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Medical audit data: counting is not enough.

OBJECTIVE: To assess the meaningfulness of a year's worth of audit data relating to all the inpatients of one consultant general surgeon and to question the usefulness of certain outcome measures. DESIGN: Analysis of records entered on to audit computer (Dunnfile) and relating to inpatient episodes for one consultant general surgeon over one year. Data obtained were compared with ward records and the patient administration system to check their accuracy. SETTING: The three hospitals and 12 wards in Brighton health district where the surgeon admitted patients. SUBJECTS: 859 Records relating to inpatient episodes from 1 January to 31 December 1988. These covered 655 main procedures and 79 secondary procedures performed at the same time. MAIN OUTCOME MEASURES: Procedures were analysed by complexity of operation (BUPA code) and grade of surgeon; complications were counted and rates constructed by surgeon and by BUPA code: returns to theatre were analysed. RESULTS: Simple counts revealed some data, such as the fact that one registrar performed more major operations (32) than the senior registrars (22 and 14), and an analysis of complications showed that he had a lower complication rate (11.4% v 20.0% and 19.4%). But the simple complication rate disclosed nothing about whether the complication was avoidable. Likewise, the number of returns to theatre needed further qualification. Analysis of data collection for February to April 1988 showed a 30% deficit of information on the audit system compared with ward records and prompted a re-examination of everyone's role in collecting data. After the year's audit there was still a 17% shortfall compared with the district's patient administration system, though some of this was accounted for by a backlog of work. CONCLUSIONS: It is difficult to ensure adequate data collection and entails everyone in an unfamiliar discipline. Connecting the audit system to the patient administration system would help. Despite the limitations of crude analyses of workload and complications rates, the audit data helped to measure activity and in the management of the firm. Nevertheless, time and care have to be taken in presenting and interpreting audit data carefully. IMPLICATIONS: Counting is not enough.

Aged

Extending the use of clinical audit data: a resource planning model.

OBJECTIVE: To create a means by which we can examine and understand the interrelations among the fundamental elements of hospital inpatient care (patients, beds, theatre time, and staff). DESIGN: Predictive study of resource utilisation based on a computerised clinical information system of five years' audit data from a surgical management system. SETTING: One surgical firm (of one consultant, one registrar, and one preregistration houseman) in a district general hospital. PATIENTS: 5267 Patients whose admission records were part of the five years' audit of surgical management. MAIN OUTCOME MEASURES: Mean length of stay; number of occupied beds; turnover interval; throughput (patients/bed); percentage elective theatre occupancy; waiting time for elective admissions; and theatre, hotel, and total costs. RESULTS: Predicted outcome was analysed in the model, taking the actual outcomes in 1988-9 as baseline values, for four clinical scenarios: an increase in accident and emergency admissions, a reduction in beds, a reduced length of stay, and creation of a new firm. Baseline values showed a mean stay of just over five days in 15 beds and with a theatre occupancy of 94%; the total cost was 812,000 pounds (hotel costs 597,000 pounds). Increasing the accident and emergency admissions to 460/year (19%), based on projected trends from 1984 to 1988, resulted in increased hotel costs (55,000 pounds) and reducing bed numbers (by halving admissions) in decreased use of theatres to 71%, decreased throughput, and increased waiting time, from 20 to 92 weeks, at a saving of 99,000 pounds (12%). Reducing stay marginally reduced bed occupancy (8%) and hotel costs (14%), and creating a new surgical team considerably reduced bed occupancy (14%) and waiting time for elective operations (by 20%). The minimum number of beds for referrals, accident and emergency admissions, and planned admissions was 9.0; that for urgent elective admissions was 3.3 and for non-urgent admissions was 2.4. CONCLUSION: A well designed clinical information system with the routine collection of data can provide the necessary output data to enable resource modelling. IMPLICATION: Use of such a model will allow clinicians to participate in resource planning on the basis of what is actually happening within the hospital.

Data Interpretation, Statistical

The role of data audits in detecting scientific misconduct. Results of the FDA program.

To evaluate the extent of the problem of scientific misconduct in investigational drug trials, we reviewed data from 1955 routine audits conducted by the US Food and Drug Administration (FDA) from June 1977 to April 1988. Serious deficiencies were detected in 12% of audits prior to October 1985, but in only 7% since that date. At the same time, there was no evidence of a decline over time in the rate of detection of many categories of deficiencies, and some investigators were able to continue to participate in drug trials after flagrant violations of recognized norms of research. The data auditing program should be continued, but additional measures are needed to regulate misconduct. These must be tailored to the variety of causes of misconduct, ranging from negligence to fraud. Possible additional approaches could include certifying the competence of potential investigators; peer-reviewed, competitive application for the opportunity to conduct FDA-authorized clinical trials; limiting an investigator's level of participation in clinical trials; penalizing manufacturers who fail to detect their investigators' misconduct; and permitting the FDA to suspend investigators prior to a hearing. Measures taken should maximize public utility at the least economic cost to society and should be evaluated thoroughly.

Biomedical Research

Breast cancer data collection for surgical audit.

Data are available about the mortality, the incidence, the stage, the survival, and the treatment of breast cancer. In this country mortality data are published by the OPCS and HIPE and evidence exists to show that there is a considerable shortfall in both these sources. The incidence of breast cancer is recorded by the Regional Cancer Registries and published by OPCS. The registries supply OPCS with a minimum data set which does not include the stage of the disease, which is important, and does include the quadrant, which is not. Audit shows marked regional variations in completeness of registration. International comparisons with Scandinavia are unfavourable and show what can be achieved. Patients who develop breast cancer but do not die from it may be cured. The discrepancy between incidence and mortality, which varies both geographically and historically, should therefore provide a valuable insight into changing survival, but does not do so because the data are unreliable. Wide variations in survival figures in the medical literature are probably due to variations in staging conventions rather than different treatments. It is clear that cancer stages carry a more favourable prognosis, but it still cannot be proved that earlier diagnosis in a particular individual prolongs the life of that individual. This unproven hypothesis is the rationale for mammographic screening. Data on treatment in hospitals do not link diagnosis to operation, so that it is impossible to separate operations for benign breast disease from those for cancer. The OPCS classification of operations is complex with many open-ended choices. Doctors do not participate in the coding process and clerks cannot make up for this. Radiotherapy and chemotherapy data are not collected nationally and the four regional registries who do collect it also rely on their clerks' interpretation of medical notes. Data on the use of tamoxifen are consistent and of high quality.An extensive data gathering mechanism is in place for breast cancer. A huge body of information exists about the disease which should form a valuable database. The poor quality of this information reduces its usefulness. It is the responsibility of doctors to agree on a data set and to ensure its collection. They do it in Scandinavia.

Breast Neoplasms

Cost of urology: financial audit in a clinical department.

OBJECTIVES: To cost a clinical unit over one month in 1991, to cost treatment of individual patients from audit data, and to compare this costing method with the hospital charging system. DESIGN: A financial breakdown was obtained for one month's work. Ward stay, operating time, investigations, and outpatient visits were costed and a formula (episode = days on ward+hours of operating+investigations+outpatient visits) was used to cost patient episodes from audit data. SETTING: The adult urology unit in a teaching hospital. MAIN OUTCOME MEASURES: Costs for each part of patients' treatment. RESULTS: Total cost was 147,796 pounds for 159 admissions, 738 inpatient days, 131 operations in 29 operating lists, and 615 outpatient visits. An uncomplicated transurethral prostatectomy cost 1140 pounds but complications increased this to 1500 pounds in another patient. The costs of diagnostic cystoscopy were 130 pounds in outpatients, 240 pounds in day surgery, and 430 pounds in inpatients. Hospital charges do not reflect the individual costs of treatment, charges being greater than costs for some patients and lower than costs for others. CONCLUSIONS: Clinicians can produce a financial analysis of their work and cost their patients' treatment. Audit is strongly advocated as a resource planning tool.

Adult

Quality assurance and monitoring in the Hypertension Prevention Trial. Hypertension Prevention Trial Research Group.

The Hypertension Prevention Trial (HPT), was a randomized, controlled, multicenter (four clinics, four resource centers) trial designed to test the feasibility of achieving and sustaining dietary changes in the intake of calories, sodium, and potassium and to assess the effect of those changes on blood pressure in a normotensive population. The trial involved 841 men and women (plus a test cohort of 78) who, at the first baseline (BL) examination were in the age range of 25-49 years and had diastolic blood pressure (DBP) greater than or equal to 76 but less than 100 mm Hg (average of two readings), and at the examination prior to randomization (BL 2) had DBP greater than or equal to 78 but less than 90 mm Hg (also averaged). Participants were randomly assigned to a control treatment group (no dietary counseling) or to one of four dietary treatment groups involving counseling designed to reduce calorie intake, reduce sodium intake, reduce sodium and calorie intake, and reduce sodium and increase potassium intake. This chapter describes HPT procedures for training and certifying clinic staff, for data entry checks and data audits of its distributed data entry system, and for inspecting clinical equipment. Replicate analyses were performed regularly by the two arms of the Data Coordinating Center. The Food Coding Center and the Central Laboratory were evaluated by both internal and external monitoring techniques. The performance monitoring report, prepared semiannually for the governing committees of the HPT, reported on the effectiveness of quality assurance procedures and served to alert staff to developing problems.

Adult

Evaluating the quality of the maternity services--a discussion paper.

OBJECTIVE: A review of the use of computer collected audit data in assessing the quality of maternity services. SETTING: All maternity units managed by the North West Thames Regional Health Authority. RECOMMENDATIONS: A system of audit must supply information that is both credible and of interest to clinicians managers and consumers. The information should be adjusted for differences in populations to allow valid comparisons between units. It needs to be presented in an easily digested form. One way of implementing audit would be to establish a regional group representative of clinicians, patients and managers who would initially interpret the data and make recommendations. A local group of similar composition would be asked to comment on and respond to these with a plan for the following year. Changes would be monitored by analysis of the routinely collected data. CONCLUSIONS: Medical audit in the maternity services requires new concepts if it is to influence the quality of clinical care and the use of resources available to provide that care. The appropriate balance needs to be found between the perspectives of clinicians, patients and managers. A major challenge is the collection of valid data. This has largely been overcome by the St Mary's maternity information system. The next stage is to devise a system of audit that is epidemiologically sound and is acceptable to those who will be asked to implement the lessons that emerge. Only then will it be possible to determine whether clinical practice and the use of resources can be altered to the benefit of patients.

Data Collection

Audit of the quality of hospital discharge data.

An audit of the quality of computerised hospital discharge data, in General Medicine and Paediatrics in Dundee, showed that the national data set was often inaccurate. Structured discharge summaries checked by senior medical staff are recommended.

Abstracting and Indexing

Nutrition and growth analysis of very low birth weight infants.

The growth and nutrition of 220 very low birth weight infants were reviewed after comprehensive data on all infants in the hospital were entered into the Neonatal Intensive Care Unit Audit Data Base for 2 years prospectively. Fluid and energy (parenteral and oral) intakes were compared in four birth weight categories (1, less than or equal to 750 g; 2, 751 to 1000 g; 3, 1001 to 1250 g; 4, 1251 to 1500 g). Parenteral nutrition was the major source of first nutrition for the small infants, but seldom did it alone provide adequate nutrition for very low birth weight infants. The age of the first nutrition (parenteral and/or oral nutrition other than dextrose) decreased with increasing birth weight. The age of the first oral feedings was later for the infants of the lower birth weights but enteral feeding became the major nutrition for all weight categories by the second week of life. During the first 50 days the infants accumulated a deficit of 3780 to 5460 kJ relative to their estimated need of 504 kJ/kg per day, with the smaller infants accumulating a significantly larger deficit. The growth of infants appropriate for gestational age and of infants small for gestational age differed from each other and from the commonly used graph of Dancis et al (J Pediatr. 1948;33:570-572).

Alberta

Magnitude of antibiotic use.

Trends in antibiotic prescribing can be examined by a review of data from dispensed prescriptions and from antibiotic certification records of the Food and Drug Administration (FDA). Prescription data on selected oral antibiotics and anti-infectives were obtained from IMS America's National Prescription Audit. Data compiled between 1965 and 1977 show increasing use until 1973--with a plateau thereafter--for antibiotics judged by physicians to be relatively "safe," namely, the erythromycins, ampicillin and other penicillins, and the cephalosporins. Tetracycline use, although rising until 1973, declined somewhat thereafter, perhaps because of increasing concern with dental staining in children. Sulfonamide use has declined steadily since 1965, presumably for safety reasons. Used of clindamycin was nearing a level similar to that of cephalosporin use until 1975, when its risk of precipitating severe colitis, including pseudomembranous colitis, became well-known. The FDA's antibiotic certification records show that the volume of injectable cephalosporins and gentamicin administered has increased steadily and as of 1977 was still rising.

Administration, Oral

Six flaws revealed: how to make your audit/MCE studies more meaningful.

A study that lacks a definite design lacks direction and is defeated before it starts. Careful study design, however, is not the only indication of a successful audit. Approaching variation analysis in a positive rather than punitive manner enhances the committee's ability to recognize important findings and discover imaginative uses for audit data. When problems in care are revealed through evaluation activities, the committee must make recommendations that are appropriate to the causes of the problem and that can be readily implemented. An audit committee that discharges these responsibilities will produce a study that should surely yield informative data. The committee's ultimate goal--improved patient care--can not be far behind.

Analysis of Variance

Medical costs of osteoporosis.

Global healthcare expenditure has risen at an alarming rate over the past thirty years and the situation is most pronounced in the USA, which now spends 12% of its gross domestic product on healthcare. The greatest component of this expenditure is accounted for by the costs of hospitalisation, and is also particularly centred on the elderly sector of the population - a group that, relative to other sections of the population, will expand over the next thirty years. Osteoporosis, a chronic, disabling disorder, predominantly affects the elderly. Growth in the recognition and level of intervention in osteoporosis, when viewed alongside the increase in the elderly population, emphasises the need to examine the costs of osteoporosis against the already burgeoning healthcare bill. A detailed study in the USA in 1986 assessed the direct medical costs of osteoporosis in women over the age of 45; analysis included the costs of hospitalisation, nursing home care and outpatient services. The results of this survey revealed a figure for total direct costs of $5.15 billion, with hospital and nursing home care being the greatest contributors. A subsequent analysis of data for 1989 has shown expenditure to have risen to over $6 billion. This form of economic assessment of direct medical costs, based on discharge surveys and audit data, is likely to be reasonably accurate for osteoporosis-related hip and wrist fractures, which will generally present to hospitals, but less so for vertebral fractures, which have a varied clinical presentation.(ABSTRACT TRUNCATED AT 250 WORDS)

Age Factors

Combined surgical audit by microcomputer involving units in four health regions.

General surgeons from hospitals in four well-separated health districts collected audit data about their patients using common software. They pooled their results in order to make comparisons between their practices. Data on 22,497 admissions including 17,473 operations were available. The data were found to be easy to collect and analyse using this program. There were significant differences in overall complication rates between the four centres, but these seem to be explained by differences in the emergency workload, case mix, and age range of the population treated. A study of inguinal hernia repairs and appendectomies showed low complication rates with no significant differences between centres, with the single exception of a higher incidence of wound problems in one centre. Because of the multiplicity of factors affecting them, complication rates could only be properly understood in a professional surgical context. Isolated figures would be open to damaging misrepresentation. Meetings between surgeons well armed with their own results seem to be the best way to forward the audit process.

Age Factors

Acute ischaemia of the lower limb: the effect of centralizing vascular surgical services on morbidity and mortality.

Surgical audit data for two 5-year periods (1974-78 and 1983-87) have been compared in a Health Board Area to assess the impact of centralization of emergency vascular services on the treatment of the acutely ischaemic lower limb. Patient populations in each period were comparable. Mortality rates remained constant in both periods at approximately 30 per cent. A significant improvement in overall limb salvage was observed (from 54 to 67 per cent, P less than 0.05). Limb salvage in survivors was improved from 80 to 95 per cent (P less than 0.001) and was paralleled by an increase in the number of reconstructive vascular procedures performed. We concluded that the centralization of emergency vascular services has not led to a reduced risk of mortality but has been associated with improved limb salvage.

Acute Disease