Quality Of Life Assessment In Patients Research Articles

Impact of quality of life on mortality risk in patients with esophageal cancer: a systematic review and meta-analysis.

This systematic review and meta-analysis investigated the impact of quality of life (QoL) on mortality risk in patients with esophageal cancer. A literature search was conducted using the CINAHL, PubMed/MEDLINE, and Scopus databases for articles published from inception to December 2022. Observational studies that examined the association between QoL and mortality risk in patients with esophageal cancer were included. Subgroup analyses were performed for time points of QoL assessment and for types of treatment. Seven studies were included in the final analysis. Overall, global QoL was significantly associated with mortality risk (hazard ratio 1.02, 95% confidence interval 1.01-1.04; p < 0.00004). Among the QoL subscales of QoL, physical, emotional, role, cognitive, and social QoL were significantly associated with mortality risk. A subgroup analysis by timepoints of QoL assessment demonstrated that pre- and posttreatment global and physical, pretreatment role, and posttreatment cognitive QoL were significantly associated with mortality risk. Moreover, another subgroup analysis by types of treatment demonstrated that the role QoL in patients with surgery, and the global, physical, role, and social QoL in those with other treatments were significantly associated with mortality risk. These findings indicate that the assessment of QoL in patients with esophageal cancer before and after treatment not only provides information on patients' condition at the time of treatment but may also serve as an outcome for predicting life expectancy. Therefore, it is important to conduct regular QoL assessments and take a proactive approach to improve QoL based on the results of these assessments.

Multi-Site Randomized Trial of Inpatient Palliative Care for Hospitalized Patients Undergoing Hematopoietic Stem Cell Transplantation

Background: Patients with hematologic malignancies experience a substantial decline in their quality of life (QOL) and psychological health during their hospitalization for hematopoietic stem cell transplantation (HSCT). Early single center studies established the feasibility and promising preliminary efficacy of integrating palliative care during the HSCT hospitalization. However, data to test the efficacy of this care model across diverse care settings are lacking. Methods:We conducted a multi-site randomized trial among 360 adults with hematologic malignancies undergoing autologous or allogeneic HSCT at three academic institutions. Patients were randomly assigned to an inpatient palliative care intervention (n= 180) versus usual care (n=180), stratified by study site and type of HSCT. Intervention participants met with a palliative care clinician at least twice weekly during the HSCT hospitalization to address their physical and psychological symptoms. Patients assigned to usual care received all supportive care measures provided by the HSCT team and could be seen by palliative care upon request. We assessed patient QOL (Functional Assessment of Cancer Therapy (FACT) - Bone Marrow Transplant), depression and anxiety symptoms (Hospital Anxiety and Depression Scale), post-traumatic stress (PTSD) symptoms (PTSD Checklist), symptom burden (Edmonton Symptom Assessment Scale-Revised), and fatigue (FACT-Fatigue, higher scores indicate lower fatigue) at baseline and week-2 during hospitalization. The primary endpoint was QOL at week-2 during the HSCT hospitalization when patients typically experience their QOL nadir during HSCT. We used analysis of covariance, adjusting for baseline scores, to evaluate the effect of the intervention on patient-reported outcomes at week-2. Results:We enrolled 69.5% (360/518) of eligible patients (mean age = 55.4 (SD=12.5), 61.9% male, 76.6% White, 23.4% racial minorities, 8.7% Hispanic ethnicity, and 50.2% underwent allogeneic HSCT) between October 2018 and July 2022. Compared to those receiving usual care, participants receiving the inpatient palliative care intervention reported better QOL (95.5 vs. 89.3, P&amp;lt;0.001), and lower depression (5.9 vs. 6.9, P=0.041) and PTSD symptoms (26.0 vs. 28.2, P = 0.022) at week-2. Intervention participants also reported lower symptom burden (35.3 vs. 40.1, P=0.018) and better fatigue scores (28.6 vs. 25.6, p=0.014) compared to those assigned to usual care at week-2 during HSCT hospitalization. Anxiety symptoms (HADS-A) did not demonstrate a measurable difference between the two groups at week-2 during HSCT. Conclusions: In this multi-site randomized clinical trial, inpatient palliative care led to substantial improvements in patients' QOL, depression and PTSD symptoms, symptom burden, and fatigue during HSCT hospitalization compared to usual care. Integrated palliative care should be considered a new standard of care for patients hospitalized for HSCT.

Quality of Life Analysis in Patients with AA Using the QLQ-AA/PNH-54 at Initial Diagnosis of AA - a Registry Based Analysis

Objectives: Aplastic anemia (AA) and paroxysmal nocturnal hemoglobinuria (PNH) are ultra-rare, acquired bone marrow failure syndromes (BMFS) with need for long-term care and high morbidity despite recent therapeutic advances. There is a lack of disease-specific assessment tools of quality of life (QoL) in AA/PNH patients. So far, QoL has mostly been estimated according to surrogate parameters (e.g. blood counts, transfusion dependence or toxicity of treatment in AA patients) or has been assessed with tools specifically designed for cancer patients (e.g. EORTC Quality of Life Questionnaire QLQ-C30) or with tools focusing on fatigue (e.g. Functional Assessment of Chronic Illness Therapy, FACIT-Fatigue, PNH patients). Therefore, the QLQ-AA/PNH-54 has been developed to allow a patient tailored QoL assessment in patients with AA or PNH. Here, we present the first descriptive data of the QLQ-AA/PNH-54 of 74 AA patients at the timepoint of initial diagnosis collected between 2018 and 2020 (prior to the SARS-CoV-2 pandemic). Methods: The QLQ-AA/PNH-54 was designed, psychometrically validated, and is currently finally validated for PNH within the IPIG (international PNH interest group)-registry. Parallel to this process, the tool was implemented within the Aachen AA/BMF registry as an instrument for real-life QoL evaluation in AA patients. In total, 54 QoL items regarding physical functioning (21 items), psychological aspects (26 items) and health care related issues (7 items) are comprised. Patients rank the occurrence of each item within the last 14 days on a scale between 0 and 3 (0 = did not occur, 1 = low, 2 = moderate, 3 = severe). Results: 74 AA patients (37 female/ 37 male, mean/median/range age 38.42/ 35.47/ 11-73 years) were included. Patients were diagnosed with nsAA (n=11), sAA (n=23), vsAA (n=18), AA NOS (n=20) and AA/PNH-Overlap (n=2), respectively. Broken down into different functional scales, the most frequently and highest rated scales concerned psychosocial aspects (&amp;gt; 60 % of the patients scored 1-3; &amp;gt; 30% of the patients scored 3). Patients were especially burdened by worries and uncertainties with regards to their future, activity planning security and need for cautiousness in everyday life. Tiredness was the major symptom reported in relation to physical functioning. Patients often feared deterioration of their blood results as the most important health care-related issue. In comparison, low occurrence of pain, orthostatic dysregulation, susceptibility for infections, dyspnea, sleep disturbance and tendency to bleed was reported regarding physical functioning (scored 0 by over 40 to over 50 % of the patients). Similarly, low scores were reported for impairment of activities of daily life in terms of completion of household tasks and hobbies or loss of physical attraction. Conclusion: QoL of AA patients at initial diagnosis was mainly impaired by tiredness and a high psychological burden. Interestingly, complications frequently feared and highlighted by treating physicians had a minor impact on patients' QoL. These results emphasize the importance of further QoL analysis from patient view and recommend to especially focus on the psychological burden of AA patients in patient communication at initial diagnosis.

Endovascular Treatment of Peripheral Arteriovenous Malformations (AVMs): Do Angiographic Outcomes Relate to the Quality of Life?

Patients with arteriovenous malformations (AVMs) have a lower health-related quality of life (QoL) than the general population. QoL assessment of patients with peripheral AVMs after endovascular treatment is scarce in the literature. Radiologic and clinical outcomes are not always correlated in vascular malformation treatment. This study aimed to investigate the relationship between clinical outcomes, QoL, and angiographic outcomes. Patients with peripheral AVM that underwent endovascular treatment between January 2009 and December 2021 in a single center were retrospectively evaluated. Patients' characteristics (age, sex), AVM characteristics (Schobinger classification, location, angiographic architecture), previous treatment, treatment characteristics (type of endovascular approach, embolizing agent and number of sessions), percentages of angiographic response, complications, and recurrence were evaluated. The angiographic architecture was evaluated according to the Yakes classification. The questionnaire was applied for evaluation of clinical response and QoL. Patients older than 12 years and those who can be contacted were included in clinical and QoL analysis. Clinical response was defined as improvement in the patient's most important pretreatment symptom. Treatment response was defined as clinical response plus >50% angiographic response. Eighty-six patients (41 males [47.7%], 45 females [52.3%]) were included in angiographic analysis. The mean age was 28.44±12.99 years (range=5-61). Forty-three patients (50%) had previous treatment. The median number of sessions was 2 (range 1-15, InterQuartile Range [IOR]=2). Sixty-one patients (30 males [49.2%], 31 females [50.8%]) were included in clinical analysis. The clinical response rate was 73.8%, 95% confidence interval (CI) [0.60, 0.84]. The treatment response rate was 45.9%, 95% CI [0.33, 0.59]. The complication rate was 8.2%. Before treatment, 48 patients (78.7%) reported a negative impact on their QoL. Thirty-three of 48 patients (68.8%) reported improvement on their QoL after treatment. Higher Schobinger stages were related to a negative impact on QoL before treatment (p<0.01). Yakes types were not related to QoL (p=0.065). Clinical response was related to improvement on QoL after treatment (p<0.01). Angiographic and treatment responses were not related to improved QoL after treatment (p=0.52 and p=0.055, respectively). Angiographic architecture and outcomes were not always reflected in QoL after endovascular treatment. This study's findings will help clinicians with what to focus on in AVM treatment and how to monitor patients with peripheral AVM after endovascular treatment. Rather than relying too much on the angiographic response, patients should be checked for symptoms and quality of life improvement. No clear data in the literature regarding the applicability of the Yakes Classification in patients with previous treatment. This study questioned the applicability of the Yakes Classification in patients with previous treatments. In this study, type 4 AVMs were more common in patients with previous treatment.

Baseline Quality of Life is a Strong and Independent Prognostic Factor for Overall Survival in Metastatic Colorectal Cancer.

Previous studies have established that higher baseline quality of life (QOL) scores are associated with improved survival in patients with metastatic colorectal cancer (mCRC). We examined the relationship between overall survival (OS) and baseline QOL. A total of 1 247 patients with mCRC participating in N9741 (comparing bolus 5-FU/LV, irinotecan [IFL] vs infusional 5-FU/leucovorin [LV]/oxaliplatin [FOLFOX] vs. irinotecan/oxaliplatin [IROX]) provided data at baseline on overall QOL using a single-item linear analogue self-assessment (LASA) 0-100 point scale. The association of OS according to clinically deficient (defined as CD-QOL, score 0-50) vs not clinically deficient (nCD-QOL, score 51-100) baseline QOL scores was tested. A multivariable analysis using Cox proportional hazards modeling was performed to adjust for the effects of multiple baseline factors. An exploratory analysis was performed evaluating OS according to baseline QOL status among patients who did or did not receive second-line therapy. Baseline QOL was a strong predictor of OS for the whole cohort (CD-QOL vs nCD-QOL: 11.2months vs 18.4months, P < .0001), and in each arm IFL 12.4 vs 15.1months, FOLFOX 11.1 months vs 20.6months, and IROX 8.9months vs 18.1months. Baseline QOL was associated with baseline performance status (PS) (P < .0001). After adjusting for PS and treatment arm, baseline QOL was still associated with OS (P = .017). Baseline QOL is an independent prognostic factor for OS in patients with mCRC. The demonstration that patient-assessed QOL and PS are independent prognostic indicators suggests that these assessments provide important complementary prognostic information.

Quality of life in Hidradenitis Suppurativa (Acne Inversa): A scoping review.

Hidradenitis Suppurativa (HS) is a chronic, relapsing, inflammatory skin condition which is physically, psychologically and socially disabling and often affects a patient's quality of life (QOL). There are numerous QOL tools used in dermatology. However, assessment of QOL in patients with HS is difficult due to the inability of generic QOL tools to specifically capture QOL in patients with HS. Numerous HS-specific QOL tools have been developed in recent years. It is important to identify evidence on full psychometric evaluation of these tools. There has been a gradual increase in the use of generic and disease-specific QOL tools in the last few decades. The aim of this scoping review (SR) is to evaluate the most widely used generic QOL tools and HS-specific QOL tools to identify the psychometric evaluation of such tools. Design: An SR guided by Joanna Briggs Institute manual and Arskey O'Malley framework guidelines. Data extraction included the studies available on full psychometric evaluation of the most widely used dermatology generic QOL tools in HS and HS-specific QOL tools. Ten papers were included in the review, eight papers demonstrated HS-specific QOL assessment tools. The psychometric properties of these tools were underpinned by reliability, validity and sensitivity measurement. Six disease-specific tools were identified in this SR. However, they all lack full psychometric evaluation. This review indicates that an extensive research in the field of QOL tools for HS is much needed. It is crucial to develop user-friendly and validate disease-specific tools to measure the real impact of disease on patients QOL. QOL instruments can evaluate the impact on life of an HS patient, thus helping improve intervention and management of disease. There is a necessity for more research into existing HS-specific QOL tools and they should be widely tested and fully validated.

Community pharmacists' measurement of health-related quality of life for breast cancer with positive hormone receptors: A prospective observational study.

Many patients with hormone-receptor positive breast cancer undergo prolonged treatment. However, the long-term patient quality of life assessment has not been examined. Using community pharmacists' assistance is one method for assessing long-term quality of life. Thus, this study aimed to understand the ongoing health-related quality of life and quality-adjusted life year among breast cancer patients so that community pharmacists may contribute to their pharmacotherapy. We conducted a prospective observational study with 22 breast cancer patients who had health-related quality of life at the initial measurement and 6 months later. Regarding the health-related quality of life, quality-adjusted life year concerning all patients was 0.890 (95% confidence interval: 0.846-0.935). Quality-adjusted life year concerning those younger than 65 years was 0.907 (95% confidence interval: 0.841-0.973), and that for individuals older than 65 years was 0.874 (95% confidence interval: 0.804-0.943). The adjuvant chemotherapy group had a lower health-related quality of life at the initial measurement (0.887; 95% confidence interval: 0.833-0.941) but showed a higher quality of life 6 months later (0.951; 95% confidence interval: 0894-1.010). Quality-adjusted life year for individuals regarding adjuvant chemotherapy was 0.919 (95% confidence interval: 0.874-0.964). In contrast, the life-prolonged group had a higher health-related quality of life at the initial measurement, which was lower 6 months later. As a result of measuring quality of life using the EuroQol 5-dimensions-5-levels, this study revealed a decline in health-related quality of life in patients undergoing hormonal therapy for breast cancer. The study is expected to assist community pharmacists in managing outpatients.

A Multicenter Prospective Trial of Electronic Skin Surface Brachytherapy for Keratinocyte Carcinoma: Early Cosmesis, Quality of Life, and Adverse Events

Keratinocyte carcinomas are amenable to many treatments, including radiation therapy (RT). Electronic skin surface brachytherapy (ESSB) enables the precise delivery of radiation without radioisotopes. In this prospective multicenter clinical trial, we characterized early outcomes of ESSB prospectively through both patient- and clinician-reported measures. To corroborate the cosmesis observations, we also assessed patient-reported quality of life (QoL) and adverse events. Patients ≥60 years old with stage T1N0M0 keratinocyte carcinoma were treated with ESSB. At 2-, 6-, and 12-weeks post-treatment, cosmesis from ESSB was assessed by both the patient and a clinician study investigator as either "good," "fair," or "bad." The Skindex-16 and the Skin Cancer Index (SCI) were used to assess patient QoL before and after treatment. Adverse events were assessed using the Common Toxicity Criteria for Adverse Events, version 4.0. Cosmesis and QoL were collected at 97% (99/102) of possible patient follow-up times. By 12 weeks post-treatment, 93.9% (31/33) of patient-reported and 96.9% (31/32) of clinician-reported cosmesis outcomes were "good." Compared with baseline, total Skindex-16 score significantly deteriorated at 2 weeks post-treatment (10.5 vs 24.5, P <.001), but significantly improved at 6 weeks (10.5 vs 4.7, P=.014) and 12 weeks (10.5 vs 2.1, P=.001) post-treatment. The total SCI score significantly improved from baseline to 6 weeks (78.4 vs 89.0, P=.001) post-treatment. The most frequent adverse events were radiation dermatitis, skin pain, and pruritus. All adverse events resolved to Grade ≤1 by 12 weeks post-treatment. This prospective, multicenter study demonstrated that ESSB is associated with a high rate of "good" early patient-reported cosmesis and increasing QoL and satisfaction with time. Validated assessments demonstrated a significant improvement in quality of life and resolution of moderate early adverse events by 6 to 12 weeks after treatment and corroborate the observation of favorable cosmesis.

Quality of Life (QoL) of Children and Adolescents Participating in a Precision Medicine Trial for High-Risk Childhood Cancer.

Precision medicine is changing the treatment of childhood cancer globally, however little is known about quality of life (QoL) in children and adolescents participating in precision medicine trials. We examined QoL among patients enrolled in PRISM, the Zero Childhood Cancer Program's precision medicine trial for high-risk childhood cancer. We assessed patient QoL via self-report (aged 12-17 years) and parent-proxy (aged 4-17 years) completion of the EQ-5D-Y. We analysed data using descriptive statistics and regression models. Patients (n = 23) and parents (n = 136) provided data after trial enrolment and following receipt of trial results and treatment recommendations (n = 8 patients, n = 84 parents). At enrolment, most patients were experiencing at least some difficulty across more than one QoL domain (81% patient self-report, 83% parent report). We did not find strong evidence of a change in QoL between timepoints, or of demographic or disease factors that predicted parent-reported patient QoL (EQ-VAS) at enrolment. There was strong evidence that receiving a treatment recommendation but not a change in cancer therapy was associated with poorer parent-reported patient QoL (EQ-VAS; Mdiff = -22.5, 95% CI: -36.5 to -8.5, p = 0.006). Future research needs to better understand the relationship between treatment decisions and QoL and would benefit from integrating assessment of QoL into routine clinical care.

Psychological mobile app for patients with acute myeloid leukemia (AML): A randomized clinical trial.

12018 Background: Patients with AML experience substantial decline in their quality of life (QOL) and mood during their hospitalization for intensive chemotherapy. Yet, few interventions have been developed to enhance patient-reported outcomes during treatment. Methods: We conducted a randomized trial of a psychological mobile app (DREAMLAND) for patients with a new diagnosis of AML receiving intensive chemotherapy at Massachusetts General Hospital and Dana-Farber Cancer Institute. Patients were randomly assigned to DREAMLAND or usual care. DREAMLAND was tailored to the AML trajectory and included four required modules focused on 1) supportive psychotherapy to help patients deal with the initial shock of diagnosis; 2) psychoeducation to manage illness expectations; 3) psychosocial skill-building to promote effective coping; and 4) self-care. The primary endpoint was feasibility defined as at least 60% of eligible patients enrolling, and 60% of those enrolled completing at least 60% of the required modules. We assessed patient QOL (Functional-Assessment-of-Cancer-Therapy-Leukemia), psychological distress (Hospital-Anxiety-and-Depression-Scale [HADS] and Patient-Health-Questionnaire-9 [PHQ-9]), symptom burden (Edmonton-Symptom-Assessment-Scale), and self-efficacy (Cancer Self-Efficacy Scale) at baseline and day +20 post chemotherapy. We used ANCOVA to assess the effect of DREAMLAND on outcomes. Results: We enrolled 66.7% (60/90) of eligible patients and 62.1% completed ≥ 75% of intervention modules. At day +20 after intensive chemotherapy, patients randomized to DREAMLAND reported improved QOL (132.06 vs. 110.72, P = 0.001), lower anxiety (3.54 vs. 5.64, P = 0.010) and depression (HADS: 4.76 vs. 6.29, P = 0.121; PHQ-9: 4.62 vs. 8.35, P &lt; 0.001) symptoms, and improved symptom burden (24.89 vs. 40.60, P = 0.007) and self-efficacy (151.84 vs. 135.43, P = 0.004) compared to the usual care group. Conclusions: A psychological mobile app for patients newly diagnosed with AML is feasible to integrate during hospitalization for intensive chemotherapy and may improve QOL, mood, symptom burden, and self-efficacy. Clinical trial information: NCT03372291.

Herbal medicinal product Sinupret extract (BNO 1016) is safe and effective in the treatment of acute viral rhinosinusitis

Aim. The pooled efficacy data of two similar randomized placebo-controlled clinical trials were analyzed. Safety was evaluated on the basis of the individual trials.&#x0D; Materials and methods. The efficacy analysis was based on 589 patients. Treatment was performed orally with either 3160 mg BNO 1016 (n=294) or 31 tablet placebo (n=295) for 15 days. In both trials patients underwent five visits to the investigational sites. Symptoms were evaluated according to the EPOS 2012 guideline. Ultrasonography was used to confirm the diagnosis at onset of treatment and the remission of symptoms at the last visit. Efficacy was evaluated by the investigator as the mean major symptom score (MSS) at the end of treatment (visit 5, day 14). Patients reported symptoms and social/emotional consequences of rhinosinusitis using a quality of life questionnaire (SNOT-20 GAV).&#x0D; Results. MSS improved during the treatment period by a mean of 10.021.61 score points to 2.472.55 for BNO 1016 and of 9.871.52 to 3.633.63 for placebo. Differences between treatment groups at end of therapy (1.163.14 score points; p0.0001) and patient-assessed quality of life (p=0.0015) were statistically significant in favor of BNO 1016.&#x0D; Conclusion. Daily intake of 480 mg of BNO 1016 for 15 days is an effective treatment in acute viral rhinosinusitis.

The impact of minimally invasive palliative decompression of bile ducts on quality of life in patients with distal malignant mechanical jaundice

Palliative treatment for mechanical jaundice is aimed at improving patient quality of life (QoL) and prolonging life. The current QoL studies indicate that there is limited evidence on various techniques for decompression of bile ducts (BD) in terms of their impact on quality of life in patients with distal malignant mechanical jaundice, and their data are contradictory.&#x0D; The aim of the study is to evaluate the effect of minimally invasive palliative techniques on QoL in patients with distal mechanical jaundice (MJ) after palliative decompression of bile ducts.&#x0D; Materials and methods. From 2017 to 2021, 98 patients who underwent palliative decompression of bile ducts for distal MJ of malignant origin were examined. A validated MOS SF‑36 questionnaire was used to assess patient QoL. The survey was conducted before the minimally invasive intervention and 2 months after it. Depending on the technique used for decompression of BD, patients were divided into the following groups: percutaneous transhepatic biliary drainage (PTBD) — 25, internal‑external transpapillary biliary drainage (IETBD) — 19, internal‑external biliary‑jejunal drainage (IEBJD) — 29, and endoscopic retrograde biliary stenting (ERBS) — 25.&#x0D; Results. Before treatment, a low level of patient QoL was detected in all groups on all scales of physical and psychological components of health (all p &gt; 0.05). After 2 months, in the PTBD group, the indicator of the Mental Component Summary (MCS) decreased by an average of 6.9 ± 1.2 points (due to the deterioration of the indicator of social functioning scales by 12.5 ± 5.0 points and mental health by 11.1 ± 1.8 points), while the indicator of the Physical Component Summary (PCS) improved by 11.3 ± 1.1 points. In the IETBD and IEBJD groups, there was an improvement in MCS (by 11.7 ± 1.3 points and 13.0 ± 1.1 points, respectively) and PCS (by 5.2 ± 1.2 and 8.6 ± 1.1 points). With regard to MCS and PCS, slight improvement (by 4.7 ± 2.2 and 2.0 ± 1.9 points) was observed in the ERBS group.&#x0D; Conclusions. The IEBJD technique provided important advantages in comparison with other minimally invasive palliative techniques for decompression of BD in terms of its impact on patient QoL. Patients in the IEBJD group had better PCS scores (on average, 47.3 ± 1.3 points) compared to the IETBD (42.1 ± 1.5 points) and ERBS (39.1 ± 1.3 points, p &lt; 0.05) groups, and those in the PTBD group (46.2 ± 1.4 points) had better scores than patients in the IETBD group (p &lt; 0.05). In the IETBD and IEBJD groups, MCS scores were better 41.9 ± 1.1 and 40.3 ± 1.1 points, respectively) compared to the PTBD (22.6 ± 0.9 points) and ERBS (34.0 ± 1.1 points, p &lt; 0.05) groups, and in the ERBS group, they were better than in the PTBD group.&#x0D;

Pharmaceutical intervention for adverse events improves quality of life in patients with cancer undergoing outpatient chemotherapy

BackgroundThe effect of pharmaceutical intervention to treat adverse events on quality of life (QOL) in outpatients receiving cancer chemotherapy is unclear. We investigated whether pharmaceutical intervention provided by pharmacists in collaboration with physicians improves QOL with outpatient cancer chemotherapy.MethodsWe conducted a single-center retrospective descriptive study of pharmaceutical intervention for patients receiving outpatient cancer chemotherapy at Gifu University Hospital between September 2017 and July 2020. We assessed patient QOL using the Japanese version of the EuroQol 5 Dimension5 Level (EQ-5D-5L). Adverse events were graded using the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. We compared the EQ-5D-5L utility value and incidence of grade 2 or higher adverse events before and after pharmaceutical intervention.ResultsOur analysis included 151 patients who underwent 210 chemotherapy cycles. Pharmaceutical intervention significantly improved patients’ EQ-5D-5L utility values from 0.8197 to 0.8603 (P < 0.01). EQ-5D-5L utility values were significantly improved after pharmaceutical intervention for nausea and vomiting (pre-intervention 0.8145, post-intervention 0.8603, P = 0.016), peripheral neuropathy (pre-intervention 0.7798, post-intervention 0.7988, P = 0.032) and pain (pre-intervention 0.7625, post-intervention 0.8197, P = 0.035). Although not statistically significant, the incidence of grade 2 or higher adverse events, including nausea and vomiting, dermopathy, pain, oral mucositis, diarrhea and dysgeusia, tended to be lower post-intervention than pre-intervention.ConclusionsPharmaceutical intervention by pharmacists in collaboration with physicians may improve QOL in patients undergoing outpatient cancer chemotherapy.

The Effect of Diabetes on Health-Related Quality of Life in Emirati Patients

Background: Diabetes mellitus (DM) is known to negatively affect quality of life (QoL), yet very few studies have been done on QoL of patients with diabetes in the United Arab Emirates population. Objectives: The aim of this study was to assess the impact of DM on health-related QoL (HRQoL) of patients with diabetes of Emirati nationality. Methods: Two hundred and forty Emirati patients with diabetes, treated at the Dubai Diabetes Center, were randomly selected and interviewed using the Short Form-36 questionnaire to assess HRQoL domains. Appropriate statistical measures were performed to associate HRQoL domains with diabetes-related factors. Results: HRQoL satisfaction scores for physical and mental health domains were very high for the majority of participants. Male participants ranked significantly higher median scores in all HRQoL domains than females (77.36 vs. 65.28, p = 0.004). There was a significant (p < 0.001) negative correlation between diabetes duration and the total averaged score for all sub-domains, and significant (p < 0.001) negative correlations between glycated hemoglobin percentage (HBA1c%) and all sub-domains of HRQoL. Patients without complications had significantly better scores in all HRQoL sub-domains than patients suffering from any complications. Median total HRQoL score for those with neuropathy compared to those without neuropathy was 63.9 versus 82.6 (p < 0.001), for nephropathy was 43.6 versus 72.5 (p < 0.001), for retinopathy 50.7 versus 76.0 (p < 0.001), for ischemic heart disease 54.1 versus 77.3 (p < 0.001), and for cerebrovascular disease 36.7 versus 72.4 (p < 0.001). Multiple regression showed 3 significant predictors for the total averaged score from all HRQoL sub-domains; these were age (p = 0.007), HbA1c% (p < 0.001), and the number of complications related to DM (p = 0.001). Conclusion: HRQoL in Emirati patients with diabetes was significantly associated with the presence of diabetes-related complications, glycemic control, and age of the patient. The assessment of QoL in patients with diabetes can be a valuable measure for the healthcare providers to assess patient’s well-being.

Optimal assessment of quality of life for patients with prostate cancer.

The burden of cancer and oncologic treatment is reflected not only through morbidity and mortality, but also through impacts on patient quality of life (QoL). However, QoL has not been historically measured or addressed with the same rigorous methodology as traditional disease-related outcomes such as overall survival and progression, as these are driven by objective measurements and events. Prostate cancer (PCa) is one of the most prevalent non-cutaneous cancers in men around the world. Both the cancer and its treatment significantly impact patients' physical, emotional, sexual, social, and overall QoL. Ensuring assessment and integration of QoL in research and clinical care enables improvement in treatment outcomes that matter most to patients while also facilitating alignment of healthcare priorities with reimbursements. Great strides toward this end have been made over the last decade, but significant room for improvement remains. To ensure high quality, reliable data collection, QoL assessment tools must be psychometrically validated, standardized, widely implemented across trials, and regularly assessed to allow internal and external validity, longitudinal comparative effectiveness research, and quality control. Additional consideration should be taken for instruments used to measure the aspects of QoL specific to minority, caregiver, and elderly populations. Open clinical questions include how providers should weight changes in different QoL subscales and how clinically meaningful difference thresholds should be defined. Review of ongoing clinical trials encouragingly reveals an increased focus on measuring and improving QoL for men with PCa which will inform the way we utilize QoL assessments. However, additional efforts herein described are needed to fully optimize these processes. In summary, this review will explain the rationale for QoL assessments in PCa populations, discuss requirements for effective implementation, describe considerations for vulnerable and under-evaluated populations, and summarize ongoing clinical trials assessing patient QoL.

Quality of Life Outcomes in Primary Caregivers of Children with Esophageal Atresia

To investigate the quality of life (QoL) impact on primary caregivers of children with esophageal atresia. We used a prospective cohort study design, inviting primary caregivers of children with esophageal atresia to complete the following questionnaires: Parent Experience of Child Illness (PECI), Patient-Reported OutcomesMeasurement Information System (PROMIS) Anxiety, PROMIS Depression, 12-Item Short Form Survey (SF-12), and Pediatric Quality of Life Inventory (PedsQL). The PECI, PROMIS Anxiety and Depression, and SF-12 assessed caregiver QoL, and the PedsQL assessed patient QoL. Patients with Gross type E esophageal atresia served as controls. The primary caregivers of 100 patients (64 males, 36 females; median age, 4.6years; range, 3.5months to 19.0years) completed questionnaires. The majority (76 of 100) of patients had Gross type C esophageal atresia. A VACTERL (vertebral anomalies, anorectal malformation, cardiac anomalies, tracheoesophageal fistula, renal anomalies, limb anomalies) association was found in 30, ≥1 esophageal dilatation was performed in 57, and fundoplication was performed in 11/100. When stratified by esophageal atresia types, significant differences were found in 2 PECI subscales (unresolved sorrow/anger, P=.02; uncertainty, P=.02), in PROMIS Anxiety (P=.02), and in SF-12 mental health (P=.02) and mental component summary scores (P=.02). No significant differences were found for VACTERL association, nor esophageal dilatation. Requirement for fundoplication resulted in lower SF-12 general health score, and lower PedsQL social and physical functioning scores. We have demonstrated that caring for a child with esophageal atresia and a previous requirement for fundoplication impacts caregiver QoL.

Immediate and long-term results of proximal gastric resection depending on the methods of the digestive tract continuity restoring

Proximal gastric resection (PGR) is still one of the most difficult and dangerous surgical interventions, and it is the only method of curative treatment of diseases of the cardiac part of the stomach in many cases. 5 types of gastrointestinal reconstruction are mainly performed after PRG: submerged rectal esophagogastroanastomosis, antireflux interposition of the jejunal segment, interposition of the jejunal segment of the jejunal pocket, interposition of the jejunal segment as a double tract and reconstruction with the formation of a gastric tube. Modern literature includes many works devoted to the development of methods of physiological reconstruction after subtotal and total removal of the stomach; however, none of the existing methods is recognized as optimal. Among the main indicators characterizing the effectiveness of PGR are the frequency and severity of the development of a large group of functional disorders, characterized as «diseases of the operated stomach», or «post-gastro-resection disorders», which significantly worsen the quality of life (QOL) and reduce the working capacity, which causes disability of the operated patients Assessment of QoL after surgery for diseases of the cardiac stomach is a fundamentally important component of monitoring the effectiveness of treatment and, therefore, allows one to determine the indications for certain types of interventions. The available world scientific literature does not provide convincing data on the assessment of QOL in patients after proximal resection for cardiac part of the stomach diseases, since there are no clear criteria for its assessment depending on the chosen methods and methods of reconstruction of gastrointestinal tract (GIT). In this regard, there is a need for further study of proximal resection with reconstruction of the gastrointestinal tract in surgical diseases of the cardiac part of the stomach on the basis of analysis of immediate and long-term results, as well as the quality of life of patients who underwent these surgical interventions.

Abstract OT-14-01: Adaption of the EORTC quality of life breast cancer module for male breast cancer - phase I

Abstract Background: Approximately 1% of all new cases of breast cancer (BC) occur in men. Care of male BC is largely based on extrapolation from treatment strategies and management of symptoms in women. The impact of BC diagnosis and therapy on Quality of Life (QoL) in women with BC is well documented. Comprehensive, prospective data about QoL in men treated for BC are sparse. Due to the lack of a validated male BC QoL questionnaire, we previously evaluated the QoL of the male BC using the original EORTC QLQ-C30 and breast module QLQ BR23 with “female” items replaced by male-specific items from the EORTC QoL prostate module (EORTC QLQ-PR25). The development of a validated worldwide questionnaire for male BC is sponsored by EORTC QoL Group and will be completed in cooperation with EORTC Breast Group and the International Male BC Program (a cooperation between EORTC-BCG, TBCRC, within the BIG and NABCG networks) Trial design: The evaluation of the QoL issues relevant for male BC, as well as the translation of issues into items to build the tool for QoL assessment in male BC will be carried out through four phases: 1. A systematic Literature review 2. Interviews with patients 3. Interviews with Health Care Professionals (HCP) 4. Consultation of experts in Oncology and QoL Inclusion criteria: • Histologically proven early BC or metastatic BC in male patients • Age ≥ 18 years • Ability to understand and fill out questionnaires • Written informed consent Exclusion criteria: • Other cancer in the past 5 years except non-melanotic skin cancer • Patients participating in interventional clinical studies with QoL as primary endpoint • Any condition potentially hampering compliance with the study protocol Aims: The study proposes to carry out an evaluation of the QoL issues relevant for male patients with BC, and translating the issues into questions to build the tool for an adequate QoL assessment in these patients. The specific aims are: 1) To carry out an evaluation of the existing EORTC QLQ-BR 45 (adapting for male BC) and for suitability of use in male BC patients 2) To carry out an evaluation of the EORTC QLQ-PR25 (adapting for male BC) for suitability of use in male BC patients 3) To provide recommendations to the EORTC on a suitable assessment approach to assess QOL in male BC Statistical methods: A systematic literature review to assess what factors are unique to male BC patients in influencing their QoL and what QoL measures exist for them will be performed. This will be conducted by reviewing all studies with male BC participants and including investigator brochures describing side effects in male BC patients, as well as by evaluating issues captured by other existing EORTC modules. The final list of potential QoL issues relevant to the male BC will be tested for relevance and importance in semi-structured qualitative interviews with patients and HCP. A total of 2-5 patients per year will be recruited from collaborating hospitals/countries. At least 40 in total will be interviewed before, during, or after treatment for male BC. At least 2 experts/country from the all collaborating centres will be included in the interview to discuss and consider the potential issues. Finally, the issue list will be translated into questions to build the tool for a QoL assessment in male BC patients. Present accrual and target accrual This study started in October 2019. A systematic literature review has been completed. Seventeen centres from worldwide are participating in the study. New centers may still join. Contact information for people with a specific interest in the trial Vesna Bjelic-Radisic E-Mail: Vesna.Bjelic-Radisic@helios-gesundheit.de Fatima Cardoso e-mail: fatimacardoso@fundacaochampalimaud.pt Citation Format: Vesna Bjelic-Radisic, Fatima Cardoso, Joachim Weis, Eveline Bleiker, David Cameron, Galina Velikova, Karatzyna Pogoda, Samantha Serpentini, Kevin Punie, Rinat Yerushalmi, Erika Matos, Birgit Carly, Ivana Bozovic-Spasojevic, Markus Fleisch, Zoe Luisa Probst, Sina Maria Schafer, Nicola Russell, Sofie Tombeur, Joanna Vermeij, Heidi Roelstraete, Kathryn Ruddy, Juan I Arraras, Andrew Bottomley. Adaption of the EORTC quality of life breast cancer module for male breast cancer - phase I [abstract]. In: Proceedings of the 2020 San Antonio Breast Cancer Virtual Symposium; 2020 Dec 8-11; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2021;81(4 Suppl):Abstract nr OT-14-01.

Analysis of a treatment strategy for advanced stage oral squamous cell carcinoma patients. A 100-day multimodal approach

Aim The present study aimed to evaluate the feasibility and efficacy of neoadjuvant chemoradiotherapy (NACRT) followed by definitive surgery and free fibular transfer in advanced stage oral squamous cell carcinoma patients. Methods Patients diagnosed with resectable oral squamous cell carcinoma, Stage IVa were enrolled for the study. The patients underwent a planned protocol of neoadjuvant radiotherapy and concurrent chemotherapy, insertions of dental implants in fibula followed by curative and reconstructive surgery. Objective response rate, overall survival, disease free survival and patient quality of life assessments were carried out. Results A total of eight patients with Stage IVa oral squamous cell carcinoma were enrolled for the study and treated according to the planned protocol. All patients completed neoadjuvant chemoradiotherapy and surgery; 6 (75%) patients achieved complete response while 2 exhibited partial response (downstaging) on post surgical pathological analysis. After a median follow-up time of 24.6 months and maximal follow up of 34 months, the overall survival was 75% and disease free survival was 87%. Two patients suffered from trismus and are currently undergoing oral physiotherapy. Six patients had orocutaneous fistula which healed. One had extrusion of fibular graft and two patients died. Conclusion The present study elucidates a treatment strategy for patients with locally advanced squamous cell carcinoma validated for better functional and aesthetic outcome with improved quality of life. Further evaluation is required in a bigger cohort size.

Tools for quality of life assessment in patients with obstructive sleep apnea

Obstructive sleep apnea (OSA) is found in 24% of men and 9% of older women. Given the high prevalence of the OSA syndrome and its effects on physical and mental function, the quality of life (QoL) in OSA has aroused great interest in the modern scientific literature. The interest in QoL in patients with OSA is so great that various studies are being conducted. The purpose of this article is to present the various tools for assessing QoL in patients with OSA. For the period January 2020 - June 2020, in the available database (PubMed, BioMedCentral, ScienceDirect, Scopus, Web of Science), a systematic analysis of scientific publications examining the assessment of QoL in patients with OSA was performed. This review illustrates the variety of tools used to study the assessment of health-related QoL and OSA. The published data in the research are mostly limited to the assessment of CPAP, and the effects on QoL after the performed surgical, dental and behavioral treatments for OSA remain largely unexplored.