BackgroundAlthough several reports have suggested that patient-generated data from Internet sources could be used to improve drug safety and pharmacovigilance, few studies have identified such data sources in Japan. We introduce a unique Japanese data source: tōbyōki, which translates literally as “an account of a struggle with disease.”ObjectiveThe objective of this study was to evaluate the basic characteristics of the TOBYO database, a collection of tōbyōki blogs on the Internet, and discuss potential applications for pharmacovigilance.MethodsWe analyzed the overall gender and age distribution of the patient-generated TOBYO database and compared this with other external databases generated by health care professionals. For detailed analysis, we prepared separate datasets for blogs written by patients with depression and blogs written by patients with rheumatoid arthritis (RA), because these conditions were expected to entail subjective patient symptoms such as discomfort, insomnia, and pain. Frequently appearing medical terms were counted, and their variations were compared with those in an external adverse drug reaction (ADR) reporting database. Frequently appearing words regarding patients with depression and patients with RA were visualized using word clouds and word cooccurrence networks.ResultsAs of June 4, 2016, the TOBYO database comprised 54,010 blogs representing 1405 disorders. Overall, more entries were written by female bloggers (68.8%) than by male bloggers (30.8%). The most frequently observed disorders were breast cancer (4983 blogs), depression (3556), infertility (2430), RA (1118), and panic disorder (1090). Comparison of medical terms observed in tōbyōki blogs with those in an external ADR reporting database showed that subjective and symptomatic events and general terms tended to be frequently observed in tōbyōki blogs (eg, anxiety, headache, and pain), whereas events using more technical medical terms (eg, syndrome and abnormal laboratory test result) tended to be observed frequently in the ADR database. We also confirmed the feasibility of using visualization techniques to obtain insights from unstructured text-based tōbyōki blog data. Word clouds described the characteristics of each disorder, such as “sleeping” and “anxiety” in depression and “pain” and “painful” in RA.ConclusionsPharmacovigilance should maintain a strong focus on patients’ actual experiences, concerns, and outcomes, and this approach can be expected to uncover hidden adverse event signals earlier and to help us understand adverse events in a patient-centered way. Patient-generated tōbyōki blogs in the TOBYO database showed unique characteristics that were different from the data in existing sources generated by health care professionals. Analysis of tōbyōki blogs would add value to the assessment of disorders with a high prevalence in women, psychiatric disorders in which subjective symptoms have important clinical meaning, refractory disorders, and other chronic disorders.
Objective: To search for signs and symptoms before serious infection (SI) occurs in tocilizumab (TCZ)-treated rheumatoid arthritis (RA) patients. Methods: Individual case safety reports, including structured (age, sex, adverse event [AE]) and unstructured (clinical narratives) data, were analyzed by automated text mining from a Japanese post-marketing AE-reporting database (16 April 2008-10 April 2015) assuming the following: treated in Japan; TCZ RA treatment; 1 SI; unable to exclude causality between TCZ and SIs. Results: The database included 7653 RA patients; 1221 reports met four criteria, encompassing 1591 SIs. Frequent SIs were pneumonia (15.9%), cellulitis (9.9%), and sepsis (5.0%). Reports for 782 patients included SI onset date; 60.7% of patients had signs/symptoms 28 days before SI diagnosis, 32.7% had signs/symptoms with date unidentified, 1.7% were asymptomatic, and 4.9% had unknown signs/ symptoms. The most frequent signs/symptoms were for skin (swelling and pain) and respiratory (cough and pyrexia) infections. Among 68 patients who had normal laboratory results for C-reactive protein, body temperature, and white blood cell count, 94.1% had signs or symptoms of infection. Conclusion: This study identified prodromal signs and symptoms of SIs in RA patients receiving TCZ. Data mining clinical narratives from post-marketing AE databases may be beneficial in characterizing SIs. ARTICLE HISTORY
Background Gaining insights that cannot be obtained from health care databases from patients has become an important topic in pharmacovigilance. Objective Our objective was to demonstrate a use case, in which patient-generated data were incorporated in pharmacovigilance, to understand the epidemiology and burden of illness in Japanese patients with systemic lupus erythematosus. Methods We used data on systemic lupus erythematosus, an autoimmune disease that substantially impairs quality of life, from 2 independent data sets. To understand the disease’s epidemiology, we analyzed a Japanese health insurance claims database. To understand the disease’s burden, we analyzed text data collected from Japanese disease blogs (tōbyōki) written by patients with systemic lupus erythematosus. Natural language processing was applied to these texts to identify frequent patient-level complaints, and term frequency–inverse document frequency was used to explore patient burden during treatment. We explored health-related quality of life based on patient descriptions. Results We analyzed data from 4694 and 635 patients with systemic lupus erythematosus in the health insurance claims database and tōbyōki blogs, respectively. Based on health insurance claims data, the prevalence of systemic lupus erythematosus is 107.70 per 100,000 persons. Tōbyōki text data analysis showed that pain-related words (eg, pain, severe pain, arthralgia) became more important after starting treatment. We also found an increase in patients’ references to mobility and self-care over time, which indicated increased attention to physical disability due to disease progression. Conclusions A classical medical database represents only a part of a patient's entire treatment experience, and analysis using solely such a database cannot represent patient-level symptoms or patient concerns about treatments. This study showed that analysis of tōbyōki blogs can provide added information on patient-level details, advancing patient-centric pharmacovigilance.
BACKGROUND Gaining insights that cannot be obtained from health care databases from patients has become an important topic in pharmacovigilance. OBJECTIVE Our objective was to demonstrate a use case, in which patient-generated data were incorporated in pharmacovigilance, to understand the epidemiology and burden of illness in Japanese patients with systemic lupus erythematosus. METHODS We used data on systemic lupus erythematosus, an autoimmune disease that substantially impairs quality of life, from 2 independent data sets. To understand the disease’s epidemiology, we analyzed a Japanese health insurance claims database. To understand the disease’s burden, we analyzed text data collected from Japanese disease blogs (tōbyōki) written by patients with systemic lupus erythematosus. Natural language processing was applied to these texts to identify frequent patient-level complaints, and term frequency–inverse document frequency was used to explore patient burden during treatment. We explored health-related quality of life based on patient descriptions. RESULTS We analyzed data from 4694 and 635 patients with systemic lupus erythematosus in the health insurance claims database and tōbyōki blogs, respectively. Based on health insurance claims data, the prevalence of systemic lupus erythematosus is 107.70 per 100,000 persons. Tōbyōki text data analysis showed that pain-related words (eg, pain, severe pain, arthralgia) became more important after starting treatment. We also found an increase in patients’ references to mobility and self-care over time, which indicated increased attention to physical disability due to disease progression. CONCLUSIONS A classical medical database represents only a part of a patient's entire treatment experience, and analysis using solely such a database cannot represent patient-level symptoms or patient concerns about treatments. This study showed that analysis of tōbyōki blogs can provide added information on patient-level details, advancing patient-centric pharmacovigilance.
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