Usability and Safety of Software Medical Devices: Need for Multidisciplinary Expertise to Apply the IEC 62366: 2007.

Software medical devices must now comply with the "ergonomics" essential requirement of the Medical Device Directive. However, the usability standard aiming to guide the manufacturers is very difficult to understand and apply. Relying on a triangulation of methods, this study aims to highlight the need to combine various expertises to be able to grasp the standard. To identify the areas of expertise on which the usability standard relies, an analytical review of this document was performed as well as an analysis of a discussion forum dedicated to it and an analysis of a case study of its application for CE marking. The results show that the IEC 62366 is a usability standard structured as a risk management one. It obviously requires Human Factors/Ergonomics expertise to be able to correctly identify and prevent risks of use errors, but it also requires risk management expertise to be able to grasp the issues of the risk analysis and master the related methods.

Application and Outcomes of Treatment Guidelines in a Utilization Review Program.

The value of treatment guidelines in improving outcomes for patients and controlling costs is significantly enhanced in Washington by incorporating guidelines into a structured UR program. This article describes: (1) how the Washington Department of Labor and Industries (L&I) UR program uses guidelines; and (2) the impact of the UR program on costs and outcomes. The impact of guideline implementation in the Washington program is considerable. In 2014, the L&I program produced net savings of $7,519,823, and the return on investment was approximately $2.00. The impact on clinical outcomes includes an overarching effect from use of best practices.

[Calculation of standardised unit costs from a societal perspective for health economic evaluation]. / Ermittlung standardisierter Bewertungssätze aus gesellschaftlicher Perspektive für die gesundheitsökonomische Evaluation.

PURPOSE: Due to demographic aging, economic evaluation of health care technologies for the elderly becomes more important. A standardised questionnaire to measure the health-related resource utilisation has been designed. The monetary valuation of the resource use documented by the questionnaire is a central step towards the determination of the corresponding costs. The aim of this paper is to provide unit costs for the resources in the questionnaire from a societal perspective. METHODS: The unit costs are calculated pragmatically based on regularly published sources. Thus, an easy update is possible. RESULTS: This paper presents the calculated unit costs for outpatient medical care, inpatient care, informal and formal nursing care and pharmaceuticals from a societal perspective. CONCLUSION: The calculated unit costs can serve as a reference case in health economic evaluations and hence help to increase their comparability.

Condition Code 44 or Condition Code W2?

When hospitals determine after discharge that a patient did not meet inpatient criteria, they can file a provider liable claim using Condition Code W2 and be reimbursed for all services as if the patient were an outpatient, according to Deborah Hale, CCS, CCDS. The claims must be filed within 12 months after discharge. The medical record must be reviewed by the physician advisor and the utilization review committee before the claim is submitted. It is still advantageous to get the patient status right up front.

The appropriateness method has acceptable reliability and validity for assessing overuse and underuse of surgical procedures.

OBJECTIVE: To summarize the findings of methodological studies on the RAND/University of California Los Angeles (RAND/UCLA) appropriateness method, which was developed to assess if variation in the use of surgical procedures is because of overuse and/or underuse. STUDY DESIGN AND SETTING: A MEDLINE literature search was performed. Studies were included if they assessed the reliability or validity of the RAND/UCLA appropriateness method for a surgical procedure or the effect of altering panelist composition or eliminating in-person discussion between rating rounds. Information was abstracted on procedure, study design, and findings. RESULTS: One thousand six hundred one titles were identified, and 37 met the inclusion criteria. The test-retest reliability is good to very good (kappa, 0.64-0.81) for total knee and hip joint replacement, coronary artery bypass grafting (CABG), and carotid endarterectomy (CEA). The interpanel reliability is moderate to very good (kappa, 0.52-0.83) for CABG and hysterectomy. Construct validity has been demonstrated by comparing the appropriateness method with guidelines and/or evidence-based approaches for endoscopy, colonoscopy, CABG, hysterectomy, and CEA. Predictive validity has been studied for cardiac revascularization, in which concordance with appropriateness classification is associated with better clinical outcomes. CONCLUSION: Our findings support use of the appropriateness method to assess variation in the rates of the procedures studied by identifying overuse and underuse. Further methodological research should be conducted as appropriateness criteria are developed and implemented for a broader range of procedures.

Comparing diagnosis-related group systems to identify design improvements.

The objective of this research was to compare the casemix systems used in the United Kingdom (UK), Australia and the United States of America (USA) to identify possible improvements in the design of the UK Healthcare Resource Groups. The data consisted of over 12 million inpatient and day case discharge records from 574 National Health Service acute hospitals in England for 2001-2002. These data were grouped into four casemix systems, namely Versions 3.1 and 3.5 of Healthcare Resource Groups, the United States-based All Patient Diagnosis Related Groups, and the Australian Refined Diagnosis Related Groups. The statistical performance of the groups was measured using the reduction in variance (RIV) statistic. The Australian Refined Diagnosis Related Groups produced the best RIV overall but this grouper had the advantage of more groups than the others. The comparison of the performance of the chapters within each grouper showed that each had some chapters with a better RIV than the other groupers. Comparing the performance of these groupers was successful in identifying changes to the Healthcare Resource Groups that improved its performance. Further revision of the Healthcare Resource Groups should be focused on the chapters with the best potential for improved performance.

Unmeasured improvement work: the lack of routinely collected, service-related data in NHS endoscopy units in England involved in "modernisation".

BACKGROUND: The availability of routinely collected service-related endoscopy data from NHS endoscopy units has never been quantified. METHODS: This retrospective observational study asked 19 endoscopy units to submit copies of all in-house, service-related endoscopy data that had been routinely collected by the unit - Referral numbers, Activity, Number of patients waiting and Number of lost slots. Nine of the endoscopy units had previously participated in the Modernising Endoscopy Services (MES) project during 2003 to redesign their endoscopy services. These MES sites had access to additional funding and data collection software. The other ten (Control sites) had modernised independently. All data was requested in two phases and corresponded to eight specific time points between January 2003 and April 2006. RESULTS: Only eight of 19 endoscopy units submitted routinely collected, service-related data. Another site's data was collected specifically for the study. A further two units claimed to routinely collect service-related data but did not submit any to the study. The remaining eight did not collect any service-related endoscopy data routinely and liaised with their Trust for data. Of the eight sites submitting service-related data, only three were MES project sites. Of these three, the data variables collected were limited and none collected the complete set of endoscopy data variables requested. Of the other five sites, two collected all four endoscopy data types. Data for the three MES project sites went back as far as January 2003, whilst the five Control sites were only able to submit data from December 2003 onwards. CONCLUSION: There was a lack of service-related endoscopy data routinely collected by the study sites, especially those who had participated in the MES project. Without this data, NHS endoscopy services cannot have a true understanding of their services, cannot identify problems and cannot measure the impact of any changes. With the increasing pressures placed on NHS endoscopy services, the need to effectively inform redesign plans is paramount. We recommend the compulsory collection of service-related endoscopy data by all NHS endoscopy units using a standardised format with rigorous guidelines.

Paying the price of excluding patients from a trauma registry.

BACKGROUND: The goal of this study was to evaluate the impact of different trauma registry exclusion criteria on the assessment of trauma populations and outcome. METHODS: All patients admitted to a Canadian regional trauma center from April 1, 1993 to March 31, 2002 with a diagnosis of trauma (ICD-9 codes 800 to 959) were reviewed. TOTAL included everyone. REGISTRY included only patients meeting any of four criteria: death during hospital stay, transfer received from another hospital, admission to the intensive care unit, or hospital stay of 3 days or more. NOHIP excluded patients with isolated hip fracture. REG/NOHIP combined both. ISS12 and ISS15 excluded patients with ISS <12 and 15, respectively. RESULTS: There were 6,839 trauma patients. The percentage of excluded patients by group was: REGISTRY, 21.2%; NOHIP, 14.7%; REG/NOHIP, 34.9%; ISS12, 75%; and ISS15, 80.3%. Median length of stay was 7 days. Exclusions represented a total number of hospitalization days varying from 1.9% to 65.5% of TOTAL. Mortality was 6.9% for TOTAL, 8.6% for REGISTRY (p < 0.001), 5.7% for NOHIP (p = 0.009), 7.5% for REG/NOHIP (p=NS), 16.1% for ISS12 (p < 0.001), and 20.4% for ISS15 (p < 0.001). In groups with exclusions, transfer to long-term care varied from 0.14% to 23.5% in the excluded patients. For rehabilitation, these percentages varied from 0.14% to 17.6%. CONCLUSIONS: Registry exclusion criteria significantly alter the apparent severity of injury and resource utilization. The use of divergent exclusion criteria in the analysis of trauma registry data may be misleading.

Emergency department visits in Wisconsin 1998-2002: trends in usage and accuracy of reported data.

INTRODUCTION: There is a paucity of data regarding the utilization of emergency departments (EDs) across Wisconsin. It is unknown if national trends in increased utilization are consistent within our state. Several years ago, mandatory reporting of ED visits to the Department of Health and Family Services was instituted and, if accurate, may provide a method for tracking ED usage. METHODS: We conducted a survey of existing EDs to study the trend in patient visits for the 5-year time period 1998-2003. Data reported in the surveyed departments were compared to those reported to the state database. RESULTS: On average, all EDs reported a consistent yearly increase in patient visits over the time period (an average overall increase of 10%). On average, this increase was larger for smaller hospitals. Growth was consistent over the time period, but the yearly rate steadily slowed down. Data reported to the state consistently underreported the actual census. CONCLUSION: All sizes of EDs across Wisconsin continue to show increases in ED utilization. The growth rate is consistent but may be slowing. This has implications for planning for ED resources. Reported data have many discrepancies and need to be independently checked before they can be utilized in any research or planning.

West Virginia Medical Institute: the Quality Improvement Organization for West Virginia.

The Federal Quality Improvement program, (QIO), charged with quality improvement and some case review activities is conducted under a contract with the Centers for Medicare and Medicaid Services (formerly HCFA), now CMS. Every state has one organization which handles this program and in West Virginia, the West Virginia Medical Institute has been responsible for this work for over 30 years. When case review is involved, the conclusions are communicated to individual physicians and hospitals. Occasionally, serious quality of care concerns are encountered. This article explains the case review process and why cases are selected, and also makes suggestions about how individual physicians may appeal or respond. It is designed to help enhance understanding of the program and its goals.

The reliability of assessing the appropriateness of requested diagnostic tests.

Despite a poor reliability, peer assessment is the traditional method to assess the appropriateness of health care activities. This article describes the reliability of the human assessment of the appropriateness of diagnostic tests requests. The authors used a random selection of 1217 tests from 253 request forms submitted by general practitioners in the Maastricht region of The Netherlands. Three reviewers independently assessed the appropriateness of each requested test. Interrater kappa values ranged from 0.33 to 0.42, and kappa values of intrarater agreement ranged from 0.48 to 0.68. The joint reliability coefficient of the 3 reviewers was 0.66. This reliability is sufficient to review test ordering over a series of cases but is not sufficient to make case-by-case assessments. Sixteen reviewers are needed to obtain a joint reliability of 0.95. The authors conclude that there is substantial variation in assessment concerning what is an appropriately requested diagnostic test and that this feedback method is not reliable enough to make a case-by-case assessment. Computer support maybe beneficial to support and make the process of peer review more uniform.

Identifying and validating managed care data.

In a managed care organization, data can be the key to facilitating high-quality care and to managing patient care delivery systems effectively, in addition to monitoring costs. Reviewing electronic data requests before contacting data producers, asking the right questions about data, and knowing how to identify good data can help financial managers use data effectively to provide information. In the managed care environment, information is only as good as the steps taken to obtain and validate the data.

Pediatric length of stay guidelines and routine practice: the case of Milliman and Robertson.

BACKGROUND: Guidelines for inpatient length of stay (LOS) have been developed by Milliman and Robertson (M&R) and are widely applied by health plans. This study was designed to compare LOS for several pediatric conditions with the M&R LOS criteria using recent data and to determine if concordance of actual practice with M&R LOS criteria varied between children and adults. DESIGN: Administrative data from Pennsylvania hospitals from 1996 through 1998 were used to examine LOS for hospital discharges for 12 selected diagnoses for which M&R published guidelines for children and adults. PATIENTS: Discharge data for all patients discharged from public and private hospitals in Pennsylvania for which 1 of 12 selected diagnoses were examined. MAIN OUTCOME MEASURE: Length of stay. RESULTS: In Pennsylvania hospitals from 1996 through 1998, pediatric LOS was divergent for all conditions examined, although not to the extent found in a previous study examining data from New York State. Of note, median LOS for some conditions was shorter than M&R LOS criteria. The percentage of pediatric hospital discharges that exceeded the M&R LOS criteria ranged from 25% for pneumonia to 84% for meningitis. Adult hospital discharges exceeded M&R LOS criteria to a greater extent than did pediatric discharges for all conditions except for sickle cell crisis and meningitis. CONCLUSIONS: The M&R LOS criteria were divergent from routine practice for both children and adults. Greater divergence of adult discharges illustrates the need to consider comorbid conditions when implementing these guidelines. Thus, patient care may suffer if guidelines are implemented in an uninformed way. These findings emphasize the importance of using the best possible science when producing guidelines such as these.