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The investigation and management of stable angina. Report of a working party of the Joint Audit Committee of the British Cardiac Society and the Royal College of Physicians of London.

This paper is a summary of present practices in the investigation and management of angina. The mechanism, incidence, and prevalence of angina are reviewed, the roles of invasive and non-invasive investigations assessed, and the indications for coronary angioplasty and coronary bypass grafting discussed. Basic audit data sets for primary, secondary, and tertiary care are proposed and potential audit initiatives suggested.

Angina Pectoris↗

Promotion of breastfeeding intervention trial (PROBIT): a cluster-randomized trial in the Republic of Belarus. Design, follow-up, and data validation.

This paper summarizes the objectives, design, follow-up, and data validation of a cluster-randomized trial of a breastfeeding promotion intervention modeled on the WHO/UNICEF Baby-Friendly Hospital Initiative (BFHI). Thirty-four hospitals and their affiliated polyclinics in the Republic of Belarus were randomized to receive BFHI training of medical, midwifery, and nursing staffs (experimental group) or to continue their routine practices (control group). All breastfeeding mother-infant dyads were considered eligible for inclusion in the study if the infant was singleton, born at > or = 37 weeks gestation, weighed > or = 2500 grams at birth, and had a 5-minute Apgar score > or = 5, and neither mother nor infant had a medical condition for which breastfeeding was contraindicated. One experimental and one control site refused to accept their randomized allocation and dropped out of the trial. A total of 17,795 mothers were recruited at the 32 remaining sites, and their infants were followed up at 1, 2, 3, 6, 9, and 12 months of age. To our knowledge, this is the largest randomized trial ever undertaken in area of human milk and lactation. Monitoring visits of all experimental and control maternity hospitals and polyclinics were undertaken prior to recruitment and twice more during recruitment and follow-up to ensure compliance with the randomized allocation. Major study outcomes include the occurrence of > or = 1 episode of gastrointestinal infection, > or = 2 respiratory infections, and the duration of breastfeeding, and are analyzed according to randomized allocation ("intention to treat"). One of the 32 remaining study sites was dropped from the trial because of apparently falsified follow-up data, as suggested by an unrealistically low incidence of infection and unrealistically long duration of breastfeeding, and as confirmed by subsequent data audit of polyclinic charts and interviews with mothers of 64 randomly-selected study infants at the site. Smaller random audits at each of the remaining sites showed extremely high concordance between the PROBIT data forms and both the polyclinic charts and maternal interviews, with no evident difference in under- or over-reporting in experimental vs control sites. Of the 17,046 infants recruited from the 31 participating study sites, 16,491 (96.7%) completed the study and only 555 (3.3%) were lost to follow-up. PROBIT's results should help inform decision-making for clinicians, hospitals, industry, and governments concerning the support, protection, and promotion of breastfeeding.

Adult↗

Presentation of electronic patient data and medical audit.

With the increasing use of computers to store patient data and to use these data as an electronic patient record to support the direct patient care these data now play an essential role in the care process. Such a role can be expected to expand in the years to come. It is widely recognised that such use of data for direct support of patient care increases the need for security (in particular integrity and availability). However, until now little attention has been paid to the requirements for the system from the point of view of medical audit. If the data retrieved may play an important role in the care process it is important to be able to judge whether the health care professional has acted properly in view of the electronic information that was (or could have been) at his disposal. During one of the IMIA working conferences this issue was identified. In this paper the issue is explored further. Both requirements and technical consequences are discussed.

Computer Communication Networks↗

Influence of guidelines on CPR decisions: an audit of clerking proforma.

We audited documentation rates and implementation of cardiopulmonary resuscitation (CPR) decisions for patients admitted under the Department of Elderly Care Medicine, Mayday University Hospital, Croydon, as new guidelines and a proforma were introduced. For the first audit, data were collected from 75 departmental discharges. Following introduction of a proforma, six point prevalence audits were performed of all elderly care inpatients. Consultant documentation improved from 27/75 (36%) to 102/109 (94%), 135/148 (91%), 133/140 (95%), 96/119 (81%), 148/157 (94%) and 167/169 (98%) in audits 2, 3, 4, 5, 6 and 7 respectively. The percentages of decisions that were Do Not Attempt Resuscitation (DNAR) were 64% 72%, 45%, 68% and 62% in audits 3 to 7 respectively. For audit 5 our guidelines required discussion with patient before making a DNAR order, whereas the guidelines applicable for the other audits did not stipulate discussion. The fall in documentation rates and proportion of CPR decisions that were DNAR in audit 5 were statistically significant. There was no significant difference in age, diagnosis, cognitive function or disability between patients in those audits (3-7) when these parameters were recorded. Introducing a proforma significantly improved CPR decision documentation. Obligatory discussion with a patient before issuing a DNAR order was associated with a fall in documentation of decisions.

Aged↗

Nutrition and growth analysis of very low birth weight infants.

The growth and nutrition of 220 very low birth weight infants were reviewed after comprehensive data on all infants in the hospital were entered into the Neonatal Intensive Care Unit Audit Data Base for 2 years prospectively. Fluid and energy (parenteral and oral) intakes were compared in four birth weight categories (1, less than or equal to 750 g; 2, 751 to 1000 g; 3, 1001 to 1250 g; 4, 1251 to 1500 g). Parenteral nutrition was the major source of first nutrition for the small infants, but seldom did it alone provide adequate nutrition for very low birth weight infants. The age of the first nutrition (parenteral and/or oral nutrition other than dextrose) decreased with increasing birth weight. The age of the first oral feedings was later for the infants of the lower birth weights but enteral feeding became the major nutrition for all weight categories by the second week of life. During the first 50 days the infants accumulated a deficit of 3780 to 5460 kJ relative to their estimated need of 504 kJ/kg per day, with the smaller infants accumulating a significantly larger deficit. The growth of infants appropriate for gestational age and of infants small for gestational age differed from each other and from the commonly used graph of Dancis et al (J Pediatr. 1948;33:570-572).

Alberta↗

Use of multiple methods to determine factors affecting quality of care of patients with diabetes.

BACKGROUND: The process of care of patients with diabetes is complex; however, GPs are playing a greater role in its management. Despite the research evidence, the quality of care of patients with diabetes is variable. In order to improve care, information is required on the obstacles faced by practices in improving care. Qualitative and quantitative methods can be used for formation of hypotheses and the development of survey procedures. However, to date few examples exist in general practice research on the use of multiple methods using both quantitative and qualitative techniques for hypothesis generation. OBJECTIVES: We aimed to determine information on all factors that may be associated with delivery of care to patients with diabetes. METHODS: Factors for consideration on delivery of diabetes care were generated by multiple qualitative methods including brainstorming with health professionals and patients, a focus group and interviews with key informants which included GPs and practice nurses. Audit data showing variations in care of patients with diabetes were used to stimulate the brainstorming session. A systematic literature search focusing on quality of care of patients with diabetes in primary care was also conducted. RESULTS: Fifty-four potential factors were identified by multiple methods. Twenty (37.0%) were practice-related factors, 14 (25.9%) were patient-related factors and 20 (37.0%) were organizational factors. A combination of brainstorming and the literature review identified 51 (94.4%) factors. Patients did not identify factors in addition to those identified by other methods. CONCLUSION: The complexity of delivery of care to patients with diabetes is reflected in the large number of potential factors identified in this study. This study shows the feasibility of using multiple methods for hypothesis generation. Each evaluation method provided unique data which could not otherwise be easily obtained. This study highlights a way of combining various traditional methods in an attempt to overcome the deficiencies and bias that may occur when using a single method. Similar methods can also be used to generate hypotheses for other exploratory research. An important responsibility of health authorities and primary care groups will be to assess the health needs of their local populations. Multiple methods could also be used to identify and commission services to meet these needs.

Data Collection↗

Data management for toxicological studies.

Organized data management increases the reliability of statistical analysis. The basic purpose of data management is to assure the integrity and the quality of data. To assure data validity, establishing a checking system, such as data audit, would be desirable at the following points: protocol design, supervision of study schedule, definition of data, data collection, choice of tests and procedures, verification, data checking, data recording, data handling, data analysis, and data validation. To process an enormous amount of data on a multitude of items, use of a computerized system would be advantageous. The data processing system in toxicological studies should be based on a protocol-driven system, which gathers and records the data accurately. The main functions that are to be handled by computer are data collection, recording and retrieval via terminals, and statistical analysis of data and assembling of reports. One should be able to validate whether the computer system would perform its intended function accurately, reliably, and consistently. This paper discusses the basic considerations of data management and provides examples of the state of the computerized data management system and its validation.

Animals↗

[Evaluation of respiratory intensive care units at pneumology services].

Audits should be conducted in respiratory intensive care units (ICU) as in all other ICU using patient-specific indicators to assess medical activity and quality of care. However, other criteria, such as those developed by the SRLF ("Société de Réanimation de Langue Française"), should also be used. These criteria include the description of the patients previous health status, prognosis of underlying diseases, the SAPS I or SAPS II severity score at admission, the omega or TISS therapeutic scores, and the PRN index of health care burden. Medial and administrative audits are conducted using diagnosis-related groups (DRG) and case mix classification. The DRGs are used to establish an aggregate index of activity (ISA points) which contribute to the complex mechanism of budget allowance. Unfortunately, the French DRG case mix system does not provide an appropriate description of the costs of ICU stays. One of the special features of respiratory ICUs is related to patient flow. Patients are referred from a respiratory unit and discharged to a respiratory unit or a respiratory rehabilitation center. Readmissions are frequent. Many patients are also admitted only for diagnosis or a respiratory procedure requiring close surveillance. The SRLF criteria, which take into consideration all of these features, should always be used for the evaluation of quality of care. The French Society of Lung Disease (SPLF) has proposed specific standards of quality for respiratory ICU. We present here examples issuing for the ICU of the Hôtel-Dieu Hospital in Paris. The results show that non-specific national indicators, in combination with other indicators specific for respiratory ICU, provide appropriate audit data.

France↗

Magnitude of antibiotic use.

Trends in antibiotic prescribing can be examined by a review of data from dispensed prescriptions and from antibiotic certification records of the Food and Drug Administration (FDA). Prescription data on selected oral antibiotics and anti-infectives were obtained from IMS America's National Prescription Audit. Data compiled between 1965 and 1977 show increasing use until 1973--with a plateau thereafter--for antibiotics judged by physicians to be relatively "safe," namely, the erythromycins, ampicillin and other penicillins, and the cephalosporins. Tetracycline use, although rising until 1973, declined somewhat thereafter, perhaps because of increasing concern with dental staining in children. Sulfonamide use has declined steadily since 1965, presumably for safety reasons. Used of clindamycin was nearing a level similar to that of cephalosporin use until 1975, when its risk of precipitating severe colitis, including pseudomembranous colitis, became well-known. The FDA's antibiotic certification records show that the volume of injectable cephalosporins and gentamicin administered has increased steadily and as of 1977 was still rising.

Administration, Oral↗

Quality assurance responsibilities as defined by the EPA Good Automated Laboratory Practices (GALPs).

In December 1990, the Environmental Protection Agency's (EPA) Office of Information Resources Management (OIRM) issued a draft of the Good Automated Laboratory Practices (GALP). The GALPs developed from a union of existing Federal and EPA regulations and policies, including: the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA) & Toxic Substance Control Act (TSCA), Good Laboratory Practices (GLP), the EPA Information Resources Management Policy (IRMP), and the Computer Security Act of 1987. The GALPs consolidate the regulations and policies to provide a single source of reference, and sever as an extension of the GLP standards (40 CFR 160 & 792). Whereas the GLPs describe acceptable laboratory management practices, the GALPs describe acceptable automated data management practices, and give guidance for standardizing and implementing procedures to ensure the quality and integrity of automated data collection and storage. The GALPs have been formatted to parallel the structure of the GLPs. Just as the GLPs define the responsibilities of the Quality Assurance Unit (QAU) in maintaining good laboratory practices, the GALPs define the responsibilities of the QAU in maintaining good automated data practices. The QAU is charged with (i) maintaining copies of written procedures for the automated data collection system, (ii) performing inspections of laboratory operations utilizing the automated data collection system and reporting findings, (iii) ensuring authorization and documentation of deviations from written procedures, (iv) auditing data and reports from the automated data collection system to ensure they accurately represent the raw data, and (v) maintaining records of the above-defined QAU functions.(ABSTRACT TRUNCATED AT 250 WORDS)

Clinical Laboratory Information Systems↗

Underdiagnosis of obesity at a community health center.

BACKGROUND: Obesity is at epidemic proportions. This study examined the extent to which obesity is being diagnosed at a community health center residency-training site. Results were examined by provider type. Characteristics of patients with obesity diagnosed by primary care providers were compared with characteristics of patients determined to be obese by body mass index (BMI) calculation exclusively. METHODS: A cross-sectional design was used. Medical records of 465 adult patients were audited. Data collected included diagnosis of obesity, height and weight, demographics, and comorbidity. RESULTS: Of the 465 patients' charts audited, 83 contained a provider diagnosis of obesity, and 74 additional patients were determined to be obese by BMI calculation exclusively. Significant underdiagnosis occurred among all provider types (P = .036). Patients with a diagnosis of obesity had significantly higher BMI scores (38.4 vs 34.4, P = .002). Obesity was more likely to be diagnosed in female than in male patients (P = .001). Differences related to age, insurance coverage, and comorbidity were not significant. CONCLUSIONS: Obesity was found to be an underdiagnosed condition among all provider types. As evidenced by significantly higher BMI scores for provider-diagnosed obesity, the data suggest that the obesity diagnosis is made by appearance. The importance of teaching and modeling the use of BMI to diagnose obesity is underscored.

Adolescent↗

Concordance of self-reported data and medical record audit for six cancer screening procedures.

BACKGROUND: Self-reported data about the interval since last cancer screening are often used to determine whether individuals are due for periodic screening and to monitor adherence to guidelines for early cancer detection. PURPOSE: In a study conducted within the Kaiser Permanente Medical Care Program, we examined the concordance of self-reported information and medical record documentation about recency of and reasons for six procedures for early cancer detection. We also assessed the concordance of population-level estimates of screening rates based on these two sources. METHODS: Data were obtained from a mailed questionnaire or telephone interview completed by 779 men and women. The data from these randomly selected study participants (431 women and 348 men), who had been members of the health plan for the previous 5 years, were compared with information obtained from their medical charts. Intersource agreement about whether each procedure was done within the last 2 years was evaluated, with the medical record used as the gold standard. To assess the accuracy of patient self-reporting, we also calculated sensitivity, false-positive and false-negative results, and Kappa statistics. RESULTS: Concordance between self-reported data and medical record documentation was greater for procedures that generated a test report (mammogram, Pap smear, fecal occult blood test, and sigmoidoscopy) than for those generating a physician's note (clinical breast examination and digital rectal examination). Kappa statistics showed a similar pattern. Sensitivity of self-reported data was more than 90% for mammogram, clinical breast examination, Pap smear, and fecal occult blood test and nearly 80% for sigmoidoscopy and digital rectal examination. However, false-positive results were above 40%, except for fecal occult blood test and sigmoidoscopy. For all six procedures, estimated population-level rates of screening within the past 2 years would have been significantly higher (P < .0001) if self-reported data were used instead of medical record audit data. CONCLUSIONS: Self-reported data may overestimate the percentage of the population that has been screened and underestimate the interval since the last cancer detection procedures. IMPLICATIONS: Such data should be used cautiously for clinical decision making, research, and surveillance activities at both individual and population levels. Also, comparability of data should be considered when population screening rates are evaluated on the basis of different data sources.

Adult↗

Six flaws revealed: how to make your audit/MCE studies more meaningful.

A study that lacks a definite design lacks direction and is defeated before it starts. Careful study design, however, is not the only indication of a successful audit. Approaching variation analysis in a positive rather than punitive manner enhances the committee's ability to recognize important findings and discover imaginative uses for audit data. When problems in care are revealed through evaluation activities, the committee must make recommendations that are appropriate to the causes of the problem and that can be readily implemented. An audit committee that discharges these responsibilities will produce a study that should surely yield informative data. The committee's ultimate goal--improved patient care--can not be far behind.

Analysis of Variance↗

The influence of new guidelines on cardiopulmonary resuscitation (CPR) decisions. Five cycles of audit of a clerk proforma which included a resuscitation decision.

Current guidelines advise discussion with patients before issuing a 'do not attempt resuscitation' (DNAR) order. We report five audit cycles of cardiopulmonary resuscitation (CPR) documentation after introducing a proforma, the last cycle following the latest guidelines. In first audit data were collected from 75 patient discharges. CPR decisions were documented in 27 (36%). Four subsequent point prevalence audits carried out on all inpatients following proforma introduction showed documentation improved to 102/109 (94%), 135/148 (91%), 131/140 (94%) and 102/119 (86%) in cycles two, three, four and five, respectively. The last three audits also revealed that consultants consistently made more DNAR orders than trainee doctors. However, following the introduction of the latest guidelines the proportion of patients in whom a decision was made, and the percentage of those decisions that were DNAR, fell.

Cardiopulmonary Resuscitation↗

Prognostic factors in women with breast cancer: distribution by socioeconomic status and effect on differences in survival.

STUDY OBJECTIVE: To quantify and investigate differences in survival from breast cancer between women resident in affluent and deprived areas and define the contribution of underlying factors to this variation. DESIGN: Analysis of two datasets relating to breast cancer patients in Scotland: (1) population-based cancer registry data; (2) a subset of cancer registration records supplemented by abstraction of prognostic variables (stage, node status, tumour size, oestrogen receptor (ER) status, type of surgery, use of radiotherapy and use of adjuvant systemic therapy) from medical records. SETTING: Scotland. PATIENTS: (1) Cancer registration data on 21,751 women aged under 85 years diagnosed with primary breast cancer between 1978 and 1987; (2) national clinical audit data on 2035 women aged under 85 years diagnosed with primary breast cancer during 1987 for whom adequate medical records were available. MAIN RESULTS: Survival differences of 10% between affluent and deprived women were observed in both datasets, across all age groups. In the audit dataset, the distribution of ER status varied by deprivation group (65% ER positive in affluent group v 48% ER positive in deprived group; under 65 age group). Women aged under 65 with non-metastatic disease were more likely to have breast conservation than a mastectomy if they were affluent (45%) than deprived (32%); the affluent were more likely to receive endocrine therapy (65%) than the deprived (50%). However, these factors accounted for about 20% of the observed difference in survival between women resident in affluent and deprived areas. CONCLUSIONS: Deprived women with breast cancer have poorer outcomes than affluent women. This can only partly be explained by deprived women having more ER negative tumours than affluent women. Further research is required to identify other reasons for poorer outcomes in deprived women, with a view to reducing these survival differences.

Adult↗

Audit, guidelines and standards: clinical governance for hip fracture care in Scotland.

PURPOSE: To report on experience of national-level audit, guidelines and standards for hip fracture care in Scotland. METHODS: Scottish Hip Fracture Audit (from 1993) documents case-mix, process and outcomes of hip fracture care in Scotland. Evidence-based national guidelines on hip fracture care are available (1997, updated 2002). Hip fracture serves as a tracer condition by the health quality assurance authority for its work on older people, which reported in 2004. RESULTS: Audit data are used locally to document care and support and monitor service developments. Synergy between the guidelines and the audit provides a means of improving care locally and monitoring care nationally. External review by the quality assurance body shows to what extent guideline-based standards relating to A&E care, pre-operative delay, multidisciplinary care and audit participation are met. CONCLUSION: Three national-level initiatives on hip fracture care have delivered: Reliable and large-scale comparative information on case-mix, care and outcomes; evidence-based recommendations on care; and nationally accountable standards inspected and reported by the national health quality assurance authority. These developments are linked and synergistic, and enjoy both clinical and managerial support. They provide an evolving framework for clinical governance, with casemix-adjusted outcome assessment for hip fracture care as a next step.

Diagnosis-Related Groups↗

BI-RADS categorization as a predictor of malignancy.

PURPOSE: To determine the positive predictive value (PPV) of the American College of Radiology Breast Imaging Reporting and Data System (BI-RADS) categories 0, 2, 3, 4, and 5 by using BI-RADS terminology and by auditing data on needle localizations. MATERIALS AND METHODS: Between April 1991 and December 1996, 1,400 mammographically guided needle localizations were performed in 1,109 patients. Information entered into the mammographic database included where the initial mammography was performed (inside vs outside the institution), BI-RADS category, mammographic finding, and histopathologic findings. A recorded recommendation was available for 1,312 localizations in 1,097 patients, who composed the study population. RESULTS: The 1,312 localizations yielded 449 (34%) cancers (139 [31%] were ductal carcinoma in situ [DCIS]; 310 [69%] were invasive cancers) and 863 (66%) benign lesions. There were 15 (1%) category 0 lesions; the PPV was 13% (two of 15 lesions). There were 50 (4%) category 2 lesions; the PPV was 0% (0 of 40 lesions). There were 141 (11%) category 3 lesions; the PPV was 2% (three of 141 lesions). The three cancers in this group were all non-comedotype DCIS. There were 936 (71%) category 4 lesions; the PPV was 30% (279 of 936 lesions). There were 170 (13%) category 5 lesions; the PPV was 97% (165 of 170 lesions). CONCLUSION: Placing mammographic lesions into BI-RADS categories is useful for predicting the presence of malignancy. Perhaps, most important, a lesion placed into BI-RADS category 3 is highly predictive of benignity, and short-term interval follow-up as an alternative to biopsy would decrease the number of biopsies performed in benign lesions.

Biopsy↗

HbA(1c) levels among American Indian/Alaska Native adults.

OBJECTIVE: Type 2 diabetes is a major public health problem among many American Indian/Alaska Native communities. Elevated levels of HbA(1c) have been observed in younger American Indian/Alaska Native adults. The objectives of this study were: 1) to determine whether HbA(1c) levels were elevated among younger American Indian/Alaska Native adults nationally and, if so, 2) to determine the relationship between HbA(1c) levels and age due to treatment type, BMI, renal disease, duration of diabetes, survival, or a poor diabetes health care index. RESEARCH DESIGN AND METHODS: The national Indian Health Service Diabetes Care and Outcomes Audit was completed for a total of 11,419 American Indian/Alaska Native adults with type 2 diabetes from tribes across the U.S. in 1998. Glucose control was assessed by HbA(1c). BMI, diabetes duration, treatment type, and proteinuria were assessed from the Diabetes Care and Outcomes Audit data. To assess diabetes quality of care, an index was developed from six standard of care Diabetes Care and Outcomes Audit variables. RESULTS: We found HbA(1c) level decreased with increasing age. HbA(1c) levels were 9.2, 8.9, 8.8, 8.3, and 7.8 for ages 18-39, 40-49, 50-59, 60-69, and > or =70 years, respectively (P < 0.0001). This inverse relationship was not accounted for by differences in BMI, diabetes duration, treatment type, proteinuria, or health care index. CONCLUSIONS: Among American Indian/Alaska Native adults, HbA(1c) levels were highest in the youngest age-group. With increasing numbers of young American Indian/Alaska Native adults with diabetes, poorer glucose control is expected to bring concomitant increased morbidity and mortality unless more effective and efficient interventions are developed to improve glucose control among young American Indian/Alaska Native adults.

Adult↗