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Gastrointestinal-specific patient-reported outcome instruments differentiate between renal transplant patients with
L Kleinman1, R Faull, R Walker
1MEDTAP International, Inc., Seattle, Washington 98121, USA.
Background:
Gastrointestinal (GI) complications are frequently reported postrenal transplant and are often associated with immunosuppressant regimens including mycophenolate mofetil (MMF). This study evaluated the ability of two GI-specific patient-reported outcome (PRO) instruments to differentiate between patients with and without GI complaints.
Methods:
Discriminant validity of the Gastrointestinal Symptom Rating Scale (GSRS) and Gastrointestinal Quality of Life Index (GIQLI), as well as two generic instruments (Psychological General Well-Being Index (PGWB) and EQ-5D, was assessed in a multinational study of renal transplant recipients. Patients received therapy that included a calcineurin inhibitor and MMF. Both t-tests and ANOVAs were used to examine differences between patients with and without GI complaints, among levels of severity, and between patients reporting presence/absence of specific GI side effects.
Results:
Of 96 patients recruited (56% male), 43% had none, 39% mild, 13% moderate, and 6% severe GI symptoms. All GSRS subscales and the GIQLI total and four of the five subscale scores significantly differentiated between patients with/without GI complications (P < .05). The PGWB total score and three subscales, the EQ-5D significantly differentiated between the two groups (P < .05). Only GI-specific instruments discriminated between some severity levels; for example, the GSRS abdominal pain subscale discriminated between patients at all levels of severity (P < .05). The GIQLI total score and symptoms subscale differentiated between patients with no symptoms and those with mild or moderate or severe symptoms (P < .05).
Conclusions:
The GSRS and GIQLI differentiated between patients with/without GI side effects and by symptom severity better than did generic instruments, demonstrating excellent discriminant ability in this population.
Insights
Gastrointestinal symptom scales, the GSRS and GIQLI, effectively identified post-transplant patients with GI issues. These GI-specific tools better distinguished symptom severity than general health questionnaires.
Area of Science:
- Nephrology and Transplant Medicine
- Gastroenterology
- Health Outcomes Research
Background:
- Gastrointestinal (GI) complications are common after renal transplantation, frequently linked to immunosuppressants like mycophenolate mofetil (MMF).
- Assessing GI complaints in renal transplant recipients is crucial for managing treatment side effects and improving patient well-being.
- Patient-reported outcome (PRO) instruments are valuable tools for evaluating symptoms and quality of life in this patient population.
Purpose of the Study:
- To evaluate the discriminant validity of two GI-specific PRO instruments: the Gastrointestinal Symptom Rating Scale (GSRS) and the Gastrointestinal Quality of Life Index (GIQLI).
- To compare the ability of GI-specific instruments against two generic PRO instruments (Psychological General Well-Being Index (PGWB) and EQ-5D) in differentiating GI complaints.
- To assess the instruments' capacity to distinguish between varying levels of GI symptom severity in renal transplant recipients.
Main Methods:
- A multinational study involving renal transplant recipients treated with a calcineurin inhibitor and MMF.
- Assessed discriminant validity using t-tests and ANOVAs to compare GI-specific (GSRS, GIQLI) and generic (PGWB, EQ-5D) instruments.
- Examined differences between patients with and without GI complaints, across severity levels, and based on specific GI side effect presence.
Main Results:
- All GSRS subscales and the GIQLI total score/four subscales significantly differentiated patients with/without GI complications (P < .05).
- Generic instruments (PGWB, EQ-5D) also showed significant differentiation, but GI-specific instruments better identified symptom severity.
- The GSRS abdominal pain subscale and GIQLI total score/symptoms subscale demonstrated superior ability to discriminate across all severity levels.
Conclusions:
- The GSRS and GIQLI exhibit excellent discriminant ability in renal transplant recipients, effectively differentiating patients with and without GI side effects.
- GI-specific instruments provide a more nuanced assessment of symptom severity compared to generic health-related quality of life measures.
- These findings support the use of GSRS and GIQLI for evaluating GI symptoms and their severity in post-renal transplant patients.
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