Clinical data quality problems and countermeasure for real world study

Zhang, Runshun; Wang, Yinghui; Liu, Baoyan; Song, Guanyu; Zhou, Xuezhong; Fan, Shizhen; Pan, Xishui

doi:10.1007/s11684-014-0351-1

Cited by 12 publications

(8 citation statements)

References 5 publications

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“…“Big data” have emerged as a cutting-edge discipline that uses capture of data from EHRs and other high-volume data sources to efficiently generate hypotheses about the relationship between processes and outcomes. This demands an increased emphasis on the integrity of the data, with “high-quality” data defined in terms of their accuracy, availability and usability, integrity, consistency, standardization, generalizability, and timeliness [ 59 , 60 ]. Missing data may represent a significant challenge in some datasets.…”

Section: Improving Quality Of Evidence Generated From Real-world Studmentioning

confidence: 99%

Interpretation and Impact of Real-World Clinical Data for the Practicing Clinician

et al. 2018

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Real-world studies have become increasingly important in providing evidence of treatment effectiveness in clinical practice. While randomized clinical trials (RCTs) are the “gold standard” for evaluating the safety and efficacy of new therapeutic agents, necessarily strict inclusion and exclusion criteria mean that trial populations are often not representative of the patient populations encountered in clinical practice. Real-world studies may use information from electronic health and claims databases, which provide large datasets from diverse patient populations, and/or may be observational, collecting prospective or retrospective data over a long period of time. They can therefore provide information on the long-term safety, particularly pertaining to rare events, and effectiveness of drugs in large heterogeneous populations, as well as information on utilization patterns and health and economic outcomes. This review focuses on how evidence from real-world studies can be utilized to complement data from RCTs to gain a more complete picture of the advantages and disadvantages of medications as they are used in practice.Funding: Sanofi US, Inc.

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Section: Improving Quality Of Evidence Generated From Real-world Studmentioning

confidence: 99%

Interpretation and Impact of Real-World Clinical Data for the Practicing Clinician

et al. 2018

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“…Although TCM is widely used in the treatment of bronchiectasis in China, a system of syndrome differentiation using evidence-based medicine has not been established (16). Since syndrome diagnosis is key to TCM therapy, there is an urgent need for TCM researchers to perform more epidemiological studies of high methodological quality on syndrome distribution in bronchiectasis patients.…”

Section: Discussionmentioning

confidence: 99%

“…Real-world studies (RWS), in which data are collected in real-life practical circumstances, have become hotspots for clinical research (14), (15). Clinical data collected in the hospital, at home or abroad, are more accessible due to the development of information technology and wide use of hospital information systems (HIS) and electronic medical records (EMRs) (16). It is crucial to perform RWS on TCM syndromes, using large clinical datasets with modern data-mining and machine-learning techniques, to produce a scienti c and reliable evidence base for TCM, thereby transforming TCM from experience-based medicine to evidencebased medicine (16), (17).With this in mind, the present study attempted to investigate common distribution patterns and core elements of TCM syndromes in patients with bronchiectasis by searching real-world medical records for evidence of TCM treatment in patients with bronchiectasis.…”

Section: Introductionmentioning

confidence: 99%

A Real-World Data Analysis of The Distribution of Traditional Chinese Medicine Syndromes and Their Elements Among Bronchiectasis Patients

Kong

et al. 2020

Preprint

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Introduction: We sought to investigate the distribution of traditional Chinese medicine (TCM) syndromes and their elements among bronchiectasis patients using real-world data. Methods: A real-world study was performed to explore the relationship between TCM syndrome and bronchiectasis using electronic medical information from 1,113 patients in China. Factor analyses were used to reduce the dimensions of TCM syndrome elements and to detect common factors. Additionally, cluster analyses were employed to assess combinations of TCM syndrome elements. Finally, association rule analyses were performed to investigate the structures of TCM syndrome elements in order to estimate the patterns of TCM syndromes.Results: A total of 17 TCM syndrome elements were extracted using this method. There were four Shi TCM syndromes of Tan_Re_Yong_Fei (36.39%), Tan_Zhuo_Zu_Fei (12.94%), Gan_Huo_Fan_Fei (11.59%), and Feng_Re_Fan_Fei (11.32%) with >5.0% distribution frequency in total sample. The highest Xu TCM syndrome was Fei_Yin_Xu (18.24%). Factor analysis, cluster analysis, and association rule analysis found that Tan, Huo, Feng, Yin_Xu, Fei, and Gan were the core TCM syndrome elements.Conclusion: In this study, TCM Shi syndromes of Tan_Re_Yong_Fei, Tan_Zhuo_Zu_Fei, Gan_Huo_Fan_Fei, and Feng_Re_Fan_Fei were detected with a high frequency among bronchiectasis patients using real-world data, as was the TCM core Xu syndrome of Fei_Yin_Xu. The core elements of Huo, Tan, Feng, Yin_Xu, Fei and Gan were found across the entire sample.

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“…Future research, with a larger numbers of participants, is required to substantiate exploratory results and to establish the role of Chinese medicine as a standalone medical option or as a post-surgical adjunct for treatment of endometriosis. Real world studies (RWS) have become a significant hotspot for clinical research [ 192 , 193 ]. Big data in real-world clinical research could be used in the complementary alternative medical treatment of endometriosis to obtain more clinical evidence, which is more in line with the research needs of chronic disease.…”

Section: Discussionmentioning

confidence: 99%

Anti‐Angiogenic Alternative and Complementary Medicines for the Treatment of Endometriosis: A Review of Potential Molecular Mechanisms

Zheng

Cao²,

et al. 2018

Evidence-Based Complementary and Alternative Medicine

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Endometriosis is caused by the growth or infiltration of endometrial tissues outside of the endometrium and myometrium. Symptoms include pain and infertility. Surgery and hormonal therapy are widely used in Western medicine for the treatment of endometriosis; however, the side effects associated with this practice include disease recurrence and menopause, which can severely influence quality of life. Angiogenesis is the main biological mechanism underlying the development of endometriosis. Numerous natural products and Chinese medicines with potent anti-angiogenic effects have been investigated, and the molecular basis underlying their therapeutic effects in endometriosis has been explored. This review aims to describe natural products and compounds that suppress angiogenesis associated with endometriosis and to assess their diverse molecular mechanisms of action. Furthermore, this review provides a source of information relating to alternative and complementary therapeutic products that mediate anti-angiogenesis. An extensive review of the literature and electronic databases, such as the China National Knowledge Infrastructure, PubMed, and Embase, was conducted using the keywords ‘endometriosis,' ‘traditional Chinese medicine,' ‘Chinese herbal medicine,' ‘natural compounds,' and ‘anti-angiogenic' therapy. Anti-angiogenic therapy is an emerging strategy for the treatment of endometriosis. Natural anti-angiogenic products and Chinese medicines provide several beneficial clinical effects, including pain relief. In this review, we summarize clinical trials and experimental studies of endometriosis using natural products and Chinese medicines. In particular, we focus on anti-angiogenic products and alternative and complementary medicines for the treatment of endometriosis and additionally examine their therapeutic efficacy and mechanisms of action. Anti-angiogenic natural products and/or compounds provide a new approach for the treatment of endometriosis. Future work will require randomized trials with larger numbers of subjects, as well as long-term follow-up to confirm the findings described here.

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Clinical data quality problems and countermeasure for real world study

Cited by 12 publications

References 5 publications

Interpretation and Impact of Real-World Clinical Data for the Practicing Clinician

Interpretation and Impact of Real-World Clinical Data for the Practicing Clinician

A Real-World Data Analysis of The Distribution of Traditional Chinese Medicine Syndromes and Their Elements Among Bronchiectasis Patients

Anti‐Angiogenic Alternative and Complementary Medicines for the Treatment of Endometriosis: A Review of Potential Molecular Mechanisms

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