scholarly journals Factors affecting the health-related quality of life of patients with cervical dystonia and impact of treatment with abobotulinumtoxinA (Dysport): results from a randomised, double-blind, placebo-controlled study

BMJ Open ◽  
2014 ◽  
Vol 4 (10) ◽  
pp. e005150 ◽  
Author(s):  
Margaret Mordin ◽  
Catherine Masaquel ◽  
Chandra Abbott ◽  
Catherine Copley-Merriman

ObjectiveTo describe the health-related quality of life (HRQOL) burden of cervical dystonia (CD) and report on the HRQOL and patient perception of treatment benefits of abobotulinumtoxinA (Dysport).DesignThe safety and efficacy of a single injection of abobotulinumtoxinA for CD treatment were evaluated in a previously reported international, multicenter, double-blind, randomised trial. HRQOL measures were assessed in the trial and have not been previously reported.SettingMovement disorder clinics in the USA and Russia.ParticipantsPatients had to have a diagnosis of CD with symptoms for at least 18 months, as well as a total Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) score of at least 30; a Severity domain score of at least 15; and a Disability domain score of at least 3. Key exclusion criteria included treatment with botulinum toxin type A (BoNT-A) or botulinum toxin type B (BoNT-B) within 16 weeks of enrolment.InterventionsPatients were randomised to receive either 500 U abobotulinumtoxinA (n=55) or placebo (n=61).Primary and secondary outcome measuresEfficacy assessments included TWSTRS total (primary end point) and subscale scores at weeks 0, 4, 8, 12; a pain visual analogue scale at weeks 0 and 4; and HRQOL assessed by the SF-36 Health Survey (SF-36; secondary end point) at weeks 0 and 8.ResultsPatients with CD reported significantly greater impairment for all SF-36 domains relative to US norms. Patients treated with abobotulinumtoxinA reported significantly greater improvements in Physical Functioning, Role Physical, Bodily Pain, General Health and Role Emotional domains than placebo patients (p≤0.03 for all). The TWSTRS was significantly correlated with Physical Functioning, Role Physical and Bodily Pain scores, for those on active treatment.ConclusionsCD has a marked impact on HRQOL. Treatment with a single abobotulinumtoxinA injection results in significant improvement in patients’ HRQOL.Trial registration numberThe trial is registered at ClinicalTrials.gov, numbers NCT00257660 and NCT00288509.

Medicina ◽  
2007 ◽  
Vol 43 (8) ◽  
pp. 607 ◽  
Author(s):  
Kotryna Vereščiagina ◽  
Kazys Ambrozaitis ◽  
Bronius Špakauskas

Objective. For complete assessment of benefits of the surgical intervention, it is essential to provide evidence of the impact on patients in terms of health status and healthrelated quality of life. In the present study, the preoperative 36-item Short Form (SF-36) Health Survey scores were determined in patients before lumbar microdiscectomy due to better preoperative screening likewise in the control group – almost healthy population taken into account any habitual ailments experienced in an appropriate age. Patients and methods. In the present study, we investigated a cohort of 100 patients with disc herniation causing low back pain and another hundred of the control subjects, matched by age and gender. The short form 36 general health questionnaire (SF-36) was applied. Results. Estimation of the SF-36 scores showed that (1) all of the domain values were considerably lower in the preoperative patient group than in the second one (P<0.01); (2) the bodily pain scores were closely correlated to the social function scores (R=0.7, P<0.01), whereas the physical function was less related to the bodily pain (R=0.6, P<0.01). The weakest correlation was observed between bodily pain and mental health and general health (R=0.4, P<0.01). Conclusion. The present study showed that the generic instrument, SF-36 Health Survey, was optimized paraclinical method for patients predisposed to surgical treatment of the lumbar disc herniation disease likewise for normal population individuals, matched by age and sex, in the assessment of health-related quality of life.


2020 ◽  
Vol 8 ◽  
Author(s):  
Lincoln M Tracy ◽  
Dale W Edgar ◽  
Rebecca Schrale ◽  
Heather Cleland ◽  
Belinda J Gabbe ◽  
...  

Abstract Background Itch and pain are common complaints of patients with burn injuries. This study aimed to describe the prevalence and predictors of itch and moderate to severe pain in the first 12 months following a burn injury, and determine the association between itch, moderate to severe pain, work-related outcomes, and health-related quality of life following a burn injury. Methods Burn patients aged 18 years and older were recruited from five Australian specialist burn units. Patients completed the 36-item Short Form Health Survey Version 2 (SF-36 V2), the Sickness Impact Profile (SIP) work scale, and a specially developed questionnaire relating to itch at 1, 6, and 12 months post-injury. Moderate to severe pain was defined as a score less than 40 on the bodily pain domain of the SF-36 V2. Multivariate mixed-effects regression models were used to identify patient and burn injury predictors of itch and moderate to severe pain. Results Three hundred and twenty-eight patients were included. The prevalence of itch decreased from 50% at 1 month to 27% at 12 months. Similarly, the prevalence of moderate to severe pain decreased from 23% at 1 month to 13% at 12 months. Compared to patients aged 18-34, the adjusted odds of experiencing any itch were 59% (95% CI: 0.20, 0.82) and 55% (95% CI: 0.22, 0.91) lower for patients aged between 35 and 49 and ≥ 50 years, respectively. Compared to patients aged 18-34, the adjusted odds of experiencing moderate to severe pain were 3.12 (95% CI: 1.35, 7.20) and 3.42 (95% CI: 1.47, 7.93) times higher for patients aged 35-49 and ≥ 50 years, respectively. Conclusions Less than 15% of patients reported moderate or severe pain at 12 months, while approximately one-quarter of the patients reported itch at the same period. The presence of moderate to severe pain was associated with a greater negative impact on health-related quality of life and work outcomes compared to itch. Further research is needed to improve our ability to identify patients at higher risk of persistent itch and pain who would benefit from targeted review and intervention studies.


2013 ◽  
pp. 54-58
Author(s):  
Mateus Lage Martins ◽  
Rafael Corrêa Valério ◽  
Tales José Corrêa de Almeida ◽  
Vitor Rodrigues Laender ◽  
Dilermando Fazito de Resende ◽  
...  

Background: Headaches are prevalent in the pediatric population. Migraine significantly impacts the health-related quality of life (HRQoL) of sufferers. Objective: To measure the impact of migraine on the HRQoL of children, by applying the Brazilian version of the SF-36 in children with migraine and in controls. Methods: In this cross-sectional study, HRQoL was measured with the SF-36, and scores for the 8 domains of the test were contrasted comparing children (5 to 14 years) with and without migraine. Results: Sample consisted of 66 children (30 with migraine and 36 controls). Mean age was 10.9 years for migraine (Standard Deviation - SD = 3 years) and 10.4 for controls (SD = 3.1 years). Proportion of children with low HRQoL scores was significantly higher in the migraine group, relative to controls, for the 8 domains of the test: vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning, and mental health. Conclusion: Children with migraine are significantly impacted in their HRQoL, relative to children without migraine.


Author(s):  
Alok Verma ◽  
Pavan Singh ◽  
Saurabh Agarwal ◽  
Babita Gupta

Background: There is paucity of literature regarding health related quality of life (HRQoL) in Meige’s syndrome (MS) especially from India. This study assessed HRQoL in its global and disease specific aspect by previously validated instruments in patients with Meige’s syndrome.Methods: The study was performed in AIIMS, New Delhi. Subjects with Meige’s syndrome as well as age and gender matched healthy controls were enrolled from Movement Disorder and botulinum toxin clinic, Department of Neurology, AIIMS, New Delhi. Uneducated patient, those could not read questionnaires and cases who had received botulinum toxin within 6 months were excluded from the study.Results: A 14 pts of Meige’s syndrome were enrolled and 14 age matched controls were taken. All the pts of Meige’s syndrome scored worse in SF-36 as compared to controls in areas of role physical (p =0.002), bodily pain (p = 0.001), general health (p = <0.001), social functioning (p = 0.05) and role emotion (p = <0.001). 50% of patients with Meige’s syndrome had depression out of whom 21.4 % had moderate depression. Patients with Meige’s syndrome had significantly impaired scores in 10 of the 12 subscales which was profound in areas of ocular pain, near activities, distance activities, social functioning, role difficulties, dependency, driving, compared to borderline impairment in general vision, mental health, color vision.Conclusions: This study clearly demonstrated that pts with Meige’s syndrome, suffered from significant impairment in HRQoL as compared to controls. Higher proportion of patients with Meige’s syndrome suffered from moderate depression compared to their control. Pts with Meige’s syndrome had severe impairment of vision related quality of life. 


2019 ◽  
Vol 404 (7) ◽  
pp. 807-814
Author(s):  
Lo Hallin Thompson ◽  
Erik Nordenström ◽  
Martin Almquist ◽  
Anders Bergenfelz

Abstract Purpose The aim of the study was to examine subjective health-related quality of life (HRQoL) in patients undergoing adrenalectomy. Methods The study included patients scheduled for adrenalectomy 2014–2017 after giving informed consent. The SF-36 questionnaire was administrated before operation and 1 year postoperatively. Results were compared with published normative values in Sweden. Results Some 50 patients were included. SF-36 scores for the whole cohort improved significantly after adrenalectomy in all dimensions except for bodily pain. Compared with the general Swedish population, the patients reported a significantly reduced HRQoL before and after adrenalectomy in all domains except for bodily pain postoperatively. Patients with benign functional tumours had lower HRQoL in physical domains before adrenalectomy than patients with benign non-functional tumours; Physical Component Summary (PCS), median 33.1 (range 17.1–62.9) vs. 44.2 (20.0–66.5), p = 0.018. Postoperatively, HRQoL was similar in the two groups of patients. Patients with benign functional tumours reported significantly improved HRQoL in all dimensions after adrenalectomy: PCS 33.1 (17.1–62.9) preoperatively vs. 47.6 (19.8-57.3) postoperatively, p = 0.005; Mental Component Summary (MCS) 33.8 (11.8–62.0) preoperatively vs. 52.7 (16.4–59.8) postoperatively, p = 0.004. These improvements were not seen in patients with benign non-functional or malignant tumours. Patients with malignant tumours reported no difference in SF-36 scores before or after adrenalectomy compared with patients with benign non-functional tumours. Conclusions Adrenalectomy improved HRQoL in patients with benign functional tumours. Adrenalectomy did not improve HRQoL in patients with benign non-functional tumours or in patients with malignant tumours.


2020 ◽  
Vol 26 (Supplement_1) ◽  
pp. S10-S10
Author(s):  
Gary Lichtenstein ◽  
Brian Feagan ◽  
Jay Tuttle ◽  
Nathan Morris ◽  
Yan Dong ◽  
...  

Abstract Background Mirikizumab (LY3074828) is a humanized monoclonal antibody directed against the p19 subunit of IL-23, and had demonstrated efficacy in psoriasis, ulcerative colitis (UC), and Crohn’s disease. The effect of miri on health-related quality of life (HRQoL) as measured by the 36-Item Short Form Health Survey v2 Standard (SF-36) was examined in a Phase 2, multicenter, randomized, parallel-arm, double-blind placebo (PBO)-controlled trial (NCT02891226) in patients with moderate to severely active UC. Methods Patients were randomized 1:1:1:1 to receive intravenous PBO, miri 50mg or 200mg with possibility of exposure-based (EB) dose increases, or fixed miri 600mg every 4 weeks (Q4W), with efficacy assessment at Week 12. Patients with clinical response to miri at Week 12 were re-randomized 1:1 to a double-blind maintenance treatment of miri 200mg subcutaneously (SC) Q4W or 12 weeks (Q12W) and were treated through Week 52. The SF-36, a 36-item patient-completed questionnaire with recall period past 4-weeks, that measures 8 domains (physical functioning, role-physical, role-emotional, bodily pain, vitality, social functioning, mental health, and general health) and two summary scores, physical component summary (PCS) and mental component summary (MCS), was assessed at baseline and at Weeks 4, 8, 12, 24, 32, and 52. Treatment comparisons were evaluated using mixed effects for repeated measures for mean improvement of PCS, MCS, and domain score changes with treatment, geographic region, and prior biologic UC therapy use as factors. Results The PCS was significantly higher in all miri doses at Week 12 (Least Squares Mean [LSM] ± SE; PBO: 45.4±0.8; miri 50mg: 48.2±0.9, p=0.011; 200mg: 48.0±0.8, p=0.022; 600mg: 49.0±0.9, p=0.002; Fig 1A), while the MCS was significantly higher in the miri 200mg and 600mg groups (PBO: 42.5±1.2; miri 50mg: 43.8±1.3; 200mg: 46.1±1.2, p=0.028; 600mg: 48.1±1.3, p&lt;0.001; Fig 1B). Of the 8 SF-36 domains, 7 (physical functioning, role-physical, role-emotional, social functioning, vitality, bodily pain, and mental health) showed statistically significant improvement at Week 12 in at least one miri dose group compared to PBO, while 1 (general health) demonstrated a numerical improvement (Fig 1C). Patients who continued onto randomized maintenance treatment sustained the improved scores through Week 52 (Fig 2). These results paralleled the observed treatment associated benefits on clinical response and remission rates at Weeks 12 and 521. Conclusion Mirikizumab treatment results in significant improvements in patient HRQoL demonstrated by significantly improved SF-36 scores after 12 weeks of induction treatment, which were sustained during an additional 40 weeks of maintenance treatment.


2017 ◽  
Vol 24 (5) ◽  
pp. 815-821 ◽  
Author(s):  
Agoritsa Varaklioti ◽  
Nick Kontodimopoulos ◽  
Dimitris Niakas ◽  
Anna Kouramba ◽  
Olga Katsarou

Health-related quality of life (HRQoL) is increasingly implicated in contemporary hemophilia management. This study focuses on the assessment of HRQoL in Greek patients with hemophilia and the comparison with normative data from the general population, as well as on the extent arthropathy may affect the patients’ HRQoL. One hundred and nine adult patients completed the Greek social functioning (SF-36) and Haem-A-QoL questionnaires. Arthropathy was assessed by both the World Federation of Hemophilia clinical score and Pettersson radiological score. The most impaired domains of Haem-A-QoL were sports/leisure (SL) and physical health (PH; mean scores 61.2 and 42.2, respectively). The patients experienced statistically significant lower mean scores in all SF-36 domains than the normative sample, especially in role physical (RPH), bodily pain (BP), and general health (GH) subscales. Among Haem-A-QoL subscales, SL and PH were found strongly associated with severity of arthropathy using both orthopedic scores ( P < .001), and maintained the statistical significance after adjustment for age ( P < .05). A poor orthopedic status was also negatively associated with certain SF-36 subscales. However, none of these correlations remained after adjustment with age. Compared to normative data from Greece, patients with hemophilia showed deterioration in all HRQoL subscales, with a more pronounced effect in RPH, BP, and GH subscales. Health-related quality of life was strongly influenced by arthropathy, mainly in the physical aspects of HRQoL. The use of the disease-specific Haem-A-QoL tool can capture additional associations between HRQoL and hemophilic arthropathy.


Reumatismo ◽  
2019 ◽  
Vol 71 (2) ◽  
pp. 68-74 ◽  
Author(s):  
M. De Oliveira Paes Leme ◽  
S.L.K. Yuan ◽  
M. Oliveira Magalhães ◽  
S.R. Ferreira de Meneses ◽  
A.P. Marques

The objective of our study was to compare pain and health-related quality of life among patients with knee osteoarthritis (OA), chronic nonspecific low back pain (CNLBP) and fibromyalgia (FM). This cross-sectional study included 87 subjects, who were divided into three groups according to their diagnosis: knee OA (n=29), CNLBP (n=29) and FM (n=29), between March 2013 and March 2014. Pain intensity was measured using the Numeric Pain Rating Scale (NPRS), quality of pain using the McGill Pain Questionnaire (MPQ) and health-related quality of life using the 36-item Short-Form Health Survey (SF-36). Painful body areas were marked on a pain map. No statistically significant differences between groups were found for NPRS. Regarding MPQ, the knee OA group presented a lower pain-rating index in contrast to the CNLBP and FM groups, and no significant differences were found between the CNLBP and FM groups. A greater number of characteristic pain descriptors and painful locations were found in the FM group than in the CNLBP or knee OA groups. Regarding SF-36, the FM group presented statistically significant lower values for bodily pain in contrast to the knee OA group. Even though the global pain intensity was similar between groups, the findings suggest that the FM group presented the worst pain experience and a lower health-related quality of life than the knee OA group in terms of bodily pain. They also suggest that the pain experience was worse for the CNLBP group than for the knee OA group but health-related quality of life was similar.


Cephalalgia ◽  
2004 ◽  
Vol 24 (3) ◽  
pp. 188-196 ◽  
Author(s):  
C Ertsey ◽  
N Manhalter ◽  
G Bozsik ◽  
J Áfra ◽  
I Jelencsik

Health-related quality of life was studied in 35 episodic cluster headache (CH) patients during and after the cluster period, using a generic (SF-36) and a headache-specific (MSQ2.1) instrument. The results were compared with those of age-and sex-matched migraineurs ( n = 53) and healthy persons ( n = 62). During the cluster period patients had lower scores than controls in all SF-36 and MSQ2.1 domains. The difference was significant for most SF-36 and all MSQ2.1 domains. Although CH patients had lower scores than migraineurs on most scales, the difference was significant only on SF-36 scores measuring bodily pain and social functioning. There was a good correlation between the two instruments. After the termination of the cluster period the quality of life of patients was similar to that of headache-free controls. Generic and headache-specific QoL are severely impaired in CH and this impairment is at least as severe as in migraine.


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