Patient-reported Gastrointestinal Symptoms Research Articles

Gastrointestinal Symptoms Profile in Gastroparesis Compared to Other Functional and Organic Gastrointestinal Diseases.

The primary objective was to compare the patient-reported gastrointestinal symptoms profiles of pediatric patients with gastroparesis to pediatric patients with 1 of 7 other functional gastrointestinal disorders and organic gastrointestinal diseases using the Pediatric Quality of Life Inventory (PedsQL) Gastrointestinal Symptoms Scales. The gastrointestinal symptoms profiles of 64 pediatric patients with gastroparesis who manifested abnormal gastric retention based on gastric emptying scintigraphy testing were compared to 582 pediatric patients with 1 of 7 physician-diagnosed gastrointestinal disorders (functional abdominal pain, irritable bowel syndrome, functional dyspepsia, gastroesophageal reflux disease, functional constipation, Crohn disease, ulcerative colitis). The PedsQL Gastrointestinal Symptoms Scales encompass 10 individual multi-item scales which measure stomach pain, stomach discomfort when eating, food and drink limits, trouble swallowing, heartburn and reflux, nausea and vomiting, gas and bloating, constipation, blood in poop, and diarrhea/fecal incontinence, with an overall total gastrointestinal symptoms score. The gastrointestinal symptoms profile analysis identified significantly worse overall total gastrointestinal symptoms scores between pediatric patients with gastroparesis compared to all other gastrointestinal groups except for irritable bowel syndrome (most P s < 0.001), with significant differences for stomach discomfort when eating compared to all 7 other gastrointestinal groups (most P s < 0.001). Nausea and vomiting were significantly worse for gastroparesis compared to all other gastrointestinal groups except for functional dyspepsia (all P s < 0.001). Pediatric patients with gastroparesis self-reported significantly worse overall total gastrointestinal symptoms compared to all other gastrointestinal diagnostic groups except for irritable bowel syndrome, with stomach discomfort when eating and nausea and vomiting symptoms exhibiting the greatest differences compared to most gastrointestinal diagnostic groups.

Patient-reported gastrointestinal symptoms following surgery for gastric cancer and the relative risk factors.

PurposeThe study aims to assess the incidence of short-term patient-reported postoperative gastrointestinal symptoms (PGISs) after gastric cancer surgery and explore the relative risk factors for the symptoms.MethodsPatients with radical gastrectomy were included for this retrospective and observational study. Symptoms extracted from the MD Anderson Symptom Inventory Gastrointestinal Cancer Module (MDASI-GI) were collected in postdischarge week (PDW) 1 and postoperative month (POM) 1. The distributing states of symptoms were analyzed in PDW1 and POM1. Logistic regression models were used to identify risk factors for PGISs.ResultsAmong 356 patients with complete interviews, 156 (43.8%) patients reported abdominal distention in PDW1, which was significantly higher than patients in POM1 [103 (28.9%), p < 0.001]. Pain (15.2% vs. 9.8%), dysphagia (5.6% vs. 7.0%), diarrhea (3.7% vs. 3.4%), and vomiting (2.5% vs. 2.8%) had no significant differences between PDW1 and POM1. Logistic models found that risk factors for PGISs were total gastrectomy [odds ratio (OR): 1.948; 95% CI: 1.097–3.459; p = 0.023] and disturbed sleep (OR: 3.116; 95% CI: 1.831–5.303; p < 0.001) in PDW1 and female gender (OR: 1.726; 95% CI: 1.071–2.782; p = 0.025), total gastrectomy (OR: 1.729; 95% CI: 1.055–2.834; p = 0.030), and disturbed sleep (OR: 3.533; 95% CI: 1.757–7.106; p < 0.001) in POM1.ConclusionsThe main symptom after gastric cancer surgery was abdominal distention. The relative risk factors for gastrointestinal symptoms after gastric cancer surgery were total gastrectomy and disturbed sleep. Timely symptom intervention may improve the quality of life of postgastrectomy patients.

Gastrointestinal Symptoms Profile in Pediatric Patients With Gastroparesis Compared to Healthy Controls.

The primary objective was to compare the patient-reported gastrointestinal symptoms profiles of pediatric patients with gastroparesis to matched healthy controls using the Pediatric Quality of Life Inventory™ (PedsQL™) Gastrointestinal Symptoms Scales. The secondary objectives were to compare pediatric patients with gastroparesis to pediatric patients with gastroparesis-like symptoms and normal gastric emptying and to compare pediatric patients with gastroparesis-like symptoms and normal gastric emptying to matched healthy controls. The PedsQL™ Gastrointestinal Symptoms Scales were completed by 64 pediatric patients with gastroparesis, 59 pediatric patients with gastroparesis-like symptoms and normal gastric emptying, and 200 age, gender, and race/ethnicity matched healthy controls. The PedsQL™ Gastrointestinal Symptoms Scales encompass 10 individual multi-item scales which measure stomach pain, stomach discomfort when eating, food and drink limits, trouble swallowing, heartburn and reflux, nausea and vomiting, gas and bloating, constipation, blood in poop, and diarrhea/fecal incontinence. Based on gastric emptying scintigraphy testing, those with abnormal gastric retention were classified as having gastroparesis. The gastrointestinal symptoms profile analysis identified large differences between those with gastroparesis compared to healthy controls (most P <0.001), with the largest effect sizes for upper gastrointestinal symptoms including stomach pain, stomach discomfort when eating, food and drink limits, nausea, and vomiting. Those with gastroparesis self-reported similar gastrointestinal symptoms to those with normal gastric emptying, except for increased constipation. Pediatric patients with gastroparesis self-reported broad multidimensional gastrointestinal symptoms profiles in comparison to healthy controls with large differences, indicating the critical need for more highly efficacious interventions to bring patient functioning within the normal range of healthy functioning.

Patient-reported gastrointestinal symptoms in patients with peritoneal dialysis: the prevalence, influence factors and association with quality of life

BackgroundThe aims of this study were to investigate the prevalence and the influence factors of gastrointestinal symptoms, and its association with the quality of life (QOL) in peritoneal dialysis (PD) patients.MethodsContinuous ambulatory PD patients (CAPD) who followed up in our PD center between March 2016 and December 2017 were enrolled in this cross-sectional study. Gastrointestinal symptom rating scale (GSRS) was used to evaluate gastrointestinal symptoms. The related clinical data were also collected. Multiple linear regression analysis was test for the influence factors associated with score of GSRS and QOL.ResultsThis study included 471 CAPD patients. The mean age was 48.5±13.9 years, 53.9% were male and 15.1% with diabetic nephropathy. The median duration of PD was 37.3 (17.5~66.5) months. The median score of GSRS was 1.2(1.1~1.3) scores. Totally 82.2% (n=387) CAPD patients had at least one gastrointestinal symptom. Higher glycosylated hemoglobin, higher score of depression, lower diastolic blood pressure, urine output, score of instrumental activities of daily living scale and more amount of pills per day were independently associated with higher score of GSRS (all P<0.05). Score of dyspepsia and eating dysfunction were independently associated with worse score of QOL and physical health (all P<0.05).ConclusionsGastrointestinal symptoms were common but not serious in CAPD patients. Glycemic control, depression, blood pressure, urine output, activity of daily life and amount of pills were all associated with gastrointestinal symptoms. Moreover, gastrointestinal symptoms were correlated with QOL of PD patients.

Severity and Persistency of Late Gastrointestinal Morbidity in Locally Advanced Cervical Cancer: Lessons Learned From EMBRACE-I and Implications for the Future

The purpose was to evaluate patient- and treatment-related risk factors for physician-assessed and patient-reported gastrointestinal (GI) symptoms after radio(chemo)therapy and image guided adaptive brachytherapy in locally advanced cervical cancer. Of 1416 patients from the EMBRACE-I study, 1199 and 1002 were prospectively evaluated using physician-assessed (Common Terminology Criteria for Adverse Events [CTCAE]) and patient-reported (European Organization for Research and Treatment of Cancer [EORTC]) GI symptoms, respectively. CTCAE severe grade (grade [G] ≥3) events were pooled according to the location in the GI tract (anus/rectum, sigmoid, and colon/small bowel). CTCAE G ≥2 and EORTC "very much" and "quite a bit" plus "very much" scores (≥ "quite a bit") were analyzed for individual symptoms with Cox regression. Logistic regression was used for persistent G ≥1 and EORTC ≥ "quite a bit" symptoms, defined if present in at least half of follow-ups. The incidence of G ≥3 events was 2.8%, 1.8%, and 2.3% for G ≥3 anus/rectum, sigmoid, and colon/small bowel events, respectively. Among G ≥2 symptoms, diarrhea and flatulence were the most prevalent (8.5% and 9.9%, respectively). Among patient-related factors, baseline morbidity, increasing age, smoking status, and low body mass index were associated with GI symptoms tovarying degrees. Among treatment-related factors, rectum D2cm3 and the International Commission on Radiation Units and Measurements recto-vaginal reference point (ICRU RV-RP) correlated with G ≥3 anus/rectum events and moderate/persistent diarrhea, proctitis, bleeding, abdominal cramps, and difficulty in bowel control. Bowel D2cm3 correlated with G ≥3 sigmoid and colon/small bowel events and moderate/persistent diarrhea and flatulence. For external beam radiation therapy (EBRT), prescription dose correlated with G ≥3 anus/rectum, diarrhea, and difficulty in bowel control. Patients with large lymph-node boost (V57Gy) were at higher risk for G ≥3 sigmoid events, moderate/persistent diarrhea, proctitis, and cramps. The analysis showed that both EBRT and image guided adaptive brachytherapy contribute to GI symptoms after locally advanced cervical cancer treatment. Rectum D2cm3, ICRU RV-RP , and bowel D2cm3 are risk factors for GI morbidity. The risk for various symptoms was lower with an EBRT prescription of 45 Gy than 50 Gy and increased with larger V57Gy.

Gastrointestinal symptoms following treatment for anorexia nervosa: A systematic literature review.

Gastrointestinal (GI) disturbances are a frequent and burdensome experience for patients with anorexia nervosa (AN). How GI symptoms respond to current interventions is not well characterized, yet is critical to facilitate treatment success, and to inform the development of new treatments for AN. Therefore, the aim of this systematic review was to identify which treatments are effective in improving GI symptoms in patients with AN. A systematic search for studies of AN treatments measuring GI symptoms pre- and post-treatment was conducted in May 2020 (PROSPERO ID: CRD42020181328). After removal of duplicates, title and abstracts of 3,370 studies were screened. Methodological quality was assessed using National Institute of Health Quality Assessment Tool. Following full-text screening, 13 studies (12 observational studies and 1 randomized double-blind placebo-controlled trial) with 401 participants met eligibility criteria and were included. All observational studies included a component of nutritional rehabilitation, with half (n=6) involving concurrent psychological treatment. The randomized controlled trial reported a drug therapy. Eleven studies reported an improvement in all (n=6) or at least one (n=5) patient-reported GI symptom following treatment. Two studies reported no change. Methodological quality was fair or poor across all studies. This is the first systematic review to synthesize available evidence on the trajectory of patient-reported GI symptoms from commencement to end of treatment for AN. The results suggest that most studies showed improvement in one or more GI symptom in response to current treatments. Future therapeutic approaches should consider GI symptoms within their design for optimal treatment adherence and outcomes.

UCLA Scleroderma Clinical Trials Consortium Gastrointestinal Tract (GIT) 2.0 Reflux Scale Correlates With Impaired Esophageal Scintigraphy Findings in Systemic Sclerosis.

The University of California Los Angeles Scleroderma Clinical Trials Consortium Gastrointestinal Tract 2.0 (GIT 2.0) instrument is a self-report tool measuring gastrointestinal (GI) quality of life in patients with systemic sclerosis (SSc). Scarce data are available on the correlation between patient-reported GI symptoms and motility dysfunction as assessed by esophageal transit scintigraphy (ETS). We evaluated the GIT 2.0 reflux scale in patients with SSc admitted to our clinic and undergoing ETS, and correlated their findings. Thirty-one patients with SSc undergoing ETS were included. Twenty-seven were female, and 9 had diffuse cutaneous SSc. Twenty-six of 31 (84%) patients had a delayed transit and an abnormal esophageal emptying activity (EA); they also had a higher GIT 2.0 reflux score (P = 0.04). Mean EA percentage was higher in patients with none to mild GIT 2.0 reflux score (81.1 [SD 11.5]) than in those with moderate (55.7 [SD 17.8], P = 0.003) and severe to very severe scores (55.8 [SD 19.7], P = 0.002). The percentage of esophageal EA negatively correlated with the GIT 2.0 reflux score (r = -0.68, P < 0.0001), but it did not correlate with the other GIT 2.0 scales and the total GIT 2.0 score. SSc patients with impaired ETS findings have a higher GIT 2.0 reflux score. The GIT 2.0 is a complementary tool for objective measurement of esophageal involvement that can be easily administered in day-to-day clinical assessment.

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

BackgroundThere has been limited study of the prevalence of gastrointestinal symptoms and their impact on the quality of life (QOL) in kidney transplant recipients. The aim of this study was to examine the prevalence and predictors of gastrointestinal symptoms and the association with QOL in kidney transplant recipients.MethodsAll chronic kidney transplant recipients at the Princess Alexandra Hospital were provided with 3 questionnaires, the Gastrointestinal Quality of Life Index (GIQLI), the Gastrointestinal Symptoms Rating Scale (GSRS), and Structured Assessment of Gastrointestinal Symptoms (SAGIS) scale, to ascertain QOL impairment and to screen gastrointestinal symptom severity. Linear regression was used to determine the predictors of gastrointestinal QOL and gastrointestinal symptom severity.ResultsOf the 343 participants, the median age was 47 (interquartile range [IQR] 36–55) years, 58% were men, 79% were white, 39% had chronic glomerulonephritis, 83% had received their first graft, and median time since transplant was 6.3 (IQR 1.8–13.1) years. Using GSRS, 88% of participants reported at least 1 gastrointestinal symptom, most commonly indigestion (57%) and diarrhea (54%). Using GIQLI, 42% and 38% of participants reported mild and moderate QOL impairment, respectively. Gastrointestinal symptoms were predicted by female sex (coefficient −0.11, 95% CI −0.21 to −0.02) and mycophenolate (coefficient 0.0001, 95% CI 0.0001 to 0.0002), and were associated with poorer QOL (coefficient −0.38, 95% CI −0.45 to −0.30). Similar findings were observed using SAGIS for gastrointestinal symptoms.ConclusionsGastrointestinal symptoms are frequent in kidney transplant recipients, particularly in women and those receiving mycophenolate, and are strongly associated with poorer QOL.

High Patient Disease Burden in a Cross-sectional, Multicenter Contact Registry Study of Eosinophilic Gastrointestinal Diseases.

Clinical features of eosinophilic esophagitis (EoE) have been well-described in the literature, however, characterization of features experienced by patients with other eosinophilic gastrointestinal diseases (EGIDs) is lacking. Using data collected from a patient contact registry, we sought to characterize and contrast patient-reported gastrointestinal and extragastrointestinal symptoms and comorbidities in non-EoE EGIDs, including eosinophilic gastritis, gastroenteritis and colitis, relative to EoE. We conducted a cross-sectional study of contact registry data collected from 2015 to 2018. Statistical comparisons were made using chi-square (categorical measures) and the Mann-Whitney U test (continuous measures). Multivariable analyses were used to evaluate associations between treatment and feelings of isolation. Of the 715 reporting an EGID diagnosis (n = 525 EoE; n = 190 non-EoE EGID), a higher proportion of those with a non-EoE EGID reported more frequent specific and nonspecific gastrointestinal symptoms, including nausea, abdominal pain, diarrhea, constipation, and bloating (P < 0.01 for all). Participants with a non-EoE EGID were more likely to report higher frequency of fatigue, isolation, and deep muscle or joint pain (P < 0.01 for all). Specific food elimination and elemental formula treatments were associated with increased odds of more frequent (at least weekly) feelings of isolation for participants with EoE (adjusted odds rtaio [aOR]: 2.4; 95% confidence interval [CI]: 1.5--4.1 for specific food elimination and adjusted OR: 1.9; 95% CI: 1.2--3.3 for elemental formula). Significant differences exist in the symptoms and comorbidities experienced between those with EoE versus non-EoE EGIDs. Additional investigation is needed to elucidate the factors that may contribute to the high disease burden of these poorly understood conditions.

Local Dose Effects for Late Gastrointestinal Toxicity After Hypofractionated and Conventionally Fractionated Modern Radiotherapy for Prostate Cancer in the HYPRO Trial.

Purpose: Late gastrointestinal (GI) toxicity after radiotherapy for prostate cancer may have significant impact on the cancer survivor's quality of life. To date, little is known about local dose-effects after modern radiotherapy including hypofractionation. In the current study we related the local spatial distribution of radiation dose in the rectum to late patient-reported gastrointestinal (GI) toxicities for conventionally fractionated (CF) and hypofractionated (HF) modern radiotherapy in the randomized HYPRO trial.Material and Methods: Patients treated to 78 Gy in 2 Gy fractions (n = 298) or 64.6 Gy in 3.4 Gy fractions (n = 295) with available late toxicity questionnaires (n ≥ 2 within 1–5 years post-treatment) and available 3D planning data were eligible for this study. The majority received intensity modulated radiotherapy (IMRT). We calculated two types of dose surface maps: (1) the total delineated rectum with its central axis scaled to unity, and (2) the delineated rectum with a length of 7 cm along its central axis aligned on the prostate's half-height point (prostate-half). For each patient-reported GI symptom, dose difference maps were constructed by subtracting average co-registered EQD2 (equivalent dose in 2 Gy) dose maps of patients with and without the symptom of interest, separately for HF and CF. P-values were derived from permutation tests. We evaluated patient-reported moderate to severe GI symptoms.Results: Observed incidences of rectal bleeding and increased stool frequency were significantly higher in the HF group. For rectal bleeding (p = 0.016), mucus discharge (p = 0.015), and fecal incontinence (p = 0.001), significant local dose-effects were observed in HF patients but not in CF patients. For rectal pain, similar local dose-effects (p < 0.05) were observed in both groups. No significant local dose-effects were observed for increased stool frequency. Total rectum mapping vs. prostate-half mapping showed similar results.Conclusion: We demonstrated significant local dose-effect relationships for patient-reported late GI toxicity in patients treated with modern RT. HF patients were at higher risk for increased stool frequency and rectal bleeding, and showed the most pronounced local dose-effects in intermediate-high dose regions. These findings suggest that improvement of current treatment optimization protocols could lead to clinical benefit, in particular for HF treatment.

Prospective Dosimetric Evaluation of Three Radiation Delivery Techniques for Spinal Metastases and Dosimetric Predictors of Gastrointestinal Toxicity

Radiation therapy (RT) is standard in the management of spine metastases. Techniques have evolved from AP-PA beams to more conformal techniques with the aim of reducing dose to organs at risk (OAR) and toxicities. However, it is unclear if more conformal planning techniques result in a clinically significant reduction in gastrointestinal (GI) toxicities. The aims of this study are to compare RT dosimetric parameters across three modalities of delivery [AP-PA, 3D conformal (3DCRT), and SBRT] and to identify dosimetric predictors of GI toxicities. From 12/2016-4/2017, patients undergoing RT for metastatic spinal tumors were enrolled in this prospective cohort study. RT technique (AP-PA, 3DCRT, SBRT) was determined prior to enrollment. GI OARs (esophagus, stomach, and bowel bag) were delineated on the planning CT scan using established RTOG guidelines. Mean dose, max dose, V5, V10, V15, V20, V25, V30, D5cc, D2cc, D1cc, and D0.035cc were recorded from dose-volume histogram data; field length was also recorded. Patient-reported GI symptoms were assessed by the validated MD Anderson Symptom Inventory (MDASI) 1 week after RT start, at RT completion, 1 and 4 weeks post-RT. The Kruskal-Wallis test assessed differences in OAR dosimetric parameters by treatment technique. Spearman correlations assessed relationships of dosimetric parameters to GI toxicities. In total, 68 patients enrolled; the esophagus received RT in 28. Significant reductions in esophageal mean dose and V20 were noted for SBRT compared to AP-PA and 3DCRT. Mean esophageal dose correlated significantly with max change in dysphagia [r=0.41 (p=0.03)], odynophagia [0.60 (0.0007)], and GERD [0.46 (0.01)]. The stomach received RT in 26 patients and significant differences were seen in nearly all dose parameters comparing APPA, 3DCRT, and SBRT. Max change in GERD correlated with stomach D0.035cc [0.43 (0.03)]. 48 patients received RT to the bowel; when comparing RT techniques, significant differences in all dose parameters were found except mean dose and V5%. Significant correlations were noted between mean bowel dose and max change in vomiting [0.33 (0.02)] and diarrhea [0.29 (0.05)]. Significant differences were noted in the dose to GI OARs when comparing treatment techniques (AP-PA, 3DCRT, and SBRT). Mean organ dose and maximal point dose were most predictive of GI toxicities.

Migalastat improves diarrhea in patients with Fabry disease: clinical-biomarker correlations from the phase 3 FACETS trial

BackgroundFabry disease is frequently characterized by gastrointestinal symptoms, including diarrhea. Migalastat is an orally-administered small molecule approved to treat the symptoms of Fabry disease in patients with amenable mutations.MethodsWe evaluated minimal clinically important differences (MCID) in diarrhea based on the corresponding domain of the patient-reported Gastrointestinal Symptom Rating Scale (GSRS) in patients with Fabry disease and amenable mutations (N = 50) treated with migalastat 150 mg every other day or placebo during the phase 3 FACETS trial (NCT00925301).ResultsAfter 6 months, significantly more patients receiving migalastat versus placebo experienced improvement in diarrhea based on a MCID of 0.33 (43% vs 11%; p = .02), including the subset with baseline diarrhea (71% vs 20%; p = .02). A decline in kidney peritubular capillary globotriaosylceramide inclusions correlated with diarrhea improvement; patients with a reduction > 0.1 were 5.6 times more likely to have an improvement in diarrhea than those without (p = .031).ConclusionsMigalastat was associated with a clinically meaningful improvement in diarrhea in patients with Fabry disease and amenable mutations. Reductions in kidney globotriaosylceramide may be a useful surrogate endpoint to predict clinical benefit with migalastat in patients with Fabry disease.Trial registrationNCT00925301; June 19, 2009.

Does the Use of Volumetric Modulated Arc Therapy Reduce Gastrointestinal Symptoms after Pelvic Radiotherapy?

AimsGrowing numbers of patients with cancer are surviving after treatment with pelvic radiotherapy. We evaluated the technique of volumetric modulated arc therapy (VMAT), which delivers a decreased dose to the organs at risk. We aimed to determine outcomes of this technique in terms of patient-reported acute toxicity and late effects and correlate the frequency of gastrointestinal symptoms with the volume of bowel receiving radiation dose. Materials and methodsPatients who were to receive VMAT for gynaecological malignancy completed patient-reported outcomes at baseline, the end of treatment, 8 weeks and 1 year. The rates of patient-reported toxicity were correlated with the volume of bowel irradiated. ResultsThe frequencies of patient-reported gastrointestinal symptoms increased in the acute toxicity phase and tended to improve at 1 year, with the exception of faecal incontinence and rectal bleeding (P < 0.05). There was not a strong association between the volume of small bowel that was irradiated (P > 0.05 at all dose levels) and reported toxicity, suggesting that other factors are involved in the development of toxicity. ConclusionAlthough VMAT decreases the dose delivered to the small bowel, this does not translate into a reduction in patient-reported toxicity.

Spatial rectal dose/volume metrics predict patient-reported gastro-intestinal symptoms after radiotherapy for prostate cancer

Background: Gastro-intestinal (GI) toxicity after radiotherapy (RT) for prostate cancer reduces patient’s quality of life. In this study, we explored associations between spatial rectal dose/volume metrics and patient-reported GI symptoms after RT for localized prostate cancer, and compared these with those of dose–surface/volume histogram (DSH/DVH) metrics.Material and methods: Dose distributions and six GI symptoms (defecation urgency/emptying difficulties/fecal leakage, ≥Grade 2, median follow-up: 3.6 y) were extracted for 200 patients treated with image-guided RT in 2005–2007. Three hundred and nine metrics assessed from 2D rectal dose maps or DSHs/DVHs were subject to 50-times iterated five-fold cross-validated univariate and multivariate logistic regression analysis (UVA, MVA). Performance of the most frequently selected MVA models was evaluated by the area under the receiving–operating characteristics curve (AUC).Results: The AUC increased for dose-map compared to DSH/DVH-based models (mean SD: 0.64 ± 0.03 vs. 0.61 ± 0.01), and significant relations were found for six versus four symptoms. Defecation urgency and faecal leakage were explained by high doses at the central/upper and central areas, respectively; while emptying difficulties were explained by longitudinal extensions of intermediate doses.Conclusions: Predictability of patient-reported GI toxicity increased using spatial metrics compared to DSH/DVH metrics. Novel associations were particularly identified for emptying difficulties using both approaches in which intermediate doses were emphasized.

Prevalence of patient-reported gastrointestinal symptoms and agreement with clinician toxicity assessments in radiation therapy for anal cancer.

Gastrointestinal (GI) symptoms pose a significant burden to patients receiving chemoradiation therapy (CRT) for anal cancer; however, the impact of symptoms from the patient perspective has not been quantified. This retrospective study examined and compared patient and clinician reports of acute GI toxicity during CRT. Patients treated with definitive RT using intensity-modulated radiation therapy for anal cancer between 9/09 and 11/12 were reviewed. Median RT dose was 56Gy (range 45-56), and 76 patients (97%) received concurrent 5-fluorouracil-based chemotherapy. During RT, patients completed the 7-item Bowel Problem Scale (BPS) weekly. Clinicians assessed toxicity separately using CTCAE v. 3.0. Scores of BPS≥3 and CTCAE≥1 were considered to be clinically meaningful. Agreement of the two assessments was evaluated by Cohen's kappa coefficient. Seventy-eight patients completed at least one BPS and had a corresponding clinician assessment. Patients reporting scores of ≥3 was highest at week 5 (n=68) for diarrhea (44.1%), proctitis (57.4%), and mucus (48.4%), while urgency (47.6%), tenesmus (31.7%), and cramping (27%) were highest at week 4 (n=63). Baseline bleeding scores (26.7%; score ≥3) improved during treatment (13.4% at week 5). "Poor" agreement was observed between patient- and clinician-reported proctitis (Cohen'sk=0.11; n=58); however, there was "good" agreement for diarrhea (Cohen'sk=0.68; n=58). Acute GI toxicity during definitive CRT for anal cancer was most significant during weeks 4-5, while rectal bleeding improved during treatment. Discrepancies in patient- and clinician-reported symptoms demonstrate the potential for patient-reported outcomes to be useful tools for anal cancer clinical assessments.

Local Protocol Variations for Image Guided Radiation Therapy in the Multicenter Dutch Hypofractionation (HYPRO) Trial: Impact of Rectal Balloon and MRI Delineation on Anorectal Dose and Gastrointestinal Toxicity Levels

The phase 3 HYpofractionated irradiation for PROstate cancer (HYPRO) trial randomized patients with intermediate- to high-risk localized prostate cancer to conventionally fractionated (78Gy in 39 fractions) or hypofractionated (64.6Gy in 19 fractions) radiation therapy. Differences in techniques and treatment protocols were present between participating centers. This study aimed to compare dose parameters and patient-reported gastrointestinal symptoms between these centers. From the trial population, we selected patients (N=572) from 4 treatment centers who received image guided (IG) intensity modulated radiation therapy (IMRT). Center A (n=242) applied planning target volume (PTV) margins of 5 to 6mm and was considered the reference center. In center B (n=170, 7-mm margins), magnetic resonance imaging (MRI) was integrated in treatment planning. An endorectal balloon (ERB) was applied in center C (n=85, 7-mm margins). Center D (n=75) applied the largest PTV margins of 8mm. The study protocol provided identical anorectal dose constraints, and local protocols were applied for further treatment optimization. Anorectal dose-surface histograms were compared by applying t tests. Rectal complaints during follow-up (6months to 4years) were compared in a generalized linear model, adjusting for age, follow-up, treatment arm, and hormone therapy. Favorable anorectal dose distributions were found for center B (MRI delineation) and center C (ERB application) as compared with centers A and D. These were associated with significantly lower incidences of patient-reported complaints of rectal incontinence, use of incontinence pads, and rectal discomfort in these centers. Furthermore, lower incidences of increased stool frequency (≥4 per day) and mucous loss were observed for center C. Despite comparable IG-IMRT techniques and predefined dose constraints, pronounced differences in dose distributions and toxicity rates were observed. MRI delineation and ERB application were associated with favorable rectal dose parameters and toxicity profiles, whereas a 2- to 3-mm difference in PTV margins did not translate into observed differences. We conclude that choices for treatment optimization of IG-IMRT are important and clinically relevant for patients since these affect symptoms experienced in daily life.

Simplification to single-tablet regimen of elvitegravir, cobicistat, emtricitabine, tenofovir DF from multi-tablet ritonavir-boosted protease inhibitor plus coformulated emtricitabine and tenofovir DF regimens: week 96 results of STRATEGY-PI

Background: Antiretroviral therapy (ART) simplification to a single-tablet regimen can benefit HIV-1-infected, virologically suppressed, individuals on ART composed of multiple pills.Objective: We assessed long-term efficacy and safety of switching to co-formulated elvitegravir, cobicistat, emtricitabine, and tenofovir disoproxil fumarate (E/C/F/TDF) from multi-tablet ritonavir-boosted protease inhibitor (PI + RTV) plus F/TDF (TVD) regimens.Methods: STRATEGY-PI was a 96-week, phase 3b, randomized (2:1), open-label, non-inferiority study examining the efficacy, safety, and tolerability of switching to E/C/F/TDF from PI + RTV + TVD regimens in virologically suppressed individuals (HIV-1 RNA <50 copies/mL). Participants were randomized to switch to E/C/F/TDF (switch group) or to continue their PI + RTV + TVD regimens (no-switch group). Eligibility criteria included no resistance to F/TDF or history of virologic failure, and estimated creatinine clearance ≥70 mL/min.Results: At week 96, 87% (252/290) of switch and 70% (97/139) of no-switch participants maintained HIV-1 RNA <50 copies/mL (difference: 17%, 95% CI 8.7–26.0%, p < 0.001). Superiority of the switch to E/C/F/TDF vs. no-switch was due to a smaller proportion of both virologic failures (switch, 1% [3/290]; no-switch, 6% [8/139]) and discontinuations for non-virologic reasons (switch, 11% [31/290]; no-switch, 24% [33/139]). No treatment-emergent resistance was observed in switch subjects with virologic failure. Discontinuation rates from adverse events were 3% in both groups (9/293, switch; 4/140, no-switch). Switching from PI + RTV + TVD to E/C/F/TDF was associated with significant improvements in patient-reported outcomes related to gastrointestinal symptoms (nausea and bloating).Conclusion: E/C/F/TDF is a safe, effective long-term alternative to multi-tablet PI + RTV + TVD-based regimens in virologically suppressed, HIV-1-infected adults, and improves patient-reported gastrointestinal symptoms.

Burden and risk factors for gastrointestinal symptom distress in HIV patients in the modern antiretroviral era

ABSTRACTIn the modern antiretroviral (ARV) era, there is limited knowledge about the prevalence and risk factors for HIV patient-reported gastrointestinal (GI) symptoms (diarrhoea/soft stool, nausea/vomiting, bloating/painful abdomen, loss of appetite, and weight loss/wasting) and distress. We prospectively analysed data (2007–2014) on distressing GI symptoms from the Ontario HIV Treatment Network Cohort Study, which follows people attending HIV clinics. Using generalized estimating equations with a logit link, we estimated the associations of psychosocial, demographic, behavioural, and clinical factors with each GI symptoms compared to asymptomatic and non-bothersome symptoms. Among 1532 included participants, 80.4% were male, mean age was 45 years, and 64.6% reported being men who have sex with men. Most were Caucasian (56.3%), a median time since HIV diagnosis of 9.8 years (interquartile range (IQR): 4.1–16.9), and 83.1% were on ARV. More than two-thirds (68.7% (95% confidence intervals (CI): 63.1% to 69.2%)) reported one or more symptoms with a median of 1.2 (IQR: 0–1.7). The proportion remained stable over time since HIV diagnosis and ARV initiation. Risk factors varied for multivariable models. A strong association with Centre for Epidemiologic Studies Depression scale scores of ≥23 was found for all symptoms. Adjusted odds ratios (95% CI) were 1.72 (1.39–2.12), 2.95 (2.33–3.72), 2.20 (1.81–2.68), 4.97 (3.99–6.19), and 2.98 (2.52–3.82) for diarrhoea, nausea/vomiting, bloating, loss of appetite, and weight loss, respectively. With the exception of bloating, odds were significantly lower for those on ARV containing integrase inhibitors and greater for patients reporting current cannabis use. GI symptoms in the modern ARV era are highly prevalent and may arise as a common pathway of distress in response to psychosocial vulnerabilities, regardless of the stage of diagnosis. These findings support the need for integrated approaches to address psychological and physical distress in HIV disease.

A Factor Analysis Approach for Clustering Patient Reported Outcomes.

In the field of radiation oncology, the use of extensive patient reported outcomes is increasingly common to measure adverse side effects after radiotherapy in cancer patients. Factor analysis has the potential to identify an optimal number of latent factors (i.e., symptom groups). However, the ultimate goal of treatment response modeling is to understand the relationship between treatment variables such as radiation dose and symptom groups resulting from FA. Hence, it is crucial to identify clinically more relevant symptom groups and improved response variables from those symptom groups for a quantitative analysis. The goal of this study is to design a computational method for finding clinically relevant symptom groups from PROs and to test associations between symptom groups and radiation dose. We propose a novel approach where exploratory factor analysis is followed by confirmatory factor analysis to determine the relevant number of symptom groups. We also propose to use a combination of symptoms in a symptom group identified as a new response variable in linear regression analysis to investigate the relationship between the symptom group and dose-volume variables. We analyzed patient-reported gastrointestinal symptom profiles from 3 datasets in prostate cancer patients treated with radiotherapy. The final structural model of each dataset was validated using the other two datasets and compared to four other existing FA methods. Our systematic EFA-CFA approach provided clinically more relevant solutions than other methods, resulting in new clinically relevant outcome variables that enabled a quantitative analysis. As a result, statistically significant correlations were found between some dose-volume variables to relevant anatomic structures and symptom groups identified by FA. Our proposed method can aid in the process of understanding PROs and provide a basis for improving our understanding of radiation-induced side effects.

The kitchen as therapy: qualitative assessment of an integrative cuisine workshop for patients undergoing chemotherapy.

Patients undergoing chemotherapy frequently suffer from gastrointestinal (GI) symptoms and functional difficulties in preparing and eating meals. We conducted a qualitative assessment of an integrative cuisine workshop program designed for patients receiving chemotherapy, examining the effects of the program on patient-reported GI symptoms and nutritional challenges. Patients were referred to a complementary/integrative medicine (CIM)-trained physician for consultation, followed by a patient-tailored treatment program. Patients with GI-related symptoms and nutritional concerns were offered a two-session integrative cuisine workshop program. The effects of the workshops were examined using inductive and deductive qualitative research methodologies. Patient narratives, as recorded in the Measure Yourself Concerns and Wellbeing (MYCAW) study tool, and electronic medical files were analyzed. Of 125 patients referred to the integrative cuisine program, 86 participated in at least one workshop. Participants and non-participants had similar demographic and disease-related characteristics, as well as quality-of-life (QOL)-related concerns. Inductive analysis suggested that participation in the workshops was helpful in developing social relationships, providing emotional support, and enhancing spirituality and nutritional awareness. Implementing the recommended changes at home led to improved QOL-related outcomes. The predominant themes derived from deductive analysis were the implementation of dietary changes and improved gastrointestinal and emotional issues. Chemotherapy-treated patients participating in an integrative cuisine workshop program showed improved QOL outcomes, specifically GI and emotional-related symptoms, and a reduction in nutritional and functional concerns. Increased knowledge and awareness of nutrition and supplement use ultimately resulted in implementation of the CIM recommendations by patients at home.