IntroductionThe European Union (EU) Medical Device Regulation (MDR) 2017/745 challenges the medical community to engage with regulators, notified bodies and industry to develop transparent, rigorous, ...and proportionate methods to evaluate the clinical safety and efficacy of medical devices and to monitor their performance. As part of the EU Horizon 2020 funded CORE-MD project, we performed a systematic review of the published scientific evidence available for surgical heart valve replacements for native aortic and mitral valve pathologies.PurposeThe aim of this analysis is to review the scientific evidence available which supports the use of currently available surgical aortic and mitral valves.MethodsA systematic literature review was conducted using Ovid, MEDLINE, Embase, and the Cochrane Central Register of Controlled Trials (CENTRAL). We included only surgical aortic and mitral valves that received CE Mark approval from the year 2000 onwards. The date of CE-Mark approval was defined based on press releases, information provided by regulatory sources, and communications with the corresponding manufacturers. We included any study of prospective design (randomised or non-randomised clinical trials of any design) in humans, published between January 2000 and August 2021. We excluded retrospective studies, case reports, reviews, systematic reviews, meta-analyses, and expert opinion documents. Title and abstract screening, full-text review, risk of bias evaluation and data collection were performed by two authors independently, with disagreements resolved by discussion with a third author.ResultsA total of 17 surgical aortic valves and 4 surgical mitral valves were identified based on the CE mark criterion (figure 1). The initial literature search identified 4901 and 3696 potentially eligible papers in the aortic and mitral valve categories, respectively. Following title and abstract screening, 269 aortic and 59 mitral valve manuscripts underwent full text review. Finally, 39 aortic valve studies (37 unique studies) and 1 mitral valve study were included after full text review (figure 2). The majority of included studies (90%) had a non-randomised, prospective, observational design with 68% receiving industry funding. The studies predominantly originated from Europe and the USA (78%). The median number of patients included was 295 interquartile range (IQR): 153, 689 with a median maximum follow-up of 24 months IQR: 12, 60. Only 50% of the identified studies had a pre-specified registered study protocol and only 5% included a power calculation to estimate the required study size. No study reported patient involvement in the study design and only 15% of studies had a comparator group. Using the ROBINS I AND II assessment tools, 90% of the included studies were classified as having a high or serious risk of bias.Abstract 27 Figure 1Summary of key resultsFigure omitted. See PDFAbstract 27 Figure 2Literature search resultsFigure omitted. See PDFConclusionThe evidence available for currently used surgical aortic and mitral replacement heart valves is largely from small, industry funded, non-randomised controlled trials. The median duration of maximum follow up was only 24 months, the majority of studies were classed as having a high/serious risk of bias and only half had a pre-registered study protocol. These results highlight the limitations of the available scientific evidence supporting the surgical aortic and mitral valves used in current clinical practice.
ABSTRACT Understanding the clinical spectrum of SARS‐CoV‐2 infection, including the asymptomatic fraction, is important as asymptomatic individuals are still able to infect other individuals and ...contribute to ongoing transmission. The WHO Unity Household transmission investigation (HHTI) protocol provides a platform for the prospective and systematic collection of high‐quality clinical, epidemiological, serological and virological data from SARS‐CoV‐2 confirmed cases and their household contacts. These data can be used to understand key severity and transmissibility parameters—including the asymptomatic proportion—in relation to local epidemic context and help inform public health response. We aimed to estimate the asymptomatic proportion of SARS‐CoV‐2 Omicron variant infections in Unity‐aligned HHTIs. We conducted a systematic review and meta‐analysis in alignment with the PRISMA 2020 guidelines and registered our systematic review on PROSPERO (CRD42022378648). We searched EMBASE, Web of Science, MEDLINE and bioRxiv and medRxiv from 1 November 2021 to 22 August 2023. We identified 8368 records, of which 98 underwent full text review. We identified only three studies for data extraction, with substantial variation in study design and corresponding estimates of the asymptomatic proportion. As a result, we did not generate a pooled estimate or I 2 metric. The limited number of quality studies that we identified highlights the need for improved preparedness and response capabilities to facilitate robust HHTI implementation, analysis and reporting, to better inform national, regional and global risk assessments and policymaking.
The National Disability Insurance Scheme (NDIS) ushered in a transformative era in disability services in Australia, requiring new workforce models to meet evolving participant needs. Therapy ...Assistants are utilised to increase the capacity of therapy services in areas of workforce shortage. The governance arrangements required to support this emergent workforce have received limited attention in the literature. This review examined the key components and contextual factors of governance in rural settings, specifically focusing on therapy support workers under the guidance of allied health professionals in rural and remote areas. Guided by the social model of disability and the International Classification of Functioning, Disability and Health, a realist perspective was used to analyse 26 papers (after deduplication), mostly Australian and qualitative, with an emphasis on staff capabilities, training, and credentialling. Success measures were often vaguely defined, with most papers focusing on staff improvement and few focusing on client or organisational improvement. Consistent staffing, role clarity, community collaboration, and supportive leadership were identified as enabling contexts for successful governance of disability therapy support workers in rural areas. Investment in capability (soft skills) development, tailored training, competency assessment, credentialling, and supervision were identified as key activities that, when coupled with the identified enabling contexts, were likely to influence staff, client and organisational outcomes. Further research is warranted to explore long-term impacts of governance arrangements, educational program accountability, and activities targeted at enhancing staff capabilities.
IntroductionThis review determined the effectiveness of female anorgasmia treatments in premenopausal women using a systematic search strategy. This review considers all physiological, ...pharmaceutical, psychological and social treatments. Thomas and Thurston (Maturitas 2016; 87 49-60) recommend a biopsychosocial approach, where subjective distress and physical factors can coexist (Brotto et al. JSM 2010; 586-614). Yet, methodological issues are rife e.g., obtaining representative samples and limited assessment methods. Further, reviews are narrative with limited synthesis (Marchand SMR 2021; 9(2) 194-211). Frühauf et al. (Archives of Sexual Behavior 2013; 42(6) 915-933) completed a review, but there is no account for research published after 2007 and limited follow-up assessments.ObjectivesThis is the first systematic review of premenopausal anorgasmia with assessment of bias for all treatments. This review is restricted to anorgasmia to better isolate interventions and exclude comorbid conditions.Methods10 different databases were searched (2007-2021) including studies from peer-reviewed journal articles and grey literature. Results were synthesised in forest plots according to timepoints of data, alongside different treatments to determine effect size from standardised mean differences (SMD). Outcome measures included the self-reported sexual function, sexual distress and clinician observation. The SMD was used as not all scales are consistent across studies. All results given are in line with a pre-defined analysis plan.ResultsOf 1388 studies screened, 15 studies (2002-2020) were analysed: study designs were mixed with mostly self-report measures. Effective treatments included Tribulus terrestris (M=3.77, p<0.01), plasma injection (M=4.48, p<0.01), and CO2 laser therapy (M=4.06, p<0.05). For psychological studies, assessment of active sexual engagement described how subjects felt more aware of their sexuality which improved outcomes. Limitations of most studies included a very high risk of bias, notably in randomisation of subjects, allocation and outcomes. All interventions had a significant effect in independent t-tests, yet synthesis of SMDs show insignificant effect, implying data is inconclusive.ConclusionsThis review aimed to systematically appraise all treatments for orgasmic satisfaction for premenopausal women. Higher levels of significance were observed for treatments across all modalities. The efficacy of natural supplements has been disputed (IsHak et al. JSM 2010; 7(10) 3254-3268), but this review shows promise. All psychological results provided insight into the role of the therapist-client relationship and reappraisal of traumatic sexual experience. Yet, risk of bias is likely impacted by difficulty establishing standardised scientific protocol. Considerations for future research include clear statements of randomisation and multi-faceted outcome measures.Disclosure of InterestNone Declared
The methods and results of systematic reviews should be reported in sufficient detail to allow users to assess the trustworthiness and applicability of the review findings. The Preferred Reporting ...Items for Systematic reviews and Meta-Analyses (PRISMA) statement was developed to facilitate transparent and complete reporting of systematic reviews and has been updated (to PRISMA 2020) to reflect recent advances in systematic review methodology and terminology. Here, we present the explanation and elaboration paper for PRISMA 2020, where we explain why reporting of each item is recommended, present bullet points that detail the reporting recommendations, and present examples from published reviews. We hope that changes to the content and structure of PRISMA 2020 will facilitate uptake of the guideline and lead to more transparent, complete, and accurate reporting of systematic reviews.
Systematic reviews (SRs) are time and resource intensive, requiring approximately 1 year from protocol registration to submission for publication. Our aim was to describe the process, facilitators, ...and barriers to completing the first 2-week full SR.
We systematically reviewed evidence of the impact of increased fluid intake, on urinary tract infection (UTI) recurrence, in individuals at risk for UTIs. The review was conducted by experienced systematic reviewers with complementary skills (two researcher clinicians, an information specialist, and an epidemiologist), using Systematic Review Automation tools, and blocked off time for the duration of the project. The outcomes were time to complete the SR, time to complete individual SR tasks, facilitators and barriers to progress, and peer reviewer feedback on the SR manuscript. Times to completion were analyzed quantitatively (minutes and calendar days); facilitators and barriers were mapped onto the Theoretical Domains Framework; and peer reviewer feedback was analyzed quantitatively and narratively.
The SR was completed in 61 person-hours (9 workdays; 12 calendar days); accepted version of the manuscript required 71 person-hours. Individual SR tasks ranged from 16 person-minutes (deduplication of search results) to 461 person-minutes (data extraction). The least time-consuming SR tasks were obtaining full-texts, searches, citation analysis, data synthesis, and deduplication. The most time-consuming tasks were data extraction, write-up, abstract screening, full-text screening, and risk of bias. Facilitators and barriers mapped onto the following domains: knowledge; skills; memory, attention, and decision process; environmental context and resources; and technology and infrastructure. Two sets of peer reviewer feedback were received on the manuscript: the first included 34 comments requesting changes, 17 changes were made, requiring 173 person-minutes; the second requested 13 changes, and eight were made, requiring 121 person-minutes.
A small and experienced systematic reviewer team using Systematic Review Automation tools who have protected time to focus solely on the SR can complete a moderately sized SR in 2 weeks.
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