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The reporting of pilot and feasibility studies in the top dental specialty journals is suboptimal
BACKGROUND: Pilot and feasibility studies (PAFS) are smaller investigations seeking to assess the feasibility of conducting a larger more definitive study. In late 2016, the CONSORT statement was extended to disseminate good practices for reporting of randomized pilot and feasibility trials. In this...
Autores principales: | , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
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BioMed Central
2022
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9531373/ https://www.ncbi.nlm.nih.gov/pubmed/36192777 http://dx.doi.org/10.1186/s40814-022-01182-1 |
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author | Khan, Mohammed I. U. Brar, Hartirath K. Sun, Cynthia Y. He, Rebecca El-Khechen, Hussein A. Mellor, Katie Thabane, Lehana Quiñonez, Carlos |
author_facet | Khan, Mohammed I. U. Brar, Hartirath K. Sun, Cynthia Y. He, Rebecca El-Khechen, Hussein A. Mellor, Katie Thabane, Lehana Quiñonez, Carlos |
author_sort | Khan, Mohammed I. U. |
collection | PubMed |
description | BACKGROUND: Pilot and feasibility studies (PAFS) are smaller investigations seeking to assess the feasibility of conducting a larger more definitive study. In late 2016, the CONSORT statement was extended to disseminate good practices for reporting of randomized pilot and feasibility trials. In this quality assurance review, we assessed whether PAFS in the top dental speciality journals adhere to good practices of conduct and reporting, by prioritizing assessment of feasibility and stating pre-defined progression criteria to inform the decision to pursue funding for a larger trial. METHODS: With the help of a librarian, we searched MEDLINE and EMBASE from 2017 to 2020, inclusive, for PAFS in the top 3 journals from each of the 10 dental specialties. We collected data on methodological and general characteristics of the studies, their objectives, and reporting of items recommended in the CONSORT extension. RESULTS: Of the 111 trials included, 51.4% (95% CI 41.7–61.0%) stated some indication of intent to assess feasibility while zero reported progression criteria; 74.8% (95% CI 65.6–82.5%) of trials used the terms “pilot” or “feasibility” in their titles and 82.9% (95% CI 74.6–89.4%) of studies stated there is a need for a future trial, but only 9.0% (95% CI 4.4–15.9%) stated intent to proceed to one. Most of the studies, 53.2% (95% CI 43.4–62.7%), reported hypothesis testing without cautioning readers on the generalizability of the results. Studies that used the terms “pilot” or “feasibility” in their title were less likely to have feasibility objectives, compared to trials that did not, with an odds ratio (OR) of 0.310 (95% CI 0.103–0.930; p = 0.037). Compared to trials that did not conduct hypothesis testing, trials that conducted hypothesis testing were significantly less likely to assess feasibility, among them, trials that cautioned readers on the generalizability of their results had an OR of 0.038 (95% CI 0.005–0.264; p < 0.001) and trials that did not caution readers on the generalizability of their results had an OR of 0.043 (95% CI 0.008–0.238; p = 0.001). CONCLUSION: Many PAFS in dentistry are not conducted with the intent of assessing feasibility, nor do they state progression criteria, and few report intent to proceed to a future trial. Misconceptions about PAFS can lead to them being poorly conducted and reported, which has economic and ethical implications. Research ethics boards, funding agencies, and journals need to raise their standards for the conduct and reporting of PAFS, and resources should be developed to address misconceptions and help guide researchers on the best practices for their conduct and reporting. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1186/s40814-022-01182-1. |
format | Online Article Text |
id | pubmed-9531373 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2022 |
publisher | BioMed Central |
record_format | MEDLINE/PubMed |
spelling | pubmed-95313732022-10-05 The reporting of pilot and feasibility studies in the top dental specialty journals is suboptimal Khan, Mohammed I. U. Brar, Hartirath K. Sun, Cynthia Y. He, Rebecca El-Khechen, Hussein A. Mellor, Katie Thabane, Lehana Quiñonez, Carlos Pilot Feasibility Stud Research BACKGROUND: Pilot and feasibility studies (PAFS) are smaller investigations seeking to assess the feasibility of conducting a larger more definitive study. In late 2016, the CONSORT statement was extended to disseminate good practices for reporting of randomized pilot and feasibility trials. In this quality assurance review, we assessed whether PAFS in the top dental speciality journals adhere to good practices of conduct and reporting, by prioritizing assessment of feasibility and stating pre-defined progression criteria to inform the decision to pursue funding for a larger trial. METHODS: With the help of a librarian, we searched MEDLINE and EMBASE from 2017 to 2020, inclusive, for PAFS in the top 3 journals from each of the 10 dental specialties. We collected data on methodological and general characteristics of the studies, their objectives, and reporting of items recommended in the CONSORT extension. RESULTS: Of the 111 trials included, 51.4% (95% CI 41.7–61.0%) stated some indication of intent to assess feasibility while zero reported progression criteria; 74.8% (95% CI 65.6–82.5%) of trials used the terms “pilot” or “feasibility” in their titles and 82.9% (95% CI 74.6–89.4%) of studies stated there is a need for a future trial, but only 9.0% (95% CI 4.4–15.9%) stated intent to proceed to one. Most of the studies, 53.2% (95% CI 43.4–62.7%), reported hypothesis testing without cautioning readers on the generalizability of the results. Studies that used the terms “pilot” or “feasibility” in their title were less likely to have feasibility objectives, compared to trials that did not, with an odds ratio (OR) of 0.310 (95% CI 0.103–0.930; p = 0.037). Compared to trials that did not conduct hypothesis testing, trials that conducted hypothesis testing were significantly less likely to assess feasibility, among them, trials that cautioned readers on the generalizability of their results had an OR of 0.038 (95% CI 0.005–0.264; p < 0.001) and trials that did not caution readers on the generalizability of their results had an OR of 0.043 (95% CI 0.008–0.238; p = 0.001). CONCLUSION: Many PAFS in dentistry are not conducted with the intent of assessing feasibility, nor do they state progression criteria, and few report intent to proceed to a future trial. Misconceptions about PAFS can lead to them being poorly conducted and reported, which has economic and ethical implications. Research ethics boards, funding agencies, and journals need to raise their standards for the conduct and reporting of PAFS, and resources should be developed to address misconceptions and help guide researchers on the best practices for their conduct and reporting. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1186/s40814-022-01182-1. BioMed Central 2022-10-04 /pmc/articles/PMC9531373/ /pubmed/36192777 http://dx.doi.org/10.1186/s40814-022-01182-1 Text en © The Author(s) 2022 https://creativecommons.org/licenses/by/4.0/Open AccessThis article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/ (https://creativecommons.org/licenses/by/4.0/) . The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/ (https://creativecommons.org/publicdomain/zero/1.0/) ) applies to the data made available in this article, unless otherwise stated in a credit line to the data. |
spellingShingle | Research Khan, Mohammed I. U. Brar, Hartirath K. Sun, Cynthia Y. He, Rebecca El-Khechen, Hussein A. Mellor, Katie Thabane, Lehana Quiñonez, Carlos The reporting of pilot and feasibility studies in the top dental specialty journals is suboptimal |
title | The reporting of pilot and feasibility studies in the top dental specialty journals is suboptimal |
title_full | The reporting of pilot and feasibility studies in the top dental specialty journals is suboptimal |
title_fullStr | The reporting of pilot and feasibility studies in the top dental specialty journals is suboptimal |
title_full_unstemmed | The reporting of pilot and feasibility studies in the top dental specialty journals is suboptimal |
title_short | The reporting of pilot and feasibility studies in the top dental specialty journals is suboptimal |
title_sort | reporting of pilot and feasibility studies in the top dental specialty journals is suboptimal |
topic | Research |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9531373/ https://www.ncbi.nlm.nih.gov/pubmed/36192777 http://dx.doi.org/10.1186/s40814-022-01182-1 |
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