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Conclusions | FM loss, weight loss, T2DM | In contrast with other interventions geared toward weight loss where behavioral and physiological changes in NEPA and NEAT, respectively, may be expected, a more conservative and ecological 1-year exercise intervention for individuals with T2DM had no impact on NEPA and estimated NEAT on the non-exercise days, regardle... | PMC10063485 | |
Acknowledgements | The authors are grateful to all participants for their time and effort. | PMC10063485 | ||
Author’s contribution | IRC contributed to methodology, formal analysis, and writing—original draft; MHR contributed to formal analysis and writing—original draft; JPM contributed to conceptualization, methodology, formal analysis, and writing—original draft; PBJ contributed to methodology and writing—review and editing; GBR contributed to wr... | PMC10063485 | ||
Funding | Open access funding provided by FCT|FCCN (b-on). This work was conducted at the Interdisciplinary Center for the Study of Human Performance (CIPER), unit I&D 447 (UIDB/00447/2020), Faculty of Human Kinetics of the University of Lisbon, and supported by the Portuguese Foundation for Science and Technology, the Portugues... | PMC10063485 | ||
Data availability statement | The datasets used during the current intervention are available from the corresponding author on reasonable request. | PMC10063485 | ||
Declarations | PMC10063485 | |||
Conflict of interest | The authors report there are no conflicts of interest to declare. | PMC10063485 | ||
Ethical standard statement | The study was approved by the Ethics Council of the Associação Protetora dos Diabéticos de Portugal (Approval Number: 07/17/2013) and conducted in accordance with the Declaration of Helsinki for Human Studies [ | PMC10063485 | ||
Informed consent | Written informed consent was obtained from all participants before proceeding with any protocol-specific procedures. | PMC10063485 | ||
References | PMC10063485 | |||
Background: | depression, post-PCI angina, angina, anxiety | Twenty percent to 40% of patients are affected by angina after percutaneous coronary intervention (PCI), which is associated with anxiety, depression, impaired physical function, and reduced quality of life. Understanding patient and procedural factors associated with post-PCI angina may inform alternative approaches t... | PMC10101135 | |
Methods: | Angina, post-PCI angina | Two hundred thirty patients undergoing PCI completed the Seattle Angina Questionnaire (SAQ-7) and European quality of life–5 dimension–5 level (EQ-5D-5L) questionnaires at baseline and 3 months post-PCI. Patients received blinded intracoronary physiology assessments before and after stenting. A post hoc analysis was pe... | PMC10101135 | |
Results: | myocardial infarction, angina | ATRIAL FIBRILLATION, MYOCARDIAL INFARCTION | Eighty-eight of 230 patients (38.3%) reported angina 3 months post-PCI and had a higher incidence of active smoking, atrial fibrillation, and history of previous myocardial infarction or PCI. Compared with patients with no angina at follow-up, they had lower baseline SAQ summary scores (69.48±24.12 versus 50.20±22.59, | PMC10101135 |
Conclusions: | angina, less angina | Larger improvements in FFR following PCI were associated with less angina and better quality of life at follow-up. In patients with stable symptoms, intracoronary physiology assessment can inform expectations of angina relief and quality of life improvement after stenting and thereby help to determine the appropriatene... | PMC10101135 | |
Registration: | URL: | PMC10101135 | ||
What is Known | depression, Angina, angina, anxiety | RECURRENCE | Angina after percutaneous coronary intervention (PCI) is associated with long-term anxiety, depression, and impairment of both physical function and quality of life.Persistence or recurrence of angina after PCI may affect 20% to 40% of patients during short-to-medium-term follow-up. | PMC10101135 |
What the Study Adds | Angina, angina, anxiety, angina post-PCI.The, pre-PCI, post-PCI angina, depression | DISEASE | Patients with post-PCI angina reported more frequent angina and poorer quality of life at baseline yet had physiologically less severe disease and, accordingly, tended to achieve less improvement in coronary physiology metrics than those who were free from angina post-PCI.The degree of improvement in patient-reported o... | PMC10101135 |
Methods | The data that support the findings of this study are available from the corresponding author upon reasonable request. The rationale, study design, and primary outcome of the TARGET-FFR controlled trial have been published previously. | PMC10101135 | ||
Definition of Angina | angina | The presence of angina post-PCI was defined by a patient-reported follow-up SAQ-angina frequency (SAQ-AF) score of <100. Patients with a follow-up of SAQ-AF score=100 were classified as having no angina. | PMC10101135 | |
Clinical Outcomes | vessel failure, vessel myocardial infarction, cardiovascular death | Clinical outcomes at a median of 3 years post-PCI were assessed by electronic health record linkage. The primary clinical outcome was target vessel failure, a composite end point comprising cardiovascular death, target vessel myocardial infarction, and target vessel revascularization. | PMC10101135 | |
Statistical Analysis | Continuous variables are presented as mean±SD and categorical data as counts and percentages. A 2-sample | PMC10101135 | ||
Results | angina, post-PCI angina | Of 260 participants, 230 (88.5%) provided follow-up SAQ-AF scores 3 months (median [interquartile range], 105 [31] days) post-PCI. For the purposes of this analysis, patients were stratified by the presence of post-PCI angina. Eighty-eight (38.3%) of 230 patients had post-PCI angina as determined by a follow-up SAQ-AF ... | PMC10101135 | |
Baseline Demographics | Clinical characteristics at baseline are presented in Table Baseline Clinical Characteristics Stratified by Presence of Angina 3 Months Post-PCI | PMC10101135 | ||
Procedural Outcomes | Procedural and coronary physiology characteristics are presented in Table Procedural and Coronary Physiology Characteristics Stratified by Presence of Angina 3 Months Post-PCI | PMC10101135 | ||
Predictors of Post-PCI Angina | Post-PCI Angina, post-PCI angina | Univariate and multivariate analysis of predictors of post-PCI angina are presented in Table Predictors of Post-PCI Angina | PMC10101135 | |
Clinical Outcomes | vessel failure, post-PCI angina | The rate of target vessel failure at a median (interquartile range) follow-up of 3 (0.9) years was 1.7% (4/230) with no significant difference between groups (no angina, 0.7% versus post-PCI angina, 3.4%; | PMC10101135 | |
Discussion | chest tightness, angina, physician-adjudicated angina, dyspnea, chest pain, post-PCI angina, atrial fibrillation, heart failure | MYOCARDIAL INFARCTION, ANGINAL ATTACKS, ATRIAL FIBRILLATION, HEART FAILURE, HYPERTENSION | One in 3 patients in the TARGET-FFR randomized trial reported angina 3 months after undergoing PCI which, while a substantial proportion, is not unprecedented. In the ABSORB IV trial, 39% (494/1265) of patients in the drug-eluting stent arm had physician-adjudicated angina or angina-equivalent symptoms at 1-year follow... | PMC10101135 |
Procedural and Intracoronary Physiology Characteristics | Angioplasty, angina, pre-PCI, Coronary microvascular dysfunction, Post-PCI, post-PCI angina, coronary artery disease | STABLE ANGINA, CORONARY ARTERY DISEASE, CORONARY MICROVASCULAR DYSFUNCTION | There were no significant differences between groups in angiography-based parameters of coronary artery disease severity either pre- or post-PCI. Counterintuitively, patients with post-PCI angina had a higher burden of angina at baseline yet physiologically less severe lesions (significantly higher pre-PCI FFR and CFR ... | PMC10101135 |
Limitations | vessel failure | TARGET-FFR was a single-center study with a relatively homogeneous PCI practice, including high rates of lesion predilatation and high-pressure stent postdilatation. A larger multicenter trial incorporating a wider range of PCI strategies and techniques may have had a different outcome. The study was not powered for cl... | PMC10101135 | |
Conclusions | angina, post-PCI angina | The magnitude of FFR improvement following PCI correlated with angina status and quality of life at follow-up and was an independent predictor of the presence of post-PCI angina. In patients with stable symptoms, intracoronary physiology assessment can aid prediction of angina relief and quality of life improvement aft... | PMC10101135 | |
Article Information | PMC10101135 | |||
Sources of Funding | HEART | Endowment funds at the Golden Jubilee National Hospital (NHS Golden Jubilee), Glasgow, United Kingdom, with support from the British Heart Foundation (Research Excellence Award RE/18/6/34217). | PMC10101135 | |
Disclosures | MAY, COLLET | Dr Collison received consultancy fees from Abbott. Dr Mizukami received consultancy fees from Zeon Medical Inc; research grants from Boston Scientific; speaker fees from Abbott, Cathworks, Boston Scientific. Dr Collet received research grants from Biosensors, Coroventis Research, Medis Medical Imaging, Pie Medical Imag... | PMC10101135 | |
Supplemental Material | Supplemental MethodsFigure S1Tables S1–S13 | PMC10101135 | ||
Supplementary Material | PMC10101135 | |||
Nonstandard Abbreviations and Acronyms | Canadian Cardiovascular Societycoronary flow reserveEuropean quality of life-5 dimension-5 level questionnairefractional flow reservepercutaneous coronary interventionSeattle Angina QuestionnaireSeattle Angina Questionnaire-angina frequencyFor Sources of Funding and Disclosures, see page 164.Supplemental Material is av... | PMC10101135 | ||
References | PMC10101135 | |||
Background | Hypertension | HYPERTENSION | Clinical trials commonly use multiple endpoints to measure the impact of an intervention. While this improves the comprehensiveness of outcomes, it can make trial results difficult to interpret. We examined the impact of integrating patient weights into a composite endpoint on the interpretation of Control of Hypertens... | PMC9906819 |
Methods | PREGNANCY HYPERTENSION | Outcome weights were extracted from a previous patient preferences study in pregnancy hypertension (Outcome weights from the preference subgroups were integrated with CHIPS data for the seven outcomes identified in the preference study. A weighted composite score was derived for each participant by multiplying the pref... | PMC9906819 | |
Results | Composite scores were similar between trial arms with the use of equal weights or those of subgroup (1) (95% confidence intervals [CIs]: − 0.03, 0.02; | PMC9906819 | ||
Conclusions | Evidence-based recommendations for ‘tight’ control are consistent with most women’s preferences, but for a sixth of women, ‘less-tight’ control is more preference consistent. Depending on patient preferences, a single trial may support different interventions. Future trials should specify component weights to improve i... | PMC9906819 | ||
Trial registration | ClinicalTrials.gov NCT01192412 | PMC9906819 | ||
Supplementary Information | The online version contains supplementary material available at 10.1186/s13063-023-07118-1. | PMC9906819 | ||
Keywords | PMC9906819 | |||
Introduction | Hypertension | SECONDARY, HYPERTENSION | Clinical trials in cardiovascular medicine routinely use primary, secondary, and other endpoints to capture the breadth of an intervention’s effects. However, this can make the interpretation of trial results challenging, as an intervention’s effects can vary by outcome, including benefits and harms [The international ... | PMC9906819 |
Discussion | BWS | PRETERM BIRTH, PREGNANCY HYPERTENSION | This re-analysis of CHIPS trial outcomes incorporated patient views and demonstrated that integrating patient preferences for outcomes and their associated weights into trial analyses is feasible and can identify different management approaches based on the results of a single trial. Our findings suggest that while alm... | PMC9906819 |
Conclusions | This study illustrates that integrating patient values into trial analyses can change the interpretation of trial results for clinical decision-making. Future trials with composite or multiple outcomes should seek patient preference weights to improve the interpretation of trial results and support patient-centred care... | PMC9906819 | ||
Acknowledgements | We would like to acknowledge the time and contributions of the 981 participants in the CHIPS trial and the 183 participants in the preferences study that made this work possible, as well as the members of the CHIPS Study Group (Additional file | PMC9906819 | ||
Authors’ contributions | MH, NB | All authors contributed to the conceptualization and design of the study, have approved the submitted final version and have agreed to be accountable for their own contributions and the work as a whole. In addition, RKM contributed to the acquisition, analysis, and interpretation of the data and drafted the initial man... | PMC9906819 | |
Funding | This study was funded by peer-reviewed grants from two government entities: the Canadian Institutes of Health Research (MCT 87522) and the BC SUPPORT Unit (RWCT-001). Funders had no involvement in the design of the study; the collection, analysis and interpretation of the data; or the presentation of findings. | PMC9906819 | ||
Availability of data and materials | APPENDIX | The datasets used and/or analysed during the current study are not publicly posted as participant consent was not obtained for the open distribution of data. However, data are available from the corresponding author upon reasonable request. Aggregate data are available as part of the Supplementary Appendix of the initi... | PMC9906819 | |
Declarations | PMC9906819 | |||
Ethics approval and consent to participate | This study was reviewed and approved by the Behavioural Research Ethics Board (H17-01194) at the University of British Columbia. | PMC9906819 | ||
Consent for publication | Not applicable | PMC9906819 | ||
Competing interests | The authors declare that they have no competing interests. | PMC9906819 | ||
References | PMC9906819 | |||
Background | Residual neuromuscular block | COMPLICATION | Residual neuromuscular block after using neuromuscular blocking agents is a common and potentially harmful complication of general anesthesia. Neostigmine is a widely used antagonist, but its optimal dose for elderly patients is unclear. | PMC10413529 |
Objectives | cisatracurium-induced neuromuscular block | To compare the optimal dosage and safety of neostigmine for reversing shallow residual block in elderly patients after cisatracurium-induced neuromuscular block. | PMC10413529 | |
Methods | A randomized controlled trial was conducted in 196 elderly patients undergoing non-cardiac surgery under general anesthesia with cisatracurium. Patients were assigned to receive either no neostigmine (control group) or neostigmine at 20 µg/kg, 40 µg/kg or 50 µg/kg when train-of-four (TOF) ratio reached 0.2 at the end o... | PMC10413529 | ||
Results | The time to reach TOF ratio of 0.9 in the 20 µg/kg, 40 µg/kg and 50 µg/kg groups was significantly shorter than the control group (H = 104.257, | PMC10413529 | ||
Conclusions | Timely use of neostigmine after general anesthesia in elderly patients can significantly shorten time of TOF value reaching 0.9, among which 40 µg/kg dosage may be a more optimized choice. | PMC10413529 | ||
Trial registration | this study was registered on chictr.org.cn (ChiCTR2100054685, 24/12/2021). | PMC10413529 | ||
Keywords | PMC10413529 | |||
Background | MUSCLE RELAXATION, POSTOPERATIVE COMPLICATIONS | Neuromuscular blocking agents (NMBAs) are widely used to provide muscle relaxation for endotracheal intubation, certain modes of mechanical ventilation and surgical procedures. However, with the widespread application of neuromuscular blocking agents in general anesthesia, the residual effects have become one of the im... | PMC10413529 | |
Methods | PMC10413529 | |||
Study design and patient selection | Neuromuscular block | NEUROMUSCULAR BLOCK | This study was approved by the Ethics Committee of the Third Xiangya Hospital. Written informed consent was obtained from all patients. Inclusion criteria were: aged 60 to 85 years, American Society of Anesthesiology (ASA) physical status 1 to 3, and scheduled for elective surgery under general anesthesia with cisatrac... | PMC10413529 |
Procedure | nausea and vomiting, normocapnia, postoperative pain, tetanic | MUSCLE RELAXATION | On arrival at the operating room, an intravenous cannula was inserted in the forearm vein of the patient, and standard anesthesia monitoring (noninvasive blood pressure, electrocardiogram, and oxygen saturation) were established and anesthesia depth was monitored using Bispectral Index (BIS, Medtronic, Minneapolis, MN,... | PMC10413529 |
Statistical analysis | A sample size was calculated based on the primary outcome variable (the time from the administration of neostigmine to a TOF ratio of 0.9). To achieve a power of 0.8 with an alpha level of 0.05 and an effect size of f = 0.25, and considering a 10% drop out rate, a total sample size of N = 200 was needed. SPSS 22.0 soft... | PMC10413529 | ||
Results | allergies | ALLERGIES | From January 2022 to November 2022, 240 ASA I-III patients aged from 60 to 85 who were scheduled for elective non-cardiac surgery under general anesthesia were enrolled, of which 40 patients were excluded due to contraindications (n = 18), allergies (n = 12) or declined to participate (n = 10). 200 patients completed r... | PMC10413529 |
Comparison of general data and perioperative data between the groups | Table
Analysis of baseline characteristicsBMI: Body Mass Index | PMC10413529 | ||
Comparison of results of postoperative muscle relaxation monitoring | Postoperative nausea and vomiting | MUSCLE RELAXATION | As listed in Table Similar to the results of time to reach TOF value of 0.9, TOF value at 10 min after administration in 20 µg, 40 and 50 µg groups was significantly increased compared with that in control group (H = 93.351, In addition, we evaluated the postoperative outcomes of each group. As shown in the Table
Anal... | PMC10413529 |
Discussion | postoperative cognitive impairment, muscle blockade | DEGENERATION, MUSCLE RELAXATION, NEUROMUSCULAR BLOCKADE, POSTOPERATIVE COMPLICATIONS, COMPLICATION | This study explored the optimal dose of neostigmine in elderly patients to reverse the TOF value to 0.9. The results indicated that the dose of 40 µg/kg may be an optimized choice and did not increase the incidence of postoperative cognitive impairment or PONV.Incomplete neuromuscular recovery after general anesthesia ... | PMC10413529 |
Author contributions | Yan Liao and Jianbin Tong designed the study and collected the data. Mengya Cao, Yangwen Ou analyzed the data and Huifan Huang, Yan Liao drafted the manuscript. Mengya Cao and Jianbin Tong provided critical feedback on the study design, data analysis, and manuscript revisions.All authors have read and approved the fina... | PMC10413529 | ||
Funding | Not applicable. | PMC10413529 | ||
Availability of data and materials | The datasets used and/or analyzed during the current study are available from the corresponding author on reasonable request. | PMC10413529 | ||
Declarations | PMC10413529 | |||
Ethics approval and consent to participate | The study was approved by the ethics committee of the Ethics Committee of the Third Xiangya Hospital (reference number [R22008]) and written informed consent was obtained from all participants. The authors declare that all experiments were performed in accordance with relevant guidelines and regulations (such as the De... | PMC10413529 | ||
Consent for publication | Not applicable. | PMC10413529 | ||
Competing interests | The authors declare that they have no competing interests. | PMC10413529 | ||
References | PMC10413529 | |||
Background | DEL | Edited by: Mario Clerici, University of Milan, ItalyReviewed by: Camilla Tincati, University of Milan, Italy; Julian Olalla, Hospital Costa del Sol, SpainThe aim of this randomized clinical trial (RCT) was to compare immunological changes in virally suppressed people living with HIV (PLWH) switching from a three-drug r... | PMC10613634 | |
Methods | BLOOD, SECONDARY | An open-label, prospective RCT enrolling PLWH receiving a 3DR who switched to bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) or dolutegravir/lamivudine (DTG/3TC) was performed. Blood was taken at baseline and months 6 and 12. The primary outcome was the change in CD4+ or CD8+ T-cell counts and CD4/CD8 ratio ... | PMC10613634 | |
Results | Between the two arms (33 PLWH each), there was no difference in CD4+ or CD8+ T cells, CD4/CD8 ratio, and IL-6 trajectories. PLWH switching to DTG/3TC had increased levels of both transitional memory and terminally differentiated CD4+ T cells (arm–time interaction p-value = 0.02) and to a lesser extent for the correspon... | PMC10613634 | ||
Conclusion | No evidence for a difference in absolute CD4+ and CD8+ T-cell counts, CD4/CD8 ratio, and IL-6 trajectories by study arm over 12 months was found. PLWH on DTG/3TC showed higher levels of terminally differentiated and exhausted CD4+ and CD8+ T lymphocytes and non-classical monocytes at T6. Further studies are warranted t... | PMC10613634 | ||
Clinical Trial Registration | PMC10613634 | |||
Introduction | HIV-1 infection, viremia, virological failure | HIV-1 INFECTION, CHRONIC INFLAMMATION, VIREMIA | Bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) is a guideline-recommended regimen for the treatment of HIV-1 infection in both naïve and experienced patients that demonstrated high efficacy and barrier to resistance without occurrence of incident resistance among individuals experiencing virological failure ... | PMC10613634 |
Methods | INFECTIOUS DISEASE | This is an open-label, prospective, single-center, randomized trial enrolling PLWH seen for care at the Infectious Disease Clinic of Azienda Ospedaliero-Universitaria Policlinico of Modena, Italy. The study, with EudraCT Number 2018-003458-26, was approved by the local Ethical Committee with Authorization Number AOU 00... | PMC10613634 | |
Outcomes | inflammation | INFLAMMATION, SECONDARY | The primary outcome of the trial was the change in CD4+ or CD8+ T-cell counts and CD4/CD8 ratio from enrolment to week 48.The secondary outcomes were the changes in inflammation and other immune characteristics (phenotype of T cells, proportion of cells belonging to different CD4+ and CD8+ T-cell subsets, monocytes, an... | PMC10613634 |
Immunological analyses | Immunological analyses are described in detail in Supplementary Annex 2 ( | PMC10613634 | ||
Statistical analyses | AIDS | AIDS | Participants’ characteristics by study arm were described and reported as the number of participants with relative frequencies for categorical factors and as the median and interquartile range (IQR) for continuous variables.Repeated measurements of all biomarkers were available at the three fixed time points (T0 = base... | PMC10613634 |
Sample size calculations | We based the sample size calculations on the primary outcome change in CD8 count from T0 to T12. At the time of writing the trial protocol, we hypothesized that switching to DTG/3TC could be associated with a higher CD8 activation compared to switching to B/F/TAF. In particular, on the basis of data previously publishe... | PMC10613634 | ||
Results | AIDS, high-density lipoprotein | INFECTIOUS DISEASES, AIDS | Between September 2020 and January 2021, 66 patients attending the Clinic of Infectious Diseases of the Azienda Ospedaliero-Universitaria Policlinico of Modena were enrolled in the trial. Epidemiological characteristics are described in Main characteristics of target population by study arm.IQR, interquartile range; MS... | PMC10613634 |
Primary outcomes: CD4+ or CD8+ T-cell count and CD4/CD8 ratio | Concerning the primary endpoint of absolute values and change in CD4+ or CD8+ T lymphocyte count and in CD4/CD8 ratio, no evidence for a difference by study arm was found either at 6 (T6) or at 12 months (T12) after the switch (T0). All these three main immunological parameters tended to remain stable over time in both... | PMC10613634 | ||
CD4+ T-cell subsets | In contrast, when we looked at the proportion of CD4+ T-cell subsets, significant differences in trends by arm were detected for both TM and EMRA (arm–time interaction p-value = 0.02 in the adjusted analysis). The significance was likely to be driven by the trends at T6, the time at which values of both TM (−4.6 cells/... | PMC10613634 | ||
CD8+ T-cell subsets | The results for the CD8+ T-cell subsets were similar to those seen for the corresponding CD4+ T cells shown above, although none of the statistical interaction tests reached statistical significance (p = 0.09 for TM and p = 0.19 for EMRA in the adjusted analysis, CD8 subsets by study arm—adjusted analysis.
RCT, random... | PMC10613634 | ||
Monocytes | We then investigated trend in monocytes, specifically by distinguishing between classical and non-classical subsets (note that non-classical monocytes also included a small proportion of intermediate monocytes). Although no statistical significance was detected for the classical monocyte subsets (interaction p-value=0.... | PMC10613634 | ||
Inflammation: IL-6 | inflammation | INFLAMMATION | We finally analyzed the trend in IL-6, chosen as the most important cytokine related to onset and maintenance of inflammation. Because of the trend seen with the CD4+ and CD8+ TM/EMRA T cell subsets (large difference by study arm at T6 followed by an attenuation of the difference at T12), we hypothesized that this migh... | PMC10613634 |
Discussion | inflammation, atherosclerosis, HIV infection, non-AIDS | HIV INFECTION, INFLAMMATION, DYSFUNCTION, EVENTS, ATHEROSCLEROSIS, PERSISTENT INFLAMMATION, ENDOTHELIAL DYSFUNCTION | Our randomized study shows no evidence for a difference in absolute CD4+ and CD8+ T-cell counts and in CD4/CD8 ratio trajectories over 12 months of follow-up by study arm (DTG/3TC However, importantly, our data provide additional insights concerning immunological changes after switching from 3DR treatment to DTG/3TC or... | PMC10613634 |
Author’s note | Preliminary results were presented at the 30th HIV Glasgow, October 23–26, 2022. Abstract n. P099 published in | PMC10613634 | ||
Data availability statement | The raw data supporting the conclusions of this article will be made available by the authors, without undue reservation. | PMC10613634 |
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