ObjectiveAnifrolumab is a new therapeutic approach for individuals with systemic lupus erythematosus (SLE) directed at blocking the type 1 interferon pathway. Despite the expanding body of literature ...on Anifrolumab, an essential aspect remains absent: the subjective patient experience of treatment effects and implications for daily life. The present study aimed to fill this void by elucidating the nuanced perspectives of SLE patients receiving Anifrolumab treatment by conducting qualitative in-depth interviews (IDIs).MethodsSLE patients at Aarhus University Hospital who had received at least 3 infusions of Anifrolumab were approached for inclusion in a study comprising two main elements: 1) Qualitative IDIs and 2) Collection of patient data from electronic medical records (EMRs). The 60-minute IDIs were semi-structured and based on a discussion guide that included both open-ended and close-ended questions. Verbatim transcripts were coded and analyzed using qualitative software to understand concepts important to patients and to understand patients’ own experiences before and after Anifrolumab therapy. A clinical chart review was then conducted using EMR data at baseline, 3 months, and 6 months (where available) after Anifrolumab initiation.ResultsIDIs were successfully conducted with 14 patients and EMR data was collected from 16 patients (treatment days range: 62–474). The symptoms reported most prior to Anifrolumab treatment were fatigue (93%), joint pain (93%), sun sensitivity (86%), skin rashes (79%), and hair loss (71%) (figure 1a). All symptoms improved, although still present, and none worsened during the treatment (figure 1b). Patients reported significant impact of disease on daily life before treatment: day-to-day activities (79%), emotional aspects (71%), social life (71%), physical activity (64%), concentration/memory (57%), work (50%) and family/romantic relationships (50%) (figure 2a). Patients reported improvements on all aspects after treatment but were still impacted (figure 2b). From the EMR data, we observed a fall in disease activity after treatment initiation with a concomitant reduction in the use of corticosteroids.ConclusionsThis study provides valuable insights into the subjective experiences of SLE patients treated with Anifrolumab. These findings collectively contribute to a comprehensive understanding of the treatment’s efficacy and its tangible effects on both subjective and objective parameters in SLE patients.AcknowledgementsThis study was sponsored by AstraZeneca.Abstract P133 Figure 1ASymptom saliency before anifrolumab treatmentAbstract P133 Figure 1BSymptom saliency after anifrolumab treatmentAbstract P133 Figure 2AImpact saliency before anifrolumab treatmentAbstract P133 Figure 2BImpact saliency after anifrolumab treatment
ObjectiveOptimisation of health-related quality of life (HRQoL) is among goals of treatment in SLE. The Lupus Low Disease Activity State (LLDAS) has received attention as a goal whenever remission ...cannot be achieved. How SLE activity, organ damage, and LLDAS attainment relate to patient-reported outcomes (PROs) is not fully explored, which formed the scope of this investigation.MethodsWe included 327 patients with SLE from a tertiary referral centre. Longitudinal registrations of disease activity using SLEDAI-2K and physician global assessment (PhGA), organ damage using the SLICC/ACR damage index (SDI), pharmacotherapies, HRQoL using EQ-5D-3L, as well as visual analogue scale (VAS) scores for fatigue, pain, and overall SLE-related health state over a median follow-up time of 8.5 years were analysed. Incident cases (N=90) were followed for 4.3 years (median), and 86 patients with moderately/highly active, autoantibody-positive SLE were followed for 5.2 years (median).ResultsLLDAS was associated with favourable HRQoL by EQ-5D-3L (0.062; 95% CI 0.038–0.086). Increasing cSLEDAI-2K and PhGA were associated with decreasing EQ-5D-3L values (-0.009; 95% CI 0.005–0.013 and -0.064; 95% CI 0.048–0.080, respectively). Results were similar for incident cases and patients with moderately/highly active, autoantibody-positive disease. Increasing prednisone equivalent dose was associated with decreases in HRQoL on all PROs. Sustained LLDAS enhanced HRQoL by EQ-5D-3L (0.042; 95% CI 0.013–0.071) compared with not being in LLDAS or being in LLDAS for less than 18 consecutive months. Increasing SDI scores were associated with lower EQ-5D-3L values in the full population (-0.037; 95% CI 0.025–0.049), but not in incident cases or patients with moderately/highly active, autoantibody-positive disease. Advancing SDI scores were also associated with higher pain and worse overall SLE-related health state, but not fatigue. In fully adjusted models, low disease activity and being in LLDAS were associated with favourable PROs irrespective of organ damage or any history of antidepressant use.ConclusionIn one of the longest to date observational studies, we demonstrated that low disease activity and being sustainedly in LLDAS were coupled with favourable HRQoL, pain, fatigue, and overall health experience, irrespective of organ damage.AcknowledgementThis work was sponsored by AstraZeneca AB.
The aim of this study was to explore the need for a new disease-specific patient reported outcome (PRO) measure for use in clinical trials of drugs designed to target the underlying causes of ...polycystic ovary syndrome (PCOS), and in the process contribute to our understanding of the symptoms and impacts that define the patient experience with PCOS.
Semi-structured interviews were conducted in 20 women diagnosed with PCOS according to the Rotterdam criteria who had not menstruated in the previous month. The relative importance of PCOS symptoms and impact concepts to patients was determined by analyzing the frequency of their expression in the interview transcripts. These insights were compared to clinicians' perceptions of PCOS.
Pain- and discomfort-related symptoms accounted for the highest proportion (27.6%) of the 735 patient expressions, although clinicians did not consider pain to be important to patients with PCOS. The most frequently expressed individual symptoms were cramping (70% of patients; 14.7% of concepts), irregular menstruation (95% of patients; 12.2% of concepts), facial hair growth (75% of patients; 10.6% of concepts), heavy bleeding (70% of patients; 8.8% of concepts), infertility (70% of patients; 5.4% of concepts), and bloating (60% of patients; 5.2% of concepts). Cramping, heavy bleeding, and bloating were not identified by clinicians as being important to patients with PCOS. The impacts most frequently reported by patients with PCOS related to emotional well-being (e.g. anxiety/stress) and coping behaviors (e.g. acne medication, hair removal).
The only validated PCOS-specific PRO, the PCOSQ, does not capture some key PCOS symptoms and impacts expressed by patients with PCOS, most notably those related to pain and discomfort, bleeding intensity and coping behaviours. Furthermore, some key PCOS symptoms may be under-recognized in the clinic.
Celotno besedilo
Dostopno za:
DOBA, IZUM, KILJ, NUK, PILJ, PNG, SAZU, SIK, UILJ, UKNU, UL, UM, UPUK
Purpose
Fatigue is a prominent symptom in individuals with chronic lymphocytic leukemia (CLL). This work evaluates the content validity and psychometric properties of the Functional Assessment of ...Chronic Illness Therapy-Fatigue scale (FACIT-Fatigue) in patients with CLL to determine if it is fit for purpose in CLL research.
Methods
The FACIT-Fatigue yields a 13-item total score from a five-item symptom subscale and an eight-item impact subscale. To evaluate content validity, cognitive debriefing interviews were conducted with 40 patients with CLL in the first-line or relapsed or refractory setting. Psychometric properties, including structural validity, internal consistency, construct and known-groups validity, were investigated using data from a phase 3 trial in relapsed or refractory CLL (NCT02970318).
Results
Interviewed patients considered the FACIT-Fatigue items relevant to their CLL experience, understood the terminology and agreed with response options. Confirmatory factor analysis confirmed the presence of symptom and impact subscales, but also supported unidimensionality of the FACIT-Fatigue. The FACIT-Fatigue total, symptom and impact subscales demonstrated good internal consistency (Cronbach’s coefficient α > 0.85 and McDonald’s omega ω > 0.90), and strong correlations with relevant EORTC QLQ-C30 scales (all Spearman’s
r
≥ 0.5). Known-groups validity was shown by significant differences between groups defined by baseline performance status, hemoglobin level and constitutional symptoms (all
p
< .0001). Cluster analysis supported FACIT-Fatigue score thresholds of 30 and 34 to define a severe fatigue population.
Conclusions
Content validity and psychometric evaluation in patients with CLL demonstrated that the FACIT-Fatigue has good psychometric properties and is fit for purpose in CLL.
ObjectiveTo estimate the prevalence and incidence of SLE in Sweden using a recent patient cohort, and to estimate the proportion and survival of patients with moderate-to-severe disease defined from ...register data.MethodsThis observational cohort study utilized data from national registries. Adult patients were included if they had at least two secondary care visits with a primary diagnosis of SLE from 1 July 2005 to 31 December 2020.Incident patients were defined as those with no prior visits for SLE in at least the previous 4 years. Disease severity was defined using an algorithm based on previous studies.1 2 Overall survival was defined for incident patients from date of first SLE visit (presumed diagnosis date) until death, stratified by severity in the year after diagnosis.ResultsIn total, 10,186 patients were identified, of which 5,076 were diagnosed after 2006. Prevalence increased from 2006 to 2019. The estimated point prevalence of adult SLE was 93.8 per 100,000 on 31 December 2019, and the estimated average incidence rate between 2015 and 2019 was 4.1 per 100,000 (figure 1). Of incident patients (mean age 49.9, 85% females), 61% had a clinical presentation of moderate-to-severe SLE at some point during the year following diagnosis, however patients can transition between severity states over time. The proportion of patients with moderate-to-severe disease stabilised at around 45% by 4 years after diagnosis until the end of follow-up. Compared to mild SLE patients, moderate-to-severe patients had poorer survival. After 10 years, patients with severe SLE in the year following diagnosis had an 80% survival probability compared to 86% for those with mild SLE (HR 1.49, P<0.001). Patients with moderate SLE had an 81% survival probability (HR vs. mild 1.42, P<0.001) (figure 2).ConclusionsThe estimated incidence and prevalence of SLE in Sweden is consistent with previous studies. This is the first study to evaluate moderate-to-severe SLE in Sweden from registers. Previous research has shown that survival in SLE is poorer than for controls, and we show that survival is poorer in patients presenting with moderate-to-severe disease than in mild disease, highlighting the importance of improving care for this patient group.AcknowledgementsThis study was sponsored by AstraZeneca.References Garris C, Jhingran P, Bass D, et al. Healthcare utilization and cost of systemic lupus erythematosus in a US managed care health plan. J Med Econ 2013;16:667–77. Samnaliev M, Barut V, Weir S, et al. Health care utilization and costs in adults with systemic lupus erythematosus in the United Kingdom: A real-world observational retrospective cohort study. EULAR European E-Congress of Rheumatology. Online2020.Abstract O6 Figure 1Incidence and prevalence of SLE (per 100 000)Abstract O6 Figure 2Kaplan-Meier for mortality by disease severity
Background: Cognition, abilities in activities of daily living (ADL), and behavioral disturbances in patients with Alzheimer's disease (AD) all influence the number of hours informal caregivers spend ...caring for their patients, and the burden caregivers experience. However, the direct effect and relative importance of each disease severity measure remains unclear. Methods: Cross-sectional interviews were conducted with 1,222 AD patients and primary caregivers in Spain, Sweden, the U.K. and the U.S.A. Assessments included informal care hours, caregiver burden (Zarit Burden Inventory; ZBI), cognition (Mini-mental State Examination; MMSE), ADL-abilities (Disability Assessment for Dementia scale; DAD), and behavioral symptoms (Neuropsychiatric Inventory Questionnaire; NPI-severity). Results: Multivariate analyses of 866 community-dwelling patients revealed that ADL-ability was the strongest predictor of informal care hours (36% decrease in informal care hours per standard deviation (SD) increase in DAD scores). Severity of behavioral disturbances was the strongest predictor of caregiver burden (0.35 SD increase in ZBI score per SD increase in NPI-Q severity score). In addition, the effect of ADL-abilities was, although attenuated, not negligible (0.28 SD increase in ZBI score per SD increase in DAD score). Decreasing cognition (MMSE) was associated with more informal care hours and increased caregiver burden in univariate, but not in adjusted analyses. Conclusions: For patients residing in community dwellings, the direct influence of patients’ cognition on caregiver burden is limited and rather mediated by other disease indicators. Instead, the patients’ ADL-abilities are the main predictor of informal care hours, and both ADL-abilities and behavioral disturbances are important predictors of perceived caregiver burden, where the latter has the strongest effect. These results were consistent across Sweden, U.K. and the U.S.A.
Existing theories of social value orientations posit that prosocials maximize joint outcomes whereas proselfs maximize outcomes to themselves. Three studies employing a total of 157 undergraduates ...were conducted to test the alternative hypothesis that prosocials prefer equal outcomes to maximizing joint outcome. In study 1 participants completed the Triple‐Dominance Measure of Social Values in which a fourth alternative that distributed the largest joint outcome unequally was added to the alternative that distributed the outcomes equally. In accordance with the hypothesis, prosocials preferred the equal‐outcome alternative to the joint‐outcome alternative. Study 2 confirmed and extended these results by demonstrating that prosocials preferred equal outcomes to larger joint outcomes that were unequally distributed but provided both with larger outcomes. Study 3 demonstrated that in a modified prisoner's dilemma game, a preference for equal outcomes to a larger joint outcome resulted in that prosocials cooperated when they believed or knew that the other cooperated, and defected when they believed or knew that the other defected.
The main question addressed in this paper is how the great variation in the level of social trust in different countries can be explained. Most empirical research on this question has been based on ...survey data which has limitations when it comes to capturing the causal mechanisms. Building on theories that point to the importance of trustworthy governmental institutions for creating social trust, two parallel experiments were conducted in two countries where the levels of corruption and social trust are very different. One group of 64 Swedish and one group of 82 Romanian undergraduate students responded to a number of scenarios which describe situations at a police station or a doctor's surgery in a foreign country. In the scenarios, the person tries to receive immediate assistance from the police/doctor at the same time as another person who lives in the `unknown' country. These encounters varied within groups in terms of (1) whether or not a bribe was used in order to receive immediate assistance, (2) whether the other person or the official took the initiative to request/offer immediate assistance in exchange for the bribe, and (3) outcome in terms of whether immediate assistance was approved or declined as a result of the offer or demand for a bribe. Type of authority (police vs. doctor) was a between-groups factor. Subsequent to each scenario, participants' levels of various aspects of vertical and horizontal trust were measured. As hypothesized, the Romanian sample had reliably lower initial levels of horizontal trust than the Swedish sample. For both samples, however, the results showed the expected effects of bribe, initiator, and outcome on all dependent trust measures. The results supported the hypothesis that trust in authorities influences the perceptions of the trustworthiness of others in general. Even though some of the effects were stronger for one sample than for the other, the influence of vertical trust on social trust was true for both the high- and the low-trusting sample.
A conceptual framework is presented that may be utilized when analyzing changes in household travel arising from the range of potential measures available to policy makers. The proposed framework ...draws on goal setting theory in order to understand how travel is influenced by the impact various travel demand management (TDM) measures have on time, cost, and convenience of travel options. Travel is understood from a perspective assuming that it is controlled by negative feedback functioning to minimize deviations from goals nested at different levels. The conceptual framework, with its basis in goal setting and control theories, is then applied to understanding strategic and operational choice related to travel as well as habitual travel. Finally, the proposed conceptual framework is used to highlight and focus attention on key research issues that ought to be addressed if our understanding of the impact of TDM measures on household travel, and private car use in particular, is to improve.
Anifrolumab is a new therapeutic approach for individuals with systemic lupus erythematosus (SLE) directed at blocking the type 1 interferon pathway. Despite the expanding body of literature on ...Anifrolumab, an essential aspect remains absent: the subjective patient experience of treatment effects and implications on patients’ health-related quality of life (HRQoL). The present study aimed to fill this void by elucidating the nuanced perspectives of SLE patients receiving Anifrolumab treatment by conducting qualitative in-depth interviews (IDIs). SLE patients at Aarhus University Hospital who had received at least three infusions of Anifrolumab were approached for inclusion in the study, which comprised two main elements: (1) qualitative IDIs and (2) collection of patient data from electronic medical records (EMRs). The IDIs were semi-structured and based on a discussion guide that included open-ended and close-ended questions. Verbatim transcripts were coded and analysed using qualitative software to understand concepts important to patients and to understand patients’ own experiences before and after Anifrolumab therapy. A clinical chart review was conducted using EMR data at baseline, 3 months, and 6 months after Anifrolumab initiation. IDIs were completed with 14 patients, and EMR data was collected from 16 patients (treatment days range: 62-474). Of the 23 symptoms spontaneously reported by patients prior to Anifrolumab treatment, fatigue, joint pain, sun sensitivity, joint stiffness, skin rashes, and hair loss were the most common. Most symptoms improved, and none worsened during treatment. Patients reported significant impacts of disease on daily life before treatment: day-to-day activities, social life, emotional aspects, physical activity, concentration/memory, work/employment, and family/romantic relationships. Patients reported improvements in all aspects after treatment but were still impacted. From the EMR data, we observed a fall in disease activity after treatment initiation with a concomitant reduction in the use of corticosteroids. This study provides valuable insights into the subjective experiences of SLE patients treated with Anifrolumab, and the findings collectively contribute to a comprehensive understanding of the treatment’s efficacy from the patients’ perspective and its tangible effects on both subjective and objective parameters in SLE patients.
Celotno besedilo
Dostopno za:
DOBA, IZUM, KILJ, NUK, OILJ, PILJ, PNG, SAZU, UILJ, UKNU, UL, UM, UPUK
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