Repeated Measures Approach Research Articles

Remotely engaged—The role of job crafting in the change of employees' engagement after an abrupt transition to remote work

IntroductionMany employees perceived the move to remote work due to the COVID-19 pandemic as an abrupt organizational change. While research on work engagement has examined this construct in different contexts, it is unclear what may happen to work engagement in such an extreme context and over the course of time. In the current study, we examined the relationship between time and employees' work engagement after an abrupt change as well as the way job crafting interacts with this relationship. We hypothesized that a pre-transition high level of approach crafting strategies will have a negative effect, harming employees' ability to maintain their engagement over time, while a pre-transition high level of avoidance crafting strategies will actually have a mitigating effect, weakening the decrease in engagement.MaterialsWe used a three-wave longitudinal study design, collecting data during the first 3 months of the pandemic. The sample included employees from different organizations across the U.S randomly recruited through Amazon Mechanical Turk. We utilized a multilevel repeated measures approach to analyze the data.ResultsResults supported our first hypothesis, demonstrating a negative relationship between time and engagement such that engagement declined over time. Our second hypothesis was partially supported, showing that the job crafting strategy of increasing challenging demands moderated the relationship between time and engagement, such that for employees that job craft by increasing their challenging demands, at the onset of the transition, the decrease in work engagement over time was more substantial. We did not find support for our hypothesis regarding the positive effect of avoidance crafting strategies on the decrease in work engagement.DiscussionOur findings suggest that the tendency to job craft by pursuing more challenging demands at the onset of the pandemic, as an approach strategy of job crafting, gives employees an unnecessary added workload that requires the use of more resources. Over time, this extra load, depletes resource reservoirs and prohibits remaining engaged over time. In contrast, other types of approach crafting strategies seem to have no such harmful effect. Our findings highlight the importance of context, suggesting that under specifics conditions some job crafting strategies may be more energy draining than others.

Protocol and rationale for a randomized controlled SGLT2 inhibitor trial in pediatric and young adult populations with chronic kidney disease: DOUBLE PRO-TECT Alport.

Clinical trials have demonstrated positive cardiovascular and kidney outcomes of sodium-glucose-co-transporter-2 (SGLT2) inhibitors in adult patients with diabetic and other chronic kidney diseases (CKD). Whether benefits extend to children, teenagers, and young adults with early-stage CKD is unknown. For this reason, the DOUBLE PRO-TECT Alport trial (NCT05944016) will study the progression of albuminuria in young patients with Alport syndrome (AS), the most common hereditary CKD, to assess the safety and efficacy of the SGLT2-inhibitor dapagliflozin. Patients living with AS and chronically elevated albuminuria have a high risk of kidney failure before the age of 50 years. DOUBLE PRO-TECT Alport is a multicenter, randomized, double-blind, placebo-controlled trial (RCT). Participants (aged 10 to 39 years) must have a diagnosis of AS by genetic testing or kidney biopsy, be on a stable (> 3 months) maximum tolerated dose of a renin-angiotensin-system-inhibitor (RASi) and must have a Urinary Albumin to Creatinine Ratio (UACR) of >300 mg/g (pediatric) or >500 mg/g (adult).Eligible participants will be randomly assigned at a 2:1 ratio to 48 weeks of treatment with dapaglifozin 10 mg/day -to- matched placebo. Most participants are expected to be children with a normal glomerular filtration rate (eGFR). In addition to safety, the primary (change in UACR from baseline to Week 48) and key secondary (eGFR change from baseline to Week 52) efficacy outcomes will be analyzed with a mixed model repeated measures approach. Efficacy analyses will be performed primarily in the full analysis set according to the intention-to-treat principle. A sensitivity analysis will be performed using reference-based multiple imputation. DOUBLE PRO-TECT Alport will assess whether SGLT2-inhibitors can safely reduce change from baseline in UACR as a marker for progression of CKD in young patients living with AS.

Performance of mathematics students using video learning in flipped and flipped collaborative learning settings

Due to rapid technological advancement that continues to permeate almost all facets of the education sector, video learning has been explored to enhance performance, but most researchers do not incorporate flipped classroom in mathematical videos, which affects the teaching and learning of the subject in Nigeria. This study checked the effectiveness of video learning in flipped and flipped collaborative classroom on mathematics students’ achievement and retention. Using a randomized controlled trial with repeated measures approach, 70 senior secondary school students were purposively sampled from two private secondary schools in Gombe State, Nigeria, out of which they were randomly assigned into two experimental groups: video learning flipped classroom and video learning flipped collaborative classroom (VLFCC). Data was obtained using a 30-item mathematics achievement test, which was validated and pilot-tested (r=0.93). Results were computed using descriptive statistics and two-way mixed design repeated measures analysis of variance. Findings revealed that while the students’ within subject performance improved tremendously in the post-test after the four-week treatment, the students in VLFCC performed better in both achievement (F<sub>[1, 69]</sub>=1,576.362, p=0.000, effect size of (η<sub>p</sub><sup>2</sup>)<sup> </sup>of<sup> </sup>0.954) and retention (F<sub>[1, 69]</sub>=114. 119, p=0.000, with an effect size (η<sub>p</sub><sup>2</sup>) of 0.785. The finding has some implications for it exposes mathematics teachers, researchers, and policy makers to the credence of deploying video learning in flipped collaborative classroom to improve students’ performance by engaging students in collaborative learning in addition to watching pre-class videos, where students discuss in small groups in order to learn through observation, imitation, repetition and behavior modeling, thus making them to learn at their pace in order to construct their own knowledge.

Retrospective investigation of improvements in functional vision for adolescent students with cerebral vision impairments in a specialist residential school and college setting

Cerebral and/or cortical vision impairment (CVI) is the leading cause of childhood vision impairment in the Global North. Previous studies have demonstrated that the functional vision of children with CVI can develop over time, but evidence for the effectiveness of interventions is still in its infancy. In this study, we retrospectively reviewed student records from a specialist residential school and college in the United Kingdom that had implemented an evidence-based approach to assessment and intervention for adolescent students with CVI called the CVI Range. The outcome of CVI Range assessments were recorded annually over a 5-year period, and potential predictor variables such as measures of visual acuity and presence of conditions such as cerebral palsy and seizure disorders were recorded as part of standard practice within the service. A total of 73 annual assessments were analysed from a total of 24 students between the ages of 9 and 25 years old. We used a mixed model for repeated measures approach to reveal a significant fixed effect of time on functional vision that equated to a linear increase of 0.78, 95% CI [0.60, 0.97] in CVI Range Rating 2 for each year of participation on the programme. The mixed effects models also revealed significant interindividual differences in functional vision, which could be partly explained by a significant negative effect of acuity and by a joint positive effect of nystagmus and time, but not by age. These findings demonstrated that significant improvements in functional vision are still possible for students with CVI long after the accepted sensitive period of neuroplasticity in the visual cortex. Further studies incorporating research designs appropriate for evaluating complex interventions are required to determine which individual and contextual characteristics are valid and reliable predictors of improvements in functional vision for young people with CVI.

Gut Microbiota and Symptom Expression and Severity in Neonatal Abstinence Syndrome.

Problem: Neonatal abstinence syndrome (NAS) affecting neonates with fetal exposure to opioids, is defined by expression and severity of symptoms. The pathophysiology behind symptoms variability is lacking. The study aims were to examine (a) differences in gut microbiota of neonates with and without NAS, (b) the relationships between gut microbiota and symptom expression and NAS severity, and (c) the changes in the neonate gut microbiota diversity during the course of NAS treatment. Methods: A cross-sectional observational design was used to examine differences in microbiota and a longitudinal, repeated measures approach was used to determine relationships between gut microbiota and NAS symptoms. Symptom data were collected using the Finnegan Neonatal Abstinence Scoring Tool and the Neonatal Pain Agitation and Sedation Scale. Stool samples were collected for microbiome analyses with 16S rRNA microbiome sequencing. Results: Differences in alpha and beta diversity between neonates with and without NAS were seen. Relative abundance results revealed 18 taxa were different in neonates with NAS compared to neonates without NAS. No differences were found in alpha or beta diversity in neonates with NAS between enrollment and hospital discharge. There was increased abundance of Escherichia-Shigella and Bacteriodes genera related to higher symptom scores. Discussion: Differences in alpha and beta diversity between neonates with and without NAS may be due to differences in birth mode and type of feeding. The findings of specific increased bacteria related to increased symptoms in the neonates with NAS may also be influenced by birth mode and type of feeding.

Effect of game-based learning on educational technology Students’ performance: A case of simple repeated measures approach

Effect of game-based learning on educational technology Students’ performance: A case of simple repeated measures approach

Among-individual behavioural variation in the ornamental red cherry shrimp, Neocaridina heteropoda.

Personality variation, defined as among-individual differences in behaviour that are repeatable across time and context, is widely reported across animal taxa. From an evolutionary perspective, characterising the amount and structure of this variation is useful since differences among individuals are the raw material for adaptive behavioural evolution. However, behavioural variation among individuals also has implications for more applied areas of evolution and ecology-from invasion biology to ecotoxicology and selective breeding in captive systems. Here, we investigate the structure of personality variation in the red cherry shrimp, Neocaridina heteropoda, a popular ornamental species that is readily kept and bred under laboratory conditions and is emerging as a decapod crustacean model across these fields, but for which basic biological, ecological and behavioural data are limited. Using two assays and a repeated measures approach, we quantify behaviours putatively indicative of shy-bold variation and test for sexual dimorphism and/or size-dependent behaviours (as predicted by some state-dependent models of personality). We find moderate-to-high behavioural repeatabilities in most traits. Although strong individual-level correlations across behaviours are consistent with a major personality axis underlying these observed traits, the multivariate structure of personality variation does not fully match a priori expectations of a shy-bold axis. This may reflect our ecological naivety with respect to what really constitutes bolder, more risk-prone, behaviour in this species. We find no evidence for sexual dimorphism and only weak support for size-dependent behaviour. Our study contributes to the growing literature describing behavioural variation in aquatic invertebrates. Furthermore, it lays a foundation for further studies harnessing the potential of this emerging model system. In particular, this existing behavioural variation could be functionally linked to life-history traits and invasive success and serve as a target of artificial selection or bioassays. It thus holds significant promise in applied research across ecotoxicology, aquaculture and invasion biology.

Efficacy and Safety of Adding Lurasidone to Ongoing Therapy With Lithium or Valproate for the Treatment of an Acute Bipolar Depressive Episode: A Post Hoc Analysis of 2 Placebo-Controlled Trials.

The aim of this study was to compare the efficacy and safety profile of lurasidone combined with either lithium or valproate, in the short-term treatment of patients with bipolar depression. Data were pooled from two 6-week, double-blind, placebo-controlled trials of patients with bipolar depression on stable doses of lithium or valproate randomized to lurasidone (20-120 mg/d) or placebo. Efficacy measures included the Montgomery-Åsberg Depression Rating Scale, Clinical Global Impressions Bipolar Scale, and the Quick Inventory of Depressive Symptomatology via self-assessment and were analyzed using a mixed model for repeated measures approach. Notably larger week 6 effect sizes were observed when lurasidone was added to lithium, compared with when lurasidone was added to valproate, on 2 of the 3 depression outcome measures, Montgomery-Åsberg Depression Rating Scale total score (d = 0.45 vs 0.22) and Quick Inventory of Depressive Symptomatology via self-assessment (d = 0.63 vs 0.29); the efficacy advantage was smaller on the Clinical Global Impressions Bipolar Scale depression score (d = 0.34 vs 0.29). Similar adverse event profiles were observed for lurasidone treatment in combination with either lithium or valproate. The most frequently reported events (≥5%) in both groups were nausea, parkinsonism, somnolence, akathisia, and insomnia. Minimal changes in weight, lipids, and measures of glycemic control were observed during treatment with lurasidone combined with either lithium or valproate. Lurasidone added to either lithium or valproate was found to be an effective treatment for bipolar depression, with a larger antidepressant effect observed when lurasidone was combined with lithium. There were no clinically meaningful differences in the safety or tolerability of lurasidone when used adjunctively with lithium or valproate.

Training perinatal nurses in palliative communication by using scenario-based simulation: A quasi-experimental study

AimThis study aimed to assess the impact of two educational modules on enhancing the communication confidence, competence and performance of perinatal nurses in the context of palliative care. BackgroundConcerns have arisen regarding the preparedness of perinatal nurses in delivering palliative care, especially in terms of deficiencies in communication skills and negative attitudes toward making life-support decisions for parents facing neonates with terminal conditions. Bridging this gap necessitates improved perinatal palliative care education for healthcare providers. Research has shown that simulation-based teaching effectively enhances procedural competence, communication skills and confidence among healthcare professionals. However, comprehensive curricula focusing on perinatal palliative communication remain limited. DesignThis study used a quasi-experimental design employing a two-group repeated measure approach. It involved a purposive sample of 79 perinatal nurses from a hospital in northern Taiwan. MethodsA palliative communication course specifically designed for registered nurses in perinatal units was developed. Participants were allocated to either the experimental group (Scenario-Based Simulation, SBS) or the control group (traditional didactic lecture). Communication confidence and competence were assessed before and immediately after the course through structured questionnaires. Learning satisfaction was collected post-intervention and participants underwent performance evaluation by standardized parents one week later. ResultsA significant training gap in palliative care exists among nurses in OB/GYN wards, delivery rooms and neonatal critical care units, highlighting the need for continuing education. All 79 participants completed the training course. Following the intervention, nurses in the SBS group (n=39) exhibited significant improvements in self-reported confidence (p <0.05), competence (p <0.01) and performance (p <0.001) in neonatal palliative communication compared with the traditional didactic lecture group (n=40). The SBS group also received higher satisfaction ratings from nurse learners (p <0.001). ConclusionsThe research findings support scenario-based simulation as a more effective educational approach compared with traditional didactic lectures for enhancing communication confidence and competence. These results were further reinforced by evaluation from standardized patients, highlighting the value of direct feedback in enhancing nurses' performance. Tailoring SBS designs to diverse nursing contexts and incorporating a flipped approach can further enrich the overall learning experience. Given its high effectiveness and positive reception, we recommend integrating this educational module into palliative care training programs for perinatal nurses.

Terrestrial amphibians respond to rapidly changing temperatures with individual plasticity of exploratory behaviour

Terrestrial ectotherms react to acute changes in environmental temperatures by adjusting their behaviour. Evaluating the adaptive potential of these behavioural adjustments requires information on their repeatability and plasticity. We examined behavioural response (exploration) to acute temperature change in two amphibian taxa, alpine (Ichthyosaura alpestris) and smooth (Lissotriton vulgaris) newts. These responses were investigated at both population and individual levels under multiple thermal contexts (dimensions), represented by the direction and range of changing temperature and rearing thermal regimes. Population-level analyses showed species-specific, non-additive effects of direction and range of temperature change on acute thermal reaction norms for exploration, but explained only a low amount (7–23%) of total variation in exploration. In contrast, within- and among-individual variation in acute thermal reaction norm parameters explained 42–50% of total variation in the examined trait. Although immediate thermal responses varied among individuals (repeatability = 0.07 to 0.53), they were largely shaped by environmental contexts during repeated trials. We conclude that these amphibians respond to acute temperature change through individual plasticity of behavioural traits. A repeated-measures approach under multiple thermal contexts will be needed to identify the selective and plastic potential of behavioural responses used by juvenile newts and perhaps other ectotherm taxa to cope with rapidly changing environmental temperatures.

Effects of inpatient energy management education and high-intensity interval training on health-related quality of life in persons with multiple sclerosis: A randomized controlled superiority trial with six-month follow-up.

Fatigue is one of the most frequent symptoms in persons with multiple sclerosis (pwMS) and impacts health-related quality of life (HRQoL). A multidisciplinary rehabilitation approach is recommended for the treatment of fatigue in pwMS. However, high-quality evidence exists only for unimodal interventions, such as physical therapies/exercise or energy/fatigue management programmes. The primary objective of the current study was to test the hypothesis that a combination of inpatient energy management education (IEME) and high-intensity interval training (HIIT) is superior to a combination of progressive muscle relaxation (PMR) and moderate continuous training (MCT) for improving HRQoL at 6-month follow-up in fatigued pwMS. A randomized (1:1) controlled superiority trial with fatigued pwMS >18 years of age, with Expanded Disability Status Scale (EDSS) score ≤6.5, recruited at the Valens clinic, Switzerland. Participants in the experimental group performed IEME twice and HIIT 3 times per week and those in the usual care group performed PMR twice and MCT 3 times per week, during a 3-week inpatient rehabilitation stay. Primary outcome was HRQoL (Physical and Mental Component Scales of the Medical Outcome Study 36-item Short Form Health Survey (SF-36)), assessed at entry to the clinic (T0), after 3 weeks' rehabilitation (T1) and 4 (T2) and 6 (T3) months after T0. Secondary outcomes included SF-36 subscales, fatigue (Fatigue Scale for Motor and Cognitive Functions (FSMC)), mood (Hospital Anxiety and Depression Scale (HADS)), self-efficacy for performing energy conservation strategies (Self-Efficacy for Performing Energy Conservation Strategies Assessment (SEPECSA)), self-perceived competence in activities of daily living (Occupational Self Assessment (OSA)) and cardiorespiratory fitness (peak oxygen consumption (VȮ2peak)). Data were analysed using a mixed model for repeated measures approach. A total of 106 pwMS (age (years): 49.75 (9.87), 66% female, EDSS: 4.64 (1.32)) were recruited. There were no significant group×time interaction effects in the primary and secondary outcomes. There were significant between-group differences in the pairwise comparisons of the group×time interaction in favour of the IEME+HIIT group at: (i) T1 in cardiorespiratory fitness (p=0.011) and SEPECSA (p=0.032); (ii) T2 in SF-36 mental health subscale (p=0.022), HADS anxiety subscale (p=0.014) and SEPECSA (p=0.040); (iii) T3 in SF-36 physical functioning subscale (p=0.012) and SEPECSA (p=0.003). IEME+HIIT was not superior to PMR+MCT regarding the effects on HRQoL (SF-36 Physical and Mental Component Scales) at 6-month follow-up in pwMS. However, there were significant between-group differences in favour of IEME+HIIT in physical functioning and mental health (SF-36 subscales), anxiety (HADS), cardiorespiratory fitness (VȮ2peak) and self-efficacy (SEPECSA) at different measurement time-points that need to be considered in clinical practice.

Effect of dietary energy source on pregnancy rates and reproductive physiology of pastured beef heifers

Proper production of steroid hormones, such as progesterone (P4), is essential for maintenance of pregnancy. Provision of gluconeogenic substrates from the diet may alter postabsorptive energy supplies and associated hormone signaling in a manner supportive of elevating P4 concentrations. Crossbred Angus heifers (n=27) were balanced for pre-trial bodyweight (BW) and body condition score (BCS), then assigned to isoenergetic diets leveraging starch (ES) or fat (EF) as the primary source of energy (45.7% starch vs 11.5% fat). The heifers were placed on the assigned diets 8 days prior to the initiation of estrous synchronization and continued the diets through the second pregnancy diagnosis, 52 days after the initial insemination. On day 28 post-breeding, pregnancy status was diagnosed via ultrasonography. Measurements of follicle size and number were collected via rectal palpation and ultrasonography on days −10, −8, −4, and day 0 relative to breeding. Blood samples were collected on days −10, 1 through 7, 10, 14, 18, 21, 24, and 28 to analyze plasma for P4 concentrations and placental-associated glycoprotein (PAG) concentrations. Data were analyzed using a linear mixed effects model with a fixed effect for treatment and a random effect for pen. Observations collected over time were analyzed using a repeated measures approach with fixed effects for treatment, time, initial condition, and a random effect for pen. Interactions between treatment and pregnancy status were also tested for PAG and P4 concentrations. No treatment differences were observed in final BCS (P=0.12) and total dry matter intake (DMI; P=0.51), though heifers on the ES treatment tended to reach an increased BW (P=0.10). Although heifers fed ES diets had numerically higher conception rates compared to heifers fed EF diets (71.4% vs. 66.7%), there was no statistically significant difference. Furthermore, there were no significant differences observed among diets in terms of pregnancy outcomes, follicle size, or number. A treatment by pregnancy status interaction was detected for both PAG and P4 concentrations. These results suggest that short-term dietary starch supplementation provided around the time of breeding can result in shifts to reproductive hormone abundance that may be conducive for pregnancy establishment.

The Effect of Using Literature Circle Activities on English-Speaking Skills and Critical Thinking Skills of EFL Learners

This study aims to investigate the effect of using the literature circle activities on EFL learners&amp;#39; CEFR B2 English-speaking skills and development of critical thinking skills. The study design employed a single-group repeated-measure approach, which included three repeated experimental tests, as well as pretest and posttest data for both quantitative and qualitative analysis. The independent variable in this study was the literature circle activities based on Reader Response theory, while the dependent variables were the English-speaking skills and critical thinking ability of the participants. To assess the participants&amp;#39; English-speaking skills, descriptive statistics were employed, and the data were collected using CEFR B2 English-speaking skill tests. Critical thinking ability was evaluated through content analysis of the participants&amp;#39; responses. The research instruments utilized in this study included literature circle activities lesson plans, the CEFR B2 English-speaking skill test, the critical thinking skill test, and interviews conducted with the participants. A total of 9 upper secondary EFL students were selected for the study using purposive sampling and classified into three groups based on their English proficiency levels: low, medium, and high. The findings revealed that the students demonstrated improvement in their English-speaking abilities, reaching the CEFR B2 level as evidenced by the pretest and post-test results. Furthermore, their English-speaking skills exhibited progressive enhancement during the three-unit tests that followed their engagement in the literature circle activities. Moreover, the results from the critical thinking skill test indicated that the students had developed critical thinking skills after participating in the literature circle activities. Content analysis of their writing responses demonstrated a gradual increase in their ability to reason and think critically following their involvement in the literature circle activities.

MSR100 Validation of a Mixed Model for Repeated Measures Approach to Including Trials with Varying Follow-up in Indirect Treatment Comparisons of Long-Term Outcomes

MSR100 Validation of a Mixed Model for Repeated Measures Approach to Including Trials with Varying Follow-up in Indirect Treatment Comparisons of Long-Term Outcomes

0642 Effect of Iloperidone on Sleep Symptoms in Bipolar Patients with Manic and Mixed Episodes: A Randomized, Placebo Controlled Study

Abstract Introduction Iloperidone, a dopamine D2 receptor and serotonin 5HT2A receptor antagonist, was evaluated for the treatment of acute manic and mixed episodes associated with bipolar I disorder in adults in a phase 3 clinical trial. A core symptom of bipolar I disorder is disturbance in sleep. During manic episodes this commonly presents as reduced need for sleep with studies finding that 69%–99% of bipolar individuals report a lessened need for sleep or difficulties in falling and/or staying asleep. Here we present a post hoc analysis evaluating iloperidone effects on the sleep component of the Young Mania Rating Scale (YMRS) in patients with bipolar I disorder which addresses both sleep and the reduced need for sleep in that component. Methods This was a multicenter, randomized, double-blind, placebo-controlled, parallel-group study of iloperidone in patients with acute manic or mixed episodes associated with bipolar I disorder. Patients received four weeks of double-blind treatment. The primary analysis demonstrating an overall improvement from baseline YMRS score in iloperidone assigned patients versus placebo assigned patients (p = 0.000008) at the end of the study (week 4). A YMRS item level analysis evaluated changes on YMRS single items including the sleep component in the intent-to-treat population (N = 392) using a mixed-effects model for repeated measures approach. Results The least squares mean difference (LSMD) in change from baseline to day 28 was statistically significant on the YMRS sleep component in favor of iloperidone versus placebo (iloperidone = -1.26, placebo = -0.95; p = 0.008). Conclusion In addition to improving overall mania symptoms as reported by the YMRS, improvements were also seen in iloperidone treated patients in the sleep component which at baseline included assessments of both decreased sleep and decreased need or denial of the need for sleep. Support (if any) This work was supported by Vanda Pharmaceuticals Inc.

Validity and reliability of an opto-electric training system in elite and national level ISSF air rifle shooters

The validity of a commonly used optoelectronic training system was examined by identifying the variables that predicted shot score, investigating their ability to discriminate standard, and assessing the predictive variables’ test–retest error. A repeated-measures approach assessed test–retest error, a cross-sectional approach compared standards of shooters and an observational approach examined predictors of shot score. 21 elite and 8 national-standard athletes participated. Multiple linear regression, independent t tests, typical error and coefficient of variation assessed predictors of shot score, discrimination between standards and test–retest error respectively. Stability of aiming predicted 84.2% of the variance in shot score. Six Scatt Expert variables, 10a0, 10a5, 10.0, 10.5, Speed in the last 250 mm, and stability of aiming, discriminated standard (P < 0.05). Test–retest error ranged from a coefficient of variance of 0.72% for 10a0 to 30.69% for Accuracy of Aiming. Stability of aiming had a typical error of 0.55 mm and a coefficient of variance of 13.93%. Results suggest that this optoelectronic training system possesses construct validity if stability of aiming is used as the outcome measure.

Dioptric differences between clinically determined and metric-optimised refractions for adults with Down syndrome.

Refractions based on the optimisation of single-value wavefront-derived metrics may help determine appropriate corrections for individuals with Down syndrome where clinical techniques fall short. This study compared dioptric differences between refractions obtained using standard clinical techniques and two metric-optimised methods: visual Strehl ratio (VSX) and pupil fraction tessellated (PFSt), and investigated characteristics that may contribute to the differences between refraction types. Thirty adults with Down syndrome (age = 29 ± 10 years) participated. Three refractive corrections (VSX, PFSt and clinical) were determined and converted to vector notation (M, J0 , J45 ) to calculate the dioptric difference between pairings of each type using a mixed model repeated measures approach. Linear correlations and multivariable regression were performed to examine the relationship between dioptric differences and the following participant characteristics: higher order root mean square (RMS) for a 4 mm pupil diameter, spherical equivalent refractive error and Vineland Adaptive Behavior Scales (a measure of developmental ability). The least squares mean estimates (standard error) of the dioptric differences for each pairing were as follows: VSX versus PFSt = 0.51 D (0.11); VSX versus clinical = 1.19 D (0.11) and PFSt versus clinical = 1.04 D (0.11). There was a statistically significant difference in the dioptric differences between the clinical refraction and each of the metric-optimised refractions (p < 0.001). Increased dioptric differences in refraction were correlated with increased higher order RMS (R = 0.64, p < 0.001 [VSX vs. clinical] and R = 0.47, p < 0.001 [PFSt vs. clinical]) as well as increased myopic spherical equivalent refractive error (R = 0.37, p = 0.004 [VSX vs. clinical] and R = 0.51, p < 0.001 [PFSt vs. clinical]). The observed differences in refraction demonstrate that a significant portion of the refractive uncertainty is related to increased higher order aberrations and myopic refractive error. Methodology surrounding clinical techniques and metric-optimisation based on wavefront aberrometry may explain the difference in refractive endpoints.

5613341 REAL-WORLD CHANGES IN KIDNEY FUNCTION FOR PATIENTS WITH SICKLE CELL DISEASE OR OTHER ANAEMIAS RECEIVING IRON CHELATION THERAPY IN THE US

Background: Treating sickle cell disease (SCD) and other anaemias with frequent blood transfusions increases the bodily iron burden, which can be mitigated through iron chelation therapy (ICT).1 As these populations age, impaired kidney function becomes more prevalent, which is also impacted by disease progression and use of ICT.1 An understanding of how kidney function changes over time for real-world patients on ICT is critical for optimal long-term management. Aims: To evaluate real-world changes in kidney function, specifically in estimated glomerular filtration rate (eGFR) and serum creatinine levels in patients with SCD or other anaemias and who received ICT in the United States (US). Methods: Electronic medical records were gathered from the TriNetX electronic database, representing 46 US healthcare organisations. Records were dated between 1999 and 2021 (data cutoff date: September 7, 2021). The baseline period for each patient was defined as the 365 days prior to the date ICT was first dispensed; the follow-up period was the following 730 days (24 months). eGFR and serum creatinine assessments during the follow-up period were analysed using a mixed model repeated measures approach, adjusted for first iron chelation event, age, sex, race, time of assessment, and baseline eGFR, creatinine, and haemoglobin. Eligible patients had to have at least 2 eGFR measurements during follow-up. Study endpoints were changes in eGFR, serum creatinine level, proteinuria, and albuminuria over time, as well as the proportion of patients with SCD or other anaemias who developed kidney impairment (eGFR <60 mL/min/1.73m2) during follow-up. Results: Analyses of eGFR and creatinine levels were conducted on a total of 1527 patients diagnosed with SCD (n = 1510) or other anaemias (n = 17). More patients were first dispensed deferasirox (n =1237) than deferoxamine (n = 223) and deferiprone (n = 67). Compared to baseline, eGFR values remained stable over 24 months after patients were dispensed deferiprone, while there were statistically significant decreases in eGFR over the same period for those given deferasirox or deferoxamine (Table 1). The proportions of patients with SCD or other anaemias who developed kidney impairment during follow-up were 13.9% (deferasirox), 9.2% (deferoxamine), and 11.9% (deferiprone). There were statistically significant reductions in eGFR and statistically significant increases in serum creatinine over 24 months from baseline among patients who first received deferasirox and deferoxamine (Table 1). Proteinuria and albuminuria analyses were not completed due to insufficient data; similarly, a small number of patients in the database were diagnosed with other anaemias to support distinct, formal analysis for this patient group. Summary/Conclusion: The data from this real-world US analysis indicate patients who were prescribed deferiprone had worse baseline kidney function prior to initiation of ICT. The data also indicate that deferiprone has a lesser detrimental impact on kidney function as measured by eGFR and serum creatinine level. This study could not assess treatment adherence. Although there are limitations owing to the retrospective nature of the data, the results may assist clinicians should in their choice of ICT for patients who have or are at risk for developing kidney impairment.Reference 1. Bhandari, Galanello, Eur J Haematol 2012; 89:187

Health-related quality of life (HRQoL) associated with fruquintinib in the global phase 3, placebo-controlled, double-blind FRESCO-2 study.

67 Background: The global phase 3 FRESCO-2 study, (NCT04322539) demonstrated that fruquintinib (F) vs placebo (P) significantly improved OS (HR=0.66 [95% CI: 0.55-0.80]; p&lt;0.001) and PFS (HR=0.32 [95% CI: 0.27-0.39]; p&lt;0.001) in heavily pre-treated patients (pts) with refractory metastatic colorectal cancer (mCRC). F safety profile was consistent with the established monotherapy profile. Here we report the HRQoL and tolerability results. Methods: Pts were randomized 2:1 to F + BSC or P + BSC. EORTC QLQ-C30 and EQ-5D-5L were assessed at baseline and on Day (D) 1 of each Cycle (C) until treatment discontinuation, and ECOG PS was assessed at baseline, D1 of each C, and D21 of C1 to C3. Least-squares mean (LSM) change from baseline to post-baseline visits and the difference between F and P in QLQ-C30 scale scores (e.g. global health status [GHS]/QoL) and EQ-5D-5L scale scores (e.g. visual analog scale [VAS]) were calculated using mixed model repeated measures approach. For each scale, the appropriate minimally important difference (MID) thresholds were determined to evaluate the improvement or deterioration. Time to deterioration (TTD), defined as worsening from baseline in scale-specific MID or death, was analyzed using Kaplan-Meier method, adjusted log-rank test, and stratified Cox PH model. QLQ-C30 and EQ-5D-5L analyses were conducted on the ITT population, and ECOG PS was on the safety population. Results: 691 pts were randomized (F: 461 vs P: 230) and 686 pts received study drug (F: 456 vs P: 230). Median treatment Cycles received (range) were 3 (1, 20) for F vs 2 (1, 13) for P. More than 79% of pts on both arms had a baseline and ≥1 post-baseline assessment for QLQ-C30, EQ-5D-5L, and ECOG PS. GHS/QoL was similar between F and P at baseline; the LSM differences between F and P were 1.7 (95% CI: -1.7, 5.0) for C2 and 1.6 (95% CI: -3.2, 6.4) for C3. At C4, &lt;30 P patients were available. The % of patients who remained stable (MID -6.38 to &lt;8.43) or improved (≥8.43) was numerically higher for F vs P (C2: 61.5% vs 57.1%; C3: 56.4% vs 50.9%). Median TTD was 2.1 months in F and 1.8 months in P (HR=0.9; 95% CI: 0.7-1.0; P=0.098). EQ-5D VAS was similar between F and P at baseline; the LSM differences between F and P were 0.6 (95% CI: -2.3, 3.5) for C2 and 1.4 (95% CI: -2.8, 5.6) for C3. The % of patients who remained stable (MID -7 to &lt;7) or improved (≥7) was similar for F and P (C2: 64.6% vs 58.3%; C3: 64.2% vs 64.8%). Median TTD was 2.6 months in F and 1.9 months in P (HR=0.8; 95% CI: 0.6-0.9; P=0.001). The % of patients with ≥1-point increase from baseline in ECOG PS was 52.1% in F vs 54.0% in P. Conclusions: HRQoL is not negatively impacted by treatment with F. TTD in health utility instrument EQ-5D is improved for patients receiving F. These results, along with improved OS and PFS and favorable toxicity profile, further support F as a potential new treatment option for patients with refractory mCRC. Clinical trial information: NCT04322539 .

Changes to coping and its relationship to improved wellbeing in the optimal health program for chronic disease

BackgroundAdaptive-style coping strategies are associated with favourable mental health and quality of life outcomes among individuals with chronic disease. The Optimal Health Program (OHP) is a psychosocial self-efficacy program that empowers individuals to be active leaders in their health and wellness management. This study aimed to evaluate the impact of the OHP on coping styles. MethodsAdults with Type 1 or Type 2 diabetes, chronic kidney disease, stroke survivors, and stroke carers were recruited from St. Vincent's Hospital, Australia, to participate in one of three trials evaluating the efficacy of the OHP compared to usual care for the management of these chronic conditions. Coping was assessed at baseline, then at 3, 6- and 12-months post baseline. To examine changes in coping in association with OHP participation, we conducted a linear mixed-effects model, using the repeated measures approach. ResultsThe sample was comprised of 411 participants, with 76 (18.5%) stroke survivors, 69 (16.8%) stroke carers, 151 (36.7%) chronic kidney disease patients, and 115 (28.0%) diabetes mellitus patients. There were significant group by time interactions for problem-focused coping, instrumental support, positive reframing, and self-blame, indicating that participants in the OHP arm improved significantly more than those in the control group with regard to coping styles. Many interactions were significant at 3 and 6 months, but not 12 months. ConclusionThe OHP was successful in improving adaptive coping behaviours and decreasing maladaptive coping behaviours in the short-term, but the effects were not maintained at 12 months. Additional booster sessions may be helpful in sustaining intervention effects. This study serves as support for the importance of interventions targeting the psychosocial and physical health aspects of chronic disease to improve individuals’ overall wellbeing.