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Relation to past work on group discussion [ | CMT | (PDF)Click here for additional data file.We thank Edward Kennedy for useful comments on the initial design of this study. We are also grateful to the support team of the Microsoft Conference Management Toolkit (CMT) for their continuous support and help with multiple customization requests. We thank Christopher Baethge for pointing out that the earlier version of this work had a slightly larger value in Row 1 of | PMC10337975 | |
Background | intermittent visual stimuli | Stroboscopic training is based on an exercise with intermittent visual stimuli that force a greater demand on the visuomotor processing for improving performance under normal vision. While the stroboscopic effect is used as an effective tool to improve information processing in general perceptual-cognitive tasks, there is still a lack of research focused on identifying training protocols for sport-specific settings. Therefore, we aimed at assessing the effects of | PMC10211363 | |
Methods | Fifty young volleyball athletes (26 males and 24 females; mean age, 16.5 ± 0.6 years) participated in this study and were each divided randomly into an experimental group and a control group, who then both performed identical volleyball-specific tasks, with the experimental group under stroboscopic influence. The participants were evaluated three times using laboratory based tests for simple and complex reaction speed, sensory sensitivity and saccade dynamics; before the after the 6-week-long training (short-term effect) and 4 weeks later (long-term effect). In addition, a field test investigated the effects of the training on reactive agility. | PMC10211363 | ||
Results | A significant TIME | PMC10211363 | ||
Conclusions | There was a larger effectiveness from the 6-week volleyball-specific training in the stroboscopic group compared to the non-stroboscopic group. The stroboscopic training resulted in significant improvements on most measures (three of five) of visual and visuomotor function with more marked enhancement in visuomotor than in sensory processing. Also, the stroboscopic intervention improved reactive agility, with more pronounced performance gains for short-term compared to the long-term changes. Gender differences in response to the stroboscopic training are inconclusive, therefore our findings do not offer a clear consensus. | PMC10211363 | ||
Introduction | In the fast-paced scenario of a volleyball game, players need to rapidly process a considerable amount of information in order to make appropriate motor action responses. In this regard, perceptual-cognitive abilities seem to be a crucial aspect of skilled performance under time pressure. Previous studies have identified several key perceptual-cognitive functions important for skilled player performance. Specifically, compared to non-athletes or novices, experienced volleyball players have an advantage in eye movement dynamics (In open-skill sports, expert players have a superior ability to interact with dynamic environments in real-time (Recently, stroboscopic training has been indicated as an effective tool to enhance perceptual-cognitive functions and physical performance (Recent evidence (Also, to the authors’ knowledge, there are limited studies about the use of Based on the reported research gaps, the current study aimed at investigating the effect of stroboscopic training on young volleyball players. The 6-week program was based on | PMC10211363 | ||
Materials and Methods | PMC10211363 | |||
Participants | To determine the minimum sample size required for this study, a power analysis was conducted using G*Power 3.1 (Heinrich Heine Universität Düsseldorf, Düsseldorf, Germany) ( | PMC10211363 | ||
Descriptive (mean ± standard deviation) characteristics of the experimental sample. |
The ‘ | PMC10211363 | ||
Measurements | PMC10211363 | |||
Laboratory testing | To evaluate perceptual-cognitive functions (simple reaction speed, complex reaction speed, and sensory sensitivity), a computer-assisted Vienna Test System application (Schuhfried, Austria) was used. To this purpose, a computer (CPU 1.6 GHz) with a monitor (Dell P1913, diagonal 19″, resolution 1,280 × 1,024 pixels, refresh rate 85 Hz) and SCHUHFRIED response panel with foot-operated keys were used. Vienna Tests System is a reliable and valid psychometric tool used previously in sports vision training intervention ( | PMC10211363 | ||
Simple reaction speed | To assess simple reaction speed, the S1 version of the Reaction Time test was administered. Participants were required to respond to randomly generated light stimuli in the form of a yellow circle appearing at different time intervals (ranging from 2.5 to 6.0 s) at the bottom center of the screen. A total of 28 stimuli were presented during the test. To begin the test, participants placed their index finger on the ‘waiting key’ and in response to the stimulus, the finger was moved from the ‘waiting key’ to the ‘response key’. After the response was made, the finger returned to its initial position. Participants were instructed to respond to the visual stimuli as quickly as possible. Two variables were calculated: simple reaction time (ms), defined as the interval of time between the appearance of the stimulus and lifting the finger from the ‘waiting key’, and simple motor time (ms), which characterizes the interval of time from lifting the ‘waiting key’ to pressing the ‘response key’. | PMC10211363 | ||
Complex reaction speed | To assess complex reaction speed, the Determination Test version S1 was used. The Determination Test is a comprehensive and multifaceted reaction test that includes the presentation of both visual stimuli, such as colored stimuli and auditory signals, and is used in sports diagnostics ( | PMC10211363 | ||
Sensory sensitivity | The flicker-fusion frequency test is a widely used and objective measure of central nervous system function capacity, including cortical arousal and visual sensory sensitivity threshold ( | PMC10211363 | ||
Saccade dynamics | To initiate a saccadic response, a free-viewing visual search activity was conducted, without any design specific to sports, where participants were instructed to identify a target (a red letter ‘E’) from a field of 47 distractors, including an inverted red letter ‘E’ (‘Ǝ’), a red letter ‘F’, and a blue letter ‘E’ ( | PMC10211363 | ||
Field test | PMC10211363 | |||
Reactive agility | Following the testing procedure by | PMC10211363 | ||
A schematic of the reactive agility test. | PMC10211363 | |||
Experimental procedure | The experiment involved a 6-week training period. The experiment was performed three times per week during the initial part of regular trainings. The pre-tests, post-tests and 4-week retention tests included both a laboratory test (perceptual-cognitive function) and a field test (reactive agility). The total duration of the testing session for one person did not exceed 60 min, with the experimental time for the laboratory sub-tests approximately 40 min, and for the field test 20 min (including warm-up). To minimize potential bias and ensure that the observed effects were truly due to the stroboscopic protocol, and also for logistical reasons, the participants were divided into four groups: a female stroboscopic group, a male stroboscopic group, a female non-stroboscopic group, and a male non-stroboscopic group. Each group was tested on a separate day. Each testing session took place under the same conditions, starting at 9 am. The participants were familiarized with the tests (lab and field) prior to data acquisition using familiarization sessions to avoid any potential learning effects. Furthermore, a standard procedure, including an instruction and practice phase, was carried out in the Vienna Test System prior to each measurement. A method of randomizing the order of tests was used to control for potential order effects. Both, the stroboscopic and non-stroboscopic groups completed identical sport-specific exercises, under either stroboscopic or normal visual conditions, respectively. Each group trained on a separate court. Three volleyball-specific training protocols were undertaken. Protocol I ‘wall passing drills’ consisted of three tasks with the ball, including forms of reaction time exercise ( | PMC10211363 | ||
A graphical illustration of the study protocols with examples of the exercises. | (A) Protocol I: “Wall Passing Drills”: The player stands in front of a wall on which numbers are placed as optotypes. They bounce the ball off the wall, make an overhead pass above themselves, and then touch the designated number before returning to the starting position for the next bounce. (B) Protocol II: “Partner Passing Drills”: The player makes an overhead shot above themselves, and on the second touch, passes the ball to their partner. During the first pass, the partner signals one of four colors (blue, green, red, yellow). After the pass, the player must touch the designated color marker and return to the defensive position, and be ready for the next pass. (C) Protocol III: “Passing Rotation Drill”: The players are arranged in two pairs and positioned facing each other. They make overhead or forearm passes to their partner, then simultaneously switch positions according to a rotation scheme to keep the ball in play. The graphic illustrations were prepared using the Easy Sports-Graphics software. | PMC10211363 | ||
Statistical analyses | Descriptive statistics were presented as means and standard deviations. Normality of the data was examined using a Shapiro-Wilk test, and the homogeneity of variances was confirmed using a Levene test ( | PMC10211363 | ||
Results | The control analyses revealed no differences between the groups in anthropometric measures, gender, average training time per week, and training exposure time (as shown in We used the mixed model ANOVA (main effects of TIME and GROUP) to analyze the variability of the perceptual-motor test results of the groups using stroboscopic glasses and without. The descriptive statistics of the sample in pre, post, and retention conditions for stroboscopic and non-stroboscopic groups are presented in | PMC10211363 | ||
Descriptive statistics of the visual, visuomotor and reactive agility parameters in the stroboscopic and non-stroboscopic groups in pre-tests, post-tests, and retention tests. | PMC10211363 | |||
Interaction plots of visual and visuomotor parameters by TIME and GROUP: stroboscopic (black dots) | Pre-test, post-test, and retention test values are presented as means and 95% CIs. Significant changes ( | PMC10211363 | ||
Simple reaction speed | The ANOVA on the motor time component of the simple reaction speed test revealed a significant main effect for TIME (F | PMC10211363 | ||
Complex reaction speed | Regarding complex reaction speed, we observed a statistically significant effect of TIME (F | PMC10211363 | ||
Sensory sensitivity | FLICKER | The analyses of sensory sensitivity (flicker frequency) did not reveal a significant main effect either for TIME (F | PMC10211363 | |
Saccade dynamics | Regarding saccade dynamics, the analyses revealed a significant effect of TIME (F | PMC10211363 | ||
Reactive agility | The analyses of reactive agility revealed a significant main effect of TIME (F | PMC10211363 | ||
Discussion | Our study evaluated the effects of stroboscopic intervention on visual, visuomotor and reactive agility in youth volleyball players. The results indicated that stroboscopic training were more effective than regular training, with the stroboscopic group showing significant short and long-term improvements in simple motor reaction time and saccade velocity, as well as larger gains in complex reaction speed and reactive agility (in the short-term). Additionally, gender differences in response to the stroboscopic intervention were identified in two out of six variables.Our findings add further support to the suggestions (It appears that stroboscopic protocols may have specific effects on certain types of tasks, as demonstrated in our study, where it improved simple motor time (the speed of a simple reaction involving hand movement) in the stroboscopic group but not in the non-stroboscopic group. The adaptation to stroboscopic training used in sport-specific exercises, by better processing and integrating visual information for efficient movement execution, led to improved coordination and an increase in movement speed. This aligns with previous studies, which have found that stroboscopic protocols are effective in enhancing eye-hand coordination in dynamic and complex coordination tasks (This study gives partly supporting evidence to the claim that stroboscopic protocols improve the speed of cognitive and information processes created by the action of multiple stimuli on the player sensory system. We observed a significant effect of the ‘TIME’ factor in the complex reaction speed, which suggests that both groups improved their reaction speed in complex tasks, with more pronounced gains in the stroboscopic group. The main focus of the protocols (especially protocol 2) was to perform specific volleyball exercises that involved complex reaction tasks (To our best knowledge, this is the first study where the positive impact of stroboscopic training on saccadic dynamics was reported. In stroboscopic conditions, a player is forced to utilize the limited visual samples, which may cause increased efficiency in the oculomotor system. In consequence, the temporal integration of information during stroboscopic protocols becomes more efficient (Reactive agility improvements in the post (stroboscopic group) and retention test (non-stroboscopic group) were further observed in the field test; however, final training effects did not differ between groups. While both groups showed improvement in reactive agility, the study results indicate a clear positive impact of stroboscopic intervention on reactive agility. However, it is important to note that reactive agility is also closely associated with motor and biomechanical components, such as running speed and technique, balance, strength and muscle power of the lower limbs (We found significant gender differences in relation to test result variability only for two of the six analyzed parameters, The present study provides novel insights into the relationship between stroboscopic training and visual and visuomotor performance in young volleyball players. However, this study is not free of limitations. First, in our study, there is a lack of specific volleyball skill tests that should be designed to transfer standardized laboratory tasks (near transfer) to more sport-specific conditions (far transfer). Achieving far transfer after different kinds of perceptual and cognitive training is so far poorly investigated in research studies ( | PMC10211363 | ||
Conclusion | The present results demonstrate a significantly greater effectiveness of 6-week volleyball-specific training in the group using stroboscopic eyewear compared to those who trained using regular methods. Stroboscopic intervention resulted in significant improvements in most measures (three of five) of visual and visuomotor function, with greater enhancement in visuomotor than in sensory processing. Additionally, the stroboscopic training improved reactive agility, with more pronounced performance gains in short-term changes compared to long-term changes. Gender differences in response to the stroboscopic training are inconclusive, and our findings do not offer a clear consensus on this issue. | PMC10211363 | ||
Supplemental Information | PMC10211363 | |||
Raw data: laboratory and field test results before and after the 6-week long reactive training and later a 4-week retention period. | The data was used for statistical analyses to compare stroboscopic Click here for additional data file. | PMC10211363 | ||
Additional Information and Declarations | PMC10211363 | |||
Competing Interests | The authors declare that they have no competing interests. | PMC10211363 | ||
Data Availability | The following information was supplied regarding data availability:The raw measurements are available in the | PMC10211363 | ||
References | PMC10211363 | |||
Abstract | Considering equity in early childhood development (ECD) is important to ensure healthy development for every child. Equity-informative cost-effectiveness analysis can further guide decision makers to maximize outcomes with limited resources while promoting equity. This cost-effectiveness study aimed to examine the equity impacts of a multicomponent ECD intervention in rural Vietnam. We estimated the cost-effectiveness of the intervention with a 30-month time horizon from the service provider and household perspectives with equity considerations. Data were from a cluster-randomized controlled trial comparing the intervention with the local standard of care. The incremental cost-effectiveness ratios (ICERs) per child cognitive development score gained were estimated by household wealth quintile and maternal education level, adjusted for cluster effects and baseline characteristics such as maternal parity and age. A 3% discount rate was applied to costs, and non-parametric cluster bootstrapping was used to examine uncertainty around ICERs. Children in the intervention had higher cognitive development scores than those in the control arm across all subgroups. Based on intervention recurrent cost, the ICER per cognitive development score gained was lower in children from the poorest quintile (−US$6) compared to those from the richest quintile (US$16). Similarly, the ICER per cognitive development score gained was lower in children whose mothers had the lowest education level (−US$0.02) than those with mothers who had the highest education level (US$7). Even though our findings should be interpreted with caution due to the insufficient study power, the findings suggest that the intervention could promote equity while improving child cognitive development with greater cost-effectiveness in disadvantaged groups.Ensuring child health and well-being is one of the key priority areas in Vietnam. To support mothers and children in rural Vietnam, this cost-effectiveness study aimed to examine the equity impacts of an early childhood development intervention.With a 30-month time horizon, the intervention was more cost-effective in children in the poorest two quintiles than those in the higher wealth quintiles and more cost-effective in children with mothers who had less educated mothers than those with more educated mothers.Even though our findings should be interpreted with caution due to the insufficient study power, the findings suggest that the intervention could promote equity while improving child cognitive development with greater cost-effectiveness in disadvantaged groups. | PMC10506530 | ||
Introduction | deaths | The world has achieved reductions in child mortality with efforts to combat poverty and hunger. Globally, the under-5 mortality rate decreased by 59% from 93.0 deaths per 1000 live births in 1990 to 37.7 in 2019 (The analyses of cohort data found that linear growth during the first 2 years of life was a strong predictor of educational attainment and adult intelligence quotients (Ensuring child health and well-being is one of the key priority areas in Vietnam. However, the World Bank Group Human Capital Index 2020 estimated that children born in Vietnam today would be 69% as productive when they grow up as they could be with complete education and full health ( | PMC10506530 | |
Methods | PMC10506530 | |||
Study setting | This trial was conducted in Ha Nam, a rural Red River delta province in northern Vietnam from 2018 to 2020. According to the census in 2021, the population in the province was 875 200, the under-5 mortality rate per 1000 live births was 18 and the average age of first marriage was 26 years ( | PMC10506530 | ||
Study design and intervention | Trials-Equity | This study is based on a cluster-randomized controlled trial comparing a multicomponent ECD intervention, ‘Learning Clubs’, with the usual standard of maternal and child healthcare in rural Vietnam (As outlined in previous studies, the primary outcome was child cognitive development composite score at 2 years of age assessed by the Bayley Scale of Infant and Toddler Development Third Edition (Bayley-III). The number of clusters and sample size were determined to detect a difference in the proportion of children scoring <1 SD on the Bayley-III of 15% in the control arm and 8% in the intervention arm (with 80% statistical power and a significance level of 0.05; intracluster correlation coefficient = 0.03) (This study followed Consolidated Standards of Reporting Trials-Equity guidelines 2017 ( | PMC10506530 | |
Outcome and cost measures | Outcome and cost measures were reported in Learning Clubs effects and cost-effectiveness studies (Costs were collected from the service provider and household perspectives including intervention costs, mother’s time to participate in the intervention, and out-of-pocket healthcare costs, as outlined in the cost-effectiveness study ( | PMC10506530 | ||
Equity measures | We conducted subgroup analyses based on household wealth and mother’s education at baseline to examine how costs and effects are distributed by socioeconomic groups. Household Wealth Index was calculated according to the World Bank method ( | PMC10506530 | ||
Analysis | We followed the similar methods as the cost-effectiveness study of the ‘Learning Clubs’ cluster-randomized trial (Multiple imputations were used to handle missing data on out-of-pocket healthcare costs based on the log multiple imputation predictive mean matching algorithm as reported in the cost-effectiveness study (The incremental cost-effectiveness ratios (ICERs) were estimated by dividing the mean difference in costs by the mean difference in effects for each subgroup based on household wealth and mother’s education level. In addition to estimating ICERs based on intervention cost and out-of-pocket healthcare cost adjusting for cluster effects and baseline characteristics, we also estimated ICERs under different scenarios that include intervention cost alone without out-of-pocket healthcare costs or results adjusting for cluster effects. We used non-parametric cluster bootstrapping by randomly resampling clusters with replacement and presented mean and 95% CI of ICERs from 1000 bootstrap replications by subgroups. The bootstrap estimates were plotted on the cost-effectiveness plane and used to estimate the probability that the intervention was cost-saving or cost-effective. Since there was no national cost-effectiveness threshold per child cognitive score gained, we used alternative threshold of US$56, which is 2% of Vietnam’s gross domestic product (GDP) (All analyses used the SAS 9.4 software and Microsoft Excel Office 2019. | PMC10506530 | ||
Results | PMC10506530 | |||
Baseline characteristics | The two arms (622 infants in intervention; 546 infants in control) had comparable household wealth status and mother’s education levels (Baseline characteristics by household wealth quintile and mother’s education level | PMC10506530 | ||
Equity impact on cost-effectiveness | We assessed child cognitive development score across socioeconomic groups by trial arms (Child cognitive score by (a) household wealth quintile and (b) mother’s education level. The difference in cognitive development score between the intervention and control arms was statistically significant in children from the poorest quintile but not in those from richest quintile (There was a wide range of 95% CI for out-of-pocket healthcare costs in all subgroups with no significant difference between the trial arms (Cost-effectiveness to improve child cognitive development by household wealth quintile and mother’s education level (base-case)Costs are in US$ 2019.Intervention cost data from the trial’s main cost-effectiveness study (Outcome and cost by household wealth quintile are adjusted for the number of household members, parity, mother’s age, mother’s occupation, father’s age, father’s education, father’s occupation and mother’s education. Outcome and cost by mother’s education are adjusted for the number of household members, parity, mother’s age, mother’s occupation, father’s age, father’s education, father’s occupation and household wealth.The base-case ICER per cognitive development score gained showed that the intervention was more cost-effective in children from two poorest quintiles than richer quintiles (The mean ICER of bootstrap samples ranged from −US$13 (95% CI −62 to 21) in Quintile 2 to US$25 in Quintile 4 (95% CI −2 to 87) based on intervention recurrent cost when adjusting for cluster effects and baseline characteristics (ICERs per child cognitive development score gained by household wealth quintile and mother’s education level (1000 times bootstrapping)Costs are in US$ 2019. ICER = Incremental cost-effectiveness ratios.Outcome and cost by household wealth quintile are adjusted for the number of household members, parity, mother’s age, mother’s occupation, father’s age, father’s education, father’s occupation, and mother’s education. Outcome and cost by mother’s education are adjusted for the number of household members, parity, mother’s age, mother’s occupation, father’s age, father’s education, father’s occupation, and household wealth.The probability that the intervention was cost-saving or cost-effective was estimated based on 1000 bootstrapped estimates. The estimates in the north-east quadrant on the cost-effectiveness plane (Cost-effectiveness plane of 1000 bootstrap iterations by (a) household wealth quintile and (b) mother’s education level based on intervention recurrent cost and out-of-pocket healthcare cost. Costs are in US dollars (USD) 2019. | PMC10506530 | ||
Discussion | deaths | This study assessed the impacts on equity of the multicomponent ECD ‘Learning Clubs’ intervention, which has previously been found to be an effective intervention to improve child development (Household wealth and maternal education are well-known social determinants of children’s health. Multi-country studies have found that around half of the total deaths in children aged under-5 were in those in the poorest two quintiles (Research evidence in equity-informative cost-effectiveness of ECD intervention is scarce. To our knowledge, no existing studies have examined the distributional cost-effectiveness of multicomponent ECD interventions in low- and middle-income countries. A scoping review on equity in economic evaluations of ECD interventions in low- and middle-income countries identified that most studies solely focused on health, and no study measured child cognitive, language, motor or social and emotional development (Better value for money of interventions for children from low socioeconomic backgrounds does not mean that ECD policies and programmes should only target the poorest children. Marmot and colleagues argued that focusing solely on the most disadvantaged may stigmatize them and weaken social cohesion across the population (Our findings should be interpreted with some caution considering study limitations. First, the study was not powered to detect subgroup differences as this equity analysis was not planned beforehand. A descriptive assessment study noted that many studies have been underpowered for subgroup analyses because sample size calculations are usually based on comparison between trial arms rather than on differential effects within subgroups ( | PMC10506530 | |
Conclusion | The ‘Learning Clubs’ intervention is likely to be more cost-effective in children from low socioeconomic backgrounds than those from high socioeconomic backgrounds. Even though our findings should be interpreted with caution due to the insufficient study power, the findings suggest that the intervention could promote equity with greater cost-effectiveness in disadvantaged groups. | PMC10506530 | ||
Acknowledgements | HaNam | DISEASE | We thank the Vietnam Ministry of Health’s Department of Maternal and Child Health, in particular, Dr Nguyen Duc Vinh, and the Head of the Breastfeeding Unit, Dr Nguyen Mai Huong for reviewing our programme content and ensuring its alignment with national policies. We thank the World Health Organization Vietnam Office’s support with the global perspectives. We appreciate all the support from the HaNam Province Communist Party Peoples’ Committee, the Provincial Centre for Disease Control, in particular, Dr Nguyen Thanh Duong, and the Deputy Directors of the Health Department, including Dr Van Tat Pham and Dr Truong Thanh Phong, in programme implementation. We are very grateful to the Vietnam National Women’s Union who served as Learning Clubs facilitators. We appreciate the Research and Training Centre for Community Development staff who managed programme implementation and facilitator training. We are grateful to the HaNam Provincial Centre for Disease Control staff who conducted data collection and the Green Pine Clinic staff who conducted child development assessments. We are grateful that the national and provincial trainers and the community members reviewed programme content. We appreciate the expertise and time from the Data Safety Monitoring Board. Finally, we greatly appreciate the time and commitment of all the facilitators and the participants in Vietnam. | PMC10506530 |
Abbreviations | Bayley-III = Bayley Scales of Infant and Toddler Development Third EditionCI = Confidence IntervalECD = Early Childhood DevelopmentICER = Incremental cost-effectiveness ratiosSD = Standard deviationVND = Vietnamese dong | PMC10506530 | ||
Data availability | The data will be shared on reasonable request to the corresponding author considering privacy concerns. | PMC10506530 | ||
Funding | This work was supported by the Australian National Health and Medical Research Council Project Grant [GNT1100147] to conduct a cluster-randomised controlled trial. The economic evaluation research was funded by Grand Challenges Canada under the Saving Brains Initiative [seed funding 2014–2015, TTS-1803-22331]. The funders had no part in study design, data collection, analysis, interpretation of data, writing of the report and the decision to submit the paper for publication. At the time of submission, Y.B. was supported by the Australian Government Research Training Program Scholarship. J.F. was supported by the Finkel Professorial Fellowship, which was funded by the Finkel Family Foundation. The sponsors had no role in study design and publication of the study. | PMC10506530 | ||
Author contributions | All authors contributed to the study design and data interpretation. Th.T., T.N., Tu.T., H.T. and J.F. collected the data. Y.B. wrote the first draft of the manuscript and conducted data analysis with support from Z.A., Th.T., A.O., and J.F. All authors contributed to data interpretation and critically reviewed the manuscript. All authors approved the final manuscript. | PMC10506530 | ||
Reflexivity statement | The investigators include nine women and three men. Four of them are Vietnamese, five of them are Australian, one is Australian and Kosovar, one is South Korean and one is Dutch. Three authors are based in Vietnam, one in Iraq, one in Zimbabwe and seven in Australia. The authors are at different levels of seniority from PhD Candidate to Professor in the areas of global health, health economics, and epidemiology. | PMC10506530 | ||
Ethical approval | Approval to conduct the project was provided by the Monash University Human Research Ethics Committee (Certificate Number 20160683), Melbourne, Australia, and the Institutional Review Board of the Hanoi School of Public Health (Certificate Number 017-017-377IDD-YTCC), Hanoi, Vietnam. Participants provided informed consent. | PMC10506530 | ||
Conflict of interest statement | None declared. | PMC10506530 | ||
References | PMC10506530 | |||
Background | ATRIAL FIBRILLATION (AF) | IMPACT-AF is a prospective, randomized, cluster design trial comparing atrial fibrillation (AF) management with a computerized decision support system (CDS) to usual care (control) in the primary care setting of Nova Scotia, Canada. The objective of this analysis was to compare the resource use and costs between CDS and usual care groups.
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Methods | Case costing data, 12-month self-administered questionnaires, and monthly diaries from IMPACT-AF were used in this analysis. Descriptive statistics were used to compare costs and resource use between groups. All costs are presented in 2021 Canadian dollars and cover the 12-month period of participation in the study.
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Results | EMERGENCY | A total of 1,145 patients enrolled in the trial. Case costing data were available for 466 participants (41.1%), 12-month self-administered questionnaire data for 635 participants (56.0%) and monthly diary data for 223 participants (19.7%). Emergency department visits and hospitalizations comprised the most expensive component of AF care. Across all three datasets, there were no statistically significant differences in costs or resource use between CDS and usual care groups.
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Conclusions | Although there were no significant differences in resource use or costs among CDS and usual care groups in the IMPACT-AF trial, this study provides insight into the methodology and practical challenges of collecting economic data alongside a trial. | PMC10585905 | ||
Registration | -20 | Clinicaltrials.gov (registration number: NCT01927367, date of registration: 2013-08-20). | PMC10585905 | |
Supplementary Information | The online version contains supplementary material available at 10.1186/s12911-023-02329-7. | PMC10585905 | ||
Keywords | PMC10585905 | |||
Introduction | arrhythmia | ATRIAL FIBRILLATION (AF), ARRHYTHMIA | Atrial fibrillation (AF) is the most common arrhythmia, affecting approximately 200,000 Canadians [A review of 27 studies found the cost of AF to be substantial, at both the individual and healthcare system levels, reflecting patients’ need for resource-intensive (i.e., hospitalization and acute care) and long-term treatments (e.g., anticoagulation treatment) [The objective of this analysis was to evaluate whether an electronic clinical decision support (CDS) system designed to assist both providers and patients with evidence-based management strategies for AF could reduce resource use and costs for AF patients compared to the usual standard of care. | PMC10585905 |
Methods | PMC10585905 | |||
Trial design | Atrial Fibrillation | SECONDARY, ATRIAL FIBRILLATION | This is a pre-specified analysis of secondary cost and resource use outcomes of the Integrated Management Program Advancing Community Treatment of Atrial Fibrillation (IMPACT-AF) study. IMACT-AF was a prospective, randomized, unblinded, cluster designed trial of a CDS system for the management of AF in primary care. The study protocol [ | PMC10585905 |
Intervention | stroke, bleeding, AF | STROKE, BLEEDING | The CDS in the IMPACT-AF trial was a web-based software tool designed to support the management of AF patients in primary care. It offered best practice recommendations in regard to diagnostic assessment and treatment, per Canadian AF clinical guidelines, allowed surveillance of AF patients through a range of data sources (electronic laboratory results and patient-reported data), and prompted primary care providers to respond to critical alerts and trends. The system also had web-based education and support for providers and patients. Specific features of the CDS included:
Translation of best-evidence to primary care providers (PCPs) through computerization of Canadian AF clinical guidelines;Enabling specific tasks such as auto-calculation of stroke and bleeding risk scores, monitoring of international normalized ratio (INR) and creatinine clearance with subsequent recommendations for medication dosing adjustment, assisting with optimal warfarin management via a dosing calculator, and providing recommendations for initiation and switching OACs based on patient clinical characteristics and ability to pay for medications;Providing a non-vitamin-K antagonist (NOAC) special authorization tool that aligns with the Nova Scotia Seniors Pharmacare exception status criteria and automatically prepopulates a drug coverage application form.Additional information on the CDS is reported elsewhere [ | PMC10585905 |
Participants | Primary care practices in the province of Nova Scotia, Canada were randomized 1:1 to CDS (intervention) and usual care (control) groups. Patients within each practice were recruited by their provider to participate. Inclusion criteria were: 18 years of age or older, having electrocardiographically confirmed AF or documentation of past diagnosis or management of AF in their medical record, and ability to communicate in English and provide informed consent. The only exclusion criterion was having a poor likelihood of surviving 12 months after enrollment. | PMC10585905 | ||
Data collection | Clinical, laboratory, and treatment data relevant to the AF management of each participating patient were collected through electronic and/or paper medical record review by trained study abstractors at baseline and 12 months. Three sources of costing and resource use data were collected as part of the study: case costing data, self-administered questionnaire (12 months), and monthly diaries. Each dataset was designed to evaluate different types of costs. A detailed description of each source of costing and resource use data is provided below. | PMC10585905 | ||
Case costing data | pulmonary embolism, dyspnea, syncope, stroke, pulmonary edema, flutter, congestive heart failure, presyncope, presyncope/syncope, embolism, ischemic attack/stroke | PULMONARY EMBOLISM, TRANSIENT ISCHEMIC ATTACK, DEEP VEIN THROMBOSIS, STROKE, PULMONARY EDEMA, WEST, FLUTTER, CONGESTIVE HEART FAILURE, ACUTE CORONARY SYNDROME, ATRIAL FIBRILLATION, EMBOLISM | The case costing data recorded public payer costs for AF-related hospitalizations and ER visits. Case costing data were provided by the Nova Scotia Health Authority (NSHA). As part of the case costing procedure, the NSHA documented all participant-incurred costs for emergency room (ER) visits and hospitalizations located in the Central Zone of the province of Nova Scotia, which includes the capital city of Halifax as well as rural communities located in the Eastern Shore and West Hants counties [At 12-months, the IMPACT-AF study team reviewed each participant’s medical chart to determine whether there was an AF-related ER visit or unplanned cardiovascular hospitalization during the study period. A visit to the ER was classified as AF-related due to one of the following causes: acute coronary syndrome, presyncope/syncope, transient ischemic attack/stroke, atrial fibrillation, flutter, worsening congestive heart failure including pulmonary edema or dyspnea of cardiac origin. An unplanned cardiovascular hospitalization (admission with an overnight stay in hospital) was predefined as due to one of the following causes: acute coronary syndrome, presyncope / syncope, transient ischemic attack / stroke, atrial fibrillation, flutter, pulmonary embolism / deep vein thrombosis /systemic embolism, worsening congestive heart failure including pulmonary edema or dyspnea of cardiac origin. The IMPACT-AF study team shared this list of AF-related ER visits and unplanned cardiovascular hospitalizations with NSHA staff, who provided detailed costing data for each encounter.The costs provided by the NSHA are categorized as direct medical and non-medical costs. Direct medical costs are defined as the expenditures associated with health care provided to patients including medication, laboratory and imaging tests, and health care professionals. Direct non-medical costs are the expenses required to support the delivery of care services including housekeeping, power, security, and administration (also known as overhead costs) [ | PMC10585905 |
Self-administered questionnaire | The self-administered questionnaire recorded patient’s reported AF-related resource use during the trial in addition to other information (e.g., sociodemographic characteristics and HRQoL). All patients were invited to complete a questionnaire (paper or electronic) 12-months after study entry. The questionnaire collected information about whether the patient had experienced any AF-related ER visits, cardiovascular hospitalizations, family physician visits and specialist visits (cardiologist, AF clinic/anticoagulation nurse, complementary health care professional, or internal medicine specialist) in the past 12 months. Patients were also asked if they had taken any AF-relevant medications (e.g., NOAC, St John’s Wort, non-steroidal anti-inflammatory (NSAIDS)), hired a paid caregiver or experienced any time lost from work due to their AF. | PMC10585905 | ||
Monthly diaries | Patients were also asked to complete monthly diaries (paper or online) during the 12-month study period, which were designed to record more comprehensive data on healthcare encounters, out-of-pocket costs, and indirect cost (i.e., productivity loss) that they, family members or caregivers incurred as part of AF-related care. This includes family physician visits, walk-in and/or after-hours clinics, specialist visits, INR testing, emergency department visits, and hospitalizations. For each type of healthcare resource, the patient was instructed to record the monthly number of visits, time spent on visit(s), out-of-pocket visit expenses, distance travelled, and time missed from work. Patients were also invited to record the monthly time costs for informal caregivers, including the hours missed from work or time spent accompanying the patient to appointments or providing AF-related care.The monthly diaries were meant to supplement the self-administered questionnaire by providing a more detailed picture of the resource use for each patient, such as the time, expenses and distance travelled to received AF-related care. They were designed with input from health economists and clinical experts to ensure that items aligned with healthcare services a typical AF patient would seek. It was anticipated that monthly data collection from the diaries would minimize recall bias compared to the 12-month self-administered questionnaire [ | PMC10585905 | ||
Statistical analysis | SECONDARY | Descriptive statistics were used to summarize the sociodemographic and clinical characteristics of patients. Since the distribution of the resource use and costing data is highly skewed, we present both medians and means. Costs were collected in 2017 Canadian dollars according to the timelines of the study and converted to 2021 dollars using the Canadian Consumer Price Index (CPI). All costs cover the 12-month period of participation in the study. The estimates obtained from the monthly diaries were summed across the 12 months to calculate a total per-patient estimate for the 12-month follow-up period.As cost and resource use were secondary outcomes of the IMPACT-AF trial, completion of the self-administered questionnaire and diaries was voluntary in nature and not a mandatory component of participation in the trial. As a result, some patients did not want to complete either but did provide consent for the study team to collect their healthcare data from medical records. This permitted the evaluation of the study’s primary outcome measure (presented in a previous manuscript). In total, 93 out of 1,145 participants (8%) chose this option (Given the amount and nature of missing data, results are reported as complete case analyses. When the proportion of missing data is substantial (greater than 40%), imputation may not provide an unbiased, reliable estimate [The IMPACT-AF trial was powered to detect a statistically significant difference in relative risk reduction for the study’s primary efficacy endpoint (a composite of unplanned cardiovascular hospitalizations and AF-related emergency department visits) and not to detect any meaningful differences in resource use or costs between study arms. As such, the analyses presented in this paper are considered pre-specified secondary endpoints [ | PMC10585905 | |
Availability of data and materials | The data that support the findings of this study are available on request from the corresponding author, FX. | PMC10585905 | ||
Ethics | All methods were carried out in accordance with local guidelines and regulations. Ethics approval was provided by the Nova Scotia Health Authority Research Ethics Board. All participants provided written informed consent. | PMC10585905 | ||
Results | PMC10585905 | |||
Sensitivity analyses | We conducted a sensitivity analysis to explore differences in resource use and costs between participants living in rural and urban locations. There were statistically significant differences between the two groups for the mean time missed from work for GP visits ( | PMC10585905 | ||
Discussion | ’ | This study evaluated the resource use and costs associated with an electronic clinical decision support system for AF patients in Nova Scotia, Canada. During the 12-month follow-up period, there were no statistically significant differences in costs or resource use between CDS and usual care groups. Nevertheless, the data obtained from this study provide important insight into the management of AF in a single payer system at the primary care level.Similar to other costing studies among the AF patient population, ER visits and hospitalizations comprised the expensive component of AF care [There are several reasons why patients’ costs may have been lower in the IMPACT-AF trial than other studies on the economic costs of AF. The first reason is that Nova Scotia has a public payer system in which the costs for hospitalizations, ER visits, family physicians, specialists, lab tests and, often, medications are covered by the province. This would reduce the cost burden for patients. A second reason is that participants in the study were being treated by primary health care professionals. Patients whose AF required management by specialists or a hospital-based AF clinic, with higher attendant costs, were excluded from the trial. A third reason why costs could have been lower in the IMPACT-AF trial is how they were measured. In the 12-month questionnaire and monthly diaries, participants were asked to report ‘AF-related’ costs and resource use. While some guidance was provided on potential reasons for AF-related ER visits (e.g., a racing heart), patients had to determine themselves if the visit was for their AF. A patient, for example, might see their physician for a reason other than AF, which could be opportunely addressed at the same visit. These patients might not see the association when filling out the study materials, which could result in underreporting of the costs or resource use associated with managing their AF. In addition, participants were instructed to only record certain costs in the diaries, such as the money spent for parking or on services received. The diaries did not include gas or meal expenses. As a result, the true costs that participants incurred due to their AF would have been higher as the data obtained from the diaries did indicate that some participants were driving long distances to receive AF care. The recently validated Cost for Patients Questionnaire identified a range of costs to be considered for patients, including travel costs, parking fees, prescription drugs, care services, medical devices, household renovations, medical tests, paramedical services, caregivers, accommodation for travel as well as costs associated with lost productivity [While out of pocket costs and time lost from work were minimal for most of the patients in our study, some reported driving long distances to receive care. Specifically, participants reported travelling a mean distance of 121 km for INR testing and 58 km for family physician visits. This speaks to the frequency of INR visits relative to other types of care evaluated as well as the accessibility of AF care in Nova Scotia. Fifty-four percent of participants in this study lived in a rural area, where access to labs and family physicians are limited. The fact that participants reported travelling the longest distance for INR testing is a consideration for why AF patients should receive a NOAC instead of warfarin as these medications don’t require lab monitoring. Much of the costs associated with warfarin monitoring is indirect; the province pays for the labs and tests, which are inexpensive at $3.85 per test. However, it is the patient who pays for the time, effort, and expense involved with getting to the lab appointments.Limitations of this study include the low percentage of patients who completed the diary and 12-month questionnaire. Case costing data sourced from administrative records provided the most accurate estimates of resource use and costs, but they were only available for central zone hospitals. Thus, apart from 75 patients (16.5%) who travelled from their residence in a rural location to a central zone hospital to receive care or received care at one of the rural facilities within the central zone, the case costing dataset excluded the majority of study participants from such districts (In addition to covering a limited group of participants, the case costing dataset provided information on ER visit and hospitalization costs only. To supplement this dataset, participants were asked to complete a monthly diary and 12-month questionnaire. The use of monthly diaries enabled a detailed record of the resources used and costs incurred from the patient perspective. Moreover, since monthly diaries collect information prospectively over a period of time, there is less recall error compared to a retrospective 12-month questionnaire [Another limitation of the study was the fact that only 3 in 4 providers in the CDS arm completed their training on how to use the CDS tool [ | PMC10585905 | |
Conclusion | AF | Despite the lack of any significant differences in resource use or costs among CDS and usual care groups in the IMPACT-AF trial, this study provides unique insight into the economic burden of AF among patients treated in the primary care setting. While much of the AF literature reports on the management of AF by cardiologists or other specialists [ | PMC10585905 | |
Acknowledgements | Preliminary results were presented in an abstract published by Value in Health. The authors wish to acknowledge the participation and/or support of the primary care providers, their patients and staff, the study office team, Dalhousie University Faculty of Computer Science, and all the other stakeholders who contributed in some way to the IMPACT-AF study, including the Nova Scotia Department of Health and Wellness for sharing of relevant provincial datasets. Special thanks to Susan Alexander for her support. | PMC10585905 | ||
Authors’ contributions | BH contributed to data analysis and interpretation, drafting and revising of the manuscript. JLC contributed to the conceptualization and design of the study, data interpretation, revising the manuscript, acquisition of data and funding. RP contributed to the conceptualization and design of the study, data interpretation, and revising the manuscript. LT contributed to the design of the study, data interpretation, and revising the manuscript. GAF contributed to the design of the study, data interpretation, and revising the manuscript. JHM contributed to the design of the study, data interpretation, and revising the manuscript. JNW contributed to project administration, acquisition of data, data interpretation, and revising the manuscript. LMH contributed to project administration, acquisition of data, data interpretation, and revising the manuscript. AC contributed to the design of the study, data interpretation, revising the manuscript, and acquisition of funding. SHC contributed to the design of the study, data interpretation, revising the manuscript, and acquisition of funding. BK contributed to the design of the study, data interpretation, and revising the manuscript. FX contributed to the design of the study, data interpretation, and revising the manuscript. | PMC10585905 | ||
Funding | Funding provided as an unrestricted grant from Bayer Inc. The funding body played no role in the design of the study and collection, analysis, interpretation of data, and in writing the manuscript. | PMC10585905 | ||
Availability of data and materials | The data that support the findings of this study are available on request from the corresponding author, FX. | PMC10585905 | ||
Declarations | PMC10585905 | |||
Ethics approval and consent to participate | All methods were carried out in accordance with local guidelines and regulations. Ethics approval was provided by the Nova Scotia Health Authority Research Ethics Board. All participants provided written informed consent. | PMC10585905 | ||
Consent for publication | Not applicable. | PMC10585905 | ||
Competing interests | RP | JC reports grants from Bayer Inc., during the conduct of the study; personal fees from Bayer and Servier, outside the submitted work. RP reports grants from Bayer and Pfizer, during the conduct of the study. JMK reports other fees from Merck Canada, Bayer, and Pfizer, outside the submitted work. AC and SHC are employees of Bayer Inc. JNW reports personal fees from Nova Scotia Health Authority during the conduct of the study. BK is an employee of Hoffman-La Roche Limited. All other authors declare no competing interests. | PMC10585905 | |
References | PMC10585905 | |||
Methods | celiac disease autoimmunity | Stool samples were collected from 78 Swedish children with celiac disease autoimmunity participating in a randomized, double-blind, placebo-controlled clinical trial to either receive a mixture of supplementation with | PMC10636941 | |
Results | Three different single-cell protists were identified, of which the highest prevalence was found for | PMC10636941 | ||
Conclusions | celiac disease autoimmunity | The prevalence of single-cell protists is low in children with celiac disease autoimmunity. The colonization was stable regardless of the probiotic intervention and associated with increased diversity of the fecal bacteriome but inversely associated with some beneficial bacteria. | PMC10636941 | |
Graphical Abstract | PMC10636941 | |||
Supplementary Information | The online version contains supplementary material available at 10.1186/s13071-023-06027-1. | PMC10636941 | ||
Keywords | Open access funding provided by Lund University. | PMC10636941 | ||
Background | celiac disease, enteropathy, Celiac disease, gastrointestinal infections | CELIAC DISEASE, CELIAC DISEASE, GASTROINTESTINAL INFECTIONS, ENTEROPATHY, ENTEROVIRUS, CDA | The main protist of the human gut is Celiac disease is a chronic enteropathy due to an immune-mediated response to dietary gluten from wheat, rye and barley, arising in a small proportion of individuals who are genetically susceptible because carrying human leukocyte antigens (HLA) haplotypes DQ2 and/or DQ8 [In contrast to the above study, recent prospective birth cohort studies on gastrointestinal infections have shown that patients who develop celiac disease have more frequent enterovirus [The present study builds on the probiotic intervention trial in children with CDA [ | PMC10636941 |
Materials and methods | PMC10636941 | |||
Study population | Celiac Disease, Diabetes | CELIAC DISEASE, DIABETES | The Celiac Disease Prevention with Probiotics (CiPP) study, a double-blind placebo-controlled randomized clinical trial, was performed at the Department of Clinical Sciences, Unit of Celiac Disease and Diabetes, Lund University, Malmö, Sweden [Workflow of the study. | PMC10636941 |
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