Quality of life (QoL) and symptom burden in patients (pts) with advanced melanoma during the treatment-free interval (TFI) after discontinuation of nivolumab (NIVO) or NIVO plus ipilimumab (IPI).

2019 ◽  
Vol 37 (15_suppl) ◽  
pp. 9568-9568
Author(s):  
Fiona Taylor ◽  
Meredith M. Regan ◽  
Dirk Schadendorf ◽  
Michael B. Atkins ◽  
Rachael Lawrance ◽  
...  
Keyword(s):  
Symptom Burden ◽  
Data Interpretation ◽  
Advanced Melanoma ◽  
Sensitivity Analyses ◽  
Placebo Patient ◽  
First Year ◽  
Utility Index ◽  
Patient Reported ◽  
Eortc Qlq C30 ◽  
Eortc Qlq

9568 Background: The TFI after discontinuation of study therapy has been reported to be longer with NIVO+IPI compared to NIVO or IPI alone, but QoL during the TFI has not been reported in advanced melanoma (MEL) studies. 1-y data from CheckMate (CM) 067 showed maintenance of QoL after treatment (tx) discontinuation with NIVO or NIVO+IPI. Here, we present long-term QoL results from CM 067 during the TFI (period off study tx and free of subsequent therapy), based on an updated 4-y dataset. Methods: In CM 067, 945 pts were randomized 1:1:1 to receive NIVO 3 mg/kg + placebo; NIVO 1 mg/kg + IPI 3 mg/kg × 4, then NIVO 3 mg/kg; or IPI 3 mg/kg × 4 + placebo. Patient-reported outcomes (PRO) were collected using the EORTC QLQ-C30 (5 functional domains, 9 symptoms, global health status) and EQ-5D-3L (utility index, visual analog scale) at baseline, on-tx visits, and follow-up (FU) visits 1 (FU1; 30 d after last dose) and 2 (FU2; 84 d after FU1). EQ-5D-3L was also collected at survival FU visits every 3 mo after FU2 in the first year and every 6 mo thereafter. Within the PRO analysis population, 480 of 764 pts who discontinued protocol tx (for any reason, including drug toxicity; n = 155) had PRO scores, collected prior to initiation of subsequent anticancer therapy, evaluated. Mean changes in PRO scores from last on-tx visit were reported for each FU visit. Results: Across tx arms, PRO scores were maintained from last on-tx visit to FU1 or FU2 for pts who discontinued for any reason. EORTC QLQ-C30 functional and symptom scales remained stable during the TFI. Among pts who discontinued tx due to toxicity, clinically meaningful deterioration in QoL was observed in a few subscales at FU1, but QoL was restored to the same level as the last on-tx visit in all except one subscale by FU2. PRO scores remained stable beyond FU2 for the EQ-5D-3L, regardless of reason for discontinuation. Data interpretation at later FU visits was limited due to smaller sample sizes. Sensitivity analyses for mean change in PRO scores from randomization to FU visits will be presented. Conclusions: QoL was maintained during the TFI, compared to last on-tx visit, in pts with MEL treated with NIVO or NIVO+IPI.

Patient-reported quality of life (QoL) of advanced melanoma patients in a Phase 3 study of nivolumab (NIVO) with or without ipilimumab (IPI) versus IPI: CheckMate 067 4-year data.

2019 ◽  
Vol 37 (15_suppl) ◽  
pp. 9551-9551
Author(s):  
Dirk Schadendorf ◽  
James M.G. Larkin ◽  
Jedd D. Wolchok ◽  
Vanna Chiarion-Sileni ◽  
Fiona Taylor ◽  
...  
Keyword(s):  
Health Status ◽  
Global Health ◽  
Mixed Model ◽  
Advanced Melanoma ◽  
Global Health Status ◽  
Mixed Model Analysis ◽  
Patient Reported ◽  
Eortc Qlq C30 ◽  
Eortc Qlq

9551 Background: Early CheckMate 067 data showed maintenance of QoL in patients with advanced melanoma treated with NIVO with or without IPI based on 1-year data; however, the long-term QoL of these patients has not been evaluated previously. The patient-reported outcomes (PRO) analyses presented here for CheckMate 067 is the first time QoL results have been evaluated in this melanoma population over a 4-year period. Methods: In CheckMate 067, 945 patients were randomized 1:1:1 to receive NIVO (3mg/kg Q2W) + placebo (PBO), NIVO+IPI (1mg/kg+3mg/kg Q3W X 4) followed by NIVO (3mg/kg Q2W), or IPI (3mg/kg Q3W X 4) + PBO. PRO data were collected using the EORTC QLQ-C30 (5 functional domains, 9 symptoms, global health status) and EQ-5D-3L (utility index, VAS) at baseline, weeks 1 and 5 of each 6-week tx cycle, and off-tx follow-up (FU) visits. Mean changes in PRO scores from baseline (randomization) were evaluated descriptively for the PRO analysis population, with conclusions drawn from time points with ≥30 patients completing assessments per tx arm. Least square mean changes from baseline were assessed using a longitudinal mixed model analysis adjusting for repeated measures, including all on-tx data for patients. Results: Completion rates at baseline ranged from 89-92% across tx arms. Of 813 patients included in the PRO analysis population (278 NIVO, 274 NIVO+IPI, 261 IPI), > 200 receiving tx remained for the first year, > 100 receiving tx remained after 2 years, and > 50 receiving tx remained after 3 years. QoL, including assessment of functioning and symptom burden, was maintained for the duration of tx and in FU, with no sustained clinically meaningful deterioration in any tx arm. Global health status (EORTC QLQ-C30) and general QoL (EQ-5D-3L VAS) were also maintained during prolonged tx. Overall, results from the mixed model analysis support the long-term maintenance of QoL over the course of tx. Conclusions: Patient-reported QoL and symptoms in patients with advanced melanoma were maintained from baseline during extended tx with NIVO with or without IPI. Clinical trial information: NCT01844505.

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

2017 ◽  
Vol 35 (4_suppl) ◽  
pp. 583-583 ◽  
Author(s):  
Stacie Hudgens ◽  
Jonathon Gable ◽  
Matthew H. Kulke ◽  
Emily Bergsland ◽  
Lowell Brian Anthony ◽  
...  
Keyword(s):  
Carcinoid Syndrome ◽  
Tryptophan Hydroxylase ◽  
Life Questionnaire ◽  
Meaningful Change ◽  
Pivotal Phase ◽  
European Organization ◽  
Gi Symptoms ◽  
Patient Reported ◽  
Eortc Qlq C30 ◽  
Eortc Qlq

583 Background: Telotristat ethyl is a tryptophan hydroxylase inhibitor in development for the treatment of carcinoid syndrome (CS) in patients who receive somatostatin analog (SSA) therapy. In TELESTAR, a pivotal Phase 3 study, telotristat ethyl significantly reduced bowel movement (BM) frequency compared to placebo. Objective: The objective of this study was to psychometrically assess meaningful change in BM frequency using data collected within the TELESTAR study. Methods: An anchor-based approach consisted of mapping change from baseline in BM frequency to other patient reported assessments of change. These included the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Core Questionnaire (EORTC QLQ-C30) Diarrhea Symptom responders, the EORTC GI.NET21 GI Symptom responders, and patient reported adequate relief at Week 12 (responders had a ≥ 10-point decrease in scores 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), effect size (ES: calculated as the difference between mean on-treatment and baseline BM frequency, divided by the standard deviation of the baseline), and related confidence intervals. Results: There were 135 patients with CS, with a mean age of 63.6 years and mean baseline BM frequency of 5.7 BM/day. Anchor-based analyses indicated significant differences in BM frequency between adequate relief groups at Week 12 (ES: -1.58 vs. -0.79; p = 0.014), responders and non-responders on the EORTC QLQ-C30 Diarrhea Symptoms domain (ES: -1.24 vs. -0.59; p < 0.0001), and responders and non-responders on the EORTC GI.NET21 GI Symptoms Domain (ES: -1.49 vs. -0.75; p = 0.0053). These corresponded to BM frequency reductions of 1.7-1.9 BM/day, or ≥ 30%. Conclusions: Results of this study indicated that patients with CS experienced clinically meaningful reductions in BM frequency of ≥ 30% over the course of 12 weeks.

scholarly journals Effects on patient-reported outcomes of “Screening of Distress and Referral Need” implemented in Dutch oncology practice

2019 ◽  
Vol 28 (7) ◽  
pp. 3391-3398
Author(s):  
Floor M. van Nuenen ◽  
Stacey M. Donofrio ◽  
Marrit A. Tuinman ◽  
Harry B. M. van de Wiel ◽  
Josette E. H. M. Hoekstra-Weebers
Keyword(s):  
Patient Reported Outcomes ◽  
Distress Screening ◽  
Social And Emotional ◽  
Distress Level ◽  
Patient Reported ◽  
Specialized Care ◽  
Eortc Qlq C30 ◽  
Screening For Distress ◽  
Oncology Practice ◽  
Eortc Qlq

Abstract Purpose This study investigated the effect of the “Screening for Distress and Referral Need” (SDRN) process (completing a screening instrument; patient-caregiver discussion about the patient’s responses, regardless of distress level, and possible referral to specialized care), implemented in Dutch oncology practice on patient-reported outcomes (PROs). Methods A non-randomized time-sequential study was conducted to compare two cohorts. Cohort 1 respondents (C1) were recruited before and cohort 2 respondents (C2) after SDRN implementation in nine Dutch hospitals. Participants completed the EORTC-QLQ-C30, HADS, Patient Satisfaction Questionnaire-III, and the Distress Thermometer and Problem List (DT&PL). Descriptive analyses and univariate tests were conducted. Results C2 respondents (N = 422, response = 54%) had significantly lower mean scores on the practical (t = 2.3; p = 0.02), social (t = 2.3; p = 0.03), and emotional PL domains (t = 2.9; p = 0.004) compared with C1 (N = 518, response = 53%). No significant differences were found on quality of life, anxiety, depression, satisfaction with care, distress level, the spiritual and physical PL domains, or on referral wish. Conclusions After implementation of SDRN, patients report significantly fewer psychosocial (practical, social, and emotional) problems on the DT/PL but responses on the other patient-reported outcomes were comparable. These results add to the mixed evidence on the beneficial effect of distress screening. More and better focused research is needed.

scholarly journals Rectal spacer hydrogel in 1.5T MR-guided and daily adapted SBRT for prostate cancer: dosimetric analysis and preliminary patient-reported outcomes

2021 ◽  
Vol 94 (1117) ◽  
pp. 20200848
Author(s):  
Filippo Alongi ◽  
Michele Rigo ◽  
Vanessa Figlia ◽  
Francesco Cuccia ◽  
Niccolò Giaj-Levra ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Planning Target Volume ◽  
Patient Reported Outcomes ◽  
Target Volume ◽  
Spacer Group ◽  
End Of Treatment ◽  
Patient Reported ◽  
Eortc Qlq C30 ◽  
Dosimetric Analysis ◽  
Eortc Qlq

Objective: The main aim of the current analysis was to explore the hypothetical advantages using rectal spacer during 1.5T MR-guided and daily adapted prostate cancer stereotactic body radiotherapy (SBRT) compared to a no-rectal spacer hydrogel cohort of patients. Methods: The SBRT-protocol consisted of a 35 Gy schedule delivered in 5 fractions. Herein, we present a dosimetric analysis between spacer and no-spacer patients. Furthermore, treatment tolerability and feasibility were preliminarily assessed according to clinicians-reported outcomes at the end of treatment and patient-reported outcomes measures (PROMs) in both arms. Toxicity and quality of life were assessed at baseline and after treatment using the Common Terminology Criteria for Adverse Events v. 5.0, International Prostatic Symptoms Score, ICIQ-SF, IIEF-5, and EORTC-QLQ-C30 and PR-25 questionnaires. Results: 120 plans (pre- and daily adaptive SBRT planning) were analyzed in 20 patients (10 patients in spacer group and 10 patients in no-spacer group) treated using 1.5T MR-guided adaptive SBRT. Statistically significant dosimetric advantages were observed in favor of the spacer insertion, improving the planning target volume coverage in terms of V33.2Gy >95% and planning target volume 37.5 Gy <2% mainly during daily-adapted SBRT. Also, rectum V32, V28 and V18Gy and bladder V35Gy <1 cc were significantly reduced in the spacer cohort. Concerning the PROMS, all questionnaires showed no difference between the pre- and post-SBRT evaluation in both arms, excepting the physical functioning item of EORTC QLQ-C30 questionnaire that was declined in the no-spacer group. Conclusion: These preliminary results strongly suggest the adoption of perirectal spacer due to dosimetric advantages not only for rectal sparing but also for target coverage. Longer follow-up is required to validate the clinical impact in terms of clinicians-reported toxicity and PROMs. Advances in knowledge: This the first experience reporting preliminary data concerning the potential dosimetric impact of rectal hydrogel spacer on MR-guided SBRT for prostate cancer.

Comparison of patient-reported late treatment toxicity (LENT–SOMA) with quality of life (EORTC QLQ-C30 and QLQ-H&N35) assessment after head and neck radiotherapy

2010 ◽  
Vol 97 (2) ◽  
pp. 270-275 ◽  
Author(s):  
Kean Fatt Ho ◽  
Damien J.J. Farnell ◽  
Jacqueline A. Routledge ◽  
Meriel P. Burns ◽  
Andrew J. Sykes ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Head And Neck ◽  
Treatment Toxicity ◽  
Patient Reported ◽  
Eortc Qlq C30 ◽  
Late Treatment ◽  
Eortc Qlq ◽  
Head And Neck Radiotherapy

Prospective Validation of the Italian Myeloproliferative Neoplasm Symptom Assessment Form (MPN-SAF: Italian) In 186 MPN Patients

Blood ◽  
2010 ◽  
Vol 116 (21) ◽  
pp. 5060-5060
Author(s):  
Robyn Scherber ◽  
Tiziano Barbui ◽  
Alessandro M. Vannucchi ◽  
Francesco Passamonti ◽  
Giovanni Barosi ◽  
...  
Keyword(s):  
Research Funding ◽  
Patient Reported Outcomes ◽  
Myeloproliferative Neoplasm ◽  
Office Visit ◽  
Symptom Assessment ◽  
Advisory Committees ◽  
Patient Reported ◽  
Eortc Qlq C30 ◽  
The Usa ◽  
Eortc Qlq

Abstract Abstract 5060 Background: The Myeloproliferative Neoplasm Symptom Assessment Form (MPN-SAF) is a concise instrument of patient reported outcomes (PRO) designed to assess the unique spectrum of symptoms present in the majority of patients (Mesa et. al. Cancer 2007). We sought to validate the Italian Translation of the MPN-SAF which addresses 19 separate symptoms reported by MPN patients. Methods: Translation: We utilized the standard practice of PRO translation in which 3 independent translations are created by 3 independent translators fluent in both languages. A fourth translator then discussed the translations with the other translators and a consensus translation was obtained. Validation: Patients self completed the MPN-SAF: Italian at the time of a physician office visit and the Italian EORTC-QLQ-C30 (a widely used instrument of PRO for cancer patients) was co-administered for validation purposes. Results: Patients and Symptomatic Burden: 186 patients were prospectively enrolled (ET (N=88; 47%), PV (N=69; 37%) and MF (N=29; 16%)) a median of 6 years (range:0-29) from their diagnosis. Patients were of a median age (62; range 29–91 years) and gender (56% females) typical of the disease. 72% (N=135) had received some form of non-aspirin medical therapy for their disease, and 68% were on therapy at the time of completing the questionnaire. Patients frequently had a history of either thrombotic events (31%) and/or hemorrhagic events (13%). The MPN-SAF measured 19 items in the enrolled patients (data summarized in Table 1). Validation Analysis: EORTC-QLQ-C30: Consistent with our experience with the MPN-SAF:English, Pearson correlations between MPN-SAF:Italian individual symptom scores and the Italian EORTC-QLQ C30 showed excellent correlations with co-validation questions including fatigue, pain, insomnia, (all p<0.001). Excellent correlations were demonstrated between EORTC-QLQ-C30 subscales and corresponding MPN-SAF measurements. Comparison with MPN-SAF:English: Comparison with 102 patients prospectively completing the MPN-SAF: English (ET=20, PV=23, MF=59) in the USA indicated very strong correlations (when controlling for MPN subtype) in the prevalence of all 19 items assessed and only subtle differences in terms of symptomatic severity for fatigue, itching and insomnia. Conclusions: The MPN-SAF:Italian is an easy to administer, clear, 19-item inventory of patient-reported outcomes that is specific to MPNs. Additionally, the instrument is validated by 1) comparison to previously validated Italian instruments and 2) the correlation with the MPN-SAF:English. Utilization of the instrument in Italian MPN clinical trials will allow for useful comparison to patients completing the MPN-SAF in other countries and will serve as a valuable clinical marker of disease symptom severity. Disclosures: Vannucchi: Novartis: Membership on an entity's Board of Directors or advisory committees. Mesa:SBio: Research Funding; Novartis: Research Funding; Celgene: Research Funding; Incyte: Research Funding; Roche: Research Funding; eisai: Research Funding; telik: Research Funding.

Minimal clinically important difference (MCID) for the functional assessment of cancer therapy: Cognitive function (FACT-Cog) in breast cancer patients.

2013 ◽  
Vol 31 (15_suppl) ◽  
pp. 6589-6589
Author(s):  
Alexandre Chan ◽  
Yu Lee Foo ◽  
Maung Shwe Ham Guo ◽  
Yuan Chuan Kee ◽  
Yee Pin Tan ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Cancer Patients ◽  
Minimal Clinically Important Difference ◽  
Cognitive Deterioration ◽  
Size Estimation ◽  
Breast Cancer Patients ◽  
Clinically Important Difference ◽  
Patient Reported ◽  
Eortc Qlq C30 ◽  
Eortc Qlq

6589 Background: Establishing the Minimal Clinically Important Difference (MCID) is essential for interpreting the clinical relevance of patient reported outcomes. This is the first study to date to determine the MCID of FACT-Cog, a 37-item validated subjective neuropsychological instrument designed to evaluate cancer patients’ perceived cognitive deterioration on their quality of life. Methods: This prospective, observational study involved 220 breast cancer patients who have completed FACT-Cog and EORTC-QLQ-C30 at two time points: baseline and at least 3 months following chemotherapy. The MCID was computed using 3 approaches: 1) an anchor-based approach utilized the validated EORTC-QLQ-C30-Cognitive Functioning scale (CF) as the anchor for patients who showed a minimal deterioration on the CF (defined as a one-step deterioration on the CF scale); 2) a Receiver Operating Characteristic (ROC) curve was used to identify an optimal MCID cut-off point for deterioration; 3) a distribution-based approach utilized the 0.33 SD, 0.5 SD and one standard error of measurement (SEM) of the total FACT-Cog score (148 points) to estimate the MCID. Results: There was moderate correlation between the mean change scores of FACT-Cog and CF (rp= 0.43, p<0.001). The CF-anchored MCID was 9.6 points (95% CI 4.4 - 14.8). MCID derived from the ROC method was 7.5 points (AUC: 0.75; sensitivity: 75.6%; specificity: 68.8%). Using the distribution-based approach, MCID corresponding to effect sizes of 0.33SD to 0.5SD of the total FACT-Cog score ranged from 6.9 – 10.3 points and one-SEM criterion resulted in a MCID estimate of 10.6 points. Combining results from all approaches, the MCID identified for FACT-Cog ranged from 6.9 – 10.6 points (4.7% to 7.2% of total score). Conclusions: A 6.9 to 10.6 points reduction of the FACT-Cog score corresponds to the smallest clinically-relevant perceived cognitive deterioration. These estimates are important as they can facilitate the interpretation of patient-reported cognitive changes and sample size estimation in future studies.

Patient-reported outcomes (PROs) from TH3RESA, a phase 3 study of trastuzumab emtansine (T-DM1) versus treatment of physician’s choice (TPC) in patients with pretreated HER2-positive advanced breast cancer.

2014 ◽  
Vol 32 (26_suppl) ◽  
pp. 153-153 ◽  
Author(s):  
Karen Bartley ◽  
Hans Wildiers ◽  
Sung-Bae Kim ◽  
Ian E. Krop ◽  
Jennifer Kang ◽  
...  
Keyword(s):  
Health Status ◽  
Objective Response ◽  
Cox Proportional Hazards ◽  
Her2 Positive ◽  
Meaningful Improvement ◽  
Symptom Bother ◽  
Patient Reported ◽  
Eortc Qlq C30 ◽  
Eortc Qlq ◽  
The Impact

153 Background: Progression-free survival and objective response rate were significantly improved with T-DM1 vs TPC in TH3RESA. The impact of treatment on quality of life is a key aspect in determining treatment value. Here we present the PRO results from the TH3RESA study. Methods: Patients were randomized 2:1 to T-DM1 (3.6 mg/kg every 21 days) or TPC. Patients were asked to complete the EORTC QLQ-C30 (a 30-item questionnaire assessing symptom bother, functioning and health status) and the EORTC QLQ-BM22 (a 22-item survey evaluating pain from bone metastases) at the start of each cycle. Data from patients with a baseline and ≥1 post-baseline assessment were included; a clinically meaningful difference was defined as ≥10 points. Time to pain progression (TPP) was assessed using the Kaplan-Meier method and Cox proportional-hazards models. Results: A greater proportion of patients in the T-DM1 arm (n=297) vs. the TPC arm (n=117) experienced a clinically meaningful improvement in global health status (57.8% [95% CI; 52.0–63.3] vs. 47.1% [95% CI; 38.4–56.4]). The most bothersome symptoms in the T-DM1 arm as measured by the EORTC QLQ-C30 were fatigue and pain. Over the first 10 T-DM1 treatment cycles, 19–30% of patients reported being impacted “quite a bit” or “very much” by fatigue, and 16–25% by pain. Nausea/vomiting and diarrhea were perceived as more tolerable, with 1–5% and 1–4% of patients reporting “quite a bit” or “very much” impact, respectively. TTP was 2.9 months in the T-DM1 arm vs 3.6 months in the TPC arm, but was not significantly different (HR 1.12 [95% CI; 0.82–1.52], p = 0.495). Mean baseline EORTC QLQ-BM22 pain scores were similar in the T-DM1 (n = 306) and TPC arms (n = 130); (25.4 ± 23.8 [SD]) and (27.3 ± 24.4), respectively. There were no clinically meaningful changes in pain levels from baseline over time in either arm. Conclusions: For patients on T-DM1, the most impactful symptoms were fatigue and pain, while the least bothersome were diarrhea and nausea/vomiting; distribution of severity of impact was relatively stable over the first 10 cycles of treatment. TPP was similar between the T-DM1 and TPC arms. Clinical trial information: NCT01419197.

Quality of Life after Free Fibula Flap Reconstruction of Segmental Mandibular Defects

2017 ◽  
Vol 34 (02) ◽  
pp. 108-120 ◽  
Author(s):  
Marcus Nyberg ◽  
Therese Karlsson ◽  
Andri Thórarinsson ◽  
Göran Kjeller ◽  
Mattias Lidén ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Symptom Burden ◽  
Free Fibula Flap ◽  
Cancer Group ◽  
Fibula Flap ◽  
Duration Of Surgery ◽  
Eortc Qlq C30 ◽  
Free Fibula ◽  
Eortc Qlq

Background Free fibula flap (FFF) is considered gold standard in the reconstruction of mandibular defects. Despite the frequent use, patients' quality of life (QoL) after reconstruction has been sparsely investigated. This study aims to evaluate QoL and outcomes in patients who have undergone FFF reconstruction of segmental mandibular defects. Methods A retrospective cohort study of consecutive patients (n = 73) operated at a single center during the years 2000 to 2014 was performed. Charts were reviewed and all living patients (n = 41) were invited to fill out three quality of life questionnaires (QLQ): SF-36, EORTC QLQ-C30, and QLQ-H&N35. Factors associated with poor outcome were derived from regression models and the results of the QLQs were compared with Swedish reference populations. Subgroup analysis was performed for two groups depending on reconstructive indication: cancer and osteoradionecrosis (ORN). Results The response rate of the QLQs was 93%. General QoL did not differ from reference populations, but the study group had significantly larger proportions of poor functioning patients in three domains in EORTC QLQ-C30: global health status, role functioning, and social functioning. Patients also reported a high incidence of poor functioning/high symptom burden in EORTC QLQ-H&N35, with a significantly higher frequency in the ORN group compared with the cancer group for the domains “swallowing” and “social eating.” The overall flap success rate was 92% and complication rate was 48%. Previous surgery had a significant association with reoperation due to bleeding, and longer duration of surgery was significantly associated with local infection. Conclusion When evaluated with validated QLQs, most patients experienced persistent functional loss in one or several domains, but still perceived a general QoL that is close to that of reference populations. Patients having ORN as the indication for surgery, as compared with cancer, reported a higher frequency of poor functioning patients in disease-specific QoL domains.

scholarly journals Functional health and symptoms in Spain before and during the COVID-19 pandemic

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Jens Lehmann ◽  
Bernhard Holzner ◽  
Johannes M. Giesinger ◽  
Andrew Bottomley ◽  
Shaad Ansari ◽  
...  
Keyword(s):  
General Population ◽  
Symptom Burden ◽  
Functional Health ◽  
Cross Sectional ◽  
Social Distancing ◽  
Global Quality ◽  
Global Quality Of Life ◽  
Eortc Qlq C30 ◽  
Eortc Qlq ◽  
The Impact

Abstract Background The impact of the coronavirus disease (COVID-19) pandemic on wellbeing and health has so far been studied using mostly cross-sectional designs. To place recent findings into context, we compared symptoms and functional health status in two independent samples assessed before and during the COVID-19 pandemic. Methods Participants were recruited via an online panel using quota sampling. We assessed symptoms, functional health, and global quality of life with the EORTC QLQ-C30 in two general population samples in Spain (collected in July 2019 and April 2020). We also assessed several COVID-19 related variables, such as adherence to social distancing. Results Data from N = 1010 participants before the pandemic (mean age 47.1 years, 50.5% female) were compared with data from N = 504 participants during the pandemic (mean age 47.1 years, 50.8% female). Participants during the pandemic (vs. before the pandemic) reported lower role functioning and emotional functioning, as well as less symptom burden. A lower degree of social distancing was associated with better functional health and lower symptom burden. Conclusion Our findings indicate an impact of the COVID-19 pandemic on functional health and symptom burden in the Spanish general population. The comparison of before and during the pandemic can be used to benchmark results raised only during the pandemic.

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