Impact of physician education on inappropriate use of Prevacid

AJG – September, 2000

Abstracts

Conclusions: 1- FNA and EMR are useful tools to establish a histologic diagnosis in patients undergoing EUS. 2-In this series EMR had a greater yield to establish the diagnosis than FNA without increasing the rate of complications. Groups

Location

N

B

M

Final diagnosis

Size

Group I FNA

Esophagus

8

24

2

Stromal tumors 5 (leyomioma 4/ undifferentiated 1).

5–80 mm

Gastric Duodenum

16 2

Group II EMR

Esophagus

3

Gastric

5

6

2

Carcinoid 2 benign changes 19. Leyomioma 1

Lipoma 2 Pancreatic rest 1 Inflamatory Polyps 2 Carcinoid 2

Mean 42mm

5–26mm

mean 14.7mm

B⫽Benign; M⫽Malignant.

795 Evaluation of the rating form for inflammatory bowel diseases patients concerns (RFIPC) spanish translation in Puerto Ricans with IBD Torres EA FACG, Pérez C, Chinea B, Arroyo J, Aponte N, Guzmán A, Magno P, Provenzale Dawn, FACG. University of Puerto Rico, San Juan, PR; Duke University Medical Center, Durham, NC. Health related quality of Life (HRQL) can be measured in patients with IBD using disease-specific instruments such as the RFIPC. The RFIPC measures concerns over impact of disease, sexual intimacy, complications and body stigma, using 25 questions on a visual analogue scale of 100. There is no Spanish translation of the RFIPC. A general instrument, the Short Form-36 (Medical Outcomes Trust), is available in Spanish. Aim: We evaluated the reliability and validity of a Spanish translation of the RFIPC using the SF-36 in Puerto Ricans with IBD. Methods: The RFIPC was translated from English into Spanish using back-translation. The Spanish translation was done by two bilingual Puerto Rican physicians and translated back into English by two independent English-speaking bilingual scientists. The back-translations were compared to the original by a third English speaking physician. After informed consent, 30 consecutive patients from the IBD clinics received the RFIPC and SF-36. A second RFIPC was completed two weeks later. The RFIPC’s were compared for test-retest reliability to determine consistency over time and internal consistency. The RFIPC was compared with the SF-36 for validity. The relationship between overall RFIPC sumscore and SF-36 subscales’ scores was evaluated using Spearman’s correlation. Two-sided p values were calculated. The protocol was approved by the IRB. Results: Test-retest reliability using Spearman’s correlation was 0.82 (p⬍.0001) and internal consistency measured with Cronbach’s alpha was 0.87. When subscale individual items were analyzed for internal consistency, Cronbach’s alpha ranged from 0.75 to 0.81. There were significant correlations between the RFIPC and SF-36 subscales for role limitations due to physical and emotional problems (r⫽⫺.60 and r⫽⫺.62, p⬍.001). A bordeline significant correlation between the physical functioning SF-36 subscale and RFIPC was found (r⫽⫺.33, p⫽.08). Conclusions: The Spanish translation of the RFIPC is a reliable and valid instrument for measuring HRQL in patients with IBD. Its application will be important in the management of Hispanic populations with IBD.

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796 Health related quality of life (HRQL) in Puerto Ricans with inflammatory bowel disease (IBD) Torres Esther A., Pérez Cynthia, Chinea Betty, Arroyo Javier, Aponte Néstor, Guzmán Aileen, Magno Priscilla, Provenzale Dawn. University of Puerto Rico, San Juan, PR; Duke University Medical Center, Durham, NC. HRQL is an important aspect in the treatment of patients. The disease specific instrument Rating Form for Inflammatory Bowel Diseases Patients Concern (RFIPC) has been used extensively to measure the HRQL in patients with IBD. No data exists for Hispanics with IBD. Aim: To describe the HRQL in Puerto Ricans with IBD, using the Spanish translation of the RFIPC. Methods: After obtaining informed consent, 87 consecutive patients from the IBD Clinics of the UPR self-administered the RFIPC under supervision. The RFIPC measures concerns in four areas using 25 questions on a visual analogue scale of 100. We calculated the median and interquartile ranges. Medians for ulcerative colitis (UC) and Crohn’s disease (CD) were compared using the Wilcoxon rank-sum test. The protocol was approved by the IRB of the University of Puerto Rico. Results: 45 patients with UC (18M:21F, median age 34) and 42 with CD (21M:21F, median age 38) were tested. Median scores for all IBD were 57.2 for impact of disease, 38.6 for sexual intimacy, 67.0 for complications and 68.5 for body stigma (higher scores reflect a worse quality of life). Median scores for CD and UC did not differ (p⬎0.05) for any subscale. Conclusions: The median RFIPC scores of Puerto Ricans were higher for all items than the means reported in a national survey by Drossman. Concerns for UC and CD were similar in our population. Although this may be result of a referral bias in our population, it may also reflect different attitudes and concerns based on cultural differences. If confirmed, the management of Hispanics with IBD must address these issues.

797 Impact of physician education on inappropriate use of Prevacid Unger Jeffrey S. MD, Bini Edmund J. MD, Reilly Joseph PharmD, Weinshel Elizabeth H. MD. VA New York Harbor Healthcare System (NYHHCS) and NYU School of Medicine, New York, N.Y. Objective: The aims of this study were to prospectively assess current prescribing practices among physicians at the NYHHCS and to determine if an educational program reviewing guidelines for lansoprazole (Prevacid) use would alter prescribing practices and have an impact on inappropriate Prevacid use. Methods: All new Prevacid prescriptions filled at the NYHHCS were identified between November 1, 1999 and December 31, 1999. Patient characteristics, indications and dosages of Prevacid use were determined by reviewing the computerized medical record. Prescriptions were stratified as appropriate, inappropriate, or unknown based on pre-determined criteria. The appropriate indications were extracted from published prospective trials. Subsequently, an educational campaign including e-mailings to all providers and a lecture on the appropriate use of Prevacid was given to physicians at the NYHHCS. The educational campaign cited literaturesupported indications, dosing per indication, and duration of treatment. Subsequently, new prescriptions for Prevacid were again tracked from March 1, 2000 to April 30, 2000 and the indications and dosages for Prevacid utilization were determined. Results: There were 220 Prevacid prescriptions written before and 186 after the educational campaign, of which 69 (before) and 73 (after) were excluded because of inadequate documentation. The patient characteristics including age, gender, race and NSAID use and the provider profiles were similar in the pre- and post-education groups. The number of inappropriate prescriptions decreased from 56.3% before to 42.5% after the educational campaign (P ⫽ 0.026). The proportion of inappropriate prescriptions differed significantly between attending physicians, residents and Nurse Practitioners (60.6% vs. 42.5% vs. 61.1%; P⫽0.02). After the educational

2644

Abstracts

campaign, the number of inappropriate prescriptions written by attending physicians and residents decreased while those written by Nurse Practitioners did not change. Conclusions: More than half of Prevacid prescriptions that were written at our teaching hospital were inappropriate. Education of health care providers can have a significant impact on prescribing practices and may result in considerable cost savings.

798 The celecoxib long-term safety study (CLASS): Cardiovascular (CV) safety of celecoxib is equivalent to NSAIDs Whelton A. on behalf of the CLASS investigators. Universal Clinical Research Center, Inc., Hunt Valley, MD 21030, United States; and Department of Medicine, Johns Hopkins Medical School, Baltimore, MD; and Clinical Research and Development, G.D. Searle, Skokie, IL 60077. Objective: It has been hypothesized that inhibition of vascular prostacyclin synthesis with corresponding lack of inhibition of platelet thromboxane production by cycloxygenase-2 specific inhibitors might result in an increased risk of CV events. Methods: In a randomized, double-blind, trial, 7968 patients with osteoarthritis (OA) or rheumatoid arthritis (RA) were randomized to receive celecoxib 400 mg bid or a conventional NSAID (ibuprofen 800 mg tid or diclofenac 75 mg bid) for up to 15 months. Approximately 22% (n ⫽ 1739) of patients were taking low-dose aspirin (ASA). ⱕ325 mg/day). Results: The incidence of thromboembolic CV events were similar between the celecoxib and NSAID groups for the entire patient cohort (2.5% vs 2.1%) and for patients who were not taking low-dose ASA (1.5% vs 1.2%). Conclusions: No evidence was found to suggest that celecoxib at supratherapeutic doses was associated with increased incidence of thromboembolic CV events. Sponsored by GD Searle & Co.

AJG – Vol. 95, No. 9, 2000

Previous reports suggest EUS makes an accurate diagnosis in only 2/3 of malignant GI stromal tumors. Adding fine needle aspiration provides tissue only for cytology, but histology is usually necessary for accurate diagnosis. Purpose: To prospectively evaluate effectiveness of EUS and histology from endoscopically obtained tissue (H-ET) in guiding management of SM tumors. Methods: 130 patients with SM lesions were evaluated by EUS (129); tissue was obtained from gut wall abnormalities by snare (5), forceps (11), and/or guillotine deep biopsy needle (73) depending on the layer of the lesion. Results: Sex: 63 female, 67 male. Lesion location: esophagus 37, stomach 87, duodenum 4, colon 2. EUS diagnosed extraluminal lesions in 19 (15%), vascular structures in the gut wall in 6 (5%), thick gastric folds in 11 (8%), and solitary SM lesions in 94 (72%), all of which had previous nondiagnostic standard biopsies. EUS or histology diagnosed a neoplasm in 27, of which two were false positive (1 leiomyoma, 1 inflammatory ulcer). Of the 25 (19%) true positive neoplasms, 18 were solitary lesions: adenocarcinoma 2, squamous carcinoma 2, sarcoma 4, neurosarcoma 1, rhabdomyosarcoma 1, schwannoma 1, leiomyoblastoma 3, lymphoma 1, granular cell tumor 1, carcinoma-in-situ 1, adenoma 1. Five thick folds were lymphoma. Two extraluminal neoplasms included 1 splenic metastasis and 1 pancreatic cystadenocarcinoma. There were no false negatives. True negatives included all other patients (103). Neoplasms were ⬍1 cm in 1, ⬍2 cm in 3, ⬍3 cm in 3, ⱖ 3 cm in 18. Ten of 74 (13%) histologically benign lesions were ⱖ3 cm. Extraluminal growth pattern, involvement of longitudinal muscularis propria, and abnormal 5-layer architecture at the margin of the lesion correlated highly with neoplasia. Size, echogenicity, and ulceration were criteria that required further evaluation with biopsy. 100% of patients with neoplasia received appropriate therapy, either resection (16) or only chemoradiation (9). Only 5 of 105 (5%) of nonneoplastic SM lesions were resected, including the 2 false positives. Conclusions: Up to 1 of 5 GI SM lesions are neoplastic. EUS plus H-ET can be used to direct further management since all neoplasms were diagnosed without false negatives. Moreover, neoplastic potential cannot be inferred by size.

799 The celecoxib long-term safety study (CLASS): Celecoxib is associated with less renal toxicity compared to conventional NSAIDs Whalton A. on behalf of the CLASS investigators. Universal Clinic Research Center Inc., Hunt Valley, MD 21030, United States; and Department of Medicine, Johns Hopkins Medical School, Baltimore, MD; and Clinical Research and Development, GD Searle, Skokie, IL 60077. Conventional NSAIDs, which nonselectively inhibit cyclooxygenase (COX)-1 and COX-2, are associated with deleterious effects on renal function. Celecoxib specifically inhibits COX-2. Such specific inhibition may result in the reduced incidence of renal toxicity. In a randomized, double-blind trial with exposures up to 15 months, 7968 patients with osteoarthritis (OA) or rheumatoid arthritis (RA) received supratherapeutic doses of celecoxib (400 mg bid) vs therapeutic doses of conventional NSAIDs: ibuprofen (800 mg tid) or diclofenec (75 mg bid). Fewer celecoxib-treated patients experienced renal toxicity compared to patients treated with diclofenec or ibuprofen. Creatinine and/or BUN elevations were reported in 1.3%, 2.1%, and 1.4% of the respective groups. Conclusions: Celecoxib at supratherapeutic doses was associated with a lower incidence of renal toxicity compared to conventional NSAIDs at ordinary therapeutic doses. Sponsored by GD Searle & Co.

800 Accurate diagnosis of gastrointestinal (GI) submucosal (SM) lesions with endoscopic ultrasound (EUS) and histology Zakai David M., M.D., Snady Harry, M.D., FACG, Paradiso Harriette, B.S., Agarwal Banke, M.D. New York, NY.

801 Reduced expression of serotonin receptor (SR) in the left colon of patients with colonic inertia (CI) Zhao Rong Hua MD, Baig Khurrum M. MD, Thaler Klaus J. MD, Mack Judith# PhD, Abramson Susan# PhD., Woodhouse Sherry MD, Tamir Hadassah* MD, Weiss Eric G. MD, Nogueras Juan J. MD, Wexner Steven D. MD. Depts. of Colorectal Surgery, #Research Laboratory and Pathology, Cleveland Clinic Florida, Fort Lauderdale, Florida and *Division of Neuroscience, New York State Psychiatric Institute, New York, NY. Aim: To investigate the expression of SR in the left colon of patients with CI as compared to controls. Methods: 16 patients who underwent subtotal colectomy for CI were assessed. Colonic transit time was measured with a radiopaque marker technique and presented as the number of retained markers in the colon on day 5. The control group consisted of 18 patients who underwent left hemicolectomy for colonic carcinoma. Formalin-fixed, paraffin-embedded, histologically normal tissues from the left colon were used. Immunohistochemical staining of SR was performed on 4␮m tissue sections with rabbit anti-idiotypic antibodies to SRs, biotinylated secondary antibody and enzyme-labeled-streptavidin. The average positive area (square pixel) in mucosa (MU), muscular propria (MM), submucosa (SM), circular and longitudinal muscles (CM and LM) per microscopic field (63⫻) was calculated based on measuring the positively stained area in 15–20 randomly chosen microscopic fields in each related structure. A computer image analysis system (Scion Image) was used for analysis. Results: SR protein was mainly detected in the MM, CM, and LM, rarely in MU and SM. In MM and CM, the positive areas were significantly lower