Adherence to guideline recommendations for Barrett's esophagus (BE) surveillance endoscopies: Effects of dedicated BE endoscopy lists.

Background and study aims For non-dysplastic Barrett's Esophagus (BE) patients, guidelines recommend endoscopic surveillance every 3 to 5 years with four-quadrant random biopsies every 2 cm of BE length. Adherence to these guidelines is low in clinical practice. Pooling BE surveillance endoscopies on dedicated endoscopy lists performed by dedicated endoscopists could possibly enhance guideline adherence, detection of visible lesions, and dysplasia detection rates (DDRs). Patients and methods Data were used from the ACID-study (Netherlands Trial Registry NL8214), a prospective trial of BE surveillance in the Netherlands. BE patients with known or previously treated dysplasia were excluded. Guideline adherence, detection of visible lesions, and DDRs were compared for patients on dedicated and general endoscopy lists. Results A total of 1,244 patients were included, 318 on dedicated lists and 926 on general lists. Endoscopies on dedicated lists showed significantly higher adherence to the random biopsy protocol (85% vs. 66%, P <0.01) and recommended surveillance intervals (60% vs. 47%, P <0.01) compared to general lists. Detection of visible lesions (8.8% vs. 8.1%, P =0.79) and DDRs were not significantly different (6.9% and 6.6%, P =0.94). None (0.0%) of the patients scheduled on dedicated lists and 10 (1.1%) on general lists were diagnosed with esophageal adenocarcinoma ( P =0.07). In multivariable analysis, dedicated lists were significantly associated with biopsy protocol adherence and adherence to surveillance interval recommendations with odds ratios of 4.45 (95% confidence interval [CI] 2.07-9.57) and 1.64 (95% CI 1.03-2.61), respectively. Conclusions Dedicated endoscopy lists are associated with better adherence to the random biopsy protocol and surveillance interval recommendations.

Triage of colonoscopies: open access endoscopy versus outpatient consultation with a gastroenterologist.

BACKGROUND AND STUDY AIMS: In many Dutch hospitals, open access referral for colonoscopy is authorized by a gastroenterologist after screening a standard referral letter (SRL) without face-to-face contact with the patient. We investigated the added value of a 7.5 min outpatient consultation with a gastroenterologist (OC), regarding the patient indications, priority for colonoscopy, and the frequency of correct information about patient medications and comorbidities on SRLs. PATIENTS AND METHODS: In a prospective, blinded, single-center study, gastroenterologists assessed SRLs for the accuracy and priority of the colonoscopy request (SRL). These data were compared to results from the OC, and primary outcomes were the number of patients who were not recommended for colonoscopy and priority scheduling of colonoscopy for suspicion of cancer. RESULTS: Patients were analyzed using both SRL and OC and, of 255 patients, 224 of them underwent colonoscopy. Colonoscopy was not recommended for 6.3 % and 11.4 % of patients using the SRL and OC, respectively (P = 0.02). Using the SRL, gastroenterologists did not recommend colonoscopy for seven patients, but the same patients were recommended for colonoscopy when OC was available. This was explained because the indications on the SRL did not match the information obtained from OC. Compared to OC , more colonoscopies were prioritized when the SRL was used to make decisions. Cancer was detected in 7/112 (SRL ) versus 7/65 (OC ) of priority-scheduled patients. SRLs did not report the use of coumarins and insulin in 1.6 % of patients or the prevalence of serious comorbid conditions in 52 % of patients. CONCLUSIONS: A 7.5 min outpatient consultation with a gastroenterologist improved the identification of indications for colonoscopy, decreased priority scheduling of patients, and increased the number of patients diagnosed with cancer in the prioritized group. SRLs frequently omitted patients' medications and comorbidities.

Esophageal stents for the relief of malignant dysphagia due to extrinsic compression.

BACKGROUND AND STUDY AIMS: In patients with primary esophageal cancer, luminal patency can be restored by placement of a self-expandable metal stent (SEMS). The use of SEMS in patients with dysphagia caused by malignant extrinsic compression has largely been unreported. In this study we evaluated the efficacy of SEMS in a large cohort of patients with malignant extrinsic compression. PATIENTS AND METHODS: This was a prospective single-center study. Between 1995 and 2009, 50 consecutive patients with malignant extrinsic compression who had undergone SEMS placement were included (mean age 64 years; 37-males). In the majority of patients, extrinsic esophageal compression was caused by obstructive pulmonary cancer (n = 23) and by mediastinal metastasis after esophagectomy for esophageal cancer (n = 16). RESULTS: Stent placement was technically successful in all patients. Severe complications occurred in 5 / 50 patients (10 %) including perforation during dilation prior to stent insertion (n = 2) and hemorrhage (n = 3). Two patients (4 %) died from bleeding. Mild complications were seen in 9 / 50 patients (18 %). Recurrent dysphagia occurred in eight patients (16 %) and was successfully managed by subsequent endoscopic intervention. Median survival after stent placement was 44 days (range 5 days - 2 years). The median stent patency of 46 days in this series exceeded median patient survival. CONCLUSIONS: Insertion of an SEMS is an effective palliative treatment for patients with dysphagia due to malignant extrinsic compression. In spite of the short survival, some patients present with recurrent dysphagia, which can be managed effectively by endoscopic re-intervention.

Short-term esophageal stenting in the management of benign perforations.

OBJECTIVES: The standard approach to benign esophageal perforations consists of conservative treatment or surgery. In this study, we investigated the efficacy of short-term stent placement for nonmalignant esophageal perforations. METHODS: This is a prospective single-center study of patients with benign esophageal perforations in whom a removable self-expandable stent was placed. Data were collected from a prospective database, endoscopy records, and operation reports. To obtain follow-up data, we contacted the patients, their relatives, or their general practitioner. RESULTS: A total of 33 patients underwent stent insertion owing to an iatrogenic perforation (n=19), Boerhaave's syndrome (n=10), or other causes (n=4); this resulted in an immediate and complete sealing of the lesion in 32 patients (97%). Stents migrated in 11 patients (33%). Four patients required an esophageal resection for failed stent therapy (n=3) and failed stent removal (n=1). The 90-day mortality rate was 15%. A total of 33 endoscopic stent extractions were attempted. Overall, 23 stents were extracted within 6 weeks (group I) and 10 stents between 6 and 84 weeks (group II). Extractions were uncomplicated in all patients in group I (100%) vs. in 5 patients in group II (50%) (P=0.001). Six extraction-related complications occurred in group II, including two self-limiting bleedings, three stent fractures, and one impacted stent. CONCLUSIONS: In patients with a benign esophageal perforation, temporary stent therapy is effective and provides a good alternative to surgery. Complications due to stent removal can be prevented by removal of the prosthesis within 6 weeks after insertion, without compromising the efficacy of treatment.

INTERMAP: the dietary data--process and quality control.

The aim of this report is to describe INTERMAP standardized procedures for assessing dietary intake of 4680 individuals from 17 population samples in China, Japan, UK and USA: Based on a common Protocol and Manuals of Operations, standardized collection by centrally trained certified staff of four 24 h dietary recalls, two timed 24-h urines, two 7-day histories of daily alcohol intake per participant; tape recording of all dietary interviews, and use of multiple methods for ongoing quality control of dietary data collection and processing (local, national, and international); one central laboratory for urine analyses; review, update, expansion of available databases for four countries to produce comparable data on 76 nutrients for all reported foods; use of these databases at international coordinating centres to compute nutrient composition. Chinese participants reported 2257 foods; Japanese, 2931; and UK, 3963. In US, use was made of 17,000 food items in the online automated Nutrition Data System. Average time/recall ranged from 22 min for China to 31 min for UK. Among indicators of dietary data quality, coding error rates (from recoding 10% random samples of recalls) were 2.3% for China, 1.4% for Japan, and UK; an analogous US procedure (re-entry of recalls into computer from tape recordings) also yielded low discrepancy rates. Average scores on assessment of taped dietary interviews were high, 40.4 (Japan) to 45.3 (China) (highest possible score: 48); correlations between urinary and dietary nutrient values--similar for men and women--were, for all 4680 participants, 0.51 for total protein, range across countries 0.40-0.52; 0.55 for potassium, range 0.30-0.58; 0.42 for sodium, range 0.33-0.46. The updated dietary databases are valuable international resources. Dietary quality control procedures yielded data generally indicative of high quality performance in the four countries. These procedures were time consuming. Ongoing recoding of random samples of recalls is deemed essential. Use of tape recorded dietary interviews contributed to quality control, despite feasibility problems, deemed remediable by protocol modification. For quality assessment, use of correlation data on dietary and urinary nutrient values yielded meaningful findings, including evidence of special difficulties in assessing sodium intake by dietary methods.

Accuracy of energy intake data estimated by a multiple-pass, 24-hour dietary recall technique.

OBJECTIVE: This study examined the accuracy of a multiple-pass, 24-hour dietary recall method for estimating energy intakes of men and women by comparing it with energy intake required for weight maintenance. DESIGN: Three-day, multiple-pass, 24-hour recalls were obtained on randomly selected days during a self-selected diet period when subjects were preparing their own meals and during a controlled diet period when all meals were provided by the study. During the dietary intervention, weight was maintained; body weight and dietary intake were monitored closely, thereby allowing estimation of the energy intake required for weight maintenance. SUBJECTS/SETTING: Seventy-eight men and women (22 to 67 years old) from the Dietary Effects on Lipoprotein and Thrombogenic Activity (DELTA) study participated in this study. All 24-hour recalls were collected using a computer-assisted, interactive, multiple-pass telephone interview technique. Energy requirements for each individual were determined by the energy content of the DELTA study foods provided to maintain weight. STATISTICAL ANALYSIS: Paired and independent t tests were conducted to examine differences among study variables. Agreement between recalled energy intake and weight maintenance energy intake was analyzed using the Bland-Altman technique. RESULTS: Compared with weight maintenance energy intake, during the self-selected diet period men and women underestimated energy intake by 11% and 13%, respectively. During the controlled diet period, men underestimated energy intake by 13%, whereas women overestimated energy by 1.3%. APPLICATIONS/CONCLUSIONS: Men had a tendency to under-estimate energy intake irrespective of the recording period. The accuracy of the recalled energy intake of women may be influenced by recording circumstances. Researchers should examine the factors influencing underreporting and overreporting by individuals and their impact on macronutrient and micronutrient intakes. Also, strategies need to be developed to minimize underreporting and overreporting.

Diet design for a multicenter controlled feeding trial: the DELTA program. Delta Research Group.

OBJECTIVE: To describe the process and results of diet standardization, diet validation, and monitoring of diet composition, which were key components of protocol 1 of Dietary Effects on Lipoproteins and Thrombogenic Activity (DELTA-1), the initial protocol in a program of multicenter human feeding studies designed to evaluate the effects of amount and type of fat on lipoproteins and hemostasis parameters in various demographic groups. DESIGN: DELTA-1 was based on a randomized, blinded, crossover experimental design. Three diets were fed for 8 weeks to 103 healthy men and women aged 22 to 67 years at 4 field centers. Diet A, an average American diet, was designed to provide 37% of energy from fat, 16% of energy from saturated fatty acids (SFAs); diet B (step 1 diet) was designed to provide 30% of energy from fat, 9% of energy from SFA; and diet C (low SFA diet) was designed to provide 26% of energy from fat, 5% of energy from SFA. Key features of diet standardization included central procurement of fat-containing foods, inclusion of standard ingredients, precision weighing of foods--especially sources of fat and cholesterol--and use of standardized written procedures. SETTING: For menu validation, a set of 12 menus for each diet was prepared in duplicate and chemically assayed. For monitoring of diet composition during the study, an 8-day diet cycle (6 weekday and 2 weekend menus) was sampled by every field center twice during each of 3 feeding periods. STATISTICAL ANALYSES: Means (+/- standard error) were calculated and compared with target nutrient specifications. RESULTS: DELTA-1 was able to provide a standardized diet that met nutrient specifications across 4 field centers over 24 weeks of participant feeding spanning a total of 8 months. APPLICATIONS: Prestudy chemical validation of menus and continuous sampling and assay of diets throughout the study are essential to standardize experimental diets and to ensure that nutrient target goals are met and maintained throughout a controlled multicenter feeding study.

Lifestyle intervention: results of the Treatment of Mild Hypertension Study (TOMHS).

BACKGROUND: Questions regarding the efficacy of nonpharmacologic approaches for the treatment of stage 1 hypertension were addressed as part of the Treatment of Mild Hypertension Study (TOMHS), a 4-year, randomized clinical trial (N = 902). This report describes the lifestyle intervention program used in TOMHS, presents data on the lifestyle changes observed, and focuses on the effect of weight loss on blood pressure and blood lipid levels. METHODS: Participants were randomly assigned to receive either placebo or one of five different antihypertensive medications. All took part in a lifestyle intervention program to reduce weight and sodium and alcohol intake and to increase physical activity. RESULTS: Substantial changes from baseline levels were achieved for all lifestyle intervention variables. Mean weight change was -10.5 lb (-5.6%) at 1 year, -8.5 lb (-4.5%) at 2 years, -7.4 lb (-4.0%) at 3 years, and -5.7 lb (-3.0%) at 4 years. At 4 years, 70% of participants remained below baseline weight and 34% maintained a weight loss of 10 lb or greater. Mean change in urinary sodium excretion was -12.5 mmol/8 hr (-23%) at 1 year, -10.7 mmol/8 hr (-20%) at 2 years, -8.4 mmol/8 hr (-16%) at 3 years, and -4.6 mmol/8 hr (-9%) at 4 years. Alcohol intake declined by 1.6 drinks/week among drinkers at 4 years. Reported leisure physical activity increased by 86% at 1 year and remained 50% above baseline at 4 years. Beneficial changes in blood pressure and serum lipids were associated with these changes. CONCLUSIONS: These results support a role for lifestyle interventions as the initial treatment for stage 1 hypertension and demonstrate that such interventions can be successfully implemented in the clinical setting.

Do hypertensive patients have a different diurnal pattern of electrolyte excretion?

Studies generally indicate that excretion of sodium, potassium, and water is greater during the day than during the night. To determine whether hypertensive patients exhibit this same pattern of excretion, diurnal variations in excretion of sodium, potassium, creatinine, and water were examined in 107 hypertensive men and women from a clinical trial on control of hypertension by nonpharmacological means--the Hypertension Control Program. Each participant provided two carefully timed 24-hour urine collections divided into daytime and overnight specimens. The median ratios of 24-hour to 8-hour overnight excretion were 2.84, 3.95, 2.99, and 2.77 for sodium, potassium, creatinine, and water, respectively. Thus, more than half of this hypertensive group exhibited a greater rate of sodium and water excretion during sleep than during daytime hours, a reversal of the usual pattern. When the group was subdivided based on age, sex, race, trial randomization group, use of diuretics, and hypertension severity, women had significantly lower ratios of 24-hour to overnight excretion for sodium and water than men and blacks had significantly lower 24-hour to overnight ratios for water and potassium than whites. When the 24-hour to overnight ratios for these hypertensive patients were compared with those for a group of 30 men and women with high-normal blood pressure, those with high-normal blood pressure had significantly larger ratios for sodium and water excretion than the hypertensive group. The results of this study suggest that hypertensive patients may have a different diurnal pattern of sodium and water excretion than normotensive subjects and that further research is needed to clarify this issue.

Nutritional therapy for high blood pressure. Final report of a four-year randomized controlled trial--the Hypertension Control Program.

A four-year trial assessed whether less severe hypertensives could discontinue antihypertensive drug therapy, using nutritional means to control blood pressure. Randomization was to three groups: group 1--discontinue drug therapy and reduce overweight, excess salt, and alcohol; group 2--discontinue drug therapy, with no nutritional program; or group 3--continue drug therapy, with no nutritional program. In groups 1 and 2 patients resumed drug therapy if pressure rose to hypertensive levels. Loss of at least 4.5 kg (10 + lb) was maintained by 30% of group 1, with a group mean loss of 1.8 kg (4 lb); sodium intake fell 36% and modest alcohol intake reduction was reported. At four years, 39% in group 1 remained normotensive without drug therapy, compared with 5% in group 2. Study findings demonstrated that nutritional therapy may substitute for drugs in a sizable proportion of hypertensives or, if drugs are still needed, can lessen some unwanted biochemical effects of drug treatment.

Nonpharmacological control of hypertension.

Ability to safely withdraw well-controlled mild hypertensives from drugs is being tested in a three-group randomized trial. Group I (intervention) was removed from drugs after the first 2 months of nutrition counseling. Counseling is continuing through the remaining years of the trial to achieve a minimum weight loss of 10 lb if overweight, reduction of sodium intake to less than 1,800 mg, and reduction of alcohol intake to not more than two drinks per day. Group II (the first control group) was also removed from drugs to see if previous long-term blood pressure control had a carryover effect without dietary change. Blood pressure is monitored frequently in both groups, with return to drug treatment in the event of specified blood pressure rise. Group III (the second control group) has remained on drugs for comparison of blood pressure and biochemical variables. In Group I mean 30-month weight loss was 8 lb, with 35% losing 10+ lb; sodium intake was reduced by 38%. Blood pressure control without drugs was maintained for 47% of Group I patients but only 16% of group II patients (P less than 0.05). These findings indicate it may be possible, after establishing good blood pressure control, to maintain control in a sizable proportion without medication, when reduction of weight, sodium, and alcohol intake is achieved.

Trial on control of hypertension by nutritional means: three-year results.

Ability to safely withdraw medication from well-controlled mild hypertensives was tested in a 3-group randomized trial. Group I (Intervention): drugs were stopped 2 months after nutrition counseling began. Counselling continued throughout the remaining years of the trial to achieve: a minimum of 10 lb weight loss if overweight; reduction of sodium intake to 1800 mg/day or less; reduction of alcohol intake to not more than 2 drinks per day. Group II (control group 1): drugs were stopped to see if previous long-term blood pressure control had a carryover effect without diet change. Pressure was monitored frequently in both groups with return to treatment if diastolic blood pressure rose to 90 mmHg or above. Group III (control group 2) remained on drugs for comparison of blood pressure and biochemical variables. In Group I mean weight loss at 3 years was 7 lb (3.18 kg) with 39% losing 10 lb (4.55 kg) or more; sodium intake was reduced by 37%. Blood pressure control without drugs was achieved in 44% of Group I patients. This compares with only 15% in Group II. These findings suggest it may be possible after establishing good blood pressure control, to maintain control in a sizeable proportion with less or no medication, when reduction of weight, sodium, and alcohol is achieved.