Disease Quality Of Life Questionnaire Research Articles

Effectiveness of iliac vein stenting combined with high ligation/endovenous laser treatment of the great saphenous veins in patients with Clinical, Etiology, Anatomy, Pathophysiology class 4 to 6 chronic venous disease

BackgroundLower limb chronic venous disease (CVD), resulting from iliac vein compression syndrome (IVCS), manifests as a series of symptoms ranging from varicose veins to venous ulcerations. Stent implantation has been considered an effective treatment method; however, the management of CVD has rarely been reported. In the present study, we evaluated the treatment and outcomes of patients with CVD. MethodsWe performed a retrospective cohort study of patients with severe iliac vein stenosis with lower limb CVD. The patients were divided into two groups: group 1 had received stenting alone (n = 42), and group 2 had received stenting and high ligation/endovenous laser treatment (n = 29). We evaluated the clinical outcomes using the Venous Clinical Severity Score and visual analog scale, and assessed the quality of life (QoL) using the Chronic Venous Disease QoL questionnaire at a median follow-up point of 15 months (range, 6-25 months). ResultsIn our cohort, the prevalence rate of nonthrombotic IVCS (NIVCS) was 11.7% (98 of 838 patients). The technical success rate was 100%, without severe complications. During the study period, three group 1 patients and two group 2 patients were lost to follow-up. The overall patency rate in the patients with NIVCS during a mean follow-up period of 15.0 months (range, 6-25 months) was 94.4%. For patients with a Clinical, Etiology, Anatomy, Pathophysiology (CEAP) clinical class of <4, all parameters showed similar improvements in the two groups, except for the disappearance of varicose veins. However, in patients with a CEAP clinical class of ≥4, the combination therapy significantly improved their QoL. The Venous Clinical Severity Score reduction was 4.64 ± 1.72 in group 1 and 11.89 ± 1.82 in group 2 (P < .01). Pain, scored using the visual analog scale, demonstrated a decrease from 4.41 to 2.52 (P < .05) in group 1 and 4.71 to 0.53 (P < .01) in group 2. The relief rate of stasis dermatitis in groups 1 and 2 was 26.9% and 90.5%, respectively (P < .05), and the venous ulceration healing rate was 16.7% and 87.5%, respectively (P < .05). ConclusionsThe prevalence of NIVCS should not be overlooked. The proposed combination treatment is an effective therapeutic strategy for patients with NIVCS and advanced CVD (CEAP clinical class, ≥4) during short-term follow-up.

Mental Effects of Excess Parathyroid Hormone in Hemodialysis Patients: A Possible Role for Parathyroid 2 Hormone Receptor?

Depression as measured by the kidney disease quality of life (KDQOL) form is known to be an independent risk factor for mortality dialysis patients. Excess parathyroid hormone (PTH) has long been associated with neuropsychiatric disturbances. Those psychiatric complications are currently attributed to hypercalcemia with very little evidence; however, with the discovery of the parathyroid hormone 2 receptor (PTH2R) in the brain which can be activated by PTH, PTH2R might indicate a direct effect of PTH. As secondary and tertiary hyperparathyroidism is common in dialysis patients where the serum calcium is low or normal, we chose to investigate a possible relationship between PTH levels and depression in dialysis patients. This was a matched pair observational study with 10 patients with intact PTH values above 1000 pg/mL who were matched with 10 patients who had PTH values less than 400 pg/mL for the presence of diabetes, years on dialysis, duration of dialysis time, Kt/V, hemoglobin, and 25 OH vitamin D levels, as well as intravenous iron and erythropoietin administration. The Kidney Disease Quality of Life questionnaire (KDQOL-36) scores and patient Health Questionnaire scores were analyzed during that time. All variables underwent tests for normality and matched pair t-test. All subscales of the KDQOL-36 were worse in the high PTH group with the effect on daily life reaching P = 0.01 and the burden of disease and symptoms both reaching P = 0.02. PTH and PTH2R may be appropriate targets for investigations to improve the quality of life in hemodialysis patients.

Susceptibility-weighted MR imaging (SWI) of basal ganglia iron deposition in the early and advanced stages of Parkinson's disease

Parkinson's disease (PD) is the second most common neurodegenerative disease after Alzheimer's disease and the first one among the nosological entities of parkinsonism. Susceptibility-weighted imaging (SWI), magnetic resonance imaging (MRI) pulse sequence, which allows the in vivo estimation of the values of iron deposition in different areas of the brain, is a potential technique for the early diagnosis of PD and for the study of the pathogenesis of its complications.Objective: to compare the values of iron deposition in the basal ganglia in Stages II and III PD and to determine the relationship of clinical findings to the level of iron deposition according to the SWI findings.Patients and methods. Twenty-four patients with Hoehn and Yahr Stages II (n=24) and III (n=12) PD were examined. All the patients underwent brain MRI on a Siemens TrioTim (3T) MRI scanner by using pulse sequences T1, T2, SWI and subsequently quantifying the iron deposition (SPIN software). The accumulation of iron is visualized as an area of reduced signal intensity on SWI, and its estimation in accordance with the SPIN program has accordingly a smaller value. The regions of interest on both sides were the dentate nucleus, substantia nigra, red nucleus, putamen, globus pallidus, and head of the caudate nucleus. The examination protocol also included tests using the following scales: the Unified Parkinson's Disease Rating Scale (UPDRS), the Mini-Mental State Examination (MMSE), Frontal Assessment Batter (FAB), Freezing of Gait (FOG), Gait and Balance Scale (GABS), the Epworth Daytime Sleepiness Scale, the Parkinson's Disease Quality of Life Questionnaire (PDQ), the Beck Depression Inventory, and the Clock-Drawing Test.Results and discussion. The investigators found significant (p&lt;0.05) correlations between the clinical picture and the level of iron deposition in the regions of interest in patients with Stage II PD: FOG – left caudate nucleus (r=-0.94); GABS – left caudate nucleus (r=-0.94); and in patients with stage III of the disease: UPDRS (full) – left red nucleus (r=-0.82), right globus pallidus (r=-0,80), left putamen (r=-0,96); UPDRS (Section 2) – left red nucleus (r=-0.77), left globus pallidus (r=-0.84); UPDRS (Section 3) – right putamen (r=-0,85), right globus pallidus (r=-0.78), left globus pallidus (r=-0,92); FOG – left globus pallidus (r=-0.81); GABS – left red nucleus (r=-0.96), left putamen (r=0.82), right putamen (r=-0.89), left globus pallidus (r=-0.82), right globus pallidus (r=-0.85), left caudate nucleus (r=-0.82), right caudate nucleus (r=-0.89); Beck Depression Inventory – right substantia nigra (r=-0.82).Conclusion. SWI measurement of the values of iron deposition in the structures of the extrapyramidal system in PD provides an additional insight into the pathological processes occurring in them.

Utility of the Pediatric Allergic Disease Quality of Life Questionnaire for childhood eczema.

Childhood atopic dermatitis (AD) is a chronic inflammatory disease associated with pruritus and sleep loss. It is important to evaluate quality-of-life (QoL) impairment objectively in atopic diseases in children. To investigate the utility of the Pediatric Allergic Disease Quality of Life Questionnaire (PADQLQ) in children with eczema. PADQLQ, Patient-Oriented Eczema Measure (POEM, a short-term subjective symptom score), Nottingham Eczema Severity Score (NESS, a long-term subjective symptom score) and Children's Dermatology Life Quality Index (CDLQI, a short-term subjective symptom score) were compared and correlations evaluated. PADQLQ, POEM, NESS and CDLQI correlated well with each other (n = 132 sets; Spearman correlations: rho = 0·48-0·70, P < 0·001). A Bland-Altman plot showed a reasonably good agreement between CDLQI and PADQLQ. PADQLQ showed that symptoms of asthma, allergic conjunctivitis and allergic rhinitis were present in 20-30%, 45-71% and 58-67% of children with AD, respectively. Nevertheless, there was no association of eczema symptomatology by POEM or NESS with the severity of other allergic diseases. PADQLQ correlates well with AD-specific severity and QoL scores and reflects all allergic symptoms that holistically influence QoL in children with AD. PADQLQ is hence a composite severity score in terms of clinical symptomatology and QoL impairment for AD.

Validating the Parkinson's disease caregiver burden questionnaire (PDCB) in German caregivers of advanced Parkinson's disease patients.

Advanced Parkinson's disease (PD) may place a high burden on patients and their caregivers. Understanding the determinants of caregiver burden is of critical importance. This understanding requires the availability of adequate assessment tools. Recently, the Parkinson's disease caregiver burden questionnaire (PDCB) has been developed as a PD-specific measure of caregiver burden. However, the PDCB has only been evaluated in a sample of Australian caregivers of patients at a less advanced stage of the disease. We tested whether a German translation of the PDCB qualifies as an adequate measure of caregiver burden in a German sample of caregivers of advanced patients with PD. We collected PDCB data from 65 caregivers of advanced patients with PD. Reliability of the scale was assessed and compared against the original version. To validate the German version of the PDCB, we examined the correlations with the caregiver burden inventory (CBI), the short form 36 health survey (SF-36), the Parkinson's disease quality of life questionnaire 39 (PDQ-39), disease duration, and the amount of caregiving time. The total PDCB score proved to be reliable and to be significantly related to CBI and SF-36 scores. PDCB scores also increased with increasing amounts of caregiving time. The German version of the PDCB appears to be an adequate measure of caregiver burden in caregivers of advanced PD patients.

The combined polymorphisms of interleukin-6-174GG genotype and interleukin-10 ATA haplotype are associated with a poor quality of life in patients with chronic hepatitis C.

Chronic hepatitis C (CHC) is associated with a decreased health-related quality of life (HRQOL). More recent studies have pointed toward a genetic basis of patient-reported quality of life outcomes. Taking into account that the influence of single-nucleotide polymorphisms (SNPs) on the HRQOL of CHC patients has not been studied, we investigated the combined IL10-1082G/A, - 819C/T, and - 592C/A SNPs, and IL6-174G/C SNP. We also evaluated the association between demographic, clinical, psychiatric, virological, and genetic variables with domains and summaries of HRQOL in CHC patients. 132 consecutive CHC patients and 98 controls underwent psychiatric evaluation by using the Mini International Neuropsychiatric Interview. HRQOL was assessed by a generic questionnaire, the Medical Outcomes Study 36-Item Short Form Health Survey (SF-36), and by the specific Liver Disease Quality of Life Questionnaire (LDQOL). IL6 and IL10 polymorphisms were evaluated by Taqman SNP genotyping assay. Multivariate analysis was used to evaluate the associations. Major depressive disorder was associated with lower SF-36 and LDQOL scores in seven and ten domains, respectively. Diabetes and hypertension were also associated with reduced HRQOL. CHC patients carrying the combination of IL10 ATA haplotype/IL6-GG genotype had lower scores in the SF-36-physical functioning domain, and reduced scores in the LDQOL effects of liver disease on activities of daily living, quality of social interaction, and sexual function domains than the non-carriers of the combined haplotype/genotype. This is the first study to demonstrate that combined IL6 high-producer GG genotype and IL10 low-producer ATA haplotype is associated with poorer HRQOL in CHC patients.

Quality of life in Turkish patients with autoimmune blistering diseases: Reliability and validity of the autoimmune bullous disease quality of life and the treatment of autoimmune bullous disease quality of life questionnaires

Background: The Autoimmune Bullous Disease Quality of Life (ABQOL) and the Treatment of Autoimmune Bullous Disease Quality of Life (TABQOL) questionnaires, which are specific for autoimmune blistering diseases (AIBDs), were developed in Australia. Aims and Objectives: The aim of this study was to validate the Turkish version of the ABQOL and TABQOL questionnaires and to assess the reliability of them in the Turkish population. Materials and Methods: The Turkish versions of the ABQOL and TABQOL questionnaires were produced by forward–backward translation of the original English version. The patients were requested to complete ABQOL and TABQOL questionnaires on day 0 and after 7 days for a 2nd time sent by post. Furthermore, patients also completed other health-related quality of life scales on day 0. Results: A total of 68 patients with AIBDs were recruited. A subset of 20 (29.4%) patients completed the day 7 questionnaire. Both the Turkish versions of the ABQOL and TABQOL questionnaires had a high internal consistency (0.86 and 0.88, respectively) and test–retest reliability (0.87 and 0.87, respectively). The correlation between ABQOL and TABQOL scores was moderate (Pearson's R = 0.609). Conclusion: We have shown that the Turkish versions of ABQOL and TABQOL questionnaires are valid and reliable instruments. They can be used to measure treatment burden in Turkish AIBD patients.

Assessment of the quality of life of Egyptian and Tunisian autoimmune bullous diseases’ patients using an Arabic version of the autoimmune bullous disease quality of life and the treatment of autoimmune bullous disease quality of life questionnaires

AbstractBackground: The Autoimmune Bullous Disease Quality of Life (ABQOL) and the Treatment of Autoimmune Bullous Disease Quality of Life (TABQOL) questionnaires proved to be reliable tools that measure the disease and treatment burden.Objectives: We aimed to assess the ABQOL and TABQOL in the Arabic population.Methods: The English questionnaires were translated into the Arabic language by a certified translation agency. Eighty autoimmune bullous disease (AIBD) patients were included in this study. Patients were asked to answer 2 questionnaires. After 1 week the same patients were asked to answer the same questionnaires again.Results: The age of the patients ranged from 19 to 81 years (mean=46), 19 males, 61 females. The ABQOL ranged from 0-37 (mean=16.4±9.2). The TABQOL ranged from 2-43 (mean=21.5±9.4). Test-retest reliability was acceptable, Cronbach’s alpha was 0.76 for ABQOL and 0.74 for TABQOL. There was no significant correlation between the age of the patients and ABQOL, r =-0.2, p value was 0.183. There was a significant negative correlation between the age of the patients and the TABQOL, r=−0.2, p value was 0.039. There was a significant negative correlation between the education of the patients and the TABQOL, r=−0.3, p value was 0.007.Study limitations: Small sample size of some AIBDs and patients with severe disease.Conclusion: Objective and valuable measurements such as ABQOL and TABQOL are now available to help physicians understand their patient’s distress and should be used in every patient with AIBD. Younger and less educated patients appear to have more effects on their QOL from the treatments.

Exercise training as an adjunctive therapy to montelukast in children with mild asthma: A randomized controlled trial.

Background:This study investigated the effectiveness and safety of exercise training (ET) as an adjunctive therapy to montelukast for children with mild asthma (MA).Methods:A total of 72 children, ages 4 to 12 years with MA were randomly assigned to a treatment group or a control group at a ratio of 1:1. The subjects in the treatment group received ET plus montelukast, while the participants in the control group received montelukast alone. The primary endpoint was lung function, as measured by forced expiratory volume in 1 second (FEV1) and ratio between FEV1 and forced vital capacity (FEV1/FVC). The secondary endpoints included the symptom improvements, as measured by clinical assessment score, and quality of life (QoL), as assessed with Paediatric Allergic Disease Quality of Life Questionnaire (PADQLQ) scores. In addition, adverse events were also assessed during the period of this study. All outcomes were measured at baseline, at the end of 6-week treatment and 2-week follow-up after the treatment.Results:After 6-week treatment and 2-week follow-up, although ET plus montelukast did not show better effectiveness in improving lung function, as evaluated by the FEV1 (P > .05) and FEV1/FVC (P > .05) than montelukast alone, significant relief in clinical symptoms (P < .01), and improvement in QoL (P < .01) have achieved. Additionally, both groups had similar safety profile.Conclusion:The results of this study showed that ET as an adjunctive therapy to montelukast may benefit for children with MA. Further studies are still needed to warrant the results of this study.

Comparison of EQ-5D-5L, VAS, and SF-6D in Thai Patients on Peritoneal Dialysis

To compare the utility scores derived from the 5-level EuroQol 5-dimensional questionnaire (EQ-5D-5L), the visual analogue scale (VAS), and the 6-dimensional health state short form (SF-6D) in Thai patients on peritoneal dialysis. Data were obtained from the 36-Item Kidney Disease Quality of Life questionnaire and the EuroQol questionnaires (EQ-5D-5L and VAS) via face-to-face interview for 64 patients on peritoneal dialysis. We compared the ceiling effect of all the utility tools by calculating the proportion at the highest scores. The mean difference in utility scores defined by patients' demographic characteristics and clinical laboratory value was evaluated using independent t tests or the Mann-Whitney U test. Moreover, the correlation was assessed using the Pearson correlation coefficient. The agreements among the instruments were illustrated with the Bland and Altman plots. The mean score of the EQ-5D-5L, SF-6D, and VAS were 0.801, 0.784, and 0.733, respectively. The EQ-5D-5L presented a higher percentage of the ceiling effect than did the SF-6D and VAS. The EQ-5D-5L was able to distinguish the mean difference between age groups with significant difference (P<.001). The Pearson correlation coefficients between utility scores and the 3 dimensions of the 36-Item Kidney Disease Quality of Life questionnaire had a significantly positive correlation, especially for the SF-6D. The Bland and Altman plots portrayed that the utility scores from the EQ-5D-5L were lower than those from the SF-6D and VAS among the patients in the poorer health state. Among the SF-6D, EQ-5D-5L, and VAS, only the EQ-5D-5L could distinguish the utility scores between different age groups. Nevertheless, the EQ-5D-5L presented the ceiling effect, whereas there was no evidence of the ceiling effect for the SF-6D. The SF-6D presented better correlation with the kidney disease-specific dimensions than did the EQ-5D-5L and VAS. Thus, the advantages and disadvantages of each utility tool should be considered.

Development and Validation of the Singapore Thyroid Eye Disease Quality of Life Questionnaire.

PurposeCurrent instruments to assess thyroid eye disease (TED) quality of life (QoL) were not developed using modern psychometric theory and may not be applicable to Asian populations. Therefore, we developed a psychometrically robust questionnaire, the Singapore Thyroid Eye Disease Quality of Life questionnaire (STED-QoL), for assessing QoL in Asian patients.MethodsThis cross-sectional study was conducted at the Singapore National Eye Centre between 2012 and 2015. In Phase 1, content for the questionnaire was developed using qualitative methods. A total of 20 patients participated in three different focus groups. Thematic analysis was conducted to identify relevant themes from which 12 items, rated on a 5-point Likert-type scale, were generated. In Phase 2, the pilot instrument was administered to 59 TED patients and psychometric assessment of the STED-QoL was conducted using Rasch analysis.ResultsAfter collapsing categories from five to four and deleting two misfitting items, we generated a 10-item STED-QoL befitting the Rasch model. The scale showed good criterion validity, with scores decreasing as severity of TED worsened: mild (1.78 logits), moderate (0.27 logits), and severe (0.92 logits). A ‘Psychosocial' subscale also had adequate psychometric properties and psychosocial scores were significantly worse in those who underwent surgery for TED compared to those who had not (0.41 vs. 1.82 logits, P = 0.021).ConclusionsThe STED-QoL is a robust 10-item questionnaire specifically developed to measure the impact of TED on QoL and psychosocial well-being in an Asian population.Translational RelevanceQoL assessment is important for holistic management of TED patients.

PUK37 - USE OF HEALTH-RELATED QUALITY OF LIFE (HRQOL) INSTRUMENTS IN CLINICAL TRIALS OF ANAEMIA OF CHRONIC KIDNEY DISEASE (CKD)

Anaemia is common in patients with chronic kidney disease (CKD). Symptoms include fatigue, weakness, dyspnoea, dizziness, headaches, pallor, and decreased mental acuity, which could impact on health-related quality of life (HRQoL). This research identifies instruments used to measure HRQoL in anaemia of CKD. A targeted search of PubMed, Embase, and clinicaltrials.gov was performed to identify key phase III clinical trials (defined as those used as evidence in EMA/FDA submissions, HTAs from the EU5/The Netherlands/Sweden, or clinical guidelines) and phase III trials of treatments in development for anaemia of CKD from January 2003 to March 2018. Thirty-four completed key phase III clinical trials were identified, of which nine collected HRQoL data. Thirty-five phase III trials of treatments in development (all hypoxia-inducible factor [HIF] stabilisers) were identified, of which 20 measure HRQoL. Five generic instruments were identified; the most commonly used were the 36-item Short Form (SF-36; seven key trials; 16 trials of HIF stabilisers) and EuroQol Five-Dimensions questionnaires (EQ-5D; 16 trials of HIF stabilisers). Four disease-relevant instruments were used, among them the Functional Assessment of Cancer Therapy-Anaemia (FACT-An; 11 trials of HIF stabilisers) and Kidney Disease Quality of Life questionnaires (KDQOL; two key trials). One disease-specific instrument, the Chronic Kidney Disease-Anaemia Symptoms questionnaire (CKD-AQ), is being used in four trials of HIF stabilisers but is not publicly available for review. The energy and physical activity domains covered in generic instruments may be particularly relevant to the anaemia symptoms of fatigue, weakness, and dyspnoea. The pain and mental/emotional well-being domains are also of potential interest. Symptoms such as headaches, dizziness, and pallor are only captured by disease-relevant instruments. In the absence of a validated anaemia of CKD-specific instrument, a combination of generic and disease-specific instruments for related conditions may allow the most accurate valuation of HRQoL change.

Palliative long-term abdominal drains versus repeated drainage in individuals with untreatable ascites due to advanced cirrhosis: study protocol for a feasibility randomised controlled trial

BackgroundUK deaths due to chronic liver diseases such as cirrhosis have quadrupled over the last 40 years, making this condition now the third most common cause of premature death. Most patients with advanced cirrhosis (end-stage liver disease [ESLD]) develop ascites. This is often managed with diuretics, but if refractory, then the fluid is drained from the peritoneal cavity every 10–14 days by large volume paracentesis (LVP), a procedure requiring hospital admissions. As the life expectancy of patients with ESLD and refractory ascites (if ineligible for liver transplantation) is on average ≤ 6 months, frequent hospital visits are inappropriate from a palliative perspective. One alternative is long-term abdominal drains (LTADs), used successfully in patients whose ascites is due to malignancy. Although inserted in hospital, these drains allow ascites management outside of a hospital setting. LTADs have not been formally evaluated in patients with refractory ascites due to ESLD.Methods/designDue to uncertainty about appropriate outcome measures and whether patients with ESLD would wish or be able to participate in a study, a feasibility randomised controlled trial (RCT) was designed. Patients were consulted on trial design. We plan to recruit 48 patients with refractory ascites and randomise them (1:1) to either (1) LTAD or (2) current standard of care (LVP) for 12 weeks. Outcomes of interest include acceptability of the LTAD to patients, carers and healthcare professionals as well as recruitment and retention rates. The Integrated Palliative care Outcome Scale, the Short Form Liver Disease Quality of Life questionnaire, the EuroQol 5 dimensions instrument and carer-reported (Zarit Burden Interview) outcomes will also be assessed. Preliminary data on cost-effectiveness will be collected, and patients and healthcare professionals will be interviewed about their experience of the trial with a view to identifying barriers to recruitment.DiscussionLTADs could potentially improve end-of-life care in patients with refractory ascites due to ESLD by improving symptom control, reducing hospital visits and enabling some self-management. Our trial is designed to see if such patients can be recruited, as well as to inform the design of a subsequent definitive trial.Trial registrationISRCTN, ISRCTN30697116. Registered on 7 October 2015.

Determinants for asthma control, quality of life and use of complementary and alternative medicine in asthmatic pediatric patients in four cities.

Asthmais a significant chronic health problem worldwide. Management aims at disease control by reducing functional impairment and exacerbations and improving quality of life (QoL). We report a multi-center study to survey asthma control and QoL in four cities in the Pearl River Delta. The conjoint survey involved ten Hong Kong pediatric hospitals/units, two Shenzhen hospitals, two Macau hospitals, and two Guangzhou hospitals on asthmacontrol (using Asthma Control Test) and QoL (Pediatric Allergic Disease Quality of Life Questionnaire, PADQLQ). Acceptability of a treatment is graded as very good/good/fair/poor. Good asthma control was only reported in 80% subjects in Hong Kong, but higher in sister cities (85-94%, P < 0.001). Allergic rhinitis, "incense burning", and "smoker in family" were prevalent among the four cities. Logistic regression showed better control of asthma was associated with better PADQLQ (B = - 0.029, P < 0.001), better acceptability of bronchodilator (B = - 1.488, P = 0.025), negatively with "smoker in family" (B = - 0.83, P = 0.015) and various PADQLQ domains. Conversely, worse PADQLQ was associated with allergic rhinitis severity (B = 4.77, P < 0.001), poor control of asthma (B = 7.56, P < 0.001), increased frequency of traditional Chinese medicine use (B = 1.7, P < 0.05), increased frequency of bronchodilator usage (B = 1.05, P < 0.05), "smoker in family" (B = 4.05, P < 0.05), and incense burning at home (B = 3.9, P < 0.05). There are some clinical and cultural differences among the four southern Chinese cities within the Guangdong province. This study identifies potentially modifiable environmental and treatment factors associated with poor asthma control and QoL for health-care interventions. Having a smoker in the family is independently associated with poor asthma control and QoL.

Assessment of Duodopa® effects on quality of life of patients with advanced Parkinson's disease and their caregivers.

The gold standard of treatment in Parkinson's disease (PD) is levodopa/carbidopa whose long-term use induces motor and non-motor fluctuations and dyskinesias. Continuous infusion of intrajejunal levodopa/carbidopa intestinal gel (Duodopa®) reduces motor and non-motor symptoms and dyskinesias, and improves the quality of life of patients. The aim of this open observational prospective study was to evaluate the impact of Duodopa® on conditions of PD patients and caregivers, and their quality of life. We enrolled 12 patients with advanced PD and their caregivers. The PD patients were assessed at baseline, 3 and 6 months after Duodopa® treatment initiation using Unified Parkinson's Disease Rating Scale-PartIII and IV (UPDRS-III and IV), Unified Dyskinesia Rating Scale (UdysRS), Beck Depression Inventory (BDI-II), Hamilton Anxiety Rating Scale (HAM-A) and Parkinson's Disease Quality of Life Questionnaire (PDQ-39). The caregivers were assessed, at the same time as the patients, using BDI-II, HAM-A, Caregiver Burden Inventory (CBI) and SF-36 Health Status Questionnaire. Six months after Duodopa® therapy, the scores of UPDRS-III and IV, UdysRS, BDI-II, HAM-A and PDQ-39 were significantly decreased (p < 0.01). After Duodopa® therapy, in caregiver group the scores of BDI-II, HAM-A and CBI were significantly decreased and the scores of SF-36 Health Status Questionnaire were significantly increased (p < 0.01). A reduction of anxiety after therapy correlated with mental status domains of SF-36 Health Status Questionnaire (r = 0.56). Overall, Duodopa® is effective even in the short time to improve the clinical conditions of PD patients and caregivers and their quality of life.

Quality of life and Parkinson’s disease: Philippine translation and validation of the Parkinson’s disease questionnaire

The 39-item Parkinson’s Disease Quality of Life Questionnaire (PDQ-39) is the most widely used self-administered questionnaire assessing the quality of life of Parkinson’s disease (PD) patients. We translated the PDQ-39 into the Filipino language as the Philippine-PDQ-39 (P-PDQ-39) and used it to assess the quality of life of Filipino patients with PD. The original PDQ-39 was translated into Filipino using forward and backward translation by independent bilingual translators and used among 100 consecutively sampled PD patients. Baseline demographic data, disease duration and levodopa equivalent dose were collected. Internal consistency was measured using Chronbach’s α. The following rating scales and questionnaires were correlated with P-PDQ-39 through Pearson’s correlation coefficient to assess construct validity: modified Hoehn & Yahr Stage, Hospital Anxiety and Depression Scale-Pilipino (HADS-P), Unified Parkinson’s Disease Rating Scale (UPDRS) Parts I-III, and Non-motor symptom Assessment Scale for Parkinson’s Disease (NMSS). The mobility and activities of daily living domains of the P-PDQ-39 were well correlated with the Hoehn & Yahr stage of the patients and the UPDRS II and III scores emphasizing the value of motor symptoms in quality of life. Non motor symptoms in PD were also important determinants of quality of life as demonstrated in the correlation of HADS-P and NMSS Total scores with the P-PDQ 39 domains. The P-PDQ-39 is a valid assessment tool for assessing the quality of life of Filipino-speaking PD patients.

The effect of autoimmune blistering diseases on work productivity.

Autoimmune blistering diseases (AIBD) are known to negatively impact upon quality of life (QoL); however, there is a paucity of research on the effect of AIBD on work productivity. AIBD can be quite disfiguring in terms of a patient's appearance due to their blistering nature. To determine the impact of AIBD on work productivity and to determine whether patients are stigmatized at work due to their appearance. Sixty-one patients with AIBD completed the Work Productivity and Activity Impairment Questionnaire-Specific Health Problem (WPAIQ-SHP), the Dermatology Life Quality Index (DLQI), the Autoimmune Bullous Disease Quality of Life (ABQOL) and the Treatment of Autoimmune Bullous Disease Quality of Life questionnaires (TABQOL). Non-responders to treatment had more work and activity impairment compared to responders. Worse WPAIQ-SHP scores were correlated with higher ABQOL, TABQOL and DLQI scores. Approximately 14.8% of subjects experienced stigmatization at work due to their appearance. The most common body areas stigmatized were easily visible sites, particularly the hands, arms and feet, with the majority of occurrences related to co-workers; for some patients, this stigmatization occurred on a daily basis. Loss of productivity at work was statistically much higher in those with higher disease severity, ABQOL & TABQOL scores and in non-responders to treatment. Autoimmune blistering diseases negatively impacts upon work productivity and activity. Stigmatization was common in the workplace which leads to increased stress, itself a stimulator of pemphigus.

PGI26 - A Review of Patient-Reported Outcomes in Nonalcoholic Steatohepatitis (NASH)

Nonalcoholic steatohepatitis (NASH) is characterized by fat build up in the liver and results in inflammation and liver cell damage. NASH is rapidly becoming one of the top causes of cirrhosis, hepatocellular carcinoma and indication for liver transplantation. Patient-reported outcome (PRO) measures are an important component to assessing disease impact and therapy response in patients with NASH. The objective of this research is to identify commonly used PROs in NASH, evaluate their development, and assess their utility in various types of studies. A literature review using PubMed and a search on clinicaltrials.gov was conducted to identify PROs used in NASH studies. These PROs were evaluated against the FDA’s PRO Guidance criteria with regard to: (1) content validity, particularly patient input in concept elicitation, item generation, and cognitive debriefing; and (2) psychometric testing, particularly construct validity, internal consistency reliability, test-retest reliability, and responsiveness. Each criteria was assessed and given a rating. Finally, an attempt was made to make recommendations on which PROs should be used in different types of studies. Only one NASH-specific PRO publication currently exists: the NASH-CHECK. The NASH-CHECK has only gone through qualitative validation and needs further psychometric analyses. Other PROs used in NASH are generic liver-related measures such as the Chronic Liver Disease Questionnaire, the EORTC QLQ-HCC18 (EORTC Quality of Life Questionnaire - Hepatocellular Carcinoma / Primary Liver Cancer Module), and the LDQOL | Liver Disease Quality of Life Questionnaire. Generic VAS scales have also been used to measure condition- specific symptoms such as itching. Other PRO measures have been appropriately validated but not in specifically in the NASH population. Most PROs used in NASH are borrowed from other diseases or are general PROs and do not address the specific symptoms or concerns of NASH patients. As such, there is need for further NASH-specific PRO development.

Domains of health-related quality of life in age-related macular degeneration: a qualitative study in the Chinese cultural context

ObjectiveTo explore which areas of health-related quality of life were affected in Chinese patients, and to identify whether the areas are well covered by validated questionnaires.DesignA qualitative study based on...

Long-term Efficacy of Safinamide on Parkinson's Disease Chronic Pain.

IntroductionChronic pain is an important yet overlooked non-motor symptom of Parkinson’s disease (PD), caused by an imbalance of the dopaminergic and glutamatergic systems. Safinamide has a multimodal mechanism of action, dopaminergic (reversible MAO-B inhibition) and non-dopaminergic (modulation of the abnormal glutamate release), that might be beneficial for both motor and non-motor symptoms.ObjectivesTo investigate the long-term (2-year) efficacy of safinamide on PD chronic pain and to confirm the positive effects observed after 6 months of treatment.MethodsThis is a post hoc analysis of the data from the 2-year study 018, focused on the reduction of concomitant pain treatments and on the scores of pain-related items of the Parkinson’s disease quality of life questionnaire (PDQ-39).ResultsSafinamide, compared with placebo, significantly improved the PDQ-39 items 37 (“painful cramps or spasm,” p = 0.0074) and 39 (“unpleasantly hot or cold,” p = 0.0209) and significantly reduced the number of concomitant pain treatments by 26.2% (p = 0.005). A significantly greater proportion of patients in the safinamide group was not using pain drugs after 2 years of treatment (p = 0.0478).ConclusionsThe positive effects of safinamide on PD chronic pain were maintained in the long term. Further investigations are desirable to confirm their clinical relevance.FundingZambon SpA.