Abstract:
BACKGROUND:Patient-reported outcome (PRO) measures historically used in inflammatory bowel disease have been considered inadequate to support future drug labelling claims by regulatory agencies. AIMS:To develop PRO tools for use in Crohn's disease (CD) and ulcerative colitis (UC) following guidance issued by the US FDA and the ISPOR (International Society for Pharmacoeconomics and Outcomes Research). METHODS:Concept elicitation and cognitive interviews were conducted in adult patients (≥18 years) across the United States and Canada. Semi-structured interview guides were used to collect data, and interview transcripts were coded and analysed. Concept elicitation results were considered alongside existing literature and clinical expert opinion to identify candidate PRO items. Cognitive interviews evaluated concept relevance, interpretability and structure, and facilitated instrument refinement. Concept elicitation participants, except those with an ostomy, underwent centrally read endoscopy to assess inflammatory status. RESULTS:In all, 54 participants (mean age: 46.2 years; 66.7% female) were included in the CD concept elicitation interviews. In total, 80 symptom concepts and 61 impact concepts were identified. After three waves of cognitive interviews, the 31-item Symptoms and Impacts Questionnaire for CD (SIQ-CD) was developed. In the UC concept elicitation phase, 53 participants were interviewed (mean age: 41.4 years; 49.1% female). In total, 79 symptoms concepts and 49 impact concepts were identified. Following two waves of cognitive interviews, the 29-item Symptoms and Impacts Questionnaire for UC (SIQ-UC) was developed. Both instruments include four symptom and six impact domains. CONCLUSIONS:We developed PROs to support CD and UC drug labelling claims. Psychometric validation studies to evaluate instrument reliability and responsiveness are ongoing.
journal_name
Aliment Pharmacol Therjournal_title
Alimentary pharmacology & therapeuticsauthors
Dulai PS,Jairath V,Khanna R,Ma C,McCarrier KP,Martin ML,Parker CE,Morris J,Feagan BG,Sandborn WJdoi
10.1111/apt.15726subject
Has Abstractpub_date
2020-06-01 00:00:00pages
1047-1066issue
11eissn
0269-2813issn
1365-2036journal_volume
51pub_type
杂志文章abstract:BACKGROUND:Two studies were carried out in order to investigate the issue of meal-provoked nocturnal gastrooesophageal reflux. METHODS:In Experiment 1, 20 symptomatic reflux patients underwent both pH and polysomnographic monitoring on two nights. On one night, patients ate a non-provocative meal prior to 19.00 hours,...
journal_title:Alimentary pharmacology & therapeutics
pub_type: 临床试验,杂志文章
doi:10.1046/j.1365-2036.1998.00407.x
更新日期:1998-10-01 00:00:00
abstract::The effect of 7 days of oral dosing with 5 mg day-1 and 20 mg day-1 omeprazole on basal and pentagastrin-stimulated gastric acid output was studied in nine duodenal ulcer patients. Basal acid output measured 5-6 h post-dosing was decreased by a mean of 75% on 5 mg omeprazole and by 90% on 20 mg omeprazole (P less than...
journal_title:Alimentary pharmacology & therapeutics
pub_type: 临床试验,杂志文章,随机对照试验
doi:10.1111/j.1365-2036.1988.tb00696.x
更新日期:1988-06-01 00:00:00
abstract:BACKGROUND:Comparative long-term efficacy of entecavir (ETV) and tenofovir disoproxil fumarate (TDF) for prevention of disease progression to hepatocellular carcinoma (HCC) among high-risk patients with chronic hepatitis B (CHB)-related compensated cirrhosis is controversial. AIMS:To compare the long-term efficacy of ...
journal_title:Alimentary pharmacology & therapeutics
pub_type: 杂志文章
doi:10.1111/apt.16116
更新日期:2020-12-01 00:00:00
abstract:BACKGROUND:Even in the biologic era, corticosteroid dependency in IBD patients is common and causes a lot of morbidity, but methods of withdrawal are not well described. AIM:To assess the effectiveness of a corticosteroid withdrawal method. METHODS:Twelve patients (10 men, 2 women; 6 ulcerative colitis, 6 Crohn's dis...
journal_title:Alimentary pharmacology & therapeutics
pub_type: 杂志文章
doi:10.1111/j.1365-2036.2009.04136.x
更新日期:2009-11-15 00:00:00
abstract::The goals of the Baveno workshops were to develop consensus definitions of key events related to portal hypertension and variceal bleeding, and to produce guidelines to facilitate the conduct and reporting of clinical trials. The consensus definitions concern the diagnosis of active bleeding, failure to control bleedi...
journal_title:Alimentary pharmacology & therapeutics
pub_type: 杂志文章,评审
doi:10.1111/j.1365-2036.2004.02108.x
更新日期:2004-09-01 00:00:00
abstract:BACKGROUND:The efficacy of each probiotic should be evaluated separately. Previously, we have shown that Lactobacillus GG (LGG) is effective in treating acute gastroenteritis (AGE) in children. AIM:To update our 2007 meta-analysis on the effectiveness of LGG in treating AGE in children. METHODS:The Cochrane Library, ...
journal_title:Alimentary pharmacology & therapeutics
pub_type: 杂志文章,meta分析
doi:10.1111/apt.12403
更新日期:2013-09-01 00:00:00
abstract:BACKGROUND:Anti-TNFα agents have revolutionised management of chronic inflammatory diseases. Paradoxically, these agents might provoke development of de novo autoimmune diseases. AIM:To examine whether there is an increased risk of developing Crohn's disease (CD) and ulcerative colitis (UC) while under treatment with ...
journal_title:Alimentary pharmacology & therapeutics
pub_type: 杂志文章
doi:10.1111/apt.15370
更新日期:2019-08-01 00:00:00
abstract::Thirteen patients with Zollinger-Ellison syndrome were investigated: 8 without, and 5 with, previous gastric surgery. After 7-34 months of treatment with famotidine, 8 out of 13 patients were resistant to this drug. Omeprazole 60 mg/day was administered to these 8 patients; after one month, the dose was reduced to 40 ...
journal_title:Alimentary pharmacology & therapeutics
pub_type: 杂志文章
doi:10.1111/j.1365-2036.1993.tb00086.x
更新日期:1993-04-01 00:00:00
abstract:BACKGROUND:Tegaserod, a 5-hydroxytryptamine-4 receptor agonist, enhances gastric emptying, but its effects on proximal stomach function have not been studied. AIM:To study the effect of tegaserod on gastric compliance, accommodation and perception of distension in humans. METHODS:Nineteen healthy volunteers (10 femal...
journal_title:Alimentary pharmacology & therapeutics
pub_type: 临床试验,杂志文章,随机对照试验
doi:10.1046/j.1365-2036.2003.01775.x
更新日期:2003-11-15 00:00:00
abstract:BACKGROUND:Ursodeoxycholic acid (UDCA) prolongs transplantation-free survival in primary biliary cirrhosis (PBC). However, the optimal therapeutic dose has not been established. AIM:To compare the effects of UDCA administered in daily doses of 10 vs. 20 mg/kg on symptoms, liver biochemistry and biliary UDCA enrichment...
journal_title:Alimentary pharmacology & therapeutics
pub_type: 临床试验,杂志文章,多中心研究,随机对照试验
doi:10.1046/j.1365-2036.1998.00395.x
更新日期:1998-10-01 00:00:00
abstract:BACKGROUND:Liver transplantation (LT) offers a possible cure for carefully selected patients with hepatocellular carcinoma (HCC). Studies report that preoperative alpha-fetoprotein (AFP) is a prognostic indicator that can predict survival and recurrence in these patients. AIM:To undertake a systematic review of availa...
journal_title:Alimentary pharmacology & therapeutics
pub_type: 杂志文章,评审
doi:10.1111/j.1365-2036.2012.05060.x
更新日期:2012-05-01 00:00:00
abstract:BACKGROUND:Idiopathic noncirrhotic portal hypertension (INCPH) has been reported increasingly in patients with HIV infection. AIM:To evaluate the number of nationwide diagnosed HIV-associated INCPH cases and to assess its clinical features, risk factors and outcome. METHODS:All HIV centres in the Netherlands were con...
journal_title:Alimentary pharmacology & therapeutics
pub_type: 杂志文章
doi:10.1111/apt.12049
更新日期:2012-11-01 00:00:00
abstract:BACKGROUND:Drug toxicity is a well-known cause of acute pancreatitis (AP). Although many drugs have been associated with AP, the magnitude of the risk of most of them remains largely unknown. AIM:To determine the pancreatotoxic risk of a wide range of drugs. METHODS:The hospital-based Berlin case-control surveillance...
journal_title:Alimentary pharmacology & therapeutics
pub_type: 杂志文章
doi:10.1111/apt.12461
更新日期:2013-10-01 00:00:00
abstract:BACKGROUND:Helicobacter pylori eradication has become the standard treatment for duodenal ulcer. However, there is no relevant evidence for antibacterial treatment of the white scar stage of duodenal ulcer (duodenal ulcer scar) in patients with no past history of duodenal ulcer. AIM:To investigate whether H. pylori er...
journal_title:Alimentary pharmacology & therapeutics
pub_type: 临床试验,杂志文章,随机对照试验
doi:10.1046/j.1365-2036.2002.01174.x
更新日期:2002-02-01 00:00:00
abstract:BACKGROUND:Few studies have evaluated interferon and ribavirin therapy in hepatitis C virus-infected patients with persistently normal alanine aminotransferase (ALT) levels. AIM:To determine the efficacy and safety of combination therapy in this population, and to evaluate the impact of treatment on health-related qua...
journal_title:Alimentary pharmacology & therapeutics
pub_type: 杂志文章
doi:10.1111/j.1365-2036.2006.02819.x
更新日期:2006-03-15 00:00:00
abstract:BACKGROUND:Chronic continuous abdominal pain (CCAP) is characteristic of centrally mediated gastrointestinal pain disorders. It consumes significant healthcare resources yet is poorly understood, with minimal cohort-specific data in the literature. AIMS:To examine in a large cohort of CCAP patients, (a) diagnostic fea...
journal_title:Alimentary pharmacology & therapeutics
pub_type: 杂志文章
doi:10.1111/apt.15241
更新日期:2019-05-01 00:00:00
abstract:BACKGROUND:Capsule endoscopy can identify lesions of the small bowel that cannot be detected by other techniques. In addition to patient safety, quality of care and cost-efficiency, good preparation is an important factor for good visualization. AIM:To evaluate the efficacy of oral sodium phosphate preparation. METHO...
journal_title:Alimentary pharmacology & therapeutics
pub_type: 杂志文章,多中心研究
doi:10.1111/j.1365-2036.2005.02647.x
更新日期:2005-11-15 00:00:00
abstract:BACKGROUND:Butyrate, propionate and acetate are short chain fatty acids (SCFA), important for maintaining a healthy colon and are considered as protective in colorectal carcinogenesis. However, they may also regulate immune responses and the composition of the intestinal microbiota. Consequently, their importance in a ...
journal_title:Alimentary pharmacology & therapeutics
pub_type: 杂志文章,评审
doi:10.1111/apt.14689
更新日期:2018-07-01 00:00:00
abstract:BACKGROUND:Proton pump inhibitor (PPI) use is associated with an increased risk of Clostridium difficile infection (CDI), though the mechanism is unclear. PPI induced alterations to the gut microbiome may facilitate the emergence of CDI, though the effects of PPIs on gut microbiota are not well characterised. [Correcti...
journal_title:Alimentary pharmacology & therapeutics
pub_type: 杂志文章
doi:10.1111/apt.13568
更新日期:2016-05-01 00:00:00
abstract:BACKGROUND:Irritable bowel syndrome (IBS) and functional dyspepsia (FD) are common functional disorders without defined pathology. Mast cells and eosinophils interact with T lymphocytes and may alter enteric nerve and smooth muscle function. AIM:To examine mast cell, eosinophil and intraepithelial lymphocyte populatio...
journal_title:Alimentary pharmacology & therapeutics
pub_type: 杂志文章
doi:10.1111/j.1365-2036.2009.03937.x
更新日期:2009-04-01 00:00:00
abstract:BACKGROUND:Up to 80% of patients with Crohn's disease require an abdominal operation in their lifetime. As the use of vedolizumab is increasing for the treatment of Crohn's disease, it is important to understand its potential association with post-operative complications. AIM:We sought to compare 30-day postoperative ...
journal_title:Alimentary pharmacology & therapeutics
pub_type: 杂志文章
doi:10.1111/apt.14459
更新日期:2018-03-01 00:00:00
abstract:OBJECTIVE:To determine whether flumecinol (3-trifluoromethyl-alpha-ethylbenzhydrol, Zixoryn) is effective in ameliorating pruritus of cholestasis, particularly in primary bilary cirrhosis. METHODS AND RESULTS:50 patients (46 with primary biliary cirrhosis, PBC) took oral flumecinol 600 mg or identical placebo once wee...
journal_title:Alimentary pharmacology & therapeutics
pub_type: 临床试验,杂志文章,随机对照试验
doi:10.1111/j.1365-2036.1994.tb00297.x
更新日期:1994-06-01 00:00:00
abstract:BACKGROUND:Factors associated with mortality and disease progression in non-alcoholic fatty liver disease (NAFLD) and non-alcoholic steatohepatitis (NASH) are poorly understood. AIMS:To assess the impact of liver disease severity, demographics and comorbidities on all-cause mortality and liver disease progression in a...
journal_title:Alimentary pharmacology & therapeutics
pub_type: 杂志文章
doi:10.1111/apt.16016
更新日期:2020-10-01 00:00:00
abstract:BACKGROUND:Helicobacter-negative gastritis and duodenitis occur more often in patients with inflammatory bowel disease (IBD) than in non-IBD controls. Preliminary evidence suggests that they are particularly common among children. AIM:To study the age-specific occurrence of gastritis and duodenitis among paediatric IB...
journal_title:Alimentary pharmacology & therapeutics
pub_type: 杂志文章
doi:10.1111/j.1365-2036.2012.05090.x
更新日期:2012-06-01 00:00:00
abstract:BACKGROUND:The prevalence of coeliac disease (CD) may be increased in individuals with dyspepsia, but evidence is conflicting. AIMS:To conduct a systematic review and meta-analysis of studies reporting prevalence of CD in dyspepsia. METHODS:MEDLINE, EMBASE, and CINAHL were searched up to February 2009. Case series an...
journal_title:Alimentary pharmacology & therapeutics
pub_type: 杂志文章,meta分析,评审
doi:10.1111/j.1365-2036.2009.04008.x
更新日期:2009-07-01 00:00:00
abstract:BACKGROUND:Different authors have postulated both toxic and protective effects for nitric oxide (NO) in the pathophysiology of active inflammation. AIM:To examine the role of NO, especially that produced by the inducible form of nitric oxide synthase (iNOS), by investigating the effects of NOS inhibitors and NO donors...
journal_title:Alimentary pharmacology & therapeutics
pub_type: 杂志文章
doi:10.1046/j.1365-2036.2000.014s1026.x
更新日期:2000-04-01 00:00:00
abstract:AIM:To evaluate the efficacy of omeprazole plus clarithromycin and furazolidone in Helicobacter pylori eradication and duodenal ulcer healing in Brazilian patients. METHODS:Forty H. pylori-positive patients with duodenal ulcer were randomized to receive 20 mg omeprazole o.m. or b.d. for 1 month plus 500 mg clarithromy...
journal_title:Alimentary pharmacology & therapeutics
pub_type: 临床试验,杂志文章,随机对照试验
doi:10.1046/j.1365-2036.1999.00653.x
更新日期:1999-12-01 00:00:00
abstract:BACKGROUND:Diagnosis of inflammatory bowel disease (IBD) is based on clinical presentation, colonoscopy and histology. Differentiation of Crohn's disease (CD) and ulcerative colitis (UC) can be difficult in some patients. Endoscopic ultrasound (EUS) provides high resolution images of the gastrointestinal wall (GI) and ...
journal_title:Alimentary pharmacology & therapeutics
pub_type: 杂志文章
doi:10.1111/apt.12671
更新日期:2014-04-01 00:00:00
abstract:BACKGROUND:The detrimental effect of smoking on development and progression of Crohn's disease (CD) is generally accepted. AIM:To evaluate the awareness of smoking risks in a Belgian inflammatory bowel disease (IBD) population. METHODS:In the out-patient clinic of a tertiary referral centre, 625 consecutive patients ...
journal_title:Alimentary pharmacology & therapeutics
pub_type: 杂志文章
doi:10.1111/apt.13423
更新日期:2015-12-01 00:00:00
abstract:BACKGROUND:Symptoms of lactose intolerance are often attributed to lactose malabsorption but, as this relationship has not been demonstrated when a small dose of lactose similar to that contained in one cup of milk is ingested by intolerant patients, psychological factors may play a role in altered symptom perception. ...
journal_title:Alimentary pharmacology & therapeutics
pub_type: 杂志文章
doi:10.1111/apt.12006
更新日期:2012-10-01 00:00:00