A qualitative assessment of randomized controlled trials in otolaryngology

Ah‐See, Kim; Molony, N

doi:10.1017/s0022215100140770

Cited by 40 publications

(35 citation statements)

References 7 publications

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“…Similarly, evaluations of 100 randomly selected trials with animal health or production outcomes and 100 randomly selected trials with food-safety outcomes revealed significant associations between the proportion of positive treatment effects within trials and failure to report trial features, such as random allocation to intervention group, exclusion criteria for study subjects, details of the intervention protocol, animal signalment and details of the measurement of all outcomes (Sargeant et al, 2009a,b). Sonis and Joines, 1994;Ah-See and Molony, 1998). In response to these concerns, standardized guidelines for reporting RCTs were developed and have been implemented.…”

Section: Incomplete and Inaccurate Reporting In Published Livestock Imentioning

confidence: 99%

The REFLECT Statement: Reporting Guidelines for Randomized Controlled Trials in Livestock and Food Safety: Explanation and Elaboration

Sargeant

O’Connor

Gardner

et al. 2010

Journal of Food Protection

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Concerns about the completeness and accuracy of reporting of randomized clinical trials (RCTs) and the impact of poor reporting on decision making have been documented in the medical field over the past several decades. Experience from RCTs in human medicine would suggest that failure to report critical trial features can be associated with biased estimated effect measures, and there is evidence to suggest that similar biases occur in RCTs conducted in livestock populations. In response to these concerns, standardized guidelines for reporting RCTs were developed and implemented in human medicine. The Consolidated Standards of Reporting Trials (CONSORT) statement was first published in 1996, with a revised edition published in 2001. The CONSORT statement consists of a 22-item checklist for reporting a RCT and a flow diagram to follow the number of participants at each stage of a trial. An explanation and elaboration document not only defines and discusses the importance of each of the items, but also provides examples of how this information could be supplied in a publication. Differences between human and livestock populations necessitate modifications to the CONSORT statement to maximize its usefulness for RCTs involving livestock. These have been addressed in an extension of the CONSORT statement titled the REFLECT statement: Methods and processes of creating reporting guidelines for randomized control trials for livestock and food safety. The modifications made for livestock trials specifically addressed the common use of group housing and group allocation to intervention in livestock studies; the use of deliberate challenge models in some trials and the common use of non-clinical outcomes, such as contamination with a foodborne pathogen. In addition, the REFLECT statement for RCTs in livestock populations proposed specific terms or further clarified terms as they pertained to livestock studies. KeywordsRandomized trials, livestock, challenge studies and standards RightsWorks produced by employees of the U.S. Government as part of their official duties are not copyrighted within the U.S. The content of this document is not copyrighted. AbstractConcerns about the completeness and accuracy of reporting of randomized clinical trials (RCTs) and the impact of poor reporting on decision making have been documented in the medical field over the past several decades. Experience from RCTs in human medicine would suggest that failure to report critical trial features can be associated with biased estimated effect measures, and there is evidence to suggest that similar biases occur in RCTs conducted in livestock populations. In response to these concerns, standardized guidelines for reporting RCTs were developed and implemented in human medicine. The Consolidated Standards of Reporting Trials (CONSORT) statement was first published in 1996, with a revised edition published in 2001. The CONSORT statement consists of a 22-item checklist for reporting a RCT and a flow diagram to follow the number of participants...

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Section: Incomplete and Inaccurate Reporting In Published Livestock Imentioning

confidence: 99%

The REFLECT Statement: Reporting Guidelines for Randomized Controlled Trials in Livestock and Food Safety: Explanation and Elaboration

Sargeant

O’Connor

Gardner

et al. 2010

Journal of Food Protection

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show abstract

“…For 14 items, this meant voting for wording that modified the original CONSORT item; in the other instances, this meant accepting no change in the wording from the original CONSORT item; and in 1 instance, the vote was to add 1 subitem (Table 3). Four items (1,5,6, and 7) were tabled for further discussion before voting. Tabling involved returning to the item for further discussion later in the meeting.…”

Section: Resultsmentioning

confidence: 99%

“…In human medicine, inconsistencies with the reporting of intervention studies have been documented over the past 10-15 years. [1][2][3][4][5][6] To address these deficiencies, several initiatives were implemented to improve the transparency of the conduct and reporting of intervention studies. The best-known initiative is the CONSORT statement (Consolidated Standards of Reporting Trials).…”

mentioning

confidence: 99%

The REFLECT Statement: Methods and Processes of Creating Reporting Guidelines for Randomized Controlled Trials for Livestock and Food Safety

O’Connor¹,

Lefebvre²,

Keefe³

et al. 2010

Veterinary Internal Medicne

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the attendees completed a Web-based survey indicating which CONSORT statement items would need to be modified to address unique issues for livestock trials. The consensus meeting resulted in the production of the REFLECT (Reporting Guidelines for Randomized Control Trials) statement for livestock and food safety and 22-item checklist. Fourteen items were modified from the CONSORT checklist, and an additional subitem was proposed to address challenge trials. The REFLECT statement proposes new terminology, more consistent with common usage in livestock production, to describe study subjects. Evidence was not always available to support modification to or inclusion of an item. The use of the REFLECT statement, which addresses issues unique to livestock trials, should improve the quality of reporting and design for trials reporting production, health, and food-safety outcomes.

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“…5 Randomized controlled trials are the best approaches to developing robust and locally relevant evidence. 27 A more pressing gap in Africa is the extremely few numbers of professionals in the discipline within the region. 28 Most of the trials (22 of 34) were conducted in Southern Africa, all conducted in South Africa, and followed by East Africa (9 of 34).…”

Section: Discussionmentioning

confidence: 99%

Quality of clinical trials for selected priority mental and neurological disorders in sub-Saharan Africa: a systematic review

Mulugeta¹,

Medhin²,

Yimer³

et al. 2016

OAJCT

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Background: There is a developing consensus on the effectiveness of various interventions for mental disorders in low-and middle-income countries, and it has been proposed that the main task is to scale up these interventions. In this context, we aimed to review the quality and extent of intervention trials for selected priority mental and neurological disorders in sub-Saharan Africa. Methods: Medline and African Journals Online databases were used for searching relevant articles. Both randomized and nonrandomized clinical trials for the treatment of schizophrenia, depression, maternal depression, bipolar disorder, and epilepsy/seizure disorders that involve pharmacotherapy, psychotherapy, and physical therapy were included. An extensive list of search terms that identified locations, disorders, interventions, and study types were employed. The qualities of the trials were appraised using the single-component quality assessment of the consolidated standards of reporting trials (CONSORT) statement and the Jadad scale. Results: From 1,136 studies identified, only 34 trials that fulfilled inclusion criteria were used for quality analysis. Most studies were clinical trials of treatments for epilepsy and were conducted after 2006. In terms of region, the majority of studies were conducted in South Africa (22 of the 34 studies). Approximately half of the trials (53%) were conducted in single center and the majority of the trials (71%) were pharmacotherapeutics-based intervention. In terms of methodological quality in relation to the Jadad scale, 82% fulfilled the criteria for good methodological quality with a score of 3−5. However, the methodological quality according to the CONSORT criteria was more mixed. Conclusion: The overall quality of clinical trials conducted in sub-Saharan Africa is encouraging despite the limited number of studies. However, important quality limitations remain and have not improved over time. Hence, establishing clinical trial centers in these countries may be one approach to improving quality and quantity of trials.

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A qualitative assessment of randomized controlled trials in otolaryngology

Cited by 40 publications

References 7 publications

The REFLECT Statement: Reporting Guidelines for Randomized Controlled Trials in Livestock and Food Safety: Explanation and Elaboration

The REFLECT Statement: Reporting Guidelines for Randomized Controlled Trials in Livestock and Food Safety: Explanation and Elaboration

The REFLECT Statement: Methods and Processes of Creating Reporting Guidelines for Randomized Controlled Trials for Livestock and Food Safety

Quality of clinical trials for selected priority mental and neurological disorders in sub-Saharan Africa: a systematic review

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