Accuracy and distribution of baseline categorical variables and p-values in spine randomized controlled trials
Levayer and colleagues assessed integrity issues in randomized controlled trials (RCTs) in four spine journals using baseline p-values from categorical variables, concluding that there was no evidence of ‘systemic fraudulent behaviour’. We used their published dataset to assess the accuracy of repor...
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The Royal Society
2025-01-01
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| Series: | Royal Society Open Science |
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| Online Access: | https://royalsocietypublishing.org/doi/10.1098/rsos.240170 |
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| author | Mark J. Bolland Alison Avenell Andrew Grey |
| author_facet | Mark J. Bolland Alison Avenell Andrew Grey |
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| collection | DOAJ |
| description | Levayer and colleagues assessed integrity issues in randomized controlled trials (RCTs) in four spine journals using baseline p-values from categorical variables, concluding that there was no evidence of ‘systemic fraudulent behaviour’. We used their published dataset to assess the accuracy of reported p-values and whether observed and expected distributions of frequency counts and p-values were consistent. In 51 out of 929 (5.5%) baseline variables, the sum of frequencies did not agree with the reported number of participants. For one-third of reported p-values (172 out of 522), we could not calculate a matching p-value using a range of statistical tests. Sparse data were common: for 22% (74 out of 332) of variables in which the reported p-value matched the p-value calculated from a chi-square test, the expected cells were smaller than recommended for the use of chi-square tests. There were 20–25% more two-arm trials with differences in frequency counts of 1 or 2 between-groups than expected. There were small differences between observed and expected distributions of baseline p-values, but these depended on analysis methods. In summary, incorrectly reported p-values and incorrect statistical test usage were common, and there were differences between observed and expected distributions of baseline p-values and frequency counts, raising questions about the integrity of some RCTs in these journals. |
| format | Article |
| id | doaj-art-18cf24435554473abc0cf0035c48aa75 |
| institution | Kabale University |
| issn | 2054-5703 |
| language | English |
| publishDate | 2025-01-01 |
| publisher | The Royal Society |
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| series | Royal Society Open Science |
| spelling | doaj-art-18cf24435554473abc0cf0035c48aa752025-01-17T09:03:46ZengThe Royal SocietyRoyal Society Open Science2054-57032025-01-0112110.1098/rsos.240170Accuracy and distribution of baseline categorical variables and p-values in spine randomized controlled trialsMark J. Bolland0Alison Avenell1Andrew Grey2Department of Medicine, University of Auckland, Private Bag 92 019 , Auckland 1142, New ZealandHealth Services Research Unit, University of Aberdeen, Foresterhill , Aberdeen AB25 2ZD, UKDepartment of Medicine, University of Auckland, Private Bag 92 019 , Auckland 1142, New ZealandLevayer and colleagues assessed integrity issues in randomized controlled trials (RCTs) in four spine journals using baseline p-values from categorical variables, concluding that there was no evidence of ‘systemic fraudulent behaviour’. We used their published dataset to assess the accuracy of reported p-values and whether observed and expected distributions of frequency counts and p-values were consistent. In 51 out of 929 (5.5%) baseline variables, the sum of frequencies did not agree with the reported number of participants. For one-third of reported p-values (172 out of 522), we could not calculate a matching p-value using a range of statistical tests. Sparse data were common: for 22% (74 out of 332) of variables in which the reported p-value matched the p-value calculated from a chi-square test, the expected cells were smaller than recommended for the use of chi-square tests. There were 20–25% more two-arm trials with differences in frequency counts of 1 or 2 between-groups than expected. There were small differences between observed and expected distributions of baseline p-values, but these depended on analysis methods. In summary, incorrectly reported p-values and incorrect statistical test usage were common, and there were differences between observed and expected distributions of baseline p-values and frequency counts, raising questions about the integrity of some RCTs in these journals.https://royalsocietypublishing.org/doi/10.1098/rsos.240170spinerandomized controlled trialsp-valuesrandomizationstatistical tests |
| spellingShingle | Mark J. Bolland Alison Avenell Andrew Grey Accuracy and distribution of baseline categorical variables and p-values in spine randomized controlled trials Royal Society Open Science spine randomized controlled trials p-values randomization statistical tests |
| title | Accuracy and distribution of baseline categorical variables and p-values in spine randomized controlled trials |
| title_full | Accuracy and distribution of baseline categorical variables and p-values in spine randomized controlled trials |
| title_fullStr | Accuracy and distribution of baseline categorical variables and p-values in spine randomized controlled trials |
| title_full_unstemmed | Accuracy and distribution of baseline categorical variables and p-values in spine randomized controlled trials |
| title_short | Accuracy and distribution of baseline categorical variables and p-values in spine randomized controlled trials |
| title_sort | accuracy and distribution of baseline categorical variables and p values in spine randomized controlled trials |
| topic | spine randomized controlled trials p-values randomization statistical tests |
| url | https://royalsocietypublishing.org/doi/10.1098/rsos.240170 |
| work_keys_str_mv | AT markjbolland accuracyanddistributionofbaselinecategoricalvariablesandpvaluesinspinerandomizedcontrolledtrials AT alisonavenell accuracyanddistributionofbaselinecategoricalvariablesandpvaluesinspinerandomizedcontrolledtrials AT andrewgrey accuracyanddistributionofbaselinecategoricalvariablesandpvaluesinspinerandomizedcontrolledtrials |