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PloS One 2024The thoracic surgical procedure leads to a reduction in respiratory muscle strength. To restore it, certain strategies must be employed. Physiotherapy utilizes resources... (Randomized Controlled Trial)
Randomized Controlled Trial
INTRODUCTION
The thoracic surgical procedure leads to a reduction in respiratory muscle strength. To restore it, certain strategies must be employed. Physiotherapy utilizes resources and techniques such as deep breathing stimulation, cough stimulation, use of incentive spirometers, mobilization, and ambulation. However, at times these resources and techniques may prove insufficient, and additional measures, such as Non-Invasive Ventilation (NIV), are employed Pieczkoski (2017). Non-Invasive Positive Pressure Ventilation (NPPV) has been utilized to expedite pulmonary function recovery as well as to prevent and treat postoperative pulmonary complications Nasrala 2018. NIV diminishes the risk of ventilator-associated complications due to its non-invasive nature. Consequently, NIV has been adopted to avert post-extubation complications in postoperative patients Liu 2020. The objective of this study is to conduct a randomized clinical trial and assess the efficacy of NIV in comparison to conventional physiotherapy in terms of pulmonary function among patients undergoing cardiac surgery at a selected hospital in Campina Grande, Paraíba, Brazil.
METHODS AND ANALYSES
This randomized, controlled, double-blind (patient and analyst) clinical trial will be conducted at Hospital João XXIII in Campina Grande, Paraíba, Brazil. Patients do not know which group they are allocated to. Those in the group that use CPAP or BIPAP will not be able to distinguish one from the other. The data analyst at the end of the collections will also be blinded. Only the health professional who will be applying the protocol cannot be blinded. The sample size, determined via sample calculation, yielded a total of 21 patients per group (63 patients). The patients will be allocated into 3 groups (CPAP group - CPAP + standard physiotherapy, BiPAP group - BiPAP + standard physiotherapy, and Control group - standard physiotherapy) in a 1:1:1 allocation ratio. The control group will receive the usual physiotherapeutic treatment as per the kinesiotherapy protocol. The treatment will be administered twice daily, starting in the ICU and progressing to the ward. In the CPAP group, nasal CPAP at 10cmH2O will be administered for 1 hour, twice daily, using an approved device. In the BiPAP group, nasal BiPAP with an IPAP of 13cmH2O and EPAP of 8cmH2O will be administered for 1 hour, twice daily, using an approved device. The NIV sessions will be conducted over the course of 5 days of hospitalization, both in the ICU and the ward. Assessments will be conducted at two time points: on day 1 preoperatively and on day 5 postoperatively. The following measures will be evaluated: pulmonary function, length of hospital stay, presence of postoperative pulmonary complications, score of the Minnesota Living with Heart Failure Questionnaire (MLHFQ) in its Portuguese version, functional capacity, the Global Perception of Change Scale, and the Functional Independence Measure (MIF). The normality of variables will be assessed using the Shapiro-Wilk test. IBM SPSS Statistics Base 25.0, using the Shapiro-Wilk test for normality and paired Student's t-test for pre-post intervention comparison. They will use linear mixed effects models for longitudinal analysis and GLMMs to compare NIV effects over time between groups. They will employ ITT for missing data, INAR models for time dependence, fixed effects models for endogeneity, and Cohen's d for effect sizes. Parametric model assumptions will be checked, and various models will be considered for data characteristics.
PRIMARY OUTCOMES
Pulmonary function, Length of hospital stay.
SECOND OUTCOMES
Score of the Minnesota Living with Heart Failure Questionnaire (MLHFQ) in Portuguese version, Funcional capacity, The global perception of change scale, The functional independence measure (MIF), pO2 (partial pressure of oxygen), pCO2 (partial pressure of carbon dioxide), HCO3 (bicarbonate), Arterial Oxygen Saturation (SaO2), Base Excess (BE), Presence of lung complications.
OTHER PRE-SPECIFIED OUTCOMES
Duration of cardiopulmonary bypass, type of surgery, personal history, preoperative ejection fraction, previous respiratory complications, body mass index (BMI), gender and age.
TRIAL REGISTRATION
Trial register number NCT05966337.
Topics: Humans; Noninvasive Ventilation; Cardiac Surgical Procedures; Double-Blind Method; Postoperative Complications; Randomized Controlled Trials as Topic; Male; Physical Therapy Modalities; Brazil; Female
PubMed: 38889140
DOI: 10.1371/journal.pone.0304569 -
Journal of Pharmacy & Bioallied Sciences Apr 2024To assess the dentist perception of efficiency, treatment outcome, and stability of the tooth movement treated with mysmartalign clear aligner therapy (MSA CAT).
AIM AND OBJECTIVE
To assess the dentist perception of efficiency, treatment outcome, and stability of the tooth movement treated with mysmartalign clear aligner therapy (MSA CAT).
MATERIALS AND METHOD
A cross-sectional web-based questionnaire survey was carried out to evaluate the dentist perception of MYSMARTALIGN (MSA). To determine the sample size, a pilot study has been carried out and the final sample arrived was 4990 subjects. The current study's inclusion criteria took into account those who had finished their BDS and MDS as well as dentists and orthodontists who had been using the MSA CAT system on their patients for the previous 7 years.
RESULTS
The result of the study showed that most research participants (3650) used MSA to treat mild to moderate malocclusion, and 3996 participants said that initial digital treatment plans have been authorised with no revisions. In view of efficiency, 3894 doctors were satisfied with the final outcome.
CONCLUSIONS
Finally concluded that recent survey showed that dentists were very satisfied with the effectiveness and treatment results of the MSA clear aligner procedure.
PubMed: 38882901
DOI: 10.4103/jpbs.jpbs_1095_23 -
Journal of Pharmacy & Bioallied Sciences Apr 2024The current purpose of the survey is to completely evaluate parents' attitudes, knowledge, and perceptions of myofunctional appliances.
AIM
The current purpose of the survey is to completely evaluate parents' attitudes, knowledge, and perceptions of myofunctional appliances.
MATERIALS AND METHODS
Parents in Chennai participated in this cross-sectional web-based questionnaire survey. Pilot study was carried out to determine the sample size, and 500 individuals were the final sample size. The 10 organized, predesigned, and validated questions are on awareness of myofunctional appliance.
RESULTS
The result of the survey showed that in 500 subjects, 79.8% were aware of skeletal problems. The proportion of parents willing to recommend the use of such treatments is about 70%, while 69% believe that myofunctional appliances are important in correcting skeletal problems.
CONCLUSION
The present study has established that most parents know about the functional appliance and have an understanding of how to distinguish between skeletal problems. In order to diagnose skeletal issues in an appropriate age range for the individual, more awareness about appliances is necessary and needs to be developed.
PubMed: 38882836
DOI: 10.4103/jpbs.jpbs_953_23 -
Ophthalmology Science 2024To assess the efficacy and safety of the PRIMA neurostimulation system with a subretinal microchip for improving visual acuity (VA) in patients with geographic atrophy...
OBJECTIVE
To assess the efficacy and safety of the PRIMA neurostimulation system with a subretinal microchip for improving visual acuity (VA) in patients with geographic atrophy (GA) due to age-related macular degeneration (AMD) at 48-months postimplantation.
DESIGN
Feasibility clinical trial of the PRIMA subretinal prosthesis in patients with atrophic AMD, measuring best-corrected ETDRS VA (Clinicaltrials.govNCT03333954).
SUBJECTS
Five patients with GA, no foveal light perception, and VA of logarithm of the minimum angle of resolution (logMAR) 1.3 to 1.7 (20/400-20/1000) in their worse-seeing "study" eye.
METHODS
In patients subretinally implanted with a photovoltaic neurostimulation array containing 378 pixels of 100 μm in size, the VA was measured with and without the PRIMA system using ETDRS charts at 1 m. The system's external components, augmented reality glasses, and pocket computer provide image processing capabilities, including zoom.
MAIN OUTCOME MEASURES
Visual acuity using ETDRS charts with and without the system, as well as light sensitivity in the central visual field, measured by Octopus perimetry. Anatomical outcomes demonstrated by fundus photography and OCT up to 48 months postimplantation.
RESULTS
All 5 subjects met the primary end point of light perception elicited by the implant in the scotoma area. In 1 patient, the implant was incorrectly inserted into the choroid. One subject died 18 months postimplantation due to study-unrelated reasons. ETDRS VA results for the remaining 3 subjects are reported here. Without zoom, VA closely matched the pixel size of the implant: 1.17 ± 0.13 pixels, corresponding to a mean logMAR of 1.39, or Snellen of 20/500, ranging from 20/438 to 20/565. Using zoom at 48 months, subjects improved their VA by 32 ETDRS letters versus baseline (standard error 5.1) 95% confidence intervals (13.4, 49.9; < 0.0001). Natural peripheral visual function in the treated eye did not decline after surgery or during the 48-month follow-up period ( = 0.08).
CONCLUSIONS
Subretinal implantation of PRIMA in subjects with GA experiencing profound vision loss due to AMD is feasible and well tolerated, with no reduction of natural peripheral vision up to 48 months. Prosthetic central vision provided by photovoltaic neurostimulation enabled patients to reliably recognize letters and sequences of letters, and with zoom, it improved VA of up to 8 ETDRS lines.
FINANCIAL DISCLOSURES
Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.
PubMed: 38881600
DOI: 10.1016/j.xops.2024.100510 -
Frontiers in Psychology 2024How does the human visual system assess the separation between pairs of stimuli in a frontal plane? According to the (or subtractive) view the system finds the...
How does the human visual system assess the separation between pairs of stimuli in a frontal plane? According to the (or subtractive) view the system finds the difference between the positions of the stimuli in a localization system. According to the (or additive) view the system finds the number of instances of a distance unit lying between representations of the stimuli. Critically, position is explicitly represented under the direct view, with separation being derived from position. Position is not explicitly represented under the indirect view; separation is consequently inferred by counting an internal unit of distance. Recent results favor the indirect over the direct view of separation assessment. Dissociations between assessments of separation and position, various context effects in the assessment of separation, and suggestions that position information is not cleanly accessed argue against the direct view. At the same time, various context effects in separation assessment argue for the indirect view. Recent findings regarding the brain bases of vision are consistent with the indirect view. In short, recent results suggest that assessing the separation between two frontal stimuli involves integrating distance units between representations of the stimuli.
PubMed: 38873519
DOI: 10.3389/fpsyg.2024.1410297 -
Trials Jun 2024The TRANSLATE (TRANSrectal biopsy versus Local Anaesthetic Transperineal biopsy Evaluation) trial assesses the clinical and cost-effectiveness of two biopsy procedures...
Statistical analysis plan for the TRANSLATE (TRANSrectal biopsy versus Local Anaesthetic Transperineal biopsy Evaluation of potentially clinically significant prostate cancer) multicentre randomised controlled trial.
BACKGROUND
The TRANSLATE (TRANSrectal biopsy versus Local Anaesthetic Transperineal biopsy Evaluation) trial assesses the clinical and cost-effectiveness of two biopsy procedures in terms of detection of clinically significant prostate cancer (PCa). This article describes the statistical analysis plan (SAP) for the TRANSLATE randomised controlled trial (RCT).
METHODS/DESIGN
TRANSLATE is a parallel, superiority, multicentre RCT. Biopsy-naïve men aged ≥ 18 years requiring a prostate biopsy for suspicion of possible PCa are randomised (computer-generated 1:1 allocation ratio) to one of two biopsy procedures: transrectal (TRUS) or local anaesthetic transperineal (LATP) biopsy. The primary outcome is the difference in detection rates of clinically significant PCa (defined as Gleason Grade Group ≥ 2, i.e. any Gleason pattern ≥ 4 disease) between the two biopsy procedures. Secondary outcome measures are th eProBE questionnaire (Perception Part and General Symptoms) and International Index of Erectile Function (IIEF, Domain A) scores, International Prostate Symptom Score (IPSS) values, EQ-5D-5L scores, resource use, infection rates, complications, and serious adverse events. We describe in detail the sample size calculation, statistical models used for the analysis, handling of missing data, and planned sensitivity and subgroup analyses. This SAP was pre-specified, written and submitted without prior knowledge of the trial results.
DISCUSSION
Publication of the TRANSLATE trial SAP aims to increase the transparency of the data analysis and reduce the risk of outcome reporting bias. Any deviations from the current SAP will be described and justified in the final study report and results publication.
TRIAL REGISTRATION
International Standard Randomised Controlled Trial Number ISRCTN98159689, registered on 28 January 2021 and registered on the ClinicalTrials.gov (NCT05179694) trials registry.
Topics: Humans; Male; Prostatic Neoplasms; Biopsy; Multicenter Studies as Topic; Anesthesia, Local; Data Interpretation, Statistical; Cost-Benefit Analysis; Neoplasm Grading; Perineum; Randomized Controlled Trials as Topic; Equivalence Trials as Topic; Prostate; Rectum; Predictive Value of Tests
PubMed: 38872174
DOI: 10.1186/s13063-024-08224-4 -
Scientific Reports Jun 2024Previous studies have identified differences in sensitivity characteristics between color discrimination and perception of suprathreshold color differences. However, it...
Previous studies have identified differences in sensitivity characteristics between color discrimination and perception of suprathreshold color differences. However, it remains highly unclear how color difference sensitivity changes with increasing magnitudes of color difference along various color hues. This study aimed to quantify the sensitivity transition across various magnitudes of color differences and uncover the underlying mechanisms. Color discrimination sensitivities were measured using an adaptive staircase method for 32 isoluminant pedestal colors in the u'v' chromaticity diagram. For suprathreshold color differences, we employed the Maximum Likelihood Difference Scaling (MLDS) method to measure sensitivity to various color difference levels for the same 32 colors. Our findings confirmed the differences in sensitivity characteristics between discrimination and suprathreshold color difference perception. Furthermore, we observed increased sensitivities at many color category boundaries in suprathreshold color difference perception. By investigating the relation between the category effects and the color difference size levels through a model simulation, our findings suggest that the influence of color categories on the perception of color differences may become more pronounced as the magnitude of color differences increases.
PubMed: 38871867
DOI: 10.1038/s41598-024-64215-0 -
ENeuro Jun 2024In human adults, multiple cortical regions respond robustly to faces, including the occipital face area (OFA) and fusiform face area (FFA), implicated in face...
In human adults, multiple cortical regions respond robustly to faces, including the occipital face area (OFA) and fusiform face area (FFA), implicated in face perception, and the superior temporal sulcus (STS) and medial prefrontal cortex (MPFC), implicated in higher level social functions. When in development does face selectivity arise in each of these regions? Here, we combined two awake infant functional magnetic resonance imaging (fMRI) datasets to create a sample size twice the size of previous reports (n = 65 infants, 2.6-9.6 months). Infants watched movies of faces, bodies, objects, and scenes while fMRI data were collected. Despite variable amounts of data from each infant, individual subject whole-brain activation maps revealed responses to faces compared to non-face visual categories in the approximate location of OFA, FFA, STS, and MPFC. To determine the strength and nature of face selectivity in these regions, we used cross-validated functional region of interest (fROI) analyses. Across this larger sample size, face responses in OFA, FFA, STS, and MPFC were significantly greater than responses to bodies, objects, and scenes. Even the youngest infants (2-5 months) showed significantly face-selective responses in FFA, STS, and MPFC, but not OFA. These results demonstrate that face selectivity is present in multiple cortical regions within months of birth, providing powerful constraints on theories of cortical development. Social cognition often begins with face perception. In adults, several cortical regions respond robustly to faces, yet little is known about when and how these regions first arise in development. To test whether face selectivity changes in the first year of life, we combined two datasets, doubling the sample size relative to previous reports. In the approximate location of the fusiform face area (FFA), superior temporal sulcus (STS), and medial prefrontal cortex (MPFC) but not occipital face area (OFA), face selectivity was present in the youngest group. These findings demonstrate that face-selective responses are present across multiple lobes of the brain very early in life.
PubMed: 38871455
DOI: 10.1523/ENEURO.0117-24.2024 -
PloS One 2024This study examined land use land cover change and its determinants in Tigray, Ethiopia and its livelihood zones. We used socioeconomic panel, and satellite data, and...
This study examined land use land cover change and its determinants in Tigray, Ethiopia and its livelihood zones. We used socioeconomic panel, and satellite data, and applied a mixed-effects model to analyse the factors influencing land allocation among different uses, and transition matrix to analyse land cover dynamics. The results revealed that; land use choices were influenced by plot level factors (such as plot elevation, distance, soil type and quality, and land tenure), household characteristics (such as education, dependency ratio, plot size and number owned, income, livestock and asset, perception of climate change, and access to market and main road), and community level factors (precipitation, product price, population density and livelihood zone variations). Transition matrix analysis showed that between 1986 and 2016, 12.8% of forest was converted to bare land, 6.26% bare land was converted to pasture, and 5.84% of cropland was converted to forest. However, net deforestation occurred in most of the livelihood zones. Therefore, local communities faced environmental and socio-economic challenges from capital constraints induced land fallowing, land fragmentation, and unmanaged land cover change. The study recommended sustainable land use planning and management, market linkages, improved access to roads, forestry subsidies, land tenure security, and land consolidation programs.
Topics: Ethiopia; Conservation of Natural Resources; Socioeconomic Factors; Humans; Forests; Agriculture; Climate Change
PubMed: 38870199
DOI: 10.1371/journal.pone.0304896 -
Frontiers in Psychiatry 2024Childhood sexual abuse persists as a painful societal reality, necessitating responses from institutions and healthcare professionals to prevent and address its severe...
Psychological intervention in women victims of childhood sexual abuse: a randomized controlled clinical trial comparing EMDR psychotherapy and trauma-focused cognitive behavioral therapy.
INTRODUCTION
Childhood sexual abuse persists as a painful societal reality, necessitating responses from institutions and healthcare professionals to prevent and address its severe long-term consequences in victims. This study implements an intervention comprising two psychotherapeutic approaches recommended by the WHO and international clinical guidelines for addressing short-, medium-, and long-term posttraumatic symptomatology: Trauma-Focused Cognitive Behavioral Therapy (TF-CBT) and Eye Movement Desensitization and Reprocessing (EMDR). Both approaches are adapted from group formats for implementation in small online groups via Zoom.
METHODS
The impact of both therapeutic approaches on trauma improvement was assessed in a sample of 19 women who were victims of childhood sexual abuse through a Randomized Clinical Trial comparing EMDR Psychotherapy and Trauma-Focused Cognitive Behavioral Therapy after a baseline period. Intra and inter comparison were made using statistics appropriate to the sample.
RESULTS
Both therapeutic approaches significantly reduced symptomatology across various evaluated variables, suggesting their efficacy in improving the quality of life for these individuals. Following CBT-FT treatment, patients exhibited enhanced emotional regulation, reduced reexperiencing, and avoidance. The EMDR group, utilizing the G-TEP group protocol, significantly improved dissociation, along with other crucial clinical variables and the perception of quality of life.
DISCUSSION
Although the limitations of this study must be taken into account due to the size of the sample and the lack of long-term follow-up, the results align with existing scientific literature, underscoring the benefits of trauma-focused psychological treatments. The online group format appears promising for enhancing the accessibility of psychological treatment for these women. Furthermore, the differential outcomes of each treatment support recent research advocating for the inclusion of both approaches for individuals with trauma-related symptomatology.
ETHICS AND DISSEMINATION
The study has been approved by the Ethics Committee of the Valencian International University (VIU) (Valencia, Spain) (Ref. CEID2021_07). The results will be submitted for publication in peer-reviewed journals and disseminated to the scientific community.
CLINICAL TRIAL REGISTRATION
https://clinicaltrials.gov/ct2/show/NCT04813224, identifier NCT04813224.
PubMed: 38868491
DOI: 10.3389/fpsyt.2024.1360388