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Limitations
cancer, death
CANCER, TUMOR GROWTH, RARE DISEASE, COMPLICATION
This study has some limitations. The trial was initially planned for enrollment of 30 patients to have complete data for 24 patients, providing 80% power for the primary end point. However, accrual in this rare disease was slow, with only 24 patients enrolled after 8 years (2013 to 2021). When designed in 2012, there w...
PMC10236240
Conclusions
CRS, CRC
DISEASE, APPENDICEAL CANCER
The findings of this randomized crossover trial, taking into consideration the lack of benefit from fluoropyrimidine-based chemotherapy seen in this trial and prior retrospective studies with similar conclusion, suggest that fluoropyrimidine-based chemotherapy should not be considered a standard-of-care treatment for p...
PMC10236240
2. Materials and Methods
PMC10744547
2.1. Study Design
This prospective randomized controlled trial protocol was registered with ClinicalTrials.gov under the registration number NCT03310060. Additionally, it received approval from the institutional review board and support from Chang Gung Memorial Hospital (IRB no. 201700271A3). Before surgery, informed consent was obtaine...
PMC10744547
2.2. Inclusion and Exclusion Criteria
rheumatoid arthritis, abnormal coagulation function, abnormal coagulation, end-stage arthritis, allergic reaction, liver cirrhosis, anaphylactic shock, knee joints, non-OA degenerative, end-stage renal failure
RHEUMATOID ARTHRITIS, ABNORMAL COAGULATION, ALLERGIC REACTION, SEPTIC ARTHRITIS, LIVER CIRRHOSIS, ANAPHYLACTIC SHOCK, END-STAGE RENAL FAILURE, SEVERE ANEMIA
Between September 2017 and August 2019, we consecutively assessed a series of 119 patients who underwent unilateral primary TKA for initial eligibility in this study. The inclusion criteria encompassed adult patients aged 20 to 80 years with end-stage arthritis of the knee joint necessitating TKA. The exclusion criteri...
PMC10744547
2.3. Intervention Protocol
TKAs
HAAS
The patients were randomly assigned to two groups: the TXA group and the Tisseel@ + TXA group. All TKAs were performed by the same experienced surgical team (H.N.S., Y.H.C, and C.C.H.) using the mini-midvastus approach described by Haas et al., under general anesthesia [In the TXA group, patients received an intravenou...
PMC10744547
2.4. Outcomes
blood loss, hypovolemic shock
BLOOD LOSS, HYPOVOLEMIC SHOCK
Originally, the protocol for the study designated only the total blood loss as the primary outcome. However, after team discussions, it was deemed meaningful to explore potential differences between the two groups in terms of blood transfusion rate, decrease in Hb level, and calculated blood loss. Consequently, we deci...
PMC10744547
2.5. Randomization and Blinding
BLIND
The randomization was conducted by an independent research assistant using a computer-generated method, based on the sequence of operation dates. The clinical investigators remained blind to the randomization and allocation of all patients until complete data had been collected.
PMC10744547
2.6. Minimum Sample Size
blood loss, TKA
BLOOD LOSS
The determination of the sample size was based on the research conducted by Molloy et al., who conducted a prospective randomized trial to assess perioperative blood loss following TKA [
PMC10744547
2.7. Statistical Analysis
Statistical analyses were performed using the Statistical Package for Social Sciences (SPSS) software (Version 22.0; SPSS Inc., Chicago, IL, USA). The analysis of continuous variables utilized Student’s
PMC10744547
3. Results
PMC10744547
3.1. Participants’ Flow
The participant flow is illustrated in
PMC10744547
3.2. Baseline Data
The preoperative demographics of the patients, including age, gender, body mass index (BMI), preoperative hemoglobin (Hb) level, hematocrit (Hct), international normalized ratio (INR), platelet count, and American Society of Anesthesiologists (ASA) grade, underwent comparative analysis between the two groups (
PMC10744547
3.3. Primary and Secondary Outcomes
swelling, blood loss, periprosthetic joint infection, pain, ecchymosis, hematoma
BLOOD LOSS, ECCHYMOSIS, HEMATOMA, DEEP-VEIN THROMBOSIS, COMPLICATIONS
Among the participants, none required blood transfusions perioperatively, resulting in a transfusion rate of zero in both groups. In the Tisseel@ + TXA group, the average estimated blood loss was 0.463 ± 0.2422 L, which was comparable to the TXA group’s value of 0.455 ± 0.2522 L (The assessment of perioperative wound c...
PMC10744547
4. Discussion
blood loss, postoperative blood loss, TKA, trauma
WORLD WAR II, POSTOPERATIVE COMPLICATIONS, BLOOD LOSS, BLOOD CLOTS, COMPLICATION, BLEEDING REQUIRING TRANSFUSION
Making every effort to improve the reduction in blood loss during and after surgical procedures is a fundamental aspect of all surgeries. According to Gao et al., IV TXA has shown a potential association with reduced blood transfusion requirements and higher hemoglobin levels in patients undergoing TKA. Importantly, th...
PMC10744547
Supplementary Materials
The following supporting information can be downloaded at: Click here for additional data file.
PMC10744547
Author Contributions
Conceptualization, Y.-H.C., H.-N.S. and C.-C.H.; methodology, Y.-H.C., H.-N.S. and C.-C.H.; formal analysis, C.-H.C.; investigation, C.-H.C.; data curation, C.-H.L., C.-H.C. and C.-C.H.; writing—original draft preparation, C.-H.L., C.-H.C. and C.-C.H.; writing—review and editing, C.-H.L., C.-H.C. and C.-C.H.; visualiza...
PMC10744547
Institutional Review Board Statement
The study was conducted in accordance with the Declaration of Helsinki and approved by the Institutional Review Board of Chang Gung Memorial Hospital (protocol code 201700271A3 and date of approval 5 July 2017).
PMC10744547
Informed Consent Statement
Informed consent was obtained from all subjects involved in the study.
PMC10744547
Data Availability Statement
The data presented in this study are available upon request from the corresponding author. The data are not publicly available due to privacy.
PMC10744547
Conflicts of Interest
The authors declare no conflict of interest.
PMC10744547
References
SECONDARY, PERIOPERATIVE COMPLICATION
CONSORT 2010 participant flow diagram.Demographic data.Primary and secondary outcomes in both groups.Wound condition and perioperative complications.Effect size measured by Cohen’s d.
PMC10744547
Rationale
ECOPD, COPD
PULMONARY HYPERTENSION, COPD
Pulmonary hypertension (PH) in COPD confers increased risk of exacerbations (ECOPD). Electrocardiogram (ECG) indicators of PH are prognostic both in PH and COPD. In the Beta-Blockers for the Prevention of Acute Exacerbations of COPD (BLOCK-COPD) trial, metoprolol increased risk of severe ECOPD through unclear mechanism...
PMC10634074
Objective
ECOPD
We evaluated whether an ECG indicator of PH, P-pulmonale, would be associated with ECOPD and whether participants with P-pulmonale randomized to metoprolol were at higher risk of ECOPD and worsened respiratory symptoms given the potential detrimental effects of beta-blockers in PH.
PMC10634074
Methods
ECOPD
ENLARGEMENT
ECGs of 501 participants were analyzed for P-pulmonale (P wave enlargement in lead II). Cox proportional hazards models evaluated for associations between P-pulmonale and time to ECOPD (all and severe) for all participants and by treatment assignment (metoprolol vs. placebo). Linear mixed-effects models evaluated the a...
PMC10634074
Results
ECOPD
We identified no association between P-pulmonale and risk of any ECOPD or severe ECOPD. However, in individuals with P-pulmonale, metoprolol was associated with increased risk for ECOPD (aHR 2.92, 95% CI: 1.45–5.85). There was no association between metoprolol and ECOPD in individuals without P-pulmonale (aHR 1.01, 95%...
PMC10634074
Conclusions
In individuals with P-pulmonale, metoprolol was associated with increased exacerbation risk and worsened symptoms. These findings may explain the findings observed in BLOCK-COPD.
PMC10634074
Supplementary Information
The online version contains supplementary material available at 10.1186/s12890-023-02748-2.
PMC10634074
Keywords
PMC10634074
Introduction
exacerbations, hypoxia, PH, ECOPD, deaths, Shortness of Breath, COPD
ISCHEMIC HEART DISEASE, CHRONIC OBSTRUCTIVE PULMONARY DISEASE, HYPOXIA, CARDIOVASCULAR MORBIDITY, COPD, RHD, PULMONARY HYPERTENSION
Chronic obstructive pulmonary disease (COPD) afflicts over 65 million people worldwide, resulting in 3 million deaths annually, and in the United States, direct medical costs average over ten thousand dollars annually per patient [Cardiovascular morbidity in COPD patients extends beyond the well-established link with i...
PMC10634074
Methods
PMC10634074
BLOCK-COPD
COPD
COPD
BLOCK-COPD (NCT02587351) was a prospective, multi-center, placebo-controlled, double-blind, randomized trial of spirometry confirmed COPD patients aged 40–85 years [
PMC10634074
Participants
All BLOCK-COPD participants had a standard 12-lead ECG performed at enrollment. We excluded participants with ECGs that were uninterpretable due to baseline artifact that obscured P waves (
PMC10634074
Exacerbations of COPD
chest tightness, dyspnea, wheezing, cough, ECOPD, COPD
COPD, EVENTS
An exacerbation of COPD was defined as an increase in or new onset of two or more of the following symptoms: cough, dyspnea, sputum production, wheezing, or chest tightness leading to treatment with either antibiotics or systemic glucocorticoids for at least three days. ECOPD severity was graded as mild (outpatient man...
PMC10634074
Procedures
RIGHT ATRIAL ENLARGEMENT, ENLARGEMENT
Clinical assessments included demographics, CAT and SOBQ questionnaires, 12-lead electrocardiography, and pre- and post- bronchidilator spirometry [Trained technicians collected 12-lead ECGs in a supine position at enrollment. ECGs were analyzed using electronic calipers. A group of trained physicians analyzed all ECGs...
PMC10634074
Statistical analysis
ECOPD, COPD
COPD
Continuous values were summarized using means and standard deviations (SD) and compared between groups using ANOVA tests. Categorical variables were summarized using proportions and compared between groups using chi-square tests. Interobserver agreement was assessed using Cohen’s kappa statistic. Cox proportional hazar...
PMC10634074
Results
PMC10634074
Interobserver agreement
SECONDARY
There was excellent agreement (Kappa ≥ 0.90) in P-pulmonale classification between the primary and secondary ECG observers (Supplementary Table S
PMC10634074
Discussion
exacerbations, right heart dysfunction, RV dysfunction, exacerbation-prone COPD, ECOPD, COPD, shortness of breath
RHD, COPD
In this post-hoc analysis of the BLOCK-COPD trial, we found that patients with P-pulmonale assigned to treatment with metoprolol were at increased risk of ECOPD of any severity. In addition, metoprolol assignment was associated with worsening in respiratory symptoms in the P-pulmonale group that was both statistically ...
PMC10634074
Acknowledgements
None.
PMC10634074
Authors' contributions
DMM
All authors contributed to the drafting and editing of the manuscript. Conception and design: MTD, MRL, KMK; acquisition of data for the work: TM, RCW, DMM, KP, HV; preparation of figures and tables: SXL, ESH; analysis and interpretation: SXL, ESH, TM, VB, KMK, MRL, MTD; and drafting the manuscript for important intell...
PMC10634074
Funding
Department of Defense W81XWH-15-1-0705.
PMC10634074
Availability of data and materials
The datasets used and/or analysed during the current study available from the corresponding author on reasonable request.
PMC10634074
Declarations
PMC10634074
Ethics approval and consent to participate
The University of Alabama at Birmingham Institutional Review Board (IRB) approved the study procedures with subsequent review and adoption by each study site. Participants or legal guardians provided informed consent for the parent study, BLOCK-COPD (UAB IRB # 150609007), which included permission for use of data in su...
PMC10634074
Consent for publication
Not applicable.
PMC10634074
Competing interests
LUNG
ESH has received grant support from the National Institutes of Health and the Department of Defense and clinical trial support from Fisher & Paykel Healthcare; MTD reports grants from the American Lung Association, Department of Defense, and National Institutes of Health, consulting fees from AstraZeneca, GlaxoSmithKli...
PMC10634074
References
PMC10634074
Background
The implementation of new and complex interventions in mental health settings can be challenging. This paper explores the use of a Theory of Change (ToC) for intervention design and evaluation to increase the likelihood of complex interventions being effective, sustainable, and scalable. Our intervention was developed ...
PMC10243249
Methods
A ToC represents how our designed quality improvement intervention targeting changes at service, practitioner, and patient levels was expected to improve engagement in, and the quality of, telephone-delivered psychological therapies. The intervention was evaluated following implementation in a feasibility study within ...
PMC10243249
Results
CFIR analysis highlighted a set of challenges encountered during the implementation of our service quality improvement telephone intervention that appeared to have weakened the contribution to the change mechanisms set out by the initial ToC. Findings informed changes to the intervention and refinement of the ToC and a...
PMC10243249
Conclusions
Four key recommendations that could help to optimise implementation of a complex intervention involving different key stakeholder groups in any setting were identified. These include: 1-developing a good understanding of the intervention and its value among those receiving the intervention; 2-maximising engagement from...
PMC10243249
Keywords
PMC10243249
Background
Evidence shows psychological interventions delivered by telephone can be as effective as those delivered face-to-face [The COVID-19 pandemic forced a sudden shift towards remote therapy delivery, with no preparation time in which to train practitioners in telephone-specific skills [Before the implementation of any new ...
PMC10243249
Method
PMC10243249
Description of the EQUITy intervention
The EQUITy intervention was a service quality improvement intervention designed to enhance engagement and the quality of psychological interventions delivered by telephone in primary care in the UK. In brief, the EQUITy intervention targets change at service, practitioner, and patient levels and includes three interlin...
PMC10243249
Ethical approval
WEST
Ethical approval for the EQUITy feasibility study was granted by the North West—Preston Research Ethics Committee (REF: 20/NW/0082; IRAS ID: 271710cif). All participants completed the consent form, which they returned via email.
PMC10243249
Study design & recruitment
depression, anxiety
This was a qualitative study using semi-structured interviews and a focus group with stakeholders (patients, practitioners, and service leads). Interviews [This feasibility study was conducted in three UK NHS IAPT services (currently known as Talking Therapies services) delivering guided-self-help for anxiety and/or de...
PMC10243249
Stakeholder informants: patients and professionals
depression, anxiety
Patients receiving guided-self-help for anxiety and/or depression by telephone at the services participating in the study were invited to take part in a research interview. Information packs containing an invitation letter, participant information sheet, and a consent to contact form were distributed by the service adm...
PMC10243249
Data collection
depression, anxiety
The study took place in England, UK. The EQUITy intervention was delivered to each of the three NHS IAPT services independently between November 2020 and January 2021. Data collection took place post-intervention between February and April 2021.All participants provided informed consent prior to taking part in the stud...
PMC10243249
Data analysis
ToC.
Data were analysed incorporating inductive and deductive approaches with deductive approaches informed by the CFIR framework [Firstly, researchers familiarised themselves with the transcripts and the CFIR framework. Secondly, data were coded into the corresponding domains/sub-domains of the CFIR framework and data outs...
PMC10243249
Results
Table CFIR domains and sub-domains, and key challenges identified during implementation
PMC10243249
The theory of change for the EQUITy  research
Following findings from this feasibility study, the ToC depicted in Fig. EQUITy Programme: Theory of Change updated following findings from this feasibility study and aimed to be evaluated in a randomised controlled trialNote: White boxes in grey lines indicate elements removed from the intervention prior to the commen...
PMC10243249
Discussion
The assumption that face-to-face systems and processes may simply transfer to a different medium such as the telephone, has hampered service development and delivery in the past [
PMC10243249
1-Developing a good understanding of the intervention and its value
Many factors can impede uptake of service quality improvement interventions for telephone working including competing demands on frontline providers, lack of knowledge, skills and resources, and misalignment with service priorities. Therefore, more emphasis should be placed on developing a good understanding of the int...
PMC10243249
2-Increasing engagement from key stakeholders
Findings from our study indicate that a service quality improvement telephone intervention comprised of different components targeting changes at different levels (service, professionals, and patients) requires engagement, commitment, and accountability of different key stakeholders, including service leads, team manag...
PMC10243249
3-Clear planning and communication of implementation goals
The lack of time allocated to planning behaviours and implementation tasks, alongside the lack of identification of service quality improvement telephone goals and how to incorporate the intervention in day-to-day work tasks may explain lack of implementation success. Clear planning and communication around implementat...
PMC10243249
4-Formal strategies to monitor implementation progress
Developing models to guide and identify implementation strategies such as audit feedback [
PMC10243249
Further reflections on the ToC
The ToC originally developed was in line with a pre-COVID context where the use of telephone to deliver assessment and treatment sessions in NHS Talking Therapies services varied, but many low intensity practitioners (Step 2 care) were delivering approximately 60% of their appointments by telephone [Findings from the f...
PMC10243249
Conclusions
Concerted attention to evidence-based implementation strategies is needed to reduce the likelihood of implementation failures and optimise success. Implementation strategies should emphasise the value and benefits related to implement an intervention and facilitate awareness and good understanding of what is needed and...
PMC10243249
Acknowledgements
The authors would like to thank the service leads, practitioners, and patients that participated in the study and their organisations. The authors would like to specially thank Elinor Hopkin for proofreading the final manuscript.
PMC10243249
Authors’ contributions
CF
CF, JG, HB, and PBe were involved in the conceptualization of study research goals and aims. PBe and PBo are the Principal Investigators for this research programme and were responsible of the funding acquisition. CA was a grant co-applicant. CF led the formal data analysis, and all authors were involved in regular dis...
PMC10243249
Funding
This study is funded by the National Institute for Health Research (NIHR) Programme Grants for Applied Research (project reference: RP-PG-1016–20010). Armitage is supported by NIHR Manchester Biomedical Research Centre and NIHR Greater Manchester Patient Safety Translational Research Centre. The views expressed are tho...
PMC10243249
Availability of data and materials
The dataset generated and analysed during the current study are not publicly available due to privacy and ethical restrictions (i.e. potential for breach of anonymity); but are available from the corresponding author upon reasonable request.
PMC10243249
Declarations
PMC10243249
Ethics approval and consent to participate
WEST
The authors assert that all procedures contributing to this work comply with the ethical standards of the relevant national and institutional committees on human experimentation and with the Helsinki Declaration of 1975, as revised in 2008. Ethical approval was granted by the North West—Preston Research Ethics Committe...
PMC10243249
Consent for publication
Not applicable.
PMC10243249
Competing interests
The authors declare that they have no competing interests.
PMC10243249
References
PMC10243249
Subject terms
death
REGRESSION
Hospital readmission prediction models often perform poorly, but most only use information collected until the time of hospital discharge. In this clinical trial, we randomly assigned 500 patients discharged from hospital to home to use either a smartphone or wearable device to collect and transmit remote patient monit...
PMC10203290
Introduction
Nearly 1 in 5 patients discharged from the hospital are readmitted within 30 daysThe use of remote patient monitoring (RPM) devices such as smartphones and wearables is increasing, and prior work has demonstrated they are accurate for tracking daily activity patternsThe objective of our study was to evaluate whether ho...
PMC10203290
Standard model with traditional regression
REGRESSION
These models used electronic health record data until the time of hospital discharge. As expected, since these models did not include RPM data, prediction was similar between device arms for logistic regression (AUC in smartphone arm, 0.63, 95% CI 0.61 to 0.65; AUC in wearable arm, 0.63, 95% CI 0.60 to 0.65;
PMC10203290
Standard model with machine learning regression
REGRESSION
Prediction increased when using nonparametric machine learning approaches than when using traditional parametric regression techniques (Table
PMC10203290
Enhanced prediction models with RPM data
REGRESSION
For all 5 regression approaches, prediction increased significantly when RPM data on physical activity and sleep patterns was included in the models (Figure Observed readmission rate by predicted risk quartile for the enhanced model with RPM data and ensemble machine learning. Depicted is the observed rate of hospital ...
PMC10203290
Wearable versus smartphone
In the enhanced models that incorporated RPM data, 4 of the 5 models found that the wearable arm had significantly better prediction than the smartphone arm (Table
PMC10203290
Discussion
REGRESSION
In this clinical trial, we found that hospital readmission prediction models that used traditional parametric regression approaches with electronic health record data until the time of hospital discharge performed similar to previously published models with AUCs ranging from 0.60 to 0.70Our findings reveal several impo...
PMC10203290
Limitations
This study also has limitations. First, the sample included patients with a mean age of about 46 years from medicine services at one health system who were being discharged to home and less than 10% of those approached agreed to participate, which limits generalizability. Future studies should evaluate a broader sample...
PMC10203290
Conclusions
Prediction of 30-day hospital readmission significantly improved when including remotely-monitored patient data on activity patterns after hospital discharge and using nonparametric machine learning approaches. Wearables slightly outperformed smartphones but both had good prediction. Since many patients use smartphones...
PMC10203290
Methods
PMC10203290
Study design
PREDICT (Prediction using a Randomized Evaluation of Data collection Integrated through Connected Technologies) was a 2-arm randomized clinical trial conducted remotely after patients were discharged from inpatient medicine services at two Penn Medicine hospitals in Philadelphia to their home (ClinicalTrials.gov number...
PMC10203290
Participants
Patients admitted to medicine services at two hospitals at Penn Medicine in Philadelphia (Hospital of the University of Pennsylvania and Penn Presbyterian Medical Center) were identified as potential participants using the electronic health record (EPIC) and approached in the hospital by the study team.Patients were el...
PMC10203290
Data
Comorbidity
Patient data obtained from Way to Health included demographics collected by survey during initial hospitalization (age, gender, race/ethnicity, education, marital status, annual household income, and body mass index) and RPM activity patterns transmitted from the smartphone application and wearable including daily meas...
PMC10203290
Randomization
coronary heart disease, pneumonia, diabetes
ACUTE MYOCARDIAL INFARCTION, PNEUMONIA, CHRONIC OBSTRUCTIVE PULMONARY DISEASE, CONGESTIVE HEART FAILURE, CORONARY HEART DISEASE, DIABETES
Patients were randomized electronically using block sizes of two and stratified by one of the following six primary conditions for admission: acute myocardial infarction or coronary heart disease, chronic obstructive pulmonary disease, congestive heart failure, diabetes, pneumonia, or any other condition. These conditi...
PMC10203290
Interventions
Patients assigned to the smartphone arm were set up in the hospital with the Withings Health Mate smartphone application which used accelerometers in the smartphone to track physical activity patterns. They were asked to open the application at least once a day to sync the device. These patients were told they would re...
PMC10203290
Outcome measures
death
The primary outcome was prediction of readmission to the hospital or death within 30 days of discharge.
PMC10203290
Statistical analysis
death, Comorbidity
REGRESSION
All randomly assigned patients were included in the intention-to-treat analysis. For each patient and on each day of the study (patient-day level), we obtained RPM activity data. Data could be missing for any day if the patient did not use the device, did not sync it to upload data, or the device did not capture it (e....
PMC10203290
Supplementary Information
The online version contains supplementary material available at 10.1038/s41598-023-35201-9.
PMC10203290
Author contributions
M.P. drafted the manuscript and supervised the study. K.V. and D.P. obtained funding for the study. D.S. and G.K. provided oversight for the analysis. S.P. conducted the analysis. C.E. managed participant enrollment and study operations. All authors reviewed the manuscript.
PMC10203290
Funding
This project is funded, in part, under a grant with the Pennsylvania Department of Health through the Commonwealth Universal Research Enhancement (CURE) Program. The Department specifically disclaims responsibility for any analyses, interpretations or conclusions. This trial was also supported by the University of Penn...
PMC10203290
Data availability
The datasets generated and/or analysed during the current study are not publicly available because we do not have IRB approval to share them since they contain patient information. Dr. Patel had full access to all the data in the study and takes responsibility for the integrity of the data and the accuracy of the data ...
PMC10203290