Frequency and characteristics of patient exclusion criteria in Canadian multidisciplinary pain treatment facilities: a cross-sectional study.

PURPOSE: A multidisciplinary approach is recommended for patients with complex chronic pain (CP). Many multidisciplinary pain treatment facilities (MTPFs) use patient exclusion criteria but little is known about their characteristics. The objective of this study was to describe the frequency and characteristics of exclusion criteria in public Canadian MTPFs. METHODS: We conducted a cross-sectional study in which we defined an MPTF as a clinic staffed with professionals from three disciplines or more (including at least one medical specialty) and whose services were integrated within the facility. We disseminated a web-based questionnaire in 2017-2018 to the administrative leads of MPTFs across the country. They were invited to complete the questionnaire about the characteristics of their facilities. Data were analyzed using descriptive statistics and correlation measures. RESULTS: A total of 87 MTPFs were included in the analyses. Half of them (52%) reported using three exclusion criteria or more. There was no significant association between the number of exclusion criteria and wait time for a first appointment or number of new consultations in the past year. Fibromyalgia and migraine were the most frequently excluded pain syndromes (10% and 7% of MPTFs, respectively). More than one MPTF out of four excluded patients with mental health disorders (30%) and/or substance use disorders (29%), including MPTFs with specialists in their staff. CONCLUSIONS: Multidisciplinary pain treatment facility exclusion criteria are most likely to affect CP patients living with complex pain issues and psychosocial vulnerabilities. Policy efforts are needed to support Canadian MPTFs in contributing to equitable access to pain management.

RéSUMé: OBJECTIF: Une approche multidisciplinaire est recommandée pour les patients souffrant de douleur chronique (DC) complexe. De nombreux centres multidisciplinaires de traitement de la douleur (CMTD) utilisent des critères d'exclusion des patients, mais on ne sait que peu de choses sur leurs caractéristiques. L'objectif de cette étude était de décrire la fréquence et les caractéristiques des critères d'exclusion dans les CMTD publics canadiens. MéTHODE: Nous avons mené une étude transversale dans laquelle nous avons défini un CMTD comme une clinique composée de professionnels de trois disciplines ou plus (y compris au moins une spécialité médicale) et dont les services étaient intégrés à l'établissement. En 2017-2018, nous avons fait parvenir un questionnaire en ligne aux responsables administratifs des CMTD partout au pays. Ils ont été invités à remplir le questionnaire sur les caractéristiques de leurs établissements. Les données ont été analysées à l'aide de statistiques descriptives et de mesures de corrélation. RéSULTATS: Au total, 87 CMTD ont été inclus dans les analyses. La moitié d'entre eux (52 %) ont déclaré utiliser trois critères d'exclusion ou plus. Il n'y avait pas d'association significative entre le nombre de critères d'exclusion et le temps d'attente pour un premier rendez-vous ou le nombre de nouvelles consultations au cours de la dernière année. La fibromyalgie et la migraine étaient les syndromes douloureux les plus fréquemment exclus (10 % et 7 % des CMTD, respectivement). Plus d'un CMTD sur quatre excluait les patients atteints de troubles de santé mentale (30 %) et/ou de troubles liés à l'utilisation de substances (29 %), y compris les CMTD comptant des spécialistes dans leur personnel. CONCLUSION: Les critères d'exclusion des centres multidisciplinaires de traitement de la douleur sont plus susceptibles d'affecter les patients atteints de douleur chronique vivant avec des problèmes de douleur complexes et des vulnérabilités psychosociales. Des efforts au niveau des politiques sont nécessaires pour aider les CMTD canadiens à favoriser un accès équitable à la prise en charge de la douleur.

Out of the shadows: Chronic pain in Canadian Armed Forces veterans - Proceedings of a workshop at the 2019 Forum of the Canadian Institute for Military and Veteran Health Research.

This commentary summarizes proceedings of a workshop on chronic pain in military personnel and veterans (released personnel) at the Annual Forum of the Canadian Institute for Military and Veteran Health Research in Gatineau and Ottawa on October 22, 2019. The extent and impact of chronic pain among Canadian Armed Forces (CAF) veterans and their families is significant and has been underappreciated, largely due to limited disclosure by serving and veteran military personnel, stemming from a fear of stigmatization. Living with pain is seen as a fact of life in military cultures, something to be endured and not discussed. Though progress is being made in reducing the stigma of mental illness, the discourse on chronic pain remains censored. This workshop's goal was to bring the discussion of chronic pain out of the shadows in the search for ways to help veterans and active service personnel living with chronic pain. Many points of view were brought forward at this first national Canadian multidisciplinary gathering of researchers, veterans with lived experience, clinicians, and policymakers. A CAF member described his lived experience with constant chronic pain. Clinicians described aspects of chronic pain in military personnel and veterans whom they treat in their clinics. Dr. Ramesh Zacharias described the new Chronic Pain Center of Excellence for Canadian Veterans that will be established with funding from Veterans Affairs Canada. Dr. Norman Buckley highlighted collaboration with the existing Chronic Pain Network funded by the Canadian Institute for Health Research. Audience members identified a diverse variety of issues.

Ce commentaire résume les actes d'un atelier sur la douleur chronique chez le personnel militaire et les anciens combattants (personnel libéré) tenu dans le cadre du Forum annuel de l'Institut canadien de recherche sur la santé des militaires et des vétérans à Gatineau et Ottawa le 22 octobre 2019. L'étendue et l'effet de la douleur chronique chez les anciens combattants des Forces armées canadiennes (FAC) et leurs familles sont importantes et ont été sous-estimées, en grande partie en raison de la divulgation limitée par le personnel militaire en service et les anciens combattants, découlant de la peur de la stigmatisation. Le fait de vivre avec la douleur est considéré comme faisant partie de la vie dans les cultures militaires, quelque chose qu'il faut endurer et dont il ne faut pas discuter. Bien que des progrès aient été réalisés dans la réduction de la stigmatisation de la maladie mentale, le discours sur la douleur chronique continue d'être censuré. L'objectif de cet atelier était de faire sortir de l'ombre la discussion sur la douleur chronique afin de chercher des moyens d'aider les anciens combattants et le personnel de service actif vivant avec la douleur chronique. De nombreux points de vue ont été exprimés lors de cette première rencontre multidisciplinaire nationale canadienne réunissant des chercheurs, des anciens combattants ayant vécu l'expérience de la douleur chronique, des cliniciens et des décideurs. Un membre des FAC a décrit l'expérience de douleur chronique qu'il a vécue. Les cliniciens ont décrit les aspects de la douleur chronique chez le personnel militaire et les anciens combattants qu'ils traitent dans leurs cliniques. Le Dr Ramesh Zacharias a décrit le nouveau Centre d'excellence sur la douleur chronique pour les vétérans canadiens qui sera établi grâce au financement d'Anciens Combattants Canada. Le Dr Norman Buckley a souligné la collaboration avec le Réseau de douleur chronique existant financé par l'Institut canadien de la recherche en santé. Les membres de l'audience ont relevé divers problèmes.

Challenges With Continuous Pulse Oximetry Monitoring and Wireless Clinician Notification Systems After Surgery: Reactive Analysis of a Randomized Controlled Trial.

BACKGROUND: Research has shown that introducing electronic Health (eHealth) patient monitoring interventions can improve healthcare efficiency and clinical outcomes. The VIGILANCE (VItal siGns monItoring with continuous puLse oximetry And wireless cliNiCian notification aftEr surgery) study was a randomized controlled trial (n=2049) designed to assess the impact of continuous vital sign monitoring with alerts sent to nursing staff when respiratory resuscitations with naloxone, code blues, and intensive care unit transfers occurred in a cohort of postsurgical patients in a ward setting. This report identifies and evaluates key issues and challenges associated with introducing wireless monitoring systems into complex hospital infrastructure during the VIGILANCE eHealth intervention implementation. Potential solutions and suggestions for future implementation research are presented. OBJECTIVE: The goals of this study were to: (1) identify issues related to the deployment of the eHealth intervention system of the VIGILANCE study; and (2) evaluate the influence of these issues on intervention adoption. METHODS: During the VIGILANCE study, issues affecting the implementation of the eHealth intervention were documented on case report forms, alarm event forms, and a nursing user feedback questionnaire. These data were collated by the research and nursing personnel and submitted to the research coordinator. In this evaluation report, the clinical adoption framework was used as a guide to organize the identified issues and evaluate their impact. RESULTS: Using the clinical adoption framework, we identified issues within the framework dimensions of people, organization, and implementation at the meso level, as well as standards and funding issues at the macro level. Key issues included: nursing workflow changes with blank alarm forms (24/1030, 2.33%) and missing alarm forms (236/1030, 22.91%), patient withdrawal (110/1030, 10.68%), wireless network connectivity, false alarms (318/1030, 30.87%), monitor malfunction (36/1030, 3.49%), probe issues (16/1030, 1.55%), and wireless network standards. At the micro level, these issues affected the quality of the service in terms of support provided, the quality of the information yielded by the monitors, and the functionality, reliability, and performance of the monitoring system. As a result, these issues impacted access through the decreased ability of nurses to make complete use of the monitors, impacted care quality of the trial intervention through decreased effectiveness, and impacted productivity through interference in the coordination of care, thus decreasing clinical adoption of the monitoring system. CONCLUSIONS: Patient monitoring with eHealth technology in surgical wards has the potential to improve patient outcomes. However, proper planning that includes engagement of front-line nurses, installation of appropriate wireless network infrastructure, and use of comfortable cableless devices is required to maximize the potential of eHealth monitoring. TRIAL REGISTRATION: ClinicalTrials.gov NCT02907255; https://clinicaltrials.gov/ct2/show/NCT02907255.

Identification of complex regional pain syndrome in the upper limb: Skin temperature asymmetry after cold pressor test.

BACKGROUND: Skin temperature asymmetry (SkTA) may assist in early identification of complex regional pain syndrome (CRPS), but previous work has been limited by methodological shortcomings including failure to account for the cutaneous nerve distribution where temperature is measured and reliance on laboratory equipment not clinically available. Pilot work suggested that a cold pressor test (CPT) provided a consistent thermoregulatory stress and might increase sensitivity/specificity of SkTA measurements generated reliably by handheld infrared (IR) thermometers. AIMS: This study investigated the sensitivity, specificity, and validity of SkTA in the upper limb to identify CRPS. METHODS: This study was part of a larger clinical trial (the SARA study: www.clinicaltrials.gov NCT02070367). Using IR thermometers, we evaluated SkTA over major peripheral nerve distributions in the hands before and after immersing a single foot in 5°C water for 30 s. Participant groups included healthy volunteers, CRPS, known nerve injury, and hand fracture. RESULTS: SkTA was measured in 65 persons, including 17 persons with CRPS (meeting Budapest criteria). Analysis of variance for n = 378 SkTA observations supported diagnosis, CPT, and nerve distribution as significant predictors (P < 0.001) explaining 94% of the variance. Post CPT, sensitivity for a >1.5°C SkTA improved to 82.4% from 58.8%, whereas specificity dropped from 56.3% to 43.8%. CONCLUSION: This study adds further support for the accuracy of SkTA as a diagnostic indicator of CRPS. Further precision in estimates will be gained from larger studies, which should also seek to replicate our findings for SkTA in the lower limbs.

Contexte: L'asymétrie de la température cutanée peut contribuer à la détection précoce du syndrome douleureux régional complexe (SDRC), mais les travaux réalisés par le passé se sont caractérisés par des insuffisances méthodologiques, parmi lesquelles l'omission de tenir compte de la distribution des nerfs cutanés à l'endroit où la température était mesurée et l'utilisation d'équipement de laboratoire non accessible cliniquement. Selon un projet pilote, un test au froid donne lieu à une tension uniforme dans la thermorégulation et pourrait donc acccroître la sensibilité/spécificité des mesures de l'asymétrie de la température cutanée obtenues de manière fiable par des thermomères infrarouges à main.But: Cette étude portait sur la sensibilité, la spécificité et la validité de l'asymétrie de la température cutanée dans les membres supérieurs pour détecter le SDRC.Méthodes: Cette étude faisait partie d'un essai clinique plus vaste (l'étude SARA : www.clinicaltrials.gov NCT02070367). À l'aide de thermomètres infrarouges, nous avons mesuré l'asymétrie de la température cutanée sur d'importantes distributions de nerfs périphériques dans les mains avant et après l'immersion d'un pied dans l'eau à 5o C pendant 30 secondes. Les groupes de participants étaient les suivants : volontaires en bonne santé, SDRC, lésion nerveuse connue et fracture à la main.Résultats: L'asymétrie de la température cutanée a été mesurée chez 65 personnes, dont 17 personnes souffrant de SDRC (répondant aux critères de Budapest). L'analyse de la variance des observations d'asymétrie de la température cutanée pour n = 378 a démontré que le diagnostic, le test au froid et la distribution des nerfs étaient des prédicteurs significatifs (p < 0,001) expliquant 94 % de la variance. La sensibilité après le test au froid pour une asymétrie de la température cutanée  > 1,5 ° C avait augmenté de 58,8 % à 82,4 %, tandis que la spécificité avait diminué de 56,3 % à 43,8 %.Conclusion: Cette étude vient appuyer l'exactitude de l'asymétrie de la température cutanée en tant qu'indicateur d'un diagnostic de SDRC. La réalisation d'études de plus grande envergure permettra d'en arriver à des estimations plus précises. De telles études devraient également chercher à reproduire nos résultats relatifs à l'asymétrie de la température cutanée dans les membres inférieurs.

Sharing some interim data in trial monitoring can mislead or unmask trial investigators: A scenario-based survey of trial experts.

BACKGROUND: Sharing masked interim results by the Data Safety Monitoring Board (DSMB) with non-DSMB members is an important issue that can affect trial integrity. Our survey's objective is to collect evidence to understand how seemingly masked interim results or result extrapolations are interpreted and discuss whether these results should be shared at interim. METHODS: Conducted a 6 scenario-question survey asking trial experts how they interpreted three kinds of seemingly masked interim results or result extrapolation measures (interim combined event rate, adaptive conditional power and "unconditional" conditional power). RESULTS: Thirty-one current Consolidated Standards of Reporting Trials group affiliates were invited for survey participation (February 2015). Response rate: 71.0% (22/31). About half, 52.6% (95% CI: 28.9%-74.0%), (10/19), correctly indicated that the interim combined event rate can be interpreted in three ways (drug X doing better than placebo, worse than placebo or the same) if shared at interim. The majority, 72.2% (95% CI: 46.5%-89.7%), (13/18), correctly indicated that the adaptive conditional power suggests relative treatment group effects. The majority, 53.3% (95% CI: 26.6%-77.0%), (8/15), incorrectly indicated that the "unconditional" conditional power suggests relative treatment group effects. DISCUSSION/CONCLUSION: Knowledge of these three results or result extrapolation measures should not be shared outside of the DSMB at interim as they may mislead or unmask interim results, potentially introducing trial bias. For example, the interim combined event rate can be interpreted in one of three ways potentially leading to mistaken guesswork about interim results. Knowledge of the adaptive conditional power by non-DSMB members is telling of relative treatment effects thus unmasking of interim results.

A survey evaluating surgeons' peri-operative usage of acetyl-salicylic acid (ASA) and their willingness to enroll their patients in a perioperative ASA randomized controlled trial.

PURPOSE: Major cardiovascular complications associated with noncardiac surgery represent a substantial population health problem for which there are no established efficacious and safe prophylactic interventions. Acetyl-salicylic acid (ASA) represents a promising intervention. The objective of this study was to determine surgeons' perioperative usage of ASA, and if they would enroll their patients in a perioperative ASA randomized controlled trial (RCT). METHODS: Cross-sectional survey of all practicing Canadian general, orthopedic, and vascular surgeons. Our mailed, self-administered survey asked surgeons to consider only their patients who were at risk of a major perioperative cardiovascular complication. RESULTS: The response rate was 906/1854 (49%). For patients taking ASA chronically, there was marked variability regarding ASA continuation prior to surgery amongst the general and orthopedic surgeons, whereas 76% of vascular surgeons continued ASA in 81-100% of their patients. For patients not taking ASA chronically, approaches to starting ASA prior to surgery were variable amongst the vascular surgeons, whereas 70% of general and 82% of orthopaedic surgeons did not start ASA. For patients taking ASA chronically, 73% of general surgeons, 70% of orthopaedic surgeons, and 36% of vascular surgeons would allow at least 40% of their patients to participate in a perioperative RCT comparing stopping versus continuing ASA. For patients not taking ASA chronically, most general (76%), orthopaedic (67%), and vascular (51%) surgeons would allow at least 40% of their patients to participate in a perioperative RCT comparing starting ASA versus placebo. CONCLUSION: This national survey demonstrates that perioperative ASA usage as reported by surgeons is variable, identifying the need for, and community interest in, a large perioperative ASA trial.

Buprenorphine transdermal system in adults with chronic low back pain: a randomized, double-blind, placebo-controlled crossover study, followed by an open-label extension phase.

BACKGROUND: Buprenorphine is a mixed-activity, partial mu-opioid agonist. Its lipid solubility makes it well suited for transdermal administration. OBJECTIVE: This study assessed the efficacy and safety profile of a 7-day buprenorphine transdermal system (BTDS) in adult (age >18 years) patients with moderate to severe chronic low back pain previously treated with > or =1 tablet daily of an opioid analgesic. METHODS: This was a randomized, double-blind, placebo-controlled crossover study, followed by an open-label extension phase. After a 2- to 7-day washout of previous opioid therapy, eligible patients were randomized to receive BTDS 10 microg/h or matching placebo patches. The dose was titrated weekly using 10- and 20-microg/h patches (maximum, 40 microg/h) based on efficacy and tolerability. After 4 weeks, patients crossed over to the alternative treatment for another 4 weeks. Patients who completed the double-blind study were eligible to enter the 6-month open-label phase. Rescue analgesia was provided as acetaminophen 325 mg to be taken as 1 or 2 tablets every 4 to 6 hours as needed. The primary outcome assessments were daily pain intensity, measured on a 100-mm visual analog scale (VAS), from no pain to excruciating pain, and a 5-point ordinal scale, from 0 = none to 4 = excruciating. Secondary outcome assessments included the Pain and Sleep Questionnaire (100-mm VAS, from never to always), Pain Disability Index (ordinal scale, from 0 = no disability to 11 = total disability), Quebec Back Pain Disability Scale (categorical scale, from 0 = no difficulty to 5 = unable to do), and the 36-item Short Form Health Survey (SF-36). Patients and investigators assessed overall treatment effectiveness at the end of each phase; they assessed treatment preference at the end of double-blind treatment. After implementation of a precautionary amendment, the QTc interval was measured 3 to 4 days after randomization and after any dose adjustment. All assessments performed during the double-blind phase were also performed every 2 months during the open-label extension. Adverse events were collected by non-directed questioning throughout the study. RESULTS: Of 78 randomized patients, 52 (66.7%) completed at least 2 consecutive weeks of treatment in each study phase without major protocol violations (per-protocol [PP] population: 32 women, 20 men; mean [SD] age, 51.3 [11.4] years; mean weight, 85.5 [19.5] kg; 94% white, 4% black, 2% other). The mean (SD) dose of study medication during the last week of treatment was 29.8 (12.1) microg/h for BTDS and 32.9 (10.7) microg/h for placebo (P = NS). During the last week of treatment, BTDS was associated with significantly lower mean (SD) pain intensity scores compared with placebo on both the VAS (45.3 [21.3] vs 53.1 [24.3] mm, respectively; P = 0.022) and the 5-point ordinal scale (1.9 [0.7] vs 2.2 [0.8]; P = 0.044). The overall Pain and Sleep score was significantly lower with BTDS than with placebo (177.6 [125.5] vs 232.9 [131.9]; P = 0.027). There were no treatment differences on the Pain Disability Index, Quebec Back Pain Disability Scale, or SF-36; however, BTDS was associated with significant improvements compared with placebo on 2 individual Quebec Back Pain Disability Scale items (get out of bed: P = 0.042; sit in a chair for several hours: P = 0.022). Of the 48 patients/physicians in the PP population who rated the effectiveness of treatment, 64.6% of patients (n = 31) rated BTDS moderately or highly effective, as did 62.5% of investigators (n = 30). Among the 50 patients in the PP population who answered the preference question, 66.0% of patients (n = 33) preferred the phase in which they received BTDS and 24.0% (n = 12) preferred the phase in which they received placebo (P = 0.001), with the remainder having no preference; among investigators, 60.0% (n = 30) and 28.0% (n = 14) preferred the BTDS and placebo phases, respectively (P = 0.008), with the remainder having no preference. The mean placebo-adjusted change from baseline in the QTc interval ranged from -0.8 to +3.8 milliseconds (P = NS). BTDS treatment was associated with a significantly higher frequency of nausea (P < 0.001), dizziness (P < 0.001), vomiting (P = 0.008), somnolence (P = 0.020), and dry mouth (P = 0.003), but not constipation. Of the 49 patients completing 8 weeks of double-blind treatment, 40 (81.6%) entered the 6-month, open-label extension study and 27 completed it. Improvements in pain scores achieved during the double-blind phase were maintained in these patients. CONCLUSIONS: In the 8-week, double-blind portion of this study, BTDS 10 to 40 microg/h was effective compared with placebo in the management of chronic, moderate to severe low back pain in patients who had previously received opioids. The improvements in pain scores were sustained throughout the 6-month, open-label extension. (Current Controlled Trials identification number: ISRCTN 06013881).

Injury measurement properties of serum interleukin-6 following lumbar decompression surgery.

BACKGROUND: Circulating interleukin-6 (IL-6) is frequently used to study surgical injury and inflammation. Measurement properties of serum IL-6 were examined following lumbar decompression surgery (LDS), including time course, sensitivity, and validity for detecting muscle trauma in comparison to the muscle cytoplasmic protein creatine kinase (CK). MATERIALS AND METHODS: Seven women and seven men had serial blood samples taken in the preoperative waiting areas, immediately after surgery, at 6, 12, 24, 48 h, 4 d, and at 6 to 7 d. Lumbar surgeries were single level, decompression, with laminotomy. RESULTS: Time to peak serum IL-6 varied across individuals (range 6 to 48 h). However, the higher of two samples drawn within the sensitive time window (6 to 24 h) had a strong correlation with peak IL-6 (r = 0.99, P < 0.001). There was a moderate correlation between the rise in serum IL-6 and rise in serum CK, r = 0.56, P < 0.05. T-tests revealed that group mean IL-6 was significantly elevated at only one serial time point (6 h), whereas group mean CK was significantly elevated at three serial time points (6, 12, 24 h) and approached significant elevation as late as 48 h (P = 0.07). Women had lower CK concentrations at 6 and 24 h but gender differences on IL-6 were not statistically significant. CONCLUSIONS: The serum IL-6 response to LDS injury can be captured in a practical manner, despite individual variability in time course. Inclusion of CK measurement may improve sensitivity to the muscle trauma component of an overall injury.