scholarly journals 0740 Quality of Life in Phase 3, Placebo-Controlled, Double-Blind, Randomized Withdrawal Study of JZP-258 in Adults with Narcolepsy with Cataplexy

SLEEP ◽  
2020 ◽  
Vol 43 (Supplement_1) ◽  
pp. A281-A282
Author(s):  
N Foldvary-Schaefer ◽  
M J Thorpy ◽  
Y Dauvilliers ◽  
A Roy ◽  
L Tang ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Short Form ◽  
Standard Of Care ◽  
Sodium Oxybate ◽  
Self Report ◽  
Double Blind Study ◽  
Open Label ◽  
Double Blind ◽  
Sf 36

Abstract Introduction Narcolepsy negatively impacts health-related quality of life (HRQoL). Sodium oxybate is a standard of care for the treatment of cataplexy and excessive daytime sleepiness in narcolepsy. JZP-258 is an oxybate product candidate with 92% less sodium. Efficacy and safety of JZP-258 were established in a double-blind randomized withdrawal study in adults with narcolepsy with cataplexy. Methods Participants 18-70 years of age began JZP-258 treatment during a 12-week, open-label, optimized treatment and titration period, followed by a 2-week stable-dose period (SDP). Participants were then randomized to receive placebo or continue JZP-258 treatment during a 2-week, double-blind, randomized withdrawal period (DBRWP). HRQoL assessments included the 36-Item Short Form Health Survey Version 2 (SF-36) and 5-level EuroQoL 5-Dimensions Self-Report Questionnaire (EQ-5D-5L). Results 201 participants enrolled; 134 were randomized and received at least 1 dose of double-blind study medication (efficacy population; placebo, n=65; JZP-258, n=69). Decreased scores (worsening) were observed in participants randomized to placebo compared with participants randomized to continue JZP-258 treatment for the SF-36 physical component summary (median [Q1, Q3], −1.92 [−3.46, 1.73] for placebo and −0.03 [−2.07, 2.41] for JZP-258; nominal P=0.02), SF-36 mental component summary (−1.92 [−6.28, 1.34] for placebo and 1.55 [−1.88, 3.78] for JZP-258; nominal P=0.03), and EQ-5D-5L visual analog scale (−5.00 [−10.0, 5.00] for placebo and 0 [0, 5.00] for JZP-258; nominal P=0.01). No change was observed in the EQ-5D-5L crosswalk index (0 [−0.05, 0.03] for placebo and 0 [−0.01, 0.03] for JZP-258; nominal P=0.39). The overall safety profile of JZP-258 was similar to sodium oxybate. Conclusion HRQoL worsened in those randomized to placebo during DBRWP but remained stable in participants who continued JZP-258 treatment. Support Jazz Pharmaceuticals

scholarly journals Evaluation of the Use of Sterilized and Non-Sterilized Peruibe Black Mud in Patients with Knee Osteoarthritis

2021 ◽  
Vol 18 (4) ◽  
pp. 1666 ◽  
Author(s):  
Paulo Fávio Macedo Gouvêa ◽  
Zélia Maria Nogueira Britschka ◽  
Cristina de Oliveira Massoco Salles Gomes ◽  
Nicolle Gilda Teixeira de Queiroz ◽  
Pablo Antonio Vásquez Salvador ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Knee Osteoarthritis ◽  
Short Form ◽  
Serum Levels ◽  
Double Blind ◽  
Sf 36 ◽  
Radiographic Grade ◽  
Physical Functions ◽  
Kellgren And Lawrence

This study aimed to evaluate the effects of treatment with Peruíbe Black Mud (PBM) on the clinical parameters and quality of life of patients with knee osteoarthritis and to compare the effects of PBM samples simply matured in seawater and PBM sterilized by gamma radiation. A controlled, double-blind trial was conducted with 41 patients divided into two treatment groups composed of 20 and 21 patients: one group was treated with matured PBM and the other with sterilized PBM. Evaluations were done using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) and the Medical Outcomes Study Short Form 36 (SF-36) questionnaires, the Kellgren and Lawrence (KL) radiographic scale, and the quantification of the serum levels of inflammatory biomarkers. An improvement in pain, physical functions, and quality of life was observed in all of the patients who underwent treatment with both simply matured and sterilized PBM. Nine patients showed remission in the KL radiographic scale, but no statistically significant differences were observed in the serum levels of inflammatory mediators before or after treatment. Peruíbe Black Mud proves to be a useful tool as an adjuvant treatment for knee osteoarthritis (OA), as shown by the results of the WOMAC and SF-36 questionnaires and by the remission of the radiographic grade of some patients on the Kellgren and Lawrence scale.

scholarly journals Quality of Life in Hypoparathyroidism Improves With rhPTH(1-84) Throughout 8 Years of Therapy

2019 ◽  
Vol 104 (7) ◽  
pp. 2748-2756 ◽  
Author(s):  
Gaia Tabacco ◽  
Yu-Kwang Donovan Tay ◽  
Natalie E Cusano ◽  
John Williams ◽  
Beatriz Omeragic ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Short Form ◽  
Calcium Supplementation ◽  
Bodily Pain ◽  
Well Being ◽  
Reference Population ◽  
Open Label ◽  
Sf 36

Abstract Context Calcium and vitamin D treatment does not improve reduced quality of life (QOL) in hypoparathyroidism. Recombinant human (rh) PTH(1-84) therapy improves QOL metrics for up to 5 years. Data on QOL beyond this time point are not available. Objectives To evaluate the effects of 8 years of rhPTH(1-84) therapy on QOL and factors associated with long-term benefit. Design Prospective, open-label trial. Setting Referral center. Patients Twenty patients with hypoparathyoidism. Main Outcome Measures RAND 36-Item Short Form Health Survey (SF-36). Results rhPTH therapy led to substantial improvement in five of the eight SF-36 domains [vitality, social functioning (SF), mental health (MH), bodily pain (BP) and general health] and three of these domains (SF, MH, BP) were no longer lower than the reference population. The improvement in the mental component summary (MCS) score was sustained through 8 years, while the physical component summary (PCS) score improved through 6 years. A lower baseline QOL score was associated with greater improvement. A threshold value <238 (MCS) and <245 (PCS) predicted long-term improvement in 90% and 100% of the cohort, respectively. In patients whose calcium supplementation was reduced, MCS and PCS scores improved more than those whose supplementation did not decline to the same extent. Improvement in PCS was greater in patients whose calcitriol dosage was reduced and duration of disease was shorter. Conclusions rhPTH(1-84) improves long-term well-being in hypoparathyroidism. The improvements are most prominent in those with impaired SF-36 at baseline and those whose requirements for conventional therapy decreased substantially.

scholarly journals Changes in the health status and functional outcomes in acute traumatic hand injury patients, during physical therapy treatment

2011 ◽  
Vol 44 (02) ◽  
pp. 362-367
Author(s):  
Rebecca John ◽  
Chhaya V. Verma
Keyword(s):  
Quality Of Life ◽  
Physical Therapy ◽  
Functional Disability ◽  
Short Form ◽  
Bodily Pain ◽  
Hand Injury ◽  
Self Report ◽  
Sf 36 ◽  
Traumatic Hand Injury

ABSTRACT Introduction: Traumatic hand injury causes chronic disability. A large number of studies have reported impairments in clinical parameters, but few studies have described their disability experience. Aims To examine the functional disability and quality of life in traumatic hand injured patients receiving physical therapy. Settings and Design: The physiotherapy department in a multi-specialty public sector hospital. Convenient sampling method was used. Materials and Methods: The 36-item short-form health survey–MOS (SF-36, v2) and disabilities of arm, shoulder and hand (DASH) questionnaire were obtained and subjects were given physiotherapy, accordingly to their condition. Questionnaires were re-administered every month till discharge. Statistical Analysis Used: A One-way ANOVA test. Results: At end of 6 months, among eight subscales of SF-36, there is improvement in mean scores of physical functioning (39.1%). The bodily pain, general health, vitality, social function, and mental health had more than 100% improvement. DASH showed regression in disability (50.8%). Conclusions: Measuring quality of life (QOL) can provide detailed assessment of physical disability and treatment effects as well as the global impact of those effects on the person's daily life. Hence, the use of self-report questionnaires such as DASH and SF-36, combined with physical performance score, helps to achieve more comprehensive evaluation of outcome.

scholarly journals Effects of subclinical hypothyroidism treatment on psychiatric symptoms, muscular complaints, and quality of life

2012 ◽  
Vol 56 (2) ◽  
pp. 128-136 ◽  
Author(s):  
Vaneska Spinelli Reuters ◽  
Cloyra de Paiva Almeida ◽  
Patrícia de Fátima dos Santos Teixeira ◽  
Patrícia dos Santos Vigário ◽  
Márcia Martins Ferreira ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Subclinical Hypothyroidism ◽  
Psychiatric Symptoms ◽  
Clinical Score ◽  
Double Blind Study ◽  
Double Blind ◽  
Sf 36 ◽  
Related Quality ◽  
The Impact

OBJECTIVES: To evaluate the impact of subclinical hypothyroidism (sHT) treatment on health-related quality of life (QoL), psychiatric symptoms, clinical score, and muscle function. MATERIALS AND METHODS: In this randomized double-blind study, patients were assigned either to treatment (n = 35) or placebo (n = 36). Clinical and psychiatric symptoms were assessed by the Zulewski, Hamilton and Beck scales. QoL was assessed by the SF-36 questionnaire. Assessments of quadriceps (QS) and inspiratory muscle (IS) strength were performed by a chair dynamometer and a manuvacuometer. RESULTS: Treatment improved IS (+11.5 ± 17.2; p = 0.041), as did QoL domains "Pain" and "Role Physical" (+19.7 ± 15.2, 0.039 and +22.1 ± 47.5, p = 0.054; respectively). Clinical and psychiatric symptoms showed similar responses to both interventions. CONCLUSIONS: sHT treatment improved IS and physical aspects of QoL, despite no impact in other muscle parameters. Clinical score, psychiatric symptoms, and SF-36 domains, based on mental dimensions of QoL may be more susceptible to "placebo effect" in patients with sHT.

Quality of life of patients with Sjogren’s disease with ongoing therapy with diseasemodifying antirheumatic drugs

2020 ◽  
pp. 33-38
Author(s):  
E. Yu. Gan ◽  
L. P. Evstigneeva
Keyword(s):  
Quality Of Life ◽  
Short Form ◽  
Life Quality ◽  
Well Being ◽  
Disease Modifying Antirheumatic Drugs ◽  
Antirheumatic Drugs ◽  
Sf 36 ◽  
Disease Modifying ◽  
Sjögren’S Disease

Purpose of the study. Assessing the association between the life quality of patients with Sjogren’s Disease and ongoing therapy with various disease-modifying antirheumatic drugs.Material and methods. The study was conducted on the basis of the regional rheumatology center of the consultative diagnostic clinic of the Sverdlovsk Regional Clinical Hospital No. 1. This work is based on the results of a simultaneous study of 74 patients with primary Sjogren’s Disease (SD), distributed in three comparison groups receiving various disease-modifying antirheumatic drugs chlorambucil, methotrexate and hydroxychloroquine. The diagnosis of SD was carried out according to European-American criteria AECGC (2002) [18]. In order to analyze the quality of life of patients with SD, the 36-Item Short Form Health Survey (SF‑36) was used. Statistical data processing was carried out using Statistica 7.0 program.Results. Assessment of the quality of life of patients with SD, which is an integrative criterion of human health and well-being, revealed the absence of statistically significant differences (p > 0.05) on eight scales and two health components of the SF‑36 questionnaire in the analyzed groups that differ in the treatment of disease-modifying antirheumatic drugs chlorambucil, methotrexate and hydroxychloroquine.Conclusions. The obtained data indicate an equivalent quality of life in SD patients treated with different disease-modifying antirheumatic drugs methotrexate, chlorambucil and hydroxychloroquine, and therefore hydroxychloroquine can be considered as an alternative basic therapy in patients with SD with certain limitations and contraindications methotrexate and chlorambucil.

Translation and Validation of the Thai Version of the Wisconsin Quality of Life Questionnaire (TH WISQoL) for Kidney Stone Patients

2020 ◽  
Vol 103 (11) ◽  
pp. 1194-1199
Keyword(s):  
Quality Of Life ◽  
Internal Consistency ◽  
Kidney Stone ◽  
Convergent Validity ◽  
Large Scale ◽  
Short Form ◽  
Outcome Measurement ◽  
Life Questionnaire ◽  
Sf 36

Objective: To develop and validate a Thai version of the Wisconsin Quality of Life (TH WISQoL) Questionnaire. Materials and Methods: The authors developed the TH WISQoL Questionnaire based on a standard multi-step process. Subsequently, the authors recruited patients with kidney stone and requested them to complete the TH WISQoL and a validated Thai version of the 36-Item Short Form Survey (TH SF-36). The authors calculated the internal consistency and interdomain correlation of TH WISQoL and compared the convergent validity between the two instruments. Results: Thirty kidney stone patients completed the TH WISQoL and the TH SF-36. The TH WISQoL showed acceptable internal consistency for all domains (Cronbach’s alpha 0.768 to 0.909). Interdomain correlation was high for most domains (r=0.698 to 0.779), except for the correlation between Vitality and Disease domains, which showed a moderate correlation (r=0.575). For convergent validity, TH WISQoL demonstrated a good overall correlation to TH SF-36, (r=0.796, p<0.05). Conclusion: The TH WISQoL is valid and reliable for evaluating the quality of life of Thai patients with kidney stone. A further large-scale multi-center study is warranted to confirm its applicability in Thailand. Keywords: Quality of life, Kidney stone, Validation, Outcome measurement

scholarly journals Comparing quality of life between patients undergoing trans-areola endoscopic thyroid surgery and trans-oral endoscopic thyroid surgery

BMC Surgery ◽  
2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Shuang Shen ◽  
Xiaochi Hu ◽  
Rui Qu ◽  
Youming Guo ◽  
Libo Luo ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Thyroid Surgery ◽  
Short Form ◽  
Endoscopic Thyroidectomy ◽  
Operation Time ◽  
Endoscopic Thyroid Surgery ◽  
Sf 36 ◽  
Areola Approach ◽  
High Level

Abstract Background Compared with conventional open surgery, endoscopic thyroidectomy via the oral vestibular approach (ETVOA) and endoscopic thyroidectomy via the areola approach (ETAA) avoided scarring of the skin, which may help patients achieve a better quality of life (QOL). However, the benefit of the QOL from this technique has not been adequately investigated, therefore this study compared the QOL outcomes between ETVOA and ETAA. Methods 131 patients were enrolled in this study. ETAA surgery and ETVOA surgery were performed in 74 patients and 57 patients, respectively. These patients were followed up at 2 weeks, 4 weeks, and 8 weeks, and their QOL was evaluated using a thyroid surgery-specific questionnaire and a short-form health survey (SF-36). Results There were no differences in clinical characteristics such as gender, age, body mass index (BMI), and tumor size between the two groups. The volume of intraoperative blood loss, cost of hospitalization, and complications between the two procedures showed no differences. Compared with ETAA, ETVOA has a longer operation time, no drainage, and shorter hospital stay. In the QOL questionnaire, several parameters in ETVOA were better. The satisfaction scores of patients undergoing ETVOA were higher. In addition, the cosmetic satisfaction in patients who received ETOVA was significantly better than that of patients who underwent ETAA. The degree of neck movement disorder in patients with ETVOA was milder. Patients who received ETVOA had higher score on the SF-36. Conclusions The trans-oral endoscopic approach can acquire better cosmetic results and achieved high-level QOL.

scholarly journals The impact of symptoms on daily life as perceived by patients with Charcot-Marie-Tooth type 1A disease

2021 ◽  
Author(s):  
Stefano Tozza ◽  
Dario Bruzzese ◽  
Daniele Severi ◽  
Emanuele Spina ◽  
Rosa Iodice ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Daily Life ◽  
Short Form ◽  
Lower Limbs ◽  
Charcot Marie Tooth ◽  
Rank Analysis ◽  
Sf 36 ◽  
Tooth Type ◽  
The Impact

Abstract Introduction In Charcot-Marie-Tooth type 1A (CMT1A) patients, daily life is mainly influenced by mobility and ambulation dysfunctions. The aim of our work was to evaluate the perception of disturbances that mostly impact on daily life in CMT1A patients and its difference on the basis of age, gender, disability, and quality of life. Methods Forty-one CMT1A patients underwent neurological assessment focused on establishing clinical disability through the Charcot-Marie-Tooth Neuropathy Score (CMTNS) and quality of life through the Short Form-36 (SF-36) questionnaire. We identified from CMT disturbances 5 categories [weakness in lower limbs (WLL), weakness in upper limbs (WUL), skeletal deformities (SD), sensory symptoms (SS), balance (B)] and patients classified the categories from the highest to the lowest impact on daily life (1: highest; 5: lowest). Ranking of the 5 categories, in the overall sample and in the different subgroups (dividing by gender, median of age and disease duration, CMTNS, domains of SF-36), was obtained and differences among subgroups were assessed using a bootstrap approach. Results Rank analysis showed that WLL was the most important disturbance on daily life whereas WUL had the lowest impact. In the older CMT1A group, the most important disturbance on daily life was B that was also the most relevant disturbance in patients with a greater disability. SD influenced daily life in younger patients. SS had less impact on daily life, with the exception of patients with a milder disability. Discussion Our findings demonstrated that the perception of disturbances that mostly impact on CMT1A patients’ daily life changes over the lifetime and with degree of disability.

scholarly journals Impact of depression on quality of life in systemic lupus erythematosus patients

2021 ◽  
Vol 57 (1) ◽  
Author(s):  
Eman M. Khedr ◽  
Rania M. Gamal ◽  
Sounia M. Rashad ◽  
Mary Yacoub ◽  
Gellan K. Ahmed
Keyword(s):  
Quality Of Life ◽  
Systemic Lupus Erythematosus ◽  
Lupus Erythematosus ◽  
Short Form ◽  
Systemic Lupus ◽  
Positive Correlation ◽  
Depressed Patients ◽  
Sf 36 ◽  
The Impact

Abstract Background Depression is common in systemic lupus erythematosus (SLE) and is an unmeasured risk factor, yet its symptoms can be neglected in standard disease evaluations. The purpose of this study was to assess the frequency and the impact of depression on quality of life in SLE patients. We recruited 32 patients with SLE and 15 healthy control volunteers in the study. The following investigations were undertaken in each patient: clinical and rheumatologic assessment, SLE Disease Activity Index-2k (SLEDAI-2k), Beck Depression Inventory (BDI), Short-Form Health Survey (SF-36) questionnaire, and routine laboratory tests. Results There was a high percentage of depression (46.9%) in the SLE patients. Regarding quality of life (SF-36), there were significant affection of the physical and mental composite summary domains (PCS and MCS) scores in lupus patients compared with controls (P < 0.000 for both) with the same significant in depressed compared with non-depressed patients. SF-36 subscales (physical function, limit emotional, emotional wellbeing, and social function) were significantly affected in depressed lupus patients compared with non-depressed patients. There was a significant negative correlation between the score of MCS domain of SF-36 with BDI (P < 0.000) while positive correlation between SLEDAI score with depression score. In contrast, there were no significant correlations between MCS or PCS with age, duration of illness, or SLEDAI-2K. Conclusions Depression is common in SLE patients and had a negative impact on quality of life particularly on MCS domain and positive correlation with disease severity score. Trial registration This study was registered on clinical trial with registration number: NCT03165682 https://clinicaltrials.gov/ct2/show/NCT03165682 on 24 May 2017.

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