scholarly journals Aripiprazole Lauroxil 2-Month Formulation With 1-Day Initiation for Acute Schizophrenia: ALPINE Exploratory Efficacy and Patient-Reported Outcomes

CNS Spectrums ◽  
2021 ◽  
Vol 26 (2) ◽  
pp. 171-172
Author(s):  
Henry Nasrallah ◽  
David Walling ◽  
Peter J. Weiden ◽  
Yangchun Du ◽  
Baiyun Yao ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Caregiver Burden ◽  
Repeated Measures ◽  
Patient Reported Outcomes ◽  
Short Form ◽  
Satisfaction Questionnaire ◽  
Efficacy Outcome ◽  
Patient Reported ◽  
Group Change

AbstractObjectiveThe randomized, controlled, phase 3b ALPINE study evaluated efficacy and safety of a 2-month formulation of aripiprazole lauroxil (AL) initiated with a 1-day regimen during hospitalization for an acute exacerbation of schizophrenia; paliperidone palmitate (PP) was included as an active control. The primary efficacy outcome, within-group change from baseline in PANSS total score at 4 weeks, was previously reported. Here we report additional exploratory PANSS subscale endpoints and patient-reported outcomes (PROs).MethodsAdults aged 18–65 years were enrolled as inpatients and randomized to AL 1064 mg q8wk or PP 156 mg q4wk and discharged after 2 weeks of study treatment if clinically stable. Patients were followed as outpatients through week 25. Exploratory efficacy endpoints were PANSS subscale (Positive, Negative, and General) and Clinical Global Impression-Severity (CGI-S) scores. The Burden Assessment Scale was administered to patients’ nonprofessional caregivers (family member or friend). Exploratory PROs (Quality of Life Enjoyment and Satisfaction Questionnaire Short Form [Q-LES-Q-SF] and Medication Satisfaction Questionnaire) were assessed during the outpatient period. Within-group changes in PANSS subscales and CGI-S scores from baseline through week 25 were analyzed for AL and PP using mixed models with repeated measures. PROs were summarized based on observed data.ResultsIn total, 200 patients were randomized (AL, n=99; PP, n=101); 99 (AL, n=56; PP, n=43) completed the 25-week study. PANSS Positive, Negative, and General subscale scores improved with AL treatment as measured by change from baseline to week 25 (least squares [LS] mean [95% CI]: Positive, −7.0 [−8.1, −6.0]; Negative, −3.7 [−4.7, −2.8]; General, −11.1 [−12.7, −9.5]), as did CGI-S scores (LS mean [95% CI] change at week 25: –1.2 [–1.4 –1.0]). Caregiver burden decreased over the treatment period, with the largest decline noted at week 9 for AL patients’ caregivers (mean change from baseline at week 9: −8.4; week 25: −8.9). Over weeks 5, 9, and 17, 70.8%−74.7% of AL-treated patients were somewhat or very satisfied with treatment. Mean Q-LES-Q-SF total scores were stable. With PP, PANSS subscale and CGI-S scores improved from baseline to study end (LS mean [95% CI] changes at week 25: Positive, −7.1 [−8.2, −5.9]; Negative, −3.5 [−4.6, −2.5]; General, −10.4 [−12.1, −8.6]; CGI-S, −1.2 [−1.5, −1.0]). Mean caregiver burden decreased (week 9: −8.8; week 25: −9.2). Most PP patients were satisfied or very satisfied with treatment (64.7%−69.3% at weeks 5, 9, and 17), and mean Q-LES-Q-SF total scores were stable.ConclusionIn ALPINE, patients who initiated AL or PP in the hospital and continued treatment during outpatient care experienced improvement in schizophrenia symptoms and reported satisfaction with medication, decreased caregiver burden, and stable quality of life.FundingAlkermes, Inc.

scholarly journals Impact of Medium Cut-Off Dialyzers on Patient-Reported Outcomes: COREXH Registry

2020 ◽  
pp. 1-9
Author(s):  
Juan Carlos Alarcon ◽  
Alfonso Bunch ◽  
Freddy Ardila ◽  
Eduardo Zuñiga ◽  
Jasmin I. Vesga ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Kidney Disease ◽  
Repeated Measures ◽  
Patient Reported Outcomes ◽  
Short Form ◽  
High Flux ◽  
Middle Molecules ◽  
Patient Reported ◽  
The Impact

<b><i>Introduction:</i></b> A new generation of hemodialysis (HD) membranes called medium cut-off (MCO) membranes possesses enhanced capacities for middle molecule clearance, which have been associated with adverse outcomes in this population. These improvements could potentially positively impact patient-reported outcomes (PROs). <b><i>Objective:</i></b> The objective of this study was to evaluate the impact of MCO membranes on PROs in a cohort of HD patients in Colombia. <b><i>Methods:</i></b> This was a prospective, multicenter, observational cohort study of 992 patients from 12 renal clinics in Colombia who were switched from high-flux HD to MCO therapy and observed for 12 months. Changes in Kidney Disease Quality of Life 36-Item Short Form Survey (KDQoL-SF36) domains, Dialysis Symptom Index (DSI), and restless legs syndrome (RLS) 12 months after switching to MCO membranes were compared with time on high-flux membranes. Repeated measures of ANOVA were used to evaluate changes in KDQoL-SF36 scores; severity scoring was used to assess DSI changes over time; Cochran’s Q test was used to evaluate changes in frequency of diagnostic criteria of RLS. <b><i>Results:</i></b> During 12 months of follow-up, 3 of 5 KDQoL-SF36 domains improved compared with baseline: symptoms (<i>p</i> &#x3c; 0.0001), effects of kidney disease (<i>p</i> &#x3c; 0.0001), and burden of kidney disease (<i>p</i> &#x3c; 0.001). The proportion of patients diagnosed with RLS significantly decreased from 22.1% at baseline to 10% at 12 months (<i>p</i> &#x3c; 0.0001). No significant differences in the number of symptoms (DSI, <i>p =</i> 0.1) were observed, although their severity decreased (<i>p</i> = 0.009). <b><i>Conclusions:</i></b> In conventional HD patients, the expanded clearance of large middle molecules with MCO-HD membranes was associated with higher health-related quality of life scores and a decrease in the prevalence of RLS.

scholarly journals Aripiprazole lauroxil 2-month formulation with 1-day initiation in patients hospitalized for an acute exacerbation of schizophrenia: exploratory efficacy and patient-reported outcomes in the randomized controlled ALPINE study

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Henry A. Nasrallah ◽  
Peter J. Weiden ◽  
David P. Walling ◽  
Yangchun Du ◽  
Baiyun Yao ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Acute Exacerbation ◽  
Caregiver Burden ◽  
Patient Reported Outcomes ◽  
Trial Registration ◽  
Symptom Improvement ◽  
Satisfaction Questionnaire ◽  
Randomized Controlled ◽  
Patient Reported

Abstract Background A randomized, controlled, phase 3b study (ALPINE) evaluated efficacy and safety of a 2-month formulation of aripiprazole lauroxil (AL) using a 1-day initiation regimen in patients hospitalized for an acute exacerbation of schizophrenia. Paliperidone palmitate (PP) was used as an active control. Exploratory endpoint assessments included severity of illness, positive and negative symptoms, quality of life, caregiver burden, and satisfaction with medication. Methods Adults were randomly assigned to AL 1064 mg q8wk or PP 156 mg q4wk as inpatients, discharged after 2 weeks, and followed through week 25. Exploratory efficacy measures included the 3 original PANSS subscales, Clinical Global Impression−Severity (CGI-S) subscale, and caregiver Burden Assessment Scale. Exploratory patient-reported outcomes (PROs) included the Quality of Life Enjoyment and Satisfaction Questionnaire Short Form (Q-LES-Q-SF) and the Medication Satisfaction Questionnaire. Within-group changes from baseline through week 25 were analyzed for AL and PP separately. PROs were summarized based on observed data. Results Of 200 patients randomized (AL, n = 99; PP, n = 101), 99 completed the study (AL, n = 56; PP, n = 43). For AL, PANSS subscale and CGI-S scores improved from baseline through week 25 (mean [SE] change from baseline at week 25: Positive, −7.5 [0.70]; Negative, −3.9 [0.46]; General, −11.8 [0.83]; CGI-S, −1.3 [0.12]). Caregiver burden also improved (mean [SD] changes from baseline at week 9: −8.4 [10.15]; week 25: −8.9 [12.36]). Most AL patients were somewhat/very satisfied with treatment at each timepoint (70.8%–74.7%); mean Q-LES-Q-SF total scores were stable in the outpatient period. For PP, results were similar: PANSS Positive, −7.3 (0.67); Negative, −3.6 (0.69); General, −10.9 (1.22); CGI-S, −1.4 (0.16); caregiver burden, week 9: −8.8 (11.89) and week 25: −9.2 (14.55); satisfaction with treatment, 64.7%–69.3%; and stable Q-LES-Q-SF scores. Conclusions ALPINE patients initiating the 2-month AL formulation using the 1-day initiation regimen as inpatients and continuing outpatient care experienced schizophrenia symptom improvement, sustained patient satisfaction with medication, stable quality of life, and reduced caregiver burden. A similar benefit pattern was observed for PP. These results support the feasibility of starting either long-acting injectable in the hospital and transitioning to outpatient treatment. Trial registration ClinicalTrials.gov identifier: NCT03345979 [trial registration date: 15/11/2017].

Compliance of subjects using electronic patient-reported outcomes (ePRO) in multinational prostate trials.

2014 ◽  
Vol 32 (4_suppl) ◽  
pp. 232-232
Author(s):  
Susan M. Dallabrida
Keyword(s):  
Quality Of Life ◽  
Prostate Cancer ◽  
Clinical Trials ◽  
Patient Reported Outcomes ◽  
Short Form ◽  
Quality Data ◽  
Data Set ◽  
Patient Reported ◽  
Clinic Visits

232 Background: Patient Reported Outcomes (PRO) and electronic PRO (ePRO) are increasingly becoming an important aspect of cancer clinical trials and patient care, especially with regard to measuring drug efficacy, patient quality of life and drug safety. Subject compliance with completion of PRO/ePRO assessments is an important component for obtaining accurate and high-quality data when conducting clinical trials. It has been hypothesized that patient health status, length of time in a trial and country of origin, may affect compliance. Methods: To address this hypothesis, an operational analysis was conducted to assess oncology subject completion compliance of PRO reports using an electronic tablet to determine its suitability and performance in use. Toward this objective, the compliance of prostate cancer patients in completing three electronic questionnaires that were administered at clinic visits was evaluated. Subjects were asked to complete the Brief Pain Inventory – Short Form (BPI-SF) at every clinic visit. At some clinic visits, subjects were asked to additionally complete the Functional Assessment of Cancer Therapy – Prostate (FACT-P) and the Euro Quality of Life 5 Dimensions (EQ-5D). Questionnaires were completed electronically on the tablet. Percent completion was calculated as the number of questionnaires completed divided by the number of questionnaires expected, based on attended clinic visits compiled for this review and the administration schedule for the questionnaires. Results: This review draws on the experience of over 1,000 subjects from 21 countries, and describes the individual and overall compliance with the expected questionnaire completion, the variance between subsequent visits, and compliance by country. Conclusions: The collection of ePRO using a clinic-based tablet yielded a highly complete data set in prostate cancer subjects demonstrating that this is an effective and feasible approach for recording symptoms and quality of life assessments.

Quality of Life and Disability in Patients with Treatment-Failure Gout

2009 ◽  
Vol 36 (5) ◽  
pp. 1041-1048 ◽  
Author(s):  
MICHAEL A. BECKER ◽  
H. RALPH SCHUMACHER ◽  
KATY L. BENJAMIN ◽  
PETER GOREVIC ◽  
MARIA GREENWALD ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Treatment Failure ◽  
Patient Reported Outcomes ◽  
Short Form ◽  
Clinical Status ◽  
Damage Index ◽  
Sf 36 ◽  
Patient Reported ◽  
Gout Flares

Objective.The relationship between self-reported quality of life and disability and disease severity was evaluated in subjects with treatment-failure gout (n = 110) in a prospective, 52-week, observational study.Methods.Subjects had symptomatic crystal-proven gout of at least 2 years’ duration and intolerance or refractoriness to conventional urate-lowering therapy. Serum uric acid (sUA) concentration, swollen and tender joint counts, frequency and severity of gout flares, tophus assessments, comorbidities, and patient-reported outcomes data [Medical Outcomes Study Short Form-36 (SF-36), Health Assessment Questionnaire-Damage Index] were collected. Analyses included correlations of patient-reported outcomes with clinical variables and changes in clinical status.Results.Mean age of study subjects was 59 years. Mean scores on SF-36 physical functioning subscales were 34.2–46.8, analogous to persons aged ≥ 75 years in the general population. Subjects with more severe gout at baseline had worse health-related quality of life (HRQOL) in all areas (p < 0.02 for all measures), compared to patients with mild-moderate disease. Number of flares reported in past year, number of tender joints, swollen joints, and tophi correlated significantly with some or all HRQOL and disability measures. sUA was not significantly correlated with any HRQOL or disability measure. Subjects with comorbidities experienced worse physical, but not mental, functioning.Conclusion.Severe gout is associated with poor HRQOL and disability, especially for patients who experience more gout flares and have a greater number of involved joints. Subject perceptions of gout-related functioning and pain severity appear to be highly sensitive indicators of HRQOL and disability.

scholarly journals Systematic Review of Patient-Reported Outcomes following Surgical Treatment of Lymphedema

Cancers ◽  
2020 ◽  
Vol 12 (3) ◽  
pp. 565 ◽  
Author(s):  
Michelle Coriddi ◽  
Joseph Dayan ◽  
Nikhil Sobti ◽  
David Nash ◽  
Johanna Goldberg ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Systematic Review ◽  
Surgical Treatment ◽  
Patient Reported Outcomes ◽  
Short Form ◽  
Future Research ◽  
Secondary Lymphedema ◽  
Patient Reported ◽  
Life Impact

Introduction: Analysis of quality of life (QOL) outcomes is an important aspect of lymphedema treatment since this disease can substantially impact QOL in affected individuals. There are a growing number of studies reporting patient-reported outcomes (PROMs) for patients with lymphedema. The purpose of this study was to conduct a systematic review of outcomes and utilization of PROMs following surgical treatment of lymphedema. Methods: A literature search of four databases was performed up to and including March, 2019. Studies included reported on QOL outcomes after physiologic procedures, defined as either lymphovenous bypass (LVB) or vascularized lymph node transplant (VLNT), to treat upper and/or lower extremity primary or secondary lymphedema. Results: In total, 850 studies were screened—of which, 32 studies were included in this review. Lymphovenous bypass was the surgical intervention in 16 studies, VLNT in 11 studies, and both in 5 studies. Of the 32 total studies, 16 used validated survey tools. The most commonly used PROM was the lymph quality of life measure for limb lymphedema (LYMQOL) (12 studies). In the remaining four studies, the upper limb lymphedema 27 scale (ULL27), the short form 36 questionnaire (SF-36), the lymphedema functioning, disability and health questionnaire (Lymph-ICF), and lymphedema life impact scale (LLIS) were each used once. QOL improvement following surgical treatment was noted in all studies. Conclusions: Physiologic surgical treatment of lymphedema results in improved QOL outcomes in most patients. The use of validated PROM tools is increasing but there is no current consensus on use. Future research to evaluate the psychometric properties of PROMs in lymphedema is needed to guide the development and use of lymphedema-specific tools.

scholarly journals How Comprehensive and Efficient Are Patient-Reported Outcomes for Rotator Cuff Tears?

2017 ◽  
Vol 5 (3) ◽  
pp. 232596711769322 ◽  
Author(s):  
Eric C. Makhni ◽  
Jason T. Hamamoto ◽  
John D. Higgins ◽  
Taylor Patterson ◽  
Justin W. Griffin ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Life Satisfaction ◽  
Rotator Cuff ◽  
Patient Reported Outcomes ◽  
Short Form ◽  
Rotator Cuff Tears ◽  
Sf 36 ◽  
Patient Reported ◽  
Functional Components

Background: Increasing emphasis is placed on patient-reported outcomes (PROs) after common orthopaedic procedures as a measure of quality. When considering PRO utilization in patients with rotator cuff tears, several different PROs exist with varying levels of accuracy and utilization. Hypothesis/Purpose: Understanding which disease-specific PRO may be most efficiently administered in patients after rotator cuff repair may assist in promoting increased patient and physician adoption of these useful scores. Using a novel assessment criterion, this study assessed all commonly used rotator cuff PROs. We hypothesize that surveys with fewer numbers of questions may remain comparable (with regard to comprehensiveness) to longer surveys. Study Design: Systematic review. Methods: Commonly utilized rotator cuff PROs were analyzed with regard to number of survey components, comprehensiveness, and efficiency. Comprehensiveness (maximum score, 11) was scored as the total number of pain (at rest/baseline, night/sleep, activities of daily living [ADLs], sport, and work) and functional (strength, motion/stiffness, and ability to perform ADLs, sport, and work) metrics included, along with inclusion of quality of life/satisfaction metrics. Efficiency was calculated as comprehensiveness divided by the number of survey components. Results: Sixteen different PROs were studied. Number of components ranged from 5 (University of California at Los Angeles score [UCLA]) to 36 (Short Form–36 [SF-36], Japanese Orthopaedic Association score [JOA]). The Quality of Life Outcome Measure for Rotator Cuff Disease (RC-QoL) included all 5 pain components, while 7 PROs contained all 5 functional components. Ten PROs included a quality of life/satisfaction component. The most comprehensive scores were the RC-QoL (score, 11) and Penn (score, 10), and the least comprehensive score was the Marx (score, 3). The most efficient PROs were the UCLA, the Quick Disabilities of the Arm, Shoulder, and Hand score (QuickDASH), and Constant scores. The least efficient scores were the JOA and SF-36 scores. Conclusion: Many commonly utilized PROs for rotator cuff tears are lacking in comprehensiveness and efficiency. Continued critical assessment of PRO quality may help practitioners identify the most comprehensive and efficient PRO to incorporate into daily clinical practice.

FC22-02 - Effect of quetiapine on functioning and quality of life in bipolar depression

2011 ◽  
Vol 26 (S2) ◽  
pp. 1935-1935 ◽  
Author(s):  
U. Gustafsson ◽  
L. Fajutrao
Keyword(s):  
Quality Of Life ◽  
Social Life ◽  
Patient Reported Outcomes ◽  
Bipolar Depression ◽  
Short Form ◽  
Depression Symptoms ◽  
Productivity Losses ◽  
Patient Reported ◽  
Overall Functioning

IntroductionDepression symptoms in bipolar disorder have debilitating effects on functioning and quality of life (QoL).ObjectivesTo assess effects of 8 weeks of quetiapine monotherapy on functioning and QoL in patients with bipolar depression (BPD).AimsTo evaluate functioning and QoL using patient-reported outcomes.MethodsData from 4 trials (BOLDER I and II; EMBOLDEN I and II) of quetiapine (300 and 600 mg/day) in BPD were combined (n = 2593). The Sheehan Disability Scale (SDS) measured functioning (BOLDER II; EMBOLDEN I and II) and the QoL Enjoyment and Satisfaction Questionnaire (Q-LES-Q)-Short Form measured QoL (BOLDER I and II; EMBOLDEN II).ResultsQuetiapine improved overall functioning (mean change [SE] in SDS total score: -7.23 [0.49], -7.49 [0.49], with quetiapine 300 mg/day and quetiapine 600 mg/day, respectively vs placebo (-5.91 [0.54]); P < 0.01 for both). Both doses improved functioning in SDS domains of work/school, social life, and family life/home responsibilities vs placebo (P < 0.05). Quetiapine 600 mg/day reduced days missed from work/school and productivity losses vs placebo (P < 0.01). QoL was improved with both quetiapine doses vs placebo (P < 0.001; least squares mean changes (SE) in Q-LES-Q total score from baseline to Day 57: 9.69 (0.51), 9.95 (0.50), and 6.81 (0.54) with quetiapine 300 mg/day, quetiapine 600 mg/day, and placebo, respectively). Tolerability was consistent with the known safety profile of quetiapine.ConclusionsQuetiapine treatment (300 and 600 mg/day) for 8 weeks significantly improved functioning and QoL vs placebo in patients with BPD.Supported by funding from AstraZeneca Pharmaceuticals LP.

Association of Physical Morbidity and Health-Related Quality of Life in a Representative Sample of Older German People

2018 ◽  
Vol 25 (4) ◽  
pp. 140-151
Author(s):  
Markus A. Wirtz ◽  
Matthias Morfeld ◽  
Elmar Brähler ◽  
Andreas Hinz ◽  
Heide Glaesmer
Keyword(s):  
Quality Of Life ◽  
Representative Sample ◽  
Short Form ◽  
Physical Symptoms ◽  
German Population ◽  
Health Related Quality ◽  
Patient Reported ◽  
Related Quality ◽  
Health Related

Abstract. The association between health-related quality of life (HRQoL; Short-Form Health Survey-12; SF-12) and patient-reported morbidity-related symptoms measured by the Patient Health Questionnaire-15 (PHQ-15) is analyzed in a representative sample of older people in the general German population. Data from 1,659 people aged 60 to 85 years were obtained. Latent class analysis identified six classes of patients, which optimally categorize clusters of physical symptoms the participants reported: musculoskeletal impairments (39.8%), healthy (25.7%), musculoskeletal and respiratory/cardiac impairments (12.8%), musculoskeletal and respiratory impairments, along with bowel and digestion problems (12.9%), general impairments (4.9%), and general impairments with no bowel and digestion problems (4.8%). The participants’ SF-12 Physical Health Scores (η2 = .39) and their Mental Health Scores (η2 = .28) are highly associated with these latent classes. These associations remain virtually identical after controlling for age. The results provide evidence that profiles of patient-reported physical impairments correspond strongly with reduced HRQoL independently from aging processes.

P048 QUALITY OF LIFE AND OTHER PATIENT REPORTED OUTCOMES IN PATIENTS WITH POUCHITIS

2020 ◽  
Vol 158 (3) ◽  
pp. S107
Author(s):  
Edward Barnes ◽  
Millie Long ◽  
Laura Raffals ◽  
Xian Zhang ◽  
Anuj Vyas ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Patient Reported Outcomes ◽  
Patient Reported
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