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The effect of continuous quality improvement on compliance with clinical practice guidelines in an optometric clinic: a retrospective review.

BACKGROUND: Quantitative documentation of quality is becoming increasingly more important. The SUNY State College of Optometry established clinical protocols outlining clinical standards for patient care. We compared documentation of actual clinical performance to these standards. METHODS: The Primary Care Service's Quality Management Team retrospectively reviews a random 10% sample of charts of patients seen in the teaching clinic of the SUNY State College of Optometry on an ongoing basis. They compare the care documented in the medical record to internally distributed clinical protocols. We reviewed the resultant data from January 1995 through June 1997 by analyzing the number of indicators that were out of compliance for each month. Then we graphed these data to ascertain trends and variability to determine what effect this continuous quality improvement process had on clinical care as measured by compliance with clinical protocols. RESULTS: A least-squares regression analysis demonstrated a correlation (0.717) between the decreasing number of items out of compliance and the time during which feedback was provided (r2 = 0.5143, p = 0.0001). These data show a distinct downward trend, indicating better compliance with the clinical protocols over time. We also found that the variability of the data decreased during the time period studied. CONCLUSIONS: A properly designed continuous quality improvement program that gives appropriate feedback to faculty optometrists and student interns measurably increased their compliance with--and decreased their variability from--this clinic's internally distributed clinical protocols over a 30-month time period.

Clinical Competence↗

Maintaining the cold chain shipping environment for Phase I clinical trial distribution.

The study aimed to demonstrate satisfactory inter-UK transit of cold storage clinical trial material. The product environment had to be maintained between 0 and 8 degrees C throughout transit until delivery. Straightforward, low cost and simplified shipping arrangements were sought that would be appropriate for small-scale Phase I clinical trial activities. A laboratory test defined an optimal three frozen gel pack configuration to maintain refrigerated environmental conditions for dummy product packs in a single type and size of insulated shipper. The internal environment was temperature monitored at 30-min intervals in all tests. Twelve Glasgow to London transits were then studied over 2 years to include all seasonal temperature variations. A configuration using three frozen gel packs and 4 h pre-chill of the transit container maintained the internal environment at 0-8 degrees C for up to 48 h during autumn, winter and spring. A modified four frozen gel pack configuration was suitable for summer transit. Thus cold shipment verification was successfully carried out for a small-scale distribution operation. It was proven that refrigerated shipping conditions could be maintained using a straightforward and cost effective 'passive' type system consisting of frozen gel packs and insulated transit containers.

Clinical Trials, Phase I as Topic↗

Geographic distribution and clinical description of leishmaniasis cases in Peru.

Studies were conducted from 1986 through 1993 to further define the geographic distribution and relative importance of different species of Leishmania as a cause of leishmaniasis in Peru. Patients with a clinical diagnosis of cutaneous and/or mucosal or diffuse cutaneous leishmaniasis were enrolled at the Naval Medical Research Institute Detachment (NAMRID) Laboratory in Lima, the Tropical Disease Clinic at San Marcos University Daniel A. Carrión, the Central Military Hospital, and a Ministry of Health hospital in Cusco, Peru. Clinical features, lesion aspirates, and biopsy tissue were obtained from each patient. All specimens were collected and assayed separately, including multiple specimens from some of the same patients for Leishmania parasites by inoculating aliquots of either aspirates or biopsy tissue suspensions onto Senekji's blood agar medium. Stocks of Leishmania isolates were used to prepare promastigotes to produce extracts for identifying the Leishmania species by the cellulose acetate electrophoresis enzyme technique. A total of 351 isolates of Leishmania were obtained from 350 patients who were infected primarily in the low and high jungle of at least 15 different Departments of Peru. Of the 351 isolates, 79% were identified as L. (V.) braziliensis, 7% as L. (V.) guyanensis, 10% as L. (V.) peruviana, 2% as L. (V.) lainsoni, and 1.7% as L. (L.) amazonensis. The clinical form of disease varied depending on the species of Leishmania, with L. (V.) braziliensis being associated most frequently with cutaneous, mucosal ulcers and mixed cutaneous and mucosal disease, and L. (V) peruviana, L. (V.) guyanensis, L. (V.) lainsoni with cutaneous lesions. Leishmania (L.) amazonensis was isolated from six patients, three with cutaneous lesions, one with mucosal lesions, and two with diffuse cutaneous lesions. Among all of the leishmaniasis cases, males were affected more frequently, and cases occurred among patients less than 10 to more than 51 years of age. These data further defined the geographic distribution and the relative frequency of Leishmania species associated with different clinical forms of leishmaniasis in Peru.

Adolescent↗

Gastric mucosal distribution and clinical efficacy of azithromycin in patients with Helicobacter pylori related gastritis.

The gastric mucosal distribution of azithromycin, the prototype of a new class of macrolide antibiotics named azalides, was studied in patients with duodenal ulcer and Helicobacter pylori-related gastritis. The time course of ulcer healing, H. pylori infection, and gastritis activity was also evaluated. Twenty patients (median age 50 years) received the following treatment for 1 month: three cycles of azithromycin (500 mg/day for 3 consecutive days) on days 1-3, 11-13 and 21-23 plus omeprazole (40 mg/day) for 30 consecutive days. Endoscopic biopsy specimens of gastric mucosa and blood samples were collected on days 0, 4, 7, 10, 20 and 30. An additional follow-up endoscopy was carried out on day 60. H. pylori infection was determined by both histology and rapid urease test. Azithromycin concentrations in both plasma and gastric mucosa were measured by a microbiological plate assay, using Micrococcus luteus NCTC 8440 as the reference organism. Azithromycin concentrations in plasma ranged between 0.17 mg/L (95% CI: 0.08-0.26; n = 5) and 0.32 mg/L (95% CI: 0.21-0.43; n = 5) throughout the treatment period. In addition, azithromycin concentrations in gastric mucosa were significantly higher than plasma concentrations at all times examined and ranged from 18.5 mg/kg (95% CI: 15-20; n = 20) to 24.6 mg/kg (95% CI: 16.8-32.4; n = 5), Indicating that the drug was highly retained in the target tissue. Accordingly, the ratio of azithromycin mucosal level to plasma concentration varied between 77.9 (95% CI: 56.5-99.3; n = 5) and 112.7 (95% CI: 100.2-125.2; n = 5). At the end of treatment (day 30) H. pylori was no longer detected in 16 of 20 patients (80%), and this finding was consistent with a marked decrease in the grading of gastritis activity. At the follow-up endoscopy (day 60) the infection was eradicated in only four patients (20%). These data indicate a favourable distribution of azithromycin into gastric mucosa of patients with H. pylori infection and suggest that this new macrolide antibiotic represents a valuable option for treatment regimens against H. pylori. However, the low eradication rate achieved with azithromycin plus omeprazole is a source of concern and requires further investigation.

Adult↗

Documenting workload to better integrate clinical and distributive services.

Use of workload and work-flow documentation in two pharmacy satellites to evaluate pharmacists' productivity is described. Workload was evaluated during 14 consecutive days in May 1983 and 7 consecutive days in May 1984. All pharmacists and technicians working in the satellites recorded times for their activities on a form that listed every possible activity; interruptions such as answering the telephone, responding to walking requests, replacing stock, and lunches and break times were also recorded. Concurrently, the clinical coordinator observed and evaluated work performed for four-hour time blocks at least once each day. Analysis of workload and work-flow information identified problems with scheduling, priorities, interruptions, and pharmacists' knowledge of clinical pharmacy practice. Based on these observations, the following changes were implemented: pharmacists were scheduled to work either inside or outside the satellites for two-week or one-month time periods, priorities were assigned to certain tasks performed inside or outside the satellites, job assignments were made based on the pharmacist's capabilities and the needs of the patient-care areas, a form for documenting potential problem orders was created, and pharmacists were evaluated monthly and given one-on-one instruction by the clinical coordinator. Documentation of time use identified problems and led to changes in assignments that better integrated clinical, educational, and distributive responsibilities for the purpose of providing more efficient and effective services.

Appointments and Schedules↗

Dynamic conical conformal radiotherapy using a C-arm-mounted accelerator: dose distribution and clinical application.

PURPOSE: The aim of this study was to solve anisotropy in the dose distributions from rotational conformal radiotherapy (RCRT) by using a C-arm-mounted accelerator. MATERIALS AND METHODS: The linac head was designed to move along the C-arm with a maximum angle of 60 degrees (from a vertical position toward the gantry). Simultaneous rotation of the gantry creates a dynamic conical irradiation technique. Dynamic conical conformal radiation therapy (Dyconic CRT) was developed by combining the technique with continuous motion of a multileaf collimator. Dose distributions were measured in phantoms using film densitometry and compared with conventional RCRT. Dose distributions in actual radiation therapy patients are also presented. RESULTS: Dyconic CRT enabled the precise delivery of noncoplanar beams without rotating the table. The measurements showed that three-dimensionally isotropic dose falloff was achieved with Dyconic CRT. Dose inhomogeneity in the sagittal direction with Dyconic CRT was compensated for by use of wedge filters. CONCLUSIONS: The drawbacks of the dose distributions produced by RCRT were overcome with the use of Dyconic CRT.

Dose-Response Relationship, Radiation↗

Morphological spectrum, distribution and clinical correlation of white matter lesions in AIDS brains.

This paper analyses the histopathological characteristics and the topographical distribution of 'pure' HIV-associated white matter lesions of the brain in 18 AIDS patients at autopsy; it includes a time-controlled correlation of neuropathology to clinical staging of the AIDS dementia complex. Three distinct lesion types can be delineated: 1 Vacuolar myelin damage (n = 15) in the hemispheric and interhemispheric white matter, in projection fibre tracts, and in intracerebral segments of cranial nerves III, VII, and VIII; 2 Angiocentric foci (n = 14), disseminated randomly in the white matter; 3 HIV leukoencephalopathy (n = 14), as previously defined, seen predominantly in the hemispheric white matter. As a sole lesion type, HIV leukoencephalopathy is found in two cases, while vacuolar myelin damage and angiocentric foci always occur in combination with one or both other types of pathology. Patients with advanced AIDS-dementia complex consistently show severe and combined white matter pathologies at autopsy. We conclude that, in addition to the previously defined features of diffuse HIV leukoencephalopathy, vacuolar myelin damage and angiocentric foci are significant and frequent components of white matter pathology in AIDS autopsies. This reflects the multitude of pathogenetic factors which co-operate in damaging the brain in AIDS. The advanced AIDS dementia complex correlates with the combined and severe white matter lesions.

Acquired Immunodeficiency Syndrome↗

The prevalence of multiple sclerosis, distribution of clinical forms of the disease and functional status of patients in Csongrád County, Hungary.

OBJECTIVE: The aim of this study was to determine the prevalence of multiple sclerosis (MS) in the population of Csongrád County, Hungary (400,128 inhabitants) and to determine the functional status (based on the Expanded Disability Status Scale; EDSS) of the patients according to the clinical forms of the disease. METHODS: The diagnosis was established with the aid of the Poser diagnostic criteria, and the degree of physical disability was determined using the Kurtzke EDSS. RESULTS: In Csongrád County, the prevalence of MS is 62/100,000. The distribution of patients according to the clinical forms of MS was as follows: 15% had the benign form, 54% had relapsing-remitting MS, 20% had secondary chronic progressive MS and 11% had the primary chronic progressive form of MS. Sixty percent of relapsing-remitting MS patients had an EDSS score of 0-4 points and 33% had an EDSS score of 4.5-6.5 points. CONCLUSION: The distribution of patients according to the clinical forms of the disease in this representative population is comparable to results in other regions of the world.

Adolescent↗

Suprapelvic phleboliths: prevalence, distribution and clinical associations.

The preliminary radiographs of 783 patients undergoing excretory urography were prospectively surveyed for the presence of abdominally located phleboliths. Two per cent demonstrated typical densities in a periureteral distribution flanking the lumbar spine where they could be confused with ureteral calculi. All these patients were multiparous females and three-quarters of them had pelvic masses (11% of all patients with pelvic masses), suggesting a possible association with gonadal vein thrombi. Altered venous flow with dilatation of ovarian veins, consequent valvular incompetence and stasis may account for the gonadal vein distribution in the pelvic mass cases. Other observed clinical conditions included hepatic disease, portal hypertension and varices. Obstruction and stasis of venous flow in hepatic disease states may lead to phlebolith formation in gastric and mesenteric varices. Unlike pelvic phleboliths, suprapelvic phleboliths are infrequent but may be detected by careful inspection of low kilovoltage films, particularly in the regions closely flanking the lumbar spine. Their presence may be associated with pelvic masses or significant chronic hepatic disease and they may be confused on plain film with ureteral calculi.

Adult↗

Consistent interethnic differences in the distribution of clinically relevant endothelial nitric oxide synthase genetic polymorphisms.

A maldistribution of endothelial nitric oxide synthase (eNOS) genetic variants may explain differences in NO-mediated effects and response to drugs among black and white subjects. While interethnic differences in the distribution of eNOS genetic variants exist in the American population, it is not known whether such interethnic differences exist in other populations. To test this possibility, we examined the distribution of genetic variants of three clinically relevant eNOS polymorphisms (T(-786)C in the promoter, the VNTR in intron 4, and the Glu298Asp variant in exon 7) in 136 black and 154 white subjects from a Brazilian population, which is very heterogeneous. We also estimated the haplotype frequency and evaluated associations between these variants. The Asp298 variant was more common in whites (32.8%) than in blacks (15.1%) (P < 0.004). Similarly, the C(-786) variant was more common in whites (41.9%) than in blacks (19.5%) (P < 0.0004). However, the 4a variant was more common in blacks (32.0%) than in whites (17.9%) (P < 0.003). The most common predicted haplotype in both ethnic groups combined only wild-type variants. While the second most common haplotype in blacks includes the variant 4a and the wild-type variants for the remaining polymorphisms, the second most common haplotype in whites includes the variants Asp298 and C(-786) and the wild-type variant for polymorphism in intron 4. The marked interethnic differences that we found in Brazilians are very similar to those previously reported in Americans. These findings strongly suggest a consistent difference in the distribution of eNOS genetic variants in blacks compared with whites and indicate that the interethnic differences do not vary with geographic origin.

Adolescent↗

[Prosthetic rehabilitation with a force-distribution prosthesis. Clinical and statistical evaluation of the results obtained in 79 oral rehabilitations].

The results obtained with 79 odontoprosthetic rehabilitations by means of removable force distribution prosthesis are reported. Using half-round section wires, this prosthesis distributed masticatory forces axially on the abutment teeth and also distributes them evenly over the edentulous crest, thus achieving a mixed dental and mucous support. Clinical and statistical assessment takes in 79 patients of both sexes aged between 22 and 69 treated over the fifteen year period since 1964. All types of edentulism according to the Kennedy classification were treated. The clinical results were considered, particularly the periodontal situation and the mechanical results, above all friction between retention and function elements of the connecting wires. Clinically, 82,2% of results were positive and 74.6% of the results were mechanically positive also.

Adult↗

Pneumococcal surface protein A (PspA) family distribution among clinical isolates from adults over 50 years of age collected in seven countries.

The pneumococcal surface protein PspA, a cell-wall-associated surface protein, is a promising component for pneumococcal vaccines. In this study, the distribution of the PspA family was determined in a panel of invasive and clinically important pneumococcal isolates from adults over 50 years of age, collected between 1995 and 2002. One thousand eight hundred and forty-seven recent isolates from invasive pneumococcal disease were obtained from seven Western countries, together with clinical data. An ELISA-based serological method was standardized in order to determine the PspA family and clade distribution. Molecular tests were used when isolates were non-typable by ELISA (PspA family typing by PCR). Only 42 (2.3 %) isolates were non-typable by ELISA and PspA family typing by PCR was performed. Finally, 3 isolates were considered as non-pneumococcal and 1844 were classified as follows: 749 (40.6 %) were PspA family 1, 1078 (58.5 %) were PspA family 2, 13 (0.7 %) were PspA family 1 and 2 and 4 (0.2 %) remained non-typable. The cross-reactivity of antibodies to PspAs of different clades was confirmed. In conclusion, inclusion of PspA family 1 and family 2 in future pneumococcal vaccines would ensure broad coverage of pneumococcal strains infecting people over 50 years of age.

Aged↗

Effects of ethnicity on the distribution of clinically relevant endothelial nitric oxide variants.

Polymorphisms in the endothelial nitric oxide synthase (eNOS) gene have been associated inconsistently with cardiovascular diseases. A maldistribution of eNOS variants among ethnic groups may explain interethnic differences in nitric oxide (NO)-mediated vasodilation and response to drugs. To test this possibility, we examined the distribution of genetic variants of three clinically relevant eNOS polymorphisms (T-786C in the promoter, the variable number of tandem repeats (VNTR) in intron 4, and the Glu298Asp variant in exon 7) in 305 ethnically well-characterized DNA samples (100 Caucasians, 100 African-Americans, and 105 Asians). We estimated the haplotype frequency, and evaluated associations between these variants. The Asp298 variant was more common in Caucasians (34.5%) than in African-Americans (15.5%) or Asians (8.6%)(P < 0.0001). The C-786 variant was also more common in Caucasians (42.0%) than in African-Americans (17.5%) or Asians (13.8%) (P < 0.0001). The 4a variant in intron 4 was more common in African-Americans (26.5%) than in Caucasians (16.0%) or Asians (12.9%) (P < 0.0001). The most common predicted haplotype in the three groups combined only wild-type variants. Asians had the highest frequency of this haplotype (77% in Asians v. 46% in the other groups). In Caucasians, the Asp298 and C-786variants were associated, and this haplotype was predicted to have a frequency of 24%. In African-Americans, the second most common haplotype included the variant 4a and wild-type variants; the Asp298 and 4a variants were associated negatively in this group. The C-786 and 4a variants were associated in Asians (P < 0.0001). The marked interethnic differences that we found in the distribution of eNOS variants, in the estimated haplotype frequency, and in the association between variants may help us to understand how the combination of these genetic variants may influence cardiovascular diseases.

Alleles↗

Leishmania isoenzyme polymorphisms in Ecuador: relationships with geographic distribution and clinical presentation.

BACKGROUND: Determinants of the clinical presentation of the leishmaniases are poorly understood but Leishmania species and strain differences are important. To examine the relationship between clinical presentation, species and isoenzyme polymorphisms, 56 Leishmania isolates from distinct presentations of American tegumentary leishmaniasis (ATL) from Ecuador were analyzed. METHODS: Isolates were characterized by multilocus enzyme electrophoresis for polymorphisms of 11 isoenzymes. Patients were infected in four different ecologic regions: highland and lowland jungle of the Pacific coast, Amazonian lowlands and Andean highlands. RESULTS: Six Leishmania species constituting 21 zymodemes were identified: L. (Viannia) panamensis (21 isolates, 7 zymodemes), L. (V.) guyanensis (7 isolates, 4 zymodemes), L. (V.) braziliensis (5 isolates, 3 zymodemes), L. (Leishmania) mexicana (11 isolates, 4 zymodemes), L. (L.) amazonensis (10 isolates, 2 zymodemes) and L. (L.) major (2 isolates, 1 zymodeme). L. panamensis was the species most frequently identified in the Pacific region and was associated with several clinical variants of cutaneous disease (CL); eight cases of leishmaniasis recidiva cutis (LRC) found in the Pacific highlands were associated with 3 zymodemes of this species. Mucocutaneous leishmaniasis found only in the Amazonian focus was associated with 3 zymodemes of L. braziliensis. The papular variant of CL, Uta, found in the Andean highlands was related predominantly with a single zymodeme of L. mexicana. CONCLUSION: Our data show a high degree of phenotypic variation within species, and some evidence for associations between specific variants of ATL (i.e. Uta and LRC) and specific Leishmania zymodemes. This study further defines the geographic distribution of Leishmania species and clinical variants of ATL in Ecuador.

Adult↗

Transferrin receptors in human tissues: their distribution and possible clinical relevance.

The distribution of transferrin receptors (TR) has been studied in a range of normal and malignant tissues using four monoclonal antibodies, BK19.9, B3/25, T56/14 and T58/1. In normal tissues TR was found in a limited number of sites, notably basal epidermis, the endocrine pancreas, hepatocytes, Kupffer cells, testis and pituitary. This restricted pattern of distribution may be relevant to the characteristic pattern of iron deposition in primary haemachromatosis. In contrast to this limited pattern of expression in normal tissue, the receptor was widely distributed in carcinomas, sarcomas and in samples from cases of Hodgkin's disease. This malignancy-associated expression of the receptor may play a role in the anaemia of advanced malignancy by competing with the bone marrow for serum iron.

Adenocarcinoma↗

[The distribution and clinical significance of IgG subclasses of anti-glomerular basement membrane antibodies].

OBJECTIVE: It was reported that major subclasses of anti-glomerular basement membrane (GBM) antibody were IgG1 and IgG4. The IgG1 subclass was mainly found in male patients and IgG4 subclass in female patients with anti-GBM disease. This study investigates the distribution of anti-GBM IgG subclasses and their association with clinical characteristics. METHODS: Sera from 50 patients diagnosed as anti-GBM disease during 1991-2003 were collected. The anti-GBM antibodies with IgG1, IgG2, IgG3, and IgG4 subclasses were detected with purified bovine alpha (IV) NC1 as solid phase ligand in ELISA. The association with clinical manifestations was further investigated. RESULTS: The positive rates of IgG anti-GBM subclasses were IgG1 94%, IgG2 56%, IgG3 12%, IgG4 88%, respectively. IgG1 and IgG4 were the main subclasses in anti-GBM IgG subclasses (P<0.01). The positive rates of the four subclasses had no significant difference between male and female, whereas the average positive percentage of IgG4 anti-GBM antibody was much higher in males than that in females (P<0.01). The average ages of patients with each subclass had no difference. The distribution of anti-GBM subclasses had no association with antineutrophil cytoplasmic antibody (ANCA), hematuria, proteinuria,or hemoptysis. The average positive percentage of IgG1 in patients with serum creatinine over 600 micromol/L was significantly higher than that in patients with serum creatinine less than 600 micromol/L (P<0.05), which suggested IgG1 might play an important role in the evolution and development of the disease. In the four patients with mild clinical presentations, three had IgG4 subclass, and only one patient who retained normal renal function in the follow-up exhibited pure IgG4 subclass. This suggested that IgG4 might not be inclined to cause severe damage. The average positive percentage of IgG4 subclass was higher in smoking patients than that in non-smoking patients (P<0.01). CONCLUSION: There is a restrictive distribution among the subclasses of anti-GBM antibody, in which IgG1 and IgG4 are the main subclasses. The distribution of anti-GBM IgG subclasses was not associated with gender.

Adolescent↗

Task analysis of home care pharmacy.

The demographics of home care pharmacists and the frequency and perceived importance of home care pharmacy tasks were studied. Two questionnaires were mailed in August 1994 to each of 1420 sites that provide home care pharmacy services. Home care pharmacists were asked to provide information on themselves and their companies and to rate 47 home care pharmacy tasks (administrative, clinical, distributive, and miscellaneous) on how often they are performed as part of the job and how essential they are for successful job performance. Of the 2840 surveys mailed to the 1420 sites, questionnaires for 87 sites were not deliverable, leaving an adjusted gross sample of 1333 sites. A total of 393 usable questionnaires were received from 326 sites (net site response rate 24.5%). Respondents tended to be male, have a B.S. degree only, and have more than six years' home care experience. The most commonly identified type of employer was an independent company. Some 34% of respondents said their company had only 1 site; another 33% stated more than 50 sites. Forty-three percent of locations had 2 pharmacist full-time equivalents. Distributive tasks had the highest frequency scores; clinical tasks were performed second most frequently. Distributive and clinical tasks also received high importance scores. The data suggests that, despite other demands on their time, home care pharmacists give considerable attention to tasks consistent with pharmaceutical care. A survey of home care pharmacists provided baseline information on demographics and the frequency and perceived importance of specific tasks.

Female↗