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A BASIC data management program for clinical laboratory audits.

Presented in this article is a simple computer program written in BASIC for audit purposes. Although it is developed with a DEC PDP-11 microcomputer, the program can be modified for other microcomputers. Shorter and less versatile than most commercially available data management programs, it is suitable for the type of audit functions likely to be encountered in clinical laboratories.

Computers↗

Ureteral necrosis after kidney transplantation: risk factors and impact on graft and patient survival.

BACKGROUND: Ischemia, the main cause of ureteral necrosis in renal transplantation, cannot alone explain the late occurrence of some fistulas beyond the first postoperative month. The aim of this study, performed on a cohort of 1,629 consecutive kidney transplantations, was to analyze the risk factors implicated in the occurrence of ureteral necrosis and its impact on graft and patient survival. METHODS: Between January 1990 and December 2001, 1,629 renal transplantations were performed in the authors' center. All biologic and clinical data were computerized in a cross-audited and validated data bank (Données Informatisées et Validées en Transplantation). The parameters studied were donor age, gender, cause of death and serum creatinine before procurement; and recipient age, gender, initial disease, panel reactive antibody, retransplantation, cold ischemia time, delayed graft function, human leukocyte antigen incompatibilities, induction and maintenance immunosuppression, right or left kidney, number of arteries, site of transplantation and the presence or not of a double-J stent. The follow-up parameters were the number and timing of acute rejection episodes, cytomegalovirus (CMV) infection (viremia, polymerase chain reaction), and acute pyelonephritis. Ureteral histologic analysis was performed in 25 cases (necrosis, leukocyte infiltration, and CMV or BK virus inclusions). Uni- and multivariate statistical tests were used (alpha risk at 5%). All of the patients with ureteral necrosis had undergone neoureterocystostomy or ureteral anastomosis with the native ureter but with a systematic double-J stent. RESULTS: Ureteral necrosis occurred in 52 of the 1,629 patients (3.2%) and was significantly and independently correlated with donor age (P=0.041) and delayed graft function (P=0.016). CMV infections were also higher in the necrosis group (P=0.001), but donor CMV status was not statistically different between the two groups (36.2% vs. 36.7%). Ureteral histologic studies showed CMV and BK virus inclusions in 4 and 2 cases, respectively, and arterial and venous thrombosis in 4 and 16 cases, respectively. No pattern of ureteral rejection was observed. Ureteral necrosis did not affect the 10-year patient and graft survival, which were 87% and 66%, respectively, for the necrosis group and 86% and 58%, respectively, for the control group (P=not significant). CONCLUSIONS: The authors' data provide new information concerning a classic surgical complication after kidney transplantation. The link they have identified between the occurrence of ureteral necrosis, donor age, and delayed graft function reemphasizes the interdependence between surgical and medical complications in kidney transplantation.

Adult↗

An audit of the quality of cancer registration data.

The accuracy of cancer registration data in the East of Scotland (Tayside) Cancer Registry was audited by comparing 200 consecutive registrations (about 10% of the annual total) with the 'gold standard' of the Histopathology records. ICD codes were independently generated by a pathologist by examining final pathology reports and then compared to those codes given by the local cancer registrar. Discrepancies were graded by the pathologist and the epidemiologist according to severity. Major errors of coding were few. Minor and moderate differences in coding occurred because of the nature and structure of the coding system and the manner in which data are retrieved. The level of detail required by the Cancer Registry needs to be evaluated.

Medical Audit↗

Coding for surgical audit.

A simple system of codes for operations, diagnoses and complications, developed specifically for computerized surgical audit, is described. This arose following a review of our established surgical audit in which problems in the retrieval of data from the database were identified. Evaluation of current methods of classification of surgical data highlighted the need for a dedicated coding system that was suitable for classifying surgical audit data, enabling rapid retrieval from large databases. After 2 years of use, the coding system has been found to fulfil the criteria of being sufficiently flexible and specific for computerized surgical audit, yet simple enough for medical staff to use.

Diagnosis-Related Groups↗

A comprehensive clinical database for mental health care in England.

BACKGROUND: Monitoring and researching clinical care calls for comprehensive clinical databases. In mental health care these need to cover all aspects of the care of each patient and to accommodate the complexity of care which may last from weeks to years. This paper describes the pilot work for a mental health clinical database intended to be implemented throughout the English National Health Service. METHODS: In collaboration with three pilot sites, a set of data extracts was defined which could reasonably easily be produced, mostly using existing statistical data collection systems. Software was designed to integrate these extracts into patient-based records describing overall spells of mental health care. These data were extracted from their systems for a 6-month pilot period. RESULTS: Two of the three sites produced data sets, which appeared to give a reasonably complete account of the work undertaken in the pilot period. Known differences in service design and clinical perspective between the two sites were clearly reflected. CONCLUSIONS: The approach to extracting and collating the data is workable within existing resources and produces illuminating data for clinical audit, management and planning. Completeness and accuracy of data is likely to be a continuing problem, as for any routine data capture exercise. However, the process of integrating data from several channels assists this, as inconsistencies become apparent and can be tackled. The approach is now being implemented throughout England.

Adolescent↗

The potential for improvement in outcome of children with intussusception in the South Island.

AIMS: To review the experience in the South Island to predict the extent to which the outcome in intussusception might be expected to improve by the introduction of management guidelines and access to a regional specialist paediatric surgical service. METHODS: Children with intussusception treated in the South Island during an eleven year period until 1998 were identified from hospital coding systems, the Southern RegionalHealth Authority and from departmental audit programmes. Details of management and outcome were analysed. RESULTS: Data proved difficult to obtain. There were 83 children identified with intussusception confirmed on enema or at surgery; 76 had an enema that was successful in 44. Delayed repeat enema and gas enema techniques were not used as frequently as might be expected. The operative rate was higher than that reported by other centres. CONCLUSIONS: Current data, coding and audit systems have significant short comings, which limit availability of reliable outcome data. Increased awareness of the expanded indications for enema reduction, use of air (rather than barium) and delayed repeat enemas, and access to specialist paediatric surgical involvement appears to increase the nonoperative rate. Implementation of guidelines for the management of intussusception might be expected to reduce by more than half the number of children undergoing surgery for this condition in the South Island.

Barium Sulfate↗

The quality of histopathology data in a computerised cancer registration system: implications for future audit of care.

Electronic linkage between pathology data sources and other information systems has not realised its full potential benefits due to the poor quality of histopathology coding. This study showed that 38% of a sample of 158 pathology reports were coded accurately. Of the incorrectly coded reports, 25% had the potential to distort published cancer incidence figures. The incidence figures of the most common cancers are less likely to be affected by coding errors. Areas in which all errors, both topographical and morphological, could have significant impact include examining resource allocation at directorate level and adjusting outcome indicators for casemix. This study concludes that electronic linkage between histopathology systems and cancer registries is not sufficient to improve the quality of registration data. As cancer registries become more dependent on computerised information provided through hospital information systems, registries need to be aware of poor quality data and put in place appropriate quality assurance measures specifically tailored to support electronic cancer registration. Purchasers and providers need to be aware that incomparable datasets could be produced if other bodies use computerised pathology datasets without first validating the data.

England↗

Mapping changes in surgical mortality over 9 years by peer review audit.

BACKGROUND: There is increasing public scrutiny of deaths among surgical patients. This analysis sought evidence of changes in practice over time in the management of patients who died under surgical care. METHODS: The surgeons and anaesthetists in National Health Service hospitals providing the care of all surgical patients in Scotland participated in the Scottish Audit of Surgical Mortality (SASM). Data from peer review audit, critical event analysis and individual feedback of deaths while in surgical care over 9 years (1994-2002) were examined for trends over time. RESULTS: Over a 9-year period, 40,448 patients died while in surgical care. Consultant surgeon and anaesthetist involvement in decision making and operating increased significantly (P < 0.001), and death after elective surgery declined to 0.27 per cent of elective operations. Adverse events were more frequently due to failures of hospital systems or process than to individual clinician errors. Fewer adverse events were identified as having contributed to or caused the death of patients over time (P < 0.001). Failure to use deep vein thrombosis (DVT) prophylaxis and failure to use high-dependency or intensive therapy units (HDU/ITU) became less common, once highlighted by the SASM. CONCLUSION: Through continuous peer review audit, the SASM has mapped and may have contributed to changes in surgical and anaesthetic practice over a 9-year period, indicating that the rate of adverse events can be decreased by changing clinician practice (DVT prophylaxis) and provision of facilities (HDU/ITU). Similar approaches should be considered by other medical specialties.

Aged↗

Gastrointestinal safety of an extended-release, nondeformable, oral dosage form (OROS: a retrospective study.

BACKGROUND: The OROS osmotic (OSM) dosage form optimises extended-release oral administration by controlling the rate of drug release for a predetermined time, providing constant, patterned, or pulsed delivery profiles. OSM products include prescription medications for urology, CNS, and cardiovascular indications, as well as over-the-counter nasal/sinus congestion medications. METHODS: This retrospective study examines US gastrointestinal (GI) safety data for the OROS dosage form following nearly two decades of use. Although GI injury and obstruction are known effects of oral medications, some reports have suggested that extended-release products pose a greater risk of GI injury and obstruction than other oral dosage forms. Products incorporating OROS technology are being prescribed to an expanding range of patients; a review of the GI safety data for this dosage form thus seemed timely and appropriate. US safety information was obtained from three sources: English language literature published from 1982 until June 1, 2000 from five major biomedical databases;postmarketing safety reports from January 1, 1983 until June 1, 2000 available through the Freedom of Information Act; andcommercial safety information obtained directly from ALZA Corporation's in-house safety database for those OSM products for which ALZA has reporting responsibility. US distribution data from IMS National Prescription Audit trade mark Plus data were used to estimate cumulative product distribution totals. These totals were combined with numbers of unique GI events to determine the estimated frequency of events. RESULTS: Nearly 13 billion OSM tablets are estimated to have been distributed in the US. The incidence of all clinically significant GI adverse events for OSM products (including intestinal, gastric, and oesophageal irritation, injury, and obstruction) reported in the US was approximately one case in >76 million tablets distributed. The majority (78%; estimated incidence: one case in 29 million tablets) of cases were reported in patients taking Procardia XL (nifedipine). Oesophageal and lower GI obstruction were reported primarily in patients with pre-existing abnormalities or disease of the GI tract. Among paediatric patients, one obstruction was reported in an estimated 37.7 million tablets distributed. Reports of GI irritation associated with OSM products were consistent with known effects of the same drug substances in other dosage forms. CONCLUSION: A review of long-term safety experience with products using OSM controlled-release technology yields a low incidence of clinically significant GI events. Properly prescribed, extended-release products provide substantial therapeutic and convenience benefits without additional risk.

Administration, Oral↗

The use of routine referral data in the development of clinical audit and management in North Lincolnshire.

As part of the national waiting list initiative, a retrospective survey of routine referrals in seven specialties to Lincoln County Hospital by general practitioners within its catchment area, during the months of January to March 1987 inclusive, was carried out, using data from the hospital's Patient Administration System and the Lincolnshire Family Practitioner Committee. These specialties were identified by managers and clinicians as those in which a significant problem of waiting times and waiting lists existed, both as perceived locally and in comparison with other districts. The total referral rate for all GPs in the study was 9.6 referrals/100 patients on their list/year, which is very close to the average of other studies published elsewhere in the country on this topic. However, the range of referral rates between practices was very wide, varying from 2.8 to 17.6. There were also wide variations within individual practices. It is therefore concluded that, taken overall, 'over-referral' by general practitioners is not the cause of any problem at Lincoln County Hospital. However, the wide variation of referral patterns has been of great interest to the general practitioners themselves. They have requested that referral rates be fed back to them routinely, in the manner of the Prescription Pricing Authority, and this will commence shortly. In addition, a working group of orthopaedic surgeons and general practitioner representatives has met to discuss the implications of the study, and the drawing up of mutually agreed referral protocols, the operation of which would be monitored jointly. The setting up of similar groups in the other specialties is under active consideration.

Catchment Area, Health↗

Diabetes--inpatient utilisation, costs and data validity. Dunedin 1985-9.

AIM: to describe the impact of diabetes on the public hospital inpatient services in one New Zealand region over the period 1985-9, from one 450 bedded university teaching hospital in a major urban centre in New Zealand serving a population of approximately 125,000 people. METHODS: by the analysis of routinely collected hospital discharge data and the application thereto of the resource utilisation system (RUS). Data validation was performed by means of a survey of clinical notes. RESULTS: admission, bed utilisation rates and associated costs for diabetes rose over the period by factors of 3.2, 3.8 and 2.8 respectively; due primarily to the management of macrovascular disease in the elderly. The rise was most marked in those 75 years and over; admission rates, bed utilisation rates and costs in this age group being respectively 1.9, 4.3 and 2.9 times greater than the 60 to 74 year age group. For admissions with diabetes as principal diagnosis, admissions for glycaemic control showed a significant decrease in lengths of stay over the period. Admissions with diabetic peripheral vascular disease were cumulatively, and per case, the most costly, the mean cost, at $16,000 per case, being 5.1 times greater than the mean cost of all admissions with diabetes as principal diagnosis. In 1989 diabetes accounted for 5% of the cost of all inpatient care provided by the hospital. These results are an underestimate, as 45% of admissions of people where diabetes should have been cited as a subsidiary diagnosis were omitted from the discharge data. CONCLUSION: diabetes is a major consumer of hospital resources in this region. As the majority of diabetes associated resource use is in the elderly, a population projected to increase significantly, consideration needs to be given to the options for the provision of care. More work also needs to be done on the reasons underlying these changes. If routinely collected data is to be used for these purposes then audit of the data must be performed or use should be restricted to certain defined groups, eg, diabetes as principal diagnosis only.

Adult↗

Data verification in the residue laboratory.

Residue analysis frequently presents a challenge to the quality assurance (QA) auditor due to the sheer volume of data to be audited. In the face of multiple boxes of raw data, some process must be defined that assures the scientist and the QA auditor of the quality and integrity of the data. A program that ensures that complete and appropriate verification of data before it reaches the Quality Assurance Unit (QAU) is presented. The "Guidelines for Peer Review of Data" were formulated by the Residue Analysis Business Center at Ricerca, Inc. to accommodate efficient use of review time and to define any uncertainties concerning what are acceptable data. The core of this program centers around five elements: Study initiation (definitional) meetings, calculations, verification, approval, and the use of a verification checklist.

Chemistry Techniques, Analytical↗

[Audits across state borders for medical consulting agencies within the German healthcare insurance system].

UNLABELLED: The Medizinischer Dienst der Krankenversicherung (MDK) is a non-profit medical consulting organisation serving the German Healthcare Insurance System. Despite its uniform commission throughout Germany, organisation and structure differ considerably between Provincial States which is reflected by differing results. A common nationwide system of key figures and indicators aims at analysing results and learning from one another. AIM: Development of an audit concept for analysing key figures and indicators within the MDK aiming at quality improvement. METHODS: Development of a system of key figures and indicators covering five spheres (products, staff, costs, data analysis, structure). Analysis by means of audits carried out across provincial state borders in five steps (audit manual, training of auditors, visitation, audit report, repetition audit). RESULTS: The system of key figures and indicators assures relevant and comparable data. Audit manual, training of auditors, visitation, and audit report meet the needs of all people and institutions involved. Preparation of auditors as well as openness, and flow of information within audited organisations offer areas for improvement. There is as yet no assessment of the cost-benefit ratio of audits. CONCLUSION: The concept presented in this article consists of two parts: A system of key figures and indicators as well as a concept for audits. The concept is suitable for a) generating and analysing relevant key figures and indicators for each MDK, and b) providing information for benchmarking between different MDK. Further development of the concept to a comprehensive management concept is necessary.

Benchmarking↗

Clinical audit of patients with cervical cancer in Slovenia--data analysis for the year 2003.

PURPOSE OF INVESTIGATION: The data gathered in 2003 on the patients with cervical cancer who regularly attended their gynecologist were analyzed with the purpose of clinical audit. METHODS: The data on newly detected patients with cervical cancer in 2003 who regularly attended their gynecologist were gathered simultaneously at three Advisory Boards for Gynecology in Slovenia. RESULTS: Of 149 patients in whom, according to our data, invasive cervical cancer had been diagnosed, 92 (61.7%) patients were examined by a gynecologist in the previous five years. In the majority of these patients, cervical cancer was diagnosed in early, localized disease stage. In the periods of 13-24 and of seven to 12 months before the diagnosis of cervical cancer, almost half the patients had Pap II, and three to six months before diagnosis, 67.6% of patients had Pap II. CONCLUSION: These results encourage us to proceed with clinical audits to analyze individual cervical cancer cases, including another independent reevaluation of cervical smears in the five-year period before diagnosis. A suitable calendar of refresher training courses on colposcopy, which should be obligatory for all performing this examination method, also needs to be set up.

Adult↗

The Australian Centre for Evidence-based Clinical Practice generic audit tool: Auditmaker for health professionals.

Audit is an important step in the process of health care evaluation and quality improvement. Some of the barriers to audit include the lack of support in initiating an audit, difficulty with data collection and lack of time. Auditmaker is a computer package that guides the clinician through the initial process of designing an audit, choosing factors and outcomes to analyse, then provides customizable data entry forms, and finally simple reports summarizing the data. It has user-friendly features, such as help buttons, drop-down lists and built in comorbidities and outcomes of common interest. It provides a generic tool for performing an audit as well as providing an opportunity for different clinicians in different institutions or practice settings to perform similar audits using the same data collection tool, which can provide the basis of benchmarking. Auditmaker is available for downloading from the ACEPBCP website: http://www.acebcp.org.au.

Australia↗

National audit of continence care: laying the foundation.

INTRODUCTION: National audit provides a basis for establishing performance against national standards, benchmarking against other service providers and improving standards of care. For effective audit, clinical indicators are required that are valid, feasible to apply and reliable. This study describes the methods used to develop clinical indicators of continence care in preparation for a national audit. AIM: To describe the methods used to develop and test clinical indicators of continence care with regard to validity, feasibility and reliability. METHOD: A multidisciplinary working group developed clinical indicators that measured the structure, process and outcome of care as well as case-mix variables. Literature searching, consensus workshops and a Delphi process were used to develop the indicators. The indicators were tested in 15 secondary care sites, 15 primary care sites and 15 long-term care settings. RESULTS: The process of development produced indicators that received a high degree of consensus within the Delphi process. Testing of the indicators demonstrated an internal reliability of 0.7 and an external reliability of 0.6. Data collection required significant investment in terms of staff time and training. CONCLUSION: The method used produced indicators that achieved a high degree of acceptance from health care professionals. The reliability of data collection was high for this audit and was similar to the level seen in other successful national audits. Data collection for the indicators was feasible to collect, however, issues of time and staffing were identified as limitations to such data collection. The study has described a systematic method for developing clinical indicators for national audit. The indicators proved robust and reliable in primary and secondary care as well as long-term care settings.

Delphi Technique↗

Quality assessment and the art of medicine: the anatomy of laceration care.

Assuring high quality medical care has remained an elusive goal because of several problems which have hampered development of effective medical audit programs: inadequate patient data, unreasonable evaluative criteria and insensitive audit procedures. The present study demonstrates the use of a clinical algorithm to help overcome these problems. An examination of medical record data from a series of 703 laceration patients treated in an emergency service yielded only 27 cases (4 per cent) with medical records sufficiently complete to use for auditing physician compliance with algorithmic criteria. Substituting a structured checklist for the handwritten note increased this rate to 86 per cent. A computer-assisted branching audit of 1,400 laceration cases demonstrated that 1) physician compliance with an algorithmic instruction varied significantly (p less than .001) according to the specific instruction, and 2) compliance with a given instruction varied significantly (p less than .001) across different providers. These results underscore the need for medical audit with educational feedback which is provider specific.

Connecticut↗