Journal articles: 'Dyspnea observation scales'

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Demoule, Alexandre, Romain Persichini, Maxens Decavèle, Capucine Morelot-Panzini, Frédérick Gay, and Thomas Similowski. "Observation scales to suspect dyspnea in non-communicative intensive care unit patients." Intensive Care Medicine 44, no. 1 (September 20, 2017): 118–20. http://dx.doi.org/10.1007/s00134-017-4934-6.

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Persichini, Romain, Frédérick Gay, Matthieu Schmidt, Julien Mayaux, Alexandre Demoule, Capucine Morélot-Panzini, and Thomas Similowski. "Diagnostic Accuracy of Respiratory Distress Observation Scales as Surrogates of Dyspnea Self-report in Intensive Care Unit Patients." Anesthesiology 123, no. 4 (October 1, 2015): 830–37. http://dx.doi.org/10.1097/aln.0000000000000805.

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Abstract Background: Dyspnea, like pain, can cause major suffering in intensive care unit (ICU) patients. Its evaluation relies on self-report; hence, the risk of being overlooked when verbal communication is impaired. Observation scales incorporating respiratory and behavioral signs (respiratory distress observation scales [RDOS]) can provide surrogates of dyspnea self-report in similar clinical contexts (palliative care). Methods: The authors prospectively studied (single center, 16-bed ICU, large university hospital) 220 communicating ICU patients (derivation cohort, 120 patients; separate validation cohort, 100 patients). Dyspnea was assessed by dyspnea visual analog scale (D-VAS) and RDOS calculated from its eight components (heart rate, respiratory rate, nonpurposeful movements, neck muscle use during inspiration, abdominal paradox, end-expiratory grunting, nasal flaring, and facial expression of fear). An iterative principal component analysis and partial least square regression process aimed at identifying an optimized D-VAS correlate (intensive care RDOS [IC-RDOS]). Results: In the derivation cohort, RDOS significantly correlated with D-VAS (r = 0.43; 95% CI, 0.29 to 0.58). A five-item IC-RDOS (heart rate, neck muscle use during inspiration, abdominal paradox, facial expression of fear, and supplemental oxygen) significantly better correlated with D-VAS (r = 0.61; 95% CI, 0.50 to 0.72). The median area under the receiver operating curve of IC-RDOS to predict D-VAS was 0.83 (interquartile range, 0.81 to 0.84). An IC-RDOS of 2.4 predicted D-VAS of 4 or greater with equal sensitivity and specificity (72%); an IC-RDOS of 6.3 predicted D-VAS of 4 or greater with 100% specificity. Similar results were found in the validation cohort. Conclusions: Combinations of observable signs correlate with dyspnea in communicating ICU patients. Future studies in noncommunicating patients will be needed to determine the responsiveness to therapeutic interventions and clinical usefulness.

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Sakuramoto, Hideaki, Chie Hatozaki, Takeshi Unoki, Gen Aikawa, Shunsuke Kobayashi, Saiko Okamoto, Shinichi Shimomura, Ayako Kawasaki, and Miwako Fukui. "Translation, reliability, and validity of Japanese version of the Respiratory Distress Observation Scale." PLOS ONE 16, no. 8 (August 11, 2021): e0255991. http://dx.doi.org/10.1371/journal.pone.0255991.

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Dyspnea is a common, distressing symptom of cardiopulmonary and neuromuscular diseases and is defined as “a subjective experience of breathing discomfort that consists of qualitatively distinct sensations that vary in intensity.” However, Japanese intensive care units (ICUs) do not routinely screen for dyspnea, as no validated Japanese version of the Respiratory Distress Observation Scale (RDOS) is available. Therefore, we aimed to translate the English version of this questionnaire into Japanese and assess its validity and reliability. To translate the RDOS, we conducted a prospective observational study in a 12-bed ICU of a universal hospital that included 42 healthcare professionals, 10 expert panels, and 128 ventilated patients. The English version was translated into Japanese, and several cross-sectional web-based questionnaires were administered to the healthcare professionals. After completing the translation process, a validity and reliability evaluation was performed in the ventilated patients. Inter-rater reliability was evaluated using Cohen’s weighted kappa coefficient. Criterion validity was ascertained based on the correlation between RDOS and the dyspnea visual analog scale. The area under the receiver operating characteristic curve analysis was used to evaluate the ability of the RDOS to identify patients with self-reported dyspnea. The average content validity index at the scale level was 0.95. Data from the 128 patients were collected and analyzed. Cohen’s weighted kappa coefficient and the correlation coefficient between the two scales were 0.76 and 0.443 (95% confidence intervals 0.70–0.82 and 0.23–0.62), respectively. For predicting self-reported dyspnea, the area under the receiver operating characteristic curve was 0.81 (95% confidence interval 0.67–0.97). The optimal cutoff used was 1, with a sensitivity and specificity of 0.89 and 0.61, respectively. Our findings indicated that the Japanese version of the RDOS is acceptable for face validity, understandability, criterion validity, and inter-rater reliability in lightly sedated mechanically ventilated patients, indicating its clinical utility.

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Bottomley, Andrew, Corneel Coens, Stefan Suciu, Mario Santinami, Willem Kruit, Alessandro Testori, Jeremy Marsden, et al. "Adjuvant Therapy With Pegylated Interferon Alfa-2b Versus Observation in Resected Stage III Melanoma: A Phase III Randomized Controlled Trial of Health-Related Quality of Life and Symptoms by the European Organisation for Research and Treatment of Cancer Melanoma Group." Journal of Clinical Oncology 27, no. 18 (June 20, 2009): 2916–23. http://dx.doi.org/10.1200/jco.2008.20.2069.

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PurposeInterferon (IFN) -based adjuvant therapy in melanoma is associated with significant side effects, which necessitates evaluation of health-related quality of life (HRQOL). Our trial examined the HRQOL effects of adjuvant pegylated IFN-α-2b (PEG-IFN-α-2b) versus observation in patients with stage III melanoma.MethodsA total of 1,256 patients with stage III melanoma were randomly assigned after full lymphadenectomy to receive either observation (n = 629) or PEG-IFN-α-2b (n = 627): induction 6 μg/kg/wk for 8 weeks then maintenance 3 μg/kg/wk for an intended total duration of 5 years. The European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire C30 was used to assess HRQOL.ResultsAt 3.8 years of median follow-up, for the primary end point, recurrence-free survival (RFS), risk was reduced by 18% (hazard rate = 0.82; P = .01) in the PEG-IFN-α-2b arm compared with observation. Significant and clinically meaningful differences occurred with the PEG-IFN-α-2b treatment arm compared with the observation group, showing decreased global HRQOL at month 3 (−11.6 points; 99% CI, −8.2 to −15.0) and year 2 (−10.5 points; 99% CI, −6.6 to −14.4). Many of the other scales showed statistically significant differences between scores when comparing the two arms. From a clinical point of view, important differences were found for five scales: two functioning scales (social and role functioning) and three symptom scales (appetite loss, fatigue, and dyspnea), with the PEG-IFN-α-2b arm being most impaired.ConclusionPEG-IFN-α-2b leads to a significant and sustained improvement in RFS. There is an expected negative effect on global HRQOL and selected symptoms when patients undergo PEG-IFN-α-2b treatment.

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Serik, S. A., O. M. Kolesnikova, A. Y. Tokarieva, and I. V. Antonova. "Evaluation of the effects of ethylmethylhydroxypyridine succinate on cognitive function and clinical-functional status of patients with chronic obstructive pulmonary disease and ischemic heart disease." Ukrainian Therapeutical Journal, no. 1 (March 27, 2023): 5–12. http://dx.doi.org/10.30978/utj2023-1-5.

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Objective — to assess the effects of ethylmethylhydroxypyridine succinate on cognitive function and clinical and functional status of patients with chronic obstructive pulmonary disease (COPD) and ischemic heart disease (IHD). Materials and methods. The study was conducted among outpatients at the clinic of the GI «L.T.Mala National Therapy Institute of NAMS of Ukraine». Examinations involved 67 patients with mean age 61.64±9.17 years. Among them, 27 were patients with COPD and IHD combination, 22 patients with isolated COPD, and 18 patients with isolated IHD. According to the study design, during telephone contact 6 months after the start of observation, all patients were administered the drug ethylmethylhydroxypyridine succinate 500 mg per day for 3 months. The evaluation of its effects on cognitive function in patients with COPD and IHD was carried at visit‑2 (after 12 months from the start of observation). All patients underwent general clinical examination, anthropometric measurements, calculation of body mass index, and spirometry before taking ethylmethylhydroxypyridine succinate (at visit‑1) and after three months of taking the drug (visit‑2). To verify the degree of dyspnea intensity, the following scales were used: five‑point scale Mediсal Research Council Dyspnea Scale in Fletcher’s modification (mMRC) and modified 10‑point Borg scale (Borg, 1982). Questionnaire САТ (COPD Assessment Test) was used to assess COPD effects on the well‑being and everyday life of the patient. Physical load tolerance was evaluated based on the 6‑minute walk test. To assess the cognitive status of patients, the Hospital Anxiety and Depression Scale scale (HADS), Generalized Anxiety Disorder test (GAD‑7), and Montreal Cognitive Assessment were used. Results. In patients with COPD, both with concomitant IHD and without it, the manifestations of shortness of breath decreased and the tolerability of physical exertion improved against the background of administration ethylmethylhydroxypyridine succinate 500 mg per day for three months. Patients with isolated IHD demonstrated improved cognitive function and reduced depressive symptoms. The anxiety decrease was observed in patients with IHD with or without concomitant COPD. Conclusions. Ethylmethylhydroxypyridine succinate can be recommended to improve cognitive function in patients with COPD and IHD.

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Eichhorst, Barbara F., Kirsten Fischer, Anna Maria Fink, Guenter Fingerle-Rowson, Anne Westermann, Clemens-Martin Wendtner, Raymonde Busch, and Michael Hallek. "Health Related Quality of Life (HRQOL) in Patients Receiving Chemoimmunotherapy with Fludarabine (F), Cyclophosphamide (C), and Rituximab (R) (FCR) or Fludarabine and Cyclophosphamide (FC) for First Line Therapy with Advanced Chronic Lymphocytic Leukemia (CLL)." Blood 114, no. 22 (November 20, 2009): 3438. http://dx.doi.org/10.1182/blood.v114.22.3438.3438.

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Abstract Abstract 3438 Poster Board III-326 INTRODUCTION Chemoimmunotherapies like the FCR combination have been shown to increase complete remission rates and progression-free survival in patients with CLL in comparison to chemotherapies without biologicals (Hallek et al., ASH 2008). Until now little is known on HRQOL outcome of CLL patients receiving chemoimmunotherapy. Therefore we assessed the HRQOL in patients with advanced CLL, who were randomized between FC and FCR treatment within an international randomized trial of the German CLL Study Group (GCLLSG). METHODS 817 pts with good physical fitness as defined by a cumulative illness rating scale (CIRS) score of up to 6 and a creatinine clearance (cr cl) ≥ 70 ml/min were enrolled between July 2003 and March 2006. Pts were randomly assigned to receive 6 courses of either FC (N=409; F 25mg/m2 i.v. d1–3 and C 250 mg/m2 i.v. d1–3; q 28 days) or FC plus R (N=408; 375 mg/m2 i.v. d 0 at first cycle and 500 mg/m2 d1 all subsequent cycles; q 28 days). The EORTC C30 questionnaires were sent to all patients included in Germany or Austria at baseline, after 3, 6, 12 months (mo) and then in yearly follow-up (FU). In all other countries questionnaires were handed out to the patients personally on the same time points during their visits in the study center. The analysis of the questionnaires was performed according to the EORTC recommendations (Aaronson et al., 1993). The questionnaire contained a global health scale, five functional scales (physical, role, cognitive, emotional and social), three symptom scales (fatigue, pain, nausea and vomiting) as well as six single items (dyspnea, appetite loss, sleep disturbances, financial impact, constipation and diarrhea). Mean score values of the EORTC scales ranged between 0 and 100. High scores in the functional scales represent good HRQOL, low scores in the symptom scales a low symptom burden. RESULTS HRQOL was evaluated in 763 (93%) of the included patients who completed at least one questionnaire (376 (49%) FC and 387 (51%) FCR treated patients). The compliance rate was significantly higher in those countries, where the questionnaire was handed out personally (96% in other countries versus 92% in Germany and Austria; P=0.013). Pts answering the baseline questionnaire and at least one further questionnaire (444; 58%) were compared to those how did not (319, 42%): pts with only one or a missing baseline questionnaire had a significantly higher CIRS score (1,7 vs 1,4; P=0.007) and more frequently leukocytopenias (24% CTC grade 3 and 4 leukocytopenias vs 13%; P< 0.001). Age, distribution of Binet stages, gender, poor prognostic factors (del(11q) or del(17p), unmutated IgVH) and treatment arms were similar distributed between both groups. There were also no differences in the rate of other toxicities or response rates. A total of 482 questionnaires were available initially, 406 at interim staging, 454 at final staging, 496 after 12 mo FU, 414 after 24 mo FU and 198 after 36 mo FU. A comparison of the two treatment arms at interim or final staging after 3 and 6 months respectively showed no significant difference between both arms with regards to the global health status, functional scales and symptom scales. Dyspnoe was scored significantly higher during FC treatment in comparison to FCR (23 versus 18; P = 0.023). At 12, 24 and 36 months of FU no significant difference between FC and FCR in all functional scales, symptom scales, single item and global health status was found. Both treatment arms showed slight improvement (defined as difference of 5-10 points) of global health status at 12 months FU in comparison to baseline (FC: 62 at baseline vs 68 at FU 12; FCR: 62 vs 70). CONCLUSIONS Although the FCR regimen is associated with a higher rate of cytopenias in patients' perception this increased hematological toxicity does not result in a difference in HRQOL between both treatment arms. After a median observation time of 38 mo the better efficacy of the FCR regimen with regards on response rates and progression-free survival does not yet result in an improved HRQOL. For the final evaluation of HRQOL outcome after chemoimmunotherapy a longer is FU is needed. Disclosures Eichhorst: Roche: Honoraria, Research Funding; Mundipharma: Research Funding; Hospira: Honoraria. Fischer:Roche: Travel Grand; Munipharma: Travel Grand. Fink:Roche: Travel Grand. Fingerle-Rowson:OrthoBiotech: Employment; Roche: Honoraria. Westermann:Roche: Travel Grand. Wendtner:Roche: Honoraria, Research Funding; Mundipharma: Honoraria, Research Funding; BayerSchering: Honoraria, Research Funding; Celgene: Honoraria, Research Funding. Hallek:Roche: Research Funding, Speakers Bureau; Mundipharma: Research Funding, Speakers Bureau.

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Burke, John M., Richard H. Van der Jagt, Brad S. Kahl, Peter Wood, Tim E. Hawkins, David MacDonald, Mark Hertzberg, et al. "Differences in Quality of Life Between Bendamustine Plus Rituximab Compared with Standard First-Line Treatments in Patients with Previously Untreated Advanced Indolent Non-Hodgkin's Lymphoma or Mantle Cell Lymphoma." Blood 120, no. 21 (November 16, 2012): 155. http://dx.doi.org/10.1182/blood.v120.21.155.155.

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Abstract Abstract 155 Background Bendamustine is a unique alkylating agent, active as monotherapy and in combination with rituximab for relapsed and refractory indolent non-Hodgkin's lymphoma (NHL). This study compared efficacy and safety of bendamustine-rituximab (BR) with standard treatment regimens of rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) and rituximab, cyclophosphamide, vincristine, and prednisone (R-CVP) in first-line treatment of patients with indolent NHL or mantle cell lymphoma (MCL). The primary objective was to determine whether the complete response rate for BR was noninferior to R-CHOP/R-CVP (presented separately). The present analysis reports results for quality of life (QOL) as measured by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (QLQ-C30). Methods Previously untreated patients with indolent NHL or MCL were randomized to receive BR (bendamustine 90 mg/m2/day on days 1 and 2; rituximab 375 mg/m2 on day 1 of each 28-day cycle) or R-CHOP/R-CVP (rituximab 375 mg/m2 and vincristine 1.4 mg/m2 (up to maximum 2 mg) on day 1 and prednisone at 100 mg on days 1–5 (of a 21-day cycle), plus either [1] cyclophosphamide 750 mg/m2 and doxorubicin 50 mg/m2 on day 1 or [2] cyclophosphamide 750 mg/m2 or 1000 mg/m2(investigator choice) on day 1. QLQ-C30 was administered at screening (baseline); after cycles 1, 3, 6, 8; and at the end-of-treatment visit. Linear transformation to standardize raw scores was performed. The QLQ-C30 is composed of 5 multi-item functional scales, 1 global health status (GHS)/QOL scale, 3 symptom scales, and 6 single-item measures; all scores could range from 0 to 100. Rising scores for functional scales and GHS/QOL indicate improvement. Rising scores for symptom scales/single items indicate worsening. GHS/QOL score change at last QLQ-C30 administration postbaseline was interpreted using analysis of covariance. Data from the last observation (end-of-treatment visit) were analyzed. Results The 447 enrolled patients were randomly assigned to 1 of the 2 treatments; 224 to BR (NHL n=187, MCL n=36, missing n=1) and 223 to R-CHOP/R-CVP (NHL n=184, MCL n=38, missing n=1). Treatment groups were well matched for demographic and clinical characteristics. Among all randomized patients, mean change in GHS/QOL score from baseline to final visit was significantly higher (indicating relative improvement) for patients treated with BR than those treated with R-CHOP/R-CVP (3.6 vs −5.1 respectively, P=0.0005). For patients with indolent NHL, mean change in GHS/QOL score by final visit was significantly higher in patients treated with BR than those receiving R-CHOP/R-CVP (2.1 vs −6.3, respectively, P=0.0021); in patients with MCL, mean change in GHS/QOL score was numerically higher in the BR group, but the difference was not statistically significant (10.9 vs 1.6, P=0.0654). All randomized patients receiving BR showed greater improvement in QLQ-C30 Emotional Functioning (from baseline to final visit), compared with patients receiving R-CHOP/R-CVP. Mean change from baseline scores (± SEM) for QLQ-C30 for Cognitive, Physical, Role, and Social Functioning scales of the QLQ-C30 decreased (signifying deteriorating effect) in both treatment groups, with patients treated with BR deteriorating less than patients treated with R-CHOP/R-CVP (Figure). For symptom scales/item measures, patients treated with BR showed larger reductions in mean scores from elevated baseline levels (signifying greater improvement), compared with R-CHOP/R-CVP for Appetite Loss (−2.9 for BR vs −1.1 for R-CHOP/R-CVP), Pain (−5.6 vs −1.7), and Constipation (−0.7 vs 1.8). For symptom scales/item measures of Dyspnea, Fatigue, and Financial Difficulties, both treatments showed deteriorating effects, with BR showing less than R-CHOP/R-CVP: Dyspnea (0.8 vs 4.8), Fatigue (0.5 vs 7.2), and Financial Difficulties (0.9 vs 1.3). Patients receiving R-CHOP/R-CVP had larger reductions in mean scores for Insomnia (−2.1 for BR vs −6.7 for R-CHOP/R-CVP), Diarrhea (0.5 vs −1.3), and Nausea and Vomiting (1.8 vs 0.9). Conclusions In this study, BR significantly improved GHS/QOL, compared with R-CHOP/R-CVP treatment, in previously untreated patients with indolent NHL or MCL. In addition, BR provided improved patient QOL scores for most aspects of functioning and symptoms, as measured by the QLQ-C30. Support: Teva Pharmaceutical Industries Ltd. Disclosures: Burke: Spectrum Pharmaceuticals: Consultancy. Off Label Use: Bendamustine is FDA-approved for adults with chronic lymphocytic leukemia or indolent B-cell non-Hodgkin's lymphoma that has progressed during or within six months of treatment with rituximab or a rituximab-containing regimen. Van der Jagt:Celgene: Consultancy, Research Funding, Sponsorship Other; Novartis: Consultancy, Research Funding, Sponsorship, Sponsorship Other; Roche: Consultancy, Sponsorship, Sponsorship Other; Teva: Consultancy, Research Funding; Incyte: Research Funding; Xanthus: Research Funding; Bristol-Myers Squibb: Consultancy. Kahl:Genentech: Membership on an entity's Board of Directors or advisory committees, Research Funding; Roche: Membership on an entity's Board of Directors or advisory committees, Research Funding; Teva: Membership on an entity's Board of Directors or advisory committees. MacDonald:Lundbeck: Membership on an entity's Board of Directors or advisory committees; Roche: Membership on an entity's Board of Directors or advisory committees, Research Funding. White:Teva Pharmaceutical Industries Ltd.: Employment. Munteanu:Teva Pharmaceutical Industries Ltd.: Employment. Clementi:Teva Pharmaceutical Industries Ltd.: Employment. Chen:Teva Pharmaceutical Industries Ltd.: Employment. Flinn:Teva: Research Funding.

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Ritchie, Ellen K., Anas Al-Janadi, Philomena Colucci, Patricia Kalafut, Dilan Paranagama, and Ruben A. Mesa. "Patient-Reported Outcomes (PRO) Data from Patients (Pts) with Essential Thrombocythemia (ET) Enrolled in the MOST Study." Blood 134, Supplement_1 (November 13, 2019): 1665. http://dx.doi.org/10.1182/blood-2019-124527.

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Introduction: ET is a chronic myeloproliferative neoplasm (MPN) characterized by thrombocytosis and an increased risk for thrombotic and hemorrhagic events. ET can be associated with substantial symptom burden, impaired quality of life (QoL), and reduced survival. PRO data pertaining to the impact of ET on QoL and symptom burden in these pts are limited. The ongoing Myelofibrosis and Essential Thrombocythemia Observational STudy (MOST) was designed to collect data about the demographics, disease burden, PROs, and management of pts with ET or myelofibrosis (MF) in clinical practices throughout the United States. This analysis describes PROs from pts with ET enrolled in MOST. Methods: MOST is a longitudinal, multicenter, noninterventional, prospective, observational study (NCT02953704). Eligible adults with ET were ≥60 years of age, had a history of thrombotic events, or were receiving ET-directed therapy. PROs were collected in conjunction with usual-care visits approximately every 6 months over a planned observation period of 36 months. Patient-reported symptom burden was assessed with the disease-specific MPN Symptom Assessment Form Total Symptom Score (MPN-SAF TSS), composed of 10 items (fatigue, early satiety, abdominal discomfort, inactivity, concentration problems, night sweats, itching, bone pain, fever [>100oF], weight loss). The MPN-SAF numbness/tingling item was also included in the questionnaire but was not included in the TSS calculation. Symptom severity was graded from 0 (absent) to 10 (worst imaginable), with a possible TSS ranging from 0 to 100. Health-related QoL was evaluated with the European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30 v3.0), composed of 5 functional scales, 3 symptom scales, 6 additional single-symptom items, and a global health/QoL scale. For functional and global health/QoL scales, higher scores indicate higher functioning and better global health/QoL, respectively. For symptom scales/items, higher scores indicate greater symptom burden. High-risk pts and low-risk pts receiving ET-directed therapy (excluding aspirin only) with baseline PRO data were included in this analysis. Data were summarized with descriptive statistics. Results: The MOST study enrolled 1234 pts with ET between Nov 29, 2016 and March 29, 2019 at 124 sites. Of these pts, 794 qualified for this analysis (data cut-off date, June 17, 2019); median age was 70 (range, 19-93) years, 80% were ≥60 years of age, 68% were women, 90% were white, 42% were working full or part-time, and 4% had a documented family history of MF, ET, or polycythemia vera. The majority of pts (87%) had high-risk ET. At enrollment, 768 pts completed the MPN-SAF. Mean (SD) TSS was 17.1 (15.6); 33% of pts had TSS ≥20. Women had higher mean (SD) TSS than men (18.5 [15.8] vs 14.2 [14.9]) and had higher mean individual symptom scores, except for weight loss and fever. The highest mean (SD) individual symptom scores were fatigue (3.4 [2.7]), numbness/tingling (2.3 [3.0]), inactivity (2.3 [2.8]), and early satiety (2.3 [2.7]) (Fig A). The most frequently reported severe symptoms (ie, score ≥7) were fatigue (17% [127/746]), numbness/tingling (14% [107/767]), and inactivity (11% [86/762]). At enrollment, 794 pts completed the EORTC QLQ-C30. The highest mean (SD) symptom scale scores (score ≥15) were fatigue (29.6 [25.8]), insomnia (28.6 [30.6]), pain (22.1 [27.9]), dyspnea (17.2 [25.5]), and constipation (15.7 [25.2]) (Fig B). The mean (SD) global health status/QoL score was 72.7 (21.9); functional scores ranged from 79.9 (21.9) for emotional functioning to 85.2 (24.1) for social functioning (Fig C). The average functional scale scores and symptom scale scores indicate higher functioning and less symptom burden, respectively, in men vs women. Conclusion: Pts with ET experienced a high symptom burden; fatigue was the most common and highest in severity. Symptom burden and quality of life scores in the current study were similar to prior reports (Emanuel J Clin Oncol 2012; Scherber Blood 2011). Women reported higher symptom burden than men in both the MPN-SAF and EORTC QLQ-30. Of note, numbness/tingling, which is not included in the MPN-SAF TSS calculation, was one of the most frequently reported severe symptoms for pts with ET in MOST. Future analyses from this trial will continue to increase understanding of the symptom burden and its impact on QoL in pts with ET. Disclosures Ritchie: Celgene, Incyte, Novartis, Pfizer: Consultancy; Genentech: Other: Advisory board; Tolero: Other: Advisory board; Pfizer: Other: Advisory board, travel support; agios: Other: Advisory board; Celgene: Other: Advisory board; Jazz Pharmaceuticals: Research Funding; Celgene, Novartis: Other: travel support; AStella, Bristol-Myers Squibb, Novartis, NS Pharma, Pfizer: Research Funding; Ariad, Celgene, Incyte, Novartis: Speakers Bureau. Al-Janadi:Incyte: Honoraria, Other: Travel, Accommodations, Expenses, Research Funding; Celgene: Honoraria, Other: Travel, Accommodations, Expenses, Research Funding, Speakers Bureau; Genentech/Abbvie: Honoraria, Other: Travel, Accommodations, Expenses, Speakers Bureau; Genentech/Roche: Honoraria, Other: Travel, Accommodations, Expenses, Speakers Bureau; Gilead Sciences: Consultancy, Honoraria, Other: Travel, Accommodations, Expenses; Sandoz-Novartis: Consultancy, Honoraria; Alexion Pharmaceuticals: Consultancy, Honoraria, Other: Travel, Accommodation, Expenses, Research Funding, Speakers Bureau; Takeda: Consultancy, Honoraria, Other: Travel, Accommodations, Expenses, Research Funding, Speakers Bureau; MEI Pharma: Research Funding; Seattle Genetics: Consultancy, Honoraria, Other: Travel, Accommodations, Expenses. Colucci:Incyte: Employment, Equity Ownership. Kalafut:Incyte: Employment, Equity Ownership. Paranagama:Incyte: Employment, Equity Ownership. Mesa:Genotech: Research Funding; Promedior: Research Funding; Sierra Onc: Consultancy; Celgene: Research Funding; AbbVie: Research Funding; Novartis: Consultancy; La Jolla Pharma: Consultancy; CTI Biopharma: Research Funding; Samus: Research Funding; Incyte: Research Funding.

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SHUBINA, KSENIIA M., VITALIY J. MISHLANOV, IGOR G. NIKITIN, KSENIIA N. BEKKER, VERONIKA V. EMELKINA, and IGOR V. SHUBIN. "THE ROLE OF SUBJECTIVE AND OBJECTIVE CRITERIA IN THE ASSESSMENT OF THE STATE OF PATIENTS WITH BRONCHOBSTRUCTIVE DISEASES IN REMOTE MONITORING CONDITIONS." Bulletin of Contemporary Clinical Medicine 16, no. 2 (April 2023): 64–71. http://dx.doi.org/10.20969/vskm.2023.16(2).64-71.

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Introduction. Wearable or home electronic devices with the function of transmitting information at a distance are used for the purpose of remote dynamic monitoring of the condition of patients. Aim. To determine the effectiveness of the use of "new" criteria for assessing the health status of patients with broncho-obstructive diseases in order to monitor remotely. Material and methods. 28 patients with broncho-obstructive diseases who were admitted for inpatient treatment were examined. Most of them had comorbidities, mainly cardiovascular pathology. A general clinical examination and special research methods were performed: an interactive survey using the respiratory module of the Electronic Polyclinic program, remote monitoring of vital signs using a smart watch and a mobile application for recording and transmitting information, a 6-minute walk test with simultaneous recording of vital signs with using a smart watch, a questionnaire and a scale for assessing the usability of the System usability scale system. The analysis of the results was performed by using the Statistica 13.0 software package. Results and discussion. Interactive survey corresponded to the severity of dyspnea according to the mMRC and Borg scales. The 6-minute walk test showed a significant limitation of physical activity and an increase in heart rate. The deep sleep phase has been limited. The CRP index averaged 7.78±8.48 µg/l. More than 85% of patients expressed their willingness to continue observation. The results of the correlation analysis demonstrated a direct relationship with the patient's physical activity assessment and the results of the 6-minute walk test, and an inverse relationship with the 6-minute walk test result and the patients' age, severity of respiratory failure and CRP concentration. The duration of deep sleep is inversely correlated with the SpO2 value. Our studies made it possible to compare the obtained data with the results of traditional methods of examining a patient, to confirm the position that the physical activity of a patient with broncho-obstructive disease is connected with indicators of the function of external respiration, and also that the total duration of sleep of COPD patients mainly consists of light sleep with a decrease in the duration of deep sleep. An inverse relationship was found with the duration of deep sleep and the concentration of CRP and the value of SpO2. The described monitoring system allows you to timely adjust the treatment regimen, reduce the number of hospitalizations, the risk of exacerbation or death.Conclusion. Additional instrumental control of vital parameters increases the efficiency of the system of long-term remote monitoring of patients with broncho-obstructive diseases. the indicators represent the severity of the symptoms of the disease and the degree of violations of the indicators of the function of external respiration.

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Scaturro, Dalila, Fabio Vitagliani, Vito Emanuele Di Bella, Vincenzo Falco, Sofia Tomasello, Lorenza Lauricella, and Giulia Letizia Mauro. "The Role of Acetyl-Carnitine and Rehabilitation in the Management of Patients with Post-COVID Syndrome: Case-Control Study." Applied Sciences 12, no. 8 (April 18, 2022): 4084. http://dx.doi.org/10.3390/app12084084.

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Post-COVID syndrome is characterized by the persistence of nonspecific disabling symptoms, even several months after the resolution of the infection, with clinical characteristics similar to fibromyalgia (FM) and a prevalence of 31%. We evaluated the effectiveness of physical exercise, in association with L-acetyl-carnitine (ALC) therapy, in patients with Post-COVID syndrome, on musculoskeletal pain, dyspnea, functional capacity, quality of life, and depression. We conducted an observational case-control study on patients with Post-COVID syndrome. The patients were randomly divided into two groups: a treatment group that received rehabilitation treatment in combination with ALC 500 mg therapy; a control group that received only rehabilitation treatment. Patients were assessed at the time of recruitment (T0) and one month after the end of therapy (T1), with the administration of rating scales: NRS, Barthel Dyspnea Index (NPI), 12-Item Short Form Survey (SF-12) scale, Fibromyalgia Impact Questionnaire (FIQ), and Patient Health Questionnaire (PHQ-9). The treatment group showed statistically higher variations in pain scores, quality of life, and depression. No statistically significant differences between the two groups emerged regarding changes in dyspnea and functional capacity scores. Combining exercise with ALC is a promising and effective treatment in the management of Post-COVID syndrome, especially for musculoskeletal pain, depression, and quality of life.

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Al-Sawaf, Othman, Brittany Gentile, Jacob Devine, Kavita Sail, Maneesh Tandon, Anna-Maria Fink, Nadine Kutsch, Barbara F. Eichhorst, Kirsten Fischer, and Michael Hallek. "Rapid Improvement of Patient-Reported Outcomes with Venetoclax Plus Obinutuzumab in Patients with Previously Untreated CLL and Coexisting Conditions: A Prospective Analysis from the CLL14 Trial." Blood 134, Supplement_1 (November 13, 2019): 4305. http://dx.doi.org/10.1182/blood-2019-126542.

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Background Chronic lymphocytic leukemia (CLL) primarily affects elderly patients, who regularly present with clinically relevant coexisting conditions. Improvement and maintenance of health-related quality of life (QoL) is an important objective of effective therapies. In the phase 3 CLL14 trial, elderly patients with CLL and comorbidities were randomized to receive either chlorambucil-obinutuzumab (ClbG) or venetoclax-obinutuzumab (VenG) over 12 cycles. In the primary analysis, treatment with VenG achieved significantly longer progression-free survival compared with ClbG (Fischer et al, 2019). Here, we report data from a longitudinal observation of patient-reported outcomes (PRO) focusing on functioning, symptoms, and QoL in patients treated in CLL14. Methods Paper PRO questionnaires were completed at each treatment cycle and every 3 months during follow-up. Disease- and treatment-related symptoms were assessed using the M.D. Anderson Symptom Inventory (MDASI) with the CLL module. Lower MDASI scores (range 0-10) indicate lower symptom severity or interference. Changes in physical functioning, role functioning, and global health status (GHS)/QoL were assessed using the EORTC Quality of Life Questionnaire Core 30 (EORTC QLQ-C30). Higher scores (range 0-100) for the functioning scales and global health status denote a better level of functioning (i.e. a better state of the patient), while higher scores on the symptom and single-item scales indicate a higher level of symptoms (i.e. a worse state of the patient). All scores are given as mean values for all patients per study arm. Results At baseline, compliance was 100% for both the EORTC and MDASI questionnaires, and completion rates remained above 90% throughout treatment and 85% throughout follow-up until month 18 after completion of study treatment. Median observation time was 28.1 months. At the start of treatment, physical function (mean 75.9 [standard deviation (SD) ±20.1] in the ClbG arm and 76.9 (±19.4) in the VenG arm), role function (73.6 [±27.86] and 72.6 [±26.9]) and GHS/QoL (63.6 [±21.0] and 60.3 [±20.5]) were comparable between treatment arms. Overall, patients reported moderate-to-high functioning and GHS/QoL, and low symptom severity, with dyspnea (21.3 [± 25.6] and 24.8 [±27.76]), fatigue (35.8 [±23.3] and 39.2 [±24.7]) and insomnia (26.9 [±29.0] and 30.8 [±30.5]) being the most severe symptoms at baseline, followed by pain (16.8 [±22.1] and 18.4 [±25.6]), appetite loss (14.7 [±23.6] and 15.6 [±26.7]), and constipation (10.9 [±20.9] and 12.8 [±23.7]). Baseline levels of physical and role functioning were maintained throughout treatment and follow-up, with no relevant improvement or deterioration. On average, patients treated with VenG showed a meaningful improvement of GHS/QoL during treatment and follow-up by at least 8 points at cycle 3, whereas less pronounced and consistent improvement was observed with ClbG at cycle 8 (Figure 1). Insomnia and fatigue scales likewise demonstrated improvement starting at cycle 3 in the VenG arm, whereas this was observed later at cycle 4 and 6, respectively, in the ClbG arm (Figures 2 and 3). According to MDASI scoring, CLL symptoms (1.5 [±1.2] and 1.6 [±1.3]), core cancer symptoms (1.5 [±1.4] and 1.8 [±1.7]), and symptom interference (2.1 [±2.3] and 2.3 [±2.3]) were generally low and comparable between treatment arms at baseline. No clinically meaningful improvements or deterioration were observed for either arm during treatment and follow-up (Figure 4). Conclusion Overall, patients treated in CLL14 with either ClbG or VenG experienced no impairment to baseline physical functioning, role functioning, and global health status/QoL during treatment and follow-up, nor increase in symptom burden and interference. This status was maintained after treatment completion and into follow-up. This analysis also shows that patients treated with VenG showed earlier improvement on the GHS/QoL scale by approximately 5 months on average compared with patients treated with ClbG. Earlier relief from insomnia and fatigue was observed with VenG, as well. As elderly patients with CLL typically experience impairment of QoL, particularly when suffering from various other conditions, such improvement should be considered a main therapeutic goal. Our data confirm that rapid and sustained improvement of QoL as measured by PRO can be achieved with a tolerable, fixed-duration treatment with VenG. Disclosures Al-Sawaf: Gilead: Honoraria, Membership on an entity's Board of Directors or advisory committees, Other: travel support; AbbVie: Honoraria, Membership on an entity's Board of Directors or advisory committees, Other: travel support; Janssen: Membership on an entity's Board of Directors or advisory committees, Other: travel support; Roche: Honoraria, Membership on an entity's Board of Directors or advisory committees, Other: travel support. Gentile:Genentech, Inc.: Employment. Devine:Genentech: Employment, Other: stock options; AbbVie: Other: Alliance Partner. Sail:AbbVie: Employment, Other: and may hold stock or stock options. Tandon:Roche: Equity Ownership; Roche Products Ltd: Employment. Fink:Celgene: Research Funding; Janssen: Membership on an entity's Board of Directors or advisory committees; Roche: Other: travel grants. Kutsch:Gilead Sciences, Inc.: Research Funding; Mundipharma, AbbVie, Janssen: Other: Travel, accomodation, expenses. Eichhorst:Gilead Sciences, Inc.: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding, Speakers Bureau; Janssen: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding, Speakers Bureau; Roche: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding, Speakers Bureau; Novartis: Consultancy, Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; Celgene: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; AbbVie: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding, Speakers Bureau; ArQule: Membership on an entity's Board of Directors or advisory committees; BeiGene: Research Funding. Fischer:AbbVie: Honoraria, Membership on an entity's Board of Directors or advisory committees; Roche: Other: travel grants. Hallek:Janssen: Membership on an entity's Board of Directors or advisory committees, Research Funding, Speakers Bureau; Roche: Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding, Speakers Bureau; AbbVie: Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding, Speakers Bureau; Gilead: Membership on an entity's Board of Directors or advisory committees, Research Funding, Speakers Bureau; Celgene: Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; Boehringer Ingelheim: Membership on an entity's Board of Directors or advisory committees, Speakers Bureau.

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Regnard, Jacques, Mathieu Veil-Picard, Malika Bouhaddi, and Olivier Castagna. "A neoprene vest hastens dyspnoea and leg fatigue during exercise testing: entangled breathing and cardiac hindrance?" Diving and Hyperbaric Medicine Journal, no. 4 (December 20, 2021): 376–81. http://dx.doi.org/10.28920/dhm51.4.376-381.

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Symptoms and contributing factors of immersion pulmonary oedema (IPO) are not observed during non-immersed heart and lung function assessments. We report a case in which intense snorkelling led to IPO, which was subsequently investigated by duplicating cardiopulmonary exercise testing with (neoprene vest test – NVT) and without (standard test – ST) the wearing of a neoprene vest. The two trials utilised the same incremental cycling exercise protocol. The vest hastened the occurrence and intensity of dyspnoea and leg fatigue (Borg scales) and led to an earlier interruption of effort. Minute ventilation and breathing frequency rose faster in the NVT, while systolic blood pressure and pulse pressure were lower than in the ST. These observations suggest that restrictive loading of inspiratory work caused a faster rise of intensity and unpleasant sensations while possibly promoting pulmonary congestion, heart filling impairment and lowering blood flow to the exercising muscles. The subject reported sensations close to those of the immersed event in the NVT. These observations may indicate that increased external inspiratory loading imposed by a tight vest during immersion could contribute to pathophysiological events.

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Brinkkemper, Tijn, Arjanne M. van Norel, Karolina M. Szadek, Stephan A. Loer, Wouter WA Zuurmond, and Roberto SGM Perez. "The use of observational scales to monitor symptom control and depth of sedation in patients requiring palliative sedation: A systematic review." Palliative Medicine 27, no. 1 (November 1, 2011): 54–67. http://dx.doi.org/10.1177/0269216311425421.

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Background: Palliative sedation is the intentional lowering of consciousness of a patient in the last phase of life to relieve suffering from refractory symptoms such as pain, delirium and dyspnoea. Aim: In this systematic review, we evaluated the use of monitoring scales to assess the degree of control of refractory symptoms and/or the depth of the sedation. Design: A database search of PubMed and Embase was performed up to January 2010 using the search terms ‘palliative sedation’ OR ‘terminal sedation’. Data sources: Retro- and prospective studies as well as reviews and guidelines containing information about monitoring of palliative sedation, written in the English, German or Dutch language were included. Results: The search yielded 264 articles of which 30 were considered relevant. Most studies focused on monitoring refractory symptoms (pain, fatigue or delirium) or the level of awareness to control the level of sedation. Four prospective and one retrospective study used scales validated in other settings: the Numeric Pain Rating Scale, the Visual Analogue Scale, the Memorial Delirium Assessment Scale, the Communication Capacity Scale and Agitation Distress Scale. Only the Community Capacity Scale was partially validated for use in a palliative sedation setting. One guideline described the use of a scale validated in another setting. Conclusions: A minority of studies reported the use of observational scales to monitor the effect of palliative sedation. Future studies should be focused on establishing proper instruments, most adequate frequency and timing of assessment, and interdisciplinary evaluation of sedation depth and symptom control for palliative sedation.

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Folch Ayora, Ana, Loreto Macia-Soler, María Isabel Orts-Cortés, Carmen Hernández, and Nuria Seijas-Babot. "Comparative analysis of the psychometric parameters of two quality-of-life questionnaires, the SGRQ and CAT, in the assessment of patients with COPD exacerbations during hospitalization: A multicenter study." Chronic Respiratory Disease 15, no. 4 (March 12, 2018): 374–83. http://dx.doi.org/10.1177/1479972318761645.

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The aim of this study was to assess health-related quality of life (HRQL) in patients with chronic obstructive pulmonary disease (COPD) and to discuss the different tools available for its assessment. The most widely used assessments are the St. George respiratory questionnaire (SGRQ) and the COPD assessment test (CAT) questionnaire. Both have a different difficulty in exam completion, calculation, and scoring. No studies exist that analyze the validity and internal consistency of using both questionnaires on patients admitted to the hospital for a COPD exacerbation. A multicenter, cross-sectional analytic observational study of patients admitted to the hospital due to a COPD exacerbation (CIE 491.2). During their hospital stay, they were administered the SGRQ and the CAT questionnaire within the framework of a therapeutic education program (APRENDEPOC). Descriptive and comparative analysis, correlations between the scales (Pearson’s correlation index), consistency and reliability calculations (Cronbach’s α), and a forward stepwise multiple linear regression were performed, with significant correlations in both questionnaires considered p < 0.01 with the total scores. A statistical significance of p < 0.05 was assumed. Altogether, 231 patients were admitted for a COPD exacerbation ( n = 77) at Hospital Clínic of Barcelona (HCB) and ( n = 154) at Hospital Universitario General of Castellón (HUGC). The sample profile was not homogeneous between both centers, with significant differences in HRQL between hospitals. Correlation were noted between both scales ( p < 0.01), along with high levels of internal consistency and reliability (CAT 0.836 vs. SGRQ 0.827). The HRQL is related to dyspnea, wheezing, daytime drowsiness, and edema, as well as to the need to sleep in a sitting position, anxiety, depression, and dependence on others in the execution of daily activities. Our regression analysis showed that the SGRQ questionnaire could predict more changes in HRQL with a higher number of variables.

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Delforge, Michel, Hadewijch De Samblanx, Hilde Demuynck, Greet Bries, Philippe Mineur, Nathalie Meuleman, Fritz Offner, et al. "International Observational Study On Bortezomib (VELCADE) in Relapsed Multiple Myeloma: Preliminary Efficacy and Quality of Life (QoL) Results From the Belgian Population." Blood 114, no. 22 (November 20, 2009): 4523. http://dx.doi.org/10.1182/blood.v114.22.4523.4523.

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Abstract Abstract 4523 Introduction Bortezomib (VELCADE) is a proteasome inhibitor for treatment of MM. The eVOBS (electronic VELCADE Observational Study) evaluates treatment and clinical outcome with bortezomib in daily practice in the relapsed setting. Enrollment in the study started in Oct 06 and is still continuing, with 3 y follow-up for every enrolled patient. This report concerns preliminary efficacy and Quality of Life (QoL) results of 136 Belgian patients included in the latest interim analysis from June 2009. Patients and Methods Adults were eligible for study if they were scheduled to initiate bortezomib within the approved indication. All bortezomib dosages and concomitant treatments were permitted, except investigational therapies. Due to the non-interventional nature of the study, no predefined response criteria were mandated; response criteria included M-protein, EBMT, SWOG, or others as defined by the investigator. QoL assessment was conducted in Belgium only, using the EORTC Quality of Life Core Questionnaire (QLQ-C30). The EORTC QLQ-C30 comprises a global health status (GHS) scale, five functional scales and six symptom scales. The questionnaire was administered at baseline and at the start of each treatment cycle. Evolution of mean scores was determined in correlation with baseline characteristics and response. Results were also analyzed for all patients and responders (partial response (PR) or better) vs. non-responders. For this, a mixed model was used comparable to that described by Lee et al. [BJH (2008) 143, 511-519], with missing data due to death being assigned the lowest possible score (model A) vs. being treated as missing (model B). Predictive value of baseline QoL scores for Overall Survival (OS) and Progression Free Survival (PFS) was assessed. Results One hundred thirty six patients (57% male) are included in this analysis, with median age of 65y, and mean time since MM diagnosis of 2.9 years. Prior number of therapies received was 1 in 56%, 2 in 27%, and 3 or more in 11%. Five % received bortezomib in first line and for 1% data were missing. 97% of patients started bortezomib at 1.3 mg/m2 on the standard schedule. Median treatment duration was 5 cycles. Of the 97 patients that were evaluated for response so far, overall response rate was 69%, with 57% PR and 12% CR/nCR. 14% and 9% of patients reached MR and SD, respectively. 78% of all enrolled patients experienced AEs of any grade, which led to discontinuation of treatment in 30%, comparable with the 37% in the APEX trial (Richardson, NEJM 2005). For QOL assessment 103 patients completed the EORTC QLQ C-30 at baseline, with this number decreasing substantially in subsequent cycles (n=42 by cycle 4). Using model A (death = worst possible outcome), a small but significant decline in QoL was seen for physical, role, emotional, cognitive and social functioning, and for symptom scales of nausea and vomiting and financial impact. Of these, only the decline in cognitive functioning remained significant when applying model B (death = missing). In the APEX trial as well there was a decline in GHS as well as in 8 of the EORTC scale scores (Lee et al BJH 2008). No significant differences were seen according to baseline data (gender, age, line of therapy, lab values). Using model A, the evolution of QoL scores was significantly worse for non-responders vs. responders on the scales of physical, cognitive and emotional functioning, nausea and vomiting, sleep disturbance, diarrhea and financial impact. When using model B, no significant differences in QOL between responder and non-responder groups were detected. Worse baseline scores for nausea and vomiting and dyspnoea were predictive for worse PFS, but only dyspnoea was predictive for worse OS. Conclusion Overall in this study a slight decline was seen for some QoL parameters over the course of treatment, consistent with findings from the APEX trial (Lee et al. BJH 2008), which included patients similar to those in the eVOBS trial (Zervas IMW 2009). Using the model that assigns “worst possible outcomes” to data missing because of death, better QoL was seen in responders vs. non-responders, suggesting better QoL is at least partly linked to response. Interpretation should be done with caution due to the number of patients and the decreasing number of returned questionnaires over time. Disclosures: Delforge: Janssen-Cilag: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees; Celgene: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees. Van Droogenbroeck:Celgene: Consultancy; BMS: Consultancy; Novartis: Consultancy; Janssen-Cilag: Consultancy. Kuijten-Celzo:Johnson & Johnson: Employment. Diels:Johnson & Johnson: Employment. Ganguly:Johnson & Johnson: Employment, Equity Ownership. Dhawan:Johnson and Johnson Research Pharmaceuticals: Employment.

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Kitsios, Georgios D., Shawna Blacka, Jana J. Jacobs, Taaha Mirza, Asma Naqvi, Heather Gentry, Cathy Murray, et al. "Subphenotypes of self-reported symptoms and outcomes in long COVID: a prospective cohort study with latent class analysis." BMJ Open 14, no. 3 (March 2024): e077869. http://dx.doi.org/10.1136/bmjopen-2023-077869.

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ObjectiveTo characterise subphenotypes of self-reported symptoms and outcomes (SRSOs) in postacute sequelae of COVID-19 (PASC).DesignProspective, observational cohort study of subjects with PASC.SettingAcademic tertiary centre from five clinical referral sources.ParticipantsAdults with COVID-19 ≥20 days before enrolment and presence of any new self-reported symptoms following COVID-19.ExposuresWe collected data on clinical variables and SRSOs via structured telephone interviews and performed standardised assessments with validated clinical numerical scales to capture psychological symptoms, neurocognitive functioning and cardiopulmonary function. We collected saliva and stool samples for quantification of SARS-CoV-2 RNA via quantitative PCR.Outcomes measuresDescription of PASC SRSOs burden and duration, derivation of distinct PASC subphenotypes via latent class analysis (LCA) and relationship with viral load.ResultsWe analysed baseline data for 214 individuals with a study visit at a median of 197.5 days after COVID-19 diagnosis. Participants reported ever having a median of 9/16 symptoms (IQR 6–11) after acute COVID-19, with muscle-aches, dyspnoea and headache being the most common. Fatigue, cognitive impairment and dyspnoea were experienced for a longer time. Participants had a lower burden of active symptoms (median 3 (1–6)) than those ever experienced (p<0.001). Unsupervised LCA of symptoms revealed three clinically active PASC subphenotypes: a high burden constitutional symptoms (21.9%), a persistent loss/change of smell and taste (20.6%) and a minimal residual symptoms subphenotype (57.5%). Subphenotype assignments were strongly associated with self-assessments of global health, recovery and PASC impact on employment (p<0.001) as well as referral source for enrolment. Viral persistence (5.6% saliva and 1% stool samples positive) did not explain SRSOs or subphenotypes.ConclusionsWe identified three distinct PASC subphenotypes. We highlight that although most symptoms progressively resolve, specific PASC subpopulations are impacted by either high burden of constitutional symptoms or persistent olfactory/gustatory dysfunction, requiring prospective identification and targeted preventive or therapeutic interventions.

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Hajdon, Aleksandra, Renata Dziubaszewska, Bożena Chmielowska, and Dawid Makowicz. "Health problems of the patient after oncological treatment for osteosarcoma with persistent thymus." Pielegniarstwo XXI wieku / Nursing in the 21st Century 21, no. 3 (September 1, 2022): 196–202. http://dx.doi.org/10.2478/pielxxiw-2022-0026.

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Abstract Introduction. Bone sarcomas, as rare tumour types, constitute only about 1% of malignant tumours. The treatment process is an additional burden on the human body, especially at a young age. The surgery has a long-term effect on the patient’s mobility and requires great effort and motivation to regain physical fitness. The discomfort resulting from having a persistent thymus gland makes it significantly more difficult for patients to return to their precancerous state. Aim. The aim of this study is to diagnose the patient’s health problems resulting from the presence of persistent thymus gland and a history of oncological treatment for osteosarcoma, together with the presentation of measures to improve functioning in daily life. Material and methods. The research method of the individual case study and the research techniques used were: interview, observation, measurement and analysis of medical records. Additionally, 9 scales were used, which allowed for a comprehensive assessment of the patient’s health status. Results and summary. The following health problems were identified: dyspnoea, cough, muscle weakness, pain in the spine and left lower limb, dizziness and fatigue. Close cooperation of the interdisciplinary team, the patient and her relatives and a holistic approach is the key to developing an effective care plan together with tailoring such therapeutic and caring activities that increase the patient’s comfort of life.

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Caocci, Giovanni, Francesca Palandri, Giuseppe Gaetano Loscocco, Alessia Tieghi, Andrea Patriarca, Alessandra Iurlo, Elisabetta Abruzzese, et al. "Health-Related Quality of Life and Symptom Burden Profile of Patients with Pre-Fibrotic and Overt Myelofibrosis: A Preliminary Report from the Gimema-Prophecy Observational Study." Blood 142, Supplement 1 (November 28, 2023): 2441. http://dx.doi.org/10.1182/blood-2023-186429.

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Background Patients with overt myelofibrosis (MF) suffer a significant symptom burden and impairment of health-related quality of life (HRQoL). However, very little evidence-based data is available on HRQoL and the symptom burden of patients with pre-fibrotic MF. Aim The primary objective of this study was to describe the HRQoL profile of patients with pre-fibrotic MF relative to patients with overt MF. The secondary objective was to examine disease-specific symptom prevalence in both groups. Methods. Baseline data from an ongoing prospective multicenter observational study by the GIMEMA Group were analyzed. The inclusion criteria of this study were: adult patients diagnosed with Philadelphia chromosome-negative myeloproliferative neoplasm (MPN), according to the 2016 WHO classification, within one year before the registration date. For the purpose of this analysis, only patients with pre-fibrotic and overt MF were considered. HRQoL profile was assessed with the EORTC QLQ-C30, which consists of 30 items and includes five functional scales (physical, role, emotional, social, and cognitive), three symptoms (fatigue, nausea, vomiting, and pain), a global health status/QoL scale and six single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). Well-established evidence-based guidelines for interpreting the QLQ-C30 were used to determine clinically meaningful differences between groups (i.e., pre-fibrotic vs overt MF). Given the exploratory nature of the study, n o statistical testing was performed on mean score differences. Symptom prevalence was assessed by items of the MPN-SAF TSS. The MPN-SAF TSS is a comprehensive and brief 10-item instrument that concisely assesses the prevalence and severity of debilitating symptoms of MF. The percentage of patients who reported symptoms on the MPN-SAF TSS was based on the number of patients who answered at least 1 on a given item. Results. Overall, 104 patients with a median age of 68 years (IQR: 59-76) were enrolled across 20 community and university-based hospitals. More than half of the patients were male (n=58; 56%), and 55 (53%) revealed splenomegaly. Thirty-five patients (34%) reported at least one comorbidity. The median time since diagnosis for the overall group was 4 months (IQR: 1-7), and there were 69 and 35 patients diagnosed with overt and pre-fibrotic MF, respectively. The median age of patients with overt MF and pre-fibrotic MF was 69 (IQR: 61-76) and 63 (IQR: 57-75), respectively. At study entry, no statistically significant differences were observed between the two groups regarding age, sex, prevalence of comorbidities, WBC, and PLT counts. However, patients with overt MF had lower Hb levels (p=.003). Inspection of the HRQoL profile, according to the EORTC QLQ-C30, showed that patients with overt MF had a statistically and clinically meaningful worse global HRQoL compared to patients' pre-fibrotic MF (Δ=11.4). The following functioning scales were also mostly impaired in patients with overt MF: role functioning (Δ=14.2), cognitive functioning (Δ=4.7), and social functioning (Δ=8.1) (Figure 1). With regard to symptoms severity, patients with overt MF reported clinically meaningful higher severity for fatigue (Δ=6), pain (Δ=7.2), insomnia (Δ=6), constipation (Δ=5.4), and appetite loss (Δ=6.8). However, patients with pre-fibrotic MF reported clinically meaningful higher severity for dyspnea (Δ=5.5). The prevalence of symptoms according to the MPN-SAF TSS, overall and by disease group, is reported in Table 1. The prevalence of symptoms in the overall group of patients was high, with the top three most prevalent symptoms being fatigue (78%), concentration problems (53%), and inactivity (50%). Notably, the prevalence of symptoms was also high in patients with pre-fibrotic MF, with some one-third of them reporting: fatigue, concentrations problem, inactivity, early satiety, abdominal discomfort, night sweats, itching, and bone pain. Conclusions. To the best of our knowledge, this is one of the first evidence describing HRQoL and the symptom burden of patients with pre-fibrotic MF. Although our preliminary data suggest that the HRQoL profile of patients with pre-fibrotic MF was generally worse than those with overt MF, our findings also indicate a high symptom prevalence in patients with pre-fibrotic MF.

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Altomare, Ivy, Aaron T. Gerds, David Lessen, Philomena Colucci, Shreekant Parasuraman, Dilan Chamikara Paranagama, and Ruben A. Mesa. "Correlation between MPN-SAF TSS and EORTC QLQ-C30 Scores in Patients with PV: Data from the Reveal Study." Blood 132, Supplement 1 (November 29, 2018): 2259. http://dx.doi.org/10.1182/blood-2018-99-112937.

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Abstract Introduction Polycythemia vera (PV) is characterized by clonal proliferation of myeloid cells and erythrocytosis. Patients with PV often present with symptoms or develop symptoms that may negatively impact quality of life (QOL). In clinical trials, the Myeloproliferative Neoplasm Symptom Assessment Form Total Symptom Score (MPN-SAF TSS) and European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC QLQ-C30) have both been used to assess symptom burden in patients with PV. This analysis was conducted in patients with PV enrolled in REVEAL, a multicenter, prospective, observational trial, in an attempt to corroborate previous work by Emanuel et al (J Clin Oncol 2012;30:4098), which demonstrated associations between the MPN-SAF TSS and EORTC QLQ-C30. Methods Patients ≥ 18 years of age with PV were enrolled and followed during usual care visits for ≤ 36 months. Patient-reported outcomes, including the MPN-SAF TSS and EORTC QLQ-C30, were collected at enrollment and at approximate 3-month intervals; only the forms completed at the time of enrollment were included in this analysis. MPN-SAF TSS items are scored on a linear analog scale ranging from 0 (absent) to 10 (worst imaginable), and individual symptom scores were added together to calculate a TSS; higher scores represent worse symptom burden. In the EORTC QLQ-C30, 28 questions are scored using a 4-point scale indicating frequency: 1 (not at all), 2 (a little bit), 3 (quite a bit), and 4 (very much); this includes 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). Two questions on overall health and QOL are rated on a 1 (very poor) to 7 (excellent) scale. Five multi-item functional scales (physical, role, cognitive, emotional, and social), 3 multi-item symptom scales (fatigue, nausea/vomiting, and pain), and a multi-item global health status/QOL scale are derived from the 30 questions. Linear transformation to 0-100 was applied to raw scores to obtain scores for each scale or single item. Higher scores for functional scales and global health status represent higher functioning and better health status/QOL, respectively. Higher scores for symptom scales/items represent higher symptom burden. Pearson correlation coefficient was used to assess correlations between MPN-SAF TSS and EORTC QLQ-C30 scales. Results As of data cutoff (April 30, 2018), 2,298 of 2,510 enrolled patients (91.6%) had completed both MPN-SAF TSS and EORTC QLQ-C30 forms at enrollment. Median age was 67 years (range, 22-97 years), 54.0% were male, and 89.7% were Caucasian. Median disease duration at the time of enrollment was 4.1 years. The majority (52.5%) of patients were treated with hydroxyurea (28.7%) or hydroxyurea with phlebotomy (23.8%). The mean MPN-SAF TSS was 18.7 (out of 100) compared to 21.8 reported by Emanuel et al 2012. The 4 symptoms with the highest mean scores were fatigue (3.5), early satiety (2.6), inactivity (2.5), and itching (2.3). The QLQ-C30 mean scores for overall QOL and health were 5.5 and 5.3, respectively. EORTC QLQ-C30 symptom scales were highest for fatigue (29.9), insomnia (28.7), and pain (20.0). Correlation between MPN-SAF TSS and EORTC QLQ-C30 results showed stronger associations between multiple items (Table). Calculated TSS had the strongest association with fatigue (r = 0.72), pain (r = 0.59), cognitive functioning (r = -0.58), and emotional functioning (r = -0.58). Problems with concentration in the MPN-SAF TSS was moderately correlated with cognitive functioning (r = -0.70) in the EORTC QLC-C30. Fatigue assessments were also moderately correlated (r = 0.65) between the MPN-SAF TSS and EORTC QLQ-C30. Conclusions In this analysis of prospectively gathered real-world data, the MPN-SAF TSS results confirm that patients with PV experience a recognizable constellation of symptoms, including fatigue, early satiety, inactivity, and itching. Not surprisingly, PV-related symptoms have a negative impact on QOL. There were moderate correlations (r = 0.5-0.75) between the MPN-SAF TSS and the EORTC QLC-C30 with respect to global health status/QOL, the 5 functional scales, and fatigue, pain, and dyspnea. Consistent with the previous analysis, this analysis provides further evidence that the MPN-SAF TSS represents an accurate, yet simple tool to assess PV-related symptoms and their potential impact on QOL. Disclosures Altomare: Novartis: Consultancy; Incyte: Consultancy; Amgen: Consultancy; Bayer: Consultancy; Genentech: Consultancy; Celgene: Other: Advisory Board Member; Ipsen: Other: Advisory Board Member. Gerds:Celgene: Consultancy; Apexx Oncology: Consultancy; Incyte: Consultancy; CTI Biopharma: Consultancy. Lessen:Abbvie: Honoraria; Teva: Honoraria, Speakers Bureau; Incyte: Honoraria, Research Funding, Speakers Bureau; Astellas: Research Funding; Bayer: Honoraria, Speakers Bureau; Amgen: Honoraria, Speakers Bureau; Portola: Honoraria, Speakers Bureau; Janssen: Research Funding. Colucci:Incyte: Employment, Equity Ownership. Parasuraman:Incyte: Employment, Equity Ownership. Paranagama:Incyte: Employment, Equity Ownership. Mesa:Pfizer: Research Funding; Incyte Corporation: Research Funding; Gilead: Research Funding; Promedior: Research Funding; NS Pharma: Research Funding; Celgene: Research Funding; Novartis: Consultancy; UT Health San Antonio - Mays Cancer Center: Employment; CTI Biopharma: Research Funding; Genentech: Research Funding.

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Niesvizky, Ruben, Ian W. Flinn, Robert Rifkin, Nashat Gabrail, Veena Charu, Billy Clowney, Yousuf Gaffar, et al. "Patient-Reported Quality of Life (QoL) in Elderly, Newly Diagnosed Multiple Myeloma (MM) Patients Receiving Bortezomib-Based Combinations: Results From All Randomized Patients in the Community-Based, Phase 3b UPFRONT Study." Blood 118, no. 21 (November 18, 2011): 1864. http://dx.doi.org/10.1182/blood.v118.21.1864.1864.

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Abstract Abstract 1864 Background: In addition to determining the efficacy and safety of different treatment options for MM, the impact of treatment and associated toxicities on patient-reported QoL should be evaluated. The US community-based phase 3b UPFRONT study compares the efficacy and safety of three bortezomib (VELCADE®, Vc)-based regimens, Vc-dexamethasone (VcD), Vc-thalidomide-dexamethasone (VcTD), and Vc-melphalan-prednisone (VcMP), followed by weekly Vc maintenance, in elderly, newly diagnosed, transplant-ineligible MM patients. Updated efficacy and safety data are reported elsewhere at this meeting; here we present patient-reported QoL results – a secondary endpoint of the trial – from all 502 randomized patients, who received up to a maximum of 13 treatment cycles. Methods: Patients with symptomatic MM were randomized (1:1:1) to receive eight 21-day cycles of VcD (Vc 1.3 mg/m2, days 1, 4, 8, 11; D 20 mg, days 1, 2, 4, 5, 8, 9, 11, 12 [cycles 1–4]), days 1, 2, 4, 5 [cycles 5–8]), VcTD (Vc as before; T 100 mg/day, days 1–21; D as before), or VcMP (Vc as before; M 9 mg/m2, and P 60 mg/m2, days 1–4, every other cycle) induction, followed by five 35-day cycles of maintenance with Vc 1.6 mg/m2, days 1, 8, 15, 22. QoL was assessed using the EORTC QLQ-C30 questionnaire, which includes global health status, physical, role, cognitive, emotional, and social functioning, and symptom scales of fatigue, nausea/vomiting, pain, dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties. Global health status scores combine overall health and QoL scores, with higher scores reflecting better health status. Questionnaires were completed prior to dosing on day 1 of cycle 1 (baseline), prior to dosing on day 1 of every odd-numbered cycle, at the end-of-treatment visit, and every 12 weeks until progressive disease. Patient-reported QoL scores presented herein represent data collected within 1 year of randomization regardless of discontinuation status; for patients who died, missing assessments were assigned the worst possible score of 0. A linear mixed effect model was used to assess QoL changes over time, both within and between treatment arms. Sensitivity analyses were conducted to test the robustness of the primary analysis. Results: Patient baseline characteristics were well balanced across the VcD (n=168), VcTD (n=167), and VcMP (n=167) arms as reported previously (Niesvizky et al, EHA 2011). Median age was 74.5 (VcD), 73.0 (VcTD), and 72.0 (VcMP) years, and 71%, 62%, and 72% of patients had ISS stage II/III disease. QoL assessments were available at baseline and ≥1 post-baseline time point for 78% (VcD), 69% (VcTD), and 78% (VcMP) of patients. Observed data showed a downward trend in mean global health status score until cycle 7 (VcD, VcMP) or 9 (VcTD), followed by a trend to stabilizing/improving score thereafter (Figure). Symptom scores changed very little during induction in all arms, except for nausea/vomiting and diarrhea, with moderate improvements seen during maintenance. After fitting observed data with a linear mixed effect model, a significant decrease in mean global health status score from baseline to cycle 7 (induction period) was evident in all arms (VcD, p=0.0127; VcTD, p<0.0001; VcMP, p=0.0157), but there were no significant inter-arm differences. During cycles 9–13 (maintenance period), mean global health status scores remained decreased from baseline in the VcD and VcTD arms, and there were significant differences between VcTD and VcMP, with lower scores in the VcTD arm. Sensitivity analyses incorporating patients' QoL data collected after discontinuation of treatment (for patients who discontinued within 1 year) and utilizing a last observation carried forward approach, gave similar results to the linear mixed effect model. Conclusions: The observed data, linear mixed model estimates, and sensitivity analyses all show a common trend to a transient decrease in QoL during VcD, VcTD, and VcMP induction followed by a subsequent trend to improvement/stabilization in QoL during single-agent Vc maintenance. The trend to decreasing QoL seen during Vc-based induction may reflect the onset of treatment-related toxicities (particularly for VcTD, which was associated with somewhat higher toxicity rates). Post-induction improvements/stabilization in QoL may reflect the beneficial impact of achieving a response and the limited toxicity profile associated with weekly Vc maintenance. Disclosures: Niesvizky: Celgene: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding, Speakers Bureau; Millennium Pharmaceuticals, Inc.: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding, Speakers Bureau; Onyx: Research Funding. Flinn:Millennium Pharmaceuticals, Inc.: Research Funding. Rifkin:Onyx: Membership on an entity's Board of Directors or advisory committees; Amgen: Speakers Bureau; Celgene: Speakers Bureau; Millennium Pharmaceuticals, Inc.: Membership on an entity's Board of Directors or advisory committees, Speakers Bureau. Charu:Pfizer: Equity Ownership; Bristol-Myers Squibb: Equity Ownership; Roche: Research Funding; GSK: Research Funding; Celgene: Research Funding; Novartis: Honoraria, Membership on an entity's Board of Directors or advisory committees; Amgen: Equity Ownership, Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding. Neuwirth:Millennium Pharmaceuticals, Inc.: Employment. Huang:Millennium Pharmaceuticals, Inc: Employment. Choi:Millennium Pharmaceuticals, Inc.: Employment. Corzo:Millennium Pharmaceuticals, Inc.: Employment.

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Hartford, Chris, Paolo Eusebi, Richard J. Kelly, Thibaud Alin, Xinyu Yang, Antoine Regnault, Dimittri Delevry, Ching Lum, and Diana Rofail. "Psychometric Evaluation of the PNH Symptom Questionnaire (PNH-SQ) Among Patients with Paroxysmal Nocturnal Hemoglobinuria from Three Phase 2 Clinical Trials with Pozelimab Monotherapy or in Combination with Cemdisiran." Blood 142, Supplement 1 (November 28, 2023): 3752. http://dx.doi.org/10.1182/blood-2023-181667.

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Background: Paroxysmal nocturnal hemoglobinuria (PNH) is a rare, acquired, life-threatening disease caused by chronic dysregulation of the complement system. PNH has a high symptom burden with significant impacts on the life of a patient. The PNH Symptom Questionnaire (PNH-SQ) is a PNH-specific patient-reported outcome (PRO) questionnaire designed to assess daily symptom severity in patients with PNH. The objective of this current study was to evaluate PNH-SQ psychometric properties among patients with PNH from three phase 2 clinical trials with pozelimab monotherapy or in combination with cemdisiran. Methods: PRO data from three phase 2 PNH clinical trials, study 1852 (NCT03946748; pozelimab monotherapy; n=24), study 2092 (NCT04811716; combination therapy; n=24), and study 20105 (NCT04888507; combination therapy; n=6), were used for analysis. The PNH-SQ is a patient-reported daily diary that assesses 10 core symptoms of PNH using a five-point severity scale (none; very mild; mild; moderate; severe; very severe) for fatigue, shortness of breath, muscle weakness, headaches, abdominal pain, pain in back or legs, and chest discomfort, and a five-point difficulty scale (none, not at all, a little bit, somewhat, quite, very) for difficulty sleeping, difficulty thinking clearly, and difficulty swallowing. Prespecified psychometric analyses were performed after study database lock using blinded data. Analyses included quality of completion (ie ePRO prevented item-level missingness) and item responses over time. Reliability and validity of daily assessments with classical test theory (internal consistency and test-retest reliability, construct validity by observing correlations between pairs of PNH-SQ items and of the PNH-SQ daily score with other PRO scores from the EORTC QLQ-C30, FACIT-Fatigue and EQ-5D) and Rasch measurement theory (RMT) analyses were conducted. Test-retest reliability (within stable patients 4 weeks apart) and construct validity of various exploratory methods for aggregating daily scores over time were assessed. Results: Completion rates of PNH-SQ items were higher in studies 20105 and 2092 (at Day 1: 54.2% in 1852 vs 83.3% in 20105 and 91.7% in 2092). Fatigue was consistently the most experienced symptom at baseline of the three studies, while difficulty swallowing was not experienced by any patient. A high proportion of ‘none’ responses were observed across all assessments. Cronbach's alpha calculated using all daily assessments was 0.75, indicating modest reliability. The correlation between each pair of items at Day 1 ranged between 0.11 and 0.93, with the lowest correlations being observed between pain items and sleep/cognitive items, and between abdominal pain and fatigue/dyspnea. At Day 1, PNH-SQ daily score trended higher according to the Patient Global Impression of Severity (PGIS)-symptoms categories and showed moderate correlations in expected direction with fatigue and pain, as assessed by FACIT-Fatigue and EORTC QLQ-C30, and lower correlations with dyspnea and overall health status (EQ-5D visual analog scale). RMT analyses of the daily PNH-SQ data highlighted that for response options “Very mild” for severity/“Not at all” for difficulty did not provide any useful information. RMT also uncovered a meaningful hierarchy of symptoms ranging from fatigue to difficulty swallowing. A fixed 7-day average led to the best test-retest reliability (intraclass correlation coefficient, 0.76). Conclusions: Our analyses documented the PNH-SQ as an instrument to capture symptoms of PNH. The most frequent symptoms reported in our sample using the PNH-SQ, fatigue, dyspnea, and headaches, were aligned with observational study data. The sample of observations from the three trials was strongly skewed towards absence of symptoms, probably reflecting the low symptomatic severity of patients included in the study. Despite this restriction, early supportive data for the scoring of the PNH-SQ from a sample of patients with PNH were obtained, generating useful insights into the function of the response scales, opportunities for the creation of daily assessments of symptom severity, and for the creation of a measure reflecting severity over a longer period, for which a fixed 7-day average appeared as a potential good scoring approach. Generating further evidence, especially in a sample of more symptomatic patients, is recommended to substantiate these results.

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Guan, Xiuwen, Xiaoyan Yan, Ying Wang, Xichun Hu, Xiaoying Sun, Zhanhong Chen, Xiaochen Zhang, et al. "Patient-reported outcomes for measuring the quality of life in advanced breast cancer treated with third-line and beyond chemotherapy-based regimens: A national cross-sectional study." Journal of Clinical Oncology 40, no. 16_suppl (June 1, 2022): 1103. http://dx.doi.org/10.1200/jco.2022.40.16_suppl.1103.

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1103 Background: Prolongation of survival and maintenance of quality of life (QoL) are the primary therapeutic goals in advanced breast cancer. Around 10% of adverse events (AEs) in the CTCAE are symptomatic AEs (e.g., nausea, sensory neuropathy), which can severely and directly affect the QoL of patients. However, seldom evidence mapped the QoL and symptomatic AEs utilizing patient-reported outcomes (PROs) in heavily pretreated breast cancer patients. This study aimed to investigate the PROs for measuring the QoL and symptomatic AEs of advanced breast cancer treated with third-line and beyond chemotherapy-based regimens in China. Methods: This national survey enrolled patients with advanced breast cancer receiving third-line and beyond chemotherapy-based regimens in 59 centers all over China from March to April in 2021. Each patient filled out a questionnaire containing demographic information, medical history, EORTC-QLQ-C30, and symptomatic AEs. The symptomatic AEs included fatigue, nausea/vomiting, pain, dyspnea, insomnia, appetite loss, constipation, diarrhea, alopecia, fever, and limb numbness. The range method was used for the linear conversion of the PRO scores, which were converted into standardized scores of 0 to 100. Results: This study enrolled 1015 patients with the median age of 52 years. The QoL of all patients were poor, with the global health status score of 52.4±17.7 (Table). All the symptomatic AE scores were low among the patients. However, no significant differences were observed in global health status and symptomatic AEs between mono-chemotherapy and multi-agent chemotherapy (All P>0.05). Conclusions: The QoL of advanced breast cancer patients treated with third-line and beyond chemotherapy were poor, especially in symptomatic AEs. In addition, the EOTRC-QLQ-C30 scale appears to underestimate the differences in symptomatic AEs between mono-chemotherapy and multi-agent chemotherapy, probably due to a lack of sensitivity of the scale, which fails to match the actual clinical observations of the PROs and QoL. Therefore, new scales need to be developed for the evaluation of symptomatic AEs and QoL in advanced breast cancer. [Table: see text]

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Svoboda, Jakub, Jonathon B. Cohen, Chaitra S. Ujjani, David Andorsky, Andre H. Goy, Anita Kumar, Scott D. Ramsey, et al. "Clinician-Based Performance Status and Its Correlation with Patient-Reported Outcomes: Findings from a Prospective Observational Study in Patients with Mantle Cell Lymphoma." Blood 138, Supplement 1 (November 5, 2021): 4115. http://dx.doi.org/10.1182/blood-2021-146874.

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Abstract Background: Performance status (PS) is used to estimate patients' general well-being and functional status. It is considered an important factor in clinical treatment decisions and determining eligibility for clinical trials, but there are limited data on how PS assessment by clinicians correlates with what patients are experiencing. We are conducting a prospective observational study (NCT03816683) of patients with mantle cell lymphoma (MCL) who are treated with a novel agent in 42 centers in the United States to track data on toxicities and outcomes. The study includes a patient portal used to prospectively collect information on patient-reported outcomes (PROs). The purpose of this study is to compare Eastern Cooperative Oncology Group (ECOG) PS as determined by clinicians with PROs recorded by patients. Methods: This observational prospective cohort study is enrolling patients with MCL who have initiated any one of several predefined novel agents within the previous 3 months. The target sample size is 250 patients who will be followed for 5 years. Retrospective data from each patient's medical history and all prospective data will be collected and entered into a physician portal, including clinician-estimated ECOG PS at each time point. A separate portal will be used to concurrently collect information from patients on their disease and treatment, in addition to validated PRO questionnaires (EQ-5D-5L and EORTC QLQ-C30). Data are entered into the portals on a quarterly basis. Descriptive analyses of the PROs and ECOG PS scores at study entry were conducted by stratifying each PRO summary and/or domain score by the ECOG PS scale score. The distribution of PRO scores with continuous measures was compared between the distribution of ECOG categories using the Kruskal-Wallis test. For PROs with ordinal scales, the association of patient-reported functioning with physician assessments of functional status (ECOG PS) was analyzed using the Jonckheere-Terpstra test. The association between baseline PROs and ECOG PS was measured using Spearman correlation coefficients. Results: Up to July 2021, we enrolled 88 patients with MCL who had ECOG PS and PRO measures recorded at baseline. Median age was 70.0 years (interquartile range [IQR]: 64.5-75.5), with 78% having past lymphoma therapy for MCL. Median number of prior therapies was 2 (IQR: 1-3). The numbers (percentages) of patients in ECOG categories 0, 1, 2, and 3 were 44/88 (50%), 35/88 (40%), 7/88 (8%), and 2/88 (2%), respectively. For EORTC QLQ-C30, we noted that physical functioning and role functioning scales were associated with ECOG PS; median physical functioning and role functioning scale scores differed between the ECOG PS categories (p=0.012 and 0.017, respectively) (Table 1). Corresponding significant inverse correlations were observed between these domains (−0.32 for physical functioning and −0.33 for role functioning). Emotional, cognitive, and social functional scales and symptom scales relating to fatigue, nausea/vomiting, pain, and dyspnea did not show this association with ECOG PS. For the EQ-5D-5L, increasing severity of problems with mobility and with usual activities was associated with worsening ECOG PS (p=0.049 and 0.001, respectively) and displayed statistically significant but weak correlations of 0.22 and 0.35, respectively. Self-care, pain/discomfort, and anxiety/depression were not associated with ECOG PS. Conclusions: In patients with MCL enrolled in a prospective observational trial, this ad hoc interim analysis of baseline ECOG PS as determined by clinicians correlated well with physical function/mobility issues reported by patients but not with other PROs such as emotional well-being or symptoms including fatigue, pain, or dyspnea that might impact patient tolerance to treatment. These very preliminary data seem to raise the question of whether PROs might be incorporated into clinician-based assessments to better predict treatment tolerance and guide treatment selection and eligibility for trials. Figure 1 Figure 1. Disclosures Svoboda: TG: Research Funding; Seattle Genetics: Consultancy, Research Funding; Pharmacyclics: Consultancy, Research Funding; Merck: Research Funding; Incyte: Research Funding; Imbrium: Consultancy; Genmab: Consultancy; Atara: Consultancy; BMS: Consultancy, Research Funding; Astra Zeneca: Consultancy, Research Funding; Adaptive: Consultancy, Research Funding. Cohen: Janssen, Adicet, Astra Zeneca, Genentech, Aptitude Health, Cellectar, Kite/Gilead, Loxo, BeiGene, Adaptive: Consultancy; Genentech, BMS/Celgene, LAM, BioINvent, LOXO, Astra Zeneca, Novartis, M2Gen, Takeda: Research Funding. Ujjani: ACDT: Honoraria; Gilead: Honoraria; TG Therapeutics: Honoraria; Adaptive Biotechnologies: Research Funding; Atara Bio: Consultancy; Epizyme: Consultancy, Membership on an entity's Board of Directors or advisory committees; Janssen: Consultancy; Kite, a Gilead Company: Honoraria; Loxo: Research Funding; AstraZeneca: Consultancy, Membership on an entity's Board of Directors or advisory committees, Research Funding; AbbVie: Consultancy, Research Funding; Pharmacyclics: Consultancy, Research Funding. Andorsky: AstraZeneca: Other: served on steering committees; Celgene/Bristol Myers Squibb: Consultancy; AbbVie: Research Funding; Epizyme: Research Funding; AbbVie: Consultancy; Celgene/Bristol Myers Squibb: Research Funding. Goy: LLC(Targeted Oncology): Consultancy; Janssen: Research Funding; COTA (Cancer Outcome Tracking Analysis): Current holder of stock options in a privately-held company, Membership on an entity's Board of Directors or advisory committees, Other: Leadership role; Bristol Meyers Squibb: Membership on an entity's Board of Directors or advisory committees; AstraZeneca: Membership on an entity's Board of Directors or advisory committees; Vincerx pharma: Membership on an entity's Board of Directors or advisory committees; Genomic Testing Cooperative: Current holder of stock options in a privately-held company, Membership on an entity's Board of Directors or advisory committees, Other: Leadership role; Infinity/Verastem: Research Funding; Rosewell Park: Consultancy; Elsevier's Practice Update Oncology, Intellisphere, LLC(Targeted Oncology): Consultancy; Hoffman la Roche: Consultancy; Xcenda: Consultancy; Michael J Hennessey Associates INC: Consultancy; Janssen: Membership on an entity's Board of Directors or advisory committees; Kite Pharma: Membership on an entity's Board of Directors or advisory committees; Gilead: Membership on an entity's Board of Directors or advisory committees; AbbVie/Pharmacyclics: Membership on an entity's Board of Directors or advisory committees; Acerta: Consultancy, Research Funding; Genentech/Hoffman la Roche: Research Funding; Karyopharm: Research Funding; Phamacyclics: Research Funding; Vincerx: Honoraria, Membership on an entity's Board of Directors or advisory committees; Physicians' Education Resource: Consultancy, Other: Meeting/travel support; AbbVie/Pharmacyclics: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding; Incyte: Honoraria; Novartis: Consultancy, Honoraria; MorphoSys: Honoraria, Other; Medscape: Consultancy; Xcenda: Consultancy, Honoraria; OncLive Peer Exchange: Honoraria; Janssen: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding; Celgene: Consultancy, Honoraria, Research Funding; Elsevier PracticeUpdate: Oncology: Consultancy, Honoraria; Kite, a Gilead Company: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding; AstraZeneca: Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding; Constellation: Research Funding; Bristol Meyers Squibb: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees; Hackensack Meridian Health, Regional Cancer Care Associates/OMI: Current Employment. Kumar: Seattle Genetics: Research Funding; Pharmacyclics: Research Funding; Abbvie Pharmaceuticals: Research Funding; Astra Zeneca: Honoraria, Other: Advisory Board, Research Funding; Kite Pharmaceuticals: Other: advisory board , Research Funding; Adaptive Biotechnologies, Celgene, Abbvie Pharmaceticals, Pharmacyclics, Seattle Genetics: Research Funding; Celgene: Honoraria, Other: advisory board, Research Funding. Ramsey: AstraZeneca: Honoraria, Membership on an entity's Board of Directors or advisory committees. Wallington: AstraZeneca: Current Employment; Open Health: Ended employment in the past 24 months. Eudicone: Astrazeneca: Current Employment, Divested equity in a private or publicly-traded company in the past 24 months. Hermann: AstraZeneca: Current Employment, Current equity holder in publicly-traded company. Wang: Clinical Care Options: Honoraria; The First Afflicted Hospital of Zhejiang University: Honoraria; OMI: Honoraria; Mumbai Hematology Group: Honoraria; Newbridge Pharmaceuticals: Honoraria; Physicians Education Resources (PER): Honoraria; Lilly: Research Funding; Molecular Templates: Research Funding; CStone: Consultancy; Janssen: Consultancy, Honoraria, Research Funding; Anticancer Association: Honoraria; BeiGene: Consultancy, Honoraria, Research Funding; Moffit Cancer Center: Honoraria; BioInvent: Research Funding; Juno: Consultancy, Research Funding; Bayer Healthcare: Consultancy; Kite Pharma: Consultancy, Honoraria, Research Funding; Hebei Cancer Prevention Federation: Honoraria; Imedex: Honoraria; Epizyme: Consultancy, Honoraria; CAHON: Honoraria; DTRM Biopharma (Cayman) Limited: Consultancy; AstraZeneca: Consultancy, Honoraria, Research Funding; Loxo Oncology: Consultancy, Research Funding; Oncternal: Consultancy, Research Funding; Pharmacyclics: Consultancy, Research Funding; VelosBio: Consultancy, Research Funding; Genentech: Consultancy; Dava Oncology: Honoraria; Scripps: Honoraria; Miltenyi Biomedicine GmbH: Consultancy, Honoraria; Celgene: Research Funding; BGICS: Honoraria; InnoCare: Consultancy, Research Funding; Chinese Medical Association: Honoraria; Acerta Pharma: Consultancy, Honoraria, Research Funding. Pagel: Epizyme: Consultancy; Incyte/MorphoSys: Consultancy; Pharmacyclics/AbbVie: Consultancy; MEI Pharma: Consultancy; BeiGene: Consultancy; AstraZeneca: Consultancy; Gilead: Consultancy; Actinium Pharmaceuticals: Consultancy; Kite, a Gilead Company: Consultancy.

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Efficace, Fabio, Pasquale Niscola, Andrea Patriarca, Francesco Cottone, Giuseppe A. Palumbo, Giovanni Caocci, Marilena Fedele, et al. "Pretreatment Health-Related Quality of Life Profile According to the EORTC QLQ-C30 in Patients with Myelodysplastic Syndromes (MDS): Analysis on 443 Lower-Risk MDS Patients." Blood 132, Supplement 1 (November 29, 2018): 2293. http://dx.doi.org/10.1182/blood-2018-99-110921.

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Abstract Background: Understanding health-related quality of life (HRQOL) profile, including functional aspects and symptom burden, of yet untreated patients with myelodysplastic syndromes (MDS) is important to help clinicians to better identify subgroup of patients in need of special attention from the very beginning of therapy. Aims: The primary objective of this study was to investigate baseline (i.e., pretreatment) HRQOL profile of untreated patients with lower-risk MDS, examining differences by age, gender, risk score category and comorbidity. A secondary objective was to provide age and sex baseline reference HRQOL values, according to the EORTC QLQ-C30 questionnaire, to be used as benchmark comparisons in future MDS studies. Methods: This analysis is based on 443 newly diagnosed adult MDS patients with International Prognostic Scoring System (IPSS) risk score of low (46 %) or intermediate-1 (54%), enrolled in an international prospective cohort observational study. Median age was 75 years (range 32-94), with 261 men (59%) and 182 (41%) women. HRQOL was assessed by the EORTC QLQ-C30 questionnaire at study entry, before any treatment (except for transfusions). This well validated questionnaire consists of five functioning scales: physical, role, emotional, cognitive and social; three symptom scales: fatigue, nausea/ vomiting and pain; six single item scales: dyspnoea, sleep disturbance, appetite loss, constipation, diarrhea and financial impact; and the global health status/HRQOL scale. The items were scaled and scored using the recommended EORTC procedures. At the time of baseline HRQOL assessment, 111 (25%) patients had received at least one red blood cell transfusion. We used Wilcoxon-Mann-Whitney and Kruskal-Wallis tests for all comparisons. We used the false discovery rate approach to account for multiple testing, with a nominal α-level=0.05. In addition to statistical significance, clinically relevant HRQOL differences were also evaluated based on previously published criteria (Cocks K, et al, J Clin Oncol 29:89-96, 2011). Results: There were not statistically significant differences in any of the HRQOL scales measured by the EORTC QLQ-C30, by the specific IPSS risk category (i.e., low risk vs intermediate-1 risk score). Overall, women reported worse HRQOL scores than men, with clinically relevant differences for physical (Δ=-7.1, P=0.002), role (Δ=-9.9, P=0.002) and emotional functioning, (Δ=-10, P<0.001), nausea/vomiting (Δ=3.7, P<0.001), insomnia (Δ=7.6, P=0.011) and appetite loss (Δ=5.6, P=0.019). Younger patients also reported better outcomes than older patients and this was more evident in the Physical Functioning domain. Also, HRQOL profile varied substantially by number of comorbidities (zero, one, two or more). In general, there was a worsening HRQOL trend with the increase of comorbidities. However, HRQOL impairments were markedly larger in patients with at least two comorbidities, who showed both small and medium clinically relevant differences, when compared to patients with no comorbidities. The largest differences between patients with no comorbidity and those with two or more were found in the following HRQOL domains: Physical Functioning (Δ=-15.3, P<0.001), Fatigue (Δ=-11.9, P<0.001) and Global health status/QOL (Δ=10.0, P<0.001). Full baseline reference values by specific age group categories and sex, according to the EORTC QLQ-C30, are reported in Table 1. Conclusion: Pretreatment HRQOL profile in lower-risk MDS patients vary substantially by age group categories, sex and number of comorbidities, and these differences should be highly considered at the time of treatment start. As in MDS research, the EORTC QLQ-C30 is currently one of the most frequently used HRQOL measure, our baseline reference values provide benchmark data against which other MDS studies using this questionnaire may be compared. Disclosures Efficace: Bristol Meyers Squibb: Consultancy; Seattle Genetics: Consultancy; Orsenix: Consultancy; Incyte: Consultancy; TEVA: Research Funding; TEVA: Consultancy; Lundbeck: Research Funding; Amgen: Consultancy; AMGEN: Research Funding. Palumbo:Celgene: Honoraria, Membership on an entity's Board of Directors or advisory committees; Novartis: Honoraria, Membership on an entity's Board of Directors or advisory committees. Platzbecker:Celgene: Research Funding. Stauder:Novartis: Honoraria, Membership on an entity's Board of Directors or advisory committees; Teva: Research Funding; Celgene: Honoraria, Membership on an entity's Board of Directors or advisory committees. Breccia:Novartis: Honoraria; Incyte: Honoraria; Pfizer: Honoraria; BMS: Honoraria. Voso:Celgene: Research Funding, Speakers Bureau. Santini:AbbVie: Membership on an entity's Board of Directors or advisory committees; Celgene: Honoraria, Research Funding; Amgen: Membership on an entity's Board of Directors or advisory committees; Janssen: Honoraria, Membership on an entity's Board of Directors or advisory committees; Otsuka: Consultancy; Novartis: Honoraria. Lubbert:Teva: Other: Study drug; Celgene: Other: Travel Grant; Janssen: Honoraria, Research Funding. Cuneo:Gilead: Other: advisory board, Speakers Bureau; Abbvie: Other: advisory board, Speakers Bureau; Roche: Other: advisory board, Speakers Bureau; janssen: Other: advisory board, Speakers Bureau.

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Efficace, Fabio, Pier Luigi Zinzani, Francesca Bonifazi, Michele Clerico, Annalisa Chiappella, Domenico Russo, Riccardo Saccardi, et al. "Health-Related Quality of Life Profile and Symptom Burden of Patients with Aggressive B-Cell Lymphomas Just before CAR-T-Cell Therapy: A Real-World Study By the Gimema." Blood 142, Supplement 1 (November 28, 2023): 7384. http://dx.doi.org/10.1182/blood-2023-180012.

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Background Although efficacy and safety data on chimeric antigenic receptor (CAR) T-cell therapy for patients aggressive B-cell lymphomas are being accumulated, there is limited research on health-related quality of life (HRQoL) and symptom burden of these patients. Additionally, the few HRQoL data available mainly stems from selected patients enrolled in clinical trial settings. Objective The primary objective of this study was to compare HRQoL of patients with relapsed/refractory aggressive B-cell lymphomas just before receiving CAR T-cell infusion in real-life, with that of their peers in the general population. Secondary objectives were to describe the prevalence of disease-specific symptoms and worries, and to investigate the relationships between symptom burden and HRQoL and functional outcomes. Methods: Baseline data from an ongoing prospective observational study by the Italian GIMEMA Group were analyzed. Inclusion criteria were: adult patients with diffuse large B-cell lymphoma (DLBCL) not otherwise specified, primary mediastinal large B-cell lymphoma, high grade B-cell lymphoma, and DLBCL transformed by indolent lymphoma and mantle cell lymphoma, scheduled to receive CAR T-cell therapy. HRQoL was assessed with the EORTC QLQ-C30 and its recently validated module for patients with high-grade non-Hodgkin lymphoma (EORTC QLQ-NHL-HG29). Multivariable linear regression analyses were performed to estimate the overall mean difference in the QLQ-C30 scores between patients and the general population, adjusting for age, sex and comorbidity. Evidence-based guidelines for interpretation of the QLQ-C30 were used to determine clinically meaningful differences between groups. The prevalence of patients who reported symptoms and worries on the QLQ-NHL-HG29 was based on the number of patients who answered, “a little,” “quite a bit,” or “very much” on a given item. This was assessed overall and by age groups. For descriptive purposes, we divided the sample by the median age, deriving two subgroups: younger (with a median age of 50 years; IQR: 41 - 56) and older patients (with a median age of 65 years; IQR: 63 - 71). Mean scores of functional and global QoL scales of the EORTC QLQ-C30 were analyzed by severity of symptom burden. Patients were categorized as having high or low symptom burden based on the median score of the validated symptom burden scale of the QLQ-NHL-HG29 questionnaire. Results Overall, 65 patients enrolled across 9 centers were analyzed. Median age at study entry was 61 years (IQR, 50-65) and 21 (32%) were women. Median time since diagnosis was 2 years (IQR, 1-4). Eighteen patients (28%) had already received autologous hematopoietic stem cell transplantation (auto-HSCT) before study inclusion. Median number of previous lines of therapy was 2 (IQR: 2-3), and eleven patients (18%) reported at least 1 comorbidity. Patients reported statistically and clinically meaningful worse scores across several domains, compared with their peers in the general population. The top three largest statistically and clinically meaningful differences with regard to functional scales were observed for role functioning (Δ=26.8, p<.001), social functioning (Δ=17.6, p<.001) and the global QoL scale (Δ=14.3, p<.001). With regard to symptoms, the two largest statistically and clinically meaningful worse symptoms, compared to the general population, were observed for fatigue (Δ=14.2, P<.001), dyspnea (Δ=10.9, p=.003) and financial difficulty (Δ=10.6, p=.001). Prevalence of symptoms and worries was high with more than 50% of patients reporting 14 different symptoms and worries. Younger patients tended to report a higher prevalence in regard to specific worries. The top ten most prevalent symptoms and worries by the QLQ-NHL-HG29, overall and by age groups, are reported in Table 1. Patients with a greater symptom burden had a clinically meaningful worse global QoL, and worse physical, role, social, and cognitive functioning compared to those with a lower symptom burden (Figure 1). Conclusion: Using a validated disease-specific measure for high-grade non-Hodgkin lymphoma, we observed that just before CAR T-cell therapy in real-life, patients report substantial HRQoL impairments and a high prevalence of symptoms and worries. Our findings also suggest to pay special attention to patients with a greater symptom burden, being a vulnerable group with important HRQoL and functional impairments.

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Efficace, Fabio, Gianluca Gaidano, Massimo Breccia, Pasquale Niscola, Francesco Cottone, Luana Fianchi, Maria Teresa Voso, et al. "Age and Gender-Related Pretreatment Quality of Life Profiles in Patients with Higher-Risk Myelodysplastic Syndromes. Establishing Benchmark Data from an International Study." Blood 126, no. 23 (December 3, 2015): 2099. http://dx.doi.org/10.1182/blood.v126.23.2099.2099.

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Abstract Background: Patients myelodysplastic syndromes (MDS) diagnosed with higher-risk disease have poor prognosis thus making improvements in health-related quality of life (HRQOL) a major goal of therapy. Understanding HRQOL profile of untreated patients is important to help clinicians to better target subpopulations in need of special attention from the very beginning of therapy. Aims: The primary objective of this study is to investigate whether HRQOL differences exist by age and gender in untreated patients with higher-risk MDS. A secondary objective is to provide age and gender pretreatment HRQOL profiles to be used as reference baseline data for comparing HRQOL of MDS patients under treatments. Methods: This analysis is based on 280 adult patients diagnosed with IPSS risk score of intermediate-2 (74%) and high-risk (26%), enrolled in an international prospective observational study. Median age of patients was 71 years (range 32-89), 176 were men (63%) and 104 (37%) women. HRQOL was assessed at study entry and before treatment for higher-risk disease (except for transfusions), with the EORTC QLQ-C30, the most widely used HRQOL outcome measure in MDS research. Thus, our data are likely to further ease interpretation of outcomes in many studies using this questionnaire. One hundred seventy-five patients had received at least one red blood cell transfusion at the time of baseline HRQOL assessment. HRQoL data of MDS patients were age-gender matched with those general population norms. Wilcoxon-Mann-Whitney and Wilcoxon signed ranks tests were used for unmatched and matched comparisons, respectively (α=0.05). Effect sizes were also computed. Results: No statistically significant differences existed in any of the HRQOL domain by IPSS category (intermediate-2 versus high-risk). However, HRQOL profiles differed by age and gender and results are reported in Table 1. Women generally reported lower HRQOL scores than men, with statistically significant impairments in the global quality of life (P=0.008), role (P=0.014), emotional (P=0.024) and social functioning (P=0.028). When compared to their peers in the general population, HRQOL was found to be impaired in all age group categories (Figure 1, A and B). However, the magnitude of impairments across HRQOL domains was markedly larger in younger patients (aged 30-59 years) compared to older age groups (≥60 years). The top three largest impairments in this younger group were found for: fatigue (ES=2.47, P<0.001), dyspnea (ES=2.14, P<0.001) and role functioning RP (ES=1.96, P<0.001). This latter aspect indicates the ability to perform daily activities. Conclusion: Pretreatment HROQL of higher-risk MDS patients vary by age and gender and current reference data will help making more accurate comparisons with HRQOL of patients under treatment. Clinicians should also pay special attention to younger patients, as these are those most in need of HRQOL improvements. Figure 1. Adjusted mean differences between MDS patients and their respective control groups by age categories (30-59 years, 60-69 years, 70-79 years and over 80) in functional aspects and global quality of life. A score below 0 line means worse outcomes for MDS patients. *= Statistically significant (P<0.05) **= Statistically significant (P<0.001) Figure 1. Adjusted mean differences between MDS patients and their respective control groups by age categories (30-59 years, 60-69 years, 70-79 years and over 80) in functional aspects and global quality of life. A score below 0 line means worse outcomes for MDS patients. / *= Statistically significant (P<0.05) **= Statistically significant (P<0.001) Figure 2. Adjusted mean differences between MDS patients and their respective control groups by age categories (30-59 years, 60-69 years, 70-79 years and over 80) in symptom scales. A score above 0 line means worse outcomes for MDS patients. *=Statistically significant (P<0.05) **=Statistically significant (P<0.001) Figure 2. Adjusted mean differences between MDS patients and their respective control groups by age categories (30-59 years, 60-69 years, 70-79 years and over 80) in symptom scales. A score above 0 line means worse outcomes for MDS patients. / *=Statistically significant (P<0.05) **=Statistically significant (P<0.001) Figure 3. Quality of life profile by the EORTC QLQ-C30 in higher risk-MDS patients by gender and age groups. Means scores of the EORTC QLQ-C30 are reported. Figure 3. Quality of life profile by the EORTC QLQ-C30 in higher risk-MDS patients by gender and age groups. Means scores of the EORTC QLQ-C30 are reported. Disclosures Gaidano: MorphoSys; Roche; Novartis; GlaxoSmithKline; Amgen; Janssen; Karyopharm: Honoraria, Other: Advisory boards; Celgene: Research Funding. Santini:celgene, Janssen, Novartis, Onconova: Honoraria, Research Funding. Platzbecker:Celgene: Honoraria; GlaxoSmithKline: Honoraria, Research Funding; Novartis: Honoraria; Amgen, Inc.: Honoraria. Di Renzo:Celgene: Research Funding.

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Efficace, Fabio, Gianluca Gaidano, Maria Teresa Voso, Giovanni Caocci, Massimo Breccia, Anna Angela Di Tucci, Reinhard Stauder, et al. "Investigating Preferences and Factors Associated with Involvement In Treatment Decision-Making In Newly Diagnosed Patients with High-Risk Myelodysplastic Syndromes: An International Multicenter Study." Blood 116, no. 21 (November 19, 2010): 4953. http://dx.doi.org/10.1182/blood.v116.21.4953.4953.

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Abstract Abstract 4953 Background: Shared decision-making between patients and physicians is broadly advocated in medicine, however little research is available to understand whether this approach would be desirable to all patients regardless of disease type and severity or individual patient characteristics. While clinical decision-making in high-risk myelodysplastic syndromes (MDS) is critical for a number of reasons including: associated comorbidity, symptom burden, and limited life expectancy, no evidence-base data currently exist on patients' preferences. Aim: The objective of this study is twofold: 1) to investigate to what extent high-risk MDS patients prefer to be involved in treatment decision making during consultation just after diagnosis; 2) to identify possible clinical, socio-demographic and patient-reported health status factors associated with patients' preferences for involvement in treatment decisions. Patients and Methods: Data were gathered through an ongoing international prospective observational study involving 15 countries that recruits newly diagnosed patients with intermediate-2 or high-risk IPSS score. All patients were classified according to the WHO histology classification. During the first encounter with their treating physicians, discussing treatment options just after diagnosis, patients were administered a previously internationally validated “control preference scale”. This scale broadly categorizes patients into one of three roles depending on the extent of their preferred involvement in treatment decision-making: “active” (where the patient themselves prefer to decide on which would be the most appropriate treatment option for themselves); “collaborative/shared” (where the patient and the doctor jointly decided on the most appropriate treatment option); “passive” (where the patient prefer to leave decision on the most appropriate treatment option to the doctor). Associations with the following variables were investigated: performance status, comorbidity (“Hematopoietic Cell Transplantation”-“Comorbidity index”), living arrangements, age, gender, education, cultural group, IPSS risk category, evolution from lower IPSS risk scores and patient-reported symptoms (using symptom scales of the EORTC QLQ-C30). Descriptive statistics were used and Mann-Whitney U-test, Kruskall-Wallis test and Fisher's exact test were used as appropriate to test statistical significance of performed comparisons. Results: Study population included overall 121 patients (38% female and 62% male). Mean age of patients was 69 years (min:31.3 max: 87.9) and 80% were diagnosed with IPSS int-2 risk score and 20% with IPSS high risk score. Twenty-six percent evolved from lower IPSS risk scores, while 74% were newly diagnosed with higher-risk. Forty-nine percent favored a passive while only 13% preferred an active role in treatment decision-making; the remaining 38% favored a collaborative/shared decision-making approach. Investigation of factors possibly related to preferred roles, found that passive role was significantly associated with lower education levels (P=.04). Among lower educated patients, 62.5% preferred a passive role compared with only 5% preferring an active role. When investigating relationships with patient-reported symptoms, a general trend for patients preferring a passive role, showing worse outcomes, was also evident. Higher symptom mean scores were found for passive vs. active role groups, being respectively: 46 (sd.26.6) vs. 37 (sd.29.9) for fatigue; 20 (sd.31.8) vs. 2 (sd.8.6) for constipation; 34 (sd.33) vs. 24 (sd.29.5) for dyspnea. Exploratory analysis showed that overall mean symptom score was statistically significant worse in patients preferring a passive role vs. those preferring an active role (P=.01). While other trends of associations were noted, these were not statistically significant. Conclusion: This is the first evidence suggesting that a consistent percentage of high-risk MDS patients prefer a passive role when discussing treatment options with their treating physicians at the time of diagnosis. There is also an indication that these patients are those with lower education levels and presenting with a higher symptom burden. Results need to be confirmed in a larger sample size. Disclosures: No relevant conflicts of interest to declare.

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Tedeschi, Alessandra, Idanna Innocenti, Francesco Albano, Alessandro Gozzetti, Luciano Levato, Marika Porrazzo, Gianluigi Reda, et al. "Chronic Lymphocytic Leukemia (CLL) Patients Quality of Life (QoL): A Cross-Sectional Analysis of the Italian Experience in the Choice Study during the First Wave of the COVID-19 Pandemic." Blood 138, Supplement 1 (November 5, 2021): 4680. http://dx.doi.org/10.1182/blood-2021-150274.

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Abstract Introduction Although plenty of data exists on efficacy and safety of CLL drugs, their impact on patients' Health-Related Quality of Life (HRQoL) is largely unknown (1-2). Documentation of drug safety via traditional use of adverse events (AE) in hematology is limited if not complemented with Patient-Reported Outcomes (PRO) measures (3-4). Incorporation of HRQoL PROs is now essential to better evaluate risk-benefit of new therapeutic approaches and it is also highly valued by regulatory stakeholders (5). Most PRO data currently available for CLL patients (pts) came from randomized controlled trial settings (6-7), hence limiting generalizability of findings to CLL real-life patients. CHOICE study was designed to investigate CLL patients' QoL and preference towards different treatment profiles through a Discrete Choice Experiment (DCE) methodology in Italy. Due to the timelines of the study, which started in February 2020, the related data offer an insight into patients' perception and worries during the first wave of the COVID-19 pandemic. Methods This cross sectional, multi-center, observational study included CLL patients, treatment naïve during the watch & wait period (W&W) or already TREATED (around 50% each, controlled at site level), who signed the informed consent for study participation. Exclusion criteria were inability to take oral drugs, cognitive disorders that could impair the comprehension of the questionnaires and concomitant treatment for other malignancies. Patients were asked to fill in the following HRQoL questionnaires: EQ-5D-5L, EORTC QLQ-C30 and QLQ CLL-16, as well as a DCE questionnaire, (described elsewhere). Each questionnaire was completed by the patient on a tablet - using an App specifically developed for the study. Results 401 pts were enrolled in Italy in 16 hematology centers (Feb - July 2020); 199 W&W and 196 TREATED pts completed the questionnaires and were included in the evaluable population. Main patients' characteristics are shown in Table 1. 73.7% of TREATED pts were ON-treatment (30.8% were in 1st-line, 69,2% in further lines) and 26.3% were OFF-treatment; the majority of pts (55,6%) were currently treated with a target therapy (Table1). The EQ-5D-5L questionnaire showed no significant differences between groups. In both groups more than 80% of pts reported low values (1 or 2, indicating no or small impact) on all items. Median VAS was 75 for the TREATED group and 80 for the W&W group (0-100; higher scores indicate higher QoL). QLQ C-30 / CLL-16 scores had very similar results between TREATED and W&W pts suggesting a limited impact of CLL on pts QoL. The median (IQR) QoL Scale was 83.3 (67- 83) for TREATED and 83.3 (67- 92) for W&W pts (0-100; all functional scales had high scores, that represent a better level of functioning; all symptoms' scales had low values, representing a less important symptomatology or problem, Figure 1). The main symptoms reported were fatigue, insomnia, pain, and dyspnea, while the main worry was for "future health" (Figure 1). Distribution of data was statistically different between the 2 groups only for the Role functioning Scale (p=0.024) and the Social Functioning Scale (p=0.003) of QLQ-C30 and for the Infection Scale (p<0.001) of QLQ CLL-16, always with slightly but significantly better results for the W&W group. Conclusions CHOICE study helps to understand the CLL patients' mindset and feeling in the light of the COVID-19 pandemic impact on health care for this category of pts, highlighting their preferences and worries in a large cohort of pts in Italy, allowing a comparison between TREATED and W&W pts. The main limitation of the study was its cross-sectional design, which does not allow us to evaluate any change in QoL neither with respect to the impact of the pandemic, nor to the effects of the treatment, if any. CLL pts showed a good QoL, as confirmed by both EQ-5D-5L and EORTC QLQ C-30 / CLL-16 scores, with very similar results between TREATED and W&W pts (although slightly better results in the W&W vs TREATED group). The results of the present study are consistent with previous reports, and fatigue was the most reported symptom, while worry for future health was the most relevant score in CLL-16 questionnaire. Hospital accesses reduction that was detected during the pandemic might have influenced patients' response, as well as the extreme attention towards the danger of infections, and might have impacted patients' perception on future health. Figure 1 Figure 1. Disclosures Tedeschi: Beigene: Honoraria, Speakers Bureau; AstraZeneca: Honoraria, Speakers Bureau; AbbVie: Honoraria, Speakers Bureau; Janssen: Honoraria, Speakers Bureau. Gozzetti: Janssen: Honoraria; AbbVie: Honoraria. Reda: Beigene: Consultancy; Astra Zeneca: Consultancy; Abbvie: Consultancy; Janssen: Consultancy. Gualberti: AbbVie: Current Employment. Malgieri: AbbVie: Current Employment. Finsinger: AbbVie: Current Employment.

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Efficace, Fabio, Gianluca Gaidano, Maria Teresa Petrucci, Pasquale Niscola, Lucia Tognazzi, Elisabetta Antonioli, Francesco Cottone, et al. "The Accuracy of the International Myeloma Working Group Frailty Score in Capturing Health-Related Quality of Life Profile of Patients with Relapsed Refractory Multiple Myeloma." Blood 138, Supplement 1 (November 5, 2021): 115. http://dx.doi.org/10.1182/blood-2021-145977.

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Abstract Background Clinical decision-making in patients with relapsed refractory multiple myeloma (RRMM) is challenging and identification of patients who can benefit the most from a given therapy is of critical importance. The International Myeloma Working Group (IMWG) index is one of the most robust scores to evaluate frailty, and it has been validated for patients with newly diagnosed MM. However, little is known on its applicability in the setting of RRMM and of its relationships with patient-reported health-related quality of life (HRQoL). Objectives The primary objective of this study was to investigate whether the IMWG frailty score is able to detect distinct patient-reported HRQoL profiles in the setting of RRMM. A secondary objective was to assess the prevalence of patient-reported clinically important symptoms by frailty groups (ie., fit, intermediate-fit, and frail). Patients and Methods This was an international (Italy and UK) prospective cohort observational study that consecutively enrolled patients from 30 centers. The patients were eligible if they had received at least 1 prior therapy (but no more than 5) and had RRMM according to IMWG criteria. An additional inclusion criterion at the time of study entry was the availability of all variables incorporated into the IMWG frailty score to allow classification of patients in the following three groups: fit, intermediate-fit and frail. Baseline assessment of HRQOL was mandatory to be included in this study and patients completed a set of well-validated measures including the EORTC QLQ-C30 and its myeloma module (QLQ-MY20). The scores from EORTC QLQ-C30 and MY20 questionnaires were summarized by means and standard deviations, overall and by frailty group. Unadjusted differences in mean scores were compared between frailty groups. We also estimated the adjusted mean differences in HRQoL scores of respectively fit and intermediate groups vs frail patients, using a multivariable linear regression model, adjusting for a number of key potential confounders including: sex, education, time since diagnosis, number of previous lines of therapy, previous transplantation, currently receiving therapy, myeloma status (refractory vs relapsed only) and type of MM at diagnosis (secretory vs else). We also assessed the prevalence of clinically important symptoms, based on previously published evidence-based thresholds, by IMWG frailty group. Results Overall, 365 RRMM patients were enrolled between November 2017 and December 2018. Median age was of 69.7 years (IQR, 62.7-75.0) and 296 had received at least two previous lines of therapy. According to the IMWG frailty score evaluation at study entry, 192 (53%), 85 (23%) and 88 (24%) patients were classified as fit, intermediate-fit and frail. Each group was associated with a clearly distinct patient-reported HRQoL profile with both fit and intermediate-fit groups reporting statistically and clinically meaningful better outcomes (ie., improved functional status and lower symptom burden) than frail patients in the majority of the scales from the EORTC QLQ-C30 and QLQ-MY20. For example, mean scores of the EORTC QLQ-C30 physical functioning scale were 71.2, 62.2, and 47.5 for fit, intermediate-fit and frail patients, respectively (p<0.001) (i.e., higher score indicates better functioning). Similarly, the mean score of the QLQ-MY-20 disease symptoms scale was 22.8, 25.9 and 35.9 for fit, intermediate-fit and frail patients, respectively (p<0.001) (i.e., higher score indicates higher symptom burden). Adjusted mean score differences (resulting from multivariable analysis) confirmed clinically relevant differences across most scales of the EORTC QLQ-C30 and QLQ-MY20. Additionally, the prevalence of patient-reported clinically important symptoms was statistically significant different across the three IMWG frailty groups with regard to pain (p=0.002), dyspnea (p=0.004), fatigue (p<0.001), insomnia (p=0.022) constipation (p=0.003) and appetite loss (p=0.001). Details are reported in Figure. Conclusions: In the setting of RRMM, the IMWG frailty score is able to detect clearly distinct patient-reported HRQoL profiles. Current findings may lay the groundwork for the development of a patient-centered frailty index, which also incorporates HRQoL data, to be used in patients with RRMM treated in real-life. Figure 1 Figure 1. Disclosures Efficace: Janssen: Consultancy; Abbvie: Consultancy, Other: Grants (to Institution); Amgen: Consultancy, Other: Grants (to Institution); Takeda: Consultancy. Gaidano: Incyte: Membership on an entity's Board of Directors or advisory committees; Beigene: Membership on an entity's Board of Directors or advisory committees; Janssen: Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; Astrazeneca: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees; Abbvie: Membership on an entity's Board of Directors or advisory committees, Speakers Bureau. Petrucci: BMS: Honoraria, Other: Advisory Board; Takeda: Honoraria, Other: Advisory Board; Amgen: Honoraria, Other: Advisory Board; GSK: Honoraria, Other: Advisory Board; Karyopharm: Honoraria, Other: Advisory Board; Janssen-Cilag: Honoraria, Other: Advisory Board; Celgene: Honoraria, Other: Advisory Board. Tafuri: Celgene: Research Funding; Roche: Research Funding; Novartis: Research Funding. Larocca: Amgen: Honoraria; Bristol-Myers Squibb: Honoraria, Other: Advisory Board; Celgene: Honoraria, Other: Advisory Board; Janssen: Honoraria, Other: Advisory Board; GSK: Honoraria; Takeda: Other: Advisory Board. Molica: Abbvie: Consultancy, Honoraria; Janssen: Consultancy, Honoraria; Astrazeneca: Honoraria. Gozzetti: Janssen: Honoraria; AbbVie: Honoraria. Vignetti: Amgen: Consultancy, Honoraria; Incyte: Honoraria; Novartis: Honoraria. Cavo: Novartis: Honoraria; Celgene: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Other: Travel Accommodations, Speakers Bureau; Adaptive Biotechnologies: Consultancy, Honoraria; Takeda: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; Amgen: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; GlaxoSmithKline: Consultancy, Honoraria; AbbVie: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees; Sanofi: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; Janssen: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Other: TRAVEL, ACCOMMODATIONS, EXPENSES, Speakers Bureau; Bristol-Myers Squib: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Speakers Bureau.

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Bright, Binu, Anu PS, and Gireesh Kumar KP. "Diagnostic Accuracy of Non-Contact Infrared Thermometer in Comparison with Mercury Thermometer and Digital Thermometers." International Journal of Health Sciences and Research 13, no. 3 (March 14, 2023): 187–94. http://dx.doi.org/10.52403/ijhsr.20230318.

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BACKGROUND: Body temperature is a vital parameter in patient assessment. Fever is a common presentation in patients arriving at all health care setups. [1] It is a transient pathological state characterised by a disturbance in the hypothalamus thermoregulation system and, as a result, an increase in the body's temperature above the normal range. Normal body temperature values range from 36.5 to 37.4 °C depending on physiological variations, patient characteristics, and measurement sites. [2] Fever is a sign of underlying pathology – infection, infestation, inflammation, autoimmune diseases, malignancy, medication adverse reaction, intracranial haemorrhage or pulmonary embolism. Fever is also an important symptom in COVID-19 patients, typically appearing 12–14 days after exposure. And that made screening patients for elevated body temperature an essential initial triaging tool during the pandemic. [3] [4] A clinical thermometer is the equipment used for measuring body temperature. Several thermometers are available, each with its advantages, disadvantages, applicability, reliability and sensitivity. [5] Mercury-in-glass thermometers were the standard way to measure temperature for many years. They were taken off the market in the late 2000s because mercury is toxic to the environment. After that, many thermometers came into use, including digital, tympanic or axillary thermometers and non-contact infrared thermometers. Presently digital thermometers occupy the bedside at both homes and hospitals, including clinics. [6] [7] [8] The COVID-19 pandemic brought in, at large scales, the use of a non-contact infrared thermometer as a screening tool to measure body temperature. [9] [10] Our knowledge of the relative performance of different types of thermometers, including differences in temperature measured, is limited despite the essential role they play in clinical practice. So, it's essential to understand how different thermometers work and how accurate they are at making diagnoses. [11] [12] This is especially crucial considering the triage significance of fever measurement in clinical settings, especially emergency care, to refer patients to appropriate care pathways. OBJECTIVES: To evaluate the diagnostic accuracy of non-contactable infrared thermometers in comparison with mercury and digital thermometers. METHODOLOGY: The prospective observational study was conducted on 210 patients of both genders, of all age groups, presenting with or without fever to the ED of AIMS, Kochi, and a quaternary during the period from January to June 2022. The data we collected and statistically analysed from the study population are age, sex, presenting complaints, co-morbidities, heart rate, blood pressure, respiratory rate, SpO2, and body temperature being simultaneously measured with mercury, digital and non-contact infrared thermometers. The temperature of all patients was recorded using mercury, a digital thermometer placed in each axilla simultaneously, and a non-contactable infrared thermometer on the forehead. Mercury in glass thermometer was placed in axilla with the bulb of the thermometer in the tip of the axilla for 2 minutes. The digital thermometer was placed in a similar fashion in the other axilla and removed from the axilla after the beep was heard and temperature displayed was noted. The infrared thermometer is placed near the forehead or wrist, with a 5cm gap between the two. The trigger button is gently pressed, and the temperature shown on the LCD screen is recorded. RESULT: The study group included 53% males and 47% females. 58% belonged to the age group between 46 and 75 years, 30% between 16 and 45 years of age, 11% between 76 and 99 years and 1% below 15 years of age. Fever was present in 20.5% of the patients and the rest had other symptoms like vomiting, diarrhoea, cough, dyspnoea, fatigue, weakness, body pain and pedal oedema. 57% had two comorbidities, 29% were with more than 2 comorbidities while 14% had no known comorbidities. The body temperatures measured by mercury and digital thermometers were almost identical – Normal in 85.5%, above normal in 14% and below normal in 0.5%; but with a non-contact infrared thermometer, the same were 97.5%, 2.5% and 0% respectively. DISCUSSION: This study is highly relevant in the current scenario where the pandemic situation is almost over and a lot of institutions who invested in NCIT have started considering them for use as alternative devices for recording temperature. In our study, non-contact infrared thermometer failed in detecting fever in several affected patients, or misread normal temperature as elevated and was not capable of detecting hypothermia. Additional research is required to compare its accuracy and precision to other invasive and non-invasive core body temperature testing methods. The study finding of a rise in heart and respiratory rates in fever patients, though non-specific, concur with inferences from other similar studies. CONCLUSION: Our study concluded that the accuracy of non-contactable infrared thermometers is less reliable than mercury and digital thermometers for routine clinical practice. Though, the non-contact infrared thermometer was widely being used during the pandemic scenario, our study results do not favour its use other situations like the clinics, intensive care units or emergency departments. Key words: [Mercury, Digital, Infrared, Thermometer, COVID, Healthcare technology]

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Decavèle, Maxens, Emmanuel Rozenberg, Marie-Cécile Niérat, Julien Mayaux, Elise Morawiec, Capucine Morélot-Panzini, Thomas Similowski, Alexandre Demoule, and Martin Dres. "Respiratory distress observation scales to predict weaning outcome." Critical Care 26, no. 1 (June 6, 2022). http://dx.doi.org/10.1186/s13054-022-04028-7.

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Abstract Background Whether dyspnea is present before starting a spontaneous breathing trial (SBT) and whether it may affect the outcome of the SBT is unknown. Mechanical Ventilation—Respiratory Distress Observation Scale (MV-RDOS) has been proposed as a reliable surrogate of dyspnea in non-communicative intubated patients. In the present study, we sought (1) to describe the evolution of the MV-RDOS during a SBT and (2) to investigate whether MV-RDOS can predict the outcome of the SBT. Methods Prospective, single-center study in a twenty-two bed ICU in a tertiary center. Patients intubated since more 48 h who had failed a first SBT were eligible if they meet classical readiness to wean criteria. The MV-RDOS was assessed before, at 2-min, 15-min and 30-min (end) of the SBT. The presence of clinically important dyspnea was inferred by a MV-RDOS value ≥ 2.6. Results Fifty-eight patients (age 63 [51–70], SAPS II 66 [51–76]; med [IQR]) were included. Thirty-three (57%) patients failed the SBT, whose 18 (55%) failed before 15-min. Twenty-five (43%) patients successfully passed the SBT. A MV-RDOS ≥ 2.6 was present in ten (17%) patients before to start the SBT. All these ten patients subsequently failed the SBT. A MV-RDOS ≥ 2.6 at 2-min predicted a SBT failure with a 51% sensibility and a 88% specificity (AUC 0.741 95% confidence interval [CI] 0.616–0.866, p = 0.002). Best cut-off value at 2-min was 4.3 and predicted SBT failure with a 27% sensibility and a 96% specificity. Conclusion Despite patients met classical readiness to wean criteria, respiratory distress assessed with the MV-RDOS was frequent at the beginning of SBT. Measuring MV-RDOS before to initiate a SBT could avoid undue procedure and reduce patient’s exposure to unnecessary mechanical ventilation weaning failure and distress.

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Bourgeon-Ghittori, Irma, Maryline Couette, Sylvie Marini, Rachida Ouedraogo, Aline Alves, Keyvan Razazi, Damien Carras, Ann-Cecile Pallud, Nancy Kentish-Barnes, and Armand Mekontso Dessap. "Corporeal rehabilitation to manage acute stress in critically ill patients." Annals of Intensive Care 12, no. 1 (June 10, 2022). http://dx.doi.org/10.1186/s13613-022-01019-3.

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Abstract Background Intensive care unit (ICU) patients often endure discomfort and distress brought about by their medical environment and the subjective experience of their stay. Distress, pain, and loss of control are important predictors of future neuropsychiatric disorders. Depression, anxiety, and post-traumatic stress are common after discharge. We aimed at mitigating acute stress and discomfort via a novel intervention based on body image rehabilitation and rehabilitation of senses performed following a holistic approach guided by positive communication (corporeal rehabilitation care, CRC). Results We conducted a prospective observational study on 297 consecutively enrolled patients participating in at least one CRC session. Benefits of CRC were assessed on both subjective analogical scales of stress, pain, and well-being criteria, and objective clinical measures of dyspnea, respiratory rate, and systolic arterial pressure, just after CRC and long after (a median of 72 min later) to estimate its remote effect. Results showed that CRC had a positive effect on all overt measures of distress (acute stress, pain, discomfort) just after CRC and remotely. This beneficial effect was also observed on dyspnea and respiratory rate. Results also showed that best CRC responders had higher baseline values of stress and heart rate and lower baseline values of well-being score, indicating that the care targeted the population most at risk of developing psychological sequelae. Interestingly, a positive CRC response was associated with a better survival even after adjustment for physiologic severity, indicating a potential to identify patients prompt to better respond to other therapeutics and/or rehabilitation. Conclusion This study demonstrated the feasibility of an innovative holistic patient-centered care approach and its short-term positive effects on critical parameters that are considered risk factors for post-intensive care syndrome. Further studies are warranted to study long-term benefits for patients, and overall benefits for relatives as well as ICU staff.

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Haller, Heidemarie, Kyung-Eun Choi, Silke Lange, Sherko Kümmel, Anna Paul, Holger Cramer, Gustav Dobos, and Petra Voiss. "Effects of an Integrative Mind-body-medicine Group Program for Breast Cancer Patients during Chemotherapy: An Observational Study." Current Pharmaceutical Design 26 (December 11, 2020). http://dx.doi.org/10.2174/1381612826666201211111122.

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Background: Breast cancer is one of the leading cancers in women in the Western world. Cancer treatment, especially chemotherapy, is often associated with physical and psychosocial side effects. Objective: To improve the quality of life and manage side effects, a new integrative mind-body-medicine group concept for breast cancer patients receiving chemotherapy was developed and pilot tested. Methods: Breast cancer patients participated in a 66 hours mind-body-medicine group program tailored to the needs of cancer patients during chemotherapy. The program was integrated into standard care encompassing mindfulness training, yoga, moderate exercise, nutrition, complementary self-help strategies, cognitive restructuring, and acupuncture. Quality of life (EORTC QLQ-C30), depression and anxiety (HADS), stress (PSS-10), and fatigue (BFI) were assessed before and after the program as well as satisfaction and safety. Analyses were carried out exploratory with paired samples t-tests. Results: Fifty-seven female patients, 51.3±10.5 years, with breast cancer diagnoses were enrolled. After completing the program, global EORTC quality of life was improved (Δ=9.5; 95%-CI=[2.9|16.1]; p=.005), although the EORTC-symptom scales fatigue (Δ=9.9; 95%-CI=[1|18.8]; p=.030), nausea (Δ=7.1; 95%-CI=[0.6|13.6]; p=.031), and dyspnea (Δ=12.5; 95%- CI=[2.9|22.1]; p=.011) increased. Stress (Δ=-3.5; 95%-CI=[-5|-2.1]; p=.000), anxiety (Δ=-3.8; 95%-CI=[-4.9|-2.7]; p=.000), and depression (Δ=-3.9; 95%-CI=[-4.9|-2.8]; p=.000) were also significantly reduced. Regarding intensity of (Δ=0.2; 95%- CI=[-0.8|0.5]; p=.644) and the impairment through fatigue (Δ=0.1; 95%-CI=[-0.8|0.6]; p=.696), no significant worsening was observed. Patients were satisfied with the program. No serious adverse events were reported. Conclusion: Breast cancer patients benefit from an integrative mind-body-medicine group program during chemotherapy regarding the quality of life and psychological symptoms. Randomized controlled trials are warranted.

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Izzo, Rosanna, Carmen Zincarelli, Michele Onufrio, Adriana D’Alessio, Giovanni Di Ruocco, Matteo Nicola Dario Di Minno, and Annaitalia Pisacreta. "Early rehabilitation treatment in hospitalized patients with severe COVID-19: Effects on autonomy and quality of life." Physiotherapy Practice and Research, July 2, 2022, 1–7. http://dx.doi.org/10.3233/ppr-220667.

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PURPOSE: The aim of our study is to evaluate effects of early rehabilitation treatment in hospitalized patients with severe COVID-19, in order to improve patients’ autonomy and quality of life. METHODS: This observational study has been performed in hospitalized patients with severe COVID-19. All patients were evaluated at T0 using specific scales: Modified Barthel Index (MBI) for autonomy in ADL, Mini Mental State Examination (MMSE) for cognitive status, Borg scale for dyspnoea, EQ5D scale for quality of life. In absence of contraindications for the rehabilitation treatment, patients start early a rehabilitation protocol consisting of one session (30 minutes) per day, for 2 to 3 weeks; these scales have been repeated at patient’s demission (T1). RESULTS: 70 patients (37 women and 33 men, with average age of 71 years) with severe COVID-19 were included in the study. After rehabilitation treatment, MBI increases statistically significantly from T0 to T1 (39.8±35.0 with 95% CI 31.6–48, vs 69.8±38.1 with 95% CI 60.8–78.7, p < 0.001); besides MBI at T0 correlates inversely and statistically significantly with all EQ-5D variables at T0, similarly at T1 (p < 0.001), indicating the improvement of autonomy and therefore of the quality of life. The MMSE correlates statistically significantly with MBI at T0 and T1 (r = 0.569, r = 0.747 respectively, p < 0.001), indicating that an adequate cognitive status is connected with a greater increase in autonomy in ADL after rehabilitation treatment. MBI correlates directly and significantly with the PaO2/FiO2 value both at T0 and T1 (r = 0.263 with p = 0.039, r = 0.389 with p = 0.023 respectively), indicating that improving the oxygen exchanges also improves the patient’s autonomy. CONCLUSIONS: An early rehabilitation treatment should promote autonomy and a better quality of life in patients with COVID-19.

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Louis, Gilles, Florence Schleich, Michèle Guillaume, Delphine Kirkove, Halehsadat Nekoee Zahrei, Anne-Françoise Donneau, Monique Henket, et al. "Development and validation of a predictive model combining patient-reported outcome measures (PROMs), spirometry and FeNO for asthma diagnosis." ERJ Open Research, November 24, 2022, 00451–2022. http://dx.doi.org/10.1183/23120541.00451-2022.

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INTRODUCTIONAlthough asthma is a common disease, its diagnosis remains a challenge in clinical practice with both over/under-diagnosis. Here, we performed a prospective observational study investigating the value of symptom intensity scales alone or combined with spirometry and FeNO to aid in asthma diagnosis.METHODSWe recruited, over a 38-month period, 303 untreated patients complaining with symptoms suggestive of asthma (cough, chest tightness, dyspnea, airway secretion and wheezing). The whole cohort was split in a training cohort (n=166) for patients recruited in odd months and a validation cohort (n=137) for the patients recruited in even months. Asthma was diagnosed either by a positive reversibility test (≥12% and 200 ml) and/or a positive bronchial challenge test (PC20M≤8 mg·ml−1). In order to assess the diagnostic performance of symptoms, spirometric indices and FeNO, we performed ROC curve analysis and multivariable logistic regression to identify the independent factors associated with asthma in the training cohort. Then, the derived predictive models were applied to the validation cohort.RESULTS63% of patients in the derivation cohort and 58% in the validation cohort were diagnosed as being asthmatics. After logistic regression wheezing was the only symptom to be significantly associated with asthma. Similarly, FEV1% predicted, FEV1/FVC% and FeNO were significantly associated with asthma. A predictive model combining these four parameters yielded an AUC of 0.76 (95%CI: 0.66–0.84) in the training cohort and 0.73 (95%CI: 0.65–0.82) when applied to the validation cohort.CONCLUSIONCombining wheezing intensity scale with spirometry and FeNO may help in improving asthma diagnosis accuracy in clinical practice.

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Chia, Claramae Shulyn, Chin-Ann Johnny Ong, Hong-Yuan Zhu, Cindy Lim, Jolene Si Min Wong, Grace Hwei Ching Tan, and Melissa Ching Ching Teo. "Can baseline quality of life scores predict for morbidity and survival after CRS and HIPEC: a prospective study of 151 patients." Pleura and Peritoneum, April 4, 2022. http://dx.doi.org/10.1515/pp-2021-0148.

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Abstract Objectives Various studies have shown that good quality of life (QoL) can be achieved after cytoreductive surgery (CRS) and hyperthermic intraperitoneal chemotherapy (HIPEC). There is prognostic value of baseline QoL in post-operative outcome in Western setting. Our prospective study aims to validate these observations and elucidate clinical factors that predict poorer QoL in Asian peritoneal carcinomatosis patients. Methods European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire was administered to patients before CRS and HIPEC and thereafter at 3, 6 and 12 months. Results A total of 151 patients underwent 155 surgeries. Four hundred and seventy two questionnaires were completed. Median disease-free survival (DFS) was 16.5 months. Three year DFS and overall survival (OS) were 24.0% and 73.0% respectively. Post-operative global health status significantly increased at 3, 6 and 12 months. The decreases in functional scales recovered to baseline by 1-year post-surgery. Peritoneal carcinomatosis index (PCI), presence of stoma, peritonectomy duration, death within one year, post-operative complication and length of SICU stay negatively influenced QoL. Complication rates were higher in patients with lower global health status, physical and role functioning scores and higher symptom summary scores at baseline. Lower social functioning score, and higher pain, dyspnoea and symptom summary scores at baseline were significantly associated with poorer OS. Conclusions Various clinical factors can help us predict a patient’s QoL after surgery. Several baseline factors were also able to predict morbidity and survival. Going forward, we can use these factors to help us better select patients who will have a greater benefit from CRS and HIPEC.

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Nakshbandi, Gizal, Catharina C. Moor, Katerina Antoniou, Vincent Cottin, Anna-Maria Hoffmann-Vold, Edwin A. Koemans, Michael Kreuter, Philip L. Molyneaux, Wim A. Wuyts, and Marlies S. Wijsenbeek. "Study protocol of an international patient-led registry in patients with pulmonary fibrosis using online home monitoring: I-FILE." BMC Pulmonary Medicine 23, no. 1 (February 2, 2023). http://dx.doi.org/10.1186/s12890-023-02336-4.

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Abstract Background Pulmonary fibrosis (PF) is caused by a heterogeneous group of diseases, with a high inter-individual variability in disease trajectory. Identifying disease progression in patients with PF has impact on clinical management decisions. However, strategies to early identify and predict disease progression for these patients are currently lacking. In this study, we aim to assess long-term FVC change in patients with PF measured with home spirometry, and evaluate the feasibility of a multinational patient-led registry in PF. In addition, we will assess validity of patient-reported outcomes (PROMs) for the different subgroups of patients with PF. Methods In this international, prospective, multicenter, observational study, we aim to include 700 patients across seven European countries. Patients will monitor their disease course for a period of two years using an online home monitoring program (I-FILE), which includes home spirometry, pulse oximetry, and PROMs. Results will be directly sent to the hospital via the online application. Patients will be asked to perform daily home spirometry and pulse oximetry in the first three months, followed by once weekly measurements for a period of two years. PROMs will be completed in the online I-FILE application every six months, including the King’s brief Interstitial Lung Disease Health Status, The EuroQol five dimensions five-level, Visual Analogue Scales on cough, dyspnea, fatigue and general complaints, Leicester Cough Questionnaire, Fatigue Assessment Scale, Work Productivity and Activity Impairment Questionnaire, Global Rating of Change Scale, and Living with Pulmonary Fibrosis questionnaire. Discussion This study will provide much needed insights in disease trajectories of the different subgroups of patients with PF. Simultaneously, the I-FILE study will yield valuable information on the use and feasibility of home-based data collection. This international patient-led registry will facilitate trans-border collaboration to further optimize care and research for patients with PF. Trial registration: The study was registered on the 12th of March 2020 in the International Clinical Trial Registry, www.clinicaltrials.gov; Identifier: NCT04304898.

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Ou, Yali, Yanan Zhang, Chao Jin, Liang Ning, Yi Xiao, and Guolong Yu. "Clinical characteristics of somatization symptoms of Chinese outpatients in the Department of Cardiology." Journal of Clinical and Basic Psychosomatics, September 25, 2023, 0636. http://dx.doi.org/10.36922/jcbp.0636.

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Somatization symptoms are common in patients with cardiovascular disease (CVD). However, it is challenging to improve these symptoms as the cardiologists in general hospitals, whom these patients sought medical attention from, are imperceptible to signs of psychological disorders, thereby leading to unnecessarily high medical costs and failure of improving the symptoms. Therefore, this study aimed to explore the clinical characteristics and factors that affect somatization symptoms in Chinese outpatients with CVD, providing results that could benefit the improvement of diagnosis and intervention of psychological disorders in the future. We conducted a cross-sectional and observational study in a tertiary general hospital in Hunan, China, from August 2020 to July 2021. Patient health questionnaire-15 (PHQ-15), general anxiety disorder-7 (GAD-7), PHQ-9, and a general demographic data questionnaire were used to screen outpatients for suspected psychiatric disorders. Of the 808 patients in this study, somatization symptoms occurred in 93.1% (752/808) of the sample. In patients with somatization symptoms, the mean total score on the PHQ-15 was 8.54 ± 2.67, and the prevalence of anxiety or depression was 78.7%. The PHQ-15 symptom items with a positive rate of >50% were sleep disorders, chest pain, headache, dyspnea, palpitation, and dizziness. The severity of somatization symptoms differed based on gender (P = 0.0341) and past hospitalization history (P = 0.023). In addition, there was a correlation between somatization symptoms and scores on the GAD-7 (P = 0.0282) and PHQ-9 scales (P = 0.0011). Linear correlation analysis found that PHQ-15 scores were significantly linked to GAD-7 (r = 0.4787, P < 0.001) and PHQ-9 scores (r = 0.5141, P < 0.001) in patients with somatization symptoms. Stepwise logistic regression analysis indicated that female gender, PHQ-9, and GAD-7 scores could positively predict somatization symptoms. In conclusion, somatization symptoms are prevalence in Chinese outpatients treated in the cardiology department. Anxiety, depression, and gender are the main factors affecting somatization symptoms.

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Gómez-Sánchez, Leticia, Olaya Tamayo-Morales, Nuria Suárez-Moreno, Jesus F. Bermejo-Martín, Andrea Domínguez-Martín, José A. Martín-Oterino, José I. Martín-González, et al. "Relationship between the structure, function and endothelial damage, and vascular ageing and the biopsychological situation in adults diagnosed with persistent COVID (BioICOPER study). A research protocol of a cross-sectional study." Frontiers in Physiology 14 (September 12, 2023). http://dx.doi.org/10.3389/fphys.2023.1236430.

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Background: SARS-CoV-2 infection affects the vascular endothelium, which mediates the inflammatory and thrombotic cascade. Moreover, alterations in the endothelium are related to arterial stiffness, which has been established as a marker of cardiovascular disease. The objective of this study is to analyse how the structure, vascular function, vascular ageing and endothelial damage are related to the biopsychological situation in adults diagnosed with persistent COVID and the differences by gender.Methods: This cross-sectional, descriptive, observational study will be carried out in the Primary Care Research Unit of Salamanca (APISAL) and in the BioSepsis laboratory of the University of Salamanca. The sample will be selected from the persistent COVID monographic office at the Internal Medicine Service of the University Hospital of Salamanca, and from the population of subjects diagnosed with persistent COVID in the clinical history of Primary Care. Through consecutive sampling, the study will include 300 individuals diagnosed with persistent COVID who meet the diagnosis criteria established by the WHO, after they sign the informed consent. Endothelial damage biomarkers will be measured using ELLA-SimplePlexTM technology (Biotechne). Their vascular structure and function will be analysed by measuring the carotid intima-media thickness (Sonosite Micromax); the pulse wave and carotid-femoral pulse wave velocity (cfPWV) will be recorded with Sphygmocor System®. Cardio Ankle Vascular Index (CAVI), brachial-ankle pulse wave velocity (baPWV) and ankle-brachial index will be analysed with Vasera VS-2000®. The integral assessment of the subjects with persistent COVID will be conducted with different scales that evaluate fatigue, sleep, dyspnea, quality of life, attention, nutrition state, and fragility. We will also evaluate their lifestyles (diet, physical activity, smoking habits and alcohol consumption), psychological factors, and cognitive deterioration, which will be gathered through validated questionnaires; moreover, physical activity will be objectively measured using a pedometer for 7 days. Body composition will be measured through impedance using an Inbody 230. Vascular ageing will be calculated with 10 and 90 percentiles of cfPWV and baPWV. Furthermore, we will analyse the presence of vascular injury in the retina, heart, kidneys and brain, as well as cardiovascular risk. Demographic and analytical variables will also be gathered.Discussion: Arterial stiffness reflects the mechanic and functional properties of the arterial wall, showing the changes in arterial pressure, blood flow, and vascular diameter that occur with each heartbeat. SARS-CoV-2 affects the endothelial cells that are infected with this virus, increasing the production of pro-inflammatory cytokines and pro-thrombotic factors, which can cause early vascular ageing and an increase of arterial stiffness. Persistent COVID is a complex heterogeneous disorder that affects the lives of millions of people worldwide. The identifications of potential risk factors to better understand who is at risk of developing persistent COVID is important, since this would enable early and appropriate clinical support. It is unknown whether vascular alterations caused by COVID-19 resolve after acute infection or remain over time, favouring the increase of arterial stiffness and early vascular ageing. Therefore, it is necessary to propose studies that analyse the evolution of persistent COVID in this group of patients, as well as the possible variables that influence it.Clinical Trial registration:ClinicalTrials.gov, identifier NCT05819840

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Journal articles on the topic 'Dyspnea observation scales'

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