Assessment of automated clinical trial recruitment and enrolment using patient-facing technology.

OBJECTIVE: Interactive patient care systems (IPCS) at the bedside are becoming increasingly common, but evidence is limited as to their potential for innovative clinical trial implementation. The objective of this study was to test the hypothesis that the IPCS could feasibly be used to automate recruitment and enrolment for a clinical trial. METHODS: In medical-surgical units, we used the IPCS to randomise, recruit and consent eligible subjects. For participants not interacting with IPCS study materials within 48 hours, study staff-initiated recruitment in-person. Eligible study population included all caregivers and any patients >6 years old admitted to medical-surgical units and oncology units September 2015 to January 2016. OUTCOMES: randomisation assessed using between-group comparisons of patient characteristics; recruitment success assessed by rates of consent; paperless implementation using successful acquisition of electronic signature and email address. We used χ2 analysis to assess success of randomisation and recruitment. RESULTS: Randomisation was successful (n=1012 randomised, p>0.05 for all between-group comparisons). For the subset of eligible, randomised patients who were recruited, IPCS-only recruitment (consented: 2.4% of n=213) was less successful than in-person recruitment (61.4% of n=87 eligible recruited, p<0.001). For those consenting (n=61), 96.7% provided an electronic signature and 68.9% provided email addresses. CONCLUSIONS: Our results suggest that as a tool at the bedside, the IPCS offers key efficiencies for study implementation, including randomisation and collecting e-consent and contact information, but does not offer recruitment efficiencies. Further research could assess the value that interactive technologies bring to recruitment when paired with in-person efforts, potentially focusing on more intensive user-interface testing for recruitment materials. TRIAL REGISTRATION NUMBER: NCT02491190.

Improving Portfolio Assessment: Addressing Challenges in Transition to Eportfolio.

BACKGROUND: As health care education programs adopt electronic portfolios (eportfolios), a midwestern university baccalaureate nursing program faces challenges in transitioning from a 25-year-old paper-based system to eportfolio. METHOD: Process improvements and faculty development were implemented through collaboration with the information technology (IT) department and the involvement of students as ambassadors. Pre- and posttransition surveys and portfolio benchmarks were used to evaluate the efficacy of the new eportfolio system. RESULTS: Results of faculty and student surveys revealed improved positive experiences regarding the value, clarity, and ease of use of the eportfolio system. Benchmark deficits decreased from six of eight portfolio criteria in Fall 2017 to none in Fall 2019. CONCLUSION: Buy-in through faculty and student involvement, along with a user-centered design, are essential for a successful eportfolio transition. Student and faculty engagement would be secured when they are well-informed in the transition process. [J Nurs Educ. 2020;59(12):705-708.].

Information processing in electronic medical records: A survey validation.

OBJECTIVE: The purpose of this study was to validate the Clinical Information Processing Instrument. This instrument attempts to examine information processing in electronic medical records (EMRs). We drew upon the theory of swift and even flow to guide survey development and construction. MATERIALS AND METHODS: We used a mixed-methods approach to gather data from registered nurses. Nurses were invited to participate in focus groups, an expert panel, and the survey validation process. A semi-structured questionnaire addressed the following themes: method of communication, quality of information, and usability of the system. RESULTS: We conducted a confirmatory factor analysis using structural equation modelling. The Kaiser-Meyer-Olkin measure was greater than 0.7 (0.90), and the Bartlett's test of sphericity was significant (X2  = 1519.03, df = 105, P < 0.001). The proposed structural equation model was analysed and revised to a final model that was statistically significant. The final survey, Clinical Information Processing Instrument, contained 18 Likert scale questions that supported the tenets of the theory of swift and even flow. DISCUSSION: The nurses perceived EMRs as efficient for medication management, time management, and communication. The Clinical Information Processing Instrument is a validated survey tool that assesses information flow in EMRs. CONCLUSIONS: The Clinical Information Processing Instrument was validated as an approach to analyse the utility of EMR in disseminating information among clinical staff. To increase the utility and meaningful use of EMR systems, it is important to consider factors that affect the distribution of information among clinicians.

Tearing Down the Walls of Revenue Cycle Silos.

Data evolution is forcing revenue cycle silos to crumble. And that's a good thing.

Standard claims and appeals forms. Final rule.

The Department of Veterans Affairs (VA) amends its adjudication regulations and the appeals regulations and rules of practice of the Board of Veterans' Appeals (Board) to require that all claims governed by VA's adjudication regulations be filed on standard forms prescribed by the Secretary, regardless of the type of claim or posture in which the claim arises. This rulemaking also eliminates the constructive receipt of VA reports of hospitalization or examination and other medical records as informal claims for increase or to reopen while retaining the retroactive effective date assignment for awards for claims for increase which are filed on a standard form within 1 year of such hospitalization, examination, or treatment. This final rule also implements the concept of an intent to file a claim for benefits, which operates similarly to the current informal claim process, but requires that the submission establishing a claimant's effective date of benefits must be received in one of three specified formats. Finally, these amendments will provide that VA will accept an expression of dissatisfaction or disagreement with an adjudicative determination by the agency of original jurisdiction(AOJ) as a Notice of Disagreement (NOD) only if it is submitted on a standardized form provided by VA for the purpose of appealing the decision, in cases where such a form is provided. Although a standardized NOD form will only initially be provided in connection with decisions on compensation claims, VA may require a standard NOD form for any type of claim for VA benefits if, in the future, it develops and provides a standardized NOD form for a particular benefit. The purpose of these amendments is to improve the quality and timeliness of the processing of veterans' claims for benefits by standardizing the claims and appeals processes through the use of forms.

[Standardization and archiving of clinical reviews: search for optimal solutions].

The article refers to the necessity of the optimization processes for standardization and archiving of clinical examinations at the different stages of care, including also outpatient care. The compromise solution to the problem has been offered in the article.

[French hospital discharge database: data production, validity, and origins of errors in the field of severe maternal morbidity]. / Le programme de médicalisation du système d'information (PMSI) - processus de production des données, validité et sources d'erreurs dans le domaine de la morbidité maternelle sévère.

BACKGROUND: The organization of obstetric care in France brings all women in contact with the hospital system. Thus, hospital discharge data from the Program of Medicalization of the Information System (PMSI) constitute a potentially valuable source of information, particularly regarding rare events such as severe maternal morbidity. These data cover a large population but their quality has not been assessed in that field. Our objectives were to study the processes of production and the validity of PMSI data related to severe maternal morbidity. METHODS: The study was conducted in four French tertiary teaching hospitals (Caen, Cochin [AP-HP, Paris], Grenoble and Lille). First, the organization of each step of the medical information process -production, formatting, verification and processing- was detailed in each center with a standardized form. Second, the validation study was based on the comparison of data related to severe maternal morbid events in the PMSI from these centers for 2006 and 2007, with the content of medical records which constituted the gold standard. Indicators of sensitivities and positive predictive values of PMSI were calculated. RESULTS: The processes of PMSI data production showed major differences between the four centers. In hospital discharge data, diagnoses (eclampsia and pulmonary embolism) had a high proportion of false-positives (68%). Inversely, procedures (four procedures for management of severe haemorrhage) had less than 1% of false-positives, but a low sensitivity with 37% false-negatives which could be corrected in 95%. Regarding intensive care provision, all indicators of hospital data quality were very high. In addition, the validity of hospital data in centers 1 and 2 was higher for all events. CONCLUSION: The heterogeneity of the process of PMSI data production is associated with a variable quality of these data. Intensive care provision can be used in the PMSI, as well as procedures after correction. For diagnoses, the quality of the PMSI data is better in centers having both computerized medical records and steps for verification of medical information.

Administrative simplification: adoption of standards for health care electronic funds transfers (EFTs) and remittance advice. Interim final rule with comment period.

This interim final rule with comment period implements parts of section 1104 of the Affordable Care Act which requires the adoption of a standard for electronic funds transfers (EFT). It defines EFT and explains how the adopted standards support and facilitate health care EFT transmissions.

Electronic trauma patient outcomes assessment tool: performance improvement in the trauma intensive care unit.

An electronic dashboard can enhance compliance with a specific checklist of indicators with daily management of injured patients in a trauma intensive care unit effectively. A performance management electronic dashboard monitored 24 indicators in the trauma intensive care unit over a 3-year period. Over a 3-year period, utilization of the electronic dashboard improved from 64% to 100% and mean compliance rose from 94.8% to 97.4%. Implementation of an electronic dashboard enhances compliance in managing trauma patients in a sustainable manner, allows immediate correction of deficiencies, monitors trends, and facilitates performance improvement/patient safety initiatives of a trauma program.

Administrative simplification: adoption of operating rules for eligibility for a health plan and health care claim status transactions. Interim final rule with comment period.

Section 1104 of the Administrative Simplification provisions of the Patient Protection and Affordable Care Act (hereafter referred to as the Affordable Care Act) establishes new requirements for administrative transactions that will improve the utility of the existing HIPAA transactions and reduce administrative costs. Specifically, in section 1104(b)(2) of the Affordable Care Act, Congress required the adoption of operating rules for the health care industry and directed the Secretary of Health and Human Services to "adopt a single set of operating rules for each transaction * * * with the goal of creating as much uniformity in the implementation of the electronic standards as possible." This interim final rule with comment period adopts operating rules for two Health Insurance Portability and Accountability Act of 1996 (HIPAA) transactions: eligibility for a health plan and health care claim status. This rule also defines the term "operating rules" and explains the role of operating rules in relation to the adopted transaction standards. In general, transaction standards adopted under HIPAA enable electronic data interchange through a common interchange structure, thus minimizing the industry's reliance on multiple formats. Operating rules, in turn, attempt to define the rights and responsibilities of all parties, security requirements, transmission formats, response times, liabilities, exception processing, error resolution and more, in order to facilitate successful interoperability between data systems of different entities.

Health insurance reform; announcement of maintenance changes to electronic data transaction standards adopted under the Health Insurance Portability and Accountability Act of 1996. Notification.

This document announces maintenance changes to some of the Health Insurance Portability and Accountability Act of 1996 standards made by the Designated Standard Maintenance Organizations. The maintenance changes are non-substantive changes to correct minor errors, such as typographical errors, or to provide clarifications of the standards adopted in our regulations entitled "Health Insurance Reform; Modifications to the Health Insurance Portability and Accountability Act (HIPAA) Electronic Transaction Standards," published in the Federal Register on January 16, 2009. This document also instructs interested persons on how to obtain the corrections.

European coding system for tissues and cells: a challenge unmet?

The Comité Européen de Normalisation (European Committee for Standardization, CEN) Workshop on Coding of Information and Traceability of Human Tissues and Cells was established by the Expert Working Group of the Directorate General for Health and Consumer Affairs of the European Commission (DG SANCO) to identify requirements concerning the coding of information and the traceability of human tissues and cells, and propose guidelines and recommendations to permit the implementation of the European Coding system required by the European Tissues and Cells Directive 2004/23/EC (ED). The Workshop included over 70 voluntary participants from tissue, blood and eye banks, national ministries for healthcare, transplant organisations, universities and coding organisations; mainly from Europe with a small number of representatives from professionals in Canada, Australia, USA and Japan. The Workshop commenced in April 2007 and held its final meeting in February 2008. The draft Workshop Agreement went through a public comment phase from 15 December 2007 until 15 January 2008 and the endorsement period ran from 9 April 2008 until 2 May 2008. The endorsed CEN Workshop Agreement (CWA) set out the issues regarding a common coding system, qualitatively assessed what the industry felt was required of a coding system, reviewed coding systems that were put forward as potential European coding systems and established a basic specification for a proposed European coding system for human tissues and cells, based on ISBT 128, and which is compatible with existing systems of donation identification, traceability and nomenclatures, indicating how implementation of that system could be approached. The CWA, and the associated Workshop proposals with recommendations, were finally submitted to the European Commission and to the Committee of Member States that assists its management process under article 29 of the Directive 2004/23/EC on May 25 2008. In 2009 the European Commission initiated an impact assessment on the Workshop proposals and recommendations. In the absence of an agreed pan-European direction various initiatives have continued work using, adopting or adapting their preferred, or existing, methods.

Potential impact of HITECH security regulations on medical imaging.

Title XIII of Division A and Title IV of Division B of the American Recovery and Reinvestment Act (ARRA) of 2009 [1] include a provision commonly referred to as the "Health Information Technology for Economic and Clinical Health Act" or "HITECH Act" that is intended to promote the electronic exchange of health information to improve the quality of health care. Subtitle D of the HITECH Act includes key amendments to strengthen the privacy and security regulations issued under the Health Insurance Portability and Accountability Act (HIPAA). The HITECH act also states that "the National Coordinator" must consult with the National Institute of Standards and Technology (NIST) in determining what standards are to be applied and enforced for compliance with HIPAA. This has led to speculation that NIST will recommend that the government impose the Federal Information Security Management Act (FISMA) [2], which was created by NIST for application within the federal government, as requirements to the public Electronic Health Records (EHR) community in the USA. In this paper we will describe potential impacts of FISMA on medical image sharing strategies such as teleradiology and outline how a strict application of FISMA or FISMA-based regulations could have significant negative impacts on information sharing between care providers.

Health insurance reform; modifications to the Health Insurance Portability and Accountability Act (HIPAA) electronic transaction standards. Final rule.

This final rule adopts updated versions of the standards for electronic transactions originally adopted under the Administrative Simplification subtitle of the Health Insurance Portability and Accountability Act of 1996 (HIPAA). This final rule also adopts a transaction standard for Medicaid pharmacy subrogation. In addition, this final rule adopts two standards for billing retail pharmacy supplies and professional services, and clarifies who the "senders" and "receivers" are in the descriptions of certain transactions.

HIPAA administrative simplification: modifications to medical data code set standards to adopt ID-10-CM and ICD-10-PCS. Final rule.

This final rule adopts modifications to two of the code set standards adopted in the Transactions and Code Sets final rule published in the Federal Register pursuant to certain provisions of the Administrative Simplification subtitle of the Health Insurance Portability and Accountability Act of 1996 (HIPAA). Specifically, this final rule modifies the standard medical data code sets (hereinafter "code sets") for coding diagnoses and inpatient hospital procedures by concurrently adopting the International Classification of Diseases, 10th Revision, Clinical Modification (ICD-10-CM) for diagnosis coding, including the Official ICD-10-CM Guidelines for Coding and Reporting, as maintained and distributed by the U.S. Department of Health and Human Services (HHS), hereinafter referred to as ICD-10-CM, and the International Classification of Diseases, 10th Revision, Procedure Coding System (ICD-10-PCS) for inpatient hospital procedure coding, including the Official ICD-10-PCS Guidelines for Coding and Reporting, as maintained and distributed by the HHS, hereinafter referred to as ICD-10-PCS. These new codes replace the International Classification of Diseases, 9th Revision, Clinical Modification, Volumes 1 and 2, including the Official ICD-9-CM Guidelines for Coding and Reporting, hereinafter referred to as ICD-9-CM Volumes 1 and 2, and the International Classification of Diseases, 9th Revision, Clinical Modification, Volume 3, including the Official ICD-9-CM Guidelines for Coding and Reporting, hereinafter referred to as ICD-9-CM Volume 3, for diagnosis and procedure codes, respectively.

[Systematic search for information on ethical issues in HTA reports on medical technologies or interventions]. / Systematische Gewinnung von Informationen zu ethischen Aspekten in HTA-Berichten zu medizinischen Technologien bzw. Interventionen.

BACKGROUND: The aim of a health technology assessment (HTA) is the complete and comprehensive evaluation of a medical technology or intervention. This includes the consideration of ethical aspects associated with the use of a medical technology or with the technology evaluation process. In this context, ethics, as a moral philosophy, embraces issues of autonomy, beneficence, non-maleficence, and justice. OBJECTIVES: Presentation of the working steps to retrieve information on ethical aspects; documentation and description of the various information sources available, as well as of the search terms and strategies tailored to the respective information sources. PROCEDURES: In addition to well-known national and international information sources such as bibliographic databases for HTA, biomedical sciences (e.g., MEDLINE), social sciences, and psychology, ethics databases are also used in the retrieval of information, which is performed analogously to the working steps applied in the retrieval of information for the evaluation of a health technology's clinical benefit. The databases allow search queries that present a combination of thesaurus and free-text terms or those that exclusively consist of free-text terms. The search results are completed by supplementary handsearching of ethics journals, websites of HTA institutions and institutions/organisations with key activities involving ethics and, if necessary, requests to ethics experts. CONCLUSION: Although the search for information on ethical issues of medical technologies is performed according to the same procedures as those that are followed in clinical benefit assessments, specific search strategies and additional specialist information sources are needed.