Toward assessing clinical trial publications for reporting transparency.

OBJECTIVE: To annotate a corpus of randomized controlled trial (RCT) publications with the checklist items of CONSORT reporting guidelines and using the corpus to develop text mining methods for RCT appraisal. METHODS: We annotated a corpus of 50 RCT articles at the sentence level using 37 fine-grained CONSORT checklist items. A subset (31 articles) was double-annotated and adjudicated, while 19 were annotated by a single annotator and reconciled by another. We calculated inter-annotator agreement at the article and section level using MASI (Measuring Agreement on Set-Valued Items) and at the CONSORT item level using Krippendorff's α. We experimented with two rule-based methods (phrase-based and section header-based) and two supervised learning approaches (support vector machine and BioBERT-based neural network classifiers), for recognizing 17 methodology-related items in the RCT Methods sections. RESULTS: We created CONSORT-TM consisting of 10,709 sentences, 4,845 (45%) of which were annotated with 5,246 labels. A median of 28 CONSORT items (out of possible 37) were annotated per article. Agreement was moderate at the article and section levels (average MASI: 0.60 and 0.64, respectively). Agreement varied considerably among individual checklist items (Krippendorff's α= 0.06-0.96). The model based on BioBERT performed best overall for recognizing methodology-related items (micro-precision: 0.82, micro-recall: 0.63, micro-F1: 0.71). Combining models using majority vote and label aggregation further improved precision and recall, respectively. CONCLUSION: Our annotated corpus, CONSORT-TM, contains more fine-grained information than earlier RCT corpora. Low frequency of some CONSORT items made it difficult to train effective text mining models to recognize them. For the items commonly reported, CONSORT-TM can serve as a testbed for text mining methods that assess RCT transparency, rigor, and reliability, and support methods for peer review and authoring assistance. Minor modifications to the annotation scheme and a larger corpus could facilitate improved text mining models. CONSORT-TM is publicly available at https://github.com/kilicogluh/CONSORT-TM.

Confirm or refute?: A comparative study on citation sentiment classification in clinical research publications.

Quantifying scientific impact of researchers and journals relies largely on citation counts, despite the acknowledged limitations of this approach. The need for more suitable alternatives has prompted research into developing advanced metrics, such as h-index and Relative Citation Ratio (RCR), as well as better citation categorization schemes to capture the various functions that citations serve in a publication. One such scheme involves citation sentiment: whether a reference paper is cited positively (agreement with the findings of the reference paper), negatively (disagreement), or neutrally. The ability to classify citation function in this manner can be viewed as a first step toward a more fine-grained bibliometrics. In this study, we compared several approaches, varying in complexity, for classification of citation sentiment in clinical trial publications. Using a corpus of 285 discussion sections from as many publications (a total of 4,182 citations), we developed a rule-based method as well as supervised machine learning models based on support vector machines (SVM) and two variants of deep neural networks; namely, convolutional neural network (CNN) and bidirectional long short-term memory (BiLSTM). A CNN model augmented with hand-crafted features yielded the best performance (0.882 accuracy and 0.721 macro-F1 on held-out set). Our results show that baseline performances of traditional supervised learning algorithms and deep neural network architectures are similar and that hand-crafted features based on sentiment dictionaries and rhetorical structure allow neural network approaches to outperform traditional machine learning approaches for this task. We make the rule-based method and the best-performing neural network model publicly available at: https://github.com/kilicogluh/clinical-citation-sentiment.