Patient-Reported Gastrointestinal Symptoms and the Association With Quality of Life Following Kidney Transplantation

Chan, Samuel; Cao, Christopher; Pascoe, Elaine M.; Johnson, David W.; Shah, Ayesha; Holtmann, Gerald; Campbell, Scott; Francis, Ross; Isbel, Nicole M.; Hawley, Carmel M.

doi:10.1016/j.ekir.2020.10.013

Cited by 20 publications

(17 citation statements)

References 35 publications

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“…Of note is that women experienced more gastrointestinal symptoms, in particular more abdominal pain and constipation. This finding is in line with Chan et al (17) However, the reason is not clear. The menstrual cycle, menopause, and irritable bowel syndrome being more common in women and women having a lower threshold in reporting symptoms could play a role (27,28).…”

Section: Discussionsupporting

confidence: 69%

The Burden of Gastrointestinal Complaints in Kidney Transplant Recipients Using Tacrolimus With and Without Mycophenolate Mofetil: A Randomized Controlled Study

Fatly¹,

Betjes²,

Gestel³

et al. 2022

Front. Nephrol.

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BackgroundTacrolimus (TAC) combined with mycophenolate mofetil (MMF) is the immunosuppressive regimen in the majority of solid organ transplant recipients. Gastrointestinal complaints are frequent, which is considered predominantly a side effect of MMF. However, systematic research in this field is lacking. The aim of this study is to systematically investigate the burden of gastrointestinal complaints in TAC-treated kidney transplant recipients with and without MMF.MethodsIn a single-center, open-label, randomized controlled trial, low immunological risk recipients were randomized to either TAC and MMF or to TAC monotherapy from 6 months after kidney transplantation onwards [NTR4672],. They filled in the Gastrointestinal Symptom Rating Scale questionnaire, which covers five dimensions (abdominal pain, reflux, indigestion, constipation, and diarrhea), 6, 12, and 15 months after transplantation.ResultsSeventy-nine recipients were randomized and 72 completed all questionnaires (34 TACmono and 38 TAC/MMF). At baseline, the mean age was 59 years with 72% male, mean BMI 28 kg/m2, eGFR 55 ml/min/1.73m2, mean daily dose MMF 1200 mg and TAC 5.8 mg, with trough levels of 2.1 mg/L and 7.4 ug/L. Six months after transplantation, 75% of recipients reported troublesome symptoms (score ≥3). Diarrhea was the most troublesome (mean 3.3) and discontinuing MMF significantly reduced it (mean Δ score between month 6 and 15 TAC/MMF -0.9 vs. TACmono -1.8, p=0.03). In recipients with troublesome symptoms, abdominal pain (2.7 to 1.8, p=0.003), indigestion (2.8 to 2.3, p=0.012), and reflux (2.9 to 1.7, p=0.007) significantly decreased over time, independent of MMF use.ConclusionThe majority of kidney transplant recipients with TAC and MMF experienced troublesome gastrointestinal symptoms 6 months after transplantation. While constipation remained troublesome, indigestion, abdominal pain, and reflux improved over time by month 15. Diarrhea only improved after discontinuing MMF.

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Section: Discussionsupporting

confidence: 69%

The Burden of Gastrointestinal Complaints in Kidney Transplant Recipients Using Tacrolimus With and Without Mycophenolate Mofetil: A Randomized Controlled Study

Fatly¹,

Betjes²,

Gestel³

et al. 2022

Front. Nephrol.

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“…Secondly, condition- or symptom-specific measures assess PROs within either a condition or disease, or across certain symptoms. Examples include the Kidney Disease Quality of Life instrument (KDQoL) ( 50 ), Kidney Transplant Questionnaire ( 51 ), Modified Transplant Symptom Occurrence and Symptom Distress Scale ( 52 ), End-stage Renal Disease Symptom Checklist—Transplantation Module (ESRD-SCLTM) ( 53 ), and Gastrointestinal Symptom Rating Scale (GSRS) ( 54 ). Finally, preference-based (or utility) measures assess a value (i.e., from <0 [worse than being dead] to 1 [full health]), assigned to the health state described by the patient.…”

Section: Selection Of Appropriate Promsmentioning

confidence: 99%

“…The instrument chosen should be determined by the RCT aims and the type of intervention. For example, an intervention that aims to alleviate gastrointestinal side effects—either through additional medication or substitution of immunosuppressants or dose adjustments—might select the GSRS and the Gastrointestinal Quality of Life Index as being relevant validated instruments ( 54 ). Similarly, instruments assessing anxiety, depression, or mood swings may be required to address the intervention aim.…”

Section: Proms For Symptoms and Side Effectsmentioning

confidence: 99%

Patient-Reported Outcomes as Endpoints in Clinical Trials of Kidney Transplantation Interventions

Tong

Oberbauer²,

Bellini³

et al. 2022

Transpl Int

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Patient-reported outcomes (PROs) that assess individuals’ perceptions of life participation, medication adherence, disease symptoms, and therapy side effects are extremely relevant in the context of kidney transplantation. All PROs are potentially suitable as primary or secondary endpoints in interventional trials that aim to improve outcomes for transplant recipients. Using PRO measures (PROMs) in clinical trials facilitates assessment of the patient’s perspective of their health, but few measures have been developed and evaluated in kidney transplant recipients; robust methodologies, which use validated instruments and established frameworks for reporting, are essential. Establishing a core PROM for life participation in kidney transplant recipients is a critically important need, which is being developed and validated by the Standardized Outcomes in Nephrology (SONG)-Tx Initiative. Measures involving electronic medication packaging and smart technologies are gaining traction for monitoring adherence, and could provide more robust information than questionnaires, interviews, and scales. This article summarizes information on PROs and PROMs that was included in a Broad Scientific Advice request on clinical trial design and endpoints in kidney transplantation. This request was submitted to the European Medicines Agency (EMA) by the European Society for Organ Transplantation in 2016. Following modifications, the EMA provided its recommendations in late 2020.

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“…The literature suggests that kidney transplantation improves survival rates among patients on renal replacement therapy [11,12]. However, kidney transplantation requires long-term immunosuppressive therapy, which is associated with significant side effects (such as recurrent infection, metabolic disorder, renal toxicity, fatigue, and poor self-perception of physical appearance) that may negatively affect patient's healthrelated quality of life (HRQOL) [13][14][15][16]. HRQOL is a significant independent predictor of hospitalization and mortality in patients on renal replacement therapy [17,18].…”

Section: Introductionmentioning

confidence: 99%

Quality of life for kidney transplant recipients and hemodialysis patients in Palestine: a cross-sectional study

Sarhan

Jarareh²,

Shraim

2021

BMC Nephrol

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Background Health related quality of life (HRQOL) is an important indicator of medical treatment and is a strong predictor of disability and mortality. The literature has shown mixed evidence about whether kidney transplantation improves HRQOL compared with other renal replacement modalities. The aim of this study was to compare the HRQOL in kidney transplant recipients (KTRs) and hemodialysis (HD) patients. Methods A cross-sectional study of 100 KTRs and 272 HD patients from two central kidney units in the West Bank, Palestine. The HRQOL was assessed using the Short Form-36 Health Survey. Multivariable linear regression was used to estimate differences in mean HRQOL scores between KTRs and HD patients. Results As compared to HD patients, KTRs had higher clinically important HRQOL in main domains and subscales of the SF-36 including physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, mental health, ranging between 15.5 for social functioning (95% Confidence Interval (CI) 10.1, 20.7) to 32.6 for general health (95% CI 24.0, 41.1). Conclusions We found that KTRs have better HRQOL than HD patients in physical and mental components of the SF-36 scale including physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. Further longitudinal research comparing HRQOL among KTRs and the general population may identify key modifiable factors associated with lower HRQOL among KTRs that are amenable to intervention.

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Patient-Reported Gastrointestinal Symptoms and the Association With Quality of Life Following Kidney Transplantation

Cited by 20 publications

References 35 publications

The Burden of Gastrointestinal Complaints in Kidney Transplant Recipients Using Tacrolimus With and Without Mycophenolate Mofetil: A Randomized Controlled Study

The Burden of Gastrointestinal Complaints in Kidney Transplant Recipients Using Tacrolimus With and Without Mycophenolate Mofetil: A Randomized Controlled Study

Patient-Reported Outcomes as Endpoints in Clinical Trials of Kidney Transplantation Interventions

Quality of life for kidney transplant recipients and hemodialysis patients in Palestine: a cross-sectional study

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