Overview of Current Herb-Drug Interaction Databases.

An HERB-Drug Interaction (HDI) database is a structured data collection method for HDI information extracted from scattered literatures for quick retrieval. Our review summarized the ten currently available HDI databases, including those databases comprising HDI on the market. A detailed comparison on the scope of monographs, including the nature of content extracted from the original literature and user interfaces of these databases, was performed, and the number of references of fifty popular herbs in each HDI database was counted and presented in a heatmap to give users an intuitive understanding of the focuses of different HDI databases. Since it is well known that the development and maintenance of databases need continuous investment of capital and manpower, the sustainability of these databases was also reviewed and compared. Recently, artificial intelligence (AI) technologies, especially Natural Language Processing (NLP), have been applied to screen specific topics from massive articles and automatically identify the names of drugs and herbs in the literature. However, its application on the labor-intensive extraction and evaluation of HDI-related experimental conditions and results from literature remains limited due to the scarcity of these HDI data and the lack of well-established annotated datasets for these specific NLP recognition tasks. In view of the difficulties faced by current HDI databases and potential expansion of AI application in HDI database development, we propose a standardized format for data reporting and use of Concept Unique Identifier (CUI) for medical terms in the literature to accelerate the structured data collection. SIGNIFICANCE STATEMENT: The worldwide popularity of botanical and/or traditional medicine products has raised safety concerns due to potential HDI. However, the publicly available HDI databases are mostly outdated or incomplete. Through our review of the currently available HDI databases, a clear understanding of the key issues could be obtained and possible solutions to overcome the labour-intensive extraction as well as professional evaluation of information in HDI database development are proposed.

Predication of the underlying mechanism of Bushenhuoxue formula acting on knee osteoarthritis via network pharmacology-based analyses combined with experimental validation.

ETHNOPHARMACOLOGICAL RELEVANCE: Knee osteoarthritis (KOA) is the most common chronic joint disorder worldwide, which is also a principle consideration for disability. The Bushenhuoxue formula (BSHXF) is a traditional herbal formula which widely applied to the treatment of KOA. However, its pharmacological mechanisms of action have not been clarified. AIMS OF THE STUDY: The study aimed to identify the potential targets and mechanisms of BSHXF in the treatment of KOA through pharmacology-based analyses and experimental validation. MATERIALS AND METHODS: The TCMSP database was applied to obtain the chemical compounds and targets of BSHXF, while the protein targets in KOA were determined through GeneCards and OMIM databases. The herb-compound-target and protein-protein interaction (PPI) networks were constructed for topological analyses and hub-targets screening. GO and KEGG enrichment analyses were performed on these core nodes to identify the critical biological processes and signaling pathways. Then destabilization of medial meniscus (DMM)-induced C57BL/6J mice model was established to detect the level of apoptosis via TUNEL assessment, while the expressions of CASP3, CASP8 and CASP9 were determined by immunohistochemistry. RESULTS: A total of 154 active compounds and 58 targets were predicted. DAVID, ClueGO and Metascape enrichment analyses all proved that BSHXF plays an essential role in regulating apoptosis. Moreover, 3 central nodes of BSHXF are recognized as the active factors involved in the main biological functions, suggesting a potential mechanism of BSHXF for KOA treatment. In vivo experiment revealed that BSHXF significantly inhibited apoptosis and down-regulated the expressions of CASP3, CASP8 and CASP9. CONCLUSION: Based on network pharmacology and experimental validation, our study indicated that BSHXF exerted anti-apoptosis effect through inhibiting the expressions of CASP3, CASP8 and CASP9, which could be considered as an effective method for KOA treatment.

Reporting quality of Cochrane systematic reviews with Chinese herbal medicines.

BACKGROUND: Chinese herbal medicines (CHMs) are the major interventions of traditional Chinese medicine (TCM), which are typically administered as either single herbs or formulas. The Cochrane systematic reviews (SRs) of CHMs are essential references for evaluating the efficacy and safety of CHMs interventions; they are expected to be accurate and reliable. This study aimed to assess the reporting quality of these SRs, particularly whether necessary information related to CHM was adequately reported. METHODS: The Cochrane Database was systematically searched for all SRs of CHM that were published up to 31 December 2017. The primary analysis was to assess their reporting quality based on 27-item of the Preferred Reporting Items for Systematic reviews and Meta-Analyses (PRISMA) and 9-item of CHM-related information designed according to TCM theory. Descriptive statistics were additionally used to analyze their baseline characteristics. RESULTS: A total of 109 Cochrane SRs of CHM were identified from 1999 to 2017. For 27-item of PRISMA, 26 had the reporting compliances higher than 50%, of which 11 were fully reporting (100%). However, for CHM-related information, 65 (59.6%) SRs did not report the specific name of the CHM in the title, 42 (38.5%) lacked TCM-related rationales in the introduction, 62 (56.9%) did not include CHM-related characteristics in the additional analyses, and 77 (70.6%) did not analyze CHM results in terms of TCM-related theories in the discussion. Of 97 SRs that included clinical trials, 38 (39.2%) did not provide the details of composition and dosage of CHMs, 85 (87.6%) did not report the CHM sources, 13 (13.4%) did not provide the dosage form, 95 (97.9%) lacked CHM quality control information, and 57 (58.8%) did not describe details of the controls. For 62 (72.9%) of 85 SRs that included meta-analysis, it was impossible to assess whether meta-analysis had been properly conducted due to inadequate reporting of CHM interventions. CONCLUSION: Although the Cochrane SRs of CHM showed reporting compliance with PRISMA checklist, their reporting quality needs improvement, especially about full reporting of CHM interventions and of TCM-related rationales. Reporting guideline of "PRISMA extension for CHM interventions" should be developed thus to improve their quality.

ETM-DB: integrated Ethiopian traditional herbal medicine and phytochemicals database.

BACKGROUND: Recently, there has been an increasing tendency to go back to nature in search of new medicines. To facilitate this, a great deal of effort has been made to compile information on natural products worldwide, and as a result, many ethnic-based traditional medicine databases have been developed. In Ethiopia, there are more than 80 ethnic groups, each having their indigenous knowledge on the use of traditional medicine. About 80% of the population uses traditional medicine for primary health care. Despite this, there is no structured online database for Ethiopian traditional medicine, which limits natural products based drug discovery researches using natural products from this country. DESCRIPTION: To develop ETM-DB, online research articles, theses, books, and public databases containing Ethiopian herbal medicine and phytochemicals information were searched. These resources were thoroughly inspected and the necessary data were extracted. Then, we developed a comprehensive online relational database which contains information on 1054 Ethiopian medicinal herbs with 1465 traditional therapeutic uses, 573 multi-herb prescriptions, 4285 compounds, 11,621 human target gene/proteins, covering 5779 herb-phenotype, 1879 prescription-herb, 16,426 herb-compound, 105,202 compound-phenotype, 162,632 compound-gene/protein, and 16,584 phenotype-gene/protein relationships. Using various cheminformatics tools, we obtained predicted physicochemical and absorption, distribution, metabolism, excretion, and toxicity (ADMET) properties of ETM-DB compounds. We also evaluated drug-likeness properties of these compounds using FAF-Drugs4 webserver. From the 4285 compounds, 4080 of them passed the FAF-Drugs4 input data curation stage, of which 876 were found to have acceptable drug-likeness properties. CONCLUSION: ETM-DB is the largest, freely accessible, web-based integrated resource on Ethiopian traditional medicine. It provides traditional herbal medicine entities and their relationships in well-structured forms including reference to the sources. The ETM-DB website interface allows users to search the entities using various options provided by the search menu. We hope that our database will expedite drug discovery and development researches from Ethiopian natural products as it contains information on the chemical composition and related human target gene/proteins. The current version of ETM-DB is openly accessible at http://biosoft.kaist.ac.kr/etm .

Completeness of ANZACS-QI Cardiac Implanted DEVICE Registry and agreement with national datasets: ANZACS-QI 30.

AIMS: The ANZACS-QI Cardiac Implanted Device Registry (ANZACS-QI DEVICE) collects data on cardiac implantable electronic devices inserted in New Zealand. We evaluated completeness of data capture and quality of ANZACS-QI DEVICE in 2016. METHODS: Complete datasets within ANZACS-QI DEVICE, comprising DEVICE-PPM (permanent pacemakers) and DEVICE-ICD (implantable cardioverter defibrillators), from 1 January 2016 to 31 December 2016 were linked with the National Hospitalisation dataset (all New Zealand public hospital admissions). The total number of implants included procedures captured in either dataset. Variables assessed included age, gender, ethnicity, procedure type, implanting centre, admission and procedure date. RESULTS: DEVICE-PPM captured 85.9% of all PPM procedures (n=2,512). This was similar regardless of age, sex and ethnicity. In the 84.4% of procedures captured in both datasets, agreement was >97% for all variables except admission date (90.1%). DEVICE-ICD captured 81.3% of all ICD procedures (n=690). Capture was similar across age, sex and ethnicity groups. In the 76.8% of procedures captured in both datasets, agreement was >96% for all variables except admission date (90.6%). CONCLUSION: The ANZACS-QI DEVICE registry had a good capture rate and excellent agreement with the national dataset. This high concordance supports the use of both datasets for future research.

Evaluation of the HealthImpact Diabetes Risk Model in the Veterans Health Administration.

BACKGROUND: HealthImpact is a novel algorithm using administrative health care data to stratify patients according to risk for incident diabetes. OBJECTIVES: To (a) independently assess the predictive validity of HealthImpact and (b) explore its utility in diabetes screening within a nationally integrated health care system. METHODS: National Veterans Health Administration data were used to create 2 cohorts. The replication cohort included patients without diagnosed diabetes as of October 1, 2012, to determine if HealthImpact scores were significantly associated with diabetes (type 1 or 2) incidence within the subsequent 3 years. The utility cohort included patients without diagnosed diabetes as of August 1, 2015, and assessed diabetes screening rates in the 2 years surrounding this index date, stratified by HealthImpact scores. RESULTS: The 3-year incidence of diabetes in the replication cohort (n = 3,287,240) was 9.1%. Of 100,617 (3.1%) patients with HealthImpact scores > 90, 30,028 developed diabetes, yielding a positive predictive value of 29.8%. These patients accounted for 9.9% of all incident diabetes cases (sensitivity). Sensitivity and negative predictive value improved with descending HealthImpact threshold scores (e.g., > 75, > 50), whereas specificity and positive predictive value declined. Of 3,499,406 patients in the utility cohort, 85.3% received either a blood glucose or hemoglobin A1c test during the 2-year observation period. Among 101,355 patients with a HealthImpact score > 90, nearly all (98.3%) were screened, and 86.3% had an A1c test. CONCLUSIONS: Our independent analysis corroborates the validity of HealthImpact in stratifying patients according to diabetes risk. However, its practical utility to enhance diabetes screening in a real-world clinical environment will be strongly dependent on the pattern and frequency of existing screening practices. DISCLOSURES: This work was supported by the Iowa City VA Health Care System and by the Department of Veterans Affairs, Office of Research and Development, Health Services Research and Development Service (Lund, CIN 13-412). The authors have no conflicts of interest. The views expressed in this article are those of the authors and do not necessarily reflect the position or policy of the Department of Veterans Affairs or the U.S. government.

Affective auditory stimulus database: An expanded version of the International Affective Digitized Sounds (IADS-E).

Using appropriate stimuli to evoke emotions is especially important for researching emotion. Psychologists have provided several standardized affective stimulus databases-such as the International Affective Picture System (IAPS) and the Nencki Affective Picture System (NAPS) as visual stimulus databases, as well as the International Affective Digitized Sounds (IADS) and the Montreal Affective Voices as auditory stimulus databases for emotional experiments. However, considering the limitations of the existing auditory stimulus database studies, research using auditory stimuli is relatively limited compared with the studies using visual stimuli. First, the number of sample sounds is limited, making it difficult to equate across emotional conditions and semantic categories. Second, some artificially created materials (music or human voice) may fail to accurately drive the intended emotional processes. Our principal aim was to expand existing auditory affective sample database to sufficiently cover natural sounds. We asked 207 participants to rate 935 sounds (including the sounds from the IADS-2) using the Self-Assessment Manikin (SAM) and three basic-emotion rating scales. The results showed that emotions in sounds can be distinguished on the affective rating scales, and the stability of the evaluations of sounds revealed that we have successfully provided a larger corpus of natural, emotionally evocative auditory stimuli, covering a wide range of semantic categories. Our expanded, standardized sound sample database may promote a wide range of research in auditory systems and the possible interactions with other sensory modalities, encouraging direct reliable comparisons of outcomes from different researchers in the field of psychology.

Public Regulatory Databases as a Source of Insight for Neuromodulation Devices Stimulation Parameters.

OBJECTIVE: The Shannon model is often used to define an expected boundary between non-damaging and damaging modes of electrical neurostimulation. Numerous preclinical studies have been performed by manufacturers of neuromodulation devices using different animal models and a broad range of stimulation parameters while developing devices for clinical use. These studies are mostly absent from peer-reviewed literature, which may lead to this information being overlooked by the scientific community. We aimed to locate summaries of these studies accessible via public regulatory databases and to add them to a body of knowledge available to a broad scientific community. METHODS: We employed web search terms describing device type, intended use, neural target, therapeutic application, company name, and submission number to identify summaries for premarket approval (PMA) devices and 510(k) devices. We filtered these records to a subset of entries that have sufficient technical information relevant to safety of neurostimulation. RESULTS: We identified 13 product codes for 8 types of neuromodulation devices. These led us to devices that have 22 PMAs and 154 510(k)s and six transcripts of public panel meetings. We found one PMA for a brain, peripheral nerve, and spinal cord stimulator and five 510(k) spinal cord stimulators with enough information to plot in Shannon coordinates of charge and charge density per phase. CONCLUSIONS: Analysis of relevant entries from public regulatory databases reveals use of pig, sheep, monkey, dog, and goat animal models with deep brain, peripheral nerve, muscle and spinal cord electrode placement with a variety of stimulation durations (hours to years); frequencies (10-10,000 Hz) and magnitudes (Shannon k from below zero to 4.47). Data from located entries indicate that a feline cortical model that employs acute stimulation might have limitations for assessing tissue damage in diverse anatomical locations, particularly for peripheral nerve and spinal cord simulation.

Development and implementation of a psychotherapy tracking database in primary care.

INTRODUCTION: Although there is a rapid increase in the integration of behavioral health services in primary care, few studies have evaluated the effectiveness of these services in real-world clinical settings, in part due to the difficulty of translating traditional mental health research designs to this setting. Accordingly, innovative approaches are needed to fit the unique challenges of conducting research in primary care. The development and implementation of one such approach is described in this article. METHOD: A continuously populating database for psychotherapy services was implemented across 5 primary care clinics in a large health system to assess several levels of patient care, including service utilization, symptomatic outcomes, and session-by-session use of psychotherapy principles by providers. RESULTS: Each phase of implementation revealed challenges, including clinician time, dissemination to clinics with different resources, and fidelity of data collection strategy across providers, as well as benefits, including the generation of useful data to inform clinical care, program development, and empirical research. DISCUSSION: The feasible and sustainable implementation of data collection for routine clinical practice in primary care has the potential to fuel the evidence base around integrated care. The current project describes the development of an innovative approach that, with further empirical study and refinement, could enable health care professionals and systems to understand their population and clinical process in a way that addresses essential gaps in the integrated care literature. (PsycINFO Database Record

North American Population-Based Validation of the National Comprehensive Cancer Network Practice Guideline Recommendation of Pelvic Lymphadenectomy in Contemporary Prostate Cancer.

BACKGROUND: National Comprehensive Cancer Network (NCCN) guidelines recommend a pelvic lymph node dissection (PLND) in prostate cancer (PCa) patients treated with radical prostatectomy (RP) if a nomogram predicted risk of lymph node invasion (LNI) is ≥2%. We examined this and other thresholds, including nomogram validation. METHODS: We examined records of 26,713 patients treated with RP and PLND between 2010 and 2013, within the Surveillance, Epidemiology, and End Results database. Nomogram thresholds of 2-5% were tested and external validation was performed. RESULTS: LNI was recorded in 4.7% of patients. Nomogram accuracy was 80.4% and maintained minimum accuracy of 75.6% in subgroup analyses, according to age, race, and nodal yield >10. With the NCCN recommended 2% nomogram threshold, PLND could be avoided in 22.3% of patients at the expense of missing 3.0% of individuals with LNI. Alternative thresholds of 3%, 4%, and 5% yielded respective PLND avoidance rates of 60.4%, 71.0%, and 79.8% at the expense of missing 17.8%, 27.2%, and 36.6% of patients with LNI. NCCN cut-off recommendation was best satisfied with a threshold of <2.6%, at which PLND could be avoided in 13,234 patients (49.5%) versus missing 141 patients with LNI (11.2%). CONCLUSION: NCCN LNI nomogram remains accurate in contemporary patients. However, the 2% threshold appears to be too strict, since only 22.3% of PLNDs can be avoided, instead of the stipulated 47.7%. The optimal 2.6% threshold allows a higher rate of PLND avoidance (49.5%), at the cost of 11.2% missed instances of LNI, as recommended by NCCN guidelines. PATIENT SUMMARY. External validation in contemporary SEER prostate cancer patients showed that the NCCN nomogram remains accurate for predicting lymph node invasion and seems to be optimal at an alternative 2.6% threshold, with best ratio of avoided pelvic lymph node dissections (49.5%) and missed LNIs (11.2%), as recommended by NCCN guideline. Prostate 77:542-548, 2017. © 2017 Wiley Periodicals, Inc.

Towards a Holistic Biomedical Information Platform for Primary and Secondary Use Settings.

BACKGROUND: Clinical information is often used for biomedical research. Data warehouses can help providing researchers with data and the opportunity to find eligible participants for clinical trials. OBJECTIVES: To define an information platform for healthcare and biomedical research based on requirements by clinicians and researchers. METHODS: Interviews with clinicians, researchers, data privacy officers, IT and hospital administration combined with a questionnaire sent to 60 medical departments at our hospital were conducted. RESULTS: Resulting requirements were grouped and a platform architecture was designed based on the requirements. CONCLUSION: Requirements lead to a single platform supporting both, patient care and biomedical research.

Culinary Spice Plants in Dietary Supplement Products and Tested in Clinical Trials.

Dried plant parts used as culinary spices (CSs) in food are permitted as dietary ingredients in dietary supplements (DSs) within certain constraints in the United States. We reviewed the amounts, forms, and nutritional support (structure/function) claims of DSs that contain CS plants listed in the Dietary Supplement Label Database (DSLD) and compared this label information with trial doses and health endpoints for CS plants that were the subject of clinical trials listed in clinicaltrials.gov. According to the DSLD, the CS plants occurring most frequently in DSs were cayenne, cinnamon, garlic, ginger, pepper, rosemary, and turmeric. Identifying the botanical species, categorizing the forms used, and determining the amounts from the information provided on DS labels was challenging. CS plants were typically added as a component of a blend, as the powered biomass, dried extracts, and isolated phytochemicals. The amounts added were declared on about 55% of the labels, rendering it difficult to determine the amount of the CS plant used in many DSs. Clinicaltrials.gov provided little information about the composition of test articles in the intervention studies. When plant names were listed on DS labels and in clinical trials, generally the common name and not the Latin binomial name was given. In order to arrive at exposure estimates and enable researchers to reproduce clinical trials, the Latin binomial name, form, and amount of the CS plant used in DSs and tested in clinical trials must be specified.

The quality of evidence in Chinese meta-analyses needs to be improved.

OBJECTIVES: We conducted a systematic review using GRADE (Grading of Recommendations Assessment, Development and Evaluation) system to assess the quality of evidence of Chinese meta-analyses (MAs). DESIGN/SETTING: A systematic review of MAs listed in Chinese Biomedicine Literature Database from January 2010 to December 2012. METHODS: Mesh term "meta-analysis" was used to search the Chinese Biomedicine Literature Database from January 2010 to December 2012. Characteristics and main outcomes of each included MA were extracted, and the GRADE system was used to assess the quality of evidence for each outcome. A 10% random sample of Cochrane MAs between 2010 and 2012 was also assessed as control group. RESULTS: A total of 564 Chinese MAs (including 1,237 main outcomes) and 95 Cochrane MAs (including 251 main outcomes) were identified. Almost half (600, 48.5%) of the outcomes in Chinese MAs were rated as low, and the proportion of outcomes with high or moderate quality of evidence was lower in Chinese MAs than Cochrane MAs (Chinese, 406 [32.8%] vs. Cochrane MAs, 155 [61.8%], P < 0.001). Of the outcomes in Chinese MAs, 1,012 (81.8%) were downgraded for risk of bias. Other common factors for downgrading were imprecision (448, 36.2%), publication bias (418, 33.8%), inconsistency (351, 28.4%), and indirectness (1, 0.1%). CONCLUSIONS: Chinese MAs were of low quality of evidence. Risk of bias, inconsistency, and publication bias were the three most common downgrade factors in Chinese MAs. Efforts must be made to improve quality of evidence of Chinese MAs, and a call for more rigorous training of investigators in China is warranted.

[Comprehensive evaluation of drug interaction screening programs: discrepancies and concordances]. / Gyógyszerkölcsönhatások kiszurésére szolgáló adatbázisok értékelése: ellentmondások és egyezoségek.

INTRODUCTION: Recognition of potentially harmful drug interactions is one of the duties of healthcare. However, solutions involving databases are fraught with contradictions due to the lack of standardized principles and data. AIM: The aims of the authors were to perform a comparative evaluation of Hungarian and international databases and to explore ambiguities and contradictions in order to develop more standardized criteria for screening interactions. METHOD: Four Hungarian and two English-language websites and software, and the summaries of product characteristics were compared. The authors analyzed 40 drug-drug and 8 drug-supplement interactions and looked at 8 cases, which represent 28 pairs of interacting substances. RESULTS: The databases warn about most interactions, but these warnings were rarely helpful in preventing undesired consequences. The authors found discrepancies between the databases in 70% of interactions. When looking at different products with the same active ingredients, discrepancies cropped up in 0-66.7% of the cases. Up to 80% of searches for supplementary product interactions did not produce satisfactory results. CONCLUSIONS: In the present situation mapping these ambiguities and creating a standardized classification system would be advantageous.

Pesticide residues in essential oils: evaluation of a database.

In the context of a revision of the European Pharmacopoeia (Ph. Eur.) general monograph Essential oils (2098), the need to include a test for pesticides is being discussed. According to published literature, some oils, mainly those produced by cold pressing (e.g. citrus oils), can contain relevant amounts of pesticide residues, whereas distilled oils showed positive findings in only a few cases. Recent evaluation of a database containing 127 517 sets of data compiled over 8 years, showed positive results in 1 150 cases (0.90 per cent), and the limits of Ph. Eur. general chapter 2.8.13 Pesticide residues or Regulation (EC) 396/2005, both applicable to herbal drugs, were exceeded in 392 cases (0.31 per cent, equivalent to 34.1 per cent of the positive results), particularly in cases of oils produced by cold pressing. From these results, it can be concluded that a general test on pesticides in the Ph. Eur. general monograph on essential oils is not required for most oils used in medicinal products. Therefore, it is proposed to limit the testing of essential oils for pesticide residues to those cases where potential residues are more of a concern, either due to the type of production process or to those processes where pesticides are actively used during cultivation of the plant (e.g. as documented according to Good Agricultural and Collection Practice (GACP)). Furthermore, in order to assess any potential risk, an approach using the Acceptable Daily Intake (ADI) can be made.

The heavy metals cadmium, lead and mercury in raw materials of animal origin: evaluation of data from practice.

Raw materials from animal origin are widely used in homoeopathy. Due to the lack of dedicated limits, the quality requirements for herbal drugs of the European Pharmacopoeia (Ph. Eur.) and/or the German Homoeopathic Pharmacopoeia (Homöopathisches Arzneibuch, HAB), including limits for heavy metals such as cadmium, lead and mercury, have been applied. A recent database evaluation shows that for some raw materials of animal origin the Ph. Eur. limits for herbal drugs cannot be met in practice. For this reason proposals for new limits for cadmium, lead and mercury are made based on recent experiences from the companies' daily practice. These specific limits are suggested to be included in the individual monographs of the Ph. Eur. or at least the German HAB, respectively, for Ambra grisea, Euspongia officinalis, Formica rufa and Sepia officinalis.

Validation of a certified nurse-midwifery database for use in quality monitoring and outcomes research.

INTRODUCTION: Certified nurse-midwives (CNMs) and certified midwives (CMs) attend 11% of US vaginal births, and CNM/CM databases include a rich source of information on the birth outcomes of women not generally available through obstetric electronic health records (oEHRs). Although CNM databases are in wide use, studies on their validity are sparse. We examined the validity of a practice-specific CNM birth database compared with an oEHR in a large tertiary-care facility. METHODS: The study population consisted of all 3133 births in a large CNM practice that were entered into a practice-specific electronic birth database from 2001 to 2008. We assessed agreement with the oEHR overall and according to individual maternal demographic characteristics; obstetric, medical, and social risk factors; labor and birth information; and newborn characteristics. We also evaluated whether there were differences in agreement according to early versus later study periods and by years of CNM clinical experience. RESULTS: Overall agreement between the CNM birth database and the oEHR was 92.4%. Agreement between the CNM birth database and the oEHR was greater than 90% for maternal age, race/ethnicity, route and type of birth, major genital tract trauma, newborn weight, and primary clinician attending the birth. Lower agreement rates for smoking, total weight gain in pregnancy, beginning of pregnancy body mass index, and anesthesia for birth were due, in part, to missing information in the oEHR. Agreement did not vary significantly by early versus late study periods or by years of CNM clinical experience. DISCUSSION: Findings indicate that a CNM/CM birth database is a valid data source for quality monitoring and outcomes research and may contain more complete information for some variables than the oEHR.