Children's Shyness, Frontal Brain Activity, and Anxiety in the Perioperative Context.

Although preoperative anxiety affects up to 75% of children undergoing surgery each year and is associated with many adverse outcomes, we know relatively little about individual differences in how children respond to impending surgery. We examined whether patterns of anterior brain electrical activity (i.e., a neural correlate of anxious arousal) moderated the relation between children's shyness and preoperative anxiety on the day of surgery in 70 children (36 girls, Mage = 10.4 years, SDage = 1.7, years, range 8 to 13 years) undergoing elective surgery. Shyness was assessed using self-report approximately 1 week prior to surgery during a preoperative visit (Time 1), preoperative anxiety was assessed using self-report, and regional EEG (left and right frontal and temporal sites) was assessed using a dry sensory EEG headband on the day of surgery (Time 2). We found that overall frontal EEG alpha power moderated the relation between shyness and self-reported preoperative anxiety. Shyness was related to higher levels of self-reported anxiety on the day of surgery for children with lower average overall frontal alpha EEG power (i.e., higher cortical activity) but not for children with higher average overall frontal alpha EEG power (i.e., lower cortical activity). These results suggest that the pattern of frontal brain activity might amplify some shy children's affective responses to impending surgery. Findings also extend prior results linking children's shyness, frontal brain activity, and anxiety observed in the laboratory to a real-world, ecologically salient environment.

Evaluating the impacts of patient engagement on a national health research network: results of a case study of the Chronic Pain Network.

BACKGROUND: The Chronic Pain Network (CPN) is a pan-Canadian research network focused on innovating and improving the quality and delivery of pain prevention, assessment, management and research for all Canadians. An important focus of the CPN is to work in collaboration with patient partners. Patient partners, researchers and clinicians work together in all aspects of the research network including on funded research projects and in the governance of the Network. Given this focus, the CPN identified the importance of evaluating their patient engagement work to understand its functioning and impact. METHODS: The objective of this exploratory evaluation case study was to understand the impacts of patient engagement on the CPN. The CPN worked with an external evaluation team which established an arms-length approach to the evaluation. Interviews were conducted with CPN members, including patient partners, leadership, funded researchers and committee co-chairs, at three discrete time points to trace the evolution of the patient engagement program within the Network. Key Network documents were also collected and reviewed. Data were analyzed following each set of interviews using content analysis guided by the principles of constant comparison and qualitative description. A final round of analysis was conducted using the Engage with Impact Toolkit, an impact measurement framework, to identify impacts of engagement. RESULTS: Impacts of patient engagement were identified at the individual, network, funded research project and research community levels. These impacts were observed in the following areas: (1) building community; (2) developing knowledge, skills and resources; (3) increasing confidence; (4) influencing priorities and decisions; (5) enabling additional opportunities; (6) promoting culture change; and, (7) coping with experiences of living with chronic pain. CONCLUSIONS: While not without challenges, the patient engagement efforts of the CPN demonstrates the impact engaging patient partners can have on a national research network and related policy activities. Understanding the approaches to, and impacts of, patient engagement on health research networks can illuminate the value of having patient partners engaged in all aspects of a research network and should serve as encouragement to others who look to take on similar work.

The Chronic Pain Network (CPN) is one of a group of research networks that was funded by the Canadian Institutes of Health Research (CIHR) to support patient-oriented research in chronic diseases. From the beginning of its work, the CPN has included patients as partners. Patient partners are co-chairs of all Network governance committees, funded projects are required to include patient partners in their work and there is a committee dedicated to engagement, the Patient Engagement (PE) committee. The PE Committee determined that it was important to evaluate how the CPN was engaging with patient partners and collaborated with the Public and Patient Engagement Collaborative (PPEC) to evaluate this work. The PPEC, along with members of the PE Committee, identified understanding the impact of patient engagement as an important part of the evaluation. This paper provides a description of the impacts of patient engagement on the people who were involved in the CPN, on the CPN's work and way of being, and on the broader pain research community. Based on the results from three sets of interviews and review of Network documents, we share impacts identified in seven areas: (1) building community; (2) developing knowledge, skills and resources; (3) increasing confidence; (4) influencing priorities and decisions; (5) enabling additional opportunities; (6) promoting culture change; and, (7) coping with experiences of living with chronic pain. This research shows us the impact that engaging patient partners can have on a national research network, and the areas where greater focus could, perhaps, lead to even greater impacts in future networks.

Risk and protective factors in predicting pediatric acute postsurgical pain: A systematic review and meta-analysis.

OBJECTIVE: Acute postsurgical pain (APSP), defined as pain within 3 months after surgery, is reported in most surgical pediatric patients, and a significant number of patients experience pain interfering with their daily life activities. We aimed to identify perioperative and psychosocial factors associated with APSP severity in pediatric patients undergoing surgery. METHOD: MEDLINE, EMBASE, CINAHL, PsycINFO, Web of Science, and CENTRAL were searched from database inception to October 2021. Studies that reported an association between risk or protective factors and acute pain in children were included. The primary outcome was the magnitude of association between identified factors and APSP, as measured by standardized effect sizes. RESULTS: Thirty-eight studies (7,936 participants aged 1-18 years) were included. Meta-analysis of 12 studies (1,192 participants) revealed child preoperative pain, pain immediately after surgery, anticipated pain, temperament, pain catastrophizing, age, preoperative anxiety, parent pain catastrophizing, and parent preoperative anxiety were positively associated with APSP. Child pain coping efficacy was protective against APSP. We identified several modifiable child and parent psychosocial factors as predictors of APSP severity. CONCLUSION: Given the small degree of association between identified factors and postsurgical pain, there is value in pursuing other factors that may better explain the variability in pain. Recognizing patients at risk for moderate to severe APSP enables early implementation of interventions to minimize pain burden. Interventions to enhance coping, an adaptive characteristic, may also help to reduce APSP. (PsycInfo Database Record (c) 2023 APA, all rights reserved).

Transition to Virtual Care Services during COVID-19 at Canadian Pain Clinics: Survey and Future Recommendations.

Introduction: Due to the COVID-19 pandemic, healthcare centers quickly adapted services into virtual formats. Pain clinics in Canada play a vital role in helping people living with pain, and these clinics remained essential services for patients throughout the pandemic. This study aimed to (1) describe and compare the transition from in-person to virtual pain care services at Canadian pain clinics during the onset of the COVID-19 pandemic and (2) provide postpandemic recommendations for pain care services to optimize the quality of patient care. Materials and Methods: We used a qualitative participatory action study design that included a cross-sectional survey for data collection and descriptive analysis to summarize the findings. Survey responses were collected between January and March of 2021. The survey was administered to the leadership teams of 11 adult pain clinics affiliated with the Chronic Pain Centre of Excellence for Canadian Veterans. Responses were analyzed qualitatively to describe the transition to the virtual pain services at pain clinics. Results: We achieved a 100% response rate from participating clinics. The results focus on describing the transition to the virtual care, current treatment and services, the quality of care, program sustainability, barriers to maintaining virtual services, and future considerations. Conclusions: Participating clinics were capable of transitioning pain care services to the virtual formats and have in-person care when needed with proper safety precautions. The pandemic demonstrated that it is feasible and sustainable for pain clinics to have a hybrid of virtual and in-person care to treat those living with pain. It is recommended that moving forward, there should be a hybrid of both virtual and in-person care for pain clinics. Ministries of Health should continue to develop policies and funding mechanisms that support innovations aimed at holistic healthcare, interdisciplinary teams, and the expansion of clinics' geographical reach for patient access.

Children's shyness and frontal electroencephalogram delta-beta correlation in the pediatric surgical setting.

The prospect of surgery is a unique psychologically threatening context for children, often leading to experiences of preoperative anxiety. Recent research suggests that individual differences in children's temperament may influence responses to the surgical setting. In the present study, we examined whether individual differences in shyness were related to differences in frontal electroencephalogram (EEG) delta-beta correlation, a proposed neural correlate of emotion regulation and dysregulation, among children anticipating surgery. Seventy-one children (36 boys, Mage  = 10.3 years, SDage  = 1.7 years) undergoing elective surgery self-reported on their own shyness, and their parents also reported on their child's shyness. Using a mobile, dry sensor EEG headband, frontal EEG measures were collected and self- and observer-reported measures of state anxiety were obtained at the children's preoperative visit (Time 1) and on the day of surgery (Time 2). A latent cluster analysis derived classes of low shy (n = 37) and high shy (n = 34) children using the child- and parent-reported shyness measures. We then compared the two classes on frontal EEG delta-beta correlation using between- and within-subjects analyses. Although children classified as high versus low in shyness had higher self- and observer-reported state anxiety across both time periods, frontal EEG delta-beta correlation increased from T1 to T2 only among low shy children using a between-subjects delta-beta correlation measure. We discuss the interpretation of a relatively higher delta-beta correlation as a correlate of emotion regulatory versus dysregulatory strategies for some children in a "real-world," surgical context.

Interventions to Influence Opioid Prescribing Practices for Chronic Noncancer Pain: A Systematic Review and Meta-Analysis.

CONTEXT: This study is a systematic review of interventions to improve adherence to guideline recommendations for prescribing opioids for chronic noncancer pain. EVIDENCE ACQUISITION: Investigators searched CINAHL, Embase, MEDLINE, PsycINFO, the Cochrane Library, and Joanna Briggs Institute Evid Based Pract database from inception until June 3, 2019. Interventional studies to improve adherence to recommendations made by opioid guidelines for chronic noncancer pain in North America were eligible if outcomes included adherence to guideline recommendations or change in quantity of opioids prescribed. Data were extracted independently and in duplicate. Quantitative synthesis was performed using random effects meta-analysis. Confidence in evidence was determined using the Grades of Recommendation, Assessment, Development, and Evaluation. EVIDENCE SYNTHESIS: A total of 20 studies (8 controlled and 12 prospective cohort) involving 1,491 providers and 72 clinics met inclusion. Interventions included education, audit and feedback, interprofessional support, shared decision making, and multifaceted strategies. Multifaceted interventions improved the use of urine drug testing (n=2, or =2.31, 95% CI=1.53, 3.49, z=3.98, p<0.01; high-certainty evidence), treatment agreements (n=2, or =1.96, 95% CI=1.47, 2.61, z=4.56, p<0.01; moderate-certainty evidence), and mental health screening (n=2, 2.57-fold, 95% CI=1.56, 4.24, z=2.32, p=0.02; low-certainty evidence) when prescribing opioids for chronic noncancer pain. Very low-certainty evidence suggests that several interventions improved the use of treatment agreements, urine drug testing, and prescription drug monitoring programs. CONCLUSIONS: Mostly very low-certainty evidence supports a number of interventions for improving adherence to risk management strategies when prescribing opioids for chronic noncancer pain; however, the effect on patient important outcomes (e.g., overdose, addiction, death) is uncertain.

Accessing care in multidisciplinary pain treatment facilities continues to be a challenge in Canada.

BACKGROUND: Multidisciplinary pain treatment facilities (MPTFs) are considered the optimal settings for the management of chronic pain (CP). This study aimed (1) to determine the distribution of MPTFs across Canada, (2) to document time to access and types of services, and (3) to compare the results to those obtained in 2005-2006. METHODS: This cross-sectional study used the same MPTF definition as in 2005-2006-that is, a clinic staffed with professionals from a minimum of three different disciplines (including at least one medical specialty) and whose services were integrated within the facility. A comprehensive search strategy was used to identify existing MPTFs across Canada. Administrative leads at each MPTF were invited to complete an online questionnaire regarding their facilities. RESULTS: Questionnaires were completed by 104 MPTFs (response rate 79.4%). Few changes were observed in the distribution of MPTFs across Canada compared with 12 years ago. Most (91.3%) are concentrated in large urban cities. Prince Edward Island and the Territories still lack MPTFs. The number of pediatric-only MPTFs has nearly doubled but remains small (n=9). The median wait time for a first appointment in publicly funded MPTFs is about the same as 12 years ago (5.5 vs 6 months). Small but positive changes were also observed. CONCLUSION: Accessibility to public MPTFs continues to be limited in Canada, resulting in lengthy wait times for a first appointment. Community-based MPTFs and virtual care initiatives to distribute pain services into regional and remote communities are needed to provide patients with CP with optimal care.

Applying Serum Cytokine Levels to Predict Pain Severity in Cancer Patients.

BACKGROUND AND AIM: Cancers originating in the breast, lung and prostate often metastasize to the bone, frequently resulting in cancer-induced bone pain that can be challenging to manage despite conventional analgesic therapy. This exploratory study's aim was to identify potential biomarkers associated with cancer-induced pain by examining a sample population of breast cancer patients undergoing bisphosphonate therapy. METHODS: A secondary analysis of the primary study was performed to quantify serum cytokine levels for correlation to pain scores. Cytokines with statistically significant correlations were then input into a stepwise regression analysis to generate a predictive equation for a patient's pain severity. In an effort to find additional potential biomarkers, correlation analysis was performed between these factors and a more comprehensive panel of cytokines and chemokines from breast, lung, and prostate cancer patients. RESULTS: Statistical analysis identified nine cytokines (GM-CSF, IFNγ, IL-1ß, IL-2, IL-4, IL-5, IL-12p70, IL-17A, and IL-23) that had significant negative correlations with pain scores and they could best predict pain severity through a predictive equation generated for this specific evaluation. After performing a correlation analysis between these factors and a larger panel of cytokines and chemokines, samples from breast, lung and prostate patients showed distinct correlation profiles, highlighting the clinical challenge of applying pain-associated cytokines related to more defined nociceptive states, such as arthritis, to a cancer pain state. CONCLUSION: Exploratory analyses such as the ones presented here will be a beneficial tool to expand insights into potential cancer-specific nociceptive mechanisms and to develop novel therapeutics.

Attitudes Towards and Management of Opioid-induced Hyperalgesia: A Survey of Chronic Pain Practitioners.

OBJECTIVES: Opioid-induced hyperalgesia (OIH) is a phenomenon whereby opioids increase patients' pain sensitivity, complicating their use in analgesia. We explored practitioners' attitudes towards, and knowledge concerning diagnosis, risk factors, and treatment of OIH. MATERIALS AND METHODS: We administered an 18-item cross-sectional survey to 850 clinicians that managed chronic pain with opioid therapy. RESULTS: The survey response rate was 37% (318/850). Most respondents (240/318, 76%) reported they had observed patients with OIH in their practice, of which 38% (84/222) reported OIH affected >5% of their chronic pain patients. The majority (133/222, 60%) indicated that OIH could result from any dose of opioid therapy. The most commonly endorsed chronic pain conditions associated with the development of OIH were fibromyalgia (109/216, 51%) and low back pain (91/216, 42%), while 42% (91/216) indicated that no individual chronic pain condition was associated with greater risk of OIH. The most commonly endorsed opioids associated with the development of OIH were oxycodone (94/216, 44%), fentanyl (86/216, 40%), and morphine (84/216, 39%); 27% (59/216) endorsed that no specific opioid was more likely to result in OIH. Respondents commonly managed OIH by opioid dose reduction (147/216, 68%), administering a nonopioid adjuvant (133/216, 62%), or discontinuing opioids (95/216, 44%). DISCUSSION: Most clinicians agreed that OIH is a complication of opioid therapy, but were divided regarding the prevalence of OIH, etiological factors, and optimal management.

Prescriber adherence to guidelines for chronic noncancer pain management with opioids: Systematic review and meta-analysis.

OBJECTIVE: This review quantified prescriber adherence to opioid prescribing guidelines for chronic noncancer pain (CNCP). METHOD: We searched CINAHL, Embase, MEDLINE, PsycINFO, the Cochrane Library, and the Joanna Briggs Institute EBP Database from inception until June 3, 2019. Studies that focused on provider adherence to opioids guidelines for CNCP in North America were eligible. Four reviewers screened studies, extracted data, and assessed study quality. RESULTS: Thirty-eight studies were eligible, comprising 17 cross-sectional studies (n = 11,835 providers) and 22 chart reviews (n = 22,512 patients). Survey data indicated that adherence was 49% (95% CI [40, 59]) for treatment agreements, 33% (95% CI [19%, 47%]) for urine drug testing, 48% (95% CI [26%, 71%]) for consultation with drug monitoring program, 57% (95% CI [35%, 79%]) for assessing risk of aberrant medication-taking behavior, and 61% (95% CI [35%, 87%]) for mental health screening. Chart review data indicated that the proportion of patients with documentation was 40% (95% CI [29, 51]) for treatment agreements, 41% (95% CI [32%, 50%]) for urine drug testing, 40% (95% CI [2%, 78%]) for consultation with drug monitoring program, 41% (95% CI [20%, 64%]) for assessing risk of aberrant medication-taking behavior, and 22% (95% CI [9%, 33%]) for mental health screening. Year of publication, practice guideline referenced, and risk of bias explained significant heterogeneity. No study evaluated whether nonadherence to recommendations reflected well-justified deviations to care. CONCLUSIONS: Adherence to guideline recommendations for opioids for CNCP is low. It is unclear whether nonadherence reflects thoughtful deviations in care. (PsycInfo Database Record (c) 2020 APA, all rights reserved).

Identifying appropriate outcomes to help evaluate the impact of the Canadian Guideline for Safe and Effective Use of Opioids for Non-Cancer Pain.

BACKGROUND: The Canadian Guideline for Safe and Effective Use of Opioids for Chronic Non-Cancer Pain (COG) was developed in response to increasing rates of opioid-related hospital visits and deaths in Canada, and uncertain benefits of opioids for chronic non-cancer pain (CNCP). Following publication, we developed a list of evaluable outcomes to assess the impact of this guideline on practice and patient outcomes. METHODS: A working group at the National Pain Centre at McMaster University used a modified Delphi process to construct a list of clinical and patient outcomes important in assessing the uptake and application of the COG. An advisory group then reviewed this list to determine the relevance and feasibility of each outcome, and identified potential data sources. This feedback was reviewed by the National Faculty for the Guideline, and a National Advisory Group that included the creators of the COG, resulting in the final list of 5 priority outcomes. RESULTS: Five outcomes were judged clinically important and feasible to measure: 1) Effects of opioids for CNCP on quality of life, 2) Assessment of patient's risk of addiction before starting opioid therapy, 3) Monitoring patients on opioid therapy for aberrant drug-related behaviour, 4) Mortality rates associated with prescription opioid overdose and 5) Use of treatment agreements with patients before initiating opioid therapy for CNCP. Data sources for these outcomes included patient's medical charts, e-Opioid Manager, prescription monitoring programs and administrative databases. CONCLUSION: Measuring the impact of best practice guidelines is infrequently done. Future research should consider capturing the five outcomes identified in this study to evaluate the impact of the COG in promoting evidence-based use of opioids for CNCP.

Allodynography: Reliability of a New Procedure for Objective Clinical Examination of Static Mechanical Allodynia.

OBJECTIVE: There is a need for reliable and valid clinical assessment tools for quantifying allodynia in neuropathic pain. Allodynography has been proposed as a useful standardized procedure for clinical assessment of mechanical allodynia. This study (www.clinicaltrials.gov NCT02070367) undertook preliminary investigation of the measurement properties of allodynography, a new standardized clinical examination procedure for mapping the area of cutaneous allodynia. METHODS: Persons with pain in one upper extremity after complex regional pain syndrome, a peripheral nerve injury, or who had recently experienced a hand fracture were recruited for assessment of static mechanical allodynia (based on perception of a 15g force stimulus delivered by Semmes-Weinstein monofilament #5.18 as painful) by two raters at baseline; the assessment was repeated one week later. RESULTS: Single-measures estimates suggested inter-rater reliability for allodynography was excellent at an intraclass correlation coefficient (ICC) of 0.97 (N = 12); test-retest reliability was also excellent at ICC = 0.89 (N = 10) for allodynography (P < 0.001 for both). Confidence intervals' lower bounds confirm inter-rater reliability as excellent (0.90) but were less definitive for test-retest (0.59). CONCLUSIONS: This preliminary study supports the inter-rater and test-retest reliability of allodynography. Studies on larger samples in multiple contexts and reporting other measurement properties are warranted.

Evaluating a sensitive issue: reliability of a clinical evaluation for allodynia severity.

Purpose/Aim: Allodynia is a common feature of neuropathic pain with few validated clinical evaluation options. We identified a need to estimate the measurement properties of the standardised evaluation procedure for static mechanical allodynia severity popularised by the somatosensory rehabilitation of pain method, known as the rainbow pain scale. This study (www.clinicaltrials.gov. NCT02070367) undertook preliminary investigation of the inter-rater and test-retest reliability of the rainbow pain scale.Methods: Persons with pain in one upper extremity after Complex Regional Pain Syndrome, a peripheral nerve injury or a recent hand fracture were recruited for assessment of static mechanical allodynia threshold using calibrated monofilaments by two raters at baseline, and repeated assessment one week later.Results: Single measures estimates suggested inter-rater reliability was substantial for the rainbow pain scale [intra-class correlation coefficient = 0.78 (n = 31), p < 0.001]. Test-retest reliability was also excellent at with an intraclass correlation coefficient of 0.87 [n = 28, p < 0.001]. However, confidence intervals suggest the true values could be more moderate, with lower bounds of the 95% confidence interval at 0.60 and 0.74, respectively.Conclusions: This pilot study has generated preliminary support for the inter-rater and test-retest reliability of the rainbow pain scale. Future studies should seek to increase confidence in estimates of reliability, and estimate validity and responsiveness to change in persons with somatosensory disorders.

Association of Temperament With Preoperative Anxiety in Pediatric Patients Undergoing Surgery: A Systematic Review and Meta-analysis.

Importance: Preoperative anxiety is associated with poor behavioral adherence during anesthetic induction and adverse postoperative outcomes. Research suggests that temperament can affect preoperative anxiety and influence its short- and long-term effects, but these associations have not been systematically examined. Objective: To examine the associations of temperament with preoperative anxiety in young patients undergoing surgery. Data Sources: Studies from MEDLINE, Embase, CINAHL, PsycINFO, Web of Science, and the Cochrane Central Register of Controlled Trials databases were searched from database inception to June 2018. Study Selection: All prospective studies reporting associations of temperament with preoperative anxiety were included. Overall, 43 of 5451 identified studies met selection criteria. Data Extraction and Synthesis: Using the PRISMA guidelines, reviewers independently read 43 full-text articles, extracted data on eligible studies, and assessed the quality of each study. Data were pooled using the Lipsey and Wilson random-effects model. Main Outcomes and Measures: Primary outcome was the association of temperament with preoperative anxiety in patients undergoing surgery. Results: A total of 23 studies, with 4527 participants aged 1 to 18 years, were included in this review. Meta-analysis of 12 studies including 1064 participants revealed that emotionality (r = 0.11; 95% CI, 0.04 to 0.19), intensity of reaction (r = 0.29; 95% CI, 0.11 to 0.46), and withdrawal (r = 0.40; 95% CI, 0.23 to 0.55) were positively associated with preoperative anxiety, whereas activity level (r = -0.23; 95% CI, -0.31 to -0.16) was negatively correlated with preoperative anxiety. Impulsivity was not significantly associated with preoperative anxiety. Conclusions and Relevance: This systematic review and meta-analysis provided evidence suggesting that temperament may help identify pediatric patients at risk of preoperative anxiety and guide the design of prevention and intervention strategies. Future studies should continue to explore temperament and other factors influencing preoperative anxiety and their transactional effects to guide the development of precision treatment approaches and to optimize perioperative care.

Vital sign monitoring with continuous pulse oximetry and wireless clinical notification after surgery (the VIGILANCE pilot study)-a randomized controlled pilot trial.

BACKGROUND: Respiratory depression is a serious perioperative complication associated with morbidity and mortality. Recently, technology has become available to wirelessly monitor patients on regular surgical wards with continuous pulse oximetry and wireless clinician notification with alarms. When a patient's SpO2 falls below a set threshold, the clinician is notified via a pager and may intervene earlier to prevent further clinical deterioration. To date, the technology has not been evaluated with a randomized controlled trial (RCT). METHODS: We designed a parallel-group unblinded pilot RCT of a wireless monitoring system on two surgical wards in an academic teaching hospital. Postsurgical patients with an anticipated length of stay of at least 1 day were included and randomized to standard care or standard care plus wireless respiratory monitoring for up to a 72-h period. The primary outcomes were feasibility outcomes: average patients recruited per week and tolerability of the system by patients. Secondary outcomes included (1) respiratory events (naloxone administration for respiratory depression, ICU transfers, and cardiac arrest team activation) and (2) system alarm types and details. The analysis of the outcomes was based on descriptive statistics and estimates reported using point (95% confidence intervals). Criteria for success of feasibility were recruitment of an average of 15 patients/week and 90% of the patients tolerating the system. RESULTS: The pilot trial enrolled 250 of the 335 patients screened for eligibility, with 126 and 124 patients entering the standard monitoring and wireless groups, respectively. Baseline demographics were similar between groups, except for slightly more women in the wireless group. Average patient recruitment per week was 14 95% CI [12, 16] patients. The wireless monitoring was quite tolerable with 86.6% (95% CI 78.2-92.7%) of patients completing the full course, and there were no other adverse events directly attributable to the monitoring. With regard to secondary outcomes, the respiratory event rate was low with only 1 event in the wireless group and none in the control group. The average number of alarms per week was 4.0 (95% CI, 1.6-6.4). CONCLUSIONS: This pilot study demonstrated adequate patient recruitment and high tolerability of the wireless monitoring system. A full RCT that is powered to detect patient important outcomes such as respiratory depression is now underway. TRIAL REGISTRATION: ClinicalTrials.gov, Registration number NCT02907255, registered 7 September 2016-retrospectively registered.

Opioids for Chronic Noncancer Pain: A Systematic Review and Meta-analysis.

Importance: Harms and benefits of opioids for chronic noncancer pain remain unclear. Objective: To systematically review randomized clinical trials (RCTs) of opioids for chronic noncancer pain. Data Sources and Study Selection: The databases of CENTRAL, CINAHL, EMBASE, MEDLINE, AMED, and PsycINFO were searched from inception to April 2018 for RCTs of opioids for chronic noncancer pain vs any nonopioid control. Data Extraction and Synthesis: Paired reviewers independently extracted data. The analyses used random-effects models and the Grading of Recommendations Assessment, Development and Evaluation to rate the quality of the evidence. Main Outcomes and Measures: The primary outcomes were pain intensity (score range, 0-10 cm on a visual analog scale for pain; lower is better and the minimally important difference [MID] is 1 cm), physical functioning (score range, 0-100 points on the 36-item Short Form physical component score [SF-36 PCS]; higher is better and the MID is 5 points), and incidence of vomiting. Results: Ninety-six RCTs including 26 169 participants (61% female; median age, 58 years [interquartile range, 51-61 years]) were included. Of the included studies, there were 25 trials of neuropathic pain, 32 trials of nociceptive pain, 33 trials of central sensitization (pain present in the absence of tissue damage), and 6 trials of mixed types of pain. Compared with placebo, opioid use was associated with reduced pain (weighted mean difference [WMD], -0.69 cm [95% CI, -0.82 to -0.56 cm] on a 10-cm visual analog scale for pain; modeled risk difference for achieving the MID, 11.9% [95% CI, 9.7% to 14.1%]), improved physical functioning (WMD, 2.04 points [95% CI, 1.41 to 2.68 points] on the 100-point SF-36 PCS; modeled risk difference for achieving the MID, 8.5% [95% CI, 5.9% to 11.2%]), and increased vomiting (5.9% with opioids vs 2.3% with placebo for trials that excluded patients with adverse events during a run-in period). Low- to moderate-quality evidence suggested similar associations of opioids with improvements in pain and physical functioning compared with nonsteroidal anti-inflammatory drugs (pain: WMD, -0.60 cm [95% CI, -1.54 to 0.34 cm]; physical functioning: WMD, -0.90 points [95% CI, -2.69 to 0.89 points]), tricyclic antidepressants (pain: WMD, -0.13 cm [95% CI, -0.99 to 0.74 cm]; physical functioning: WMD, -5.31 points [95% CI, -13.77 to 3.14 points]), and anticonvulsants (pain: WMD, -0.90 cm [95% CI, -1.65 to -0.14 cm]; physical functioning: WMD, 0.45 points [95% CI, -5.77 to 6.66 points]). Conclusions and Relevance: In this meta-analysis of RCTs of patients with chronic noncancer pain, evidence from high-quality studies showed that opioid use was associated with statistically significant but small improvements in pain and physical functioning, and increased risk of vomiting compared with placebo. Comparisons of opioids with nonopioid alternatives suggested that the benefit for pain and functioning may be similar, although the evidence was from studies of only low to moderate quality.

Healthcare provider knowledge, attitudes, beliefs, and practices surrounding the prescription of opioids for chronic non-cancer pain in North America: protocol for a mixed-method systematic review.

BACKGROUND: Evidence from diverse areas of medicine (e.g., cardiovascular disease, diabetes) indicates that healthcare providers (HCPs) often do not adhere to clinical practice guidelines (CPGs) despite a clear indication to implement recommendations-a phenomenon commonly termed clinical inertia. There are a variety of reasons for clinical inertia, but HCP-related factors (e.g., knowledge, motivation, agreement with guidelines) are the most salient and amenable to intervention aimed to improve adherence. CPGs have been developed to support the safe and effective prescription of opioid medication for the management of chronic non-cancer pain. The extent of physician uptake and adherence to such guidelines is not yet well understood. The purpose of this review is to synthesize the published evidence about knowledge, attitudes, beliefs, and practices that HCPs hold regarding the prescription of opioids for chronic non-cancer pain. METHODS: An experienced information specialist will perform searches of CINAHL, Embase, MEDLINE, and PsycINFO bibliographic databases. The Cochrane library, PROSPERO, and the Joanna Briggs Institute will be searched for systematic reviews. Searches will be performed from inception to the present. Quantitative and qualitative study designs that report on HCP knowledge, attitudes, beliefs, or practices in North America will be eligible for inclusion. Studies reporting on interventions to improve HCP adherence to opioid prescribing CPGs will also be eligible for inclusion. Two trained graduate-level research assistants will independently screen articles for inclusion, perform data extraction, and perform risk of bias and quality assessment using recommended tools. Confidence in qualitative evidence will be evaluated using the Grades of Recommendation, Assessment, Development, and Evaluation-Confidence in the Evidence from Qualitative Reviews (GRADE-CERQual) approach. Confidence in quantitative evidence will be assessed using the GRADE approach. DISCUSSION: The ultimate goal of this work is to support interventions aiming to optimize opioid prescribing practices in order to prevent opioid-related morbidity and mortality without restricting a HCP's ability to select the most appropriate treatment for an individual patient. SYSTEMATIC REVIEW REGISTRATION: PROSPERO CRD42018091640 .

Exploring factors associated with views on sharing of certain interim trial result measures by the data safety monitoring board (DSMB) with non-DSMB members.

BACKGROUND: Sharing interim result measures by the Data Safety Monitoring Board (DSMB) with non-DSMB members is an important issue that can affect trial integrity. Currently, it is unclear if there are demographic factors associated with sharing such information. This study's objective is to primarily explore the demographic factors associated with the DSMB sharing certain interim result measures and secondarily, explore demographic factors associated with the perceived usefulness in sharing certain interim result measures, with non-DSMB members. METHODS: We conducted an online survey of members of the Society of Clinical Trials (SCT) and International Society of Clinical Biostatistics (ISCB) in 2015 asking their professional views on the DSMB sharing interim trial results, specifically the interim control event rate (IControlER), interim combined even rate (ICombinedER), adaptive conditional power (ACP) and unconditional conditional power (UCP) with non-DSMB members. Binary logistic and multiple linear regressions were used to explore if demographic factors were associated with sharing a certain interim result measure and the perceived usefulness of sharing that interim result measure, respectively. Multiple imputation (MI) was used to evaluate the impact of missing data as a sensitivity analysis. RESULTS: Approximately 3136 (936 from SCT + ~ 2200 from ISCB) members were invited (response rate of 12%; [371/3136]. Two main findings: (1) involvement in more than 15 private industry-sponsored trials was associated with not endorsing the sharing of the IControlER (odds ratio [OR] = 2.92; 95% confidence interval [CI]: 1.31, 6.52]; p = 0.012), and (2) involvement in more than 15 private industry-sponsored trials was associated positively with an increase in the perceived usefulness in sharing the ACP by 2.35 points (beta coefficient estimate = 2.35 [95% CI: 0.45, 4.05], p = 0.017. The findings were similar after sensitivity analyses. CONCLUSIONS: An individual involved with more than 15 trials that had some form of private industry sponsorship is a demographic factor associated with NOT sharing the IControlER by the DSMB and an increased perceived usefulness in sharing the ACP at interim. Further studies are needed to evaluate for these demographic factors given the limitations of this study related to missing data. Due to some key limitations, regarding high non-response and missing data, we caution interpreting the results as definitive, but rather look at them as a first exploratory step to find potential associations for further evaluation.

Audiovisual interventions for parental preoperative anxiety: A systematic review and meta-analysis.

OBJECTIVE: To systematically review and meta-analyze studies assessing the effectiveness of audiovisual (AV) interventions aimed at reducing anxiety in parents whose children are undergoing elective surgery. METHODS: A comprehensive search of multiple electronic databases was performed. A narrative synthesis of findings and random-effects meta-analyses were used to summarize the results. Our primary outcome was parental anxiety. Secondary outcomes included children's preoperative anxiety and postoperative outcomes; parental satisfaction, knowledge, and need for anesthesia information. Risk of bias was appraised within and across studies. RESULTS: Our search yielded 723 studies and 11 were included. A Standardized Mean Difference (SMD) of -0.53 (95% CI [-0.91, -0.15], p < .01) was found between parental anxiety scores in AV interventions and control groups. In terms of children's preoperative anxiety, there was a SMD of -0.59 (95% CI [-1.11, -0.07], p < .05) between children's anxiety scores in AV intervention and nonintervention participants. Furthermore, AV interventions were shown to shorten the recovery time for children undergoing surgery (SMD = -0.21; 95% CI [-0.39, -0.02], p = .03) but did not lead to improvements on other postoperative outcomes. CONCLUSIONS: These findings suggest that AV interventions have modest, positive effects on both parental and children's preoperative anxiety. Although a statistically significant medium size effect was detected, the clinical significance of this finding requires further exploration. Further research aimed at developing better AV interventions to help guide future practice is warranted. (PsycINFO Database Record