Screening for lung cancer with computed tomography: protocol for systematic reviews for the Canadian Task Force on Preventive Health Care.

PURPOSE: Lung cancer is the leading cause of cancer deaths in Canada, and because early cancers are often asymptomatic screening aims to prevent mortality by detecting cancer earlier when treatment is more likely to be curative. These reviews will inform updated recommendations by the Canadian Task Force on Preventive Health Care on screening for lung cancer. METHODS: We will update the review on the benefits and harms of screening with CT conducted for the task force in 2015 and perform de novo reviews on the comparative effects between (i) trial-based selection criteria and use of risk prediction models and (ii) trial-based nodule classification and different nodule classification systems and on patients' values and preferences. We will search Medline, Embase, and Cochrane Central (for questions on benefits and harms from 2015; comparative effects from 2012) and Medline, Scopus, and EconLit (for values and preferences from 2012) via peer-reviewed search strategies, clinical trial registries, and the reference lists of included studies and reviews. Two reviewers will screen all citations (including those in the previous review) and base inclusion decisions on consensus or arbitration by another reviewer. For benefits (i.e., all-cause and cancer-specific mortality and health-related quality of life) and harms (i.e., overdiagnosis, false positives, incidental findings, psychosocial harms from screening, and major complications and mortality from invasive procedures as a result of screening), we will include studies of adults in whom lung cancer is not suspected. We will include randomized controlled trials comparing CT screening with no screening or alternative screening modalities (e.g., chest radiography) or strategies (e.g., CT using different screening intervals, classification systems, and/or patient selection via risk models or biomarkers); non-randomized studies, including modeling studies, will be included for the comparative effects between trial-based and other selection criteria or nodule classification methods. For harms (except overdiagnosis) we will also include non-randomized and uncontrolled studies. For values and preferences, the study design may be any quantitative design that either directly or indirectly measures outcome preferences on outcomes pertaining to lung cancer screening. We will only include studies conducted in Very High Human Development Countries and having full texts in English or French. Data will be extracted by one reviewer with verification by another, with the exception of result data on mortality and cancer incidence (for calculating overdiagnosis) where duplicate extraction will occur. If two or more studies report on the same comparison and it is deemed suitable, we will pool continuous data using a mean difference or standardized mean difference, as applicable, and binary data using relative risks and a DerSimonian and Laird model unless events are rare (< 1%) where we will pool odds ratios using Peto's method or (if zero events) the reciprocal of the opposite treatment arm size correction. For pooling proportions, we will apply suitable transformation (logit or arcsine) depending on the proportions of events. If meta-analysis is not undertaken we will synthesize the data descriptively, considering clinical and methodological differences. For each outcome, two reviewers will independently assess within- and across-study risk of bias and rate the certainty of the evidence using GRADE (Grading of Recommendations Assessment, Development, and Evaluation), and reach consensus. DISCUSSION: Since 2015, additional trials and longer follow-ups or additional data (e.g., harms, specific patient populations) from previously published trials have been published that will improve our understanding of the benefits and harms of screening. The systematic review of values and preferences will allow fulsome insights that will inform the balance of benefits and harms. SYSTEMATIC REVIEW REGISTRATION: PROSPERO CRD42022378858.

Pet therapy in the emergency department and ambulatory care: A systematic review and meta-analysis.

BACKGROUND: Pet therapy, or animal-assisted interventions (AAIs), has demonstrated positive effects for patients, families, and health care providers (HCPs) in inpatient settings. However, the evidence supporting AAIs in emergency or ambulatory care settings is unclear. We conducted a systematic review to evaluate the effectiveness of AAIs on patient, family, and HCP experience in these settings. METHODS: We searched (from inception to May 2020) Medline, Embase, Cochrane CENTRAL, PsycINFO, and CINAHL, plus gray literature, for studies assessing AAIs in emergency and ambulatory care settings on: (1) patient and family anxiety/distress or pain and (2) HCP stress. Screening, data extraction, and quality assessment were done in duplicate with conflicts adjudicated by a third party. Random-effects meta-analyses are reported as mean differences (MDs) or standardized mean differences (SMDs) and 95% confidence intervals (CIs), as appropriate. RESULTS: We included nine randomized controlled trials (RCTs; 341 patients, 146 HCPs, 122 child caregivers), four before-after (83 patients), and one mixed-method study (124 patients). There was no effect across three RCTs measuring patient-reported anxiety/distress (n = 380; SMD = -0.36, 95% CI = -0.95 to 0.23, I2  = 81%), while two before-after studies suggested a benefit (n = 80; SMD = -1.95, 95% CI = -2.99 to -0.91, I2  = 72%). Four RCTs found no difference in measures of observed anxiety/distress (n = 166; SMD = -0.44, 95% CI = -1.01 to 0.13, I2  = 73%) while one before-after study reported a significant benefit (n = 60; SMD = -1.64, 95% CI = -2.23 to -1.05). Three RCTs found no difference in patient-reported pain (n = 202; MD = -0.90, 95% CI = -2.01 to 0.22, I2  = 68%). Two RCTs reported positive but nonsignificant effects on HCP stress. CONCLUSIONS: Limited evidence is available on the effectiveness of AAIs in emergency and ambulatory care settings. Rigorous studies using global experience-oriented (or patient-identified) outcome measures are required.

Comparison of active versus passive surveillance adverse event reporting in a paediatric ambulatory chiropractic care setting: a cluster randomised controlled trial.

OBJECTIVES: This pragmatic, cluster, stratified randomised controlled trial (RCT) compared the quantity and quality of adverse event (AE) reports after chiropractic manual therapy in children less than 14 years of age, using active versus passive surveillance reporting systems. METHOD: Data were collected between November 2014 and July 2017 from 60 consecutive paediatric patient visits to participating chiropractors. Those allocated to active surveillance collected AE information with three paper-based questionnaires (two from patients, one from chiropractors) to identify any new or worsening symptoms after treatment. Passive surveillance involved AE information reported by chiropractors on a web-based system. To assess quality of reporting, AE reports greater than mild were reviewed by content experts. The primary outcome was the cumulative incidence of AE reports in active versus passive surveillance. RESULTS: Ninety-six chiropractors agreed to participate and enrolled in the study: 34 chiropractors in active surveillance with 1894 patient visits from 1179 unique patients and 35 chiropractors in passive surveillance with 1992 patient visits from 1363 unique patients. In the active arm, AEs were reported in 8.8% (n=140, 95% CI 6.72% to 11.18%) of patients/caregivers, compared with 0.1% (n=2, 95% CI 0.02% to 0.53%) in the passive arm (p<0.001). The quality of AE reports was not evaluated because the five AE reports reviewed by the content experts were determined to be of mild severity. CONCLUSION: We found that active surveillance resulted in significantly more AE reports than passive surveillance. Further prospective active surveillance research studies should be conducted with children receiving chiropractic manual therapy to understand mechanisms and risk factors for moderate and severe AEs, and to further explore how and when to solicit patient safety information.

Vitamin D supplementation to improve pregnancy and perinatal outcomes: an overview of 42 systematic reviews.

OBJECTIVE: To review the evidence to assess effectiveness of vitamin D supplementation during pregnancy and associations of serum vitamin D levels with perinatal outcomes. DESIGN: Overview of systematic reviews (SRs). DATA SOURCES: Searches conducted in January 2019: Ovid Medline (1946-), Cochrane Library databases. ELIGIBILITY CRITERIA FOR SELECTING STUDIES: Two reviewers independently screened titles and abstracts, and full texts using predefined inclusion criteria: SRs evaluating vitamin D supplementation in pregnant women and/or examining the association between serum vitamin D levels reporting at least one predefined perinatal outcome. Only SRs with high AMSTAR scores were analysed. DATA EXTRACTION AND SYNTHESIS: Data were extracted independently by one reviewer and checked by a second. Results were assessed for quality independently by two reviewers using GRADE criteria. RESULTS: Thirteen SRs were included, synthesising evidence from 204 unique primary studies. SRs of randomised controlled trials (RCTs) with the highest level of evidence showed no significant benefit from vitamin D in terms of preterm birth (RR 1.00 (95% CI 0.77, 1.30); high quality), pre-eclampsia (RR 0.91 (0.45, 1.86); low quality), gestational diabetes (RR 0.65 (0.39, 1.08); very low quality), stillbirth (RR 0.75 (0.50, 1.12); high quality), low birth weight (RR 0.74 (0.47, 1.16); low quality), caesarean section (RR 1.02 (0.93, 1.12); high quality). A significant difference was found for small for gestational age (RR 0.72 (0.52, 0.99); low quality). SRs of observational studies showed associations between vitamin D levels and preterm birth (RR 1.19 (1.08, 1.31); moderate quality), pre-eclampsia (RR 1.57 (1.21, 2.03) for 25-hydroxy vitamin D (25 (OH)D)<50 nmol/L subgroup; low quality), gestational diabetes (RR 1.12 (1.02, 1.22) for 25 (OH)D<50 nmol/L and RR 1.09 (1.03, 1.15)<75 nmol/L; moderate quality) and small for gestational age (RR 1.35 (1.18, 1.54)<50 nmol/L; low quality). SRs showed mixed results for associations between vitamin D and low birth weight (very low quality) and caesarean section (very low quality). CONCLUSION: There is some evidence from SRs of observational studies for associations between vitamin D serum levels and some outcomes; however SRs examining effectiveness from RCTs showed no effect of vitamin D supplementation in pregnancy with the exception of one predefined outcome, which had low quality evidence. Credibility of the evidence in this field is compromised by study limitations (in particular, the possibility of confounding among observational studies), inconsistency, imprecision and potential for reporting and publication biases.

Efficacy of music on sedation, analgesia and delirium in critically ill patients. A systematic review of randomized controlled trials.

PURPOSE: To systematically synthesize randomized controlled trial data on the efficacy of music to provide sedation and analgesia, and reduce incidence of delirium, in critically ill patients. MATERIAL AND METHODS: Relevant databases (Medline, PubMed, Embase, CINAHL, Cochrane, Alt Healthwatch, LILACS, PsycINFO, CAIRSS, RILM) were searched from inception to April 26, 2018. We also searched the reference lists of included publications and for ongoing trials. The selection of relevant articles was conducted by two researchers at two levels of screening. Data collection followed the recommendations from the Cochrane Systematic Reviews Handbook. We used the Cochrane Collaboration's tool for assessing risk of bias. Quality of the evidence was rated according to GRADE. RESULTS: The review identified six adult studies and no neonatal or pediatric studies. A descriptive analysis of study results was performed. Meta-analysis was not feasible due to heterogeneity. One study reported a reduction in sedation requirements with the use of music while the other five did not find any significant differences across groups. CONCLUSIONS: This systematic review revealed limited evidence to support or refute the use of music to reduce sedation/analgesia requirements, or to reduce delirium in critically ill adults, and no evidence in pediatric and neonatal critically ill patients.

Adjunct clinical interventions that influence vaginal birth after cesarean rates: systematic review.

BACKGROUND: Rates of cesarean deliveries have been increasing, and contributes to the rising number of elective cesarean deliveries in subsequent pregnancies with associated maternal and neonatal risks. Multiple guidelines recommend that women be offered a trial of labor after a cesarean (TOLAC). The objective of the study is to systematically review the literature on adjunct clinical interventions that influence vaginal birth after cesarean (VBAC) rates. METHODS: We searched Ovid Medline, Ovid Embase, Wiley Cochrane Library, CINAHL via EBSCOhost; and Ovid PsycINFO. Additional studies were identified by searching for clinical trial records, conference proceedings and dissertations. Limits were applied for language (English and French) and year of publication (1985 to present). Two reviewers independently screened comparative studies (randomized or non-randomized controlled trials, and observational designs) according to a priori eligibility criteria: women with prior cesarean sections; any adjunct clinical intervention or exposure intended to increase the VBAC rate; any comparator; and, outcomes reporting changes in TOLAC or VBAC rates. One reviewer extracted data and a second reviewer verified for accuracy. Two reviewers independently conducted methodological quality assessments using the Mixed Methods Appraisal Tool (MMAT). RESULTS: Twenty-three studies of overall moderate to good methodological quality examined adjunct clinical interventions affecting TOLAC and/or VBAC rates: system-level interventions (three studies), provider-level interventions (three studies), guidelines or information for providers (seven studies), provider characteristics (four studies), and patient-level interventions (six studies). Provider-level interventions (opinion leader education, laborist, and obstetrician second opinion for cesarean sections) and provider characteristics (midwifery antenatal care, physicians on night float call schedules, and deliveries by family physicians) were associated with increased rates of VBAC. Few studies employing heterogeneous designs, sample sizes, interventions and comparators limited confidence in the effects. Studies of system-level and patient-level interventions, and guidelines/information for providers reported mixed findings. CONCLUSIONS: Limited evidence indicates some provider-level interventions and provider characteristics may increase rates of attempted and successful TOLACs and/or VBACs, whereas other adjunct clinical interventions such as system-level interventions, patient-level interventions, and guidelines/information for healthcare providers show mixed findings.

Active versus passive adverse event reporting after pediatric chiropractic manual therapy: study protocol for a cluster randomized controlled trial.

BACKGROUND: Patient safety performance can be assessed with several systems, including passive and active surveillance. Passive surveillance systems provide opportunity for health care personnel to confidentially and voluntarily report incidents, including adverse events, occurring in their work environment. Active surveillance systems systematically monitor patient encounters to seek detailed information about adverse events that occur in work environments; unlike passive surveillance, active surveillance allows for collection of both numerator (number of adverse events) and denominator (number of patients seen) data. Chiropractic manual therapy is commonly used in both adults and children, yet few studies have been done to evaluate the safety of chiropractic manual therapy for children. In an attempt to evaluate this, this study will compare adverse event reporting in passive versus active surveillance systems after chiropractic manual therapy in the pediatric population. METHODS/DESIGN: This cluster randomized controlled trial aims to enroll 70 physicians of chiropractic (unit of randomization) to either passive or active surveillance system to report adverse events that occur after treatment for 60 consecutive pediatric (13 years of age and younger) patient visits (unit of analysis). A modified enrollment process with a two-phase consent procedure will be implemented to maintain provider blinding and minimize dropouts. The first phase of consent is for the provider to confirm their interest in a trial investigating the safety of chiropractic manual therapy. The second phase ensures that they understand the specific requirements for the group to which they were randomized. Percentages, incidence estimates, and 95% confidence intervals will be used to describe the count of reported adverse events in each group. The primary outcome will be the number and quality of the adverse event reports in the active versus the passive surveillance group. With 80% power and 5% one-sided significance level, the sample size was calculated to be 35 providers in each group, which includes an 11% lost to follow-up of chiropractors and 20% of patient visits. DISCUSSION: This study will be the first direct comparison of adverse event reporting using passive versus active surveillance. It is also the largest prospective evaluation of adverse events reported after chiropractic manual therapy in children, identified as a major gap in the academic literature. TRIAL REGISTRATION: ClinicalTrials.gov, ID: NCT02268331 . Registered on 10 October 2014.

Attitudes and Opinions of Doctors of Chiropractic Specializing in Pediatric Care Toward Patient Safety: A Cross-sectional Survey.

OBJECTIVE: The purpose of this cross-sectional survey was to evaluate attitudes and opinions of doctors of chiropractic (DCs) specializing in pediatric care toward patient safety. METHODS: The Medical Office Survey on Patient Safety Culture of the Agency for Healthcare Research and Quality was adapted for providers who use spinal manipulation therapy and sent out to 2 US chiropractic organizations' pediatric council members (n = 400) between February and April 2014. The survey measured 12 patient safety dimensions and included questions on patient safety items and quality issues, information exchange, and overall clinic ratings. Data analyses included a percent composite average and a nonrespondent analysis. RESULTS: The response rate was 29.5% (n = 118). Almost one- third of respondents' patients were pediatric (≤17 years of age). DCs with a pediatric certification were 3 times more likely to respond (P < .001), but little qualitative differences were found in responses. The patient safety dimensions with the highest positive composite percentages were Organizational Learning (both administration and clinical) and Teamwork (>90%). Patient Care Tracking/Follow-up and Work Pressure and Pace were patient safety dimensions that had the lowest positive composite scores (<85%). The responses also indicated that there was concern regarding information exchange with insurance/third-party payors. Two quality issues identified for improvement were (1) updating a patient's medication list and (2) following up on critically abnormal results from a laboratory or imaging test within 1 day. The average overall patient safety rating score indicated that 83% of respondents rated themselves as "very good" or "excellent." CONCLUSIONS: Compared with 2014 Agency for Healthcare Research and Quality physician referent data from medical offices, pediatric DCs appear to have more positive patient safety attitudes and opinions. Future patient safety studies need to prospectively evaluate safety performance with direct feedback from patients and compare results with these self-assessed safety attitudes, as well as make further use of this survey to develop a comparable database for spinal manipulation providers.

Barriers to Implementing a Reporting and Learning Patient Safety System: Pediatric Chiropractic Perspective.

A reporting and learning system is a method of monitoring the occurrence of incidents that affect patient safety. This cross-sectional survey asked pediatric chiropractors about factors that may limit their participation in such a system. The list of potential barriers for participation was developed using a systematic approach. All members of the 2 pediatric councils associated with US national chiropractic organizations were invited to complete the survey (N = 400). The cross-sectional survey was created using an online survey tool (REDCap) and sent directly to member emails addressed by the respective executive committees. Of the 400 potential respondents, 81 responded (20.3%). The most common limitations to participating were identified as time pressure (96%) and patient concerns (81%). Reporting and learning systems have been utilized to increase safety awareness in many high-risk industries. To be successful, future patient safety studies with pediatric chiropractors need to ensure these barriers are understood and addressed.

Music to reduce pain and distress in the pediatric emergency department: a randomized clinical trial.

IMPORTANCE: Many medical procedures aimed at helping children cause them pain and distress, which can have long-lasting negative effects. Music is a form of distraction that may alleviate some of the pain and distress experienced by children while undergoing medical procedures. OBJECTIVE: To compare music with standard care to manage pain and distress. DESIGN, SETTING, AND PARTICIPANTS: Randomized clinical trial conducted in a pediatric emergency department with appropriate sequence generation and adequate allocation concealment from January 1, 2009, to March 31, 2010. Individuals assessing the primary outcome were blind to treatment allocation. A total of 42 children aged 3 to 11 years undergoing intravenous placement were included. INTERVENTIONS: Music (recordings selected by a music therapist via ambient speakers) vs standard care. MAIN OUTCOMES AND MEASURES: The primary outcome was behavioral distress assessed blinded using the Observational Scale of Behavioral Distress-Revised. The secondary outcomes included child-reported pain, heart rate, parent and health care provider satisfaction, ease of performing the procedure, and parental anxiety. RESULTS: With or without controlling for potential confounders, we found no significant difference in the change in behavioral distress from before the procedure to immediately after the procedure. When children who had no distress during the procedure were removed from the analysis, there was a significantly less increase in distress for the music group (standard care group = 2.2 vs music group = 1.1, P < .05). Pain scores among children in the standard care group increased by 2 points, while they remained the same in the music group (P = .04); the difference was considered clinically important. The pattern of parent satisfaction with the management of children's pain was different between groups, although not statistically significant (P = .07). Health care providers reported that it was easier to perform the procedure for children in the music group (76% very easy) vs the standard care group (38% very easy) (P = .03). Health care providers were more satisfied with the intravenous placement in the music group (86% very satisfied) compared with the standard care group (48%) (P = .02). CONCLUSIONS AND RELEVANCE: Music may have a positive impact on pain and distress for children undergoing intravenous placement. Benefits were also observed for the parents and health care providers. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00761033.

Parenteral ω-3 fatty acid lipid emulsions for children with intestinal failure and other conditions: a systematic review.

BACKGROUND: There is growing interest in the use of ω-3 fatty acid (n-3FA) lipid emulsions to prevent complications associated with parenteral nutrition. The authors systematically reviewed the evidence on the benefits and safety of n-3FA compared with standard lipid emulsions in children with intestinal disease, critical illness, trauma, or postoperative complications. MATERIALS AND METHODS: The authors searched 4 bibliographic databases from their inception to March 2011, conference proceedings, trial registries, and reference lists. Two reviewers independently selected studies, assessed methodological quality, and rated the strength of the evidence. One reviewer extracted and a second reviewer verified data. The authors summarized findings qualitatively and conducted meta-analysis when appropriate. RESULTS: Five randomized controlled trials with unclear risk of bias and 3 high-quality prospective cohort studies were included. The studies examined premature, low birth weight infants (n = 6) and children with heart disease (n = 1) or intestinal failure (n = 1). The strength of evidence was consistently low or very low across all lipid emulsion comparisons and outcomes. In young children, n-3FA emulsions resulted in improvement in some biochemical outcomes of intestinal failure-associated liver disease but no difference in mortality. Few studies examined patient-important outcomes, such as length of hospital and intensive care stay; need for transplantation, growth, and cognitive development; or the long-term effects and potential harms associated with these therapies. CONCLUSIONS: Currently, there is a lack of sufficient high-quality data to support the use of parenteral n-3FA lipid emulsions in children. Future trials examining long-term clinical outcomes and harms are needed.

Music for pain and anxiety in children undergoing medical procedures: a systematic review of randomized controlled trials.

OBJECTIVE: The aim of this study was to conduct a systematic review of the efficacy of music therapy (MT) on pain and anxiety in children undergoing clinical procedures. METHODS: We searched 16 electronic databases of published and unpublished studies, subject bibliographies, reference lists of relevant articles, and trials registries. Two reviewers independently screened 4559 citations and reviewed the full manuscript of 393 studies. Nineteen studies met the inclusion criteria: randomized controlled trial, children aged 1 month to 18 years were examined, music was used as an intervention, and the study measured pain or anxiety. Music therapy was considered active if a music therapist was involved and music was used as a medium for interactive communication. Passive music therapy was defined as listening to music without the involvement of a music therapist. RESULTS: The 19 included trials involved 1513 subjects. The methodological quality of the studies was generally poor. Overall, MT showed a significant reduction in pain and anxiety (standardized mean difference [SMD] -0.35; 95% confidence interval [CI], -0.55 to -0.14; 9 studies; N = 704; I(2) = 42%). When analyzed by outcome, MT significantly reduced anxiety (SMD -0.39; 95% CI, -0.76 to -0.03; 5 studies; n = 284; I(2) = 52.4%) and pain (SMD -0.39; 95% CI, -0.66 to -0.11; 5 studies; N = 465; I(2) = 49.7%). There was no evidence of publication bias. CONCLUSIONS: Music is effective in reducing anxiety and pain in children undergoing medical and dental procedures. Music can be considered an adjunctive therapy in clinical situations that produce pain or anxiety.