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Enhancement of data collection from Welsh 'shopping basket' ready-to-eat food surveillance programme.

The method of data collection from the Welsh 'shopping basket' ready-to-eat food sampling programme has recently been reviewed, with the principal aim of reducing the resources required for inputting and audit of data. The subsequent improvements made have been primarily software based and they have made data collection, audit and analysis significantly faster and more efficient.

Data Collection↗

Underlying dimensions and individual differences in auditory, visual, and auditory-visual vowel perception by hearing-impaired children.

Vowel perception studies were conducted on a group of four adolescent children with congenital profound sensorineural hearing impairments in the three conditions of audition alone, vision alone, and audition plus vision. Data were analyzed using the ALSCAL multidimensional scaling procedure to identify the underlying dimensions and individual differences in dimension emphasis. The three dimensions obtained from the analysis of data for the audition alone condition were interpreted as the parameters of first and second formant frequencies, and vowel length. The one dimension for the vision alone condition was interpreted as the parameter of the width of the internal lip opening. The three dimensions for the audition plus vision condition were interpreted as the parameters of first formant frequency, vowel length, and the width of the internal lip opening. Subject variations in parameter preferences were observed for the audition alone and audition plus vision conditions but not for the vision alone condition.

Adolescent↗

Review of the Indian market of anti-tuberculosis drugs: focus on the utilisation of rifampicin-based products.

SETTING: There is a need to better understand the extent of the utilisation of rifampicin in the market, particularly in fixed-dose combinations (FDC). OBJECTIVE: To review the Indian market of antituberculosis drugs, as this is the largest single market in the world of this therapeutic class. DESIGN: Review and analysis of the sales data proffered by the Indian market audit. Estimated data relating to public sector product usage were utilised in order to obtain a more complete scenario. RESULTS: The use of rifampicin-based products is very important in the Indian market of anti-tuberculosis drugs. Particularly common is the use of FDCs, which represent 62% of anti-tuberculosis drugs sold in the private market. CONCLUSIONS: The Indian market for anti-tuberculosis drugs is very large and well integrated. FDCs are widely used. In addition to double- and triple-drug FDCs, four-drug combinations have recently been introduced into the market. The Indian industry also exports raw materials and pharmaceutical specialities.

Antibiotics, Antitubercular↗

Dinner Bed and Breakfast for Older People: early experiences of a short-term service to manage acute hospital demand.

AIMS: The paper describes a service (Dinner Bed and Breakfast [DBB]) to provide short-term rest home care to acutely unwell elderly people as an alternative to acute hospital admission. This was part of a larger project to manage acute general hospital demand. Service changes were introduced after an initial audit cycle and key outcomes monitored. METHOD: Retrospective audit of patient data for three audit periods. RESULTS: The interim outcomes (at conclusion of DBB funding) in the initial audit were 46% of patients able to return home, 32% remained in the rest home, and 22% were admitted to hospital. The proportion of patients returning home from DBB increased to 68% over the study period. At final outcome (at end of index illness), the return home rate increased from 73% to 85% and the number requiring permanent rest home care decreased from 22% to 14%. CONCLUSIONS: Short-term rest home care may be a viable alternative to acute hospital care, but the service needs to include appropriate patient selection, multidisciplinary care, and ongoing monitoring of patient outcomes. One of the risks of this service is patients staying on in rest home care. Short-term enhanced home care may be preferable to rest home care to avoid this risk. The shift of care (from acute hospital to community) caused strain on specialist geriatric services, which was not planned or funded.

Aged↗

Auditing drug metabolism protocols, data, and reports.

A critical component of the drug discovery process is to assess the safety and metabolic disposition of a drug. This can be accomplished by evaluating drug concentration levels as part of safety assessment studies (toxicokinetics) and identifying the drug's presence in and throughout the body by conducting ADME (adsorption, distribution, metabolism, and excretion) studies. From a regulatory perspective, the major difference between these two types of evaluations is that toxicokinetic studies are under the purview of the Good Laboratory Practice (GLP) regulations (21 CFR 58) and ADME studies are not. International debate continues to resolve around the need to consider the applicability of the GLPs to ADME studies. While it is recognized that the current regulatory intent between ADME and toxicokinetic studies differs, this inspecting/auditing approach treats them generally the same. It assures management and external reviewers that data integrity measures are in place for all drug metabolism studies conducted by the facility.

Animals↗

The Data Protection Act 1998: an audit of its effect on surgical trainees' practice.

The Data Protection Act 1998 came into force in March 2000 and has significant implications on our normal practice. A survey of surgical specialist registrars was made to establish knowledge of the Act and adherence to its eight principles. Knowledge was patchy and adherence minimal, Simple guidelines are suggested to help juniors keep within the principles of the Act.

Computer Security↗

The contribution of multiple data sources to a clinical audit of lymphoma in a teaching hospital.

OBJECTIVE: To assess the independent contribution of data sources used for case ascertainment in a clinical audit of the outcome of lymphoma patients in our institution. DESIGN: In the absence of a unified register of lymphoma patients diagnosed and/or treated in our institution, we used an elective approach to case ascertainment. Sources included two internal databases (computerized discharge data for hospitalizations and outpatient oncology database) and one external (Israel Cancer Registry) database. Histologic diagnosis was confirmed by search of on-line pathology files or discharge summaries. Demographic, histologic and survival characteristics were compared among patients identified through each data source. Survival was assessed via record linkage with the Population Registry. SETTING: A tertiary care university teaching hospital. STUDY PARTICIPANTS: Seven hundred and twelve patients with lymphoma diagnosed between 1987 and 1992. RESULTS: All three sources contributed independently to the total, with the majority (583 or 82%) via hospitalizations. Overlap among the sources was minimal with only 73 (10.3%) of the patients being common to all three sources. Differences (P < 0.05) in the age distribution, country of birth and population groups (defined by religion) as well as histologic diagnoses among the sources were noted. In addition, survival of those ascertained via the outpatient database was higher than those ascertained from other sources (P=0.02 for Hodgkin's disease) even after controlling for age. CONCLUSIONS: The use of multiple data sources for case ascertainment in clinical audit is justified when no patient register exists. The results indicate that use of a single internal data source would have resulted both in an underestimate of the scope of lymphoma in our institution and significant bias in terms of patient characteristics and outcome.

Adolescent↗

Predictors of success following endovascular aneurysm repair: mid-term results.

OBJECTIVE: Australian cases of endovascular aneurysm repair (EVAR) performed between 1999 and 2001 have been evaluated to determine the mid-term (6 months to 5 years) safety and efficacy of the procedure. This study looks at predictors of success, based on mid-term follow-up data. DESIGN OF STUDY: This study uses results obtained from a prospective semi-voluntary register (audit) of Australian data obtained from surgeons in the private and public sector. RESULTS: Peri-operative mortality for patients enrolled in the audit was 1.8%. Ninety-three percent of procedures were technically successful (890/961). Nearly 13% of patients have had re-interventions (mostly endoluminal) at follow-up. Analysis of audit data shows that the likelihood of experiencing post-operative complications or requiring additional procedures increases with ASA rating, increasing age, large pre-operative aneurysm size, aneurysm angle >45 degrees and number of co-morbid conditions diagnosed. CONCLUSIONS: This study confirms satisfactory mid-term results in a, national rather than unit specific, setting. Predictors of clinical failure or need for re-intervention include large aneurysm size, neck angulation >or=45 degrees and short infrarenal neck.

Aged↗

Clinical trials integrity: a CRO perspective.

When contract research organizations (CROs) were first formed, pharmaceutical companies outsourced to them only certain aspects of the conduct of their clinical trials. At first CROs were highly specialized entities, providing, for example, either biostatistical advice, clinical research associates who monitored investigational sites for regulatory compliance, or regulatory support. Gradually, full service CROs emerged, offering a full range of services for clinical trials, including the selection of investigators and investigational sites, assistance with patient recruitment, safety surveillance and reporting, site audits, and data management and biostatistics. This evolving relationship between CROs and the pharmaceutical and medical device industries has resulted in CROs assuming more and more of the regulatory and ethical risks and responsibilities inherent in the conduct of clinical trials. In this full service role, CROs, unlike sponsors, are not interested in the outcome of study, but like sponsors, are subject to heavy regulation by the federal government, must follow applicable state laws, must respect international guidelines, and are obliged to follow their own operating procedures. Moreover, they are judged by the industry on the basis of the scope and quality of services provided, including the degree of adherence to the research protocol, regulatory requirements, and timelines; the quality of the professional working relationships with investigators and institutions, both academic and community-based; and the validity of the data. Further, CROs are subject to comprehensive audits by sponsoring companies, FDA, and other regulatory authorities. For all these reasons, CROs are being tasked with strict vigilance of all stages of the clinical trial process to ensure that the laws, regulations, and industry standards designed for the protection of human subjects and data integrity are maintained.

Advisory Committees↗

A survey of consultants treating upper aerodigestive tract cancer in the UK.

A study was undertaken to determine the current service provision for the treatment of upper aerodigestive tract (UAT) cancers in the UK. A postal questionnaire was sent to all consultant members of relevant specialist societies, with 1041 (74%) responding. Treatment of UAT cancer is widely dispersed with over 900 consultants from five major disciplines treating, on average, less than 10 cases per year. There were few regional or provider differences in the facilities and services available and in processes used for assessing patients. There is little systematic collection of data for audit or research and some consultants do not record stage. The involvement of other disciplines in the assessment process, use of joint clinics, counselling, specialist nursing and therapy services appears to be low. There is a need for rationalisation of head and neck cancer services; for more systematic collection of data for audit and research and for improvements in the use of joint clinics and support services.

Cancer Care Facilities↗

Putting smart money to work for quality improvement.

OBJECTIVE: To investigate the effects of paying physicians for performance on quality measures of diabetes care when combined with other care management tools. DATA SOURCES/STUDY SETTING: In 2001, a managed care organization in upstate New York designed and implemented a pilot program to financially reward doctors for the quality of care delivered to diabetic patients. In addition to paying a performance bonus, physicians were also supplied with a diabetic registry and met in groups to discuss progress in meeting goals for diabetic care. Primary data on diabetes care at the patient level were collected from each physician during the 8-month period, April 2001-January 2002. STUDY DESIGN: Physicians were scored on individual process and outcome measures of diabetes care on three separate occasions; these individual scores were combined into a composite score on which the financial reward was allocated. The study design is pre/post for the patients whose physicians participated in the performance pay program. The control group is a large sample of the health plan's diabetic members. DATA COLLECTION: Data on patient outcomes were self-reported by physicians participating in the study. These data were audited with spot checks of medical charts. Data for the control group were collected as part of the health plan's annual HEDIS data collection. PRINCIPAL FINDINGS: Physicians and patients achieved significant improvement on five out of six process measures, and on two out of three outcome measures (HbA1c control and LDL control). Thirteen out of 21 physicians improved their average composite score enough to earn some level of financial reward. Of the eight physicians not receiving any of the three levels of reward, six improved their composite scores. CONCLUSIONS: Financial incentives for physicians, bundled with other care management tools, led to improvement on objectively measured quality of care for diabetic patients. Self-selection by physicians into the pay pilot and the small sample size of participating physicians limit the generalizability of the results.

Case-Control Studies↗

Expenditures for psychotropic medications in the United States in 1985.

OBJECTIVE: Psychotropic medications have seldom been included in estimates of the costs of mental health services. In the infrequent case that these costs have been assessed, they have been estimated by using national surveys of consumers of health services. The objective of this study was to estimate the costs of prescriptions for psychotropic medications in the United States in 1985 and to assess the difference with the most recent cost estimate from a health services survey (1977). METHOD: Study data were based on retail costs of psychotropic medications reported to the Pharmaceutical Data Service Alpha National Prescription and Sales Audit. The data come from a computerized survey panel of 2,250 pharmacies representative of the more than 14,000 pharmacies nationwide. The database includes all medication prescriptions filled, whether paid with cash or Medicaid or reimbursed by third-party payment. Analyses were limited to psychotropic medication prescriptions. RESULTS: In 1985, $1.45 billion was spent on outpatient psychotropic medications. Nearly $868 million (60% of the total) was spent on antianxiety and sedative-hypnotic medications, while approximately $263 million (18%) was spent on antipsychotic medications, $240 million (17%) on antidepressants, and $84 million (5%) on combination psychotropic medications. These expenditures were much higher than would have been expected given the most recent health services estimate of $513 million. CONCLUSIONS: These results demonstrate the substantial cost of psychotropic medications in 1985. The finding that the cost of psychotropic medications was so high, in contrast to the lower estimate from the 1977 survey, demonstrates the importance of obtaining more frequent cost estimates and basing future estimates on medication databases.

Costs and Cost Analysis↗

Evaluation of 238 consecutive patients with the extended data set of the Standardised Audit for Hip Fractures in Europe (SAHFE).

PURPOSE: The aim of this paper is to introduce the extended data set inquiries of the Standardised Audit of Hip Fractures in Europe (SAHFE) and to report our experiences of its use. METHOD: The extended SAHFE data set was applied to 238 consecutive patients (mean age 78.4 (50 - 102) years, 52 males, 186 females) aged over 50 years with non-pathological fractures of the hip. The extended data set contains 95 questions concerning the patient's abilities prior fall and at follow-up, detailed background factors, concomitant diseases, additional details of the injury, treatment, fracture type and reduction and complications. RESULTS: Thirty-nine percent of the fractures occurred at home and 38% in a hospital. Thirteen percent of the cervical fractures were non-displaced (Garden 1 & 2) and half of the trochanteric fractures intertrochanteric two-part fractures (A11 - A13). The mean Garden alignment index evaluated from antero-posterior roentgenograms changed from the preoperative 144 degrees to the postoperative 168 degrees and that from lateral projections from 144 degrees to 171 degrees , respectively. Most of the patients (89%) had associated diseases, especially cardiovascular conditions. The patients' functioning was significantly impaired at four months compared with the preoperative situation according to the ADL score. The need for social support and assistance had increased, respectively. A total of 63% of the surgeries were delayed for more than 24 hours. Low molecular weight heparin was given to every patient for thromboembolic prophylaxis and 92% received antibiotic prophylaxis. Urinary tract (21%) and chest infections (7%) were the most common complications. The deep infection rate was 2.5%. CONCLUSION: The extended SAHFE data set is useful and makes it possible to study in more detail the background and outcome factors of hip fractures in a standardized manner.

Activities of Daily Living↗

Prospective vs retrospective data for evaluating emergency care: a research methodology.

Emergency department records and patient charts do not provide enough or sufficiently detailed data for audit of quality of care in a high volume emergency department. As a solution, at the Department of Emergency Medicine, University of Southern California School of Medicine, three emergency medical technicians--hospital-based paramedics--were trained as observers of patient process and treatment. In addition to basic identification information, the form completed by observers listed 21 procedural steps and process data such as sequence, time for completion, type of personnel performing, necessary equipment and supplies, and space for comments. Direct observation of patient process was carried out in 442 patients, a total of 3,882 procedures was observed and recorded. The direct observation is perhaps the most accurate method of data collection for auditing purposes because it reflects actual events. This data was used by the Research Peer Review Committee to help rate the quality of patient treatment process.

Emergency Service, Hospital↗