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Penile cancer in the UK: clinical presentation and outcome in 1998/99.

OBJECTIVE: To use the British Association of Urological Surgeons (BAUS) Cancer Registry data to audit a cohort of patients with penile cancer, and thus evaluate current management practices in the UK. PATIENTS AND METHODS: In all, 243 patients were registered over an 18-month period shortly before the publication of the UK National Institute of Clinical Excellence cancer guidelines. Clinical data, including preceding skin disorders, the clinical presentation, management, treatment-related complications and the outcome in terms of local, nodal or distant disease recurrence, survival and cause of death, were sought from the originating clinician. RESULTS: Data were obtained on 193 patients (79% of the initial population). One consultant reported five patients and the most from one centre was eight. A painless lump or ulcer was the commonest presentation; 45 patients had pre-existing skin disorders. The median age was 65.5 years and 67 patients were aged < 60 years. Squamous cell carcinoma accounted for 94% of the pathology. There were wide variations in treatment for patients of similar disease stage. Twenty-six patients had palpable regional nodes and 44 had a lymph node dissection; complications were reported in 43, including 18 of 44 having node dissection. The median follow-up was 27.7 months from the date of diagnosis. Death from penile cancer was recorded in one of 22 patients with stage 0 disease and seven of nine with stage IV disease. Positive lymph nodes had a detrimental effect on survival. CONCLUSION: Experience in the management of penile cancer is shared by many urological surgeons in the UK. These data provide a 'baseline' against which to measure the outcome of specialist multidisciplinary team activity.

Adult↗

Use of a clinical audit to promote the quality use of medicines to rural and remote general practitioners.

Very few methods have been shown to change prescribing behaviour. Queensland Rural Medical Support Agency's Quality Use of Medicines (QUM) Program aims to engage rural general practitioners (GPs) in the development of strategies to improve health outcomes in relation to the quality use of medicines. The present paper describes the development of a tool to audit the management of heart failure in rural general practice and to encourage rural GPs to undertake such an audit as a method of continuing medical education. A self-administered retrospective clinical audit of heart failure patients was undertaken by rural and remote GPs. Fourteen doctors undertook the audit, providing data on 270 patient cases. Patient data collected include 30% not receiving adequate angiotensin-converting enzyme inhibitor doses, 45% of patients who may benefit from a beta-blocker and 14% of patients taking a drug known to aggravate heart failure. The majority of participants would review a patient following the audit and 93% confirmed that the audit assisted them in identifying patients whose heart failure management could be enhanced. The clinical audit provided results and a commentary to allow GPs reflective educational opportunities through the dissemination of results and engagement with appropriate educational organisations (e.g. Australian College of Rural and Remote Medicine) to inform the development of educational standards for personal development programs in QUM. Audits must be relevant and practical to meet the learning needs of GPs.

Adrenergic beta-Antagonists↗

The reliability of team-based primary data collectors for the collection of exposure and protective equipment use data in community sport.

OBJECTIVE: Reliable data allows for the generalisation of study findings to the wider population. The aim of this study was to assess the reliability of using community team based primary data collectors for the collection of exposure and protective equipment use data. METHODS: Nine clubs (23 teams) from a metropolitan Australian Football league in Victoria each provided one primary data collector to monitor exposure and protective equipment use over a regular playing season. Four random audits of this data collection for each team were conducted throughout the regular playing season. The audits were compared with data collected by the club data collectors and the level of agreement assessed. RESULTS: Although exposure data agreement was higher during competition and protective equipment use agreement higher during training, there was no significant difference in data collected by the primary data collectors and the random audits. CONCLUSIONS: The use of trained data collectors associated with Australian Football teams provides reliable information about player exposure and protective equipment use in community intervention studies.

Athletic Injuries↗

Are outcome data regarding the survivors of neonatal care available from routine sources?

AIM: To determine whether existing information and surveillance systems can be used to provide follow up data on groups of infants at increased risk of disability--for example, the survivors of neonatal intensive care. METHODS: A survey was made of maternity, neonatal, and community child health information systems and surveillance programmes in the Trent Regional Health Authority. Children known to have received neonatal intensive care in Trent between 1 August 1992 and 31 July 1993, and a random sample of normal children in two health districts (data quality check) were included. A data linkage study was made to determine whether follow up information about a random sample of infants, known to be at increased risk of poor outcome, could be identified on community child health databases. Two widely accepted datasets (birth and 2 years) were used as standards for this exercise. The quality of data was audited. RESULTS: All clinical items of the birth minimum dataset were routinely recorded by at least one agency in each health district in Trent. Of the descriptive items, only the mother's age on leaving full time education was not collected. At 2 years, all clinical items were collected as part of the routine surveillance programme, but data were recorded using a system which severely limited interpretation. Data quality, in terms of the number of errors introduced at data entry, was very good with only 1.1% of the check items (4/368) incorrectly recorded. Only two districts had organised electronic transfer of data between maternity, neonatal, and community child health systems. The mother's NHS number, although available, was not routinely recorded by any system. The NHS number of the infant was routinely collected by six out of 12 community paediatric services. Data linkage was attempted in six districts with appropriate community child health databases. Just over 70% of the intensive care sample was successfully linked with follow up information on child health systems. CONCLUSIONS: The existing programmes for routine child surveillance could provide outcome data for high risk groups of infants, such as the survivors of neonatal intensive care. However, the present coding system used for data entry is inadequate. Furthermore, rates of identification, without the use of a unique identifier (NHS number) for each subject, are currently insufficient for monitoring health status in later life.

Child Health Services↗

Quality assurance management methods applied to a local-level primary health care system in rural Nigeria.

Introduction. Management of primary health care (PHC) systems in less developed countries is often impeded by factors such as poorly trained personnel, limited financial resources, and poor worker morale. This study explored the ability of local-level PHC supervisors in rural Nigeria to use quality assurance (QA) management methods to improve the quality of the PHC system. Methods. PHC supervisors from Bama Local Government Area were trained for 3 days in the use of QA methods and tools. The supervisors targeted the supervisory system and the health information system (HIS) for improvement. Health worker performance in diarrhoea case management was assessed, using a simulated case, to measure the impact of supervision. A HIS audit assessed data collection forms used by 17 PHC facilities. Gaps in quality were monitored over a 2-month study period and flaws in work processes were modified. Results. PHC supervisors introduced a checklist during monthly visits to facilities to monitor how workers managed cases of diarrhoea. Performance in history-taking, physical examination, disease classification, treatment and counselling improved over the evaluation period. The HIS audit found that a variety of reporting forms were used at PHC facilities. After HIS reporting was standardized, the number of health facilities using a daily disease registry significantly improved during the study period. Conclusions. QA management methods were used by PHC supervisors in Nigeria to improve supervision and the HIS. QA management methods are appropriate for improving the quality of the PHC in Nigeria and in other less developed countries where at least a minimal PHC infrastructure exists.

Developing Countries↗

Can improved software facilitate the wider use of ambulatory blood pressure measurement in clinical practice?

BACKGROUND: 24-h ambulatory blood pressure measurement (ABPM) is now recognized as being indispensable in the diagnosis and management of hypertension. The technique must, therefore, be made available in primary care, but in doing so it must be recognized that unfamiliarity with the technique may lead to misinterpretation of data. OBJECTIVE: To facilitate the wider application of ABPM, especially in primary care, we examined the features that would facilitate the development of a standardized user-friendly software program for the presentation, analysis and interpretation of data. METHODS AND RESULTS: The following features were considered essential to any software program for ABPM: standardized plots of 24-h profiles; computer interpretation of ABPM data and patterns; a user-friendly one-page report, flexible statistical analysis, and the facility to group data and to export data for audit and research analysis. The dabl ABPM program incorporating these features was introduced into the Blood Pressure Unit, Beaumont Hospital in 2000 and has been used in over 15 000 ABPM recordings. The program is now being used widely in general practice and specialized centres. CONCLUSIONS: It is feasible to design a software program to provide a standardized plotting format for ABPM, a basic analysis of data for day-to-day clinical work, or elaborate analyses for research, and an interpretative report to assist diagnosis and to provide an educational process for doctors and nurses not familiar with the technique.

Blood Pressure Monitoring, Ambulatory↗

A multicentre retrospective audit of outcome of patients undergoing curative resection for rectal cancer.

AIM: This study describes the outcome of patients with rectal cancer treated in four New Zealand public hospitals before the advent of specialised colorectal units in order to provide a baseline against which any changes in management can be measured. METHODS: A retrospective review of case notes of patients who underwent resection of rectal cancer with curative intent over a period of 7-10 years up to 1995 in Christchurch, Wellington, Nelson, and Masterton Public Hospital's, was undertaken. Patients were identified from hospital records using a combination of methods (pathology data bases, clinical case mix data, operating logs and audit data). Metastatic disease was considered to be present if confirmed on histology or the clinical course of the patient was consistent with metastatic disease. Patients were excluded if there was perioperative evidence of metastatic disease or if they had transanal excision. Previously published results from Auckland and Dunedin Hospitals are compared. RESULTS: 524 patients with rectal cancer were identified who had undergone surgery with curative intent in the four hospitals. The overall permanent stoma rate was 37%. The overall 30-day mortality was 2.9%, five-year survival was 63% and local recurrence at five years was 26%. CONCLUSION: While low perioperative mortality and good long-term survival were achieved, there were high rates of local recurrence. These data are a baseline against which the impact of new approaches to curative resection for rectal cancer can be measured.

Colorectal Neoplasms↗

Candidaemia in a large teaching hospital: a clinical audit.

BACKGROUND: Candidaemias are associated with significant morbidity and mortality. The British Society of Medical Mycology and Infectious Diseases Society of America recently published audit standards, to address the changing epidemiology of candidaemia and to improve outcomes. AIM: To investigate the local epidemiology of candidaemia and the standard of care in a large teaching hospital. DESIGN: Retrospective audit. METHODS: Data were obtained for all candidaemia episodes over the 4-year period ending July 2004, from the medical and nursing notes, laboratory computer and patient administration system. RESULTS: We identified 92 episodes in 90 patients. The main predisposing factors were being on an intensive care unit, having a central venous catheter, and (for neonates) prematurity. Central venous catheters were removed at a mean 1.8 days following candidaemia; 79% (37/47) were removed within 48 h (the audit standard). Identification and susceptibility tests were performed for 94.7% of isolates. All were susceptible to amphotericin B; 87% were susceptible to fluconazole. Antifungal treatment was started within 24 h of a positive blood culture in 84% of episodes. Initial antifungal therapy was appropriate in 95% (61/64) of treated cases. Most patients (81%) who survived or completed their intended course of treatment before death received at least 2 weeks treatment. However, only 45% of those transferred to other hospitals had accompanying guidance on the intended further duration of therapy. Thirty-day mortality was 41%. After adjustment for age, the presence of Candida-related complications was associated with an odds ratio for mortality of 6.5 (95% CI 1.2-36.5, p = 0.03). DISCUSSION: Overall the audit standards set by the BSMM and IDSA were met, and discrepancies did not lead to a change in outcome. Improved intravenous catheter care, a more pro-active approach to searching for complications, and improvement in the inter-hospital transfer process, will assist in reducing morbidity and mortality.

Adolescent↗

Commercial managed care plans leaving the Medicaid managed care program in New York State: impact on quality and access.

UNLABELLED: To develop sufficient managed care capacity to accomplish the goal of transitioning Medicaid recipients into managed care, state policymakers have relied on commercial health maintenance organizations to open their panels of providers to the Medicaid population. However, while commercial health maintenance organization involvement in Medicaid managed care was high initially, since 1996 New York State has had 14 commercial plans leave the New York State Medicaid Managed Care Program. It has been speculated that the exodus of these commercial plans would have a negative impact on Medicaid enrollees' access and quality of care. This paper attempts to evaluate the impact of this departure from the perspective of quality and access measures and plan audit performance. Univariate and multivariate analyses were performed to evaluation the effect of commercial managed care plans leaving the Medicaid program. The overall performance of plans that remained in the program was compared to that of the plans that chose to leave for the two time periods 1996-1997 and 1998-2000. Access to care, quality of care, and annual audit performance data were analyzed. The departure of commercial health plans from the New York State Medicaid Managed Care Program has not had a statistically significant negative effect on the quality of care provided to Medicaid recipients as evaluated by standardized performance measures. In addition, there were no instances when there was a negative impact of the exit of the commercial plans on access to care. Managed care plans that chose to remain in Medicaid passed the Quality Assurance Reporting Requirements audit at a significantly (P < .01) higher rate than plans that chose to leave. CONCLUSIONS: A program consisting of health plans voluntarily participating and committed to Medicaid managed care can provide Medicaid recipients with appropriate access to high-quality health care. The exodus of commercial health plans from New York's Medicaid Managed Care Program during the time periods studied did not result in a detectable adverse impact on the quality of care for enrollees.

Adolescent↗

Adherence to the guidelines of the CCCE in the treatment of node-positive breast cancer patients.

Guidelines are tools to improve the quality of care in daily practice. To accomplish adherence, active implementation is needed. The effect of audit, group-oriented feedback and educational activities to increase guideline adherence were investigated in this study. Treatment according to a guideline for premenopausal node-positive breast cancer patients from 1988 to 1992 (P1) and from 1996 to 1998 (P2) was assessed using the following indicators: percentage of patients with breast-conserving surgery, secondary surgery, > or = 10 reported resected axillary lymph nodes, reported tumour differentiation grade, reported hormonal receptor status, chemotherapy received (CT), start of CT < or = 28 days after surgery, Dose Intensity (DI) > or = 85% and completion of CT < or = 1 week beyond the ideal duration of CT. Data were audited from patients' records. The first audit resulted in a quality programme with feedback focused on the delivery of chemotherapy and resected axillary lymph nodes and educational sessions. A Fisher's exact test was used to estimate significant differences between the two time periods. In P1, 323 patients and in P2, 155 patients were eligible for treatment according to the guideline. The percentage of patients with > or = 10 lymph nodes improved from 65.3 to 81.3% (P=0.0004), as did the percentage with a reported oestrogen receptor (ER) status, from 84.8 to 96.8% (P=0.00004), progesterone receptor (PR) status from 82.3% to 97.4% (P<0.000001) and with a DI > or = 85%, from 74.9 to 93.9% (P=0.000003). Adherence varied between the hospitals. In conclusion, significant improvements were observed for the indicators of resected axillary lymph nodes and DI of chemotherapy, which may be attributed to the quality programme. Repeated assessment of the adherence to the guideline is important to observe changes and interhospital variations in order to remain focused on areas for improvement.

Aged↗

Tutorial reduces protocol deviations in multicenter ACTG trials with pharmacology endpoints.

PURPOSE: The AIDS Clinical Trials Group (ACTG) pharmacology quality assurance program requires clinical research staff to demonstrate minimum competencies in clinical pharmacology research. To achieve this goal, a tutorial was designed to improve the accuracy and completeness of data collected in ACTG pharmacology protocols. METHOD: Clinical research staff at AIDS Clinical Trials Units (ACTUs) access the tutorial through the network's Website. The tutorial presents pharmacokinetic study concepts by contrasting poor with perfect study conduct to illustrate the influence of data quality on conclusions. Case report forms and laboratory data were audited retrospectively to examine the pre- and posttutorial incidence of targeted errors. RESULTS: During a 2-year period, 236 study nurses at 64 main and subunit ACTUs completed the tutorial. The percentage of visits with dosing and/or sampling errors dropped from 13% to 4%. The percentage of samples with errors decreased from 6% to 3%. Sample-time errors (blood drawn outside of the 15-minute target time) decreased slightly, from 2.9% to 2.4%, but the discrepancies found in the recording of sample times decreased from 3% to <1%. CONCLUSION: The ACTG clinical pharmacology tutorial program improved accuracy of both protocol conduct and data collection for pharmacology objectives.

Acquired Immunodeficiency Syndrome↗

Biologically based validation of PC electrophysiology data collection systems utilizing the Good Automated Laboratory Practices.

Since there was a scientific need to conduct electrophysiology measurements to detect possible ocular (electroretinography, ERG), central neurotoxic (quantitative electroencephalography, qEEG), and cardiac (electrocardiography, ECG) effects in animals used in certain regulatory studies, the acquisition of suitable automated PC software systems were required. This article describes the process by which these systems were validated to ensure that they met the scientific requirements, while also addressing the principles of Good Automated Laboratory Practices (GALP). After a thorough search of existing commercial packages, a plan was developed specific for each PC-based collection system selected for evaluation. The common elements of each plan included consideration of both scientific and GALP elements, such as necessary biological response variables, raw data acquisition and identification, acceptance criteria, security, protection, storage media, data integrity, audit requirements and standard operating procedures. The authors' approach to validation for each electrophysiology system was to determine scientific needs for accuracy, precision, and detection limit of biological effects concurrent with GALP requirements. The selected software systems were employed in separate scientific GLP studies conducted in dogs, rats, and mini-pigs to demonstrate the ability to detect cholinesterase effects due to multiple infusions of physostigmine, based on parallel measurement of cholinesterase biomarkers. Since the systems were designed for human usage, certain adaptations were necessary. A critical assumption to be tested was the ability of the system's algorithms to adequately capture and assimilate the data in an accurate fashion. Concomitantly, the related GALP needs, such as data integrity, security, CD-ROM archive, and personnel training requirements were evaluated, implemented, and defined to accommodate the application and process needs. The biological approach to validation of these PC-based electrophysiology systems met the necessary scientific acceptance criteria as well as compliance requirements in order to be used in regulatory studies.

Algorithms↗

Audit of the histopathological diagnosis of non-neoplastic colorectal biopsies: achievable standards for the diagnosis of inflammatory bowel disease.

AIM: To assess the performance of a histopathology department in diagnosing inflammatory bowel diseases with comparison of reports from other centres. STUDY POPULATION: 1067 sets of endoscopic biopsies received in the department of histopathology, Royal Hallamshire Hospital, 1990-1995. METHODS: The histopathological diagnosis of non-neoplastic endoscopic colorectal biopsies was audited using data from histopathology reports. The biopsy diagnosis by the initial reporting pathologist and final diagnosis after additional investigations (endoscopy, radiology, microbiology) or surgery were used to derive sensitivity, specificity, and positive predictive values for categories of disease. RESULTS: Diagnosis was validated for 1067 biopsy sets (43% of those initially assessed). For all biopsies (with or without active inflammation) reports highly suggestive or suggestive of Crohn's disease had a sensitivity of 50%; for ulcerative colitis the comparable figure was 62%. Sensitivity was the same for both diagnoses (74%) in those biopsies with active inflammation. Positive predictive values for highly suggestive diagnoses of ulcerative colitis or Crohn's disease were 100%. In all biopsies the specificity of a histopathological diagnosis of normality was 96%. CONCLUSIONS: These results compare favourably with the other published audits and present an achievable level of performance for non-specialist hospitals with non-specialist histopathology services.

Adolescent↗

Attitudes to evidence on complementary medicine: the perspective of British healthcare purchasers.

OBJECTIVES: To determine the attitude of those who make decisions on the allocation of health-care resources (health-care purchasers/commissioners) towards the relative importance of different types of evidence on complementary medicine. DESIGN: Questionnaire study of GPs and Directors of Public Health. SETTING: General practices in the UK and Directors of Public Health of Health Authorities in the Greater London region. SUBJECTS: 500 randomly selected general practices in 10 randomly selected UK regions, 100 randomly selected general practices who had previously referred to the Royal London Homoeopathic Hospital and all 28 directors of public health of health authorities in the Greater London region. MAIN OUTCOME MEASURE: Importance of the following on a four point scale ranging from 0 (not important) to 3 (very important): randomized clinical trials, audit outcome data from homoeopathic hospitals, uncontrolled outcome studies, patient satisfaction, patient demand, economic evaluation, colleagues' views, expert opinion, theoretical understanding, laboratory research, safety and availability of literature. RESULTS: 462 general practitioners and 19 Directors of Health Authorities responded. Safety data and randomised clinical trials were considered very important, colleagues' views and patient demand as slightly important, uncontrolled outcome studies as not important. The remaining aspects were considered to be important. Differences between the categories of respondents were small. CONCLUSIONS: While randomized clinical trials remain very important, more emphasis should be placed on further substantiating the safety and value for money of complementary medicine in 'real world' clinical settings.

Attitude of Health Personnel↗

Combating information overload: a six-month pilot evaluation of a knowledge management system in general practice.

A six-month prospective study was conducted on the usefulness and usability of a representative electronic knowledge management tool, the WAX Active Library, for 19 general practitioners (GPs) evaluated using questionnaires and audit trail data. The number of pages accessed was highest in the final two months, when over half of the access trails were completed within 40 seconds. Most GPs rated the system as easy to learn, fast to use, and preferable to paper for providing information during consultations. Such tools could provide a medium for the activities of knowledge officers, help demand management, and promote sharing of information within primary care groups and across NHSnet or the Internet.

Adult↗

Demographic variables routinely collected at colposcopic examination do not predict who will default from conservative management of cervical intraepithelial neoplasia I.

OBJECTIVE: As a result of the low incidence of progression from low grade epithelial abnormalities to cervical intraepithelial neoplasia (CIN) 3 or cervical cancer, a conservative approach to management is supported, especially in young women. Loss to follow-up is a recognised problem with a conservative approach however, with women defaulting known to experience higher rates of cancer. AIM: To determine if any routinely collected demographic variables could predict which Australian women would subsequently default from care having initially elected to have conservative management of CIN 1 lesions. METHODS: Prospectively collected data was audited on 279 women with a colposcopically directed biopsy diagnosis of CIN 1, confirmed on external review, who were enroled by their own choice into a conservative management program and monitored until a definitive lesion outcome was determined. Women who defaulted from follow-up and were lost to care providers despite follow-up appointments and reminder letters were compared to women who completed follow-up with either lesion resolution or progression requiring treatment, to establish if there were any demographic variables to predict default from care. RESULTS: Fifty-two (18.5%) women subsequently defaulted from follow-up. There were no significant differences in age, parity, proportion of women who were pregnant at diagnosis, smoking status, immunosuppressed or had a 'human papillomavirus (HPV) effect' reported on Pap-smear or colposcopic examination. CONCLUSION: We cannot easily identify a subgroup of women who are more likely to default from follow-up of CIN 1 using routinely collected demographic data. Default from follow-up is a major risk with conservative approaches and further research to reduce default rates are required.

Adult↗

Pain management documenting the decision making process.

From patient admission to discharge, pain is a critical symptom of concern to the nurse case manager. This descriptive study examined nurses' decision-making regarding pain management as documented in clinical records of patients after orthopedic surgery. Using a Nurses' Pain Management Audit Tool, data analysis revealed that during the first 24 hours after emergence from the Post-Anesthesia Care Unit, these patients received less than 50% of the narcotic doses available for their pain relief. Nurses documented less than 25% of the "ideal occurrences" possible for pain assessment, as described in the Agency for Health Care Policy and Research Guidelines. Incomplete databases for guiding patient outcomes of effective pain management were perpetuated by insufficient documentation. Nurse case managers could stimulate increased commitment and quality improvement in pain management as a crucial aspect of patient care.

Adult↗

[Evaluation of information for renal insufficiency patients before dialysis].

The aim of this audit was to assess the quality of information given to patients before dialysis and to improve the use of this information on the acceptability of the treatment. Methods were those used in medical audit: retrospective data collection in a sample of patients, comparison to a set of standards given by professionals and recommendations disseminated in the group of professionals. Results showed that patients received a partial information on the various techniques used in dialysis. More complete information is needed. Recommendations consisted in a specialised team giving a detailed information on the disease and the techniques used in dialysis, with a psychological assistance. After implementation of this team, re-assessment showed a consistent benefit of structured information and entailed the necessity to improve the process of information delivery by general practitioners and specialists.

Adult↗