2024
Reporting of surrogate endpoints in randomised controlled trial protocols (SPIRIT-Surrogate): extension checklist with explanation and elaboration
Manyara A, Davies P, Stewart D, Weir C, Young A, Blazeby J, Butcher N, Bujkiewicz S, Chan A, Dawoud D, Offringa M, Ouwens M, Hróbjartsson A, Amstutz A, Bertolaccini L, Bruno V, Devane D, Faria C, Gilbert P, Harris R, Lassere M, Marinelli L, Markham S, Powers J, Rezaei Y, Richert L, Schwendicke F, Tereshchenko L, Thoma A, Turan A, Worrall A, Christensen R, Collins G, Ross J, Taylor R, Ciani O. Reporting of surrogate endpoints in randomised controlled trial protocols (SPIRIT-Surrogate): extension checklist with explanation and elaboration. The BMJ 2024, 386: e078525. PMID: 38981624, PMCID: PMC11231880, DOI: 10.1136/bmj-2023-078525.Peer-Reviewed Original ResearchConceptsTrial protocolRandomised controlled trial protocolTarget outcomesReduce research wasteStandard Protocol ItemsRandomised controlled trialsIntervention effectsProtocol ItemsInterpretation of findingsResearch wasteImprove reportingPrimary outcome(sIntervention trialsControlled trialsChecklistSurrogate endpointsInterventionItemsIncreasing callsTrialsGuidelinesOutcomesLimited informationOutcome(sHarm
2022
PreScription DigitaL ThErapEutic for Patients with Insomnia (SLEEP-I): a protocol for a pragmatic randomised controlled trial
Dreyer RP, Berkowitz A, Yaggi HK, Schneeberg L, Shah ND, Emanuel L, Kolla B, Jeffery MM, Deeg M, Ervin K, Thorndike F, Ross JS. PreScription DigitaL ThErapEutic for Patients with Insomnia (SLEEP-I): a protocol for a pragmatic randomised controlled trial. BMJ Open 2022, 12: e062041. PMID: 35940841, PMCID: PMC9364397, DOI: 10.1136/bmjopen-2022-062041.Peer-Reviewed Original ResearchConceptsPrescription digital therapeuticPatient-reported outcomesHealthcare utilisationClinical outcomesDigital therapeuticsIndividual patient-reported outcomesReal-world patient experienceInsomnia Severity Index scoreSeverity Index scoreHealth utility scoresInstitutional review boardCognitive behavioral therapyPeer-reviewed journalsSecondary outcomesPrimary outcomeTrial protocolDaytime sleepinessChronic insomniaMayo ClinicHealth centersDepressive symptomsPatient experienceSleep outcomesIndex scoreSleep diary
2021
Heart Watch Study: protocol for a pragmatic randomised controlled trial
Dhruva SS, Shah ND, Vemulapalli S, Deshmukh A, Beatty AL, Gamble GM, Freeman JV, Hummel JP, Piccini JP, Akar JG, Ervin K, Arges KL, Emanuel L, Noseworthy PA, Hu T, Bartlett V, Ross JS. Heart Watch Study: protocol for a pragmatic randomised controlled trial. BMJ Open 2021, 11: e054550. PMID: 35234659, PMCID: PMC8719216, DOI: 10.1136/bmjopen-2021-054550.Peer-Reviewed Original ResearchConceptsHealthcare utilisationSecondary outcomesAtrial fibrillationAtrial flutterDuke University Health SystemRoutine clinical care settingsAtrial Fibrillation EffectLife global scoresTime of cardioversionAdditional secondary outcomesPopulation of patientsPatient-reported outcomesClinical care settingsUniversity Health SystemQuality of lifeInstitutional review boardMulticentre pragmaticPeer-reviewed journalsPrimary outcomePatients' qualityTrial protocolClinical trialsMayo ClinicECG featuresCare settingsGuidelines for Reporting Trial Protocols and Completed Trials Modified Due to the COVID-19 Pandemic and Other Extenuating Circumstances
Orkin AM, Gill PJ, Ghersi D, Campbell L, Sugarman J, Emsley R, Steg PG, Weijer C, Simes J, Rombey T, Williams HC, Wittes J, Moher D, Richards DP, Kasamon Y, Getz K, Hopewell S, Dickersin K, Wu T, Ayala AP, Schulz KF, Calleja S, Boutron I, Ross JS, Golub RM, Khan KM, Mulrow C, Siegfried N, Heber J, Lee N, Kearney PR, Wanyenze RK, Hróbjartsson A, Williams R, Bhandari N, Jüni P, Chan AW, Orkin A, Gill P, Ghersi D, Campbell L, Sugarman J, Emsley R, Steg P, Weijer C, Simes J, Rombey T, Williams H, Wittes J, Moher D, Richards D, Kasamon Y, Getz K, Hopewell S, Dickersin K, Wu T, Ayala A, Schulz K, Calleja S, Boutron I, Ross J, Golub R, Khan K, Mulrow C, Siegfried N, Heber J, Lee N, Kearney P, Wanyenze R, Hróbjartsson A, Williams R, Bhandari N, Jüni P, Chan A, Kiermer V, Corrigan-Curay J, Concato J. Guidelines for Reporting Trial Protocols and Completed Trials Modified Due to the COVID-19 Pandemic and Other Extenuating Circumstances. JAMA 2021, 326: 257-265. PMID: 34152382, DOI: 10.1001/jama.2021.9941.Peer-Reviewed Reviews, Practice Guidelines, Standards, and Consensus Statements