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PubMed1986

Functional equality of coordinating centers in a multicenter clinical trial. Experience of the International Mexiletine and Placebo Antiarrhythmic Coronary Trial (IMPACT).

The International Mexiletine and Placebo Antiarrhythmic Coronary Trial (IMPACT) included clinical centers in both Europe and North America. The clinics were monitored by two Regional Coordinating Centers: one located in Baltimore, Maryland, for North American clinics; the other in Lyon, France, for European clinics. These coordinating Centers were in turn monitored by an independent Data Audit Center located in Chicago, Illinois. This article describes how computer systems and operational procedures were developed to allow the three IMPACT centers to exchange processed files for a common analysis by the two Regional Coordinating Centers. The problems encountered and the advantages of this organization are described and discussed.

Arrhythmias, Cardiac↗

PubMed2005

Data from regulatory studies: What do they tell? What don't they tell?

Phase III studies of antiepileptic drugs (AEDs) are specifically designed to satisfy strict regulatory criteria. As they are conducted in protocol-restricted patient populations over short treatment periods and employ fixed study designs and dosing schedules, they are not fully representative of 'real-life' clinical practice. Therefore, in order to provide an overall assessment of clinical performance, regulatory studies must be backed up by post-marketing clinical experience. Phase IV studies provide information on a drug's performance in a setting more closely representing real clinical practice, with broader patient populations and a more flexible approach to individual treatment. Prospective long-term studies allow the determination of efficacy and safety (and cost-effectiveness) over extended treatment periods; these studies and audit data provide a means of assessing idiosyncratic side effects, unusual interactions and the effects of an AED in rare patient groups. By complementing regulatory evidence with real-life clinical experience, a comprehensive assessment of the risks and benefits of an AED can be made.

Adverse Drug Reaction Reporting Systems↗

PubMed2001

A single-centre study of 1000 consecutive peribulbar blocks.

PURPOSE: To assess the efficacy and safety of the peribulbar block as practised by anaesthetists in a District General Hospital and also to assess the effect of using the 'painless local' subconjunctival injection on the pain of the peribulbar block. METHOD: Audit data collected from 1000 consecutive patients undergoing peribulbar blocks with 2% lignocaine were analysed. Efficacy was assessed by visual rating scores for operative pain, eye movement, intraocular pressure and reinjection rate, and safety by looking at complications. Comparison of pain of injection scores was used to assess the effect of the 'painless local' injection. Visual rating scores for pain were analysed using the Mann-Whitney U-test. RESULTS: Akinesia was achieved in 79% of blocks and operative pain scores were very low (median = 0, IQR = 0). All complications recorded were minor and there were no sight- or life-threatening events. The 'painless local' injection given to 499 patients resulted in significantly lower visual rating scores for pain of injection (p<0.05). CONCLUSION: These data suggest that the peribulbar block is a safe and effective method of providing anaesthesia for eye surgery provided that it is taught methodically and practised by experienced staff. The 'painless local' injection reduces the pain experienced during administration of this block.

Adult↗

PubMedDate not supplied

A comparative financial analysis of multi-institutional organizations by ownership type.

Concern about future directions in healthcare exists, with corporate consolidation seen as likely and necessary. To understand this transformation, the author examines the financial growth trends among the nation's leading corporate providers. Investor-owned (IO) and not-for-profit (NFP) firms are compared using audited data on four financial accounts (assets, debt, equity and income) and three financial ratios (liquidity, leverage, and profitability). The author analyzes financial trends from 1978 to 1982 and looks beyond the significant differences in the balance sheet and income statement accounts to a significant similarity in ratio trends between the NFP and the IO firms' financial conditions. The implications of these findings are discussed in terms of future forms of corporate providers.

Financial Audit↗

PubMed1997

Variations in the management of cancer in the NHS: a legitimate cause for concern?

Wide variations still exist in the UK in the management of common cancers in adults. Comprehensive high-quality audit data are needed to relate variations in outcomes to differences in clinical management. The management of cancer in the elderly is often difficult due to co-morbidity. Access to oncological advice should be available to all patients irrespective of age. Development of and adherence to nationally agreed treatment protocols is a key measure in reducing variations in treatment and in outcomes for patients with cancer.

Adult↗

PubMed1992

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↗

PubMed1994

Female mortality in reproductive ages in Dar es Salaam, Tanzania.

An audit of all cases of female mortality in the reproductive age groups has been performed in Dar es Salaam during 1991-93. Multiple sources of information was used to collect information on deaths. None of the sources of information on death was alone adequate. 73% of the interviews was done at home. The mother or another close relative was interviewed in more than 70% of the cases. A total of 645 deaths were identified and 18% of these were related to pregnancy. Fever, shortness of breath and weight loss were the most common symptoms before death followed by pallor and vomiting. Almost 90% visited a health facility before death. AIDS (27%), tuberculosis (13%) and malaria (12%) were the most common causes of death. Diagnosis could not be made from audit data in 22 cases, and the relatives attributed 7.6% of all deaths to witchcraft or just God's will. AIDS and related diseases are now a major cause of death in the female reproductive age group. There is need to identify preventive measures of this disease as well as prevention of malaria and tuberculosis.

Adolescent↗

PubMed1993

Screening for colorectal neoplasia: physicians' adherence to complete diagnostic evaluation.

This prospective study was done in a health maintenance organization colorectal cancer screening program to determine whether 166 persons found to have abnormal fecal occult blood test results typically underwent complete diagnostic evaluation (i.e., either colonoscopy or barium enema x-ray plus flexible sigmoidoscopy). Chart audit data show that 137 (82%) subjects contacted a physician to discuss follow-up. A complete diagnostic evaluation was recommended to only 52 (38%) patients who talked with a physician. Forty-two (81%) patients who were advised to get a complete diagnostic evaluation actually complied. Significant differences in clinical findings were observed for patients who did and did not have a complete diagnostic evaluation.

Colorectal Neoplasms↗

PubMed1999

Complexity- and risk-adjusted model for measuring surgical outcome.

BACKGROUND: Although currently available surgical scoring systems have good outcome predictive power, their use is often limited by complexity and their non-dynamic nature. The aim of this study was to develop and test a risk adjustment for general surgical audit which is both simple and dynamic, while preserving a high predictive power for surgical morbidity. METHODS: Twelve easily measured, well defined prognostic variables for morbidity were identified from the Otago Surgical Audit data collection form and stratified into suitable categories. Logistic regression was used to adjust for confounding between factors, identifying risk factors with the strongest prognostic value for the outcome of severe and intermediate complications. The resulting model was tested by back-validation and validation. RESULTS: The derived risk adjustment included all 12 variables. Adjusted odds ratios for all variables were markedly lower than unadjusted values. After logistic regression, the strongest predictors of postoperative morbidity were duration of operation, operation category, inpatient status and organ system in which the procedure was carried out. The area under the receiver operating characteristic curve was 0.86. CONCLUSION: A simple dynamic model for surgical morbidity has been developed which is comparable to previously published surgical scoring systems in terms of predictive power. This risk adjustment tool can be incorporated into the existing audit system, enabling comparison of surgical unit performance.

Adolescent↗

PubMed2002

The "jaundice hotline" for the rapid assessment of patients with jaundice.

PROBLEM: Patients with jaundice require rapid diagnosis and treatment, yet such patients are often subject to delay. DESIGN: An open referral, rapid access jaundice clinic was established by reorganisation of existing services and without the need for significant extra resources. BACKGROUND AND SETTING: A large general hospital in a largely rural and geographically isolated area. KEY MEASURES FOR IMPROVEMENT: Waiting times for referral, consultation, diagnosis, and treatment, length of stay in hospital, and general practitioners' and patients' satisfaction with the service. STRATEGIES OF CHANGE: Referrals were made through a 24 hour telephone answering machine and fax line. Initial assessment of patients was carried out by junior staff as part of their working week. Dedicated ultrasonography appointments were made available. EFFECTS OF CHANGE: Of 107 patients seen in the first year of the service, 62 had biliary obstruction. The mean time between referral and consultation was 2.5 days. Patients who went on to endoscopic retrograde cholangiopancreatography waited 5.7 days on average. The mean length of stay in hospital in the 69 patients who were admitted was 6.1 days, compared with 11.5 days in 1996, as shown by audit data. Nearly all the 36 general practices (95%) and the 30 consecutive patients (97%) that were surveyed rated the service as above average or excellent. LESSONS LEARNT: An open referral, rapid access service for patients with jaundice can shorten time to diagnosis and treatment and length of stay in hospital. These improvements can occur through the reorganisation of existing services and with minimal extra cost.

Adolescent↗

PubMed2006

Prospective audit of colorectal resections in a peripheral public hospital.

BACKGROUND: Colorectal disease requiring surgery is common in New Zealand where there is no established national colorectal screening programme. We established an audit to review our current practice in colorectal surgery. METHODS: Prospective audit data were collected on consecutive patients undergoing colorectal resection between April 2003 and December 2004, using a standardized pro forma. RESULTS: In all, 170 colorectal resections were carried out of which 117 (69%) were for malignancy and 120 (71%) were elective. Median patient age was 72 years (interquartile range 62-78 years) and median length of stay was 10 days (interquartile range 8-14 days). Colonoscopy was the most common method of investigation. In elective patients with malignancy, the average delay between onset of symptoms and surgery was 25 weeks. Duke's stage C was the most common stage at presentation (44%). Complications developed in 83 (49%) of patients including 20 (12%) patients returned to theatre, 5 (3%) anastomotic leaks and 8 deaths (5%). In patients undergoing surgery aged over 80 (n = 40) the median length of stay was 10 days (7-14) with a complication rate of 21 (55%) including 5 (13%) who were returned to theatre and 6 (16%) deaths. CONCLUSION: This audit has confirmed that there is an acceptable level of care at Taranaki Base Hospital when compared with those in published work. Elective patients with malignancy have a delay of nearly 6 months between the onset of symptoms and surgery. Patients in Taranaki are more likely to present with an advanced stage of tumour compared with other unscreened populations.

Aged↗

PubMed2001

Quality assurance in a multidisciplinary symptomatic breast assessment clinic.

BACKGROUND: Although quality assurance guidelines for surgeons have been issued and adopted for use in population-based breast screening programs in Australia, similar guidelines are unavailable for women referred with symptomatic breast problems. METHODS: Six hundred and ninety-six women who attended the Royal Adelaide Hospital Women's Health Centre between February and November 1998 for investigation and management of a new breast-related complaint were prospectively evaluated. Investigation strategies and outcomes of the initial consultation were determined and the results compared with the performance quality standards for symptomatic breast disease according to the British Association of Surgical Oncology (BASO) Breast Surgeons' Group. RESULTS: A breast lump was the presenting symptom in 45%, while breast pain was present in 26%. Ninety per cent of women referred with breast symptoms were given a definitive benign or malignant diagnosis at the initial clinic visit. Although the median time delay between the date of general practitioner referral and breast clinic appointments for all patients was < or =7 days, the time delay for 'urgent' cases was not met according to BASO performance indicators. All other Royal Adelaide Hospital Breast Clinic audit data were within the range suggested by BASO performance indicators for new consultations in a symptomatic breast assessment clinic. CONCLUSIONS: A multidisciplinary breast clinic in a public hospital setting is able to provide clinical services to symptomatic women, with the majority of patients obtaining a confident diagnosis at the first presentation. Performance indicators for symptomatic breast disease are useful in identifying inadequacies at the clerical or clinical level which, following the implementation of subsequent changes, may lead to improvement in patient outcomes.

Adolescent↗

PubMed2002

Refusing analgesics: using continuous improvement to improve pain management on a surgical ward.

Despite advances in pain control many patients experience moderate to severe pain whilst in hospital. Contributory factors include inadequate assessment and documentation of pain, as well as patient and professional misconceptions. A 28-bedded surgical ward in a District General Hospital in the South of England was the setting for the project. A small preliminary audit of pain on this ward indicated that some patients experienced postoperative pain, which was not effectively controlled. A 'continuous improvement' framework was used to increase understanding of the problem and identify an aim for the project, which was to reduce the number of patients refusing analgesics when offered by nurses. An audit to ascertain how many patients refused analgesia revealed that, of 133 patients offered, 93 (70%) refused. Using the 'Model for Improvement' (Langley et al., 1996) a number of changes were introduced, including a patient information sheet, regular documented pain assessment and an innovative staff education programme. To evaluate if the changes in practice had been successful, further audit data were collected from 167 patients. Sixty-three (44%) accepted analgesics, indicating a significant decrease in the number refusing (P = 0.005). This small project demonstrated that continuous improvement methodology can improve the management of pain and quality of care for patients. Such an approach brings practitioner and patient into meaningful understanding and offers solutions which are realistic, achievable and sustainable over time. Despite finite resources and increased pressure on staff it is possible to motivate people when they feel they have ownership and change is meaningful. Continuous improvement methods offer an exciting, feasible, patient-centred approach to improving care.

Analgesics↗

PubMed1998

Mature results from three large controlled studies with raltitrexed ('Tomudex').

Since the publication of the results of phase I dose-finding studies, an extensive phase II and III clinical study programme has been undertaken to study the clinical efficacy and tolerability of the quinazoline folate analogue raltitrexed ('Tomudex'), a novel direct and specific inhibitor of thymidylate synthase. Two international phase III trials, studies 3 and 12, have compared raltitrexed 3 mg m(-2) with 5-fluorouracil (5-FU) plus low-dose leucovorin (LV) (Mayo regimen) or high-dose LV (Machover regimen) respectively. A North American study (study 10) was originally set up to compare two raltitrexed dosage arms (3.0 and 4.0 mg m[-2]) with 5-FU and low-dose LV, but the 4.0 mg m(-2) arm was discontinued prematurely because of excessive toxicity. Minimum follow-up times for studies 3, 10 and 12 were 15.5, 12 and 9 months, respectively (for data other than survival), with corresponding survival follow-up times of 26, 12 and 17 months. Objective response rates were similar for raltitrexed and 5-FU + LV, and palliative improvements were seen to a similar extent with both treatments in all phase III studies. Survival was statistically similar for raltitrexed and 5-FU + LV in both studies 3 and 12. Raltitrexed was, however, associated with inferior survival to 5-FU + low-dose LV in study 10, but there appears to be evidence that this was linked to an unconscious effect on investigator behaviour of early toxicity problems in this trial, in that patients appeared to be withdrawn from raltitrexed treatment without progression or protocolled toxicity. Moreover, it appeared that 5-FU + LV patients were continued on treatment after disease progression. 5-FU-based therapy was associated with a higher incidence of mucositis than raltitrexed in all studies, with the attainment of statistical significance in studies 3 and 12. Elevations in hepatic transaminase levels were seen with raltitrexed, but these are thought to be of no clinical significance. Overall, much greater levels of toxicity were seen with 5-FU + LV than with raltitrexed in early treatment cycles. In addition, retrospective UK audit data have shown the monthly cost of raltitrexed therapy to be similar to that of Mayo and continuous infusion 5-FU regimens, and appreciably lower than that of the de Gramont regimen of 5-FU (bolus + 22-h infusion) + high-dose LV. Thus, raltitrexed is an effective alternative to 5-FU-based therapy in patients with advanced colorectal cancer, with an acceptable and, unlike 5-FU, predictable toxicity profile. In particular, patients receiving raltitrexed may benefit from the minimization or avoidance of mucositis, and both patients and healthcare providers may find the convenient administration schedule of the drug advantageous.

Antineoplastic Combined Chemotherapy Protocols↗

PubMed1995

Is day case liver biopsy underutilised?

Day case liver biopsies are rarely performed nationally but have been routine practice in selected patients in our hospital since 1989. We have audited our experience of this procedure to compare its safety, and efficacy with inpatient biopsy and assess patient acceptability. Audit data were collected retrospectively on liver biopsies performed at a teaching hospital over 42 months. Acceptability of day case biopsy was assessed by a questionnaire. A total of 182 of 546 biopsies were day cases (33%). The specimen quality was similar in both groups. The overall complication rate did not significantly differ between the two groups (2.7% day case v 3.3% inpatients). There were no deaths or episodes of haemorrhage in the day cases but one patient developed a pneumothorax. Some 91% of those who had a day case biopsy were satisfied with the procedure. Day case liver biopsy is safe, effective, and acceptable in selected patients.

Adult↗

PubMed2004

A simple tool for rapid access to a symptomatic breast clinic.

AIM: The introduction of a rapid referral system has led to an increase in the number of patients with benign disease using clinic appointments. This situation could delay those patients, who do have cancer but are not referred within these rapid referral guidelines. Existing guidelines fail to benefit those patients with lower risk symptoms. We reviewed prospective audit data from patients referred to a symptomatic breast unit with the aim of introducing a referral schema based upon symptoms, age and relative risk of cancer. METHOD: Demographic details, mode of referral, history and presenting symptoms were collected from each of the 2064 patients referred to the James Cook University Hospital (JCUH) breast unit from April 2001 to March 2002. RESULTS: Odds Ratios (OR) from eight dependent variables gave a 30% improvement in prediction accuracy of breast cancer. From these findings a breast referral schema is presented that is designed to expedite referral from primary care of those patients most at risk. CONCLUSIONS: Use of the schema within primary care could lead to an increase in the early referral of patients with breast cancer.

Adolescent↗

PubMedDate not supplied

Local anaesthesia for vitreoretinal surgery: an audit of patient and surgical experience.

PURPOSE: Local anaesthesia for vitreoretinal surgery is little used as these procedures are deemed to be too long and uncomfortable for patients to tolerate. In this unit anterior intraconal local anaesthesia is used for most routine surgery. We undertook an audit to ensure that surgical standards and patient acceptability were not compromised. METHODS: A prospective observational audit was performed. Audit data included: Grade of anaesthetist and surgeon; details of anaesthetic and operation; compliance of patient; operating conditions and pain scores. Anaesthesia was provided with a combined peribulbar and intraconal anaesthetic, using bicarbonate buffered lignocaine and bupivacaine 50:50 mixture. RESULTS: 135 (76%) had local anaesthesia alone, 13 (7%) had local anaesthesia with sedation and 29 (16%) had general anaesthesia. 96.4% of patients were compliant and 98.8% of operating conditions were good or excellent. The mean perioperative pain score was 0.1 (range of 0-1), 97% said they would choose local anaesthesia again. CONCLUSIONS: LA for vitreoretinal surgery is a useful and flexible method of anaesthesia, which has been shown to have excellent patient tolerance.

Adult↗

PubMed2005

Setting up and auditing guideline- and evidence-based cardiac rehabilitation.

BACKGROUND: Rehabilitation is available to only a minority of post-myocardial infarction (MI) patients and is of variable quality. Guidelines now recommend individualised care delivered by hospital, primary care and community services, but there is little evidence of the feasibility, acceptability or effectiveness of this approach. AIMS: To demonstrate the feasibility of guideline-based rehabilitation, to audit delivery and outcome and to identify problems. METHODS: A four-phase stepped programme for post-MI patients was developed based on individualised in-hospital care and aftercare from a menu of options. Delivery involved co-ordination between hospital services, primary care and community services. Self-report audit data were collected in hospital and at 3 months post-discharge by postal questionnaire and telephone calls. Clinical information was recorded from hospital, telephone and outpatient contacts. Delivery of care to patients receiving interventions was recorded. RESULTS: It was possible to negotiate individualized plans for all patients and to monitor progress for 3 months after discharge. The rehabilitation team achieved high rates of delivery of agreed interventions, considerably better than delivery by primary care. Problems largely related to difficulties and failures in communication. Patients with major social or psychological difficulties were the most difficult to treat. CONCLUSION: Guideline-based rehabilitation is feasible, but there is a need to improve the coordination of delivery of later steps of care and also to refine specialist interventions.

Adult↗