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What do rheumatologists do? A pilot audit study.

Four consultant rheumatologists from different health districts compared their out-patient and in-patient workloads for 3 months. Data collection proved simple and valuable to each local unit. Inflammatory joint disease (particularly severe rheumatoid arthritis) dominated the workload in all centres. Large differences in the number of new referrals with osteoarthritis, soft tissue diseases and polymyalgia rheumatica were observed. Differences were also apparent in the organization of clinics, provision of follow-up appointments for different diagnostic groups, and usage of steroid injections. Although there may be a variety of explanations for these similarities and differences, the data emphasize the need for further audit of rheumatology practice in the UK.

Ambulatory Care Facilities↗

[Quality control in clinical trials].

Quality control (QC) in clinical trials means the procedures which insure protection of human subjects from research risk, reliability of the data, and thereby assures internal consistency. This has been developed since 1970s in the US, by establishing various regulations which are now called GCP. From the viewpoint of total QC, it should be emphasized that rigorous review of protocol by the Institutional Review Board and obtaining Informed Consent are prerequisites for insuring the quality of the given trial at high scientific level. When pursuing a clinical trial, first of all, facilities of the institutions and the ability of investigators must be of high quality. For this reason, at each institution previous data related to trials should be thoroughly reviewed and analyzed prior to developing a protocol. Educational courses in QC in clinical practice are invaluable. QC of diagnosis means, for example, central pathology review and standardization of diagnostic procedures and process. Secondly, at each institution, data managers collect the data and submit them to the central office at the indicated time. In order to evolve clinical trial, continuous education for data managers and expansion of their job are encouraged. Thirdly, at the statistical center independent from the research group office, subject-specific data managers, the biostatistical staff, must check submitted forms for completeness, consistency and accuracy. Finally, at the data analysis, quality evaluation of the research should also be carried out. Throughout the trial, monitoring and audit are particularly important to assure quality. The sponsor has the responsibility of monitoring the trial and make rigorous onsite visits, and the individual study group also have a monitoring program, while the FDA and the NCI audit by themselves. The purpose of audit is not only to assure data reliability but also to check out patient compliance to drug, education as to regulations and rules of clinical trials and the analysis of violations so as to provide suggestions to improve medical care.

Clinical Trials as Topic↗

How accurate are hospital discharge data for evaluating effectiveness of care?

Demand for quality of care data has led to publication of adjusted mortality rates of hospitals and physicians. Yet the accuracy of databases used for this purpose is questionable, raising the possibility that consumer-oriented profiles of providers could be misleading. A stratified random sample of discharge abstract records of Medicare-aged patients hospitalized in California were audited by the state's health data agency. The results of the audit were analyzed to determine the effect that coding errors have on expected death rates assigned to hospitals as risk-adjustment measures in the annual Medicare hospital mortality report. Discharge abstracts of Medicare-aged patients contained many errors among coded risk factors used to calculate expected death rates. Comorbidities and transfers from nursing homes were seriously underreported and 'urgency of admission' was often miscoded. Hospitals differed with respect to error rates (P < .0001); these varying levels of miscoding caused measurement errors that ranged in size from 0.2 to 2.2 expected 30-day deaths per 100 admissions (10th vs. 90th percentile). Detailed knowledge of the limitations of claims data can help analysts minimize the impact of coding error. Beyond this, quality control of data used for outcomes research needs strengthening.

Abstracting and Indexing↗

Diabetes registers: a grassroots approach.

OBJECTIVES: To compile a register of diabetic patients within the catchment area of a district general hospital and evaluate the characteristics of the population using aggregated data from a general practice audit. DESIGN: Cross sectional study. Practices identified all known diabetics and completed a questionnaire from information in each patient's medical record. SETTING: Practices affiliated to a district audit group in south east England. MAIN OUTCOME MEASURES: Number of participating practices; prevalence of diabetes and its complications; and sex distribution of patients, age at diagnosis and review, treatment, and metabolic control. Comparisons with similar data from other studies. RESULTS: 41 out of 43 practices participated, and 2574 diabetic patients were identified (prevalence 1.18%). 52.4% of patients were male. The mean age was 61.6 years. 32% of patients were treated with insulin, 51.5% with oral hypoglycaemic agents, 16.5% with diet alone. The mean random blood glucose concentration was 10.4 mmol/l and glycosylated haemoglobin 10.1%. 8% had proteinuria, 7% a history of myocardial infarction, 5% a history of stroke, and 2% a diabetes related amputation. These proportions were not significantly different from those found in studies performed by different methods in Poole, Islington, Powys, Trowbridge, and Southall. CONCLUSION: It is feasible to compile a register of diabetic patients in a district and evaluate their characteristics by using only general practice sources.

Age of Onset↗

Cardiopulmonary disease in newborns: a study in continuing medical education.

A film emphasizing the importance of tachypnea as an early manifestation of congenital heart disease was shown to physicians and nurses at 27 hospitals as part of their regular continuing medical education activities. To evaluate the effects of the program, investigators developed a pretest-posttest design which included a nonequivalent control group. Pretest and posttest data were obtained through chart audit of referrals from subjects in experimental and control groups. Dependent variables used to test the hypothesis included the age at which infants were referred and the age at which tachypnea was noted. Analysis of the data yielded significant gain scores for the experimental group, while changes in the control group were not significant. The findings indicate that a need-oriented educational program can have a measurable impact on improving the quality of patient care.

Age Factors↗

Computerized quality assurance of decisions to transfuse blood components to critically ill patients.

BACKGROUND: In critically ill patients optimal transfusion therapy for most clinical settings has not been determined. The objective of this study was to evaluate the impact of a computerized audit on transfusion decisions of red blood cells (RBC), fresh frozen plasma (FFP), and platelets among critically ill patients. METHODS: Two hundred and ninety consecutive patients admitted to nine-bed medical-surgical intensive care unit at a university hospital were included in this prospective study. Prior to the study, the criteria for transfusions of RBCs, FFP and platelets were established. Phase I, the first 3-month period served as a control period. During phase II the fulfilment of these criteria was prospectively monitored by an audit software belonging to the computerized blood request program. If the predefined transfusion criteria were not met the audit software was automatically activated. The last 3-month period, phase III, was to assess if possible effects on transfusion decisions were permanent. RESULTS: The proportion of RBC transfusions administered according to predefined trigger during the study phases I, II, and III were 55.9%, 75.1% and 67.9%, respectively (P < 0.001). The proportion of FFP and platelet transfusions according to a predefined trigger did not differ statistically significantly between the study phases. Logistic multiple regression analysis revealed an independent effect of the audit phase on the decision to transfuse RBCs and FFP. CONCLUSIONS: The data suggests that a computerized prospective transfusion audit has impact on the realisation of predefined transfusion decisions.

Adult↗

Towards the audit of geriatric day hospitals: a pilot project in west Surrey/north east Hampshire.

Following the recommendation of a report on the performance of two geriatric day hospitals (GDHs) in West Surrey and North East Hampshire District Health Authority in 1988, a pilot study was set up to assess the efficacy of a proposed form of audit involving multidisciplinary teams. An outcome measure which consisted of four different scales was developed and agreed upon by the multi-professional team. These scales were used to work out a composite index (Patient Achievement Inventory-PAI). In addition, a new data form was designed for collection of patient data. To carry out this prospective clinical audit, targets were agreed for each patient, and progress was measured against them. Sixty-one (61) patients were studied (30 and 31 per respective hospital). Data form completion was 90 per cent and 81 per cent respectively. The PAI index proved to be reliable (kappa index of agreement = 0.72), and useful as an outcome measure. However, because the PAI index is made up of ordinal scales, it can only be used to measure change within individuals, not between them. The outcome measures, data forms and the continuous audit of these two GDHs proved to be meaningful and acceptable in practice.

Aged↗

Development of a treatment outcome standard as a result of a clinical audit of the outcome of fixed appliance therapy undertaken by hospital-based consultant orthodontists in the UK.

Bristol's much-publicised cardiac surgery problems and subsequent enquiry(1) have drawn attention to the need for audit of treatment outcomes throughout all hospital specialties. Patient anxiety, government policy and the desire of the professions to re-establish public confidence, have further encouraged changes to the system. For medical and dental specialties, such challenges have already been taken up by the Royal Colleges with the establishment of clinical effectiveness committees. Hospitals have modified their procedures and, for consultants, yearly appraisal is already a reality. The Orthodontic Clinical Effectiveness Working Party of the Royal College of Surgeons of England (now the Clinical Effectiveness Committee of the British Orthodontic Society) set up this audit to measure the outcome of fixed appliance treatment and to establish a benchmark for the standard of treatment to be expected from a consultant orthodontist. This paper describes how the audit was carried out, presents the findings and goes on to discuss some of the wider issues involved in audit, clinical governance and appraisal. The Consultant Orthodontists Group of the British Orthodontic Society funded this audit and the results and data set of dental casts remain their property.

Benchmarking↗

Features of primary health care teams associated with successful quality improvement of diabetes care: a qualitative study.

BACKGROUND: In quality improvement activities such as audit, some general practices succeed in improving care and some do not. With audit of care likely to be one of the major tools in clinical governance, it would be helpful to establish what features of primary health care teams are associated with successful audit in general practice. OBJECTIVE: The aim of the present study was to identify those features of primary health care teams that were associated with successful quality improvement during systematic audit of diabetes care. METHOD: Semi-structured tape-recorded interviews were carried out with lead GPs and practice nurses in 18 general practices in Leicestershire that had the opportunity to improve their care and had completed two data collections in a multipractice audit of diabetes care. The interviewees were asked to describe their practice's approach to audit and the transcripts were coded for common features and judged for strength of feeling by blinded independent raters. Features common to practices that had, and those that had not, managed to improve diabetes care were identified. RESULTS: Six features were identified reliably in the transcripts by blinded independent raters. Four were significantly associated with the successful improvement of care. Success was more likely in teams in which: the GP or nurse felt personally involved in the audit; they perceived their teamwork as good; they had recognized the need for systematic plans to address obstacles to quality improvement; and their teams had a positive attitude to continued monitoring of care. A positive attitude to audit and a personal interest in the disease were not associated with improvement in care. CONCLUSIONS: Success in improving diabetes care is associated with certain organizational features of primary health care teams. Experimental studies are required to determine whether the development of teamwork enables practice teams to identify and overcome systematically the obstacles to improved quality of patient care that face them.

Diabetes Mellitus↗

Audit of the use of benzathine penicillin, post-treatment syphilis serology and partner notification of patients with early infectious syphilis.

Recent increases in the incidence of early infectious syphilis have been particularly noted in men who have sex with men (MSM). Case-notes of 40 consecutive patients with infectious syphilis and follow-up data for one year were audited. Of the 40 patients, six were HIV co-infected. In all, 31 men received benzathine penicillin as first line while the remaining had other treatments. About 17 (42.5%) failed to attend for any post-treatment serological tests. Of the remainder, 17 (42.5%) attended for the first appointment and only 13 (32.5%) attended for the full one year follow-up. In all, 40 men in the study had 362 sexual contacts of which only 44 (12.2%) elected to be screened. This study illustrates the successful use of benzathine penicillin as first-line treatment, lack of patient compliance with post-treatment serological follow-up and difficulty with partner notification.

Adolescent↗

Hospital in-patients with diabetes: increasing prevalence and management problems.

AIMS: To re-assess the prevalence, management problems, clinical outcomes and discharge summaries of hospital in-patients with diabetes. METHODS: Case records of all patients occupying in-patient beds were audited on a single weekday in 2003 in a large urban hospital and repeated after 3 months. Data was compared with an identical audit 12 years previously. RESULTS: Over 12 years the number of beds available for admission (1191) had reduced by 25% with a bed occupancy of 97%. Diabetes prevalence had increased from 7.0% to 11.1% (P < 0.01) (97% Type 2). Diabetes management was considered inappropriate in 29%, more than in 1991 (20%). After 3 months, discharge summaries had been completed on 75% of patients but diabetes was mentioned in only 53%. CONCLUSION: The prevalence of in-patient diabetes (11.1%) was over 50% greater and diabetes management was suboptimal in more patients than in 1991. In many length of stay was prolonged and almost half of the discharge summaries did not mention diabetes. These findings have major implications for service delivery and resource planning.

Adult↗

The National Cancer Institute audit of the National Surgical Adjuvant Breast and Bowel Project Protocol B-06.

BACKGROUND: The National Surgical Adjuvant Breast and Bowel Project (NSABP) Protocol B-06, a clinical trial sponsored by the National Cancer Institute (NCI), has provided evidence of the value of lumpectomy and breast irradiation for treating women with breast cancer in an early stage. Publicity generated by the discovery that the study included fraudulent data on patients enrolled by St. Luc Hospital in Montreal aroused concern about the overall accuracy of the data and conclusions. To address this concern, the NCI conducted an audit of other participating institutions. METHODS: In 1994, data on 1554 of the 1809 randomized patients (85.9 percent) enrolled by centers other than St. Luc Hospital were audited at 37 clinical sites in North America. The audit included data on eligibility, survival, disease-free survival, the length of time to a recurrence of cancer in the ipsilateral breast, and documentation of signed informed consent. RESULTS: End points were assessed for all 1554 patients, and eligibility was assessed for 1507 patients; 47 patients were excluded because their forms were not complete or not returned. A total of 1429 patients had their eligibility status verified. Of a total of 7770 data points examined with respect to the number of positive nodes at base line, treatment characteristics, first events (excluding death), recurrence of cancer in the ipsilateral breast, and survival, 7577 (97.5 percent) were verified, 123 (1.6 percent) could not be verified, and 70 (0.9 percent) were discrepant with the NSABP file. Of the 1554 patients, 1340 (86.2 percent) had all audited items (including eligibility) verified, 69 (4.4 percent) had at least one discrepant item, and 113 (7.3 percent) had at least one unverified item (as a result of missing or incomplete data); 32 (2.1 percent) were not assessed for eligibility but had no other discrepant or unverifiable items. Written informed consent was documented for 1098 patients before surgery and 210 after surgery; no date appeared on the signed form for 137. The informed-consent status was not verified for 71 patients and could not be determined for 38. The rates of verification of end-point data and documentation of written informed consent were similar among the total-mastectomy group, the lumpectomy group, and the group treated by lumpectomy and breast irradiation. CONCLUSIONS: The audit confirms the adequacy of the data on which the reanalysis of Protocol B-06 and the results after 12 years of follow-up are based.

Breast Neoplasms↗

Computerized dispensing system: reducing the time of dispensing medicines.

We have developed a new computerized dispensing system which reduces the time needed to dispense medicines. This system is so designed to assist the pharmacist with various tasks. These include receiving prescriptions, dispensing of medicines, checking for accuracy, and payment. This system consists of automated dispensing devices, a tray-transfer line, a reception number indicator screen installed in the waiting room, and a terminal to provide patients with additional information. The prescription data are instantly transmitted to the respective dispensing positions and the prescriptions are dispensed simultaneously. The trays travel efficiently on the tray-transfer line. The host computer performs such functions as input of information of prescriptions, accounting calculations, integrating prescription audit, and preparation of printing data for medicine bags. The control computer, which receives prescription data from the host computer, sorts and sends instruction data on prescriptions to the automated dispensing machines, outputs instructions on the preparation of medicines in the manual dispensing sector, and controls the tray-transfer line, the turn tables and the reception number indicator screen. This computerized dispensing system has produced the following results: (1) improvement in the quality of the dispensing work; (2) reduction in the time required for dispensing medicines; (3) improvement in the quality of service to patients; (4) improvement in the efficiency of the clerical work in non-dispensing work; (5) improvement in work efficiency.

Computers↗

Information management and informatics: need for a modern pathology service.

Requirements for information technology in pathology now extend well beyond the provision of purely analytical data. With the aim of achieving seamless integration of laboratory data into the total clinical pathway, "informatics"--the art and science of turning data into useful information--is becoming increasingly important in laboratory medicine. Informatics is a powerful tool in pathology--whether in implementing processes for pathology modernization, introducing new diagnostic modalities (e.g. proteomics, genomics), providing timely and evidence-based disease management, or enabling best use of limited and often costly resources. Providing appropriate information to empowered and interested patients--which requires critical assessment of the ever-increasing volume of information available--can also benefit greatly from appropriate use of informatics. General trends in medical informatics are reflected in current priorities for laboratory medicine, including the need for unified electronic records, computerized order entry, data security and recovery, and audit. The increasing demands placed on pathology information systems in the context of wider developmental change in healthcare delivery are explored in this paper.

Data Collection↗

Quality improvement data analysis of a mass casualty event.

Trauma auditing is important for monitoring the process of trauma care and outcome prediction. This pilot study was conducted to evaluate quality improvement (QI) data following a mass casualty event and discuss its impact on the trauma care process and outcome. A pre-designed trauma quality improvement data set was used for all 103 injured patients admitted to Asir Central Hospital, Saudi Arabia, who were involved in a single motor vehicle crash. Most of the trauma management variations from norms occurred during the initial assessment and resuscitation phase of care, and these had the greatest impact on morbidity and mortality. Trauma management variations throughout all phases of care were associated with 10% and 9% incidence of preventable morbidity and mortality, respectively. Efforts including rigorous educational programs should be made to stress the initial assessment and resuscitation phase of care. Successful regionalized trauma care systems involving quality improvement programs report significant reduction in morbidity and mortality rates from trauma.

Accidents, Traffic↗