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Results
PMC9869378
Participant flow
A total of 346 participants who completed eligibility screening between February 2019 and March 2020, were randomised to VP or PV sequence (173 each). Of these, valid HbA1c data were obtained in 261 participants after vildagliptin and 237 participants after pioglitazone, with 203 participants completing both assessment...
PMC9869378
Baseline data
diabetes
OBESE, DIABETES
The mean (SD) for age was 57.5 (10.9) years, HbA1c 75 (12) mmol/mol), [9% 1.1)], diabetes duration 9 (6) years; 41% of participants were women, 55% were Māori and/or Pacific (Baseline demographics and clinical characteristics.Data are n (%) or mean (SD). OHTG refers to obese (BMI ≥ 30kg/m*Other medication includes acar...
PMC9869378
Outcomes
deaths, strokes, Triglycerides reduced
ADVERSE EVENTS, MYOCARDIAL INFARCTION, STROKES
Overall, a greater mean decrease in HbA1c was observed after pioglitazone than after vildagliptin treatment (adjusted mean difference -4.9mmol/mol [-0.5%], 95%CI -6.3, -3.5; p < 0.0001) (The estimated medication effects on HbA1c and its interaction with ethnicity (primary outcome analysis).ITT, intention to treat; PP, ...
PMC9869378
Discussion
obesity, T2D, myocardial infarction, weight gain, 4.7mmol/mol greater reduction, diabetes
OBESITY, MYOCARDIAL INFARCTION, ADVERSE EVENTS, DISEASE, INSULIN RESISTANCE, TYPE 2 DIABETES, DIABETES
This multicentre, two-way, randomised crossover trial showed that the glucose-lowering response to pioglitazone relative to vildagliptin was not different between people of Māori or Pacific ethnicity and other New Zealand ethnicities. However, there was a significant interaction in relative glucose-lowering by OHTG sta...
PMC9869378
Data availability statement
The raw data supporting the conclusions of this article will be made available by the authors, without undue reservation.
PMC9869378
Ethics statement
The studies involving human participants were reviewed and approved by NZ Health and Disability Ethics Committee. The patients/participants provided their written informed consent to participate in this study.
PMC9869378
Author contributions
PRS
RM designed the trial. YJ was responsible for the statistical analysis of the data. TRM was responsible for the genetic analysis plan. ML designed the population-specific genetic variant panel. TM assisted with genetic analysis of the data. RM and PRS obtained funding. RB, RY, RT-C, KS, GD, KAM, RD, PC, AM, NN, FK, JH,...
PMC9869378
Acknowledgments
Diabetes
ADVERSE EVENTS, DIABETES
We are grateful to all the participants who took part in this study. We acknowledge Yiping Zou and Stacey Ruru for assisting with the data collection for this trial. We are grateful for the helpful input from John Baker in the planning of this trial; pharmacist Dale Griffiths and the team from zoom pharmacy who dispens...
PMC9869378
Conflict of interest
RP, Nordisk
Authors RP and RM have received speaking honoraria from Lilly, Boehringer Ingelheim, Astra Zeneca, Sanofi, Novo Nordisk, also Novartis (RM) and Inova pharmaceuticals (RP). RP is a member of the Lilly, Novo Nordisk and Dexcom New Zealand advisory boards. Authors KAM, RD, PC were employed by Ventures/Pinnacle Incorporate...
PMC9869378
Publisher’s note
All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article, or claim that may be made by its manufacturer, is not guaranteed or ...
PMC9869378
Supplementary material
The Supplementary Material for this article can be found online at: Click here for additional data file.
PMC9869378
References
PMC9869378
Background
cord injury, traumatic cervical SCI, Traumatic
Traumatic cervical spinal cord injury (SCI) results in reduced sensorimotor abilities that strongly impact on the achievement of daily living activities involving hand/arm function. Among several technology-based rehabilitative approaches, Brain-Computer Interfaces (BCIs) which enable the modulation of electroencephalo...
PMC10662594
Methods
traumatic cervical SCI
This randomized controlled trial will include 30 participants with traumatic cervical SCI in the subacute phase randomly assigned to 2 intervention groups: the BCI-assisted hand MI training and the hand MI training not supported by BCI. Both interventions are delivered (3 weekly sessions; 12 weeks) as add-on to standar...
PMC10662594
Discussion
traumatic
We expect the BCI-based intervention to promote meaningful cortical sensorimotor plasticity and eventually maximize recovery of arm functions in traumatic cervical subacute SCI. This study will generate a body of knowledge that is fundamental to drive optimization of BCI application in SCI as a top-down therapeutic int...
PMC10662594
Trial registration
cord injury
Name of registry: DiSCIoser: improving arm sensorimotor functions after spinal cord injury via brain-computer interface training (DiSCIoser). Trial registration number: NCT05637775; registration date on the ClinicalTrial.gov platform: 05-12-2022.
PMC10662594
Keywords
PMC10662594
Background
Traumatic, stroke, traumatic SCI, injury between stroke, ischaemia, trauma
CERVICAL LESIONS, STROKE, ISCHAEMIA, SPINAL CORD
Traumatic Spinal Cord Injury (SCI) represents a devastating condition for physical and social well-being [Over the last decade, the epidemiology of traumatic SCI has progressively changed with an increase in cervical lesions, particularly at C1-C4 levels [Technological advances have led to the development of novel inte...
PMC10662594
Aim and hypotheses
stroke, traumatic cervical SCI, traumatic
STROKE
The “DiSCIoser'' study is a randomized controlled trial (RCT) designed to provide evidence for a significant improvement of hand sensorimotor function induced by a BCI-assisted MI training in patients with traumatic SCI.Based on our previous findings on the efficacy of BCI-supported MI training in patients with stroke ...
PMC10662594
Methods/design
hand movements
SECONDARY, BLIND
A total cohort of 30 participants will be enrolled and randomized in a single centre, single blind RCT to investigate the efficacy of BCI-MI training for hand movements, delivered during the subacute phase of SCI (hospitalization period). The primary and secondary outcome measures collected from participants assigned t...
PMC10662594
Study design
ASIA
SPINAL CORD
The DiSCIoser trial is designed as a randomized, controlled, assessors blinded single-centre trial with 2 parallel groups with 1:1 allocation ratio. The study flow is illustrated in Fig. DiSCIoser Randomized Controlled Trial summary. All Spinal Cord Injury (SCI) patients admitted to the Spinal Unit at Fondazione Santa ...
PMC10662594
Sample size
ASIA
The sample size was calculated on the hypothesis that experimental intervention (BCI-MI training) is superior in improving the primary outcome measure. Based on preliminary findings in the Upper Extremity Motor Scores (UEMS) from the International Standards for Neurological Classification of SCI (ISNCSCI) ASIA Impairme...
PMC10662594
Inclusion/exclusion criteria
traumatic brain injury, epilepsy, ASIA, traumatic, psychiatric, impulsivity, neurological deficits, cognitive comorbidities
EPILEPSY
The specific Inclusion and Exclusion criteria are listed below:Inclusion criteria:age between 18 and 70 years,current hospitalization at FSL site for rehabilitation care,subacute traumatic cervical SCI (30–90 days after the event),classification according to ISNCSCI ASIA Impairment Scale A-D,lesion level between C1 and...
PMC10662594
Assessments
PMC10662594
Primary
Changes from pre-
PMC10662594
Secondary
humour, Pain, pain
SECONDARY, SPINAL CORD
The secondary outcome measures are the changes from pre- muscle strength: the GRASSP motor score of bilateral arms that ranges from 0 (maximum impairment) to 50 (normal) for each side [muscle tone: the Modified Ashworth Scale (MAS) for the muscle tone assessment of upper and lower limbs [pain: the International SCI Pai...
PMC10662594
Neurophysiological assessment
This includes:the Motor Evoked Potentials (MEPs) to evaluate the changes in corticospinal tract integrity. MEPs will be recorded from the bilateral Abductor Digiti Minimi (ADM, for the upper limbs) and Abductor Hallucis (AH, for the lower limbs) muscles by following the methodology reported in [the Somatosensory Evoked...
PMC10662594
Neuroimaging assessment
head and neck coil
The neuroimaging protocol is derived from Cohen-Adad et al. [All scans will be performed at FSL Neuroimaging Unit on a high-performance 3 T scanner (Siemens Magnetom Prisma) equipped with a 64-channel head and neck coil and a 32-channel spine array, after 2Scans will be collected in both experimental and control groups...
PMC10662594
Neuropsychological and user experience assessment
The Neuropsychological assessment at Finally, the user experience assessment of the technology-based training [at each single training session: before starting an adapted version of the Questionnaire for Current Motivation (QCM) [at the first and last training session: the National Aeronautics and Space Administration ...
PMC10662594
Randomization procedure and methods
The random allocation sequence of participants to experimental (BCI-MI training) or control (Control-MI training) intervention groups will be generated by using Matlab (The MathWorks Inc, Natick, Massachusetts, USA, release 2019a).The randomization sequence will be stratified by age (2 categories: ≤ 50 years old and > ...
PMC10662594
Intervention
PMC10662594
Dosage of intervention training
ADVERSE EVENTS, ADVERSE EFFECTS
Both BCI-MI and Control-MI training will be completed in 12 weeks with a weekly frequency of 3 sessions per week, lasting 45 min. Treatment adherence is set at 12 of the 36 intervention training sessions. We do not expect the BCI-MI and Control-MI interventions to cause adverse effects (non-invasive procedure; no drug-...
PMC10662594
BCI-assisted motor imagery training (BCI-MI, experimental intervention)
SPINAL CORD
An all-in-one BCI-supported MI training station (Fig. DiSCIoser BCI station. The Brain-Computer Interface training station developed for patients with Spinal Cord Injury to practice the kinaesthetic motor imagery of hand closing and opening in a close-loop condition. The system is equipped with a laptop, a commercial w...
PMC10662594
Motor imagery training without BCI support (Control-MI, control intervention)
The Control-MI training will be implemented under the same conditions as the experimental intervention (BCI-MI training). Specifically, the station (Fig. 
PMC10662594
Training sessions
During training sessions, all participants will be seated on a comfortable chair (or on their wheelchair) in a dimly lit room with their hands and forearms resting under the BCI station screen (Fig. Participants will be instructed by the therapists to perform the kinesthetic MI of both hands movements either closing or...
PMC10662594
Statistical analysis
PMC10662594
Primary analyses
Baseline characteristics will be described by summary statistics for each group (experimental and control intervention). Differences between groups at baseline The primary analysis will be performed in per protocol (PP) population on GRASSP somatosensory score changes between
PMC10662594
Secondary analyses
SECONDARY
All secondary outcomes will be compared between groups. T-test for independent samples and non-parametric tests will be used for continuous and categorical data, respectively. Further explorative analyses will be carried out on primary and secondary outcomes in subgroups of participants identified by strata used in ran...
PMC10662594
Data collection and management
CRF
CRF
An ad hoc CRF is implemented for all type and timing assessments.Specifically, the CRF will consist of two sections:i) the “Baseline and Randomization Section” which will contain each participant demographic, neurological and clinical data and all data collected for the screening section including the Informed Consent,...
PMC10662594
Confidentiality
Confidentiality and Privacy will be managed according to Italian National Law.Personal data are regarded as strictly confidential. Original paper CRFs containing study data are stored at FSL and subjected to all GDPR (UE 2016/679) security regulation and backup as clinical/medical records. Data are entered using partic...
PMC10662594
Trial monitoring
Database collection within and between Experimental and Control intervention group will be monitored and the trial responsible will be alerted if any deviation occurs. Any modifications to the protocol which may impact on the conduct of the study, including changes of study objectives, study design, participant populat...
PMC10662594
Dissemination of results
Media
Main results will be subjected to publications in scientific peer-reviewed journals; results will be also presented at clinical neuroscience and/or Neuroengineering (Society for Neuroscience conference; BCI international conference; IEEE; National Society for Neurorehabilitation) conferences. Media and public outreach ...
PMC10662594
Discussion
Traumatic cervical SCI, long-term disability
Traumatic cervical SCI may lead to long-term disability for which cost-effective rehabilitation options are critically needed. The DiSCIoser study aims at providing evidence for the clinical/neurophysiological efficacy of BCI-based intervention to promote meaningful cortical sensorimotor plasticity and eventually maxim...
PMC10662594
Acknowledgements
We would like to acknowledge the contribution of the following members of the project team: Neurophysiology Technicians Marco Secci, Fondazione Santa Lucia, IRCCS, Rome, Italy; Giorgio Tartaglia, Fondazione Santa Lucia, IRCCS, Rome, Italy; Giovanni Nicolai, Fondazione Santa Lucia, IRCCS, Rome, Italy. Research Staff Chi...
PMC10662594
Authors’ contributions
DM
DM in collaboration with GS and FC led the study conceptualization, design and application for funding. DM is the grant holder and manages the trial. FP is responsible for the clinical trial and data interpretation; FC manages the design and implementation of the BCI technology; EC is responsible for BCI technology imp...
PMC10662594
Funding
FOUNDER
This project is funded by the Italian National Ministry of Health (MoH) under the programme Ricerca Finalizzata 2019 (grant # RF-2019-12369396), after a peer-reviewed process. The views and opinions expressed herein are those of the authors and do not necessarily reflect those of the founder MoH, that had no role in th...
PMC10662594
Availability of data and materials
Not applicable.
PMC10662594
Declarations
PMC10662594
Ethics approval and consent to participate
The study protocol and related procedures are approved by the institutional review board, the Independent Ethical Committee of the Fondazione Santa Lucia, IRCCS, Rome, Italy (
PMC10662594
Consent for publication
Not applicable.
PMC10662594
Competing interests
The authors declare that they have no competing interests.
PMC10662594
References
PMC10662594
1. Introduction
Unequal opportunities and constricting sociocultural norms are inimical to gender equity and development. Curbs and controls at household and community level often disallow women to pursuit their goals for a healthy and dignified living [Boosting investments in social sector (mainly health and education) and physical i...
PMC10624310
2. TARA pilot
Transformative Action for Rural Adolescents (TARA) pilot is an 18-month intervention launched in November 2019 in Rohtas district of Bihar with funding support from Bill and Melinda Gates Foundation (BMGF) and GAP Inc. PCI in coordination with ICRW and Gap Inc. customized the PACE curriculum for the intervention to be ...
PMC10624310
3. Data and methods
PMC10624310
3.1 Data
The impact evaluation is based on the baseline and endline survey data collected by the PCI team. A two-arm (intervention and comparison groups) cluster randomized controlled design was used based on two rounds of representative quantitative cross-sectional surveys with adolescent girls (15–19 years). The baseline surv...
PMC10624310
3.2 Outcome measures
Core to the TARA’s programmatic approach is an evidence-based, gender-integrated life skills training and mentoring program, called Personal Advancement & Career Enhancement (P.A.C.E.) that addresses five core domains. The impact across these five domains of empowerment, employment and adolescent health and nutrition i...
PMC10624310
3.3 Correlates
Participation of the adolescent girls in the community activities under the TARA intervention is the main explanatory variable (S2 Table in
PMC10624310
3.4 Statistical and econometric analysis
Descriptive statistics is provided for the outcome measures and the key explanatory variables (
PMC10624310
Background characteristics of the sample from control and intervention areas.
PMC10624310
4. Results
The background characteristics of the intervention and comparison group across baseline and endline period is similar (The mean domain specific scores for the comparison and intervention group have increased between the baseline and endline period (
PMC10624310
Dietary intake from various food groups (based on 24-hour recall) and practice of minimum dietary diversity (%) in comparison and intervention groups.
PMC10624310
Logistic regression (odds ratio) and Poisson regression (incidence rate ratio) for higher domain scores (top two quintiles) for comparison and intervention groups.
REGRESSION
Note:***, ** and * denotes p-value significance at 1%, 5% and 10%, respectively.The models are adjusted for age of the adolescent, schooling status, maternal and paternal education, household size, household occupation, family type, social group, poverty status, household construction material and household assets-base...
PMC10624310
5. Discussion
anxiety, anemia, micronutrient deficiency
EVENTS, ANEMIA
This study evaluates the impact of delivering PACE++ curriculum for adolescent girls in community settings of rural Bihar. Based on the quasi-experimental study design, the study focused on domains related to gender attitudes, empowerment and dietary practices. The five salient findings of the study are as follows. Fir...
PMC10624310
6. Conclusion
ADVERSE EFFECTS
The TARA intervention contributed to the development of the strategies for engaging and empowering adolescent girls through augmenting health and nutrition issues in the widely used PACE curriculum and also implementing this in community-based settings. Both the changes are extremely important as adolescent well-being ...
PMC10624310
Supporting information
(DOC)Click here for additional data file.(ZIP)Click here for additional data file.(DOCX)Click here for additional data file.
PMC10624310
References
PMC10624310
Subject terms
RPE
CORTEX
The benefits of transcranial direct current stimulation (tDCS) on brain function, cognitive response, and motor ability are well described in scientific literature. Nevertheless, the effects of tDCS on athletes’ performance remain unclear. To compare the acute effects of tDCS on the running performance of 5000 m (m) ru...
PMC10250526
Introduction
RPE
SECONDARY, CORTEX
Transcranial direct current stimulation (tDCS) is a neuromodulation technique that delivers a constant, low-intensity flow of electric current to the scalpStimuli in the motor cortex (M1) region can directly influence sport performanceHowever, some studies failed to identify any acute stimulation effect on M1. In amate...
PMC10250526
Materials and methods
PMC10250526
Participants
muscle pain
UPPER RESPIRATORY TRACT COMPLICATIONS
Twenty-four runners participating in the running club of the Universidade Federal de Sergipe (UFS) were eligible for the study. The study was designed to be single-blinded, randomized and counter-balanced. Randomization was done using Microsoft Excel 2021 software. Blinding was achieved by telling all participants that...
PMC10250526
Ethical consideration
The entire procedure was explained to the athletes, who signed the informed consent form. The study was approved by the Ethics Committee on Human Beings of UFS (CAAE: 56703722.2.0000.5546), according to the Helsinki declaration, with Brazilian Clinical rials Registry, (03/27/2023), (RBR-4yt3pvc).
PMC10250526
Experimental protocol
The athletes visited the Physical Education Department—athletics track at UFS to perform a familiarization session on the procedure and data collection. Initially, we collected the peak torque in three trials, with 30 s of recovery between them. The tDCS was performed for 20 min at an intensity of 2 mA. After a 10-min ...
PMC10250526
Transcranial direct current stimulation (tDCS)
The tDCS was applied according to the guidelines proposed by Vitor-Costa et al.
PMC10250526
Peak torque
Peak torque (Pt) was evaluated as the maximum isometric torque generated by the knee extensor muscles. The Pt was determined by multiplying the peak isometric force and the length of the segment, given by the distance between the attachment point of the load cell cable and the center of the knee joint. For this evaluat...
PMC10250526
Running test
Vollo®
After the stimulation, the athletes were instructed to start the 5000 m course on the official athletics track at the command of the sound signal. The time to complete the course was recorded using a manual stopwatch (Vollo® VL-512) as well as the average speed of each athlete was observed, through the total time to co...
PMC10250526
Perceived effort and internal load of the training session
The CR-10
PMC10250526
Statistics
RPE
The normality of the data was assessed by the Shapiro–Wilk test followed by a paired Student’s t-test to compare the Pt and the total time to complete the course between the groups. The RPE and internal charge at each lap were examined by two-way analysis of variance (ANOVA). Tukey’s post-hoc test for multiple comparis...
PMC10250526
Ethics approval and consent to participate
The study was approved by the Ethics Committee on Human Beings of Universidade Federal de Sergipe (CAAE: 56703722.2.0000.5546), according to the Helsinki declaration.
PMC10250526
Results
PMC10250526
Primary outcomes
No difference was observed between the groups for peak torque (p = 0.70; 95% CI ± 1.11; d = 0.18). Figure Peak torque (Nm) pre and post 5000 m of running and tDCS with 2 mA intensity; ANODAL (n = 9) and SHAM (n = 9). All values are presented as mean ± standard deviation. p = 0.70.Peak torque (Nm) pre and post 5000 m of...
PMC10250526
Secondary outcomes
There was no difference in RPE between the groups (F [1,11] = 1.60, p = 0.23 95% CI − 1.55 to 0.39; d = 0.60). Similarly, the internal load showed no difference (F [1,14] = 0.12, p = 0.73; 95% CI − 0.77 to 1.09; d = 0.17). Figures Perception of Effort at each 400 m lap. Values are presented as mean ± standard deviation...
PMC10250526
Discussion
RPE, fatigue
CORTEX
The objective of the present study was to analyze the effects of tDCS on 5000 m running performance, muscle strength and RPE in runners. The results show that 20 min of stimulation with an intensity of 2 mA on the primary motor cortex promoted improved athletic performance by reducing the running time in the Anodal gro...
PMC10250526
Acknowledgements
This paper and the research behind would not have been possible without the members of the Group of studies and Research of performance, sport, health and Paralympic Sports (GEPEPS). The scientific research group also read the draft manuscript and provided comments prior to the journal review process. We would like to ...
PMC10250526
Author contributions
L.F.S. and E.V.M.P., Planning, Searching, Data Extraction. D.S.S., M.D.J.A., M.S.S.F., Planning, search, data extraction and partial correction of the document. A.F.Z. and H.R.N. Planning, research, partial correction of the document and quality analysis. B.K., K.W. and F.J.A. Article review and writing contributions. ...
PMC10250526
Data availability
The datasets used and/or analysed during the current study are available from the corresponding author on reasonable request.
PMC10250526
Competing interests
Leila Fernanda dos Santos, Devisson dos Santos Silva, Micael Deivison de Jesus Alves, Erika Vitoria Moura Pereira, Hortência Reis do Nascimento, Matheus Santos de Sousa Fernandes, Aristela de Freitas Zanona, Beat Knechtle, Katja Weiss, Felipe J. Aidar and Raphael Fabricio de Souza declare that they have no competing in...
PMC10250526
References
PMC10250526
4. Discussion
depression, traumatic, post-traumatic stress symptoms, anxiety
FIRE
In general, the SFA program trainings were well received with the majority of participants in the peer team training and taking the online trainings reporting high levels of satisfaction and increased interest in the topic. Most notably, there were statistically significant findings related to questions about how prepa...
PMC10671183
Author Contributions
Conceptualization, S.A.J., N.J., W.S.C.P. and R.G.; methodology, S.A.J., W.S.C.P. and C.K.H.; software, C.K.H.; validation, C.K.H. and W.S.C.P.; formal analysis, N.J., C.M.K. and C.K.H.; investigation, S.A.J., P.W., F.L., N.J. and C.M.K.; resources, S.A.J. and W.S.C.P.; data curation, N.J., C.M.K. and C.K.H.; writing—o...
PMC10671183
Institutional Review Board Statement
The study was conducted in accordance with the Declaration of Helsinki and approved by the Institutional Review Board of NDRI-USA (protocol code 015-649, approved on 24 August 2015).
PMC10671183
Informed Consent Statement
Informed consent was obtained from all subjects involved in the study.
PMC10671183
Data Availability Statement
Data are available upon request.
PMC10671183
Conflicts of Interest
PTSD
FRANK
The author listed immediately below certifies that they have NO conflict of interest to declare: Frank Leto. The authors whose names are listed immediately below report the following conflicts of interest related to the work under consideration: Sara A. Jahnke, Nattinee Jitnarin, Christopher Kaipust, Brittany S. Holler...
PMC10671183
References
Seven Cs of Stress First Aid.Stress First Aid (SFA) Protocol.Overview of Study Design.Perceptions of Department Readiness by Intervention Condition.Social Support from Department by Intervention Condition.Negative Reactions to Behavioral Health Issues by Intervention Condition.Participant Characteristics at Post-Interv...
PMC10671183
Background
Telephone triage has been established in many countries as a response to the challenge of non-urgent use of out-of-hours primary care services. However, limited evidence is available regarding the effect of training interventions on clinicians’ telephone consultation skills and patient outcomes.
PMC9807970
Methods
REGRESSION, RESPIRATORY TRACT INFECTIONS
This was a pragmatic randomized controlled educational intervention for telephone triage nurses in 59 Norwegian out-of-hours general practitioners’ (GPs) cooperatives, serving 59% of the Norwegian population. Computer-generated randomization was performed at the level of out-of-hours GP cooperatives, stratified by the ...
PMC9807970
Results
sore throat, Laryngitis, pneumonia
REGRESSION, LARYNGITIS, SORE THROAT, PNEUMONIA
The regression showed that the intervention did not change the number of consultations for RTIs between the two groups of out-of-hours GP cooperatives (incidence rate ratio 0.99, 95% confidence interval 0.91–1.07). The winter season’s out-of-hours patient population was younger and had a higher proportion of RTIs than ...
PMC9807970
Conclusions
The intervention did not influence the out-of-hours attendance. This finding may be due to the intervention’s limited scope and the intention-to-treat design. Changing a population’s out-of-hours attendance is complicated and needs to be targeted at several organizational levels.
PMC9807970