Adherence to key recommendations for design and analysis of stepped-wedge cluster randomized trials: A review of trials published 2016-2022
CONCLUSIONS: Future methods development should prioritize methods for SW-CRTs with binary or time-to-event outcomes, small numbers of clusters, continuous recruitment designs, multivariate outcomes, or time-dependent repeated measures. Trialists, journal editors, and peer reviewers should be aware that SW-CRTs have additional methodological requirements over parallel arm designs including the need to account for period effects as well as complex intracluster correlations.PMID:37990575 | DOI:10.1177/17407745231208397 (Source: Clinical Trials)
Source: Clinical Trials - November 22, 2023 Category: Research Authors: Pascale Nevins Mary Ryan Kendra Davis-Plourde Yongdong Ouyang Jules Antoine Pereira Macedo Can Meng Guangyu Tong Xueqi Wang Luis Ortiz-Reyes Agn ès Caille Fan Li Monica Taljaard Source Type: research
Evaluating whether the proportional odds models to analyse ordinal outcomes in COVID-19 clinical trials is providing clinically interpretable treatment effects: A systematic review
CONCLUSION: The common odds ratio from proportional odds models often differs substantially to odds ratios from clinically important binary outcomes, and similar to composite outcomes, a beneficial common OR from a proportional odds model does not necessarily indicate a beneficial effect on the most important categories within the ordinal outcome.PMID:37982237 | DOI:10.1177/17407745231211272 (Source: Clinical Trials)
Source: Clinical Trials - November 20, 2023 Category: Research Authors: Masuma Uddin Nasir Z Bashir Brennan C Kahan Source Type: research
Evaluating whether the proportional odds models to analyse ordinal outcomes in COVID-19 clinical trials is providing clinically interpretable treatment effects: A systematic review
CONCLUSION: The common odds ratio from proportional odds models often differs substantially to odds ratios from clinically important binary outcomes, and similar to composite outcomes, a beneficial common OR from a proportional odds model does not necessarily indicate a beneficial effect on the most important categories within the ordinal outcome.PMID:37982237 | DOI:10.1177/17407745231211272 (Source: Clinical Trials)
Source: Clinical Trials - November 20, 2023 Category: Research Authors: Masuma Uddin Nasir Z Bashir Brennan C Kahan Source Type: research
Determining a risk-proportionate approach to the validation of statistical programming for clinical trials
CONCLUSION: We have developed a risk-based approach to the validation of statistical programming. It endeavours to facilitate the implementation of targeted quality assurance measures while making efficient use of limited resources.PMID:37957825 | DOI:10.1177/17407745231204036 (Source: Clinical Trials)
Source: Clinical Trials - November 14, 2023 Category: Research Authors: Carrol Gamble Steff Lewis Deborah Stocken Edmund Juszczak Mike Bradburn Caroline Dor é Sharon Kean Source Type: research
Reporting and impact of subsequent cycle toxicities in oncology phase I clinical trials
CONCLUSION: Reporting of subsequent cycle toxicity is uncommon in oncology phase I clinical trial publications and becoming less common over time. Guidelines for reporting of phase I oncology clinical trials should expand to include toxicity data beyond the first cycle.PMID:37961910 | DOI:10.1177/17407745231210872 (Source: Clinical Trials)
Source: Clinical Trials - November 14, 2023 Category: Research Authors: Avina Rami Steven G DuBois Kevin Campbell Source Type: research
Leveraging the functionality of Research Electronic Data Capture (REDCap) to enhance data collection and quality in the Opioid Analgesic Reduction Study
CONCLUSION: Research Electronic Data Capture is an effective digital health technology that can be maximized to contribute to the success of a clinical trial. The Research Electronic Data Capture infrastructure and enhanced functionality used in Opioid Analgesic Reduction Study provides the framework and the logic that ensures complete, accurate, data while guiding an effective, efficient workflow that can be followed by team members across sites. This enhanced data reliability and comprehensive quality management processes allow for better preparedness and readiness for clinical monitoring and regulatory reporting.PMID:37...
Source: Clinical Trials - November 14, 2023 Category: Research Authors: Janine Fredericks-Younger Patricia Greenberg Tracy Andrews Pamela B Matheson Paul J Desjardins Shou-En Lu Cecile A Feldman Source Type: research
Perspectives of adults with neurofibromatosis regarding the design of psychosocial trials: Results from an anonymous online survey
CONCLUSION: This study conducted the largest survey assessing physical symptoms, mental health needs, and preferences for psychosocial trials in adults with neurofibromatosis. Results indicate a high prevalence of disease manifestations, psychosocial difficulties, and untreated mental health problems in adults with neurofibromatosis and a high degree of willingness to participate in psychosocial clinical trials. Patient preferences should be considered when designing and implementing psychosocial interventions to develop the most feasible and meaningful studies.PMID:37962219 | DOI:10.1177/17407745231209224 (Source: Clinical Trials)
Source: Clinical Trials - November 14, 2023 Category: Research Authors: Pamela L Wolters Nour Al Ghriwati Melissa Baker Staci Martin Dale Berg Gregg Erickson Barbara Franklin Vanessa L Merker Beverly Oberlander Stephanie Reeve Claas Rohl Tena Rosser Ana-Maria Vranceanu Source Type: research
Determining a risk-proportionate approach to the validation of statistical programming for clinical trials
CONCLUSION: We have developed a risk-based approach to the validation of statistical programming. It endeavours to facilitate the implementation of targeted quality assurance measures while making efficient use of limited resources.PMID:37957825 | DOI:10.1177/17407745231204036 (Source: Clinical Trials)
Source: Clinical Trials - November 14, 2023 Category: Research Authors: Carrol Gamble Steff Lewis Deborah Stocken Edmund Juszczak Mike Bradburn Caroline Dor é Sharon Kean Source Type: research
Reporting and impact of subsequent cycle toxicities in oncology phase I clinical trials
CONCLUSION: Reporting of subsequent cycle toxicity is uncommon in oncology phase I clinical trial publications and becoming less common over time. Guidelines for reporting of phase I oncology clinical trials should expand to include toxicity data beyond the first cycle.PMID:37961910 | DOI:10.1177/17407745231210872 (Source: Clinical Trials)
Source: Clinical Trials - November 14, 2023 Category: Research Authors: Avina Rami Steven G DuBois Kevin Campbell Source Type: research
Leveraging the functionality of Research Electronic Data Capture (REDCap) to enhance data collection and quality in the Opioid Analgesic Reduction Study
CONCLUSION: Research Electronic Data Capture is an effective digital health technology that can be maximized to contribute to the success of a clinical trial. The Research Electronic Data Capture infrastructure and enhanced functionality used in Opioid Analgesic Reduction Study provides the framework and the logic that ensures complete, accurate, data while guiding an effective, efficient workflow that can be followed by team members across sites. This enhanced data reliability and comprehensive quality management processes allow for better preparedness and readiness for clinical monitoring and regulatory reporting.PMID:37...
Source: Clinical Trials - November 14, 2023 Category: Research Authors: Janine Fredericks-Younger Patricia Greenberg Tracy Andrews Pamela B Matheson Paul J Desjardins Shou-En Lu Cecile A Feldman Source Type: research
Perspectives of adults with neurofibromatosis regarding the design of psychosocial trials: Results from an anonymous online survey
CONCLUSION: This study conducted the largest survey assessing physical symptoms, mental health needs, and preferences for psychosocial trials in adults with neurofibromatosis. Results indicate a high prevalence of disease manifestations, psychosocial difficulties, and untreated mental health problems in adults with neurofibromatosis and a high degree of willingness to participate in psychosocial clinical trials. Patient preferences should be considered when designing and implementing psychosocial interventions to develop the most feasible and meaningful studies.PMID:37962219 | DOI:10.1177/17407745231209224 (Source: Clinical Trials)
Source: Clinical Trials - November 14, 2023 Category: Research Authors: Pamela L Wolters Nour Al Ghriwati Melissa Baker Staci Martin Dale Berg Gregg Erickson Barbara Franklin Vanessa L Merker Beverly Oberlander Stephanie Reeve Claas Rohl Tena Rosser Ana-Maria Vranceanu Source Type: research
Determining a risk-proportionate approach to the validation of statistical programming for clinical trials
CONCLUSION: We have developed a risk-based approach to the validation of statistical programming. It endeavours to facilitate the implementation of targeted quality assurance measures while making efficient use of limited resources.PMID:37957825 | DOI:10.1177/17407745231204036 (Source: Clinical Trials)
Source: Clinical Trials - November 14, 2023 Category: Research Authors: Carrol Gamble Steff Lewis Deborah Stocken Edmund Juszczak Mike Bradburn Caroline Dor é Sharon Kean Source Type: research
Reporting and impact of subsequent cycle toxicities in oncology phase I clinical trials
CONCLUSION: Reporting of subsequent cycle toxicity is uncommon in oncology phase I clinical trial publications and becoming less common over time. Guidelines for reporting of phase I oncology clinical trials should expand to include toxicity data beyond the first cycle.PMID:37961910 | DOI:10.1177/17407745231210872 (Source: Clinical Trials)
Source: Clinical Trials - November 14, 2023 Category: Research Authors: Avina Rami Steven G DuBois Kevin Campbell Source Type: research
Leveraging the functionality of Research Electronic Data Capture (REDCap) to enhance data collection and quality in the Opioid Analgesic Reduction Study
CONCLUSION: Research Electronic Data Capture is an effective digital health technology that can be maximized to contribute to the success of a clinical trial. The Research Electronic Data Capture infrastructure and enhanced functionality used in Opioid Analgesic Reduction Study provides the framework and the logic that ensures complete, accurate, data while guiding an effective, efficient workflow that can be followed by team members across sites. This enhanced data reliability and comprehensive quality management processes allow for better preparedness and readiness for clinical monitoring and regulatory reporting.PMID:37...
Source: Clinical Trials - November 14, 2023 Category: Research Authors: Janine Fredericks-Younger Patricia Greenberg Tracy Andrews Pamela B Matheson Paul J Desjardins Shou-En Lu Cecile A Feldman Source Type: research
Perspectives of adults with neurofibromatosis regarding the design of psychosocial trials: Results from an anonymous online survey
CONCLUSION: This study conducted the largest survey assessing physical symptoms, mental health needs, and preferences for psychosocial trials in adults with neurofibromatosis. Results indicate a high prevalence of disease manifestations, psychosocial difficulties, and untreated mental health problems in adults with neurofibromatosis and a high degree of willingness to participate in psychosocial clinical trials. Patient preferences should be considered when designing and implementing psychosocial interventions to develop the most feasible and meaningful studies.PMID:37962219 | DOI:10.1177/17407745231209224 (Source: Clinical Trials)
Source: Clinical Trials - November 14, 2023 Category: Research Authors: Pamela L Wolters Nour Al Ghriwati Melissa Baker Staci Martin Dale Berg Gregg Erickson Barbara Franklin Vanessa L Merker Beverly Oberlander Stephanie Reeve Claas Rohl Tena Rosser Ana-Maria Vranceanu Source Type: research
