Integrated care pathways in the private sector.
ICPs are evidence- and outcome-based. The variances they expose can be analysed along with audit data. ICPs provide a useful audit tool, provided they are acted upon.
Blood Transfusion↗
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Results for “data auditing”
Explore indexed PubMed citations for clinical trials, systematic reviews and public health research. Read source abstracts and follow each citation to its original PubMed record.
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Toward protecting the safety of participants in clinical trials.
It is a widely held belief that the current system of oversight of clinical research, particularly the means of assessing risks and minimizing harms to participants in clinical trials, could be improved. In particular, the system is inefficient with overemphasis on the monitoring ability of some groups such as research ethics review boards and investigators, underemphasis on others such as data monitoring committees (DMCs) and sponsors, confusion about responsibilities for safety and imperfect communication between these different groups. Research ethics review boards are not able to perform safety monitoring by review of individual adverse events and are often burdened by duplicative reviews of large multicenter studies. There are no standards for DMCs to ensure they can reliably identify safety issues. Sponsors may be overreliant on data audits and slow to disseminate safety data in a coherent summary. Investigators, their staffs and clinical sites may not fully appreciate all the nuances of good clinical practice or may be inattentive to the daily conduct of studies. Regulators, particularly those in the United States, have failed to completely harmonize their policies with each other or with international regulatory agencies. We recommend well-designed monitoring plans for all studies that are appropriate to their scope and risk, more centralized review of large multisite studies and closer local scrutiny of single-institution studies. In addition, sponsors should pay greater attention to monitoring adverse events and keeping up-to-date databases or investigator's brochures emphasizing safety issues. A minimal standard of education or expertise in good clinical practice should be established for investigators, their staffs and research ethics review board members. DMC composition and functions should be standardized and regulations should be harmonized nationally and internationally. Finally, there should be a concerted effort to study the efficacy of various components of the system.
Clinical Trials Data Monitoring Committees↗
Clinical audit activities in surgery.
Large scale audits can attract the participation of the majority of surgeons. They require careful planning and must be supported by an infrastructure to co-ordinate the running of the audit and to ensure accuracy of data. Audits can be important sources of information for the development of evidence-based guidelines, and this approach is a good strategy for bringing the lessons obtained from the audit to the profession. Audits that work closely with professional bodies produce the best results and are enhanced by patient representation. Risk stratification is an essential component of comparative studies and should be incorporated to ensure that multi-centre audits are systematic.
Child↗
Auditing clinical research data: objectives, applications and results.
Formal auditing of clinical research data has become a standard contemporary practice within the pharmaceutical industry. Its basic purpose is to provide documentation relevant to an assessment of the quality and integrity of data collected in the course of a clinical trial. This paper outlines the audit procedures developed within one major pharmaceutical firm. These procedures require an intensive investigation of internal and external aspects of study management, records management, data entry, data analysis and statistical report preparation. A qualitative evaluation of the results achieved by this auditing procedure are presented.
Clinical Trials as Topic↗
Regional profile data as basis for social work audit.
Profile data obtained in a regional survey of social work practice have been used by one social work department of a general hospital to identify three problem areas of practice with patients whose discharges are delayed beyond medical necessity. The authors describe the department's analysis of the data, its identification of a topic of concern, and the subsequent steps taken in a departmental audit.
Activities of Daily Living↗
Endoluminal repair of abdominal aortic aneurysm-contemporary Australian experience.
OBJECTIVE: An audit was established in November 1999 by the Australian Government Department of Health and Ageing to determine the mid- to long-term safety and efficacy of endoluminal graft repair (ELG) of abdominal aortic aneurysm (AAA). The audit has been undertaken by the Australian Safety and Efficacy Register for New Interventional Procedures-Surgical (ASERNIP-S). This study reviews contemporary Australian practice, based on audit data supplied to ASERNIP-S. DESIGN OF STUDY: This study is a prospective voluntary register (audit) of Australian data obtained from the private and public sector. Data were collected for ELG repairs performed between 1 November 1999 and 16 May 2001. Follow-up is continuing. Results. Seventy-nine vascular surgeons have contributed data on 950 patients (816 male, 134 female, of median age 75.5 (range 36-94)). The mean aneurysm size was 57.5 mm (+/-10.2) and 44% of procedures were performed on aneurysms less than 55 mm in diameter. Fifty four percent of patients were considered suitable for open repair. Most ELG procedures were performed in an angiography or endovascular suite, under general anaesthetic using an open technique via the femoral arteries. Perioperative mortality was 1.7%, mostly from cardiac causes. Prior to discharge 7.2% of patients experienced an endoleak and 18.6% had systemic complications. The average length of stay was 7.4 days (median 5 days). Unsuccessful exclusion of the aneurysm occurred in 6.7% of cases. CONCLUSIONS: Endovascular repair of AAAs is a well accepted procedure and is performed by the majority of vascular surgeons in Australia. Australian surgeons are taking a rather aggressive approach to the management of aortic aneurysms, particularly in the moderate to higher risk patient groups. Mortality rates are low, given the elderly population in question and morbidity rates acceptable. ASERNIP-S is continuing to collect follow-up data for this patient cohort.
Aged↗
Evaluating the quality of the maternity services--a discussion paper.
OBJECTIVE: A review of the use of computer collected audit data in assessing the quality of maternity services. SETTING: All maternity units managed by the North West Thames Regional Health Authority. RECOMMENDATIONS: A system of audit must supply information that is both credible and of interest to clinicians managers and consumers. The information should be adjusted for differences in populations to allow valid comparisons between units. It needs to be presented in an easily digested form. One way of implementing audit would be to establish a regional group representative of clinicians, patients and managers who would initially interpret the data and make recommendations. A local group of similar composition would be asked to comment on and respond to these with a plan for the following year. Changes would be monitored by analysis of the routinely collected data. CONCLUSIONS: Medical audit in the maternity services requires new concepts if it is to influence the quality of clinical care and the use of resources available to provide that care. The appropriate balance needs to be found between the perspectives of clinicians, patients and managers. A major challenge is the collection of valid data. This has largely been overcome by the St Mary's maternity information system. The next stage is to devise a system of audit that is epidemiologically sound and is acceptable to those who will be asked to implement the lessons that emerge. Only then will it be possible to determine whether clinical practice and the use of resources can be altered to the benefit of patients.
Data Collection↗
Hospital monitoring of pressure ulcers in the UK.
Hospital trusts and health authorities are increasingly being expected to report on numbers of patients with pressure ulcers. Although pressure ulcer audits should be undertaken in a systematic way, there are no agreed standards and little is known about the current status of pressure ulcer monitoring. A postal survey was conducted to establish a national picture of both assessment and audit of pressure ulcers. Questionnaires were sent to 276 acute hospital trusts throughout the UK; 204 were returned, giving a response rate of 74%. Fewer than half of the trusts (40%) employed a tissue viability nurse, and 28.5% of respondents were another type of clinical nurse specialist. Most hospitals used single scales for grading pressure ulcers and risk assessment but the frequency and method of such surveys varied considerably. Relatively few hospitals (5%) monitored the number of pressure ulcers on a daily basis, 30% made some form of weekly return and 22% made monthly returns. The authors conclude that there are national variations with respect to the pressure ulcer assessment tools used to provide audit data, and to the methodology and documentation used to collate data. A national consensus is recommended on auditing of pressure ulcers in the UK.
Hospitalization↗
Surgical capability and surgical pathology in Papua New Guinea in the year 2000.
BACKGROUND: Papua New Guinea (PNG) is a country of 4.5 million people with an annual health budget of only 96 million Kina (1K = US$0.35). There are 19 hospitals in the country and national surgeons are now staffing most of these hospitals. This review aims to describe the surgical pathology in the year 2000 and the capability of PNG surgeons to manage it. METHODS: A review of publications, reports and surgical audit data on surgery in PNG was conducted. Surgical audit has been computerized for over 5 years. The review also draws on personal experience and data from MMed theses submitted to the University of Papua New Guinea. RESULTS: Surgical pathology Surgical practice in PNG remains very general. Late presentation and advanced disease are common. Trauma, infection, malignancy and congenital anomalies dominate the surgical scene. The pattern of disease is different from what is found in the West. Western diseases are emerging with the incidence of appendicectomy rising from 5/100,000 to 75/100,000 in the past 30 years. The incidence of diabetes and gallstones has also risen. Osteoporosis, Colles' and neck of femur fractures are rare. Surgical capability The standard of surgical care is acceptable with a low wound infection rate for clean and clean-contaminated abdominal surgery of 0.9% and an anastomotic leak rate of 1.6%. Transurethral prostatectomy is also being performed to a satisfactory standard for head injuries admitted with a Glasgow Coma Score of 6-8 and a good outcome is achieved in over 70% of cases. Hospital mortality for surgical admissions is 3.7%. Subspecialties in orthopaedics, urology and head and neck surgery have been established. Neurosurgery, paediatric and cardiac surgery are being developed. Priorities for the next decade Papua New Guinea needs to continue to develop surgical subspecialties, particularly paediatric and neurosurgery, while maintaining a broad competence in general surgery. Services for burns, spinal injuries, rehabilitation and oncology need to be improved. Surgeons need to be more involved in rural health and teaching basic skills to primary health-care workers. Acquisition, maintenance and repair of surgical equipment needs to be improved so that PNG's well-trained surgeons can have the right tools for their trade. CONCLUSIONS: Papua New Guinea offers a wide range of surgical pathology. The standard of surgery in PNG is reasonable but there are many areas that need development during the period of the next national health plan, 2001-2010. Australasian surgery has many opportunities to assist surgeons in PNG to achieve their objectives.
Diabetes Mellitus↗
Overview of the reanalysis of the Harvard Six Cities Study and American Cancer Society Study of Particulate Air Pollution and Mortality.
This article provides an overview of the Reanalysis Study of the Harvard Six Cities and the American Cancer Society (ACS) studies of particulate air pollution and mortality. The previous findings of the studies have been subject to debate. In response, a reanalysis team, comprised of Canadian and American researchers, was invited to participate in an independent reanalysis project to address the concerns. Phase I of the reanalysis involved the design of data audits to determine whether each study conformed to the consistency and accuracy of their data. Phase II of the reanalysis involved conducting a series of comprehensive analyses using alternative statistical methods. Alternative models were also used to identify covariates that may confound or modify the association of particulate air pollution as well as identify sensitive population subgroups. The audit demonstrated that the data in the original analyses were of high quality, as were the risk estimates reported by the original investigators. The sensitivity analysis illustrated that the mortality risk estimates reported in both studies were found to be robust against alternative Cox models. Detailed investigation of the covariate effects found a significant modifying effect of education and a relative risk of mortality associated with fine particles and declining education levels. The study team applied spatial analytic methods to the ACS data, resulting in various levels of spatial autocorrelations supporting the reported association for fine particles mortality of the original investigators as well as demonstrating a significant association between sulfur dioxide and mortality. Collectively, our reanalysis suggest that mortality may be attributable to more than one component of the complex mixture of ambient air pollutants for U.S. urban areas.
Air↗
Identifying problems with data collection at a local level: survey of NHS maternity units in England.
OBJECTIVES: To document the extent to which maternity data are collected and how they are recorded, and to identify problems that may affect their availability throughout the NHS. METHODS: Postal survey in September 1997 with structured questionnaires. SETTING: 207 NHS trusts with maternity units in England. PARTICIPANTS: Heads of midwifery in maternity units. MAIN OUTCOME MEASURES: Extent to which maternity data were routinely recorded, how they were recorded and evaluated, and to whom they were made available. RESULTS: 167 (81%) of questionnaires were returned, representing 166 trusts. Of these trusts, 165 collected >/=17 of the 19 data items in HES maternity tail, and 158 collected >/=40 of the 45 items selected from Körner dataset. Only 18 collected all five items selected from the "indicators of success," and 17 did not collect any. In 58 of trusts data were primarily recorded on paper. A computerised maternity information system was used by 106 (63%) of trusts, but many recorded data on paper first. Thirty four did not audit data for accuracy. Most trusts analysed data not routinely collected at national level, but 18 did not analyse HES maternity tail and 17 did not analyse Körner data. CONCLUSIONS: Improvement is needed in quality, completeness, and availability of maternity data at a national level, particularly if the NHS information strategy is to be successfully implemented. Although most of the data items in national datasets are recorded locally, variations in the way data are defined, recorded, and analysed and lack of linkage between computer systems restrict their access, availability, and use at local, district, and national levels.
Data Collection↗
Routine receiver operating characteristic analysis in mammography as a measure of radiologists' performance.
A system for calculating receiver operating characteristic (ROC) curves from routine audit data is described. Both diagnostic opinion and pathology outcome data from the symptomatic mammography department were recorded in an audit database, from which ROC curves were calculated. A comparison of overall radiologists' performance was made and the appropriate performance indices discussed. Similar data were collected from the breast screening centre where the same radiologists read mammograms. The radiologists' performance in the symptomatic department was compared with that in the breast screening centre and was found to be better in the screening centre. The difference could not be wholly attributed to the different age distribution of women and highlighted the different nature of the diagnostic task and the differing sampled populations. ROC curves were drawn for different clinical signs to determine any particular area of difficulty the radiologist may experience. ROC analysis as part of routine audit can be used for maintaining and improving the quality of an individual's performance, and targeting learning on areas of particular weakness.
Adult↗
Royal College of Surgeons comparative ENT audit 1990.
The Royal College of Surgeons Comparative Audit Service was set up in 1990 so that surgeons could pool their audit data, to provide 'standards' with which to compare their own figures. A total of 405 consultant otolaryngologists were circularized in December 1991 inviting them to return data about their resources, workload, case-mix and complications, and about two specific audit topics-Myringoplasty and Carcinoma of the Larynx--for the calendar year 1990. A total of 65 consultants returned proformas with data on 52208 admissions and 31240 surgical procedures. The 'average' respondent admitted 829 patients in the year (19% of these day cases and 14% emergencies) and performed 744 surgical procedures with a mean complication rate of 1.39% using three theatre sessions per week. Cancelled theatre sessions per annum per consultant ranged from 0 to 71. The mean known success rate after myringoplasty was 65%, with hearing improvement in 53%. The 'average' ENT surgeon saw 3.5 new cases of invasive carcinoma of the larynx and treated 69% of these with radiotherapy alone, compared with 14% surgery alone. As well as allowing a profile to be drawn up of the 'average' respondent, this audit allowed individual consultants returning data to compare their own figures in detail with the pooled data, which were presented graphically at a meeting in April 1992.
Carcinoma↗
Quality of diagnosis and procedure coding in ICD-10 administrative data.
OBJECTIVES: The International Classification of Disease, 10th Revision (ICD-10) was introduced worldwide beginning in the late 1990s. Because there have been no published data on the quality of coding using ICD-10, the aim of our analysis is to assess the quality of ICD-10 coding in routinely collected hospital discharge data from Australia, which began using ICD-10 in 1998. METHODS: Audit data from the years 1998-1999 (n = 7004) and 2000-2001 (n = 7631), excluding same-day chemotherapy and dialysis cases, were used in data analysis. Quality measures included prevalence comparisons, sensitivity, positive predictive value (PPV), and the kappa statistic. RESULTS: Comparison of the audit sample to public hospital discharges showed little difference in age and gender, with audited cases more likely to be overnight stays. There was no difference in the median number of hospital assigned diagnosis and procedure codes per discharge. Agreement of the principal diagnosis code was 85% at the 3-digit level and 79% at the 4-digit level in 1998-1999; this rate had improved to 87% and 81% in 2000-2001. Principal procedure code agreement was 85% in 1998-1999 and 83% in 2000-2001 at the 5-digit level, and 81% and 80% at the 7-digit level, respectively. Specific major diagnoses, comorbid diagnoses, major procedures, and minor procedures showed good-to-excellent coding quality. CONCLUSIONS: The transition to ICD-10 has occurred with no loss of data quality, with data showing a high level of reliability and adherence to coding standards. When consideration is given to the nature of the analysis, administrative data can provide highly reliable population-based estimates of hospitalization rates.
Adult↗
Audit of the quality of hospital discharge data.
An audit of the quality of computerised hospital discharge data, in General Medicine and Paediatrics in Dundee, showed that the national data set was often inaccurate. Structured discharge summaries checked by senior medical staff are recommended.
Abstracting and Indexing↗
A proposal for a national mammography database: content, purpose, and value.
A national mammography database is a centralized, computerized method of data collection consisting of two possible parts: a national mammography audit and a system for monitoring and tracking patients. A national mammography audit refers to collecting and analyzing medical audit data of individual mammography practices at a national level and is a critical step in improving the interpretive component of mammography. The monitoring and tracking component refers to a centralized system that provides women and physicians with a recruitment and follow-up mechanism to optimize participation in mammography services. Both parts of a national mammography database represent important components in the improvement of mammography quality. However, unique scientific, legal, and fiscal concerns are important to consider before establishing a national mammography database.
Female↗
National benchmarking as a support system for clinical governance.
Audit of the management of acute asthma in hospital has developed in tandem with guidelines produced and updated by the British Thoracic Society (BTS), on the principle that agreed guidelines combined with systematic review of practice by periodic audit are more likely to result in improvements in practice than guidelines alone. A short audit data set was distilled from previous experience with more elaborate tools and made available nationally to audit departments and through letters to consultant members of the BTS. Hospitals have been able to contribute since 1990. The data set reflects key items of the process of care: peak flow measured on admission and twice daily during the hospital stay; blood gases on admission; systemic corticosteroids as an inpatient; discharged with inhaled and oral corticosteroids; written self-management plans; follow-up arrangements. Data from 4,741 admissions over a seven year period are presented. The proportion of patients nationally receiving these items of asthma care is given. The median values for hospital performance improved significantly over the seven years, although there is potential for further improvement. If these data represent the national picture, they could form the basis upon which to set national standards for the care of patients with acute asthma in hospital. A further result of the developing audit has been the recognition of the value of external benchmarking in providing a context for the interpretation of local audit results. This audit system provides hospitals with a quick and easy method of obtaining an overview of local performance, with comparative national data for the same year. This has potential as a tool for clinical governance with much wider applicability, providing the data are handled carefully, particularly as the variability between hospitals diminishes over time.
Asthma↗
Managing data for a multicountry longitudinal study: experience from the WHO Multicentre Growth Reference Study.
The World Health Organization (WHO) Multicentre Growth Reference (MGRS) data management protocol was designed to create and manage a large data bank of information collected from multiple sites over a period of several years. Data collection and processing instruments were prepared centrally and used in a standardized fashion across sites. The data management system contained internal validation features for timely detection of data errors, and its standard operating procedures stipulated a method of master file updating and correction that maintained a clear trail for data auditing purposes. Each site was responsible for collecting, entering, verifying, and validating data, and for creating site-level master files. Data from the sites were sent to the MGRS Coordinating Centre every month for master file consolidation and more extensive quality control checking. All errors identified at the Coordinating Centre were communicated to the site for correction at source. The protocol imposed transparency on the sites' data management activities but also ensured access to technical help with operation and maintenance of the system. Through the rigorous implementation of what has been a highly demanding protocol, the MGRS has accumulated a large body of very high-quality data.
Child Development↗