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Subject terms
congenital heart disease, CHD
We aimed to explore the effects of perioperative exercise on cardiorespiratory endurance in children with congenital heart disease (CHD) in plateau areas after surgical repair. Fifty children with CHD in the plateau admitted to our hospital were randomly divided into the exercise and control groups. The exercise group ...
PMC10593799
Introduction
Congenital heart disease, congenital disease, CHD
CONGENITAL DISEASE, DISEASES
Congenital heart disease (CHD) is the most common congenital disease in newborns; it is caused by abnormal development of the heart and/or large blood vessels in the fetus and includes heart wall, valve, and vascular malformationsAn active lifestyle is critical to the long-term health of patients with CHD. The current ...
PMC10593799
Methods
PMC10593799
Patient information
The study protocol was approved by the ethics committee of Zhengzhou Cardiovascular Hospital, affiliated to Southern Medical University (2020-10-002-F02). Patients in plateau areas who were admitted to the Cardiovascular Surgery Department of Zhengzhou Cardiovascular Hospital] between January 2020 and July 2022 were in...
PMC10593799
Inclusion criteria
CHD
The inclusion criteria were CHD diagnosed using cardiac color Doppler ultrasound that required surgical repair after evaluation, the ability to independently complete the 6-MWT and exercise training procedure, aged less than 18 years, and signed informed consent by the parent or guardian.
PMC10593799
Exclusion criteria
emphysema
RESPIRATORY INSUFFICIENCY, HYPERSENSITIVITY, EMPHYSEMA
The exclusion criteria were unstable vital signs, the inability to perform exercise due to muscle and joint problems, severe instability of the airways (patients with severe emphysema), bronchial non-specifically marked hypersensitivity, and severe gas exchange impairment (total or partial respiratory insufficiency).
PMC10593799
Withdrawal criteria
POSTOPERATIVE COMPLICATIONS
Patients could withdraw from the study voluntarily or if they were unable to complete the study procedures due to serious postoperative complications.
PMC10593799
Collection of basic clinical data
After admission, age, sex, height, and weight of each enrolled patient were collected. Body mass index (BMI) was calculated, and the left ventricular ejection fraction (LVEF) was assessed using echocardiography.
PMC10593799
Exercise ability assessment
PMC10593799
Preparation of the patient
AIDS
(1) The patient should wear comfortable clothing as well as appropriate shoes for exercise. (2) Patients should use their usual walking aids during the test (cane, walker, etc.) (3) The patient’s usual medical regimen should be continued. (4) A light meal is acceptable before early morning or early afternoon tests. (5)...
PMC10593799
Preparation of the test
(1) Make sure the ambient temperature was kept at 20–25 °C with proper ventilation. (2) Repeat testing was performed at approximately the same time each day by the same professionally trained technician who was unaware of the groupings. (3) A “warm-up” period before the test should not be performed. (4) The serial numb...
PMC10593799
Performing the cardiopulmonary exercise test
dyspnea
BLOOD
An incremental, symptom-limited CPET was performed on a cycle ergometer (Jaeger, German model: MasterScreen CPX)) with continuous measurements of oxygen consumption, carbon dioxide production, minute ventilation, heart rate, 12-lead electrocardiography, and oxygen saturation measured by pulse oximetry. Average resting ...
PMC10593799
Performing the 6-MWT
THORACIC
The 6-MWT was performed on flat ground in a hospital room. In accordance with the guidelines of the American Society of Thoracic Surgery, the total length was 30 meters (m). Marks were made at every 3 m, and there were signs at the turn-back point. Participants were instructed to walk with the following information:(1)...
PMC10593799
Exercise training procedure
All children with CHD were postoperatively admitted to the intensive care unit. Within 24 h of being transferred from the intensive care unit to the general ward, the exercise group received exercise therapy based on the routine nursing treatment of the control group. The bedside power bicycle 30-min intervention progr...
PMC10593799
Statistical analysis
The primary hypothesis of the current study was that children who received a perioperative exercise intervention beginning within 24 h postoperatively would show significantly higher 6MWD than those who received routine nursing and treatment. According to our pre-experiment, based on a two-sided t-test with an All stat...
PMC10593799
Results
atrial fibrillation
ATRIAL FIBRILLATION, EVENTS, PAROXYSMAL ATRIAL FIBRILLATION
A total of 50 patients who met the inclusion criteria were included in this study, and all of them completed the requirements of the experimental protocol in a standardized manner, with no withdrawals. Among them, 15 were able to perform the CPET independently and complete it preoperatively. The 50 participants were ra...
PMC10593799
CPET for 15 children in two groups
congenital heart disease
DISEASE
Statistical testing revealed no significant differences in the demographic, LVEF, preoperative 6MWD and disease types. The CPET results exhibited no significant differences in load at peak, VODemographic, LVEF, preoperative 6MWD, CPET and disease type of the total cohort and two groups.Data are expressed as the mean ± ...
PMC10593799
The relationship of VO
Preoperative VOCorrelation analysis of VO2peak and 6-MWT pre-operatively.
PMC10593799
Exercise training in the two groups
ventricle septal defect, patent ductus arteriosus, bicuspid aortic valve, atrial septal defect
DISEASE
Statistical testing revealed no significant differences in the preoperative general demographic data, LVEF, and disease type of the exercise and control groups (Table Demographics, LVEF, and disease type of the total cohort and two groups.BMI, body mass index; LVEF, left ventricular ejection fraction; ASD, atrial septa...
PMC10593799
Author contributions
S.X. conceived the idea for the study. H.Z. led the work group. R.Q. drafted the text and provided editorial oversight. S.L. performed section of statistical analyses. H.W. provided editorial oversight. S.L./X.H./W.L./F.H. reviewed and commented on the final draft of the manuscript. R.Q./Y.Z./B.Y. co-led the work group...
PMC10593799
Funding
Funding was provided by Henan Provincial Key R&D and Promotion Project (Grant Number 212102310788), Henan Province Medical Science and Technology Research Plan Joint Construction Project (Grant Number LHGJ20200733) and Hubei Provincial Engineering Research Centre of Vascular Interventional Therapy.
PMC10593799
Data availability
The datasets used and/or analyzed in this study are available from the corresponding author upon reasonable request.
PMC10593799
Competing interests
The authors declare no competing interests.
PMC10593799
References
PMC10593799
Abstract
PMC10209436
Background
human immunodeficiency virus type 1 (HIV-1) RNA
Dolutegravir concentrations are reduced by efavirenz induction effect necessitating twice-daily dolutegravir dosing when coadministered. Efavirenz induction persists for several weeks after stopping, which could potentially select for dolutegravir resistance if switching occurred with unsuppressed human immunodeficienc...
PMC10209436
Methods
virologic failure
We conducted a randomized, double-blind, placebo-controlled, phase 2 trial in Khayelitsha, South Africa. Eligible patients had virologic failure (2 consecutive HIV-1 RNA ≥1000 copies/mL) on first-line TEE. Participants were randomly assigned (1:1) to switch to tenofovir-lamivudine-dolutegravir (TLD) with a supplementar...
PMC10209436
Results
One hundred thirty participants were randomized (65 to each arm). Median baseline HIV-1 RNA was 4.0 log
PMC10209436
Conclusions
Our findings do not support the need for initial dolutegravir dose adjustment in patients switching to TLD who failed first-line TEE.
PMC10209436
Clinical Trials Registration
toxic, breast cancer
BREAST CANCER
NCT03991013.Among adults switching to second-line tenofovir-lamivudine-dolutegravir with unsuppressed HIV-1 RNA levels and substantial baseline nucleoside reverse transcriptase inhibitor resistance, a high proportion achieved virologic suppression.Clinical Trials Registration. NCT03991013Dolutegravir with 2 nucleoside ...
PMC10209436
METHODS
PMC10209436
Study Design and Participants
virologic failure
ARTIST is a noncomparative, randomized, double-blind, placebo-controlled, phase 2, 48-week trial of second-line TLD with or without a lead-in supplementary dolutegravir dose in patients with virologic failure on first-line TEE. A detailed protocol describing our methods has been published [Eligible patients were adults...
PMC10209436
Randomization, Allocation Concealment, and Masking
Participants were randomly assigned (1:1) to a second-line regimen consisting of tenofovir (300 mg), lamivudine (300 mg), and dolutegravir (50 mg), given as a once-daily fixed-dose combination tablet, with an additional lead-in dose of dolutegravir (50 mg) or placebo taken 12 hours later for the first 14 days. An indep...
PMC10209436
Procedures
Follow-up study visits with clinicians occurred at weeks 2, 4, 8, 12, 16, 20, and 24 (with a visit window of ±16 days at each visit except the week 24 visit, which had a window of ±6 weeks). Plasma HIV-1 RNA was measured at baseline and every visit from week 4 onward. If any HIV-1 RNA after week 12 was ≥50 copies/mL, o...
PMC10209436
Outcomes
virologic failure, AIDS, virologic suppression, intolerance or adverse event
ADVERSE EVENT, ADVERSE EVENTS, ADVERSE EVENT, AIDS, SECONDARY
The primary outcome was proportion with virologic suppression (defined as HIV-1 RNA <50 copies/mL) at week 24. We conducted a modified intention-to-treat (mITT) analysis according to the US Food and Drug Administration (FDA) snapshot approach, which defines failure as any 1 of HIV-1 RNA measurements ≥50 copies/mL, miss...
PMC10209436
Statistical Considerations
A sample size of 57 participants in each arm was estimated to produce a 95% confidence interval (CI) of 72%–92%, assuming the proportion achieving virologic suppression of 82% at week 24 (as achieved in the dolutegravir arm of the DAWNING study [
PMC10209436
Ethics Approval
Written informed consent was obtained from all participants. This study was approved by the Human Research Ethics Committee at the University of Cape Town (Ref 039/2019). We registered the study protocol on ClinicalTrials.gov (NCT03991013). A trial steering committee with independent members provided trial oversight an...
PMC10209436
RESULTS
death, human immunodeficiency virus type 1, psychosis, virologic failure, SAEs, acute kidney injury, insomnia, Insomnia, headache, coronavirus disease 2019
PULMONARY TUBERCULOSIS, CORONAVIRUS DISEASE 2019, ADVERSE EVENTS, SENSITIVITY, ADVERSE EVENT, HUMAN IMMUNODEFICIENCY VIRUS TYPE
Participants were recruited between 28 August 2020 and 10 November 2021. Of 178 adults screened, 130 participants were randomly assigned to receive lead-in supplementary dolutegravir (n = 65) or placebo (n = 65) (Eligibility assessment, randomization, treatment, and follow-up. *Eight patients had CD4 count <100 cells/µ...
PMC10209436
DISCUSSION
virologic failure, TLD, insomnia
DRUG INTERACTION
In our study, second-line TLD produced acceptable rates of virologic suppression at 24 weeks in adults with virologic failure on first-line TEE, with and without a lead-in supplementary dolutegravir dose. No emergent dolutegravir resistance occurred over 24 weeks among our cohort of patients who switched with unsuppres...
PMC10209436
CONCLUSIONS
The ARTIST study provides additional evidence that maintaining tenofovir and lamivudine with dolutegravir is effective and well tolerated in second-line ART. Our results provide evidence over 24 weeks that patients with unsuppressed HIV-1 RNA levels on first-line TEE can safely switch to second-line TLD without a lead-...
PMC10209436
Notes
PMC10209436
References
PMC10209436
Key Points
PMC10548310
Question
dementia
Do physicians prioritize different ethical considerations when considering deprescribing medications for older adults (aged ≥65 years) with dementia?
PMC10548310
Findings
dementia
ADVERSE DRUG EVENT
In this national survey study of 890 primary care physicians, 9 factors influencing deprescribing decisions for older adults with dementia were prioritized. When a medication may increase risk of an adverse drug event or have limited benefit as a treatment, physicians are sensitive to concerns that deprescribing would ...
PMC10548310
Meaning
dementia
Results of this survey study suggest that managing symptoms and well-being and working with other clinicians are priorities for clinicians managing medications for older adults with dementia.
PMC10548310
Importance
dementia
Physicians endorse deprescribing of risky or unnecessary medications for older adults (aged ≥65 years) with dementia, but there is a lack of information on what influences decisions to deprescribe in this population.
PMC10548310
Objective
dementia
To understand how physicians make decisions to deprescribe for older adults with moderate dementia and ethical and pragmatic concerns influencing those decisions.
PMC10548310
Design, Setting, and Participants
A cross-sectional national mailed survey study of a random sample of 3000 primary care physicians from the American Medical Association Physician Masterfile who care for older adults was conducted from January 15 to December 31, 2021.
PMC10548310
Main Outcomes and Measures
dementia
REGRESSION, ADVERSE DRUG EVENT
The study randomized participants to consider 2 clinical scenarios in which a physician may decide to deprescribe a medication for older adults with moderate dementia: 1 in which the medication could cause an adverse drug event if continued and the other in which there is no evidence of benefit. Participants ranked 9 f...
PMC10548310
Results
A total of 890 physicians (35.0%) returned surveys; 511 (57.4%) were male, and the mean (SD) years since graduation was 26.0 (11.7). Most physicians had a primary specialty in family practice (50.4% [449 of 890]) and internal medicine (43.5% [387 of 890]). A total of 689 surveys were sufficiently complete to analyze. I...
PMC10548310
Conclusions and Relevance
dementia
Findings from this national survey study of primary care physicians suggests that understanding ethical aspects of physician decision-making can inform clinician education about medication management and deprescribing decisions for older adults with moderate dementia.This survey study of primary care physicians assesse...
PMC10548310
Introduction
dementia, cognitive impairment
DRUG INTERACTIONS, ADVERSE DRUG EVENTS, ADVERSE EFFECTS
Deprescribing has been defined in several studiesFurther, these ethical dilemmas related to optimal prescribing arise ubiquitously for clinicians treating people living with dementia who are particularly vulnerable to serious harm from polypharmacy (adverse drug events or drug interactions), treatment burden, and cogni...
PMC10548310
Methods
PMC10548310
Study Design and Sample
We mailed a self-administered 24-question survey entitled “Understanding Physician Deprescribing Decisions” (eMethods in
PMC10548310
Survey Development
The survey was designed around 2 common scenarios in which clinicians may consider deprescribing: situations in which treatment presented an increased risk of an ADE and situations in which treatment would produce limited benefit (
PMC10548310
Clinical Scenarios and Bioethical and Pragmatic Factors for Best-Worst Scaling Questions
fracture, dementia, BWS
ADVERSE DRUG EVENT
Deprescribing scenarios: (1) increased risk of ADE: “There is evidence for increased risk of a serious acute adverse drug event (eg, fall or fracture) that could happen at any time if this drug is continued,” and (2) limited benefit: “There is no evidence of benefit for this medication in the older adult dementia popul...
PMC10548310
Survey Administration and Data Collection
Using the Dillman tailored design method for mailed surveys,
PMC10548310
Statistical Analysis
BWS
REGRESSION
Descriptive statistics were used to present self-reported demographic responses. We performed conditional logit regression to analyze the BWS questions because it is grounded in random utility theory and explains real-world choice behaviors.We also calculated individual best-minus-worst scores based on the difference b...
PMC10548310
Results
PMC10548310
Respondent Characteristics
Of the 3000 invited physicians, 454 were excluded as undeliverable or ineligible (ie, retired, deceased, or no longer practicing medicine); of 2546 who were presumed to receive surveys, 890 physicians returned surveys (511 [57.4%] were male, and the mean [SD] years since graduation was 26.0 [11.7]), giving a response r...
PMC10548310
Survey Flowchart
SECONDARY
The eligibility specified for the 2 random samples were identical. The difference between the denominator for 2 random sample populations is due to the changes/updates to the American Medical Association Physician Masterfile at each date (ie, more physicians becoming eligible at a later date in 2021). Eligible physicia...
PMC10548310
Self-Reported Characteristics of Respondents Included in Analyses
ADVERSE DRUG EVENT
Abbreviation: ADE, adverse drug event.No significant differences were observed between the 2 different survey groups (increased risk of ADE vs limited benefit), and the number of responses varied between 681 and 689 given that some respondents did not answer all questions.
PMC10548310
Relative Importance of 9 Barriers That May Influence a Physician’s Decision to Deprescribe a Medicine in an Older Adult With Moderate Dementia
ADVERSE DRUG EVENT
A phrase was assigned a value of −1 if chosen as the smallest barrier and 1 if chosen as the biggest barrier. We set the smallest barrier (perceived as the least important) as the reference at 1 so that a phrase with a relative preference of 2 means the phrase/barrier was perceived as twice as important compared with t...
PMC10548310
Variability of Perceived Barriers Between Individual Physicians
ADVERSE DRUG EVENT
This figure shows the number of times each phrase/barrier was chosen as the biggest and smallest barrier to deprescribing a medication (across the series of 12 sets of 3 phrases/barriers presented to each respondent) and ranked from biggest (right) to smallest barrier (left). Each phrase/barrier was presented 4 times t...
PMC10548310
Discussion
dementia
We conducted a national survey study exploring how primary care physicians prioritize barriers linked to several ethical and pragmatic considerations when making deprescribing decisions in caring for older individuals living with moderate dementia. To our knowledge, this is the first exploration of how ethical consider...
PMC10548310
Strengths and Limitations
dementia, Alzheimer disease
ADVERSE EFFECTS, ALZHEIMER DISEASE
Our national survey study of physicians had some key strengths. First, the survey used BWS methods to elicit respondent preferences in a complete ranking as compared with Likert scale methods. Second, the survey was conducted and framed around a particularly relevant and vulnerable patient population that is at great r...
PMC10548310
Conclusions
dementia
Understanding ethical aspects of physician decision-making can inform clinician education about medication management and deprescribing decisions for older adults with moderate dementia. This research highlights that clinician education on deprescribing should include shared decision-making to prioritize goals of care ...
PMC10548310
Background
OHCA, cardiac arrest
CARDIAC ARREST
Telephone-Cardiopulmonary Resuscitation (T-CPR) significantly increases rate of bystander resuscitation and improves patient outcomes after out-of-hospital cardiac arrest (OHCA). Nevertheless, securing correct execution of instructions remains a difficulty. ERC Guidelines 2021 recommend standardised instructions with c...
PMC10067171
Methods
OHCA
A simulation study with 48 OHCA scenarios was conducted. In a non-randomised trial study lay rescuers were instructed using the real-life-CPR protocol of the regional dispatch centre and as the intervention a modified T-CPR protocol, including specific check for breathing (head tilt-chin lift instructions). Resuscitati...
PMC10067171
Results
Check for breathing was performed by 64.3% (
PMC10067171
Conclusion
Correct check for breathing seems to be a problem for lay rescuers, which can be decreased by describing the assessment in more detail. Hence, T-CPR protocols should provide standardised explicit instructions on how to perform airway assessment. Each protocol should be evaluated for practicability.
PMC10067171
Keywords
Open Access funding enabled and organized by Projekt DEAL.
PMC10067171
Background
OHCA, cardiac arrest
CARDIAC ARREST
Out-of-hospital cardiac arrest (OHCA) is a worldwide common condition with a global incidence of 83.7/100,000 per year [Instructions to check for breathing prove to be particularly difficult in T-CPR protocols [
PMC10067171
Methods
PMC10067171
Study design
This controlled non-randomised trial was part of the exploratory observational project MV|LIFE|DRONE-Pilot, funded by the German Federal Ministry of Health and approved by the Ethics Committee of Greifswald University (BB124/19). In each simulation, lay rescuers were instructed with T-CPR to resuscitate.
PMC10067171
Participants
OHCA
The lay rescuers were recruited through media as well as word-of-mouth communication. Participation in the study and the collection of anonymous data was based on obtaining written informed consent from all participants. Lay rescuers were informed they would encounter a simulated OHCA and would have to resuscitate for ...
PMC10067171
Measurement and data sources
chest compression
EVENT
The simulation room was equipped with two cameras, which recorded every event in image and sound. The execution of each step of the dispatcher's instructions was measured categorically by analysing the simulation videos. To investigate the impact of the wording of check for breathing instruction the original T-CPR prot...
PMC10067171
Bias
During the scenarios T-CPR was instructed by an emergency physician, who had been trained in T-CPR by a dispatcher before the first session of the study. To avoid bias the simulated dispatcher was not aware of the study hypothesis and was located in a different room. He did not see the rescuers and communication was po...
PMC10067171
Study size
Sample size of our study (
PMC10067171
Statistical methods
®
Statistical evaluation were performed with SPSS® Statistics Version 27 (IBM Corporation Armonk, New-York, USA). Graphs were created using Prism 9® (GraphPad Software Inc., Boston, USA). Descriptive representation of nominal variables is presented with numbers (n) and valid percentages (%). Normal distribution was deter...
PMC10067171
Results
A total of 48 resuscitation simulations with 48 lay rescuers were conducted. Because of missing SimPad® data and discontinuation of the simulation by participants, seven simulations had to be excluded. As a result, 41 simulations were available for analysis.The anonymous survey which followed the simulation was not com...
PMC10067171
Quality of execution of T-CPR instructions
Table Execution of the T-CPR instructions
PMC10067171
Quality of chest compressions
Specified, Specified Chest compression
The mean chest compression rate did not differ significantly between groups and was 103.1 ± 14.0 bpm in the intervention group and 91.5 ± 17.2 bpm in the original wording group (CPR-QualityInitialOriginal Specified 0 – 1 MinOriginal Specified 1 – 2 MinOriginal Specified 2 – 3 MinOriginal Specified TotalOriginal Specifi...
PMC10067171
Discussion
PMC10067171
Quality of execution of T-CPR instructions
SECONDARY
Significantly fewer lay rescuers (64.3%) performed a check for breathing in the original wording group in comparison with the specified instruction (92.6%) asking for head tilt-chin lift. In the intervention group the head tilt-chin lift manoeuvre was performed significantly more often and the time duration for check f...
PMC10067171
Quality of CPR
chest compression
The mean chest compression frequency did not differ significantly between both groups. Plata et al. also showed non-guideline compliant chest compression frequencies in a randomised controlled simulated T-CPR manikin trial with 78 bpm [The average compression depth over the entire time was lower in the original wording...
PMC10067171
Limitation
OHCA, cardiac arrest
CARDIAC ARREST
The foremost limitation results from the chosen study design, which is a non-randomized simulation trial. The present study was part of a large feasibility study. Due to this, randomisation was not possible. The study design as a non-randomised trial study is a limitation. We have to assume that mainly participants wit...
PMC10067171
Conclusions
chest compression
Most of the instructions given in the T-CPR protocol were executed adequately. However, check of consciousness was a difficulty for the participants in the original wording group. With the specified wording including head tilt-chin lift instructions check for breathing was carried out significantly more adequately. It ...
PMC10067171
Acknowledgements
We would like to thank Dr Karl Thies, Dr Tobias Kozlowski and Dr Jan Bartels for their medical and technical support in carrying out the study. We especially thank all the study participants.
PMC10067171
Authors’ contributions
CM
MB has contributed to: Conceptualisation, Methodology, Investigation, Project administration, Funding acquisition, Review and Editing. KH has contributed to: Conceptualisation and Funding acquisition. CM, BM and PB have contributed to: Methodology, Review and Editing. CRH has contributed to: Methodology, Formal analysi...
PMC10067171
Funding
Open Access funding enabled and organized by Projekt DEAL. The project MV|LIFE|DRONE-Pilot was funded by the German Federal Department of Health (ZMVI1-2519FEP006). The study sponsor was not involved in the study design, collection, analysis, interpretation of data or the writing of the manuscript and the decision to s...
PMC10067171
Availability of data and materials
The datasets used and analysed during the current study are available from the corresponding author on reasonable request.
PMC10067171
Declarations
PMC10067171
Ethics approval and consent to participate
All methods were carried out in accordance with the relevant guidelines and regulations and all participants submitted their informed consent in written form. The ethics committee of University Greifswald approved the study on 2019–09-26 (BB124/19).
PMC10067171
Consent for publication
Not applicable.
PMC10067171
Competing interests
The authors declare that they have no competing interests.
PMC10067171
References
PMC10067171
Background
ambulatory diabetes, hypertensive
Medication reconciliation is an evidence-based practice that reduces medication-related harm to patients. This study evaluated the effect of educational intervention on medication reconciliation practice of pharmacists among ambulatory diabetes and hypertensive patients.
PMC10652589
Methods
hypertensive, intervention-46, diabetes
DIABETES
A non-randomized clinical trial on medication reconciliation practice was carried out among 85 and 61 pharmacists at the intervention site and control site, respectively. Medication reconciliation was carried out among 334 (intervention-183; control-151) diabetes and/or hypertensive patients by the principal investigat...
PMC10652589