Cardiovascular and Neuropsychiatric Events after Varenicline Use for Smoking Cessation.

RATIONALE: Varenicline aids in smoking cessation but has also been associated with serious adverse events. OBJECTIVES: The aim of this study was to determine the risks of cardiovascular and neuropsychiatric events after varenicline receipt in a real-world setting. METHODS: A population-based, self-controlled risk interval study using linked universal health administrative data from the diverse, multicultural population of Ontario, Canada, was conducted. In two separate analyses, new varenicline users between September 1, 2011 and February 15, 2014 were observed from 1 year before to 1 year after varenicline receipt. The relative incidences of cardiovascular and neuropsychiatric hospitalizations and emergency department visits in the 12 weeks after varenicline receipt (the risk interval) compared with the remaining observation period (the control interval) were estimated in two separate fixed-effect conditional Poisson regressions. Sensitivity analyses tested the robustness of the results. MEASUREMENTS AND MAIN RESULTS: Among 56,851 new users of varenicline, 6,317 cardiovascular and 10,041 neuropsychiatric hospitalizations and emergency department visits occurred from 1 year before to 1 year after receipt. The incidence of cardiovascular events was 34% higher in the risk compared with the control interval (relative incidence, 1.34; 95% confidence interval, 1.25-1.44). Findings were consistent in sensitivity analyses, most notably in those without any history of previous cardiovascular disease. The relative incidence of neuropsychiatric events was marginally significant in the primary (relative incidence, 1.06; 95% confidence interval, 1.00-1.13) but not all sensitivity analyses. CONCLUSIONS: Varenicline appears to be associated with an increased risk of cardiovascular but not neuropsychiatric events.

The minimally effective dose of sucrose for procedural pain relief in neonates: a randomized controlled trial.

BACKGROUND: Orally administered sucrose is effective and safe in reducing pain intensity during single, tissue-damaging procedures in neonates, and is commonly recommended in neonatal pain guidelines. However, there is wide variability in sucrose doses examined in research, and more than a 20-fold variation across neonatal care settings. The aim of this study was to determine the minimally effective dose of 24% sucrose for reducing pain in hospitalized neonates undergoing a single skin-breaking heel lance procedure. METHODS: A total of 245 neonates from 4 Canadian tertiary neonatal intensive care units (NICUs), born between 24 and 42 weeks gestational age (GA), were prospectively randomized to receive one of three doses of 24% sucrose, plus non-nutritive sucking/pacifier, 2 min before a routine heel lance: 0.1 ml (Group 1; n = 81), 0.5 ml (Group 2; n = 81), or 1.0 ml (Group 3; n = 83). The primary outcome was pain intensity measured at 30 and 60 s following the heel lance, using the Premature Infant Pain Profile-Revised (PIPP-R). The secondary outcome was the incidence of adverse events. Analysis of covariance models, adjusting for GA and study site examined between group differences in pain intensity across intervention groups. RESULTS: There was no difference in mean pain intensity PIPP-R scores between treatment groups at 30 s (P = .97) and 60 s (P = .93); however, pain was not fully eliminated during the heel lance procedure. There were 5 reported adverse events among 5/245 (2.0%) neonates, with no significant differences in the proportion of events by sucrose dose (P = .62). All events resolved spontaneously without medical intervention. CONCLUSIONS: The minimally effective dose of 24% sucrose required to treat pain associated with a single heel lance in neonates was 0.1 ml. Further evaluation regarding the sustained effectiveness of this dose in reducing pain intensity in neonates for repeated painful procedures is warranted. TRIAL REGISTRATION: ClinicalTrials.gov : NCT02134873. Date: May 5, 2014 (retrospectively registered).

The role of organizational context in moderating the effect of research use on pain outcomes in hospitalized children: a cross sectional study.

BACKGROUND: Despite substantial research on pediatric pain assessment and management, health care professionals do not adequately incorporate this knowledge into clinical practice. Organizational context (work environment) is a significant factor in influencing outcomes; however, the nature of the mechanisms are relatively unknown. The objective of this study was to assess how organizational context moderates the effect of research use and pain outcomes in hospitalized children. METHODS: A cross-sectional survey was undertaken with 779 nurses in 32 patient care units in 8 Canadian pediatric hospitals, following implementation of a multifaceted knowledge translation intervention, Evidence-based Practice for Improving Quality (EPIQ). The influence of organizational context was assessed in relation to pain process (assessment and management) and clinical (pain intensity) outcomes. Organizational context was measured using the Alberta Context Tool that includes: leadership, culture, evaluation, social capital, informal interactions, formal interactions, structural and electronic resources, and organizational slack (staff, space, and time). Marginal modeling estimated the effects of instrumental research use (direct use of research knowledge) and conceptual research use (indirect use of research knowledge) on pain outcomes while examining the effects of context. RESULTS: Six of the 10 organizational context factors (culture, social capital, informal interactions, resources, and organizational slack [space and time]) significantly moderated the effect of instrumental research use on pain assessment; four factors (culture, social capital, resources and organizational slack time) moderated the effect of conceptual research use and pain assessment. Only two factors (evaluation and formal interactions) moderated the effect of instrumental research use on pain management. All organizational factors except slack space significantly moderated the effect of instrumental research use on pain intensity; informal interactions and organizational slack space moderated the effect of conceptual research use and pain intensity. CONCLUSIONS: Many aspects of organizational context consistently moderated the effects of instrumental research use on pain assessment and pain intensity, while only a few influenced conceptual use of research on pain outcomes. Organizational context factors did not generally influence the effect of research use on pain management. Further research is required to further explore the relationships between organizational context and pain management outcomes.

Integrating a Career Planning and Development Program into the Baccalaureate Nursing Curriculum: Part I. Impact on Students' Career Resilience.

Student nurses often embark on their professional careers with a lack of the knowledge and confidence necessary to navigate them successfully. An ongoing process of career planning and development (CPD) is integral to developing career resilience, one key attribute that may enable nurses to respond to and influence their ever-changing work environments with the potential outcome of increased job satisfaction and commitment to the profession. A longitudinal mixed methods study of a curriculum-based CPD program was conducted to determine the program's effects on participating students, new graduate nurses, and faculty. This first in a series of three papers about the overall study's components reports on undergraduate student outcomes. Findings demonstrate that the intervention group reported higher perceived career resilience than the control group, who received the standard nursing curriculum without CPD. The program offered students the tools and resources to become confident, self-directed, and active in shaping their engagement in their academic program to help achieve their career goals, whereas control group students continued to look uncertainly to others for answers and direction. The intervention group recognized the value of this particular CPD program and both groups, albeit differently, highlighted the key role that faculty played in students' career planning.

A scoping review of the epidemiology and treatment of painful procedures in hospitalized neonates: What has changed in the past three decades?

BACKGROUND: Care of newborns hospitalized in the neonatal intensive care unit (NICU) includes multiple painful procedures/day. Epidemiologic studies have reported the frequency and nature of procedures and treatment interventions. However, evidence on the changing trends in the nature and frequency of neonatal pain procedures or treatments over time is absent or inconclusive. We aimed to determine the frequency and nature of painful procedures/neonate/day in the NICU. DATABASES AND DATA TREATMENT: MEDLINE and Embase searches were conducted from database inception to July 2023. Studies that reported the nature and frequency of painful procedures and associated pain treatments in neonates were included. Standard inverse-variance random-effects meta-analyses were used to combine studies. Heterogeneity between studies was quantified using the I2 statistic. RESULTS: Of 2622 unique citations, 64 full-text articles were reviewed; 23 were included. Six additional studies identified in a previous review, and six publications from reference lists were added, resulting in 35 studies. The mean number of painful procedures/neonate/day was 7.38 (95% CI 5.60, 9.17; range <2 to 17). Although the frequency of painful procedures in more recent studies was reduced, it was not statistically significant (p = 0.16). Painful procedures were more frequent during longer observation periods. Needle-related procedures were most common and did not change over time. Procedure-related treatment was suboptimal and inconsistently reported. CONCLUSIONS: Frequency of painful procedures in the NICU has shown a clinically important decrease but has not significantly changed over time. A paradigm shift moving responsibility from providers to systems in changing pain practices in the NICU is required. SIGNIFICANCE STATEMENT: The decrease in the daily frequency of painful procedures in hospitalized neonates might be clinically relevant but is not yet statistically significant. Pain treatment is insufficiently documented and reported. This lack of progress in neonatal care might be a result of the complexity of defining pain and stress; inconsistencies in determining the burden of procedural pain; the influence of barriers and facilitators on practice change; and the focus on an individual rather than system responsibility for pain prevention and treatment.

Assessment of complementary health approaches use in pediatric oncology: Modification and preliminary validation of the "Which Health Approaches and Treatments Are You Using?" (WHAT) questionnaires.

OBJECTIVE: Complementary Health Approaches (CHA) are commonly used by children with cancer; however, a few health care providers (HCPs) inquire about the use of CHA. A standardized questionnaire could facilitate such clinical discussions. We aimed to adapt and determine the face and content validity of the "Which Health Approaches and Treatments are you using?" (WHAT) child and parent-report questionnaires in pediatric oncology. METHODS: An electronic Delphi survey that included children with cancer (8-18 years), parents, and HCPs and CHA researchers was conducted to reach consensus on the content of the WHAT questionnaires in pediatric oncology. Children and parents from the Hospital for Sick Children (SickKids), and HCPs and researchers from the International Society of Pediatric Oncology and Pediatric Complementary and Alternative Medicine Research and Education Network completed the survey. To determine the face and content validity of the questionnaires, two iterative cycles of individual interviews were conducted with purposive samples of children (8-18 years), parents, and HCPs from SickKids. RESULTS: Consensus was reached on all domains and items of the original WHAT questionnaires after one Delphi cycle (n = 61). For face and content validity testing, the first cycle of interviews (n = 19) revealed that the questionnaires were mostly comprehensive and relevant. However, the paper-based format of the original WHAT was not user-friendly, and generic items were vague and not aimed at facilitating clinical dialogues about CHA use. The WHAT questionnaires were then modified into electronic cancer-specific self- and proxy-report questionnaires including 13 and 15 items, respectively. The second cycle (n = 21) showed no need for further changes. CONCLUSIONS: The modified electronic cancer-specific WHAT questionnaires showed adequate face and content validity. The next step is to determine inter-rater reliability, construct validity, and feasibility of administration of the modified WHAT questionnaires in pediatric oncology.

Cumulative sucrose exposure for repeated procedural pain in preterm neonates and neurodevelopment at 18 months of corrected age: a prospective observational longitudinal study.

INTRODUCTION: Oral sucrose is repeatedly administered to neonates in the neonatal intensive care unit (NICU) to treat pain from commonly performed procedures; however, there is limited evidence on its long-term cumulative effect on neurodevelopment. We examined the association between total sucrose volumes administered to preterm neonates for pain mitigation in the NICU and their neurodevelopment at 18 months of corrected age (CA). METHODS: A prospective longitudinal single-arm observational study that enrolled hospitalised preterm neonates <32 weeks of gestational age at birth and <10 days of life was conducted in four level III NICUs in Canada. Neonates received 0.1 mL of 24% sucrose 2 min prior to all commonly performed painful procedures during their NICU stay. Neurodevelopment was assessed at 18 months of CA using the Bayley Scales of Infant and Toddler Development, Third Edition (Bayley-III). Multiple neonatal and maternal factors known to affect development were adjusted for in the generalised linear model analysis. RESULTS: 172 preterm neonates were enrolled and 118 were included in the analysis at 18 months of CA. The total mean sucrose volume administered/neonate/NICU stay was 5.96 (±5.6) mL, and the mean Bayley-III composite scores were: cognitive 91 (±17), language 86 (±18) and motor 88 (±18). There was no association between Bayley-III scores and the total sucrose volume: cognitive (p=0.57), language (p=0.42) and motor (p=0.70). CONCLUSION: Cumulative sucrose exposure for repeated procedural pain in preterm neonates was neither associated with a delay in neurodevelopment nor neuroprotective effects at 18 months of CA. If sucrose is used, we suggest the minimally effective dose combined with other non-pharmacological interventions with demonstrated effectiveness such as skin-to-skin contact, non-nutritive sucking, facilitated tucking and swaddling. TRIAL REGISTRATION NUMBER: NCT02725814.

A longitudinal observational study on the epidemiology of painful procedures and sucrose administration in hospitalized preterm neonates.

Although sucrose is widely administered to hospitalized infants for single painful procedures, total sucrose volume during the entire neonatal intensive care unit (NICU) stay and associated adverse events are unknown. In a longitudinal observation study, we aimed to quantify and contextualize sucrose administration during the NICU stay. Specifically, we investigated the frequency, nature, and severity of painful procedures; proportion of procedures where neonates received sucrose; total volume of sucrose administered for painful procedures; and incidence and type of adverse events. Neonates <32 weeks gestational age at birth and <10 days of life were recruited from four Canadian tertiary NICUs. Daily chart reviews of documented painful procedures, sucrose administration, and any associated adverse events were undertaken. One hundred sixty-eight neonates underwent a total of 9093 skin-breaking procedures (mean 54.1 [±65.2] procedures/neonate or 1.1 [±0.9] procedures/day/neonate) during an average NICU stay of 45.9 (±31.4) days. Pain severity was recorded for 5399/9093 (59.4%) of the painful procedures; the majority (5051 [93.5%]) were heel lances of moderate pain intensity. Sucrose was administered for 7839/9093 (86.2%) of painful procedures. The total average sucrose volume was 5.5 (±5.4) mL/neonate or 0.11 (±0.08) mL/neonate/day. Infants experienced an average of 7.9 (±12.7) minor adverse events associated with pain and/or sucrose administration that resolved without intervention. The total number of painful procedures, sucrose volume, and incidence of adverse events throughout the NICU stay were described addressing an important knowledge gap in neonatal pain. These data provide a baseline for examining the association between total sucrose volume during NICU stay and research on longer-term behavioral and neurodevelopmental outcomes.

Inter-Rater Reliability, Construct Validity, and Feasibility of the Modified "Which Health Approaches and Treatments Are You Using?" (WHAT) Questionnaires for Assessing the Use of Complementary Health Approaches in Pediatric Oncology.

BACKGROUND: This study aimed to test the inter-rater reliability, construct validity, and feasibility of the modified "Which Health Approaches and Treatments Are You Using?" (WHAT) questionnaires in pediatric oncology; Methods: Parent-child dyads were invited to complete self- and proxy-report-modified WHAT, Pediatric Quality of Life Inventory, demographics, a diary of the child's recent use of CHA, and a questionnaire assessing the aspects of feasibility. Parents were asked to complete a satisfaction of their children's use of the CHA survey; Results: Twenty-four dyads completed the study. The mean weighted kappa showed strong inter-rater reliability (k = 0.77, SE = 0.056), and strong agreements between the modified WHAT and the diary (self-report [k = 0.806, SE = 0.046] and proxy-report [k = 0.894, SE = 0.057]). Significant relationships were found only between recent and non-recent CHA users in relation to the easy access to CHA (self-report [p = 0.02], proxy-report [p < 0.001]). The mean scores of the feasibility scale (out of 7.0) for the self- and proxy-report were 5.64 (SD = 0.23) and 5.81 (SD = 0.22), respectively, indicating the feasibility of the modified WHAT; Conclusions: The findings provide initial evidence of the reliability and validity of the modified WHAT and their feasibility. Further research is needed to test the theoretical relationships and further explore the validity and reliability of the modified WHAT.

The effectiveness of repeated sucrose for procedural pain in neonates in a longitudinal observational study.

Goal: To determine the analgesic effectiveness of repeated sucrose administration for skin-breaking (SB) procedures over the Neonatal Intensive Care Unit (NICU) hospitalization of preterm infants. Methods: Longitudinal observational study, conducted in four level III Canadian NICUs. Eligible infants were <32 weeks gestational age at birth, and <10 days of life at enrollment. Infants received 24% sucrose (0.12 ml) prior to all painful procedures. The Premature Infant Pain Profile - Revised (PIPP-R) was used at 30 and 60 seconds after a medically-required SB procedure as soon as possible after enrollment and weekly up to three additional times for scheduled procedures. Results: 172 infants (57.3% male, gestational age 28.35 (±2.31) weeks) were included. The mean 30 s PIPP-R scores were 6.11 (±3.68), 5.76 (±3.41), 6.48 (±3.67), and 6.81 (±3.69) respectively; there were no statistically significant interactions of study site by time (p = 0.31) or over time (p = 0.15). At 60 s, mean PIPP-R scores were 6.05 (±4.09), 5.74 (±3.67), 6.19 (±3.7), and 5.99 (±3.76) respectively; there were no study site by time interactions (p = 0.14) or differences over time (p = 0.52). There was a statistically significant site difference in the effectiveness of sucrose at 30 and 60 seconds (p < 0.01). Conclusions: Consistently low PIPP-R scores following a skin-breaking procedure indicated that the analgesic effectiveness of the minimal dose of sucrose was sustained over time in the NICU. Further research is required to determine the optimal combination of sucrose and other pain management strategies to improve clinical practice and the impact of consistent use of repeated use of sucrose on neurodevelopment.

Training and capacity development in patient-oriented research: Ontario SPOR SUPPORT Unit (OSSU) initiatives.

BACKGROUND: In Canada, the Canadian Institutes of Health Research launched the Strategy for Patient-Oriented Research (SPOR) in 2011. The strategy defines 'patient-oriented research' as a continuum of research that engages patients as partners, focuses on patient priorities, and leads to improved patient outcomes. The overarching term 'patient' is inclusive of individuals with personal experience of a health issue as well as informal caregivers including family and friends. The vision for the strategy is improved patient experiences and outcomes through the integration of patient-oriented research findings into practice, policy, and health system improvement. Building capacity in patient-oriented research among all relevant stakeholders, namely patients, practitioners, organizational leaders, policymakers, researchers, and research funders is a core element of the strategy. MAIN BODY: The objective of this paper is to describe capacity building initiatives in patient-oriented research led by the Ontario SPOR SUPPORT Unit in Ontario, Canada over the period 2014-2020. CONCLUSION: The Ontario SPOR SUPPORT Unit Working Group in Training and Capacity Development has led numerous capacity building initiatives: developed a Capacity Building Compendium (accessed greater than 45,000 times); hosted Masterclasses that have trained hundreds of stakeholders (patients, practitioners, organizational leaders, policymakers, researchers, and trainees) in the conduct and use of patient-oriented research; funded the development of online curricula on patient-oriented research that have reached thousands of stakeholders; developed a patient engagement resource center that has been accessed by tens of thousands of stakeholders; identified core competencies for research teams and research environments to ensure authentic and meaningful patient partnerships in health research; and shared these resources and learnings with stakeholders across Canada, North America, and internationally.

In 2011, Canada developed a Strategy for Patient-Oriented Research. The aim of the strategy was to ensure that patients were included as equal partners in research, with the goal to improve the patient experience and enhance health outcomes using research findings to influence clinical care, policy, and health system improvement. Building capacity in patient-oriented research is a core element of the strategy. Since 2014, the Ontario SPOR SUPPORT Unit has led numerous initiatives to build capacity in patient-oriented research. Successes include a Capacity Building Compendium (a catalogue of resources that has been accessed greater than 45,000 times); courses on how to do and how to use patient-oriented research that have trained hundreds of patients, practitioners, organizational leaders, policymakers, and researchers; created online patient-oriented research materials; developed a patient engagement resource center; identified what is required to ensure authentic and meaningful patient partnerships in research; and shared these resources and learnings widely.

Benchmarking pain outcomes for children with sickle cell disease hospitalized in a tertiary referral pediatric hospital.

BACKGROUND: Painful vaso-occlusive crisis (VOC) is the most common reason for hospitalization in children with sickle cell disease. OBJECTIVE: To benchmark pain outcomes in sickle cell disease, including process outcomes (eg, pain assessment and documentation practices, pain management interventions) and clinical outcomes (eg, pain intensity over hospital stay), to identify areas for improvement. METHODS: A retrospective study was conducted on electronic charts of children hospitalized with a primary diagnosis of VOC between July 2007 and August 2008. RESULTS: A convenience sample of 50 admissions was used. In terms of clinical outcomes, patients presented to the emergency department with an initial median pain intensity of 9/10 (interquartile range 8/10 to 10/10). Forty-three per cent had not used opioids for pain relief at home. The mean (± SD) length of stay was 4.0±2.3 days. For most patients, median scores for highest daily pain intensity remained moderate to high throughout hospitalization, although scores did decrease significantly per day of hospitalization. In terms of process outcomes, pain intensity was assessed according to hospital standards on 25% of days in both the emergency department and the ward. There was no discrepancy between prescribed and administered opioid doses and medication use. In 95% of cases, strong opioid use was in a subtherapeutic or low therapeutic dosage range. CONCLUSIONS: The results showed three areas to target for improvement: improved pain assessment and documentation using valid pain tools; more aggressive multimodal management for peak VOC pain; and better education and support for pain management at home. Further studies are required to evaluate optimal pain treatment practices.

Do patients consider preoperative chemoradiation for primary rectal cancer worthwhile?

BACKGROUND: The objective of this study was to elicit future patients' preferences for preoperative chemoradiation (pre-CRT) for rectal cancer to determine whether patients' preferences are consistent with current treatment guidelines. METHODS: During a standardized interview, the treatment protocol, risks, benefits, and long-term outcomes associated with 1) surgery alone (SA) and 2) pre-CRT followed by surgery (CR + S) were described to healthy individuals, and a threshold task was performed. Each participant was asked which treatment option they would prefer when the risk of local recurrence was set initially at 15% for both options. If the participant indicated SA (which was expected), then the risk of local recurrence for CR + S was lowered systematically until the participant's preference changed from SA to CR + S. This threshold point represented the risk of local recurrence for pre-CRT that the participant would require before they would choose treatment with pre-CRT. RESULTS: Fifty individuals participated in the study, and the majority were well educated. Twenty-seven of 50 participants (54%) required a risk of local recurrence with CR + S of ≤ 5% (ie, equivalent to an absolute risk reduction ≥ 10%) before they would choose treatment with pre-CRT. Regression analysis did not identify any variables that were predictive of the participants' preferences. CONCLUSIONS: Participants seemed to highly value functional outcomes and seemed willing to accept a higher risk of local recurrence to achieve this. Therefore, developers of future guidelines may need to downgrade the use of pre-CRT for all patients with stage II/III tumors from a guideline to an option.

The Postoperative Pain Assessment Skills pilot trial.

UNLABELLED: BACKGROUND/ OBJECTIVES: Pain-related misbeliefs among health care professionals (HCPs) are common and contribute to ineffective postoperative pain assessment. While standardized patients (SPs) have been effectively used to improve HCPs' assessment skills, not all centres have SP programs. The present equivalence randomized controlled pilot trial examined the efficacy of an alternative simulation method - deteriorating patient-based simulation (DPS) - versus SPs for improving HCPs' pain knowledge and assessment skills. METHODS: Seventy-two HCPs were randomly assigned to a 3 h SP or DPS simulation intervention. Measures were recorded at baseline, immediate postintervention and two months postintervention. The primary outcome was HCPs' pain assessment performance as measured by the postoperative Pain Assessment Skills Tool (PAST). Secondary outcomes included HCPs knowledge of pain-related misbeliefs, and perceived satisfaction and quality of the simulation. These outcomes were measured by the Pain Beliefs Scale (PBS), the Satisfaction with Simulated Learning Scale (SSLS) and the Simulation Design Scale (SDS), respectively. Student's t tests were used to test for overall group differences in postintervention PAST, SSLS and SDS scores. One-way analysis of covariance tested for overall group differences in PBS scores. RESULTS: DPS and SP groups did not differ on post-test PAST, SSLS or SDS scores. Knowledge of pain-related misbeliefs was also similar between groups. CONCLUSIONS: These pilot data suggest that DPS is an effective simulation alternative for HCPs' education on postoperative pain assessment, with improvements in performance and knowledge comparable with SP-based simulation. An equivalence trial to examine the effectiveness of deteriorating patient-based simulation versus standardized patients is warranted.

Development and validation of the RACER (Readiness for Adult Care in Rheumatology) transition instrument in youth with juvenile idiopathic arthritis.

BACKGROUND: Current evidence suggests that many adolescents with juvenile idiopathic arthritis (JIA) do not successfully transfer to adult care, which can result in adverse health outcomes. Although a growing number of clinical programs have been designed to support healthcare transition, there is a lack of psychometrically sound instruments to evaluate their impact on development of transition-related knowledge and skills in youth with JIA. The purpose of this study was to develop and validate RACER (Readiness for Adult Care in Rheumatology), a self-administered instrument designed to measure stages of readiness for key transition-related skills in adolescents with JIA. METHODS: A phased approach was used to develop and evaluate the validity and reliability of RACER. Phase 1 A was a consensus conference with 19 key stakeholders to inform instrument domains and items. Phase 1B determined initial content validity using a sample of 30 adolescents with JIA and 15 clinical and research experts. Finally, Phase 2 was a prospective cohort study with repeated measures to evaluate the internal consistency, test-retest reliability, construct validity and responsiveness of the instrument within a sample of adolescents with JIA. RESULTS: In Phase 1 A, initial item generation yielded a total of 242 items across six domains from the consensus conference, which was subsequently reduced to a 32-item instrument. Phase 1B established the content validity of the instrument in adolescents with JIA. In the Phase 2 study, with a sample of 96 adolescents, the RACER instrument exhibited good internal consistency in five of its six subscales (Cronbach's α > 0.7), and strong test-retest reliability between the first two administrations (ICC = 0.83). It also showed robust convergent validity by highly correlating with measures of self-management (SMSAG, rho = 0.73) and transition (TRANSITION-Q, rho = 0.76). The RACER was not correlated with unrelated measures (discriminant validity; PedsQL, rho = 0.14). The RACER scores increased significantly over time as expected, supporting measure responsiveness. CONCLUSIONS: The RACER is a reliable and valid instrument which is sensitive to change for assessing transition readiness in adolescents with JIA.

Questionnaires assessing the use of complementary health approaches in pediatrics and their measurement properties: A systematic review.

OBJECTIVES: To identify questionnaires assessing the use of complementary health approaches (CHA) in pediatrics, describe their content, and appraise the methodological quality of the studies and the measurement properties of the questionnaires. METHOD: Major electronic databases were searched from 2011 to 2020. Studies which aimed to assess the use of CHA and studies which reported developing and validating CHA questionnaires in pediatrics were included. Two reviewers independently screened the studies, extracted the data, and rated the methodological quality of the studies and measurement properties of the questionnaires using the COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) checklist. When consensus was not reached, a third reviewer was consulted. RESULTS: Thirty-eight studies were included. From these studies, 35 CHA questionnaires with a variety of different items were identified. Only two studies aimed to evaluate the measurement properties of two questionnaires. One questionnaire, available as a self- and proxy-report, was initially validated in children with juvenile idiopathic arthritis, and the other, available as an interviewer-administered questionnaire, was validated in children with cancer. According to the COSMIN, the methodological quality of both studies was inadequate or doubtful, and both questionnaires was not thoroughly validated. CONCLUSION: This systematic review showed a lack of a thoroughly validated CHA questionnaire in pediatrics. However, two questionnaires were found to hold promise. To address this gap, one of the existing questionnaires should be adapted and further validated.

A prospective evaluation of sexual function and quality of life after ileal pouch-anal anastomosis.

PURPOSE: This study was designed to assess the effect of ileal pouch-anal anastomosis on sexual function and quality of life in men and women. METHODS: Sexual function of patients undergoing ileal pouch-anal anastomosis from February 2005 to June 2006 was prospectively evaluated using the International Index of Erectile Function in men and Female Sexual Function Index in women. Quality of life was assessed using the Short Inflammatory Bowel Disease Questionnaire. Preoperative scores were compared with scores at 6 and 12 months postoperatively. RESULTS: Of 110 patients eligible for inclusion, 59 (53.6 percent) agreed to participate. Male sexual function and erectile function scores remained high 12 months after surgery (mean International Index of Erectile Function score 51.7 preoperative vs. 58.3 at 12 months postoperative; P = not significant (NS)). Abnormal sexual function decreased from 33.3 percent before surgery to 22.7 percent 12 months after surgery (P = NS). Female sexual function improved 12 months after surgery (mean Female Sexual Function Index score 19.2 preoperative vs. 27 at 12 months postoperative; P = 0.031). Abnormal sexual function decreased from 73.1 percent before surgery to 25 percent 12 months after surgery (P = 0.001). Quality of life significantly improved after ileal pouch-anal anastomosis in both sexes. CONCLUSIONS: In men, ileal pouch-anal anastomosis does not have an adverse effect on sexual function, whereas sexual function in women seems to improve 12 months after surgery.

The iPeer2Peer Program: a pilot randomized controlled trial in adolescents with Juvenile Idiopathic Arthritis.

BACKGROUND: Adolescents with Juvenile Idiopathic Arthritis (JIA) are at risk for physical, emotional, social and role challenges that negatively impact quality of life. Peer mentoring has been shown to improve positive health behaviours in adolescents with chronic disease while simultaneously providing social support. The objectives of this paper are to examine the feasibility and acceptability of an online peer mentoring program (iPeer2Peer Program) for adolescents with JIA. METHODS: The iPeer2Peer program was examined using a waitlist pilot randomized control trial (RCT). Participants were randomly allocated to the intervention or wait-list control group via a secure, web-based randomization service. Health care providers and investigators were blinded to participant group allocation. Trained peer mentors (16-25 years; successfully managing their JIA) were matched to participants (12-18 years; diagnosed with JIA) randomized to the intervention group to provide peer support and education for effective self-management of JIA. Participant-mentor pairings connected ten times over 8 weeks using Skype video calls. Primary outcomes focused on implementation (i.e. measures of feasibility and acceptability). Secondary outcomes focused on effectiveness (i.e. measures of self-management, self-efficacy, pain, social support and quality of life). RESULTS: Thirty adolescents (mean age 14.3 ± 1.7 years, 97 % female) completed the RCT (intervention n = 16, control n = 14). PRIMARY OUTCOMES: One third (32 %) of adolescents approached agreed to participate, completed baseline measures and were randomized. Half of pairings completed ten calls within 8 weeks. Average call length was twice the required amount with call lengths of 44.72 ± 15.76 min. Participants reported satisfaction with the program and all reported that they would recommend it to their peers. Participants' mean engagement level with the program was 8.53/10 (range = 7-10). SECONDARY OUTCOMES: Participants who completed the iPeer2Peer Program demonstrated improvements in their perceived ability to manage JIA (p < 0.04), compared to controls. No adverse events were reported. CONCLUSION: The iPeer2Peer Program is a promising intervention that improves acceptability of self-management and peer support treatments for adolescents with JIA. By using the Internet to connect mentors to adolescents with JIA it may also improve accessibility to these resources. Findings will be used to adapt the program and refine the methodology for a full-scale RCT. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT01986400 . Registered November 11, 2013.

Platelet interactions with calcium-phosphate-coated surfaces.

Many studies have shown that calcium-phosphate (CaP)-coated endosseous implants exhibit more peri-implant bone formation and bone contact at early healing times than uncoated implants. Since the rate of healing is influenced by blood/implant interactions and possibly the degree of blood platelet activation, the aim of this study was to determine whether the topography, microtopography, or the presence of calcium (Ca) and phosphate (PO(4)) ions in the implant surface plays a predominant role in platelet activation. We define the threshold between topography and microtopography as the limit of the scale range of platelets themselves; thus, a microtopographic surface is defined by one which exhibits features 3mum. With the help of four international collaborating laboratories, we prepared 11 titanium and CaP-modified titanium surfaces each with different (micro)topographies and interrogated these surfaces with both platelet adhesion (lactate dehydrogenase activity) and platelet activation (microparticle formation and P-selectin expression) assays. Our results show that: calcium (Ca)- and phosphate (PO(4))-containing surfaces of increasing surface microtopographical complexity exhibit increasing platelet activation; surfaces with similar surface microtopographies show similar levels of platelet activation regardless of the presence of Ca and PO(4) in the surface; and that surface microtopography is responsible for platelet activation rather than the presence of Ca and PO(4) in the surface.

Can a tailored knowledge translation strategy improve short term outcomes? A pilot study to increase compliance with bowel preparation recommendations in general surgery.

BACKGROUND: Previous studies have shown that practices supported by level I evidence may take up to 20 years before they are adopted. Although mechanical bowel preparation (MBP) has been a routine practice in colorectal surgery, there is strong evidence dating back to the early 1990s suggesting that in most patients MBP before elective colorectal surgery is not required. The objective of this study was to determine if surgical practices pertaining to bowel preparation could be altered using a tailored knowledge translation strategy. METHODS: A multi-faceted strategy including guideline development, consensus, education by opinion leaders, audit and feedback, and reminder cards was used in this before-after study. The primary outcome was compliance with the recommendations presented in the guideline regarding MBP, normal diet on the day prior to surgery, and enemas. RESULTS: Two-hundred eighty-two patients were enrolled in the study with 111 enrolled before the intervention and 171 enrolled after the intervention. Demographic and clinical characteristics between the 2 groups were similar. Overall, there was a 7.8% increase in compliance with MBP recommendations (81.1% vs 88.4%, P = .038), a 10.2% increase in compliance with diet recommendations (45.6% vs 55.8%, P = .080), and a 5.6% increase in compliance with enema recommendations (88.5% vs 94.2%, P < .001). CONCLUSION: The results of this study reveal that a tailored, multi-faceted knowledge translation strategy is effective in changing surgeon behavior.