Development of a Crohn's index for survey research

Sandler, Robert S.; Jordan, Matthew Carey; Kupper, Lawrence L.

doi:10.1016/0895-4356(88)90046-7

Cited by 70 publications

(42 citation statements)

References 18 publications

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“…Thirty-nine new cases of IBD were diagnosed and registered in the RNH registry. Of those 39 patients, 18 were unknown in the IBD-SL registration. After verification of the exact data of diagnosis and diagnostic criteria, 12 patients could be excluded.…”

Section: Population and Designmentioning

confidence: 98%

Fatigue and health-related quality of life in inflammatory bowel disease

Romberg‐Camps

Bol

Dagnelie

et al. 2010

Inflammatory Bowel Diseases

195

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Section: Population and Designmentioning

confidence: 98%

Fatigue and health-related quality of life in inflammatory bowel disease

Romberg‐Camps

Bol

Dagnelie

et al. 2010

Inflammatory Bowel Diseases

195

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“…In addition, complications such as arthritis or arthralgia, iritis or uveitis, erythema nodosum, and pyoderma gangrenosum also contribute points to the score [14] . It has been observed that the major contribution to the variability of the CDAI arises from the first three symptoms, diarrhoea, abdominal pain and general well-being, whereas the other components, while adding points to a score and increasing the severity, are less responsive overall to changes over relatively short periods of time such as one or two months, which is typical for an induction trial [15] . In addition, it is worth noting that the variables of abdominal pain and general well-being contribute significantly to the overall score, although these particular symptoms are highly subjective and may be affected to a greater extent by the placebo response.…”

Section: Crohn's Diseasementioning

confidence: 99%

The Placebo Response Rate in Irritable Bowel Syndrome and Inflammatory Bowel Disease

Sands¹

2009

Dig Dis

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The placebo response is the efficacy attributable to a treatment that is thought to have no specific pharmacologic effect on the condition being treated. Although potentially helpful in clinical practice, high and unpredictable placebo response rates present a major impediment to the success of clinical trials in inflammatory bowel disease (IBD) and irritable bowel syndrome (IBS). Diverse factors contribute to the placebo response rates observed in clinical trials. These include patient characteristics, physician factors, frequency of study visits, characteristics of the outcome measures, concomitant treatments, regression to the mean, properties of the intervention and treatment setting, timing of the primary endpoint and natural history of the condition. Measures that may minimize the placebo response in IBD clinical trials include early timing of the primary endpoint, minimizing the number of study visits, restricting the patient population to those with documented inflammation (such as elevated biomarkers of inflammation or evidence of mucosal inflammation), including patients with more severe symptoms (i.e. greater disease activity) and enrolling patients with prior failure of immune modulators or biologics. Attempts to limit the placebo response in IBS studies have proven more difficult. Factors associated with higher placebo response rates in IBS studies include longer duration of treatment, greater number of office visits, frequency of administration of study intervention and overall treatment effect of the active agent under study. In the future, improved understanding of the factors that drive the placebo response rate should lead to more efficient study design and drug development.

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“…General health-related quality of life (HRQL) was measured by the SF-12 version 2 and disease-specific HRQL by the Short Inflammatory Bowel Disease Questionnaire (SIBDQ), an abbreviated validated version of the IBDQ (17). For Crohn's disease patients, disease severity was measured using the Chapel Hill Index, a validated selfreport instrument, that is based on and correlates with the Crohn's Disease Activity Index (18). Similarly, the Simple Colitis Clinical Activity Index was used to measure disease severity in ulcerative colitis (19).…”

Section: Study Instrumentsmentioning

confidence: 99%