Longitudinal Changes In Health-related Quality Research Articles

Health-related quality of life after open-wedge high tibial osteotomy.

(1) To monitor longitudinal changes in health-related quality of life (HRQOL), pain, knee function, and return to work (RtW) following high tibial osteotomy (HTO) for medial compartment osteoarthritis (OA), and (2) to investigate the influences of psychopathological comorbidities on preoperative impairment and post-operative course. Sixty-four patients were prospectively followed for 24months after HTO to determine HRQOL, pain, functional outcome, and RtW. Psychopathological comorbidities (e.g. depression) were determined preoperatively. Patients with no psychological distress (ND) were compared to patients with psychological distress (PD) in order to investigate the influence of psychopathological comorbidities on outcome. There was a significant increase in HRQOL and decrease in pain from 6month follow-up on. Functional outcomes increased significantly from 12month follow-up on. In general, there was a steady state of outcomes from 6- to 12-month follow-up on. At final follow-up, 90% returned to their previous occupation without limitations. Mental component summary (MCS) and functional outcome showed a positive correlation with RtW, while depression had a negative one. A significantly inferior outcome of group PD versus ND was observed at baseline and early follow-up. RtW was significantly prolonged in group PD (8.9±7.6 vs. 3.9±3months; p<0.001). At final follow-up, both groups presented with comparable outcomes. HTO for medial compartment OA significantly improves HRQOL, pain, and knee function. Time to RtW is high and critically depends on PD. Further, extend of preoperative impairments, an initially inferior course, and inferior MCS outcome was influenced by PD. However, otherwise no significant differences were observed between groups PD and ND at final follow-up. Prospective case series, II.

Identifying reprioritization response shift in a stroke caregiver population: a comparison of missing data methods.

Response shift (RS) is an important phenomenon that influences the assessment of longitudinal changes in health-related quality of life (HRQOL) studies. Given that RS effects are often small, missing data due to attrition or item non-response can contribute to failure to detect RS effects. Since missing data are often encountered in longitudinal HRQOL data, effective strategies to deal with missing data are important to consider. This study aims to compare different imputation methods on the detection of reprioritization RS in the HRQOL of caregivers of stroke survivors. Data were from a Canadian multi-center longitudinal study of caregivers of stroke survivors over a one-year period. The Stroke Impact Scale physical function score at baseline, with a cutoff of 75, was used to measure patient stroke severity for the reprioritization RS analysis. Mean imputation, likelihood-based expectation-maximization imputation, and multiple imputation methods were compared in test procedures based on changes in relative importance weights to detect RS in SF-36 domains over a 6-month period. Monte Carlo simulation methods were used to compare the statistical powers of relative importance test procedures for detecting RS in incomplete longitudinal data under different missing data mechanisms and imputation methods. Of the 409 caregivers, 15.9 and 31.3 % of them had missing data at baseline and 6 months, respectively. There were no statistically significant changes in relative importance weights on any of the domains when complete-case analysis was adopted. But statistical significant changes were detected on physical functioning and/or vitality domains when mean imputation or EM imputation was adopted. There were also statistically significant changes in relative importance weights for physical functioning, mental health, and vitality domains when multiple imputation method was adopted. Our simulations revealed that relative importance test procedures were least powerful under complete-case analysis method and most powerful when a mean imputation or multiple imputation method was adopted for missing data, regardless of the missing data mechanism and proportion of missing data. Test procedures based on relative importance measures are sensitive to the type and amount of missing data and imputation method. Relative importance test procedures based on mean imputation and multiple imputation are recommended for detecting RS in incomplete data.

Longitudinal changes in health-related quality of life for chronic diseases: an example in hemophilia A.

Patients with well-managed rare chronic diseases such as hemophilia maintain a stable health state and health-related quality of life (HrQoL) that may be affected by acute events. Longitudinal HrQoL assessments analyzed using multivariate multilevel (MVML) modelling can determine the impact of such events on individuals (within-person effect) and identify factors influencing within-population differences (between-person effect). To demonstrate the application of MVML modelling in a longitudinal study of HrQoL in hemophilia A. Using data on 136 adults and 125 children from a two-year observational cohort study of burden of illness in US hemophilia A patients, MVML modelling determined the effect of time-invariant (sociodemographic and clinical characteristics) and time-varying factors (bleeding frequency, emergency room visits, and missed work/school days) on within-person and between-person HrQoL changes. HrQoL was assessed using the SF-12 health survey (adults) and PedsQL inventory (children) at baseline, then every 6months. In children, within-person (p < 0.0001) and between-person (p < 0.0001) psychosocial functioning was reduced by each additional bleed and missed day (within-person: p = 0.0089; between-person: p = 0.0060). Within-person physical functioning was reduced by each additional bleed (p < 0.0001), emergency room (ER) visit (p = 0.0284), and missed day (p = 0.0473). Between-persons, additional missed days (p < 0.0001) significantly decreased physical functioning. In adults, each additional missed day reduced SF-12 Health Survey mental (p = 0.0025) and physical (p = 0.0093) component summary scores. Each additional bleed also decreased physical component summary (PCS) significantly (p = 0.0093). This study demonstrated the applicability of MVML modelling in identifying time-invariant and time-varying factors influencing HrQoL in a rare chronic disease population. Small but significant within-person and between-person changes in HrQoL with each additional acute event experienced were identified, which if frequent, could have a large cumulative impact. The results suggest that MVML modelling may be applied to future studies of longitudinal change in HrQoL in other rare chronic disease populations.

Nationwide Japanese Prostate Cancer Outcome Study of Permanent Iodine-125 Seed Implantation (J-POPS)

To evaluate the safety and efficacy of brachytherapy with permanent iodine-125 seed implantation (PI) for prostate cancer. The nationwide Japanese Prostate Cancer Outcome Study of Permanent Iodine-125 Seed Implantation (J-POPS) has continued since July 2005. This manuscript presents the rationale, J-POPS study design, and the characteristics of initial participants enrolled in this study from July 2005 to June 2007. All participants were treated with PI in accordance with the American Brachytherapy Society recommendations. The primary outcome measure was biochemical progression-free survival. Progression-free survival, overall survival, cause-specific survival, longitudinal changes in health-related quality of life, disease-specific quality of life, the International Prostate Symptom Score, and the incidence of adverse events were also investigated as secondary outcome measurements. Overall, 6,927 patients were enrolled by the end of 2010, that is approximately 40 % of all cases treated around the country. During the first 2 years, 2,354 participants were enrolled and 2,339 were actually treated with PI. The age range of participants was 45 to 89 years (median 69 years) and their risk classifications were 1,037 (44.3 %) at low risk, 1,126 (48.1 %) at intermediate risk, and 134 (5.7 %) at high risk, in addition to 16 participants whose classification was unknown. Of all patients, 76.6 % were treated with PI without external beam radiation therapy and 49.3 % received neoadjuvant hormone therapy. The J-POPS, a nationwide prospective cohort study that enrolled approximately 40 % of all PI cases in Japan, will provide highly reliable evidence, including outcomes and quality of life, after long-term follow-up.

Longitudinal changes in health-related quality of life in normal glucose tolerance, prediabetes and type 2 diabetes: results from the KORA S4/F4 cohort study.

The aim of this study was to examine how transition between normal glucose tolerance, prediabetes and diabetes over a 7 year period is associated with change in health-related quality of life (HRQL) in an elder German population-based cohort. We used data from 1,046 participants of the KORA S4/F4 cohort study aged 55-74 years at baseline. Based on an oral glucose tolerance test, prediabetes was defined as impaired fasting glucose and/or impaired glucose tolerance. HRQL was assessed with the SF-12 questionnaire. Using linear regression, we estimated mean change in HRQL over time, depending on glucose status at baseline and follow-up, adjusted by demographic and lifestyle variables. Individuals progressing to prediabetes or diabetes experienced a greater loss in the physical component score than patients with persistent normal glucose tolerance (-2.31 and -7.44 vs. -1.08), but the difference was only significant for subjects converting to diabetes. Subjects with prediabetes at baseline and diabetes at follow-up had a significant loss in mental health compared to subjects with persistent prediabetes. There is first evidence that worsening of glucose metabolism over time is associated with deteriorating HRQL, however, further and larger longitudinal studies are needed to confirm these findings.

Longitudinal change in health-related quality of life after intensity-modulated radiation monotherapy for clinically localized prostate cancer

Purpose The purpose of the study is to assess longitudinal changes in general and disease-specific health-related quality-of-life (HRQOL) indices after intensity-modulated radiotherapy (IMRT) monotherapy for patients with localized prostate cancer (PCA).Methods Between 2006 and 2010, 91 patients with localized PCA underwent IMRT monotherapy and were enrolled into this prospective study. At baseline, and at 3, 6, 12, and 24 months after IMRT, the general and prostate-specific HRQOL were estimated using physical (PCS) and mental component summaries (MCS) calculated using the Medical Outcomes Study 8-Item Short Form Health Survey and Expanded Prostate Cancer Index Composite (EPIC).ResultsFor 2 years, there were no significant changes in EPIC scores in all subscales of urinary domain, hormonal function, and bother. Bowel and sexual function scores decreased after IMRT and did not return to those at baseline (p = 0.006 and < 0.001, respectively). PCS began to decrease at 3 months after IMRT and then returned to the baseline score at 24 months. In contrast, the MCS score began to significantly increase after IMRT, and thereafter the score remained constant until 24 months (p < 0.001). On multivariate logistic regression analysis, urinary (p = 0.003) and sexual functions (p = 0.0005) at baseline were identified as significant predictors of EPIC urinary irritative/obstructive score and sexual function at 24 months after IMRT.ConclusionUrinary function, including irritative/obstruction symptoms and hormonal function, was not affected by IMRT. However, bowel and sexual function decreased after IMRT. These findings will provide important information for PCA patients considering IMRT.

Longitudinal Changes in Health-Related Quality of Life Scores in Brazilian Incident Peritoneal Dialysis Patients (Brazpd): Socio-Economic Status Not a Barrier

A large proportion of the patients on peritoneal dialysis (PD) in Brazil have low levels of education and family income. The present study assessed whether education level and family income are associated with baseline and longitudinal changes in health-related quality of life (HRQOL) scores during the first year of PD therapy. We evaluated 1624 incident patients from the Brazilian Peritoneal Dialysis Multicenter Study (BRAZPD) at baseline, and 486 of them after 12 months. The SF-36 was used to determine HRQOL and the Karnofsky index (KI), physical performance. At baseline, patients received high KI scores compared with scores on the SF-36. The means of the mental and physical components at baseline and after 12 months were 39.9 ± 10.5 compared with 38.7 ± 11.7 and 41.8 ± 9.6 compared with 40.7 ± 9.8 respectively, which were not statistically different. A multivariate regression analysis showed that age, sex, diabetes, and cardiovascular disease were predictors of the mental component (respectively, β = 0.12, p < 0.001; β = 0.11, p < 0.001; β = -0.08, β = 0.007; and β = -0.07, p = 0.007) and that age, sex, diabetes, cardiovascular disease, hemoglobin, glucose, and creatinine were predictors of the physical component (respectively, β = -0.28, p < 0.001; β = 0.06, p = 0.009; β = -0.09, p = 0.002; β = -0.09, p = 0.001; β = 0.07, p = 0.004; β = -0.05, p = 0.040; and β = 0.05, p = 0.040). Education level and family income were not significantly associated with HRQOL (mental and physical components) in the multivariate regression. The results indicate that, as predictors, family income and education level have no impact on HRQOL, supporting the idea that socio-economic status should not be a barrier to the selection of PD as a treatment modality in Brazil.

PSY67 - Longitudinal changes in health-related quality of life for chronic diseases: An example from the hemophilia utilization group study part va (HUGS Va)

PSY67 - Longitudinal changes in health-related quality of life for chronic diseases: An example from the hemophilia utilization group study part va (HUGS Va)

Changes in health‐related quality of life by occupational status among women diagnosed with breast cancer—a population‐based cohort study

To investigate whether longitudinal changes in health-related quality of life (HRQoL) among breast cancer patients vary by prediagnosis occupational status or postdiagnosis changes in working time. We identified 1573 patients in the Breast Cancer Quality Register of Central Sweden and asked them to participate in a longitudinal questionnaire study. A total of n = 841 women completed three questionnaires within a mean time of 4, 16, and 38 months postdiagnosis. Generalized estimating equation models were used to examine changes in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire and the Breast Cancer-Specific Quality of Life Questionnaire subscales stratified by prediagnosis occupational status and postdiagnosis changes in working time. Over time, the proportion of employed women reporting good functioning increased more, and the proportion reporting a high level of symptoms decreased more compared with women on sick leave/disability pension and retirement pensioners (p < 0.001). The latter two also showed a worsening in several subscales (p < 0.05). Among employed women, more consistent improvements in role and social functioning were observed among those with an increase/no change in working time than among those who had decreased it or stopped working (p < 0.05). A decrease in the proportion reporting pain was observed among women with an increase/no change in working time compared with women with decreased working time, among whom the proportion reporting pain increased (p = 0.008). Being employed prediagnosis and resuming work to the same extent as prior to the breast cancer diagnosis are associated with consistent improvements in HRQoL. These results highlight the importance of interventions to improve HRQoL and policies to support return to work following diagnosis.

Improved Quality of Life (QOL) Outcomes in Patients With Head-and-Neck Squamous Cell Carcinoma (HNSCC) Treated With Intensity Modulated Radiation Therapy (IMRT) Compared to 3-dimensional Conformal Radiation Therapy (3D-CRT): Evidence From a Prospective Randomized Study

Improved Quality of Life (QOL) Outcomes in Patients With Head-and-Neck Squamous Cell Carcinoma (HNSCC) Treated With Intensity Modulated Radiation Therapy (IMRT) Compared to 3-dimensional Conformal Radiation Therapy (3D-CRT): Evidence From a Prospective Randomized Study

Impact of diagnosis and treatment of clinically localized prostate cancer on health‐related quality of life for older Americans

Few studies have measured longitudinal changes in health-related quality of life (HRQOL) among patients with prostate cancer starting before their cancer diagnosis or have provided simultaneous comparisons with a matched noncancer cohort. In the current study, the authors addressed these gaps by providing unique estimates of the effects of a cancer diagnosis on HRQOL accounting for the confounding effects of ageing and comorbidity. Data from the Surveillance, Epidemiology, and End Results registry were linked with Medicare Health Outcomes Survey (MHOS) data. Eligible patients (n = 445) were Medicare beneficiaries aged ≥65 years from 1998 to 2003 whose first prostate cancer diagnosis occurred between their baseline and follow-up MHOS. By using propensity score matching, 2225 participants without cancer were identified from the MHOS data. Analysis of covariance models were used to estimate changes in HRQOL as assessed with the Medical Outcomes Study Short Form-36 survey and the activities of daily living scale. Before diagnosis, patients with prostate cancer reported HRQOL similar to that of men without cancer. After diagnosis, men with prostate cancer experienced significant decrements in physical, mental, and social aspects of their lives relative to controls, especially within the first 6 months after diagnosis. For men who were surveyed beyond 1 year after diagnosis, HRQOL was similar to that for controls. However, an increased risk for major depressive disorder was observed among men who received either conservative management or external beam radiation. The current findings illustrated the time-sensitive nature of decline in HRQOL after a cancer diagnosis and enhanced understanding of the impact of prostate cancer diagnosis and treatment on physical, mental, and social well being among older men.

Safety and efficacy of single-agent adjuvant trastzumab in older women with breast cancer.

TPS109 Background: Trastuzumab is a humanized monoclonal antibody targeting the extracellular domain of the human epidermal growth factor receptor 2 (HER2) protein. The addition of trastuzumab to adjuvant chemotherapy, either concomitant or sequential, leads to better outcomes for women with HER2-positive breast cancer and in the setting of metastatic disease, single agent trastuzumab is effective and extremely well tolerated. The main adverse effect of trastuzumab is cardiotoxicity, which necessitated discontinuation prior to the planned one year of therapy in 17% of women on adjuvant trials. Since age is a risk factor for the cardiotoxicity of trastuzumab, and women ≥ 65 years were under-represented in trastuzumab clinical trials, determination of the safety and efficacy of trastuzumab in this patient population is lacking. This study is designed to define the risk-benefit profile of adjuvant single-agent trastuzumab in older women. Methods: This open label, single arm, multi-center, phase II study will include 124 women with stage I-III, HER2+ (defined as either 3+ by immunohistochemistry or gene amplified by fluorescent in situ hybridization), breast cancer who undergo primary surgery (mastectomy or lumpectomy) with at least a sentinel lymph node dissection, and are unwilling to undergo or are unable to tolerate adjuvant chemotherapy. Trastuzumab will be given, at 8mg/kg IV loading dose followed by 6mg/kg IV every three weeks, for 52 weeks. Patients will be followed prospectively for five years or until death, whichever comes first. The primary objective of the study is to evaluate the three-year cumulative incidence of cardiac events. Secondary objectives include i) the three-year cumulative incidence of asymptomatic decline in Left Ventricular Ejection Fraction; ii) the five-year cumulative incidence of cardiac events; iii) three-year disease-free and overall survival; iv) identification of correlative biomarkers of cardiac events (troponin-I, N-terminal brain natriuretic protein, and pro-inflammatory cytokines); and v) the longitudinal changes in Health-related Quality of Life, functional, cognitive, and mental status. Ten patients have been enrolled thus far.

Evidence of disagreement between patient-perceived change and conventional longitudinal evaluation of change in health-related quality of life among older adults

Objective: To identify agreement levels between conventional longitudinal evaluation of change (post—pre) and patient-perceived change (post—then test) in health-related quality of life. Design: A prospective cohort investigation with two assessment points (baseline and six-month follow-up) was implemented. Setting: Community rehabilitation setting. Subjects: Frail older adults accessing community-based rehabilitation services. Intervention: Nil as part of this investigation. Main measures: Conventional longitudinal change in health-related quality of life was considered the difference between standard EQ-5D assessments completed at baseline and follow-up. To evaluate patient-perceived change a ‘then test’ was also completed at the follow-up assessment. This required participants to report (from their current perspective) how they believe their health-related quality of life was at baseline (using the EQ-5D). Patient-perceived change was considered the difference between ‘then test’ and standard follow-up EQ-5D assessments. Results: The mean (SD) age of participants was 78.8 (7.3). Of the 70 participants 62 (89%) of data sets were complete and included in analysis. Agreement between conventional (post—pre) and patient-perceived (post—then test) change was low to moderate (EQ-5D utility intraclass correlation coefficient (ICC) = 0.41, EQ-5D visual analogue scale (VAS) ICC = 0.21). Neither approach inferred greater change than the other (utility P =0.925, VAS P =0.506). Mean (95% confidence interval (CI)) conventional change in EQ-5D utility and VAS were 0.140 (0.045,0.236) and 8.8 (3.3,14.3) respectively, while patient-perceived change was 0.147 (0.055,0.238) and 6.4 (1.7,11.1) respectively. Conclusions: Substantial disagreement exists between conventional longitudinal evaluation of change in health-related quality of life and patient-perceived change in health-related quality of life (as measured using a then test) within individuals.

Deterioration in quality of life following hip fracture: a prospective study.

To examine longitudinal change in health-related quality of life (HRQoL) following hip fracture in elderly subjects, 32 patients with hip fractures and 29 sex-matched non-fracture control subjects (mean +/- SD age 82 +/- 8 and 86 +/- 6 years respectively) were enrolled in a prospective, case-control study. Fracture subjects completed a generic questionnaire, Short Form 36 (SF-36), and a disease-targeted measure, the revised Osteoporosis Assessment Questionnaire (OPAQ2), on two separate occasions, within 1 week of fracture and 12-15 weeks after fracture. Controls completed both questionnaires on two occasions 12 weeks apart. SF-36 scores were significantly correlated with OPAQ2 in comparable domains of Physical Function (r = 0.76), General Health (r = 0.70) and Mental Health/Tension (r=0.86). Control subjects had stable scores with the OPAQ2 and SF-36. At 3 months after fracture there was a significant reduction in HRQoL in the SF-36 domains Physical Function (-51%), Vitality (-24%) and Social Function (-26%) and in the OPAQ2 domains Physical Function (-20%), Social Activity (-49%) and General Health (-24%). Hip fracture patients thus had a lower baseline HRQoL and experienced a significant deterioration in HRQoL after hip fracture on both the SF-36 and OPAQ2. HRQoL should be part of a comprehensive assessment of the costs of osteoporosis including fracture-associated morbidity.