The aim of the study was to compare the inter-rater reliability, concurrent validity, completion time, and ease of use of two methodological quality (MQ) assessment tools for cross-sectional studies: ...an adapted Newcastle–Ottawa Scale (NOS) and the Appraisal Tool for Cross-Sectional Studies (AXIS).
Two raters applied the NOS and AXIS to 63 cross-sectional studies of health-related quality of life and breast cancer.
AXIS demonstrated poor inter-rater reliability (intraclass correlation coefficient ICC = 0.49) and required more than double the amount of time to complete compared with the NOS, which demonstrated moderate reliability (ICC = 0.73). For concurrent validity, weak and moderate positive relationships existed between NOS and AXIS (rater 1: r = 0.26; rater 2: r = 0.45). Ease of using the tools was affected by the indirectness of MQ assessments, perceived thoroughness of the tools’ content, and user experience.
This study was the first to assess the psychometric properties of a cross-sectional NOS and AXIS. The results did not support a clear choice between selecting either tool for evaluating MQ in cross-sectional studies.
Background
Presently, no validated data exist on symptom severity and disease‐specific quality‐of‐life (QoL) for patients with mastocytosis. Simultaneously, clinical trials and drug application ...processes increasingly mandate reporting patients’ perspectives on symptoms and QoL. We report on the development and validation of the mastocytosis quality‐of‐life questionnaire (MQLQ) and the mastocytosis symptom assessment form (MSAF).
Methods
Both outcome measures were developed in a standardized stepwise method, starting with the identification of items in focus groups (n = 12), item reduction and subsequent cross‐sectional validation in a 63% female cohort of 164 adult patients with indolent systemic mastocytosis.
Results
The MSAF reveals that fatigue is the severest mastocytosis symptom while the MQLQ indicates that fear of anaphylaxis mostly impacts QoL. Cross‐sectional validity was assessed by correlating both individual domains and the total scores of the MQLQ and MSAF with independent measures of mastocytosis. The total scores of both the MQLQ (P < 0.001; Spearman's r: 0.568) and the MSAF (P < 0.001; Spearman's r: 0.559) correlated significantly with the consensus on physician‐scored mediator symptoms. The MQLQ domains displayed a high internal consistency (Cronbach's alpha: 0.841–0.958) and the domains ‘bones’, ‘skin symptoms’ and ‘anaphylaxis’ differed significantly between patients with and without osteoporosis, urticaria pigmentosa or anaphylaxis, respectively (P < 0.001).
Conclusions
The MQLQ is the first disease‐specific QoL questionnaire for mastocytosis and is complemented by the MSAF, a short and convenient symptom scoring form. Both patient‐reported outcome measures are valid, reliable and discriminate between patients with different disease characteristics, making them useful instruments for clinical research.
Background
Quality of life is a phenomenon that recently required lots of concern, especially for older adults, since healthy aging and longevity have become the focus in life. Most research on the ...quality of life addresses certain issues of older people having special diseases, health problems, and disorders. Our research is based on holistic quality of life empowering multiple areas of life/domains of older adults without addressing their diseases or health disorders.
Aim
Our research aims at evaluating the quality of life of the research participants (older people), addressing their problematic areas and suggestions for better quality of life.
Methods
The conducted research implied mixed methods as quantitative survey and reflection based on interviews. We chose participants from the III age university and the ongoing project “Healthy Aging Program”.
Results
The research results showed the lowest ratings for emotional and physical health and the highest rating for social health. Also, older adults tend to avoid specifying precise measures to improve their quality of life and demonstrate a more conservative stance regarding the implementation of more radical changes in improving water consumption, exercising, meal planning, and enhancing psychosocial well-being.
Conclusions
The overall quality of life rating was lower than the average. Older adults are not sufficiently prepared or educated to make significant changes to develop healthier habits in their quality-of-life improvement, though, they demonstrate concern about their quality of life.
Purpose For adolescents and young adults (AYAs), the impact of a cancer diagnosis and subsequent treatment is likely to be distinct from other age groups given the unique and complex psychosocial ...challenges of this developmental phase. In this review of the literature, we report the health-related quality of life (HRQoL) issues experienced by AYAs diagnosed with cancer and undergoing treatment. Methods MEDLINE, EMBASE, CINAHL, PsychINFO and the Cochrane Library Databases were searched for publications reporting HRQoL of AYAs. Issues generated from interviews with AYAs or from responses to patient reported outcome measures (PROMs) were extracted. Results 166 papers were reviewed in full and comprised 72 papers covering 69 primary studies, 49 measurement development or evaluation papers and 45 reviews. Of the 69 studies reviewed, 11 (16%) used interviews to elicit AYAs' descriptions of HRQoL issues. The majority of the PROMs used in the studies represent adaptations of paediatric or adult measures. HRQoL issues were organised into the following categories: physical, cognitive, restricted activities, relationships with others, fertility, emotions, body image and spirituality/outlook on life. Conclusion The HRQoL issues presented within this review are likely to be informative to health care professionals and AYAs. The extensive list of issues suggests that the impact of a cancer diagnosis and treatment during adolescence and young adulthood is widespread and reflects the complexities of this developmental phase.
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.
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.
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.
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Dostopno za:
DOBA, IZUM, KILJ, NUK, PILJ, PNG, SAZU, SIK, UILJ, UKNU, UL, UM, UPUK