Bristol Stool Form Scale reliability and agreement decreases when determining Rome III stool form designations.

BACKGROUND: Rater reproducibility of the Bristol Stool Form Scale (BSFS), which categorizes stools into one of seven types, is unknown. We sought to determine reliability and agreement by individual stool type and when responses are categorized by Rome III clinical designation as normal or abnormal (constipation or diarrhea). METHODS: Thirty-four gastroenterology providers from three institutions rated 35 stool photographs using the BSFS. Twenty rerated the photographs. KEY RESULTS: 1190 individual stool type ratings were completed. Though only four photographs had absolute agreement (all Type 1 or Type 7), general agreement was high with 1132 (95.1%) of ratings being within one category type of the modal rating. Inter-rater and intra-rater reliability of the BSFS by individual stool type was excellent with intraclass correlations of 0.88 (95% CI: 0.86-0.90, p < 0.001) and 0.89 (95% CI: 0.86-0.91, p < 0.001), respectively. However, agreement decreased when using Rome III designations with 13 (37%) photographs having significantly diverging classifications (semi-interquartile range = 0.5). These 13 photographs were rated by the majority of raters as either type 2 vs type 3 or type 5 vs type 6 stools, representing the boundaries of normal vs abnormal stools. Inter-rater and intra-rater reliability of the BSFS by Rome III clinical categorization decreased with intraclass correlations of 0.75 (95% CI: 0.69-0.81, p < 0.001) and 0.65 (95% CI: 0.49-0.81, p < 0.001), respectively. CONCLUSIONS & INFERENCES: The Bristol Stool Form Scale has excellent reliability and agreement when used to rate individual stool type by raters. However, BSFS reliability and agreement decreases when determining Rome III stool form categories.

Agreement between prospective diary data and retrospective questionnaire report of abdominal pain and stooling symptoms in children with irritable bowel syndrome.

BACKGROUND: In functional gastrointestinal disorders, patient recall of symptoms drives diagnostic decisions and evaluation of treatment response, and research conclusions about potential treatments. In pediatrics, parent report also impacts assessment and care. Hence, identifying methods for accurately capturing patient and parent report of irritable bowel syndrome (IBS) symptoms is important. This study evaluated correspondence between retrospective questionnaire (parent and child report) and prospective diary data for children and adolescents with IBS. METHODS: Participants included 50 children/adolescents with IBS per Rome III criteria. Children completed a 2-week pain and stool diary. Children and parents subsequently completed a 2-week recall questionnaire, reporting number of pain days, maximum pain, days without bowel movement, and days with diarrhea during the diary interval. Intraclass correlation coefficients and Bland-Altman plots assessed agreement. KEY RESULTS: For pain and days without bowel movement, overall agreement between child recall questionnaire and child diary was strong, although under conditions likely to facilitate agreement and with individual variation observed. Parent recall and child diary were less concordant, and agreement about diarrhea was poor for parent and child. Age did not significantly correlate with agreement. CONCLUSIONS & INFERENCES: Child questionnaire with short recall interval may be a reasonable approximation for diary data, although this varies by individual and replication/investigation of lengthier recall are needed. Relying on parent questionnaire does not appear a suitable proxy, and recall of stool form by both parent and child appears more problematic. These results combined with existing literature support use of diary data whenever possible.

Statistical issues in analyzing 24-hour dietary recall and 24-hour urine collection data for sodium and potassium intakes.

Dietary recalls and urine assays provide different metrics for assessing sodium and potassium intakes. Means, variances, and correlations of data obtained from these two modes of measurement differ. Pooling of these data is not straightforward, and results from studies employing the different modes may not be comparable. To explore differences between these metrics, the authors used data from the Trial of Nonpharmacologic Intervention in the Elderly (TONE), which included repeated standardized 24-hour dietary recalls and 24-hour urine collections administered over 3 years of follow-up, to estimate sodium and potassium intakes. The authors examined data from 341 control participants assigned to usual care that were collected between August 1992 and December 1995. Dietary recalls yielded estimates of sodium intake that averaged 22% less than those from urine assays and estimates of potassium intake that averaged 16% greater than those from urine assays. Sodium intake estimates were less repeatable (r = 0.22 for diet; r = 0.30 for urine) than potassium intake estimates (r = 0.49 for diet; r = 0.50 for urine), making relations with outcomes more difficult to characterize. Overall, the performance of the two measurement modes was fairly similar across demographic subgroups. Errors in separate estimations of long term sodium and potassium intakes using short term data were strongly correlated, more strongly than the underlying long term intakes of these electrolytes. Because of the correlated measurement error, estimated regression coefficients for linear models including both electrolytes as predictors may be confounded such that the separate relations between these nutrients and outcomes such as blood pressure cannot be reliably estimated by common analytical strategies.

Hybrid dialysis: recirculation peritoneal dialysis revisited.

In a crossover trial, eight patients were studied during one treatment each of automated peritoneal dialysis (APD) and hybrid dialysis (HyD). During HyD, a fixed quantity of peritoneal dialysis fluid (PDF) was continuously removed at a flow rate of 141.3 +/- 23. 7 mL/min, dialyzed against the secondary dialysate (250 +/- 53.5 mL/min) generated by the hemodialysis delivery system with single-needle dialysis capability, and the regenerated PDF (PDF(HyD)) was reinfused into the peritoneal cavity. Despite using a smaller volume (6,195 +/- 737 versus 13,321 +/- 1,201 mL; P < 0. 0001) of PDF(HyD) with a lower glucose concentration (729 +/- 562 versus 1,659 +/- 373 mg/dL; P < 0.0001) and osmolality (331 +/- 79 versus 387 +/- 184 mOsm/kg; P < 0.001) during HyD compared with APD (PDF(APD)), weight loss was similar with both treatments (1.4 +/- 1. 0 versus 1.6 +/- 1.2 kg). Lactate levels were lower (3.2 +/- 2.5 versus 11.4 +/- 5.4 mEq/L), but pH (7.5 +/- 1.3 versus 5.6 +/- 0.9; P < 0.001) and bicarbonate concentration (22.6 +/- 8.0 versus 11.9 +/- 7.9 mEq/L; P < 0.0001) were greater in PDF(HyD) than PDF(APD). Although the mean dialysate calcium level was lower (6.0 +/- 0.5 versus 6.9 +/- 1.1 mg/dL; P < 0.001) in PDF(HyD), it was more stable throughout the dialysis compared with PDF(APD). A steeper concentration gradient between the blood and dialysate resulted in greater clearance of urea (26.5 +/- 9.1 versus 11.0 +/- 4.7 mL/min; P = 0.04), creatinine (24.1 +/- 11.4 versus 12.0 +/- 7.9 mL/min; P = 0.03), phosphate (19.2 +/- 4.3 versus 9.8 +/- 7.2 mL/min; P = 0.01), and uric acid (15.6 +/- 6.9 versus 9.1 +/- 2.7 mL/min; P = 0.04) and a greater percentage of reduction in values for blood urea nitrogen (20.7% +/- 7.7% versus 11.6% +/- 5.5%; P = 0.02), serum creatinine (16.1% +/- 5.3% versus 6.6% +/- 3.0%; P < 0.001), phosphate (22.7% +/- 8.9% versus 9.8% +/- 4.5%; P = 0.004), and uric acid (15.8% +/- 2.9% versus 6.3% +/- 3.4%; P < 0.001) during HyD than APD. To conclude, HyD is a novel dialytic technique that uses biocompatible bicarbonate-based dialysate to achieve excellent clearance of uremic toxins and ultrafiltration with minimal glucose load.

L-Carnitine supplementation combined with aerobic training does not promote weight loss in moderately obese women.

L-Carnitine (L-C) transports fatty acids into mitochondria for oxidation and is marketed as a weight loss supplement. In a double-blind investigation to test the weight loss efficacy of L-C, 36 moderately overweight premenopausal women were pair matched on Body Mass Index (BMI) and randomly assigned to two groups (N = 18). For 8 weeks the L-C group ingested 2 g twice daily of L-C, while the placebo (P) group ingested the same amount of lactose. All subjects walked for 30 min (60-70% maximum heart rate) 4 days/week. Body composition, resting energy expenditure (REE) and substrate utilization were estimated before and after treatment. For the subjects who completed the study (15 P, 13 L-C), no significant changes in mean total body mass (TBM), fat mass FM, and resting lipid utilization occurred over time, nor were there any significant differences between groups for any variable. Conversely REE increased significantly for all subjects, but no between group differences existed. Five of the L-C group experienced nausea or diarrhea and consequently did not complete the study. Eight weeks of L-C ingestion and walking did not significantly alter the TBM or FM of overweight women, thereby casting doubt on the efficacy of L-C supplementation for weight loss.

Nucleic acid immunization protects dogs against challenge with virulent canine parvovirus.

Nucleic acid vaccines (NAVs) use expression vectors encoding one or more antigen genes to transfect host cells inducing both humoral and cellular immunity against the expressed antigen. NAV offers major advantages over conventional vaccines for the protection of humans and animals. This study shows that a plasmid DNA (pGT36VP1) encoding the full length VP1 region of canine parvovirus (CPV) induces immunity that protects dogs against challenge with virulent virus. Five dogs without anti-CPV antibodies were injected at 9 months of age with increasing doses of pGT36VP1 or saline. NAV vaccinated dogs showed an increase of serum IgG titer starting 1 week post-injection which peaked at week 2 and remained detectable for at least 14 weeks. A second dose of NAV resulted in an anamnestic response within 1 week. IgG titers peaked at week 3 and 4 after the second injection. All pGT36VP1 vaccinated dogs were protected against infection after virulent CPV challenge regardless of dose and the unvaccinated control dog was fully susceptible. This study demonstrated for the first time that a NAV can protect dogs against an infectious disease.

Pilot study to enhance start-up of a multicenter nutrition intervention trial.

Multicenter trials are important for answering questions that require large numbers of subjects. Such trials require standardized implementation of behavioral change programs across diverse populations, regions, and staff. Researchers involved with the Trial of Nonpharmacologic Interventions in the Elderly conducted a 17-week pilot study of their most complex intervention (combined weight and sodium reduction) before actual start-up of the main study. This allowed staff to rehearse implementing the program and to identify and address intervention and standardization issues. Registered dietitians in 4 US communities recruited 28 participants for the pilot study, using eligibility criteria similar to those for the main trial. Participant evaluations reflected high satisfaction with the program materials and overall approach. Minor protocol changes suggested by results of the pilot study were made easily in time for start-up of the main study. Reductions in weight and sodium intake were less than targeted but were sufficient to suggest that the intervention would be effective under optimal conditions. This partial achievement of goals in the pilot study underscored the need to allow for a learning curve, for without it standardization and outcomes of the main study would be compromised.

Cardiovascular autonomic dysfunction: diagnosis and prognosis.

The symptoms of cardiovascular autonomic dysfunction may be subtle and occur late in the course of diabetes. They include abnormal exercise-induced cardiovascular performance, postural hypotension, and cardiac denervation syndrome. Autonomic nervous system testing involves an evaluation of the responses of complex reflex pathways. Some of the most commonly used and validated cardiovascular autonomic tests are RR-variation, the Valsalva manoeuvre, and postural testing. Sinus arrhythmia during breathing is termed RR-variation. In diabetic patients with autonomic neuropathy the magnitude of the RR-variation is decreased. Abnormal exercise-induced cardiovascular performance has been observed in diabetic subjects with abnormal RR-variation due to autonomic neuropathy. The Valsalva manoeuvre consists of forced expiration against a standardized resistance for a specified period of time. The reflex bradycardia that follows the Valsalva period in normal subjects is lacking in diabetic patients with clinical evidence of autonomic neuropathy. Postural hypotension in diabetics may be due to neuropathy or to a variety of secondary causes. An algorithm is presented to facilitate assessment of diabetic patients with postural symptoms. Treatment of postural hypotension should be directed primarily to the correction of secondary causes, in the absence of which the symptoms can be controlled by mechanical measures, plasma volume expansion, and vasoconstriction. Cardiac denervation syndrome may result in denervation supersensitivity and afferent (pain) nerve dysfunction. The RR-variation is a sensitive indicator of impairment of cardiac autonomic innervation and is a simple method for identifying asymptomatic patients at risk for painless ischaemia. Formal cardiovascular stress testing may be prudent before initiating an exercise programme in such individuals.

Noneffect of rifampin on theophylline disposition in rabbits.

The pharmacokinetic disposition of theophylline after a single 10mg/kg intravenous dose of aminophylline was evaluated in six rabbits. Three then received rifampin (50mg/kg) a day for 14 days and the disposition of theophylline was re-evaluated in all six rabbits after another 10mg/kg aminophylline dose. The mean theophylline half life before rifampin treatment of 5.11 +/- 0.71 hrs was not different (p greater than 0.10) from the half life of 4.54 +/- 0.71 hrs after treatment with rifampin. In the non-rifampin treated rabbits, the initial mean theophylline half life of 4.78 +/- 1.05 was not different p greater than 0.80) from the half life of 4.94 +/- 1.92 hrs after fourteen days. No significant alterations in clearance or area under the curve were noted for either group. Power analysis indicated that three rabbits were sufficient to detect at least a 25% change in the parameters as being significant (p less than 0.05).

Thyroid function in patients with breast cancer.

Thyroid function has been assessed in 40 patients with breast cancer and compared with an age-matched control female population. The free thyroxine index was lower and the level of thyroid-stimulating hormone in the serum higher in the cancer group and these changes became more marked at 6 months. It is concluded that patients with breast cancer show more evidence of hypothyroidism as time progresses.

Thyrotoxicosis: relations between clinical state and biochemical changes during carbimazole treatment.

The relation between clinical and biochemical changes in thyrotoxicosis were studied in 12 patients with Graves's disease who were being treated with carbimazole. Clinical assessment (using the Crooks-Wayne index) was combined with the measurement of free thyroxine and triiodothyronine indices (FT4I and FT3I) and the assessment of two tissue markers of thyroid hormone action--sex-hormone-binding globulin (SHBG) levels and the thyrotrophin responses to TRH. In general the FT4I and FT3I fell rapidly once treatment was started, and returned to normal in one to four weeks, followed shortly by SHBG levels. The thyrotrophin response returned at this time in two patients, who still had borderline high levels of FT3I and SHBG. The clinical score fell more slowly and variably and was less closely related to any of the biochemical indices than these were to each other. During the early phase of treatment with antithyroid drug the clinical evaluation may be an unreliable indicator of persisting thyroid hormone excess, and when the patient seems clinically but not biochemically thyrotoxic the symptoms should be treated on their own merits with beta-blocking drugs and not with increased doses of antithyroid drugs.