Search PubMed⌕ Search

Biomedical subjects

E J Irvine

Publications and source records attributed to E J Irvine.

At least 37 records · Page 2Linked to original sources
PubMed1999

Development and subsequent refinement of the inflammatory bowel disease questionnaire: a quality-of-life instrument for adult patients with inflammatory bowel disease.

BACKGROUND: Health-related quality of life (HRQOL) describes the physical, social, and emotional attitudes and behavior of people in relation to health status. By the 1980s, HRQOL was noted to be impaired in chronic diseases but inflammatory bowel disease, had not been extensively described. METHODS: This review summarizes the results of several studies describing the development and application of a disease-specific HRQOL instrument, the Inflammatory Bowel Disease Questionnaire (IBDQ). RESULTS: An initial study described how patients with inflammatory bowel disease identified 150 problems they had experienced in four domains: bowel, systemic, emotional, and social function. Almost half of patients underreported impairment until encouraged by a reminder list. Thirty-two questions were included in the final questionnaire and were scored on a 7-point scale from I (worst) to 7 (best) for a range of possible scores from 32 to 224. Physicians' and spouses' global assessments correlated poorly with patient-reported HRQOL. Subsequent validation of the IBDQ suggested a strong correlation with disease severity (r = -0.5; p < 0.001) and a test-retest reliability of 0.7. Mean score changes of 16 to 30 points have been linked to changes in therapy. Statistically significant differences also occur between active and inactive disease. Results of four clinical trials have included the IBDQ as a measure of outcome. A self-administered version and a shortened version of the IBDQ have also been validated. CONCLUSIONS: The IBDQ is a valid, reliable, and sensitive measure that can be meaningfully applied in clinical trials. The short IBDQ may also be useful in clinical research and office practice.

Adult↗
PubMed1999

Functional bowel disorders and functional abdominal pain.

The Rome diagnostic criteria for the functional bowel disorders and functional abdominal pain are used widely in research and practice. A committee consensus approach, including criticism from multinational expert reviewers, was used to revise the diagnostic criteria and update diagnosis and treatment recommendations, based on research results. The terminology was clarified and the diagnostic criteria and management recommendations were revised. A functional bowel disorder (FBD) is diagnosed by characteristic symptoms for at least 12 weeks during the preceding 12 months in the absence of a structural or biochemical explanation. The irritable bowel syndrome, functional abdominal bloating, functional constipation, and functional diarrhea are distinguished by symptom-based diagnostic criteria. Unspecified FBD lacks criteria for the other FBDs. Diagnostic testing is individualized, depending on patient age, primary symptom characteristics, and other clinical and laboratory features. Functional abdominal pain (FAP) is defined as either the FAP syndrome, which requires at least six months of pain with poor relation to gut function and loss of daily activities, or unspecified FAP, which lacks criteria for the FAP syndrome. An organic cause for the pain must be excluded, but aspects of the patient's pain behavior are of primary importance. Treatment of the FBDs relies upon confident diagnosis, explanation, and reassurance. Diet alteration, drug treatment, and psychotherapy may be beneficial, depending on the symptoms and psychological features.

Abdominal Pain↗
PubMed1998

Development of a questionnaire to measure quality of life in patients with irritable bowel syndrome.

OBJECTIVE: To develop a questionnaire for measuring health-related quality of life (HRQL) in patients with Irritable Bowel Syndrome (IBS). METHODS: We surveyed the existing literature, and interviewed patients and clinicians, to develop a list of 182 potential problems for IBS patients. One hundred patients with IBS completed a questionnaire in which they told us whether each of the 182 items was a problem for them, and if so the magnitude of their importance in their lives. RESULTS: Patients identified four major problem areas: bowel symptoms, fatigue, activity limitations, and emotional dysfunction. On the basis of these findings, we constructed a 26-item questionnaire which, in pre-testing, 16 patients found clear and easy to complete. CONCLUSION: We have developed a questionnaire that measures HRQL in IBS patients and is suitable for use as an outcome measure in clinical trials in IBS.

Activities of Daily Living↗
PubMed1998

Terminal ileal imaging with ileoscopy versus small-bowel meal with pneumocolon.

Disease of the terminal ileum can be diagnosed by ileocolonoscopy or barium radiography. We compared the diagnostic accuracy in the terminal ileum of ileocolonoscopy and small-bowel meal with pneumocolon. Consecutive patients during an 18-month period who had both ileocolonoscopy and small bowel meal with pneumocolon were identified and their colonoscopy reports, radiographs, and ileal biopsies reviewed blindly by paired gastroenterologists, radiologists, and pathologists, respectively. A gold-standard diagnosis was determined for each patient by consensus. Of 48 study subjects, 14 (29.2%) had Crohn's disease, 5 (10.4%) had lymphoid nodular hyperplasia, and 29 (60.4%) were normal. The sensitivity for a diagnosis of Crohn's ileitis was 92.9% for ileocolonoscopy and 100% for small-bowel meal, while their specificities were 100% and 97.1% respectively. The gold standard diagnosis confirmed ileocolonoscopic findings in 45 patients (93.8%) and radiographic findings in 42 patients (87.5%). Agreement between ileocolonoscopy and small bowel meal occurred in 39 cases (81.2%). By combining histology with ileocolonoscopy, the sensitivity and specificity could be increased to 100% for all diagnoses. Ileocolonoscopy and small-bowel meal with pneumocolon are complementary techniques for imaging the terminal ileum. A prospective comparative trial is now needed to more objectively assess their accuracy, cost effectiveness, and adverse effects.

Adolescent↗
PubMed1997

Rectal corticosteroids versus alternative treatments in ulcerative colitis: a meta-analysis.

BACKGROUND: Clear strategies to optimise the use of corticosteroids in ulcerative colitis are lacking. AIM: A meta-analysis was undertaken to examine critically the role of rectal corticosteroids in the management of active distal ulcerative colitis. METHODS: All reported randomised controlled trials were retrieved by searching the Medline and EMBASE databases and the bibliographies of relevant studies. Trials which met inclusion criteria were assessed for scientific rigour. Data were extracted by two independent observers according to predetermined criteria. RESULTS: Of 83 trials retrieved, 33 met inclusion criteria. Pooled odds ratios (POR) showed conventional rectal corticosteroids and rectal budesonide to be clearly superior to placebo. In seven trials, rectal 5-aminosalicylic acid (5-ASA) was significantly better than conventional rectal corticosteroids for inducing remission of symptoms, endoscopy, and histology with POR of 2.42 (95% confidence interval (CI) 1.72-3.41), 1.89 (95% CI 1.29-2.76), and 2.03 (95% CI 1.28-3.20), respectively. Rectal budesonide was of comparable efficacy to conventional corticosteroids but produced less endogenous cortisol suppression. Side effects, although inconsistently reported, were generally minor. A cost comparison of rectal preparations showed 5-ASA to be less expensive than corticosteroids. CONCLUSIONS: Rectal 5-ASA is superior to rectal corticosteroids in the management of distal ulcerative colitis.

Administration, Oral↗
PubMed1997

Successful therapy of refractory erythema nodosum associated with Crohn's disease using potassium iodide.

Erythema nodosum is a common extraintestinal manifestation of Crohn's disease. While mild skin involvement often responds to conservative management, severe or refractory cases may require systemic corticosteroid or immunosuppressive therapy. This report describes successful treatment of severe, refractory erythema nodosum associated with Crohn's colitis using oral potassium iodide. While the mechanism of action of this agent is poorly understood, it appears to be an effective and nontoxic therapy for Crohn's-related erythema nodosum and warrants further evaluation in a placebo controlled trial.

Administration, Oral↗
PubMed1997

Quality of life issues in patients with inflammatory bowel disease.

The assessment of health-related quality of life (HRQOL) plays an increasingly important role in the evaluation of therapeutic interventions in various chronic diseases, including inflammatory bowel disease (IBD). There are three main types of HRQOL instruments, each of which have specific strengths and limitations. Global assessments provide a general impression of the patient's HRQOL, but they do not identify specific domains of dysfunction. Generic instruments can be used to show similarities or differences among groups or populations, but they may not be sensitive to changes over time or after treatment in groups of patients with specific diseases. Disease-specific instruments, which are derived from and validated in particular disease groups, are the most sensitive indicators of change in HRQOL over time or with treatment. There are several potential sources of bias in HRQOL measurement, and certain instruments are more or less sensitive and reliable than others in detecting impaired function in patients with IBD. Despite differences between studies regarding specific HRQOL findings, as a group, these assessments confirm that HRQOL can be impaired significantly in patients with IBD. Reliable validated HRQOL instruments should be applied with the same methodological rigor as other assessments in clinical trials of different therapeutic strategies for patients with IBD.

Humans↗
PubMed1996

Does self-administration of a quality of life index for inflammatory bowel disease change the results?

We assessed the effect of self-administration of a disease-specific health-related quality of life instrument, the Inflammatory Bowel Disease Questionnaire (IBDQ), on score results. Patients were assessed at two visits in two tertiary centers. "Experienced" patients (N = 31) with Crohn's disease had previously completed the IBDQ several times while "novices" (N = 37) with Crohn's disease or ulcerative colitis had no prior exposure to the IBDQ. At each visit a self-administered IBDQ followed by a nurse-administered IBDQ (score range, 1-7; absolute score range, 32-224) and disease activity were assessed. At visit 1, the mean rates of discrepant responses between nurse and self-administered scores were 24 +/- 15% in experienced patients and 34 +/- 17% in novice patients (p = 0.018), which fell to 21 +/- 16 and 23 +/- 10%, respectively, by visit 2 (p = NS). However, discrepancy rates were not significantly different between novice and experienced patients when adjusted by center. Discrepancies occurred randomly in all 32 IBDQ items. Eighty percent of all discrepant responses differed by only one grade of a seven-point Likert scale. Baseline self-administered scores for all patients were 4.80 +/- 1.24 (absolute score, 153.0 +/- 39.9). Mean score differences at each visit (nurse minus self) were very small, ranging from 0.029 to 0.136, and would not be considered clinically important. Intraclass correlation coefficients between the nurse and self-administered IBDQ and the four dimensional scores were > or = 0.97 by visit 2, indicating excellent concordance and minimal observer error. Mean changes in score over time were of comparable magnitude for both self (0.320 +/- 0.819) and nurse (0.260 +/- 0.831) assessments. We conclude that the IBDQ may be reliably used as a self-administered instrument in clinical trials.

Adult↗
PubMed1996

Measuring quality of life: a review.

Measuring health-related Quality of Life (HRQOL) is becoming increasingly sophisticated as the number of available instruments and potential applications increases. Global, generic and disease-specific HRQOL instruments may be used alone or in combination and each type has advantages and disadvantages. As with any set of observations, the results of HRQOL assessment must be carefully interpreted with the knowledge and consideration of the setting as well as the potential effects of extraneous factors. Application of HRQOL is not meant to stand on its own or to replace other parameters of disease outcome but to complement what is available in the hope of generally improving medical care.

Gastrointestinal Diseases↗
PubMed1996

Quality of life in inflammatory bowel disease and other chronic diseases.

Health-related Quality of Life (HRQOL) status is a meaningful part of assessing the impact of disease in patients with chronic bowel disorders. It is influenced by the clinical condition but also by environmental and patient-related factors. This manuscript will highlight how HRQOL measurement can be used in chronic bowel disorders, using examples in inflammatory bowel disease, and how different types of instruments or study design may change the picture of health status.

Chronic Disease↗
PubMed1996

The Short Inflammatory Bowel Disease Questionnaire: a quality of life instrument for community physicians managing inflammatory bowel disease. CCRPT Investigators. Canadian Crohn's Relapse Prevention Trial.

OBJECTIVE: Health-related quality of life (HRQOL) affects outcome in chronic diseases such as inflammatory bowel disease (IBD). The inflammatory bowel disease questionnaire (IBDQ), a disease-specific HRQOL questionnaire, can define changes in health status in IBD, but simple instruments are needed for daily application. The present study proposed to develop a short version of the IBDQ, the SIBDQ, for community physicians. METHODS: Using data from a clinical trial in 149 patients with Crohn's disease, 10 items were selected (by forward stepwise regression) that best explained the variance of the IBDQ or dimensional scores (bowel, systemic, social, emotional). The validity, reliability, and responsiveness of the SIBDQ were then assessed in 150 different patients with Crohn's disease and 45 with ulcerative colitis. All scores were reported with a 7-point scale (1 = poor HRQOL, 7 = optimum HRQOL). RESULTS: Mean SIBDQ scores were similar (p = 0.22) in Crohn's patients among 14 participating centers at study entry. Mean scores were lower in active Crohn's disease (range 4.00-4.92) than inactive disease (range 4.67-5.83; p = 0.0015). In active ulcerative colitis, the mean SIBDQ was 4.79 +/- 1.17 compared to 5.90 +/- 0.80 (p = 0.0006) in inactive disease. The SIBDQ explained 92% and 90% of the IBDQ variance in Crohn's disease and ulcerative colitis, respectively. In patients with stable Crohn's disease, the test-retest reliability coefficient was 0.65 and Crohnbach's alpha was 0.78, indicating good reliability. In patients with Crohn's disease who relapsed during follow-up, the mean SIBDQ decreased by -0.93 + 0.55 (p = 0.001). CONCLUSION: The SIBDQ is valid, reliable, and able to detect meaningful clinical changes in HRQOL that might occur in the office setting.

Adult↗
PubMed1995

Methotrexate for the treatment of Crohn's disease. The North American Crohn's Study Group Investigators.

BACKGROUND: Although corticosteroids are highly effective in improving symptoms of Crohn's disease, they may have substantial toxicity. In some patients, attempts to discontinue corticosteroids are unsuccessful. METHODS: We conducted a double-blind, placebo-controlled multicenter study of weekly injections of methotrexate in patients who had chronically active Crohn's disease despite a minimum of three months of prednisone therapy. Patients were randomly assigned to treatment with intramuscular methotrexate (25 mg once weekly) or placebo for 16 weeks. The patients also received prednisone (20 mg once a day), which was tapered over 10 weeks unless their condition worsened. The primary outcome measure was clinical remission at the end of the 16-week trial. Remission was defined by the discontinuation of prednisone and a score of < or = 150 points on the Crohn's Disease Activity Index. RESULTS: A total of 141 patients were randomly assigned in a 2:1 ratio to methotrexate (94 patients) or placebo (47 patients). After 16 weeks, 37 patients (39.4 percent) were in clinical remission in the methotrexate group, as compared with 9 patients (19.1 percent) in the placebo group (P = 0.025; relative risk, 1.95; 95 percent confidence interval, 1.09 to 3.48). The patients in the methotrexate group received less prednisone overall than those in the placebo group (P = 0.026). The mean (+/- SE) score on the Crohn's Disease Activity Index after 16 weeks of treatment was significantly lower in the methotrexate group (162 +/- 12) than in the placebo group (204 +/- 17, P = 0.002). The changes in quality-of-life scores and serum orosomucoid concentrations were similar. In the methotrexate group, 16 patients (17 percent) withdrew from treatment because of adverse events (including asymptomatic elevation of serum aminotransferase in 7 and nausea in 6), as compared with 1 patient (2 percent) in the placebo group. CONCLUSIONS: In a group of patients with chronically active Crohn's disease, methotrexate was more effective than placebo in improving symptoms and reducing requirements for prednisone.

Adult↗
PubMed1995

Rectal aminosalicylate therapy for distal ulcerative colitis: a meta-analysis.

BACKGROUND: To summarize and quantify the evidence supporting rectal 5- or 4-aminosalicylate (ASA) therapies for disease exacerbation or remission maintenance in distal ulcerative colitis, we performed a meta-analysis. METHODS: All randomized, double-blind controlled trials involving aminosalicylate therapy were retrieved from a MEDLINE search, review articles on ulcerative colitis therapy or their bibliographies. Of 55 studies retrieved, 19 met the inclusion criteria. Appraisal and data extraction were performed by two observers and scoring disagreements were resolved by consensus. RESULTS: Eleven trials tested 5-ASA and three tested 4-ASA in active ulcerative colitis. 5-ASA was superior to placebo for inducing remission or symptomatic improvement in active ulcerative colitis with a pooled odds ratio of 7.36 (95% Confidence interval (CI): 4.72-11.47). In four trials the pooled odds ratio for endoscopic improvement was 10.04 (95% CI: 5.72-17.61) and for histological improvement 10.31 (95% CI: 5.85-18.18). Studies evaluating 4-ASA suggest a benefit similar to prednisolone in treating active disease. Five trials assessed remission maintenance with 5-ASA, and when compared to placebo gave a pooled odds ratio of 16.22 (95% CI: 4.71-55.92). No dose-response relationship was observed. ASA compounds were not therapeutically superior to other treatments. CONCLUSIONS: We conclude that rectal 5-ASA is effective therapy for active distal ulcerative colitis. More trials are needed to assess 4-ASA, dose-response effects and the ideal regimen for remission maintenance.

Administration, Rectal↗
PubMed1995

Quality of Life in inflammatory bowel disease: biases and other factors affecting scores.

Health-Related Quality of Life (HRQOL) measurement has become a key element in the assessment of chronic diseases during the execution of clinical research and in the delivery of health care. Poor HRQOL is clearly recognized in patients with inflammatory bowel disease (IBD) and relates to the type of disease (Crohn's disease or ulcerative colitis) and disease severity. It is also linked to non-disease elements e.g., gender, age, personality, cultural factors and coping skills. The dynamic properties of HRQOL may be depicted using different measurement tools and the portrayal may well differ when using a generic- or a disease-specific instrument. HRQOL status also changes with time, as do disease and non-disease parameters. Several examples of population selection bias are demonstrated using the Sickness Impact Profile (SIP), the time trade-off and the McMaster Inflammatory Bowel Disease Questionnaire (IBDQ). While HRQOL is generally good in IBD patients, mean HRQOL scores are still significantly depressed compared to normal controls. The IBDQ, a disease-specific HRQOL instrument, has yielded consistent results in both cross-sectional studies and prospective clinical trials. Such HRQOL instruments can be used to identify the types of new therapies that are needed, subgroups of patients which might benefit from specific treatments, patient satisfaction, treatment efficacy and efficiency. These applications must always be undertaken with careful attention to rigorous research methodology.

Bias↗
PubMed1995

Usual therapy improves perianal Crohn's disease as measured by a new disease activity index. McMaster IBD Study Group.

Troublesome perianal disease occurs in approximately 35% of patients with Crohn's disease, yet conventional disease activity indices do not reflect the severity of this feature. To assess the degree of impairment and response to therapy, we identified five simple elements and graded each on a 5-point Likert scale in 37 patients at 124 visits. At each visit a Crohn's Disease (CDAI) or Simple Activity Index (HBDAI), Perianal Disease Activity Index (PDAI), and treatment were recorded. The PDAI was validated against physician (MDGA) and patient (PGA) global assessments, and treatment was prescribed for the perianal disease. Measurement error was evaluated in 19 patients who were clinically stable at two consecutive visits. The ability of the PDAI to detect important clinical change was tested in 20 subjects exhibiting a change on PGA at consecutive visits. There were strong correlations between PDAI, MDGA, and PGA scores at all visits (R = 0.66-0.72; p < 0.001), whereas the CDAI and HBDAI correlated poorly with PDAI (R < 0.23). Physicians prescribed more aggressive therapy for higher PDAI scores (r = 0.53). Mean PDAI scores between visits in clinically stable subjects were not significantly different [5.58 +/- 2.79 (initial); 5.42 +/- 2.55 (follow-up); p = 0.63]. PDAI significantly improved between visits when the perianal disease had improved (PDAI score difference 3.05 +/- 2.96; P = .0002). We conclude that the PDAI is simple and clinically useful for patient management. It should now be assessed in a clinical trial.

Adolescent↗
PubMed1994

Quality of life: a valid and reliable measure of therapeutic efficacy in the treatment of inflammatory bowel disease. Canadian Crohn's Relapse Prevention Trial Study Group.

BACKGROUND/AIMS: Quality of life (QOL), a subjective index of health perception and function, embraces physical, social, and emotional performance but has not had a prominent role in clinical trials of inflammatory bowel disease (IBD). To test the robustness of the Inflammatory Bowel Disease Questionnaire (IBDQ), a disease-specific QOL index, this study assessed its validity, reliability, and responsiveness during a multicenter trial. METHODS: Three hundred five patients with stable Crohn's disease received cyclosporin or placebo for 18 months. IBDQ and dimensional scores (bowel, social, systemic, and emotional) were correlated with disease activity (Crohn's disease activity index [CDAI] and Harvey-Bradshaw index). Concordance of IBDQ scores was tested in 280 stable subjects. Linear regression evaluated change in IBDQ scores over time. RESULTS: IBDQ scores correlated highly with CDAI (r = -0.67; P < 0.0001). The reliability coefficient for IBDQ score was 0.70 vs. 0.66 for CDAI and 0.55 for Harvey-Bradshaw index. Regression line slopes of IBDQ scores were significantly different in patients who deteriorated from those who remained stable ([b] < 0.15; P < 0.0001). QOL scores were lower in patients who required surgery. CONCLUSIONS: The IBDQ is a valid reliable assessment tool that reflects important changes in the health status of patients with IBD. The IBDQ is a robust measure of therapeutic efficacy and should be used in future clinical trials in IBD.

Adult↗