Health-related Quality Of Life Effects Research Articles

Health-Related Quality of Life effects of rectus repair during body contouring surgery in post-bariatric patients: A prospective study.

Massive weight loss after bariatric surgery often leads to psychological and physical dissatisfaction, resulting in an increased demand for body contouring surgery (BCS). As a result of these surgeries, Health-Related Quality of Life (HRQL) is improved. However, little is known about the impact of rectus plication during BCS on HRQL. This multicenter prospective cohort study included post-bariatric primary BCS patients with a minimum follow-up period of 12 months between January 2016 and December 2019. Patients were divided into two groups based on plication status. Using the BODY-Q, a patient-reported outcome measure, HRQL was measured preoperatively and at least 12 months postoperatively. Six HRQL domains were investigated: Body image, physical function, psychological function, sexual function, social function, and physical symptoms. A total of 305 patients were included in this study: 201 of these patients (66%) did not undergo plication, while 104 patients (34%) did. HRQL improved significantly 12 months after BCS in all measured domains, regardless of plication status. Delta scores were significantly higher in the plication group in all HRQL domains. After adjusting for baseline score and other significant variables through multivariate linear regression, three scales remained significant: Body image (P = 0.001), psychological function (P = 0.035), and sexual function (P = 0.035). Three out of six domains showed significant improvement in HRQL after BCS with rectus plication, predominantly body image. Preoperative counseling and surgical planning could benefit from this information. The long-term effects of rectus plication on HRQL should be explored in future research.

Ther-PO-05 - Health-related quality of life effect of mogamulizumab by patient blood involvement

Ther-PO-05 - Health-related quality of life effect of mogamulizumab by patient blood involvement

The relative value of carer and patient quality of life: A person trade-off (PTO) study

Carer quality of life is increasingly considered alongside patient quality of life in economic evaluation. Important questions remain about how to value carer and patient quality of life effects alongside one another. In this study, we estimated the relative social value of two conceptualisations of carer quality of life (health-related and care-related) compared to patient quality of life. Relative valuations were estimated using a person trade-off (PTO) study with 990 representative members of the UK public. Participants chose between hypothetical services that improved the quality of life of carers and patients, iterating to a point of indifference. Overall 84% of participants completing the task were willing to trade patient and carer quality of life effects. Relative to a reference point of 1 for patient health-related quality of life, we estimated a social value of 0.74 for carer health-related quality of life effects and 0.69 for carer care-related quality of life effects. In conclusion, public preferences appear to support the inclusion of carer quality of life effects within economic evaluation. The results provide a means to value different carer quality of life outcomes in economic evaluation, where such values are needed and deemed appropriate.

Qol-P-04 - Health-related quality of life effect of mogamulizumab by patient blood involvement

Background: Cutaneous T-cell lymphomas (CTCL) are a rare group of non-Hodgkin lymphomas that present in skin. The most studied subtypes, mycosis fungoides (MF) and Sézary syndrome (SS), together represent around two-thirds of all cases. MF/SS disease staging is multi-compartmental utilising a modified TNMB classification. Leukemic involvement in MF/SS has previously been found to be an independent prognostic factor affecting overall survival, disease-specific survival and increasing risk of disease progression (Agar 2010, Am Soc J Clin Oncol), although further research is ongoing.

TCL-389: Health-Related Quality of Life Effect of Mogamulizumab by Patient Blood Involvement

Context Cutaneous T-cell lymphomas (CTCLs) are rare non-Hodgkin lymphomas that present in skin and include mycosis fungoides (MF) and Sezary syndrome (SS) subsets. Leukemic involvement is an independent prognostic factor affecting overall and disease-specific survival and increasing the risk of disease progression (Agar 2010, Am Soc J Clin Oncol). CTCL has serious negative effects on patient quality of life (QoL). Therefore, treatment goals include reducing the burden of disease, delaying progression, and improving or preserving QoL. Objective This post hoc analysis of MAVORIC trial data sought to determine whether baseline blood tumor burden affected treatment effects on patient QoL. Design The Phase 3 MAVORIC trial (NCT01728805) compared vorinostat 400 mg daily PO to mogamulizumab 1.0 mg/kg weekly for the first 28-day cycle, then on days 1 and 15 of subsequent cycles. Patient-reported outcome (PRO) analysis of health-related QoL (HRQoL) was performed using the validated Skindex-29 and FACT-G (Functional Assessment of Cancer Therapy-General) instruments. Pruritus was assessed using ItchyQoL and Pruritus Likert scales. All PROs were administered at baseline; Skindex-29 and FACT-G were then administered at every other treatment visit (Cycle 1, 3, 5, …), and ItchyQoL and Pruritus Likert scales were administered every 4 weeks at each cycle. Results Overall, no statistically significant differences between mogamulizumab and vorinostat were seen for patients without blood involvement. Statistically significant differences were seen for patients with blood involvement, with mogamulizumab-treated patients seeing statistically significant improvement in Skindex-29 for treatment Cycles 3–11 in all domains (emotional, functional, symptoms) and in the functional domain of ItchyQoL at most time points. In mogamulizumab-treated patients with blood involvement, the Pruritus Likert Scale score showed a reduction in itch from Cycle 1 and a trend toward reducing levels of itch over 12 cycles. The FACT-G Total Score showed the greatest improvement from baseline for mogamulizumab-treated patients with blood involvement compared to those without blood involvement and all vorinostat-treated patients. Conclusions Mogamulizumab patients with blood involvement saw greater HRQoL improvement than those without blood involvement. Mogamulizumab offers QoL benefit, assessed across a number of PROs, especially to patients with blood involvement (B1 or B2). Supported by Kyowa Kirin, Inc.

Poster: TCL-389: Health-Related Quality of Life Effect of Mogamulizumab by Patient Blood Involvement

Poster: TCL-389: Health-Related Quality of Life Effect of Mogamulizumab by Patient Blood Involvement

ES19.05 Incorporating Patient Reported Outcomes into the Lung Cancer Registry

Coupled with advances in early detection, the rapid pace of innovation in lung cancer research is beginning to improve survival rates and extend lives for those diagnosed with lung cancer. Many more people are surviving with the disease long-term and facing new challenges (Vavala et al., Respirology, 2020). As survivorship increases, there is a growing imperative to more completely understand health-related quality of life issues that people with lung cancer are facing. This is compounded by the plethora of new treatment options – many of which do not yet have sufficient follow-up data to understand long-term side-effects and impacts on health and well-being. Patient reported outcomes are an essential part of understanding the true patient experience. Physician and patient reporting of symptomatic toxicities are often not concordant (DiMaio et al., Journal of Clinical Oncology, 2015). Incorporating patient reported symptom reporting into clinical workflow has even been demonstrated to not only reduce emergency department visits but to improve overall survival (Basch et al, Journal of Clinical Oncology, 2016). Real-world data sources like the Lung Cancer Registry (www.lungcancerregistry.org) provide access to thousands of patients globally that are living with lung cancer. Multiple studies have now been incorporated into the Lung Cancer Registry to demonstrate the feasibility and accessibility of collecting patient reported outcomes in a real-world setting as well as to better understand quality of life issues. An initial study examining the feasibility of collecting patient-reported outcomes from people diagnosed with lung cancer taking PD-1/PD-L1 immune checkpoint inhibitors in a real-world setting was performed in the Registry in 2018-2019 (Jim et al., manuscript submitted). This examination of 226 people revealed that 25% of patients experienced a treatment delay, 12% had an emergency room visit, and 9% were hospitalized due to toxicity. There was no significant difference in health-related quality of life events between the four immune checkpoint inhibitors examined. Notably, patients reported a lower overall health related quality of life, functional well-being, and emotional well-being compared to general population and cancer norms (Brucker et al., Eval Health Prof, 2005). Fatigue, aching joints, aching muscles, insomnia, shortness of breath, itching, and skin dryness were reported by more than half of study participants. These data indicate key areas of concern for those who are may be living long-term on or after treatment with immune checkpoint inhibitor therapy and underscore the importance of appropriate palliative and survivorship care. After confirming the feasibility of the immunotherapy study, the Lung Cancer Registry incorporated longitudinal tracking of patient-reported outcomes on a quarterly basis, starting in late November, 2019. Multiple stakeholders, including patients, caregivers, academic, and industry collaborators were consulted in the design of the questionnaires. After providing informed consent for an IRB-approved, observational research study, participants are asked about symptoms and side-effects every three months and complete the EORTC QLQ-C30 quality of life survey instrument (Aaronsen et al, J Natl Cancer Inst, 1993) as well as the EORTC LC-29 survey (Koller et al., Lancet Oncol, 2020). This data is coupled with patient-provided information about changes in cancer status (such as stage, recurrence, and biomarker testing) and information on treatment changes. Early analyses of these data show that the questionnaires are feasible and demonstrate expected trends, such as reduced physical functioning in stage IV patients currently taking first or second line chemotherapy compared to similar patients currently taking a targeted therapy or immunotherapy. Finally, the Lung Cancer Registry has partnered with a multidisciplinary team of investigators (including patients and patient advocates) to launch a landmark study on Women’s sexual health (https://www.iaslc.org/iaslc-news/ilcn/shawl-largest-study-its-kind-evaluates-sexual-dysfunction-women-lung-cancer). Initially prompted by patient experiences that were expressed to the principal investigator, this study utilizes PROMIS measures assessing sexual health (Flynn et al., J Sex Med, 2013) to understand sexual side effects after lung cancer treatment. To date, there is very little known on this topic. Clinical trials for new lung cancer therapeutics generally do not collect this information. The study will be actively accruing until the end of Q1 2021. The investigators aim to learn more about the problems being faced with the goal of providing effective management strategies in the future. Taken together, all of these studies underscore the need to learn directly from people living with lung cancer to ensure that we are effectively designing and implementing appropriate supportive care and side-effect management within clinical care pathways. Utilizing real-world sources such as registries to complement quality of life data being collected in lung cancer clinical trials will improve knowledge around toxicities and side-effects and can lead to new management strategics and overall improved well-being for those diagnosed with lung cancer. patient reported outcomes, quality of life, Survivorship

CLO19-059: A Systematic Review and Meta- Analysis of Randomized Controlled Trials to Evaluate the Risk of Health-Related Quality of Life Events in Patients With Hormone Receptor-Positive HER2-Negative Metastatic Breast Cancer Treated With CDK 4/6 Inhibitors

Background: Pain, fatigue, hot flushes, and rash significantly contribute to quality of life in breast cancer patients undergoing chemotherapy. Hormone receptor-positive breast cancer is a common entity among women worldwide. In cancer cells, CDK4/6 activity is over expressed, which can lead to amplification or overexpression of the genes encoding for CDK 4/6 or the cyclin D, ultimately leading to endocrine therapy resistance. We undertook a systematic review and meta-analysis of randomized controlled trials (RCT) to determine the risk of health-related quality of life (HRQOL) events associated with CDK 4/6 inhibitors. Methods: We conducted a comprehensive literature search using MEDLINE, EMBASE databases, and meeting abstracts from inception through September 2018. RTCs that mention HRQOL events as adverse effects were incorporated in the analysis. Mantel-Haenszel (MH) method was used to calculate the estimated pooled risk ratio (RR) with 95%CI. Random effects model was applied. Results: 8 RCTs (7 phase III and 1 phase II) with a total of 4,557 patients were eligible. The study arms used palbociclib/ribociclib/abemaciclib with letrozole or anastrozole or fulvestrant or other hormonal agent while the control arms utilized placebo in combination with letrozole or anastrozole or fulvestrant or other hormonal agent. The RR of all-grade side effects were as follows: fatigue, 1.226 (95% CI: 1.079–1.393; P=.002); back pain, 0.971 (95% CI: 0.844–1.117; P=.681); arthralgia, 0.978 (95% CI: 0.830–1.152; P=.790); headache, 1.046 (95% CI: 0.928–1.179; P=.459); alopecia, 2.635 (95% CI: 1.966–3.533; P<.001); hot flushes, 0.901 (95% CI: 0.766–1.060; P=.210); and rash, 2.068 (95% CI: 1.604–2.666; P<.001). The RR of high-grade side effects were as follows: fatigue, 3.487 (95% CI: 1.765–6.889; P<.001); back pain, 1.364 (95% CI: 0.695–2.679; P=.367); arthralgia, 1.148 (95% CI: 0.509–2.593; P=.740); headache, 0.807 (95% CI: 0.303–2.147; P=.667); and rash, 3.018(95% CI: 0.954–9.554; P=.060). Conclusions: Our study showed that the risk of developing all grades of fatigue and any-grade alopecia and rash was significantly with CDK 4/6 inhibitors. Prompt intervention with good supportive care is required.

EPR19-071: Risk of Hematologic Toxicities and Health-Related Quality of Life Events in Patients With Hematologic Malignancies Treated With Ibrutinib: A Combined Analysis of 6 Phase III Trials

Background: Bruton’s tyrosine kinase (BTK) is essential for signaling of B-cell and chemokine receptors. Ibrutinib targets BTK and has become frontier in many hematologic malignancies. We undertook systematic review and pooled analysis of randomized controlled trials (RCTs) to determine the risk of hematologic toxicities and health-related quality of life (HRQOL) events associated with ibrutinib. Methods: We performed a comprehensive literature search using MEDLINE, EMBASE databases, and meeting abstracts through September 2018. Phase III RCTs that mention hematologic toxicities and HRQOL events as adverse effects were incorporated in the analysis. Mantel-Haenszel method was used to calculate the estimated pooled risk ratio with 95% CI. Random effects model was applied. Results: 6 phase III RCTs with a total of 1,811 patients with chronic lymphocytic leukemia/small lymphocytic lymphoma, mantle-cell lymphoma, and Waldenstrom’s macroglobulinemia were eligible. Studies compared Ibrutinib (I) vs ofatumumab, I vs chlorambucil, I+ bendamustine (B) + rituximab (R) vs placebo + B+ R, I vs temsirolimus and I vs R were included in the analysis. The relative risks (RR) of all-grade side effects were as follows: anemia, 0.812 (95% CI: 0.565–1.168; P=.261); neutropenia, 0.956 (95% CI: 0.720–1.268; P=.754); thrombocytopenia, 1.054 (95% CI: 0.450–2.470; P=.904); fatigue, 0.896 (95% CI: 0.761–1.056; P=.192); pyrexia, 1.123 (95% CI: 0.893–1.413; P=.322); and arthralgia, 1.863 (95% CI: 1.101–3.152; P=.020). The RR of high-grade adverse effects were as follows: anemia, 0.522 (95% CI: 0.371–0.733; P<.0001); neutropenia, 0.969 (95% CI: 0.751–1.249; P=.807); thrombocytopenia, 0.608 (95% CI: 0.252–1.470; P=.270); fatigue, 0.618 (95% CI: 0.396–0.964; P=.034); pyrexia, 1.165 (95% CI: 0.534–2.542; P=.701); and arthralgia, 3.623 (95% CI: 0.743–17.663; P=.111). Conclusion: Ibrutinib increased the risk of all-grade arthralgia whereas the risks of high-grade anemia and fatigue were significantly lower in the study arm, favoring ibrutinib.

1761P - Risk of health-related quality of life events and pulmonary toxicities in recurrent ovarian cancer patients treated with poly adenosine diphosphate ribose polymerase (PARP) inhibitors maintenance

1761P - Risk of health-related quality of life events and pulmonary toxicities in recurrent ovarian cancer patients treated with poly adenosine diphosphate ribose polymerase (PARP) inhibitors maintenance

Risk of Gastrointestinal Toxicities and Health-Related Quality of Life Events in Patients with Multiple Myeloma Treated with Daratumumab

Risk of Gastrointestinal Toxicities and Health-Related Quality of Life Events in Patients with Multiple Myeloma Treated with Daratumumab

Risk of health-related quality of life events and pulmonary toxicities in patients with advanced neuroendocrine tumors treated with everolimus: A meta-analysis of phase 3 randomized controlled trials.

e16185Background: Autocrine activation of mTOR signaling pathway, mediated via insulin-like growth factor 1, was shown to involve in neuroendocrine tumor (NET) progression. Everolimus (E), an oral ...

Risk of health-related quality of life events from pain and fatigue among patients with hormone receptor-positive HER-2 negative metastatic breast cancer treated with CDK 4/6 inhibitor.

215 Background: Molecular heterogeneity in breast cancer has led to increasing attention in the role of cell cycle signaling especially the cyclins and their associated proteins, cycle-dependent kinases (CDK), in carcinogenesis and treatment resistance in hormone receptor-positive metastatic breast cancer. Many CDK 4/6 agents have been proven beneficial. Nevertheless, health-related quality of life from pain and fatigue remains a concern. We performed a systematic review and meta-analysis of randomized controlled trials (RCT) to determine these risks. Methods: MEDLINE, EMBASE databases and meeting abstracts from inception through June 2017 were queried. RCTs that mention back pain, pain in arms and legs, arthralgia and fatigue as adverse effects were incorporated in the analysis. Mantel-Haenszel method was used to calculate the estimated pooled risk ratio with 95% confidence interval (CI). Random effects model was applied. Results: A total of 2671 patients with hormone receptor-positive HER2-negative metastatic breast cancer from four phase 3 studies and one phase 2 study were eligible for analysis. The study arms used palbociclib-letrozole, palbociclib-fulvestrant, ribociclib-letrozole and abemaciclib-fulvestrant while the control arms utilized placebo in combination with letrozole or fulvestrant. The relative risk (RR) of all-grade back pain was 0.97 (95% CI: 0.81- 1.16; p = 0.76); all-grade pain in arms and legs was 0.98 (95% CI: 0.74- 1.30; p = 0.90); all-grade arthralgia was 0.98 (95% CI: 0.75- 1.27; p = 0.88); and all-grade fatigue was 1.35 (95% CI: 1.20- 1.52; p < 0.0001). The RR of high-grade back pain was 1.47 (95% CI: 0.51- 4.23; p = 0.46); high-grade pain in arms and legs was 0.12 (95% CI: 0.02- 0.73; p = 0.02); high-grade arthralgia was 1.14 (95% CI: 0.40- 3.26; p = 0.79); and high-grade fatigue was 3.06 (95% CI: 1.41- 6.61; p = 0.004). Conclusions: Patients on CDK4/6 inhibitor-based regimens experienced a significant increase in all-grades of fatigue with a relative risk of 3.06 for grade 3 and 4 fatigue whereas they noted a decrease in high-grade pain in the arms and legs favoring CDK 4/6 inhibitor based regimens.

Health-related quality of life effects of enzalutamide in patients with metastatic castration-resistant prostate cancer: an in-depth post hoc analysis of EQ-5D data from the PREVAIL trial

BackgroundThe effect of enzalutamide on health-related quality of life (HRQoL) in the PREVAIL trial in chemotherapy-naïve men with metastatic castration-resistant prostate cancer was analyzed using the generic EQ-5D instrument.MethodsPatients received oral enzalutamide 160 mg/day (n = 872) or placebo (n = 845). EQ-5D index and EQ-5D visual analogue scale (EQ-5D VAS) scores were evaluated at baseline, week 13, and every 12 weeks until week 61 due to sample size reduction thereafter. Changes on individual dimensions were assessed, and Paretian Classification of Health Change (PCHC) and time-to-event analyses were conducted.ResultsWith enzalutamide, EQ-5D index and EQ-5D VAS scores declined more slowly versus placebo and time to diverge from full health was prolonged. Average decline in EQ-5D index (−0.042 vs. –0.070; P < .0001) and EQ-5D VAS (−1.3 vs. –4.4; P < .0001) was significantly smaller with enzalutamide. There were significant (P < .05) between-group differences favoring enzalutamide in Pain/Discomfort to week 37, Anxiety/Depression at week 13, and Usual Activities at week 25, but no significant differences for Mobility and Self-care. The PCHC analysis showed more enzalutamide patients reporting improvement than placebo patients at weeks 13, 25, and 49 (all P < .05) and week 37 (P = .0512). Enzalutamide was superior (P ≤ .0003) to placebo for time to diverge from full health and time to first deterioration on Pain/Discomfort and Anxiety/Depression dimensions.ConclusionsThis in-depth post hoc analysis showed that enzalutamide delayed HRQoL deterioration and had beneficial effects on several HRQoL domains, including Pain/Discomfort and the proportion of patients in full health, compared with placebo, and may help to support future analyses of this type.Trial registrationNCT01212991

A randomized controlled trial of the effects of muscle stretching, manual therapy and steroid injections in addition to ‘stay active’ care on health-related quality of life in acute or subacute low back pain

Objective: To evaluate the health-related quality of life effects of muscle stretching, manual therapy and steroid injections in addition to ‘stay active’ care in acute or subacute low back pain patients. Study design: A randomized, controlled trial during 10 weeks with four treatment groups. Setting: Nine primary health care and one outpatient orthopaedic hospital department. Subjects: One hundred and sixty patients with acute or subacute low back pain. Interventions: Ten weeks of ‘stay active’ care only (group 1), or ‘stay active’ and muscle stretching (group 2), or ‘stay active’, muscle stretching and manual therapy (group 3), or ‘stay active’, muscle stretching, manual therapy and steroid injections (group 4). Main measures: The Gothenburg Quality of Life instrument subscales Well-being score and Complaint score. Results: In a multivariate analysis adjusted for possible outcome affecting variables other than the treatment given Well-being score was 68.4 (12.5), 72.1 (12.4), 72,3 (12.4) and 72.7 (12.5) in groups 1–4, respectively (P for trend <0.05). There were significant trends for the well-being components patience (P < 0.005), energy (P < 0.05), mood (P < 0.05) and family situation (P < 0.05). The remaining two components and Complaint score showed a non-significant trend towards improvement. Conclusion: The effects on health-related quality of life were greater the larger the number of treatment modalities available. The ‘stay active’ treatment group, with the most restricted number of modalities, had the most modest health-related quality of life improvement, while group 4 with the most generous choice of treatment modalities, had the greatest improvement.

Education for dialysis patients lowers long-term phosphate levels and maintains health-related quality of life

This study aims at biological, knowledgeable, behavioral and health-related quality of life effects of self-dosing of phosphate binders before and after an education program in patients with CKD. The following 12-month study included 43 patients with CKD Stage 4 - 5 and plasma phosphate levels repeatedly above recommended maximum level. Patients underwent a structured educational program regarding calcium and phosphate balance, food intake and phosphate binders comprising a 60-min session, 3 - 5 times during a 2-month period (intervention). Patients' knowledge on the topics included in the program was assessed before and after the program as well as phosphate levels. The mean plasma phosphate level had decreased significantly directly after the intervention (1.87 mmol/l, p < 0.05) and remained low over time; 1.78 mmol/l at 12 months follow-up (p < 0.001). The patients' self-reported knowledge regarding food intake, calcium/phosphate balance and self-dosing of phosphate binders increased significantly after instruction (p < 0.001). A structured education program focusing on calcium and phosphate balance and self-dosing of phosphate binders significantly increased the patients' self-reported knowledge regarding these issues which in turn led to changes in behaviors reflected in decreased long-term plasma phosphate levels.

Effect of an individualised education programme on asthma control, inhaler use skill, asthma knowledge and health‐related quality of life among poorly compliant Korean adult patients with asthma

This study assessed the effect of an individualised education programme on asthma control, inhaler use, asthma knowledge and health-related quality of life among poorly compliant adult Korean patients with asthma. Previous studies show that proper educational strategies are necessary to increase asthma knowledge and skills to improve patients' self-management and health-related quality of life. A one-group quasi-experimental design with repeated measurements. Adult patients with asthma (n = 101) were recruited from University hospital located in K City, Korea. Three interventions consisting of 30-minute sessions of individualised education were provided by an education team. Peak expiratory flow rate (PEFR), daily record card (DRC) scores, skill scores for use of metered dose inhaler, level of asthma knowledge and health-related quality of life scores were obtained before the intervention and 2-4 and 4-8 weeks after the intervention. One-way repeated measures analysis of variance was used to identify the effect of the education programme on the dependent variables. Peak expiratory flow rate, DRC scores, inhaler using skill scores and health-related quality of life scores benefitted from intervention, whereas knowledge score did not. The effect on the PEFR and DRC score was sustained, with that of inhaler use skill increased over time from 4-8 weeks. However, the health-related quality of life effect was not sustained for 4-8 weeks after the intervention. Repetitive education and innovative education methods may be needed to improve and to maintain pulmonary function, symptom control, asthma knowledge and health-related quality of life of poorly compliant adult Korean patients with asthma. This study confirmed the importance of education for patients suffering from asthma in managing their symptoms and promoting their quality of life.

Improvements in health-related quality of life with once-daily (evening) or twice-daily dosing of mometasone furoate dry powder inhaler (MF-DPI) in children with asthma

16 Improvements in Health-Related Quality of Life With Once-Daily (Evening) or Twice-Daily Dosing of Mometasone Furoate Dry Powder Inhaler (MF-DPI) in Children With Asthma M. Noonan1, M. E. Ruff2, P. Chervinsky3, W. Berger4; 1Allergy Associates Research, Portland, OR, 2Pharmaceutical Research & Consulting, Dallas, TX, 3New England Clinical Studies, North Dartmouth, MA, 4Southern California Research, Mission Viejo, CA. RATIONALE: To evaluate the effects of mometasone furoate dry powder inhaler (MF-DPI) 100 mcg administered once daily in the evening (QD PM) on health-related quality of life (HQOL) in children with asthma previously maintained on inhaled corticosteroids (ICS). METHODS: A randomized, placebo-controlled, 12-week study in children (4 11 years of age) with asthma evaluated (as secondary efficacy variables) the HQOL effects of MF-DPI 100 mcg QD PM, MF-DPI 100 mcg BID, and placebo. The HQOL data were collected using the Child Health Questionnaire Parent Form (CHQ-PF28) and an asthma-specific module (ASM). The primary HQOL variables were changes from baseline in the physical summary score (PSS) of CHQ-PF28, and in the disability domain of the ASM. Data for the HQOL domains were analyzed for Week 8, Week 12 and endpoint using ANOVA. RESULTS: Of 296 randomized subjects, 292 (99%) completed both HQOL questionnaires at baseline and endpoint. Mean HQOL scores were similar among treatment groups at baseline, and suggested impaired function and well-being compared with the general population. At endpoint, the mean PSS improved significantly with MF-DPI 100 mcg QD PM vs placebo (3.4 and -2.1, respectively; p = 0.002). The mean ASM-disability score also improved significantly with MF-DPI 100 mcg QDPM vs placebo (9.2 and 0.3, respectively; p<0.001). Mean PSS and ASM-disability improvements with MF-DPI 100 mcg BID (2.3 and 6.8, respectively) were similar to those observed with MF-DPI 100 mcg QD PM. CONCLUSIONS: Treatment with MF-DPI 100 mcg QD PM significantly improves quality of life in children with asthma. Funding: Schering-Plough 18 Onset of Improvements of Lung Function With Mometasone Furoate Dry Powder Inhaler (MF-DPI) in ICS-Naive Patients With Asthma B. Prenner1, R. Berkowitz2, G. W. Bensch3, B. N. Lutsky4; 1Allergy Associates Medical Group, San Diego, CA, 2Rx Research, Atlanta Allergy & Asthma Clinic, Marietta, GA, 3Allergy, Immunology, and Asthma Medical Group, Stockton, CA, 4Schering-Plough Research Institute, Kenilworth, NJ. RATIONALE: To evaluate the onset of improvements in lung function with mometasone furoate dry powder inhaler (MF-DPI) administered as 200 mcg once daily in the evening (QD PM). METHODS: Randomized, double-blind, placebo-controlled, efficacy and safety study of 12 weeks of treatment with MF-DPI 200 mcg QD PM in subjects ≥12 years of age with asthma previously maintained on shortacting beta-agonists (SABA) alone. Changes from baseline in forced expiratory volume in 1 second (FEV1) at Weeks 1, 2, 4, 8, 12 and endpoint (primary variable) were assessed. RESULTS: Mean improvement from baseline in FEV1 was 11.7% at Week 1 (first assessment) in the MF-DPI group, compared with a 4.3% increase in the placebo group (p<.01). FEV1 improved consistently with MF-DPI throughout the study period, and improvements with MF-DPI at each assessment were significantly greater than those with placebo (p<.01). A mean increase of 18.5% was observed at Week 12, compared with a 7.6% increase with placebo (p<.01). At endpoint, the mean increase from baseline in FEV1 was 16.8% on MF-DPI, compared with 6% on placebo (p<.01). Treatment with MF-DPI was well tolerated, with no unusual or unexpected adverse events reported. No clinically meaningful changes in laboratory parameters, vital signs, or physical examinations were noted in either treatment group. CONCLUSIONS: In patients previously maintained with SABA alone, MF-DPI 200 mcg QD PM improved lung function rapidly and provided consistent improvements with continued treatment. The results reported here support and extend those observed in other studies in which MF-DPI 200 mcg QD PM was evaluated. Funding: Schering-Plough Research Institute

Evaluating the health-related quality of life effects of cochlear implants: a prospective study of an adult cochlear implant program

This paper prospectively documents the health-related quality of life (HRQoL) and social participation benefits of adult patients receiving cochlear implants in Australia and New Zealand. Thirty-four consecutively implanted patients completed the Assessment of Quality of Life (AQoL) and Hearing Participation Scale (HPS) instruments before implantation, and at 3– and 6–month follow-ups. Implantation resulted in significant improvements in AQoL and HPS scores. The effect size was 1.09 for both measures. Those in the top socio-economic tertile obtained the greatest gains. The HRQoL and social participation benefits were slightly larger than those reported elsewhere. This may be because participants used more recent technology (Nucleus 24 rather than Nucleus 22) and received auditory and self-efficacy training as part of their rehabilitation. The results suggest that cochlear implants have a large beneficial effect. They show that social and HRQoL outcomes can be parsimoniously measured using the HPS and AQoL instruments.

Hypertension and current issues in compliance and patient outcomes.

Economic and human costs associated with untreated or inadequately controlled hypertension and its complications continue to be an issue in the United States despite the availability of numerous antihypertensive agents. Knowledge of hypertension, product profiles, tolerability concerns, convenience of dosing, health-related quality of life effects, and cost of therapy are some of the factors that may influence the compliance of patients to their medication regimens. Recent reports on patient noncompliance have focused on patient-provider relationships, psychosocial barriers, home blood pressure monitoring, and electronic monitoring systems to improve blood pressure control. The use of health-related quality of life assessment in antihypertensive studies and in routine clinical practice provides another opportunity to optimize a patient's regimen for short- and long-term hypertension control in a cost-effective manner.