PeerJ:Clinical Trialshttps://peerj.com/articles/index.atom?journal=peerj&subject=3630Clinical Trials articles published in PeerJThe application of two drainage angles in neurocritical care patients with complicated pneumonia: a randomized controlled trialhttps://peerj.com/articles/169972024-02-292024-02-29Anna ZhaoHuangrong ZengHui YinJinlin WangWenming YuanChao LiYan ZhongLanlan MaChongmao LiaoHong ZengYan Li
Background
Although head elevation is an early first-line treatment for elevated intracranial pressure (ICP), the use of the head-down or prone position in managing neurocritical patients is controversial because a change in a position directly affects the intracranial and cerebral perfusion pressure, which may cause secondary brain injury and affect patient outcomes. This study compared the effects of two postural drainage positions (30° head-up tilt and 0° head flat) on the prognosis of neurocritical care patients with complicated pneumonia and a clinical pulmonary infection score (CPIS) ≥5 points to provide a reference for selecting appropriate postural drainage positions for patients with pneumonia in neurocritical care units.
Methods
A prospective randomized controlled study was conducted with 62 neurocritical care patients with complicated pneumonia. The patients were categorized into control (=31) and experimental (=31) groups in a 1:1 ratio using a simple randomized non-homologous pairing method. Emphasis was placed on matching the baseline characteristics of the two groups, including patient age, sex, height, weight, Glasgow Coma Scale score, heart rate, mean arterial pressure, cough reflex, and mechanical ventilation usage to ensure comparability. Both groups received bundled care for artificial airway management. The control group maintained a standard postural drainage position of 0° head-flat, whereas the experimental group maintained a 30° head-up tilt. The efficacy of the nursing intervention was evaluated by comparing the CPIS and other therapeutic indicators between the two groups after postural drainage.
Results
After the intervention, the within-group comparison showed a significant decrease in the CPIS (P < 0.001); procalcitonin levels showed a significant decreasing trend (P < 0.05); the arterial oxygen pressure significantly increased (P < 0.05); the oxygenation index significantly increased (P < 0.001); and the aspiration risk score showed a significant decreasing trend (P < 0.001). A between-group comparison showed no significant differences in any of the indicators before and after the intervention (P < 0.05).
Conclusion
Postural drainage positions of 30° head-up tilt and 0° head-flat can improve the CPIS and oxygenation in patients without adverse effects. Therefore, we recommend that patients under neurological intensive care and having pneumonia be drained in a 30° head-up tilt position with good centralized care of the lung infection.
Trial registration
The study, “Study of Angles of Postural Drainage in Neurocritical Patients with Pneumonia,” was registered in the Protocol Registration Data Element Definitions for Interventional Study database (# ChiCTR2100042155); date of registration: 2021-01-14.
Background
Although head elevation is an early first-line treatment for elevated intracranial pressure (ICP), the use of the head-down or prone position in managing neurocritical patients is controversial because a change in a position directly affects the intracranial and cerebral perfusion pressure, which may cause secondary brain injury and affect patient outcomes. This study compared the effects of two postural drainage positions (30° head-up tilt and 0° head flat) on the prognosis of neurocritical care patients with complicated pneumonia and a clinical pulmonary infection score (CPIS) ≥5 points to provide a reference for selecting appropriate postural drainage positions for patients with pneumonia in neurocritical care units.
Methods
A prospective randomized controlled study was conducted with 62 neurocritical care patients with complicated pneumonia. The patients were categorized into control (=31) and experimental (=31) groups in a 1:1 ratio using a simple randomized non-homologous pairing method. Emphasis was placed on matching the baseline characteristics of the two groups, including patient age, sex, height, weight, Glasgow Coma Scale score, heart rate, mean arterial pressure, cough reflex, and mechanical ventilation usage to ensure comparability. Both groups received bundled care for artificial airway management. The control group maintained a standard postural drainage position of 0° head-flat, whereas the experimental group maintained a 30° head-up tilt. The efficacy of the nursing intervention was evaluated by comparing the CPIS and other therapeutic indicators between the two groups after postural drainage.
Results
After the intervention, the within-group comparison showed a significant decrease in the CPIS (P < 0.001); procalcitonin levels showed a significant decreasing trend (P < 0.05); the arterial oxygen pressure significantly increased (P < 0.05); the oxygenation index significantly increased (P < 0.001); and the aspiration risk score showed a significant decreasing trend (P < 0.001). A between-group comparison showed no significant differences in any of the indicators before and after the intervention (P < 0.05).
Conclusion
Postural drainage positions of 30° head-up tilt and 0° head-flat can improve the CPIS and oxygenation in patients without adverse effects. Therefore, we recommend that patients under neurological intensive care and having pneumonia be drained in a 30° head-up tilt position with good centralized care of the lung infection.
Trial registration
The study, “Study of Angles of Postural Drainage in Neurocritical Patients with Pneumonia,” was registered in the Protocol Registration Data Element Definitions for Interventional Study database (# ChiCTR2100042155); date of registration: 2021-01-14.Effect of dynamic taping on neck pain, disability, and quality of life in patients with chronic non-specific neck pain: a randomized sham-control trialhttps://peerj.com/articles/167992024-01-262024-01-26Mohammad SidiqAksh ChahalBalamurugan JanakiramanFaizan KashooSharad Kumar KediaNeha KashyapRicha Hirendra RaiNeha VyasT.S. VeeragoudhamanKrishna Reddy VajralaMegha YadavShahiduz ZafarSanghamitra JenaMonika SharmaShashank BaranwalMshari AlghadierAbdullah AlhusayniAbdullah AlzahraniVijay Selvan Natarajan
Background
In 2020, 203 million people experienced neck pain, with a higher prevalence in women. By 2050, it is predicted that neck pain will affect 269 million people, representing a 32.5% increase. Physical rehabilitation is often employed for the treatment of chronic non-specific neck pain (CNSNP) and the associated functional loss. Taping is frequently used as an adjunct treatment alongside primary physical rehabilitation. Unlike kinesio tape (KT), the therapeutic benefits of dynamic tape (DT) have not been thoroughly explored and documented in non-athletic conditions. Therefore, the aim of this trial was to determine the effects of DT on pain, disability, and overall well-being in individuals experiencing CNSNP.
Methods
A prospective parallel-group active controlled trial was conducted at a single center, involving 136 patients with CNSNP, randomly allocated in a 1:1 ratio. The sham taping group (STC) received standard physiotherapy care (n = 67) alongside DT without tension, while the dynamic taping group (DTC) (n = 69) underwent standard cervical offloading technique with appropriate tension in addition to standard physiotherapy care. Demographic information and three patient-reported outcome measures (PROMs), namely the Neck Disability Index (NDI), Visual Analogue Scale (VAS), and the World Health Organization—Five Well-Being Index (WHO-5), were collected for each participant at three time points (baseline, four weeks post-taping, and four weeks follow-up).
Results
At baseline, no significant differences were observed between the STC and DTC for any outcome measure. Notably, all three PROMs exhibited a significant improvement from baseline to four weeks post-intervention, with moderate to small effect sizes (NDI ηp2 = 0.21, VAS ηp2 = 0.23, and WHO-55 ηp2 = 0.05). The WHO-5 scores for both groups demonstrated improvement from baseline through follow-up (p < 0.001). The NDI and VAS scores ameliorated from baseline to the four weeks post-taping period, with marginal improvements observed during the four weeks follow-up.
Conclusion
The incorporation of DT as an adjunct to standard physiotherapy care yielded enhancements in pain levels, functional disability, and well-being among patients with CNSNP when compared to the sham group. However, the sustainability of these improvements beyond the taping period lacks statistical significance and warrants further validation.
Background
In 2020, 203 million people experienced neck pain, with a higher prevalence in women. By 2050, it is predicted that neck pain will affect 269 million people, representing a 32.5% increase. Physical rehabilitation is often employed for the treatment of chronic non-specific neck pain (CNSNP) and the associated functional loss. Taping is frequently used as an adjunct treatment alongside primary physical rehabilitation. Unlike kinesio tape (KT), the therapeutic benefits of dynamic tape (DT) have not been thoroughly explored and documented in non-athletic conditions. Therefore, the aim of this trial was to determine the effects of DT on pain, disability, and overall well-being in individuals experiencing CNSNP.
Methods
A prospective parallel-group active controlled trial was conducted at a single center, involving 136 patients with CNSNP, randomly allocated in a 1:1 ratio. The sham taping group (STC) received standard physiotherapy care (n = 67) alongside DT without tension, while the dynamic taping group (DTC) (n = 69) underwent standard cervical offloading technique with appropriate tension in addition to standard physiotherapy care. Demographic information and three patient-reported outcome measures (PROMs), namely the Neck Disability Index (NDI), Visual Analogue Scale (VAS), and the World Health Organization—Five Well-Being Index (WHO-5), were collected for each participant at three time points (baseline, four weeks post-taping, and four weeks follow-up).
Results
At baseline, no significant differences were observed between the STC and DTC for any outcome measure. Notably, all three PROMs exhibited a significant improvement from baseline to four weeks post-intervention, with moderate to small effect sizes (NDI ηp2 = 0.21, VAS ηp2 = 0.23, and WHO-55 ηp2 = 0.05). The WHO-5 scores for both groups demonstrated improvement from baseline through follow-up (p < 0.001). The NDI and VAS scores ameliorated from baseline to the four weeks post-taping period, with marginal improvements observed during the four weeks follow-up.
Conclusion
The incorporation of DT as an adjunct to standard physiotherapy care yielded enhancements in pain levels, functional disability, and well-being among patients with CNSNP when compared to the sham group. However, the sustainability of these improvements beyond the taping period lacks statistical significance and warrants further validation.Reduction of SARS-CoV-2 viral load in saliva after rinsing with mouthwashes containing cetylpyridinium chloride: a randomized clinical studyhttps://peerj.com/articles/150802023-12-182023-12-18Leticia M. BezinelliLuciana CorrêaStephany BeyerstedtMarcella L. FrancoÉrika B. RangelCarlos Guillermo BenítezNelson HamerschlakJoão R.R. PinhoDebora HellerFernanda P. Eduardo
Background
Symptomatic patients with COVID-19 typically have a high SARS-CoV-2 viral load in their saliva. Procedures to reduce the viral load in their oral cavity are important for mitigating the viral transmission.
Methods
This randomized clinical trial investigated the impact of two mouthwashes (0.075% cetylpyridinium chloride plus 0.28% zinc lactate (CPC+Zn) (n = 32), and 0.075% cetylpyridinium chloride (CPC) (n = 31)) on the viral load of SARS-CoV-2 in saliva when compared to the distilled water negative control (n = 32). Saliva was collected before (T0) and after (5 min, T1; 30 min, T2; and 60 min, T3) the intervention. Viral load in saliva was measured by qRT-PCR assays. The data in both groups was normalized for T0 and Negative Control, resulting in fold change values.
Results
CPC+Zn oral solution reduced the viral load in saliva by 6.34-fold at T1, 3.6-fold at T2 and 1.9-fold at T3. Rinsing with the CPC mouthwash reduced the viral load in saliva by 2.5-fold at T1, 1.9-fold at T2 and 2.0-fold at T3.
Conclusion
CPC+Zn mouthwash or with the CPC mouthwash reduced the viral load in saliva of COVID-19 patients immediately after rinsing. These reductions extended up to 60 min.
Background
Symptomatic patients with COVID-19 typically have a high SARS-CoV-2 viral load in their saliva. Procedures to reduce the viral load in their oral cavity are important for mitigating the viral transmission.
Methods
This randomized clinical trial investigated the impact of two mouthwashes (0.075% cetylpyridinium chloride plus 0.28% zinc lactate (CPC+Zn) (n = 32), and 0.075% cetylpyridinium chloride (CPC) (n = 31)) on the viral load of SARS-CoV-2 in saliva when compared to the distilled water negative control (n = 32). Saliva was collected before (T0) and after (5 min, T1; 30 min, T2; and 60 min, T3) the intervention. Viral load in saliva was measured by qRT-PCR assays. The data in both groups was normalized for T0 and Negative Control, resulting in fold change values.
Results
CPC+Zn oral solution reduced the viral load in saliva by 6.34-fold at T1, 3.6-fold at T2 and 1.9-fold at T3. Rinsing with the CPC mouthwash reduced the viral load in saliva by 2.5-fold at T1, 1.9-fold at T2 and 2.0-fold at T3.
Conclusion
CPC+Zn mouthwash or with the CPC mouthwash reduced the viral load in saliva of COVID-19 patients immediately after rinsing. These reductions extended up to 60 min.Psychometric validation of the Ostomy Skin Tool 2.0https://peerj.com/articles/166852023-12-182023-12-18Gregor JemecNana Overgaard HerschendHelle Doré HansenAmy FindleyAbi WilliamsKate SullyTonny KarlsmarkZenia Størling
Background
Peristomal skin complications (PSCs) pose a major challenge for people living with an ostomy. To avoid severe PSCs, it is important that people with an ostomy check their peristomal skin condition on a regular basis and seek professional help when needed.
Aim
To validate a new ostomy skin tool (OST 2.0) that will make regular assessment of the peristomal skin easier.
Methods
Seventy subjects participating in a clinical trial were eligible for the analysis and data used for the validation. Item-level correlation with anchors, inter-item correlations, convergent validity of domains, test-retest reliability, anchor- and distribution-based methods for assessment of meaningful change were all part of the psychometric validation of the tool.
Results
A final tool was established including six patient reported outcome items and automatic assessment of the discolored peristomal area. Follow-up with cognitive debriefing interviews assured that the concepts were considered relevant for people with an ostomy.
Conclusion
The OST 2.0 demonstrated evidence supporting its reliability and validity as an outcome measure to capture both visible and non-visible peristomal skin complications.
Background
Peristomal skin complications (PSCs) pose a major challenge for people living with an ostomy. To avoid severe PSCs, it is important that people with an ostomy check their peristomal skin condition on a regular basis and seek professional help when needed.
Aim
To validate a new ostomy skin tool (OST 2.0) that will make regular assessment of the peristomal skin easier.
Methods
Seventy subjects participating in a clinical trial were eligible for the analysis and data used for the validation. Item-level correlation with anchors, inter-item correlations, convergent validity of domains, test-retest reliability, anchor- and distribution-based methods for assessment of meaningful change were all part of the psychometric validation of the tool.
Results
A final tool was established including six patient reported outcome items and automatic assessment of the discolored peristomal area. Follow-up with cognitive debriefing interviews assured that the concepts were considered relevant for people with an ostomy.
Conclusion
The OST 2.0 demonstrated evidence supporting its reliability and validity as an outcome measure to capture both visible and non-visible peristomal skin complications.Effectiveness of a respiratory rehabilitation program including an inspiration training device versus traditional respiratory rehabilitation: a randomized controlled trialhttps://peerj.com/articles/163602023-12-152023-12-15Zacarías Sánchez-MiláVanesa Abuín-PorrasCarlos Romero-MoralesJaime Almazán-PoloJorge Velázquez Saornil
Background
In the context of COVID-19, respiratory training is vital for the care and recuperation of individuals. Both exercise-based and instrumental respiratory training have been employed as interventions to enhance respiratory function, providing relief from symptoms in those impacted by the virus. The aim of this study was to evaluate the efficacy of two different respiratory rehabilitation programs.
Methods
A total of 200 participants affected with COVID-19 respiratory sequels were recruited, with a block randomization regarding sex to ensure equal and appropriate applicability of the results. An experimental controlled and randomized study was conducted, with participants engaging in a 31 days respiratory rehabilitation program, (a) experimental group, inspiratory training device combined with aerobic exercise and (b) traditional respiratory exercises combined with aerobic exercise.
Results
Both groups improved in cardiorespiratory parameters, with a decrease in systolic and diastolic pressure, dyspnea and lower limbs fatigue, and increased oxygen saturation, 6 min walking distance, diaphragmatic thickness, forced vital capacity, forced expiratory volume during the first second, peak expiratory flow rate, forced inspiratory vital capacity and maximal inspiratory pressure. Comparison between groups showed statistically significant differences in all variables except for oxygen saturation, 6 min walking distance and diaphragmatic thickness. The results of this study support the use of specific inspiration training devices for respiratory rehabilitation in COVID-19 sequels.
Background
In the context of COVID-19, respiratory training is vital for the care and recuperation of individuals. Both exercise-based and instrumental respiratory training have been employed as interventions to enhance respiratory function, providing relief from symptoms in those impacted by the virus. The aim of this study was to evaluate the efficacy of two different respiratory rehabilitation programs.
Methods
A total of 200 participants affected with COVID-19 respiratory sequels were recruited, with a block randomization regarding sex to ensure equal and appropriate applicability of the results. An experimental controlled and randomized study was conducted, with participants engaging in a 31 days respiratory rehabilitation program, (a) experimental group, inspiratory training device combined with aerobic exercise and (b) traditional respiratory exercises combined with aerobic exercise.
Results
Both groups improved in cardiorespiratory parameters, with a decrease in systolic and diastolic pressure, dyspnea and lower limbs fatigue, and increased oxygen saturation, 6 min walking distance, diaphragmatic thickness, forced vital capacity, forced expiratory volume during the first second, peak expiratory flow rate, forced inspiratory vital capacity and maximal inspiratory pressure. Comparison between groups showed statistically significant differences in all variables except for oxygen saturation, 6 min walking distance and diaphragmatic thickness. The results of this study support the use of specific inspiration training devices for respiratory rehabilitation in COVID-19 sequels.Assessing the magnitude of changes from protocol to publication—a survey on Cochrane and non-Cochrane Systematic Reviewshttps://peerj.com/articles/160162023-10-022023-10-02Maximilian SiebertLaura CaquelinMeisser MaderaRoberto Acosta-DigheroFlorian NaudetMarta Roqué
Objective
To explore differences between published reviews and their respective protocols in a sample of 97 non-Cochrane Systematic Reviews (non-CSRs) and 97 Cochrane Systematic Reviews (CSRs) in terms of PICOS (Patients/Population, Intervention, Comparison/Control, Outcome, Study type) elements and the extent to which they were reported.
Study Design and Setting
We searched PubMed and Cochrane databases to identify non-CSRs and CSRs that were published in 2018. We then searched for their corresponding Cochrane or PROSPERO protocols. The published reviews were compared to their protocols. The primary outcome was changes from protocol to review in terms of PICOS elements.
Results
We identified a total of 227 changes from protocol to review in PICOS elements, 1.11 (Standard Deviation (SD), 1.22) changes per review for CSRs and 1.23 (SD, 1.12) for non-CSRs per review. More than half of each sub-sample (54.6% of CSRs and 67.0% of non-CSRs) (Absolute Risk Reduction (ARR) 12.4% [−1.3%; 26.0%]) had changes in PICOS elements. For both subsamples, approximately a third of all changes corresponded to changes related to primary outcomes. Marked differences were found between the sub-samples for the reporting of changes. 95.8% of the changes in PICOS items were not reported in the non-CSRs compared to 42.6% in the CSRs (ARR 53.2% [43.2%; 63.2%]).
Conclusion
CSRs showed better results than non-CSRs in terms of the reporting of changes. Reporting of changes from protocol needs to be promoted and requires general improvement. The limitations of this study lie in its observational design. Registration: https://osf.io/6j8gd/.
Objective
To explore differences between published reviews and their respective protocols in a sample of 97 non-Cochrane Systematic Reviews (non-CSRs) and 97 Cochrane Systematic Reviews (CSRs) in terms of PICOS (Patients/Population, Intervention, Comparison/Control, Outcome, Study type) elements and the extent to which they were reported.
Study Design and Setting
We searched PubMed and Cochrane databases to identify non-CSRs and CSRs that were published in 2018. We then searched for their corresponding Cochrane or PROSPERO protocols. The published reviews were compared to their protocols. The primary outcome was changes from protocol to review in terms of PICOS elements.
Results
We identified a total of 227 changes from protocol to review in PICOS elements, 1.11 (Standard Deviation (SD), 1.22) changes per review for CSRs and 1.23 (SD, 1.12) for non-CSRs per review. More than half of each sub-sample (54.6% of CSRs and 67.0% of non-CSRs) (Absolute Risk Reduction (ARR) 12.4% [−1.3%; 26.0%]) had changes in PICOS elements. For both subsamples, approximately a third of all changes corresponded to changes related to primary outcomes. Marked differences were found between the sub-samples for the reporting of changes. 95.8% of the changes in PICOS items were not reported in the non-CSRs compared to 42.6% in the CSRs (ARR 53.2% [43.2%; 63.2%]).
Conclusion
CSRs showed better results than non-CSRs in terms of the reporting of changes. Reporting of changes from protocol needs to be promoted and requires general improvement. The limitations of this study lie in its observational design. Registration: https://osf.io/6j8gd/.Pathway2Targets: an open-source pathway-based approach to repurpose therapeutic drugs and prioritize human targetshttps://peerj.com/articles/160882023-09-292023-09-29Mauri Dobbs SpendloveTrenton M. GibsonShaney McCainBenjamin C. StoneTristan GillBrett E. Pickett
Background
Recent efforts to repurpose existing drugs to different indications have been accompanied by a number of computational methods, which incorporate protein-protein interaction networks and signaling pathways, to aid with prioritizing existing targets and/or drugs. However, many of these existing methods are focused on integrating additional data that are only available for a small subset of diseases or conditions.
Methods
We have designed and implemented a new R-based open-source target prioritization and repurposing method that integrates both canonical intracellular signaling information from five public pathway databases and target information from public sources including OpenTargets.org. The Pathway2Targets algorithm takes a list of significant pathways as input, then retrieves and integrates public data for all targets within those pathways for a given condition. It also incorporates a weighting scheme that is customizable by the user to support a variety of use cases including target prioritization, drug repurposing, and identifying novel targets that are biologically relevant for a different indication.
Results
As a proof of concept, we applied this algorithm to a public colorectal cancer RNA-sequencing dataset with 144 case and control samples. Our analysis identified 430 targets and ~700 unique drugs based on differential gene expression and signaling pathway enrichment. We found that our highest-ranked predicted targets were significantly enriched in targets with FDA-approved therapeutics for colorectal cancer (p-value < 0.025) that included EGFR, VEGFA, and PTGS2. Interestingly, there was no statistically significant enrichment of targets for other cancers in this same list suggesting high specificity of the results. We also adjusted the weighting scheme to prioritize more novel targets for CRC. This second analysis revealed epidermal growth factor receptor (EGFR), phosphoinositide-3-kinase (PI3K), and two mitogen-activated protein kinases (MAPK14 and MAPK3). These observations suggest that our open-source method with a customizable weighting scheme can accurately prioritize targets that are specific and relevant to the disease or condition of interest, as well as targets that are at earlier stages of development. We anticipate that this method will complement other approaches to repurpose drugs for a variety of indications, which can contribute to the improvement of the quality of life and overall health of such patients.
Background
Recent efforts to repurpose existing drugs to different indications have been accompanied by a number of computational methods, which incorporate protein-protein interaction networks and signaling pathways, to aid with prioritizing existing targets and/or drugs. However, many of these existing methods are focused on integrating additional data that are only available for a small subset of diseases or conditions.
Methods
We have designed and implemented a new R-based open-source target prioritization and repurposing method that integrates both canonical intracellular signaling information from five public pathway databases and target information from public sources including OpenTargets.org. The Pathway2Targets algorithm takes a list of significant pathways as input, then retrieves and integrates public data for all targets within those pathways for a given condition. It also incorporates a weighting scheme that is customizable by the user to support a variety of use cases including target prioritization, drug repurposing, and identifying novel targets that are biologically relevant for a different indication.
Results
As a proof of concept, we applied this algorithm to a public colorectal cancer RNA-sequencing dataset with 144 case and control samples. Our analysis identified 430 targets and ~700 unique drugs based on differential gene expression and signaling pathway enrichment. We found that our highest-ranked predicted targets were significantly enriched in targets with FDA-approved therapeutics for colorectal cancer (p-value < 0.025) that included EGFR, VEGFA, and PTGS2. Interestingly, there was no statistically significant enrichment of targets for other cancers in this same list suggesting high specificity of the results. We also adjusted the weighting scheme to prioritize more novel targets for CRC. This second analysis revealed epidermal growth factor receptor (EGFR), phosphoinositide-3-kinase (PI3K), and two mitogen-activated protein kinases (MAPK14 and MAPK3). These observations suggest that our open-source method with a customizable weighting scheme can accurately prioritize targets that are specific and relevant to the disease or condition of interest, as well as targets that are at earlier stages of development. We anticipate that this method will complement other approaches to repurpose drugs for a variety of indications, which can contribute to the improvement of the quality of life and overall health of such patients.An observational study on the adherence to study registrations in German interventional and observational studies from various fieldshttps://peerj.com/articles/160152023-09-252023-09-25Christian ThieleGerrit Hirschfeld
Background
The registration of studies, especially in the case of clinical trials, is required by the declaration of Helsinki and the policies of various scientific journals. However, numerous analyses have found considerable discrepancies between published articles and accompanying trial registrations. The aim of this study is to assess such discrepancies for a sample of studies with recruiting locations in Germany. Additionally, the association between the adherence to registrations and possible involvement of Coordinating Centers for Clinical Studies (KKS) as well as Universities of Excellence was tested.
Methods
For a sample of 376 interventional or observational study registrations, we found 115 published articles. Subsequently, we searched for discrepancies in the study design, the key inclusion criteria, the interventions, the blinding, and a primary and a secondary outcome.
Results
We found discrepancies in 26% of all studies, most frequently in the secondary outcomes, where 16.5% of the secondary outcomes per study that were registered in most detail had discrepancies. When running regression models for adherence discrepancies, the only variable that had a statistically significant association with better adherence was registration on ClinicalTrials.gov. The association of potential involvement of a KKS with adherence ratings was positive, too, but statistically insignificant.
Conclusions
In summary, the amount of discrepancies between registrations and published articles remains elevated.
Background
The registration of studies, especially in the case of clinical trials, is required by the declaration of Helsinki and the policies of various scientific journals. However, numerous analyses have found considerable discrepancies between published articles and accompanying trial registrations. The aim of this study is to assess such discrepancies for a sample of studies with recruiting locations in Germany. Additionally, the association between the adherence to registrations and possible involvement of Coordinating Centers for Clinical Studies (KKS) as well as Universities of Excellence was tested.
Methods
For a sample of 376 interventional or observational study registrations, we found 115 published articles. Subsequently, we searched for discrepancies in the study design, the key inclusion criteria, the interventions, the blinding, and a primary and a secondary outcome.
Results
We found discrepancies in 26% of all studies, most frequently in the secondary outcomes, where 16.5% of the secondary outcomes per study that were registered in most detail had discrepancies. When running regression models for adherence discrepancies, the only variable that had a statistically significant association with better adherence was registration on ClinicalTrials.gov. The association of potential involvement of a KKS with adherence ratings was positive, too, but statistically insignificant.
Conclusions
In summary, the amount of discrepancies between registrations and published articles remains elevated.Effects of home-based telerehabilitation on dynamic alterations in regional intrinsic neural activity and degree centrality in stroke patientshttps://peerj.com/articles/159032023-09-012023-09-01Jing ChenJing LiFenglei QiaoZhang ShiWeiwei Lu
Objective
To explore the effects of home-based telerehabilitation (TR) on dynamic alterations in regional intrinsic neural activity and degree centrality in stroke patients by resting-state functional MRI (fMRI) methods.
Methods
The neuroimaging data of 52 stroke patients were analyzed. Dynamic regional spontaneous neural activity (dynamic amplitude of low-frequency fluctuations, dALFF; and dynamic regional homogeneity, dReHo) and dynamic degree centrality (dDC) were compared between the TR and conventional rehabilitation (CR) groups. A flexible factorial model was employed to investigate the expected effects.
Results
The patients in the TR group showed increased dALFF in the right precuneus and bilateral precentral gyrus (PreCG) and reduced dALFF in the right inferior parietal lobule by the analysis of main effects. Significant differences between groups were detected in the right precuneus, right fusiform gyrus and left middle frontal gyrus for dReHo and in the left cingulate gyrus, right middle temporal gyrus and left precuneus for dDC. A significant correlation was found in the TR group between the changed dALFF in the left PreCG and the changed Fugl-Meyer assessment (FMA) scores from baseline to postrehabilitation.
Conclusions
This study implied that home-based TR training can alter the patterns of dynamic spontaneous brain activity and functional connectivity in certain brain regions. The identification of key brain regions by neuroimaging indicators such as dynamic regional brain activity and degree centrality in the recovery process would provide a theoretical basis for noninvasive brain stimulation technology and strategies for formulating targeted rehabilitation programs for stroke patients with motor dysfunction.
Objective
To explore the effects of home-based telerehabilitation (TR) on dynamic alterations in regional intrinsic neural activity and degree centrality in stroke patients by resting-state functional MRI (fMRI) methods.
Methods
The neuroimaging data of 52 stroke patients were analyzed. Dynamic regional spontaneous neural activity (dynamic amplitude of low-frequency fluctuations, dALFF; and dynamic regional homogeneity, dReHo) and dynamic degree centrality (dDC) were compared between the TR and conventional rehabilitation (CR) groups. A flexible factorial model was employed to investigate the expected effects.
Results
The patients in the TR group showed increased dALFF in the right precuneus and bilateral precentral gyrus (PreCG) and reduced dALFF in the right inferior parietal lobule by the analysis of main effects. Significant differences between groups were detected in the right precuneus, right fusiform gyrus and left middle frontal gyrus for dReHo and in the left cingulate gyrus, right middle temporal gyrus and left precuneus for dDC. A significant correlation was found in the TR group between the changed dALFF in the left PreCG and the changed Fugl-Meyer assessment (FMA) scores from baseline to postrehabilitation.
Conclusions
This study implied that home-based TR training can alter the patterns of dynamic spontaneous brain activity and functional connectivity in certain brain regions. The identification of key brain regions by neuroimaging indicators such as dynamic regional brain activity and degree centrality in the recovery process would provide a theoretical basis for noninvasive brain stimulation technology and strategies for formulating targeted rehabilitation programs for stroke patients with motor dysfunction.Effect of sit-to-stand-based training on muscle quality in sedentary adults: a randomized controlled trialhttps://peerj.com/articles/156652023-07-122023-07-12Rodrigo Lizama-PérezLuis Javier Chirosa-RíosGuido Contreras-DíazDaniel Jerez-MayorgaDaniel Jiménez-LupiónIgnacio Jesús Chirosa-Ríos
The aim of this study was to compare the effects of sit-to-stand (STS) training programs with 5 vs. 10 repetitions on muscle architecture and muscle function in sedentary adults. Sixty participants were randomly assigned into three groups: five-repetition STS (5STS), 10-repetition STS (10STS), or a control group (CG). Participants performed three sets of five or 10 repetitions of the STS exercise three times per week for 8 weeks. Before and after 8 weeks, all groups performed ultrasound measures to evaluate muscle thickness (MT), pennation angle (PA), and fascicle length (FL), and the five-repetition STS test to estimate the relative STS power and muscle quality index (MQI). After 8 weeks, both experimental groups improved MQI (40–45%), relative STS power (29–38%), and MT (8–9%) (all p < 0.001; no differences between the 5STS vs. 10STS groups). These improvements in both groups resulted in differences regarding the CG, which did not present any change. In addition, only the 5STS group improved PA (15%; p = 0.008) without differences to the 10STS and CG.This suggests that STS training is time-effective and low-cost for improving muscle function and generating adaptations in muscle architecture.
The aim of this study was to compare the effects of sit-to-stand (STS) training programs with 5 vs. 10 repetitions on muscle architecture and muscle function in sedentary adults. Sixty participants were randomly assigned into three groups: five-repetition STS (5STS), 10-repetition STS (10STS), or a control group (CG). Participants performed three sets of five or 10 repetitions of the STS exercise three times per week for 8 weeks. Before and after 8 weeks, all groups performed ultrasound measures to evaluate muscle thickness (MT), pennation angle (PA), and fascicle length (FL), and the five-repetition STS test to estimate the relative STS power and muscle quality index (MQI). After 8 weeks, both experimental groups improved MQI (40–45%), relative STS power (29–38%), and MT (8–9%) (all p < 0.001; no differences between the 5STS vs. 10STS groups). These improvements in both groups resulted in differences regarding the CG, which did not present any change. In addition, only the 5STS group improved PA (15%; p = 0.008) without differences to the 10STS and CG.This suggests that STS training is time-effective and low-cost for improving muscle function and generating adaptations in muscle architecture.