Challenges in efficacy research: the case of feeding alternatives in patients with dementia.

AIMS: To explore factors at the family caregiver and nursing home administrative levels that may affect participation in a clinical trial to determine the efficacy of hand feeding vs. percutaneous gastrostomy tube feeding in persons with late-stage dementia. BACKGROUND: Decision-making regarding use of tube feeding vs. hand feeding for persons with late-stage dementia is fraught with practical, emotional and ethical issues and is not informed by high levels of evidence. DESIGN: Qualitative case study. METHODS: Transcripts of focus groups with family caregivers were reviewed for themes guided by behavioural theory. Analyses of notes from contacts with nursing home administrators and staff were reviewed for themes guided by an organizational readiness model. Data were collected between the years 2009-2012. RESULTS: Factors related to caregiver willingness to participate included understanding of the prognosis of dementia, perceptions of feeding needs and clarity about research protocols. Nursing home willingness to participate was influenced by corporate approval, concerns about legal and regulatory issues, and prior relationships with investigators. CONCLUSION: Participation in rigorous trials requires lengthy navigation of complex corporate requirements and training competent study staff. Objective deliberation by caregivers will depend on appropriate recruitment timing, design of recruitment materials and understanding of study requirements. The clinical standards and policy environment and the secular trends there-in have relevance to the responses of people at all levels.

Influence of race and sex on prevalence and recurrence of colon polyps.

BACKGROUND: African Americans (AAs) have a higher incidence of colorectal cancer (CRC) and present with more advanced disease compared with whites. An increased prevalence of polyps has also been noted in men regardless of race. We sought to validate these observations and assess whether the increase in CRC in AAs is owing to polyp prevalence or incidence differences vs other factors. METHODS: A detailed endoscopy database was used to identify patients undergoing their first outpatient colonoscopy for screening or minimal symptoms from January 26, 1996, through September 19, 2006. Multivariate models were constructed to predict prevalence and incidence of polyps. RESULTS: Of individuals undergoing colonoscopies, 3732 met our study criteria (41.3% male and 29.2% AA); 761 (20.4%) had polyps. Male sex (odds ratio, 1.67; 95% confidence interval [CI], 1.39-2.02) independently predicted polyps but race did not. A random 100-patient sample showed no significant racial difference in the proportion of adenomatous polyps among those with polyps (68.0% white vs 60.0% AA, P = .60). Of 57 patients who had a follow-up colonoscopy a median of 3.6 years after their index procedure, 18 (31.6%) were male, 7 (12.3%) were AA, and 19 (33.3%) were older than 65 years. Thirty-five (61.4%) had a polyp recurrence. Adjusting for time to subsequent colonoscopy and other confounders, neither male sex (adjusted hazard ratio, 0.98; 95% CI, 0.43-2.21) nor race (1.89; 0.68-5.24) significantly predicted incidence of recurrent polyps. CONCLUSIONS: In this series, male sex but not race predicted prevalence of polyps. Incidence of recurrent polyps was higher in neither male patients nor AAs, but the power of this analysis is limited.

Risk factors for gastrointestinal ulcer disease in the US population.

PURPOSE: Gastrointestinal (GI) ulcers are frequently seen in patients with multiple chronic medical conditions. Few studies have described the overall prevalence, comorbidities, or risk factors associated with this diagnosis. We sought to determine among a national dataset if individuals with certain medical comorbidities are at increased risk for gastrointestinal ulcer disease, while controlling for relevant confounders. RESULTS: The overall prevalence of GI ulcer is 8.4%. A significant increased risk of ulcer history is associated with older age (OR 1.67), African-Americans (OR 1.20) current (OR 1.99) and former (OR 1.55) tobacco use, former alcohol use (OR 1.29), obesity (OR 1.18), chronic obstructive pulmonary disease (OR 2.34), chronic renal insufficiency (OR 2.29), coronary heart disease (OR 1.46), and three or more doctor visits in a year (OR 1.49). CONCLUSIONS: This large US population-based study reports on a number of demographic, behavioral, and chronic medical conditions associated with higher risk of gastrointestinal ulcer disease.

Evaluation of percutaneous endoscopic feeding tube placement in obese patients.

BACKGROUND: Percutaneous endoscopic feeding tube placement is generally safe and effective for establishing enteral access. In certain subpopulations, such as obese patients, substantial data are limited. This study evaluates the success rate and potential for late complications with placement of feeding tubes in obese patients. METHODS: The Medical University of South Carolina endoscopy database was queried for adult patients with a body mass index >or=30 kg/m(2) who had undergone percutaneous endoscopic gastrostomy, percutaneous endoscopic gastrojejunostomy, and direct percutaneous jejunostomy placement procedures between the years 2000 and 2006. RESULTS: Sixty-seven subjects met the inclusion criteria. Percutaneous endoscopic feeding tube placement was successful in 60 of 67 individuals (89.6%) with an average procedure time of 15.5 minutes (range, 5-70 minutes). Postplacement complications occurred in 26 of 59 subjects (44.1%) and included peristomal pain (8.5%), cellulitis (8.5%), inadvertent removal (6.8%), peritubular leak (6.8%), nausea (3.4%), and hemoperitoneum (3.4%). In multivariable logistic regression analysis, weight >250 pounds (>113 kg) predicted a significantly increased likelihood of complications (adjusted odds ratio = 3.86; 95% confidence interval, 1.02-14.57). Other covariates did not significantly affect the complication rate. CONCLUSIONS: Percutaneous enteral access device placement in obese patients is generally safe, and a body mass index >or=30 kg/m(2) alone should not be a procedural contraindication. Adherence to safe enteral access placement techniques and close periprocedure follow-up should occur in obese patients, especially those weighing >250 pounds (>113 kg). More research is needed to fully evaluate the efficacy of enteral access in this population.

Bayesian Adaptation of the Summary ROC Curve Method for Meta-analysis of Diagnostic Test Performance.

Meta-analytic methods for diagnostic test performance, Bayesian methods in particular, have not been well developed. The most commonly used method for meta-analysis of diagnostic test performance is the Summary Receiver Operator Characteristic (SROC) curve approach of Moses, Shapiro and Littenberg. In this paper, we provide a brief summary of the SROC method, then present a case study of a Bayesian adaptation of their SROC curve method that retains the simplicity of the original model while additionally incorporating uncertainty in the parameters, and can also easily be extended to incorporate the effect of covariates. We further derive a simple transformation which facilitates prior elicitation from clinicians. The method is applied to two datasets: an assessment of computed tomography for detecting metastases in non-small-cell lung cancer, and a novel dataset to assess the diagnostic performance of endoscopic ultrasound (EUS) in the detection of biliary obstructions relative to the current gold standard of endoscopic retrograde cholangiopancreatography (ERCP).

Risk factors for complications after ERCP: a multivariate analysis of 11,497 procedures over 12 years.

BACKGROUND: Complications of ERCP are an important concern. We sought to determine predictors of post-ERCP complications at our institution. METHODS: GI TRAC is a comprehensive data set of patients who underwent ERCP at our institution from 1994 through 2006. Logistic regression models were used to evaluate 4 categories of complications: (1) overall complications, (2) pancreatitis, (3) bleeding, and (4) severe or fatal complications. Independent predictors of complications were determined with multivariable logistic regression. RESULTS: A total of 11,497 ERCP procedures were analyzed. There were 462 complications (4.0%), 42 of which were severe (0.36%) and 7 were fatal (0.06%). Specific complications of pancreatitis (2.6%) and bleeding (0.3%) were identified. Overall complications were statistically more likely among individuals with suspected sphincter of Oddi dysfunction (SOD) (odds ratio [OR] 1.91) and after a biliary sphincterotomy (OR 1.32). Subjects with a history of acute or chronic pancreatitis (OR 0.78) or who received a temporary small-caliber pancreatic stent (OR 0.69) had fewer complications. Post-ERCP pancreatitis was more likely to occur after a pancreatogram via the major papilla (OR 1.70) or minor papilla (OR 1.54) and among subjects with suspected SOD with stent placement (OR 1.45) or without stent placement (OR 1.84). Individuals undergoing biliary-stent exchange had less-frequent pancreatitis (OR 0.38). Biliary sphincterotomy was associated with bleeding (OR 4.71). Severe or fatal complications were associated with severe (OR 2.38) and incapacitating (OR 7.65) systemic disease, obesity (OR 5.18), known or suspected bile-duct stones (OR 4.08), pancreatic manometry (OR 3.57), and complex (grade 3) procedures (OR 2.86). CONCLUSIONS: This study characterizes a large series of ERCP procedures from a single institution and outlines the incidence and predictors of complications.

The impact of race on weight loss after Roux-en-Y gastric bypass surgery.

BACKGROUND: Gastric bypass surgery for morbid obesity has dramatically increased in volume over the past decade. Caucasian patients have been noted previously to lose more weight after bariatric surgery than African-Americans patients. Data regarding predictors of maintaining weight loss after surgery are minimal. We sought to determine predictors of long-term weight loss after bariatric surgery. METHODS: Retrospective analysis using a multivariate logistic regression model of all patients undergoing Roux-en-Y gastric bypass surgery at the Medical University of South Carolina from May 1993 to December 2004 for whom 2 years of follow-up data was available. Our dependent variable was the percentage of weight lost from baseline, dichotomized at +/-35%. Our primary independent variable was race, defined as Caucasian, African-American, or other. Relevant covariates were added to the model to control for their potential effects on outcome. RESULTS: One hundred eleven patients (17 male/94 female; 85% Caucasian, mean age 44 years (range 18-68 years). In our model, Caucasian subjects (adjusted odds ratio [OR] = 7.60, 95% confidence intervals [95%CI] = 1.83-31.5) and late post surgical complications (adjusted OR = 2.67, 95%CI = 1.05-6.80) significantly predicted weight loss at 2 years, after controlling for relevant confounders. Other covariates did not significantly impact the model. CONCLUSION: Race and late post surgical complications significantly impacted the percentage of weight loss at 2 years for patients undergoing Roux-en-Y gastric bypass surgery at our institution. Future research should be directed at determining potential genetic and/or social reasons for these differences.

Feeding alternatives in patients with dementia: examining the evidence.

Percutaneous endoscopic gastrostomy tubes are being placed with increasing frequency in the United States among elderly patients with dementia. Health care providers believe there may be long-term benefits for enteral feeding in this population, yet previous study of this topic has failed to yield any convincing evidence to support this hypothesis. In this study, we review the evidence regarding outcomes for artificial enteral feeding in older individuals with dementia. We found that there is a lack of evidence supporting artificial feeding in the specific outcomes of survival, pressure ulcers, nutrition, and aspiration pneumonia. A brief discussion regarding hand feeding is included. The data suggest that hand feeding may be a viable alternative to tube feeding in elderly patients with dementia, although a direct comparison trial of the 2 interventions is lacking.

Endoscopic ultrasound: a meta-analysis of test performance in suspected biliary obstruction.

BACKGROUND & AIMS: Endoscopic ultrasound (EUS) achieves high-resolution images of the bile duct and pancreas, while avoiding the risks of ERCP (endoscopic retrograde cholangiopancreatography). It appears comparable to MRCP (magnetic resonance cholangiopancreatography), although its use is less widely disseminated. We aimed to summarize EUS test performance in suspected biliary disease with meta-analysis. METHODS: MEDLINE search (January 1987-September 2006), selected reference lists, external experts, and manual search of abstracts were used. Studies permitting (re)construction of 2 x 2 tables for EUS versus a gold standard were used. Random-effects models were used to estimate pooled sensitivity and specificity after adjusting for a number of potential confounders. Summary receiver operating characteristic analysis, with the sensitivity corresponding to the point on the receiver operating characteristic curve where sensitivity equals specificity (Q*) and area under the curve, was performed. The effects of sample size, quality, disease prevalence and spectrum, pancreatitis, echoendoscope type, and EUS era on diagnostic performance were assessed. Performance regarding presence of obstruction, choledocholithiasis, and malignancy was analyzed. RESULTS: Thirty-six eligible, non-overlapping studies met inclusion criteria (3532 subjects). EUS had a high overall pooled sensitivity (88%; 95% confidence interval, 85%-91%) and specificity (90%; 87%-93%) for biliary obstruction (area under the curve = 0.97; Q* = 0.92). EUS had higher sensitivity (89%; 87%-91%) and specificity (94%; 91%-96%) for choledocholithiasis than for malignancy (sensitivity, 78%; 69%-85%; specificity, 84%; 78%-91%). Smaller studies and ones mainly studying patients with suspected strictures were associated with lower test performance. CONCLUSIONS: There is excellent overall accuracy for EUS in diagnosing choledocholithiasis, with less impressive results for malignancy (when fine-needle aspiration is not used).

National patterns and correlates of complementary and alternative medicine use in adults with diabetes.

OBJECTIVE: The aim of this study was to determine national patterns and correlates of complementary and alternative medicine (CAM) use among adults with diabetes. METHODS: The authors compared CAM use in 2474 adults with and 28,625 adults without diabetes who participated in the most comprehensive national survey on CAM use (2002 National Health Interview Survey). Eight CAM use categories were created, including dietary, herbal, chiropractic, yoga, relaxation, vitamin, prayer, and other (acupuncture, Ayurveda, biofeedback, chelation, energy healing or Reiki therapy, hypnosis, massage, naturopathy, and homeopathy). An overall CAM use category also was created that excluded vitamins and prayer. Patterns of use were compared with chi-square and independent correlates of CAM use with multiple logistic regression controlling for relevant covariates. STATA was used for analysis to account for the complex survey design. RESULTS: Prevalence of overall use of CAM did not differ significantly by diabetes status (47.6 versus 47.9%, p = 0.81). Diabetes was not an independent predictor of overall use of CAM (OR 0.93, 95% confidence interval [CI] 0.83, 1.05). However, persons with diabetes were more likely to use prayer (OR 1.19, 95% CI 1.05, 1.36), but less likely to use herbs (OR 0.86, 95% CI 0.75, 0.99), yoga (OR 0.56, 95% CI 0.43, 0.72), or vitamins (OR 0.82, 95% CI 0.72, 0.93) than people without diabetes after controlling for relevant covariates. Independent correlates of overall use of CAM differed by age, income, employment, comorbidity, and health status between people with and without diabetes. CONCLUSIONS: This study found that there has been a dramatic increase in overall use of CAM in adults with diabetes; diabetes was not an independent predictor of overall use of CAM; and people with diabetes were more likely to use prayer, but less likely to use herbs, yoga, or vitamins compared to persons without diabetes.

Association between complementary and alternative medicine use, preventive care practices, and use of conventional medical services among adults with diabetes.

OBJECTIVE: To assess the association between complementary and alternative medicine (CAM) use, preventive care practices, and use of conventional medical services among adults with diabetes. RESEARCH DESIGN AND METHODS: We analyzed data on 2,474 adults with diabetes. We created an overall CAM-use category based on use of any of the following: diets, herbs, chiropractic care, yoga, relaxation, acupuncture, ayuverda, biofeedback, chelation, energy healing, Reiki therapy, hypnosis, massage, naturopathy, and homeopathy. We used multiple logistic regression to assess the effect of CAM use on preventive care practices (receipt of influenza and pneumonia vaccines) and use of conventional medical services (number of primary care and emergency department visits). STATA was used for statistical analysis to account for the complex survey design. RESULTS: A total of 48% of adults with diabetes used some form of CAM. CAM use was independently associated with receipt of pneumonia vaccination (odds ratio 1.56 [95% CI 1.26-1.94]) but not significantly associated with receipt of influenza vaccination (1.17 [0.92-1.48]). CAM use was independently associated with visiting the emergency department (1.34 [1.06-1.70]), having six or more primary care visits (1.44 [1.14-1.83]), and having eight or more primary care visits (1.66 [1.22-2.25]). CONCLUSIONS: In contrast to the findings of previous studies, CAM use appears to be associated with increased likelihood of receipt of preventive care services and increased emergency department and primary care visits. CAM use may not be a barrier to use of conventional medical services in adults with diabetes.