Protocol The QUEST initiative – QUality of life Evaluation STudy: Assessing Health Related Quality of Life in patients receiving Medicinal Cannabis (Preprint)

2021 ◽  
Author(s):  
Margaret-Ann Tait ◽  
Daniel S.J. Costa ◽  
Rachel Campbell ◽  
Richard Norman ◽  
Stephan Schug ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Multiple Sclerosis ◽  
Chronic Pain ◽  
Short Form ◽  
Health Related Quality ◽  
Patient Reported ◽  
Related Quality ◽  
Health Related ◽  
Medicinal Cannabis

BACKGROUND Existing evidence supports several countries introducing legislations to allow cannabis-based medicine as adjunctive treatment for the symptomatic relief of chronic pain, chemotherapy-induced nausea, spasticity in multiple sclerosis, epileptic seizures, depression, and anxiety. However, clinical trial participants do not represent the entire spectrum of disease and health status seen in patients currently accessing medicinal cannabis in practice. OBJECTIVE This study will collect real-world data to evaluate health-related quality of life and symptoms in patients prescribed medicinal cannabis oil formulations, and describe any differences over time from baseline, before starting therapy, to 3 months and 12 months on therapy. METHODS Adult patients newly prescribed medicinal cannabis oil by Authorised Prescribers and under the Special Access Schemes across clinics within Australia will be screened for eligibility and sent an invitation to participate. A sample size of 2142 is required with a minimum follow-up of 3 months. All participants will complete the EQ-5D, QLQ-C30, DASS21, Patients’ global impression of change, PROMIS Short Form v1.0 Sleep Disturbance 8b, and PROMIS Fatigue 13a/FACIT-Fatigue questionnaires. Patients with chronic pain conditions will also complete PROMIS Scale v1.0 - Pain Intensity 3a, and PROMIS Short Form v1.0 - Pain Interference 8a. Patients with movement disorders will also complete Neuro-QoL v1.0 – Upper Extremity Function (Fine Motor, ADL) – Short Form, and if Chorea is indicated, the Neuro-QoLTM Short Form v2.0 – HDQLIFE – Chorea 6a. All questionnaires will be administered at baseline, 2 weeks (titration), monthly to 3 months, then every 2 months up to one year. RESULTS Participant recruitment commenced in November 2020. By June 2021, 1095 patients had been screened for the study by 69 doctors in centres across six Australian states; Australian Capital Territory, New South Wales, Queensland, South Australia, Victoria, and Western Australia. Of the 1095 patients screened, 833 participants have completed questionnaires and remained on the study. Final results are expected to be published in 2022. Results from this study will show whether patient-reported outcomes improve in patients accessing prescribed medicinal cannabis from baseline to 3-months, and if any changes are maintained over a 12-month period. This study will also identify if there are differences in improvements in PROs between patients with different chronic conditions (e.g. chronic pain, multiple sclerosis, epilepsy, Parkinson’s disease, or cancer). CONCLUSIONS This study protocol contains detailed methods that will be used across multiple sites in Australia. The findings from this study have potential to be integral to treatment assessment and recommendations for chronic pain sufferers and other patients with health indicators for accessing medicinal cannabis. CLINICALTRIAL ANZCTR Trial Registration: 12621000063819

Association of Physical Morbidity and Health-Related Quality of Life in a Representative Sample of Older German People

2018 ◽  
Vol 25 (4) ◽  
pp. 140-151
Author(s):  
Markus A. Wirtz ◽  
Matthias Morfeld ◽  
Elmar Brähler ◽  
Andreas Hinz ◽  
Heide Glaesmer
Keyword(s):  
Quality Of Life ◽  
Representative Sample ◽  
Short Form ◽  
Physical Symptoms ◽  
German Population ◽  
Health Related Quality ◽  
Patient Reported ◽  
Related Quality ◽  
Health Related

Abstract. The association between health-related quality of life (HRQoL; Short-Form Health Survey-12; SF-12) and patient-reported morbidity-related symptoms measured by the Patient Health Questionnaire-15 (PHQ-15) is analyzed in a representative sample of older people in the general German population. Data from 1,659 people aged 60 to 85 years were obtained. Latent class analysis identified six classes of patients, which optimally categorize clusters of physical symptoms the participants reported: musculoskeletal impairments (39.8%), healthy (25.7%), musculoskeletal and respiratory/cardiac impairments (12.8%), musculoskeletal and respiratory impairments, along with bowel and digestion problems (12.9%), general impairments (4.9%), and general impairments with no bowel and digestion problems (4.8%). The participants’ SF-12 Physical Health Scores (η2 = .39) and their Mental Health Scores (η2 = .28) are highly associated with these latent classes. These associations remain virtually identical after controlling for age. The results provide evidence that profiles of patient-reported physical impairments correspond strongly with reduced HRQoL independently from aging processes.

Effects of BG-12 (dimethyl fumarate) on health-related quality of life in patients with relapsing–remitting multiple sclerosis: findings from the CONFIRM study

2013 ◽  
Vol 20 (2) ◽  
pp. 253-257 ◽  
Author(s):  
Mariko Kita ◽  
Robert J Fox ◽  
J Theodore Phillips ◽  
Michael Hutchinson ◽  
Eva Havrdova ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Multiple Sclerosis ◽  
Short Form ◽  
Dimethyl Fumarate ◽  
Phase Iii ◽  
Health Related Quality ◽  
Relapsing Remitting ◽  
Related Quality ◽  
Health Related

Multiple sclerosis (MS) has a significant impact on health-related quality of life (HRQoL) with symptoms adversely affecting many aspects of everyday living. BG-12 (dimethyl fumarate) demonstrated significant efficacy in the phase III studies DEFINE and CONFIRM in patients with relapsing–remitting MS. In CONFIRM, HRQoL was worse in patients with greater disability at baseline, and who relapsed during the study, and improved with BG-12 treatment. Mean Short Form-36 Physical Component Summary scores for BG-12 increased over 2 years and scores for placebo decreased. Coupled with clinical and neuroradiological benefits, these HRQoL results further support BG-12 as an effective oral treatment for relapsing MS.

Evaluation of an Instrument Assessing Influence of Gout on Health-Related Quality of Life

2008 ◽  
Vol 35 (12) ◽  
pp. 2406-2414 ◽  
Author(s):  
JAN D. HIRSCH ◽  
SUSAN J. LEE ◽  
ROBERT TERKELTAUB ◽  
DINESH KHANNA ◽  
JASVINDER SINGH ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Short Form ◽  
Demographic Data ◽  
Reliability And Validity ◽  
Health Related Quality ◽  
Patient Reported ◽  
Related Quality ◽  
Health Related ◽  
The Impact

ObjectiveTo evaluate the reliability and validity of an instrument assessing the influence of gout (acute and chronic) on health-related quality of life (HRQOL).MethodsFocus groups were used to examine the content of an existing Gout Assessment Questionnaire (GAQ1.0). GAQ2.0 was developed, consisting of a section describing the impact of gout on HRQOL [Gout Impact (GI)] and 4 sections describing subjects’ gout overall and demographic data. The GAQ2.0 and the Medical Outcomes Study Short Form-36 Version 2 (SF-36v2) were completed by gout patients in 3 US cities. GI scales were examined using clinical judgment, review of item statistics, Rasch analysis, and confirmatory factor analysis.ResultsSubjects (n = 308) were predominantly male (90.2%), Caucasian (75.9%), with a mean age 62.2 ± 11.8 years. Half the subjects (49.7%) reported ≥ 3 attacks in the past year. Two-week test-retest reliability for each scale was good (0.77 to 0.89) for all 5 GI scales. All scales achieved high sufficient (0.86 to 0.89) or excellent (0.93 to 0.97) ratings based on 10-item adjusted alpha coefficients. Correlations and tests among known groups indicated subjects with more severe gout had higher GI scores (i.e., greater gout impact). GI scores correlated more highly with patient-reported measures of gout severity than the SF-36v2 and several traditional measures of gout severity.ConclusionThe GAQ2.0 is an instrument for measuring the impact of gout on HRQOL. The GI section exhibited acceptable reliability and validity characteristics. Future studies should assess GI responsiveness, minimally important differences, and psychometric properties in other patient populations.

scholarly journals The impact of ocrelizumab on health-related quality of life in individuals with multiple sclerosis

2021 ◽  
Vol 7 (2) ◽  
pp. 205521732110075
Author(s):  
Bonnie I Glanz ◽  
Jonathan Zurawski ◽  
Emily C Casady ◽  
Rebecca Shamah ◽  
Mira Weiner ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Multiple Sclerosis ◽  
Clinical Characteristics ◽  
Health Related Quality ◽  
Sf 36 ◽  
Patient Reported ◽  
Related Quality ◽  
Health Related ◽  
The Impact

Background Ocrelizumab is approved for the treatment of both relapsing and progressive multiple sclerosis (MS). Objective To examine the impact of ocrelizumab on health-related quality of life (HRQOL) in individuals with MS. Methods Ninety-eight individuals with relapsing and 32 with progressive MS were enrolled. Participants were administered a battery of patient-reported outcome (PRO) measures at their first ocrelizumab infusion, and infusions at 6 and 12 months. PRO measures included the Medical Outcomes Study SF-36 and Neuro-QoL. Results At baseline, participants had low mean scores across HRQOL domains. After 12 months, increases were observed on SF-36 Role-Physical, General Health, Vitality, Role-Emotional, Mental health and Mental Component Summary. On Neuro-QoL, improvements were seen in Positive Affect, Anxiety, Emotional and Behavioral Dyscontrol and Fatigue. Several demographic and clinical characteristics were associated with HRQOL at baseline. The strongest associations were between physical HRQOL measures and measures of MS disability. Associations between the longitudinal change in HRQOL scores and baseline demographic and clinical characteristics were mild. Conclusions We observed significant improvements across multiple mental HRQOL domains at 12 months in individuals treated with ocrelizumab. These findings support the use of HRQOL measures to provide a subjective measure of treatment impact that complements traditional outcomes.

Using the Short Form-36 with Multiple Sclerosis Patients in Five Countries: A Cross-Cultural Comparison

1999 ◽  
Vol 85 (1) ◽  
pp. 19-31 ◽  
Author(s):  
Lilian Pfennings ◽  
Leo Cohen ◽  
Deborah Miller ◽  
Laurent Gerbaud ◽  
Luc Vleugels ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Multiple Sclerosis ◽  
Short Form ◽  
Cross Cultural ◽  
Cultural Comparison ◽  
Health Related Quality ◽  
Cross Cultural Comparison ◽  
Related Quality ◽  
Health Related

Questionnaires measuring health-related quality of life are increasingly used in international studies of medical effectiveness. It is important to know if data from these instruments are comparable across countries. We initiated a collaboration among five research groups—from the USA, The Netherlands, Belgium, France, and the UK—in the field of health-related quality of life in multiple sclerosis. All groups used the 36-item Short Form Health Survey. The goal of our study was to make a cross-cultural comparison. In the five countries under study the sample size varied from 50 to 134 patients with multiple sclerosis. The survey was completed by a total of 457 patients, who were heterogeneous in relation to age, duration of illness, severity and type of multiple sclerosis. There appeared to be major differences among the samples in scores on each of the eight scales. These findings may be influenced by differences in method of recruitment, demographic and disease-related characteristics, administration, and cultural factors. After having performed a number of analyses, it appeared that the differences were mainly attributable to sampling effects; however, cultural influences could not be excluded.

scholarly journals Impact of Visual Impairment on Health-Related Quality of Life in Multiple Sclerosis

2010 ◽  
Vol 12 (2) ◽  
pp. 83-91 ◽  
Author(s):  
Vivek S. Pawar ◽  
Gauri Pawar ◽  
Lesley-Ann Miller ◽  
Iftekhar Kalsekar ◽  
Jan Kavookjian ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Multiple Sclerosis ◽  
Visual Impairment ◽  
Life Questionnaire ◽  
Health Related Quality ◽  
Patient Reported ◽  
Related Quality ◽  
Health Related ◽  
The Impact

The aim of this study was to evaluate the impact of visual impairment on health-related quality of life (HRQOL) in patients with multiple sclerosis (MS). Patients at an outpatient MS clinic were asked to complete a battery of patient-reported outcome questionnaires. Health-related quality of life was measured using the Hamburg Quality of Life Questionnaire for Multiple Sclerosis (HAQUAMS), while visual impairment was measured using the Visual Function Questionnaire (VFQ). Hierarchical regression was used to determine the relative contribution of visual impairment to HRQOL. Usable responses were obtained for 116 MS patients. Those with higher levels of visual impairment (lower scores on the VFQ) reported significantly lower HRQOL (β = –0.01, P = .0007). Visual impairment also explained an additional 4% variance in the HRQOL scores, independent of disability and depression (ΔR2 = 0.04, F7,108 = 36.58). Overall, disability was the strongest predictor of HRQOL, explaining over 60% of the variation in HRQOL scores. The model explained 70% of the total variance in HRQOL. Given the prevalence of visual impairment and its influence on overall HRQOL, MS patients should be routinely screened using standard ophthalmic examination procedures or self-administered questionnaires such as the VFQ.

scholarly journals Short Report: Impact of Sleep Disorders on Depression and Patient-Perceived Health-Related Quality of Life in Multiple Sclerosis

2019 ◽  
Vol 21 (1) ◽  
pp. 10-14 ◽  
Author(s):  
Emily K. White ◽  
Amy B. Sullivan ◽  
Michelle Drerup
Keyword(s):  
Quality Of Life ◽  
Multiple Sclerosis ◽  
Sleep Disorders ◽  
Sleep Disorder ◽  
Health Related Quality ◽  
Patient Reported ◽  
Related Quality ◽  
Health Related ◽  
The Impact

Abstract Background: Sleep disorders in multiple sclerosis (MS) are associated with reduced health-related quality of life (HRQOL) and depression. However, research investigating and comparing how the two most common sleep disorders—insomnia and obstructive sleep apnea (OSA)—affect depression and HRQOL in MS is limited. The goal of this study is to examine the impact of diagnosed sleep disorders on patient-reported 1) HRQOL and 2) depressive symptoms in patients with MS. Methods: We performed a retrospective medical record review of 531 adult patients with MS: 287 (54%) with a comorbid sleep disorder (insomnia or OSA) and 244 (46%) without a diagnosed sleep disorder. Results: Neither 1) average ratings of depression or HRQOL nor 2) the proportion of moderate depression or moderately impaired HRQOL differed between individuals with MS and insomnia and those with MS and OSA. Neither sleep disorder predicted increased depression or poorer HRQOL. However, individuals with MS and a comorbid sleep disorder (insomnia or OSA) had poorer HRQOL compared with those without a diagnosed sleep disorder (MS only). Conclusions: Presence of a diagnosed sleep disorder may negatively affect HRQOL in MS. Providers should continue to screen for sleep disorders given their negative impact on patients with MS and the availability of effective treatments for insomnia and OSA.

The impact of sexual dysfunction on health-related quality of life in people with multiple sclerosis

2013 ◽  
Vol 20 (5) ◽  
pp. 610-616 ◽  
Author(s):  
Laura C Schairer ◽  
Frederick W Foley ◽  
Vance Zemon ◽  
Tuula Tyry ◽  
Denise Campagnolo ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Multiple Sclerosis ◽  
Sexual Dysfunction ◽  
Short Form ◽  
Health Related Quality ◽  
Related Quality ◽  
Health Related ◽  
The Impact ◽  
Disability Level

Background: Sexual dysfunction is a prevalent symptom in multiple sclerosis (MS) that may affect patients’ health-related quality of life (HrQoL). Objective: The objective of this paper is to examine the impact of sexual dysfunction on HrQoL in a large national sample using The Multiple Sclerosis Intimacy and Sexuality Questionnaire-19 (MSISQ-19). Methods: Participants were recruited from a large MS registry, the North American Research Committee on Multiple Sclerosis (NARCOMS) Registry. Participants self-reported demographic information and completed the Patient Determined Disease Steps (PDDS), MSISQ-19, and the Short Form-12 (SF-12). Results: The study population included 6183 persons (mean age: 50.6, SD = 9.6; 74.7% female, 42.3% currently employed). Using multivariate hierarchical regression analyses, all variables excluding gender predicted both the physical component summary (PCS-12) and the mental component summary (MCS-12) of the SF-12. Scores on the MSISQ-19 uniquely accounted for 3% of the variance in PCS-12 scores while disability level, as measured by PDDS, accounted for 31% of the variance. Conversely, MSISQ-19 scores uniquely accounted for 13% of the variance in MCS-12 scores, whereas disability level accounted for less than 1% of the variance. Conclusion: In patients with MS, sexual dysfunction has a much larger detrimental impact on the mental health aspects of HrQoL than severity of physical disability.

Personality traits predict perceived health-related quality of life in persons with multiple sclerosis

2015 ◽  
Vol 22 (4) ◽  
pp. 551-558 ◽  
Author(s):  
Ignazio Roberto Zarbo ◽  
Eleonora Minacapelli ◽  
Monica Falautano ◽  
Silvia Demontis ◽  
Giovanni Carpentras ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Multiple Sclerosis ◽  
Personality Traits ◽  
Short Form ◽  
Eysenck Personality Questionnaire ◽  
Health Related Quality ◽  
Sf 36 ◽  
Related Quality ◽  
Health Related

Background: Personality traits can affect health-related quality of life (HRQoL) in different disorders. In multiple sclerosis (MS), personality traits can determine patients’ willingness to take on more risky treatment options, predispose to neuropsychiatric symptoms and affect coping strategies. Objectives: We investigated the role of personality traits as possible predictors of HRQoL in a large cohort of persons with MS (PwMS). Methods: In total, 253 consecutively recruited PwMS were screened for intellectual deficits with Raven Colour Progressive Matrices (RCPM), state anxiety with STAI-X1 and major depression on a clinical basis. PwMS’ self-perceived mental and physical health status was measured with the 36-Item Short Form Health Survey (SF-36), and the personality profile with the Eysenck Personality Questionnaire (EPQ-R). The correlation between HRQoL and personality traits was investigated by means of analysis of variance, adjusting for possible confounders. Results: Of the 253 MS patients, 195 (F:M=2.75), aged 41.7±10.2 years were included in the analysis. The variance of SF-36 mental and physical composite score was largely explained by extraversion and neuroticism. Conclusions: Our data confirm that PwMS’ HRQoL is largely influenced by personality traits, which may therefore act as predictors of perceived quality of life and should be included in clinical and experimental settings focusing on HRQoL.

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