Pub Date : 2022-07-03DOI: 10.21801/ppcrj.2022.82.5
Haley Rafferty, Elisa Rocha, Paola Gonzalez-Mego, Clara L Ramos, Mirret M El-Hagrassy, Muhammed E Gunduz, Elif Uygur-Kucukseymen, Hanan Zehry, Swapnali S Chaudhari, Paulo Ep Teixeira, Gleysson R Rosa, Ana L Zaninotto, Christopher Connor, Uri Eden, Ciro Ramos-Estebanez, Felipe Fregni, Laura Dipietro, Timothy Wagner
Introduction: Run-In (RI) periods can be used to improve the validity of randomized controlled trials (RCTs), but their utility in Chronic Pain (CP) RCTs is debated. Cost-effectiveness analysis (CEA) methods are commonly used in evaluating the results of RCTs, but they are seldom used for designing RCTs. We present a step-by-step overview to objectively design RCTs via CEA methods and specifically determine the cost effectiveness of a RI period in a CP RCT.
Methods: We applied the CEA methodology to data obtained from several noninvasive brain stimulation CP RCTs, specifically focusing on (1) defining the CEA research question, (2) identifying RCT phases and cost ingredients, (3) discounting, (4) modeling the stochastic nature of the RCT, and (5) performing sensitivity analyses. We assessed the average cost-effectiveness ratios and incremental cost effectiveness ratios of varied RCT designs and the impact on cost-effectiveness by the inclusion of a RI period vs. No-Run-In (NRI) period.
Results: We demonstrated the potential impact of varying the number of institutions, number of patients that could be accommodated per institution, cost and effectiveness discounts, RCT component costs, and patient adherence characteristics on varied RI and NRI RCT designs. In the specific CP RCT designs that we analyzed, we demonstrated that lower patient adherence, lower baseline assessment costs, and higher treatment costs all necessitated the inclusion of an RI period to be cost-effective compared to NRI RCT designs.
Conclusions: Clinical trialists can optimize CP RCT study designs and make informed decisions regarding RI period inclusion/exclusion via CEA methods.
{"title":"Cost-Effectiveness Analysis to Inform Randomized Controlled Trial Design in Chronic Pain Research: Methods for Guiding Decisions on the Addition of a Run-In Period.","authors":"Haley Rafferty, Elisa Rocha, Paola Gonzalez-Mego, Clara L Ramos, Mirret M El-Hagrassy, Muhammed E Gunduz, Elif Uygur-Kucukseymen, Hanan Zehry, Swapnali S Chaudhari, Paulo Ep Teixeira, Gleysson R Rosa, Ana L Zaninotto, Christopher Connor, Uri Eden, Ciro Ramos-Estebanez, Felipe Fregni, Laura Dipietro, Timothy Wagner","doi":"10.21801/ppcrj.2022.82.5","DOIUrl":"https://doi.org/10.21801/ppcrj.2022.82.5","url":null,"abstract":"<p><strong>Introduction: </strong>Run-In (RI) periods can be used to improve the validity of randomized controlled trials (RCTs), but their utility in Chronic Pain (CP) RCTs is debated. Cost-effectiveness analysis (CEA) methods are commonly used in evaluating the results of RCTs, but they are seldom used for designing RCTs. We present a step-by-step overview to objectively design RCTs via CEA methods and specifically determine the cost effectiveness of a RI period in a CP RCT.</p><p><strong>Methods: </strong>We applied the CEA methodology to data obtained from several noninvasive brain stimulation CP RCTs, specifically focusing on (1) defining the CEA research question, (2) identifying RCT phases and cost ingredients, (3) discounting, (4) modeling the stochastic nature of the RCT, and (5) performing sensitivity analyses. We assessed the average cost-effectiveness ratios and incremental cost effectiveness ratios of varied RCT designs and the impact on cost-effectiveness by the inclusion of a RI period vs. No-Run-In (NRI) period.</p><p><strong>Results: </strong>We demonstrated the potential impact of varying the number of institutions, number of patients that could be accommodated per institution, cost and effectiveness discounts, RCT component costs, and patient adherence characteristics on varied RI and NRI RCT designs. In the specific CP RCT designs that we analyzed, we demonstrated that lower patient adherence, lower baseline assessment costs, and higher treatment costs all necessitated the inclusion of an RI period to be cost-effective compared to NRI RCT designs.</p><p><strong>Conclusions: </strong>Clinical trialists can optimize CP RCT study designs and make informed decisions regarding RI period inclusion/exclusion via CEA methods.</p>","PeriodicalId":74496,"journal":{"name":"Principles and practice of clinical research (2015)","volume":"8 2","pages":"31-42"},"PeriodicalIF":0.0,"publicationDate":"2022-07-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9769699/pdf/nihms-1831819.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9861773","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2022-07-01DOI: 10.21801/ppcrj.2022.82.2
Laura Michelle Santana Rodriguez, Amanda Marcinowska, C. Go, A. González, Gabriela Pinto, Q. Nai, Vasthala Juvvingunta, Oriana Escobar, J. P. Lima, Enrique O. Bedoya-Ismodes, Mohammad Mohsin Arshad, Ana Carolina Benites, Renata Couto, Abel Perez, Andres Pavlovic, Samuel Ramos Garcia, Jaweria Akram, Jesabelle Dominguez, Luisa dos Santos, Wei Zhang, Michael Sheng-Fu Feng, Basil Alshekh, Priscila Prais Carneiro, Suellen Riccio, Daniel Urla, Ygor N Junqueira, J. Rojas, Arturo Tamayo, Elly Pichardo, Lucas Pepe Mena, Diego Daniel Garcia, D. Schwartz
{"title":"The effect of SpeechVive device on speech intelligibility in Parkinson’s Disease patients: Randomized Clinical Trial Protocol","authors":"Laura Michelle Santana Rodriguez, Amanda Marcinowska, C. Go, A. González, Gabriela Pinto, Q. Nai, Vasthala Juvvingunta, Oriana Escobar, J. P. Lima, Enrique O. Bedoya-Ismodes, Mohammad Mohsin Arshad, Ana Carolina Benites, Renata Couto, Abel Perez, Andres Pavlovic, Samuel Ramos Garcia, Jaweria Akram, Jesabelle Dominguez, Luisa dos Santos, Wei Zhang, Michael Sheng-Fu Feng, Basil Alshekh, Priscila Prais Carneiro, Suellen Riccio, Daniel Urla, Ygor N Junqueira, J. Rojas, Arturo Tamayo, Elly Pichardo, Lucas Pepe Mena, Diego Daniel Garcia, D. Schwartz","doi":"10.21801/ppcrj.2022.82.2","DOIUrl":"https://doi.org/10.21801/ppcrj.2022.82.2","url":null,"abstract":"","PeriodicalId":74496,"journal":{"name":"Principles and practice of clinical research (2015)","volume":" ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2022-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"42799809","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2022-07-01DOI: 10.21801/ppcrj.2022.82.3
Francisco J. Barrera, Sofía Mariño-Velasco, J. Zuñiga-Hernandez, P. L. Castillo-Morales, Miguel Zambrano-Lucio, J. Brito, R. Rodríguez‐Gutiérrez
{"title":"Are Patients Acknowledged in Clinical Research? A Systematic Survey","authors":"Francisco J. Barrera, Sofía Mariño-Velasco, J. Zuñiga-Hernandez, P. L. Castillo-Morales, Miguel Zambrano-Lucio, J. Brito, R. Rodríguez‐Gutiérrez","doi":"10.21801/ppcrj.2022.82.3","DOIUrl":"https://doi.org/10.21801/ppcrj.2022.82.3","url":null,"abstract":"","PeriodicalId":74496,"journal":{"name":"Principles and practice of clinical research (2015)","volume":" ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2022-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"48433695","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2022-07-01DOI: 10.21801/ppcrj.2022.82.1
A. Bhandari, A. Concha-Mejía, A. Vásquez, A. Peralta, A. Rivera, G. Vallejos, H. Lu, J. Cardoso-Mourao, L. Assad, L. Handal, L. Kirihara, M. DeCain, M. Değer, M. Jimenez, M. Schulz, N. Mazariegos, N.V. Racu, N. Rincon, P. Parra, S. Arroub, S. Kalmadka, S. Olagun, V. Balbuena
{"title":"The impact of positive social reinforcement on time-to-attrition from the Diabetes Prevention Program in college students at high risk for Type II Diabetes: a study protocol for a phase 3, multicenter, cluster randomized trial","authors":"A. Bhandari, A. Concha-Mejía, A. Vásquez, A. Peralta, A. Rivera, G. Vallejos, H. Lu, J. Cardoso-Mourao, L. Assad, L. Handal, L. Kirihara, M. DeCain, M. Değer, M. Jimenez, M. Schulz, N. Mazariegos, N.V. Racu, N. Rincon, P. Parra, S. Arroub, S. Kalmadka, S. Olagun, V. Balbuena","doi":"10.21801/ppcrj.2022.82.1","DOIUrl":"https://doi.org/10.21801/ppcrj.2022.82.1","url":null,"abstract":"","PeriodicalId":74496,"journal":{"name":"Principles and practice of clinical research (2015)","volume":" ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2022-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"46345376","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2022-04-01DOI: 10.21801/ppcrj.2022.82.4
J S Ho, E Slawka, K Pacheco-Barrios, A Cardenas-Rojas, L Castelo-Branco, F Fregni
{"title":"The pros and cons of tDCS as a therapeutic tool in the rehabilitation of chronic pain.","authors":"J S Ho, E Slawka, K Pacheco-Barrios, A Cardenas-Rojas, L Castelo-Branco, F Fregni","doi":"10.21801/ppcrj.2022.82.4","DOIUrl":"https://doi.org/10.21801/ppcrj.2022.82.4","url":null,"abstract":"","PeriodicalId":74496,"journal":{"name":"Principles and practice of clinical research (2015)","volume":"8 2","pages":"26-30"},"PeriodicalIF":0.0,"publicationDate":"2022-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9531671/pdf/nihms-1821801.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10718084","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2022-03-31DOI: 10.21801/ppcrj.2022.81.3
Adriana Yock-Corrales, P. Rino
{"title":"The Importance of the Development of a Pediatric Emergency Research Network in Latin-America: RIDEPLA (Red de Investigación y Desarrollo de la Emergencia Pediátrica en Latino-America)","authors":"Adriana Yock-Corrales, P. Rino","doi":"10.21801/ppcrj.2022.81.3","DOIUrl":"https://doi.org/10.21801/ppcrj.2022.81.3","url":null,"abstract":"","PeriodicalId":74496,"journal":{"name":"Principles and practice of clinical research (2015)","volume":" ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2022-03-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"46121218","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2022-03-31DOI: 10.21801/ppcrj.2022.81.1
M. Zahid, N. Tahir, K. Quadri, A. Azhar, M. Shabir, Abdul Wahab, Urfi Urfi, Kinza Waqar, Danish Nadeem
{"title":"Mental health status of medical staff working in hospitals during COVID-19 pandemic in Pakistan: A cross-sectional study","authors":"M. Zahid, N. Tahir, K. Quadri, A. Azhar, M. Shabir, Abdul Wahab, Urfi Urfi, Kinza Waqar, Danish Nadeem","doi":"10.21801/ppcrj.2022.81.1","DOIUrl":"https://doi.org/10.21801/ppcrj.2022.81.1","url":null,"abstract":"","PeriodicalId":74496,"journal":{"name":"Principles and practice of clinical research (2015)","volume":" ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2022-03-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"48274632","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2022-03-31DOI: 10.21801/ppcrj.2022.81.2
L. Otalvaro Acosta, C. Raggio, M. Younis, R. Motta, J. Espinoza, J. Szászdi, P. Lopez, M. Fernandez, L. Rocha, D. Schoene, S. A. Abu Jamra, E. Saldanha, J. Guajardo, K. Ariza, J. Li, K. Loss
{"title":"Effects of home air purifiers in the quality of life of patients with chronic obstructive pulmonary disease in Mexico City: a phase III, single-center, triple-blinded, randomized controlled trial (GREAT-COPD)","authors":"L. Otalvaro Acosta, C. Raggio, M. Younis, R. Motta, J. Espinoza, J. Szászdi, P. Lopez, M. Fernandez, L. Rocha, D. Schoene, S. A. Abu Jamra, E. Saldanha, J. Guajardo, K. Ariza, J. Li, K. Loss","doi":"10.21801/ppcrj.2022.81.2","DOIUrl":"https://doi.org/10.21801/ppcrj.2022.81.2","url":null,"abstract":"","PeriodicalId":74496,"journal":{"name":"Principles and practice of clinical research (2015)","volume":" ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2022-03-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"42096064","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2022-03-31DOI: 10.21801/ppcrj.2022.81.4
Juliana Kazumi Saeki, V. Suen, P. Fassini
{"title":"A systematic review on transcranial direct current stimulation (tDCS) in the treatment of obesity","authors":"Juliana Kazumi Saeki, V. Suen, P. Fassini","doi":"10.21801/ppcrj.2022.81.4","DOIUrl":"https://doi.org/10.21801/ppcrj.2022.81.4","url":null,"abstract":"","PeriodicalId":74496,"journal":{"name":"Principles and practice of clinical research (2015)","volume":" ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2022-03-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"44442022","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2022-03-31DOI: 10.21801/ppcrj.2022.81.7
International Symposium of Neuromodulation Scientific Team
{"title":"XIII International Symposium of Neuromodulation: Conference Abstracts","authors":"International Symposium of Neuromodulation Scientific Team","doi":"10.21801/ppcrj.2022.81.7","DOIUrl":"https://doi.org/10.21801/ppcrj.2022.81.7","url":null,"abstract":"","PeriodicalId":74496,"journal":{"name":"Principles and practice of clinical research (2015)","volume":" ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2022-03-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"43001134","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
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