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The effects of regionalization on clinical outcomes for a high risk surgical procedure: a study of the Whipple procedure in New York State.

The purpose of this study was to analyze the effects on clinical outcomes of regionalization for a high risk surgical procedure, pancreaticoduodenectomy (the Whipple procedure). Claims data were examined for all Medicare patients undergoing the procedure in New York State for the 4-year period 1991-1994. Outcomes were analyzed for two regional hospitals and for 115 other hospitals that performed the procedure. In-hospital mortality and length of stay were significantly less at the two high volume regional hospitals when compared with the remaining low volume hospitals. In-hospital mortality rates at all hospitals generally decreased as the number of procedures increased. The results of this study demonstrate that there is significant value in regionalization for even relatively lower volume high risk surgical procedures.

Aged↗

Intraperitoneal chemohyperthermia using a closed abdominal procedure and cytoreductive surgery for the treatment of peritoneal carcinomatosis: morbidity and mortality analysis of 216 consecutive procedures.

BACKGROUND: Peritoneal carcinomatosis has been regarded as a lethal clinical entity. Recently, aggressive treatments combining intraperitoneal chemohyperthermia (IPCH) with cytoreductive surgery have resulted in long-term survival in selected patients. The aim of this trial was to analyze the mortality and morbidity of 216 consecutive treatments of peritoneal carcinomatosis by IPCH by using a closed abdominal procedure combined with cytoreductive surgery. METHODS: Between February 1989 and August 2001, 207 patients who underwent 216 IPCH procedures using a closed abdominal procedure with mitomycin C, cisplatin, or both were prospectively studied. RESULTS: The postoperative mortality and morbidity rates were 3.2% and 24.5%, respectively. The most frequent complications were digestive fistula (6.5%) and hematological toxicity (4.6%). Morbidity was statistically linked with the carcinomatosis stage (P =.016), the duration of surgery (P =.005), and the number of resections and peritonectomy procedures (P =.042). Duration of surgery and carcinomatosis stage were the most common predictors of morbidity. CONCLUSIONS: The frequency of complications after IPCH and cytoreductive surgery was mainly associated with the carcinomatosis stage and the extent of the surgical procedure. The IPCH closed abdominal procedure has shown an acceptable frequency of adverse events.

Adult↗

Liposomal lidocaine to improve procedural success rates and reduce procedural pain among children: a randomized controlled trial.

BACKGROUND: Historically, children have been undertreated for their pain, and they continue to undergo painful cutaneous procedures without analgesics. A new topical anesthetic, liposomal lidocaine 4% cream (Maxilene, RGR Pharma, Windsor, Ont.), has become available. It has pharmacologic properties that are superior to other topical anesthetics, including an onset of action of only 30 minutes. We sought to determine the success rate of cannulation, analgesic effectiveness, procedure duration and rate of adverse skin reactions when liposomal lidocaine is used before intravenous cannulation of children. METHODS: In this double-blind randomized controlled trial, children aged 1 month to 17 years received liposomal lidocaine or placebo before cannulation. Success on first cannulation attempt was recorded, and, among children 5 years and older, pain was evaluated before and after the attempt by the child, parents and research assistant using a validated measure (Faces Pain Scale-Revised). For children younger than 5 years, pain was evaluated by the parents and research assistant only. The total duration of the procedure and adverse skin reactions were also recorded. RESULTS: Baseline characteristics did not differ (p > 0.05) between children who received liposomal lidocaine (n = 69) and those who received placebo (n = 73). Cannulation on the first attempt was achieved in 74% of children who received liposomal lidocaine compared with 55% of those who received placebo (p = 0.03). Among children 5 years of age and older (n = 67), lower mean pain scores during cannulation were reported by those receiving liposomal lidocaine (p = 0.01). Similarly, lower mean pain scores during cannulation were reported by the parents and research assistant for all children who received liposomal lidocaine than for all those who received placebo (p < 0.001). The mean total procedure duration was shorter with liposomal lidocaine (6.7 v. 8.5 minutes; p = 0.04). The incidence of transient dermal changes was 23% in both groups (p = 1.0). CONCLUSIONS: Use of liposomal lidocaine was associated with a higher intravenous cannulation success rate, less pain, shorter total procedure time and minor dermal changes among children undergoing cannulation. Its routine use for painful cutaneous procedures should be considered whenever feasible.

Adolescent↗

IFCC primary reference procedures for the measurement of catalytic activity concentrations of enzymes at 37 degrees C. Part 1. The concept of reference procedures for the measurement of catalytic activity concentrations of enzymes.

This paper is the first in a series dealing with reference procedures for the measurement of catalytic activity concentrations of enzymes at 37 degrees C and with the certification of reference preparations. Other parts deal with: Part 2. Reference Procedure for the Measurement of Catalytic Concentration of Creatine Kinase; Part 3. Reference Procedure for the Measurement of Catalytic Concentration of Lactate Dehydrogenase; Part 4. Reference Procedure for the Measurement of Catalytic Concentration of Alanine Aminotransferase; Part 5. Reference Procedure for the Measurement of Catalytic Concentration of Aspartate Aminotransferase; Part 6. Reference Procedure for the Measurement of Catalytic fication of Four Reference Materials for the Determination of Enzymatic Activity of y-Glutamyltransferase, Lactate Dehydrogenase, Alanine Aminotransferase and Creatine Kinase at 37 degrees C. A document describing the determination of preliminary reference values is also in preparation.

Catalysis↗

IFCC primary reference procedures for the measurement of catalytic activity concentrations of enzymes at 37 degrees C. Part 2. Reference procedure for the measurement of catalytic concentration of creatine kinase.

This paper is the second in a series dealing with reference procedures for the measurement of catalytic activity concentrations of enzymes at 37 degrees C and the certification of reference preparations. Other parts deal with: Part 1. The Concept of Reference Procedures for the Measurement of Catalytic Activity Concentrations of Enzymes; Part 3. Reference Procedure for the Measurement of Catalytic Concentration of Lactate Dehydrogenase; Part 4. Reference Procedure for the Measurement of Catalytic Concentration of Alanine Aminotransferase; Part 5. Reference Procedure for the Measurement of Catalytic Concentration of Aspartate Aminotransferase; Part 6. Reference Procedure for the Measurement of Catalytic Concentration of gamma-Glutamyltransferase; Part 7. Certification of Four Reference Materials for the Determination of Enzymatic Activity of gamma-Glutamyltransferase, Lactate Dehydrogenase, Alanine Aminotransferase and Creatine Kinase at 37 degrees C. A document describing the determination of preliminary reference values is also in preparation. The pro- described 30 degrees C IFCC reference method (1). Differences are tabulated and commented on in Appendix 3.

Body Temperature↗

Procedural justice and status: status salience as antecedent of procedural fairness effects.

The current article explores status as an antecedent of procedural fairness effects (the findings that perceived procedural fairness affects people's reactions, e.g., their relational judgments). On the basis of the literature, the authors proposed that salience of the general concept of status leads people to be more attentive to procedural fairness information and that, as a consequence, stronger procedural fairness effects should be found. In correspondence with this hypothesis, Experiment 1 showed stronger procedural fairness effects on people's relational treatment evaluations in a status salient condition compared with a control condition. Experiment 2 replicated this effect and, in further correspondence with the hypothesis, showed that status salience led to increased cognitive accessibility of fairness concerns. Implications for the psychology of procedural justice are discussed.

Adolescent↗

Does payment drive procedures? Payment for specialty services and procedure rate variations in 3 HMOs.

OBJECTIVE: To study how payment for specialty services affects the rates of performance of invasive procedures by physicians in a number of specialties. STUDY DESIGN: Observational study. PATIENTS AND METHODS: Administrative data from 1996-1997 and 1997-1998 from 3 large health maintenance organizations (HMOs) in the Midwestern and western United States were used to study variations in procedure rates associated with different methods of paying for cardiology, gastroenterology, ophthalmology, orthopedic, and ear, nose and throat services within each HMO. The age-, sex-, and comorbidity adjusted probabilities of undergoing selected, potentially discretionary procedures, were compared within each plan by payment method. RESULTS: After adjustment, rates under fee-for-service payment tended to be higher than those under capitation or salary payment, whereas there was no clear pattern for salary versus capitation payment. Even within a single specialty in a single plan, however, rates did not always follow the same pattern for different procedures. CONCLUSIONS: The payment method for specialty services used by these 3 health plans was variably associated with how likely patients were to undergo a variety of invasive procedures. The effects of contract payment methods for specialty services on health care costs, quality, and outcomes should be further studied, but such studies will challenge the capabilities of health plan data systems.

Adult↗

The Ross procedure is the procedure of choice for congenital aortic valve disease.

OBJECTIVES: The Ross procedure has emerged as an attractive option for aortic valve replacement in children and young adults. Our objective was to review our experience with the Ross procedure in young patients with congenital aortic valve disease. We also sought for evidence of growth in the autograft. METHODS: From January 1990 to July 2000, 260 patients underwent the Ross procedure for various aortic valve diseases. There were 136 patients less than 18 years of age. Fifty-three (38%) of these patients had congenital aortic valve disease. Ages ranged from 3 months to 18 years (mean, 8 plus minus 5 years; median, 9 years). Ten patients were less than 2 years of age. Pure aortic stenosis was present in 18 patients, mixed stenosis and regurgitation in 32, and pure aortic regurgitation in 3. The aortic valve was bicuspid in 29 patients. Twenty-nine patients had previous procedures, mostly balloon dilation of the aortic valve (n = 8) or surgical aortic valvotomy (n = 12). RESULTS: In all patients immediate results demonstrated a normally functioning neoaortic valve with not more than trivial aortic valve regurgitation. In the patients with stenosis, all levels of obstruction were relieved, and the gradient across the left ventricular outflow tract was completely abolished. Hospital mortality was 3 (5.6%) of 53 (overall Ross mortality was 34 of 260 [1.5%]). The patients were followed up for a mean of 4 years and up to 10 years. One patient died late of a noncardiac cause. Actuarial survival at 10 years was 94% plus minus 2%, and freedom from all events was 93% plus minus 5%. Only 1 patient needed autograft replacement for endocarditis. Intervention related to right ventricle-pulmonary artery conduit was required in 3 patients: balloon dilatation in 2, and reoperation in 1. At last follow-up, all patients but one were classified as being in New York Heart Association functional class I or II with normal or near-normal autograft valve function. Serial measurement of the left ventricular outflow tract and aortic root showed that as patients grew, the size of the outflow tract increased. When indexed to body surface area, this increase correlated with the patients' expected somatic growth. CONCLUSIONS: The Ross procedure for congenital aortic valve disease in children and young adults offers excellent hemodynamics, with the added advantage of real potential for growth. It should be considered the treatment of choice in this age group.

Adolescent↗

An improved procedure to quantify tumour vascularity using true colour image analysis. Comparison with the manual hot-spot procedure in a human melanoma xenograft model.

In a number of recent papers, the degree of tumour vascularization has been described as a promising new prognostic factor. Methods for the assessment of vascular density involve immunohistochemical staining of the vasculature, followed by counting the number of vessel profiles in the angiogenic hot spot. One of the problems of this procedure is the selection of the angiogenic hot spot, which has been described as being subject to inter-observer variation. In this study, the value of true colour image analysis in reducing inter-observer variation has been assessed. Highly (MV3) and poorly (M14) vascularized human melanoma xenografts were used to evaluate the image analysis procedure, and the image analysis results were compared with results from the conventional manual hot-spot procedure. Assessment by image analysis was performed on measurement fields covering the entire tumour tissue specimens rather than on a single hot-spot field. Also, by selecting the most densely vascularized area from all fields assessed by the semi-automatic procedure, it was possible to objectify the hot spot selection (automated hot-spot procedure). Manual assessment showed a good correlation between two independent observers for MV3 xenografts (r = 0.74, P = 0.014), but a poor correlation for M14 xenographs (r = 0.4, P > 0.05). Automated assessment by different operators showed good correlations for both MV3 xenografts (r = 0.99, P < 0.001) and M14 xenografts (r = 0.80, P = 0.006). It is concluded that although both manual vessel counting and semi-automated image analysis can differentiate between the level of vascularization in the two types of xenograft (P < 0.001 for both methods), the automated method is favourable in that it showed no significant inter-observer effects. In M14 xenografts, the manual hot-spot vessel densities did not correlate well with the automated hot-spot densities (r = 0.27, P > 0.05), indicating that selection of angiogenic hot spots in this tumour type is indeed subject to observer bias. The automated hot-spot vessel densities were a reliable indicator of overall tumour vessel density in both tumour types. Image analysis allows analysis of vessel subclasses based on morphological criteria such as vessel profile area or diameter. In the model system used, the discrimination between MV3 and M14 xenografts was further enhanced by selectively examining vessels with diameters between 6 and 9 microns (P < 0.0005). In conclusion, image analysis appears to offer an objective and more reproducible method to quantify tumour vascularity than manual counting of vessel profiles in the hot spot. Analysis of subclasses of vessels may further enhance the value of vessel density measurements in discriminating between tumour types differing in biological behaviour.

Animals↗

Comparison of three sequential extraction procedures (original and modified 3 steps BCR procedure) applied to sediments of different origin.

The 3 steps sequential extraction procedure proposed by the Standards Measurements and Testing program (SM&T--formerly BCR) of the European Union has been applied for the speciation of metals in sediments. Results obtained by the application of the BCR standardized procedure were compared to those of two four step sequential extraction procedures, which are different from the BCR procedure only for the introduction of an additional step with NaOCl, as 2nd and 3rd step respectively. Five different metals have been taken into consideration: Cd, Cu, Ni, Pb and Zn. The analytical performances of the laboratory have been evaluated using three certified reference materials: the BCR 601 lake sediment for the BCR sequential extraction procedure, PACS-1 and MESS-1 for total metal concentration. Results showed that the efficiency of NaOCl treatment is higher or at least equal to that of H2O2 treatment and that its selectivity is quite satisfying. Moreover the NaOCl treatment doesn't significantly influence the extraction of the easily reducible fraction.

Certification↗

Radiographic comparative evaluation of the Sauve-Kapandji procedure and the Darrach procedure for rheumatoid wrist reconstruction.

For surgical treatment of rheumatoid wrists, we have routinely selected the Sauve-Kapandji (S-K) procedure or the Darrach procedure based on predetermined indications. In this study, we conducted a retrospective radiographic comparative evaluation of the changes in the carpus after the two procedures. The S-K group and the Darrach group each consisted of 13 wrists of 10 patients (all women). The indications for the Darrach procedure were the presence of radiolunate fusion, radial shelf formation, and old age. The carpal height ratio (CHR) and the ulnocarpal distance ratio (UCDR) were determined on wrist radiograms obtained before operation and at the final follow-up. The mean follow-up period was 4 years. Fisher's test was used to analyze the differences between the two groups. Both groups showed a decrease in mean CHR and an increase in mean UCDR at the final follow-up compared to the values before the operation, and there were no statistically significant differences. Furthermore, in the Darrach group, no significant differences in changes of the carpus were observed between patients with or without a radial shelf. We concluded that the present results do not support the superiority of the S-K method over the Darrach procedure for rheumatoid wrist reconstruction based on a radiographic evaluation.

Journal Article↗

Procedure rates and outcomes of coronary revascularization procedures in California and New York.

OBJECTIVE: Background data were obtained on all California hospitals performing coronary artery bypass grafting and percutaneous coronary intervention procedures and compared with reports published by the state of New York to develop a collaborative quality improvement program for cardiac surgery programs. METHODS: The Patient Discharge Database of the Office of Statewide Health Planning and Development was queried for the years 1999-2001. In-hospital mortality and risk factors for coronary artery bypass grafting and percutaneous coronary intervention were obtained by using demographic data and International Classification of Diseases-Ninth Revision-Clinical Modification procedure and diagnosis codes. Risk models were developed by means of logistic regression analysis. RESULTS: Overall coronary artery bypass grafting mortality was 33% higher and percutaneous coronary intervention mortality was twice as high in California compared with that in New York. Procedural volume (per unit population) was higher in New York. In high-volume California hospitals (>300 procedures per year), coronary artery bypass grafting mortality was similar (California, 2.42%; New York, 2.25%). Excess coronary artery bypass grafting mortality (>4.0%) occurred only in low-volume programs. Risk adjustment did not change the volume effect for coronary artery bypass grafting. No volume effect was noted for risk-adjusted percutaneous coronary intervention mortality. There were no obvious differences in risk factors between California and New York. Programs performing relatively fewer coronary artery bypass grafting procedures compared with percutaneous coronary interventions were found to have significantly higher coronary artery bypass grafting mortality after adjusting for volume effects. Percutaneous coronary intervention volume is increasing and coronary artery bypass grafting volume is decreasing in both California and New York. CONCLUSIONS: Excess coronary artery bypass grafting mortality in California is related to the large number of low-volume programs. Excess percutaneous coronary intervention mortality might be related to case selection or timing of intervention. A relationship between percutaneous coronary intervention volume and coronary artery bypass grafting mortality is suggested in which increasing percutaneous coronary intervention volume relative to coronary artery bypass grafting volume might have the effect of shifting patients with undefined higher risk characteristics to coronary artery bypass grafting.

Adolescent↗

Exponentially adjusted moving mean procedure for quality control. An optimized patient sample control procedure.

The idea of using patient samples as the basis for control procedures elicits a continuing fascination among laboratorians, particularly in the current environment of cost restriction. Average of normals (AON) procedures, although little used, have been carefully investigated at the theoretical level. The performance characteristics of Bull's algorithm have not been thoroughly delineated, however, despite its widespread use. The authors have generalized Bull's algorithm to use variably sized batches of patient samples and a range of exponential factors. For any given batch size, there is an optimal exponential factor to maximize the overall power of error detection. The optimized exponentially adjusted moving mean (EAMM) procedure, a variant of AON and Bull's algorithm, outperforms both parent procedures. As with any AON procedure, EAMM is most useful when the ratio of population variability to analytical variability (standard deviation ratio, SDR) is low.

Algorithms↗

Assessing procedural skills in context: Exploring the feasibility of an Integrated Procedural Performance Instrument (IPPI).

BACKGROUND: The assessment of clinical procedural skills has traditionally focused on technical elements alone. However, in real practice, clinicians are expected to be able to integrate technical with communication and other professional skills. We describe an integrated procedural performance instrument (IPPI), where clinicians are assessed on 12 clinical procedures in a simulated clinical setting which combines simulated patients (SPs) with inanimate models or items of medical equipment. Candidates are observed remotely by assessors whose data are fed back to the clinician within 24 hours of the assessment. This paper describes the feasibility of IPPI. RESULTS: A full-scale IPPI and 2 pilot studies with trainee and qualified health care professionals has yielded an extensive data set including 585 scenario evaluations from candidates, 60 from clinical assessors and 31 from simulated patients (SPs). Interview and questionnaire data showed that for the majority of candidates IPPI provided a powerful and valuable learning experience. Realism was rated highly. Remote and real-time assessment worked effectively, although for some procedures limited camera resolution affected observation of fine details. DISCUSSION: IPPI offers an innovative approach to assessing clinical procedural skills. Although resource-intensive, it has the potential to provide insight into individual's performance over a spectrum of clinical scenarios and at no risk to the safety of patients. Additional benefits of IPPI include assessment in real time from experts (allowing remote rating by external examiners) as well as provision of feedback from simulated patients.

Clinical Competence↗

Gastric drainage procedures: effects in normal dogs. I. Introduction and description of surgical procedures.

Gastric drainage procedures are commonly used in veterinary medicine, particularly in dogs in attempts to prevent recurrence of gastric dilatation-volvulus (GDV). The following five different procedures have been most commonly described: the Fredet-Ramstedt pyloromyotomy (FRP); Heineke-Mikulicz pyloroplasty (HMP); Finney pyloroplasty (FP); Jaboulay's gastroduodenostomy (JG); and antral gastrojejunostomy (AG). These surgical procedures have not been compared in a controlled study. This first article of a series of three describes the gastric drainage procedures performed in 30 normal dogs for a comparative study. The FRP and HMP were the fastest and easiest procedures to perform. The degree of difficulty was found to be increased but similar for FP, JG, and AG. No complication occurred during or immediately after surgery.

Animals↗

[Comparison of TIPS, a modified Sugiura procedure and TIPS plus a modified Sugiura procedure for portal hypertension].

OBJECTIVE: Transjugular intrahepatic portosystemic shunts (TIPS), a modified Sugiura procedure and TIPS plus a modified Sugiura procedure were compared to evaluate their clinical results in treatment of portal hypertension. METHODS: Ninety patients with portal hypertension respectively underwen TIPS (group I, n = 30), a modified Sugiura procedure (group II, n = 30) and TIPS plus a modified Sugiura procedure (group III, n = 30). The rates of rebleeding and encephalopathy, and the mortality of patients with portal hypertension were observed. RESULTS: The early postoperative complications were observed in 23.33% of the patients in group I, in 30.0% of those in group II, and in 20.0% of those in group III. The early postoperative rates of rebleeding were 6.67% in group I, 10% in group II, and 0% in group III. Hepatic encephalopathy was seen in 16.67% of the patients in group I, 0% in group II and 13.33% in group III. The early mortality was 3.33% in group I. During follow-up for 1 - 36 months, the rates of rebleeding were 34.48% in group I, 33.33% in group II, and 3.33% in group III. The rates of encephalopathy and mortality were respectively 17.20% and 20.69% in group I, 3.33% and 13.33% in group II, 3.33% and 3.33% in group III. The shunt patency in group III was higher than that in group I. CONCLUSION: Combination of TIPS and a modified Sugiura procedure can be effective to prevent and treat variceal bleeding.

Adult↗

Problems in the Munz and Smouse procedure for operationalizing reactions to test anxiety: proposal of a new procedure.

Three problems in the Munz and Smouse procedure make it unacceptable as an operationalization of four reactions to test anxiety alluded to by Alpert and Haber. As a demonstration of two of the problems, the procedure was applied to the scores of 176 male and female college students. A new procedure for operationalizing the four reactions, which avoids the problems in the Munz and Smouse procedure, was described. Practical problems likely to be encountered in using the new procedure were discussed.

Anxiety↗

The analysis of lysergide (LSD): the development of novel enzyme immunoassay and immunoaffinity extraction procedures together with an HPLC-MS confirmation procedure.

A forensic procedure for the screening and confirmation of the presence of lysergide (lysergic acid diethylamide, LSD) in urine is described together with the evaluation of a novel enzyme immunoassay (EIA) and immunoaffinity extraction procedure. Following initial screening using either an established radioimmunoassay (RIA) or a novel EIA procedure, a quantitative estimate is established using a conventional high performance liquid chromatography-fluorescence (HPLC) technique following solid phase extraction. Final confirmation and quantitation, without derivatization, is established using HPLC in combination with electrospray ionization (ESI) mass spectrometry using methysergide as an internal standard. The detection limit of LSD in urine is 0.5 ng/mL. A blind trial confirmed the validity of the results. The choice of internal standard is discussed. Consideration is given to the photosensitivity of LSD solutions. A study of potential interferants in the HPLC-MS confirmation of LSD is presented and shows that for the wide range of compounds studied, there are none that would interfere with this confirmation technique. A comparison is shown between solid phase and immunoaffinity extraction/clean up procedures, and between RIA and EIA screening procedures.

Chromatography, Affinity↗