Gastrointestinal (GI)-Specific patient reported outcomes instruments differentiate between renal transplant patients with or without GI symptoms: results from a South American cohort

Machnicki, Gerardo; Pefaur, Jacqueline; Gaite, Luis; Linchenco, Ana M; Raimondi, C.; Schiavelli, Rubén; Otero, A.; Margolis, Mary Kay

doi:10.1186/1477-7525-6-53

Cited by 13 publications

(15 citation statements)

References 16 publications

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“…Subscale scores range from 1 to 7 and higher scores represent more discomfort. A total score is derived by summing the individual item scores, and ranges from 15 to 105 [ 32 ].…”

Section: Methodsmentioning

confidence: 99%

Changes in salivary physiological stress markers induced by muscle stretching in patients with irritable bowel syndrome

Hamaguchi

Fukudo

Kanazawa

et al. 2008

BioPsychoSocial Med

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Background: Psychophysiological processing has been reported to play a crucial role in irritable bowel syndrome (IBS) but there has been no report on modulation of the stress marker chromogranin A (CgA) resulting from muscle stretching. We hypothesized that abdominal muscle stretching as a passive operation would have a beneficial effect on a biochemical index of the activity of the sympathetic/adrenomedullary system (salivary CgA) and anxiety.

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“…Subscale scores range from 1 to 7 and higher scores represent more discomfort. A total score is derived by summing the individual item scores, and ranges from 15 to 105 [ 32 ].…”

Section: Methodsmentioning

confidence: 99%

Changes in salivary physiological stress markers induced by muscle stretching in patients with irritable bowel syndrome

Hamaguchi

Fukudo

Kanazawa

et al. 2008

BioPsychoSocial Med

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“…Innovative designs should also be put forward. For example, in the PROGIS study, data were used to psychometrically validate the PROMs for Argentina and Chile [29]. This project added to the existing validation literature and also provided information on the test-retest reliability of the questionnaires, which had not been previously explored.…”

Section: Discussionmentioning

confidence: 99%

Patient-Reported Outcomes in Latin America: Implementation in Research and Role in Emerging HTA Systems

Winnette

Zarate

Machnicki

et al. 2015

Value in Health Regional Issues

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PROs are increasingly important in LatAm. Future efforts should aim to strengthen the operational and research infrastructure around PROs in the region. Innovation should be encouraged, including studying alternative methods of eliciting health utilities for economic evaluation. A wider scope around PRO uses for decision making by HTA bodies is an international trend with potential positive prospects in LatAm.

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“…In an optional follow-up visit, 6–12 weeks after Visit 2, the GSRS, GIQLI, and PGWB questionnaires were administered again. Valid and reliable self-administered measures with good psychometric characteristics 23 , 24 that allow comparison with the results from related clinical studies were used to assess GI symptoms, their impact on daily life, and the well-being of the patients. All questionnaires for the patients were translated into German.…”

Section: Methodsmentioning

confidence: 99%

Impact of switching from mycophenolate mofetil to enteric-coated mycophenolate sodium on gastrointestinal side effects in patients with autoimmune disease: a Phase III, open-label, single-arm, multicenter study

Manger¹,

Hiepe²,

Schneider³

et al. 2015

CEG

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BackgroundThe purpose of this study was to assess changes in gastrointestinal symptom severity in patients with autoimmune disease who were switched from mycophenolate mofetil to enteric-coated mycophenolate sodium (EC-MPS).MethodsIn this national, explorative, single-arm study, 111 patients were enrolled and switched to equimolar EC-MPS at baseline. The primary endpoint was change in the Gastrointestinal Symptom Rating Scale (GSRS) total score after 6–8 weeks of treatment (Visit 2). The optional follow-up visit was 6–12 weeks after completion of the study (Visit 2). Secondary endpoints were changes in GSRS subscale score; changes in gastrointestinal-related quality of life measured by the Gastrointestinal Quality of Life Index (GIQLI); and general health-related quality of life (HRQoL) measured by Psychological General Well-Being Index and assessment of overall treatment effect (OTE). Change was evaluated by paired t-tests.ResultsAt Visit 2, the mean ± standard deviation GSRS total score improved from 2.28±1.13 to 2.02±0.93 points. The change (−0.28±0.92 points, P=0.002) was statistically significant. The change at the follow-up visit (−0.36±0.94 points, P=0.001) was statistically significant and more than the minimal clinical important difference. GSRS subscores showed statistically significant and clinically relevant improvement for abdominal pain (−0.51±1.2 points, P<0.001) and indigestion (−0.42±1.33 points, P=0.002). Overall GIQLI score showed significant improvement from baseline to Visit 2 (−5.8±18.6 points, P=0.002). Per OTE, improvement was reported in 44.1% and 34.2% patients as rated by physicians and patients, respectively. The majority of patients (55%) reported OTE-HRQoL as unchanged. Diarrhea and nausea were the commonly reported adverse events.ConclusionPatients switched to EC-MPS experienced less gastrointestinal symptom burden and showed improvement in HRQoL.

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Gastrointestinal (GI)-Specific patient reported outcomes instruments differentiate between renal transplant patients with or without GI symptoms: results from a South American cohort

Cited by 13 publications

References 16 publications

Changes in salivary physiological stress markers induced by muscle stretching in patients with irritable bowel syndrome

Changes in salivary physiological stress markers induced by muscle stretching in patients with irritable bowel syndrome

Patient-Reported Outcomes in Latin America: Implementation in Research and Role in Emerging HTA Systems

Impact of switching from mycophenolate mofetil to enteric-coated mycophenolate sodium on gastrointestinal side effects in patients with autoimmune disease: a Phase III, open-label, single-arm, multicenter study

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