics used to evaluate the models. METHODS We conducted a systematic search for articles using IEEE Xplore, ACM DL, and Ovid MEDLINE databases following the PRISMA Extension for Scoping Reviews (PRISMA-ScR) guidelines. The study included in this scoping review had to fulfill several selection criteria; to be specifically about skin cancer, detecting or classifying skin cancer, and using AI technologies. Study selection and data extraction were conducted by two reviewers independently. Extracted data were synthesized narratively, where studies were grouped based on the diagnostic AI techniques and their evaluation metrics. RESULTS We retrieved 906 papers from the 3 databases, but 53 studies were eligible for this review. While shallow techniques were used in 14 studies, deep techniques were utilized in 39 studies. The studies used accuracy (n=43/53), the area under receiver operating characteristic curve (n=5/53), sensitivity (n=3/53), and F1-score (n=2/53) to assess the proposed models. Studies that use smaller datasets and fewer diagnostic classes tend to have higher reported accuracy scores. CONCLUSIONS The adaptation of AI in the medical field facilitates the diagnosis process of skin cancer. However, the reliability of most AI tools is questionable since small datasets or low numbers of diagnostic classes are used. In addition, a direct comparison between methods is hindered by a varied use of different evaluation metrics and image types.


2021 ◽  
Vol 7 (3) ◽  
pp. e001108
Author(s):  
Omar Heyward ◽  
Stacey Emmonds ◽  
Gregory Roe ◽  
Sean Scantlebury ◽  
Keith Stokes ◽  
...  

Women’s rugby (rugby league, rugby union and rugby sevens) has recently grown in participation and professionalisation. There is under-representation of women-only cohorts within applied sport science and medicine research and within the women’s rugby evidence base. The aims of this article are: Part 1: to undertake a systematic-scoping review of the applied sport science and medicine of women’s rugby, and Part 2: to develop a consensus statement on future research priorities. This article will be designed in two parts: Part 1: a systematic-scoping review, and Part 2: a three-round Delphi consensus method. For Part 1, systematic searches of three electronic databases (PubMed (MEDLINE), Scopus, SPORTDiscus (EBSCOhost)) will be performed from the earliest record. These databases will be searched to identify any sport science and medicine themed studies within women’s rugby. The Preferred Reporting Items for Systematic Reviews and Meta-analyses extension for Scoping Reviews will be adhered to. Part 2 involves a three-round Delphi consensus method to identify future research priorities. Identified experts in women’s rugby will be provided with overall findings from Part 1 to inform decision-making. Participants will then be asked to provide a list of research priority areas. Over the three rounds, priority areas achieving consensus (≥70% agreement) will be identified. This study has received institutional ethical approval. When complete, the manuscript will be submitted for publication in a peer-reviewed journal. The findings of this article will have relevance for a wide range of stakeholders in women’s rugby, including policymakers and governing bodies.


2021 ◽  
pp. 152483802110131
Author(s):  
Ateka A. Contractor ◽  
Stephanie V. Caldas ◽  
Megan Dolan ◽  
Nicole H. Weiss

To examine the existing knowledge base on trauma experiences and positive memories, we conducted a scoping review of trauma and post-trauma factors related to positive memory count. In July 2019, we searched PubMed, Medline, PsycINFO, Web of Science, Cumulative Index of Nursing and Allied Health Literature, Embase, and PTSDpubs for a combination of words related to “positive memories/experiences,” “trauma/posttraumatic stress disorder (PTSD),” and “number/retrieval.” Twenty-one articles met inclusion criteria (adult samples, original articles in English, peer-reviewed, included trauma-exposed group or variable of trauma exposure, trauma exposure examined with a trauma measure/methodology, assessed positive memory count, empirical experimental/non-experimental study designs). Following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews guidelines, two authors reviewed abstracts, completed a secondary search, and independently extracted data. Our review indicated (1) that depression and PTSD were most researched; (2) no conclusive relationships of positive memory count with several psychopathology (depression, acute stress disorder, eating disorder, and anxiety), cognitive/affective, neurobiological, and demographic factors; (3) trends of potential relationships of positive memory count with PTSD and childhood interpersonal traumas (e.g., sexual and physical abuse); and (4) lower positive memory specificity as a potential counterpart to greater overgeneral positive memory bias. Given variations in sample characteristics and methodology as well as the limited longitudinal research, conclusions are tentative and worthy of further investigations.


2021 ◽  
Vol 10 (1) ◽  
Author(s):  
M. F. Van den Bosch ◽  
C. M. Wiepjes ◽  
M. Den Heijer ◽  
L. J. Schoonmade ◽  
R. E. G. Jonkman ◽  
...  

Abstract Background Gender-affirming hormone (GAH) therapy aims to support the transition of transgender people to their gender identity. GAHs can induce changes in their secondary sex characteristics such as the development of breasts in transgender females and increased muscle mass in transgender males. The face and its surrounding tissues also have an important role in gender confirmation. The aim of this scoping review is to systematically map the available evidence in order to provide an overview of the effects of GAH therapy on the hard and soft tissues of the craniofacial complex in transgender people. Methods/design The Preferred Reporting Items for Systematic Reviews and Meta-Analyses Protocols (PRISMA) extension for Scoping Reviews was consulted for reporting this protocol. The methods were based on the Arksey and O’Malley’s framework and the Reviewer’s Manual of the Joanna Briggs Institute for conducting scoping reviews. Ten transgender people were involved in the development of the primary research question through short interviews. The eligibility criteria were defined for transgender people undergoing GAH therapy and for quantitative and qualitative outcomes on the hard and soft tissues of the craniofacial complex. Eligible sources of evidence include observational, experimental, qualitative, and mixed method studies. No exclusion criteria will be applied for the language of publication and the setting. To identify eligible sources of evidence, we will conduct searches from inception onwards in PubMed, Embase.com, the Cochrane Library, Web of Science Core Collection, Scopus, CINAHL, LIVIVO, and various grey literature sources such as Google Scholar. Two reviewers will independently select eligible studies in these information sources and will subsequently conduct data extraction. The same operators will chart, categorize, and summarize the extracted data. A narrative summary of findings will be conducted. Frequency counts of quantitative and qualitative data on items such as concepts, populations, interventions, and other characteristics of the eligible sources will be given. Where possible, these items will be mapped descriptively. Discussion We chose the scoping review over the systematic review approach, because the research questions are broad-spectrum and the literature is expected to be widely scattered. No systematic review has previously assessed this topic. Identifying knowledge gaps in this area and summarizing and disseminating research findings are important for a wide spectrum of stakeholders, in particular, for transgender people who want to undergo additional interventions such as plastic or orthognathic surgery or orthodontics. Systematic review registration This protocol was registered in the Open Science Framework: https://osf.io/e3qj6


BMJ Open ◽  
2020 ◽  
Vol 10 (12) ◽  
pp. e040922
Author(s):  
Bethany Villas ◽  
Uira Duarte Wisnesky ◽  
Sandra Campbell ◽  
Lauren Slavik ◽  
Amynah S. Mevawala ◽  
...  

Review question/objectiveThe purpose of this proposed review is twofold: first, to understand the role of occupational therapy presented in the musicians’ health literature; and second, to explore the potential for this role.IntroductionThe intense movement, awkward postures, concentration and emotional communication required of musicians can place them at increased risk of music-related health conditions, such as musculoskeletal disorders and performance anxiety. The development of music-related health conditions can be emotionally and financially devastating. The role of occupational therapy in musicians’ health has been previously discussed; however, no rigorous reviews of the scholarly literature have been published. We will, therefore, undertake a scoping review with the following research questions: (1) what is known about the role of occupational therapy in instrumental musicians’ health? and (2) what is the potential role of occupational therapy in musicians’ health?Methods and analysisA preliminary search of Medline, CINAHL, SCOPUS and Web of Science was previously undertaken by the first author to determine the extent of the research on this topic and to confirm that no other reviews have been conducted or are in progress. Study selection and analysis will follow the Joanna Briggs Institute and the Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for scoping reviews guidelines for conducting a scoping review.Ethics and disseminationFormal ethics approval is not required at our institution for a review of published literature. The results of this review will be shared through peer-reviewed publications, conference presentations and traditional and social media.


Children ◽  
2021 ◽  
Vol 8 (7) ◽  
pp. 558
Author(s):  
Beth Skelton ◽  
Kathleen Knafl ◽  
Marcia Van Riper ◽  
Louise Fleming ◽  
Veronica Swallow

Care coordination is a critical component of health management aimed at linking care providers and health-information-involved care management. Our intent in this scoping review was to identify care coordination needs of families of children with Down syndrome (DS) and the strategies they used to meet those needs, with the goal of contributing to the evidence base for developing interventions by using an mHealth application (mHealth apps) for these families. Using established guidelines for scoping reviews, we searched five databases, yielding 2149 articles. Following abstract and full-text review, we identified 38 articles meeting our inclusion criteria. Studies incorporated varied in regard to research designs, samples, measures, and analytic approaches, with only one testing an intervention by using mHealth apps. Across studies, data came from 4882 families. Common aspects of families’ care coordination needs included communication and information needs and utilization of healthcare resources. Additional themes were identified related to individual, family, and healthcare contextual factors. Authors also reported families’ recommendations for desirable characteristics of an mHealth apps that addressed the design of a personal health record, meeting age-specific information needs, and ensuring access to up-to-date information. These results will further the development of mHealth apps that are tailored to the needs of families with a child with DS.


2021 ◽  
pp. 105413732199581
Author(s):  
Patricia Moyle Wright

A scoping review of parental bereavement in older age was conducted to identify the unique needs of older adults after the loss of an adult child. Inclusion and exclusion criteria were developed in accordance with the stated objectives of this review, which was guided by the Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews (PRISMA-ScR). In total, 26 research studies were included. The data were then analyzed using a systematic approach for organizing and synthesizing key data. The results indicated that some consequences and mediators of parental bereavement are similar regardless of age. But, older adults experience greater loneliness, isolation, and stigma than their younger counterparts. Older parents are also at greater risk for physical decline, mortality, and institutionalization following the death of an adult child. Religious and cultural mores also have influence on the bereavement process.


Author(s):  
Miriam Blume ◽  
Petra Rattay ◽  
Stephanie Hoffmann ◽  
Jacob Spallek ◽  
Lydia Sander ◽  
...  

This scoping review systematically mapped evidence of the mediating and moderating effects of family characteristics on health inequalities in school-aged children and adolescents (6–18 years) in countries with developed economies in Europe and North America. We conducted a systematic scoping review following the PRISMA extension for Scoping Reviews recommendations. We searched the PubMed, PsycINFO and Scopus databases. Two reviewers independently screened titles, abstracts and full texts. Evidence was synthesized narratively. Of the 12,403 records initially identified, 50 articles were included in the synthesis. The included studies were conducted in the United States (n = 27), Europe (n = 18), Canada (n = 3), or in multiple countries combined (n = 2). We found that mental health was the most frequently assessed health outcome. The included studies reported that different family characteristics mediated or moderated health inequalities. Parental mental health, parenting practices, and parent-child-relationships were most frequently examined, and were found to be important mediating or moderating factors. In addition, family conflict and distress were relevant family characteristics. Future research should integrate additional health outcomes besides mental health, and attempt to integrate the complexity of families. The family characteristics identified in this review represent potential starting points for reducing health inequalities in childhood and adolescence.


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