Therapeutic intent of proton pump inhibitor prescription among elderly nonsteroidal anti-inflammatory drug users.

BACKGROUND: Prescription of proton pump inhibitors (PPIs) has increased dramatically. AIM: To assess therapeutic intent of PPI prescription among elderly veterans prescribed nonsteroidal anti-inflammatory drugs. METHODS: Medical-record abstraction identified therapeutic intent of PPI prescription. An 'appropriate therapeutic intent' was defined as symptomatic gastro-oesophageal reflux disease or endoscopic oesophagitis, Zollinger-Ellison disease, dyspepsia, upper gastrointestinal event, Helicobacter pylori infection or nonsteroidal anti-inflammatory drug gastroprotection. Logistic regression predicted the outcome while adjusting for clinical characteristics. RESULTS: Of 1491 patients [mean 73 years (s.d. 5.6), 73% white and 99.8% men], among those charts which did document a therapeutic indication, 88.8% were appropriate. Prior gastroscopy was predictive of an appropriate therapeutic intent (OR 2.7; 95% CI: 1.9-3.7). Prescription to patients who used VA pharmacy services only, to in-patients, or by a cardiologist or an otolaryngologist were less likely to be appropriate. Gastroprotection was poorly recognized as an indication for PPI prescription, except by rheumatologists (OR 46.7; 95% CI: 15.9-136.9), or among highly co-morbid patients (OR 1.8; 95% CI: 1.1-2.9). Among in-patients, 45% of PPI prescriptions were initiated for unknown or inappropriate reasons. CONCLUSIONS: Type of provider predicts appropriate PPI use. In-patient prescription is associated with poor recognition of necessary gastroprotection and unknown therapeutic intent.

Identification of Helicobacter pylori infected patients, using administrative data.

BACKGROUND: Helicobacter pylori is a prevalent organism implicated in peptic ulcer disease. AIM: To validate administrative data for diagnosis of H. pylori-infected patients. METHODS: Administrative data identified patients with ICD-9 code for H. pylori (041.86) or prescription of eradication therapy; diagnosis was confirmed by chart abstraction. Multivariable regression assessed predictors of infection considering drug therapy, ICD-9 code 041.86, procedure code, in-patient or out-patient diagnostic code, age, gender and race to generate an algorithm for validation. RESULTS: The test cohort of 531 patients (361 potential cases; 170 random controls) was primarily male (94%), Caucasian (59%) and elderly [67 years (s.d. 10)]. The positive predictive value (PPV) of ICD-9 code 041.86 was 100% and 97.4% if from an in-patient or out-patient encounter, respectively. Eradication drug therapy had a PPV of 73.7% (triple therapy) and 97.7% (quadruple therapy). The strongest predictors were out-patient ICD-9 code 041.86 (OR 8.1; 95% CI: 7.0-9.1); eradication drug therapy (OR 7.4; 95% CI: 6.6-8.3); oesophagogastroduodenoscopy (OR 3.5; 95% CI: 3.3-3.6); and age > or =70 (OR 1.2; 95% CI: 1.1-1.4). An algorithm including these data elements yielded a c-statistic of 0.93 and PPV of 97.9%. CONCLUSIONS: Administrative data can diagnose H. pylori-infected patients. The diagnostic algorithm includes presence of eradication drug therapy overlapping with an out-patient ICD-9 code 041.86 among elderly adults.

National mortality following upper gastrointestinal or cardiovascular events in older veterans with recent nonsteroidal anti-inflammatory drug use.

BACKGROUND: Upper gastrointestinal events (UGIE), myocardial infarction (MI) and cerebrovascular accident (CVA) are known morbidities among recent NSAID users. AIM: To assess all-cause mortality following UGIE, MI or CVA among recent NSAID users. METHODS: Veterans >65 prescribed an NSAID at any Veterans Affairs (VA) facility were identified using prescription fill data and their records linked to a merged VA-Medicare database. Each person-day was assessed for NSAID, coxib or proton pump inhibitor (PPI) exposure. Incidence density ratios and hazard rates of death were calculated following UGIE, MI and CVA adjusting for demographics, co-morbidity, prescription channeling, geographic location and pharmacological covariates. RESULTS: Among 474 495 patients [97.8% male; 85.3% white; 73.9 years (s.d. 5.6)], death followed at a rate of 5.5 per 1000 person-years (95% CI: 5.4-5.6) post-UGIE, 17.7 per 1000 person-years (95% CI: 17.5-17.9) post-MI and 21.8 per 1000 person-years (95% CI: 21.6-22.0) post-CVA. CVA was associated with greatest risk of death [hazard ratio (HR) 12.4; 95% CI: 10.9-14.3] followed by MI (HR 10.7; 95% CI: 9.2-11.6) and UGIE (HR 3.3; 95% CI: 2.8-3.9). Predictors of mortality were advancing age and co-morbidity, increased use of coxibs and failure to ensure adequate gastroprotection. CONCLUSION: Among elderly veterans with recent NSAID use, an UGIE, MI or CVA is a clinically relevant premorbid event.

Barriers to physician adherence to nonsteroidal anti-inflammatory drug guidelines: a qualitative study.

BACKGROUND: Despite wide availability of physician guidelines for safer use of nonsteroidal anti-inflammatory drugs (NSAIDs) and widespread use of these drugs in the US, NSAID prescribing guidelines have been only modestly effective. AIM: To identify and describe comprehensively barriers to provider adherence to NSAID prescribing guidelines. METHODS: We conducted interviews with 25 physicians, seeking to identify the major influences explaining physician non-adherence to guidelines. Interviews were standardized and structured probes were used for clarification and detail. All interviews were audio-taped and transcribed. Three independent investigators analysed the transcripts, using the constant-comparative method of qualitative analysis. RESULTS: Our analysis identified six dominant physician barriers explaining non-adherence to established NSAID prescribing guidelines. These included (i) lack of familiarity with guidelines, (ii) perceived limited validity of guidelines, (iii) limited applicability of guidelines among specific patients, (iv) clinical inertia, (v) influences of prior anecdotal experiences and (vi) medical heuristics. CONCLUSIONS: A heterogeneous set of influences are barriers to physician adherence to NSAID prescribing guidelines. Suggested measures for improving guideline-concordant prescribing should focus on measures to improve physician education and confidence in guidelines, implementation of physician/pharmacist co-management strategies and expansion of guideline scope.

Cyclooxygenase-2 selectivity of non-steroidal anti-inflammatory drugs and the risk of myocardial infarction and cerebrovascular accident.

AIM: To assess degree of cyclooxygenase-2 (COX-2) selectivity of a non-steroidal anti-inflammatory drug (NSAID) and risk of myocardial infarction (MI) or cerebrovascular accident (CVA). METHODS: Prescription fill data were linked to medical records of a merged VA-Medicare dataset. NSAIDs were categorized by Cox-2 selectivity. Incidence of CVA and MI within 180 days of index prescription was assessed using Cox-proportional hazards models adjusted for gender, race, cardiovascular and pharmacological risk factors and propensity for prescription of highly COX-2 selective NSAIDs. RESULTS: Of 384,322 patients (97.5% men and 85.4% white), 79.4% were prescribed a poorly selective, 16.4% a moderately selective and 4.2% a highly selective NSAID. There were 985 incident cases of MI and 586 cases of CVA in >145 870 person-years. Highly selective agents had the highest rate of MI (12.3 per 1000 person-years; [95% CI: 12.2-12.3]) and CVA (8.1 per 1000 person-years; [95% CI: 8.0-8.2]). Periods without NSAID exposure were associated with lowest risk. In adjusted models, highly selective COX-2 selective NSAIDs were associated with a 61% increase in CVA and a 47% increase in MI, when compared with poorly selective NSAIDs. CONCLUSIONS: The risk of MI and CVA increases with any NSAID. Highly COX-2 selective NSAIDs confer the greatest risk.

Validation of administrative data used for the diagnosis of upper gastrointestinal events following nonsteroidal anti-inflammatory drug prescription.

AIMS: To validate veterans affairs (VA) administrative data for the diagnosis of nonsteroidal anti-inflammatory drug (NSAID)-related upper gastrointestinal events (UGIE) and to develop a diagnostic algorithm. METHODS: A retrospective study of veterans prescribed an NSAID as identified from the national pharmacy database merged with in-patient and out-patient data, followed by primary chart abstraction. Contingency tables were constructed to allow comparison with a random sample of patients prescribed an NSAID, but without UGIE. Multivariable logistic regression analysis was used to derive a predictive algorithm. Once derived, the algorithm was validated in a separate cohort of veterans. RESULTS: Of 906 patients, 606 had a diagnostic code for UGIE; 300 were a random subsample of 11 744 patients (control). Only 161 had a confirmed UGIE. The positive predictive value (PPV) of diagnostic codes was poor, but improved from 27% to 51% with the addition of endoscopic procedural codes. The strongest predictors of UGIE were an in-patient ICD-9 code for gastric ulcer, duodenal ulcer and haemorrhage combined with upper endoscopy. This algorithm had a PPV of 73% when limited to patients >or=65 years (c-statistic 0.79). Validation of the algorithm revealed a PPV of 80% among patients with an overlapping NSAID prescription. CONCLUSIONS: NSAID-related UGIE can be assessed using VA administrative data. The optimal algorithm includes an in-patient ICD-9 code for gastric or duodenal ulcer and gastrointestinal bleeding combined with a procedural code for upper endoscopy.

Predicting which patients can resume oral nutrition after percutaneous endoscopic gastrostomy tube placement.

BACKGROUND: Percutaneous endoscopic gastrostomy tubes are placed with high frequency and relative safety for a variety of indications. One of these indications is temporary nutritional support for patients expected to resume oral nutrition. AIMS: To determine if baseline clinical characteristics can predict which patients attain the clinical goal of resuming oral nutrition with consequent tube removal. METHODS: We conducted a single site observational cohort study from December 1999 to April 2001, enrolling all patients scheduled for percutaneous endoscopic gastrostomy placement. Standard descriptive and bivariate analyses were performed. Cox proportional hazard models were constructed to identify patient characteristics prior to percutaneous endoscopic gastrostomy placement that might predict resumption of oral nutrition with tube removal. RESULTS: Bivariate analyses revealed four potential clinical predictors: age < 65 years, localized head and neck cancer, serum albumin > or = 3.75 g/dL, and serum creatinine < or = 1.1 mg/dL. In multivariable analysis, age < 65 years (HR = 3.7, 95% CI: 1.0-14.3) and a diagnosis of localized head and neck cancer (HR = 4.6, 95% CI: 1.4-15.0) predicted resumption of oral nutrition with percutaneous endoscopic gastrostomy removal. CONCLUSIONS: When discussing percutaneous endoscopic gastrostomy placement, doctors should consider the likelihood of achieving clinically important outcomes such as the resumption of oral nutrition with tube removal. This clinical goal is unlikely for older patients with diagnoses other than localized head and neck cancer.

Increased use of low anterior resection for veterans with rectal cancer.

BACKGROUND: Two surgical procedures with curative intent are available to patients with rectal cancer: lower anterior resection and abdominoperineal resection; however, lower anterior resection may improve quality of life and functional status. AIM: To examine temporal changes in after lower anterior resection and abdominoperineal resection between 1989 and 2000. Potential factors associated with the use of lower anterior resection were evaluated. METHODS: Using national administrative data, we identified patients who received lower anterior resection or abdominoperineal resection. Logistic regression models examined the association between use of lower anterior resection and time period of surgical resection. RESULTS: A total of 5201 rectal cancer patients underwent resection. The use of lower anterior resection increased from 40.0% (1989-91) to 50.1% (1998-2000) paralleled by a corresponding decline in abdominoperineal resection (60.1 to 49.9%; P < 0.001). Patients who received surgery during 1992-94, 1995-97 and 1998-2000 were 6, 7 and 28% more likely to receive lower anterior resection, when compared with 1989-1991 after adjusting for demographic characteristics, co-morbidity and hospital surgical volume. Older age, lower co-morbidity score and lower hospital surgical volume were predictive of lower anterior resection. CONCLUSIONS: An increase in the use of lower anterior resection for rectal cancer was observed over time. This observed increase in use is not confined to high-volume hospitals.

Meta-analysis of short-term outcomes after laparoscopic resection for colorectal cancer.

BACKGROUND: The safety and efficacy of laparoscopic resection (LR) for colorectal cancer remains to be established. METHODS: A meta-analysis of randomized clinical trials comparing the short-term outcomes of laparoscopic with those of open resection for colorectal cancer was undertaken. A literature search was performed for relevant articles published by the end of 2002. Two reviewers independently appraised the trials using a predetermined protocol. Results were analysed using Comprehensive Meta-analysis. RESULTS: The outcomes of 2512 procedures from 12 trials were analysed. LR took on average 32.9 per cent longer to perform than open resection but was associated with lower morbidity rates. Specifically, wound infection rates were significantly lower (odds ratio 0.47 (95 per cent confidence interval 0.28 to 0.80); P = 0.005). In patients undergoing LR, the average time to passage of first flatus was reduced by 33.5 per cent, that to tolerance of a solid diet by 23.9 per cent and that to 80 per cent recovery of peak expiratory flow by 44.3 per cent. Early narcotic analgesia requirements were also reduced by 36.9 per cent, pain at rest by 34.8 per cent and during coughing by 33.9 per cent, and hospital stay by 20.6 per cent. There were no significant differences in perioperative mortality or oncological clearance. CONCLUSION: LR for colorectal cancer is associated with lower morbidity, less pain, a faster recovery and a shorter hospital stay than open resection, without compromising oncological clearance.

Systematic review: the methodological quality of trials affects estimates of treatment efficacy in functional (non-ulcer) dyspepsia.

AIM: To evaluate treatment efficacy using objective quality criteria. METHODS: A systematic review was performed of randomized controlled trials of endoscopically investigated dyspepsia (1979-2003) using the Jadad score and Rome II guidelines. The Jadad score differentiated studies as 'high quality' (score 4-5/5) vs. 'poor quality' (score 1-3/5). Three key Rome II guidelines on study design (cut-off of 0/3 or > 0/3) were also compared with the Jadad score. RESULTS: Poor quality trials suggested a benefit of prokinetic therapy [relative risk (RR) of remaining dyspeptic, 0.47; 95% confidence interval (CI), 0.39-0.56), which was not confirmed in high quality trials (RR, 1.0; 95% CI, 0.84-1.19). There was a marked benefit of H2-receptor antagonist therapy in poor quality trials (RR, 0.68; 95% CI, 0.61-0.76), but a marginal benefit in good quality trials (RR, 0.87; 95% CI, 0.79-0.97). Trial quality did not affect the small statistically significant benefit seen with Helicobacter pylori eradication. Two high quality trials suggested a limited benefit with the use of proton pump inhibitors, with no poor quality trials to provide a comparison. Separation of the studies by the Rome II criteria had a similar impact on the calculated treatment estimates. CONCLUSIONS: The magnitude of benefit of prokinetic and H2-receptor antagonist therapies reported in previous meta-analyses has been over-estimated. The quality of trials has an impact on the efficacy estimates of treatment. The Rome II criteria for study methodology may be appropriate for judging study quality.

Selective cannulation of the common bile duct: a prospective randomized trial comparing standard catheters with sphincterotomes.

BACKGROUND: Current recommendations for the use of standard catheters or sphincterotomes for the initial attempt at selective common bile duct cannulation have been made in the absence of prospective comparative data. METHODS: A prospective study was carried out in which patients were randomized to undergo cannulation with a standard catheter or a sphincterotome (standard or wire-guided). Multivariate models were constructed to determine significant independent predictors of the success rates of initial and selective cannulation and the number of attempts and time needed to achieve selective cannulation. RESULTS: Eighty-three successive patients were evaluated; 36 were excluded because they had undergone previous therapeutic endoscopic retrograde cholangiopancreatography (ERCP) or a Billroth II operation. Of the 47 patients (28 women, mean age 60.6 +/- 14.5 years), indications for ERCP included suspected bile duct stones in 41 patients, pancreatico-biliary malignancies in 4, and biliary leaks in 2. Eighteen patients were randomized to undergo selective common bile duct cannulation with standard catheter and 29 to standard/wire-guided sphincterotome. Initial common bile duct cannulation for the standard catheter and standard/wire-guided sphincterotome groups was successful in 12 (67% [95% CI: 41%, 87%]) and 28 (97% [95% CI: 82%, 100%]) patients, respectively (95% CI for the difference: -0.57 to -0.03, p = 0.009). Using intention to treat analysis, selective common bile duct cannulation was successful for standard catheter and standard/wire-guided sphincterotome patients in 17 (94% [95% CI: 73%, 99%]) and 28 (97% [95% CI: 82%, 100%]) cases, respectively (95% CI for the difference: -0.15 to +0.10, p > 0.05). The mean number of attempts required to achieve selective common bile duct cannulation were 12.4 +/- 6.0 and 2.8 +/- 3.1 (p = 0.0001). The mean time taken to achieve selective common bile duct cannulation was 13.5 +/- 6.14 and 3.1 +/- 5.1 minutes (p = 0.0001). Multivariate modeling revealed that the initial choice of catheter was the only significant independent predictor of the time taken and the number of attempts performed to achieve selective common bile duct cannulation (p = 0. 0001 for each model). CONCLUSION: The use of standard/wire-guided sphincterotome was superior to that of standard catheter for the initial attempt at cannulation of the common bile duct. The number of attempts required may bear clinical significance with regard to the development of post-ERCP pancreatitis and warrants further study.