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Objectives: The aim of this review is to describe the interaction of clinical documentation with patient care, measures of patient acuity, quality metrics, research database accuracy, and healthcare reimbursement in order to highlight potential areas of improvement for intensivists., Data Sources: An online search of PubMed was undertaken as well as review of resources published by the American Academy of Pediatrics, the Society of Critical Care Medicine, the American Medical Association, and the Association of Clinical Documentation Improvement Specialists., Study Selection: Selected publications included those that described coding, medical record documentation, healthcare reimbursement, quality metrics, administrative databases, Clinical Documentation Improvement programs, medical scribe programs, and various payment models., Data Extraction: Relevant information was extracted to highlight the impact of diagnosis documentation on patient care, perceived patient severity of illness, quality metrics, and healthcare reimbursement. Query data from our hospital's Clinical Documentation Improvement program were reviewed to highlight areas of improvement within our own Division of Critical Care Medicine. Additionally, interventions to improve clinical documentation were incorporated into this review., Data Synthesis: Available data in the literature indicate that documentation of precise diagnoses in the medical record has a positive impact on quality metrics, accuracy of administrative databases, hospital reimbursement, and perceived patient complexity. However, there is insufficient data to make conclusions regarding documentation of specific diagnoses and effects on patient care. Administrative responsibilities associated with documentation have been increasing, especially with the introduction of electronic medical records., Conclusions: Documentation of specific diagnoses in the medical record is important in the broad context of our existing medical system but there is an associated burden in doing so. Widespread implementation of electronic medical record systems has inadvertently led to clinician dissatisfaction and burnout. Research is needed to further evaluate the impact of documentation on patient care as well as steps to decrease the associated burden.

Primary health care electronic medical records were analyzedin Rio de Janeiro for two chronic diseases, namely, hypertension and diabetes, in a population-based study with a cross-sectional epidemiological design that considered the Rio de Janeiro population enrolled in Family Health Teams. Calculation of the prevalence rate was stratified by gender and age group, and the condition of the disease was measured by family doctors in their visits using the ICD-10.Except for the last two age groups (75-79 years and 80 years and over), with apparent under-registration of the diagnosed cases, a positive association was found between prevalence rates and age in both genders. The generation of objective and reliable statistical information is fundamental for local management, allowing the evaluation of demographic dynamics and the peculiarities of each territory, and assisting in the planning and monitoring of the quality of Rio de Janeiro people's records registered in each family health unit. Thus, the regular management of duplicate records in the registered user roster is essential to minimize the over-registration of clinical cases reported in the electronic medical records.

Aims: Monitoring risk-based approaches in clinical trials are encouraged by regulatory guidance. However, the impact of a targeted source data verification (SDV) on data-management (DM) workload and on final data quality needs to be addressed., Methods: MONITORING was a prospective study aiming at comparing full SDV (100% of data verified for all patients) and targeted SDV (only key data verified for all patients) followed by the same DM program (detecting missing data and checking consistency) on final data quality, global workload and staffing costs., Results: In all, 137 008 data including 18 124 key data were collected for 126 patients from 6 clinical trials. Compared to the final database obtained using the full SDV monitoring process, the final database obtained using the targeted SDV monitoring process had a residual error rate of 1.47% (95% confidence interval, 1.41-1.53%) on overall data and 0.78% (95% confidence interval, 0.65-0.91%) on key data. There were nearly 4 times more queries per study with targeted SDV than with full SDV (mean ± standard deviation: 132 ± 101 vs 34 ± 26; P = .03). For a handling time of 15 minutes per query, the global workload of the targeted SDV monitoring strategy remained below that of the full SDV monitoring strategy. From 25 minutes per query it was above, increasing progressively to represent a 50% increase for 45 minutes per query., Conclusion: Targeted SDV monitoring is accompanied by increased workload for DM, which allows to obtain a small proportion of remaining errors on key data (<1%), but may substantially increase trial costs., (© 2019 The British Pharmacological Society.)

Objectives: To determine the effect of a domain-specific ontology and machine learning-driven user interfaces on the efficiency and quality of documentation of presenting problems (chief complaints) in the emergency department (ED)., Methods: As part of a quality improvement project, we simultaneously implemented three interventions: a domain-specific ontology, contextual autocomplete, and top five suggestions. Contextual autocomplete is a user interface that ranks concepts by their predicted probability which helps nurses enter data about a patient's presenting problems. Nurses were also given a list of top five suggestions to choose from. These presenting problems were represented using a consensus ontology mapped to SNOMED CT. Predicted probabilities were calculated using a previously derived model based on triage vital signs and a brief free text note. We evaluated the percentage and quality of structured data captured using a mixed methods retrospective before-and-after study design., Results: A total of 279,231 consecutive patient encounters were analyzed. Structured data capture improved from 26.2% to 97.2% (p < 0.0001). During the post-implementation period, presenting problems were more complete (3.35 vs 3.66; p = 0.0004) and higher in overall quality (3.38 vs. 3.72; p = 0.0002), but showed no difference in precision (3.59 vs. 3.74; p = 0.1). Our system reduced the mean number of keystrokes required to document a presenting problem from 11.6 to 0.6 (p < 0.0001), a 95% improvement., Discussion: We demonstrated a technique that captures structured data on nearly all patients. We estimate that our system reduces the number of man-hours required annually to type presenting problems at our institution from 92.5 h to 4.8 h., Conclusion: Implementation of a domain-specific ontology and machine learning-driven user interfaces resulted in improved structured data capture, ontology usage compliance, and data quality., (Copyright © 2019 Elsevier B.V. All rights reserved.)

Data collection for clinical research can be difficult, and electronic health record systems can facilitate this process. The aim of this study was to describe and evaluate the secondary use of electronic health records in data collection for an observational clinical study. We used Cerner Millennium®, an electronic health record software, following these steps: (1) data crossing between the study's case report forms and the electronic health record; (2) development of a manual collection method for data not recorded in Cerner Millennium®; (3) development of a study interface for automatic data collection in the electronic health records; (4) employee training; (5) data quality assessment; and (6) filling out the electronic case report form at the end of the study. Three case report forms were consolidated into the electronic case report form at the end of the study. Researchers performed daily qualitative and quantitative analyses of the data. Data were collected from 94 patients. In the first case report form, 76.5% of variables were obtained electronically, in the second, 95.5%, and in the third, 100%. The daily quality assessment of the whole process showed complete and correct data, widespread employee compliance and minimal interference in their practice. The secondary use of electronic health records is safe and effective, reduces manual labor, and provides data reliability. Anesthetic care and data collection may be done by the same professional.

Background: Researchers are increasingly interested in measuring race/ethnicity, but some survey respondents skip race/ethnicity items., Objectives: The main objectives of this study were to investigate the extent to which racial/ethnic groups differ in skipping race/ethnicity survey items, the degree to which this reflects reluctance to disclose race/ethnicity, and the utility of imputing missing race/ethnicity., Research Design: We applied a previously developed method for imputing race/ethnicity from administrative data (Medicare Bayesian Improved Surname and Geocoding 2.0) to data from a national survey where race/ethnicity was usually self-reported, but was sometimes missing. A linear mixed-effects regression model predicted the probability of self-reporting race/ethnicity from imputed racial/ethnic probabilities., Subjects: In total, 508,497 Medicare beneficiaries responding to the 2013-2014 Medicare Consumer Assessment of Healthcare Providers and Systems surveys were included in this study., Measures: Self-reported race/ethnicity and estimated racial/ethnic probabilities., Results: Black beneficiaries were most likely to not self-report their race/ethnicity (6.6%), followed by Hispanic (4.7%) and Asian/Pacific Islander (4.7%) beneficiaries. Non-Hispanic whites were the least likely to skip these items (3.2%). The 3.7% overall rate of missingness is similar to adjacent demographic items. General patterns of item missingness rather than a specific reluctance to disclose race/ethnicity appears to explain the elevated rate of missing race/ethnicity among Asian/Pacific Islander and Hispanic beneficiaries and most but not all among Black beneficiaries. Adding imputed cases to the data set did not substantially alter the estimated overall racial/ethnic distribution, but it did modestly increase sample size and statistical power., Conclusions: It may be worthwhile to impute race/ethnicity when this information is unavailable in survey data sets due to item nonresponse, especially when missingness is high.

Physician Orders for Life-Sustaining Treatment forms convert patient wishes into physician orders to direct care patients receive near the end of life. Recent evidence of the challenges and opportunities for honoring patient end-of-life wishes in the emergency department (ED) is presented. The forms can be very helpful in directing whether cardiopulmonary resuscitation and intubation are desired in the first few minutes of a patient's presentation. After initial stabilization, understanding the intent of end-of-life orders and the scope of further interventions requires discussion with the patient or a surrogate. The emergency medicine provider must be committed both to honoring initial resuscitation orders and to the conversations required to narrow the gap between ED care and patient wishes so that people receive care best aligned with their wishes., (Copyright © 2018 American College of Emergency Physicians. Published by Elsevier Inc. All rights reserved.)

Background: Effective interdisciplinary communication of imaging findings is vital for patient care, as referring physicians depend on the contained information for the decision-making and subsequent treatment. Traditional radiology reports contain non-structured free text and potentially tangled information in narrative language, which can hamper the information transfer and diminish the clarity of the report. Therefore, this study investigates whether newly developed structured reports (SRs) of prostate magnetic resonance imaging (MRI) can improve interdisciplinary communication, as compared to non-structured reports (NSRs)., Methods: 50 NSRs and 50 SRs describing a single prostatic lesion were presented to four urologists with expert level experience in prostate cancer surgery or targeted MRI TRUS fusion biopsy. They were subsequently asked to plot the tumor location in a 2-dimensional prostate diagram and to answer a questionnaire focusing on information on clinically relevant key features as well as the perceived structure of the report. A validated scoring system that distinguishes between "major" and "minor" mistakes was used to evaluate the accuracy of the plotting of the tumor position in the prostate diagram., Results: The mean total score for accuracy for SRs was significantly higher than for NSRs (28.46 [range 13.33-30.0] vs. 21.75 [range 0.0-30.0], p < 0.01). The overall rates of major mistakes (54% vs. 10%) and minor mistakes (74% vs. 22%) were significantly higher (p < 0.01) for NSRs than for SRs. The rate of radiologist re-consultations was significantly lower (p < 0.01) for SRs than for NSRs (19% vs. 85%). Furthermore, SRs were rated as significantly superior to NSRs in regard to determining the clinical tumor stage (p < 0.01), the quality of the summary (4.4 vs. 2.5; p < 0.01), and overall satisfaction with the report (4.5 vs. 2.3; p < 0.01), and as more valuable for further clinical decision-making and surgical planning (p < 0.01)., Conclusions: Structured reporting of prostate MRI has the potential to improve interdisciplinary communication. Through SRs, expert urologists were able to more accurately assess the exact location of single prostate cancer lesions, which can facilitate surgical planning. Furthermore, structured reporting of prostate MRI leads to a higher satisfaction level of the referring physician., Competing Interests: The authors have declared that no competing interests exist.

Introduction: Clinical documentation is the key determinant of inpatient acuity of illness and payer reimbursement. Every inpatient hospitalization is placed into a diagnosis related group with a relative value based on documented procedures, conditions, comorbidities and complications. The Case Mix Index (CMI) is an average of these diagnosis related groups and directly impacts physician profiling, medical center profiling, reimbursement, and quality reporting. We hypothesize that a focused, physician-led initiative to improve clinical documentation of vascular surgery inpatients results in increased CMI and contribution margin., Methods: A physician-led coding initiative to educate physicians on the documentation of comorbidities and conditions was initiated with concurrent chart review sessions with coding specialists for 3 months, and then as needed, after the creation of a vascular surgery documentation guide. Clinical documentation and billing for all carotid endarterectomy (CEA) and open infrainguinal procedures (OIPs) performed between January 2013 and July 2016 were stratified into precoding and postcoding initiative groups. Age, duration of stay, direct costs, actual reimbursements, contribution margin (CM), CMI, rate of complication or comorbidity, major complication or comorbidity, severity of illness, and risk of mortality assigned to each discharge were abstracted. Data were compared over time by standardizing Centers for Medicare and Medicaid Services (CMS) values for each diagnosis related group and using a CMS base rate reimbursement., Results: Among 458 CEA admissions, postcoding initiative CEA patients (n = 253) had a significantly higher CMI (1.36 vs 1.25; P = .03), CM ($7859 vs $6650; P = .048), and CMS base rate reimbursement ($8955 vs $8258; P = .03) than precoding initiative CEA patients (n = 205). The proportion of admissions with a documented major complication or comorbidity and complication or comorbidity was significantly higher after the coding initiative (43% vs 27%; P < .01). Among 504 OIPs, postcoding initiative patients (n = 227) had a significantly higher CMI (2.23 vs 2.05; P < .01), actual reimbursement ($23,203 vs $19,909; P < .01), CM ($12,165 vs $8840; P < .01), and CMS base rate reimbursement ($14,649 vs $13,496; P < .01) than precoding initiative patients (n = 277). The proportion of admissions with a documented major complication or comorbidity and complication or comorbidity was significantly higher after the coding initiative (61% vs 43%; P < .01). For both CEA and OIPs, there were no differences in age, duration of stay, total direct costs, or primary insurance status between the precoding and postcoding patient groups., Conclusions: Accurate and detailed clinical documentation is required for key stakeholders to characterize the acuity of inpatient admissions and ensure appropriate reimbursement; it is also a key component of risk-adjustment methods for assessing quality of care. A physician-led documentation initiative significantly increased CMI and CM., (Copyright © 2018 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.)

Opening and charting in the incorrect patient electronic record presents a patient safety issue. The authors investigated the prevalence of reported errors and whether efforts utilizing the anesthesia time-out and barcoding have decreased the incidence of errors in opening and charting in the patient electronic medical record in the perioperative environment. The authors queried the database for all surgeries and procedures requiring anesthesia from January 2009 to September 2012. Of the 115,760 records of anesthesia procedures identified, there were 57 instances of incorrect record opening and charting during the study period. A decreasing trend was observed for all sites combined (p < 0.0001) and at the off-site locations (p = 0.0032). All locations and the off-site locations demonstrated a statistically significant decreasing pattern of errors over time. Barcoding and the anesthesia time-out may play an important role in decreasing errors in incorrect patient record opening in the perioperative environment., (© The Author(s) 2015.)

Background The availability of clinical information and a pertinent clinical question can improve the diagnostic accuracy of the imaging process. Purpose To examine if an electronic request form forcing referring clinicians to provide separate input of both clinical information and a clinical question can improve the quality of the request. Material and Methods A total of 607 request forms in the clinical worklists for a computed tomography (CT) scan of the thorax, the abdomen or their combination, were examined. Using software of our own making, we examined the presence of clinical information and a clinical question before and after the introduction of a new, more compelling order method. We scored and compared the quality of the clinical information and the clinical question between the two systems and we examined the effect on productivity. Results Both clinical information and a clinical question were present in 76.7% of cases under the old system and in 95.3% under the new system ( P < 0.001). Individual characteristics of the clinical information and the clinical question however, with the exception of incompleteness, showed little improvement under the new system. There was also no significant difference between the two systems in the number of requests requiring further search. Conclusion The introduction of electronic radiology request forms compelling referring clinicians to provide separate input of clinical information and a clinical question provides only limited benefit to the quality of the request. Raising awareness among clinicians of the importance of a well-written request remains essential.

Background: The accurate recording of findings in clinical medicolegal cases is important, yet the current J88 form used for this purpose in South Africa has been reported to have many flaws. In addition, there are reports of poor completion of the form, which could in part be due to its poor design and clarity., Objective: To describe the process that was undertaken to revise the current J88 form., Methods: A repetitive consultative process was used to revise the current J88 form and to obtain inputs from relevant government institutions., Results: A brief outline of the changes that have been made to the current J88 form and the reasons why these changes were proposed by national experts is provided., Conclusion: The revised J88 form will provide clearer guidance to healthcare providers on the completion of necessary information in an expedited fashion. It is hoped that the form will soon be approved by the necessary government institutions.

Objective: To evaluate associations between the electronic environment, clerical burden, and burnout in US physicians., Participants and Methods: Physicians across all specialties in the United States were surveyed between August and October 2014. Physicians provided information regarding use of electronic health records (EHRs), computerized physician order entry (CPOE), and electronic patient portals. Burnout was measured using validated metrics., Results: Of 6375 responding physicians in active practice, 5389 (84.5%) reported that they used EHRs. Of 5892 physicians who indicated that CPOE was relevant to their specialty, 4858 (82.5%) reported using CPOE. Physicians who used EHRs and CPOE had lower satisfaction with the amount of time spent on clerical tasks and higher rates of burnout on univariate analysis. On multivariable analysis, physicians who used EHRs (odds ratio [OR]=0.67; 95% CI, 0.57-0.79; P<.001) or CPOE (OR=0.72; 95% CI, 0.62-0.84; P<.001) were less likely to be satisfied with the amount of time spent on clerical tasks after adjusting for age, sex, specialty, practice setting, and hours worked per week. Use of CPOE was also associated with a higher risk of burnout after adjusting for these same factors (OR=1.29; 95% CI, 1.12-1.48; P<.001). Use of EHRs was not associated with burnout in adjusted models controlling for CPOE and other factors., Conclusion: In this large national study, physicians' satisfaction with their EHRs and CPOE was generally low. Physicians who used EHRs and CPOE were less satisfied with the amount of time spent on clerical tasks and were at higher risk for professional burnout., (Copyright © 2016 Mayo Foundation for Medical Education and Research. Published by Elsevier Inc. All rights reserved.)

The development of functioning of emergency medical care is one of directions of national health care development. The article presents analysis of indices of functioning of emergency medical care in the Russian Federation: number of stations (departments), medical personnel supply, rate of completed visits of emergency teams, number ofpersons cared during visits, number of hospitalized patients transported by emergency teams (shifts), number of cars of emergency medical care, number of road accidents visited by emergency teams, number of victims of road accidents, immediacy offunctioning. The history ofmaintenance of report documentation of emergency medical care is presented and its complicity of its filling-in is marked.

Measurement of youth's physical activity levels is recommended to ensure that children are meeting recommended activity guidelines. This article describes the creation of an instrument to measure youth's levels of physical activity, where a strong test validation perspective (Benson, 1998) was followed to create the scale. The development process involved a mixed-method (qualitative followed by quantitative) framework. First, focus groups were conducted, where results informed item creation. Next, three alternative forms were created with different response formats to measure childrens' frequency of participation in various physical activities and intensity of participation. Lastly, a sample of over 500 middle school children was obtained, where three different response scales were investigated. The optimal scale considered measurement of physical activity using a three-point Likert frequency; intensity of activity participation did not strongly contribute to the measurement of children's activity levels. The final version form is thought to be acceptable for use with children in surveillance and large-group studies, as well as in smaller sample applications.

Background: Most of the current scores and outcome prediction calculations in traumatology are based on the Abbreviated Injury Scale (AIS). However, this is not routinely used for documentation and coding of injuries in many countries, including Germany. Instead of the AIS, the International Classification of Diseases (ICD) is used. While the ICD functions as the basis for automated calculating of the diagnosis-related groups (DRG), no possibility of simple conversion of the 10th version of the ICD into AIS is available so far., Objectives: The aim of this work is to develop and apply a methodology for simple conversion from ICD 10 to current AIS., Materials and Methods: The developed mapping procedure was based on a 1 : n relationship between trauma codes of ICD-10-GM and the codes of the AIS2005. Calculated ISS from the conversion codes were then compared with the actual ISS coding available from the clinical trauma documentation., Results: It can be shown that, despite the considerable differences in the structure and systematic of both classification systems, an automated translation is technically possible., Conclusions: The preliminary result of the mapping suggests, however, that despite the technical feasibility of a reliable conversion and comparability of ICD 10 and AIS in the required quality is still questionable. An automated conversion is still possible and quality would possibly improve by inclusion of additional information., (Georg Thieme Verlag KG Stuttgart · New York.)

Aim: The aim of this project was to perform an empirical evaluation of the impact of on site source data verification (SDV) on the data quality in a clinical trial database to guide an informed decision on selection of the monitoring approach., Methods: We used data from three randomized phase III trials monitored with a combination of complete SDV or partial SDV. After database lock, individual subject data were extracted from the clinical database and subjected to post hoc complete SDV. Error rates were calculated with focus on the degree of on study monitoring and relevance and analyzed for potential impact on end points., Results: Data from a total of 2566 subjects including more than 3 million data fields were 100% source data verified post hoc. An overall error rate of 0.45% was found. No sites had 0% errors. 100% SDV yielded an error rate of 0.27% as compared with partial SDV having an error rate of 0.53% (P < 0.0001). Comparing partly and fully monitored subjects, minor differences were identified between variables of major importance to efficacy or safety., Conclusions: The findings challenge the notion that a 0% error rate is obtainable with on site monitoring. Data indicate consistently low error rates across the three trials analyzed. The use of complete vs. partial SDV offers a marginal absolute error rate reduction of 0.26%, i.e. a need to perform complete SDV of about 370 data points to avoid one unspecified error and does not support complete SDV as a means of providing meaningful improvements in data accuracy., (© 2014 The British Pharmacological Society.)

The surge of interest in pain from many types of physicians over the past few decades has resulted in a specialty with unique challenges. In response to the growth in pain medicine, pain fellowships have emerged to appropriately diagnose and to treat a wide variety of pain conditions. Despite improvements and standardization among pain fellowships, education in the basics of billing and coding is typically limited. Though courses on proper billing practices exist within the specialty of pain medicine, many new practitioners are challenged by clinical responsibilities with limited training with regards to billing and coding of pain services. Inaccurate billing and coding can result in financial issues and legal ramifications. ICD-10, which is expected later this year, will present additional challenges to effective billing and coding. In summary, there are frequent changes to the rules and regulations governing pain management that can significantly impact practice management. Strong consideration should be made by stakeholders in any pain practitioner to attend regular educational meetings and take steps necessary for continued compliance, efficiency, quality, and profitability. A basic primer on concepts related to billing and code terminology, therefore, is presented for clinicians.

Two national surveillance systems capturing reports of fatal Q fever were compared with obtained estimates of Q fever underreporting in the United States using capture-recapture methods. During 2000-2011, a total of 33 unique fatal Q fever cases were reported through case report forms submitted to the Centers for Disease Control and Prevention and through U.S. death certificate data. A single case matched between both data sets, yielding an estimated 129 fatal cases (95% confidence interval [CI] = 62-1,250) during 2000-2011. Fatal cases of Q fever were underreported through case report forms by an estimated factor of 14 and through death certificates by an estimated factor of 5.2., (© The American Society of Tropical Medicine and Hygiene.)

Translating huge medical terminologies like SNOMED CT is costly and time consuming. We present a methodology that acquires substring substitution rules for single words, based on the known similarity between medical words and their translations, due to their common Latin / Greek origin. Character translation rules are automatically acquired from pairs of English words and their automated translations to German. Using a training set with single words extracted from SNOMED CT as input we obtained a list of 268 translation rules. The evaluation of these rules improved the translation of 60% of words compared to Google Translate and 55% of translated words that exactly match the right translations. On a subset of words where machine translation had failed, our method improves translation in 56% of cases, with 27% exactly matching the gold standard.

A relational database model is presented that stores the hierarchical linkages between clinical events with qualifier codes, such that the explicit contextual meaning of an event's attributes is preserved upon retrieval. A retrospective analysis of 302 forms built upon the model showed that 91% of 17,899 data elements requested by clinicians and researchers from 19 clinics were successfully represented, but that 62% were never used more than once. These results reinforce the specificity of clinic-specific databases and the need for unambiguous, explicitly-stored clinical data.

Unlabelled: Reuse of data from EHRs is essential for many purposes. The objective of the study was to explore how distributed electronic health record (EHR) data can be reused for privacy-preserving statistical query and processing., Method: We have designed and created a proof of concept prototype solution based on the OpenEHR specification to ensure interoperability and to query the EHRs. XMPP was used for communication between the distributed processing components., Results: We have created a two-phased process where a distributed virtual dataset is first created and thereafter processed using distributed privacy-preserving statistical queries., Conclusion: Health authorities in Norway are currently defining the set of archetypes for the national interoperability program. This will create a common information schema enabling reuse of EHR data for statistical query and processing in a privacy-preserving manner. One benefit of the approach is that information transformation between information models for clinical use and statistical processing can be avoided.

The healthcare sector globally is confronted with increasing internal and external pressures that urge for a radical reform of health systems' status quo. The role of technological innovations such as Electronic Health Records (EHR) is recognized as instrumental in this transition process as it is expected to accelerate organizational innovations. This is why the widespread uptake of EHR systems is a top priority in the global healthcare agenda. The successful co-deployment though of EHR systems and organizational innovations within the context of secondary healthcare institutions is a complex and multifaceted issue. Existing research in the field has made little progress thus emphasizing the need for further research contribution that will incorporate a holistic perspective. This paper presents insights about the EHR-organizational innovation interplay from a public hospital in Greece into a socio-technical analytical framework providing a multilevel set of action points for the eHealth roadmap with worldwide relevance.

Objective: The radiology report serves as the primary method of communication about imaging findings. Traditional free-text (i.e., unstructured) radiology reporting entails dictating in a stream-of-consciousness manner. Structured reporting aims to standardize the format and lexicon used in reports. This standardization may improve the communication of findings, allowing ease of reading and comprehension. A structured reporting template may also be used as a checklist while reviewing a case, which may facilitate focused attention and analysis. The goal of this study was to compare unstructured and structured reports in terms of their completeness and effectiveness., Materials and Methods: Radiology trainees were given an educational lecture on the background of reporting and were provided with a structured reporting template for dictating chest radiographs. Twelve trainees completed the study. Sixty reports from before and 60 reports from after the intervention were each independently scored by four blinded physician raters for completeness and effectiveness., Results: Structured reports were found to be statistically significantly more complete and more effective than unstructured reports (mean completeness score, 4.42 vs 3.99, p<0.001; mean effectiveness score, 4.11 vs 3.85, p<0.001). A combined score was calculated for each report and was higher for the structured reports (mean combined score, 8.54 vs 7.83, p<0.001)., Conclusion: Structured chest radiograph reports were more complete and more effective than unstructured chest radiograph reports. Although additional studies are needed for validation, this study suggests that structured reporting may represent an improved reporting method for radiologists.

The paper reviews the problem of using structured radiology reports. Their salient features are as follows: to work out a protocol in accordance with some pattern, to divide it into subheadings arranged consecutively and logically and broken down by main anatomical structures, types of disease, and study, and to use standardized terminology. The RSNA proposed RadLex system is the most known example of structured reports. The experience in using these protocols has shown that the latter may improve the clearness and informative value of roentgenologists' opinions and alleviate their understanding by physicians of other specialties. However, the systems of writing the structured radiology reports have a number of constraints for the time being, which interfere with their wide clinical introduction. Nonetheless, their use is substantially increasing in the years ahead.

Introduction: Medical documentation is a time-consuming task and there is a growing number of documentation requirements. In order to improve documentation, harmonization and standardization based on existing forms and medical concepts are needed. Systematic analysis of forms can contribute to standardization building upon new methods for automated comparison of forms. Objectives of this research are quantification and comparison of data elements for breast and prostate cancer to discover similarities, differences and reuse potential between documentation sets. In addition, common data elements for each entity should be identified by automated comparison of forms., Materials and Methods: A collection of 57 forms regarding prostate and breast cancer from quality management, registries, clinical documentation of two university hospitals (Erlangen, Münster), research datasets, certification requirements and trial documentation were transformed into the Operational Data Model (ODM). These ODM-files were semantically enriched with concept codes and analyzed with the compareODM algorithm. Comparison results were aggregated and lists of common concepts were generated. Grid images, dendrograms and spider charts were used for illustration., Results: Overall, 1008 data elements for prostate cancer and 1232 data elements for breast cancer were analyzed. Average routine documentation consists of 390 data elements per disease entity and site. Comparisons of forms identified up to 20 comparable data elements in cancer conference forms from both hospitals. Urology forms contain up to 53 comparable data elements with quality management and up to 21 with registry forms. Urology documentation of both hospitals contains up to 34 comparable items with international common data elements. Clinical documentation sets share up to 24 comparable data elements with trial documentation. Within clinical documentation administrative items are most common comparable items. Selected common medical concepts are contained in up to 16 forms., Discussion: The amount of documentation for cancer patients is enormous. There is an urgent need for standardized structured single source documentation. Semantic annotation is time-consuming, but enables automated comparison between different form types, hospital sites and even languages. This approach can help to identify common data elements in medical documentation. Standardization of forms and building up forms on the basis of coding systems is desirable. Several comparable data elements within the analyzed forms demonstrate the harmonization potential, which would enable better data reuse., Conclusion: Identifying common data elements in medical forms from different settings with systematic and automated form comparison is feasible., (Copyright © 2014 Elsevier Inc. All rights reserved.)

Background and Purpose: To ascertain the rate, type, significance, trends and the potential risk factors associated with radiotherapy incidents in a large academic department., Materials and Methods: Data for all radiotherapy activities from July 2001 to January 2011 were reviewed from radiotherapy incident reporting forms. Patient and treatment data were obtained from the radiotherapy record and verification database (MOSAIQ) and the patient database (HOSPRO). Logistic regression analyses were performed to determine variables associated with radiotherapy incidents., Results: In that time, 65,376 courses of radiotherapy were delivered with a reported incident rate of 2.64 per 100 courses. The rate of incidents per course increased (1.96 per 100 courses to 3.52 per 100 courses, p<0.001) whereas the proportion of reported incidents resulting in >5% deviation in dose (10.50 to 2.75%, p<0.001) had decreased after the introduction of an online electronic reporting system. The following variables were associated with an increased rate of incidents: afternoon treatment time, paediatric patients, males, inpatients, palliative plans, head-and-neck, skin, sarcoma and haematological malignancies. In general, complex plans were associated with higher incidence rates., Conclusion: Radiotherapy incidents were infrequent and most did not result in significant dose deviation. A number of risk factors were identified and these could be used to highlight high-risk cases in the future. Introduction of an online electronic reporting system resulted in a significant increase in the number of incidents being reported., (Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.)

Abstract Whenever personal data is processed, privacy is a serious issue. Especially in the document-centric e-health area, the patients' privacy must be preserved in order to prevent any negative repercussions for the patient. Clinical research, for example, demands structured health records to carry out efficient clinical trials, whereas legislation (e.g. HIPAA) regulates that only de-identified health records may be used for research. However, unstructured and often paper-based data dominates information technology, especially in the healthcare sector. Existing approaches are geared towards data in English-language documents only and have not been designed to handle the recognition of erroneous personal data which is the result of the OCR-based digitization of paper-based health records.

Introduction: Use of electronic health record (EHR) systems can place a considerable data entry burden upon the emergency department (ED) physician. Voice recognition data entry has been proposed as one mechanism to mitigate some of this burden; however, no reports are available specifically comparing emergency physician (EP) time use or number of interruptions between typed and voice recognition data entry-based EHRs. We designed this study to compare physician time use and interruptions between an EHR system using typed data entry versus an EHR with voice recognition., Methods: We collected prospective observational data at 2 academic teaching hospital EDs, one using an EHR with typed data entry and the other with voice recognition capabilities. Independent raters observed EP activities during regular shifts. Tasks each physician performed were noted and logged in 30 second intervals. We compared time allocated to charting, direct patient care, and change in tasks leading to interruptions between sites., Results: We logged 4,140 minutes of observation for this study. We detected no statistically significant differences in the time spent by EPs charting (29.4% typed; 27.5% voice) or the time allocated to direct patient care (30.7%; 30.8%). Significantly more interruptions per hour were seen with typed data entry versus voice recognition data entry (5.33 vs. 3.47; p=0.0165)., Conclusion: The use of a voice recognition data entry system versus typed data entry did not appear to alter the amount of time physicians spend charting or performing direct patient care in an ED setting. However, we did observe a lower number of workflow interruptions with the voice recognition data entry EHR. Additional research is needed to further evaluate the data entry burden in the ED and examine alternative mechanisms for chart entry as EHR systems continue to evolve.

The analysis of literature data showed that the creation and implementation of a new form of radiology reports into clinical practice is an actual problem of modern medicine. Although imaging modalities have undergone dramatic evolution over the past century, radiology reporting has remained largely static, in both content and structure. In recent years the necessity to create a structured reporting is widely discussed in the literature. A universal format of radiology report hasn't been found yet. The standard of reporting system is absent, a wide variety of styles in radiology reporting currently exists. The challenging goal is improvement of existing protocols and creation of a new form of radiology reports--the protocols of the future.

When modelling and simulating healthcare related processes, free-text data is often the only possible source of information. This data may contain vocabulary variations such as mistyped, misspelled and/or abbreviated words. This paper describes a semi-automated approach to free-text normalisation based on a combination of commonly used techniques and local expertise of medical oncology nurses. The approach emphasises the effectiveness of the vocabulary creation process through an interactive software application. When local knowledge is successfully captured, normalisation of large data sets can be done very rapidly with a high accuracy rate achieved. Furthermore, the techniques for localised normalisation can have significant benefits to free-text parsing accuracy when data is aggregated from multiple sites (hospitals). This research may lead to increased understanding of issues associated with chemotherapy related free-text data which in turn may impact patient treatment safety.

To enhance the preparedness of graduates from the Biochemistry and Biotechnology (BCBT) Major at Minnesota State University Moorhead for employment in the bioscience industry we have developed a new Industry certificate program. The BCBT Industry Certificate was developed to address specific skill sets that local, regional, and national industry experts identified as lacking in new B.S. and B.A. biochemistry graduates. The industry certificate addresses concerns related to working in a regulated industry such as Good Laboratory Practices, Good Manufacturing Practices, and working in a Quality System. In this article we specifically describe how we developed a validation course that uses Standard Operating Procedures to describe grading policy and laboratory notebook requirements in an effort to better prepare students to transition into industry careers., (© 2013 by The International Union of Biochemistry and Molecular Biology.)

Templated boilerplate structures pose challenges to natural language processing (NLP) tools used for information extraction (IE). Routine error analyses while performing an IE task using Veterans Affairs (VA) medical records identified templates as an important cause of false positives. The baseline NLP pipeline (V3NLP) was adapted to recognize negation, questions and answers (QA) in various template types by adding a negation and slot:value identification annotator. The system was trained using a corpus of 975 documents developed as a reference standard for extracting psychosocial concepts. Iterative processing using the baseline tool and baseline+negation+QA revealed loss of numbers of concepts with a modest increase in true positives in several concept categories. Similar improvement was noted when the adapted V3NLP was used to process a random sample of 318,000 notes. We demonstrate the feasibility of adapting an NLP pipeline to recognize templates.

Objective: Barriers to executing large-scale randomized controlled trials include costs, complexity, and regulatory requirements. We hypothesized that source document verification (SDV) via remote electronic monitoring is feasible., Methods: Five hospitals from two NIH sponsored networks provided remote electronic access to study monitors. We evaluated pre-visit remote SDV compared to traditional on-site SDV using a randomized convenience sample of all study subjects due for a monitoring visit. The number of data values verified and the time to perform remote and on-site SDV was collected., Results: Thirty-two study subjects were randomized to either remote SDV (N=16) or traditional on-site SDV (N=16). Technical capabilities, remote access policies and regulatory requirements varied widely across sites. In the adult network, only 14 of 2965 data values (0.47%) could not be located remotely. In the traditional on-site SDV arm, 3 of 2608 data values (0.12%) required coordinator help. In the pediatric network, all 198 data values in the remote SDV arm and all 183 data values in the on-site SDV arm were located. Although not statistically significant there was a consistent trend for more time consumed per data value (minutes +/- SD): Adult 0.50 +/- 0.17 min vs. 0.39 +/- 0.10 min (two-tailed t-test p=0.11); Pediatric 0.99 +/- 1.07 min vs. 0.56 +/- 0.61 min (p=0.37) and time per case report form: Adult: 4.60 +/- 1.42 min vs. 3.60 +/- 0.96 min (p=0.10); Pediatric: 11.64 +/- 7.54 min vs. 6.07 +/- 3.18 min (p=0.10) using remote SDV., Conclusions: Because each site had different policies, requirements, and technologies, a common approach to assimilating monitors into the access management system could not be implemented. Despite substantial technology differences, more than 99% of data values were successfully monitored remotely. This pilot study demonstrates the feasibility of remote monitoring and the need to develop consistent access policies for remote study monitoring.

Tablet computers have become a mainstream product in today's personal, educational, and business worlds. These tablets offer computing power, storage, and a wide range of available products to meet nearly every user need. To take advantage of this new computing technology, a system was developed for the Apple iPad (Apple Inc. 1 Infinite Loop Cupertino, CA 95014) to perform health and safety inspections in the field using editable PDFs and saving them to a database while keeping the process easy and paperless.

The objectives of QMS for quality assurance of products are achieved by formulation, implement, and management of document system. Document (includes record) system is important constituent part of QMS. In this paper, the important issues and relative requirements of GMP on the establishment and management of documentation within quality management system (QMS) of medical device enterprises are discussed with the aim of providing reference for relative enterprises to build and improve their QMS and to implement GMP.

Introduction: Accurate and legible record keeping is a crucial part of good medical practice. Surgical Hospital Audit of Record Keeping (SHARK) is a new audit and teaching tool for junior doctors. The author has designed the tool, based on the Royal College of Surgeons guidelines, to anonymously score the different surgical teams' medical records within a hospital. It takes into account regular record keeping during ward rounds, together with the operation note and admission clerking., Methods: The SHARK audit tool assesses 45 individual areas within surgical records. Fifteen points are apportioned for an initial surgical clerking, 13 for a subsequent record entry, and 17 for the operation note to give an overall score out of 45. It was implemented at 2 hospitals and used to educate medical students., Results: The results were poor and improved with education at both sites. There was 80% total agreement with a κ coefficient for interobserver reliability of 0.6., Conclusion: This study shows that the SHARK tool is simple to use, repeatable, and reliable in improving record keeping., (Copyright © 2013 Association of Program Directors in Surgery. Published by Elsevier Inc. All rights reserved.)

The proportion of patients considered to be cured is a key indicator to assess national tuberculosis (TB) control. In France, TB treatment outcome monitoring was implemented in 2007. This article presents national results on treatment outcome among patients with pulmonary TB reported in France in 2009 and explores determinants of potentially unfavourable outcome. Information on treatment outcome was reported for 63% of eligible pulmonary cases of whom 70% had a successful outcome. In a multivariate analysis, potentially unfavourable outcome (17%), compared to treatment success, was significantly associated with being male, born abroad and having lived in France for less than 10 years, being in congregate settings when treatment was initiated, or having a previous history of anti-TB treatment. Enhanced awareness of treatment outcome monitoring is essential to improve the coverage and the quality of information. Earlier diagnosis and improved management of the disease in the elderly may reduce death due to TB. The high proportion of potentially unfavourable outcomes should be further investigated as they may require additional vigilance and/or actions in term of efforts of TB control in some population groups.

Background: In biomedical research, the signed consent form must be checked for compliance with regulatory requirements. Checking usually is performed on site, most frequently after a participant's final enrollment., Purpose: We piloted a procedure for remote preenrollment consent forms checking. We applied it in five trials and assessed its efficiency to reduce form nonconformity before participant enrollment., Methods: Our clinical trials unit (CTU) routinely uses a consent form with an additional copy that contains a pattern that partially masks the participant's name and signature. After completion and signatures by the participant and investigator, this masked copy is faxed to the CTU for checking. In case of detected nonconformity, the CTU suspends the participant's enrollment until the form is brought into compliance. We checked nonconformities of consent forms both remotely before enrollment and on site in five trials conducted in our CTU. We tabulated the number and nature of nonconformities by location of detection: at the CTU or on site. We used these data for a pseudo before-and-after analysis and estimated the efficiency of this remote checking procedure in terms of reduction of nonconformities before enrollment as compared to the standard on-site checking procedure. We searched for nonconformity determinants among characteristics of trials, consent forms, investigator sites, and participants through multivariate logistic regression so as to identify opportunities for improvement in our procedure., Results: Five trials, starting sequentially but running concurrently, with remote preenrollment and on-site checking of consent forms from 415 participants screened in 2006-2009 led to 518 consent forms checked; 94 nonconformities were detected in 75 forms, 75 (80%) remotely and 19 more (20%) on site. Nonconformities infrequently concerned dates of signatures (7%) and information about participants (12%). Most nonconformities dealt with investigator information (76%), primarily contact information (54%). The procedure reduced nonconformities by 81% (95% confidence interval (CI): 73%-89%) before enrollment. Nonconforming consent forms dropped from 25% to 0% over the period, indicating a rapid learning effect between trials. Fewer nonconformities were observed for participants screened later in a trial (odds ratio (95% CI): 0.5 (0.3-0.8); p = 0.004), indicating a learning effect within trials. Nonconformities were more common for participants enrolled after screening (2.4 (1.1-5.3); p = 0.03), indicating a stricter scrutiny by form checkers., Limitations: Although our study had a pseudo before-and-after design, no major bias was identified. Power and generalizability of our findings were sufficient to support implementation in future trials., Conclusions: This procedure substantially limited nonconformity of consent forms with regulatory requirements before enrollment, thus proving a key component of a risk-based monitoring strategy that has been recommended to optimize resources for clinical research.

The article covers scientific basis and elaboration of system concerning self-evaluation of athletes' health state. The study comprised 2 steps. During the first step, a group of 62 athletes (45 males and 17 females) performed methods of self-evaluation of health state through a list of changes, tests and stress testing. The second step included processing and generalization of the data obtained and specification of an integral scale of self-evaluation of athletes health state.

This study sought to evaluate the agreement between therapist report and coder observation of therapy practices. The study sampled session data from a community-based, randomized trial of treatment for youth ages 7 to 13. We used therapist report of session content and coverage gathered using formal Consultation Records and developed complimentary records for coders to use when watching or listening to therapy tape. We established initial reliability between coders and then conducted a random, stratified, and comprehensive sample of sessions across youth (N = 121), therapists (N = 57), conditions (MATCH and Standard Manuals), and study sites (Honolulu and Boston) to code and compare with therapist record reports. Intraclass correlation coefficients (ICCs) representing coder versus therapist agreement on manual content delivered ranged from .42 to 1.0 across conditions and problem areas. Analyses revealed marked variability in agreement regarding whether behavioral rehearsals took place (ICCs from -.01 to 1.0) but strong agreement on client comprehension of therapy content and homework assignments. Overall, the findings indicate that therapists can be accurate reporters of the therapeutic practices they deliver, although they may need more support in reporting subtle but valuable aspects of implementation such as types of behavioral rehearsals. Developing means to support accurate reporting is important to developing future clinical feedback methodology applicable to the implementation of evidence-based treatments in the real world.