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Abbreviations: | overweight | CHRONIC DISEASES, OBESE | body mass indexgut microbiotawaist circumferenceClinicalTrials.gov Identifier: NCT05667038. Saudi Food and Drug Authority (SFDA) on 12/8/2021, SCTR No. 21070702.The authors have no conflicts of interest to disclose.This study was funded by Chair for Biomarkers of Chronic Diseases (CBCD) KSU.Data sharing not applicable to this article as no datasets were generated or analyzed during the current study.Ethical approval was obtained from the Institutional Review Board at King Saud University—College of Medicine, No. E-20-5503, dated 12/07/2021Written consent was provided by each subject prior to inclusion.How to cite this article: Almalki SM, Al-Daghri NM, Al-Juhani ME, Alfawaz HA. Effect of multi-strain probiotics as an anti-obesity among overweight and obese Saudi adults. Medicine 2023;102:16(e33245). | PMC10118337 |
References | PMC10118337 | |||
Key Points | PMC10690466 | |||
Question | chronic stroke | What is the cost-effectiveness of exercise or cognitive and social enrichment activities to improve cognition among older adults with chronic stroke? | PMC10690466 | |
Findings | Cognitive and social enrichment | In this economic evaluation with 120 older adults from a randomized clinical trial, the multicomponent exercise program conducted over a 6-month period was cost-effective for cognitive function, with limited impact on health-related quality of life. Cognitive and social enrichment activities incurred higher costs compared with the balance and tone control group. | PMC10690466 | |
Meaning | chronic stroke | These findings suggest that multicomponent exercise may be a cost-effective approach to improving cognitive function in older adults with chronic stroke.This economic evaluation is a cost-effectiveness and cost-utility analysis of multicomponent exercise or cognitive and social enrichment activities compared with a balance and tone program using data from a randomized clinical trial. | PMC10690466 | |
Importance | chronic stroke, stroke, Cognitive impairment | STROKE | Cognitive impairment is prevalent in survivors of stroke, affecting approximately 30% of individuals. Physical exercise and cognitive and social enrichment activities can enhance cognitive function in patients with chronic stroke, but their cost-effectiveness compared with a balance and tone program is uncertain. | PMC10690466 |
Objective | To conduct a cost-effectiveness and cost-utility analysis of multicomponent exercise or cognitive and social enrichment activities compared with a balance and tone program. | PMC10690466 | ||
Design, Setting, and Participants | stroke | STROKE | This economic evaluation used a Canadian health care systems perspective and the Vitality study, a randomized clinical trial aimed at improving cognition after stroke with a 6-month intervention and a subsequent 6-month follow-up (ie, 12 months). The economic evaluation covered the duration of the Vitality trial, between June 6, 2014, and February 26, 2019. Participants were community-dwelling adults aged 55 years and older who experienced a stroke at least 12 months prior to study enrollment in the Vancouver metropolitan area, British Columbia, Canada. Data were analyzed from June 1, 2022, to March 31, 2023. | PMC10690466 |
Interventions | Participants were randomly assigned to twice-weekly classes for 1 of the 3 groups: multicomponent exercise program, cognitive and social enrichment activities program, or a balance and tone program (control). | PMC10690466 | ||
Main Outcomes and Measures | Alzheimer Disease | ALZHEIMER DISEASE | The primary measures for the economic evaluation included cost-effectiveness (incremental costs per mean change in cognitive function, evaluated using the Alzheimer Disease Assessment Scale–Cognitive-Plus), cost-utility (incremental cost per quality-adjusted life-year gained), intervention costs, and health care costs. Since cognitive benefits 6 months after intervention cessation were not observed in the primary randomized clinical trial, an economic evaluation at 12 months was not performed. | PMC10690466 |
Results | Alzheimer Disease, CAD | ALZHEIMER DISEASE, CAD | Among 120 participants (mean [SD] age, 71 [9] years; 74 [62%] male), 34 were randomized to the multicomponent exercise program, 34 were randomized to the social and cognitive enrichment activities program, and 52 were randomized to the balance and tone control program. At the end of the 6-month intervention, the cost per mean change in Alzheimer Disease Assessment Scale–Cognitive-Plus score demonstrated that exercise was more effective and costlier compared with the control group in terms of cognitive improvement with an incremental cost-effectiveness ratio of CAD −$8823. The cost per quality-adjusted life-year gained for both interventions was negligible, with exercise less costly (mean [SD] incremental cost, CAD −$32 [$258]) and cognitive and social enrichment more costly than the control group (mean [SD] incremental cost, CAD $1018 [$378]). The balance and tone program had the lowest delivery cost (CAD $777), and the exercise group had the lowest health care resource utilization (mean [SD] $1261 [$1188]) per person. | PMC10690466 |
Conclusions and Relevance | chronic stroke | The findings of this economic evaluation suggest that exercise demonstrated potential for cost-effectiveness to improve cognitive function in older adults with chronic stroke during a 6-month intervention. | PMC10690466 | |
Introduction | poststroke cognitive impairment, death, disability, Stroke | STROKE | Stroke is a significant global public health concern, ranking as the second leading cause of death worldwide and a leading cause of serious disability.While there are currently no pharmacological interventions approved for poststroke cognitive impairment, interventions, such as exercise and cognitive training, have shown promise in several studies. | PMC10690466 |
Methods | This economic evaluation used data from a randomized clinical trial, approved by the University of British Columbia’s Clinical Research Ethics Board and the Vancouver Coastal Health Research Institute. Prior to participating in the study, all participants provided written and informed consent. The trial was registered at ClinicalTrials.gov (identification No. | PMC10690466 | ||
Study Design | chronic stroke | We conducted an economic evaluation alongside the Vitality study, a 3-group RCT that examined the efficacy of exercise and cognitive and social enrichment activities to promote cognitive function in individuals with chronic stroke. | PMC10690466 | |
Participants | RECRUITMENT | Details on participants recruitment were previously reported in the study protocol and the primary report. | PMC10690466 | |
Measures | stroke, depression, Depression | STROKE | The Vitality study collected descriptive and demographic variables, including age, body mass index, biological sex, educational status, and stroke type. Cognitive function was assessed using the Mini-Mental State Examination,Secondary outcome measures included depression (assessed using the Center for Epidemiological Studies Depression scale | PMC10690466 |
Intervention | The 3 interventions consisted of 60-minute classes conducted twice a week for 26 weeks. Trained instructors led the classes, maintaining a ratio of 1 instructor for every 4 participants. | PMC10690466 | ||
Exercise | There were 34 participants randomized in the exercise group. Participants in the exercise group were involved in activities adapted from the community-based Fitness and Mobility Exercise program. | PMC10690466 | ||
Cognitive and Social Enrichment | word list memorization | There were 34 participants in the cognitive and social enrichment group. Participants engaged in cognitive exercises covering memory, learning, attention, and executive functions, alongside social and cognitive enrichment activities. Activities included word list memorization, brain training using a tablet application (Lumosity; Lumos Labs), and group social games. | PMC10690466 | |
Active Control | STRETCHES | The balance and tone group included 52 participants. The program included stretches, deep breathing and relaxation techniques, general posture education, and core control exercises in the sitting position. This group served as a control for confounding variables, such as exercise received from community center visits and lifestyle changes unrelated to the study participation. | PMC10690466 | |
Patient Engagement | poststroke | Participants in the Vitality study were not engaged as patient partners in the study design. Interested parties, such as neurologists and physiotherapists, who actively support poststroke care were part of the study team and involved in the study design. | PMC10690466 | |
Costs | Health resource utilization was monitored using self-reported questionnaires at 3, 6, and 12 months. | PMC10690466 | ||
QALYs | QALYs were assessed using the area under the curve analysis of health state utility values obtained from the Euro-Quality of Life–3 Domains–5 Levels (EQ-5D-3L) questionnaire. | PMC10690466 | ||
Effectiveness | Alzheimer Disease | ALZHEIMER DISEASE | The Alzheimer Disease Assessment Scale–Cognitive-Plus (ADAS-Cog-Plus) was the primary measure of cognitive function. | PMC10690466 |
Overview of Economic Evaluation | Using a Canadian health care system perspective, we conducted a cost-effectiveness and cost-utility analysis alongside the Vitality RCT. | PMC10690466 | ||
Statistical Analysis | All analyses for this economic evaluation used Stata version 17 (StataCorp). Data were analyzed from June 1, 2022, to March 31, 2023. | PMC10690466 | ||
Cost-Effectiveness | The primary measure in the cost-effectiveness analysis was the incremental cost-effectiveness ratio (ICER), calculated by comparing the mean cost difference between intervention and control groups to the mean effectiveness difference, based on changes in ADAS-Cog-Plus after the 6-month exercise intervention. Although no established minimally clinically important difference (MCID) exists for the ADAS-Cog-Plus, an MCID of 3 points for the 13-item ADAS-Cog in recommended. | PMC10690466 | ||
Cost-Utility Analysis | The outcome of the cost-utility analysis was the incremental cost-utility ratio (ICUR). The ICUR was calculated by ascertaining the mean difference in cost of providing the interventions compared with the control and dividing that by the mean difference in QALY. The difference in cost divided by the difference is utility was calculated for exercise vs balance and tone and cognitive and social enrichment vs balance and tone. A change of 0.03 QALYs, based on the EQ-5D-3L, is considered the MCID.The study used 5000 iterations of bootstrapping to estimate ICERs and ICURs with 95% CIs and plotted costs and effectiveness on a cost-effectiveness plane. The intervention’s cost-effectiveness probability was determined based on the quadrant placement. | PMC10690466 | ||
Base Case Analysis | The primary analysis estimated the ICERs and ICURs using the complete case data set, which included subsets for cost-effectiveness analysis (participants with complete costs and ADAS-Cog-Plus score data) and cost-utility analysis (participants with complete costs and QALY data). The number and proportion of participants with complete data and included in the analysis are presented in eTable 1 in | PMC10690466 | ||
Sensitivity and Subgroup Analyses | SENSITIVITY | Sensitivity analysis was conducted using multiple imputations to assess uncertainty regarding missing data handling. We also conducted 3 subgroup analyses to examine the cost-effectiveness variation among participants based on literature indicating differing costs and cost-effectiveness for different subgroups: participants with a baseline ADAS-Cog-Plus score greater than 0, | PMC10690466 | |
Results | Among 120 participants in the Vitality study, mean (SD) baseline age was 71 (9) years, and 74 (62%) were male ( | PMC10690466 | ||
Participant Characteristics at Baseline | cognitive impairment, dementia, motor impairment, comorbid illnesses, Alzheimer Disease Assessment Scale-Cognitive, disability | Abbreviations: BMI, body mass index (calculated as weight in kilograms divided by height in meters squared); EQ-5D-3L, Euro-Quality of Life–3 Domains–5 Levels.Range, 0 (worst) to 30 (best); scores between 26 and 30 are considered within reference range.Range, 0 (worst) to 30 (best); scores between 24 and 30 are considered within reference range.Represents the number of comorbid illnesses and ranges from 0 (best) to 18 (worst); higher scores are associated with lower physical function.Range, 0 (best) to 60 (worst).Range, 0 (worst) to 100 (best); scores greater than 79 indicate mild motor impairment; 56 to 79, moderate impairment; 36 to 55, severe impairment; and 0 to 35, severe impairment.The Alzheimer Disease Assessment Scale-Cognitive Plus is a measure of cognitive function ranging from −3.46 (best) to 4.31 (worst). Scores of −1 imply healthy cognitive functioning; 0, mild cognitive impairment; and 1, dementia.Range, −0.34 (worst) to 1 (best). The EQ-5D-3L and was used to estimate health utility values.Range, 0 (worst) to 8 (best).Range, 0 (worst) to 12 (best); scores of 9 or less indicate increased risk for disability. | PMC10690466 | |
Health Care Resource Use and Costs | Unit costs for health care cost items are presented in | PMC10690466 | ||
Unit Cost Items for Health Care Resource Utilization for Participants in the Vitality Study | Abbreviation: NA, not applicable.Estimated from Vitality study expense records.Estimated from 2021 British Columbia Medical services plan.Calculated from the Vancouver General Hospital fully allocated cost model. | PMC10690466 | ||
Results of Cost-Effectiveness and Cost-Utility Analyses for Vitality Study at End of Intervention and Follow-Up | CAD | REGRESSION, CAD | Abbreviations: ICER, incremental cost-effectiveness ratio; ICUR, incremental cost-utility ratio; NA, not applicable; QALY, quality-adjusted life-year.There is no willingness-to-pay threshold for which we can be 95% confident that the 2 therapies differed in value.QALYs are adjusted for baseline utility using a linear regression model.Expressed as estimate (95% CI), with 95% CIs indicating that for willingness-to-pay threshold of at least CAD $0 and no more than CAD $14 589, we can be 95% confident that the therapy with the larger point estimate for effect represents good value compared with the alternative.Expressed as estimate (95% CI), with 95% CIs indicating that there is no willingness-to-pay threshold for which we can be 95% confident that the 2 therapies differ in value. | PMC10690466 |
QALYs | cognitive and social enrichment | REGRESSION | The mean (SD) adjusted incremental QALYs at the end of the 6-month intervention was 0.009 (0.008) QALYs for exercise vs balance and tone groups and 0.010 (0.009) QALYs for cognitive and social enrichment vs balance and tone groups. The mean (SD) adjusted incremental QALYs after follow-up was 0.002 (0.008) years for exercise vs balance and tone groups and 0.004 (0.010) QALYs for cognitive and social enrichment vs balance and tone groups. QALYs were adjusted using a regression model that considered baseline utility and group. | PMC10690466 |
Cost-Effectiveness of Exercise Program vs Balance and Tone Program at 6 Months | Alzheimer Disease | ALZHEIMER DISEASE | A. Orange lines indicate 0 on the x and y axes; orange dots, incremental cost effectiveness ratio estimates; light blue line and circles, 5000 bootstrapped estimates. B. Gray line indicates probability of incremental cost effectiveness ratio acceptance for different willingness-to-pay thresholds. ADAS-Cog-Plus indicates Alzheimer Disease Assessment Scale–Cognitive-Plus; ICER, incremental cost-effectiveness ratio. | PMC10690466 |
Cost Utility of Exercise Program and Cognitive and Social Enrichment Program vs Balance and Tone Program at 6 and 12 Months | Thick orange lines indicate 0 on the x and y axes; orange dots, incremental cost effectiveness ratio estimates; circles, 5000 bootstrapped estimates; QALY, quality-adjusted life-year. | PMC10690466 | ||
Sensitivity and Subgroup Analyses | HEMORRHAGIC STROKE | Exercise was cost-effective for improving cognitive function, but not quality of life. Subgroup analyses revealed cost savings for exercise in participants aged 80 years and older, as well as participants who had a hemorrhagic stroke. The sensitivity analysis using imputed data produced results consistent with the base case analysis, confirming that the exercise program, while costlier, was more effective than the balance and tone program. eTable 2, eTable 3, eTable 4 and the eAppendix in | PMC10690466 | |
Discussion | chronic stroke, cognitive and social enrichment, cognitive improvements | This economic evaluation using data from the Vitality study found that at the end of the 6-month intervention, the exercise program was more effective in improving cognitive function among older adults with chronic stroke at additional cost compared with the control balance and tone program. As demonstrated by the primary RCT, exercise led to significant cognitive improvements, surpassing the MCID of 3 points on the 13-item ADAS-Cog.The cost-utility analysis demonstrated that neither exercise nor cognitive and social enrichment activities led to changes in health-related quality of life at the end of the intervention and follow-up. This study was powered to detect changes in cognitive function rather than quality of life; therefore, it lacked statistical power to detect differences in quality of life. Additionally, the limited responsiveness of the EQ-5D-3L might not capture condition-specific changes in quality of life.The social and cognitive enrichment intervention had higher delivery costs, and participants use more health care resources. Exercise, despite being more costly to deliver than the balance and tone program, led to the lowest health care resource utilization. Participants in the exercise group had lower health care costs for practitioner visits and laboratory tests. We posit that this may be attributed to exercise leading to improvement in cardiovascular fitness and overall health, resulting in reduced visits to practitioners.The exploratory subgroup analyses revealed that exercise was cost-saving for participants aged 80 years and older. This finding aligns with previous research that has demonstrated cost savings associated with exercise as a fall prevention strategy in older adults.This study provides novel health economic data on the effectiveness of exercise for improving cognitive function in older adults with chronic stroke. Furthermore, since this was a trial-based economic evaluation, the study benefits from the design of the clinical trial, such as randomization and blinding, ensuring comparable data collection among intervention and control groups. | PMC10690466 | |
Limitations | This study has limitations. The time horizon of the economic evaluation may not capture the longer-term costs and benefits of the interventions. | PMC10690466 | ||
Conclusions | chronic stroke, stroke, Cognitive and social enrichment | STROKE | This economic evaluation provides novel evidence supporting the potential for multicomponent exercise as a cost-effective intervention for improving cognitive function in older adults with chronic stroke and reducing the economic burden of stroke. Cognitive and social enrichment activities show promise for improving cognitive function after stroke but come with higher costs. Future research should focus on optimizing the cost-effectiveness of these interventions and enhancing the health-related quality of life for this population. | PMC10690466 |
Background | Impairments of trunk movements, stroke, thoracic movements, orthosis, AFOs, gait of stroke, AFO | STROKE | Impairments of trunk movements in gait of stroke are often reported. Ankle foot orthosis (AFO) is commonly used to improve gait of stroke; however, the effect of different types of AFOs on the pelvic and thoracic movements during gait in stroke has not been clarified. | PMC9901085 |
Methods | stroke, AFO | STROKE | Thirty-four patients with stroke were randomly allocated to undergo 2 weeks of gait training by physiotherapists while wearing a rigid AFO (RAFO) with a fixed ankle or an AFO with an oil damper (AFO-OD) that provides plantarflexion resistance and free dorsiflexion. A motion capture system was used for measurements of shod gait without AFO at baseline and with and without AFO after gait training. Two-way repeated ANOVA, Wilcoxon signed-rank test, and Mann–Whitney | PMC9901085 |
Results | AFOs | INTERACTIONS | Twenty-nine patients completed the study (AFO-OD group: 14, RAFO group: 15). Interactions were found in pelvic rotation angle, change of shank-to-vertical angle (SVA) in the stance, and paretic to non-paretic step length, which increased in AFO-OD group with AFOs ( | PMC9901085 |
Supplementary Information | The online version contains supplementary material available at 10.1186/s12938-023-01068-0. | PMC9901085 | ||
Keywords | PMC9901085 | |||
Background | Stroke, stoke, stroke, disability, orthosis, AFOs, hemiplegic, impairments of the trunk function, AFO | STROKE, STROKE | Stroke is the primary cause of mortality and disability for adults [Many studies found that variability of trunk movement increased significantly in the gait of stoke. The paretic pelvis was upward in the stance phase and downward in the swing phase, contrary to the healthy group [Moreover, the impairments of the trunk function could not only affect trunk movement but also affect lower limb motor recovery. Several studies illustrated that thoracic rotation and pelvic obliquity were negatively correlated with the recovery of lower limb movement [Ankle foot orthosis (AFO) is widely used to improve stroke gait [Plenty of studies had clarified the effect of the AFO-OD in view of low limb kinetics and kinematics, and only a few previous studies focused on the effect on the thorax and pelvis. Lan et al. found using AFOs improved the walking capacity by improving the stability and concordant of the trunk in hemiplegic patients [ | PMC9901085 |
Relevance | AFOs | The correlation coefficient between parameters that showed interactions within each group wearing AFOs in this study was calculated and is shown in Fig. Correlation coefficient between parameters: SVA was positively correlated with pelvic tilt at contralateral foot off ( | PMC9901085 | |
Discussion | spasticity, thoracic movements, stroke, AFOs, knee flexion phenomenon, knee hyperextension, knee pain, AFO | STROKE | In the current study, we evaluated the effect of two AFOs, namely, AFO-OD and RAFO on the pelvic and thoracic movements in the gait of stroke patients after two weeks of training. Our results proved the hypothesis that there were direct effects on the thorax and pelvis movement using different AFOs in patients with stroke, and the effects were different.When the patient wore the AFO-OD, the pelvis rotated more to the non-paretic side at initial contact, which was followed by an increase in step length, speed, and change of SVA in stance, compared to not wearing the AFO. Some studies also showed that pelvic rotation anteriorly translated the hip, contributing to increased stride length and higher speed [In the RAFO group, the patient walking with AFO instead led to a significantly decreased change of SVA in stance (with AFO:27.91 ± 10.38°, without AFO: 31.29 ± 8.19°), which was even less than when the patient walked without AFO in the AFO-OD group (with AFO: 35.46 ± 12.38°, without AFO: 32.78 ± 11.11°). RAFO generated overlarge plantar flexion and dorsiflexion resistance, stopping ankle dorsiflexion and limiting shank forward inclination in the paretic stance. And the restriction of shank forward progression in the RAFO group also notably provided a control effect on the knee joint and prevented excessive knee flexion phenomenon in late stance. We even observed knee hyperextension (− 1.97°), which could impair walking speed, reduce gait symmetry, decrease gait efficiency, increase use of energy during walking, and might be associated with knee pain [Another notable finding in this study was that the thoracic rotation to non-paretic side at IC and CFO increased in the AFO-OD group and was positively correlated with the pelvic rotation at IC in both groups. The thorax and pelvis rotated synchronously in the same direction, which is called an in-phase rotation. In normal gait, the thorax and pelvis rotated more anti-phase (opposite direction) [The AFO-OD with plantarflexion resistance enabled the gradual movement to plantar flexion in loading response. With the kinematic chain of the lower limb, relatively upright alignment of the lower limb and improved pelvic rotational movement resulted in the improvement in velocity, step length, and shank progression, which meant better performance, although there was still in-phase rotation of the pelvis and thorax. The RAFO with plantarflexion and dorsiflexion stop decreased SVA progression in stance, affecting the forward tilt of the pelvis, and might result in knee hyperextension in late stance. This study suggested that clinicians should give more consideration to the effects of different types of AFOs on trunk posture in clinical gait training for stroke patients, and in the future, we would conduct more studies on AFOs based on this research and explore the correlation between lower limb biomechanics and trunk biomechanics in stroke gait.This study has some limitations. Firstly, the resistive moment of the AFO-OD was the same in this study, but it should probably be adjusted for each patient. The trim line and elasticity might affect the fixed resistance generated by the RAFO, but it could not be assessed in this study. Secondly, this study included a relatively wide range of patients in Brunnstrom stage III–V. Although the degree of spasticity of the patient was controlled by MAS, there might be potential differences in dissociation movements and spasticity of lower limbs among different Brunnstrom stages. Therefore, the gait of patients should be analyzed in each Brunnstrom stage in future studies. | PMC9901085 |
Conclusion | stroke, AFOs, AFO | STROKE | This randomized controlled trial assessed the effect of different types of AFOs on gait with stroke by comparing the effects of a rigid AFO, which relatively stopped both dorsiflexion and plantarflexion, and the AFO-OD which generated plantarflexion and enabled free dorsiflexion. The findings in 29 patients with stroke showed the paretic step length, pelvic and thoracic rotation at initial contact, and the change of SVA in single stance improved more significantly in participants who underwent gait training using an AFO-OD than in those using a RAFO. Pelvic rotation at initial contact correlated with the change of SVA in stance and thoracic rotation. Pelvic rotation and lower limb kinematics exhibited significant improvements with AFO-OD, reflecting more desirable gait performance. On the other hand, the increase in the thoracic in-phase rotation might expose the effect of insufficient trunk control and dissociation movement. | PMC9901085 |
Methods | PMC9901085 | |||
Participants | musculoskeletal or cognitive problems, subacute stroke, spasticity, AFO | A total of 34 patients with subacute stroke (more than 14 and less than 180 days after onset) who were hospitalized for rehabilitation treatment in a rehabilitation facility in China from June 2020 to August 2021 participated in this study. The following inclusion criteria and exclusion criteria were applied. The inclusion criteria were as follows: Brunnstrom stage of the lower limb over grade II; age within 18–80 years old; and ability to walk safely on level ground using any type of AFOs, using canes if necessary. The exclusion criteria included spasticity grade over 2 on the Modified Ashworth Scale, musculoskeletal or cognitive problems, and pregnancy.All participants underwent gait training under the supervision of physiotherapists. None had previously used an AFO, and all were enrolled in the study when they began walking 8 m under supervision. All procedures were approved by the local ethics committee of the International University of Health & Welfare (No.19 Io-144–2) and China Rehabilitation Research Center (2019–116-2). Informed consent was obtained from all participants before they participated in this study. | PMC9901085 | |
AFOs and equipment | ankle joints, damper joints, AFOs, metatarsophalangeal joints, AFO | The two types of AFOs shown in Fig. AFOs used in this study. A schematic design of the AFO with oil damper unit. The oil damper unit consists of a hydraulic cylinder(1), a ring portion metal plate (2), and a metal plate (3). An adjustment screw (4) controls the flow rate of the oil by varying the orifice diameter; the smaller the orifice diameter, the lower the flow rate, allowing for greater resistance to plantarflexion of the ankle joint at heel strike. A spring (5) assists with dorsiflexion. The rod cap (6) is used to set the initial angle of the ankle jointThe initial ankle joints of both AFOs were set to a neutral position. All AFOs in two groups were customized by three orthotists in the prosthetic and orthotic department of the facility. Eight oil damper joints were prepared (4 right and 4 left) for the AFO-OD group. The AFOs were fitted well to ensure suitability.Gait was measured by a three-dimensional (3D) motion capture system with 6 motion capture cameras (Qualisys AB, Sweden) and 2 force plates (Bertec Corp, USA), which were placed diagonally adjacent to each other in the middle of the eight-meter walkway. Thirty-seven infrared reflective markers were positioned at specified landmarks of participants according to Plug-In-Gait Marker Placement. Markers were set on the lower limbs (both metatarsophalangeal joints, heels, ankles, shanks, knees, thighs, and hips) and the upper limbs (both wrists, elbows, and shoulders). Markers were also placed on the thorax (the spinous processes of the 7th cervical vertebra, the 7th thoracic vertebrae, the xiphoid process of the sternum, and the jugular notch where the clavicles meet the sternum) and on the pelvis (both anterior superior iliac spines and the posterior superior iliac spines). The trajectories of markers and the ground reaction force data were sampled at the frequency of 200 Hz and 1000 Hz, respectively. | PMC9901085 | |
Study protocol | AFOs, hemiplegic, AFO | First, shod gait without AFO was measured at each participant’s self-selected walking speed in an 8-m walkway. Each participant was required to land their hemiplegic lateral foot exactly intact on one of the force platforms during one test and repeat three times. We divided the gait cycle according to the ground reaction force and analyzed this gait cycle.Next, the participants were randomly allocated to an AFO-OD group or a RAFO group in order of participation. Then, the participants started gait training sessions that were performed for 1 h daily over 2 weeks under the supervision of physiotherapists. The training sessions were the same for both groups and included the simulated practical walk and general exercises, such as range of motion exercises, balance training, muscle training, and step training. At last, after 2 weeks, gait was measured with and without allocated AFOs separately using the same method. | PMC9901085 | |
Data processing | pelvic, AFOs | Marker trajectories and force plate data were low-pass filtered by a second-order Butterworth filter with cutoffs of 6 and 18 Hz, respectively. The gait cycle was defined as the loading response, single stance, preswing, and swing phase of the paretic limb. These phases were distinguished by the vertical component of the ground reaction force (GRF) with a force threshold of 10 N for heel contact and toe off the ground. Joint kinematics and kinetics were calculated using an inverse dynamic model. The pelvic and thoracic angles were calculated as the Euler angles at four moments in three planes, respectively. The four moments included IC, CFO, CIC, and FO. Initial contact of the paretic side was defined as IC, and the IC of the non-paretic side was defined as the CIC. The angle of inclination of the shank segment to the vertical (shank-to-vertical angle, SVA) in the sagittal plane was calculated given its importance in assessing the effect of AFOs on gait[A total of 24 pelvic and thoracic parameters, 17 temporal and spatial factors, SVA, and ground reaction forces, and 16 lower extremity joint kinematics were calculated in this study. Visual 3D software version 2020.11.2 (C-Motion Inc., Kingston, ON, Canada) was used in all the post-data processing. | PMC9901085 | |
Statistical analysis | AFOs, AFO | All gait parameters were calculated as the average of three gait cycles for each condition, with/without an AFO before training and after training. All data were checked for normality distribution by the Shapiro–Wilk test.First, we compared the consistency of the baseline data, including the first shod gait data without AFO and general information. An independent t-test was performed for normally distributed data and a Mann–Whitney To know the effect of different types of AFOs after the gait training, two-way repeated ANOVA was performed for normally distributed data, with paired factors (condition, with and without AFOs) and an unpaired factor (type of AFOs). If no interaction was found, the main effects of the two factors were assessed. In cases of interaction, a comparison was made between conditions in each AFO group using one-way ANOVA. For the data that were not normally distributed, the effect of the conditions was compared using the Wilcoxon signed-rank test and the effect of the types of AFOs was examined using the Mann–Whitney Finally, the correlation analysis of the parameters showing significant interaction was done for each group. The level of significance was set at | PMC9901085 | |
Acknowledgements | The authors would like to acknowledge the support from China Rehabilitation Science Institute and China Rehabilitation Research Centre for this research. They also thank all patients who participated in this study and the physiotherapists who assisted with gait training and obtaining measurements. | PMC9901085 | ||
Author contributions | HL | RECRUITMENT | HL, JZ, L-F C, and SY conceptualized and designed the study. JZ and L-F C provided clinical support and clinical resources for experiments. HZ, HG, and L-F C performed patient recruitment physical therapy and data collection. HL, X-Q C, and Z-Y G performed data analysis and interpretation. HL drafted the manuscript. X-Q C reviewed the manuscript at multiple iterations with HL. All the authors read and approved the final manuscript. | PMC9901085 |
Funding | This research is funded by National Key R&D Program of China (Grant 2020YFC2007604, 2022YFC3600305) and Fundamental Research Funds for Central Public Welfare Research Institutes (Grant 2020CZ-6,2021CZ-11, 2022CZ-2). | PMC9901085 | ||
Availability of data and materials | The raw data were generated at China Rehabilitation Research Center. Derived data supporting the findings of this study are available from the author H.L. on request. | PMC9901085 | ||
Declarations | PMC9901085 | |||
Ethics approval and consent to participate | All procedures were approved by the local ethics committee of the International University of Health & Welfare (No.19 Io-144–2) and China Rehabilitation Research Center(2019–116-2). Trial registration:UMIN000038694, Registered 21 November 2019, | PMC9901085 | ||
Consent for publication | Not applicable. | PMC9901085 | ||
Competing interests | The authors declare that they have no competing interests. | PMC9901085 | ||
References | PMC9901085 | |||
Abstract | PMC10256891 | |||
Introduction | Learned smoking cues from a smoker’s environment are a major cause of lapse and relapse. Quit Sense, a theory-guided Just-In-Time Adaptive Intervention smartphone app, aims to help smokers learn about their situational smoking cues and provide in-the-moment support to help manage these when quitting. | PMC10256891 | ||
Methods | A two-arm feasibility randomized controlled trial ( | PMC10256891 | ||
Results | Self-reported smoking outcome completion rates at 6 months were 77% (95% CI 71%, 82%), viable saliva sample return rate was 39% (95% CI 24%, 54%), and health economic data 70% (95% CI 64%, 77%). Among Quit Sense participants, 75% (95% CI 67%, 83%) installed the app and set a quit date and, of those, 51% engaged for more than one week. The 6-month biochemically verified sustained abstinence rate (anticipated primary outcome for definitive trial), was 11.5% (12/104) among Quit Sense participants and 2.9% (3/105) for usual care (adjusted odds ratio = 4.57, 95% CIs 1.23, 16.94). No evidence of between-group differences in hypothesized mechanisms of action was found. | PMC10256891 | ||
Conclusions | Evaluation feasibility was demonstrated alongside evidence supporting the effectiveness potential of Quit Sense. | PMC10256891 | ||
Implications | RECRUITMENT | Running a primarily automated trial to initially evaluate Quit Sense was feasible, resulting in modest recruitment costs and researcher time, and high trial engagement. When invited, as part of trial participation, to install a smoking cessation app, most participants are likely to do so, and, for those using Quit Sense, an estimated one-half will engage with it for more than 1 week. Evidence that Quit Sense may increase verified abstinence at 6-month follow-up, relative to usual care, was generated, although low saliva return rates to verify smoking status contributed to considerable imprecision in the effect size estimate. | PMC10256891 | |
Introduction | The total number of smokers worldwide is increasing,Any smoking early in a quit attempt (a “lapse”) is highly predictive of longer-term return to smoking (“relapse”),There is a lack of effective support to help smokers manage cue-induced cravings. Steady-state medications such as bupropion, Varenicline, and nicotine patches, do not address cue-induced cravings.Meta-analyses pooling smoking cessation smartphone app evaluations have yet to demonstrate a benefit,The Quit Sense app was developed as a passive measurement JITAI for smoking cessation to address the gap in support for managing situational cues to smoke. It is trained by the smoker before their quit attempt starts so the app, and the smoker, can learn their smoking habits, including the locations where they smoke and the smoking cues which precede their smoking whilst they are within these locations. Then, once their quit attempt starts, Quit Sense delivers behavioral support triggered by and tailored to users’ smoking locations and their associated smoking cues. Hence, Quit Sense succeeds in providing “in the moment” support to smokers, including the provision of lapse prevention strategies, and is both engaged with and found to be acceptable. | PMC10256891 | ||
Methods | PMC10256891 | |||
Design | A two-arm parallel randomized controlled feasibility trial, allocating smokers recruited online (1:1 ratio) to a “usual care” arm (referral to NHS SmokeFree website) or an intervention arm who received “usual care” plus an invitation to install the Quit Sense app. A nested qualitative process evaluation and a Study-Within-A-Trial (SWAT), evaluating retention incentives, were also undertaken though reported elsewhere. For full details of study methods, see the trial protocol.Ethical approval was received by the Wales REC7 NHS Research Ethics Committee (19/WA/0361) and a trial steering committee with a majority of independent members oversaw trial conduct. The trial was preregistered (ISRCTN12326962). | PMC10256891 | ||
Participants | Inclusion criteria were: A current smoker; aged 16 years and above; smoked at least 7 cigarettes per week; willing to make a quit attempt within 14 days of enrollment; own an Android smartphone (version 5.0 or above); a resident in England; able to provide informed consent; not having previously participated in the trial. | PMC10256891 | ||
Sample Size. | Sample size was based on achieving adequate precision for key “full trial” parameters. In line with guidance on feasibility trials with binary outcome measures, | PMC10256891 | ||
Procedure | RECRUITMENT, RECRUITMENT | Recruitment took place through paid-for online adverts with Facebook (including Instagram) and Google Search, limited to England-based IP addresses and targeted at Android devices. Online adverts were managed and optimized by a partner company called Nativve. Advert campaigns were run in two phases; from November 27, to December 12, 2020 and from January 5, to January 25, 2021. It was preplanned that if, after the first phase of recruitment or 35% of the target sample was reached, less than 45% of the sample were categorized as low socioeconomic status (SES) then over-sampling using advert targeting would be undertaken to increase low SES representation. Low SES was defined using the National Statistics Socio-Economic Classification,Clicking a study advert took individuals to the study website with study information including a downloadable participant information sheet. Those interested completed a screening survey and, if eligible, were asked to provide consent to participate using an e-signature. REDCaptcha, a captcha module available in REDCap, | PMC10256891 | |
Randomization. | Randomization was stratified by smoking rate (<16 vs. ≥ 16 cigarettes/day; based on mean smoking rates from similar trials) | PMC10256891 | ||
Interventions | PMC10256891 | |||
Usual Care. | After randomization, both arms received an automated text message with a link to the NHS SmokeFree website ( | PMC10256891 | ||
Quit Sense App. | smoking behavior, mood,Stage 2 | Quit Sense arm participants also received an automated text message providing a link to the Quit Sense app on the Google Play store, along with a unique activation code. If the app had not been installed after 3 days, participants were sent a reminder text message to encourage installation. Five days later, if still not installed, a further text message was sent inviting participants to reply by selecting one of the five pre-specified reasons for not having installed the app.Quit Sense, a context-aware Just-In-Time Adaptive Intervention (JITAI), is informed by learning theory and two theory-guided SMS text message systems,A central feature is “Geofence-Triggered Support” (GTS), which is orientated around three stages within the app:Stage 1 (“train the app”): Using a real-time smoking reporting tool, the user trains the app to learn about their smoking behavior until their quit date arrives. Users are asked to report smoking using this tool each time they smoke. For each report, the user indicates the situational context when they “light up” (stress, mood,Stage 2 (“commit to quit” – a 28-day abstinence challenge): After their quit date has passed, the app monitors the user’s location. If they enter and remain in (≥5 minutes) a smoking geofence, the app will determine whether to trigger a GTS message, based on smoking reporting history (using frequency thresholds) and time of day, for that location. GTS messages are tailored to the situation and many are also tailored using the context information from the smoking reports. GTS messages provide lapse prevention support to help manage or avoid potential cue-induced cravings. Further decisions about whether to trigger messages are made after each 3-hour interval of remaining in that location (default between 8:00 AM and 9:30 PM or defined by the user). New geofences are created if lapses are reported, as with stage 1.Stage 3 (“maintain the change”): The app continues to deliver GTS for 2 further months but reduces the frequency by one-half every month. After 3 months post-quit date, the GTS support stops, unless the user opts to restart their quit attempt, which they can do at any time.Quit Sense had additional features, relevant to all stages unless specified (for details see protocolAn End of Day survey with feedback messages after completion.A “my profile” section providing days quit and money saved, a self-monitoring calendar showing emoji feedback for smoking, cravings, and self-efficacy for each end-of-day survey and smoking pattern graphical and written feedback for reported smoking triggers.A library of cessation advice messages across key topics.Scheduled morning daily support messages oriented around the quit date.Quit date reset option, either manually triggered or offered if relapse (more than one smoking episode reported each day over 2 consecutive days) is determined. | PMC10256891 | |
Measures | At 6 weeks, participants were sent a text message with a questionnaire link, 1 day after receiving a prenotification text message alerting them to the questionnaire link message and a texted £5 Amazon voucher for completing it. A reminder text message was sent if the survey was not completed 4 days later, after which participants were informed a researcher would call to complete it over the phone. The researcher made up to five contact attempt episodes.Six and a half months after enrollment (“6-month follow-up”), the same procedure as for the 6-week questionnaire was undertaken for the 6-month questionnaire, with participants randomized to receive either a £10 or £20 Amazon voucher incentive for completion, as part of the SWAT (with trial arm included as a stratifier to ensure the balance between incentive groups), reported elsewhere. If manual follow-up by telephone was unsuccessful, participants were sent a text inviting a response to the primary smoking outcome question. Participants reporting 7-day abstinence at 6 months were sent a postal saliva test kit and texted a £5 voucher incentive by the lead researcher if returned to the testing laboratory. | PMC10256891 | ||
Feasibility Outcomes. | Feasibility outcomes used to estimate key parameters to inform a future trial included:Completeness of the anticipated primary outcome for a future definitive trial (see smoking outcomes).Abstinence rate of usual care arm (anticipated primary outcome).Advertising cost per recruit.Rates of app installation, use, and acceptability (recommend Quit Sense to a friend and ease of use [5-point scale]).Completion of smoking cessation-related resource use, including usual care use, and quality of life (EQ-5D-5L)Hypothesized mechanisms of action of Quit Sense (see smoking outcomes). | PMC10256891 | ||
Smoking and Related Outcomes. | As a feasibility trial, there was no primary outcome, but the anticipated primary abstinence outcome for any future definitive trial was based on the Russell standardHypothesized mechanisms of action collected at 6 weeks included lapse incidence in the first 2 weeks of a quit attempt or since enrollment if no attempt was made, mean frequency of use category (0, 1–5, 6–10, and >10 times) across 20 lapse prevention strategies for avoiding or coping with the desire to smoke, | PMC10256891 | ||
Analysis | REGRESSION, SENSITIVITY | Feasibility outcomes are described as proportions or summary statistics with 95% CIs. To estimate the intervention effect on abstinence, lapse incidence, and use of lapse prevention strategies, we used multiple logistic regression, providing ORs with 95% CIs, while adjusting for stratification variables and any prognostic covariates (baseline variables that are known to affect the outcome and may be unbalanced between trial arms), as defined by the prespecified statistical analysis and health economics plan (SHEAP; Between-group analyses of mechanisms of action variables were undertaken with the 2-sample Sensitivity analyses of abstinence at 6 months were conducted excluding withdrawals, as well as a complete case analysis. Although planned, a missing data analysis using the full information maximum likelihood method was not technically possible in commonly available statistical software. | PMC10256891 | |
Results | Smoking Dependence | There were 1275 study website landings from the online adverts, of which 323 (25%) people completed the eligibility assessment. Of those assessed for eligibility, 93% (299) were eligible and of those eligible, 70% (209) consented and were randomized (117 in phase one and 92 in phase two). One additional individual was randomized but had been enrolled by their partner and so was removed. See Trial flow.
Participant Characteristics at BaselineWISDM = Wisconsin Inventory of Smoking Dependence Motives.At 6 weeks, 149 (71%; 95% CI 65%, 77%) were followed up and at 6 months this was 160 (77%; 95% CI 71%, 82%). There were six withdrawals, four from the Quit Sense arm and two from the usual care arm. Completion of self-reported abstinence for the primary outcome at 6 months was 77% (160/209; 95% CI 71%, 82%)). By arm, response rates were 78% and 75% for the Quit Sense and usual care arms, respectively. The return of a viable saliva sample for biochemical validation of those self-reporting abstinence for the primary outcome was 39% (16/41; 95% CI 24%, 54%), and by arm 52% (13/25) and 19% (3/16) for Quit Sense and usual care arms respectively. At the 6-month follow-up, the response rate for both resource use and quality of life data were 147/209 (70%; 95% CI 64%, 77%).Advertising running costs were £2796 and advert costs were £804.44 for Facebook and £412.49 for Google search (grand total £4012.93). Total cost per recruit was £19.20 (US$23.80) (£13.38 running costs, £5.82 advert costs). 195 participants were recruited via Facebook and 14 from Google, with lower advert costs per recruit for Facebook (£4.13) than Google (£29.46). See The installation rate of the Quit Sense app, defined as receipt of the unique code provided to intervention participants by the app’s server, was 75% (95% CI 67%, 83%; 78/104) (Use of Quit Sense app (Quit Sense arm only)
Analysis of the primary smoking outcome, which we anticipated would be used in a future study, found a higher abstinence rate in the Quit Sense arm (11.5%; 12/104) compared to the usual care arm (2.9%; 3/105) (unadjusted OR: 4.44, 95% CI 1.21, 16.21, Between-Arm Differences in Abstinence for Smoking Outcomes
By using the Bayesian approach relevant in preliminary trials, it is estimated there is 90% probability that the underlying OR favoring the intervention is 1.7 or higher, 93% that it is 1.5 or higher, and 85% that it is 2.0 or higher, indicating good support for a subsequent trial in which this range of effect sizes is considered.Because of imbalanced saliva sample return rates between arms, we undertook a post hoc sensitivity analysis for the primary smoking outcome but using self-reported prolonged abstinence only. The findings favored the Quit Sense arm, though the between-arm difference was not statistically significant (Quit Sense 24.0%; usual care 15.2%, OR: 1.76, 95% CI 0.88, 3.53, At 6 weeks of follow-up, 70.4% in the Quit Sense arm and 80.8% in the usual care arm reported smoking in the first 2 weeks of a quit attempt (or since enrollment if no quit date was set) which was not statistically significant ( | PMC10256891 | |
Discussion | RECRUITMENT | This was the first randomized controlled trial of a JITAI smartphone app for smoking cessation that uses passive measurement to trigger behavioral support. The automated online trial design employed was feasible and successful in reaching the target sample size within the relatively short recruitment timeframe. The cost per participant was compared favorably with other online digital cessation trials.The trial also demonstrated that three-quarters of smokers assigned to the Quit Sense app would install it on their phones and engage with it at least to the point of setting a quit date. Very few evaluations report the uptake rates for cessation apps and those that do have either offered incentives for installationTrial findings provided promising evidence that Quit Sense increased verified cessation at 6 months compared to usual care, though with considerable imprecision in line with a feasibility trial and due to low return rates of saliva samples. No between-arm differences were observed at 6 weeks of follow-up, suggesting any benefit from Quit Sense, relative to usual care, was more likely because of maintaining abstinence in the longer term rather than from increasing the proportion of participants initiating a quit attempt. However, there was no quantitative evidence that Quit Sense affected the hypothesized mechanisms of action at 6 weeks of follow-up. The qualitative process evaluation provided some insights into how Quit Sense was felt to bring about abstinence among those participants interviewed and is reported elsewhere. | PMC10256891 | |
Strengths and Limitations | coronavirus disease 2019 | CORONAVIRUS DISEASE 2019, RECRUITMENT | One innovation employed was those trial procedures, other than manual follow-up and saliva sample posting, were fully automated once setup, meaning study running costs were relatively low. Approximately half of the participants did not require any human involvement at any stage of their trial involvement and for those that did; it was mainly manual telephone follow-up. As the automated procedures were successful, few changes would be needed when running a definitive evaluation, further reducing resource need and the risk of recruitment and measurement issues.Further strengths were applying robust randomization and intervention delivery fidelity, publishing protocols, and making the statistical and health economic analysis plan publicly accessible prior to analysis, embracing key principles of open science.A key limitation was the poor return rate of saliva samples and that this was imbalanced between arms. It is possible the overall response was affected by the coronavirus disease 2019 pandemic, for example, more limited access to postal services due to changes in movement and time spent outside of the home or hesitation to provide a sample. The low incentive of £5 for a returned sample is likely to have been a factor. Similar trials have provided higher incentives for saliva returns and achieved higher response rates, including digital cessation intervention trials of online smokers (£20 incentive, 75% response rate; personal communication)An additional limitation was that the oldest participant was 61 years old and so our sample did not include those in older age groups. This likely reflects the online advertising approach adopted, although the mean age of participants in the present trial aligns closely with digital cessation trials that recruited offline.A further limitation was that this trial was undertaken during an unprecedented time of changed habits and routines due to the coronavirus disease 2019 pandemic. Participants reported reduced movement due to lockdown and similar measures to reduce movement outside of the home. It is likely this affected the exposure and time spent in different smoking locations and consequently the app’s ability to deliver context-specific support. Furthermore, the app’s use of geofencing to specify locations has potential for measurement error which can cause false negatives, where no support message is sent because of uncertainty as to whether an individual is within a geofence, due to poor location accuracy. | PMC10256891 |
Conclusions | The primarily automated trial design and processes for evaluating Quit Sense were feasible and enabled successful trial delivery within anticipated timeframes, cost, and participation rates. Evidence was consistent with Quit Sense leading to a higher rate of biochemically verified abstinence relative to usual care and all end-of-trial abstinence measures favored the app and represented clinically meaningful effects. Improving saliva sample response rates and sample diversity through advert targeting are two areas for improvement in a definitive trial, which is warranted by the findings from this feasibility trial. | PMC10256891 | ||
Supplementary Material | A Contributorship Form detailing each author’s specific involvement with this content, as well as any supplementary data, are available online at Click here for additional data file.Click here for additional data file. | PMC10256891 | ||
Acknolwedgments | WEST, RECRUITMENT | The authors are very grateful to the following for their contribution, time and efforts in ensuring the success of this project: The participants, the patient and public involvement and engagement panel, Antony Colles and Claire West for database, website and data collection setup, Nativve, who managed the online recruitment, the Norwich Clinical Trials Unit and NHS Norfolk and Waveney ICB. | PMC10256891 | |
Funding | This study is funded by the NIHR Public Health Research Programme (17/92/31). The views expressed are those of the authors and not necessarily those of the NIHR or the Department of Health and Social Care. Tim Coleman is an NIHR Senior Investigator. | PMC10256891 | ||
Declaration of Interests | PMC10256891 | |||
Data Availability | The data underlying this article will be shared on reasonable request to the corresponding author. | PMC10256891 | ||
References | PMC10256891 | |||
Background | Perturbation-based balance training (PBT) is an emerging intervention shown to improve balance recovery responses and reduce falls in everyday life in older adults. However, perturbation interventions were heterogeneous in nature and need improvement. This study aims to investigate the effects of a PBT protocol that was designed to address previously identified challenges of PBT, in addition to usual care, on balance control and fear of falling in older adults at increased risk of falling. | PMC10191085 | ||
Methods | Community-dwelling older adults (age ≥ 65 years) who visited the hospital outpatient clinic due to a fall incident were included. Participants received PBT in addition to usual care (referral to a physiotherapist) versus usual care alone. PBT consisted of three 30-minute sessions in three weeks. Unilateral treadmill belt accelerations and decelerations and platform perturbations (shifts and tilts) were applied during standing and walking on the Computer Assisted Rehabilitation Environment (CAREN, Motek Medical BV). This dual-belt treadmill embedded in a motion platform with 6 degrees of freedom is surrounded by a 180° screen on which virtual reality environments are projected. Duration and contents of the training were standardised, while training progression was individualised. Fear of falling (FES-I) and balance control (Mini-BESTest) were assessed at baseline and one week post-intervention. Primary analysis compared changes in outcome measures between groups using Mann-Whitney U tests. | PMC10191085 |
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