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PubMed2006

The roles of policy and professionalism in the protection of processed clinical data: a literature review.

BACKGROUND: Routinely collected clinical data is increasingly used for health service management, audit, and research. Even apparently anonymised data are subject to data protection. The relevant principles were set out in a treaty of the Council of Europe and subsequent policy has been based on these. However, little has been written about implementing policy and the role of health informaticians in this process. OBJECTIVE: To define the elements of an effective implementation policy; the role of the health informatician in protecting processed clinical data. METHODS: We performed a literature review of bibliographic databases, a manual search of the major medical informatics associations' websites, relevant working groups and an affiliated journal. Fifty-four papers relevant to implementation were identified. RESULTS: The effective implementation of policy requires consideration of technical, organisational, personnel and professional issues. However, there is no clearly defined formula for successful implementation of data protection policy. CONCLUSIONS: Patients and professionals need a system they can trust, and processes that can be easily incorporated into everyday practice. The lack of a core generalisable theory or strong professional code in health informatics limits the ability of the health informaticians to implement policy.

Confidentiality↗
PubMed1976

Quality assurance: the cost of utilization review and the educational value of medical audit in a university hospital.

The components of mandated quality assurance, that is, utilization review (UR) and medical audit, have been analyzed to determine their cost-effectiveness and educational value in a university hospital. At Ths in 1975 were $205,272--$6.71 per admission or $0.69 per patient day. The average costs per admission and per patient day in teaching hospitals in the New York area in 1975 were $10.42 and $0.93, respectively. It is anticipated that these costs will increase markedly in 1976 because of admission review. Since 1972 approximately 9,500 hospital charts have been reviewed annually to identify an average of six patients per year who required the intervention of the UR committee because of unnecessarily prolonged length of stay. The cost of identifying each patient was $33, 212. In the university hospital, the active participation of the graduate (house) staff in patient care renders the requirements for certification/recertification of the need for hospital services or admission review superfluous. From September, 1973, through December, 1975, 15 studies of evaluation of medical care (medical audit) have been completed at an average cost of $4,788 per audit. In ten audits the principal criticism was inadequate documentation of data in the hospital record. Nine audits were critical of excessive use of laboratory services and deviations of practice were identified in seven audits. Medical audit has failed to achieve its objective to identify the educational needs of the hospital staff. It is suggested that a more satisfactory and less costly form of medical audit should be devised. Clinical studies, published in scientific journals, should be considered in the context of medical audit.

Adolescent↗
PubMed1991

Use of ampicillin-sulbactam before and after formulary inclusion.

The use of ampicillin-sulbactam before and after the product was formally placed on a hospital formulary is described. In October 1987 the pharmacy and therapeutics committee at an acute-care institution granted ampicillin-sulbactam temporary formulary inclusion on the condition that its use be audited. Formal inclusion was to be based on the results of this preinclusion audit. A second audit was to be performed if formal inclusion was granted. The data were collated after each audit, and for each patient an infectious-disease consultant proposed an alternative antimicrobial regimen representing what would probably have been prescribed had ampicillin-sulbactam not been available. Sixty-four patients received the product during the six-month preinclusion audit period. Ampicillin-sulbactam was given to 37% of the patients for indications listed in FDA-approved labeling. The dosage was considered appropriate in 88% of the patients. Clinical outcome was considered successful in 84% of the patients who received the product for known infections. Therapy with ampicillin-sulbactam was less expensive (by $4125) in 35 patients and more costly (by $1523) in 29 patients; the projected annual savings were $7805. After formal inclusion on the formulary, ampicillin-sulbactam was prescribed for some 700 patients over a 16-month period. A review in 49 patients showed appropriate indication and dosage for 63% and 84% of the patients, respectively, and an 84% rate of therapeutic success. The extrapolated cost savings were $26,429 per year. After formulary inclusion, the use of ampicillin-sulbactam increased, as did the frequency of its use for indications appearing in FDA-approved labeling.

Ampicillin↗
PubMed1986

Combined computer generated discharge documents and surgical audit.

A computerised audit system using a commercially available database program and a word processing program was devised to produce discharge documents close to the time of discharge. The data were available for audit of the surgical unit's work. It was found that secretarial time was more efficiently used and general practitioners received more information about their patients earlier than before.

Computers↗
PubMed1987

Monitoring accountability of a clinical nutrition service.

The first step in the effort to establish a stronger link between nutrition care intervention and health status is to identify actual services provided. This study examined the accountability of a clinical dietetic staff by using an explicit procedure that made it possible for performance to be measured. Data were gathered at an urban teaching hospital to determine the nutrition care provided as compared with stated standards. Using the Policy and Procedure Manual as the written standard, the authors analyzed data from medical record audit, time utilization studies, staff interviews, and monthly reports. The level of accountability was very high, with less than 1 discrepancy in 10, for all the data collected. The dietetic staff members at the hospital verified the attainment of established standards by clearly and specifically documenting their services. It would appear that a decision about priorities and responsibilities had been made that was well supported by staff and institution. The establishment of a nutrition care team, in which clinical dietitians assumed a supervisory role that promoted and supported delegation to dietetic technicians and dietetic assistants, also contributed to good performance.

Connecticut↗
PubMed2000

Practical considerations in case study research: the relationship between methodology and process.

This paper explores the extent to which the design of a research study is influenced by pragmatic as well as theoretical considerations by describing the authors' experience of conducting multiple case studies in the context of a policy-orientated research project. The case studies in question formed part of a collaborative project exploring the development of innovative roles in nursing and the professions allied to medicine. The researchers adopted Yin's approach to the conduct of multiple case studies to explore issues relating to the effectiveness of new roles, their resource implications and educational issues surrounding their development. They address the fact that methodological decisions have practical implications and also explore the effects of practical and ethical issues on research design. Three purposively selected acute National Health Service Trust hospitals in England formed the case study sites for the work recorded in this paper. In each Trust, three nursing roles were selected, making nine cases for study. A variety of data collection strategies were used including semi-structured interviews with post-holders and other stakeholders (n = 51), non-participant observation of meetings, collection of audit, financial and statistical data and review of relevant documentation. This paper describes some of the dilemmas which arose during the course of the study, the rationale for methodological decisions taken to resolve these dilemmas and the steps taken to enhance rigour. In particular, the authors discuss the problems associated with obtaining informed consent in the context of qualitative research and with member validation of transcripts in a context where confidentiality was crucial. The decision to present findings thematically rather than as individual cases is justified both in terms of the nature and purpose of the research and in relation to the particular importance of anonymity and confidentiality in this study. Finally, the degree of reciprocity between researcher and researched is discussed.

Attitude of Health Personnel↗
PubMed1993

Accuracy of a computer-based anaesthetic audit system.

The accuracy of an anaesthetic computer-based audit system was assessed. In a retrospective survey of operations performed 4 months previously only 50% of the patients' notes could be found, and 40% of these notes did not contain an anaesthetic chart. A prospective survey was also performed. The accuracy with which the computer output reflected the anaesthetic technique was found to be 52% in the retrospective survey and 33% in the prospective survey. The authors conclude that audit systems should be audited before their generated data are used for decision-making.

Anesthesia↗
PubMed1995

Culture audits: a tool for change.

The culture audit, which has five phases--needs awareness, diagnosis, planning, action, and evaluation--is a critical tool for easing cultural transformation in healthcare organizations. The objective of the audit--usually conducted by outsiders--is to help leaders better understand the current culture and adapt the culture to enhance organizational performance. Most leaders contract with an outsider to facilitate the needs exploration process, often with the guidelines of an advisory team of managers and staff. During the diagnosis phase, the audit team chooses the data-gathering methods, collects and analyzes the data, and develops a model of the culture. The third phase of the culture audit involves planning interventions. Once leaders have a clear picture of their organization's culture, they must ascertain whether the culture will enhance or impede the changes demanded by healthcare reform and an increasingly competitive environment. During the action phase, the culture begins to move toward its desired future. This transition generally requires change in all the organization's systems, including technology, structure, rewards, decision making, budgeting, and managing. Finally, the organization assesses the impact of its culture on its performance. Using the original diagnosis as a baseline and the organization performance goals, the evaluation process maps the changing culture against the benchmark beginning and the goals.

Data Collection↗
PubMed1996

Mammography outcomes analysis: potential panacea or Pandora's box?

As a consequence of the demand for and perceived value of mammography outcomes analysis, collection of community-based mammography data by the NHMN and others has begun and is supported by the radiologists involved. Radiologists are increasing their use of standardized coding of report data necessary for clear communication and data collection but remain justifiably concerned about the confidentiality of these data. If stronger protection of these data is forthcoming, more radiologists will be encouraged to perform practice audits. The pooling of community-based data as exemplified by NHMN will create statistics that measure the actual practice of mammography and estimate its impact on breast cancer. For individual radiologists, the audit process will improve their mammography skills through direct feedback of results and provide important information about their patterns of interpretation. Although this approach will create community standards, comparisons with such standards may be more applicable among various communities than among individual radiologists because of the statistical variation created by the relatively small numbers of cancers found by individual radiologists, the differences in populations served by these radiologists, and the variability in reproducing the audit by individuals or groups. Pooled community data, however, will still be useful to community radiologists as general standards toward which to strive. We believe that medical audits offer important potential public health benefits for breast cancer control. Insofar as confidentiality issues cannot be effectively addressed by individual radiologists, institutions in a position to be advocates should immediately explore how legal underpinnings can be put in place to protect the audit process from disclosure. With such protection, the audit process may fulfill its potential for the radiologist's pivotal role in breast cancer control; without it, the process may prove to be a Pandora's box for the community radiologist.

Data Collection↗
PubMed2004

Testing for prostate and colorectal cancer: comparison of self-report and medical record audit.

BACKGROUND: Self-reported data are often used to determine cancer screening test utilization, but self-report may be inaccurate. METHODS: We interviewed members of three health maintenance organizations and reviewed their medical records for information on digital rectal exam (DRE), prostate-specific antigen (PSA) test, fecal occult blood test (FOBT), sigmoidoscopy, and colonoscopy (response rate 65%). We calculated the sensitivity, specificity, concordance, and kappa statistic to compare the two sources for black men (n = 363), white and other men (n = 847), and women (n = 920) by study location. RESULTS: For DRE, FOBT, sigmoidoscopy, and colonoscopy, testing rates determined by self-report were higher than those in medical records. Kappa statistics showed fair to good agreement (0.40-0.80) for PSA, sigmoidoscopy, and colonoscopy among most subgroups. For DRE and FOBT, the agreement was poor except among participants from one HMO. Sensitivity was > or = 80% for sigmoidoscopy among most subgroups, and > or = 85% for endoscopy (sigmoidoscopy and colonoscopy), >75% for DRE, and > or = 63% for PSA among all subgroups. Specificity exceeded 80% for FOBT and colonoscopy among all subgroups. Agreement was lower among older age groups. For all tests, agreement was poor between the reasons for testing. CONCLUSION: Overreporting for some cancer tests should be considered when using self-reported data to evaluate progress towards reaching national goals for prevention behaviors.

Aged↗
PubMed1995

Porphyromonas gingivalis: a proteinase/gene accounting audit.

Analysis of the available data on the Porphyromonas gingivalis proteinase system suggests that at most three different genes encode arginine-X- and lysine-X-specific cysteine proteinases. These are synthesized as polyproteins containing a prepropeptide, a catalytic domain and a hemagglutinin domain. Post-translational processing of each precursor is responsible for the variety of proteinase forms that are seen.

Base Sequence↗
PubMed2004

Alcohol drinking patterns and health care utilization in a managed care organization.

OBJECTIVE: To estimate the relationship between current drinking patterns and health care utilization over the previous two years in a managed care organization (MCO) among individuals who were screened for their alcohol use. STUDY DESIGN: Three primary care clinics at a large western MCO administered a short health and lifestyle questionnaire to all adult patients on their first visit to the clinic from March 1998 through December 1998. Patients who exceeded the National Institute on Alcohol Abuse and Alcoholism (NIAAA) guidelines for moderate drinking were given a more comprehensive alcohol screening using a modified version of the Alcohol Use Disorders Identification Test (AUDIT). Health care encounter data for two years preceding the screening visit were linked to the remaining individuals who responded to one or both instruments. Using both quantity-frequency and AUDIT-based drinking pattern variables, we estimated negative binomial models of the relationship between drinking patterns and days of health care use, controlling for demographic characteristics and other variables. PRINCIPAL FINDINGS: For both the quantity-frequency and AUDIT-based drinking pattern variables, current alcohol use is generally associated with less health care utilization relative to abstainers. This relationship holds even for heavier drinkers, although the differences are not always statistically significant. With some exceptions, the overall trend is that more extensive drinking patterns are associated with lower health care use. CONCLUSIONS: Based on our sample, we find little evidence that alcohol use is associated with increased health care utilization. On the contrary, we find that alcohol use is generally associated with decreased health care utilization regardless of drinking pattern.

Adult↗
PubMed1996

Planning for coronary angioplasty: guidelines for training and continuing competence. British Cardiac Society (BCS) and British Cardiovascular Intervention Society (BCIS) working group on interventional cardiology.

The following recommendations are made: 1 Existing centres undertaking angioplasty should increase their activity, and the target figure of 400 PTCA procedures per million of the United Kingdom population should be achieved by the end of 1996-97, or immediately thereafter. 2 Angioplasty centres should be appropriately equipped to undertake PTCA safely and effectively and provide a reliable emergency service. They should have a minimum of two trained PTCA operators jointly undertaking a minimum of 200 procedures per year at that centre, and have regular meetings to share experience. 3 Angioplasty operators should ensure that where the need arises patients undergoing PTCA can receive immediate attention from a trained operator at any time until discharge from hospital. 4 Trained operators should undertake at least 1-2 PTCA procedures per week (> 60 procedures per year) to maintain competence, and those undertaking so few procedures should increase their activity over the next three years to more than 100 a year. 5 Trainers should have performed at least 500 procedures before formally training others and should undertake a minimum of 125 procedures a year to maintain accreditation as a trainer. 6 Surgical cover for PTCA procedures should be mandatory and on site cover remains the strongly preferred option. Where surgical cover is provided off site, this should be at a centre less than 30 minutes away by road. Whether provided on or off-site it should be possible to establish cardiopulmonary bypass within 90 minutes of the decision being made to refer the patient for surgery. 7 All operators and interventional centres should audit their activity and results, review these data locally with colleagues, and provide regular audit returns to the national database run by BCIS. This will allow future recommendations concerning standards to take more account of risk stratification and actual outcomes, and not place such emphasis merely on volumes of activity. 8 These recommendations should be reviewed in three years.

Angioplasty, Balloon, Coronary↗
PubMed2006

Departmental audit of tonsillectomy haemorrhage rates: pitfalls in interpretation.

Concerns that a largely anecdotal increase in post tonsillectomy haemorrhage rates was related to the introduction of disposable instruments have prompted much investigation. The result has been, rather, to highlight other variables influencing this risk, but especially to insist on the following: 1. Training in traditional 'cold' techniques. 2. Regular departmental audit of haemorrhage rates. 3. Presentation of such data to patients to ensure informed consent. This audit demonstrates the pitfalls in interpretation of crude data, unadjusted for case-mix, in predicting individual patient risk and in national ranking of unit performance.

Adolescent↗
PubMed2006

Funnel plots, performance variation and the Myocardial Infarction National Audit Project 2003-2004.

BACKGROUND: Clinical governance requires health care professionals to improve standards of care and has resulted in comparison of clinical performance data. The Myocardial Infarction National Audit Project (a UK cardiology dataset) tabulates its performance. However funnel plots are the display method of choice for institutional comparison. We aimed to demonstrate that funnel plots may be derived from MINAP data and allow more meaningful interpretation of data. METHODS: We examined the attainment of National Service Framework standards for all hospitals (n = 230) and all patients (n = 99,133) in the MINAP database between 1st April 2003 and 31st March 2004. We generated funnel plots (with control limits at 3 sigma) of Door to Needle and Call to Needle thrombolysis times, and the use of aspirin, beta-blockers and statins post myocardial infarction. RESULTS: Only 87,427 patients fulfilled criteria for analysis of the use of secondary prevention drugs and 15,111 patients for analysis by Door to Needle and Call to Needle times (163 hospitals achieved the standards for Door to Needle times and 215 were within or above their control limits). One hundred and sixteen hospitals fell outside the 'within 25%' and 'more than 25%' standards for Call to Needle times, but 28 were below the lower control limits. Sixteen hospitals failed to reach the standards for aspirin usage post AMI and 24 remained below the lower control limits. Thirty hospitals were below the lower CL for beta-blocker usage and 49 outside the standard. Statin use was comparable. CONCLUSION: Funnel plots may be applied to a complex dataset and allow visual comparison of data derived from multiple health-care units. Variation is readily identified permitting units to appraise their practices so that effective quality improvement may take place.

Data Display↗
PubMed1976

Orphan data and the unclosed loop: a dilemma in PSRO and medical audit.

The experience of the Utah Professional Review Organization in conducting medical audit as a PSRO prototype, and later a PSRO, suggests that usage of diagnosis-oriented process audits, using criteria similar to those supplied by the American Medical Association, will result in accumulation of vast amounts of unusable data. Even studies based on outcome data may fail to change physician behavior substantially because of communication difficulties between the PSRO or hospital conducting the evaluation and the physicians subject to the audit. UPRO's experience suggests that medical audit can be made more effective if it employs a special study format that looks at a particular element of care, selected for its importance to patient welfare and potential for improvement. The study should be based on criteria solidly validated by clinical research, and should involve a direct and personal interaction between the review body and the physician being reviewed.

Education, Medical, Continuing↗