2024
Recommendations for monitoring adherence and fidelity in pragmatic trials based on experience in the Pain Management Collaboratory
Dziura J, Gilstad-Hayden K, Coffman C, Long C, Yu Q, Buta E, Coggeshall S, Geda M, Peduzzi P, Kyriakides T. Recommendations for monitoring adherence and fidelity in pragmatic trials based on experience in the Pain Management Collaboratory. Pain Medicine 2024, 25: s41-s48. PMID: 39514878, PMCID: PMC11548857, DOI: 10.1093/pm/pnae080.Peer-Reviewed Original ResearchConceptsPain Management CollaboratoryPragmatic trialPragmatic Explanatory Continuum Indicator SummaryMonitor adherenceElectronic health recordsFidelity dataIntervention deliveryIntervention fidelityIndicator SummaryHealth recordsTrial interventionProtocol adherenceParticipant engagementStudy teamAdherence dataAdherenceTrial integrityInterventionParticipantsSafety monitoring boardFrequent sourcePainLevel of monitoringTrialsMonitoring board
2017
Interactive Voice Response–Based Self-management for Chronic Back Pain: The COPES Noninferiority Randomized Trial
Heapy AA, Higgins DM, Goulet JL, LaChappelle KM, Driscoll MA, Czlapinski RA, Buta E, Piette JD, Krein SL, Kerns RD. Interactive Voice Response–Based Self-management for Chronic Back Pain: The COPES Noninferiority Randomized Trial. JAMA Internal Medicine 2017, 177: 765-773. PMID: 28384682, PMCID: PMC5818820, DOI: 10.1001/jamainternmed.2017.0223.Peer-Reviewed Original ResearchConceptsPerson cognitive-behavioural therapyChronic back painNumeric rating scaleCognitive behavioral therapyBack painChronic painPrimary outcomeSleep qualityVeterans Affairs Health Care SystemPrespecified noninferiority marginAverage pain intensityNonpharmacologic treatment optionsPain-related interferenceChronic pain treatmentSelf-management trialCognitive behavioral therapy deliveryIndividual CBT sessionsEvidence-based treatmentsQuality of lifeSelf-help manualHealth care systemIVR monitoringNonpharmacologic interventionsSecondary outcomesStandard therapy