Sample size estimation practices in research protocols submitted to Danish scientific ethics committees

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Sample size estimation practices in research protocols submitted to Danish scientific ethics committees. / Flege, Marius Molsted; Thomsen, Simon Francis.

I: Contemporary Clinical Trials Communications, Bind 11, 2018, s. 165-169.

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningfagfællebedømt

Harvard

Flege, MM & Thomsen, SF 2018, 'Sample size estimation practices in research protocols submitted to Danish scientific ethics committees', Contemporary Clinical Trials Communications, bind 11, s. 165-169. https://doi.org/10.1016/j.conctc.2018.08.003

APA

Flege, M. M., & Thomsen, S. F. (2018). Sample size estimation practices in research protocols submitted to Danish scientific ethics committees. Contemporary Clinical Trials Communications, 11, 165-169. https://doi.org/10.1016/j.conctc.2018.08.003

Vancouver

Flege MM, Thomsen SF. Sample size estimation practices in research protocols submitted to Danish scientific ethics committees. Contemporary Clinical Trials Communications. 2018;11:165-169. https://doi.org/10.1016/j.conctc.2018.08.003

Author

Flege, Marius Molsted ; Thomsen, Simon Francis. / Sample size estimation practices in research protocols submitted to Danish scientific ethics committees. I: Contemporary Clinical Trials Communications. 2018 ; Bind 11. s. 165-169.

Bibtex

@article{ba456205cd80483c95426602eb848e13,
title = "Sample size estimation practices in research protocols submitted to Danish scientific ethics committees",
abstract = "Background: Sample size in research projects is estimated before initiation of the study to minimise type 1 and type 2 error, while keeping the study's financial cost and subject enrolment to a minimum. This study investigates project-specific factors potentially associated with correct estimation of sample size in study protocols. Methods: Examination of 189 non-commercially sponsored study protocols (84 randomised controlled trials (RCTs) and 105 non-RCT studies) submitted to the Scientific Ethics Committees of The Capitol Region of Denmark from 2013 to 2015. Results: 119 (63{\%}) study protocols contained a sample size calculation, with a significantly higher rate of sample size calculations in RCT vs non-RCT study protocols (76{\%} vs. 52{\%}, p < 0.001). Significantly more intervention studies than non-intervention studies (69{\%} vs 52{\%}, p = 0.020), studies including blood samples compared to those without (69{\%} vs. 55{\%}, p = 0.045), studies funded by a foundation donation compared to those with no funding (68{\%} vs. 49{\%}, p = 0.040) performed sample size calculations. Further, increasing number of sick patients enrolled (p = 0.048) and newer studies (p = 0.032) were more likely to include a sample size calculation in the protocol. Conclusions: Estimation of sample size is more often reported in RCT than non-RCT study protocols. Also, intervention studies, studies funded by a foundation donation, studies including blood samples, studies with a greater amount of sick participants and chronologically newer study protocols more often reported a sample size calculation.",
author = "Flege, {Marius Molsted} and Thomsen, {Simon Francis}",
year = "2018",
doi = "10.1016/j.conctc.2018.08.003",
language = "English",
volume = "11",
pages = "165--169",
journal = "Contemporary Clinical Trials Communications",
issn = "2451-8654",
publisher = "Elsevier",

}

RIS

TY - JOUR

T1 - Sample size estimation practices in research protocols submitted to Danish scientific ethics committees

AU - Flege, Marius Molsted

AU - Thomsen, Simon Francis

PY - 2018

Y1 - 2018

N2 - Background: Sample size in research projects is estimated before initiation of the study to minimise type 1 and type 2 error, while keeping the study's financial cost and subject enrolment to a minimum. This study investigates project-specific factors potentially associated with correct estimation of sample size in study protocols. Methods: Examination of 189 non-commercially sponsored study protocols (84 randomised controlled trials (RCTs) and 105 non-RCT studies) submitted to the Scientific Ethics Committees of The Capitol Region of Denmark from 2013 to 2015. Results: 119 (63%) study protocols contained a sample size calculation, with a significantly higher rate of sample size calculations in RCT vs non-RCT study protocols (76% vs. 52%, p < 0.001). Significantly more intervention studies than non-intervention studies (69% vs 52%, p = 0.020), studies including blood samples compared to those without (69% vs. 55%, p = 0.045), studies funded by a foundation donation compared to those with no funding (68% vs. 49%, p = 0.040) performed sample size calculations. Further, increasing number of sick patients enrolled (p = 0.048) and newer studies (p = 0.032) were more likely to include a sample size calculation in the protocol. Conclusions: Estimation of sample size is more often reported in RCT than non-RCT study protocols. Also, intervention studies, studies funded by a foundation donation, studies including blood samples, studies with a greater amount of sick participants and chronologically newer study protocols more often reported a sample size calculation.

AB - Background: Sample size in research projects is estimated before initiation of the study to minimise type 1 and type 2 error, while keeping the study's financial cost and subject enrolment to a minimum. This study investigates project-specific factors potentially associated with correct estimation of sample size in study protocols. Methods: Examination of 189 non-commercially sponsored study protocols (84 randomised controlled trials (RCTs) and 105 non-RCT studies) submitted to the Scientific Ethics Committees of The Capitol Region of Denmark from 2013 to 2015. Results: 119 (63%) study protocols contained a sample size calculation, with a significantly higher rate of sample size calculations in RCT vs non-RCT study protocols (76% vs. 52%, p < 0.001). Significantly more intervention studies than non-intervention studies (69% vs 52%, p = 0.020), studies including blood samples compared to those without (69% vs. 55%, p = 0.045), studies funded by a foundation donation compared to those with no funding (68% vs. 49%, p = 0.040) performed sample size calculations. Further, increasing number of sick patients enrolled (p = 0.048) and newer studies (p = 0.032) were more likely to include a sample size calculation in the protocol. Conclusions: Estimation of sample size is more often reported in RCT than non-RCT study protocols. Also, intervention studies, studies funded by a foundation donation, studies including blood samples, studies with a greater amount of sick participants and chronologically newer study protocols more often reported a sample size calculation.

U2 - 10.1016/j.conctc.2018.08.003

DO - 10.1016/j.conctc.2018.08.003

M3 - Journal article

VL - 11

SP - 165

EP - 169

JO - Contemporary Clinical Trials Communications

JF - Contemporary Clinical Trials Communications

SN - 2451-8654

ER -

ID: 212848516