The Quality of Life after Brain Injury (QOLIBRI) score was developed to assess disease-specific health-related quality of life (HRQoL) after traumatic brain injury (TBI). So far, validation studies ...on the QOLIBRI were only conducted in cohorts with traumatic brain injury. This study investigated the longer-term residuals in severely injured patients, focusing specifically on the possible impact of major TBI.
In a prospective questionnaire investigation, 199 survivors with an injury severity score (ISS) > 15 participated in one-year follow-up. Patients who had sustained major TBI (abbreviated injury scale, AIS head > 2) were compared with patients who had no or only mild TBI (AIS head ≤ 2). Univariate analysis (ANOVA, Cohen's kappa, Pearson's r) and stepwise linear regression analysis (B with 95% CI, R, R
) were used.
The total QOLIBRI revealed no differences in one-year outcomes between patients with versus without major TBI (75 and 76, resp.; p = 0.68). With regard to the cognitive subscore, the group with major TBI demonstrated significantly more limitations than the one with no or mild TBI (p < 0.05). The AIS head correlated significantly with the cognitive dimension of the QOLIBRI (r = - 0.16; p < 0.05), but not with the mental components of the SF-36 or the TOP. In multivariate analysis, the influence of the severity of head injury (AIS head) on total QOLIBRI was weaker than that of injured extremities (R
= 0.02; p < 0.05 vs. R
= 0.04; p = 0.001) and equal to the QOLIBRI cognitive subscore (R
= 0.03, p < 0.01 each).
Given the unexpected result of similar mean QOLIBRI total score values and only minor differences in cognitive deficits following major trauma independently of whether patients sustained major brain injury or not, further studies should investigate whether the QOLIBRI actually has the discriminative capacity to detect specific residuals of major TBI. In effect, the score appears to indicate mental deficits following different types of severe trauma, which should be evaluated in more detail.
NCT02165137 ; retrospectively registered 11 June 2014.
Background: In SURMOUNT-1, a phase 3, 72-week, randomized, double-blind clinical trial in participants with obesity, tirzepatide, a novel glucose-dependent insulinotropic polypeptide (GIP) and ...glucagon-like peptide-1 (GLP-1) receptor agonist, resulted in significantly greater weight reduction than placebo. Changes in participantreported health-related quality of life (HRQoL) were also assessed in the SURMOUNT-1 trial using the Impact of Weight on Quality of Life-Lite Clinical Trials Version (IWQOL-Lite-CT) instrument. Methods: The IWQOL-Lite-CT (20 items) was collected at baseline and endpoint of the primary treatment period (week 72 or early discontinuation). Participants with complete data were included in the analysis; tirzepatide 5 mg, N=545; tirzepatide 10 mg, N=539; tirzepatide 15 mg, N=535; placebo, N=477. The physical function (5 items) and psychosocial (13 items) composite scores were calculated. The sum of all items provided the total score. Scores were transformed to a scale of 0 to 100 (representing poorest to best quality of life). Change in transformed scores from baseline to endpoint (last nonmissing value prior to treatment discontinuation) were analyzed using an analysis of covariance (ANCOVA) model. Results: Mean scores at baseline with tirzepatide 5 mg, 10 mg, and 15 mg doses and placebo were: total, 64.2, 61.9, 63.0, and 63.2; physical function, 64.4, 61.9, 63.3, and 64.0; and psychosocial, 64.3, 62.1, 63.2, and 63.2, respectively. Significant improvements in all scores were observed with tirzepatide 5 mg, 10 mg, and 15 mg doses compared with placebo at endpoint (all p<0.001): mean total score increased by 18.6, 21.2, and 22.6, versus 10.5; mean physical function score increased by 17.8, 20.7, and 21.8, versus 10.1; and mean psychosocial score increased by 19.6, 22.1, and 23.6 versus 11.0, respectively. Conclusions: In SURMOUNT-1, the IWQOL-Lite-CT indicated significantly improved physical and psychosocial function among participants treated with tirzepatide versus placebo.
Summary
Objective
To evaluate whether vagus nerve stimulation (VNS) as adjunct to best medical practice (VNS + BMP) is superior to BMP alone in improving long‐term health‐related quality of life ...(HRQoL).
Methods
PuLsE (Open Prospective Randomized Long‐term Effectiveness) was a prospective, randomized, parallel‐group, open‐label, and long‐term effectiveness study (conducted at 28 sites in Europe and Canada). Adults with pharmacoresistant focal seizures (n = 112) received VNS + BMP or BMP (1:1 ratio). Medications and VNS parameters could be adjusted as clinically indicated for optimal seizure control while minimizing adverse effects. Primary endpoint was mean change from baseline HRQoL (using Quality of Life in Epilepsy Inventory‐89 total score; QOLIE‐89). Secondary endpoints included changes in seizure frequency, responder rate (≥50% decrease in seizure frequency), Centre for Epidemiologic Studies Depression scale (CES‐D), Neurological Disorders Depression Inventory‐Epilepsy scale (NDDI‐E), Clinical Global Impression‐Improvement scale (CGI‐I), Adverse Event Profile (AEP), and antiepileptic drug (AED) load. The study was prematurely terminated due to recruitment difficulties prior to completing the planned enrollment of n = 362. Results for n = 96 who had baseline and at least one follow‐up QOLIE‐89 assessment (from months 3‐12) were included in this analysis. Mixed model repeated measures (MMRM) analysis of variance was performed on change from baseline for the primary and secondary endpoints.
Results
Significant between‐group differences in favor of VNS + BMP were observed regarding improvement in HRQoL, seizure frequency, and CGI‐I score (respective p‐values < 0.05, 0.03, and 0.01). More patients in the VNS + BMP group (43%) reported adverse events (AEs) versus BMP group (21%) (p = 0.01), a difference reflecting primarily mostly transient AEs related to VNS implantation or stimulation. No significant difference between treatment groups was observed for changes in CES‐D, NDDI‐E, AEP, and AED load.
Significance
VNS therapy as a treatment adjunct to BMP in patients with pharmacoresistant focal seizures was associated with a significant improvement in HRQoL compared with BMP alone.
A PowerPoint slide summarizing this article is available for download in the Supporting Information section here.
Objective: The purpose of this study was to quantify the effect of physical activity (in both descriptive and intervention studies) on health-related quality of life (HRQOL) in children and ...adolescents from both healthy and chronic illness populations. Method: A systematic review of PubMed, PsycINFO, and ProQuest identified 33 studies of physical activity and HRQOL in youth, including descriptive and prepost intervention designs. Results: In descriptive studies (N = 14), there was a small, positive association between physical activity and HRQOL based on child-reports (Hedges' g = .302, p < .001, 95% confidence interval, CI .178, .426) and a negligible association based on parent-proxy reports (Hedges' g = .115, p = .101, 95% CI −.023, .253). Intervention studies (N = 19) yielded a small, positive effect of physical activity intervention on HRQOL based on child-reports (Hedges' g = .279, p = .014, 95% CI .057, .500) and a medium, positive effect based on parent-proxy reports (Hedges' g = .522, p = .012, 95% CI .117, .928). Intervention effects were attenuated by removal of a single study. Hypothesized and exploratory moderators did not moderate the relationship between physical activity and HRQOL. Conclusions: Findings supported the primary hypothesis that physical activity was related to better HRQOL in youth, although the magnitude of these effects did not represent a minimal clinically important difference (MCID) in most studies. Future studies are needed to assess HRQOL in youth before and after exercise interventions to quantify the type, frequency, duration, and intensity of physical activity needed to change HRQOL.
Objective
The aim of this study was to determine the relationship between Oral Health Related Quality of Life (OHRQoL) and general health‐related quality of life (GHRQoL) in partially edentulous ...patients before and after implant placement.
Material and methods
After obtaining informed consent, using convenient sampling method, 102 participants (64 female and 38 male participants with an age range of 18–81 years) were included in the study. Participants were required to fill EuroQol‐5D (EQ‐5D) and the Oral Health Impact Profile‐14 (OHIP‐14) questionnaire before implant surgery and three months after prosthetic placement. Data were not normally distributed, so non‐parametric tests were used for data analysis.
Results
Data analysis was carried out on 93 participants. After implant treatment, Visual Analogue Scale (VAS) and EQ‐5D score significantly increased by 0.05 and 0.06 units, respectively (p < .001 and p = .004, respectively). Also, the total OHIP‐14 score significantly decreased from 15.89 to 6.18 after implant treatment (p < .001).
Conclusion
Results indicated an increase in general and oral health‐related quality of life after implant treatment. According to this study, there was a positive weak relationship between GHRQoL and OHRQoL before and after implant treatment.
Summary
Objective
To develop and validate a shortened version of the Quality of Life in Childhood Epilepsy Questionnaire (QOLCE). A secondary aim was to compare baseline risk factors predicting ...health‐related quality of life (HRQoL) in children newly diagnosed with epilepsy, as identified using the original and shortened version.
Methods
Data came from the Health‐Related Quality of Life in Children with Epilepsy Study (HERQULES, N = 373), a multicenter prospective cohort study. Principal component analysis reduced the number of items from the original QOLCE, and factor analysis was used to assess the factor structure of the shortened version. Convergent and divergent validity was assessed by correlating the Child Health Questionnaire (CHQ) with the shortened QOLCE. Multiple regression identified risk factors at diagnosis for HRQoL at 24 months.
Results
A four‐factor, higher‐order, 55‐item solution was obtained. A total of 21 items were removed. The final model represents functioning in four dimensions of HRQoL: Cognitive, Emotional, Social, and Physical. The shortened QOLCE demonstrated acceptable fit: Bentler's Comparative Fit Index = 0.944; Tucker‐Lewis Index = 0.942; root mean square approximation = 0.058 (90% CI: 0.056–0.061); weighted root mean square residuals (WRMR) = 1.582, and excellent internal consistency (α = 0.96, subscales α > 0.80). Factor loadings were good (first‐order: λ = 0.66–0.93; higher‐order λ = 0.66–0.85; p < 0.001 for all). The shortened QOLCE scores correlated strongly with similar subscales of the Child Health Questionnaire (ρ = 0.38–0.70) while correlating weakly with dissimilar subscales (ρ = 0.30–0.31). While controlling for HRQoL at diagnosis, predictors for better HRQoL at 24 months were the following: no cognitive problems reported (p = 0.001), better family functioning (p = 0.014), fewer family demands (p = 0.008), with an interaction between baseline HRQoL and cognitive problems (p = 0.011).
Significance
Results offer initial evidence regarding reliability and validity of the proposed 55‐item shortened version of the QOLCE (QOLCE‐55). The QOLCE‐55 produced results on risk factors consistent with those found using the original measure. Given the fewer items, QOLCE‐55 may be a viable option reducing respondent burden when assessing HRQoL in children with epilepsy.
Background:
The symptoms that have the largest impact on health-related quality of life (HRQoL) in people with multiple sclerosis (MS) may vary by MS phenotype (relapsing-remitting MS (RRMS), ...secondary progressive MS (SPMS) and primary progressive MS (PPMS)). Knowing these symptoms assists in symptom management.
Objective:
To examine the associations between 13 common MS symptoms and HRQoL in the total sample and stratified by MS phenotype.
Method:
The study included 1985 participants. HRQoL was measured with two multi-attribute utility instruments: assessment of quality of life with eight dimensions (AQoL-8D) and European quality of life with five dimensions and five levels for each dimension (EQ-5D-5L). Multivariable linear regression was used to identify the symptoms that had the largest impact on the HRQoLs.
Results:
Feelings of depression, pain, fatigue, and feelings of anxiety were most strongly associated with AQoL-8D and EQ-5D-5L. Walking difficulties additionally contributed to reduced EQ-5D-5L. The strongest single predictors in the multivariable analyses were feelings of depression or pain for AQoL-8D and walking difficulties for EQ-5D-5L, irrespective of MS phenotype.
Conclusion:
The strongest single predictors for the AQoL-8D and EQ-5D-5L were feelings of depression, pain and walking difficulties, irrespective of MS phenotype. Reducing these symptoms may have the largest impact on improving HRQoL in all MS phenotypes of people with MS.
EQ-5D in Central and Eastern Europe: 2000-2015 Rencz, Fanni; Gulácsi, László; Drummond, Michael ...
Quality of Life Research,
11/2016, Letnik:
25, Številka:
11
Journal Article, Book Review
Recenzirano
Odprti dostop
Objective Cost per quality-adjusted life year data are required for reimbursement decisions in many Central and Eastern European (CEE) countries. EQ-5D is by far the most commonly used instrument to ...generate utility values in CEE. This study aims to systematically review the literature on EQ-5D from eight CEE countries. Methods An electronic database search was performed up to 1 July 2015 to identify original EQ-5D studies from the countries of interest. We analysed the use of EQ-5D with respect to clinical areas, methodological rigor, population norms and value sets. Results We identified 143 studies providing 152 countryspecific results with a total sample size of 81,619: Austria (n = 11), Bulgaria (n = 6), Czech Republic (n = 18), Hungary (n = 47), Poland (n = 51), Romania (n = 2), Slovakia (n = 3) and Slovenia (n = 14). Cardiovascular (21 %), neurologic (17 %), musculoskeletal (15 %) and endocrine, nutritional and metabolic diseases (13 %) were the most frequently studied clinical areas. Overall, 112 (78 %) of the studies reported EQ VAS results and 86 (60 %) EQ-5D index scores, of which 27 (31 %) did not specify the applied tariff. Hungary, Poland and Slovenia have population norms. Poland and Slovenia also have a national value set. Conclusions Increasing use of EQ-5D is observed throughout CEE. The spread of health technology assessment activities in countries seems to be reflected in the number of EQ-5D studies. However, improvement in informed use and methodological quality of reporting is needed. In jurisdictions where no national value set is available, in order to ensure comparability we recommend to apply the most frequently used UK tariff. Regional collaboration between CEE countries should be strengthened.
Endpoints of active periodontal therapy Loos, Bruno G.; Needleman, Ian
Journal of clinical periodontology,
July 2020, 2020-07-00, 20200701, Letnik:
47, Številka:
S22
Journal Article
Recenzirano
Odprti dostop
Aim
Position paper on endpoints of active periodontal therapy for designing treatment guidelines. The question was as follows: How are, for an individual patient, commonly applied periodontal probing ...measures—recorded after active periodontal therapy—related to (a) stability of clinical attachment level, (b) tooth survival, (c) need for re‐treatment or (d) oral health‐related quality of life.
Methods
A literature search was conducted in Ovid MEDLINE(R) and Epub Ahead of Print, In‐Process & Other Non‐Indexed Citations and Daily <1946 to 07 June 2019>.
Results
A total of 94 papers were retrieved. From the literature search, it was found that periodontitis patients with a low proportion of deep residual pockets after active periodontal therapy are more likely to have stability of clinical attachment level over a follow‐up time of ≥1 year. Other supporting literature confirms this finding and additionally reports, at the patient level, that probing pocket depths ≥6 mm and bleeding on probing scores ≥30% are risks for tooth loss. There is lack of evidence that periodontal probing measures after completion of active periodontal treatment are tangible to the patient.
Conclusions
Based on literature and biological plausibility, it is reasonable to state that periodontitis patients with a low proportion of residual periodontal pockets and little inflammation are more likely to have stability of clinical attachment levels and less tooth loss over time. Guidelines for periodontal therapy should take into consideration (a) long‐term tangible patient outcomes, (b) that shallow pockets (≤4 mm) without bleeding on probing in patients with <30% bleeding sites are the best guarantee for the patient for stability of his/her periodontal attachment, (c) patient heterogeneity and patient changes in immune response over time, and (d) that treatment strategies include lifestyle changes of the patient. Long‐term large population‐based and practice‐based studies on the efficacy of periodontal therapies including both clinical and patient‐reported outcomes (PROs) need to be initiated, which include the understanding that periodontitis is a complex disease with variation of inflammatory responses due to environment, (epi)genetics, lifestyle and ageing. Involving people living with periodontitis as co‐researchers in the design of these studies would also help to improve their relevance.
Validation study of a wellbeing scale Yaaqeib, Saad; Lambert, Louise; Hadjisolomou, Stavros ...
PloS one,
05/2022, Letnik:
17, Številka:
5
Journal Article
Recenzirano
The Scale of Positive and Negative Experience (SPANE) is an emerging wellbeing scale to measure the frequency of positive and negative emotions. This study explores the psychometric properties of ...SPANE on a sample from the Arab Gulf region. The Arab Gulf region shares cultural elements with the broader Muslim and Arab world, but maintains distinct features that warrants validation studies for psychological instruments. There were 1393 participants from Saudi Arabia, Oman, Kuwait and other Arab Gulf countries. The factorial structure of SPANE was examined using a principal axis factor analysis, followed up with a confirmatory factor analysis. The convergent validity was examined by correlating SPANE with the Satisfaction with Life Scale (SWLS). The findings confirmed a two-factor structure of SPANE, and demonstrated adequate psychometric properties and convergent validity. In conclusion, this study indicates that SPANE shows sufficient validity for use as a measure of wellbeing in the Arab Gulf region.
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