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9 results on '"Adjudication Committee"'

1. Implementing stakeholder engagement to explore alternative models of consent: An example from the PREP-IT trials.

Author

Pechero, Guillermo, Pfaff, Branden, Rao, Mayank, Pogorzelski, David, McKay, Paula, Spicer, Ella, Howe, Andrea, Demyanovich, Haley K, Sietsema, Debra L, McTague, Michael F, Ramsey, Lolita, Holden, Martha, Rudnicki, Joshua, Wells, Jeff, Medeiros, Michelle, Slobogean, Gerard P, Sprague, Sheila, PREP-IT Investigators, Wells, Jeffrey, Bhandari, Mohit, Steering Committee, Adjudication Committee, Data and Safety Monitoring Committee, Research Methodology Core, Patient Centred Outcomes Core, Orthopaedic Surgery Core, Operating Room Core, Infectious Disease Core, Military Core, PREP-IT Clinical Sites, O'Toole, Robert V, D'Alleyrand, Jean-Claude, Eglseder, Andrew, Johnson, Aaron, Langhammer, Christopher, Lebrun, Christopher, Manson, Theodore, Nascone, Jason, Paryavi, Ebrahim, Pensy, Raymond, Pollak, Andrew, Sciadini, Marcus, Degani, Yasmin, O'Hara, Nathan N, Joseph, Katherine, Camara, Megan, Aqueous-PREP and PREPARE, Aqueous-PREP, and PREPARE

Subjects
PREP-IT Investigators, Steering Committee, Adjudication Committee, Data and Safety Monitoring Committee, Research Methodology Core, Patient Centred Outcomes Core, Orthopaedic Surgery Core, Operating Room Core, Infectious Disease Core, Military Core, PREP-IT Clinical Sites, Aqueous-PREP and PREPARE, Aqueous-PREP, PREPARE, Cluster randomized crossover, Consent, Deferred consent, Patient advisors, Stakeholder engagement, Trial design
Abstract

IntroductionCluster randomized crossover trials are often faced with a dilemma when selecting an optimal model of consent, as the traditional model of obtaining informed consent from participant's before initiating any trial related activities may not be suitable. We describe our experience of engaging patient advisors to identify an optimal model of consent for the PREP-IT trials. This paper also examines surrogate measures of success for the selected model of consent.MethodsThe PREP-IT program consists of two multi-center cluster randomized crossover trials that engaged patient advisors to determine an optimal model of consent. Patient advisors and stakeholders met regularly and reached consensus on decisions related to the trial design including the model for consent. Patient advisors provided valuable insight on how key decisions on trial design and conduct would be received by participants and the impact these decisions will have.ResultsPatient advisors, together with stakeholders, reviewed the pros and cons and the requirements for the traditional model of consent, deferred consent, and waiver of consent. Collectively, they agreed upon a deferred consent model, in which patients may be approached for consent after their fracture surgery and prior to data collection. The consent rate in PREP-IT is 80.7%, and 0.67% of participants have withdrawn consent for participation.DiscussionInvolvement of patient advisors in the development of an optimal model of consent has been successful. Engagement of patient advisors is recommended for other large trials where the traditional model of consent may not be optimal.

Published
2021

2. Managing work flow in high enrolling trials: The development and implementation of a sampling strategy in the PREPARE trial.

Author

Pogorzelski, David, Nguyen, Uyen, McKay, Paula, Thabane, Lehana, Camara, Megan, Ramsey, Lolita, Seymour, Rachel, Goodman, J Brett, McGee, Sheketha, Fraifogl, Joanne, Hudgins, Andrea, Tanner, Stephanie L, Bhandari, Mohit, Slobogean, Gerard P, Sprague, Sheila, PREP-IT Investigators Executive Committee:, Steering Committee, Adjudication Committee, Data and Safety Monitoring Committee, Research Methodology Core, Patient Centred Outcomes Core, Orthopaedic Surgery Core, Operating Room Core, Infectious Disease Core, Military Core, McMaster University Methods Center, University of Maryland School of Medicine Administrative Center, University of Maryland School of Pharmacy, The PATIENTS Program, PREP-IT Clinical Sites: Lead Clinical Site (Aqueous-PREP and PREPARE), Aqueous-PREP and PREPARE, Aqueous-PREP, PREPARE, and PREP-IT Investigators Executive Committee

Subjects
PREP-IT Investigators Executive Committee:, Steering Committee, Adjudication Committee, Data and Safety Monitoring Committee, Research Methodology Core, Patient Centred Outcomes Core, Orthopaedic Surgery Core, Operating Room Core, Infectious Disease Core, Military Core, McMaster University Methods Center, University of Maryland School of Medicine Administrative Center, University of Maryland School of Pharmacy, The PATIENTS Program, PREP-IT Clinical Sites: Lead Clinical Site, Aqueous-PREP and PREPARE, Aqueous-PREP, PREPARE, PREP-IT Investigators Executive Committee, Cluster crossover, Pragmatic, Sampling, Sampling framework, Sampling strategy, Work flow
Abstract

IntroductionPragmatic trials in comparative effectiveness research assess the effects of different treatment, therapeutic, or healthcare options in clinical practice. They are characterized by broad eligibility criteria and large sample sizes, which can lead to an unmanageable number of participants, increasing the risk of bias and affecting the integrity of the trial. We describe the development of a sampling strategy tool and its use in the PREPARE trial to circumvent the challenge of unmanageable work flow.MethodsGiven the broad eligibility criteria and high fracture volume at participating clinical sites in the PREPARE trial, a pragmatic sampling strategy was needed. Using data from PREPARE, descriptive statistics were used to describe the use of the sampling strategy across clinical sites. A Chi-square test was performed to explore whether use of the sampling strategy was associated with a reduction in the number of missed eligible patients.Results7 of 20 clinical sites (35%) elected to adopt a sampling strategy. There were 1539 patients excluded due to the use of the sampling strategy, which represents 30% of all excluded patients and 20% of all patients screened for participation. Use of the sampling strategy was associated with lower odds of missed eligible patients (297/4545 (6.5%) versus 341/3200 (10.7%) p

Published
2021

3. Research Project Rubric

Author

Adjudication Committee, WLURA

Subjects
rubric, Information Literacy, Library and Information Science
Published
2022

6. Research Worksheet

Author

Adjudication Committee, WLURA

Subjects
Information Literacy, Library and Information Science
Published
2022

8. Integration of the Duke Activity Status Index into preoperative risk evaluation: a multicentre prospective cohort study

Author

Wijeysundera, DN, Beattie, WS, Hillis, GS, Abbott, TEF, Shulman, MA, Ackland, GL, Mazer, CD, Myles, PS, Pearse, RM, Cuthbertson, BH, Measurement of Exercise Tolerance before Surgery Study Investiga, Wallace, S, Farrington, C, Thompson, B, Ellis, M, Borg, B, Kerridge, RK, Douglas, J, Brannan, J, Pretto, J, Godsall, MG, Beauchamp, N, Allen, S, Kennedy, A, Wright, E, Malherbe, J, Ismail, H, Riedel, B, Melville, A, Sivakumar, H, Murmane, A, Kenchington, K, Kirabiyik, Y, Gurunathan, U, Stonell, C, Brunello, K, Steele, K, Tronstad, O, Masel, P, Dent, A, Smith, E, Bodger, A, Abolfathi, M, Sivalingam, P, Hall, A, Painter, TW, Macklin, S, Elliott, A, Carrera, AM, Terblanche, NCS, Pitt, S, Samuels, J, Wilde, C, Leslie, K, MacCormick, A, Bramley, D, Southcott, AM, Grant, J, Taylor, H, Bates, S, Towns, M, Tippett, A, Marshall, F, Kunasingam, J, Yagnik, A, Crescini, C, Yagnik, S, McCartney, CJL, Choi, S, Somascanthan, P, Flores, K, Karkouti, K, Clarke, HA, Jerath, A, McCluskey, SA, Wasowicz, M, Granton, JT, Day, L, Pazmino-Canizares, J, Oh, P, Belliard, R, Lee, L, Dobson, K, Chan, V, Brull, R, Ami, N, Stanbrook, M, Hagen, K, Campbell, D, Short, T, Van Der Westhuizen, J, Higgie, K, Lindsay, H, Jang, R, Wong, C, Mcallister, D, Ali, M, Kumar, J, Waymouth, E, Kim, C, Dimech, J, Lorimer, M, Tai, J, Miller, R, Sara, R, Collingwood, A, Olliff, S, Gabriel, S, Houston, H, Dalley, P, Hurford, S, Hunt, A, Andrews, L, Navarra, L, Jason-Smith, A, Thompson, H, McMillan, N, Back, G, Croal, BL, Lum, M, Martin, D, James, S, Filipe, H, Pinto, M, Kynaston, S, Phull, M, Beilstein, C, Bodger, P, Everingham, K, Hu, Y, Niebrzegowska, E, Corriea, C, Creary, T, Januszewska, M, Ahmad, T, Whalley, J, Haslop, R, McNeil, J, Brown, A, MacDonald, N, Pakats, M, Greaves, K, Jhanji, S, Raobaikady, R, Black, E, Rooms, M, Lawrence, H, Koutra, M, Pirie, K, Gertsman, M, Jack, S, Celinski, M, Levett, D, Edwards, M, Salmon, K, Bolger, C, Loughney, L, Seaward, L, Collins, H, Tyrell, B, Tantony, N, Golder, K, Stephens, RCM, Gallego-Paredes, L, Reyes, A, Gutierrez Del Arroyo, A, Raj, A, Lifford, R, International and National Coordinators, Central Project Office Operations Committee, CPET Methods Committee, Outcome Adjudication Committee, and International Steering Committee

Abstract

BACKGROUND: The Duke Activity Status Index (DASI) questionnaire might help incorporate self-reported functional capacity into preoperative risk assessment. Nonetheless, prognostically important thresholds in DASI scores remain unclear. We conducted a nested cohort analysis of the Measurement of Exercise Tolerance before Surgery (METS) study to characterise the association of preoperative DASI scores with postoperative death or complications. METHODS: The analysis included 1546 participants (≥40 yr of age) at an elevated cardiac risk who had inpatient noncardiac surgery. The primary outcome was 30-day death or myocardial injury. The secondary outcomes were 30-day death or myocardial infarction, in-hospital moderate-to-severe complications, and 1 yr death or new disability. Multivariable logistic regression modelling was used to characterise the adjusted association of preoperative DASI scores with outcomes. RESULTS: The DASI score had non-linear associations with outcomes. Self-reported functional capacity better than a DASI score of 34 was associated with reduced odds of 30-day death or myocardial injury (odds ratio: 0.97 per 1 point increase above 34; 95% confidence interval [CI]: 0.96-0.99) and 1 yr death or new disability (odds ratio: 0.96 per 1 point increase above 34; 95% CI: 0.92-0.99). Self-reported functional capacity worse than a DASI score of 34 was associated with increased odds of 30-day death or myocardial infarction (odds ratio: 1.05 per 1 point decrease below 34; 95% CI: 1.00-1.09), and moderate-to-severe complications (odds ratio: 1.03 per 1 point decrease below 34; 95% CI: 1.01-1.05). CONCLUSIONS: A DASI score of 34 represents a threshold for identifying patients at risk for myocardial injury, myocardial infarction, moderate-to-severe complications, and new disability.

Published
2020

9. Association of preoperative anaemia with cardiopulmonary exercise capacity and postoperative outcomes in noncardiac surgery: a substudy of the Measurement of Exercise Tolerance before Surgery (METS) Study.

Author

Bartoszko, J., Thorpe, K.E., Laupacis, A., Wijeysundera, D.N., METS Study Investigators, International and National Coordinators, Central Project Office Operations Committee, CPET Methods Committee, Outcome Adjudication Committee, and International Steering Committee

Subjects
*EXERCISE tolerance, *SURGICAL site infections, *ANAEROBIC threshold, *OXYGEN consumption, *EXERCISE tests
Abstract

Background: Preoperative anaemia is associated with elevated risks of postoperative complications. This association may be explained by confounding related to poor cardiopulmonary fitness. We conducted a pre-specified substudy of the Measurement of Exercise Tolerance before Surgery (METS) study to examine the associations of preoperative haemoglobin concentration with preoperative cardiopulmonary exercise testing performance (peak oxygen consumption, anaerobic threshold) and postoperative complications.Methods: The substudy included a nested cross-sectional analysis and nested cohort analysis. In the cross-sectional study (1279 participants), multivariate linear regression modelling was used to determine the adjusted association of haemoglobin concentration with peak oxygen consumption and anaerobic threshold. In the nested cohort study (1256 participants), multivariable logistic regression modelling was used to determine the adjusted association of haemoglobin concentration, peak oxygen consumption, and anaerobic threshold with the primary endpoint (composite outcome of death, cardiovascular complications, acute kidney injury, or surgical site infection) and secondary endpoint (moderate or severe complications).Results: Haemoglobin concentration explained 3.8% of the variation in peak oxygen consumption and anaerobic threshold (P<0.001). Although not associated with the primary endpoint, haemoglobin concentration was associated with moderate or severe complications after adjustment for peak oxygen consumption (odds ratio=0.86 per 10 g L-1 increase; 95% confidence interval, 0.77-0.96) or anaerobic threshold (odds ratio=0.86; 95% confidence interval, 0.77-0.97). Lower peak oxygen consumption was associated with moderate or severe complications without effect modification by haemoglobin concentration (P=0.12).Conclusion: Haemoglobin concentration explains a small proportion of variation in exercise capacity. Both anaemia and poor functional capacity are associated with postoperative complications and may therefore be modifiable targets for preoperative optimisation. [ABSTRACT FROM AUTHOR]

Published
2019
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