Responsiveness and interpretation of a symptom severity index specific to upper gastrointestinal disorders

Revicki, Dennis A.; Rentz, Anne M.; Tack, Jan; Stanghellini, Vincenzo; Talley, Nicholas J.; Kahrilas, Peter J.; Loge, Christine de la; Trudeau, Elyse; Dubois, Dominique

doi:10.1016/s1542-3565(04)00348-9

Cited by 80 publications

(94 citation statements)

References 18 publications

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“…The GCSI has been suggested as a useful questionnaire for gastroparetic symptoms [11,12,13]. This study has evaluated symptoms of gastroparesis in patients with a variety of symptoms undergoing GES using the GCSI.…”

Section: Discussionmentioning

confidence: 99%

“…Recently, the Gastroparesis Cardinal Symptom Index (GCSI) has been developed for symptoms of gastroparesis [11,12,13]. It queries 9 symptoms of which the patients assess the severity using a 0–5 Likert scale.…”

Section: Introductionmentioning

confidence: 99%

“…The GCSI combines the individual symptom scores into three subscales including nausea/vomiting, postprandial fullness/early satiety, and bloating [11]. The GCSI is part of a larger questionnaire PAGI-SYM (Patient Assessment of Upper Gastrointestinal Symptom severity index) for gastroparesis, dyspepsia, and gastroesophageal reflux [13]. Although the GCSI symptom questionnaire has been validated with other questionnaires in patients with gastroparesis [11,12,13], its ability to associate symptoms with DGE has not been studied.…”

Section: Introductionmentioning

confidence: 99%

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Symptoms of Gastroparesis: Use of the Gastroparesis Cardinal Symptom Index in Symptomatic Patients Referred for Gastric Emptying Scintigraphy

Cassilly¹,

Wang²,

Friedenberg³

et al. 2008

Digestion

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Background/Aim: The Gastroparesis Cardinal Symptom Index (GCSI) was developed to assess symptoms of gastroparesis. The aim of this study was to correlate symptoms using the GCSI with delayed gastric emptying (DGE) in symptomatic patients referred for gastric emptying scintigraphy (GES). Methods: A total of 226 consecutive symptomatic patients referred for GES completed the 9-question GCSI. GES was performed using a ⁹⁹Tc-labeled egg meal. Gastroparesis was defined as DGE at 2 h and/or 4 h. Results: Using linear regression, nausea (p = 0.09), not able to finish a normal-size meal (p = 0.005), postprandial fullness subscore (p = 0.01), and total GCSI score (p = 0.06) were predictors of the gastric retention values at 2 h, but not at 4 h. Patients with gastroparesis had significant higher symptom scores for nausea (p = 0.035) and vomiting (p = 0.040) compared to patients with normal gastric emptying. The positive predictive value varied between 51 and 61% for total GCSI scores between 20 and 35, respectively. Conclusion: The individual symptoms of nausea, vomiting, and early satiety were associated with DGE at 2 h but not at 4 h. In contrast, the total or average GCSI score did not reliably predict the diagnosis of gastroparesis in symptomatic patients referred for GES.

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Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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Symptoms of Gastroparesis: Use of the Gastroparesis Cardinal Symptom Index in Symptomatic Patients Referred for Gastric Emptying Scintigraphy

Cassilly¹,

Wang²,

Friedenberg³

et al. 2008

Digestion

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“…128 Responsiveness has been evaluated in an 8-week study in GERD and FD, using OTE as a comparator. 129 The questionnaire has also been translated and validated in many different cultural and linguistic settings. Disadvantages of the PAGI-SYM questionnaire are the equal weighting of different symptoms when making up total or subscales, and the inclusion of a broad range of symptoms that are not specific for FD.…”

Section: Disease Specific Instruments (Multidimensional)mentioning

confidence: 99%

“…However, subscales were proposed for use in specific disorders. 129 The PAGI-SYM has been used in a study evaluating the 5-HT1A agonist R137696 in FD, where no efficacy was demonstrated.…”

Section: Disease Specific Instruments (Multidimensional)mentioning

confidence: 99%

Review article: endpoints used in functional dyspepsia drug therapy trials

Ang

Talley

Simrén

et al. 2011

Alimentary Pharmacology &Amp; Therapeutics

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MATERIALS AND METHODS Identification of relevant studiesTo identify relevant studies, both computerised (Medline) and manual searches were performed, using the cited references of the retrieved articles. MeSH and freetext terms for FD therapies were combined with the terms dyspepsia, clinical trials, symptom assessment, questionnaires, patient reported measures and randomised for searches conducted for the time period between January 1979 and December 2008. FD therapeutic trials were retrieved and studied, with emphasis on the method used for evaluating outcome measures. Article reference lists were examined for relevant articles. Analysis of both full articles and abstracts was conducted, with particular emphasis on outcome measures. The literature search was performed independently by two of the authors, and their retrievals were merged. Inclusion criteriaThe following criteria were used to select trials for analysis: (i) randomised double blind controlled trials (RCT), (ii) parallel or single cross-over trial designs, (iii) adult patients with FD, (iv) baseline gastroscopy to exclude structural pathology; (v) comparison of therapy vs. active or placebo control; (vi) clear description of the method of assessing outcome measures for FD symptoms and (vii) articles in English. Outcome measuresOne of the main difficulties encountered with therapeutic trials in FGIDs, and FD in particular where efficacy has not been established for any treatment, is the lack of objectively measurable outcome measures. [11][12][13][14] In FD, symptom patterns do not correlate well with putative pathophysiological mechanisms such as gastric accommodation, sensitivity to distension and gastric emptying rates. 15 In the absence of quantifiable surrogate markers for symptom improvement, evaluation of treatment response has to rely on patient's reporting of symptom intensities. Several types of outcome measures have been used in FD clinical trials. These can be broadly classified into global outcomes, generic instruments and disease specific instruments.16 Global outcomes are measured either by a dichotomous binary type response (e.g. yes ⁄ no to symptom improvement) or a scoring method which can either be a Likert scale (categorical) or a visual analogue scale (VAS). Likert scales allow easier interpretation for the physician compared with the VAS, with 5-point or 7-point scales providing greater sensitivity than 4-point scales. 17 The VAS and 7-point Likert scales exhibit comparable responsiveness, although the ease of administration and interpretation of the 7-point scale recommend its use in clinical trials. 18 The Likert scale is often incorporated into global scales, such as the overall treatment effect (OTE), 19 generic instruments and disease specific R Re ev vi ie ew w: : d dy ys sp pe ep ps si ia a e en nd dp po oi in nt ts s f fo or r u us se e i in n d dr ru ug g t th he er ra ap py y t tr ri ia al ls s

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Web-Based Educational Intervention for Patients With Uninvestigated Dyspepsia Referred for Upper Gastrointestinal Tract Endoscopy

et al. 2021

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IMPORTANCE Diagnostic yield of upper gastrointestinal (GI) tract endoscopy for uninvestigated dyspepsia is low, and its clinical implications are limited. There is an unmet need for better strategies to reduce the volume of upper GI tract endoscopic procedures for dyspepsia.OBJECTIVE To study the effectiveness of a web-based educational intervention as a tool to reduce upper GI tract endoscopy in uninvestigated dyspepsia. DESIGN, SETTING, AND PARTICIPANTSThis open-label, multicenter, randomized clinical trial enrolled participants between November 1, 2017, and March 31, 2019, with follow-up 52 weeks after randomization, at 4 teaching hospitals in the Netherlands. Participants included patients with uninvestigated dyspeptic symptoms who were referred for upper GI tract endoscopy by their general health care clinician without prior consultation of a gastroenterologist. A total of 119 patients, aged 18 to 69 years, were included. Patients were excluded if any of the following red flag symptoms were present: (indirect) signs of upper GI tract hemorrhage (hematemesis, melena, hematochezia, or anemia), unintentional weight loss of 5% or higher of normal body weight during a period of 6 to 12 months, persistent vomiting, dysphagia, or jaundice.INTERVENTIONS Patients were randomly assigned (1:1) to education (intervention) or upper GI tract endoscopy (control). Education consisted of a self-managed web-based educational intervention, containing information on gastric function, dyspepsia, and upper GI tract endoscopy. MAIN OUTCOMES AND MEASURESDifference in the proportion of upper GI tract endoscopy procedures between those who received access to the web-based educational intervention and those who did not at 12 weeks and 52 weeks after randomization, analyzed in the intention-to-treat population. Secondary outcomes included quality of life (Nepean Dyspepsia Index) and symptom severity (Patient Assessment of Gastrointestinal Disorders Symptom Severity Index) measured at baseline and 12 weeks. RESULTSOf 119 patients included (median age, 48 years [interquartile range, 37-56 years]; 48 men [40%]), 62 were randomized to web-based education (intervention) and 57 to upper GI tract endoscopy (control). Significantly fewer patients compared with controls underwent upper GI tract endoscopy after using the web-based educational intervention: 24 (39%) vs 47 (82%) (relative risk, 0.46; 95% CI, 0.33-0.64; P < .001). Symptom severity and quality of life improved equivalently in both groups. One additional patient in the intervention group required upper GI tract endoscopy during follow-up.CONCLUSIONS AND RELEVANCE Findings of this study indicate that web-based patient education is an effective tool to decrease the need for upper GI tract endoscopy in uninvestigated dyspepsia.

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Responsiveness and interpretation of a symptom severity index specific to upper gastrointestinal disorders

Cited by 80 publications

References 18 publications

Symptoms of Gastroparesis: Use of the Gastroparesis Cardinal Symptom Index in Symptomatic Patients Referred for Gastric Emptying Scintigraphy

Symptoms of Gastroparesis: Use of the Gastroparesis Cardinal Symptom Index in Symptomatic Patients Referred for Gastric Emptying Scintigraphy

Review article: endpoints used in functional dyspepsia drug therapy trials

Web-Based Educational Intervention for Patients With Uninvestigated Dyspepsia Referred for Upper Gastrointestinal Tract Endoscopy

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