Inspired to Garden: A Qualitative Study of Participants' Experiences in an Academic Medical Center Garden.

Introduction Gardening is a healthy activity that promotes nutrition and satisfaction, with positive impacts on patients with chronic diseases, including patients with obesity, diabetes, and cardiovascular disease. Hospital-based gardening programs may provide opportunities to introduce patients to gardening. However, few studies have included participant experience as a metric of evaluation. The objective of this study was to explore participant experience in a hospital-based gardening intervention designed for individuals with metabolic syndrome. Methods This study was a qualitative evaluation of free text responses from four questions included in post-participation questionnaires from 59 community-dwelling adults who participated in a hospital-based garden program located at the University of Vermont Medical Center in 2020 and 2021. Eligible participants included a convenience sample of novice gardeners with self-reported hypertension, diabetes, pre-diabetes, or overweight/obesity. We used an interpretative phenomenological approach to analyze the questionnaire data. The phenomenological cycle for each of the questions included: 1) reading and re-reading participant responses, 2) exploratory noting, 3) constructing experimental statements, 4) searching for connections across statements, and 5) naming the themes. This process also involved working with individual question-level themes to develop group themes across questions. Results This dataset was one of positivity about gardening, new information gleaned, and the quality of instruction. Several themes and codes emerged: program implementation (new knowledge, new skills, new connections, instructor ability, climate), self-efficacy (confidence, vicarious experience, mastery experience, verbal persuasion), and future change (behavior change, future issues/problem-solving, passing it on). Conclusion This study supports analyzing participant experience as part of hospital-based gardening interventions. We found positivity around program implementation, increased self-efficacy, and intentions to change behavior in ways that support healthy lifestyles.

Screening for the primary prevention of fragility fractures among adults aged 40 years and older in primary care: systematic reviews of the effects and acceptability of screening and treatment, and the accuracy of risk prediction tools.

BACKGROUND: To inform recommendations by the Canadian Task Force on Preventive Health Care, we reviewed evidence on the benefits, harms, and acceptability of screening and treatment, and on the accuracy of risk prediction tools for the primary prevention of fragility fractures among adults aged 40 years and older in primary care. METHODS: For screening effectiveness, accuracy of risk prediction tools, and treatment benefits, our search methods involved integrating studies published up to 2016 from an existing systematic review. Then, to locate more recent studies and any evidence relating to acceptability and treatment harms, we searched online databases (2016 to April 4, 2022 [screening] or to June 1, 2021 [predictive accuracy]; 1995 to June 1, 2021, for acceptability; 2016 to March 2, 2020, for treatment benefits; 2015 to June 24, 2020, for treatment harms), trial registries and gray literature, and hand-searched reviews, guidelines, and the included studies. Two reviewers selected studies, extracted results, and appraised risk of bias, with disagreements resolved by consensus or a third reviewer. The overview of reviews on treatment harms relied on one reviewer, with verification of data by another reviewer to correct errors and omissions. When appropriate, study results were pooled using random effects meta-analysis; otherwise, findings were described narratively. Evidence certainty was rated according to the GRADE approach. RESULTS: We included 4 randomized controlled trials (RCTs) and 1 controlled clinical trial (CCT) for the benefits and harms of screening, 1 RCT for comparative benefits and harms of different screening strategies, 32 validation cohort studies for the calibration of risk prediction tools (26 of these reporting on the Fracture Risk Assessment Tool without [i.e., clinical FRAX], or with the inclusion of bone mineral density (BMD) results [i.e., FRAX + BMD]), 27 RCTs for the benefits of treatment, 10 systematic reviews for the harms of treatment, and 12 studies for the acceptability of screening or initiating treatment. In females aged 65 years and older who are willing to independently complete a mailed fracture risk questionnaire (referred to as "selected population"), 2-step screening using a risk assessment tool with or without measurement of BMD probably (moderate certainty) reduces the risk of hip fractures (3 RCTs and 1 CCT, n = 43,736, absolute risk reduction [ARD] = 6.2 fewer in 1000, 95% CI 9.0-2.8 fewer, number needed to screen [NNS] = 161) and clinical fragility fractures (3 RCTs, n = 42,009, ARD = 5.9 fewer in 1000, 95% CI 10.9-0.8 fewer, NNS = 169). It probably does not reduce all-cause mortality (2 RCTs and 1 CCT, n = 26,511, ARD = no difference in 1000, 95% CI 7.1 fewer to 5.3 more) and may (low certainty) not affect health-related quality of life. Benefits for fracture outcomes were not replicated in an offer-to-screen population where the rate of response to mailed screening questionnaires was low. For females aged 68-80 years, population screening may not reduce the risk of hip fractures (1 RCT, n = 34,229, ARD = 0.3 fewer in 1000, 95% CI 4.2 fewer to 3.9 more) or clinical fragility fractures (1 RCT, n = 34,229, ARD = 1.0 fewer in 1000, 95% CI 8.0 fewer to 6.0 more) over 5 years of follow-up. The evidence for serious adverse events among all patients and for all outcomes among males and younger females (<65 years) is very uncertain. We defined overdiagnosis as the identification of high risk in individuals who, if not screened, would never have known that they were at risk and would never have experienced a fragility fracture. This was not directly reported in any of the trials. Estimates using data available in the trials suggest that among "selected" females offered screening, 12% of those meeting age-specific treatment thresholds based on clinical FRAX 10-year hip fracture risk, and 19% of those meeting thresholds based on clinical FRAX 10-year major osteoporotic fracture risk, may be overdiagnosed as being at high risk of fracture. Of those identified as being at high clinical FRAX 10-year hip fracture risk and who were referred for BMD assessment, 24% may be overdiagnosed. One RCT (n = 9268) provided evidence comparing 1-step to 2-step screening among postmenopausal females, but the evidence from this trial was very uncertain. For the calibration of risk prediction tools, evidence from three Canadian studies (n = 67,611) without serious risk of bias concerns indicates that clinical FRAX-Canada may be well calibrated for the 10-year prediction of hip fractures (observed-to-expected fracture ratio [O:E] = 1.13, 95% CI 0.74-1.72, I2 = 89.2%), and is probably well calibrated for the 10-year prediction of clinical fragility fractures (O:E = 1.10, 95% CI 1.01-1.20, I2 = 50.4%), both leading to some underestimation of the observed risk. Data from these same studies (n = 61,156) showed that FRAX-Canada with BMD may perform poorly to estimate 10-year hip fracture risk (O:E = 1.31, 95% CI 0.91-2.13, I2 = 92.7%), but is probably well calibrated for the 10-year prediction of clinical fragility fractures, with some underestimation of the observed risk (O:E 1.16, 95% CI 1.12-1.20, I2 = 0%). The Canadian Association of Radiologists and Osteoporosis Canada Risk Assessment (CAROC) tool may be well calibrated to predict a category of risk for 10-year clinical fractures (low, moderate, or high risk; 1 study, n = 34,060). The evidence for most other tools was limited, or in the case of FRAX tools calibrated for countries other than Canada, very uncertain due to serious risk of bias concerns and large inconsistency in findings across studies. Postmenopausal females in a primary prevention population defined as <50% prevalence of prior fragility fracture (median 16.9%, range 0 to 48% when reported in the trials) and at risk of fragility fracture, treatment with bisphosphonates as a class (median 2 years, range 1-6 years) probably reduces the risk of clinical fragility fractures (19 RCTs, n = 22,482, ARD = 11.1 fewer in 1000, 95% CI 15.0-6.6 fewer, [number needed to treat for an additional beneficial outcome] NNT = 90), and may reduce the risk of hip fractures (14 RCTs, n = 21,038, ARD = 2.9 fewer in 1000, 95% CI 4.6-0.9 fewer, NNT = 345) and clinical vertebral fractures (11 RCTs, n = 8921, ARD = 10.0 fewer in 1000, 95% CI 14.0-3.9 fewer, NNT = 100); it may not reduce all-cause mortality. There is low certainty evidence of little-to-no reduction in hip fractures with any individual bisphosphonate, but all provided evidence of decreased risk of clinical fragility fractures (moderate certainty for alendronate [NNT=68] and zoledronic acid [NNT=50], low certainty for risedronate [NNT=128]) among postmenopausal females. Evidence for an impact on risk of clinical vertebral fractures is very uncertain for alendronate and risedronate; zoledronic acid may reduce the risk of this outcome (4 RCTs, n = 2367, ARD = 18.7 fewer in 1000, 95% CI 25.6-6.6 fewer, NNT = 54) for postmenopausal females. Denosumab probably reduces the risk of clinical fragility fractures (6 RCTs, n = 9473, ARD = 9.1 fewer in 1000, 95% CI 12.1-5.6 fewer, NNT = 110) and clinical vertebral fractures (4 RCTs, n = 8639, ARD = 16.0 fewer in 1000, 95% CI 18.6-12.1 fewer, NNT=62), but may make little-to-no difference in the risk of hip fractures among postmenopausal females. Denosumab probably makes little-to-no difference in the risk of all-cause mortality or health-related quality of life among postmenopausal females. Evidence in males is limited to two trials (1 zoledronic acid, 1 denosumab); in this population, zoledronic acid may make little-to-no difference in the risk of hip or clinical fragility fractures, and evidence for all-cause mortality is very uncertain. The evidence for treatment with denosumab in males is very uncertain for all fracture outcomes (hip, clinical fragility, clinical vertebral) and all-cause mortality. There is moderate certainty evidence that treatment causes a small number of patients to experience a non-serious adverse event, notably non-serious gastrointestinal events (e.g., abdominal pain, reflux) with alendronate (50 RCTs, n = 22,549, ARD = 16.3 more in 1000, 95% CI 2.4-31.3 more, [number needed to treat for an additional harmful outcome] NNH = 61) but not with risedronate; influenza-like symptoms with zoledronic acid (5 RCTs, n = 10,695, ARD = 142.5 more in 1000, 95% CI 105.5-188.5 more, NNH = 7); and non-serious gastrointestinal adverse events (3 RCTs, n = 8454, ARD = 64.5 more in 1000, 95% CI 26.4-13.3 more, NNH = 16), dermatologic adverse events (3 RCTs, n = 8454, ARD = 15.6 more in 1000, 95% CI 7.6-27.0 more, NNH = 64), and infections (any severity; 4 RCTs, n = 8691, ARD = 1.8 more in 1000, 95% CI 0.1-4.0 more, NNH = 556) with denosumab. For serious adverse events overall and specific to stroke and myocardial infarction, treatment with bisphosphonates probably makes little-to-no difference; evidence for other specific serious harms was less certain or not available. There was low certainty evidence for an increased risk for the rare occurrence of atypical femoral fractures (0.06 to 0.08 more in 1000) and osteonecrosis of the jaw (0.22 more in 1000) with bisphosphonates (most evidence for alendronate). The evidence for these rare outcomes and for rebound fractures with denosumab was very uncertain. Younger (lower risk) females have high willingness to be screened. A minority of postmenopausal females at increased risk for fracture may accept treatment. Further, there is large heterogeneity in the level of risk at which patients may be accepting of initiating treatment, and treatment effects appear to be overestimated. CONCLUSION: An offer of 2-step screening with risk assessment and BMD measurement to selected postmenopausal females with low prevalence of prior fracture probably results in a small reduction in the risk of clinical fragilityfracture and hip fracture compared to no screening. These findings were most applicable to the use of clinical FRAX for risk assessment and were not replicated in the offer-to-screen population where the rate of response to mailed screening questionnaires was low. Limited direct evidence on harms of screening were available; using study data to provide estimates, there may be a moderate degree of overdiagnosis of high risk for fracture to consider. The evidence for younger females and males is very limited. The benefits of screening and treatment need to be weighed against the potential for harm; patient views on the acceptability of treatment are highly variable. SYSTEMATIC REVIEW REGISTRATION: International Prospective Register of Systematic Reviews (PROSPERO): CRD42019123767.

Reporting guideline for overviews of reviews of healthcare interventions: development of the PRIOR statement.

OBJECTIVE: To develop a reporting guideline for overviews of reviews of healthcare interventions. DESIGN: Development of the preferred reporting items for overviews of reviews (PRIOR) statement. PARTICIPANTS: Core team (seven individuals) led day-to-day operations, and an expert advisory group (three individuals) provided methodological advice. A panel of 100 experts (authors, editors, readers including members of the public or patients) was invited to participate in a modified Delphi exercise. 11 expert panellists (chosen on the basis of expertise, and representing relevant stakeholder groups) were invited to take part in a virtual face-to-face meeting to reach agreement (≥70%) on final checklist items. 21 authors of recently published overviews were invited to pilot test the checklist. SETTING: International consensus. INTERVENTION: Four stage process established by the EQUATOR Network for developing reporting guidelines in health research: project launch (establish a core team and expert advisory group, register intent), evidence reviews (systematic review of published overviews to describe reporting quality, scoping review of methodological guidance and author reported challenges related to undertaking overviews of reviews), modified Delphi exercise (two online Delphi surveys to reach agreement (≥70%) on relevant reporting items followed by a virtual face-to-face meeting), and development of the reporting guideline. RESULTS: From the evidence reviews, we drafted an initial list of 47 potentially relevant reporting items. An international group of 52 experts participated in the first Delphi survey (52% participation rate); agreement was reached for inclusion of 43 (91%) items. 44 experts (85% retention rate) completed the second Delphi survey, which included the four items lacking agreement from the first survey and five new items based on respondent comments. During the second round, agreement was not reached for the inclusion or exclusion of the nine remaining items. 19 individuals (6 core team and 3 expert advisory group members, and 10 expert panellists) attended the virtual face-to-face meeting. Among the nine items discussed, high agreement was reached for the inclusion of three and exclusion of six. Six authors participated in pilot testing, resulting in minor wording changes. The final checklist includes 27 main items (with 19 sub-items) across all stages of an overview of reviews. CONCLUSIONS: PRIOR fills an important gap in reporting guidance for overviews of reviews of healthcare interventions. The checklist, along with rationale and example for each item, provides guidance for authors that will facilitate complete and transparent reporting. This will allow readers to assess the methods used in overviews of reviews of healthcare interventions and understand the trustworthiness and applicability of their findings.

Incidence and outcomes of critical illness in Indigenous Peoples: a systematic review protocol.

BACKGROUND: Indigenous Peoples experience health inequities across the continuum of health services. Improvements for Indigenous patients and their families during vulnerable experiences with the healthcare system may have a significant impact on the patient experience and outcomes. Improved understanding of the occurrence of critical illness in Indigenous Peoples and their use of critical care services, as a strategic priority, may aid in the development of initiatives for improving health equity. A global focus was selected to learn from Indigenous populations' experiences with critical care, as the understanding of critical illness among Indigenous Peoples in Canada is not well understood. This protocol outlines a systematic review focused on describing the incidence of critical illness and utilization of critical care services among Indigenous Peoples. METHODS: Ovid MEDLINE/PubMed, Ovid EMBASE, Google Scholar, and Cochrane Central Register of Controlled Trials will be searched. Relevant Canadian sites for gray literature (National Collaborating Centre for Indigenous Health, First Nations Health Authority, Canadian Institutes of Health Research Institute of Indigenous Peoples' Health, National Association of Friendship Centres, the Alberta First Nations Information Governance Centre, Métis Nation of Alberta) will also be searched. We will include studies of adults (≥18 years) either without critical illness (i.e., general population) or with critical illness (i.e., admitted to an intensive care unit (ICU)). The exposure of interest will be Indigenous identity. Primary outcome measures are ICU admission and ICU mortality. Because heterogeneity in populations, comparisons, and outcome measures is anticipated, it is likely that the findings will be summarized using a narrative synthesis. A meta-analysis will be performed if there is sufficient evidence on one or more outcomes of interest. DISCUSSION: This systematic review will provide a better understanding of the epidemiology, risk factors, and outcomes of critical illness and utilization of critical care services among Indigenous Peoples. The knowledge generated will be applied to a broader program of work designed to create ethical space to co-design, implement, and evaluate a culturally competent, safe, and innovative model for critical care services for Indigenous People. SYSTEMATIC REVIEW REGISTRATION: PROSPERO CRD42021254661.

Consequences of Structural Urbanism: Urban-Rural Differences in Cancer Patients' Use and Perceived Importance of Supportive Care Services from a 2017-2018 Midwestern Survey.

BACKGROUND: Structural inequities, in part, undergird urban-rural differences in cancer care. The current study aims to understand the potential consequences of structural inequities on rural and urban cancer patients' access to and perceived importance of supportive cancer care resources. METHODS: We used data collected from November 2017 to May 2018 from a larger cross-sectional needs assessment about patients' support needs, use of services, and perceptions at a Midwestern United States cancer center. Oncology patients received a study packet during their outpatient clinic visit, and interested patients consented and completed the questionnaires. RESULTS: Among the sample of 326 patients, 27% of the sample was rural. In adjusted logistic regression models, rural patients were less likely to report using any secondary support services (15% vs. 27%; OR = 0.43, 95%CI [0.22, 0.85], p = 0.02) and less likely than urban counterparts to perceive secondary support services as very important (51% vs. 64%; OR = 0.57, 95%CI [0.33, 0.94], p = 0.03). CONCLUSION: Structural inequities likely have implications on the reduced access to and importance of supportive care services observed for rural cancer patients. To eliminate persistent urban-rural disparities in cancer care, rural residents must have programs and policies that address cancer care and structural inequities.

Screening for Gestational Diabetes: Updated Evidence Report and Systematic Review for the US Preventive Services Task Force.

Importance: Gestational diabetes is associated with several poor health outcomes. Objective: To update the 2012 review on screening for gestational diabetes to inform the US Preventive Services Task Force. Data Sources: MEDLINE, EMBASE, and CINAHL (2010 to May 2020), ClinicalTrials.gov, reference lists; surveillance through June 2021. Study Selection: English-language intervention studies for screening and treatment; observational studies on screening; prospective studies on screening test accuracy. Data Extraction and Synthesis: Dual review of titles/abstracts, full-text articles, and study quality. Single-reviewer data abstraction with verification. Random-effects meta-analysis or bivariate analysis (accuracy). Main Outcomes and Measures: Pregnancy, fetal/neonatal, and long-term health outcomes; harms of screening; accuracy. Results: A total of 76 studies were included (18 randomized clinical trials [RCTs] [n = 31 241], 2 nonrandomized intervention studies [n = 190], 56 observational studies [n = 261 678]). Direct evidence on benefits of screening vs no screening was limited to 4 observational studies with inconsistent findings and methodological limitations. Screening was not significantly associated with serious or long-term harm. In 5 RCTs (n = 25 772), 1-step (International Association of Diabetes and Pregnancy Study Group) vs 2-step (Carpenter and Coustan) screening was significantly associated with increased likelihood of gestational diabetes (11.5% vs 4.9%) but no improved health outcomes. At or after 24 weeks of gestation, oral glucose challenge tests with 140- and 135-mg/dL cutoffs had sensitivities of 82% and 93%, respectively, and specificities of 82% and 79%, respectively, against Carpenter and Coustan criteria, and a test with a 140-mg/dL cutoff had sensitivity of 85% and specificity of 81% against the National Diabetes Group Data criteria. Fasting plasma glucose tests with cutoffs of 85 and 90 mg/dL had sensitivities of 88% and 81% and specificities of 73% and 82%, respectively, against Carpenter and Coustan criteria. Based on 8 RCTs and 1 nonrandomized study (n = 3982), treatment was significantly associated with decreased risk of primary cesarean deliveries (relative risk [RR], 0.70 [95% CI, 0.54-0.91]; absolute risk difference [ARD], 5.3%), shoulder dystocia (RR, 0.42 [95% CI, 0.23-0.77]; ARD, 1.3%), macrosomia (RR, 0.53 [95% CI, 0.41-0.68]; ARD, 8.9%), large for gestational age (RR, 0.56 [95% CI, 0.47-0.66]; ARD, 8.4%), birth injuries (odds ratio, 0.33 [95% CI, 0.11-0.99]; ARD, 0.2%), and neonatal intensive care unit admissions (RR, 0.73 [95% CI, 0.53-0.99]; ARD, 2.0%). The association with reduction in preterm deliveries was not significant (RR, 0.75 [95% CI, 0.56-1.01]). Conclusions and Relevance: Direct evidence on screening vs no screening remains limited. One- vs 2-step screening was not significantly associated with improved health outcomes. At or after 24 weeks of gestation, treatment of gestational diabetes was significantly associated with improved health outcomes.

Impact of Psychological Distress on Treatment Timeliness in Oncology Patients at a Safety-Net Hospital.

BACKGROUND: Psychological distress is common in patients with cancer. Distress can affect patients' engagement with treatment. We examined the relationship between psychological distress and treatment timeliness in a sample of adult oncology patients at a safety-net hospital. METHODS: A retrospective review was conducted of all patients screened for distress at a first outpatient oncology visit between March 1, 2014, and December 31, 2015 (n=500). The analytic sample (n=96) included patients with a new cancer diagnosis and a curative-intent treatment plan for lymphoma (stage I-IV), solid tumor malignancy (stage I-III), or head and neck cancer (stage I-IVb). Distress was measured using the Hospital Anxiety and Depression Scale. Using Poisson regression, we determined the effects of depression and anxiety on treatment timeliness. Patient age, sex, race/ethnicity, insurance type, cancer site, and cancer stage were included as covariates. RESULTS: Mean patient age was 54 years. The median treatment initiation interval was 28 days. Clinically significant anxiety was present in 34% of the sample, and clinically significant depression in 15%. Greater symptom severity in both anxiety and depression were associated with a longer treatment initiation interval after controlling for demographics and disease factors. The average days to treatment (DTT) was 4 days longer for patients with elevated anxiety scores and for those with elevated depression scores compared with those without. Overall survival was not associated with anxiety, depression, or DTT. CONCLUSIONS: In this safety-net patient sample, greater psychological distress was associated with slower time to treatment. As of writing, this is a new finding in the literature, and as such, replication studies utilizing diverse samples and distress measurement tools are needed.

Creating efficiencies in the extraction of data from randomized trials: a prospective evaluation of a machine learning and text mining tool.

BACKGROUND: Machine learning tools that semi-automate data extraction may create efficiencies in systematic review production. We evaluated a machine learning and text mining tool's ability to (a) automatically extract data elements from randomized trials, and (b) save time compared with manual extraction and verification. METHODS: For 75 randomized trials, we manually extracted and verified data for 21 data elements. We uploaded the randomized trials to an online machine learning and text mining tool, and quantified performance by evaluating its ability to identify the reporting of data elements (reported or not reported), and the relevance of the extracted sentences, fragments, and overall solutions. For each randomized trial, we measured the time to complete manual extraction and verification, and to review and amend the data extracted by the tool. We calculated the median (interquartile range [IQR]) time for manual and semi-automated data extraction, and overall time savings. RESULTS: The tool identified the reporting (reported or not reported) of data elements with median (IQR) 91% (75% to 99%) accuracy. Among the top five sentences for each data element at least one sentence was relevant in a median (IQR) 88% (83% to 99%) of cases. Among a median (IQR) 90% (86% to 97%) of relevant sentences, pertinent fragments had been highlighted by the tool; exact matches were unreliable (median (IQR) 52% [33% to 73%]). A median 48% of solutions were fully correct, but performance varied greatly across data elements (IQR 21% to 71%). Using ExaCT to assist the first reviewer resulted in a modest time savings compared with manual extraction by a single reviewer (17.9 vs. 21.6 h total extraction time across 75 randomized trials). CONCLUSIONS: Using ExaCT to assist with data extraction resulted in modest gains in efficiency compared with manual extraction. The tool was reliable for identifying the reporting of most data elements. The tool's ability to identify at least one relevant sentence and highlight pertinent fragments was generally good, but changes to sentence selection and/or highlighting were often required. PROTOCOL: https://doi.org/10.7939/DVN/RQPJKS.

Risk factors for severity of COVID-19: a rapid review to inform vaccine prioritisation in Canada.

OBJECTIVES: Rapid review to determine the magnitude of association between potential risk factors and severity of COVID-19, to inform vaccine prioritisation in Canada. SETTING: Ovid MEDLINE(R) ALL, Epistemonikos COVID-19 in L·OVE Platform, McMaster COVID-19 Evidence Alerts and websites were searched to 15 June 2020. Eligible studies were conducted in high-income countries and used multivariate analyses. PARTICIPANTS: After piloting, screening, data extraction and quality appraisal were performed by a single experienced reviewer. Of 3740 unique records identified, 34 were included that reported on median 596 (range 44-418 794) participants, aged 42-84 years. 19/34 (56%) were good quality. OUTCOMES: Hospitalisation, intensive care unit admission, length of stay in hospital or intensive care unit, mechanical ventilation, severe disease, mortality. RESULTS: Authors synthesised findings narratively and appraised the certainty of the evidence for each risk factor-outcome association. There was low or moderate certainty evidence for a large (≥2-fold) magnitude of association between hospitalisation in people with COVID-19, and: obesity class III, heart failure, diabetes, chronic kidney disease, dementia, age >45 years, male gender, black race/ethnicity (vs non-Hispanic white), homelessness and low income. Age >60 and >70 years may be associated with large increases in mechanical ventilation and severe disease, respectively. For mortality, a large magnitude of association may exist with liver disease, Bangladeshi ethnicity (vs British white), age >45 years, age >80 years (vs 65-69 years) and male gender among 20-64 years (but not older). Associations with hospitalisation and mortality may be very large (≥5-fold) for those aged ≥60 years. CONCLUSIONS: Increasing age (especially >60 years) may be the most important risk factor for severe outcomes. High-quality primary research accounting for multiple confounders is needed to better understand the magnitude of associations for severity of COVID-19 with several other factors. PROSPERO REGISTRATION NUMBER: CRD42020198001.

Screening for chlamydia and/or gonorrhea in primary health care: systematic reviews on effectiveness and patient preferences.

BACKGROUND: We conducted systematic reviews on the benefits and harms of screening compared with no screening or alternative screening approaches for Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG) in non-pregnant sexually active individuals, and on the relative importance patients' place on the relevant outcomes. Findings will inform recommendations by the Canadian Task Force on Preventive Health Care. METHODS: We searched five databases (to January 24, 2020), trial registries, conference proceedings, and reference lists for English and French literature published since 1996. Screening, study selection, and risk of bias assessments were independently undertaken by two reviewers, with consensus for final decisions. Data extraction was conducted by one reviewer and checked by another for accuracy and completeness. Meta-analysis was conducted where appropriate. We used the GRADE approach to rate the certainty of the evidence. The Task Force and content experts provided input on determining thresholds for important effect sizes and on interpretation of findings. RESULTS: Of 41 included studies, 17 and 11 reported on benefits and harms of screening, respectively, and 14 reported on patient preferences. Universal screening for CT in general populations 16 to 29 years of age, using population-based or opportunistic approaches achieving low screening rates, may make little-to-no difference for a female's risk of pelvic inflammatory disease (PID) (2 RCTs, n=141,362; 0.3 more in 1000 [7.6 fewer to 11 more]) or ectopic pregnancy (1 RCT, n=15,459; 0.20 more per 1000 [2.2 fewer to 3.9 more]). It may also not make a difference for CT transmission (3 RCTs, n=41,709; 3 fewer per 1000 [11.5 fewer to 6.9 more]). However, benefits may be achieved for reducing PID if screening rates are increased (2 trials, n=30,652; 5.7 fewer per 1000 [10.8 fewer to 1.1 more]), and for reducing CT and NG transmission when intensely screening high-prevalence female populations (2 trials, n=6127; 34.3 fewer per 1000 [4 to 58 fewer]; NNS 29 [17 to 250]). Evidence on infertility in females from CT screening and on transmission of NG in males and both sexes from screening for CT and NG is very uncertain. No evidence was found for cervicitis, chronic pelvic pain, or infertility in males from CT screening, or on any clinical outcomes from NG screening. Undergoing screening, or having a diagnosis of CT, may cause a small-to-moderate number of people to experience some degree of harm, mainly due to feelings of stigmatization and anxiety about future infertility risk. The number of individuals affected in the entire screening-eligible population is likely smaller. Screening may make little-to-no difference for general anxiety, self-esteem, or relationship break-up. Evidence on transmission from studies comparing home versus clinic screening is very uncertain. Four studies on patient preferences found that although utility values for the different consequences of CT and NG infections are probably quite similar, when considering the duration of the health state experiences, infertility and chronic pelvic pain are probably valued much more than PID, ectopic pregnancy, and cervicitis. How patients weigh the potential benefits versus harms of screening is very uncertain (1 survey, 10 qualitative studies); risks to reproductive health and transmission appear to be more important than the (often transient) psychosocial harms. DISCUSSION: Most of the evidence on screening for CT and/or NG offers low or very low certainty about the benefits and harms. Indirectness from use of comparison groups receiving some screening, incomplete outcome ascertainment, and use of outreach settings was a major contributor to uncertainty. Patient preferences indicate that the potential benefits from screening appear to outweigh the possible harms. Direct evidence about which screening strategies and intervals to use, which age to start and stop screening, and whether screening males in addition to females is necessary to prevent clinical outcomes is scarce, and further research in these areas would be informative. Apart from the evidence in this review, information on factors related to equity, acceptability, implementation, cost/resources, and feasibility will support recommendations made by the Task Force. SYSTEMATIC REVIEW REGISTRATION: International Prospective Register of Systematic Reviews (PROSPERO), registration number CRD42018100733 .

LOCATE: a prospective evaluation of the value of Leveraging Ongoing Citation Acquisition Techniques for living Evidence syntheses.

BACKGROUND: Living systematic reviews (LSRs) can expedite evidence synthesis by incorporating new evidence in real time. However, the methods needed to identify new studies in a timely manner are not well established. OBJECTIVES: To explore the value of complementary search approaches in terms of search performance, impact on results and conclusions, screening workload, and feasibility compared to the reference standard. METHODS: We developed three complementary search approaches for a systematic review on treatments for bronchiolitis: Automated Full Search, PubMed Similar Articles, and Scopus Citing References. These were automated to retrieve results monthly; pairs of reviewers screened the records and commented on feasibility. After 1 year, we conducted a full update search (reference standard). For each complementary approach, we compared search performance (proportion missed, number needed to read [NNR]) and reviewer workload (number of records screened, time required) to the reference standard. We investigated the impact of the new trials on the effect estimate and certainty of evidence for the primary outcomes. We summarized comments about feasibility. RESULTS: Via the reference standard, reviewers screened 505 titles/abstracts, 24 full texts, and identified four new trials (NNR 127; 12.4 h). Of the complementary approaches, only the Automated Full Search located all four trials; these were located 6 to 12 months sooner than via the reference standard but did not alter the results nor certainty in the evidence. The Automated Full Search was the most resource-intensive approach (816 records screened; NNR 204; 17.1 h). The PubMed Similar Articles and Scopus Citing References approaches located far fewer records (452 and 244, respectively), thereby requiring less screening time (9.4 and 5.2 h); however, each approach located only one of the four new trials. Reviewers found it feasible and convenient to conduct monthly screening for searches of this yield (median 15-65 records/month). CONCLUSIONS: The Automated Full Search was the most resource-intensive approach, but also the only to locate all of the newly published trials. Although the monthly screening time for the PubMed Similar Articles and Scopus Citing Articles was far less, most relevant records were missed. These approaches were feasible to integrate into reviewer work processes. SYSTEMATIC REVIEW REGISTRATION: Open Science Framework. https://doi.org/10.17605/OSF.IO/6M28H .

A systematic review of factors that influence the acceptability of vaccines among Canadians.

BACKGROUND: Canada's National Advisory Committee on Immunization (NACI) provides guidance on the use of vaccines in Canada. To support the expansion of its mandate to include considerations for vaccine acceptability when making recommendations, the NACI Secretariat developed a matrix of factors that influence acceptability. To inform and validate the matrix, we systematically reviewed evidence for factors that influence vaccine acceptability, and for interventions aimed at improving acceptability. METHODS: On 10-11 October 2018 we searched four bibliographic databases, the Theses Canada Portal, and ClinicalTrials.gov. Two reviewers agreed on the included studies. From each study, we extracted information about the participants, intervention or exposure, comparator, and relevant outcomes. Due to heterogeneity in the reported factors and acceptability indicators we synthesized the findings narratively. We appraised the certainty of evidence using GRADE. For each vaccine-preventable disease we populated a matrix of factors for which there was evidence of an influence on acceptability. RESULTS: One hundred studies (>1 million participants) contributed data relevant to the public, 16 (6191 participants) to healthcare providers, and three (84 participants) to policymakers. There were 43 intervention studies (~2 million participants). Across vaccines, we identified low certainty evidence for 70 factors relevant to the general population, 56 to high-risk groups, and 30 to healthcare providers. The perceived safety and importance of the vaccine, vaccination history, and receiving a recommendation from a healthcare provider were common influential factors. We found low certainty evidence that reminders for childhood vaccines and policies or delivery models for rotavirus vaccines could improve uptake and coverage. Evidence for other interventions was of very low certainty. CONCLUSIONS: The NACI vaccine acceptability matrix is useful for categorizing acceptability factors for the general public. Reminder systems may improve the uptake of childhood vaccines. Policies that make the rotavirus vaccine universally available and easily accessible may improve coverage. FUNDING: This systematic review was completed under contract to the Public Health Agency of Canada, Contract #4600001536.

Decoding semi-automated title-abstract screening: findings from a convenience sample of reviews.

BACKGROUND: We evaluated the benefits and risks of using the Abstrackr machine learning (ML) tool to semi-automate title-abstract screening and explored whether Abstrackr's predictions varied by review or study-level characteristics. METHODS: For a convenience sample of 16 reviews for which adequate data were available to address our objectives (11 systematic reviews and 5 rapid reviews), we screened a 200-record training set in Abstrackr and downloaded the relevance (relevant or irrelevant) of the remaining records, as predicted by the tool. We retrospectively simulated the liberal-accelerated screening approach. We estimated the time savings and proportion missed compared with dual independent screening. For reviews with pairwise meta-analyses, we evaluated changes to the pooled effects after removing the missed studies. We explored whether the tool's predictions varied by review and study-level characteristics. RESULTS: Using the ML-assisted liberal-accelerated approach, we wrongly excluded 0 to 3 (0 to 14%) records that were included in the final reports, but saved a median (IQR) 26 (9, 42) h of screening time. One missed study was included in eight pairwise meta-analyses in one systematic review. The pooled effect for just one of those meta-analyses changed considerably (from MD (95% CI) - 1.53 (- 2.92, - 0.15) to - 1.17 (- 2.70, 0.36)). Of 802 records in the final reports, 87% were correctly predicted as relevant. The correctness of the predictions did not differ by review (systematic or rapid, P = 0.37) or intervention type (simple or complex, P = 0.47). The predictions were more often correct in reviews with multiple (89%) vs. single (83%) research questions (P = 0.01), or that included only trials (95%) vs. multiple designs (86%) (P = 0.003). At the study level, trials (91%), mixed methods (100%), and qualitative (93%) studies were more often correctly predicted as relevant compared with observational studies (79%) or reviews (83%) (P = 0.0006). Studies at high or unclear (88%) vs. low risk of bias (80%) (P = 0.039), and those published more recently (mean (SD) 2008 (7) vs. 2006 (10), P = 0.02) were more often correctly predicted as relevant. CONCLUSION: Our screening approach saved time and may be suitable in conditions where the limited risk of missing relevant records is acceptable. Several of our findings are paradoxical and require further study to fully understand the tasks to which ML-assisted screening is best suited. The findings should be interpreted in light of the fact that the protocol was prepared for the funder, but not published a priori. Because we used a convenience sample, the findings may be prone to selection bias. The results may not be generalizable to other samples of reviews, ML tools, or screening approaches. The small number of missed studies across reviews with pairwise meta-analyses hindered strong conclusions about the effect of missed studies on the results and conclusions of systematic reviews.

Guidance for overviews of reviews continues to accumulate, but important challenges remain: a scoping review.

BACKGROUND: Overviews of reviews (overviews) provide an invaluable resource for healthcare decision-making by combining large volumes of systematic review (SR) data into a single synthesis. The production of high-quality overviews hinges on the availability of practical evidence-based guidance for conduct and reporting. OBJECTIVES: Within the broad purpose of informing the development of a reporting guideline for overviews, we aimed to provide an up-to-date map of existing guidance related to the conduct of overviews, and to identify common challenges that authors face when undertaking overviews. METHODS: We updated a scoping review published in 2016 using the search methods that had produced the highest yield: ongoing reference tracking (2014 to March 2020 in PubMed, Scopus, and Google Scholar), hand-searching conference proceedings and websites, and contacting authors of published overviews. Using a qualitative meta-summary approach, one reviewer extracted, organized, and summarized the guidance and challenges presented within the included documents. A second reviewer verified the data and synthesis. RESULTS: We located 28 new guidance documents, for a total of 77 documents produced by 34 research groups. The new guidance helps to resolve some earlier identified challenges in the production of overviews. Important developments include strengthened guidance on handling primary study overlap at the study selection and analysis stages. Despite marked progress, several areas continue to be hampered by inconsistent or lacking guidance. There is ongoing debate about whether, when, and how supplemental primary studies should be included in overviews. Guidance remains scant on how to extract and use appraisals of quality of the primary studies within the included SRs and how to adapt GRADE methodology to overviews. The challenges that overview authors face are often related to the above-described steps in the process where evidence-based guidance is lacking or conflicting. CONCLUSION: The rising popularity of overviews has been accompanied by a steady accumulation of new, and sometimes conflicting, guidance. While recent guidance has helped to address some of the challenges that overview authors face, areas of uncertainty remain. Practical tools supported by empirical evidence are needed to assist authors with the many methodological decision points that are encountered in the production of overviews.

The semi-automation of title and abstract screening: a retrospective exploration of ways to leverage Abstrackr's relevance predictions in systematic and rapid reviews.

BACKGROUND: We investigated the feasibility of using a machine learning tool's relevance predictions to expedite title and abstract screening. METHODS: We subjected 11 systematic reviews and six rapid reviews to four retrospective screening simulations (automated and semi-automated approaches to single-reviewer and dual independent screening) in Abstrackr, a freely-available machine learning software. We calculated the proportion missed, workload savings, and time savings compared to single-reviewer and dual independent screening by human reviewers. We performed cited reference searches to determine if missed studies would be identified via reference list scanning. RESULTS: For systematic reviews, the semi-automated, dual independent screening approach provided the best balance of time savings (median (range) 20 (3-82) hours) and reliability (median (range) proportion missed records, 1 (0-14)%). The cited references search identified 59% (n = 10/17) of the records missed. For the rapid reviews, the fully and semi-automated approaches saved time (median (range) 9 (2-18) hours and 3 (1-10) hours, respectively), but less so than for the systematic reviews. The median (range) proportion missed records for both approaches was 6 (0-22)%. CONCLUSION: Using Abstrackr to assist one of two reviewers in systematic reviews saves time with little risk of missing relevant records. Many missed records would be identified via other means.

Quality and risk of bias appraisals of systematic reviews are inconsistent across reviewers and centers.

OBJECTIVE: The objective of the study was to evaluate the inter-rater and intercenter reliability, usability, and utility of A MeaSurement Tool to Assess systematic Reviews (AMSTAR), AMSTAR 2, and Risk Of Bias In Systematic reviews (ROBIS). STUDY DESIGN AND SETTING: This is a prospective evaluation using 30 systematic reviews of randomized trials, undertaken at three international centers. RESULTS: Reviewers completed AMSTAR, AMSTAR 2, and ROBIS in median (interquartile range) 15.7 (11.3), 19.7 (12.1), and 28.7 (17.4) minutes and reached consensus in 2.6 (3.2), 4.6 (5.3), and 10.9 (10.8) minutes, respectively. Across all centers, inter-rater reliability was substantial to almost perfect for 8/11 AMSTAR, 9/16 AMSTAR 2, and 12/24 ROBIS items. Intercenter reliability was substantial to almost perfect for 6/11 AMSTAR, 12/16 AMSTAR 2, and 7/24 ROBIS items. Intercenter reliability for confidence in the results of the review or overall risk of bias was moderate (Gwet's first-order agreement coefficient (AC1) 0.58, 95% confidence intervals [CI]: 0.30 to 0.85) to substantial (AC1 0.74, 95% CI: 0.30 to 0.85) for AMSTAR 2 and poor (AC1 -0.21, 95% CI: -0.55 to 0.13) to moderate (AC1 0.56, 95% CI: 0.30 to 0.83) for ROBIS. It is not clear whether using the appraisals of any tool as an inclusion criterion would alter an overview's findings. CONCLUSIONS: Improved guidance may be needed to facilitate the consistent interpretation and application of the newer tools (especially ROBIS).

Digital Technology Distraction for Acute Pain in Children: A Meta-analysis.

CONTEXT: Digital distraction is being integrated into pediatric pain care, but its efficacy is currently unknown. OBJECTIVE: To determine the effect of digital technology distraction on pain and distress in children experiencing acutely painful conditions or procedures. DATA SOURCES: Medline, Embase, Cochrane Library, Cumulative Index to Nursing and Allied Health Literature, PsycINFO, Institute of Electrical and Electronics Engineers Xplore, Ei Compendex, Web of Science, and gray literature sources. STUDY SELECTION: Quantitative studies of digital technology distraction for acutely painful conditions or procedures in children. DATA EXTRACTION: Performed by 1 reviewer with verification. Outcomes were child pain and distress. RESULTS: There were 106 studies (n = 7820) that reported on digital technology distractors (eg, virtual reality and video games) used during common procedures (eg, venipuncture, dental, and burn treatments). No studies reported on painful conditions. For painful procedures, digital distraction resulted in a modest but clinically important reduction in self-reported pain (standardized mean difference [SMD] -0.48; 95% confidence interval [CI] -0.66 to -0.29; 46 randomized controlled trials [RCTs]; n = 3200), observer-reported pain (SMD -0.68; 95% CI -0.91 to -0.45; 17 RCTs; n = 1199), behavioral pain (SMD -0.57; 95% CI -0.94 to -0.19; 19 RCTs; n = 1173), self-reported distress (SMD -0.49; 95% CI -0.70 to -0.27; 19 RCTs; n = 1818), observer-reported distress (SMD -0.47; 95% CI -0.77 to -0.17; 10 RCTs; n = 826), and behavioral distress (SMD -0.35; 95% CI -0.59 to -0.12; 17 RCTs; n = 1264) compared with usual care. LIMITATIONS: Few studies directly compared different distractors or provided subgroup data to inform applicability. CONCLUSIONS: Digital distraction provides modest pain and distress reduction for children undergoing painful procedures; its superiority over nondigital distractors is not established. Context, preferences, and availability should inform the choice of distractor.

Preferred Reporting Items for Overviews of Reviews (PRIOR): a protocol for development of a reporting guideline for overviews of reviews of healthcare interventions.

BACKGROUND: Overviews of reviews (i.e., overviews) compile information from multiple systematic reviews to provide a single synthesis of relevant evidence for healthcare decision-making. Despite their increasing popularity, there are currently no systematically developed reporting guidelines for overviews. This is problematic because the reporting of published overviews varies considerably and is often substandard. Our objective is to use explicit, systematic, and transparent methods to develop an evidence-based and agreement-based reporting guideline for overviews of reviews of healthcare interventions (PRIOR, Preferred Reporting Items for Overviews of Reviews). METHODS: We will develop the PRIOR reporting guideline in four stages, using established methods for developing reporting guidelines in health research. First, we will establish an international and multidisciplinary expert advisory board that will oversee the conduct of the project and provide methodological support. Second, we will use the results of comprehensive literature reviews to develop a list of prospective checklist items for the reporting guideline. Third, we will use a modified Delphi exercise to achieve a high level of expert agreement on the list of items to be included in the PRIOR reporting guideline. We will identify and recruit a group of up to 100 international experts who will provide input into the guideline in three Delphi rounds: the first two rounds will occur via online survey, and the third round will occur during a smaller (8 to 10 participants) in-person meeting that will use a nominal group technique. Fourth, we will produce and publish the PRIOR reporting guideline. DISCUSSION: A systematically developed reporting guideline for overviews could help to improve the accuracy, completeness, and transparency of overviews. This, in turn, could help maximize the value and impact of overviews by allowing more efficient interpretation and use of their research findings.

Screening to prevent fragility fractures among adults 40 years and older in primary care: protocol for a systematic review.

PURPOSE: To inform recommendations by the Canadian Task Force on Preventive Health Care by systematically reviewing direct evidence on the effectiveness and acceptability of screening adults 40 years and older in primary care to reduce fragility fractures and related mortality and morbidity, and indirect evidence on the accuracy of fracture risk prediction tools. Evidence on the benefits and harms of pharmacological treatment will be reviewed, if needed to meaningfully influence the Task Force's decision-making. METHODS: A modified update of an existing systematic review will evaluate screening effectiveness, the accuracy of screening tools, and treatment benefits. For treatment harms, we will integrate studies from existing systematic reviews. A de novo review on acceptability will be conducted. Peer-reviewed searches (Medline, Embase, Cochrane Library, PsycINFO [acceptability only]), grey literature, and hand searches of reviews and included studies will update the literature. Based on pre-specified criteria, we will screen studies for inclusion following a liberal-accelerated approach. Final inclusion will be based on consensus. Data extraction for study results will be performed independently by two reviewers while other data will be verified by a second reviewer; there may be some reliance on extracted data from the existing reviews. The risk of bias assessments reported in the existing reviews will be verified and for new studies will be performed independently. When appropriate, results will be pooled using either pairwise random effects meta-analysis (screening and treatment) or restricted maximum likelihood estimation with Hartun-Knapp-Sidnick-Jonkman correction (risk prediction model calibration). Subgroups of interest to explain heterogeneity are age, sex, and menopausal status. Two independent reviewers will rate the certainty of evidence using the GRADE approach, with consensus reached for each outcome rated as critical or important by the Task Force. DISCUSSION: Since the publication of other guidance in Canada, new trials have been published that are likely to improve understanding of screening in primary care settings to prevent fragility fractures. A systematic review is required to inform updated recommendations that align with the current evidence base.