David M. Radosevich

Total Pancreatectomy and Islet Autotransplantation for Chronic Pancreatitis

BACKGROUND Total pancreatectomy (TP) with intraportal islet autotransplantation (IAT) can relieve pain and preserve β-cell mass in patients with chronic pancreatitis (CP) when other therapies fail. We report on a >30-year single-center series. STUDY DESIGN Four hundred and nine patients (including 53 children, 5 to 18 years) with CP underwent TP-IAT from February 1977 to September 2011 (etiology: idiopathic, 41%; Sphincter of Oddi dysfunction/biliary, 9%; genetic, 14%; divisum, 17%; alcohol, 7%; and other, 12%; mean age was 35.3 years, 74% were female; 21% has earlier operations, including 9% Puestow procedure, 6% Whipple, 7% distal pancreatectomy, and 2% other). Islet function was classified as insulin independent for those on no insulin; partial, if known C-peptide positive or euglycemic on once-daily insulin; and insulin dependent if on standard basal-bolus diabetic regimen. A 36-item Short Form (SF-36) survey for quality of life was completed by patients before and in serial follow-up since 2007, with an integrated survey that was added in 2008. RESULTS Actuarial patient survival post TP-IAT was 96% in adults and 98% in children (1 year) and 89% and 98% (5 years). Complications requiring relaparotomy occurred in 15.9% and bleeding (9.5%) was the most common complication. IAT function was achieved in 90% (C-peptide >0.6 ng/mL). At 3 years, 30% were insulin independent (25% in adults, 55% in children) and 33% had partial function. Mean hemoglobin A1c was <7.0% in 82%. Earlier pancreas surgery lowered islet yield (2,712 vs 4,077/kg; p = 0.003). Islet yield (<2,500/kg [36%]; 2,501 to 5,000/kg [39%]; >5,000/kg [24%]) correlated with degree of function with insulin-independent rates at 3 years of 12%, 22%, and 72%, and rates of partial function 33%, 62%, and 24%. All patients had pain before TP-IAT and nearly all were on daily narcotics. After TP-IAT, 85% had pain improvement. By 2 years, 59% had ceased narcotics. All children were on narcotics before, 39% at follow-up; pain improved in 94%; and 67% became pain-free. In the SF-36 survey, there was significant improvement from baseline in all dimensions, including the Physical and Mental Component Summaries (p < 0.01), whether on narcotics or not. CONCLUSIONS TP can ameliorate pain and improve quality of life in otherwise refractory CP patients, even if narcotic withdrawal is delayed or incomplete because of earlier long-term use. IAT preserves meaningful islet function in most patients and substantial islet function in more than two thirds of patients, with insulin independence occurring in one quarter of adults and half the children.

Effects of a geriatric nurse practitioner on process and outcome of nursing home care.

We compared measures of quality of care and health services utilization in 30 nursing homes employing geriatric nurse practitioners with those in 30 matched control homes. Information for this analysis came from reviews of samples of patient records drawn at comparable periods before and after the geriatric NPs were employed. The measures of geriatric nurse practitioner impact were based on comparisons of changes from pre-NP to post-NP periods. Separate analyses were done for newly admitted and long-stay residents; a subgroup of homes judged to be best case examples was analyzed separately as well as the whole sample. Favorable changes were seen in two out of eight activity of daily living (ADL) measures: five of 18 nursing therapies; two of six drug therapies; six of eight tracers. There was some reduction in hospital admissions and total days in geriatric NP homes. Overall measures of medical attention showed a mixed pattern with some evidence of geriatric NP care substituted for physician care. These findings suggest that the geriatric NP has a useful role in nursing home care.

Improving Diabetes Care in Practice: Findings from the TRANSLATE trial

OBJECTIVE—The purpose of this study was to determine whether implementation of a multicomponent organizational intervention can produce significant change in diabetes care and outcomes in community primary care practices. RESEARCH DESIGN AND METHODS—This was a group-randomized, controlled clinical trial evaluating the practical effectiveness of a multicomponent intervention (TRANSLATE) in 24 practices. The intervention included implementation of an electronic diabetes registry, visit reminders, and patient-specific physician alerts. A site coordinator facilitated previsit planning and a monthly review of performance with a local physician champion. The principle outcomes were the percentage of patients achieving target values for the composite of systolic blood pressure (SBP) <130 mmHg, LDL cholesterol <100 mg/dl, and A1C <7.0% at baseline and 12 months. Six process measures were also followed. RESULTS—Over 24 months, 69,965 visits from 8,405 adult patients with type 2 diabetes were recorded from 238 health care providers in 24 practices from 17 health systems. Diabetes process measures increased significantly more in intervention than in control practices, giving net increases as follows: foot examinations 35.0% (P < 0.0.001); annual eye examinations 25.9% (P < 0.001); renal testing 28.5% (P < 0.001); A1C testing 8.1%(P < 0.001); blood pressure monitoring 3.5% (P = 0.05); and LDL testing 8.6% (P < 0.001). Mean A1C adjusted for age, sex, and comorbidity decreased significantly in intervention practices (P < 0.02). At 12 months, intervention practices had significantly greater improvement in achieving recommended clinical values for SBP, A1C, and LDL than control clinics (P = 0.002). CONCLUSIONS—Introduction of a multicomponent organizational intervention in the primary care setting significantly increases the percentage of type 2 diabetic patients achieving recommended clinical outcomes.

Randomized trial examining the effect of two prostate cancer screening educational interventions on patient knowledge, preferences, and behaviors

AbstractOBJECTIVE: To assess the effect of video and pamphlet interventions on patient prostate cancer (CaP) screening knowledge, decision-making participation, preferences, and behaviors. DESIGN: Randomized, controlled trial. SETTING: Four midwestern Veterans Affairs medical facilities. PATIENTS/PARTICIPANTS: One thousand, one hundred fifty-two male veterans age 50 and older with primary care appointments at participating facilities were randomized and 893 completed follow-up. INTERVENTIONS: Patients were randomized to mailed pamphlet, mailed video, or usual care/control. MEASUREMENTS AND MAIN RESULTS: Outcomes assessed by phone survey 2 weeks postintervention included a 10-item knowledge index; correct responses to questions on CaP natural history, treatment efficacy, the prostate-specific antigen (PSA)’s predictive value, and expert disagreement about the PSA; whether screening was discussed with provider; screening preferences; and PSA testing rates.Mean knowledge index scores were higher for video (7.44; P=.001) and pamphlet (7.26; P=.03) subjects versus controls (6.90). Video and pamphlet subjects reported significantly higher percentages of correct responses relative to controls to questions on CaP natural history (63%, 63%, and 54%, respectively); treatment efficacy (19%, 20%, and 5%), and expert disagreement (28%, 19%, and 8%), but not PSA accuracy (28%, 22%, and 22%). Pamphlet subjects were more likely than controls to discuss screening with their provider (41% vs 32%; P=.03) but video subjects were not (35%; P=.33). Video and pamphlet subjects were less likely to intend to have a PSA, relative to controls (63%, 65%, and 74%, respectively). PSA testing rates did not differ significantly across groups. CONCLUSIONS: Mailed interventions enhance patient knowledge and self-reported participation in decision making, and alter screening preferences. The pamphlet and video interventions evaluated are comparable in effectiveness. The lower-cost pamphlet approach is an attractive option for clinics with limited resources.

A new enzyme mixture to increase the yield and transplant rate of autologous and allogeneic human islet products

Background. The optimal enzyme blend that maximizes human islet yield for transplantation remains to be determined. In this study, we evaluated eight different enzyme combinations (ECs) in an attempt to improve islet yield. The ECs consisted of purified, intact or truncated class 1 (C1) and class 2 (C2) collagenases from Clostridium histolyticum (Ch), and neutral protease (NP) from Bacillus thermoproteolyticus rokko (thermolysin) or Ch (ChNP). Methods. We report the results of 249 human islet isolations, including 99 deceased donors (research n=57, clinical n=42) and 150 chronic pancreatitis pancreases. We prepared a new enzyme mixture (NEM) composed of intact C1 and C2 collagenases and ChNP in place of thermolysin. The NEM was first tested in split pancreas (n=5) experiments and then used for islet autologous (n=21) and allogeneic transplantation (n=10). Islet isolation outcomes from eight different ECs were statistically compared using multivariate analysis. Results. The NEM consistently achieved higher islet yields from pancreatitis (P<0.003) and deceased donor pancreases (P<0.001) than other standard ECs. Using the NEM, islet products met release criteria for transplantation from 8 of 10 consecutive pancreases, averaging 6510±2150 islet equivalent number/gram (IEQ/g) pancreas and 694,681±147,356 total IEQ/transplantation. In autologous isolation, the NEM yielded more than 200,000 IEQ from 19 of 21 pancreases (averaging 422,893±181,329 total IEQ and 5979±1469 IEQ/kg recipient body weight) regardless of the severity of fibrosis. Conclusions. A NEM composed of ChNP with CIzyme high intact C1 collagenase recovers higher islet yield from deceased and pancreatitis pancreases while retaining islet quality and function.

Quality of Life Improves for Pediatric Patients After Total Pancreatectomy and Islet Autotransplant for Chronic Pancreatitis

BACKGROUND & AIMS Total pancreatectomy (TP) and islet autotransplant (IAT) have been used to treat patients with painful chronic pancreatitis. Initial studies indicated that most patients experienced significant pain relief, but there were few validated measures of quality of life. We investigated whether health-related quality of life improved among pediatric patients undergoing TP/IAT. METHODS Nineteen consecutive children (aged 5-18 years) undergoing TP/IAT from December 2006 to December 2009 at the University of Minnesota completed the Medical Outcomes Study 36-item Short Form (SF-36) health questionnaire before and after surgery. Insulin requirements were recorded. RESULTS Before TP/IAT, patients had below average health-related quality of life, based on data from the Medical Outcomes Study SF-36; they had a mean physical component summary (PCS) score of 30 and mental component summary (MCS) score of 34 (2 and 1.5 standard deviations, respectively, below the mean for the US population). By 1 year after surgery, PCS and MCS scores improved to 50 and 46, respectively (global effect, PCS P < .001, MCS P = .06). Mean scores improved for all 8 component subscales. More than 60% of IAT recipients were insulin independent or required minimal insulin. Patients with prior surgical drainage procedures (Puestow) had lower yields of islets (P = .01) and greater incidence of insulin dependence (P = .04). CONCLUSIONS Quality of life (physical and emotional components) significantly improve after TP/IAT in subsets of pediatric patients with severe chronic pancreatitis. Minimal or no insulin was required for most patients, although islet yield was reduced in patients with previous surgical drainage operations.

Total pancreatectomy and islet autotransplantation in children for chronic pancreatitis: Indication, surgical techniques, postoperative management, and long-term outcomes

Objective:Describe the surgical technique, complications, and long-term outcomes of total pancreatectomy and islet autotransplantation (TP-IAT) in a large series of pediatric patients. Background:Surgical management of childhood pancreatitis is not clear; partial resection or drainage procedures often provide transient pain relief, but long-term recurrence is common due to the diffuse involvement of the pancreas. Total pancreatectomy (TP) removes the source of the pain, whereas islet autotransplantation (IAT) potentially can prevent or minimize TP-related diabetes. Methods:Retrospective review of 75 children undergoing TP-IAT for chronic pancreatitis who had failed medical, endoscopic, or surgical treatment between 1989 and 2012. Results:Pancreatitis pain and the severity of pain statistically improved in 90% of patients after TP-IAT (P < 0.001). The relief from narcotics was sustained. Of the 75 patients undergoing TP-IAT, 31 (41.3%) achieved insulin independence. Younger age (P = 0.032), lack of prior Puestow procedure (P = 0.018), lower body surface area (P = 0.048), higher islet equivalents (IEQ) per kilogram body weight (P = 0.001), and total IEQ (100,000) (P = 0.004) were associated with insulin independence. By multivariate analysis, 3 factors were associated with insulin independence after TP-IAT: (1) male sex, (2) lower body surface area, and (3) higher total IEQ per kilogram body weight. Total IEQ (100,000) was the single factor most strongly associated with insulin independence (odds ratio = 2.62; P < 0.001). Conclusions:Total pancreatectomy and islet autotransplantation provides sustained pain relief and improved quality of life. The &bgr;-cell function is dependent on islet yield. Total pancreatectomy and islet autotransplantation is an effective therapy for children with painful pancreatitis that failed medical and/or endoscopic management.

Limitations of the pelvic examination for evaluation of the female pelvic organs

To assess factors influencing an accurate pelvic examination under the best possible circumstances.

The incontinence-associated dermatitis and its severity instrument: development and validation.

PURPOSE: To develop and test the validity and interrater reliability of the Incontinence-Associated Dermatitis and its Severity Instrument, a novel tool describing incontinence-associated dermatitis and its severity. METHODS: Investigators consulted 2 certified WOC nurse experts to determine face validity of the instrument. Seven additional certified WOC nurses evaluated the tool for content validity. The instrument was tested for interrater reliability by attendees at the 2007 WOCN Society National Conference and employees at a health care system in Minnesota. Criterion validity was determined by comparing IAD severity scores of testers with those of the 2 WOC experts and PI. RESULTS: Consultants determined that the instrument had face and content validity. Two hundred forty-seven attendees at the WOCN Societys National Conference (mean nursing experience 25 ± 9 years [mean ± SD]), 100 nursing staff in Minnesota: 84 staff nurses (mean nursing experience 17 ± 12 years), and 16 nursing assistants (mean nursing experience 7 ± 7 years) determined that the instrument has content validity. There were no significant differences in scores of IAD severity for the 4 cases among the 3 types of testers (P > .05). Overall agreement between the 347 raters and the experts using intraclass correlation was 0.98 (P [SUPERSCRIPT EQUALS SIGN] .006). CONCLUSION: The Incontinence-Associated Dermatitis and its Severity Instrument demonstrated good validity and interrater reliability and its development fulfills an unmet need in both research and clinical practice settings.

Measuring patient knowledge of the risks and benefits of prostate cancer screening

This manuscript describes the development and validation of measures assessing patient knowledge about the risks and benefits of prostate cancer (CaP) screening. The measures described include a 10-item knowledge index and four single-item measures, used in previous studies, that assess knowledge of: CaP natural history and treatment efficacy, expert disagreement over the value of CaP screening, and the accuracy of the prostate specific antigen (PSA) test for CaP. We assessed the validity and reliability of these measures on a sample of 1152 male veteran patients age 50 and older. All knowledge index items had acceptable levels of discrimination, difficulty, and reliability. The index demonstrated strong evidence for construct and criterion validity. Much weaker validity evidence was found for the four single-item knowledge questions. The 10-item index developed in this study provides a valid and reliable tool for assessing patient knowledge of the risks and benefits of CaP screening.