scholarly journals Evaluation of meaningful change in bowel movement frequency for patients with carcinoid syndrome

2019 ◽  
Vol 3 (1) ◽  
Author(s):  
Stacie Hudgens ◽  
John Ramage ◽  
Matthew Kulke ◽  
Emily Bergsland ◽  
Lowell Anthony ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Effect Size ◽  
Carcinoid Syndrome ◽  
Bowel Movement ◽  
Life Questionnaire ◽  
Meaningful Change ◽  
Movement Frequency ◽  
Bowel Movements ◽  
Bowel Movement Frequency

Abstract Background Carcinoid syndrome is associated with a reduced quality of life that can be attributed to symptoms such as diarrhea and fatigue as well as social and financial issues. This study was conducted to psychometrically assess meaningful change in bowel movement frequency among carcinoid syndrome patients using data from the TELESTAR clinical study. Methods An anchor-based approach for deriving meaningful change thresholds consisted of mapping change from baseline bowel movement frequency to other patient-reported assessments of change. These included the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Core Questionnaire (QLQ-C30) Diarrhea Symptom responders, the EORTC Gastrointestinal NET questionnaire (GI.NET21) GI Symptom responders, and reported adequate relief at Week 12 (≥ 10-point score decrease from Day 1 to Week 12). Parameters included within-group mean change from baseline to Week 12, t-tests of the change (Wilcoxon rank sum for adequate relief), and effect size. Results There were 135 carcinoid syndrome patients with a mean baseline frequency of 5.7 bowel movements a day. A distribution-based method yielded meaningful change estimates of 0.62 bowel movements a day for overall frequency and 0.83 bowel movements a day at Week 12. Anchor-based analysis indicated a large effect size among patients who reported adequate relief at Week 12 (− 1.58; n = 18; P = 0.014), the QLQ-C30 Diarrhea domain responders (− 1.24; n = 40; P < 0.001), and the GI.NET21 GI Symptoms Domain responders (− 1.49; n = 25; P = 0.005). Exit interview data for meaningful change yielded effect size estimates of − 1.57 for overall change during the Double-blind Treatment Period and − 1.97 for change between Baseline and Week 12. Conclusions Meaningful change derivation is critical to interpret patient outcomes for evaluating treatment efficacy. In this study, carcinoid syndrome patients experienced clinically meaningful reductions in bowel movement frequency of ≥30% over 12 weeks with telotristat ethyl treatment. Trial registration NCT01677910.

Evaluation of disease-specific and functional symptom items on carcinoid tumor patients treated with telotristat ethyl.

2019 ◽  
Vol 37 (4_suppl) ◽  
pp. 427-427
Author(s):  
Stacie Hudgens ◽  
Pablo Lapuerta ◽  
Lysbeth Floden
Keyword(s):  
Quality Of Life ◽  
Weight Gain ◽  
Carcinoid Syndrome ◽  
Bowel Movement ◽  
Phase Iii ◽  
Odds Ratios ◽  
European Organisation ◽  
Movement Frequency ◽  
Bowel Movement Frequency

427 Background: Within the pivotal, phase III TELESTAR trial, telotristat ethyl significantly reduced bowel movement (BM) frequency compared to placebo ( P < 0.001) (NCT01677910). Assessing patient-related outcomes can help understand the impact of changes in BM frequency on patient lives. An analysis was done to determine whether individual items on patient-reported outcome measures show relevant patterns over the course of treatment for patients with carcinoid syndrome (CS). Methods: The TELESTAR study was a phase III, double-blind, parallel-group, randomized, placebo-controlled study comparing placebo (PBO) to telotristat ethyl (TE) in 135 patients with Carcinoid Syndrome (CS). Clinical quality of life (QoL) measurements included the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) and European Organisation for Research and Treatment of Cancer (EORTC) GI.NET21 scales. Analyses on identified individual gastrointestinal (GI) symptom and role function items were conducted using longitudinal generalized estimation equations (GEE; reference=PBO) to characterize the likelihood of a 1-grade categorical improvement (e.g., improvement by one category on the verbal response scale). Forest plots of odds ratios (OR) and associated confidence intervals (CI) on individual items are presented. Results: At week 12, the likelihood of patients experiencing a 1-grade improvement on most GI symptoms were equivalent (OR approx. 1.0). The highest odds ratios observed with TE were for improvement in diarrhea (OR=1.86, CI=0.848-4.090) and a reduction in weight bother (OR=2.95, CI=0.713-12.199), in parallel to TELESTAR results for bowel movement frequency reduction and weight gain. Interference with daily activities (IADL) and limitations in doing work demonstrated similar outcomes (IADL OR=1.63, CI=0.617,4.288; Work OR=1.97, CI=0.722,5.376). Conclusions: The overall pattern of item level change on telotristat suggested clinical relevance for bowel movement frequency reduction and weight gain, and it was consistent with symptomatic and functional benefit in CS. Clinical trial information: NCT01677910.

scholarly journals Clinically Meaningful Change in Quality of Life and Associated Factors Among Older Patients With Atrial Fibrillation

2020 ◽  
Vol 9 (18) ◽  
Author(s):  
Hawa O. Abu ◽  
Jane S. Saczynski ◽  
Jordy Mehawej ◽  
Mayra Tisminetzky ◽  
Catarina I. Kiefe ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Atrial Fibrillation ◽  
Older Patients ◽  
Logistic Models ◽  
Life Questionnaire ◽  
Meaningful Change ◽  
Patient Centered ◽  
Factors Associated ◽  
Fair Poor

Background Among older patients with atrial fibrillation, there are limited data examining clinically meaningful changes in quality of life (QoL). We examined the extent of, and factors associated with, clinically meaningful change in QoL over 1‐year among older adults with atrial fibrillation. Methods and Results Patients from cardiology, electrophysiology, and primary care clinics in Massachusetts and Georgia were enrolled in a cohort study (2015–2018). The Atrial Fibrillation Effect on Quality‐of‐Life questionnaire was used to assess overall QoL and across 3 subscales: symptoms, daily activities, and treatment concern. Clinically meaningful change in QoL (ie, difference between 1‐year and baseline QoL score) was categorized as either a decline (≤−5.0 points), no clinically meaningful change (−5.0 to +5.0 points), or an increase (≥+5.0 points). Ordinal logistic models were used to examine factors associated with QoL changes. Participants (n=1097) were on average 75 years old, 48% were women, and 87% White. Approximately 40% experienced a clinically meaningful increase in QoL and 1 in every 5 patients experienced a decline in QoL. After multivariable adjustment, women, non‐Whites, those who reported depressive and anxiety symptoms, fair/poor self‐rated health, low social support, heart failure, or diabetes mellitus experienced clinically meaningful declines in QoL. Conclusions These findings provide insights to the magnitude of, and factors associated with, clinically meaningful change in QoL among older patients with atrial fibrillation. Assessment of comorbidities and psychosocial factors may help identify patients at high risk for declining QoL and those who require additional surveillance to maximize important clinical and patient‐centered outcomes.

scholarly journals Efficacy of naloxegol on symptoms and quality of life related to opioid-induced constipation in patients with cancer: a 3-month follow-up analysis

2020 ◽  
pp. bmjspcare-2020-002249
Author(s):  
Manuel Cobo Dols ◽  
Carmen Beato Zambrano ◽  
Luis Cabezón Gutiérrez ◽  
Rodolfo Chicas Sett ◽  
María Isabel Blancas López-Barajas ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Karnofsky Performance Status ◽  
Moderate Intensity ◽  
Life Questionnaire ◽  
Inadequate Response ◽  
Patient Assessment ◽  
Patients With Cancer ◽  
Bowel Movements

ObjectivesOpioid-induced constipation (OIC) can affect up to 63% of all patients with cancer. The objectives of this study were to assess quality of life as well as efficacy and safety of naloxegol, in patients with cancer with OIC.MethodsAn observational study was made of a cohort of patients with cancer and with OIC exhibiting an inadequate response to laxatives and treated with naloxegol. The sample consisted of adult outpatients with a Karnofsky performance status score ≥50. The Patient Assessment of Constipation Quality of Life Questionnaire (PAC-QOL) and the Patient Assessment of Constipation Symptoms (PAC-SYM) were applied for 3 months.ResultsA total of 126 patients (58.2% males) with a mean age of 61.3 years (range 34–89) were included. Clinically relevant improvements (>0.5 points) were recorded in the PAC-QOL and PAC-SYM questionnaires (p<0.0001) from 15 days of treatment. The number of days a week with complete spontaneous bowel movements increased significantly (p<0.0001) from 2.4 to 4.6 on day 15, 4.7 after 1 month and 5 after 3 months. Pain control significantly improved (p<0.0001) during follow-up. A total of 13.5% of the patients (17/126) presented some gastrointestinal adverse reaction, mostly of mild (62.5%) or moderate intensity (25%).ConclusionsClinically relevant improvements in OIC-related quality of life, number of bowel movements and constipation-related symptoms were recorded as early as after 15 days of treatment with naloxegol in patients with cancer and OIC, with a good safety profile.

scholarly journals Parkinson’s Disease-Related Motor and Nonmotor Symptoms in the Lancaster Amish

2020 ◽  
Vol 54 (5) ◽  
pp. 392-397
Author(s):  
Michael D.F. Goldenberg ◽  
Xuemei Huang ◽  
Honglei Chen ◽  
Lan Kong ◽  
Teodor T. Postolache ◽  
...  
Keyword(s):  
Parkinson’S Disease ◽  
Parkinson's Disease ◽  
Daytime Sleepiness ◽  
Bowel Movement ◽  
Motor Symptoms ◽  
Nonmotor Symptoms ◽  
Case Identification ◽  
Movement Frequency ◽  
Bowel Movements ◽  
Bowel Movement Frequency

<b><i>Introduction:</i></b> Previous research has suggested that the Amish may experience a relatively high prevalence of Parkinson’s disease (PD) and/or parkinsonian motor signs. <b><i>Methods:</i></b> In a large sample from the Amish community in Lancaster County, Pennsylvania, age ≥18 years, we assessed the prevalence of self-reported PD diagnosis. For those without self-reported PD diagnosis, we assessed the frequency of PD-related motor symptoms using a 9-item questionnaire that was designed by the PD Epidemiology Research Group. Lastly, we queried study participants for the presence of 2 nonmotor symptoms that have been commonly linked to PD: bowel movement frequency and daytime sleepiness. <b><i>Results:</i></b> Among 2,025 subjects who answered the PD questionnaire, 430 were older than 60 years. Of 430 participants ≥60 years, 5 (1.2%) reported a PD diagnosis. Of those without a PD diagnosis, 10.5% reported ≥1 and 1.2% ≥ 4 motor symptoms for the 9-item PD screening questionnaire. Of the 3,789 subjects who answered the question about bowel movement frequency, 0.7% reported ≤3 bowel movements per week. Among 1,710 subjects who answered the question about daytime sleepiness, 8.1% of the participants reported “always” sleepy during the day. <b><i>Discussion:</i></b> These data neither support a markedly higher PD prevalence in the older Lancaster Amish nor do they show dramatically higher motor and/or selected nonmotor symptoms than the general population. Future studies that employ more rigorous procedures for case identification and PD-specific preclinical symptoms/tests are needed to determine the potential differences and similarities among different Amish populations and between Amish and non-Amish populations.

The Effect of Lactobacillus reuteri Supplementation in Adults with Chronic Functional Constipation: a Randomized, Double-Blind, Placebo-Controlled Trial*

2014 ◽  
Vol 23 (4) ◽  
pp. 387-391 ◽  
Author(s):  
Veronica Ojetti ◽  
Gianluca Ianiro ◽  
Annalisa Tortora ◽  
Giovanna D‘Angelo ◽  
Teresa Antonella Di Rienzo ◽  
...  
Keyword(s):  
Bowel Movement ◽  
Lactobacillus Reuteri ◽  
Controlled Trial ◽  
Functional Constipation ◽  
Stool Consistency ◽  
Double Blind ◽  
Movement Frequency ◽  
Bowel Movements ◽  
Bowel Movement Frequency ◽  
The Mean

Background & Aims: There is a growing interest for the use of probiotics for chronic constipation. A recent randomized controlled trial (RCT) showed a positive effect of Lactobacillus reuteri (L. reuteri) on bowel movement frequency in infants with chronic constipation. The aim of the present study was to evaluate the effects of L. reuteri in adult patients with functional constipation.Methods: A double-blind, placebo RCT was conducted in 40 adults (18M/22F, 35±15 years) affected by functional constipation according to the Rome III criteria. Patients were randomly assigned to receive a supplementation of L. reuteri (DSM 17938), or matching placebo for 4 weeks. The increase of bowel movements/week was the primary outcome, while the improvement of stool consistency was the secondary outcome.Results: At week 4, the mean increase in bowel movements/week was 2.6 (SD±1.14, 95% CI:1.6-3.6) in the L. reuteri group and 1.0 (SD±1. 95% CI:0.12-1.88) in the placebo group (p=0.046). At the end of the treatment, the mean bowel movements/week was 5.28±1.93 in the L. reuteri group and 3.89±1.79 in the placebo group. There was a not significant difference in the stool consistency between the two groups.Conclusions: L. reuteri is more effective than the placebo in improving bowel movement frequency in adult patients with functional constipation as previously demonstrated in children, even if it seems to have no effect on stool consistency.

scholarly journals Psychometric properties of the thyroid-specific quality of life questionnaire ThyPRO in Singaporean patients with Graves’ disease

2021 ◽  
Vol 5 (1) ◽  
Author(s):  
Huiling Liew ◽  
Torquil Watt ◽  
Luo Nan ◽  
Alvin W. K. Tan ◽  
Yiong Huak Chan ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Psychometric Properties ◽  
Internal Consistency ◽  
Effect Size ◽  
Measurement Properties ◽  
Graves Disease ◽  
Life Questionnaire ◽  
Cronbach’S Alpha ◽  
Cronbach's Alpha

Abstract Background Graves’ disease is the most common cause of hyperthyroidism. It results in accelerated tissue metabolism with multi-organ involvement ranging from cardiovascular to neuropsychological function. This results in a negative impact on the quality of life (QOL) of the individual patient. We aim to evaluate the psychometric properties of ThyPRO, a Thyroid-related Patient Reported Outcome questionnaire, and validate its use in our multi-ethnic Asian patients with Graves’ hyperthyroidism. Methods Forty-seven consecutive Graves’ hyperthyroidism patients answered the ThyPRO questionnaire at baseline and at 4 months after treatment initiation. Data were recorded for thyroid related symptoms and signs, thyroid function tests and thyroid volume. We analyzed the internal consistency using Cronbach’s alpha, construct validity by evaluating relationship between clinical variables and ThyPRO scales, ceiling and floor effects, and responsiveness of ThyPRO to treatment based on Cohen’s effect size. Results Correlations between individual scale scores and free thyroxine concentrations were moderate and statistically significant: 0.21–0.64 (p <  0.05). There was high internal consistency between the items in this instrument, Cronbach’s alpha > 0.7 for all scales. ThyPRO was responsive to the changes in QOL after treatment (Effect Size: 0.20–0.77) in 9 of the 14 scales including the hyperthyroid symptoms and psychosocial scales (Tiredness, Cognitive complaints, Anxiety, Emotional susceptibility, Impact on Social, Daily and Sex life). Conclusion This study provides evidence that ThyPRO has satisfactory measurement properties in hyperthyroid Graves’ disease patients in Singapore population with the potential to complement clinical care.

scholarly journals Effect of Intradermal Thumbtack Needle for Functional Constipation: Study Protocol for a Real- World Clinical Trial

2021 ◽  
Author(s):  
WenQian Zhao ◽  
Ying Xu ◽  
Jingjing Liao ◽  
Ji Li ◽  
Li Wang ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Clinical Trial ◽  
Real World ◽  
Functional Constipation ◽  
Assessment Tools ◽  
Life Questionnaire ◽  
Self Rating ◽  
Bowel Movements

Abstract Background: Many high-quality clinical trials have proved the efficacy of acupuncture in the improving frequency of spontaneous bowel movements, stool characteristics, and et cetera of Functional Constipation (FC) [1]. However, the high requirement of time make many patients unable to attend, this clinical trial will demonstrate the efficacy of intradermal thumbtack needle in ameliorate spontaneous bowel movement of FC.Methods: This multi-center real world clinical trial is performed involving 482 FC patients. All patients are randomly allocated into 2 group, which are group A to receive intradermal thumbtack needle twice a week for 4 weeks (intervention group n=241) or group B to take oral administration of mosapride 3 times a day for 4 weeks (control group n=241). This trial includes a 4-week treatment period and a 4-week follow-up period. The primary outcome is the number of completely spontaneous defecation per week, we use Weekly CSBMs analyze the frequency of spontaneous defecation per week during treatment and follow-up period to compared with the baseline. The secondary outcomes include FC patients’ stool consistence, gastrointestinal or anorectal symptoms, quality of life, anxiety and depression levels during treatment and follow-up period and efficacy expectations. The relevant assessment tools include: Bristol tool Form Scale (BSFS), Cleveland Constipation Score (CCS), Patient Assessment of Constipation Quality of Life Questionnaire(PAC－QOL), Self-rating Anxiety Scale (SAS) , Self-rating Depression Scale (SDS) and Efficacy Expectancy Scale. At the end, the scales filled by patients and researchers will be entered by data administrator, all the outcome assessments will be performed by independent outcome assessors and will be analyzed by professional statisticians with SPSS 25.0 software.Discussion: We hypothesize that intradermal needle is better than or equal to positive drugs in the improving frequency of spontaneous bowel movements, stool characteristics，and et cetera of FC patients . The results of this trial will provide us with a clinical basis for the application of intradermal needles in the treatment of FC.Trial registration: Chinese Clinical Trial Registry, ChinCTR2100043684.Registered on 26 February 2021.

scholarly journals Anterior Cruciate Ligament Quality of Life Questionnaire

2014 ◽  
Vol 2 (11_suppl3) ◽  
pp. 2325967114S0014
Author(s):  
Gizem Irem Kinikli ◽  
Derya Celik ◽  
Ozgur Ahmet Atay ◽  
Inci Yuksel
Keyword(s):  
Quality Of Life ◽  
Anterior Cruciate Ligament ◽  
Effect Size ◽  
Cruciate Ligament ◽  
Life Questionnaire ◽  
Turkish Version ◽  
Quality Of Life Questionnaire ◽  
Sf 36 ◽  
Anterior Cruciate

Objectives: Despite a number of questionnaires in the area of ACL injuries there is a need for cross-cultural adaptation for patients with ACL reconstruction (ACL-R). To test the measurement properties of the Turkish version of the Anterior Cruciate Ligament Quality of Life Questionnaire (ACL-QOL). Methods: One-hundred nineteen patients with ACL-R completed internal consistency, agreement, construct validity, floor and ceiling effect analyses. Eighty out of 119 patients with ACL-R completed the Turkish adapted version of the ACL-QOL questionnaire twice for the test-retest reliability. A subgroup of thirty-nine patients undergoing physiotherapy were also asked to answer the ACL-QOL questionnaire, the Lysholm knee scale (LKS), Knee Outcome Survey – Activities of Daily Living Scale (KOS-ADLS) and the Short Form-36 (SF-36) at preoperative, 16th week and 2 years post-operatively to assess responsiveness. Results: The questionnaire had high internal consistency (Cronbach α=.95). The paired t-test showed no significant difference between the test-retest means. The intraclass correlation was excellent for reliability and agreement in five domains and overall score (ICC: 0.95, 0.95, 0.97, 0.95, 0.96, and 0.95; p<0.001). The standard error of measurement (SEM) and the minumum detectable change (MDC95) were found to be 3.14 points and 8.70 points, respectively. The questionnaire showed a fair correlation (r=0.23) with (LKS) and a poor correlation (r=0.14) with (KOS-ADLS); good and very good construct validity (r=0.51, r=0.62) with SF-36 physical component score and mental component score, respectively. We observed no ceiling and floor effects overall on the ACL-QOL questionnaire except the subdomain of “work-related concerns” (22.9%). The responsiveness demonstrated a dramatic effect size of 2.12 at the 16th week and large effect size of 0.97 at 2 years follow-up. Conclusion: The Turkish version of the ACL-QOL questionnaire is a reproducible and responsive instrument that can be used in clinical studies.

Effects of Motor Symptom Laterality on Clinical Manifestations and Quality of Life in Parkinson’s Disease

2020 ◽  
Vol 10 (4) ◽  
pp. 1611-1620 ◽  
Author(s):  
Esther Cubo ◽  
Pablo Martínez-Martín ◽  
Jerónimo González-Bernal ◽  
Elena Casas ◽  
Sandra Arnaiz ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Parkinson’S Disease ◽  
Parkinson's Disease ◽  
Effect Size ◽  
Clinical Manifestations ◽  
Motor Symptom ◽  
Life Questionnaire ◽  
Motor Symptoms ◽  
The Impact

Background: The asymmetry of motor manifestations present in Parkinson’s disease (PD) suggests the existence of differences between both hemispheres. As a consequence, this asymmetry might contribute to different PD clinical phenotypes. Objective: To study the relationship between motor symptom laterality with motor, non-motor symptoms (NMS), freezing of gait (FOG), and quality of life (QoL) impairment in PD. Methods: In this cross-sectional study, we measured motor symptoms severity and complications with the Unified Parkinsons’ disease Rating Scale (UPDRS), FOG with the FOG questionnaire, QoL with the 39-item PD Quality of Life Questionnaire Summary Index, and NMS with the NMS, Visual Analogue Scales for Pain and Fatigue, Beck Depression Inventory-II, Impulsive-Compulsive Disorders, and PD Sleep and Cognitive Rating scales. We defined left and right motor laterality using the UPDRS part III. We used comparative, regression, and effect size analyses to evaluate the impact of asymmetry on motor and NMS, FOG, and QoL. Results: 342 left (LPD) and 310 right (RPD) patients, with a mean age of 62.0±8.8 years, were included. In multivariate regression analysis, LPD was associated with a greater motor (OR = 1,50, 95% CI 1.02–2.21), FOG (OR = 1.56, 95% CI 1.01–2.41), and overall NMS impairment (OR = 1.43, 95% CI 1.001–2.06), and better QoL (OR = 0.52 95% CI 0.32–0.85). Overall, only a mild effect size was found for all comparisons in which significant differences were present. Conclusion: In this large multicenter study, motor symptom laterality seems to carry a mild but significant impact on PD clinical manifestations, and QoL.

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