Do randomised controlled trials relevant to pharmacy meet best practice standards for quality conduct and reporting?

A systematic review

Alison Ritchie, Liza Seubert, Rhonda Clifford, Danae Perry, Christine Bond* (Corresponding Author)

*Corresponding author for this work

Research output: Contribution to journalArticle

Abstract

Objectives
Evidence‐based pharmacy practice requires a dependable evidence base. Randomised controlled trials (RCTs) are the gold standard of high‐quality primary research, and tools exist to assist researchers in conducting and reporting high‐quality RCTs. This review aimed to explore whether RCTs relevant to pharmacy are conducted and reported in line with Cochrane risk of bias and CONSORT standards, respectively.

Methods
A MEDLINE search identified potential papers. After screening of titles, abstracts and full texts, the 50 most recent papers were reviewed and assessment of bias according to Cochrane domains and compliance with CONSORT checklist items was recorded. Each domain of the Cochrane tool and CONSORT checklist item and each article were given a percentage score, reported as median and interquartile range (IQR). Correlation between quality of conduct, quality of reporting, continent of origin, and journal impact factor was conducted using the R2 statistic. The median domain score for risk of bias by paper according to the Cochrane risk of bias tool was 53.0% (IQR 38.5–68.5), while the median compliance score by paper for the CONSORT checklist was 64.0% (IQR 36.0–94.0%).

key findings
The median Cochrane domain and median CONSORT item completion scores, respectively, were 50.0% (IQR 33.3–66.7%) and 59.5% (IQR 52.0–70.3%). The highest risk of bias was associated with allocation concealment and blinding, and the least well‐reported items were randomisation details, sequence generation and allocation concealment. A positive relationship between conduct and reporting of RCTs was found (R2 = 0.75), while no correlation was found between quality of conduct or quality of reporting and journal impact factor, correlation coefficients (R2 = 0.06 and R2 = 0.05, respectively).

Summary
This review identified that issues related to randomisation and blinding are often inadequately conducted or not comprehensively reported by researchers conducting pharmacy relevant RCTs, providing useful information for education and future research.
Original languageEnglish
Number of pages13
JournalInternational Journal of Pharmacy Practice
Early online date1 Oct 2019
DOIs
Publication statusE-pub ahead of print - 1 Oct 2019

Fingerprint

Practice Guidelines
Randomized Controlled Trials
Checklist
Journal Impact Factor
Random Allocation
Research Personnel
Screening
MEDLINE
Education
Compliance
Statistics
Research

Keywords

  • RCT
  • systematic review
  • pharmaceutical care
  • other

ASJC Scopus subject areas

  • Public Health, Environmental and Occupational Health
  • Health Policy
  • Pharmacy
  • Pharmaceutical Science

Cite this

@article{e795eca0d7a048958331bfc0df500444,
title = "Do randomised controlled trials relevant to pharmacy meet best practice standards for quality conduct and reporting?: A systematic review",
abstract = "ObjectivesEvidence‐based pharmacy practice requires a dependable evidence base. Randomised controlled trials (RCTs) are the gold standard of high‐quality primary research, and tools exist to assist researchers in conducting and reporting high‐quality RCTs. This review aimed to explore whether RCTs relevant to pharmacy are conducted and reported in line with Cochrane risk of bias and CONSORT standards, respectively.MethodsA MEDLINE search identified potential papers. After screening of titles, abstracts and full texts, the 50 most recent papers were reviewed and assessment of bias according to Cochrane domains and compliance with CONSORT checklist items was recorded. Each domain of the Cochrane tool and CONSORT checklist item and each article were given a percentage score, reported as median and interquartile range (IQR). Correlation between quality of conduct, quality of reporting, continent of origin, and journal impact factor was conducted using the R2 statistic. The median domain score for risk of bias by paper according to the Cochrane risk of bias tool was 53.0{\%} (IQR 38.5–68.5), while the median compliance score by paper for the CONSORT checklist was 64.0{\%} (IQR 36.0–94.0{\%}).key findingsThe median Cochrane domain and median CONSORT item completion scores, respectively, were 50.0{\%} (IQR 33.3–66.7{\%}) and 59.5{\%} (IQR 52.0–70.3{\%}). The highest risk of bias was associated with allocation concealment and blinding, and the least well‐reported items were randomisation details, sequence generation and allocation concealment. A positive relationship between conduct and reporting of RCTs was found (R2 = 0.75), while no correlation was found between quality of conduct or quality of reporting and journal impact factor, correlation coefficients (R2 = 0.06 and R2 = 0.05, respectively).SummaryThis review identified that issues related to randomisation and blinding are often inadequately conducted or not comprehensively reported by researchers conducting pharmacy relevant RCTs, providing useful information for education and future research.",
keywords = "RCT, systematic review, pharmaceutical care, other",
author = "Alison Ritchie and Liza Seubert and Rhonda Clifford and Danae Perry and Christine Bond",
note = "Funding This review received no specific grant from any funding agency in the public, commercial or not‐for‐profit sectors. Acknowledgements The study was conceived by CB, all authors contributed to the design, reviewed results and commented on successive drafts of the paper and approved the final version. AR undertook all the searches, data extraction and analyses, and prepared the first draft of the manuscript. The project was undertaken by AR as her Master of Pharmacy research project during a placement at the University of Aberdeen Scotland under the local supervision of Christine Bond. Special thanks to Moira Cruickshank, from the Health Services Research Unit at the University of Aberdeen for assistance in the construction of the search strategy.",
year = "2019",
month = "10",
day = "1",
doi = "10.1111/ijpp.12578",
language = "English",
journal = "International Journal of Pharmacy Practice",
issn = "0961-7671",
publisher = "John Wiley & Sons, Ltd (10.1111)",

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T1 - Do randomised controlled trials relevant to pharmacy meet best practice standards for quality conduct and reporting?

T2 - A systematic review

AU - Ritchie, Alison

AU - Seubert, Liza

AU - Clifford, Rhonda

AU - Perry, Danae

AU - Bond, Christine

N1 - Funding This review received no specific grant from any funding agency in the public, commercial or not‐for‐profit sectors. Acknowledgements The study was conceived by CB, all authors contributed to the design, reviewed results and commented on successive drafts of the paper and approved the final version. AR undertook all the searches, data extraction and analyses, and prepared the first draft of the manuscript. The project was undertaken by AR as her Master of Pharmacy research project during a placement at the University of Aberdeen Scotland under the local supervision of Christine Bond. Special thanks to Moira Cruickshank, from the Health Services Research Unit at the University of Aberdeen for assistance in the construction of the search strategy.

PY - 2019/10/1

Y1 - 2019/10/1

N2 - ObjectivesEvidence‐based pharmacy practice requires a dependable evidence base. Randomised controlled trials (RCTs) are the gold standard of high‐quality primary research, and tools exist to assist researchers in conducting and reporting high‐quality RCTs. This review aimed to explore whether RCTs relevant to pharmacy are conducted and reported in line with Cochrane risk of bias and CONSORT standards, respectively.MethodsA MEDLINE search identified potential papers. After screening of titles, abstracts and full texts, the 50 most recent papers were reviewed and assessment of bias according to Cochrane domains and compliance with CONSORT checklist items was recorded. Each domain of the Cochrane tool and CONSORT checklist item and each article were given a percentage score, reported as median and interquartile range (IQR). Correlation between quality of conduct, quality of reporting, continent of origin, and journal impact factor was conducted using the R2 statistic. The median domain score for risk of bias by paper according to the Cochrane risk of bias tool was 53.0% (IQR 38.5–68.5), while the median compliance score by paper for the CONSORT checklist was 64.0% (IQR 36.0–94.0%).key findingsThe median Cochrane domain and median CONSORT item completion scores, respectively, were 50.0% (IQR 33.3–66.7%) and 59.5% (IQR 52.0–70.3%). The highest risk of bias was associated with allocation concealment and blinding, and the least well‐reported items were randomisation details, sequence generation and allocation concealment. A positive relationship between conduct and reporting of RCTs was found (R2 = 0.75), while no correlation was found between quality of conduct or quality of reporting and journal impact factor, correlation coefficients (R2 = 0.06 and R2 = 0.05, respectively).SummaryThis review identified that issues related to randomisation and blinding are often inadequately conducted or not comprehensively reported by researchers conducting pharmacy relevant RCTs, providing useful information for education and future research.

AB - ObjectivesEvidence‐based pharmacy practice requires a dependable evidence base. Randomised controlled trials (RCTs) are the gold standard of high‐quality primary research, and tools exist to assist researchers in conducting and reporting high‐quality RCTs. This review aimed to explore whether RCTs relevant to pharmacy are conducted and reported in line with Cochrane risk of bias and CONSORT standards, respectively.MethodsA MEDLINE search identified potential papers. After screening of titles, abstracts and full texts, the 50 most recent papers were reviewed and assessment of bias according to Cochrane domains and compliance with CONSORT checklist items was recorded. Each domain of the Cochrane tool and CONSORT checklist item and each article were given a percentage score, reported as median and interquartile range (IQR). Correlation between quality of conduct, quality of reporting, continent of origin, and journal impact factor was conducted using the R2 statistic. The median domain score for risk of bias by paper according to the Cochrane risk of bias tool was 53.0% (IQR 38.5–68.5), while the median compliance score by paper for the CONSORT checklist was 64.0% (IQR 36.0–94.0%).key findingsThe median Cochrane domain and median CONSORT item completion scores, respectively, were 50.0% (IQR 33.3–66.7%) and 59.5% (IQR 52.0–70.3%). The highest risk of bias was associated with allocation concealment and blinding, and the least well‐reported items were randomisation details, sequence generation and allocation concealment. A positive relationship between conduct and reporting of RCTs was found (R2 = 0.75), while no correlation was found between quality of conduct or quality of reporting and journal impact factor, correlation coefficients (R2 = 0.06 and R2 = 0.05, respectively).SummaryThis review identified that issues related to randomisation and blinding are often inadequately conducted or not comprehensively reported by researchers conducting pharmacy relevant RCTs, providing useful information for education and future research.

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