Search

Background: Virtual data collection methods and consent procedures adopted in response to the COVID-19 pandemic enabled continued research activities, but also introduced concerns about equity, inclusivity, representation, and privacy. Recent studies have explored these issues from institutional and researcher perspectives, but there is a need to explore patient perspectives and preferences. This study aims to explore COVID-19 patients' perspectives about research recruitment and consent for research studies about COVID-19. Methods: We conducted an exploratory qualitative focus group and interview study among British Columbian adults who self-identified as having had COVID-19. We recruited participants through personal contacts, social media, and REACH BC, an online platform that connects researchers and patients in British Columbia. We analyzed transcripts inductively and developed thematic summaries of each coding element. Results: Of the 22 individuals recruited, 16 attended a focus group or interview. We found that autonomy and the feasibility of participation, attitudes toward research about COVID-19, and privacy concerns are key factors that influence participants' willingness to participate in research. We also found that participants preferred remote and virtual approaches for contact, consent, and delivery of research on COVID-19. Conclusions: Individuals who had COVID-19 are motivated to participate in research studies and value autonomy in their decision to participate, but researchers must be sensitive and considerate toward patient preferences and concerns, particularly as researchers adopt virtual recruitment and data collection methods. Such awareness may increase research participation and engagement. Plain English Summary: Due to the COVID-19 pandemic, many research groups started conducting research activities virtually. In this study, we invited individuals who had COVID-19 to share their views about how researchers recruit patients and get their consent to participate in studies about COVID-19. Through interviews and focus groups, we found that British Columbians who had COVID-19 are motivated to participate in COVID-related studies, as long as researchers maintain usual precautions around data privacy and accommodate preferences for participation. Future studies may use these patient perspectives to make informed decisions that will increase and support patient recruitment, consent and retention in research studies. [ABSTRACT FROM AUTHOR]

Background: Item 13 of the CONSORT guidelines recommends documentation of the participant flow in randomised clinical trials (RCTs) using a diagram. In the medical literature, the reporting of the flow of participants in RCTs has been assessed to be inadequate. The quality of reporting flow diagrams in periodontology and implantology remains unknown. The aim of this study was to assess the reporting of flow diagrams in RCTs published in periodontology and implantology journals. Materials and Methods: RCTs published between 15th January 2018 and 15th January 2022 in twelve high-ranked periodontology and implantology journals were identified. Trial characteristics at the RCT level were extracted. The flow diagram included in each RCT was assessed for completeness of reporting in relation to published criteria and the CONSORT flow diagram template. Results: From the 544 eligible articles, 85% were single-centre, 82% of parallel-group design and 79% investigated surgical interventions. Three-hundred and fifteen (58%) articles were published in CONSORT endorsing journals. A flow diagram was reported in 317 (58%) trials and reporting was more common in periodontology (73.1%). Overall, 56% of publications with a flow diagram reported a complete CONSORT flow diagram, while in 44% of flow diagrams, at least one point from the CONSORT reporting template was missing. Reasons for loss to follow-up (69.7%) and exclusions from the RCT analysis (86.4%) were poorly reported. Conclusion: The reporting of flow diagrams in periodontology and implantology RCTs was sub-optimal. Greater awareness of the importance of fully completing the participant CONSORT flow diagram is required. [ABSTRACT FROM AUTHOR]

Background: The study aimed to explore reporting characteristics of scoping reviews in dental public health and the impact of some factors on the reporting quality. Methods: This study searched for dental public health scoping reviews in PubMed and Scopus without year restrictions and restricted to English-language publications. Study selection was undertaken by two reviewers independently. One reviewer, after training, extracted data from included studies considering general study characteristics and reporting characteristics. The impact of PRISMA-ScR publication, journal endorsement, and use of study protocol on the reporting was explored. Results: Eighty-one scoping reviews were included. Five items presented rates of appropriate reporting higher than 80% considering the overall percentage. Related to the impact of PRISMA-ScR publication, six items were found more often in scoping reviews published after the publication of PRISMA-ScR than in scoping reviews published before the publication of PRISMA-ScR. With regards to journals endorsement, only two reporting characteristics were found more often in scoping reviews published in journals that endorse the PRISMA-ScR statement than in scoping reviews published in non-endorsers journals. Last, regarding the use of the pre-specified protocol, five reporting characteristics presented differences in studies reporting the use of pre-specified protocol than in studies that did not mention the use of a protocol. All differences were statistically significant. Conclusions: Important information is missing in the included scoping reviews demonstrating crucial reporting problems. [ABSTRACT FROM AUTHOR]

Background: Epidemiological studies of incidence play an essential role in quantifying disease burden, resource planning, and informing public health policies. A variety of measures for estimating cancer incidence have been used. Appropriate reporting of incidence calculations is essential to enable clear interpretation. This review uses colorectal cancer (CRC) as an exemplar to summarize and describe variation in commonly employed incidence measures and evaluate the quality of reporting incidence methods.Methods: We searched four databases for CRC incidence studies published between January 2010 and May 2020. Two independent reviewers screened all titles and abstracts. Eligible studies were population-based cancer registry studies evaluating CRC incidence. We extracted data on study characteristics and author-defined criteria for assessing the quality of reporting incidence. We used descriptive statistics to summarize the information.Results: This review retrieved 165 relevant articles. The age-standardized incidence rate (ASR) (80%) was the most commonly reported incidence measure, and the 2000 U.S. standard population the most commonly used reference population (39%). Slightly more than half (54%) of the studies reported CRC incidence stratified by anatomical site. The quality of reporting incidence methods was suboptimal. Of all included studies: 45 (27%) failed to report the classification system used to define CRC; 63 (38%) did not report CRC codes; and only 20 (12%) documented excluding certain CRC cases from the numerator. Concerning the denominator estimation: 61% of studies failed to state the source of population data; 24 (15%) indicated census years; 10 (6%) reported the method used to estimate yearly population counts; and only 5 (3%) explicitly explained the population size estimation procedure to calculate the overall average incidence rate. Thirty-three (20%) studies reported the confidence interval for incidence, and only 7 (4%) documented methods for dealing with missing data.Conclusion: This review identified variations in incidence calculation and inadequate reporting of methods. We outlined recommendations to optimize incidence estimation and reporting practices. There is a need to establish clear guidelines for incidence reporting to facilitate assessment of the validity and interpretation of reported incidence. [ABSTRACT FROM AUTHOR]

Purpose: Social media has led to fundamental changes in the way that people look for and share health related information. There is increasing interest in using this spontaneously generated patient experience data as a data source for health research. The aim was to summarise the state of the art regarding how and why SGOPE data has been used in health research. We determined the sites and platforms used as data sources, the purposes of the studies, the tools and methods being used, and any identified research gaps.Methods: A scoping umbrella review was conducted looking at review papers from 2015 to Jan 2021 that studied the use of SGOPE data for health research. Using keyword searches we identified 1759 papers from which we included 58 relevant studies in our review.Results: Data was used from many individual general or health specific platforms, although Twitter was the most widely used data source. The most frequent purposes were surveillance based, tracking infectious disease, adverse event identification and mental health triaging. Despite the developments in machine learning the reviews included lots of small qualitative studies. Most NLP used supervised methods for sentiment analysis and classification. Very early days, methods need development. Methods not being explained. Disciplinary differences - accuracy tweaks vs application. There is little evidence of any work that either compares the results in both methods on the same data set or brings the ideas together.Conclusion: Tools, methods, and techniques are still at an early stage of development, but strong consensus exists that this data source will become very important to patient centred health research. [ABSTRACT FROM AUTHOR]

Background: Missing data are common in longitudinal studies, and more so, in studies of older adults, who are susceptible to health and functional decline that limit completion of assessments. We assessed the extent, current reporting, and handling of missing data in longitudinal studies of older adults.Methods: Medline and Embase databases were searched from 2015 to 2019 for publications on longitudinal observational studies conducted among persons ≥55 years old. The search was restricted to 10 general geriatric journals published in English. Reporting and handling of missing data were assessed using questions developed from the recommended standards. Data were summarised descriptively as frequencies and proportions.Results: A total of 165 studies were included in the review from 7032 identified records. In approximately half of the studies 97 (62.5%), there was either no comment on missing data or unclear descriptions. The percentage of missing data varied from 0.1 to 55%, with a 14% average among the studies that reported having missing data. Complete case analysis was the most common method for handling missing data with nearly 75% of the studies (n = 52) excluding individual observations due to missing data, at the initial phase of study inclusion or at the analysis stage. Of the 10 studies where multiple imputation was used, only 1 (10.0%) study followed the guideline for reporting the procedure fully using online supplementary documents.Conclusion: The current reporting and handling of missing data in longitudinal observational studies of older adults are inadequate. Journal endorsement and implementation of guidelines may potentially improve the quality of missing data reporting. Further, authors should be encouraged to use online supplementary files to provide additional details on how missing data were addressed, to allow for more transparency and comprehensive appraisal of studies. [ABSTRACT FROM AUTHOR]

Background: Systematic reviews of in-vitro studies, like any other study, can be of heterogeneous quality. The present study aimed to evaluate the methodological quality of systematic reviews of in-vitro dental studies.Methods: We searched for systematic reviews of in-vitro dental studies in PubMed, Web of Science, and Scopus databases published up to January 2022. We assessed the methodological quality of the systematic reviews using a modified "A MeaSurement Tool to Assess systematic Reviews" (AMSTAR-2) instrument. The 16 items, in the form of questions, were answered with yes, no, or py (partial yes). Univariable and multivariable linear regression models were used to examine the association between systematic review characteristics and AMSTAR-2 percent score. Overall confidence in the results of the systematic reviews was rated, based on weaknesses identified in critical and non-critical AMSTAR-2 items.Results: The search retrieved 908 potential documents, and after following the eligibility criteria, 185 systematic reviews were included. The most researched topics were ceramics and dental bonding. The overall rating for the confidence in the results was critically low in 126 (68%) systematic reviews. There was high variability in the response among the AMSTAR-2 items (0% to 75% positively answered). The univariable analyses indicated dental specialty (p = 0.03), number of authors (coef: 1.87, 95% CI: 0.26, 3.47, p = 0.02), and year of publication (coef: 2.64, 95% CI: 1.90, 3.38, p < 0.01) were significantly associated with the AMSTAR-2 percent score. Whereas, in the multivariable analysis only specialty (p = 0.01) and year of publication (coef: 2.60, 95% CI: 1.84, 3.35, p < 0.001) remained significant. Among specialties, endodontics achieved the highest AMSTAR-2 percent score.Conclusions: The methods of systematic reviews of in vitro dental studies were suboptimal. Year of publication and dental specialty were associated with AMSTAR-2 scores. The overall rating of the confidence in the results was low and critically low for most systematic reviews. [ABSTRACT FROM AUTHOR]

Background: Deprescribing literature has been increasing rapidly. Our aim was to develop and validate search filters to identify articles on deprescribing in Medline via PubMed and in Embase via Embase.com .Methods: Articles published from 2011 to 2020 in a core set of eight journals (covering fields of interest for deprescribing, such as geriatrics, pharmacology and primary care) formed a reference set. Each article was screened independently in duplicate and classified as relevant or non-relevant to deprescribing. Relevant terms were identified by term frequency analysis in a 70% subset of the reference set. Selected title and abstract terms, MeSH terms and Emtree terms were combined to develop two highly sensitive filters for Medline via Pubmed and Embase via Embase.com . The filters were validated against the remaining 30% of the reference set. Sensitivity, specificity and precision were calculated with their 95% confidence intervals (95% CI).Results: A total of 23,741 articles were aggregated in the reference set, and 224 were classified as relevant to deprescribing. A total of 34 terms and 4 MeSH terms were identified to develop the Medline search filter. A total of 27 terms and 6 Emtree terms were identified to develop the Embase search filter. The sensitivity was 92% (95% CI: 83-97%) in Medline via Pubmed and 91% (95% CI: 82-96%) in Embase via Embase.com .Conclusions: These are the first deprescribing search filters that have been developed objectively and validated. These filters can be used in search strategies for future deprescribing reviews. Further prospective studies are needed to assess their effectiveness and efficiency when used in systematic reviews. [ABSTRACT FROM AUTHOR]

Objective: For assessing cost-effectiveness, Health Technology Assessment (HTA) organisations may use primary economic evaluations (P-HEs) or Systematic Reviews of Health Economic evaluations (SR-HEs). A prerequisite for meaningful results of SR-HEs is that the results from existing P-HEs are transferable to the decision context (e.g, HTA jurisdiction). A particularly pertinent issue is the high variability of costs and resource needs across jurisdictions. Our objective was to review the methods documents of HTA organisations and compare their recommendations on considering transferability in SR-HE.Methods: We systematically hand searched the webpages of 158 HTA organisations for relevant methods documents from 8th January to 31st March 2019. Two independent reviewers performed searches and selected documents according to pre-defined criteria. One reviewer extracted data in standardised and piloted tables and a second reviewer checked them for accuracy. We synthesised data using tabulations and in a narrative way.Results: We identified 155 potentially relevant documents from 63 HTA organisations. Of these, 7 were included in the synthesis. The included organisations have different aims when preparing a SR-HE (e.g. to determine the need for conducting their own P-HE). The recommendations vary regarding the underlying terminology (e.g. transferability/generalisability), the assessment approaches (e.g. structure), the assessment criteria and the integration in the review process.Conclusion: Only few HTA organisations address the assessment of transferability in their methodological recommendations for SR-HEs. Transferability considerations are related to different purposes. The assessment concepts and criteria are heterogeneous. Developing standards to consider transferability in SR-HEs is desirable. [ABSTRACT FROM AUTHOR]

Background: Retaining participants over time is a frequent challenge in research studies evaluating long-term health outcomes. This study's objective was to compare the impact of prepaid and postpaid incentives on response to a six-month follow-up survey.Methods: We conducted an experiment to compare response between participants randomized to receive either prepaid or postpaid cash card incentives within a multisite study of children under 15 years in age who were hospitalized for a serious, severe, or critical injury. Participants were parents or guardians of enrolled children. The primary outcome was survey response. We also examined whether demographic characteristics were associated with response and if incentive timing influenced the relationship between demographic characteristics and response. We evaluated whether incentive timing was associated with the number of calls needed for contact.Results: The study enrolled 427 children, and parents of 420 children were included in this analysis. Follow-up survey response did not differ according to the assigned treatment arm, with the percentage of parents responding to the survey being 68.1% for the prepaid incentive and 66.7% with the postpaid incentive. Likelihood of response varied by demographics. Spanish-speaking parents and parents with lower income and lower educational attainment were less likely to respond. Parents of Hispanic/Latino children and children with Medicaid insurance were also less likely to respond. We found no relationship between the assigned incentive treatment and the demographics of respondents compared to non-respondents.Conclusions: Prepaid and postpaid incentives can obtain similar participation in longitudinal pediatric critical care outcomes research. Incentives alone do not ensure retention of all demographic subgroups. Strategies for improving representation of hard-to-reach populations are needed to address health disparities and ensure the generalizability of studies using these results. [ABSTRACT FROM AUTHOR]

Background: The use of individual patient data (IPD) in network meta-analyses (NMA) is rapidly growing. This study aimed to determine, through simulations, the impact of select factors on the validity and precision of NMA estimates when combining IPD and aggregate data (AgD) relative to using AgD only.Methods: Three analysis strategies were compared via simulations: 1) AgD NMA without adjustments (AgD-NMA); 2) AgD NMA with meta-regression (AgD-NMA-MR); and 3) IPD-AgD NMA with meta-regression (IPD-NMA). We compared 108 parameter permutations: number of network nodes (3, 5 or 10); proportion of treatment comparisons informed by IPD (low, medium or high); equal size trials (2-armed with 200 patients per arm) or larger IPD trials (500 patients per arm); sparse or well-populated networks; and type of effect-modification (none, constant across treatment comparisons, or exchangeable). Data were generated over 200 simulations for each combination of parameters, each using linear regression with Normal distributions. To assess model performance and estimate validity, the mean squared error (MSE) and bias of treatment-effect and covariate estimates were collected. Standard errors (SE) and percentiles were used to compare estimate precision.Results: Overall, IPD-NMA performed best in terms of validity and precision. The median MSE was lower in the IPD-NMA in 88 of 108 scenarios (similar results otherwise). On average, the IPD-NMA median MSE was 0.54 times the median using AgD-NMA-MR. Similarly, the SEs of the IPD-NMA treatment-effect estimates were 1/5 the size of AgD-NMA-MR SEs. The magnitude of superior validity and precision of using IPD-NMA varied across scenarios and was associated with the amount of IPD. Using IPD in small or sparse networks consistently led to improved validity and precision; however, in large/dense networks IPD tended to have negligible impact if too few IPD were included. Similar results also apply to the meta-regression coefficient estimates.Conclusions: Our simulation study suggests that the use of IPD in NMA will considerably improve the validity and precision of estimates of treatment effect and regression coefficients in the most NMA IPD data-scenarios. However, IPD may not add meaningful validity and precision to NMAs of large and dense treatment networks when negligible IPD are used. [ABSTRACT FROM AUTHOR]

Background: The 2018 World Health Organization HIV guidelines were based on the results of a network meta-analysis (NMA) of published trials. This study employed individual patient-level data (IPD) and aggregate data (AgD) and meta-regression methods to assess the evidence supporting the WHO recommendations and whether they needed any refinements.Methods: Access to IPD from three trials was granted through ClinicalStudyDataRequest.com (CSDR). Seven modelling approaches were applied and compared: 1) Unadjusted AgD network meta-analysis (NMA) - the original analysis; 2) AgD-NMA with meta-regression; 3) Two-stage IPD-AgD NMA; 4) Unadjusted one-stage IPD-AgD NMA; 5) One-stage IPD-AgD NMA with meta-regression (one-stage approach); 6) Two-stage IPD-AgD NMA with empirical-priors (empirical-priors approach); 7) Hierarchical meta-regression IPD-AgD NMA (HMR approach). The first two were the models used previously. Models were compared with respect to effect estimates, changes in the effect estimates, coefficient estimates, DIC and model fit, rankings and between-study heterogeneity.Results: IPD were available for 2160 patients, representing 6.5% of the evidence base and 3 of 24 edges. The aspect of the model affected by the choice of modeling appeared to differ across outcomes. HMR consistently generated larger intervals, often with credible intervals (CrI) containing the null value. Discontinuations due to adverse events and viral suppression at 96 weeks were the only two outcomes for which the unadjusted AgD NMA would not be selected. For the first, the selected model shifted the principal comparison of interest from an odds ratio of 0.28 (95% CrI: 10.17, 0.44) to 0.37 (95% CrI: 0.23, 0.58). Throughout all outcomes, the regression estimates differed substantially between AgD and IPD methods, with the latter being more often larger in magnitude and statistically significant.Conclusions: Overall, the use of IPD often impacted the coefficient estimates, but not sufficiently as to necessitate altering the final recommendations of the 2018 WHO Guidelines. Future work should examine the features of a network where adjustments will have an impact, such as how much IPD is required in a given size of network. [ABSTRACT FROM AUTHOR]

Background: As realist methodology is still evolving, there is a paucity of guidance on how to conduct theory driven interviews. Realist researchers can therefore struggle to collect interview data that can make a meaningful contribution to refining their initial programme theory. Collecting data to inform realist Inital Programme Theories (IPTs) in healthcare contexts is further compounded due to the healthcare workers' busy work schedules. In this case study of team interventions in acute hospital contexts, we explore the benefits of using the Critical Incident Technique (CIT) in order to build and refine an initial programme theory. We contend that use of the CIT helps to draw on more specific experiences of "Key Informants" and therefore elicits richer and more relevant data for realist enquiry.Methods: The five steps of the CIT were mapped against realist methods guidance and adapted into an interview framework. Specifications to identify an incident as "critical" were agreed. Probes were embedded in the interview framework to confirm, refine and/or refute previous theories. Seventeen participants were interviewed and recordings were transcribed and imported for analysis into NVivo software. Using RAMESES guidelines, Context-Mechanism-Outcomes configurations were extrapolated from a total of 31 incidents.Results: We found that the CIT facilitated construction of an interview format that allowed participants to reflect on specific experiences of interest. We demonstrate how the CIT strengthened initial programme theory development as it facilitated the reporting of the specifics of team interventions and the contexts and mechanisms characteristic of those experiences. As new data emerged, it was possible to evolve previous theories synthesised from the literature as well as to explore new theories.Conclusions: Utilising a CIT framework paid dividends in terms of the relevance and usefulness of the data for refining the initial programme theory. Adapting the CIT questioning technique helped to focus the participants on the specifics relating to an incident allowing the interviewers to concentrate on probes to explore theories during the interview process. The CIT interview format therefore achieved its purpose and can be adapted for use within realist methodology. [ABSTRACT FROM AUTHOR]

Background: While randomised controlled trials (RCTs) provide high-quality evidence to guide practice, much routine care is not based upon available RCTs. This disconnect between evidence and practice is not sufficiently well understood. This case study explores this relationship using a novel approach. Better understanding may improve trial design, conduct, reporting and implementation, helping patients benefit from the best available evidence.Methods: We employed a case-study approach, comprising mixed methods to examine the case of interest: the primary outcome paper of a surgical RCT (the TIME trial). Letters and editorials citing the TIME trial's primary report underwent qualitative thematic analysis, and the RCT was critically appraised using validated tools. These analyses were compared to provide insight into how the TIME trial findings were interpreted and appraised by the clinical community.Results: 23 letters and editorials were studied. Most authorship included at least one academic (20/23) and one surgeon (21/23). Authors identified wide-ranging issues including confounding variables or outcome selection. Clear descriptions of bias or generalisability were lacking. Structured appraisal identified risks of bias. Non-RCT evidence was less critically appraised. Authors reached varying conclusions about the trial without consistent justification. Authors discussed aspects of internal and external validity covered by appraisal tools but did not use these methodological terms in their articles.Conclusions: This novel method for examining interpretation of an RCT in the clinical community showed that published responses identified limited issues with trial design. Responses did not provide coherent rationales for accepting (or not) trial results. Findings may suggest that authors lacked skills in appraisal of RCT design and conduct. Multiple case studies with cross-case analysis of other trials are needed. [ABSTRACT FROM AUTHOR]

Background: Multicenter studies from Europe and the United States have developed specifically standardized questionnaires for assessing and comparing sedentary behavior, but they cannot be directly applied for South American countries. The aim of this study was to assess the reliability and validity of the South American Youth Cardiovascular and Environmental (SAYCARE) sedentary behavior questionnaire.Methods: Children and adolescents from seven South American cities were involved in the test-retest reliability (children: n = 55; adolescents: n = 106) and concurrent validity (children: n = 93; adolescents: n = 94) studies. The SAYCARE sedentary behavior questionnaire was administered twice with two-week interval and the behaviors were parent-reported for children and self-reported for adolescents. Questions included time spent watching television, using a computer, playing console games, passive playing (only in children) and studying (only in adolescents) over the past week. Accelerometer was used for at least 3 days, including at least one weekend day. We compared values of sedentary time, using accelerometers, by quartiles of reported sedentary behavior time and their sum.Results: The reliability of sedentary behavior time was moderate for children (rho ≥0.45 and k ≥ 0.40) and adolescents (rho ≥0.30). Comparisons between the questionnaire and accelerometer showed a low overall agreement, with the questionnaire systematically underreporting sedentary time in children (at least, - 332.6 ± 138.5 min/day) and adolescents (at least, - 399.7 ± 105.0 min/day).Conclusion: The SAYCARE sedentary behavior questionnaire has acceptable reliability in children and adolescents. However, the findings of current study indicate that SAYCARE questionnaire is not surrogate of total sedentary time. [ABSTRACT FROM AUTHOR]

Background: Effectiveness of interventions in pragmatic trials may not translate directly into population impact, because of limited uptake by clinicians and/or the public. Uptake of an intervention is influenced by a number of factors.Methods: We propose a method for calculating population impact of clinical interventions that accounts for the intervention uptake. We suggest that population impact may be estimated by multiplying the two key components: (1) the effectiveness of the intervention in pragmatic trials (trial effect); and, (2) its uptake in clinical practice. We argue that participation rates in trials may be a valid proxy for uptake in clinical practice and, in combination with trial effectiveness estimates, be used to rank interventions by their likely population impact. We illustrate the method using the example of four interventions to decrease antibiotic prescription for acute respiratory infections in primary care: delayed prescribing, procalcitonin test, C-Reactive Protein, shared decision making.Results: In order to estimate uptake of interventions from trial data we need detailed reporting on the recruitment processes used for clinician participation in the trials. In the antibiotic prescribing example, between 75 and 91% of the population would still be prescribed or consume antibiotics because effective interventions were not taken up. Of the four interventions considered, we found that delayed prescribing would have the highest population impact and shared decision making the lowest.Conclusion: Estimates of uptake and population impact of an intervention may be possible from pragmatic RCTs, provided the recruitment processes for these trials are adequately reported (which currently few of them are). Further validation of this method using empirical data on intervention uptake in the real world would support use of this method to decide on public funding of interventions. [ABSTRACT FROM AUTHOR]

Background: Previous research has found that a "web-push" approach to data collection, which involves contacting people by mail to request an Internet survey response while withholding a paper response option until later in the contact process, consistently achieves lower response rates than a "paper-only" approach, whereby all respondents are contacted and requested to respond by mail.Method: An experiment was designed, as part of the Millennium Cohort Family Study, to compare response rates, sample representativeness, and cost between a web-push and a paper-only approach; each approach comprised 3 stages of mail contacts. The invited sample (n = 4,935) consisted of spouses married to U.S. Service members, who had been serving in the military between 2 and 5 years as of October, 2011.Results: The web-push methodology produced a significantly higher response rate, 32.8% compared to 27.8%. Each of the 3 stages of postal contact significantly contributed to response for both treatments with 87.1% of the web-push responses received over the Internet. The per-respondent cost of the paper-only treatment was almost 40% higher than the web-push treatment group. Analyses revealed no meaningfully significant differences between treatment groups in representation.Conclusion: These results provide evidence that a web-push methodology is more effective and less expensive than a paper-only approach among young military spouses, perhaps due to their heavy reliance on the internet, and we suggest that this approach may be more effective with the general population as they become more uniformly internet savvy. [ABSTRACT FROM AUTHOR]

Background: There is a need for improving cohort retention in longitudinal studies. Our objective was to identify cohort retention strategies and implementation approaches used in studies with high retention rates.Methods: Longitudinal studies with ≥200 participants, ≥80% retention rates over ≥1 year of follow-up were queried from an Institutional Review Board database at a large research-intensive U.S. university; additional studies were identified through networking. Nineteen (86%) of 22 eligible studies agreed to participate. Through in-depth semi-structured interviews, participants provided retention strategies based on themes identified from previous literature reviews. Synthesis of data was completed by a multidisciplinary team.Results: The most commonly used retention strategies were: study reminders, study visit characteristics, emphasizing study benefits, and contact/scheduling strategies. The research teams were well-functioning, organized, and persistent. Additionally, teams tailored their strategies to their participants, often adapting and innovating their approaches.Conclusions: These studies included specialized and persistent teams and utilized tailored strategies specific to their cohort and individual participants. Studies' written protocols and published manuscripts often did not reflect the varied strategies employed and adapted through the duration of study. Appropriate retention strategy use requires cultural sensitivity and more research is needed to identify how strategy use varies globally. [ABSTRACT FROM AUTHOR]

Background: Evidence syntheses, and in particular systematic reviews (SRs), have become one of the cornerstones of evidence-based health care. The Assessment of Multiple Systematic Reviews (AMSTAR) tool has become the most widely used tool for investigating the methodological quality of SRs and is currently undergoing revision. The objective of this paper is to present insights, challenges and potential solutions from the point of view of a group of assessors, while referring to earlier methodological discussions and debates with respect to AMSTAR.Discussion: One major drawback of AMSTAR is that it relies heavily on reporting quality rather than on methodological quality. This can be found in several items. Furthermore, it should be acknowledged that there are now new methods and procedures that did not exist when AMSTAR was developed. For example, the note to item 1 should now refer to the International Prospective Register of Ongoing Systematic Reviews (PROSPERO). Furthermore, item 3 should consider the definition of hand-searching, as the process of reviewing conference proceedings using the search function (e.g. in Microsoft Word or in a PDF file) does not meet the definition set out by the Cochrane Collaboration. Moreover, methods for assessing the quality of the body of evidence have evolved since AMSTAR was developed and should be incorporated into a revised AMSTAR tool. Potential solutions are presented for each AMSTAR item with the aim of allowing a more thorough assessment of SRs. As the AMSTAR tool is currently undergoing further development, our paper hopes to add to preceding discussions and papers regarding this tool and stimulate further discussion. [ABSTRACT FROM AUTHOR]

Background: Scoping reviews are used to identify knowledge gaps, set research agendas, and identify implications for decision-making. The conduct and reporting of scoping reviews is inconsistent in the literature. We conducted a scoping review to identify: papers that utilized and/or described scoping review methods; guidelines for reporting scoping reviews; and studies that assessed the quality of reporting of scoping reviews.Methods: We searched nine electronic databases for published and unpublished literature scoping review papers, scoping review methodology, and reporting guidance for scoping reviews. Two independent reviewers screened citations for inclusion. Data abstraction was performed by one reviewer and verified by a second reviewer. Quantitative (e.g. frequencies of methods) and qualitative (i.e. content analysis of the methods) syntheses were conducted.Results: After searching 1525 citations and 874 full-text papers, 516 articles were included, of which 494 were scoping reviews. The 494 scoping reviews were disseminated between 1999 and 2014, with 45% published after 2012. Most of the scoping reviews were conducted in North America (53%) or Europe (38%), and reported a public source of funding (64%). The number of studies included in the scoping reviews ranged from 1 to 2600 (mean of 118). Using the Joanna Briggs Institute methodology guidance for scoping reviews, only 13% of the scoping reviews reported the use of a protocol, 36% used two reviewers for selecting citations for inclusion, 29% used two reviewers for full-text screening, 30% used two reviewers for data charting, and 43% used a pre-defined charting form. In most cases, the results of the scoping review were used to identify evidence gaps (85%), provide recommendations for future research (84%), or identify strengths and limitations (69%). We did not identify any guidelines for reporting scoping reviews or studies that assessed the quality of scoping review reporting.Conclusion: The number of scoping reviews conducted per year has steadily increased since 2012. Scoping reviews are used to inform research agendas and identify implications for policy or practice. As such, improvements in reporting and conduct are imperative. Further research on scoping review methodology is warranted, and in particular, there is need for a guideline to standardize reporting. [ABSTRACT FROM AUTHOR]

Background: As a part of a larger Health Technology Assessment (HTA), the measurement error of a device used to monitor the hemoglobin concentration of a patient undergoing surgery, as well as its decision consequences, were to be estimated from published data.Methods: A Bayesian hierarchical model of measurement error, allowing the meta-analytic estimation of both central and dispersion parameters (under the assumption of normality of measurement errors) is proposed and applied to published data; the resulting potential decision errors are deduced from this estimation. The same method is used to assess the impact of an initial calibration.Results: The posterior distributions are summarized as mean ± sd (credible interval). The fitted model exhibits a modest mean expected error (0.24 ± 0.73 (-1.23 1.59) g/dL) and a large variability (mean absolute expected error 1.18 ± 0.92 (0.05 3.36) g/dL). The initial calibration modifies the bias (-0.20 ± 0.87 (-1.99 1.49) g/dL), but the variability remains almost as large (mean absolute expected error 1.05 ± 0.87 (0.04 3.21) g/dL). This entails a potential decision error ("false positive" or "false negative") for about one patient out of seven.Conclusions: The proposed hierarchical model allows the estimation of the variability from published aggregates, and allows the modeling of the consequences of this variability in terms of decision errors. For the device under assessment, these potential decision errors are clinically problematic. [ABSTRACT FROM AUTHOR]

Background: Systematic reviews are pivotal components in the development of evidence-based clinical guidelines. To evaluate the methodological quality of these systematic reviews, several tools have been proposed. Among them, the assessment of multiple systematic reviews (AMSTAR) checklist is probably used most frequently. This tool comprises 11 items related to the steps taken when conducting a systematic review, and it is claimed to have good face and content validity. The objective of this debate paper was twofold: (a) to critically evaluate the ability of all AMSTAR checklist items to adequately determine the methodological quality of a systematic review; and (b) to describe difficulties regarding interpretation of the checklist, and provide potential solutions for these difficulties. Discussion: Some items of the AMSTAR checklist seem to assess the quality of reporting of a systematic review more than its methodological quality. For example, item 7 may not "capture" the true methodological quality of primary studies included in the systematic review. Item 10 does not likely result in the collection of in-depth information on the presence of publication bias in the systematic review. Furthermore, some items may be difficult to interpret, hindering accurate assessment. For example, item 5 does not explicitly indicate whether a list of documents excluded in each phase of selection (i.e., after evaluation of titles and abstracts, and after full-text assessment) should be reported. Summary: The present debate paper evaluated and discussed some methodological limitations of the AMSTAR checklist, as well as challenges involved in evaluation of the checklist's items. Several suggestions are also made to optimize the use of this checklist. The information in this paper may stimulate further discussion among systematic reviewers, methodologists and clinicians. [ABSTRACT FROM AUTHOR]

Background: A major challenge in updating clinical guidelines is to efficiently identify new, relevant evidence. We evaluated the efficiency and feasibility of two new approaches: the development of restrictive search strategies using PubMed Clinical Queries for MEDLINE and the use of the PLUS (McMaster Premium Literature Service) database. Methods: We evaluated a random sample of recommendations from a national guideline development program and identified the references that would potentially trigger an update (key references) using an exhaustive approach. We designed restrictive search strategies using the minimum number of Medical Subject Headings (MeSH) terms and text words required from the original exhaustive search strategies and applying broad and narrow filters. We developed PLUS search strategies, matching Medical Subject Headings (MeSH) and Systematized Nomenclature of Medicine (SNOMED) terms with guideline topics. We compared the number of key references retrieved by these approaches with those retrieved by the exhaustive approach. Results: The restrictive approach retrieved 68.1 % fewer references than the exhaustive approach (12,486 versus 39,136), and identified 89.9 % (62/69) of key references and 88 % (22/25) of recommendation updates. The use of PLUS retrieved 88.5 % fewer references than the exhaustive approach (4,486 versus 39,136) and identified substantially fewer key references (18/69, 26.1 %) and fewer recommendation updates (10/25, 40 %). Conclusions: The proposed restrictive approach is a highly efficient and feasible method to identify new evidence that triggers a recommendation update. Searching only in the PLUS database proved to be a suboptimal approach and suggests the need for topic-specific tailoring. [ABSTRACT FROM AUTHOR]

Background Recent research indicates a high recall in Google Scholar searches for systematic reviews. These reports raised high expectations of Google Scholar as a unified and easy to use search interface. However, studies on the coverage of Google Scholar rarely used the search interface in a realistic approach but instead merely checked for the existence of gold standard references. In addition, the severe limitations of the Google Search interface must be taken into consideration when comparing with professional literature retrieval tools. The objectives of this work are to measure the relative recall and precision of searches with Google Scholar under conditions which are derived from structured search procedures conventional in scientific literature retrieval; and to provide an overview of current advantages and disadvantages of the Google Scholar search interface in scientific literature retrieval. Methods General and MEDLINE-specific search strategies were retrieved from 14 Cochrane systematic reviews. Cochrane systematic review search strategies were translated to Google Scholar search expression as good as possible under consideration of the original search semantics. The references of the included studies from the Cochrane reviews were checked for their inclusion in the result sets of the Google Scholar searches. Relative recall and precision were calculated. Results We investigated Cochrane reviews with a number of included references between 11 and 70 with a total of 396 references. The Google Scholar searches resulted in sets between 4,320 and 67,800 and a total of 291,190 hits. The relative recall of the Google Scholar searches had a minimum of 76.2% and a maximum of 100% (7 searches). The precision of the Google Scholar searches had a minimum of 0.05% and a maximum of 0.92%. The overall relative recall for all searches was 92.9%, the overall precision was 0.13%. Conclusion The reported relative recall must be interpreted with care. It is a quality indicator of Google Scholar confined to an experimental setting which is unavailable in systematic retrieval due to the severe limitations of the Google Scholar search interface. Currently, Google Scholar does not provide necessary elements for systematic scientific literature retrieval such as tools for incremental query optimization, export of a large number of references, a visual search builder or a history function. Google Scholar is not ready as a professional searching tool for tasks where structured retrieval methodology is necessary. [ABSTRACT FROM AUTHOR]

Background: Many prognostic models have been developed. Different types of models, i.e. prognostic factor and outcome prediction studies, serve different purposes, which should be reflected in how the results are summarized in reviews. Therefore we set out to investigate how authors of reviews synthesize and report the results of primary outcome prediction studies. Methods: Outcome prediction reviews published in MEDLINE between October 2005 and March 2011 were eligible and 127 Systematic reviews with the aim to summarize outcome prediction studies written in English were identified for inclusion. Characteristics of the reviews and the primary studies that were included were independently assessed by 2 review authors, using standardized forms. Results: After consensus meetings a total of 50 systematic reviews that met the inclusion criteria were included. The type of primary studies included (prognostic factor or outcome prediction) was unclear in two-thirds of the reviews. A minority of the reviews reported univariable or multivariable point estimates and measures of dispersion from the primary studies. Moreover, the variables considered for outcome prediction model development were often not reported, or were unclear. In most reviews there was no information about model performance. Quantitative analysis was performed in 10 reviews, and 49 reviews assessed the primary studies qualitatively. In both analyses types a range of different methods was used to present the results of the outcome prediction studies. Conclusions: Different methods are applied to synthesize primary study results but quantitative analysis is rarely performed. The description of its objectives and of the primary studies is suboptimal and performance parameters of the outcome prediction models are rarely mentioned. The poor reporting and the wide variety of data synthesis strategies are prone to influence the conclusions of outcome prediction reviews. Therefore, there is much room for improvement in reviews of outcome prediction studies. [ABSTRACT FROM AUTHOR]

Background: Following publication of the first worked example of the "best fit" method of evidence synthesis for the systematic review of qualitative evidence in this journal, the originators of the method identified a need to specify more fully some aspects of this particular derivative of framework synthesis. Methods and Results: We therefore present a second such worked example in which all techniques are defined and explained, and their appropriateness is assessed. Specified features of the method include the development of new techniques to identify theories in a systematic manner; the creation of an a priori framework for the synthesis; and the "testing" of the synthesis. An innovative combination of existing methods of quality assessment, analysis and synthesis is used to complete the process. This second worked example was a qualitative evidence synthesis of employees' views of workplace smoking cessation interventions, in which the "best fit"method was found to be practical and fit for purpose. Conclusions: The method is suited to producing context-specific conceptual models for describing or explaining the decision-making and health behaviours of patients and other groups. It offers a pragmatic means of conducting rapid qualitative evidence synthesis and generating programme theories relating to intervention effectiveness, which might be of relevance both to researchers and policy-makers. [ABSTRACT FROM AUTHOR]

Background: Use of the Internet to conduct randomised controlled trials is increasing, and provides potential to increase equity of access to medical research, increase the generalisability of trial results and decrease the costs involved in conducting large scale trials. Several studies have compared response rates, completeness of data, and reliability of surveys using the Internet and traditional methods, but very little is known about participants' attitudes towards Internet-based randomised trials or their experience of participating in an Internet-based trial. Objective: To obtain insights into the experiences and perspectives of participants in an Internet-based randomised controlled trial, their attitudes to the use of the Internet to conduct medical research, and their intentions regarding future participation in Internet research. Methods: All English speaking participants in a recently completed Internet randomised controlled trial were invited to participate in an online survey. Results: 1246 invitations were emailed. 416 participants completed the survey between May and October 2009 (33% response rate). Reasons given for participating in the Internet RCT fell into 4 main areas: personal interest in the research question and outcome, ease of participation, an appreciation of the importance of research and altruistic reasons. Participants' comments and reflections on their experience of participating in a fully online trial were positive and less than half of participants would have participated in the trial had it been conducted using other means of data collection. However participants identified trade-offs between the benefits and downsides of participating in Internet-based trials. The main trade-off was between flexibility and convenience -- a perceived benefit -- and a lack connectedness and understanding - a perceived disadvantage. The other tradeoffs were in the areas of: ease or difficulty in use of the Internet; security, privacy and confidentiality issues; perceived benefits and disadvantages for researchers; technical aspects of using the Internet; and the impact of Internet data collection on information quality. Overall, more advantages were noted by participants, consistent with their preference for this mode of research over others. The majority of participants (69%) would prefer to participate in Internet-based research compared to other modes of data collection in the future. Conclusion: Participants in our survey would prefer to participate in Internet-based trials in the future compared to other ways of conducting trials. From the participants' perspective, participating in Internet-based trials involves trade-offs. The central trade-off is between flexibility and convenience -- a perceived benefit -- and lack of connectedness and understanding - a perceived disadvantage. Strategies to maintain the convenience of the Internet while increasing opportunities for participants to feel supported, well-informed and well-understood would seem likely to increase the acceptability of Internet-based trials. [ABSTRACT FROM AUTHOR]

Background: People who inject drugs (PWID) have been identified as frequent users of emergency department (ED) and hospital inpatient services. The specific challenges of record linkage in cohorts with numerous administrative health records occurring in close proximity are not well understood. Here, we present a method for patient-specific record linkage of ED and hospital admission data for a cohort of PWID.Methods: Data from 688 PWID were linked to two state-wide administrative health databases identifying all ED visits and hospital admissions for the cohort between January 2008 and June 2013. We linked patient-specific ED and hospital admissions data, using administrative date-time timestamps and pre-specified linkage criteria, to identify hospital admissions stemming from ED presentations for a given individual. The ability of standalone databases to identify linked ED visits or hospital admissions was examined.Results: There were 3459 ED visits and 1877 hospital admissions identified during the study period. Thirty-four percent of ED visits were linked to hospital admissions. Most links had hospital admission timestamps in-between or identical to their ED visit timestamps (n = 1035, 87%). Allowing 24-h between ED visits and hospital admissions captured more linked records, but increased manual inspection requirements. In linked records (n = 1190), the ED 'departure status' variable correctly reflected subsequent hospital admission in only 68% of cases. The hospital 'admission type' variable was non-specific in identifying if a preceding ED visit had occurred.Conclusions: Linking ED visits with subsequent hospital admissions in PWID requires access to date and time variables for accurate temporal sorting, especially for same-day presentations. Selecting time-windows to capture linked records requires discretion. Researchers risk under-ascertainment of hospital admissions if using ED data alone. [ABSTRACT FROM AUTHOR]

Background: The attendance to cervical cancer screening is low among immigrants in many high-income countries. Although several interventions have been experimentally tested,implementation remains a challenge. Several factors are an impediment, including the lack of methodological descriptions of the development and implementation of such interventions. In this paper,we present in detail the development, methodological challenges and practical implementation of a community based intervention aimed to increase the participation of immigrant women in cervical cancer screening in Norway.Methods: This study was initially designed as a cluster randomized trial to be carried out in four geographical areas near Oslo between Feb-October 2017. Participants were immigrant women aged 25-69 years from Pakistan and Somalia. This paper describes the theoretical background for the development of the intervention,followed by challenges,the changes in the original design and solutions adopted related to the study design,recruitment and implementation of the intervention. The intervention was developed based on two theoretical frameworks, the Ecological and the Heron's six categories intervention framework. An oral 20-25 min presentation in the language of participants encompassing topics of cervical cancer and screening was given according to the needs detected in focus groups conducted at the beginning of the study,followed by an opportunity to raise questions and answering a short questionnaire.Results: Contrary to the initial study design, this had to be converted into a non-randomised trial due to the difficulties associated with randomization of immigrant families who are finely scattered in heavily populated towns and a high risk of contamination. We therefore adopted a pragmatic approach and recruited women in the intervention areas through a variety of channels and institutions. Neighboring areas were considered to be non-randomised controls. Female researchers with Pakistani and Somali background invited as many women as possible in the intervention areas. Among the women who were invited to participate,42% of the Pakistani and 78% of Somali attended the meetings.Conclusion: Despite the careful development of a culturally adapted health intervention in collaboration with the community; randomization and recruitment of immigrants for community trials remains challenging. Nevertheless, sharing strategies to overcome specific challenges related to promoting health interventions for immigrants, can be of potential help to scale-up interventions and for building new research projects.Trial Registration: NCT03155581 . Retrospectively registered, on 16 May 2017. [ABSTRACT FROM AUTHOR]

Background: A strong need exists for a validated tool that clearly defines peer review report quality in biomedical research, as it will allow evaluating interventions aimed at improving the peer review process in well-performed trials. We aim to identify and describe existing tools for assessing the quality of peer review reports in biomedical research.Methods: We conducted a methodological systematic review by searching PubMed, EMBASE (via Ovid) and The Cochrane Methodology Register (via The Cochrane Library) as well as Google® for all reports in English describing a tool for assessing the quality of a peer review report in biomedical research. Data extraction was performed in duplicate using a standardized data extraction form. We extracted information on the structure, development and validation of each tool. We also identified quality components across tools using a systematic multi-step approach and we investigated quality domain similarities among tools by performing hierarchical, complete-linkage clustering analysis.Results: We identified a total number of 24 tools: 23 scales and 1 checklist. Six tools consisted of a single item and 18 had several items ranging from 4 to 26. None of the tools reported a definition of 'quality'. Only 1 tool described the scale development and 10 provided measures of validity and reliability. Five tools were used as an outcome in a randomized controlled trial (RCT). Moreover, we classified the quality components of the 18 tools with more than one item into 9 main quality domains and 11 subdomains. The tools contained from two to seven quality domains. Some domains and subdomains were considered in most tools such as the detailed/thorough (11/18) nature of reviewer's comments. Others were rarely considered, such as whether or not the reviewer made comments on the statistical methods (1/18).Conclusion: Several tools are available to assess the quality of peer review reports; however, the development and validation process is questionable and the concepts evaluated by these tools vary widely. The results from this study and from further investigations will inform the development of a new tool for assessing the quality of peer review reports in biomedical research. [ABSTRACT FROM AUTHOR]

Background: While enrolling dyads in research studies is not uncommon, there is limited literature on the utility of different recruitment strategies and the resulting selection biases. This paper examined two recruitment strategies used to enroll military couples in a longitudinal study, assessing the impact of both strategies on the representativeness of the final study sample.Method: Descriptive and bivariate analyses were conducted to 1) identify characteristics associated with spouse referral, 2) compare response rates based on recruitment strategy and assess whether recruitment strategy modified correlates of response propensity among spouses, and 3) assess whether referred spouse characteristics differed from non-referred spouses in the final sample. The study sample consisted of married US service members with 2-5 years of military service as of October 2011 and their spouses.Results: Service members who referred their spouses to participate in the Millennium Cohort Family Study were more likely to be male, have children, serve in the Army, and have combat deployment experience than those who did not refer their spouse. Nearly two-thirds (n = 5331, 64.9%) of referred spouses participated in the Family Study, compared with less than one-third (n = 3458, 29.5%) of directly contacted spouses. Spouse characteristics also differed significantly between recruitment groups.Conclusions: Overall results suggest that minimal bias was introduced by using a referral recruitment methodology. Service members appeared to be more likely to refer their spouses if they perceived the research topic as relevant to their spouse, such that male service members with combat deployment experience were more likely to refer female spouses caring for multiple children. Referred spouses were significantly more likely to respond to the Millennium Cohort Family Study survey than those who were directly contacted; however, the overall success rate of using a referral strategy was less than recruiting spouses through direct contact. Differences between referred spouses and spouses contacted directly mirrored service member referring characteristics. [ABSTRACT FROM AUTHOR]

Background: Consumers, clinicians, policymakers and researchers require high quality evidence to guide decision-making in child health. Though Cochrane systematic reviews (SRs) are a well-established source of evidence, little is known about the characteristics of non-Cochrane child-relevant SRs. To complement published descriptions of Cochrane SRs, we aimed to characterize the epidemiologic, methodological, and reporting qualities of non-Cochrane child-relevant SRs published in 2014.Methods: English-language child-relevant SRs of quantitative primary research published outside the Cochrane Library in 2014 were eligible for this descriptive analysis. A research librarian searched MEDLINE, CINAHL, Web of Science, and PubMed in August 2015. A single reviewer screened articles for inclusion; a second verified the excluded studies. Reviewers extracted: general characteristics of the review; included study characteristics; methodological approaches. We performed univariate analyses and presented the findings narratively.Results: We identified 1598 child-relevant SRs containing a median (IQR) 19 (11, 33) studies. These originated primarily from high-income countries (n = 1247, 78.0%) and spanned 47 of the 53 Cochrane Review Groups. Most synthesized therapeutic (n = 753, 47.1%) or epidemiologic (n = 701, 43.8%) evidence. Though 39.3% (n = 628) of SRs included evidence related to children only, few were published in pediatric-specific journals (n = 283, 17.7%). Reporting quality seemed poor based on the items we assessed; few reviews mentioned an a-priori protocol (n = 246, 15.4%) or registration (n = 111, 6.9%), and only 23.4% (n = 374) specified a primary outcome. Many SRs relied solely on evidence from non-RCTs (n = 796, 49.8%). Less than two-thirds (n = 953, 59.6%) appraised the quality of included studies and assessments of the certainty of the body of evidence were rare (n = 102, 6.4%).Conclusions: Child-relevant Cochrane SRs are a known source of high quality evidence in pediatrics. There exists, however, an abundance of evidence from non-Cochrane SRs that may be complementary. Our findings show that high-quality non-Cochrane SRs may not be practical nor easy for knowledge users to find. Improvements are needed to ensure that evidence syntheses published outside of the Cochrane Library adhere to the high standard of conduct and reporting characteristic of Cochrane SRs. [ABSTRACT FROM AUTHOR]

Background: Limited translational success in critical care medicine is thought to be in part due to inadequate methodology, study design, and reporting in preclinical studies. The purpose of this study was to compare reporting of core features of experimental rigor: blinding, randomization, and power calculations in critical care medicine animal experimental research. We hypothesized that these study design characteristics were more frequently reported in 2015 versus 2005.Methods: We performed an observational bibliometric study to grade manuscripts on blinding, randomization, and power calculations. Chi-square tests and logistic regression were used for analysis. Inter-rater agreement was assessed using kappa and Gwet's AC1.Results: A total of 825 articles from seven journals were included. In 2005, power estimations were reported in 2%, randomization in 35%, and blinding in 20% (n = 482). In 2015, these metrics were included in 9, 47, and 36% of articles (n = 343). The increase in proportion for the metrics tested was statistically significant (p < 0.001, p = 0.002, and p < 0.001).Conclusions: Only a minority of published manuscripts in critical care medicine journals reported on recommended study design steps to increase rigor. Routine justification for the presence or absence of blinding, randomization, and power calculations should be considered to better enable readers to assess potential sources of bias. [ABSTRACT FROM AUTHOR]

Background: Systematic reviews and meta-analyses of observational studies are frequently performed, but no widely accepted guidance is available at present. We performed a systematic scoping review of published methodological recommendations on how to systematically review and meta-analyse observational studies.Methods: We searched online databases and websites and contacted experts in the field to locate potentially eligible articles. We included articles that provided any type of recommendation on how to conduct systematic reviews and meta-analyses of observational studies. We extracted and summarised recommendations on pre-defined key items: protocol development, research question, search strategy, study eligibility, data extraction, dealing with different study designs, risk of bias assessment, publication bias, heterogeneity, statistical analysis. We summarised recommendations by key item, identifying areas of agreement and disagreement as well as areas where recommendations were missing or scarce.Results: The searches identified 2461 articles of which 93 were eligible. Many recommendations for reviews and meta-analyses of observational studies were transferred from guidance developed for reviews and meta-analyses of RCTs. Although there was substantial agreement in some methodological areas there was also considerable disagreement on how evidence synthesis of observational studies should be conducted. Conflicting recommendations were seen on topics such as the inclusion of different study designs in systematic reviews and meta-analyses, the use of quality scales to assess the risk of bias, and the choice of model (e.g. fixed vs. random effects) for meta-analysis.Conclusion: There is a need for sound methodological guidance on how to conduct systematic reviews and meta-analyses of observational studies, which critically considers areas in which there are conflicting recommendations. [ABSTRACT FROM AUTHOR]

Background: Accurate smoking status is key for research purposes, but can be costly and difficult to measure. Within the Veteran's Health Administration (VA), smoking status is recorded as part of routine care as "health factors" (HF)-fields that researchers can query through the electronic health record (EHR). Many researchers are interested in using these fields to track changes in smoking status over time, however the validity of this measure for assessing change is unknown. The primary goal of this project was to examine whether HFs can be used to accurately measure change in tobacco status over time, with secondary goals of assessing the optimum timeframe for assessment and variation in accuracy by site.Methods: Secondary analysis of the Veterans VICTORY study, a pragmatic smoking cessation randomized controlled trial conducted from 2009 to 2011. Eligible subjects were identified via the EHR using a past 90-day HF indicating current tobacco use (for example: "CURRENT SMOKER", "CURRENTLY USES TOBACCO"). Participants were surveyed at 1 year to determine prolonged smoking abstinence. We identified HFs for tobacco status within +/- 120 days of the follow-up survey mailing date and recorded the temporally closest HF. Among subjects with both measures, we compared the two for agreement using kappa statistics and concordance.Results: 1713 subjects (33%) had both follow-up survey and HF data, 1594 (31%) had only a survey response, 790 (15%) had only HF and 1026 (20%) had neither. For subjects with both measures, there was 90% concordance and moderate agreement (Kappa 0.48, 95%CI 0.41-0.55, Sensitivity 54.4, 95%CI 41.1-67.7, Specificity 94.3, 95%CI 87.5-100.0).Conclusions: We found high concordance but only moderate agreement by kappa statistics between HFs and survey data. The difference is likely accounted for by the natural history of quit attempts, in which patients cycle in and out of quit attempts. HFs appear to provide an accurate measure of population level quit behavior utilizing data collected in the course of clinical care. [ABSTRACT FROM AUTHOR]