Differences In Health-related Quality Of Life Outcomes Research Articles

Health-related quality of life outcomes after neoadjuvantchemoradiotherapy for rectal cancer in NRGOncology/NSABP R-04.

BackgroundThere has been limited evaluation of health‐related quality of life (HRQOL) in rectal cancer patients receiving neoadjuvant chemoradiotherapy. HRQOL outcomes in the National Surgical Adjuvant Breast and Bowel Project R‐04 trial are examined in this article.MethodsBetween 2004 and 2010, R‐04 patients were invited to enroll in the HRQOL substudy, with questionnaires administered before randomization, after completion of chemoradiotherapy, and 1‐year after surgery. HRQOL measures included: Functional Assessment of Cancer Therapy for colorectal cancer (FACT‐C); Short Form‐36v.2 Vitality scale; a treatment‐specific symptom scale; and the FACT neurotoxicity scale. A 5‐year postsurgery assessment was added to the protocol in 2012. Mixed‐effects models examined neoadjuvant therapy treatment effects in the 1‐year sample and models that explored associations of host factors and treatment impact on 5‐year HRQOL.ResultsA total of 1373 patients completed baseline HRQOL and at least one additional assessment. The average age was 58 years (range, 23–85 years), male (68%), and 59% Stage II. There were no statistically significant differences in HRQOL outcomes by treatment arm, but HRQOL worsened from baseline to postneoadjuvant chemoradiotherapy, with statistically significant effect sizes changes ranging from 0.6 (Vitality) to 0.9 (FACT‐C Trial Outcome Index). Neurotoxicity was greater in the oxaliplatin‐treated groups. Obese/overweight patients had statistically significantly worse FACT‐C Trial Outcome Index scores than did underweight/normal weight groups. At 5 years, younger patients and those with normal baseline weight had statistically significantly better physical function scores and older patients had better mental health outcomes.ConclusionsHRQOL did not differ across the four R‐04 treatment arms; however, host factors explained significant variation in posttreatment HRQOL. ClinicalTrials.gov: NCT00058474 (https://ClinicalTrials.gov/ct2/show/NCT00058474).Lay summary This article reports on the health‐related quality of life (HRQOL) outcomes of patients treated with four different chemotherapy regimens combined with radiation in rectal cancer patients before definitive surgical treatment.There were no significant differences in HRQOL by treatment regimen, but all patients experienced decreased vitality (energy) and physical functioning. By 1 year after treatment, most patients had returned to pretreatment vitality and physical functioning, with the exception of increased neurotoxicity.In a subsample of patients assessed at 5 years after surgery, physical function was better in those who at pretreatment were younger, normal weight, and had better performance status. Mental function was better in those who at pretreatment were older and had better performance status.

A randomized comparison of health-related quality of life outcomes of dolutegravir versus efavirenz-based antiretroviral treatment initiated in the third trimester of pregnancy

IntroductionEvidence on health-related quality of life (HRQoL) outcomes is limited for new antiretroviral therapies (ART). Dolutegravir-based treatment is being rolled out as the preferred first-line treatment for HIV in many low- and middle-income countries. We compared HRQoL between treatment-naïve pregnant women randomized to dolutegravir- or efavirenz-based ART in a clinical trial in Uganda and South Africa.MethodsWe gathered HRQoL data from 203 pregnant women of mean age 28 years, randomized to either dolutegravir- or efavirenz-based ART. We used the medical outcomes study-HIV health survey at baseline, 24 and 48 weeks between years 2018 and 2019. Physical health summary (PHS) and mental health summary (MHS) scores were the primary study outcomes, while the 11 MOS-HIV subscales were secondary outcomes. We applied mixed model analysis to estimate differences within and between-treatment groups. Multivariate regression analysis was included to identify associations between primary outcomes and selected variables.ResultsAt 24 weeks postpartum, HRQoL scores increased from baseline in both treatment arms: PHS (10.40, 95% CI 9.24, 11.55) and MHS (9.23, 95% CI 7.35, 11.10) for dolutegravir-based ART; PHS (10.24, 95% CI 9.10, 11.38) and MHS (7.54, 95% CI 5.66, 9.42) for efavirenz-based ART. Increased scores for all secondary outcomes were significant at p < 0.0001. At 48 weeks, improvements remained significant for primary outcomes within group comparison. Estimated difference in PHS were higher in the dolutegravir-based arm, while increases in MHS were more for women in the efavirenz-based armat 24 and 48 weeks. No significant differences were noted for corresponding PHS scores at these time points compared between groups. Differences between arms were observed in two secondary outcomes: role function (1.11, 95% CI 0.08, 2.13), p = 0.034 and physical function outcomes (2.97, 95% CI 1.20, 4.73), p = 0.001. In the multivariate analysis, internet access was associated with higher PHS scores while owning a bank account, using the internet and longer treatment duration were associated with an increase in MHS scores.ConclusionWe found no important differences in HRQoL outcomes among HIV-positive women started on dolutegravir relative to efavirenz in late pregnancy. Increases in HRQoL in the first year after delivery provide additional support for the initiation of ART in HIV-positive women presenting late in pregnancy.Trial Registration Clinical Trial Number: NCT03249181

Quality of life outcomes from the randomized trial of hyperthermic intraperitoneal chemotherapy following cytoreductive surgery for primary ovarian cancer (KOV-HIPEC-01).

ObjectiveTo investigate the health-related quality of life (HRQOL) related to hyperthermic intraperitoneal chemotherapy (HIPEC) following primary or interval cytoreductive surgery for primary ovarian cancer.MethodsBetween 2010 and 2016, a total of 184 patients were randomly assigned to receive cytoreductive surgery with HIPEC (n=92) or without HIPEC (n=92). Quality of life (QOL) assessment was evaluated at baseline (before surgery); on postoperative day 7; after the 3rd and 6th cycle of adjuvant chemotherapy; and at 3, 6, 9, and 12 months after randomization. Patient-reported QOL was assessed using the European Organization for Research and Treatment of Cancer (EORTC) core questionnaire (EORTC-QLQ-C30), ovarian cancer questionnaire modules (QLQ-OV28), and the MD Anderson Symptoms Inventory (MDASI).ResultsOf the 184 patients enrolled, 165 (83/92 in the HIPEC group and 82/92 in the control group) participated in the baseline QOL assessment. There were no statistically significant differences in functional scales and symptom scales in QLQ-C30; symptom scales, including gastrointestinal symptoms QLQ-OV28; and severity and impact score in MDASI between the 2 treatment groups until 12 months after randomization.ConclusionHIPEC with cytoreductive surgery showed no statistically significant difference in HRQOL outcomes. Thus, implementation of HIPEC during either primary or interval cytoreductive surgery does not impair HRQOL.Trial RegistrationClinicalTrials.gov Identifier: NCT01091636

What Does the Future Hold? Health-Related Quality of Life 3-12 Years Following a Youth Sport-Related Knee Injury.

Knee trauma can lead to poor health-related quality of life (HRQoL) and osteoarthritis. We aimed to assess HRQoL 3–12 years following youth sport-related knee injury considering HRQoL and osteoarthritis determinants. Generic (EQ-5D-5L index, EQ-VAS) and condition-specific (Knee injury and Osteoarthritis Outcome Score quality of life subscale, KOOS QOL) HRQoL were assessed in 124 individuals 3–12 years following youth sport-related knee injury and 129 uninjured controls of similar age, sex, and sport. Linear regression examined differences in HRQoL outcomes by injury group. Multivariable linear regression explored the influence of sex, time-since-injury, injury type, body mass index, knee muscle strength, Intermittent and Constant Osteoarthritis Pain (ICOAP) score, and Godin Leisure-Time Exercise Questionnaire (GLTEQ) moderate-to-strenuous physical activity. Participant median (range) age was 23 years (14–29) and 55% were female. Injury history was associated with poorer KOOS QOL (−8.41; 95%CI −10.76, −6.06) but not EQ-5D-5L (−0.0074; −0.0238, 0.0089) or EQ-VAS (−3.82; −8.77, 1.14). Injury history (−5.14; −6.90, −3.38), worse ICOAP score (−0.40; −0.45, −0.36), and anterior cruciate ligament tear (−1.41; −2.77, −0.06) contributed to poorer KOOS QOL. Worse ICOAP score contributed to poorer EQ-5D-5L (−0.0024; −0.0034, −0.0015) and higher GLTEQ moderate-to-strenuous physical activity to better EQ-VAS (0.10; 0.03, 0.17). Knee trauma is associated with poorer condition-specific but not generic HRQoL 3–12 years post-injury.

Health-Related Quality of Life: A Comparative Analysis of Caregivers of People With Dementia, Cancer, COPD/Emphysema, and Diabetes and Noncaregivers, 2015-2018 BRFSS.

Many informal caregivers experience significant caregiving burden and report worsening health-related quality of life (HRQoL). Caregiver HRQoL may vary by disease context, but this has rarely been studied. Informed by the Model of Carer Stress and Burden, we compared HRQoL outcomes of prevalent groups of caregivers of people with chronic illness (i.e., dementia, cancer, chronic obstructive pulmonary disease [COPD]/emphysema, and diabetes) and noncaregivers and examined whether caregiving intensity (e.g., duration and hours) was associated with caregiver HRQoL. Using 2015-2018 Behavioral Risk Factor Surveillance System data, we identified caregivers of people with dementia (n = 4,513), cancer (n = 3,701), COPD/emphysema (n = 1,718), and diabetes (n = 2,504) and noncaregivers (n = 176,749). Regression analyses were used to compare groups. Caregiver groups showed small, nonsignificant differences in HRQoL outcomes. Consistent with theory, all caregiver groups reported more mentally unhealthy days than noncaregivers (RRs = 1.29-1.61, ps < .001). Caregivers of people with cancer and COPD/emphysema reported more physically unhealthy days than noncaregivers (RRs = 1.17-1.24, ps < .01), and caregivers of people with diabetes reported a similar pattern (RR = 1.24, p = .01). However, general health and days of interference of poor health did not differ between caregivers and noncaregivers. Across caregiver groups, most caregiving intensity variables were unrelated to HRQoL outcomes; only greater caregiving hours were associated with more mentally unhealthy days (RR = 1.13, p < .001). Results suggest that HRQoL decrements associated with caregiving do not vary substantially across chronic illness contexts and are largely unrelated to the perceived intensity of the caregiving. Findings support the development and implementation of strategies to optimize caregiver health across illness contexts.

Health-related quality of life in long-term prostate cancer survivors after nerve-sparing and non-nerve-sparing radical prostatectomy-Results from the multiregional PROCAS study.

BackgroundNerve‐sparing (NS) surgery was developed to improve postoperative sexual and potentially urological outcomes after radical prostatectomy (RP). However, it is largely unknown how NSRP affects health‐related quality of life (HRQoL) including urinary and sexual outcomes in prostate cancer (PC) survivors 5‐10 years after diagnosis in comparison with Non‐NSRP.MethodsThe study population included 382 stage pT2‐T3N0M0 PC survivors 5‐10 years post diagnosis, who were identified from the multiregional Prostate Cancer Survivorship in Switzerland (PROCAS) study. Briefly, in 2017/2018, PC survivors were identified via six population‐based cancer registries based in both German‐ and French‐speaking Switzerland. HRQoL and PC‐specific symptom burden was assessed using the EORTC QLQ‐C30 and EORTC QLQ‐PR25 questionnaires. Differences in HRQoL outcomes between survivors treated with NSRP (uni‐ & bilateral) and Non‐NSRP were analyzed with multivariable linear regression adjusted for age, years since diagnosis, cancer stage, comorbidities at diagnosis, and further therapies, if appropriate. Multiple imputation was performed to minimize the bias due to missing data.ResultsFive to ten years after diagnosis, PC survivors treated with NSRP and Non‐NSRP reported similar symptom burden and comparable HRQoL function scores. The only significant differences were reported for sexual activity, whereas PC survivors who underwent NSRP reported statistically significant (P = .031) higher sexual activity than those on Non‐NSRP. NSRP and Non‐NSRP reported similar scores for urinary symptoms and all other HRQoL outcomes.ConclusionsOur results support nerve‐sparing techniques as an option to improve postoperative sexual, but not urinary outcomes after RP in long‐term PC survivors.

Health-related quality of life in stage III melanoma patients treated with neoadjuvant ipilimumab and nivolumab followed by index lymph node excision only, compared to therapeutic lymph node dissection: First results of the PRADO trial.

10064 Background: Neoadjuvant ipilimumab and nivolumab induces high pathologic response rates of 74-78% (OpACIN and OpACIN-neo trial), thus the role of Therapeutic Lymph Node Dissections (TLND) in patients with major pathologic responses (MPR: pathological (near) complete response) is now unclear. In the PRADO trial, TLND was omitted in patients with MPR in their index lymph node ((ILN), the largest LN marked prior to neoadjuvant therapy). We sought to determine if less extensive surgery is associated with better Health Related Quality of Life (HRQoL). These are the first results of the comparison of HRQoL between patients undergoing a TLND or less extensive ILN excision. Methods: HRQoL was assessed with the European Organisation for Research and Treatment of Cancer QoL questionnaire-C30 (QLQ-C30). A generalized estimation equation was used to assess the difference in HRQoL outcomes between patients who underwent TLND (pathological non- and partial-responders, pNR/pPR) versus those who did not (pathological (near)complete responders, pNCR/pCR). Differences were adjusted for age, gender and follow-up (FU, in weeks), but not for pathological responses (pNR, pPR, pNCR &amp; pCR). Differences in QLQ-C30 scores were classified as clinically important according to published guidelines. Results: A total of 49 patients from the PRADO study had reached at least 24 weeks FU, and were included in the first explorative analysis. The median age of this study population was 58 years (range, 22-84). Questionnaire completion rates were high: 94% at baseline, 100%, 90%, 88% at week 6, 12 and 24, respectively. Sixteen (33%) patients underwent TLND versus 33 (67%) who had ILN excision only. Over a FU period of 24 weeks, patients who underwent TLND scored significantly lower on global (68 vs 78, adjusted difference (diff) = -9.53, p = .005), physical (84 vs 94 diff = -11.1, p = &lt; .001), emotional (69 vs 83, diff = -11.7, p = .001), role (70 vs 85, diff = -13, p = .004), and social functioning (81 vs 91, diff = -8.9, p = .016) and had a higher symptom burden of fatigue (35 vs 23, diff = 11.1, p = .004), insomnia (38 vs 18, diff = 16.6, p = .002) and financial impact (12 vs 4, diff = 7.9, p = .027) than patients undergoing ILN excision only. These differences were indicated as clinically relevant. Conclusions: First results from PRADO suggest that reducing the extent of surgery following neoadjuvant immunotherapy might result in better HRQoL of high-risk stage III melanoma patients. Clinical trial information: NCT02977052.

Health-related quality-of-life after radical cystectomy among Norwegian men and women compared to the general population

Objective: The aim of this study was to assess health-related quality-of-life (HRQoL) in men and women operated on with radical cystectomy, compared to the general Norwegian population.Materials and methods: All patients with bladder cancer who had undergone radical cystectomy (RC) between 2011–2017 and either received ileal conduit (IC) or orthotopic neobladder (ONB) as urinary diversion were included in a cross-sectional study. HRQoL and sociodemographic data was collected and measured with a questionnaire consisting of the generic EORTC QLQ-C30.v3 and the cancer specific EORTC QLQ-BLM30 and compared to a general population sample.Results: Of the 220 invited patients, 173 patients (78.6%) returned the questionnaires. The global quality-of-life (QoL) score was comparable with the general population. Women had significantly higher fatigue score, worse future perspective and symptoms like bloating, compared to male patients. Men had significantly lower social functioning, more constipation, diarrhoea and sleep disturbance compared to the general male population. There was no significant difference in HRQoL domains between female patients and the general female population. A follow-up (FU) period longer than 37 months since surgery was associated with significantly improved physical- and role-functioning, less fatigue and fewer problems with the urostoma, compared to a shorter FU time.Conclusion: This study found a high global QoL score after radical cystectomy, comparable with the general Norwegian population. Symptoms seem to improve over time. Difference in HRQoL outcomes between men and woman in the study population was comparable with the difference found in the general population.

Health-related quality of life and anxiety in the PAN-CAN lung cancer screening cohort

ObjectivesThe impact of lung cancer screening with low-dose chest CT (LDCT) on participants’ anxiety levels and health-related quality of life (HRQoL) is an important consideration in the implementation of such...

MP86-14 PROSTATE SPECIFIC ANTIGEN AND HEALTH-RELATED QUALITY-OF-LIFE OUTCOMES IN UNINSURED MEN WITH PROSTATE CANCER

You have accessJournal of UrologyGeneral & Epidemiological Trends & Socioeconomics: Practice Patterns, Quality of Life and Shared Decision Making V1 Apr 2017MP86-14 PROSTATE SPECIFIC ANTIGEN AND HEALTH-RELATED QUALITY-OF-LIFE OUTCOMES IN UNINSURED MEN WITH PROSTATE CANCER Avi Baskin, Joseph Shirk, Lorna Kwan, and Karim Chamie Avi BaskinAvi Baskin More articles by this author , Joseph ShirkJoseph Shirk More articles by this author , Lorna KwanLorna Kwan More articles by this author , and Karim ChamieKarim Chamie More articles by this author View All Author Informationhttps://doi.org/10.1016/j.juro.2017.02.2697AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookTwitterLinked InEmail INTRODUCTION AND OBJECTIVES Prostate Specific Antigen (PSA) continues to be a useful marker of risk strata and disease progression for patients with prostate cancer. While there have been multiple investigations into the relationship between PSA and mortality, there is a dearth in the literature describing the association between PSA and health-related quality-of-life (HRQOL) outcomes. In this study, we hypothesize that PSA is inversely related with HRQOL in patients with prostate cancer. METHODS Our cohort consisted of a prospective analysis of men from a state-funded program that provides free prostate cancer care to underinsured and uninsured low-income California residents with prostate cancer. Highest pre-treatment PSA was our primary exposure variable of interest. We created 4 strata: <10, 10-19.9, 20-49.9 and ≥50 PSA. The primary outcome variables were HRQOL at program enrollment using the RAND SF-12 to measure physical and mental health, and the UCLA Prostate Cancer Index Short Form to measure urinary, sexual and bowel habits in two domains: bother and function. Controlling for demographic and clinical variables, we conducted separate multivariable linear regression analysis for each quality of life domain. RESULTS 627 men were eligible for the study. Age, ethnicity, primary language, education and Charlson comorbidity did not differ across PSA strata. Compared to the referent group PSA <10, those with PSA ≥50 were more likely to receive androgen deprivation therapy as their primary form of treatment (p <0.01). Patients with PSAs 10-19.9 were more likely to have sexual bother (β=11.1, p<0.03) compared to the referent group. (See Table) There were no other differences in other HRQOL domains across PSA strata. CONCLUSIONS In this population, we found no statistically significant difference in HRQOL outcomes by PSA level. The finding that patients with very elevated PSA levels having outcomes that were no worse than patients with less aggressive disease is important clinically because most quality of life detriments tend to be from treatment of localized disease. Further, these findings will inform physicians on patient symptomatology despite PSA level. © 2017FiguresReferencesRelatedDetails Volume 197Issue 4SApril 2017Page: e1161-e1162 Advertisement Copyright & Permissions© 2017MetricsAuthor Information Avi Baskin More articles by this author Joseph Shirk More articles by this author Lorna Kwan More articles by this author Karim Chamie More articles by this author Expand All Advertisement Advertisement PDF downloadLoading ...

Health-related quality of life in haemodialysis patients suffering from chronic itch: results from GEHIS (German Epidemiology Haemodialysis Itch Study).

Chronic itch (CI) is a common symptom in haemodialysis (HD) patients affecting about every 4th HD patient. Though it is known that health-related quality of life (HRQOL) is impaired in HD patients, data are lacking on how CI influences HRQOL in this group of patients, also regarding sex differences and the role of sleep and pain. In order to investigate the itch prevalence and to investigate associated factors, GEHIS (German Epidemiology Haemodialysis Itch Study) was established as first cross-sectional study being representative for all dialysis units in Germany by considering their regional distribution and size of the located city according to population. HRQOL of 860 HD patients from a randomly selected cluster sample of 25 dialysis units was investigated using patient-reported outcomes as the Short-Form Health Survey (SF-12), the Hospital Anxiety and Depression Scale (HADS) as well as sleep and pain. Additionally, itch-specific QOL was assessed in HD patients affected by CI using the validated ItchyQoL. 42.8% of HD patients were female. The mean age was 67.2years (SD±13.5). Female patients showed significantly worse values in the mental component summary of the SF-12 as well as in the HADS subscale anxiety compared to male patients. Itch-specific HRQOL did not subject to sex. Patients with impairments in quality of sleep showed significantly worse values in both the SF-12 and the HADS subscales, however not in the ItchyQoL. The occurrence of pain was significantly associated with impaired SF-12, HADS and the ItchyQoL. Multivariate linear regression showed the itch-specific HRQOL to be significantly impaired with rising severity of CI. Impairments in HRQOL are a serious problem in HD patients. CI means an additional burden in affected patients, also impairing their HRQOL. GEHIS showed significant sex differences in HRQOL outcomes also in HD patients. CI and pain as well as sleep frequently occur combined and significantly impair HRQOL in HD patients. The care of HD patients should be complemented by psychosocial support and mental health services.

Health-related quality of life outcomes with prasugrel among medically managed non–ST-segment elevation acute coronary syndrome patients: Insights from the Targeted Platelet Inhibition to Clarify the Optimal Strategy to Medically Manage Acute Coronary Syndromes (TRILOGY ACS) trial

Few studies have assessed treatment effects on health-related quality of life (HRQoL) in patients with acute coronary syndrome (ACS) treated without revascularization. The TRILOGY ACS trial randomized patients with ACS to either prasugrel or clopidogrel therapy plus aspirin. Outcomes showed a complex pattern suggestive of late benefits with respect to repeat clinical events and benefits confined to patients who underwent angiography. Here, we examine the HRQoL correlates of these patterns. HRQoL was measured at baseline and 3, 12, and 24 months or end of study (EOS) in 7243 patients aged <75 years using the EuroQol 3-level, group 5-dimension index (EQ-5D). Linear mixed effects models for repeated measures were used to examine treatment differences in HRQoL overall, stratified by angiography status, and among patients who did and did not have non-fatal events. No baseline differences in HRQoL were seen between patients randomized to prasugrel (n=3620) or clopidogrel (n=3623). At 24 months, remaining patients assigned to prasugrel (n=1450) vs. clopidogrel (n=1443) had higher EQ-5D index scores (86.4 vs. 84.9, P=.01). Mixed effects models found no difference in EQ-5D scores among prasugrel and clopidogrel patients overall across subgroups stratified by angiography status. However, among patients with non-fatal clinical events, patients on clopidogrel reported a larger decrement in HRQoL than patients on prasugrel (79.5±18.1 vs. 80.6±18.0; P=.02). Overall, there was no difference in HRQoL outcomes among patients receiving prasugrel vs. clopidogrel. However, the differential effects of the treatments among patients with non-fatal events require further investigation.

Comparison of oncological and health‐related quality of life outcomes between open and robot‐assisted radical prostatectomy for localised prostate cancer – findings from the population‐based Victorian Prostate Cancer Registry

To compare the short-term oncological and health-related quality of life (HRQOL) outcomes between open (ORP) and robot-assisted (RARP) radical prostatectomy in the population-based Victorian Prostate Cancer Registry. This is a prospective cohort of patients with prostate cancer who had RP (1117 ORP and 885 RARP) between January 2009 and June 2012. The oncological outcomes of interest were: positive surgical margin (PSM) and biochemical recurrence (BCR), defined as postoperative PSA level of >0.2ng/mL. The HRQOL outcomes were: sexual and urinary bother, assessed using the Expanded Prostate Cancer Index Composite at 1- and 2-years after diagnosis. For univariate comparison of continuous variables the Student's t-test or Mann-Whitney U-test were used, and the Pearson's chi-squared test was used for categorical variables. Bonferroni correction was applied to account for multiple testing, with a threshold for significance of P < 0.003 for univariate analyses. The inverse-probability-treatment-weighting (IPTW) approach was used to adjust for differences in baseline characteristics between ORP and RARP patients [including age, National Comprehensive Cancer Network (NCCN) risk categories, hospitals, and year of RP] in all multivariate analyses. Logistic regressions were used to analyse for PSM, Cox regressions for BCR, and ordinal logistic regressions for HRQOL outcomes. All multivariate analyses also adjusted for surgeons' average annual caseload, and employed the robust standard errors for clustering by surgeon. ORP and RARP patients were followed for a median of 19and 17months, respectively. The proportion of patientswith NCCN low-risk prostate cancer was significantly higher among RARP patients (21% vs 26%; P= 0.002). Most RPs was done in private hospitals (77% ORP, and 85% RARP, P < 0.001). A higher proportion of RARP patients were operated by surgeons with higher annual caseloads (65% RARP and 53% ORP operated by surgeons with >20case/year; P < 0.001). In the IPTW-adjusted multivariate analyses, RARP patients had a lower risk of PSM (odds ratio [OR] 0.56, 95% confidence interval [CI] 0.38-0.81), and BCR (hazard ratio [HR] 0.73, 95% CI 0.55-0.99). In the sensitivity analyses (excluding public hospital patients), the lower PSM risk with RARP remained (OR 0.63, 95% CI 0.38-0.81), but the lower BCR risk with RARP was no longer statistically significant (HR 0.79, 95% CI 0.57-1.12). At 1-year follow-up, 61% of ORP and 59% of RARP patients reported 'moderate-big' sexual bother (P = 0.2), while 14% of ORP and 11% of RARP patients reported 'moderate-big' urinary bother (P = 0.08). The sexual and urinary bothers at 2years were similar between ORP and RARP. In multivariate analyses, there were no statistically significant differences in the HRQOL outcomes between ORP and RARP. We report on a large population-based comparative study of ORP and RARP with better short-term oncological outcomes favouring RARP, but no significant differences in HRQOL outcomes. The results have to be interpreted taking into account significant surgeon heterogeneity in a population-based study.

The impact of comorbidity on health-related quality of life in elderly patients with chronic myeloid leukemia.

The primary objective of this study was to investigate whether the presence of comorbidities was associated with a lower health-related quality of life (HRQOL) in elderly patients with chronic myeloid leukemia (CML). A sample of 174 CML patients aged 60years or above was analyzed. HRQOL was assessed with the Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36). A number of pre-selected sociodemographic and disease-related factors were considered as potential confounding factors for the association between comorbidity and HRQOL. Mean age of the 174 patients analyzed was 70years (range 60-87years) and 55% were male. Overall, 111 patients (64%) reported at least one comorbidity. Analysis stratified by age group category showed a greater proportion of patients with comorbidities in the older sub-group population (≥70years) compared to younger patients (60 to 69years). Differences in HRQOL outcomes between patients with no comorbidity at all and those with two or more comorbid conditions were at least twice the magnitude of a clinically meaningful difference in all the physical and mental health scales of the SF-36. In multivariate analysis, after adjusting for key confounding factors, the following scales were significantly lower in those with comorbidity: general health (p < 0.001), bodily pain (p < 0.001), physical functioning (p = 0.002), and vitality (p = 0.002). Assessing comorbidity in elderly patients with CML is important to facilitate identification of those most in need of HRQOL improvements.

Efficiency in Adult Spinal Deformity Surgery: A Multicenter Comparison of Resource Use

Introduction Decision makers and payers are placing increasing scrutiny on the costs and outcomes associated with complex spine surgery. To justify higher cost practice patterns, there must be evidence of additional patient benefit; however, little is currently known regarding the variation in resources used and associated outcomes in complex spine surgeries. Our study examines multicenter variability in patient-level surgical resource use, including implants, biologics, and length of stay, alongside health-related quality-of-life (HRQoL) improvements following adult spinal deformity (ASD) surgery. Material and Methods This is a retrospective analysis of a multicenter prospective database of consecutive patients with ASD. HRQoL outcomes were calculated from the ODI, SRS-22, and SF-36 domain scores. Changes in HRQoL were estimated as the difference between baseline and 2-year values. Patient-level surgical resources included blood use, bone morphogenetic protein (BMP), volume (ccs), length of stay (LOS), and implants. Patients were classified by sagittal modifier and analyzed across centers. The three sagittal modifier types are defined as follows: mild (SVA &lt; 4 cm, PT &lt; 20 degrees, PI–LL within 10 degrees), moderate (at least 1 of SVA 4–9.5 cm, PT 20–30 degrees; PI–LL 10–20 degrees, and no severe modifiers); and severe (at least 1 of SVA &gt; 9.5 cm, PT &gt; 30 degrees, PI–LL &gt; 20 degrees). Statistical analysis was performed using analysis of variance (ANOVA) and multivariable regression methods comparing HRQoL outcomes and resource use across center, considering the overall patient cohort and each modifier group. Results Baseline and 2-year HRQoL data were available for 226 surgical patients with ASD, with an average age of 56 (range, 18–84 years) years who were predominantly female ( N = 189, 84%). Significant differences were found in the average 2-year change in HRQoL across centers, however, this difference becomes insignificant after controlling for patients within the same major modifier groups ( p &gt; 0.05). Significant differences were found across centers in average resources used per surgery ( p &lt; 0.05), with only LOS not reaching significance ( p &gt; 0.05). Significant differences were found in average BMP and screw use across all modifier groups. After accounting for clinical, demographic, and regional characteristics at the patient level, variation among centers persisted in both screw use and total BMP volume with no corresponding statistical differences in HRQoL outcomes. Conclusion The use of additional surgical resources does not appear to impact 2-year HRQoL outcomes following surgery for ASD. To improve efficiency in ASD surgery, standardization of physician practice patterns and resource use could help curb costs without negatively impacting patient HRQoL.

Clinical Impact Correlation of a Delphi-Based Proximal Junctional Kyphosis Severity Scale and HRQOL

Introduction Proximal junctional kyphosis (PJK) and proximal junctional failure (PJF) are adverse outcomes following adult spinal surgery (ASD) surgery. There is a lack of consensus regarding which patients (pts) require revision surgery. The Hart ISSG PJK severity scale correlates with the need for revision surgery. This study evaluates the Hart International Spine Study Group (ISSG) PJK severity scale and health-related quality of life (HRQOL) measures in pts with PJK. Patients and Methods All ASD pts with PJK and/or PJF who eventually underwent revision surgery were identified from two large academic medical centers. Pts were retrospectively assigned scores based on the Hart ISSG PJK severity scale: neurological status, focal pain, instrumentation problem, kyphosis severity/PLC integrity, UIV/UIV + 1 fracture, and level of UIV. Scores range from 0 to 15. Pre-PJK revision HRQOL measures included: Oswestry disability index (ODI), short-form 36 (SF-36), and Scoliosis Research Society questionnaire (SRS30). Scores were subcategorized into 0 to 2, 3 to 5, 6 to 8, 9 to 11, and 12 to 15, and differences in HRQOL outcomes were determined with linear regression. Correlation was assessed with a Pearson correlation coefficient. Results A total of 54 cases were included, out of which 31.5% were male, and the mean age was 64.9 years. The Hart ISSG PJK severity scale scores ranged from 4 to 15, with the median being 8. PJK/PJF occurred in the upper thoracic spine in 24.1% of the cases. 54.8% had fractures and 77.8% had instrumentation issues. Overall, 55.6% had neurological deficits, with 16.7% having weakness and/or myelopathy. All pts had preoperative pain (median VAS 9/10). While statistical significance on linear regression was not seen, there were obvious trends that correlated with the Hart ISSG PJK severity scale. Higher Hart ISSG PJK severity scale scores were associated with higher ODI ( p = 0.283, r = 0.350), lower SRS30 function ( p = 0.821, r = −0.323), and lower SRS mental ( p = 0.646, r = −0.592). Conclusion The Hart ISSG PJK severity scale has been shown to be predictive in the decision making of when patients require revision surgery. Based on the current study, it may also correlate with functional outcomes, specifically ODI and SRS30 components.

Mobility, mood and site of care impact health related quality of life in Parkinson's disease

ObjectiveExamine the correlates of Health Related Quality of Life (HRQL) in a large cohort of Parkinson's disease (PD) patients from National Parkinson Foundation (NPF) Centers of Excellence (COEs). BackgroundImproving outcomes for PD will depend upon uncovering disease features impacting HRQL to identify targets for intervention and variables for risk-adjustment models. Differences in HRQL outcomes between COEs could uncover modifiable aspects of care delivery. MethodsThis cross-sectional study examined the relative contribution of demographic, social, clinical and treatment features potentially related to HRQL, as measured by the PDQ-39, in 4601 consecutive subjects from 18 COEs. Stepwise linear regression was utilized to identify correlates of HRQL. ResultsThe variability in the PDQ-39 summary index score correlated with H&Y stage (R2 = 22%), Timed up and Go (TUG) (17%), disease duration (11%), comorbidities (8%), cognitive status (8%), antidepressant use (6%) and center at which a patient received care (5%). Stepwise regression reordered the importance of the variables, with the H&Y first and TUG and the center becoming equal and the second most important variables determining the PDQ-39 total score. All independent variables together accounted for 44% of the variability in HRQL. ConclusionsWe confirmed many but not all HRQL associations found in smaller studies. A novel observation was that the site of care was an important contributor to HRQL, suggesting that comparison of outcomes and processes among centers may identify best practices.

Psychological distress and quality of life in long-term social assistance recipients compared to the Norwegian population

Mental disorders are serious public health problems and mental disorders have an impact on individuals' health-related quality of life (HRQoL). Therefore, the aim of this study was to evaluate for differences in psychological distress and HRQoL outcomes between long-term social assistance recipients (LTRs) and the general population in Norway. In addition, differences in HRQoL outcomes were evaluated in LTRs and general population who reported clinically meaningful levels of psychological distress. In this cross-sectional study, which is part of a larger study that evaluated the health and functional abilities of LTRs in Norway, 393 LTRs were compared to a similar aged group (n = 3919) from the general population. Psychological distress was measured using the Hopkins Symptom Checklist. LTRs were significantly younger (p < 0.001), more likely to be male (p = 0.001), more likely to be never married or divorced (p < 0.001), and have less education (p < 0.001) than members of the general population. LTRs reported significantly higher total mean psychological distress scores than the general population. More LTRs (57.0%) than general population (10.1%; p < 0.001) reported clinically meaningful levels of psychological distress. LTRs with a psychological distress score >1.85 reported lower mental component scores on the SF-12 than general population. In the total sample, LTRs experienced more psychological distress and reported poorer HRQoL than the general population. Clinically meaningful levels of psychological distress occurred more frequently in LTRs than general population. The LTRs and the general population with psychological distress rated both the physical and mental components of HRQoL lower than LTRs and general population without psychological distress.

Three-year health-related quality-of-life outcomes for sirolimus-treated kidney transplant patients after elimination of cyclosporine

This study compared 3-year health-related quality-of-life (HRQL) outcomes of sirolimus (SRL)-treated kidney transplant patients after elimination of cyclosporine (CsA) with patients continuing on a combined CsA and SRL regimen. A randomized, multi-country, open-label, clinical trial was performed. 430 kidney transplant patients were randomly assigned to SRL+corticosteroids (ST) (n = 215) or SRL+CsA+ST (n = 215) therapy after an initial 3-month period of combined SRL+CsA+ST treatment. HRQL was measured using the Kidney Transplant Questionnaire (KTQ) and the SF-36 Health Survey at month 3 (time of randomization) and months 12, 24, and 36 post-transplantation. Mixed-model ancova was used to evaluate treatment differences in HRQL outcomes. HRQL scores were available for 361 (86.4%) eligible study patients. Significant treatment-by-assessment time interactions, favoring SRL+ST, were found on KTQ fatigue (P = 0.0005), emotions (P = 0.028), and appearance scores (P = 0.006). Statistically significant treatment-by-assessment time interactions were observed for SF-36 vitality (P = 0.0001), general health (P = 0.011), social function (P = 0.020), and role-physical scores (P = 0.049). Vitality scores improved in the SRL+ST group (mean 3.5-point change) over 36 months, compared with decreases in the SRL+CsA+ST group (mean -3.2-point change). SRL-based therapy with early CsA-elimination results in fewer appearance-related problems, less fatigue, greater vitality, and improved general health status and social functioning compared with continuous SRL+CsA+ST treatment.

Quality of life in prostate cancer patients taking androgen deprivation therapy: Dacal K, Sereika SM, Greenspan SL, School of Medicine, University of Pittsburgh, Pittsburgh, PA

To examine the effect of androgen deprivation therapy (ADT) on health-related quality of life (HRQOL), self-reported HRQOL was compared in prostate cancer patients receiving short- (< 6 months) or long-term (> or = 6 months) ADT and healthy controls. Cross-sectional study. Academic medical center in Pittsburgh, Pennsylvania. Ninety-six men, including those with prostate cancer receiving short-term, long-term, and no ADT and healthy controls. Men taking medications or having diseases known to affect bone mineral metabolism were excluded. The 36-item Short Form Medical Outcomes Study Health Survey (an HRQOL assessment) and a comorbidity index were administered to each participant. Characteristics, including body composition (assessed using dual-energy x-ray absorptiometry) and gonadal status (serum total and free testosterone) were measured approximately 3 months or less before the HRQOL assessment. As expected, men receiving ADT had significantly lower levels of testosterone, free testosterone, and lean body mass, as well as greater body fat and comorbidity index (all P<.01) than men not receiving ADT (i.e., men with prostate cancer and healthy controls). Participants receiving ADT reported significantly poorer QOL in the areas of physical function (P<.001), general health (P<.001), and physical health component summary (P<.001) than men not receiving ADT. There were no significant differences in HRQOL outcomes between participants receiving short- or long-term ADT. Comorbidity and testosterone levels were associated with several QOL scales. After controlling for the significant joint predictors of comorbidity and total testosterone using hierarchical regression analysis, ADT was no longer a significant predictor, and only comorbidity and total testosterone contributed to the explanation of the variance of the physical health component summary. Comorbidity alone contributed to the explanation of the variance in physical function, bodily pain, general health, and vitality. Patients with prostate cancer who were receiving ADT experience worse HRQOL than those not receiving ADT, but duration of ADT was not a contributing factor. After controlling for comorbidity, total testosterone level rather than ADT accounted for a small yet statistically significant percentage of the total variance of the physical health component summary. These findings have important clinical implications regarding the decision to treat prostate cancer patients with ADT.