Gastrointestinal symptom severity in irritable bowel syndrome, inflammatory bowel disease and the general population.

BACKGROUND: Irritable bowel syndrome (IBS) and inflammatory bowel disease (IBD) patients report similar gastrointestinal (GI) symptoms, yet comparisons of symptom severity between groups and with the general population (GP) are lacking. METHODS: We compared Patient-Reported Outcomes Measurement Information System (PROMIS® ) GI symptom scales measuring gastro-esophageal reflux (GER), disrupted swallowing, diarrhea, bowel incontinence, nausea/vomiting, constipation, belly pain, and gas/bloating in: (i) USA GP sample, (ii) IBS patients, and (iii) IBD patients from tertiary care and community populations. Symptom severity scores were based on T-score metric with mean 50±10 (standard deviation) relative to the GP. KEY RESULTS: Of 1643 patients enrolled, there were 253 IBS patients (68% F, mean age 45±15 years), 213 IBD patients (46% F, mean age 41±14 years), and 1177 GP subjects (57% F, mean age 46±16 years). IBS patients reported greater severity of GER, disrupted swallowing, nausea/vomiting, belly pain, gas/bloating, and constipation symptoms than their IBD counterparts (all P<.05). Compared to the GP, IBD patients had worse belly pain, gas/bloating, diarrhea, and bowel incontinence, but less severe GER and disrupted swallowing (all P<.05), and IBS patients had more severe nausea/vomiting, belly pain, gas/bloating, and constipation (all P<.05). Women had more severe belly pain and gas/bloating than men, whereas men had more severe bowel incontinence (all P<.05). CONCLUSION & INFERENCES: IBS and IBD are associated with more severe GI symptoms compared to the GP excluding esophageal symptoms. Unlike IBD, IBS is not characterized by observable GI inflammation but patients report more severe upper and lower GI symptoms.

Randomised clinical trial: symptoms of the irritable bowel syndrome are improved by a psycho-education group intervention.

BACKGROUND: Evidence supports the effectiveness of cognitive behavioural approaches in improving the symptoms of the irritable bowel syndrome (IBS). Duration, cost and resistance of many patients towards a psychological therapy have limited their acceptance. AIM: To evaluate the effectiveness of a psycho-educational intervention on IBS symptoms. METHODS: Sixty-nine IBS patients (72% female) were randomised to an intervention or a wait-list control group. The IBS class consisted of education on a biological mind body disease model emphasising self-efficacy and practical relaxation techniques. RESULTS: Patients in the intervention showed significant improvement on GI symptom severity, visceral sensitivity, depression and QoL postintervention and most of these gains were maintained at 3-month follow-up (Hedge's g = -0.46-0.77). Moderated mediation analyses indicated change in anxiety, visceral sensitivity, QoL and catastrophising due to the intervention had moderate mediation effects (Hedge's g = -0.38 to -0.60) on improvements in GI symptom severity for patients entering the trial with low to average QoL. Also, change in GI symptom severity due to the intervention had moderate mediation effects on improvements in QoL especially in patients with low to average levels of QoL at baseline. Moderated mediation analyses indicated mediation was less effective for patients entering the intervention with high QoL. CONCLUSIONS: A brief psycho-educational group intervention is efficacious in changing cognitions and fears about the symptoms of the irritable bowel syndrome, and these changes are associated with clinically meaningful improvement in symptoms and quality of life. The intervention seems particularly tailored to patients with low to moderate quality of life baseline levels.

Influence of signalment on developing cranial cruciate rupture in dogs in the UK.

OBJECTIVES: To investigate risk factors associated with cranial cruciate ligament rupture in dogs. METHODS: Retrospective case-control study: medical records of a first-opinion veterinary practice were searched for dogs diagnosed with cranial cruciate ligament rupture (1995 to 2007). For each case, six unaffected dogs were randomly selected from all dogs presenting that day for comparison. Multi-variable binary logistic regression was performed to assess the association of variables on likelihood of cruciate rupture. RESULTS: Frequency of cranial cruciate ligament rupture was 1·19% [95% confidence interval (CI) 1·02 to 1.36%]. West Highland white terriers (n=17), Yorkshire terriers (n=14) and Rottweilers (n=11) were at significantly increased risk of cranial cruciate ligament rupture (P≤0·002). Rottweilers were at five times greater risk compared with other pure breeds (OR 5·12, 95% CI 2·281 to 11·494, P<0·001), obesity quadrupled the risk of cranial cruciate ligament rupture (OR 3·756, 95% CI 1·659 to 8·502, P=0·001) and females were twice as likely to suffer cranial cruciate ligament failure compared to males (OR 2·054, 95% CI 1·467 to 2·877, P<0·001). Dogs less than two years old were statistically less likely to sustain cranial cruciate ligament rupture than dogs older than eight years (OR 0·246, 95% CI 0·127 to 0·477, P<0·001). There was no significant difference in median weights (in kilograms) of neutered dogs, compared to their entire counterparts in either the case group (P=0·994) or in the control group (P=0·630). There was also no significant difference in body condition (-underweight/normal weight/overweight/obese) of neutered versus entire dogs among the cases (P=0·243), or the controls (P=0·211). CLINICAL SIGNIFICANCE: Cranial cruciate ligament rupture is more likely in Rottweilers and in female dogs, older dogs and obese dogs. Following multi-variable analysis, it was established that neutering was not associated with increased risk of cranial cruciate ligament rupture.

Measuring symptoms in the irritable bowel syndrome: development of a framework for clinical trials.

BACKGROUND: There is uncertainty about how to measure patient-reported outcomes (PROs) in IBS. The Food and Drug Administration (FDA) emphasizes that PROs must be couched in a conceptual framework, yet existing IBS PROs were not based on such a framework. AIM: To perform qualitative analyses to inform a new conceptual framework for IBS symptoms. METHODS: Following FDA guidance, we searched the literature for extant IBS questionnaires. We then performed interviews in IBS patients to learn about the illness experience in their own words. We cultivated vocabulary to inform a conceptual framework depicted with domains, sub-domains, and item categories, per FDA guidance. RESULTS: We identified 13 questionnaires with items encompassing 18 symptoms. We recruited 123 IBS patients for cognitive interviews. Major themes included: pain and discomfort are different - asking about discomfort is nonspecific and should be avoided in future PROs; bowel urgency is multifaceted - PROs should measure bowel immediacy, controllability, and predictability; and PROs should divide bloating into how it feels vs. how it looks. Symptom experience may be determined by 35-item categories within five domains: (i) pain; (ii) gas/bloat; (iii) diarrhoea; (iv) constipation; and (v) extraintestinal symptoms. CONCLUSIONS: We applied FDA guidance to develop a framework that can serve as the foundation for developing a PRO for IBS clinical trials.

Characterizing abdominal pain in IBS: guidance for study inclusion criteria, outcome measurement and clinical practice.

BACKGROUND: Although irritable bowel syndrome (IBS) is a multisymptom disorder, abdominal pain drives illness severity more than other symptoms. Despite consensus that IBS trials should measure pain to define study entry and determine efficacy, the optimal method of measuring pain remains uncertain. AIM: To determine whether combining information from multiple pain dimensions may capture the IBS illness experience more effectively than the approach of measuring 'pain predominance' or pain intensity alone. METHODS: Irritable bowel syndrome patients rated dimensions of pain, including intensity, frequency, constancy, predominance, predictability, duration, speed of onset and relationship to bowel movements. We evaluated the impact of each dimension on illness severity using multivariable regression techniques. RESULTS: Among the pain dimensions, intensity, frequency, constancy and predictability were strongly and independently associated with illness severity; the other dimensions had weaker associations. The clinical definition of 'pain predominance', in which patients define pain as their most bothersome symptom, was insufficient to categorize patients by illness severity. CONCLUSIONS: Irritable bowel disease pain is multifaceted; some pain dimensions drive illness more than others. IBS trials should measure various pain dimensions, including intensity, constancy, frequency and predictability; this may improve upon the customary use of measuring pain as a unidimensional symptom in IBS.

Measuring irritable bowel syndrome patient-reported outcomes with an abdominal pain numeric rating scale.

BACKGROUND: Controversy exists on how to measure patient-reported outcomes in irritable bowel syndrome (IBS) clinical trials effectively. Pain numeric rating scales (NRS) are widely used in the non-IBS pain literature. The Food and Drug Administration has proposed using the NRS in IBS. AIM: To test the psychometrics of an abdominal pain NRS in IBS. Methods We analysed data from a longitudinal cohort of Rome III IBS subjects. At entry, subjects completed a 10-point NRS, bowel symptoms, IBS severity measurements (IBS-SSS, FBDSI), health-related quality of life indices (IBS-QOL, EQ5D), and the Worker Productivity Activity Index (WPAI). We repeated assessments at 3 months along with a response scale to calculate the minimal clinically important difference. RESULTS: There were 277 subjects (82% women; age = 42 +/- 15) at baseline and 90 at 3 months. The NRS correlated cross-sectionally with IBS-SSS (r = 0.60; P < 0.0011), FBDSI (r = 0.49; P < 0.0001), IBS-QOL (r = 0.43; P < 0.0001), EQ5D (r = 0.48; P < 0.0001), presenteeism (r = 0.39; P < 0.0001), absenteeism (r = 0.17; P = 0.04) and distension (r = 0.46; P < 0.0001), but not stool frequency or form. The minimal clinically important difference was 2.2 points, correlating with a 29.5% reduction over time. CONCLUSIONS: An abdominal pain NRS exhibits excellent validity and can be readily interpreted with a minimal clinically important difference in patients with IBS. These data support the use of the NRS in IBS clinical trials.

Prospective validation of the short form liver disease quality of life instrument.

BACKGROUND: Despite the realization that health-related quality of life (HRQOL) is an important outcome in patients with liver disease, there is scarcity of disease-targeted HRQOL measures that have undergone prospective evaluation. AIM: To validate prospectively the short form of liver disease quality of life instrument (the SF-LDQOL) in patients with advanced liver disease. METHODS: The SF-LDQOL includes 36 disease-targeted items representing nine domains: symptoms of liver disease, effects of liver disease, memory/concentration, sleep, hopelessness, distress, loneliness, stigma of liver disease and sexual problems. We administered the SF-LDQOL to 156 advanced liver disease patients at baseline and at 6-month follow-up. We estimated internal consistency reliability for multi-item scales, item discrimination across scale and evaluated construct validity by estimating the associations of SF-LDQOL scores with SF-36 scores, symptom severity and disability days. To evaluate the SF-LDQOL's responsiveness, we compared HRQOL changes for patients who received with those who did not receive liver transplantation (LT). RESULTS: The internal consistency reliability coefficients were > or = 0.70 for seven of nine scales in baseline and for all scales in follow-up administration. The SF-LDQOL correlated highly with SF-36 scores, symptom severity, disability days and global health. Patients undergoing LT reported improved HRQOL compared with patients without LT and the responsiveness indices were excellent. CONCLUSIONS: This study provides support for the reliability and validity of the SF-LDQOL in patients with advanced chronic liver disease. This instrument may be useful in everyday clinical practice and in future clinical trials.

The Visceral Sensitivity Index: development and validation of a gastrointestinal symptom-specific anxiety scale.

BACKGROUND: Anxiety related to gastrointestinal sensations, symptoms or the contexts in which these may occur is thought to play a significant role in the pathophysiology as well as in the health outcomes of patients with irritable bowel syndrome. AIM: To develop a valid and reliable psychometric instrument that measures gastrointestinal symptom-specific anxiety. METHODS: External and internal expert panels as well as a patient focus group evaluated a large pool of potential item stems gathered from the psychological and gastrointestinal literature. Potential scale items were then administered to 96 patients diagnosed with irritable bowel syndrome along with a set of validating questionnaires. Final item selection was based upon rigorous empirical criteria and the psychometric properties of the final scale were examined. RESULTS: A final unidimensional 15-item scale, the Visceral Sensitivity Index, demonstrated excellent reliability as well as good content, convergent, divergent and predictive validity. CONCLUSIONS: The findings suggest that the Visceral Sensitivity Index is a reliable, valid measure of gastrointestinal symptom-specific anxiety that may be useful for clinical assessment, treatment outcome studies, and mechanistic studies of the role of symptom-related anxiety in patients with irritable bowel syndrome.

Do older internists use more hospital resources than younger internists for patients hospitalized with chest pain? A study of patients hospitalized in the coronary care and intermediate care units.

OBJECTIVES: Recent concern about escalating healthcare expenditures has prompted healthcare payers and hospitals to identify physicians whose hospital resource consumption exceeds expected norms. The goals of this study were to determine whether analyses of practice patterns in this manner may a) systematically identify older physicians as big resource "spenders," and b) provide misleading information caused by the failure to adjust utilization data for severity of illness. DESIGN: A prospective, observational study. SETTING: The coronary care and intermediate care unit in an 1,100-bed community hospital. PATIENTS: A total of 217 patients hospitalized for chest pain cared for by noncardiologists. INTERVENTIONS: None. MEASUREMENTS AND MAIN RESULTS: On initial inspection, it appeared that the patients of older physicians had longer lengths of stay and greater charge expenditures than the patients of younger physicians. However, further evaluation demonstrated that older physicians cared for older (76 vs. 67 yrs old, p = .0001) and more severely ill patients (judged by risk of complications, risk of acute ischemic heart disease, and disease staging). Older physicians cared for more severely ill myocardial infarction patients than did younger physicians (Killip Classification 2.0 vs. 1.1, p less than .00003). After adjusting for severity of illness, there were fewer differences in hospital charges and consultant use between older and younger physicians, although the patients of older physicians remained hospitalized longer. CONCLUSIONS: There is little difference in resource utilization between patients cared for by older and younger internists after controlling for severity of illness. This investigation highlights the potential hazards of ignoring severity of illness when judging physician efficiency in the coronary care unit.

The principle of parsimony: Glasgow Coma Scale score predicts mortality as well as the APACHE II score for stroke patients.

Although the development and use of severity-of-illness measures has gained widespread enthusiasm, uncertainty remains as to the optimal measure for stroke patients. The Health Care Financing Administration recently derived a severity-of-illness measure based on the APACHE II system to explain differences in Medicare mortality rates among hospitals treating stroke patients. We hypothesized that the Glasgow Coma Scale score provides prognostic information of accuracy comparable to that of the APACHE II score for stroke patients, yet is simpler and cheaper to abstract from the medical record. We therefore studied 246 patients hospitalized with stroke, including 49 oversampled mortalities. The Glasgow Coma Scale score was as accurate as the APACHE II score in predicting stroke mortality both before (r = -0.50 and r = 0.50, respectively) and after (r = -0.40 and r = 0.38, respectively) the oversampled mortalities were excluded. The APACHE II score required abstraction of 16 variables from the medical record compared with three for the Glasgow Coma Scale score and required more than three times the time to abstract from the medical record. Therefore, in the interest of parsimonious data collection, the Glasgow Coma Scale may be a preferable severity-of-illness measure for patients with stroke.

Early "step-down" transfer of low-risk patients with chest pain. A controlled interventional trial.

OBJECTIVE: To determine whether providing private practitioners with triage criteria for their low-risk chest pain patients would safely enhance bed utilization efficiency in coronary and intermediate care units. DESIGN: Prospective, controlled, interventional trial using an alternate month study design. SETTING: A large teaching community hospital. PATIENTS: Cohort of 404 low-risk patients with chest pain for whom a diagnosis of myocardial infarction has been excluded and who have not sustained complications, required interventions, or developed unstable comorbidity. INTERVENTIONS: During intervention months, private practitioners caring for low-risk patients in the coronary and intermediate care units were contacted 24 hours after admission. Physicians were informed that the transfer of low-risk patients to nonmonitored beds could probably be done safely, based on the results of a pilot study. The practitioner had the option of agreeing to or deferring patient transfer. During control months, physicians were not contacted in this way. MEASUREMENTS AND MAIN RESULTS: Use of the triage criteria by private practitioners reduced lengths of stay in the intermediate and coronary care units by 36% and 53%, respectively. Bed availability increased by 744 intermediate and 372 coronary care unit bed-days per year. Charges decreased by $2.6 million per year and profits improved by $390,000 per year. There were not significant differences in complications between control and intervention patients and in no case (95% CI, 0% to 1.6%) did the triage criteria adversely affect quality of care. CONCLUSIONS: The early transfer triage criteria may be a safe and efficacious decision aid for improving bed utilization in intermediate and coronary care units. In addition, this study shows the feasibility of and potential benefits from applying practice guidelines at a community hospital.

Breast feeding and jaundice in the first week of life.

Infants who most commonly receive treatment for neonatal hyperbilirubinemia are breast-fed babies in whom no cause for the jaundice can be determined. Hyperbilirubinemia in these newborns may not be caused by the breast feeding as such, but rather by inadequate nursing. This paper reports attempts to decrease readmissions for phototherapy at the UCLA Medical Center by inducing earlier and more functional lactation in the entire nursery population and by formula feeding infants whose bilirubins approached recommended treatment levels. Nursing was interrupted for 24 to 48 hours in 87 newborns; six still required readmission, while 81 were successfully treated at home. At the two-week well-baby visit, no differences in the incidence of breast feeding were found when comparing nonjaundiced breast-fed babies with infants who were taken off the breast or who were readmitted for phototherapy. Differences in the cost of care were significant with an average cost per patient of $126 for those treated at home compared with $1,440 for those readmitted. Policies designed to induce earlier lactation did nothing to decrease the incidence of exaggerated jaundice in the study's breast-fed population. It was concluded that supervised setting with careful counseling and follow-up, can provide an effective alternative to readmission and phototherapy in the treatment of jaundice.

Temperature and fever in the full-term newborn.

In order to establish temperature norms during the first nine days of life, a retrospective analysis of 501 neonates was completed. After norms were derived, charts of all infants born at the UCLA Medical Center in 1979 were reviewed. Data were analyzed on every infant who had a recorded temperature greater than two standard deviations above the mean high. Sustained fever was unusual but highly predictive of infection. Infants rarely had fever, however, as the only sign of infection. Single elevated temperature readings were not associated with infection.

Jaundice in the full-term neonate.

Hyperbilirubinemia is the most common problem experienced by the full-term infant in the immediate neonatal period. The development of jaundice was prospectively investigated in 866 newborns. Significant correlations were found between the serum bilirubin level and the method of birth, perinatal complications, blood group incompatibilities, birth weight, and method of feeding. Breast-feeding was highly related to the development of exaggerated jaundice. The most common occurrence of jaundice requiring phototherapy was in breast-feeding infants in whom no cause for the jaundice could be determined. Study findings were most compatible with a theory of relative caloric deprivation as an explanation of the increased incidence of hyperbilirubinemia found in breast-fed newborns.

Interaction of life events and symptoms in psychiatric patient and nonpatient married couples.

Many studies have related life events to various symptoms, but there has been little effort to examine how life events and symptoms experienced by a spouse might contribute to health change in the partner. On 3 bimonthly occasions, 115 husbands and wives completed the Schedule of Recent Experiences and a Symptom Checklist. In 40 of the couples, husbands were psychiatric outpatients, and in 75 they were nonpatients. Among nonpatient couples, symptoms in either partner were significantly predicted by the level of each one's own life events (especially undesirable events) and by the levels of symptoms in the spouse during the preceding 2 months. Among couples in which the husband was a patient, the most important predictor of symptoms in either spouse was that person's self-report of life events. Future research on the social origins of psychiatric symptoms should consider the possible contributions of a spouse's symptom state to the health of the individual under study.