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Quality of pilot trial abstracts in heart failure is suboptimal: a systematic survey

BACKGROUND: Pilot trials are miniature researches carried out with the sole aim of acting as the precursor for larger more definitive studies. Abstracts are used to summarize and introduce the findings to the reading audience. There is substantive empirical evidence showing that abstracts, despite t...

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Autores principales: Isiguzo, Godsent C., Zunza, Moleen, Chirehwa, Maxwell, Mayosi, Bongani M., Thabane, Lehana
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2018
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5977467/
https://www.ncbi.nlm.nih.gov/pubmed/29862038
http://dx.doi.org/10.1186/s40814-018-0302-8
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author Isiguzo, Godsent C.
Zunza, Moleen
Chirehwa, Maxwell
Mayosi, Bongani M.
Thabane, Lehana
author_facet Isiguzo, Godsent C.
Zunza, Moleen
Chirehwa, Maxwell
Mayosi, Bongani M.
Thabane, Lehana
author_sort Isiguzo, Godsent C.
collection PubMed
description BACKGROUND: Pilot trials are miniature researches carried out with the sole aim of acting as the precursor for larger more definitive studies. Abstracts are used to summarize and introduce the findings to the reading audience. There is substantive empirical evidence showing that abstracts, despite their important roles, are not informative enough, lacking the necessary details. This systematic survey was designed to assess the quality of reporting of heart failure pilot trial abstracts. The quality of reporting was defined as the completeness of reporting based on adherence to the CONSORT extension for reporting of pilot trial abstracts. We also identified factors associated with reporting quality. METHODS: We searched MEDLINE (PubMed), Cochrane Controlled Trials Register, Scopus, and African-wide information databases for abstracts from heart failure pilot trials in humans published from 1 January 1990 to 30 November 2016. These were assessed to determine the extent of adherence to CONSORT extension checklist for reporting of abstracts of pilot trials. We screened identified studies for inclusion based on title and abstract. Data were independently extracted by two reviewers using the checklist. We used regression analysis to assess the association between completeness of reporting (measured as the number of items in the CONSORT extension checklist for reporting of abstracts in pilot trials contained in each abstract) and factors influencing the quality of the reports. RESULTS: Two hundred and twenty-eight (228) articles were retrieved, of which 92 met the inclusion criteria. The mean CONSORT extension score was 8.3/16 (standard deviation 1.7); the least reported items were the source of funding (1% [1/92]), trial registration (13% [12/92]), randomization sequence (13% [12/92]), number randomized to each arm (16% [15/92]), and number analyzed in each arm (16% [15/92]). Multivariable regression analysis showed that pharmacological intervention pilot trials [incidence rate ratio (IRR) = 0.88; 95% confidence interval (CI), 0.81–0.97] were significantly associated with better reporting. Other factors such as structured abstract (IRR = 1.10; 95% CI, 0.99–1.23) and CONSORT endorsement (IRR = 1.10; 95% CI, 0.99–1.23) only showed minimal relationship with better reporting quality. CONCLUSION: The quality of reporting of abstracts of heart failure pilot trials was suboptimal. Pharmacological intervention was significantly associated with better reporting. These findings are consistent with previous research on reporting of trials. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (10.1186/s40814-018-0302-8) contains supplementary material, which is available to authorized users.
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spelling pubmed-59774672018-06-01 Quality of pilot trial abstracts in heart failure is suboptimal: a systematic survey Isiguzo, Godsent C. Zunza, Moleen Chirehwa, Maxwell Mayosi, Bongani M. Thabane, Lehana Pilot Feasibility Stud Research BACKGROUND: Pilot trials are miniature researches carried out with the sole aim of acting as the precursor for larger more definitive studies. Abstracts are used to summarize and introduce the findings to the reading audience. There is substantive empirical evidence showing that abstracts, despite their important roles, are not informative enough, lacking the necessary details. This systematic survey was designed to assess the quality of reporting of heart failure pilot trial abstracts. The quality of reporting was defined as the completeness of reporting based on adherence to the CONSORT extension for reporting of pilot trial abstracts. We also identified factors associated with reporting quality. METHODS: We searched MEDLINE (PubMed), Cochrane Controlled Trials Register, Scopus, and African-wide information databases for abstracts from heart failure pilot trials in humans published from 1 January 1990 to 30 November 2016. These were assessed to determine the extent of adherence to CONSORT extension checklist for reporting of abstracts of pilot trials. We screened identified studies for inclusion based on title and abstract. Data were independently extracted by two reviewers using the checklist. We used regression analysis to assess the association between completeness of reporting (measured as the number of items in the CONSORT extension checklist for reporting of abstracts in pilot trials contained in each abstract) and factors influencing the quality of the reports. RESULTS: Two hundred and twenty-eight (228) articles were retrieved, of which 92 met the inclusion criteria. The mean CONSORT extension score was 8.3/16 (standard deviation 1.7); the least reported items were the source of funding (1% [1/92]), trial registration (13% [12/92]), randomization sequence (13% [12/92]), number randomized to each arm (16% [15/92]), and number analyzed in each arm (16% [15/92]). Multivariable regression analysis showed that pharmacological intervention pilot trials [incidence rate ratio (IRR) = 0.88; 95% confidence interval (CI), 0.81–0.97] were significantly associated with better reporting. Other factors such as structured abstract (IRR = 1.10; 95% CI, 0.99–1.23) and CONSORT endorsement (IRR = 1.10; 95% CI, 0.99–1.23) only showed minimal relationship with better reporting quality. CONCLUSION: The quality of reporting of abstracts of heart failure pilot trials was suboptimal. Pharmacological intervention was significantly associated with better reporting. These findings are consistent with previous research on reporting of trials. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (10.1186/s40814-018-0302-8) contains supplementary material, which is available to authorized users. BioMed Central 2018-05-31 /pmc/articles/PMC5977467/ /pubmed/29862038 http://dx.doi.org/10.1186/s40814-018-0302-8 Text en © The Author(s). 2018 Open AccessThis article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.
spellingShingle Research
Isiguzo, Godsent C.
Zunza, Moleen
Chirehwa, Maxwell
Mayosi, Bongani M.
Thabane, Lehana
Quality of pilot trial abstracts in heart failure is suboptimal: a systematic survey
title Quality of pilot trial abstracts in heart failure is suboptimal: a systematic survey
title_full Quality of pilot trial abstracts in heart failure is suboptimal: a systematic survey
title_fullStr Quality of pilot trial abstracts in heart failure is suboptimal: a systematic survey
title_full_unstemmed Quality of pilot trial abstracts in heart failure is suboptimal: a systematic survey
title_short Quality of pilot trial abstracts in heart failure is suboptimal: a systematic survey
title_sort quality of pilot trial abstracts in heart failure is suboptimal: a systematic survey
topic Research
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5977467/
https://www.ncbi.nlm.nih.gov/pubmed/29862038
http://dx.doi.org/10.1186/s40814-018-0302-8
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