Abstract 121: Association between Diabetes Mellitus and Angina Assessed Using a Mobile Technology Platform in Patients Undergoing Percutaneous Coronary Intervention

Background: Empiric data on whether patients with diabetes suffer a differing burden of angina are conflicting. Population studies have found similar or less angina in patients with diabetes, whereas studies in patients with ACS or MI have found more angina. Few studies have incorporated coronary angiographic findings. Methods: We examined all 203 patients undergoing non-emergent PCI at our institution who completed a baseline patient-reported outcomes survey using a novel mobile technology platform integrated with the EMR between January-September, 2014. The primary exposure was diabetes status. The primary outcome was angina burden as measured by the Seattle Angina Questionnaire (SAQ) Short Form summary score (lower scores indicate worse angina). We additionally examined SAQ sub-scores for angina severity, physical limitation, and quality of life. Additional covariates selected a priori included age, race, gender, smoking, hypertension, dyslipidemia, history of MI, PCI, or heart failure, CAD presentation (asymptomatic, stable angina, UA, or NSTEMI), and number of major epicardial vessels with ≥50% stenosis on angiography. Analyses were performed using multivariable linear regression. Results: In our study, 79 patients (39%) had diabetes. Mean SAQ summary score for patients with diabetes was 55.2 (SD 28.3) versus 64.3 (SD 25.4) among patients without diabetes. In the unadjusted model, diabetes was associated with a significantly lower SAQ summary score (B: -9.1; 95% CI: -16.83, -1.38), which persisted in the fully adjusted model (B: -7.36; 95% CI: -14.19, -0.52). This effect was driven by sub-scores for angina severity (B: -7.45; 95% CI: -14.67, -0.24) and physical limitation (B: -10.88, 95% CI: -19.03, -2.72), with no association between diabetes and quality of life. Conclusion: Patients undergoing PCI with diabetes had worse burden of angina relative to those without diabetes, despite controlling for historical and angiography findings. This effect was driven by angina severity and physical limitation. Our results can guide future clinical decision-making regarding angina symptoms in this high-risk diabetic cohort. Furthermore, our study demonstrates that using a mobile technology platform is feasible for routine assessment of angina in patients with and without diabetes undergoing PCI.

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Kidney Disease Quality of Life 36-Item Short Form Survey (KDQOL-36) Normative Values for the United States Dialysis Population and New Single Summary Score

Journal of the American Society of Nephrology ◽

10.1681/asn.2018100994 ◽

2019 ◽

Vol 30 (4) ◽

pp. 654-663 ◽

Cited By ~ 16

Author(s):

John D. Peipert ◽

Devika Nair ◽

Kristi Klicko ◽

Dorian R. Schatell ◽

Ron D. Hays

Keyword(s):

Quality Of Life ◽

United States ◽

Kidney Disease ◽

Short Form ◽

The United States ◽

Summary Score ◽

Model Fit ◽

Normative Values ◽

Patient Reported

BackgroundThe Kidney Disease Quality of Life 36-item short form survey (KDQOL-36) is a widely used, patient-reported outcome measure for patients on dialysis. Efforts to aid interpretation are needed.MethodsWe used a sample of 58,851 dialysis patients participating in the Medical Education Institute (MEI) KDQOL Complete program, and 443,947 patients from the US Renal Data System (USRDS) to develop the KDQOL-36 Summary Score (KSS) for the kidney-targeted KDQOL-36 scales (Burdens of Kidney Disease [BKD], Symptoms and Problems of Kidney Disease [SPKD], and Effects of Kidney Disease [EKD]). We also used the MEI and USRDS data to calculate normative values for the Short Form-12 Health Survey’s Physical Component Summary (PCS) and Mental Component Summary (MCS), and the KDQOL-36’s BKD, SPKD, and EKD scales for the United States dialysis population. We used confirmatory factor analysis (CFA) models for KDQOL-36 kidney-targeted items, evaluated model fit with the comparative fit index (CFI; >0.95 indicates good fit) and root-mean-squared error of approximation (RMSEA; <0.06 indicates good fit), and estimated norms by matching the joint distribution of patient characteristics in the MEI sample to those of the USRDS sample.ResultsA bifactor CFA model fit the data well (RMSEA=0.046, CFI=0.990), supporting the KSS (α=0.91). Mean dialysis normative scores were PCS=37.8 and MCS=50.9 (scored on a T-score metric); and KSS=73.0, BKD=52.8, SPKD=79.0, and EKD=74.1 (0–100 possible scores).ConclusionsThe KSS is a reliable summary of the KDQOL-36. The United States KDQOL-36 normative facilitate interpretation and incorporation of patient-related outcome measures into kidney disease care.

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

European Journal of Health Psychology ◽

10.1027/2512-8442/a000019 ◽

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.

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EVALUATION OF QUALITY OF LIFE IN BRACHIAL PLEXUS INJURY PATIENTS AFTER RECONSTRUCTIVE SURGERY

Hand Surgery ◽

10.1142/s0218810406003279 ◽

2006 ◽

Vol 11 (03) ◽

pp. 103-107 ◽

Cited By ~ 27

Author(s):

Izuru Kitajima ◽

Kazureru Doi ◽

Yasunori Hattori ◽

Semih Takka ◽

Emmanuel Estrella

Keyword(s):

Quality Of Life ◽

Brachial Plexus ◽

Upper Extremity ◽

Brachial Plexus Injury ◽

Short Form ◽

Bodily Pain ◽

Summary Score ◽

Joint Function ◽

Sf 36

To evaluate the subjective satisfaction of brachial plexus injury (BPI) patients after surgery based on the medical outcomes study 36-item short form health survey (SF-36) and to correlate their SF-36 scores with upper extremity functions. Four items were assessed statistically for 30 patients: SF-36 scores after BPI surgery were compared with Japanese standard scores; the correlation between SF-36 scores and objective joint functions; difference in SF-36 scores between each type of BPI; and influence of each joint function on the SF-36 scores. The SF-36 subscale: PF — physical functioning, RP — role-physical, BP — bodily pain, and the summary score PCS — physical component summary, were significantly inferior to the Japanese standard scores. SF-36 is more sensitive to shoulder joint function than to elbow and finger joint functions. Little correlation was found between SF-36 scores and objective evaluations of joint functions. Greater effort is needed to improve the quality of life (QOL) of BPI patients. This study showed that SF-36 is not sensitive enough to evaluate regional conditions. A region- or site-specific questionnaire is required to evaluate upper extremity surgery.

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Determinants of Cancer-specific Quality of Life in Veteran Lung Cancer Survivors Eligible for Long-Term Cure

10.1101/518910 ◽

2019 ◽

Author(s):

Duc Ha ◽

Andrew L. Ries ◽

Jeffrey J. Swigris

Keyword(s):

Quality Of Life ◽

Lung Cancer ◽

Cancer Survivors ◽

Summary Score ◽

European Organization ◽

Specific Patient ◽

Patient Reported ◽

Sleep Difficulties

AbstractRationale/ObjectiveQuality of life (QoL) is an important issue in lung cancer survivors. We aimed to identify determinants of QoL in lung cancer survivors eligible for long-term cure.MethodsWe performed an exploratory analysis of a cross-sectional study of consecutive lung cancer survivors who completed curative-intent treatment ≥1 month previously. Variables tested included demographic, clinical, physiologic, and symptom-specific patient-reported outcome measures. We defined the primary outcome as a previously-validated cancer-specific QoL measure – the European Organization for Research and Treatment of Cancer QoL Questionnaire Core 30 (C30) summary score. We also verified our findings with the C30 global health status/QoL subscale and a summated score of lung cancer-specific QoL from the EORTC-Lung Cancer Module 13.ResultsIn 75 enrolled participants, measures of fatigue, depression, sleep difficulties, and dyspnea were statistically significant determinants of the C30 summary score in multivariable linear regression analyses. Together, these four symptoms accounted for approximately 85% of the variance in cancer-specific QoL (p<0.001). When we verified our findings with global QoL and lung cancer-specific QoL, fatigue and dyspnea were consistent determinants of QoL.ConclusionsWe found four symptoms – dyspnea, fatigue, depression, and sleep difficulties – that are important determinants of and together accounted for almost all of the variance in cancer-specific QoL in lung cancer survivors eligible for long-term cure. These findings have implications to reduce symptom burden and improve function and QoL in these patients.

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

Blood Purification ◽

10.1159/000508803 ◽

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

Introduction: 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). Objective: The objective of this study was to evaluate the impact of MCO membranes on PROs in a cohort of HD patients in Colombia. Methods: 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. Results: During 12 months of follow-up, 3 of 5 KDQoL-SF36 domains improved compared with baseline: symptoms (p < 0.0001), effects of kidney disease (p < 0.0001), and burden of kidney disease (p < 0.001). The proportion of patients diagnosed with RLS significantly decreased from 22.1% at baseline to 10% at 12 months (p < 0.0001). No significant differences in the number of symptoms (DSI, p = 0.1) were observed, although their severity decreased (p = 0.009). Conclusions: 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.

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Validity of the PROMIS-29 in a large Australian cohort of patients with systemic sclerosis

Journal of Scleroderma and Related Disorders ◽

10.5301/jsrd.5000243 ◽

2017 ◽

Vol 2 (3) ◽

pp. 188-195 ◽

Cited By ~ 3

Author(s):

Kathleen Morrisroe ◽

Wendy Stevens ◽

Molla Huq ◽

Joanne Sahhar ◽

Gene-Siew Ngian ◽

...

Keyword(s):

Quality Of Life ◽

Systemic Sclerosis ◽

Construct Validity ◽

Short Form ◽

Good Alternative ◽

Measurement Information ◽

Internal Reliability ◽

Sf 36 ◽

Patient Reported

Background We aimed to evaluate the construct validity of the Patient-Reported Outcomes Measurement Information System 29 (PROMIS-29) in Australian systemic sclerosis (SSc) patients. Methods SSc patients, identified through the Australian Scleroderma Cohort Study database, completed two quality-of-life instruments concurrently, the PROMIS-29 and the Medical Outcomes Study 36-Item Short Form Health Survey (SF-36). The construct validity of the PROMIS-29 was assessed by the correlations between the PROMIS-29 and the SF-36 and Health Assessment Questionnaire Disability Index (HAQ-DI). Cronbach's alpha was used to test the internal reliability of all instruments in Australian SSc patients and non-parametric correlation, including Spearman's correlation, was used to test the construct validity of PROMIS-29 against the SF-36 and HAQ-DI. Results A total of 477 completed questionnaires were returned, equating to a response rate of 59.6%. The mean (±SD) age of respondents at the time of the survey was 64.1 (±11.1) years. They were predominantly female (87.4%), with limited disease subtype (lcSSc) (77.8%) and long disease duration from onset of first non-Raynaud's phenomenon symptom at the time of survey (10.9 ± 11.1 years). For the correlation analysis between the PROMIS-29 and the legacy instruments, all Spearman correlation coefficients were in the logical direction and highly significant suggesting that the PROMIS-29 is a good alternative to other validated measures of disease burden. Conclusions Our study indicates that the PROMIS-29 questionnaire is a valid instrument for measuring health-related quality of life in Australian females with lcSSc of long duration.

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Vision-Related Quality of Life and Emotional Impact in Children with Strabismus: A Prospective Study

Journal of International Medical Research ◽

10.1177/147323000903700415 ◽

2009 ◽

Vol 37 (4) ◽

pp. 1108-1114 ◽

Cited By ~ 11

Author(s):

Y Chai ◽

Y Shao ◽

S Lin ◽

K-Y Xiong ◽

W-S Chen ◽

...

Keyword(s):

Quality Of Life ◽

Short Form ◽

Depression Scale ◽

Summary Score ◽

Anxiety And Depression ◽

Control Group ◽

Emotional Impact ◽

Surgical Interventions ◽

Related Quality

The potential impact of the surgical correction of strabismus on vision-related quality of life (VRQOL) and the symptoms of anxiety and depression in children with strabismus remain unclear. The present study included 60 children with strabismus: 30 with heterophoria and 30 with heterotropia. A healthy age-and gender-matched control group ( n = 60) was also recruited. The psychological instruments that were used were the short-form 25-item National Eye Institute Visual Functioning Questionnaire (NEI-VFQ-25) and the Hospital Anxiety and Depression Scale (HADS). The results demonstrated that eight of the 12 NEI-VFQ-25 subscales were significantly impaired in children with strabismus compared with matched controls. Compared with pre-operative values, significant improvements were noted after surgery in the NEI-VFQ-25 summary score, and the anxiety and depression scores. This study demonstrated that the NEI-VFQ-25 instrument can be used in strabismus children and that surgical interventions can improve VRQOL, anxiety and depression in strabismus patients.

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Quality of Life in Automated and Continuous Ambulatory Peritoneal Dialysis

Peritoneal Dialysis International ◽

10.3747/pdi.2010.00063 ◽

2011 ◽

Vol 31 (2) ◽

pp. 138-147 ◽

Cited By ~ 17

Author(s):

Wieneke M. Michels ◽

Sandra Van Dijk ◽

Marion Verduijn ◽

Saskia Le Cessie ◽

Elisabeth W. Boeschoten ◽

...

Keyword(s):

Quality Of Life ◽

Peritoneal Dialysis ◽

Kidney Disease ◽

Continuous Ambulatory Peritoneal Dialysis ◽

Short Form ◽

Summary Score ◽

Medical Outcomes ◽

Sf 36 ◽

Over Time

ObjectiveDespite a lack of strong evidence, automated peritoneal dialysis (APD) is often prescribed on account of an expected better quality of life (QoL) than that expected with continuous ambulatory peritoneal dialysis (CAPD). Our aim was to analyze differences in QoL in patients starting dialysis on APD or on CAPD with a follow-up of 3 years.MethodsAdult patients in the prospective NECOSAD cohort who started dialysis on APD or CAPD were included 3 months after the start of dialysis. The Medical Outcomes Survey Short Form 36 [SF-36 (Medical Outcomes Trust and QualityMetric, Lincoln, RI, USA)] and Kidney Disease and Quality of Life Short Form [KDQOL-SF (KDQOL Working Group, Santa Monica, CA, USA)] questionnaires were used to measure QoL. Differences in QoL over time were calculated using linear mixed models. Patients were followed until transplantation, death, or a first switch to any other dialysis modality.ResultsThe clinical and social characteristics of the 64 APD and 486 CAPD patients were slightly different at baseline. In the crude analysis, the pattern of the mental summary score differed between the modalities ( p = 0.03, adjusted p = 0.06), because of a different pattern for role function emotional ( p = 0.03, adjusted p = 0.05). The pattern of the physical summary score was not different between the groups. Scores on dialysis staff encouragement had a different pattern over time ( p = 0.01), because of an in-equality in scores 3 months after the start of dialysis, which disappeared after 18 months on dialysis. Over time, patients on APD scored higher on sexual function. After adjustment for age, sex, glomerular filtration rate, comorbidity, and primary kidney disease, that difference disappeared. This study showed no major differences in QoL on the KDQOL-SF and the SF-36 between the two modalities.

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Comparison of Quality of Life in Clinically Isolated Syndrome Patients Who Convert and Do Not Convert to Clinically Definite Multiple Sclerosis

International Journal of MS Care ◽

10.7224/1537-2073-11.1.17 ◽

2009 ◽

Vol 11 (1) ◽

pp. 17-24 ◽

Cited By ~ 2

Author(s):

Deborah M. Miller ◽

Craig Kollman ◽

Andrea Kalajian ◽

Paul W. O'Connor ◽

R. Philip Kinkel

Keyword(s):

Quality Of Life ◽

Multiple Sclerosis ◽

Short Form ◽

Clinically Isolated Syndrome ◽

Sf 36 ◽

Initial Symptoms ◽

Patient Reported ◽

Definite Multiple Sclerosis ◽

Clinically Definite Multiple Sclerosis

A secondary analysis was undertaken to compare patient-reported outcomes (PROs) of individuals who did and did not convert to clinically definite multiple sclerosis (CDMS) approximately 5 years after their first clinically isolated syndrome (CIS). Patients included in the analysis were participating in a long-term extension (called CHAMPIONS) of the Controlled High-Risk Avonex® Multiple Sclerosis Prevention Study (CHAMPS). The Multiple Sclerosis Quality of Life Inventory (MSQLI), a battery including the Short Form Health Status Survey (SF-36) and nine disease-specific scales, was administered to participants 5 years after their initial symptoms suggestive of MS (randomization into the CHAMPS study). Of 203 CHAMPIONS patients, 188 (93%) completed the MSQLI at enrollment into this extension study. Of these, 79 (42%) converted to CDMS. Statistically significant differences (P < .001) between those who did and did not convert to CDMS were found for 4 of the 11 MSQLI scales: the SF-36 Physical Component Summary, the Modified Fatigue Impact Scale, the Pain Effects Scale, and the Bladder Control Scale. Trends not meeting our criteria for statistical significance (P > .001 but < .01) were observed for the SF-36 Mental Component Summary, the Perceived Deficits Questionnaire, and the Mental Health Inventory. SF-36 scores for patients not converting to CDMS over 5 years were similar to those reported for age-matched normal controls. No other demographic or disease-related factors were associated with these PROs. When stratified by Expanded Disability Status Scale score, patients who converted to CDMS demonstrated statistically significant differences on the same four scales defined above that differentiated those who did and did not convert to CDMS. These data show that individuals who have CDMS but limited disability demonstrate clear evidence of diminished health-related quality of life.

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

Journal of Clinical Oncology ◽

10.1200/jco.2014.32.4_suppl.232 ◽

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.

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