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Disclosures
Hypertension, Preeclampsia
HYPERTENSION, PREECLAMPSIA
A. Jeyabalan declares Grants or contracts from Mirvie, Inc (Miracle of Life Study) to work as Site PI—overseeing sample collection for a sponsored research agreement between UPMC and Mirvie and Royalties or licenses with UpToDate to work as coauthor of 2 topics—Prevention of Preeclampsia and Chronic Hypertension in Pre...
PMC10510842
Supplemental Material
Supplemental MethodsParticipating centersProceduresKnowledge transfer programData safety and monitoring committee (DMC)Tables S1–S7Figure S1
PMC10510842
Supplementary Material
PMC10510842
Nonstandard Abbreviations and Acronyms
Preterm Preeclampsia, Preeclampsia
APPENDIX, PREECLAMPSIA
adjusted odds ratioPreeclampsia Integrated Estimate of RiskPlanned Early Delivery or Expectant Management for Late Preterm Preeclampsia Trialplacental growth factorPrematurity Reduction by Preeclampsia Caresoluble fms-like tyrosine kinase-1For Sources of Funding and Disclosures, see page 2027.L.C. Chappell and M.A.B. D...
PMC10510842
APPENDIX
PREPARE Trial group: Guilherme de Jesús MD, PhD; Wallace Mendes-Silva, MD; José Guilherme Cecatti, MD, PhD; Maria Laura Costa, MD, PhD; José Paulo Guida, MD, PhD; Lucienne Frayha, MD; Corintio Mariani-Neto, MD, PhD; Marcos Antonio Nogueira Santos, MD; José Geraldo Lopes Ramos, MD, PhD; Sérgio Hofmeister Martins-Costa, ...
PMC10510842
REFERENCES
PMC10510842
Background and Aims:
To achieve the World Health Organization’s goal of eliminating HCV by 2030, reengagement of lost to follow-up cases is mandatory. However, there is lack of evidence concerning the best strategy. Our study evaluated the effectiveness, efficiency, predictive factors, and costs of 2 different strategies.
PMC10538908
Methods:
NCT04153708
We identified patients positive for HCV antibodies without RNA requests from 2005 to 2018. Patients fulfilling trial criteria (NCT04153708) were randomized to (1) phone call or (2) letter of invitation to schedule an appointment, followed by switching strategy.
PMC10538908
Results:
Three hundred forty-five patients among 1167 lost to follow-up were identified. An analysis of the first 270 randomized patients (72% male, 51±13 y) showed a higher contact rate in the mail than in the phone call strategy (84.5% vs. 50.3%). In the intention-to-treat analysis, no differences were found related to appoin...
PMC10538908
Conclusions:
Reengagement of patients with HCV is feasible, and equally effective with similar costs in both strategies. The mail letter was more efficient, except when only 1 phone call was considered. Prior specialist’s evaluation and testing in the predirect-acting antiviral era were factors associated with nonattendance to the ...
PMC10538908
INTRODUCTION
HCV infection
CHRONIC LIVER DISEASE
HCV infection is a major public health problem and a leading cause of chronic liver disease.
PMC10538908
METHODS
PMC10538908
Study design
deaths, comorbidity, HBV and HIV tests
LIVER FIBROSIS, HIV COINFECTION
Microbiology data files from patients seen between 2005 and 2018 at our tertiary center (Hospital Universitario de Canarias), which serves a population of ~400,000 subjects, were retrospectively reviewed. From all the cases with positive HCV antibodies, we identified those with positive HCV antibodies but without RNA i...
PMC10538908
Effectiveness and efficiency analysis
SECONDARY
To compare both strategies, and as a primary aim of the study, we evaluated effectiveness as the rate of patients successfully linked to care (patients who showed up for the appointment with the specialist) and secondary efficiency by considering the number of contacts needed (total number of letters or phone calls) to...
PMC10538908
Sample size calculation
CORONAVIRUS, MAY
A sample size of 172 patients for each strategy was estimated, assuming a 15% increase in effectiveness (from 28% to 43%) of the phone call strategy over the mail strategy (power 80%, alpha error 5%) and a 10% lose in each intervention.For extraordinary reasons that may have influenced the results because of the nature...
PMC10538908
Statistics and analysis
Continuous variables were presented as mean (SD) or median (interquartile range) according to the distribution of the data. Categorical variables were presented as absolute frequencies and percentages. The chi-square test was used to compare qualitative variables. Continuous variables were analyzed using the Student In...
PMC10538908
Cost-effectiveness analysis
An economic evaluation was performed to estimate the cost of each strategy. It was calculated taking into consideration the actual number of calls, the time dedicated to each call, the number of letters sent, and the time dedicated to sending them. The cost per minute of each call, together with the cost of the adminis...
PMC10538908
Ethical aspects
This study was conducted in accordance with the ethical principles of the Declaration of Helsinki in October 2013 and approved on March 14, 2019, by The Ethics Committee of the Hospital Universitario de Canarias [code CHUC_2019_23 (VHC-ACTIVA)].
PMC10538908
RESULTS
PMC10538908
Patient selection and baseline characteristics
HIV COINFECTION
Between 2005 and 2018, 4414 patients were positive for HCV antibodies, of whom 2734 (61.9%) had a negative RNA result or a positive then negative RNA result. After exclusion of 513 (11.6%) patients who died during the study period, 1167 patients were potential candidates for initial reengagement. Finally, 822 (70.4%) w...
PMC10538908
Effectiveness of both strategies
In the phone call strategy, 15 (10.2%) patients had an incorrect phone number registered in the medical records, and 58 (39.4%) patients did not answer the phone call. Seven (4.8%) patients answered that they did not want to participate in the study. In the mail strategy, 19 (15.4%) letters failed to reach the register...
PMC10538908
Efficiency of both strategies
In the ITT analysis, 3.1 mailed letters and 8 phone calls were necessary to successfully link 1 patient to care with the specialist (RR: 2.53, 95% CI, 1.57–4.07,
PMC10538908
Switching strategies
Of 270 patients and after excluding patients who attended the appointment (n=74) and patients who declined participation (n=12), 184 patients remained to be contacted and were switched to the other strategy. Because of the time gap until the switch was performed, 5 (2.7%) patients deceased and 18 (9.8%) received HCV tr...
PMC10538908
Characteristics of reengaged patients
active infection
Of the reengaged patients, 101 attended the specialist appointment, of whom 41 (40.6%) had a positive RNA test result. Among patients with active infection, 3 (7.3%) were categorized as F3 and 11 (26.8%) as F4 using elastography. Thirty-eight patients (92.7%) started HCV therapy, and a sustained virological response wa...
PMC10538908
Cost-effectiveness analysis of each strategy
The direct cost of the phone call strategy was €430.38, whereas the mail letter strategy was €222.6. If we include the switch path in this calculation, the cost of the phone call strategy amounts to €681.08 compared with €360.8 for the mail letter strategy.The cost per patient who attended the medical visit was €621.3 ...
PMC10538908
DISCUSSION
HCV-infected, HCV microelimination, liver disease
ADVERSE EFFECTS
In this randomized clinical trial, we investigated the effectiveness and efficiency of 2 different strategies for reengagement in specialist care for HCV patients lost to follow-up. In our setting, both the strategies were feasible and similar in terms of effectiveness; meanwhile, the mail letter strategy seemed to be ...
PMC10538908
Supplementary Material
PMC10538908
SUPPLEMENTARY MATERIAL
PMC10538908
AUTHOR CONTRIBUTIONS
Alberto Hernández-Bustabad, Dalia Morales-Arraez, and Manuel Hernández-Guerra: material preparation, data collection, and analysis. Dalia Morales Arraez and Alberto Hernández Bustabad: first draft of the manuscript.
PMC10538908
ACKNOWLEDGMENTS
Claudia
The authors thank BIOAVANCE and CIBICAN for the editorial support, Alejandro Jiménez for statistical analysis, and Claudia Velázquez for the database support.
PMC10538908
FUNDING INFORMATION
This study was supported in part by grants from Fondo Europeo de Desarrollo Regional (FEDER). Dr. M. Hernandez-Guerra is the recipient of a grant from Instituto de Salud Carlos III (PI19/01756).
PMC10538908
CONFLICTS OF INTEREST
Dalia
Dr. M. Hernandez-Guerra has received research grants from Abbvie and Gilead Science and has participated as a consultant for Bayer, Intercept and Orphalan. Dr. Dalia Morales-Arráez has received a research grant from Gilead Science. The remaining authors have no conflicts to report. Written informed consent was requeste...
PMC10538908
REFERENCES
PMC10538908
Abstract
PMC10358195
Purpose
CHILDHOOD CANCER
Meeting intervention requirements is crucial in behavioral trials. We examined patterns and predictors of physical activity (PA) adherence and contamination in a 1‐year individualized randomized controlled PA behavioral intervention in childhood cancer survivors (CCS).
PMC10358195
Methods
REGRESSION, CHILDHOOD CANCER, REMISSION
CCS aged ≥16 at enrolment, <16 at diagnosis, and ≥5 years in remission were identified from the Swiss Childhood Cancer Registry. We asked participants randomized to the intervention group to perform an additional ≥2.5 h of intense PA/week and controls to continue as usual. Adherence to the intervention was assessed by ...
PMC10358195
Results
One hundred and forty‐four survivors (30.4 ± 8.7 years old, 43% females) were included. Adherence was 48% (35/73) in the intervention group, while 17% (12/71) of controls contaminated group allocation. Predictors for PA adherence were female sex (OR 2.35,
PMC10358195
Conclusion
der
DER, CHILDHOOD CANCER
Adherence to PA behavior interventions remain challenging in both groups. Further long‐term trials should consider intense motivational support within the first month, more detailed data collection for the control group, adjustments to power calculations and other study designs to minimize non‐adherence and contaminati...
PMC10358195
INTRODUCTION
cancer
CANCER
Physical activity (PA) is generally known to be associated with improved overall health including reduced all‐cause mortality, improved cardiovascular health, and lower risk of developing cancer.Many trials to increase PA are ineffective and show null results.The aim of this study was to describe and identify predictor...
PMC10358195
METHODS
PMC10358195
Trial design and participants
We used data from the SURfit study (ClinicalTrials.gov identifier: NCT02730767),
PMC10358195
Intervention and control conditions
Participants of the intervention group were asked to add ≥2.5 h of intense PA/week to their baseline activity level. Intense PA was reached when participants had a fast breathing/heartbeat for at least 20 min. Together with a physiotherapist, individualized PA programs were developed and self‐implemented into each surv...
PMC10358195
Outcome: Adherence and contamination
REGRESSION
PA levels of the intervention group were assessed by a web‐based diary filled out on daily basis. Automated reminders were sent out by email, and if participants were not responsive within 3 days, phone calls were initiated. In the diary, intervention participants registered each sport session performed, the duration a...
PMC10358195
Predictors
Predictors of adherence were not an a priori research question and were thus selected from our available data and a literature review, and on their ease to be assessed in clinical practice through simple questions at the beginning of an intended increase in PA.
PMC10358195
Statistical analyses
REGRESSION
We calculated the average PA h/week and the percentage of individual goal reached for the intervention group, overall and stratified for adherent/non‐adherent participants over the year, and for the first and second half of the 1‐year intervention period. We investigated the average number/duration of each PA session, ...
PMC10358195
RESULTS
CHILDHOOD CANCER
From a total of 1450 eligible CCS, 842 got invited for study participation whereof 151 (18%) were randomly assigned to one of the two treatment arms with 76 intervention and 75 control group participants. From those, seven participants were not included in the current analysis due to dropout reasons unrelated to the st...
PMC10358195
Details on adherence to the physical activity intervention
PA behavior
POSITIVE
Figure Percent of individual weekly physical activity goal reached based on self‐reported online diary entries. Accordingly, an example of an adherent (top) and non‐adherent (bottom) participant of the intervention group are displayed. Assessment periods at mid‐term (T6) and study end (T12) are highlighted and particip...
PMC10358195
Predictors of study adherence and contamination
Predictors of study adherence can be found in Table Predictors of study adherence for the intervention and contamination for the control group. Abbreviation: BMI, body mass index.
PMC10358195
DISCUSSION
cancer, PA behavior
CANCER
This analysis (To estimate the true treatment effect of an RCT, it is important that the intervention and the control group adhere to their allocated study program. The definition of adherence differs across exercise studiesPA hours of the intervention group were self‐reported in a web‐based diary, which has been succe...
PMC10358195
Strengths and limitations
cancer
CANCER, PHYSICAL HANDICAP
Strengths of our study include the RCT design and the long duration of a 1‐year individualized program. The schedule was embedded in each participant's daily living, allowing greatest flexibility in the planning and performing of PA as well as sustained behavioral change to take place. The PA program was followed‐up by...
PMC10358195
Practical implications
Our findings can help to improve future PA behavioral interventions. Trials should be aware of non‐adherence, especially in the beginning of a behavioral intervention. Our results showed that the attitude towards behavioral change was established in the first month of the intervention. Furthermore, contamination needs ...
PMC10358195
Conclusion
PA behavior
Adherence to the intervention, prevention of contamination in the control group and the assessment of their predictors are crucial to interpret efficacy and clinical relevance of PA behavior RCTs. Even with high motivational support, only half of the intervention group adhered to their expected exercise regimen, while ...
PMC10358195
AUTHOR CONTRIBUTIONS
PMC10358195
FUNDING INFORMATION
609020‐Scientia, Cancer
CANCER
Swiss Cancer League (KLS‐3175‐02‐2013), “Stiftung für krebskranke Kinder, Regio Basiliensis,” “Gedächtnis‐Stiftung Susy Rückert zur Krebsbekämpfung,” “Taecker‐Stiftung für Krebsforschung,” “Stiftung Henriette&Hans‐Rudolf Dubach‐Bucher,” “Stiftung zur Krebsbekämpfung,” “Stiftung Krebs‐Hilfe Zürich,” “Fondation Recherche...
PMC10358195
CONFLICT OF INTEREST STATEMENT
None.
PMC10358195
Supporting information
Figure S1. Click here for additional data file.
PMC10358195
ACKNOWLEDGMENTS
The authors thank all participants for taking part in our study and the study nurses, assistants, master students and physiotherapists for their great work.
PMC10358195
DATA AVAILABILITY STATEMENT
Data sharing is not applicable to this article as no new data were created or analyzed in this study.
PMC10358195
REFERENCES
PMC10358195
Background
EEG monitoring techniques are receiving increasing clinical attention as a common method of reflecting the depth of sedation in the perioperative period. The influence of depth of sedation indices such as the bispectral index (BIS) generated by the processed electroencephalogram (pEEG) machine to guide the management o...
PMC10557275
Methods
SECONDARY, POSTOPERATIVE COMPLICATIONS
A total of 141 participants aged ≥ 60 years undergoing abdominal major surgery were randomized to rEEG-guided anesthesia or routine care group. The rEEG-guided anesthesia group had propofol titrated to keep the rEEG waveform at the C-D sedation depth during surgery, while in the routine care group the anesthetist was m...
PMC10557275
Results
neurological and gastrointestinal complications
There were no statistically significant differences in the occurrence of postoperative respiratory, circulatory, neurological and gastrointestinal complications. Further EEG analysis revealed that lower frontal alpha power was significantly associated with a higher incidence of POD, and that rEEG-guidance not only redu...
PMC10557275
Conclusions
neurological and gastrointestinal complications
In elderly patients undergoing major abdominal surgery, rEEG-guided anesthesia did not reduce the incidence of postoperative respiratory, circulatory, neurological and gastrointestinal complications. rEEG-guided anesthesia management reduced the duration of intraoperative BS in patients and the duration of over-deep se...
PMC10557275
Keywords
PMC10557275
Introduction
neurocognitive disorders, rEEG-based intraoperative visual
Intraoperative neuromonitoring allows monitoring of the changes in brain electrical activity during the changing states of consciousness under general anesthesia and offers information on anesthesia depth. EEG monitoring can help anesthesiologists to avoid the use of unnecessary high anesthetics doses, which is able to...
PMC10557275
Materials and methods
MAY
This single-center and randomized controlled trial compared the outcomes of two parallel groups, which were the rEEG-guided group and the routine care group. The research was approved by the Clinical Research Ethics Committee of the First Affiliated Hospital of Anhui Medical University Institutional Review Board (IRB n...
PMC10557275
Participants
psychiatric illness, dementia
The male or female patients over 60 years old scheduled for elective major abdominal surgery were involved. Below present the exclusion criteria: patient refusal, a history of dementia or psychiatric illness, difficulty with follow-up, or poor compliance.
PMC10557275
Randomization, blinding, and allocation concealment
RECRUITMENT
By using randomized closed envelopes, the randomization procedure was carried out by the responsible senior consultant. The group allocation was performed following the recruitment through the opening of the sequential envelopes. The anesthesiologists were not masked due to the nature of the anesthetic technique. The p...
PMC10557275
Intervention
After the participants entered the operation room, the five-lead electrocardiogram (ECG), invasive blood pressure via a radial artery, and pulse oxygen saturation (SpO EEG tracing at various stages of anesthesia
PMC10557275
Outcomes and data collection
loss of consciousness
RESPIRATORY COMPLICATIONS, COMPLICATIONS
The demographic and hospital characteristics of the patients, such as age, body mass index, gender, coexisting medical conditions, type of operation (laparotomy or laparoscopy) were all recorded. Intraoperative data on the procedure and anesthesia were recorded, including time of induction of anesthesia (midazolam star...
PMC10557275
EEG processing
A 4-channel Sedline brain function monitor (Masimo, Irvine, CA, USA) was used for forehead EEG acquisition. The electrodes for the sensors record EEG between Fp1, Fp2, F7 and F8 with the ground electrode at Fpz, and the reference electrode at roughly 1 cm more than Fpz. A sampling rate of 178 Hz (16 bits) and a preampl...
PMC10557275
Statistical analysis
ADVERSE EVENTS
In this trial, the sample size was estimated for an α level of 0.05 and 90% power in order to detect a 10% difference in the occurrence between groups. On the basis of the preliminary results, the incidence of adverse events after surgery was indicated to be 50% in the routine care group, and we calculated that a sampl...
PMC10557275
Results
gastrointestinal, hepatobiliary-pancreatic), arthritis
MAY, ARTHRITIS
141 patients that had undergone abdominal major surgeries from November 2020 to May 2022 (e.g., gastrointestinal, hepatobiliary-pancreatic) were included in the trial. Among them, 69 were randomized to the rEEG-guided group and 72 to the routine care group, respectively. Taking into account the 5 patients within the rE...
PMC10557275
Primary outcomes
Postoperative pain
INTRAOPERATIVE COMPLICATIONS
There were no intraoperative complications in either group. There was no statistically significant difference in respiratory, cardiovascular, gastrointestinal and neurological complications between the two groups (P > 0.05). The incidence of POD was 3% in the rEEG-guided group compared to 11% in the routine care group,...
PMC10557275
Secondary outcomes
SD
In both groups, no statistically significant difference was found in the surgery type or location. There was a total of 5 patients with BS, with an incidence of 8% and a median BS duration of 5.3s in the rEEG-guided group, while the routine care group had 12 patients with BS. There was no statistically significant diff...
PMC10557275
Subgroup analyses
PMC10557275
Frontal alpha power and POD
Patients that suffer from a lower alpha power are reported to be more prone to the development of BS under anesthesia [ The receiving operating characteristic curves for the model
PMC10557275
Subgroup analysis on sedation and postoperative complications
POSTOPERATIVE COMPLICATIONS
Alpha oscillations can be viewed to be a neurophysiological biomarker of brain vulnerability [ Examples of high(left) and low(right) alpha power within a left frontal spectral display. The vertical axis is frequency (Hz). The blue and red colors represent low and high power (dB). The horizontal axis is time (s). The da...
PMC10557275
Discussion
neurological and gastrointestinal complications
POSTOPERATIVE COMPLICATIONS
In the randomized controlled trial, the impact of the raw EEG guidance of anesthesia on postoperative complications after surgery in older adults (≥ 60) undergoing major abdominal surgery was assessed. There was no statistically significant difference between the two groups in terms of postoperative respiratory, cardio...
PMC10557275
Acknowledgements
We thank our departmental colleagues for their help in recruiting patients for this study.
PMC10557275
Authors’ contributions
EG, LC and LZ designed this study. ZH and YX wrote the manuscript. ZH, YX, HZ, JL and YG performed the experiments. ZH and YH assisted with data analysis. EG and LC revised the final manuscript. All authors read and approved the final manuscript.
PMC10557275
Funding
This study was supported by China primary health care foundation (YLGX-WS-2020001 to Lijian Chen) and China primary health care foundation (WKZX2023CX170005 to Guanghong Xu) which provided funds for collection and analysis of clinical data.
PMC10557275
Data Availability
The datasets used and/or analysed during the current study available from the corresponding author on reasonable request.
PMC10557275
Declarations
PMC10557275
Ethics approval and consent to participate
MAY
The research was approved by the Clinical Research Ethics Committee of the First Affiliated Hospital of Anhui Medical University Institutional Review Board (IRB number: No. PJ2020-13-09), and written informed consent was obtained from each subject that attends the trial. In addition, the trial was registered before pat...
PMC10557275
Consent for publication
Not applicable.
PMC10557275
Competing interests
The authors declare no competing interests.
PMC10557275
Abbreviations
analgesiaPost-anesthesia
American Society of AnesthesiologistsBispectral indexBody mass indexBurst suppressionBurst suppression ratioBlood pressureConfidence intervalElectroencephalogramElectrocardiogramGamma-aminobutyric acidIntensive care unitMean arterial pressureNumeric rating scalesProcessed electroencephalogramPatient controlled intraven...
PMC10557275
References
PMC10557275
Background
In this study, we investigated the impact of 10.6-μm CO
PMC10666435
Methods
KOA
A total of 392 individuals diagnosed with KOA and meeting the specified eligibility criteria were assigned randomly into two groups: the LM treatment group and the sham LM control group (ratio 1:1). Both groups received either LM therapy or simulated LM therapy to address the affected area of the knee joint. This treat...
PMC10666435
Results
In the LM group, the fastest 15-m walking times at both Week 4 and Week 12 were significantly reduced compared to the times before treatment (all
PMC10666435
Conclusion
The use of CO
PMC10666435
Keywords
PMC10666435
Introduction
Knee osteoarthritis, pain, KOA
KNEE OSTEOARTHRITIS
Knee osteoarthritis (KOA) is a common source of impairment in the elderly [White et al. examined gait speed over a distance of 20 m in patients with KOA aged 45–79. Their findings revealed a significant reduction in gait speed at this shorter distance among patients experiencing pain symptoms [
PMC10666435
Materials and methods
PMC10666435
Ethical approval and protocol registration
This research involved a double-blind, sham-controlled, multi-site randomized trial. The details of this trial can be accessed at this URL:
PMC10666435
Sample size and recruitment
Previous studies revealed that laser moxibustion showed a significant improvement rate of 14.1% in fast walking time, while the sham laser moxibustion group only exhibited a rate of 4.8%. There was a significant difference between the two groups (To determine the appropriate sample size, a power analysis was conducted ...
PMC10666435
Eligibility criteria, randomization, and blinding
PMC10666435
Inclusion criteria
arthritic pain, knee pain, knee osteoarthritis
KNEE OSTEOARTHRITIS
Prior to enrollment, a specialist doctor conducted an assessment of knee joint function in the patients. Anteroposterior and lateral X-ray images were obtained for the affected joint, and inclusion criteria were applied to select the subjects for the study.Age 50 to 75 years.According to the American College of Rheumat...
PMC10666435