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Statistical Analysis
The statistical analyses were performed using IBM SPSS Statistics for Windows, version 23.0 (IBM Corp, Armonk, NY, USA). We analyzed the data using an intention-to-treat analysis. For participants with incomplete or missing data, we used the maximum-likelihood method for imputation [Descriptive characteristics are pres...
PMC10337399
Results
PMC10337399
Primary Outcomes
PMC10337399
Blood Sugar Control
There were no significant differences in the FPG and HbAThe GEE analyses revealed no significant group differences in FPG. The HbA
PMC10337399
Body Constitution
TCM
The TCM mHealth app group scored the highest in The GEE analyses indicated that the TCM mHealth app group showed significant improvements in
PMC10337399
Body Energy
TCM
There were no significant differences in body energy among the three groups at the three time points. Body energy increased significantly from T1 to T2 and from T1 to T3 in the TCM mHealth app group, but remained unchanged in the ordinary mHealth app and control groups (The GEE results indicated that the TCM mHealth ap...
PMC10337399
Health-Related Quality of Life
TCM
There were no significant differences in the PCS among the three groups at the three time points. The TCM mHealth app group had a significant increase in the PCS from T1 to T2 and from T1 to T3. The ordinary mHealth app group also had a significant increase in the PCS from T1 to T3 (With regard to the MCS, the TCM mHea...
PMC10337399
Secondary Outcomes
PMC10337399
BMI
There were no significant differences in BMI among the three groups at the three time points (The GEE results indicated that the TCM mHealth app group showed a significant decrease in BMI at T3 compared to that in the control group (
PMC10337399
Dietary Behavior
There were no significant differences in the DASH dietary behavior among the three groups at the three time points (
PMC10337399
Physical Activity
The ordinary mHealth app group had a significantly higher PA level than that of the other two groups across all three time points (
PMC10337399
Discussion
PMC10337399
Principal Findings
prediabetes, foods/PA, TCM
PREDIABETES
This RCT found that the TCM mHealth group showed better HbAPrevious studies showed that using an mHealth app improved HbAThe TCM dietary and PA advice used in the TCM mHealth app is mainly based on the types of foods/PA to avoid and those to consume/practice based on the individual’s body constitution. Qigong, includin...
PMC10337399
Limitations
prediabetes
PREDIABETES
This study has several limitations. First, most participants were from an outpatient department and had chronic conditions. Therefore, this sample may have had more complex health problems than present in people with prediabetes alone. The participants may be more homogeneous since they were from one single center. Sec...
PMC10337399
Conclusion
prediabetes, TCM
SECONDARY, PREDIABETES
We developed a TCM mHealth app to incorporate TCM concepts into an mHealth app for individuals with prediabetes. Compared to controls not using the app, the TCM mHealth app appeared to be effective in improving HbAThis study was funded by the Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation (TCRD-TPE-109-05...
PMC10337399
Abbreviations
diabetes
DIABETES
Body Constitution QuestionnaireDietary Approaches to Stop HypertensionDiabetes Prevention Programfasting plasma glucosegeneralized estimating equationhemoglobin Ahealth-related quality of lifemental component scoreMeridian Energy Analysis Devicemetabolic equivalentmobile healthphysical activityphysical component scorer...
PMC10337399
Data Availability
All data generated or analyzed during this study are included in this published article and its supplementary information files.
PMC10337399
Background
NEUROMUSCULAR BLOCKADE
Sugammadex is a newer medication used for rapid and reliable reversal of neuromuscular blockade. This study evaluated whether sugammadex could reduce the length of postoperative hospital stay in patients undergoing abdominal surgery.
PMC9875499
Methods
REGRESSION, SECONDARY, PULMONARY COMPLICATIONS
This single center retrospective cohort study included patients who underwent major abdominal surgery between January 2015 and October 2019. Patients were randomized according to reversal with sugammadex or spontaneous recovery. The primary outcome was length of postoperative hospital stay. The secondary outcomes were ...
PMC9875499
Results
Of the 1614 patients, 517 received sugammadex and 645 spontaneously recovered. After adjusting for potential confounders, non-linear relationship was detected between administration of sugammadex and the length of postoperative hospital stay (β = 0.29 95% confidence interval {CI}: [− 1.13, − 0.54],
PMC9875499
Conclusions
Neuromuscular blockade, pneumonia
NEUROMUSCULAR BLOCKADE, PNEUMONIA
Neuromuscular blockade reversal with sugammadex after abdominal surgery demonstrated an excellent recovery profile and was associated with decreased risk of pneumonia, although it did not affect the length of postoperative hospital stay.
PMC9875499
Supplementary Information
The online version contains supplementary material available at 10.1186/s12871-023-01979-4.
PMC9875499
Keywords
PMC9875499
Introduction
respiratory complications
RESPIRATORY COMPLICATIONS, NEUROMUSCULAR BLOCKADE
Neuromuscular blockade (NMB) is commonly used in anesthesia to facilitate endotracheal intubation and optimize surgical conditions, including during abdominal surgery [Sugammadex is a cyclodextrin that selectively binds to free rocuronium (a neuromuscular blocker) molecules in plasma. Contrary to acetylcholinesterase i...
PMC9875499
Methods
PMC9875499
Ethical statements
cancer, Cancer
CANCER, RECRUITMENT, CANCER
This study was approved by the Ethics Committee of the Jiangsu Cancer Hospital on 30 March, 2020 (approval number: R-2020-039). Patient consent was waived because of the retrospective study design. The authors did not obtain information identifying individual participants during or after data collection.In this single-...
PMC9875499
Patient involvement
Only the medical records of patients were collected, identified, and reviewed. Therefore, patients were not involved in the design and conduct of the study, selection of outcome measures, or study enrollment.
PMC9875499
Sugammadex
Rocuronium, a neuromuscular blocking agent, was administered during major abdominal surgery. Following the operation, all patients were transferred to the PACU. Anesthetists could decide whether or not to use sugammadex according to their discretion. Time of administration of sugammadex depends on the anesthesia team’s...
PMC9875499
Hospital and PACU stays
bleeding, pneumonia, atelectasis
POSTOPERATIVE COMPLICATION, BLEEDING, PNEUMONIA, ATELECTASIS
Length of stay was defined as the number of days in the postoperative hospital stay.The length of post-anesthetic care unit (PACU) stay was the duration spent in the PACU. PACU discharge criteria were as follows: (1) awake and recovery of airway protective reflex; (2) hemodynamic stability; (3) recovery of spontaneous ...
PMC9875499
Statistical analysis
REGRESSION
A propensity score matching (PSM) method was applied to minimize bias associated with confounding variables. Age (> 70 years), BMI score, ASA score (Classes 1, 2, and ≥ 3), preoperative comorbidities, duration of anesthesia, duration of surgery, intraoperative remifentanil dose, muscle relaxant dose, and type of surger...
PMC9875499
Results
PMC9875499
Patients’ demographic data
This study was conducted between January 2015 and October 2019. Of the total of 1614 patients who underwent major abdominal surgery, 421 who were aged > 70 years, and 31 whose BMI were > 35 kg/mThe demographic characteristics of the patients included in the study are presented in Supplementary Table
PMC9875499
Comparison of postoperative outcomes in the two groups
POSTOPERATIVE COMPLICATIONS
The results on the primary outcomes are presented in Table Primary postoperative outcomes before and after propensity score-matchingThe length of PACU stay were shorter in the sugammadex group than in the spontaneously recovered group and similar findings were observed in the propensity pair matched cohort (51.86 ± 27....
PMC9875499
Univariate analysis
The results of univariate analysis are presented in Supplementary Table
PMC9875499
Results of relationship between sugammadex with postoperative outcomes
diabetes
REGRESSION, HYPERTENSION, CEREBRAL INFARCTION, DIABETES
Subsequently, we performed mixed-effects linear regression analysis for factors related to postoperative outcomes as presented in Supplementary Table Effect of sugammadex on postoperative recovery, based on a propensity score-matched cohortsNon-adjusted model adjust for: NoneAdjust I adjust for: sex; age; ASA; BMI; hyp...
PMC9875499
Discussion
pneumonia, postoperative pulmonary complications, peristalsis, Postoperative pulmonary complication, Early postoperative neuromuscular recovery, gastrointestinal motility
PNEUMONIA, COMPLICATION OF ANESTHESIA, DELAYED RECOVERY FROM ANESTHESIA, POSTOPERATIVE COMPLICATIONS
Our study demonstrated that intraoperative administration of sugammadex significantly reduced the time to passage of flatus or feces and dramatically reduced PACU length of stay. However, there was no impact on the length of postoperative hospital stay.The results of our study suggested that sugammadex has a significan...
PMC9875499
Conclusions
PULMONARY COMPLICATIONS
The results of this study revealed that administration of sugammadex did not shorten hospital stay after abdominal surgery. Sugammadex was useful in decreasing recovery time in the PACU without an increase in pulmonary complications.
PMC9875499
Acknowledgements
Not applicable.
PMC9875499
Authors’ contributions
Conceptualization, J T and Z S; Methodology, J T.; Software, L W; Validation, P L, Z S and Q B; Formal Analysis, J T and J H; Investigation, J T and L W; Resources, J T; Data Curation, J F; Writing – Original Draft Preparation, J T; Writing – Review & Editing, J T, Z S and Qi B; Supervision, Z S and Q B; Project Admini...
PMC9875499
Funding
This research received no specific grant from any funding agency, commercial or not-for-profit sectors.
PMC9875499
Availability of data and materials
All data generated or analyzed during this study are included in this published article and its supplementary information file.
PMC9875499
Declarations
PMC9875499
Ethics approval and consent to participate
Cancer
CANCER
The study was conducted according to the guidelines of the Declaration of Helsinki, and approved by the Ethics Committee of Jiangsu Cancer Hospital (Nanjing, China). Approval number: R-2020-039; Approval date: 5 November, 2020. This article is a retrospective study; therefore, the Ethics Committee of Jiangsu Cancer Hos...
PMC9875499
Consent for publication
Not applicable.
PMC9875499
Competing interests
The authors declare that they have no competing interests.
PMC9875499
References
PMC9875499
Background
diabetes
CHRONIC DISEASES, DIABETES
Patient empowerment through pharmacological self-management is a common strategy in some chronic diseases such as diabetes, but it is rarely used for controlling blood pressure.
PMC9849508
Objective
hypertensive
This study aimed to assess self-monitoring plus self-titration of antihypertensive medication versus usual care for reducing systolic blood pressure (SBP) at 12 months in poorly controlled hypertensive patients.
PMC9849508
Design
The ADAMPA study was a pragmatic, controlled, randomized, non-masked clinical trial with two parallel arms in Valencia, Spain.
PMC9849508
Participants
Hypertensive
Hypertensive patients older than 40 years, with SBP over 145 mmHg and/or diastolic blood pressure (DBP) over 90 mmHg, were recruited from July 2017 to June 2018.
PMC9849508
Intervention
Participants were randomized 1:1 to usual care versus an individualized, pre-arranged plan based on self-monitoring plus self-titration.
PMC9849508
Main Measure
AMD
The primary outcome was the adjusted mean difference (AMD) in SBP between groups at 12 months.
PMC9849508
Key Results
Primary outcome data were available for 312 patients (intervention
PMC9849508
Conclusion
ADVERSE EVENTS
Self-monitoring plus self-titration of antihypertensive medication based on an individualized pre-arranged plan used in primary care may be a promising strategy for reducing blood pressure at 12 months compared to usual care, without increasing healthcare utilization or adverse events.
PMC9849508
Trial Registration
EudraCT, number 2016-003986-25 (registered 17 March 2017) and
PMC9849508
Supplementary Information
The online version contains supplementary material available at 10.1007/s11606-022-07791-z.
PMC9849508
KEY WORDS
PMC9849508
BACKGROUND
Cardiovascular diseases, premature death, hypertensive, hypertension, disability, diabetes
CHRONIC DISEASES, HYPERTENSION, CARDIOVASCULAR DISEASE, DIABETES
Cardiovascular diseases are the main cause of disability and premature death worldwide,Among the array of interventions proposed to improve BP control,Patient empowerment through pharmacological self-management is a common strategy in some chronic diseases such as diabetes, but it is rarely used for controlling BP. Whe...
PMC9849508
METHODS
PMC9849508
Study Design
The ADAMPA study is a pragmatic, controlled, randomized, non-masked clinical trial with two parallel arms. It took place in a Valencia health district (Spain) and involved 36 family doctors (27 of whom recruited patients from 15 primary healthcare centers). The study protocol was published elsewhere.
PMC9849508
Setting
RECRUITMENT
The ADAMPA study took place in one health district of the Valencia health system, serving a population of 345,000 inhabitants. This district is part of an extensive network of public hospitals and primary healthcare centers, part of the Spanish National Health System, which provides virtually universal healthcare that ...
PMC9849508
Participants
hypertension
UNCONTROLLED HYPERTENSION, HYPERTENSION
Patients with a diagnosis of hypertension in their electronic medical record, aged 40 years and over, with uncontrolled hypertension (mean BP reading on the reference arm of systolic BP (SBP) > 145 mmHg or diastolic BP (DBP) > 90 mmHg on the baseline examination) and voluntarily agreeing to join the study were eligible...
PMC9849508
Randomization and Blinding
Family doctors recruited potentially eligible patients, performed a preliminary examination, and obtained written informed consent from participants. The sample was randomized in a 1:1 ratio using a centralized online randomization system to usual care or self-management. A minimization strategyADAMPA patient flow char...
PMC9849508
Intervention
hypertension, Hypertension
HYPERTENSION, HYPERTENSION
In the intervention group, the family doctor established with each patient a reference arm to measure blood pressure and an individualized BP target. These individualized goals were decided by the physician in conjunction with the patient, who received the European Society of Hypertension (ESH) and the European Society...
PMC9849508
Outcomes
AMD
The primary outcome of the study was the adjusted mean difference (AMD) in systolic blood pressure between the intervention and control groups at 12 months. At baseline (before randomization) and follow-up visits at the primary care health center, at least two BP readings were taken in a seated position, at 1- to 2-min...
PMC9849508
Sample Size
A sample size of 382 patients was estimated in order to have 90% power to detect a 5 mmHg (SD 15 mmHg) difference in SBP between groups (primary outcome) with a two-tailed contrast and an alpha error of 0.05. This figure represents a clinically relevant difference based on previous trials.
PMC9849508
Statistical Analysis
obesity, angina, chronic kidney disease, peripheral artery disease, diabetes
ACUTE MYOCARDIAL INFARCTION, OBESITY, PERIPHERAL ARTERY DISEASE, ADVERSE EVENTS, SECONDARY, CEREBROVASCULAR DISEASE, DIABETES
The analysis was performed on an intention-to-treat basis. A descriptive analysis of the groups’ baseline characteristics was performed using the Stratified analyses of between-group MD in SBP at 12 months, with their corresponding 95% CIs, were estimated according to gender, age (40 to 64 years, 65 to 79 years, and ≥ ...
PMC9849508
Discussion
obesity, BP reduction, diabetes, hypertensive, hypotensive syncope
OBESITY, ADVERSE EVENTS, DIABETES, SECONDARY, HYPOTENSIVE SYNCOPE
The ADAMPA trial assessed the effectiveness of an intervention combining home blood pressure self-monitoring plus self-titration of antihypertensive medication (based on an individualized pre-arranged plan) and educational components versus usual care (also with educational components) in poorly controlled hypertensive...
PMC9849508
CONCLUSIONS
ADVERSE EVENTS
Self-management of blood pressure including home blood pressure monitoring, educational components, and patients’ self-titration of antihypertensive medication based on an individualized pre-arranged plan in the primary care setting may be a promising strategy for reducing blood pressure compared to usual care at 12 mo...
PMC9849508
Contributors
The authors acknowledge the trial sponsor INCLIVA Health Research Institute; its Scientific Deputy Director, Marta Peiró Signes; the rest of the staff for their support; and all the participants for their invaluable contribution to this study. We also want to acknowledge Maria Teresa García for her support with the ele...
PMC9849508
Funding
The ADAMPA study was funded by the Instituto de Salud Carlos III from the Spanish Ministry of Research, Innovation and Universities (Grant Pl16/02130 and RD16/0001/0011, cofinanced by the European Regional Development Fund) and had the collaboration of the SCReN Platform (Spanish Clinical Research Network from the Ins...
PMC9849508
Availability of Data
The datasets used and/or analyzed during the current study are available from the corresponding author on reasonable request.
PMC9849508
Declarations
PMC9849508
Ethics Approval
MAY, RECRUITMENT
The clinical research ethics committee (CEIC-HCUV) approved the study protocol on 27 April 2017, as did the Spanish Agency for Medicines and Health Products (AEMPS; Reference: MUH/CLIN/EC dated 5 May 2017). All participants signed informed consent prior to enrolment in the study. None of the health professionals involv...
PMC9849508
Conflict of Interest
The authors declare that they do not have a conflict of interest.
PMC9849508
References
PMC9849508
BACKGROUND:
preterm preeclampsia, prematurity
Early delivery in preterm preeclampsia may reduce the risks for the patient, but consequences of prematurity may be substantial for the baby. This trial evaluated whether the implementation of a risk stratification model could safely reduce prematurity.
PMC10510842
METHODS:
preeclampsia
PREECLAMPSIA
This was a stepped-wedge cluster-randomized trial in seven clusters. Patients presenting with suspected or confirmed preeclampsia between 20
PMC10510842
RESULTS:
EVENT
Between March 25, 2017 and December 24, 2019, 586 and 563 patients were analyzed in the intervention and usual care groups, respectively. The event rate was 1.09% in the intervention group, and 1.37% in the usual care group. After prespecified adjustments for variation between and within clusters over time, the adjuste...
PMC10510842
CONCLUSIONS:
preeclampsia
DISEASE, PREECLAMPSIA
The introduction of an intervention based on biomarkers and clinical factors for risk stratification did not lead to reductions in preterm deliveries. Further training on the interpretation of disease severity in preeclampsia and the development of additional risk stratification is needed before adoption into clinical ...
PMC10510842
REGISTRATION:
URL:
PMC10510842
NOVELTY AND RELEVANCE
PMC10510842
What Is New?
preeclampsia
PREECLAMPSIA
This is the first study to combine clinical and laboratory information from the fullPIERS algorithm in the care of patients with suspected or confirmed preeclampsia with the sFlt-1 (soluble fms-like tyrosine kinase-1)/PlGF (placental growth factor) ratio.
PMC10510842
What Is Relevant?
preterm preeclampsia, prematurity
PREECLAMPSIA
Early delivery in preterm preeclampsia may reduce the risks for the patient, but consequences of prematurity may be substantial for the baby. Developing risk stratification models to support decisions is a challenge in clinical practice. The risk stratification demonstrated in this study did not lead to reduction in pr...
PMC10510842
Clinical/Pathophysiological Implications?
Prematurity, preterm preeclampsia, Preeclampsia, preeclampsia
DISORDER, PRETERM BIRTH, PREMATURITY, PREECLAMPSIA, COMPLICATIONS, PREECLAMPSIA, PERINATAL MORBIDITY
It is important to consider different sFlt-1/PlGF ratio and fullPIERS thresholds for maternal and perinatal outcomes, mainly preterm deliveries. Additionally, developing a continuous knowledge transfer program to help care providers to gain confidence with new tests is crucial for implementation. Preeclampsia is a comp...
PMC10510842
METHODS
PMC10510842
Data Availability
The data that support the findings of this study are available from the corresponding author upon reasonable request.
PMC10510842
Study Design
PREECLAMPSIA
This was a stepped-wedge, cluster-randomized trial for the implementation of an intervention at the hospital level to evaluate whether this risk stratification model could safely reduce the incidence of preterm deliveries among patients with suspected or confirmed preeclampsia. The trial was conducted in seven tertiary...
PMC10510842
Participants
eclampsia, renal, cardiac or respiratory failure, abruption, coma, hemolysis, preeclampsia
ECLAMPSIA, SYNDROME, COMA, HEMOLYSIS, PREECLAMPSIA, NONREASSURING FETAL STATUS
Patients presenting with suspected or confirmed preeclampsia between 20Patients with multifetal gestations or those presenting with a diagnosis of fetal demise, nonreassuring fetal status necessitating immediate delivery at admission, eclampsia, hemolysis, elevated liver enzymes, low platelets syndrome, renal, cardiac ...
PMC10510842
Randomization and Masking
preeclampsia
EVENT, PREECLAMPSIA
Randomization was undertaken by the trial statistician through a computer-generated blocking list at the start of the trial. Random ordering was selected to minimize the rank correlation between the historical event rate and the order of implementation. The timing of implementation of the intervention to each center wa...
PMC10510842
Procedures
Preeclampsia, seizure
PREECLAMPSIA
Once the center had transitioned to implement the intervention, all patients had sFlt-1/PlGF ratio measurement and fullPIERS assessment performed as part of their routine care, and results were revealed to the clinicians. sFlt-1 and PlGF were measured using the Elecsys Preeclampsia Platform (Roche Diagnostics) and the ...
PMC10510842
Outcomes
PMC10510842
Primary Outcome
preterm preeclampsia
Proportion of patients with preterm preeclampsia who delivered <37 weeks’ gestation/total deliveries.
PMC10510842
Secondary Outcomes
death, stroke, eclampsia, coma, preterm preeclampsia, hepatic dysfunction, stillbirth, hemolysis, renal dysfunction
STROKE, THROMBOCYTOPENIA, ECLAMPSIA, PULMONARY EDEMA, SYNDROME, COMA, HEMOLYSIS, PREECLAMPSIA
Proportion of patients with preterm preeclampsia who delivered <37 weeks’ gestation/total deliveries for preeclampsia,Proportion of patients with preterm preeclampsia who delivered <34 weeks’ gestation/total deliveries for preeclampsia,Prolongation of pregnancy.Additional maternal outcomes investigated included materna...
PMC10510842
Statistical Analysis
preterm preeclampsia, prematurity
EVENT, SECONDARY, REGRESSION, PRETERM DELIVERY, HYPERTENSION, PREECLAMPSIA
We planned the study around seven clusters, each involving 1 center, and therefore 8 steps each of 4 months; and a total trial length of 8×4=32 months. Based on hospital records, we assumed an average of 330 deliveries per month in each center; and 990 per step (allowing for some delay in the full implementation of the...
PMC10510842
DISCUSSION
prematurity, eclampsia, preeclampsia
PRETERM BIRTH, ECLAMPSIA, HYPERTENSIVE DISORDER, ELEVATED BLOOD PRESSURE, PREECLAMPSIA
The trial aimed to evaluate whether a combination of the sFlt-1/PlGF ratio and the fullPIERS algorithm, by classifying patients with suspected or diagnosed preeclampsia as low risk for adverse outcomes and therefore suitable for expectant management, would safely lead to a reduction in preterm deliveries.The main findi...
PMC10510842
Perspectives
eclampsia, preeclampsia
PRETERM BIRTH, HYPERTENSION, ECLAMPSIA, PREECLAMPSIA
To our knowledge, this is the first study to combine clinical and laboratory information from the fullPIERS algorithm with the sFlt-1/PlGF ratio in the care of patients with suspected or confirmed preeclampsia. The main findings of our trial showed that the introduction of a new methodology for evaluating patients with...
PMC10510842
ARTICLE INFORMATION
PMC10510842
Acknowledgments
Prematurity, Preeclampsia
PREMATURITY, PREECLAMPSIA
The authors thank the independent Data Monitoring Committee. The authors thank all collaborators at the participant centers and their obstetricians, nurses and midwives involved in trial enrollment and management of patients. The authors thank the supporters of the study. This trial was supported by grants from Bill & ...
PMC10510842
Sources of Funding
Bill & Melinda Gates Foundation (OPP1142172), Conselho Nacional de Desenvolvimento Científico e Tecnológico—CNPq and the Brazilian Ministry of Health Brazil (401718/2015-8), Roche Diagnostics. The funders of the study had no role in study design, data collection, data analysis, data interpretation, or writing of the re...
PMC10510842