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.

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.

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.

Effectiveness and Accuracy of Tests for Preterm Delivery in Symptomatic Women: A Systematic Review.

This study systematically reviewed evidence on the effectiveness and accuracy of predictive tests for preterm delivery among symptomatic women. The study included English-language systematic reviews (SRs) on any predictive test for preterm delivery among symptomatic women and primary studies for placental alpha-microglobulin-1. PubMed, Wiley Cochrane Library, the Centre for Reviews and Dissemination Database, the National Guidelines Clearinghouse, and the TRIP database were searched for SRs, PubMed and PubMed Central via the Wiley Cochrane Library were searched for primary studies. One reviewer performed study selection, with input from a second reviewer when needed. One reviewer appraised study quality and extracted: study characteristics (i.e., country, funding source, study design [primary studies] or synthesis method [SRs], study appraisal method [SRs]), population characteristics, index test(s) and cut-off points used, comparator(s) or reference standard(s), and outcomes. A second reviewed a random 10% sample. The authors synthesized the findings narratively. Of 451 unique records, the review included 22 (17 SRs, five primary studies). For effectiveness, there was evidence for use of transvaginal sonographic cervical length assessment (15-25 mm cut point) in reducing incidence of preterm delivery at <37 weeks (relative risk 0.64; 95% CI 0.44-0.94, one SR of three trials; n = 287) but lack of support for cervicovaginal fetal fibronectin. In terms of accuracy, one high-quality study within a best-evidence SR showed that cervical length measurement was useful to predict delivery within 48 hours (LR+ 6.43, 95% CI 5.17-8.00; LR- 0.03, 95% CI 0.00-0.42; n = 510) and 7 days (LR+ 8.61, 95% CI 6.65-11.14; LR- 0.03, 95% CI 0.00-0.18; n = 510). Accuracy of placental alpha-microglobulin-1 testing was not supported for most end points. In conclusion, some evidence supports the effectiveness of cervical length as a predictor of preterm delivery in symptomatic women. Evidence for most tests is limited in quality and quantity.

A descriptive analysis of non-Cochrane child-relevant systematic reviews published in 2014.

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.

Glucocorticoids for croup in children.

BACKGROUND: Glucocorticoids are commonly used for croup in children. This is an update of a Cochrane Review published in 1999 and previously updated in 2004 and 2011. OBJECTIVES: To examine the effects of glucocorticoids for the treatment of croup in children aged 0 to 18 years. SEARCH METHODS: We searched the Cochrane Central Register of Controlled Trials (CENTRAL) (the Cochrane Library, Issue 2, 2018), which includes the Cochrane Acute Respiratory Infections Group's Specialised Register, Ovid MEDLINE Epub Ahead of Print, In-Process & Other Non-Indexed Citations and Ovid MEDLINE (1946 to 3 April 2018), and Embase (Ovid) (1996 to 3 April 2018, week 14), and the trials registers ClinicalTrials.gov (3 April 2018) and the World Health Organization International Clinical Trials Registry Platform (ICTRP, 3 April 2018). We scanned the reference lists of relevant systematic reviews and of the included studies. SELECTION CRITERIA: We included randomised controlled trials (RCTs) that investigated children aged 0 to 18 years with croup and measured the effects of glucocorticoids, alone or in combination, compared to placebo or another pharmacologic treatment. The studies needed to report at least one of our primary or secondary outcomes: change in croup score; return visits, (re)admissions or both; length of stay; patient improvement; use of additional treatments; and adverse events. DATA COLLECTION AND ANALYSIS: One author extracted data from each study and another verified the extraction. We entered the data into Review Manager 5 for meta-analysis. Two review authors independently assessed risk of bias for each study using the Cochrane 'Risk of bias' tool and the certainty of the body of evidence for the primary outcomes using the GRADE approach. MAIN RESULTS: We added five new RCTs with 330 children. This review now includes 43 RCTs with a total of 4565 children. We assessed most (98%) studies as at high or unclear risk of bias. Compared to placebo, glucocorticoids improved symptoms of croup at two hours (standardised mean difference (SMD) -0.65, 95% confidence interval (CI) -1.13 to -0.18; 7 RCTs; 426 children; moderate-certainty evidence), and the effect lasted for at least 24 hours (SMD -0.86, 95% CI -1.40 to -0.31; 8 RCTs; 351 children; low-certainty evidence). Compared to placebo, glucocorticoids reduced the rate of return visits or (re)admissions or both (risk ratio 0.52, 95% CI 0.36 to 0.75; 10 RCTs; 1679 children; moderate-certainty evidence). Glucocorticoid treatment reduced the length of stay in hospital by about 15 hours (mean difference -14.90, 95% CI -23.58 to -6.22; 8 RCTs; 476 children). Serious adverse events were infrequent. Publication bias was not evident. Uncertainty remains with regard to the optimal type, dose, and mode of administration of glucocorticoids for reducing croup symptoms in children. AUTHORS' CONCLUSIONS: Glucocorticoids reduced symptoms of croup at two hours, shortened hospital stays, and reduced the rate of return visits to care. Our conclusions have changed, as the previous version of this review reported that glucocorticoids reduced symptoms of croup within six hours.

Peer-led nutrition education programs for school-aged youth: a systematic review of the literature.

To date, the impacts of school-based, peer-led nutrition education initiatives have not been summarized or assessed collectively. This review presents the current evidence, identifies knowledge gaps, and provides recommendations for future research. PubMed, Scopus, ERIC and Google Scholar were searched for refereed Canadian and American primary studies published between January 2000 and November 2013, following Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. Seventeen articles (11 programs) from Canada (24%) and the United States (76%) were identified. The results were summarized in terms of the study population, program design and main outcomes. Common outcome measures included healthy eating knowledge (n = 5), self-efficacy or attitudes towards healthy eating (n = 13), dietary measures (n = 9) and body mass index (n = 4), all of which tended to improve as a result of the programs. More research is needed to ascertain the effect of improvements in knowledge, self-efficacy and attitudes towards healthy eating on food behaviors. When evaluated, programs were generally well received, while the long-term maintenance of positive impacts was a challenge. Studies of sustainability and feasibility to promote long-term impact are a logical next step.

Physical Activity and Fitness of First Nations Youth in a Remote and Isolated Northern Ontario Community: A Needs Assessment.

Among a group of First Nations youth, this research aimed to obtain objective measures of anthropometry, physical activity (PA) and fitness; to identify any group-level differences by sex, body mass index, waist circumference and body fat categories; to assess the barriers and supports to PA. Youth participated in anthropometric measures (BMI, waist circumference, body fat percentage), PA assessment (3 days of accelerometry) and fitness testing (guided by the Canadian Physical Activity, Fitness and Lifestyle Approach). Barriers and supports were assessed via environmental scan and focus groups. Descriptive statistics were compared to reference data. Group differences by sex, BMI status, waist circumference and body fat categories were tested using Mann-Whitney U and Chi square tests (p ≤ 0.05). Qualitative data were assembled into one file and coded manually for categories and themes. Seventy-two youth (12.1 ± 1.1 years, 61.1% male) participated in at least one measure; 36 completed the accelerometry. Sixty-three percent were overweight or obese, 51% were abdominally obese and 21% had excess body fat. Most (86.1%) met Canada's PA guidelines. Boys were more active than girls (p = 0.025) and had greater cardiorespiratory endurance (p = 0.003). Overweight, obese, or abdominally obese youth had lower cardiorespiratory endurance than normal weight youth (p < 0.001). Barriers and supports fell under the main themes: motivation, role models, personnel and facilities, environment and programs. Based on this assessment, youth in this community are active, but not sufficiently physically fit, especially among those affected by obesity and abdominal obesity. The findings, in addition to the numerous barriers to PA, support the community's desire for school-based PA programming.

Body weight perceptions and eating-related weight control behaviors of on-reserve First Nations youth from Ontario, Canada.

INTRODUCTION: Research investigating the body weight perceptions and eating-related weight control behaviors of First Nations (FN) youth living on reserve in Canada has been scarce. Knowledge of body weight perceptions may help to improve the relevance of initiatives promoting healthy weights. The purpose of this study was to examine the body weight perceptions and eating-related weight control behaviors of grade 6-8 on-reserve FN youth from seven Ontario communities. METHODS: Data were collected from December 2003 to June 2010 from a convenience sample of FN youth (aged 10-14 years) using the Waterloo Web-based Eating Behaviour Questionnaire (WEB-Q). Participants were categorized into body mass index (BMI) categories based on International Obesity Task Force (IOTF) cut points. Frequency statistics were computed in the comparison of measured BMI and weight perceptions and weight control behaviors. Differences by BMI category were tested using Pearson Χ2 tests. RESULTS: A total of 267 youth from seven Ontario FN communities participated in the study (48.6% male). Overall, 36.3% of youth were overweight and 21.3% were obese (combined total of 57.6%). Similar to non-Aboriginal youth, a greater proportion of FN girls who were at a normal weight were concerned that their weight was too high compared to boys. However, one-third of normal weight boys were currently trying to lose weight. A greater proportion of obese girls were trying to lose weight compared to boys. Overall, a large proportion of both overweight boys and girls were attempting to gain weight. CONCLUSIONS: The present study provides a unique investigation into the weight perceptions and weight control behaviors of on-reserve FN youth living in isolated communities in Ontario, Canada. Many of the perceptions elucidated in this study are similar to those observed in non-Aboriginal youth, while others differed. The knowledge of these perceptions and further research to investigate what factors influences them will help to customize health promoting initiatives that are relevant to the youth in the participating communities.

Intakes of milk and alternatives among on-reserve First Nations youth in northern and southern Ontario, Canada.

OBJECTIVE: To assess the adequacy of milk and alternatives, Ca and vitamin D intakes in First Nations (FN) youth in Ontario, Canada. Intakes were compared with the general population and dietary standards. Variation in intakes by community (proxy for remoteness) and BMI was examined. DESIGN: Data were collected by 24 h recall between November 2003 and June 2010. Intakes were analysed descriptively. Variation in intakes, by community and BMI category, was assessed using ANOVA. SETTING: Five remote FN communities of the Mushkegowuk Territory (northern Ontario, Canada) and two less-remote southern Ontario FN communities. SUBJECTS: Schoolchildren (n 457) in grades 6 to 12. RESULTS: Compared with Canada's Food Guide recommendations, 72.6 to 84.7% had an inadequate intake of milk and alternatives depending on age and sex group; 86.2% of individuals fell below the RDA for Ca; 96.4% fell below the RDA for vitamin D. Community variation in intakes was detected, although in all cases Fort Albany had higher intakes, even when it was the more northern (remote) community. A BMI × sex interaction was found for intake of milk and alternatives (P = 0.041): an inverse relationship between intake and BMI was seen in females; in males, those who were overweight had the highest intake, followed by normal-weight and obese youth. CONCLUSIONS: The nutritional inadequacies parallel the results of other Canadian studies of Aboriginal populations. Population health interventions to improve intakes are warranted. Moreover, community variation in intakes exists among FN youth in the present study (Fort Albany pairs only), but results were not as expected.

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 fragility fracture 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.

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.

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.

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.

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 .

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.

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.