Improve Health-related Quality Of Life In Patients Research Articles

Association between Geriatric 8 frailty and health-related quality of life in older patients with cancer (PROGNOSIS-G8): a Danish single-centre, prospective cohort study

Health-related quality of life (HRQoL) is highly valued among older adults with cancer. The Geriatric 8screening tool identifies individuals with frailty, but its association with HRQoL remains sparsely investigated. Herein, we evaluate whether Geriatric 8frailty is associated with short-term and long-term HRQoL in older patients with cancer. In this Danish single-centre, prospective cohort study, patients aged 70years and older, referred to oncological assessment for solid cancers, were screened with the Geriatric 8. Patients completed the European Organisation for Research and Treatment of Cancer (EORTC) Quality-of-Life Core 30 (QLQ-C30) and Elderly 14(ELD14) questionnaires at baseline, 3months, 6months, 9months, and 12months. Patient characteristics were obtained from medical records. Differences in mean global health status and QoL (GHS), measured using the two seven-point Likert scale questions from the EORTC QLQ-C30 regarding overall health and QoL during the past week, between patients with frailty (defined as a Geriatric 8score of ≤14) and without frailty within 12months were the primary outcome. Secondary outcomes were differences in the mean EORTC Summary Score comprised of all questions from the QLQ-C30 except for those included in the GHS and a question concerning financial difficulties, and five functional (physical, role, and social functioning, maintaining purpose, and family support from the EORTC QLQ-C30 and the EORTC-QLQ-ELD14), and five symptom scales (fatigue, pain, mobility, future worries, and burden of illness from the EORTC-QLQ-C30 and the EORTC-QLQ-ELD14). Analyses were done using linear mixed models. All primary and secondary outcomes were adjusted for gender, treatment intent, and cancer type and the primary outcome was also assessed by means of a responder analysis. Between June 1, 2020and Oct 15, 2021, 1398eligible patients were screened with the Geriatric 8 (908 [65%] with frailty and 490 [35%] without frailty) and provided medical record data. Of these patients, 707 (51%) also provided HRQoL data (437 [62%] with frailty and 270 [38%] without frailty). When adjusted, patients with frailty had poorer GHS(-15·1, 95% CI -18·5to -11·6; p<0·0001) at baseline and throughout follow-up (3 months -7·4, -11·0to -3·7, p=0·0001; 6months -11·7, -15·5to -7·9, p<0·0001; 9months -10·4, -14·3to -6·5, p<0·0001; 12months -10·4, -14·6to -6·2, p<0·0001) compared to patients without frailty. Adjusted summary scores were also poorer for patients with frailty (-9·9, 95% CI -12·1to -7·6; p<0·0001) compared to patients without frailty at baseline and throughout follow-up (3 months -8·2, -10·5to -5·8, p=0·0001; 6months -9·0, -11·4to -6·6, p<0·0001; 9months -9·2, -11·7to -6·8, p<0·0001; 12 months -8·9, -11·5to -6·3, p<0·0001). Patients with frailty had significantly worse physical and role functioning, mobility, and fatigue outcomes, with no differences in family support within 12months, at all timepoints. Older patients with cancer and frailty have significantly poorer HRQoL than those without frailty within the 12months following an oncology referral. Thus, by identifying and treating frailty, we can ultimately improve patient HRQoL. The Danish Cancer Society, Academy of Geriatric Cancer Research (AgeCare), Odense University Hospital, University of Southern Denmark, Dagmar Marshalls Fond, and Agnes and Poul Friis Fond.

500 - Patient-reported outcomes following 24 weeks of treatment with upadacitinib in adults with non-segmental vitiligo: results from a phase 2, randomized, double-blind, dose-ranging study

Abstract Introduction &amp; Objectives Vitiligo has a considerable negative impact on patients’ health-related quality of life (HRQoL). Patients often experience social stigma, low self-esteem, anxiety, and depression. Assessment of HRQoL is therefore recommended as part of the evaluation of disease severity and treatment benefits. Accordingly, the impacts of treatment with upadacitinib (UPA), an oral Janus kinase inhibitor, on a range of patient-reported HRQoL outcomes were evaluated as part of a phase 2, multicenter, randomized, double-blind, placebo-controlled, dose-ranging study in adults with non-segmental vitiligo. Materials &amp; Methods Adults aged 18–65 years with non-segmental vitiligo with a Facial Vitiligo Area Scoring Index score ≥0.5 and a Total Vitiligo Area Scoring Index score ≥5 at baseline were included in this 52-week study (NCT04927975). During a 24-week, double-blind, placebo-controlled treatment period (period 1), patients were randomly assigned to receive UPA 6 mg (UPA6), UPA 11 mg (UPA11), UPA 22 mg (UPA22), or placebo once daily (QD). Patient-reported HRQoL outcomes assessed at the week 24 primary analysis timepoint (ie, end of period 1) included change from baseline in vitiligo QoL (VitiQoL) total score (lower scores reflect better HRQoL), achievement of a Vitiligo Noticeability Scale (VNS) response of 4 (“a lot less noticeable”) or 5 (“no longer noticeable”), change from baseline in Dermatology Life Quality Index (DLQI; lower scores reflect better HRQoL), change from baseline in Hospital Anxiety and Depression Scale (HADS) anxiety and depression scores (where lower scores reflect less anxiety and/or depression), and achievement of a Patient’s Global Impression of Change-Vitiligo (PaGIC-V) response of 1 (“much better”) or 2 (“a little better”). Results A total of 185 patients were enrolled in the study (UPA6 n=49; UPA11, n=47; UPA22, n=43; placebo n=46). Mean reductions in VitiQoL scores from baseline to week 24 with UPA22 (−6.6) and UPA6 (−7.5) were numerically larger than with placebo (−5.5), although not statistically significant. At week 24, more patients treated with UPA22 reported a VNS response of “a lot less noticeable” or “no longer noticeable” than with placebo (11.6% vs 0%, respectively; P &amp;lt; .05). Mean reductions in DLQI scores from baseline to week 24 were significantly larger with UPA22 than with placebo (−2.2 vs −0.6; P &amp;lt; .05). HADS anxiety scores decreased from baseline to week 24 in the UPA6 and UPA22 groups, with similar reductions in HADS depression scores observed for the UPA11 and UPA22 groups; changes in HADS scores were not significantly different vs placebo. A significantly greater proportion of patients achieved a PaGIC-V response of “much better” or “a little better” with any UPA dose vs placebo: UPA6 (34.7%), UPA11 (55.3%), and UPA22 (60.5%) vs placebo (19.6%; P &amp;lt; .05 vs placebo for all UPA doses). Conclusion Among adults with non-segmental vitiligo, 24 weeks of treatment with UPA at all doses resulted in improvements compared to placebo in patient impressions of disease improvement based on PaGIC results. These initial findings suggest that UPA22 may improve patient HRQoL and perceptions of vitiligo noticeability; longer term data from the extension phase of this study will further clarify the impact of UPA treatment on QoL.

Understanding the Association between Red Blood Cell Transfusion Utilization and Humanistic and Economic Burden in Patients with β-Thalassemia from the Patients' Perspective.

We assessed the humanistic and economic burden of chronic red blood cell (RBC) transfusions on patients with β-thalassemia. This cross-sectional, US-based study included adults (≥18 years) who self-reported a β-thalassemia physician diagnosis and had received ≥1 RBC transfusion in the past 6 months. The outcomes included the Functional Assessment of Cancer Therapy-Anemia (FACT-An), Patient Health Questionnaire-9, Generalized Anxiety Disorder-7, and ad hoc questions about treatment experience, side effects, direct/indirect costs, and psychological burden. Overall, 100 patients completed the survey, of whom 70% experienced "moderate" to "extremely high" burden due to RBC transfusions, 81% reported iron overload, 42% reported compromised social lives. The mean FACT-An score was 132 (higher score indicates better outcomes; 0-188). Mean scores were 33/52 for fatigue and 20/28 for anemia symptoms in the previous 7 days. Health-related quality of life (HRQoL) temporarily improved after RBC transfusion, although patients continued to experience mild-to-severe depression and anxiety, substantial direct costs, compromised employment, and suboptimal quality of life. Over 6 months, patients dedicated a mean of 173 h to transfusion requirements and incurred out-of-pocket costs of USD 2239 for transfusions and USD 896 for additional care costs. These findings highlight the need for new treatment options to improve patient HRQoL and economic outcomes.

Observational Burden of Illness Study in Patients With Crohn’s Disease With and Without Perianal Fistulas in the United States

This study compared disease burden, experiences, and health-related quality of life (HRQoL) between patients with Crohn's perianal fistulas (CPFs) and those with Crohn's disease (CD) without perianal fistulas (PFs; non-PF CD). This cross-sectional, observational study was conducted in 3 cohorts of US patients aged 18-89 years with self-reported, physician-diagnosed CD: (1) non-PF CD; (2) CPF without PF-related surgery; and (3) CPF with PF-related surgery. Data on medical and surgical interventions, CD-specific symptoms, HRQoL (assessed using the Short Inflammatory Bowel Disease and 5-dimension EuroQol questionnaires), and fecal incontinence (assessed using Revised Faecal Incontinence Scale and Fecal Incontinence Quality of Life questionnaires) were collected via a web-enabled questionnaire. In total, 403 patients with CD completed the questionnaire (non-PF CD, n= 300; CPF without surgery, n= 51; CPF with surgery, n= 52). A high symptom burden was seen across cohorts. More patients with CPF underwent ≥1 CD-related surgery and experienced ≥1 failure of CD-related surgery (79% and 20%) vs non-PF CD (53% and 9%; P < .001). Overall HRQoL outcomes were worse for patients with CPF vs non-PF CD, with significantly worse Short Inflammatory Bowel Disease and 5-dimension EuroQol questionnaire scores for those without PF-related surgery (P < .01). Across all cohorts, 58% of patients reported experiencing fecal incontinence, which had a greater negative impact (higher Revised Faecal Incontinence Scale scores; lower Fecal Incontinence Quality of Life scores) in patients with CPF vs non-PF CD. Patients with CPF experience substantial HRQoL burden, reflecting the impact of symptoms and medical/surgical interventions. These results may help to inform comprehensive care strategies to improve patient HRQoL.

Health-related quality of life in patients given ciltacabtagene autoleucel for relapsed or refractory multiple myeloma (CARTITUDE-1): a phase 1b–2, open-label study

CARTITUDE-1 is a phase 1b-2 study evaluating ciltacabtagene autoleucel (cilta-cel), a chimeric antigen receptor T cell therapy with two B-cell maturation antigen-targeting single-domain antibodies, in patients with relapsed or refractory multiple myeloma. Primary efficacy outcomes have previously been reported. Here, we report health-related quality of life (HRQOL) secondary outcomes evaluated using patient-reported outcomes. This single-arm, open-label, phwase 1b-2 study was done at 16 centres in the USA. Patients were aged 18 years or older with diagnosis of multiple myeloma and Eastern Cooperative Oncology Group performance status of 1 or less with three or more previous lines of therapy, or were double refractory to a proteasome inhibitor and immunomodulatory drug, and had received a proteasome inhibitor, immunomodulatory drug, and anti-CD38 antibody. A single cilta-cel infusion (target dose 0·75 × 106 CAR+ T cells per kg) was administered 5-7 days after lymphodepletion. Patient-reported outcomes were assessed using the European Organisation for Research and Treatment of Cancer (EORTC) quality of life questionnaire core 30-item, pre-specified items from the EORTC myeloma module, and EuroQol five-dimensional descriptive system questionnaire. Clinically meaningful changes in patient-reported outcomes were defined by anchor-based minimally important differences. This trial is registered with ClinicalTrials.gov, NCT03548207. This trial is completed but feeding into a long-term follow-up study. Between July 16, 2018, and Oct 7, 2019, 78 patients were enrolled and underwent apheresis in phase 2 of the study. 68 patients were treated (43 [63%] male, 49 [72%] White), and their patient-reported outcomes assessed (median follow-up 16·9 months, IQR 15·7-17·5). After infusion, a transient decline was observed, followed by improvements in global health status (mean change from baseline to day 464 +8·0 points, SD 20·9), physical (+4·6 points, 21·1), and emotional functional scales (+1·9 points, 23·7) over time, and declines for symptom-based scores (-14·1 pain, SD 31·5 and -15·4 fatigue; SD 29·5), indicating improved patient HRQOL following treatment with cilta-cel. These durable HRQOL improvements are consistent with clinical findings, in which a single cilta-cel infusion led to substantial and durable responses in heavily pre-treated patients with relapsed or refractory multiple myeloma. These results support the use of cilta-cel in patients with relapsed or refractory multiple myeloma. Janssen Research & Development and Legend Biotech USA.

Quality of life following cardiac rehabilitation in cardiac surgery patients

BackgroundUndergoing cardiac surgery often result in perioperative loss of health-related quality of life (HRQOL). Although participation rates in Australia is low, cardiac rehabilitation (CR) has been demonstrated to improve patient HRQOL in cardiac patients. Literature is unclear regarding the role of CR and HRQOL in the cardiac surgery (CS) patient population.MethodsA prospective non-randomised study was conducted on eligible cardiac surgery patients between December 2009 and March 2015. HRQOL was assessed using the Short Form 12 at baseline and post-operatively at 30 days and 180 days. CR participation was recorded and barriers to CR uptake was assessed using the Cardiac Rehabilitation Enrolment Obstacles (CREO) scale.ResultsAt 180 days, 107 patients participated in CR and 111 did not participate in CR. A significant improvement from baseline mental and physical HRQOL was observed in both groups at 30 days and 180 days (p < 0.002). No significant difference between group characteristics or HRQOL was observed at any time. A trend of superior improvement in mental QOL was observed in the CR group. The study is limited by poor initial uptake (218/1772 of eligible) and may be underpowered to observe a clinical difference. A significant difference in CREO scores were observed between the two groups at 30 days (13 out of 16 questions, p < 0.001) and 180 days (11 out of 16 questions, p < 0.011).ConclusionLiterature has shown that CR may improve numerous health outcomes in cardiac and CS patients, however CR uptake in Australia is low. Mental and Physical QOL is demonstrated to improve following CS, however further research is required to delineate the role of CR and QOL in CS patients. The CREO tool utilised in this study identified numerous potentially modifiable barriers to CR uptake. Specific strategies related to the survey are suggested to improve awareness, uptake, and adherence to CR, including advocacy of home-based and telehealth services.

Long-term impact of adult WHO grade II or III gliomas on health-related quality of life: A systematic review

BackgroundGlioma diagnosis can be devastating and result in a range of symptoms. Relatively little is known about the long-term health-related quality of life (HRQOL) challenges faced by these patients. Establishing the impact of diagnosis on HRQOL could help positively tailor clinical decision making regarding patient support and treatment. The aim of this review is to identify the long-term HRQOL issues reported at least 2 years following diagnosis of WHO grade II/III glioma.MethodSystematic literature searches were carried out using Medline, EMBASE, CINAHL, PsycINFO, and Web of Science Core Collection. Searches were designed to identify patient self-reports on HRQOL aspects defined as physical, mental, or social issues. Quality assessment was conducted using the Mixed Methods Appraisal Tool (MMAT). Narrative synthesis was used to collate findings.ResultsThe search returned 8923 articles. Two hundred seventy-eight titles remained after title and abstract screening, with 21 full-text articles included in the final analysis. The majority of studies used quantitative methods, with 3 articles reporting mixed methodology. Negative emotional/psychological/cognitive changes were the most commonly reported. Physical complaints included fatigue, seizures, and restricted daily activity. Social challenges included strained social relationships and financial problems. Patient coping strategies were suggested to influence patient’s survival quality.ConclusionThe consequences of a glioma diagnosis and treatment can have substantial implications for patients’ long-term HRQOL and daily functioning. Findings from this review lay the groundwork for efforts to improve patient HRQOL in long-term survivorship.

The association between family impact and health-related quality of life of children with idiopathic central precocious puberty in Chongqing, China

BackgroundIdiopathic central precocious puberty (ICPP) reduces patient health-related quality of life (HRQoL). The impacts of disease and treatment on families are also an important concern. This study aimed to assess the association between family impact and HRQoL of children with ICPP.MethodsWe conducted a case–control study in Chongqing, China. A case group of 134 children with ICPP aged 5–12 years and their caregivers was recruited from a children’s hospital in Chongqing. A total of 210 gender- and age-matched subjects from two primary schools were selected as controls. PedsQLTM4.0 Generic Core Scales (GCS) and PedsQL™ Family Impact Module (FIM) were used in this study.ResultsChildren with ICPP scored lower than controls in all HRQoL domains except physical functioning. In particular, the two groups were significantly different in emotional functioning scores (d = 0.414, P < 0.001). Compared with controls, ICPP families had lower scores in all dimensions of the FIM scale (d = 0.288–1.030, all P < 0.05). Factors associated with HRQoL of ICPP patients included: age of patients, type of medical treatment, employment status of caregivers, educational level of caregivers, parent HRQoL and family functioning (all P < 0.05).ConclusionsChildren with ICPP demonstrated lower quality of life and greater family impact compared to healthy controls. In addition, less impact of disease on parent HRQoL and family functioning was associated with better HRQoL of ICPP patients, patients aged older, treated with drug combination, cared by employed or well-educated caregivers reported better HRQoL. Health care professionals should pay more attention to younger patients treated with GnRHa alone, and provide targeted interventions for caregivers depending on their demographic background to reduce family impact and thereby improve patient HRQoL.

Effects of Trilaciclib on Chemotherapy-Induced Myelosuppression and Patient-Reported Outcomes in Patients with Extensive-Stage Small Cell Lung Cancer: Pooled Results from Three Phase II Randomized, Double-Blind, Placebo-Controlled Studies

BackgroundChemotherapy-induced myelosuppression (CIM) and its sequalae cause significant side effects and harm to quality of life. Trilaciclib is an intravenous CDK4/6 inhibitor that is administered prior to chemotherapy to protect hematopoietic stem and progenitor cells from chemotherapy-induced damage (myeloprotection). Patients and MethodsData from three randomized, double-blind, placebo-controlled studies (NCT02499770, NCT03041311, and NCT02514447) were pooled to evaluate the effects of trilaciclib administered prior to standard-of-care chemotherapy (first-line etoposide plus carboplatin [E/P], first-line E/P plus atezolizumab, and second-/third-line topotecan) in patients with extensive-stage small cell lung cancer (ES-SCLC). The primary endpoints were duration of severe neutropenia (absolute neutrophil count < 0.5 × 109 cells/L) in cycle 1 and occurrence of severe neutropenia. Additional prespecified endpoints further assessed the effect of trilaciclib on myeloprotection, health-related quality of life (HRQoL), antitumor efficacy, and safety. ResultsOf 242 randomized patients, 123 received trilaciclib and 119 received placebo. Compared with placebo, administration of trilaciclib prior to chemotherapy resulted in significant decreases in most measures of multilineage CIM. The reduction in hematologic toxicity translated into the reduced need for supportive care interventions and hospitalizations due to CIM or sepsis and improvements in HRQoL domains related to the protected cell lineages, including fatigue, physical wellbeing, and functional wellbeing. Antitumor efficacy was similar for patients receiving trilaciclib or placebo. ConclusionAdministering trilaciclib prior to chemotherapy resulted in clinically meaningful reductions in CIM and its consequences and improved patient HRQoL, with no impact on the antitumor efficacy of three individual chemotherapy regimens used in the first- or second-/third-line treatment of ES-SCLC.

The effectiveness and cost-effectiveness of hospital-based specialist palliative care for adults with advanced illness and their caregivers.

The effectiveness and cost-effectiveness of hospital-based specialist palliative care for adults with advanced illness and their caregivers.

Effects of definitive repair surgery on health-related quality of life in patients with bile duct injury after laparoscopic cholecystectomy

Objective To investigate the effects of definitive repair surgery on health-related quality of life (HRQOL) in patients with bile duct injury after laparoscopic cholecystectomy (LC). Methods The retrospective case-control study was conducted. The clinicopathological data of 181 patients with bile duct injury caused by LC for benign gallbladder diseases who underwent definitive repair surgery and 50 patients without complications after LC for benign gallbladder diseases in the Mianyang Central Hospital from January 2000 to December 2017 were collected. There were 82 males and 99 females of 181 patients with bile duct injury, aged from 31 to 68 years, with an average age of 47 years. Definitive repair surgery was performed according to different types of bile duct injury, and questionnaire of HRQOL was conducted preoperatively and one year after operation. There were 18 males and 32 females of 50 patients without complications after LC, aged from 35 to 69 years, with an average age of 41 years. Questionnaire of HRQOL was conducted on LC patients without complications one year after operation. Observation indicators: (1) classification of bile duct injury; (2) intraoperative situations of definitive repair surgery; (3) postoperative situations of definitive repair surgery; (4) follow-up; (5) results of the SF-36 scale assessment. Follow-up was conducted by outpatient examination and telephone interview up to December 2018. Patients were reexamined liver function and color Doppler ultrasonography once every 6-12 months, and further magnetic resonance cholangiopancreatography (MRCP) or computed tomography examination to detect recurrence of anastomotic biliary stricture and cholangitis. Measurement data with normal distribution were expressed as Mean±SD, and comparison between groups was analyzed by the paired t test. Measurement data with skewed distribution were described as M (range), and count data were described as absolute numbers. Results (1) Classification of bile duct injury: of the 181 patients with bile duct injury, there were 64 cases of E1 type, 70 cases of E2 type, 35 cases of E3 type, 9 cases of E4 type, and 3 cases of E5 type. (2) Intraoperative situations of definitive repair surgery: all the 181 patinets with bile duct injury underwent definitive repair surgery successfully, including 61 undergoing end-to-end biliary anastomosis, 109 undergoing Roux-en-Y choledojejunostomy, 11 undergoing hemi-hepatectomy combined with Roux-en-Y anastomosis. There were 52 patients combined with hilar cholangioplasty. The operation time and volume of intraoperative blood loss of 181 patients were (190±126) minutes and 601.5 mL (range, 150.0-2 100.0 mL). There were 24 cases with blood transfusion and 18 cases with T-tube stent. (3) Postoperative situations of definitive repair surgery: 40 of 181 patients had complications, including 14 cases of incisional infection, 10 cases of bile leakage, 8 cases of perihepatic effusion, 7 cases of pulmonary infection, and 1 case of abdominal hemorrhage. The patient with postoperative abdominal hemorrhage underwent reoperation for hemostasis, and other patients with complications were cured after ultrasound-guided puncture and drainage or conservative treatment. Duration of postoperative hospital stay of 181 patients with bile duct injury was 12.6 days (range, 6.0-34.0 days). There was no perioperative death occurred. (4) Follow-up: 157 of 181 patients were followed up for 8.2-201.3 months, with a median follow-up time of 92.7 months. Twenty-eight patients had anastomotic stricture recurred, 16 of which were treated with reoperation, 10 were treated with endoscopic stent implantation, and 2 cases were treated with balloon dilatation in interventional department; the stricture was repaired again in all cases. Thirteen patients had recurrent cholangitis, showing no obvious anastomotic stricture on MRCP, and symptoms can be effectively controlled after conservative treatment. (5) Results of the SF-36 scale assessment: 181 patients with bile duct injury completed the SF-36 scales before definitive repair surgery, and 157 completed one year after definitive repair surgery. All the 50 patients without complications completed SF-36 scales one year after LC. The scores of HRQOL in physiological function, role functioning, somatic pain, general health, vitality, social function, emotional function, mental health, the scores of physical component summary, and mental component summary of 181 patients with bile duct injury before surgery were 79±15, 65±12, 40±17, 42±14, 59±20, 27±15, 48±23, 56±22, 60±11, and 56±11, respectively. The above indices one year after definitive repair surgery were 87±10, 78±15, 71±20, 64±20、68±19, 70±25, 67±21, 69±23, 71±13, 68±15, respectively. The above indices of 50 patients without complications one year after LC were 90±13, 81±20, 87±16, 72±20, 73±15, 86±17, 79±22, 77±19, 82±18, 79±18, respectively. The 181 patients with bile duct injury had significant elevation in above indices one year after definitive repair surgery (t=2.051, 2.016, 3.875, 3.014, 2.563, 3.225, 2.964, 2.357, 2.150, 2.203, P 0.05). Conclusion Definitive repair surgery can significantly improve HRQOL in patients with bile duct injury caused by LC. Key words: Bile duct injury; Bile duct stricture; Cholangitis; Cholecystectomy; Health-related quality of life; Definitive repair surgery; Laparoscopy

Improvements in Health-Related Quality of Life and Symptoms in Patients with Previously Untreated Chronic Lymphocytic Leukemia: Final Results from the Phase II GIBB Study of the Combination of Obinutuzumab and Bendamustine

Improvements in Health-Related Quality of Life and Symptoms in Patients with Previously Untreated Chronic Lymphocytic Leukemia: Final Results from the Phase II GIBB Study of the Combination of Obinutuzumab and Bendamustine

PCV101 ASSOCIATING HYPERLIPIDEMIA, A MODIFIABLE HEALTH CONDITION, AND CONCURRENT COMORBIDITIES TO HEALTH RELATED QUALITY OF LIFE

Very few studies have reported how comorbidity status relates to the Health-Related Quality of Life (HRQoL) of hyperlipidemia patients in the US. This study described comorbidity status in hyperlipidemia patients as well as estimated their HRQoL according to the presence of comorbid conditions using the 2014-2015 Medical Expenditure Panel Survey (MEPS) database. Eligible patients were ≥ 18 years, with a diagnosis of hyperlipidemia. HRQoL was determined by assessing the mental and physical health status for hyperlipidemia patients using SF-12 surveys in hyperlipidemia patients by the type and number of comorbidities. Comorbidity was defined by the Elixhauser Comorbidity Index Estimated SF-12 scores were calculated using the multiple regression models while controlling for age, gender, race/ethnicity, region, insurance type, marital status, education level, income level, and perceived health status. The factors associated with SF-12 in patients with dyslipidemia were determined by calculating the physical composite health score (PCS) and mental composite health score (MCS). The study included 9,691 hyperlipidemia patients (weighted N=196,643,286). The majority of dyslipidemia patients had at least one comorbidity, of which the most common ones were hypertension (68.9%), diabetes (31.7 %), mood disorder (28.9 %) and coronary heart disease (18.6%). The estimated mean PCS and MCS scores [95% confidence interval (CI)] was 43.4 [43.1, 43.6] and 51.1 [50.8, 51.4] in hyperlipidemia patients, respectively. Higher comorbidity score was significantly associated with lower PCS and MCS scores (P<0.001). Having diabetes was significantly associated with decreased PCS score (P<0.001), while having mood disorder was not (p=0.409). Having mood disorder was significantly associated with decreased MCS score (P<0.001), while having diabetes was not (P=0.455). Concurrent hyperlipidemia and comorbidities worsen HRQoL measured by individuals physical and mental health status. Hyperlipidemia modification and management may improve patient HRQoL, and may reduce comorbidity complications.

Associations between the Presence of Type 2 Diabetes and Health-Related Quality of Life (HRQoL) among US Hispanic Population

Introduction: Very few studies have captured the association in health-related quality of life (HRQoL) by the presence of type 2 diabetes (T2D) among the US Hispanic population. Aim: This study was to examine the association of the presence of T2D on HRQoL measure in the US Hispanic population. Methods: This was a cross-sectional study analyzing data from the 2014-2015 Medical Expenditure Panel Survey (MEPS). This data comprised of the Hispanic population of 13,933 members (estimated population size: 36,440,400) with T2D in the US. Two multivariate regression models were used to predict HRQoL (Short Form 12) by the presence of T2D among the Hispanic population. Results: Results showed 89.1% did not have T2D condition (n=12,423), while 10.9% had T2D conditions (n=1,510). SF-12 PCS scores were 45.85 (95% CI; 44.65, 47.05) in Hispanic population with T2D and 51.23 (95 % CI; 50.77, 51.68) in Hispanic population without T2D. SF-12 MCS scores were 52.52 (95% CI; 51.98, 53.05) in patients without T2D and 49.59 (955 CI; 48.34, 50.76) in Hispanic population with T2D conditions. Conclusion: The study suggests that the presence of T2D worsens HRQoL measured by individuals' physical and mental health status among the US Hispanic population compared with non-T2D Hispanic population. Psychiatric assessment and management of T2D minority population may improve patient HRQoL.

Patient-Reported Outcomes Validation of the FACT-Leu in Acute Myeloid Leukemia: A Review of Baseline Characteristics in AML2002

Introduction: Acute Myeloid Leukemia (AML) is an aggressive disease associated with poor health related quality of life (HRQoL) and short overall survival (OS), particularly for patients' ineligible for intensive chemotherapy. The HRQoL was evaluated in a cohort of patients with AML who were not considered eligible for standard chemotherapy based on the Functional Assessment of Cancer Therapy - Leukemia (FACT-Leu) collected at baseline of AML2002 study (NCT02472145).Methods: This analysis was based on a randomized, phase 2/3, parallel design study conducted in patients with AML. Patients' perceptions to HRQoL were evaluated using a 44-item, self-reported leukemia-specific measure, FACT-Leu. It was assessed based on 5 subscales: physical well-being (PWB), social well-being (SWB), emotional well-being (EWB), functional well-being (FWB) and leukemia-specific concerns. Additionally, FACT-Leu was also evaluated based on the trial outcome index (TOI). European Quality of Life- 5 Dimension 5-Level (EQ-5D-5L) was reported based on index values and visual analogue scale (VAS). The summary statistics from the FACT-Leu was compared to the validation paper [1]. FACT-Leu by eastern cooperative oncology group (ECOG) performance status score was also assessed based on generalized linear model and the correlation among FACT-leu subscales was assessed using the Pearsons correlation coefficientResults: Of the 309 patients (mean age 74.9 years) enrolled, 46.3% were women, 87.3% were white (Caucasian) and 70.9% had de novo AML. For these patients, ECOG performance status distribution was 0 (18%), 1 (41.9%) and 2 (40.2%). At baseline, the mean index values for VAS of EQ-5D-5L were 0.68 and 62.5, respectively, and the mean FACT-Leu was 119.6. Except SWB, other FACT-Leu subscale and aggregated scores highly correlated with FACT-Leu (0.74-0.96; p<0.0001). Both index values (0.65) and VAS of EQ-5D-5L (0.57) showed moderate correlation with FACT-Leu. The EQ-5D-5L (0.71) and VAS (0.60) showed moderate correlation with FACT-TOI (p<0.0001). Except SWB and EWB, other FACT-Leu subscales and aggregated scores showed predicted differences in means based on the ECOG score, with higher scores associated with better ECOG status. However, compared to the results of the validation paper [1], the mean subscale scores of AML ineligible for intensive chemo therapy were lower. In addition to ECOG status, sex was also a significant predictor of FACT-Leu subscales as aggregated scores except SWB and EWB with men reporting better scores.Conclusions: FACT-Leu scores were significantly associated with PS and sex. The lower mean subscale scores in Patients with AML ineligible for intensive chemotherapy highlight the need for new therapies to improve patient HRQoL in this group of patients and suggested that there is a need for optimized instruments for women. The FACT-Leu tool could facilitate targeted population interventions, potentially improving quality of life.[1] Cella, Value in Health 15 (2012) 1051-1058 DisclosuresHe:Janssen Global services: Employment. Pierson:Janssen Global Services LLC: Employment. Loefgren:Janssen Global Services LLC: Employment. Cella:Pfizer: Consultancy, Research Funding; Novartis: Consultancy, Research Funding; Janssen Global services: Consultancy, Research Funding; Bristol-Myers Squibb: Consultancy, Research Funding.

The impact of drug related problems on health-related quality of life among hypertensive patients in Jordan.

Background:Hypertension is a major cause of cardiovascular diseases with a high prevalence in Jordan. No previous studies have been carried out to determine the effect of the presence of drug-related problems (DRPs) on the health-related quality of life (HRQOL) among hypertensive patients.Objectives:The purpose of this study was to identify the influence of different types of DRPs on the HRQOL of hypertensive patients.Methods:A total of 200 hypertensive patients were recruited in this cross-sectional correlation study that was conducted across the cardiac outpatient clinic at Jordan University Hospital. Ethical approval was obtained and patients were recruited using convenience sampling technique. During the study period, patients’ data was used to evaluate their quality of life using RAND-12 scale and to identify DRPs utilizing a systematic evidence based approach.Results:200 hypertensive patients (mean age 59.7 years (SD=10.2)) were recruited in this study. Patients showed a poor quality of life on both the physical and mental domains of the RAND-12 scale. The average number of DRPs was 5.1 (SD=2.3). Multiple linear regression analysis showed that among DRPs categories, non-adherence to medications, non-adherence to non-pharmacological therapies and inadequate knowledge about medications were among the main predictors of the poor physical domain of the RAND-12 (Beta= -0.149, -0.226 and -0.230 respectively, p-value < 0.05 for all). On the other hand, only non-adherence to medication and non-adherence to non-pharmacological therapies were significantly associated with poor mental domain of the RAND-12 (Beta= -0.208 and -0.191 respectively, p-value < 0.05 for both).Conclusion:Prevalence of DRPs among hypertensive patients is a concern that needs attention. These DRPs were associated with poor HRQOL on both the physical and mental domain of the RAND-12 scale. The pharmaceutical care service delivered by pharmacists is needed to identify, prevent and resolve DRPs, which may improve patients HRQOL.

A cross sectional analysis from a single institution's experience of psychosocial distress and health-related quality of life in the primary brain tumor population.

Primary brain tumor patients experience high levels of distress. The purpose of this cross-sectional, retrospective study is to evaluate the level and different sources of psychosocial distress and how these pertain to health-related quality of life (HRQoL). The Primary and Recurrent Glioma registry at Duke's The Preston Robert Tisch Brain Tumor Center was queried retrospectively for demographic and clinical information on patients seen between December 2013 and February 2014. Data also included the National Comprehensive Cancer Network's Distress Thermometer (NCCN-DT), Functional Assessment of Cancer Therapy-Brain Cancer (FACT-Br), and Functional Assessment of Chronic Illness Therapy- Fatigue (FACIT-F). 829 subjects completed questionnaires. 54% were male; 96% completed the NCCN-DT; 33.3% had a DT score ≥4 (moderate/severe distress). Women reported DT ≥ 4 more often than men (38.6 vs 29.0%; p = 0.005). Patients within 1year of diagnosis reported DT ≥ 4 more often than those 1+ years after diagnosis (38.8 vs 30.9%; p = 0.034). 73.0% reported physical problems; the most frequent being fatigue (43.2%) and memory/concentration (40.9%). 42.0% complained of emotional problems with worry (29.4%) and nervousness (22.4%) being the most common. Patients who reported at least one practical, family, emotional or physical problem had significantly lower HRQoL scores (p < 0.001). Primary brain tumor patients experience memory dysfunction, fatigue, nervousness, worry, and financial concerns, which have a negative effect on the patient's HRQoL. By identifying and addressing these stressors, it may be possible to improve patient HRQoL.

Effects on health-related quality of life in patients treated with lurasidone for bipolar depression: results from two placebo controlled bipolar depression trials.

BackgroundDepressive symptoms associated with bipolar disorder negatively impact health-related quality of life (HRQoL). The efficacy of lurasidone in reducing depressive symptoms has been previously demonstrated. The objective of this study was to examine the direct and indirect effect (mediated through improvement in depression symptoms) of lurasidone in improving patient HRQoL.MethodsA secondary analysis of data was conducted of two 6-week, double-blind, placebo-controlled trials assessing the effect of lurasidone (lurasidone monotherapy [20–60 mg/day or 80–120 mg/day]; lurasidone adjunctive to lithium or valproate [20–120 mg/day]) in patients with bipolar depression. Patient HRQoL was measured using the Quality of Life Enjoyment and Satisfaction Questionnaire Short Form (Q-LES-Q SF). Depression symptoms were measured using the Montgomery-Asberg Depression Rating Scale (MADRS). Analysis of covariance (ANCOVA) was used to estimate the effect of lurasidone on improvement in the Q-LES-Q SF percentage maximum score from baseline to 6 weeks. Path analysis was used to evaluate the total effect (β1), as well as the indirect (β2*β3) and direct (β4) effect of lurasidone on Q-LES-Q SF change through improvements in MADRS.ResultsA total of 340 and 485 patients from the monotherapy and adjunctive therapy, respectively, were included in the analysis. At 6-weeks, ANCOVA analyses demonstrated that lurasidone provided significant improvement in adjusted mean Q-LES-Q SF scores in comparison to placebo for monotherapy (22.9 and 22.7 vs. 15.2, both p < 0.01) and adjunctive therapy (23.1 vs. 17.9, p = 0.01). Path analyses indicated that lurasidone treatment predicted MADRS improvement (monotherapy: β2 = −0.44, p < 0.001; adjunctive therapy: β2 = −0.34, p = 0.003), which subsequently predicted improvement in Q-LES-Q SF (monotherapy: β3 = −0.73, p < 0.001; adjunctive therapy: β3 = −0.75, p < 0.001); however, the effect of lurasidone on improvement in Q-LES-Q SF was largely mediated by change in MADRS (monotherapy: β4 = 0.11, p = 0.13; adjunctive therapy: β4 = 0.02, p = 0.77).ConclusionsLurasidone as a monotherapy and adjunctive to lithium or valproate is an effective treatment for improving HRQoL in patients with bipolar depression. However, improvement in HRQoL was not independent of improvement in depression, indicating that the effect of lurasidone on improving patient HRQoL may act through a reduction in depressive symptoms associated with bipolar disorder.Trial registrationClinicaltrials.gov identifiers: NCT00868699 and NCT00868452 (both registered March 23, 2009)

Psychosocial distress and its effects on the health-related quality of life of primary brain tumor patients.

9553 Background: Primary brain tumor patients experience a high level of psychosocial distress, not only due to their diminished functional and neurocognitive capacities, but also due to the psychosocial stigma of being a primary brain cancer patient. The purpose of this study is to evaluate the level of psychosocial distress, the different sources of this stress, and its effect on health-related quality of life (HRQoL) in primary brain tumor patients. Methods: Demographic and clinical information in the PRoGREss registry at Duke’s Preston Robert Tisch Brain Tumor Center was queried retrospectively for December 2013 through February 2014. Data was also obtained from patient-reported outcome questionnaires including the National Comprehensive Cancer Network’s Distress Thermometer (NCCN-DT), the Functional Assessment of Cancer Therapy-Brain Cancer (FACT-Br), and the Functional Assessment of Chronic Illness Therapy- Fatigue (FACIT-F). Results: Among the 845 subjects completing the NCCN-DT, 385 (46%) were female and 460 (54%) were male. 98% reported physical problems with the most frequent being memory/concentration (40%) and fatigue (42%), and 41% complained of an emotional problem with nervousness (22%) and worry (29%) being the most reported concerns. 12% reported insurance/financial concerns. 94% of the subjects completed the distress thermometer with a mean score of 2.68 (SD = 2.70). There was no difference in distress between tumor grades (low grade: mean = 2.73, SD = 2.89; high grade: mean = 2.67, SD = 2.62; p = 0.8297). Females (mean = 3.05, SD = 2.81) experienced significantly more distress than males (mean = 2.39, SD = 2.57; p = 0.0007), as well as a higher rate of practical (p = 0.0026), family (p = 0.0209) and emotional (p < 0.0001) problems. Patients who reported at least one practical, family, or emotional problem had significantly lower HRQoL scores (p < 0.0001). Conclusions: Primary brain tumor patients experience memory dysfunction, fatigue, nervousness, worry, and financial concerns which have a negative effect on the patient’s HRQoL. By identifying and addressing these stressors during a clinic visit, it may be possible to improve patient HRQoL.

35 * Literature review of health related quality of life measurement tools for patients with atrial fibrillation: could they be used as a patient reported outcome measure?

Introduction: The most common heart arrhythmia is atrial fibrillation (AF) where individuals can suffer symptoms that adversely affect health related quality of life (HRQoL). The main reason for rhythm control of AF is to reduce symptoms and improve patients HRQoL. Patient reported outcome measures (PROMs) were developed to measure patient's HRQoL to give an indication of improvement as a result of certain treatments. A variety of tools exist to measure HRQoL in patients with AF, these include generic measurement scales or disease specific tools. A literature review was carried out in 2013 to assess tools that measure HRQoL in AF and to consider if they had potential of being a PROM for clinical practice. Methods: Several online databases were used. Searches were restricted to those in English with full text and published from 2003-2013. Articles were excluded if it wasn't specified what tool was used, if a clinician reported outcome measure was used, if the tool was a generic HRQoL tool and where the study population wasn't AF. Results: 868 pieces of literature were identified to have used a HRQoL tool following the initial search: reduced to 26 after exclusion criteria was applied, with a total of 4 AF specific HRQoL tools which are listed below: Atrial Fibrillation Effect on Quality-of-Life (AFEQT) Development of a questionnaire to measure health-related quality of life in patients with atrial Fibrillation (AFQoL) Quality of Life of Atrial Fibrillation (AFQLQ) Quality of life in AF patients (QLAF) Each AF specific tool was examined in more detail, in particular their development, validation, application to clinical practice and limitations. 4 tools specific to AF were available to measure HRQoL. These tools have been developed in various ways, mostly based on literature reviews with all appearing to have a significant amount of clinical opinion alongside some patient input in initial stages. All mentioned tools have been validated alongside generic HRQoL tools and some with AF symptom scales. All these tools have shown to measure HRQoL but as most are made with principally clinician input in developmental stages, it is questionable if it can be classed as a PROM, thus having limited usefulness to the NHS in the collection of data. Conclusions: Due to the outcomes of this literature review it became evident how crucial the need for an AF specific PROM is. Development and validation of new HRQoL assessment tools with significant patient input in developmental stages would be beneficial to assist clinicians to decide patient treatments in clinical practice. It would further ensure that research in AF regarding HRQoL treatment is measured effectively and accurately providing an indication of the effectiveness of these treatments. An AF specific PROM recognised by the NHS could to be used in a similar way to other disease specific PROMs nationwide to compare outcomes of treatments.