Impaired QOL Research Articles

Association of Infertility with Quality of Life among Infertile Married Couples

Infertility is believed very difficult and sensitive issue for wedded couples, particularly those who have passed several years of married life. Infertile married couples could experience mental distress and also suffer from impaired health-related QoL. Aims: To assess the association of infertility with quality of life among married couples. Study Design: Cross-sectional study. Methodology: Present study enrolled 140 couples who were actively trying for conception for 3 years visiting Hameed Latif Hospital Lahore were included. Non-probability purposive sampling technique was used. Informed written consent was taken from all the participants. The overall mean score of quality of life measured by WHOQOL-BREF questionnaire. Statistical analysis: To check the correlation of infertility with quality of life, Spearman’s/ Pearson correlation was used. The P value of < 0.05 was considered as significant. Results: Out of 140 couples, mean age was 31.6±3.0 years. The mean age of female participants was 30.1 ± 2.8 and the mean age of male participants was 33.1 ± 2.4. The overall mean score of quality of life measured by WHOQOL-BREF questionnaire was 98.2 ± 11.5. The mean score of quality of life of male participants was 98.5 ± 11.5 and mean score of quality of life of female participants was 98.0 ± 11.6. Conclusion: It was concluded that quality of life of majority of the couples was not affected due to infertility. Keywords: Infertility, Quality Of Life, Physical Health, Psychological Health and Social Relationship.

Clinical value of positive BET and pelvic floor dyssynergia in Chinese patients with functional defecation disorder

Background Functional defecation disorder (FDD) is a common subtype of functional constipation (FC). Balloon expulsion test (BET) and high resolution anorectal manometry (HR-ARM) are significant tools but their results are not always consistent. Aims To investigate the characteristics of patients with positive BET and pelvic floor dyssynergia (PFD) and explore the value of both positive results in FDD diagnosis. Methods We retrospectively diagnosed FC subtypes and enrolled FDD patients based on Rome-IV criteria. They underwent HR-ARM, BET and CTT tests. Then they were classified to two groups and further stratified by FDD subtypes. Validated questionnaires were applied to investigate patients’ constipation, anxiety/depression and quality of life. Results 335 FDD patients were finally enrolled. They were classified into two groups according to whether BET and PFD were both positive (consistent or not). 84.48% showed consistent results. These patients had significantly higher anal residual pressure, lower anal relaxation rate, manometric defecation index (MDI) and a more negative rectoanal pressure gradient (RAPG) (Ps < .05). The specific distribution of FDD phenotypes in two groups showed significant difference (p = .021). Males suffered a more negative RAPG (p < .001) and age was correlated with anal relaxation rate (p < .001). A subset (177 individuals) was investigated with validated questionnaires. Scores for Defecation Symptoms, Physical Discomfort and GAD-7 score were significantly high in Consistent Group (Ps < .05). GAD-7 score was associated with Defecation Symptoms (p < .001) while anal residual pressure, GAD-7 and Defecation Symptoms score were linked to Physical Discomfort (Ps < .05). The diagnostic specificity and PPV for FDD rose significantly with positive BET and PFD. Conclusion FDD patients with positive BET and PFD suffered from severe defecation symptoms, anxiety and impaired QOL. Positive BET and PFD could be an ideal tool for screening FDD.

Self-reported quality of life in children with ventricular assist devices.

We sought to describe QOL in children with VAD and to identify factors associated with impaired QOL. There were 82 children (6-19years) in the Pediatric Interagency Registry for Mechanical Circulatory Support who completed the PedsQL +/- a VAD-specific QOL assessment pre-VAD implant (n=18), 3months post-VAD (n=63), and/or 6months post-VAD (n=38). Significantly impaired QOL is a score >1 SD below norms. Study patients were 59% male, 67% Caucasian, with cardiomyopathy diagnosis in 82%, and median age at implant of 14 y (IQR 11-17). PedsQL scores were lower than norms for physical (p<.0001) and psychosocial (p<.01) QOL in pre- and post-VAD groups. Compared to chronic health condition and complex or severe heart disease groups, PedsQL scores were lower for physical and psychosocial QOL in the pre-VAD group (p<.0001); however, psychosocial QOL was not significantly different in post-VAD groups. Psychosocial QOL was impaired in 67%, 40%, and 24% in pre-VAD, 3-month, and 6-month post-VAD groups, respectively. Total and psychosocial QOL scores were significantly higher in the 3-month and 6-month post-VAD group than pre-VAD (all p≤.02). VAD patients were most bothered by their inability to participate in usual play activities. Impaired QOL 3months post-VAD was associated with inotropic support >2weeks/ongoing post-VAD (p=.04). Physical QOL is significantly impaired in most children pre- and post-VAD. However, psychosocial QOL is not significantly impaired in most children post-VAD suggesting VAD implantation may improve psychosocial QOL in children.

Abstract 13456: Characterizing Changes in Quality of Life and in Older Patients With Acute Decompensated Heart Failure Enrolled in a Rehab Intervention Clinical Trial

Introduction: Older patients with acute decompensated heart failure (ADHF) have severely impaired QOL. We recently reported that a novel physical rehab intervention improves QOL. Here we report trajectories of improvement and relationship to participation in a rehab intervention. Methods: Patients with ADHF, regardless of EF and ≥ 60 years old were randomized to either attention control (AC) or rehab intervention (RI). Participants completed the KCCQ, a disease-specific QOL instrument, and 12-Item Short-Form Health Survey (SF-12), a general QOL instrument composed of a mental and physical composite score, at baseline (inpatient), 1 month and 3 months. Effects of the intervention were assessed using linear mixed effects models including the main effect of intervention, follow-up visit, and interaction term with adjustment for EF category, age, and sex. Results: The REHAB-HF trial enrolled 349 patients with a mean age of 72.7±8.1 years, 52% women and 49% non-white. Baseline KCCQ scores were low for both arms (Figure 1). There was a substantial increase in KCCQ score at 1 month in both arms. However, in contrast to the AC participants who showed no further improvement, RI participants continued to experience an increase in QOL at 3 months creating a significant difference between arms (p&lt; 0.01). Both SF-12 composite scores also increased in both arms at 1 month with continued improvement only in the RI arm; reaching significance for the mental composite at 1 month (50.8±1.1 vs. 46.9±1.1, p &lt; 0.01) and at 3 months (52.7±1.1 vs. 48.2±1.1, p&lt; 0.01). Conclusions: Older patients hospitalized with ADHF have severely impaired disease-specific and general QOL that improves soon after discharge. Patients receiving a novel physical rehabilitation intervention experienced an early benefit in terms of QOL that continued to improve throughout the 3 months trial period. Future studies will help determine if these benefits are sustained with longer term follow-up.

Management of Men With Lower Urinary Tract Symptoms Due to Benign Prostatic Hyperplasia During and After COVID-19

The lower urinary tract (LUT), in particular the prostate, has been theoretically recognized as a target for SARS-CoV-2. Moreover, common pathophysiological mechanisms have been described for BPE/LUTS and COVID-19, including RAS dysregulation, androgen receptors, and MetS-related factors. These factors raise concerns about the possibility of worse urological outcomes due to BPE/LUTS progression in COVID-19 patients. The available results suggest a correlation between SARS-CoV-2 infection, exacerbation or new onset of LUTS, and semen impairment. BPE patients’ care and management have been deeply affected by COVID-19. In the midst of the pandemic, the main urological guidelines suggested postponement of BPH-related deferrable medical examinations and surgery. Telemedicine, therefore, gained attention and interest. Clinical evidence of impaired QoL or complications expedited surgical intervention. An informed consent covering the risk of COVID-19 and a negative molecular PCR within 72 hours of surgery were mandatory. A reduction in procedures under general anaesthesia was recommended. Long waiting lists accrued worldwide during the pandemic, leading to regular review of the BPE waiting lists and patients’ clinical status, encouraging the increase of minimally invasive office-based procedures, even in the post-COVID-19 era, and the improvement of telemedicine. Prospective studies are still needed to assess the course of LUTS/BPE patients after COVID-19.

Associations between socioemotional alterations, quality of life, and social functioning in multiple sclerosis: A scoping review

The main aim of the present scoping review is to systematically review the available studies that investigated the associations between socioemotional alterations (i.e., social cognition impairments/alexithymia/difficulties in emotion regulation) and both reduced QoL and social functioning in patients with Multiple Sclerosis (MS). The articles were selected from the PubMed, PsycINFO, and Scopus databases. The main exclusion criteria were qualitative studies, articles that did not use validated instruments, and studies that did not investigate the association between socioemotional skills and QoL/social functioning in MS. Of the eight studies fulfilling the inclusion criteria, six found significant associations between social cognitive and emotion regulation abilities and QoL/social functioning in patients with MS, while two found no significant relationships particularly between the performance on social cognition tasks and QoL measures. Overall, the majority of findings seem to highlight that socioemotional alterations contribute to impaired QoL and social functioning in MS. However, given the still limited evidence, future studies are needed to replicate and confirm the available results, paying attention to two principal aspects: the use of standardized and ecological tasks for the assessment of social cognition skills and the recruitment of samples involving patients with different types of MS.

Evaluation of Health-Related Quality of Life in Adult Patients on Hemodialysis.

Background:Hemodialysis in end-stage renal disease patients causes disability in different domains of patient's lives, leading to impaired (quality of life [QOL]). Studies measuring the QOL in patients on renal replacement therapy are limited in the Indian scenario.Aims:To evaluate the QOL in adult patients on maintenance hemodialysis by applying the World Health Organization QOL (WHOQOL)-BREF scale.Material and Methods and Study Design:Health-related QOL was evaluated in 100 adult patients on maintenance haemodialysis for 3 months or more in Dayanand Medical College and Hospital, Ludhiana. The WHOQOL-BREF was applied in these patients and the physical, psychological, social, and environmental health domains were assessed.Results:Most common age group was 31–60 years (56%) with a mean age of 54.44 years, male: 74%. Patients with age more than 60 years had better QOL scores in the social domain which was statistically significant (P = 0.005). Male patients had better scores in all four domains and was significant in the social domain (P = 0.025). Married patients had better QOL scores in social domain. Duration of dialysis had a reverse correlation with QOL scores in physical domain with better scores in dialysis duration of <12 months. Frequency of dialysis did not significantly affect the QOL scores. QOL scores were directly related to the monthly family income in all four domains with the highest income group showing better scores (P < 0.05).Conclusion:The present study provided an insight into the factors that affect the QOL in hemodialysis patients. Patients with age >60 years had better QOL scores in the social domain. Female gender, low serum proteins, HD duration of more than 1 year, and low monthly income were found to be associated with impaired QOL domains in patients undergoing maintenance hemodialysis.

Achalasia in Children-Clinical Presentation, Diagnosis, Long-Term Treatment Outcomes, and Quality of Life.

Background: In spite of the introduction of peroral endoscopic myotomy (POEM), Heller myotomy (HM) remains the mainstay of treatment and the role of pneumatic dilatation (PD) is being debated. The aim of this study was to present a single-center experience in the diagnostic approach and treatment of esophageal achalasia (EA), including the long-term assessment of the QoL. Methods: Data collection was based on the retrospective analysis of clinical notes and prospective interviews with patients and their parents. Results: The study group consisted of 60 patients with EA (F: 26, M: 34), with a median age of 12.0 (1–17) years at diagnosis. The time from the first symptoms until the diagnosis was 1.0 year (0.5–2.0) and the most common were: regurgitation (91.3%), dysphagia (84.8%), and chest pain (47.8%). The diagnostic approach showed a high sensitivity for barium X-ray follow through, esophageal manometry, and endoscopy. Overall, a long-term good outcome of HM was achieved in 27 out of 37 patients (73%) and it was negatively affected by the time between the first symptoms and the diagnosis. Out of the 16 patients who underwent PD before HM, a good outcome was achieved in 14 patients (87.5%), compared to 13 out of 21 patients (62%) who only underwent HM (p = 0.22). Concomitant fundoplication was routinely performed, and 18% required post-operative endoscopic dilatation. At the end of the 12.1 (0.7–26.6)-year follow up, most patients had a good QoL, which significantly corresponded with the treatment outcomes. Conclusions: Patients suspected of EA should undergo a thorough clinical evaluation including a manometry, a barium X-ray, and an endoscopy. HM is a safe and effective treatment for achalasia and the outcome is not worsened by a preceding endoscopic PD. In most patients, HM alleviates symptoms, although an impaired QoL is common in long-term follow ups.

Importance of Considering Malnutrition and Sarcopenia in Order to Improve the QOL of Elderly Hemodialysis Patients in Japan in the Era of 100-Year Life.

In the current aging society of Japan, malnutrition and resultant sarcopenia have been widely identified as important symptomatic indicators of ill health and can cause impairments of longevity and quality of life in older individuals. Elderly individuals are recommended to have sufficient calorie and protein intake so as to enjoy a satisfactory quality of life, including maintaining activities of daily living in order to avoid emaciation and sarcopenia. The prevalence of emaciation and sarcopenia in elderly hemodialysis (HD) patients in Japan is higher than in non-HD elderly subjects due to the presence of malnutrition and sarcopenia associated with chronic kidney disease (CKD). Furthermore, comorbidities, such as diabetes and osteoporosis, induce malnutrition and sarcopenia in HD patients. This review presents findings regarding the mechanisms of the development of these early symptomatic conditions and their significance for impaired QOL and increased mortality in elderly HD patients.

P426 Health-Related Quality of Life and Work Productivity in patients with moderate-to-severe Inflammatory Bowel Disease in Argentina: Data from the RISE AR study

Abstract Background Patient-reported outcomes (PROs) are increasingly recognized as complementary to objective markers of disease activity, yet evidence on PROs in inflammatory bowel disease (IBD) in the real-world setting in Latin America is limited. Herein, we describe health-related quality of life (HRQoL) and work productivity and activity impairment (WPAI) of IBD patients (pts) in Argentina. Methods RISE-AR (NCT03488030) was a non-interventional study with a cross-sectional evaluation and a 3-year retrospective chart review conducted in 7 centres in Argentina (12/2018-05/2019) to assess healthcare resource utilisation, HRQoL and WPAI. Adult pts (≥18 yr old) with a previous diagnosis of moderate-to-severe (Mod/Sev) ulcerative colitis (UC) or Crohn′s disease (CD) based on clinical, endoscopic or imaging criteria ≥6 months prior to enrolment, were included. HRQoL (IBD Questionnaire [IBDQ], 5-dimensional EuroQoL measure [EQ5D]) and WPAI instruments were administered at screening. Disease activity at enrolment was classified as Mod/Sev (Harvey Bradshaw Index ≥8 or partial Mayo Score ≥5) vs. “no-or-mild” (No/Mild). A p-value ≤0.05 was considered statistically significant (Mann-Whitney U test). Results Overall, 246 pts were included (41.1% CD; 58.9% UC). At enrolment, median (range) age (years) was 39.5 (18.2-74.0) for CD (51.2% female) and 41.9 (18.0-80.4) for UC (55.2% female) pts; 20 pts (9.3% CD; 7.7% UC; excluding 4 ostomized pts) had Mod/Sev disease activity. During the previous 3 years, 17.8% (CD) and 1.4% (UC) of pts required ≥1 surgery, and 33.7% (CD) and 21.4% (UC) were hospitalized. No/Mild pts showed significantly higher overall HRQoL scores (mean±SD) vs. Mod/Sev pts in CD (IBDQ: 178.1±35.4 vs. 140.0±43.5, p&amp;lt;0.05; EQ5D [visual analogue scale]: 75.7±1.8 vs. 64.4±5.5, p&amp;lt;0.05) and UC (180.2±32.9 vs. 132.9±43.8, p&amp;lt;0.001; 77.1±1.3 vs. 57.7±5.3, p&amp;lt;0.001), respectively. Activity impairment was reported by 55.4% and 58.6% of CD and UC pts, respectively, while 37.9% and 43.9% of CD and UC employed pts (67 CD, 92 UC; Mod/Sev: 5 CD, 6 UC) reported work impairment. Mod/Sev IBD pts had higher absenteeism (30.8% vs. 6.3%, p&amp;lt;0.05) and presenteeism (20.0% vs. 7.5%, p=0.149) vs. No/Mild pts. Female gender, surgeries and hospitalizations were associated with lower QoL in the overall IBD population. Conclusion This is the first study to evaluate QoL and WPAI in IBD pts in Argentina. Pts with Mod/Sev activity showed impaired QoL and WPAI compared to No/Mild pts. Whilst, less than 10% of IBD pts had Mod/Sev disease activity at enrolment, nearly 60% of the overall IBD population reported either work or activity impairment. Thus, disease activity scores alone may fail to assess the real burden of IBD, suggesting a relevant role for PROs in disease management.

The prognostic impact of BIA-derived fat-free mass index in patients with cancer

Reduced muscle mass represents one of the top ranked phenotypic criteria for malnutrition proposed by the Global Leadership Initiative on Malnutrition. Although height-indexed fat-free mass (FFMI) thresholds have been proposed as useful surrogate measures of reduced muscle mass, the independent prognostic value of BIA-derived FFMI by bioelectric impedance analysis (BIA) in patients with cancer still needs to be fully explored. Data on body mass index (BMI), 6-month percentage of weight loss (%WL), FFMI by BIA and quality of life (QoL by EORTC Quality of Life Questionnaire [EORTC QLQ-C30]) of Italian and German patients observed prospectively until death or censoring were used (N=1217). Patients were stratified in 5 risk categories according to a robustly validated scoring system based on BMI and %WL. Low FFMI was defined as follows: men, <17kg/m2; women, <15kg/m2. Reduced FFMI was found in 234 patients (19.2%). After a median follow-up of 57 months [25th-75th, 31-60], 620 patients (50.9%) had died. The study detected differences in survival between patients presenting with and without reduced FFMI (14.0 months vs. 45.1 months; P<0.001). The fully-adjusted hazard ratio of mortality for low FFMI was 1.46 [95%CI, 1.18-1.81] (P<0.001). Low FFMI was also independently associated with reduced QoL: fully-adjusted odds ratio, 1.50 [95%CI, 1.00-2.25] (P=0.050). Reduced FFMI by BIA independently predicted survival and was associated with impaired QoL. Altered body composition should always be considered in all patients with cancer as additional phenotypic criterion of poor prognosis and BIA offers the possibility of multiple, noninvasive bedside assessments.

Long-term surgical and patient-reported outcomes of Hirschsprung Disease

BackgroundInformation is needed regarding the complex relationships between long-term functional outcomes and health-related quality of life (HRQoL) in Hirschsprung's Disease (HSCR). We describe long-term outcomes across multiple domains, completing a core outcome set through to adulthood. MethodsHSCR patients operated at a single center over a 35-year period (1978–2013) were studied. Patients completed detailed questionnaires on bowel and urologic function, and HRQOL. Patients with learning disability (LD) were excluded. Outcomes were compared to normative data. Data are reported as median [IQR] or mean (SD). Results186 patients (median age 28 [18–32] years; 135 males) completed surveys. Bowel function was reduced (BFS 17 [14–19] vs. 19 [19–20], p < 0•0001;η2 = 0•22). Prevalence and severity of fecal soiling and fecal awareness improved with age (p < 0•05 for both). Urinary incontinence was more frequent than controls, most of all in 13–26y females (65% vs. 31%,p = 0•003). In adults, this correlated independently with constipation symptoms (OR 3.18 [1.4–7.5],p = 0.008). HRQoL outcomes strongly correlated with functional outcome: 42% of children demonstrated clinically significant reductions in overall PedsQL score, and poor bowel outcome was strongly associated with impaired QOL (B = 22•7 [12•7–32•7],p < 0•001). In adults, GIQLI scores were more often impacted in patients with extended segment disease. SF-36 scores were reduced relative to population level data in most domains, with large effect sizes noted for females in General Health (g = 1.19) and Social Wellbeing (g = 0.8). ConclusionFunctional impairment is common after pull-through, but bowel function improves with age. Clustering of poor functional outcomes across multiple domains identifies a need for early recognition and long-term support for these patients.

Prostatectomy with or without post-operative radiotherapy: long-term adverse effects and quality of life

Background Few longitudinal studies have compared patient-reported long-term adverse effects after radical prostatectomy (RP) alone and RP followed by radiotherapy (RAD), also analyzing the effect of the development of post-treatment dysfunctions/problems (Symptom Burden) on Health-Related Quality of Life (HRQoL). Material and methods After median seven years since RP and six years since post-RP RAD, development of EPIC-26 Domain Summary Scores (DSS Changes) and HRQoL scores (SF-12) since the pre-RP situation were evaluated in respectively 317 prostatectomized men without and in 63 patients with additional post-RP RAD. Post-treatment inter-group differences of the prevalent Symptom Burden and of the DSS Changes were calculated. Multivariable logistic regressions evaluated the associations between DSS Changes and post-treatment impaired HRQoL. Results Compared to RP alone, post-RP RAD increased the post-treatment Symptom Burden, with least inter-group differences within the urinary irritative/obstructive and bowel domain. No significant inter-group difference emerged for the proportions of men with impaired HRQoL. The odds of impaired HRQoL increased significantly with rising DSS Changes (worsening) within the vitality/hormonal domain. Worsening within urinary incontinence and bowel domains significantly increased the odds of impaired physical QoL. High HRQoL scores before RP reduced the odds of post-treatment impaired HRQoL. Living without a partner and use of androgen deprivation therapy increased this odds. Conslusions Post-RP radiotherapy increases post-treatment Symptom Burden with negative, though limited impact on the patient’s HRQoL. Counceling before post-RP radiotherapy should cover this possible development, taking into account the patient’s social situation.

Spinal Disorders in the Oldest-Old

Adult spinal deformity causing thoracolumbar hyperkyphosis is prevalent among the aging population, and is associated with impaired ADL and QOL. Corrective spine surgery is now developing for this common condition. Old patients with Parkinson's disease frequently have osteoporosis and vertebral compression fractures, which affect spinal deformity and postural abnormality. Diffuse idiopathic skeletal hyperostosis and cervical spinal cord injury without bone injury are important spinal disorders in the aged. Neurologists should be aware of locomotive syndrome, including spinal disorders, for appropriate management of motor dysfunction in super-old patients.

392 - Quality of life with pharmacological treatment in patients with benign prostatic enlargement: Results from the evolution European prospective multicenter multi-national registry study

Lower urinary tract symptoms due to benign prostate enlargement (LUTS/BPE) can lead to significant disturbances to health-related quality of life (HRQoL) and psychological well-being. The aim of this study was to evaluate the effect of pharmacological treatment of LUTS/BPE on disease specific and generic QOL measures. Evolution was a European prospective, multicenter multi-national, observational registry collecting real-life clinical data over 2 years on the management of LUTS/BPE in primary and secondary care. This study investigated disease-specific QOL using questionnaires such as IPSS Q8, BPH Impact Index (BII) and generic QOL using questionnaires like EuroQOL Five Dimension (EQ5D) which encompassed EQ5D VAS and EQ5D health index. The registry enrolled 1838 BPE patients and 1246 patients were evaluable at the end of 24 months. Nearly 70% of patients in the study were previously treated with medical therapy and 17% of these had already discontinued medical treatment previously for various reasons with lack of efficacy being the most common. The mean time since diagnosis of LUTS in the previously treated group was 4.7 years (0–26 years). Medical management produced statistically significant improvement in QOL (disease specific and generic) in previously untreated patients and an insignificant change in generic QOL in previously treated patients. After 5-years from the onset of symptoms, LUTS/BPE patients previously treated with medication had significantly impaired QOL in patients in a manner comparable to other chronic diseases. Earlier intervention with minimally invasive surgical techniques (MIT) should be considered in LUTS/BPE patients that do not show a significant improvement in QOL with medical therapy.

Quality of life with pharmacological treatment in patients with benign prostatic enlargement: results from the Evolution European Prospective Multicenter Multi-National Registry Study.

Lower urinary tract symptoms due to benign prostate enlargement (LUTS/BPE) can lead to significant disturbances to health-related quality of life (HRQoL) and psychological well-being. The aim of this study was to evaluate the effect of pharmacological treatment of LUTS/BPE on disease specific and generic QOL measures. Evolution was a European prospective, multicenter multi-national, observational registry collecting real-life clinical data over 2years on the management of LUTS/BPE in primary and secondary care. This study investigated disease-specific QOL using questionnaires such as IPSS Q8, BPH Impact Index (BII) and generic QOL using questionnaires like EuroQOL Five Dimension (EQ5D) which encompassed EQ5D VAS and EQ5D health index. The registry enrolled 1838 BPE patients and 1246 patients were evaluable at the end of 24months. Nearly 70% of patients in the study were previously treated with medical therapy and 17% of these had already discontinued medical treatment previously for various reasons with lack of efficacy being the most common. The mean time since diagnosis of LUTS in the previously treated group was 4.7years (0-26years). Medical management produced statistically significant improvement in QOL (disease specific and generic) in previously untreated patients and an insignificant change in generic QOL in previously treated patients. After 5-years from the onset of symptoms, LUTS/BPE patients previously treated with medication had significantly impaired QOL in patients in a manner comparable to other chronic diseases. Earlier intervention with minimally invasive surgical techniques (MIT) should be considered in LUTS/BPE patients that do not show a significant improvement in QOL with medical therapy.

PD33-01 QUALITY OF LIFE WITH PHARMACOLOGICAL TREATMENT IN PATIENTS WITH BENIGN PROSTATIC ENLARGEMENT

INTRODUCTION AND OBJECTIVE: Lower urinary tract symptoms (LUTS) due to benign prostatic enlargement (BPE) can lead to significant disturbances to health-related quality of life (HRQoL) and psychological well-being. There is variability in the relationship between individual symptom severity and the bother reported by patients as symptom scores alone, may not capture their actual impact on men. The aim of this study was to evaluate the effect of pharmacological treatment of LUTS/BPE on disease-specific and generic QoL measures. METHODS: Evolution was a European prospective, multicenter multi-national, observational registry collecting real life clinical data over two years on the management of LUTS/BPE in primary and secondary care. This study investigated disease specific QOL using questionnaires like IPSS Q8, BPH Impact Index (BII) and generic QOL using questionnaires like EuroQOL Five Dimension (EQ5D) which encompassed EQ5D VAS and EQ5D health index. RESULTS: The registry enrolled 1838 BPE patients and 1246 patients were evaluable at the end of the study period (24 months). Nearly 70% of patients in the study were previously treated with medical therapy and 17% of these had already discontinued medical treatment previously for various reasons, lack of efficacy of medication being the most common. The mean time since diagnosis of LUTS in the previously treated group was 4.7 years (0-26 years). Medical management produced statistically successful improvement in QOL (disease specific and generic), albeit significantly better in previously untreated patients. CONCLUSIONS: At an average of five years from the onset of symptoms, LUTS/BPE patients previously treated with medication had significantly impaired QOL in patients in a manner comparable to other chronic diseases. Medical management was successful in producing improvement in QOL when first started in previously untreated patients, but was much less significant in the previously treated patients. We need to rethink how we treat LUTS/BPE in clinical practice in line with emerging evidence, it is imperative to offer other options like Minimally Invasive Therapy (MIT) early, especially in patients previously treated with medical therapy.Source of Funding: Financial disclosure: The Evolution registry was supported by a restricted Grantfrom GlaxoSmithKline© (GSK).

Comparison of neoadjuvant treatments followed by radical surgery or chemoradiation on quality of life in patients with stage IB2-IIA cervical cancer

ObjectiveTo compare quality of life (Qol) of patients with stage IB2-IIA cervical cancer treated by neoadjuvant treatments followed by radical surgery (NTS) or standard chemoradiation (CRT). MethodsPatients with stage IB2-IIA cervical cancer during 2006–2012 were treated with NTS or CRT and were invited to participate. The Functional Assessment of Cancer Therapy-Cervix (FACT-Cx) Questionnaire was used to assess patient Qol. A multivariable linear regression analysis was performed to identify factors associated with Qol. ResultsIn total, 90 (78.3%) out of 115 eligible patients completed the questionnaires. No significant differences were found in Qol between treatment groups, except that patients after NTS reported higher scores in the social/family well-being (e.g. satisfaction with sexual life, close relationships with partner or friends, and support from friends) than those after CRT, in particular, during 2–3 years after treatment. Results of multivariate analysis indicated that NTS was associated with better social/family functioning, while advanced stage of cervical cancer, lower family income and lower education were associated with impaired Qol in different domains. ConclusionsAlthough self-reported Qol after treatment were not significantly different, NTS treated patients reported better social/family functioning than CRT treated patients, such as satisfaction with their sexual life and close relationships with partner or friends, during 2–3 years post treatment. These results were helpful for physicians to make treatment decisions while considering treatment-related Qol, and moreover, for rehabilitation and supportive care of patients after treatment. Further validation of our findings in randomized, controlled clinical trials is warranted.

Impaired Quality of Life and Its Determinants among Postmenopausal Women of Slum Communities in Bhubaneswar, India.

Background:The severity of menopausal symptoms negatively impacts a woman's quality of life (QoL).Objective:The aim of the study was to assess the prevalence of menopause-related impaired QoL and determine its associated factors among postmenopausal women living in slum areas of Bhubaneswar, India.Materials and Methods:This cross-sectional study was conducted among 198 postmenopausal women aged 45–65 years during the year 2016–2017. The Menopause Rating Scale (MRS) was used to assess the prevalence and severity of menopausal symptoms.Results:Joint and muscular discomfort was the most prevalent moderate-to-severe symptom (90.4%), followed by hot flushes (72.8%), irritability (67.2%), and physical and mental exhaustion (64.2%). More than two-third (133, 67.2%) of women had impaired QoL (severe total MRS score ≥17). Multivariate logistic regression analysis revealed that impaired QoL was associated younger age (adjusted odds ratio [AOR]: 4.6, 95% confidence interval [CI]: 2.12–9.98), tobacco consumption (AOR: 2.0, 95% CI: 1.05–3.82), not being satisfied in relation with husband (AOR: 3.33, 95% CI: 1.84–6.06), not having autonomy in health-care decision-making in the family (AOR: 2.30, 95% CI: 1.12–4.73), history of reproductive tract infection (AOR: 4.57, 95% CI: 1.71–12.19), and earlier onset of menopause (AOR: 3.26, 95% CI: 1.18–8.96).Conclusion:The point prevalence of menopause-related impaired QOL in postmenopausal women living in slums of Bhubaneswar was high. Incorporating these determinants in the existing strategies can be useful to improve the QoL of these women.

The Psychometric Properties of the ITP Life Quality Index Assessed in a Large Multinational “Real-World” Cohort of Immune Thrombocytopaenia Patients

Background Immune Thrombocytopenia (ITP) is an autoimmune disorder caused by immunologic destruction of otherwise normal platelets, most commonly occurring in response to an unknown stimulus. ITP is diagnosed after excluding other possible causes of disease, and symptoms can present across varying severities and treatments. The poor understanding of the symptoms and cause can result in both misdiagnosis and complex treatment patterns, which may significantly affect health related quality of life (HRQoL) in this patient population. There is currently no disease specific prospective tool in routine clinical practice to capture HRQoL in the adult ITP population. To help assess the impact of this condition on HRQOL, the ITP Life Quality Index (ILQI), a 10-item patient-reported outcome (PRO) measure was developed as a tool for clinical practice to aid discussions between patients and physicians about disease experience so to inform patient-centric treatment decisions. The ILQI was originally developed by clinical experts in the field of ITP and content validity was confirmed by conducting qualitative interviews with 15 adult patients with ITP. The ILQI was then cognitively debriefed patients with ITP and items refined following qualitative analysis and additional clinical input. The ILQI was included in the ITP World Impact Survey (I-WISh), a global observational study which collected data on the impact of ITP on patients' HRQoL. This large study provided an opportunity to assess the psychometric properties of the ILQI and confirm the scoring cut-offs. Methods The I-WISh survey resulted in data from 1,507 patients with ITP across 12 countries worldwide and was used to assess the structure, reliability and validity of the ILQI. The structure of the ILQI, how the items fit into total scores and subscales, was assessed by splitting the data into two datasets. One dataset was used for identifying the structure using exploratory factor analysis and one was used for checking the structure using confirmatory factor analysis. Validity, the ability of the ILQI to measure the correct construct, was assessed through known groups and convergent validity methods. Reliability, the consistency of the ILQI items and their ability to create reproducible scores, was assessed via internal consistency methods. To understand whether each ILQI item measured ITP in a similar way across countries, differential item functioning (DIF) was assessed using Cochran-Mantel-Haenszel test and Logistic regression. Finally, existing score cut-offs (20-"significantly impaired QoL"; 30 - "severely impaired QoL") were assessed using receiver operating characteristic (ROC) curves and a simulation study was conducted to develop rules for missing data. Results Results indicated that the ILQI has an essentially unidimensional structure, supporting the creation of a total score including all 10 items. The ILQI items work together to create a reproducible total score, usable for making judgements on an individual patient basis (Omega total and Cronbach's alpha coefficients ≥ 0.90). Known groups methods showed that ILQI monotonically increased with ITP severity (linear trends p's &amp;lt;0.001). Convergent validity methods confirmed hypothesized relationships between ILQI total/item scores and items which measure aspects of HRQOL, suggesting that the ILQI total score and its items measure the same concept of interest (i.e. HRQOL). DIF analyses showed that ILQI item responses were similar between the USA and Western countries. Some uniform DIF was discovered between the USA and other countries, and some non-uniform DIF was found between the USA and China for culturally relevant items as expected. The previous clinical cut-off of 20 for "significantly impaired QoL" was supported, but a cut-off 30 may be too conservative for assessing "severely impaired QoL". Missing data simulation suggests that a total score can be created even when some items are missing. Conclusion The ILQI is a valid and reliable, unidimensional measure to assess HRQoL of patients with ITP. Despite some variations in ILQI item responses between USA and China, adoption of the ILQI in routine care will improve consistency of patient-centric decision making and may lead to better outcomes for those patients whose HRQoL has been affected. The revised cut-off scores for the ILQI developed will also aid patient-centric decision making between patients and physician. Disclosures Griffiths: Adelphi Values Ltd: Employment; Novartis: Consultancy. Grant:Novartis: Consultancy; Adelphi Values Ltd: Employment. Bonner:Adelphi Values Ltd: Employment; Novartis: Consultancy. D'Alessio:Novartis: Employment, Equity Ownership. Hill:Apellis: Honoraria; Bioverativ, a Sanofi company: Honoraria; Novartis: Speakers Bureau; Alexion: Research Funding. Provan:Rigel ONO: Consultancy, Research Funding; Novartis: Consultancy, Honoraria, Research Funding; Amgen: Consultancy, Honoraria, Research Funding; UCB: Consultancy; MedImunne: Consultancy; ONO Pharmaceutical: Consultancy. Ghanima:Bayer: Honoraria, Research Funding; Amgen: Consultancy, Honoraria; Pfizer/BMS: Research Funding; Novartis: Consultancy, Honoraria, Research Funding. Cooper:Amgen: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees; Novartis: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees; Rigel: Consultancy, Membership on an entity's Board of Directors or advisory committees; Principia: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees. Viana:Novartis: Employment, Equity Ownership.