Baseline Quality Of Life Measures Research Articles

Predictors of quality of life in patients within the first year of commencing haemodialysis based on baseline data from the PIVOTAL trial and associations with the study outcomes.

Impaired quality of life is common in patients with end-stage kidney disease. We report the baseline quality of life measures in participants from the PIVOTAL randomized controlled trial and the potential relationship with the primary outcome (all-cause mortality, myocardial infarction, stroke, and heart failure hospitalisation), and associations with key baseline characteristics. This was a post hoc analysis of 2141 patients enrolled in the PIVOTAL trial. Quality of life was measured using EQ5D index, Visual Analogue Scale, and the KD-QoL [Physical Component Score and Mental Component Score]. Mean baseline EQ5D index and visual analogue scale scores were 0.68 and 60.7 and 33.7 (Physical Component Score) and 46.0 (Mental Component Score), respectively. Female sex, higher Body Mass Index, diabetes mellitus, history of myocardial infarction, stroke or heart failure were associated with significantly worse EQ5D index and visual analogue scale. Higher C-reactive protein levels and lower transferrin saturation were associated with worse quality of life. Haemoglobin was not an independent predictor of quality of life. A lower transferrin saturation was an independent predictor of worse physical component score. A higher C-reactive protein level was associated with most aspects of worse quality of life. Impaired functional status was associated with mortality. Quality of life was impaired in patients starting haemodialysis. A higher C-reactive protein level level was a consistent independent predictor of the majority of worse quality of life. Transferrin saturation ≤ 20% was associated with worse physical component score of quality of life. Baseline quality of life was predictive of all-cause mortality and the primary outcome measure. 2013-002267-25.

The Imperative of Assessing Quality of Life in Patients Presenting to a Pancreaticobiliary Surgery Clinic.

The objective of this study was to determine baseline health-related quality of life (QoL) in patients with pancreatic adenocarcinoma, periampullary cancers, and benign pancreaticobiliary (PB) conditions at the time of the first visit to a PB surgery clinic, and to explore the relationship between QoL, demographics, clinical parameters, complications, and survival. Few studies have examined baseline QoL measures, the impact of comorbidities, age, sex, and smoking on subsequent postoperative complications and survival in patients with pancreatic adenocarcinoma, related PB cancers, and with benign PB conditions. Data were collected from scheduled patients at a PB surgery clinic between 2013 and 2018. The Brief Pain Inventory, Fact-Hepatobiliary Scale, and Facit-Fatigue questionnaires were administered. QoL parameters were compared between PB cancer patients and those with benign disease. A total of 462 individuals with PB cancers and benign diseases exhibited baseline physical well-being, functional well-being, fatigue, and overall QoL at or below the 75th percentile of wellness at the time of the first office visit. Younger age, smoking, and mental health comorbidities contributed significantly to decreased QoL. PA patients were 7 times more likely to die in the follow-up period than the benign disease group. Black patients had higher pain scores and were 3 times more likely to have a postsurgery complication. Sex differences were identified regarding fatigue, pain, and overall QoL. This large cohort of PB cancer and benign disease patients exhibited significantly impaired baseline QoL. GI problems, weight loss, smoking, cardiovascular, pulmonary disease, and history of anxiety and depression contributed significantly to reduced QoL. The study sheds a cautionary light on the burden of PB disease at the time of surgical evaluation and its relationship to diminished QoL.

What drives productivity loss in chronic rhinosinusitis? A SNOT-22 subdomain analysis.

Previous studies have shown declines in productivity due to chronic rhinosinusitis (CRS) are correlated with disease-specific quality-of-life (QOL) measures. However, it is unclear which symptom domains contribute primarily to productivity loss. This investigation sought to assess the association between CRS-specific QOL subdomain impairment and productivity loss. Prospective, multi-institutional, observational cohort study. There were 198 patients with refractory CRS enrolled between August 2012 and June 2015. Baseline QOL measures were obtained across five subdomains of the 22-item SinoNasal Outcome Test (SNOT-22). Lost productivity time was determined from patient-reported measures of annual absenteeism, presenteeism, and lost leisure time, and then monetized using annual daily wage rates from the 2012 US National Census and 2013 Department of Labor statistics. Productivity losses correlated with impairments in both SNOT-22 psychological dysfunction (Spearman correlation coefficient [Rs] = 0.428, P < .001), and sleep dysfunction domain scores (Rs = 0.355, P < .001). Higher SNOT-22 total scores also significantly correlated with increased monetized productivity losses (Rs = 0.366, P < .001). The mean annual productivity cost was $11,820/patient, whereas patients with comorbid immunodeficiency ($23,285/patient), tobacco use ($23,195/patient), and steroid dependency ($18,910/patient) reported higher than average annual productivity costs. Multivariate linear regression found maximum annual productivity costs in adjusted psychological ($13,300/patient, P < .001) and sleep dysfunction ($9,275/patient, P < .001) domains. Impairments in sleep and psychological SNOT-22 domains correlate with productivity losses. Patients with comorbid immunodeficiency, smoking, and steroid dependency had higher than average productivity losses. Targeted management of psychological and sleep dysfunction in combination with standard symptom control may improve patient-centered care and reduce the annual economic burden of CRS. 2c. Laryngoscope, 128:23-30, 2018.

Acupuncture-Related Quality of Life Changes Using PROMIS Computer Adaptive Tests in a Pragmatic Trial with Oncology and General Integrative Medicine Patients: The Role of Baseline Acupuncture Expectations.

Acupuncture has been shown to alleviate symptoms and increase general well-being in different medical patient samples. A major challenge in acupuncture clinical research is the availability of comparable and standardized patient-reported outcome measurement (PRO) tools. This study used a pragmatic design to examine longitudinal changes in quality of life (QOL) in a medical patient sample following acupuncture using PROs from the National Institutes of Health's Patient Reported Outcomes Measurement Information System (PROMIS) initiative. It also examined the role of acupuncture expectancies, as well as patient and provider perceptions of acupuncture benefit. Following informed consent, patients completed baseline QOL measures (T1) prior to their first acupuncture session. Subsequent assessments (up to 20) were completed immediately following ensuing acupuncture sessions. Patients completed assessments either on a touch-screen computer at the clinic or from their home computer. Compared with acupuncture-naïve participants, those who received prior acupuncture treatment reported significantly higher anxiety, fatigue, sleep disturbance, and lower positive affect at baseline. By the second assessment, however, these differences became nonexistent. Participants who held greater baseline acupuncture expectations (e.g., their situation would improve a lot, they would have improved coping skills, their symptoms would disappear, their energy would increase) reported significantly higher fatigue, pain interference, and problems with physical functioning. Between T1 and T2, all participants reported significant improvements in anxiety, depression, and fatigue. Exploratory longitudinal models demonstrated significant linear improvements over time in anxiety (p = 0.006), depression (p = 0.007), pain interference (p < 0.001), and sleep disturbance (p = 0.004). No linear reduction over time was found with fatigue (p = 0.587), physical function (p = 0.654), or positive affect (p = 0.247). Overall, PROMIS computer adaptive tests were able to assess domains of QOL briefly. Although pretreatment acupuncture expectations highlighted subgroup differences in outcomes at baseline, linear-growth models demonstrated the positive effects of acupuncture over time on anxiety, depression, pain interference, and sleep disturbance.

Correlates of quality of life in rural patients with heart failure.

There is abundant research indicating poor physical, psychological, and social functioning of patients with chronic heart failure (HF), a reality that can lead to poor health-related quality of life (QoL). Little is known about the experience of rural patients with HF. This study was part of a randomized clinical trial titled Rural Education to Improve Outcomes in Heart Failure (REMOTE-HF) designed to test an education and counseling intervention to improve self-care in patients with HF. We evaluated 612 rural patients. Multiple validated questionnaires were administered to assess patient perceptions of health and health literacy. Baseline factors were collected and compared with baseline QoL measures only. Patients' health-related QoL was assessed using the Minnesota Living with Heart Failure scale. The data were analyzed using a general linear model to test the association of various patient characteristics with QoL in rural patients with HF. Patients were 65.8 (+12.9) years of age. The majority were men (58.7%), married (56.4%), and had completed a high-school education (80.9%). Factors associated with reduced QoL among this population include geographic location, younger age, male sex, higher New York Heart Association class, worse HF knowledge, poorer perceived control, and symptoms of depression or anxiety. The data provided no evidence of an association between left ventricular ejection fraction and QoL. This study of rural patients with HF confirms previously identified factors associated with perceptions of QoL. However, further study is warranted with an urban control group. http://www.clinicaltrials.gov. Unique identifier: NCT00415545.

Comparison of baseline quality of life measures between renal cell carcinoma patients undergoing partial versus radical nephrectomy

BackgroundTo compare demographics, pathologic features, performance scores, comorbidities, symptoms and responses to quality of life (QoL) surveys between nephron-sparing surgery (NSS) and radical nephrectomy (RN) patients prior to surgical intervention. Previous investigators have compared QoL outcomes for patients undergoing RN and NSS; however, there are limited data comparing QoL-related characteristics at baseline between these groups.MethodsWe identified 144 patients with localized RCC who underwent either NSS (n = 71) or RN (n = 73) between May ‘07-November ‘12. We abstracted baseline data on demographic and clinic-pathologic variables as well as responses to the SF-36 and FACT-G surveys from our prospective registry. We amended the FACT-G with 8 additional questions designed to address RCC-specific QoL. For comparisons between the two groups, we employed Wilcoxon rank-sum and Fisher's Exact tests where appropriate.ResultsWe observed RN patients to have more aggressive pathology. We noted no difference in performance scores between the two groups; however, RN patients were more likely to have higher Charlson scores (p = 0.022) and various symptoms at presentation (all p <0.001). For the QoL surveys, we did not observe differences on the FACT-G; however, we noted evidence of differential scores between the two groups on specific domains of the SF-36 (e.g. Mental Health; p 0.022) and the RCC-specific QoL questions added to the FACT-G.ConclusionsWe report baseline differences between RN and NSS patients on clinico-pathologic as well as QoL-related metrics. As issues of survivorship become increasingly important, our results underscore the need to consider baseline status in evaluations of QoL-related outcomes for patients undergoing surgery for RCC.

Long-Term Effects of Doxazosin, Finasteride and Combination Therapy on Quality of Life in Men with Benign Prostatic Hyperplasia

We examined the effects of doxazosin, finasteride and combination therapy among men with benign prostatic hyperplasia on quality of life assessed with MOS-SF-36 (Medical Outcomes Study Short-Form 36) and 2 disease specific instruments (BII, benign prostatic hyperplasia Impact Index and I-PSS-QoL, International Prostate Symptom Score-QoL) during 4 years. The MTOPS (Medical Therapy of Prostatic Symptoms) study was a multicenter, randomized, double-blind, placebo controlled clinical trial with a primary outcome of time to benign prostatic hyperplasia progression. Change in quality of life was a secondary outcome. A total of 2,872 men enrolled in the MTOPS study who had 3 baseline quality of life measures and at least 1 followup measure by any of the quality of life instruments were analyzed. Compared with men assigned to placebo, men assigned to doxazosin and combination experienced a statistically significant improvement in the BII at year 4. Men assigned to each of the drug groups also experienced a significant improvement in the I-PSS-QoL compared with those assigned to placebo. Considering longitudinal changes during 4 years, a significant improvement in BII and I-PSS-QoL scores was observed in men assigned to the drug groups compared with those assigned to placebo. However, there were no significant differences for the MOS-SF-36 subscales and summary scores when drug groups were compared with the placebo group. The quality of life of men treated with doxazosin, finasteride, and the drugs combined generally improved when assessed with the BII and the I-PSS-QoL compared with those treated with placebo. Quality of life did not show improvement when measured by the MOS-SF-36.

Quality of life and psycho-emotional status of patients with psoriatic arthritis

Quality of life and psycho-emotional status of patients with psoriatic arthritis. Objective. To assess quality of life (QL) and psycho-emotional status of patients with psoriatic arthritis (PsA). Material and methods. 70 pts with definite PsA were included. QL was studied with SF-36. Psycho-emotional status of patients was assessed with Beck Depression Inventory (BDI), Hospital Anxiety and Depression Scale (HADS), Spielberger-Hanin Reactive and Personal Anxiety Scale. Results. All baseline QL measures in PsA pts were significantly lower than in control group (p<0,001). Decrease of physical health measures was most prominent. Majority of PsA pts had anxiety and depressive disorders and their intensity correlated with main clinical symptoms of PsA. Conclusion. Pts with PsA have lower QL measures than persons without joint pathology. Significant frequency and intensity of anxiety and depressive disorders require considering their drug correction.

A Prospective Study of Quality of Life in Adults with Newly Diagnosed High-grade Gliomas: The Impact of the Extent of Resection on Quality of Life and Survival

To describe the quality of life (QOL) over time for adults with newly diagnosed high-grade gliomas and to examine the relationship between QOL and outcome data collected in three prospective cooperative group clinical trials. The QOL study was a companion protocol for three Phase II high-grade glioma protocols. Five self-administered forms were completed by patients to assess QOL at study entry, 2 months, and 4 months after enrollment. QOL data were available for baseline, first, and second subsequent follow-up evaluations for 89%, 71%, and 69% of patients, respectively. A significant proportion of patients (47.1%) experienced impaired QOL (QOL < or = 50) in at least one measure at subsequent evaluations, whereas most patients (88%) with impaired QOL at baseline continued to have impaired QOL at subsequent evaluations. On multivariable analyses, baseline QOL measures were predictive of QOL at the time of follow-up. In addition, patients who underwent a gross total resection were much less likely to have impaired QOL (P = 0.006), were less likely to experience worsening depression (P = 0.0008), and were more likely to have improved QOL (P = 0.003) at their first follow-up evaluation. Changes in QOL measures over time were not found to be associated with survival in multivariable analyses that adjusted for known prognostic variables; variables that were independently associated with improved survival were better performance status (P < 0.001), younger age (P < 0.001), and greater extent of resection (P < 0.001). Baseline QOL was predictive of QOL over time. Gross total resection was associated with longer survival and improved QOL over time for patients with high-grade gliomas.

Associations between Plasma Insulin-Like Growth Factor Proteins and C-Peptide and Quality of Life in Patients with Metastatic Colorectal Cancer

Predictors of quality of life (QOL) in patients with metastatic colorectal cancer are lacking. The insulin-like growth factor (IGF) family of proteins is associated with QOL in noncancer populations. We sought to study whether these proteins are associated with QOL in patients with colorectal cancer. We used a cohort of 526 patients with metastatic colorectal cancer treated with combination chemotherapy. Plasma samples of IGF-I, IGF-II, IGF binding protein-3, and C-peptide were collected before initiation of chemotherapy. QOL was measured by the uniscale instrument and the Symptom Distress Scale at baseline and throughout treatment. Baseline plasma levels of IGF-I and IGF-II before initiation of chemotherapy were significantly associated with several important baseline QOL measures in patients with metastatic colorectal cancer. Patients with lower levels of IGF-I reported increased distress with regard to appearance, appetite, cough, and nausea intensity after adjustment for potential confounders. Similarly, decreased levels of IGF-II were predictive of worse quality related to appearance, appetite, fatigue, nausea frequency and intensity, pain frequency, and composite Symptom Distress Scale score. IGF binding protein-3 and C-peptide were not predictive of baseline QOL. Baseline biomarkers were not associated with subsequent changes in QOL during treatment. Higher body mass index was significantly associated with superior baseline QOL in several areas; nonetheless, the association of IGF-I and IGF-II with baseline QOL measures remained significant even after controlling for baseline body mass index. Baseline plasma IGF-I and IGF-II are significantly associated with symptom distress. Whether this association is simply reflective of patient nutritional status and/or disease burden or represents an independent biological effect of IGFs on QOL remains uncertain. Nonetheless, these data suggest that molecular biomarkers may be useful predictors of QOL in cancer patients.

Factors affecting baseline quality of life in two international adjuvant breast cancer trials. International Breast Cancer Study Group (IBCSG).

Quality of life (QL) is used to assess treatments in clinical trials but may be influenced by other factors. We analysed the impact of biomedical, sociodemographic and cultural factors on baseline QL indicators in two International Breast Cancer Study Group trials. Patients with stage II breast cancer were randomized within 6 weeks of primary surgery to various adjuvant treatments. They were asked to assess five indicators of QL at baseline. QL forms were available for 1231 (83%) of the 1475 premenopausal and 989 (82%) of the 1212 post-menopausal patients, who were from nine countries and spoke seven languages. Culture (defined as language/country groups) had a statistically significant impact on baseline QL measures. Premenopausal patients with poor prognostic factors showed a tendency to report worse QL, with oestrogen receptor status as an independent predictor for mood (P = 0.0005). Older post-menopausal patients reported better emotional wellbeing (P = 0.002), mood (P = 0.002), and less effort to cope (P = 0.0009) compared with younger post-menopausal patients. Co-morbidity, type of surgery, treatment assignment and sociodemographic factors showed a statistically significant impact in post-menopausal patients only. Cultural and biomedical factors influenced baseline QL and should be considered when evaluating the impact of treatment on QL in international breast cancer clinical trials.