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Year Number of Results
1971 1
1976 2
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1979 6
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1981 5
1982 10
1983 11
1984 17
1985 23
1986 18
1987 27
1988 28
1989 16
1990 40
1991 43
1992 45
1993 62
1994 75
1995 78
1996 76
1997 84
1998 97
1999 112
2000 102
2001 123
2002 149
2003 139
2004 146
2005 212
2006 239
2007 236
2008 270
2009 290
2010 343
2011 392
2012 423
2013 425
2014 462
2015 553
2016 538
2017 580
2018 690
2019 752
2020 823
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2022 871
2023 900
2024 1030
2025 93

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11,079 results

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Page 1
Feeding protocol deviation after esophagectomy: A retrospective multicenter study.
Berkelmans GHK, Kingma BF, Fransen LFC, Nieuwenhuijzen GAP, Ruurda JP, van Hillegersberg R, Luyer MDP. Berkelmans GHK, et al. Clin Nutr. 2020 Apr;39(4):1258-1263. doi: 10.1016/j.clnu.2019.05.018. Epub 2019 May 23. Clin Nutr. 2020. PMID: 31174943
This study aimed to evaluate adherence to the feeding protocol following minimal invasive esophagectomy and identify reasons for protocol deviation. ...CONCLUSION: In this study, more than half of the patients deviated from the intended feeding prot …
This study aimed to evaluate adherence to the feeding protocol following minimal invasive esophagectomy and identify reasons for p …
Statistical Considerations for Bias and Protocol Deviation in Medical Device Pivotal Clinical Study.
Xu Z, Li M. Xu Z, et al. Ther Innov Regul Sci. 2019 Sep;53(5):623-629. doi: 10.1177/2168479018804175. Epub 2018 Oct 31. Ther Innov Regul Sci. 2019. PMID: 30380916
BACKGROUND: The gold standard in conducting clinical trials/studies is to follow what is prespecified in the study protocol. However, deviations from the study protocol may occur. This article discusses the issues of protocol deviation in pivota …
BACKGROUND: The gold standard in conducting clinical trials/studies is to follow what is prespecified in the study protocol. However, …
Dofetilide Initiation and Implications of Deviation From the Standard Protocol - A Real World Experience.
Dar T, Murtaza G, Yarlagadda B, Madoukh B, Bravin L, Vuddanda V, Parikh V, Reddy M, Lakkireddy D. Dar T, et al. J Atr Fibrillation. 2019 Dec 31;12(4):2265. doi: 10.4022/jafib.2265. eCollection 2019 Dec. J Atr Fibrillation. 2019. PMID: 32435348 Free PMC article.
Therapy in 49% (93/189) of patients was noted to deviate from manufacturer recommended protocol with deviations more than once in some patients during the same hospitalization. ...The impact of these protocol deviations on drug discontinuation w …
Therapy in 49% (93/189) of patients was noted to deviate from manufacturer recommended protocol with deviations more th …
Benchmarking Protocol Deviations and Their Variation by Major Disease Categories.
Getz K, Smith Z, Jain A, Krauss R. Getz K, et al. Ther Innov Regul Sci. 2022 Jul;56(4):632-636. doi: 10.1007/s43441-022-00401-4. Epub 2022 Apr 4. Ther Innov Regul Sci. 2022. PMID: 35378712 Free PMC article.
RESULTS: The results of this working group study show that phase II and III protocols have a mean total of 75 and 119 protocol deviations, respectively, involving nearly one-third of all patients enrolled in each clinical trial. ...A strong positive relations …
RESULTS: The results of this working group study show that phase II and III protocols have a mean total of 75 and 119 protocol …
Enhanced Recovery Deviation and Failure After Pancreaticoduodenectomy: Causative Factors and Impact.
Tankel J, Sahnan K, Neumann M, Carmel O, Dagan A, Reissman P, Ben Haim M. Tankel J, et al. J Surg Res. 2020 Jan;245:569-576. doi: 10.1016/j.jss.2019.07.055. Epub 2019 Sep 5. J Surg Res. 2020. PMID: 31494390
Univariate and multivariate analyses identified variables associated with protocol deviation and failure. The relationship between protocol deviation and failure was also explored. ...The median length of stay (LoS) was 14 d (6-36). In total, 73 (75.3% …
Univariate and multivariate analyses identified variables associated with protocol deviation and failure. The relationship bet …
Protocol Deviations: A Holistic Approach from Defining to Reporting.
Galuchie L, Stewart C, Meloni F. Galuchie L, et al. Ther Innov Regul Sci. 2021 Jul;55(4):733-742. doi: 10.1007/s43441-021-00269-w. Epub 2021 Mar 29. Ther Innov Regul Sci. 2021. PMID: 33782921 Free PMC article.
Improving interpretation of existing guidelines and management of protocol deviation processes could increase process efficiencies and help reduce noise to support rapid identification of important protocol deviations. Towards this end, TransCelerate i …
Improving interpretation of existing guidelines and management of protocol deviation processes could increase process efficien …
Unreported protocol deviations - The tip of the research-berg.
Kulkarni U, Vaswani R, Guthigar M, Bhat N, Sonde L. Kulkarni U, et al. Perspect Clin Res. 2023 Apr-Jun;14(2):68-74. doi: 10.4103/picr.picr_235_21. Epub 2022 Dec 21. Perspect Clin Res. 2023. PMID: 37325575 Free PMC article.
INTRODUCTION: Failure to stay within an ethics committee (EC)-approved protocol limits is termed protocol deviation or violation (PD/PV), depending on the seriousness of the transgression and its attendant risks and/or harms. ...These responses were followed …
INTRODUCTION: Failure to stay within an ethics committee (EC)-approved protocol limits is termed protocol deviation or …
Factors influencing deviation from target temperature during targeted temperature management in postcardiac arrest patients.
Ochiai K, Otomo Y. Ochiai K, et al. Open Heart. 2023 Dec 14;10(2):e002459. doi: 10.1136/openhrt-2023-002459. Open Heart. 2023. PMID: 38101858 Free PMC article.
This study aimed to compare the conventional and modified protocols, assess the relationship between target temperature deviation and patient outcomes, and identify the factors influencing temperature deviation. ...We assessed the factors that influenced the …
This study aimed to compare the conventional and modified protocols, assess the relationship between target temperature deviation …
A Toolkit for the Management of Protocol Deviations.
Mohan S, Mehra M, Petrizzo M, Katz T. Mohan S, et al. Ther Innov Regul Sci. 2016 Nov;50(6):791-800. doi: 10.1177/2168479016647987. Epub 2016 Jul 10. Ther Innov Regul Sci. 2016. PMID: 30231739
BACKGROUND: The DIA's Good Clinical Practice and Quality Assurance Community (DIA GCP/QA) created a working group to develop templates for a protocol deviation standard operating procedure (SOP) and protocol deviation handling plan (PDHP). ...CONCLUSIO …
BACKGROUND: The DIA's Good Clinical Practice and Quality Assurance Community (DIA GCP/QA) created a working group to develop templates for a …
Characterising deviation from treat-to-target strategies for early rheumatoid arthritis: the first three years.
Wabe N, Sorich MJ, Wechalekar MD, Cleland LG, McWilliams L, Lee A, Spargo L, Metcalf RG, Hall C, Proudman SM, Wiese MD. Wabe N, et al. Arthritis Res Ther. 2015 Mar 8;17(1):48. doi: 10.1186/s13075-015-0562-0. Arthritis Res Ther. 2015. PMID: 25889527 Free PMC article.
However, successful implementation may be limited by deviations from the protocol. The aim of this study was to determine the prevalence of protocol deviation, explore the reasons and identify subsets of patients in whom treatment protocols are …
However, successful implementation may be limited by deviations from the protocol. The aim of this study was to determine the …
11,079 results
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