Health-related Quality Of Life Profile Research Articles

Randomized Controlled Trial of Trastuzumab With or Without Chemotherapy for HER2-Positive Early Breast Cancer in Older Patients.

Adjuvant trastuzumab monotherapy has not been compared with trastuzumab + chemotherapy. We investigated the relative value of trastuzumab monotherapy for older patients with breast cancer. This study was an open-label, randomized controlled study with a treatment selection design in which a noninferiority criterion was predefined. Patients aged 70-80 years with surgically treated human epidermal growth factor receptor 2-positive invasive breast cancer received trastuzumab monotherapy or trastuzumab + chemotherapy. The primary end point was disease-free survival (DFS) with assessment of prespecified hazard ratio (HR), relapse-free survival (RFS), adverse events (AEs), health-related quality of life (HRQoL), and restricted mean survival time (RMST). The study involved 275 patients (mean age, 73.5 years) who were followed up for a mean of 4.1 years (range, 0.3-8.0 years). The percentages of patients by cancer stage were as follows: I (pT > 0.5 cm), 43.6%; IIA, 41.7%; IIB, 13.5%; and IIIA, 1.1%. Three-year DFS was 89.5% with trastuzumab monotherapy versus 93.8% with trastuzumab + chemotherapy (HR, 1.36; 95% CI, 0.72 to 2.58; P = .51). At 3 years, RMST differed by -0.39 months between arms (95% CI, -1.71 to 0.93; P = .56). Three-year RFS was 92.4% with trastuzumab monotherapy versus 95.3% with trastuzumab + chemotherapy (HR, 1.33; 95% CI, 0.63 to 2.79; P = .53). Common AEs were anorexia (7.4% v 44.3%; P < .0001) and alopecia (2.2% v 71.7%; P < .0001), and grade 3/4 nonhematologic AEs occurred in 11.9% versus 29.8% (P = .0003) for trastuzumab monotherapy versus trastuzumab + chemotherapy, respectively. Clinically meaningful HRQoL deterioration rate showed significant differences at 2 months (31% for trastuzumab monotherapy v 48% for trastuzumab + chemotherapy; P = .016) and at 1 year (19% v 38%; P = .009). The primary objective of noninferiority for trastuzumab monotherapy was not met. However, the observed loss of survival without chemotherapy was < 1 month at 3 years. Therefore, and in light of the lower toxicity and more favorable HRQoL profile, trastuzumab monotherapy can be considered an adjuvant therapy option for selected older patients.

Profiles of emotional distress and growth among adolescents and young adults with cancer: A longitudinal study.

This study investigated profiles of emotional distress and growth in adolescents and young adults (AYAs) with cancer. Clinical, demographic, and psychosocial factors were examined for their potential to distinguish these profiles and predict health-related quality of life (HRQoL) of AYAs with cancer. This was a multicenter, longitudinal study of AYAs diagnosed with cancer at 14-39 years of age. Participants were assessed 3 times over 24 months following a baseline survey administered at diagnosis. Four profiles (resilient, resilient growth, distressed, distressed growth) were derived using published cutoff points on standardized measures of depression, anxiety, posttraumatic stress disorder, and posttraumatic growth. Mixed-effects models were used to examine profile correlates and the extent to which profiles were associated with HRQoL. Among 179 participants at Time 1, the proportion of profiles ranged from 18.8% for the resilient profile to 30.4% for the distressed-growth profile. These proportions remained consistent over time. Factors that appeared to distinguish these profiles included work or school status, sex, race, age at diagnosis, treatment status, prognosis, and personality characteristics. When compared to AYAs with resilient-growth profiles, HRQoL was significantly worse for AYAs reporting distressed and distressed-growth profiles, controlling for demographic, clinical, and social characteristics. The current study found 4 patterns of psychological adjustment in AYAs with cancer. The resilient-growth profile was associated with better HRQoL, whereas distressed and distressed-growth profiles were associated with worse HRQoL. (PsycInfo Database Record (c) 2020 APA, all rights reserved).

Motor neuroprosthesis for promoting recovery of function after stroke.

Motor neuroprosthesis for promoting recovery of function after stroke.

Optimising outputs from a validated online instrument to measure health-related quality of life (HRQL) in dogs.

Measurement of health-related quality of life (HRQL) is becoming increasingly valuable within veterinary preventative health care and chronic disease management, as well as in outcomes research. Initial reliability and validation of a 22 item shortened version of VetMetrica (VM), structured questionnaire instrument to measure HRQL in dogs via a mobile application was reported previously. Meaningful interpretation and presentation of the 4 domain scores comprising the HRQL profile generated by VM is key to its successful use in clinical practice and research. Study one describes transformation of domain scores from 0–6 to 0–100 and normalisation of these based on the healthy canine population in two age ranges, such that a score of 50 on a 0–100 scale represents the score for the age-related average healthy dog, and establishment of a threshold to assess domain-specific health status for individual dogs. This provides the clinician with a simple method of ascertaining the health status of an individual dog relative to the average healthy population in the same age group (norm-based scoring). Study two determines the minimum important difference (MID) in domain scores which represents the smallest improvement in score that is meaningful to the dog owner, thus providing the clinician with a means of recognising what is likely to be a significant improvement in scores for an individual dog over time. Visual representation of these guidelines for the purpose of interpreting VM profile scores is presented using case studies.

Using PROMIS® to create clinically meaningful profiles of nephrotic syndrome patients.

Nephrotic syndrome (NS) is a kidney disease known to adversely impact health-related quality of life (HRQOL). Patient-reported outcome (PRO) measures are commonly used to characterize HRQOL and the patient disease experience. This study aims to improve the interpretability and clinical utility of the Patient-Reported Outcomes Measurement Information System® (PROMIS®) by identifying distinct meaningful HRQOL profiles in children and adults with NS. Patients were from 2 prospective NS cohort studies (PROMIS-II®: 121 children; NEPTUNE: 40 children and 219 adults) with data from 6 PROMIS® domains. Latent Profile Analysis was used to identify subgroups of patients based on PROMIS® score patterns. A 3-step analysis of latent profile predictors was used to determine how clinical parameters predicted HRQOL profile membership. We identified 3 HRQOL profiles (Good, Average, and Poor) with strong indicators of membership classification (entropy >0.86). Complete proteinuria remission, reduction in symptoms, and shorter disease duration, were significant predictors of better HRQOL profile membership. Patients with NS can be classified by HRQOL into clinically meaningful categories. Integrating this approach into clinic may help in the identification of individuals with poor HRQOL will help clinicians better manage their symptoms and researchers study the causes and possible interventions for these patients. PROMIS® HRQOL profiles were reproducible in replication cohorts. (PsycINFO Database Record (c) 2019 APA, all rights reserved).

Health-Related Quality of Life Profiles among Patients with Different Road Traffic Injuries in an Urban Setting of Vietnam.

Road traffic injuries (RTIs) cause a substantial disease burden in Vietnam. Evaluating health-related quality of life (HRQOL) among patients having a diversity of RTIs informs an integral part of treatment effectiveness. This study aims to examine HRQOL of patients suffering different RTIs in Vietnam’s urban areas. A cross-sectional study was conducted on 408 patients from October to December 2018 in six hospitals in Thai Binh. The EuroQol-5 dimensions-5 levels (EQ-5D-5L) and visual analog scale (VAS) were used to assess the HRQOL of patients. Multivariable Tobit regression was applied to measure the difference of HRQOL among different kinds of injuries. The mean EQ-5D-5L and VAS score was 0.40–0.66, respectively. Mean EQ-5D-5L index was lowest in patients with oral and facial injuries (0.22) and fracture injuries (0.23), while patients having hand injuries had the highest EQ-5D-5L index (0.54). EQ-5D-5L index had a negative association with oral, facial, and fracture injuries. Meanwhile, patients with brain, fracture, and multiple injuries tended to have lower VAS score. Poor HRQOL among patients injured in road traffic were observed. Pain management, early rehabilitation, and mental health counseling services should be considered during treatment time, especially among those having the brain, oral and facial trauma, fracture, and multiple injuries.

Assessment of health-related quality of life among patients with hypertension: a cross-sectional study from Palestine

BackgroundThe ability to identify indicators of poor health-related quality of life (HRQoL) is crucial for both improving clinical care and determining targets of intervention for the prevention and treatment of disease. The main objectives of this study were to assess the HRQoL profile of individuals with hypertension in Palestine, and to determine the sociodemographic and clinical characteristics associated with poor HRQoL. MethodsA cross-sectional study was conducted, adopting the EuroQoL-5 Dimensions scale (EQ-5D-5 L) for the assessment of HRQoL. Patients with hypertension attending the outpatients' clinic at Al-Makhfyah primary health care clinic and from the outpatients' clinic at Alwatani Hospital, Nablus, Palestine, were approached for the study. The study was approved by the Institutional Review Board at An-Najah National University. Informed verbal consent was obtained from the participants before the start of the study. FindingsA total of 410 patients with hypertension were enrolled from the two centres (205 patients from each centre). Of these patients, 51·95% (213 of 410) were females. The average age of the study population was 58·37 (SD 10·65) years. The mean EQ-5D-5 L index value and EQ visual analogue scale (EQ-VAS) scores were 0·80 (SD 0·16) and 74·13 (15·62), respectively. There was a significant positive correlation (r = 0·56; p<0·001) between the EQ-5D-5L index values and the reported EQ-VAS scores. Higher EQ-5D-5L index values were significantly associated with patients who were younger than 50 years, employed, married, with income higher than US$500, who were university graduates, with a disease duration of less than 1 year, with or without one comorbid disease, and those taking 1–3 medications (Kruskal–Wallis test, p<0·05), as well as with male gender and monotherapy (Mann–Whitney test, p<0·05). InterpretationThe results highlight that specific sociodemographic and disease-related characteristics of patients with hypertension, as well as treatment factors, are strongly associated with HRQoL. The study findings may be helpful in clinical practice, particularly in the early treatment of such patients, at a point at which improvement of HRQoL is still possible. FundingNone.

Health-related quality of life, symptom burden, and comorbidity in long-term survivors of acute promyelocytic leukemia.

The objective of this study was to investigate health-related quality of life (HRQOL), symptom burden, and comorbidity profile in long-term acute promyelocytic leukemia (APL) survivors treated with standard chemotherapy. Overall, 307 long-term APL survivors were invited to participate. HRQOL was assessed with the Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36) and compared with that of age and sex-matched controls from the general population. Symptom burden was assessed with the MD Anderson Symptom Inventory (MDASI) questionnaire and comorbidity profile was also investigated. Median follow-up time since diagnosis was 14.3 years (interquartile range: 11.1-16.9 years). APL survivors had a statistically and clinically meaningful worse score for the role physical scale of the SF-36 (-9.5; 95% CI, -15.7 to -3.2, P = 0.003) than their peers in the general population. Fatigue was reported as moderate to severe by 29% of patients and 84.4% reported at least one comorbidity. Prevalence of comorbidity in APL survivors was higher than that reported by the general population. Also, marked variations were found in the HRQOL profile by number of comorbidities. Even many years after treatment ends, APL survivors treated with standard chemotherapy do not fully recover as they report HRQOL limitations and a substantial burden of symptoms.

Pretreatment Health-Related Quality of Life Profile According to the EORTC QLQ-C30 in Patients with Myelodysplastic Syndromes (MDS): Analysis on 443 Lower-Risk MDS Patients

Background:Understanding health-related quality of life (HRQOL) profile, including functional aspects and symptom burden, of yet untreated patients with myelodysplastic syndromes (MDS) is important to help clinicians to better identify subgroup of patients in need of special attention from the very beginning of therapy.Aims:The primary objective of this study was to investigate baseline (i.e., pretreatment) HRQOL profile of untreated patients with lower-risk MDS, examining differences by age, gender, risk score category and comorbidity. A secondary objective was to provide age and sex baseline reference HRQOL values, according to the EORTC QLQ-C30 questionnaire, to be used as benchmark comparisons in future MDS studies.Methods:This analysis is based on 443 newly diagnosed adult MDS patients with International Prognostic Scoring System (IPSS) risk score of low (46 %) or intermediate-1 (54%), enrolled in an international prospective cohort observational study. Median age was 75 years (range 32-94), with 261 men (59%) and 182 (41%) women. HRQOL was assessed by the EORTC QLQ-C30 questionnaire at study entry, before any treatment (except for transfusions). This well validated questionnaire consists of five functioning scales: physical, role, emotional, cognitive and social; three symptom scales: fatigue, nausea/ vomiting and pain; six single item scales: dyspnoea, sleep disturbance, appetite loss, constipation, diarrhea and financial impact; and the global health status/HRQOL scale. The items were scaled and scored using the recommended EORTC procedures. At the time of baseline HRQOL assessment, 111 (25%) patients had received at least one red blood cell transfusion. We used Wilcoxon-Mann-Whitney and Kruskal-Wallis tests for all comparisons. We used the false discovery rate approach to account for multiple testing, with a nominal α-level=0.05. In addition to statistical significance, clinically relevant HRQOL differences were also evaluated based on previously published criteria (Cocks K, et al, J Clin Oncol 29:89-96, 2011).Results:There were not statistically significant differences in any of the HRQOL scales measured by the EORTC QLQ-C30, by the specific IPSS risk category (i.e., low risk vs intermediate-1 risk score). Overall, women reported worse HRQOL scores than men, with clinically relevant differences for physical (Δ=-7.1, P=0.002), role (Δ=-9.9, P=0.002) and emotional functioning, (Δ=-10, P<0.001), nausea/vomiting (Δ=3.7, P<0.001), insomnia (Δ=7.6, P=0.011) and appetite loss (Δ=5.6, P=0.019). Younger patients also reported better outcomes than older patients and this was more evident in the Physical Functioning domain. Also, HRQOL profile varied substantially by number of comorbidities (zero, one, two or more). In general, there was a worsening HRQOL trend with the increase of comorbidities. However, HRQOL impairments were markedly larger in patients with at least two comorbidities, who showed both small and medium clinically relevant differences, when compared to patients with no comorbidities. The largest differences between patients with no comorbidity and those with two or more were found in the following HRQOL domains: Physical Functioning (Δ=-15.3, P<0.001), Fatigue (Δ=-11.9, P<0.001) and Global health status/QOL (Δ=10.0, P<0.001). Full baseline reference values by specific age group categories and sex, according to the EORTC QLQ-C30, are reported in Table 1.Conclusion:Pretreatment HRQOL profile in lower-risk MDS patients vary substantially by age group categories, sex and number of comorbidities, and these differences should be highly considered at the time of treatment start. As in MDS research, the EORTC QLQ-C30 is currently one of the most frequently used HRQOL measure, our baseline reference values provide benchmark data against which other MDS studies using this questionnaire may be compared. [Display omitted] DisclosuresEfficace:Bristol Meyers Squibb: Consultancy; Seattle Genetics: Consultancy; Orsenix: Consultancy; Incyte: Consultancy; TEVA: Research Funding; TEVA: Consultancy; Lundbeck: Research Funding; Amgen: Consultancy; AMGEN: Research Funding. Palumbo:Celgene: Honoraria, Membership on an entity's Board of Directors or advisory committees; Novartis: Honoraria, Membership on an entity's Board of Directors or advisory committees. Platzbecker:Celgene: Research Funding. Stauder:Novartis: Honoraria, Membership on an entity's Board of Directors or advisory committees; Teva: Research Funding; Celgene: Honoraria, Membership on an entity's Board of Directors or advisory committees. Breccia:Novartis: Honoraria; Incyte: Honoraria; Pfizer: Honoraria; BMS: Honoraria. Voso:Celgene: Research Funding, Speakers Bureau. Santini:AbbVie: Membership on an entity's Board of Directors or advisory committees; Celgene: Honoraria, Research Funding; Amgen: Membership on an entity's Board of Directors or advisory committees; Janssen: Honoraria, Membership on an entity's Board of Directors or advisory committees; Otsuka: Consultancy; Novartis: Honoraria. Lubbert:Teva: Other: Study drug; Celgene: Other: Travel Grant; Janssen: Honoraria, Research Funding. Cuneo:Gilead: Other: advisory board, Speakers Bureau; Abbvie: Other: advisory board, Speakers Bureau; Roche: Other: advisory board, Speakers Bureau; janssen: Other: advisory board, Speakers Bureau.

Achieving optimal response at 12\xa0months is associated with a better health-related quality of life in patients with chronic myeloid leukemia: a prospective, longitudinal, single center study

BackgroundTo assess the relationship between responses within 1 year and health-related quality of life (HRQoL) outcomes by exploring profiles of patients with CML-CP who were treated with front-line imatinib or nilotinib.MethodsA prospective, longitudinal, single-center study was conducted to assess the response to treatment with imatinib or nilotinib and the HRQoL profile of patients who were newly diagnosed with CML in chronic phase enrolled in the ENESTchina study.ResultsFifty-nine patients were randomized to receive imatinib (n = 31) or nilotinib (n = 28). With a median follow-up of 5 years, there was no difference in HRQoL profile observed between patients receiving imatinib and nilotinib. Achieving optimal response at 12 months was associated with better role limitations due to physical health problems (RP; P = 0.0019) and emotional problems (RE; P = 0.0110) and was the sole factor associated with significantly improving physical component summary over time (PCS; P = 0.0160). Achieving optimal response at 6 months had high probability of better physical functioning (PF; P = 0.0674), better social functioning (SF; P = 0.0571), and reduced role limitations due to emotional problems (RE; P = 0.0916). In addition, factors including age < 40 years, female gender, and higher level of education were also associated with better HRQoL subscale scores. However, optimal response at 3 months had no impact on HRQoL profile. The proportions of patients with failure-free survival and PFS at 5 years were significantly higher among patients who achieved optimal response at 3, 6, or 12 months than among those who did not achieve optimal response (warning or failure), and the OS rate at 5 years was significantly higher among those who achieved optimal response at 12 months. In a multivariate analysis, treatment received (nilotinib vs imatinib) was identified as an independent factor for the achievement of optimal response at both 6 months (OR, 3.9; 95% CI, 1.0–14.9) and 12 months (OR, 5.6; 95% CI, 1.7–17.9).ConclusionsAchieving optimal response at 12 months was not only associated with longer OS and reduced treatment failure rates and disease progression but also better HRQoL in newly diagnosed patients with CML-CP receiving front-line tyrosine kinase inhibitor treatment.Trial registrationChinese Clinical Trial Registry (http://www.chictr.org.cn): ChiCTR-OCH-11001699.

Non-Motor Symptoms as Predictors of Quality of Life in Egyptian Patients With Parkinson's Disease: A Cross-Sectional Study Using a Culturally Adapted 39-Item Parkinson's Disease Questionnaire.

The prevalence of non-motor symptoms (NMSs) and their impact on health-related quality of life (HRQoL) in Parkinson's disease (PD) has been reported inconsistently among different populations. In this study, we aimed to investigate the NMSs and HRQoL profiles and their correlation in Egyptian PD patients, using a culturally adapted Arabic version of the 39-item Parkinson's disease questionnaire (PDQ-39). Ninety-seven PD patients were rated using the unified Parkinson's disease rating scale (UPDRS), the non-motor symptoms scales (NMSS), Beck depression inventory (BDI), and the Arabic version of PDQ-39. We used the Spearman's rank correlation and multiple linear regression analyses to evaluate the relationship between NMSs domains and HRQoL dimensions. Fatigue/sleep (91.3%) and mood/cognitive disturbances (87%) were the most frequently and severely affected NMSS domains. Other common NMSs included urinary (75.9%), memory/attention (72.4%), gastrointestinal (67.8%), and cardiovascular problems (64.8%). The total NMSS scores were positively correlated with UPDRS I, II, and III scores. Depression was prevalent in 76.7% of PD patients. Moreover, all enrolled PD patients reported impairment in different HRQoL dimensions, especially mobility (98.9%), activities of daily living (97.8%), and emotional well-being (95.5%). The summary index of PDQ-39 was correlated to the total NMSS, UPDRS-I, UPDRS-II Off, UPDRS-III (Off and On states), and BDI scores. This study showed the high prevalence of NMSs and the value of NMSS and BDI scores as predictors of HRQoL in Egyptian PD patients. Therefore, characterizing the NMSs profile is essential for tailoring management strategies for PD patients.

Children with a History of Premature Adrenarche Have Good Health-Related Quality of Life at the Age of 12 Years

Background/Aim: Children with premature adrenarche (PA) are taller and more overweight than their healthy peers, and PA girls have a slightly accelerated pubertal development. There is some evidence that early exposure to androgens may have an influence on psychosocial development. The aim of this cross-sectional case-control study was to evaluate health-related quality of life (HRQoL) in PA children at the age of 12 years. Methods: The HRQoL was assessed for 43 PA (36 girls) and 63 control children (52 girls) at the median age of 12.0 years using the standardized 16D instrument, and the scores of the PA children were compared to those of the control children and reference population. Results: The mean overall HRQoL scores did not differ between PA and control girls, PA and control boys, or all PA and control children or the reference population. Independently of PA, overweight girls had a lower mean overall HRQoL score than lean girls, and both overweight girls and boys were on average worse off on the dimension of appearance than their lean peers. Conclusions: PA children have as good self-rated HRQoL as their peers at the age of 12 years. Overweight is associated with a worse HRQoL profile independently of PA.

Development, initial validation and reliability testing of a web-based, generic feline health-related quality-of-life instrument.

The objective of this study was to develop a valid, reliable, web-based generic feline health-related quality-of-life (HRQoL) questionnaire instrument to measure the affective impact of chronic disease. A large initial item pool, obtained through interviews with cat owners, was reduced using predetermined criteria, survey scores for relevance and clarity, and the ability of individual items to discriminate between healthy and sick cats when owners completed a prototype questionnaire. Using these data, factor analysis was used to derive a scoring algorithm and provide evidence for factorial validity. Validity was demonstrated further in a field trial using a 'known groups' approach (sick vs healthy cats will have a different HRQoL profile, and the HRQoL profile of cats will deteriorate as comorbidities increase). Test-retest reliability was assessed using intra-class correlation coefficients (ICCs). In total, 165 items were reduced to 20 and, on the basis of a factor analysis that explained 72.3% of the variation in scores input by 71 owners of 30 healthy and 41 sick cats using the prototype, these were allocated to three domains (vitality, comfort and emotional wellbeing [EWB]) with a scoring algorithm derived using item loadings. Subsequently, the owners of 36 healthy and 58 sick cats completed one or two (n = 48) assessments. Median scores (healthy vs sick) for all domains were significantly different ( P <0.001), 78% of cats were correctly classified as healthy or sick and for comorbidities the correlation coefficients were moderate (vitality 0.64; comfort 0.63; EWB 0.50). Test-retest reliability was good (ICC vitality 0.635; comfort 0.716; EWB 0.853). This study provides initial evidence for the validity and reliability of a novel HRQoL instrument to aid the assessment and management of chronic diseases of cats.

Health-related quality of life of adolescent students.

This study aimed to evaluate the perception of health related quality of life (HRQoL) of adolescent students. This is a cross-sectional study with 807 adolescents aged 10 to 17 years from two public schools of Niteroi and four private schools of Rio de Janeiro and São Gonçalo. Information on HRQoL was obtained by a reduced version of the Kidscreen questionnaire with 27 items. Student t tests were used to assess the perception of HRQoL stratified by type of school, gender, age and ownership of assets. We used linear regression models to evaluate HRQoL settings. In general, the evaluated adolescents evidenced a good HRQoL. However, results show significant differences in the perception of each HRQoL realm between subgroups. Private school adolescents had better HRQoL compared to public schools in all Kidscreen-27 realms. Older adolescents, those from public school and those with lower ownership of assets had lower HRQoL values in most realms, particularly in the 'Autonomy and Relationship with Parents' realm. Disclosure of the differentiated profile of HRQoL among adolescents is the first step towards developing action strategies in the school environment that prioritize the most vulnerable groups.

VASOVAGAL SYNCOPE PATIENTS HAVE A REDUCED QUALITY OF LIFE AND GREATER PSYCHOLOGICAL DISTRESS COMPARED TO HEALTHY SUBJECTS

Patients with vasovagal syncope (VVS) are highly symptomatic and have a reduced health-related quality of life (HRQoL). There is limited data comparing the HRQoL and psychological profile between VVS patients and healthy individuals. The purpose of this study was to examine the differences in HRQoL and psychological distress between VVS patients and healthy subjects. We tested the hypothesis that VVS patients will have greater impairment in both HRQoL and psychological profile compared to healthy individuals. The RAND 36-Item Health Survey (RAND36), Hospital Anxiety and Depression Scale (HADS), and Anxiety Sensitivity Index (ASI) were completed at baseline by VVS patients and healthy subjects enrolled in the Second Prevention of Syncope Trial (POST II), a randomized, placebo-controlled trial of fludrocortisone for VVS. Data are reported as mean±SD with Student’s t-tests. Data are available on 76 VVS patients (34±14 years; 68% F) and 85 healthy subjects (35±11 years; 80% F). For the RAND36 (Table), VVS patients reported poorer physical functioning (p < 0.001), emotional well-being (p < 0.001), social functioning (p < 0.001), and general health (p < 0.001) compared to healthy subjects. They also had less energy (p < 0.001), more pain (p < 0.001), and greater role limitations due to both physical health (p < 0.001) and emotional problems (p < 0.001). For the HADS, VVS patients had greater anxiety (p < 0.001) and were more depressed (p < 0.001). VVS patients also reported greater anxiety sensitivity in the ASI (p < 0.001). VVS patients have a reduced HRQoL and poorer psychological profile compared to healthy subjects. VVS patients may benefit from targeted interventions addressing these concerns.

The SIMS trial: adjustable anchored single-incision mini-slings versus standard tension-free midurethral slings in the surgical management of female stress urinary incontinence. A study protocol for a pragmatic, multicentre, non-inferiority randomised controlled trial

IntroductionSingle-incision mini-slings (SIMS) represent the third generation of midurethral slings. They have been developed with the aim of offering a true ambulatory procedure for treatment of female stress urinary incontinence...

The Health-Related Quality of Life of Students Involved in School Bullying

Aim: To analyse health-related quality of life (HRQL) in relation to participation in bullying (frequency and role). The main goal was to investigate how effects of bullying are related to role and to determine whether the effect of bullying involvement on HRQL is independent of perceived social support. Methods: Effects of sex and role on various HRQL dimensions were investigated in a representative sample of students (N=769) in Talavera de la Reina (Spain) using Kidscreen-52. T-tests were used to analyse sex differences in HRQL, victimisation and aggression; a chi square test was used to investigate role effects and ANOVA was used to identify the HRQL profile associated with each role. Linear regression was used to determine whether the effects of victimisation and aggression on HRQL were independent of the potential effect of social support. Results: Being involved in school bullying negatively affects children’s HRQL, whose impact is greater in aggressive victims and pure victims, respectively. Aggression has no independent effect on HRQL, whereas victimisation has a negative effect on HRQL and mood regardless of level of social support; life satisfaction is generally higher among students with social support. Conclusion: Stability and persistence of victimisation appear to influence HRQL such that the effects of bullying on HRQL are greatest in roles that have greatest involvement in bullying.

Health Related Quality of Life of Long-Term Survivors of Acute Promyelocytic Leukemia Treated with All-Trans Retinoic Acid and Chemotherapy

Background:Combined treatment with all-trans retinoic acid (ATRA) and anthracycline-based chemotherapy regimens has remarkably contributed to improve treatment outcomes in patients with Acute Promyelocytic Leukemia (APL) patients leading to cure rates above 80%. However, information is lacking on how these patients might recover in the long-term period.Objective:The primary objective of this study was to investigate long-term health-related quality of life (HRQOL) and symptom burden in APL and to examine factors predicting better long-term HRQOL outcomes.Patients and Methods:Patients with APL treated within two large GIMEMA trials (i.e., AIDA0493 and AIDA 2000) were considered. All patients received ATRA plus Idarubicin (AIDA) for induction followed by consolidation that was risk-adapted in AIDA2000 and in most cases, maintenance for 2 years . The main inclusion criterion was having survived the initial diagnosis for more than 5 years and being in complete remission (CR) at the time of study inclusion. The SF-36 was used to assess generic HRQOL. This questionnaire consists of 36 items covering eight generic health status/QoL domains: physical functioning (PF), role limitations due to physical health (RP), bodily pain (BP), general health perceptions (GH), vitality (VT), social functioning (SF), role limitations due to emotional problems (RE) and mental health (MH). Mean SF-36 scores were compared between APL patients and those from general population. To minimize bias, all comparisons were performed between APL patients and corresponding propensity score-matched peers from general population, further adjusting for education, family status and geographical area using a multivariate linear mixed model. For descriptive purposes, a cut-off of 30 years was considered to distinguish between younger and older patients at the time of diagnosis and the corresponding HRQoL profiles were compared using multivariate linear regression analysis to adjust for key potential confounders. Also, M.D. Anderson Symptom Inventory (MDASI) was assessed to investigate the profile and prevalence symptom burdenResults:Of the 307 patients, potentially eligible for this analysis and invited to participate in the study, 244 completed a HRQOL questionnaire (compliance 79.5%). No differences were found in the main socio-demographic and clinical characteristics between patients with or without a HRQOL evaluation. Mean age of patients was 52 years (range 20-90) and there were 47% males and 53% females. Median time from diagnosis was 14 years (range: 4-20). There were 81% of patients reporting at least 1 comorbidity at the time of HRQOL evaluation. APL long-term survivors reported a HRQOL profile broadly similar to that of their peers in the general population. However, the RP scale was statistically (P=0.016) and clinically meaningful worse in APL patients. Fatigue was the most prevalent symptom with 70% of patients reporting it with any level of concern, as well the most frequently reported moderate to severe symptom by 29 % of patients. Being distressed and problem with remembering things were the other two most prevalent symptoms reported by 65% and 62% of patients respectively. Being diagnosed at a younger age (<30 years) was a key factor associated with better long-term HRQOL outcomes. This was particularly relevant in physical health aspects. Detailed results of adjusted mean differences in SF-36 scores between age groups are reported in Table 1.ConclusionsAPL patients successfully treated with AIDA-like regimens may expect to have broadly similar HRQOL outcomes when compared to their peers witout cancer in the general population. However, significant limitations in work or other daily activities due to physical and emotional problems still persist after many years from diagnosis in the majority of patients. Our results also show that on the long-term period, younger APL patients recover better than older ones in terms of HRQOL outcomes. [Display omitted] DisclosuresEfficace:TEVA: Consultancy, Research Funding; Seattle Genetics: Consultancy; Bristol Myers Squibb: Consultancy; Lundbeck: Research Funding. Breccia:Novartis: Consultancy, Honoraria; Bristol Myers Squibb: Honoraria; Celgene: Honoraria; Ariad: Honoraria; Pfizer: Honoraria. Angelucci:Novartis oncology, celgene: Honoraria, Membership on an entity's Board of Directors or advisory committees. Lo Coco:Teva: Consultancy, Honoraria, Speakers Bureau; Lundbeck: Honoraria, Speakers Bureau; Novartis: Consultancy; Baxalta: Consultancy; Pfizer: Consultancy.

Burden of AL Amyloidosis on Health-Related Quality of Life in Clinic-Based, Community-Based, and Trial-Based Studies

Introduction: Light chain (AL) amyloidosis is a rare disease characterized by misfolded amyloid protein deposits in tissues and vital organs which may lead to organ failure, disability, and death. Little is known about the burden of AL amyloidosis on health-related quality of life (HRQoL) - particularly whether patients in different types of studies experience the same degree and type of burden or whether there are unique differences.The objective of this study is to compare the HRQoL profile of patients with AL amyloidosis from clinic-, community-, and clinical trial-based samples to a general population (GP) sample and other benchmarks from more commonly known diseases.MethodsSampleData were drawn from three different samples of AL amyloidosis patients:1. A clinic-based sample of AL amyloidosis patients seen at the Amyloidosis Center at Boston University between 1994 and 2014 who completed the HRQoL survey within 30 days of their initial evaluation (n=1,438)2. A community-based sample of patients who completed a cross-sectional online survey in the Fall of 2015 (n=341)3. A trial-based sample of treatment naïve patients with cardiac involvement who completed the HRQoL survey during baseline data collection of the VITAL Amyloidosis Study, a Phase 3 randomized control trial (RCT) of NEOD001 (clinical trials.gov ID: NCT02312206; n=85)MeasuresAll three studies assessed HRQoL using the SF-36® Health Survey (SF-36). The SF-36v1 was administered to the clinic-based sample and the SF-36v2 was administered to the community- and trial-based samples. The SF-36 measures eight domain scales (physical functioning (PF), role limitations due to physical health problems (RP), bodily pain (BP), general health (GH), vitality (VT), social functioning (SF), role limitations due to emotional health problems (RE), and mental health (MH)) and two component summary measures: physical (PCS) and mental (MCS).AnalysisAnalysis of variance was used to compare the norm-based SF-36 scores from patients with AL amyloidosis to that from samples representing a GP norm. The GP data were adjusted to the age and gender distribution of the patient samples using separate ordinary least-squares regression models, with each SF-36 scale or summary score as a dependent variable. Using the same method, mean SF-36 scales and summary scores in the three AL amyloidosis patient samples were compared to the mean SF-36 scores in other disease populations, including congestive heart failure (CHF) and kidney disease (KD). Established minimally important differences (MIDs) were used to determine whether deficits in HRQoL were clinically meaningful, as well as statistically significant.Results: Differences between AL amyloidosis patients’ SF-36 scores and those of the GP are presented in Table 1 by sample. Relative to the GP, patients with AL amyloidosis exhibited broad deficits in HRQoL, particularly related to physical well-being. Deficits were more prominent for PCS where the differences between the GP scores and the scores observed in all three AL amyloidosis samples were both statistically significant and clinically meaningful (p < 0.001 and D ≥ 2.0 points for all).Differing patterns of relative burden emerged when AL amyloidosis samples were compared to other common disease benchmarks:· As compared to the CHF benchmarks, scores for PCS among the community-based sample were statistically and clinically better (p < 0.001 and D=4.5); whereas, PCS scores were significantly worse among the trial-based sample (p < 0.01 and D=-8.9).· Relative to KD benchmarks, the trial-based, treatment naïve sample reported significant deficits across many scores that were comparable in the community-based sample, including RP, VT, and PCS.Conclusions: Regardless of the data source, patients with AL amyloidosis exhibited significant and clinically meaningful deficits in HRQoL compared to the GP. Despite heterogeneity across the three samples in terms of duration and severity of disease, deficits related to physical well-being were consistent and clinically meaningful. Different patterns of deficits emerged when comparing the three samples to other disease benchmarks. This may be due to the heterogeneity in the community-based sample where patients varied in duration of disease and course of treatment versus the other AL amyloidosis samples which were comprised of newly diagnosed and/or treatment naïve patients. [Display omitted] DisclosuresBayliss:Prothena Biosciences Inc: Research Funding. White:Prothena Biosciences Inc: Research Funding. McCausland:Prothena Biosciences Inc: Research Funding. Guthrie:Prothena: Employment, Equity Ownership, Other: Leadership.

Optimizing the Adverse Event and HRQOL Profiles in the Management of Primary Spine Tumors.

Systematic literature review. To investigate if evidence-based principles of oncologic resection for primary spinal tumors are correlated with an acceptable morbidity and mortality profile and satisfactory health-related quality of life (HRQOL) measures. Respecting oncologic principles for primary spinal tumor surgery is correlated with lower recurrence rates. These interventions are, however, often highly morbid. A systematic literature review was performed to address the objectives by searching MEDLINE and EBMR databases. Articles that met our inclusion criteria were reviewed. GRADE guidelines were used for recommendation formulation. A total of 25 articles addressing the morbidity and mortality profile of primary spinal tumor surgery were identified. For sacral tumors, complication rates of up to 100% have been reported and complication-related death ranged from 0% to 27%. Mobile spine tumor complication rates varied from 13% to 73.7% and complication-related death ranged from 0% to 7.7%. Seven articles examining HRQOL for this patient population were identified. The limited literature showed comparable patient HRQOL profiles to those with benign conditions such as degenerative disc disease. Respecting oncologic principles for primary spinal tumors are correlated with high adverse event rates. We recommend that primary spinal tumor surgeries be performed in experienced centers with multidisciplinary support teams and that prospective adverse event collection be promoted (strong recommendation/very low certainty of the evidence). Oncologic resection of primary tumors of the spine is associated with HRQOL that more closely approximates normative values with increasing duration of follow-up, but decreases with disease recurrence. We recommend primary spinal tumor surgery be performed with a curative intent whenever possible, even at the expense of greater initial morbidity to optimize long-term HRQOL (strong recommendation/very low certainty of the evidence). N/A.