Denial of effective treatment and poor quality of clinical information in placebo controlled trials of ondansetron for postoperative nausea and vomiting: a review of published trials

Aspinall, R.; Goodman, Neville W.

doi:10.1136/bmj.311.7009.844

Cited by 96 publications

(53 citation statements)

References 29 publications

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“…Authors or funders may have conflicts of interest that influence any of the following: the design of the study 228 ; choice of exposures, 228,229 outcomes, 230 statistical methods, 231 and selective publication of outcomes 230 and studies. 232 Consequently, the role of the funders should be described in detail: in what part of the study they took direct responsibility (eg, design, data collection, analysis, drafting of the manuscript, decision to publish).…”

Section: Other Information 22 Funding: Give the Source Of Funding Andmentioning

confidence: 99%

Strengthening the Reporting of Observational Studies in Epidemiology (STROBE): Explanation and Elaboration

et al. 2007

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Much medical research is observational. The reporting of observational studies is often of insufficient quality. Poor reporting hampers the assessment of the strengths and weaknesses of a study and the generalizability of its results. Taking into account empirical evidence and theoretical considerations, a group of methodologists, researchers, and editors developed the Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) recommendations to improve the quality of reporting of observational studies.The STROBE Statement consists of a checklist of 22 items, which relate to the title, abstract, introduction, methods, results and discussion sections of articles. Eighteen items are common to cohort studies, case-control studies and cross-sectional studies and four are specific to each of the three study designs. The STROBE Statement provides guidance to authors about how to improve the reporting of observational studies and facilitates critical appraisal and interpretation of studies by reviewers, journal editors and readers.This explanatory and elaboration document is intended to enhance the use, understanding, and dissemination of the STROBE Statement. The meaning and rationale for each checklist item are presented. For each item, one or several published examples and, where possible, references to relevant empirical studies and methodological literature are provided. Examples of useful flow diagrams are also included. The STROBE Statement, this document, and the associated web site (http://www.strobe-statement.org) should be helpful resources to improve reporting of observational research. (Epidemiology 2007;18: 805-835) R ational health care practices require knowledge about the etiology and pathogenesis, diagnosis, prognosis and treatment of diseases. Randomized trials provide valuable evidence about treatments and other interventions. However, much of clinical or public health knowledge comes from observational research. 1 About nine of ten research papers published in clinical speciality journals describe observational research. 2,3 The STROBE StatementReporting of observational research is often not detailed and clear enough to assess the strengths and weaknesses of the investigation. 4,5 To improve the reporting of observational research, we developed a checklist of items that should be addressed: the Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) Statement (Table 1). Items relate to title, abstract, introduction, methods, results and discussion sections of articles. The STROBE Statement has recently been published in several journals. 6 Our aim is to ensure clear presentation of what was planned, done, and found in an observational study. We stress that the recommendations are not prescriptions for setting up or conducting studies, nor do they dictate methodology or mandate a uniform presentation.STROBE provides general reporting recommendations for descriptive observational studies and studies that investigate 805associations between expos...

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Section: Other Information 22 Funding: Give the Source Of Funding Andmentioning

confidence: 99%

Strengthening the Reporting of Observational Studies in Epidemiology (STROBE): Explanation and Elaboration

et al. 2007

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“…So our study did not have a control group receiving placebo. [24] The percentage of patients who had nausea in 0-4 hours postoperative period was 23.33% with Granisetron, 16.67% with Ramosetron and 13.33% with Palonosetron which was statistically nonsignificant. The percentage of patients who had vomiting in 0-4 hours was 16.67% with Granisetron, 13.33% with Ramosetron and 10.00% with Palonosetron which was statistically nonsignificant.…”

Section: Discussionmentioning

confidence: 80%

A Comparative Study of Granisetron, Ramosetron and Palonosetron as Antiemetics in Prevention of Postoperative Nausea and Vomiting in Patients Undergoing Laparoscopic Surgeries

Yatoo¹,

Mahotra²,

Mehta³

et al. 2016

jemds

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“…As per Aspinall and Goodman if you have active drugs available, placebo controlled trials may be unethical because PONV are very much distressing after laparoscopic surgery. 31 Second, the patients with underlying diseases were excluded, so the results of the study should not be generalized to other patients with severe underlying diseases. Further studies should consider these limitations.…”

Section: Discussionmentioning

confidence: 99%

Effects of palonosetron and dexamethasone on postoperative nausea and vomiting in adult patients undergoing laparoscopic abdominal surgery: a randomized, double-blind, clinical trial at a tertiary care hospital

2016

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Denial of effective treatment and poor quality of clinical information in placebo controlled trials of ondansetron for postoperative nausea and vomiting: a review of published trials

Cited by 96 publications

References 29 publications

Strengthening the Reporting of Observational Studies in Epidemiology (STROBE): Explanation and Elaboration

Strengthening the Reporting of Observational Studies in Epidemiology (STROBE): Explanation and Elaboration

A Comparative Study of Granisetron, Ramosetron and Palonosetron as Antiemetics in Prevention of Postoperative Nausea and Vomiting in Patients Undergoing Laparoscopic Surgeries

Effects of palonosetron and dexamethasone on postoperative nausea and vomiting in adult patients undergoing laparoscopic abdominal surgery: a randomized, double-blind, clinical trial at a tertiary care hospital

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