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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 presented as percentages or as means and SD, as appropriate. We used the paired | PMC10337399 |
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Results | PMC10337399 |
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Primary Outcomes | PMC10337399 |
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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 |
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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 |
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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 app group showed a significant increase in body energy at T3 compared to that in the ordinary mHealth group ( | PMC10337399 |
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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 mHealth app group had a significantly higher score at T2 compared with that of the control group (The GEE results indicated that the TCM mHealth app group had a significant increase in the PCS and MCS at T2 and T3 compared with that of the control group ( | PMC10337399 |
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Secondary Outcomes | PMC10337399 |
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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 |
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Dietary Behavior | There were no significant differences in the DASH dietary behavior among the three groups at the three time points ( | PMC10337399 |
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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 |
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Discussion | PMC10337399 |
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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, including belly breathing and Baduanjin, was recommended for all participants since these exercises can improve When compared to the ordinary mHealth app group, the TCM mHealth app group did not differ significantly in improving body constitution and HbAOur study showed that both the TCM and ordinary mHealth app groups exhibited a significant improvement in HbAThis study showed effectiveness of the intervention in HbAIn this study, we found that the TCM mHealth app effectively improved the Finally, the TCM mHealth app group did show significant improvements in body constitution and body energy in our study, while the other two groups did not show changes in these factors over time. These results suggest that medical practitioners could provide the TCM mHealth app to individuals with prediabetes, through which Qigong and a Chinese dietary regimen can improve body energy, body constitution, and HRQOL. Studies with a larger sample size and longer follow-up period are needed to compare the effectiveness of the two different approaches. | 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. Second, the sample size was small. The limited sample size may be the reason for some statistically insignificant results when comparing between groups. Third, the study was an open-label trial where participants were aware of their group assignments; thus, performance bias was possible. Fourth, the study used a 12-week intervention and a 1-month follow-up period according to previous TCM lifestyle programs [ | 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). The publication fee for this manuscript is funded by the National Science and Technology Council, Taiwan (MOST 111-2314-B-A49-011-MY3).Conflicts of Interest: None declared.Definitions of terms in traditional Chinese medicine.Screenshots of the ordinary and TCM mHealth apps.Taxonomy of the behavior change techniques used in the mHealth app.CONSORT-EHEALTH checklist.Comparison of the primary and secondary outcomes among the TCM mHealth app, ordinary mHealth app, and control groups (N=121).Generalized estimating equation models to compare the differences among the three groups, using the control group as the reference.Generalized estimating equation models to compare the outcomes between the TCM mHealth app (n=42) and ordinary mHealth app groups (n=41). | 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 scorerandomized controlled trialMedical Outcome Survey Short-Formtype 2 diabetes mellitustraditional Chinese medicine | PMC10337399 |
Data Availability | All data generated or analyzed during this study are included in this published article and its supplementary information files. | PMC10337399 |
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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 |
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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 length of post-anesthetic care unit (PACU) stay, postoperative ambulation time, time-to-first-defecation, and incidence of pulmonary complications. After 1:1 propensity score matching, univariate and multiple linear regression analyses estimated the differences in outcomes. | PMC9875499 |
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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 |
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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 |
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Keywords | PMC9875499 |
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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 inhibitors, sugammadex directly encapsulates rocuronium; hence, it facilitates rapid NMB reversal [Enhanced recovery after surgery is garnering considerable attention. According to our observations, patients undergoing major abdominal surgery are at a high risk of perioperative respiratory complications due to their poor physical condition or multiple co-morbidities. Therefore, methods to ensure safe and effective rapid postoperative recovery are important considerations for surgeons and anesthesiologists.Previous studies have reported that length of hospital stay is considered an important indicator for evaluating postoperative functional recovery [ | PMC9875499 |
Methods | PMC9875499 |
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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-center retrospective observational study, 1614 consecutive patients who underwent abdominal surgery in our institution between January 2015 and October 2019 (Time of patient recruitment) were enrolled. The baseline, intraoperative, postoperative, clinical, and follow-up data of each patient were collected and retrospectively reviewed in November 2020. Physical characteristics included age, body mass index (BMI) (kg/mPatients with cancer who were scheduled for elective major abdominal surgery under general anesthesia with total intravenous anesthesia were included in the study. The exclusion criteria were as follows: (1) age < 18 years or > 70 years; (2) BMI ≥35 kg/m | 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 |
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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 clinical judgment [ | PMC9875499 |
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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 breathing, maintain airway patency, airway protective reflex recovery, respiration and oxygenation returned to preoperative basal levels (4) no obvious active bleeding, electrolyte and acid-base imbalances, and urine volume > 0.5 ml/kg/h.Postoperative complications were confirmed through review of medical records and plain film radiographs or computed tomography images for the diagnosis of atelectasis and pneumonia. | 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 surgery were matched as covariates. A 1:1 ratio matching was performed based on the propensity score with a standard caliper width of 0.2.After confirming balance in the matched cohort with generalized linear models with a logarithmic link function, Wilcoxon signed-rank test was applied for propensity-matched patients; results of dichotomous variables were expressed as relative risk (RR) and 95% confidence intervals (95% CI). Mann-Whitney U test was used for continuous outcomes in all patients. Univariate and multiple linear regression analyses were applied after PSM to evaluate the difference between the groups of length of hospital stay, time-to-first-defecation, postoperative ambulation time, and length of PACU stay. | PMC9875499 |
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Results | PMC9875499 |
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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 |
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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 ± 27.9 vs 32.82 ± 21.9 min, 52.56 ± 29.0 vs 32.77 ± 22.3 min, respectively; Regarding postoperative complications of matched cohorts in both spontaneously recovered and sugammadex groups (Table Postoperative outcomes before and after propensity score-matchingData are N (%), The Fisher’s exact test for dichotomous outcomes in all patients, | PMC9875499 |
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Univariate analysis | The results of univariate analysis are presented in Supplementary Table | PMC9875499 |
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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; hypertension; diabetes; cerebral infarction; smoking history; drinking; heart diseaseAdjust II adjust for: operation duration (minutes); dosage of muscle relaxant (mg); laparoscopic surgery; type of surgery; total remifentanil | 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 significant effect on the recovery of gastrointestinal motility concurrent with previous studies [Nevertheless, in our study, people in sugammadex group received less opioids as compared to the spontaneously recovered group, Although remifentanil is a ultrashort effect opioid, considering the adverse gastrointestinal effects of opioid use [We did not use the conventional drugs such as neostigmine as the control treatment. Neostigmine can promote intestinal peristalsis by the inhibition of acetylcholinesterase [Brueckmann et al. [Although our results indicated that administration of sugammadex effected the early recovery of bowel function and contributed to the efficiency of PACU turn over, there was no difference in length of postoperative hospital stay between the sugammadex and spontaneous recovery groups in our study. This conclusion is currently debatable because it is not concurrent with the reported results of other studies. A recent retrospective study with a large sample size reported a trend toward a shorter hospital stay and lower rate of 30-day readmissions after administration of sugammadex for NMB reversal in patients undergoing major abdominal surgery [Consistent with the aforementioned results, our analysis revealed that pancreatic surgery and hepatobiliary resection contributed to increased length of hospital and PACU stays, though these durations were significantly shorter in laparoscopy than in open surgery. However, we did not conduct an accurate evaluation for different surgical sites and specific surgical approaches; hence, the differences in the results can be attributed to this reason. Factors such as social norms, reimbursement models, and the availability of reliable rehabilitation systems remain important parameters for length of stay. Thus, postoperative hospital stays partially reflect postoperative recovery [Early postoperative neuromuscular recovery with inadequate NMB is a frequent complication of anesthesia. This period was associated with either postoperative complications or intensive care unit stay following delayed recovery from anesthesia [Postoperative pulmonary complication rate and average time from operation to discharge were reported to be significantly reduced in patients administered sugammadex than those administered pyridistigmine [Our study presents newer data that sugammadex minimizes residual NMB and results in a decreased incidence of pneumonia, but it could not reduce the incidence of other postoperative pulmonary complications. The conclusions from various studies are not uniform, because there are many mixed influencing factors such as type of surgical procedure, the patient’s own conditions, consumption of perioperative opioids, difference of surgical and anaesthetic techniques, which can all influence the incidence of postoperative pulmonary complications. Further studies are required to verify the beneficial effect of sugammadex on clinical respiratory outcomes.Our study has some limitations. First, since this single-center study was conducted with a relatively small sample size, it is not fully representative of the groups as a whole. Therefore, future multicenter prospective studies with a large sample size are necessary. Second, only patients who had undergone abdominal surgery were included in the study and opioid may also has the potential for a certain impact on intestinal motility. Third, the long-term effects of surgery on postoperative outcomes were not observed. Therefore, future retrospective studies are needed to validate these results. | 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 |
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Acknowledgements | Not applicable. | PMC9875499 |
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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 Administration, Z S. All authors read and approved the final manuscript. | PMC9875499 |
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Funding | This research received no specific grant from any funding agency, commercial or not-for-profit sectors. | PMC9875499 |
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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 |
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Declarations | PMC9875499 |
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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 Hospital & Jiangsu Institute of Cancer Research & The Affiliated Cancer Hospital of Nanjing Medical University waived the requirement to obtain written informed consent from the patients. The authors did not obtain any information identifying individual participants during or after data collection. | PMC9875499 |
Consent for publication | Not applicable. | PMC9875499 |
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Competing interests | The authors declare that they have no competing interests. | PMC9875499 |
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References | PMC9875499 |
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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 |
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Design | The ADAMPA study was a pragmatic, controlled, randomized, non-masked clinical trial with two parallel arms in Valencia, Spain. | PMC9849508 |
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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 |
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Intervention | Participants were randomized 1:1 to usual care versus an individualized, pre-arranged plan based on self-monitoring plus self-titration. | PMC9849508 |
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Main Measure | AMD | The primary outcome was the adjusted mean difference (AMD) in SBP between groups at 12 months. | PMC9849508 |
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Key Results | Primary outcome data were available for 312 patients (intervention | PMC9849508 |
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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 |
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Trial Registration | EudraCT, number 2016-003986-25 (registered 17 March 2017) and | PMC9849508 |
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Supplementary Information | The online version contains supplementary material available at 10.1007/s11606-022-07791-z. | PMC9849508 |
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KEY WORDS | PMC9849508 |
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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. When it is, it is done with very different degrees of intensity. Often, rather than a significant increase in patient empowerment (especially with regard to treatment self-adjustment), strategies involve greater monitoring and/or use of human resources (health and non-health-related) or additional technologies, such as telemonitoring.HBPM interventions with self-monitoring of blood pressure plus different strategies of self-adjustment of hypertensive medication might contribute to better hypertension control and offer promising evidence of effectiveness,The aim of this trial was to evaluate the effectiveness of an intervention including self-monitoring of blood pressure plus self-titration of antihypertensive medication (based on an individualized pre-arranged plan) and educational components versus usual care (also with educational components) for reducing blood pressure in poorly controlled hypertensive patients in the primary care setting. | PMC9849508 |
METHODS | PMC9849508 |
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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 |
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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 is free at the point of service (except for some co-payments for out-of-hospital medication). Recruitment took place from July 2017 to June 2018, with a follow-up of 12 months. | PMC9849508 |
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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 for inclusion (see exclusion criteria in eMethods in the | 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 chart. | PMC9849508 |
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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 of Cardiology’s (ESC) 2013 guidelines for the management of hypertensionParticipants proceeded to self-adjust, without any additional contact with their family doctor, other health workers, or coaches, when SBP or DBP was above the target for four or more days of the first week of the month. The self-adjustment had to be followed continuously until the following appointment with the doctor, which was 3 weeks after beginning the self-adjusted regimen (entailing strong patient empowerment). At the subsequent follow-up, a new tailored self-management plan was provided. Apart from the intervention of self-adjustment, all patients received routine hypertension care with appointments and medication changes following the family doctor’s criteria in the context of routine clinical practice. All relevant concomitant care within the usual clinical practice was at the discretion of the attending family physician.Participants in the control group were informed by their family doctor that they would continue their usual care. Next, a member of the research team recorded additional baseline data (not recorded at the moment of inclusion) and provided patients with the “Control group booklet,” containing general information and basic recommendations for improving BP control, as well as monthly registration sheets to record BP-related healthcare encounters during the two consecutive follow-up periods (at 6 months and 12 months from baseline). The control group received routine hypertension care with appointments and medication changes following the family doctor’s criteria in the context of routine clinical practice. As in the intervention group, all relevant concomitant care within the usual clinical practice was at the discretion of the family doctor. | 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 intervals. If the first two readings were substantially different (at least 10 mmHg, as recommended by the ESH/ESC guidelinesSecondary outcomes included the following: (1) AMD in DBP between the intervention and control groups at 12 months, (2) difference in the percentage of patients with optimal control between groups at 12 months (general recommendation and by age range, Table | PMC9849508 |
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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 |
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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 ≥ 80 years), baseline SBP (< 160 mmHg vs ≥ 160 mmHg), diabetes, other comorbidities (cerebrovascular disease, peripheral artery disease, chronic kidney disease, angina, or acute myocardial infarction), diabetes plus baseline SBP threshold, obesity, overweight/obesity, and obesity plus baseline SBP threshold. Differences between groups at 12 months’ follow-up were estimated for several secondary behavioral outcomes (smoking, obesity, sedentarism), health-related quality of life, the use of health services, and the incidence of adverse events during the study period.In addition, we compared pharmacological treatments between groups at the 12-month visit to provide additional information on the differential therapeutic management between groups.Two-sided | 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 patients. Our study did not show differences in the reduction of systolic blood pressure at 12 months (primary outcome) for the self-management intervention as compared to an educational-only intervention; however, the percentage of patients achieving good control at 12 months was higher in the intervention group compared to controls. Subgroup analyses for the primary outcome measure, though underpowered, showed consistent results, suggesting greater reductions in high-risk patients such as people with diabetes or with SBP above 160 mmHg. There was no evidence of between-group differences in adverse events, health services utilization, health-related quality of life, or behavioral changes, except for a reduction of the proportion of sedentary people in the intervention group (albeit with no differences with the control group at 12 months’ follow-up).Several systematic reviews have assessed home blood pressure monitoring, although results have been heterogeneous, in part due to the combination with other co-interventions.The absolute adjusted mean difference in BP (−2.9 mmHg for SBP and −1.9 mmHg for DBP) found in the ADAMPA trial falls in the lower range of similar studies,Because no other relevant changes were detected, the effect of self-monitoring may have been mediated by the intensification of antihypertensive medication, arising from doctors’ and patients’ sharpened awareness of individualized BP targets, the regular home monitoring of their attainment, and the self-adjustment of treatment in response to high BP values (in fact, additional to the medication changes made by the physicians as part of their routine clinical practice, 58% of patients self-adjusted their medication at least once without any additional contact with their family doctor). In this sense, the intervention would act mainly by reducing therapeutic inertiaRegarding secondary outcomes, we did not find differences between groups at 12 months in smoking, obesity, or sedentarism. We likewise found no differences in the use of health services, although this result is mediated by its context within a clinical trial with planned visits (for example, patients in the intervention group had to go to the practice in the following weeks after each treatment self-adjustment). In any case, and in addition to an extension of the follow-up to 24 months, we have planned qualitative studies (focus groups with doctors, nurses, and patients) and utilization studies (including aspects of inertia, adherence, and cost-effectiveness) based on data obtained from the electronic medical record, which may broaden our knowledge about the effectiveness, acceptability, and mechanisms of action of the intervention evaluated in our context.Finally, the intervention was not associated with an increase in adverse events. Nevertheless, the frequency of hypotensive syncope seemed higher in the intervention group, although the extremely low figures do not allow for comparisons between groups. This should be further studied in larger trials.The ADAMPA trial has some limitations. First, we had to stop recruiting patients prematurely for reasons unrelated to the study. Although the sample size obtained was sufficient to detect significant differences in the main analysis, the limited sample size reduces the accuracy of the estimates. Second, the ADAMPA trial is a non-masked study wherein both the patients and the research team knew the assigned group, enabling the presence of information biases such as the Hawthorne effect (patients modifying their behavior in response to their awareness of being observed), social desirability bias (patients overreporting positive behaviors or underreporting undesirable ones), and performance bias (physicians modifying their behavior). Third, throughout the study, doctors became familiar with the components of the intervention, and it is possible that they extended some of these components (e.g., fixing individualized BP targets) to the control group; this contamination bias would tend to skew the intervention effect towards the null. Fourth, the ADAMPA trial was underpowered to detect differences in clinical outcomes, but BP reduction is an excellent surrogate endpoint in hypertensive patients and is very well correlated with reductions in morbidity and cardiovascular mortality. | 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 months of follow-up, without increasing healthcare utilization or adverse events. Our results suggest that, in the context of routine clinical practice, high-level patient empowerment strategies based on self-adjustment of antihypertensive treatments, with a pre-agreed plan and, without the need of additional medical visits (except in specific cases), the involvement of health professionals or health coaches, or the use of additional resources, may have relevant potential implications for both primary care practice and the health system as a whole. | PMC9849508 |
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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 electronic data capturing and quality checks. | PMC9849508 |
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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 Instituto de Salud Carlos III; Grants PT13/0002/0031 and PT17/0017/0003). | PMC9849508 |
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Availability of Data | The datasets used and/or analyzed during the current study are available from the corresponding author on reasonable request. | PMC9849508 |
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Declarations | PMC9849508 |
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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 involved in the ADAMPA study received any payment for the recruitment and follow-up of patients or their participation in the study. | PMC9849508 |
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Conflict of Interest | The authors declare that they do not have a conflict of interest. | PMC9849508 |
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References | PMC9849508 |
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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 |
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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 adjusted risk ratio was 1.45 ([95% CI, 1.04–2.02]; | PMC10510842 |
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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 practice. | PMC10510842 |
REGISTRATION: | URL: | PMC10510842 |
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NOVELTY AND RELEVANCE | PMC10510842 |
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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 preterm deliveries. However, sFlt-1/PlGF ratio assessment may have contributed to identify patients with severe features of preeclampsia. | 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 complex disorder with diverse phenotypes that affects ≈5% of pregnant women worldwide and is a major cause of maternal and perinatal morbidity and mortality.Despite known perinatal disadvantages, mainly at gestational ages before 34 weeks of pregnancy, the incidence of preterm birth among patients with preterm preeclampsia is still high. In Brazil, preeclampsia is the indication for almost 18% of all preterm births and nearly half of all iatrogenic preterm deliveries.Current nonstandardized methods of risk stratification use clinical and biochemical criteria, but more recently, improved approaches have been described. Identification of which patients can be safely managed expectantly to minimize the effect of iatrogenic deliveries on perinatal outcomes may be beneficial. The preeclampsia integrated estimate of risk (fullPIERS) algorithm uses maternal symptoms, signs, and laboratory tests to identify patients at increased risk for maternal complications related to preeclampsia, predicting adverse maternal outcomes within 48 hours (area under receiver operating curve, 0.88), with a negative predictive value of 98%.The objective of the PREPARE (Prematurity Reduction by Preeclampsia Care) study was to test the hypothesis that risk stratification of patients with suspected or confirmed preeclampsia based on objective criteria reduced the proportion of medically indicated preterm deliveries. The intervention combined fullPIERS and sFlt-1/PlGF ratio in the same treatment guidance to advise obstetricians to defer delivery. Patients with fullPIERS <10% and sFlt-1/PlGF ratio ≤38 were considered as low risk for adverse outcomes and suitable for safe expectant management, while those identified as being at higher risk could be offered appropriate surveillance. Based on this premise, we hypothesized that using this approach we would reduce preterm deliveries related to preeclampsia. | PMC10510842 |
METHODS | PMC10510842 |
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Data Availability | The data that support the findings of this study are available from the corresponding author upon reasonable request. | PMC10510842 |
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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 centers ( | PMC10510842 |
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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 or respiratory failure, coma, active labor, abruption or emergent delivery for other indications were not included in the risk stratification component of the study.This study was approved by the national central ethical committee on research involving Human Subjects (CAAE: 53092916·4·2008·5411) and by each local ethical committee of the participating centers. The PREPARE trial was a hospital-wide intervention within a cluster trial. Informed consent at an individual participant level for the intervention was not deemed necessary by the ethics committee. | 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 was revealed only 30 days before the implementation phase to prevent changes in practice before the implementation. However, due to delays with the implementation of the test analyzers and the availability of assays, the initiation of the intervention at sites 2 and 3 was delayed. Before completion of enrollment, the Trial Steering Committee approved the analysis of results according to when the intervention actually happened, rather than when it was originally planned.At the start of the trial period, all centers were in the preintervention phase. All patients presenting with suspected or diagnosed preeclampsia in this phase were managed according to local guidance. There was no standardization of protocols for preeclampsia treatment or delivery indication. Subsequently, every 4 months, 1 randomly allocated center transitioned to the implementation of the intervention. All centers continued the baseline data collection until randomized to implementation. Once each center crossed over to the intervention phase, the intervention was continued as part of routine care until the end of the study. After the last center has crossed over, the trial continued for a final period of 5 months during which all centers received the intervention. The effectiveness of the intervention was measured by comparing the aggregated data of the centers in the prerandomization phase (preintervention) of the trial with those in the postrandomization phase (post-intervention). Routine clinical data were collected for the trial on all participating patients. | 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 results were entered into a trial-specific Global Pregnancy Collaboration database.If sFlt-1/PlGF ≤38 and fullPIERS <10% risk, patients were considered low risk. The output provided by the platform was: reassuring—low risk for adverse outcomes. The recommendations were that delivery should be delayed unless the clinical condition deteriorated, with testing repeated at least twice weekly with fullPIERS and at least weekly with sFlt-1/PlGF for reassessment,If sFlt-1/PlGF>38 and fullPIERS ≥10% risk, patients were considered not low risk. The output provided by the platform was: nonreassuring—high risk for adverse outcomes, with recommendations to increase surveillance based on the World Health Organization guideline for management and delivery, including the need for preventative therapy with antihypertensive therapy, magnesium sulfate for seizure prophylaxis, and corticosteroids for fetal benefits. | PMC10510842 |
Outcomes | PMC10510842 |
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Primary Outcome | preterm preeclampsia | Proportion of patients with preterm preeclampsia who delivered <37 weeks’ gestation/total deliveries. | PMC10510842 |
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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 maternal mortality and or severe morbidity, defined as a composite including eclampsia, hemolysis, elevated liver enzymes, low platelets syndrome, pulmonary edema, stroke or coma, and renal dysfunction. Three further maternal outcomes were considered, hepatic dysfunction, thrombocytopenia, and length of maternal hospital stay, but there was insufficient data to include them.Additional perinatal outcomes included perinatal death (stillbirth after 27 | 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 new treatment regime). We considered a clinically important improvement would be a fall from 2.0% to 1.5% in the overall rate of preterm delivery with preeclampsia. We assumed a cluster coefficient of variation of 0.4, giving an intracluster correlation of 0.0024. Power calculations were performed using the Stata command steppedwedge.Hospital baseline characteristics of pregnancy outcomes to be reported throughout the data collection period included numbers of patients with preterm preeclampsia, gestational age at delivery of all hospital deliveries, and neonatal inpatient nights in patients with preeclampsia. These characteristics were compared between periods before and after the intervention and were summarized by their means and SDs, medians and interquartile ranges, or numbers and percentages as appropriate. Centers were classified as being exposed to the intervention only after randomization.The primary goal of the study was to test whether a care pathway targeted at preventing unnecessary delivery of patients with preterm preeclampsia would safely reduce the proportion of women delivered in the centers who delivered prematurely. Important independent variables to consider were the clustering effect (ie, the effect of center), calendar time effect (since the intervention was sequentially rolled out), and intervention exposure for each center at each time point, in addition to adjustment for other characteristics. Both individual and cluster-level covariates to be included in the adjustment were prespecified and included maternal age, parity, preexisting chronic hypertension, or other risk factors for prematurity. Null hypotheses and analyses for secondary outcomes took a similar form to that for the primary outcome, with appropriate link functions in the generalized linear mixed model. Summary treatment effect estimates are adjusted and reported (adjusted risk ratios or adjusted odds ratios [aORs]) along with 95% CIs.Data analysis was performed in Stata version16 (StataCorp, College Station, TX). Standard methods were used for the descriptive tables. For the main analysis, event rates were separately estimated for each center and each month of the trial as a proportion of eligible participants with suspected or diagnosed preeclampsia. Because the month of delivery was not typically the same as the month of trial entry, deliveries were not linked to trial entry.Analysis of this data set proved more challenging than expected due to several reasons: (1) an unanticipated bias related to most of the centers with the highest event rates occurring late in the randomization sequence; (2) 2 centers starting the intervention later than planned for operational reasons due to external circumstances beyond our control. As this could be regarded as a random event, the Steering Committee decided to focus on the intervention as actually performed, rather than the intervention as originally planned. This we defined as the intention-to-treat dataset. Further, we established a per-protocol subset of the intention-to-treat dataset, restricted to (1) patients in the Intervention arm with an sFlt-1/PlGF ratio results and (2) patients in the Usual Care arm with no test results.We initially undertook an analysis as indicated in our published protocol.Accordingly, we decided to analyze the data from each center separately. The separate analyses all used binomial regression with the total number of deliveries as the denominator, with a linear effect of time as a covariate and a step change at the point the intervention was introduced. We combined the estimates in a random-effects meta-analysis.Additional risk differences are shown using the nonparametric within-period cluster-level analysis with the Monte Carlo permutation tests method described in Thompson (2018), demonstrated as reliable.As it emerged that sFlt-1/PlGF assays were not universally used outside of the trial population, the data safety and monitoring committee suggested an additional post hoc analysis to investigate the proportion of patients with preterm preeclampsia delivered <37 weeks’ gestation among total patients enrolled. Information about the data safety and monitoring committee is provided in the Results are reported as per CONSORT guidelines.The trial was registered at | 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 findings showed that the introduction of a new methodology for evaluating patients with elevated blood pressure, characterized by a biomarker test incorporating angiogenic and antiangiogenic factors, did not lead to a reduction in preterm birth. Regarding risk assessment, there was a large discrepancy between the 2 models combined (fullPIERS and sFlt-1/PlGF). The vast majority of patients admitted to the proposed intervention were classified as low risk for adverse maternal outcomes according to the fullPIERS criterion alone. However, 59.6% of these patients had sFlt-1/PlGF ratio >38, indicating a nonreassuring situation in the initial risk assessment. The implementation of the new management protocol, by increasing diagnosis and general awareness of preeclampsia among participating clinicians, may have led to earlier consideration of delivery. Regarding the safety, sensitivity analyses showed that this treatment protocol was able to identify patients at risk for preterm birth and maternal mortality or severe morbidity and, therefore, it did not put patients at risk of adverse outcomes. Overall, no differences were observed about the additional maternal and perinatal outcomes evaluated, except for a reduction in cases of eclampsia in the intervention group.To our knowledge, 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/PlGF ratio. The study evaluated management based on biomarkers in public hospitals that serve a low-income population in Brazil. It was a multicenter study that allowed the inclusion of a large number of patients.The study evaluated an important perinatal outcome, preterm birth, based on the use of biomarkers that were not in regular use by participating clinicians. We determined that management was different among the participating centers, especially in one of the centers (Finding a balance between reducing maternal adverse outcomes and the impact of prematurity is a difficult task and there is minimal evidence available to adequately guide this practice. The HYPTAT-II study (2016) compared delivery within 24 hours versus expectant management in patients with hypertensive disorders diagnosed between 34 and 37 weeks.Although the absolute occurrence of the primary outcome decreased after intervention, statistical analysis with appropriate adjustment demonstrated that the adjusted risk ratio was higher in the intervention group. There are several possible explanations for this finding: (1) the risk stratification tests are not adequate to determine timing of delivery in patients with suspected or diagnosed preeclampsia (as suggested by other authors)In conclusion, this trial demonstrate that implementation of the intervention did not decrease preterm birth for preeclampsia in this setting. The majority of patients enrolled in the trial did not meet the criteria for expectant management due to nonreassuring risk stratification. The threshold used (sFlt-1/PlGF <38) may be too low to lead to an impact in prematurity reduction as most patients entered the trial with higher sFlt-1/PlGF ratios. Future research may need to evaluate the impact of using different test thresholds for maternal and perinatal outcomes, mainly preterm deliveries. We encourage development of new trials in low- and middle-income settings, as these areas have the poorest outcomes for patients with preeclampsia and even small improvements in management may lead to great impact. Additionally, we emphasize the necessity of developing a continuous knowledge transfer program to help care providers to gain confidence and trust in reassuring results. | 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 hypertension, characterized by a biomarker test incorporating angiogenic and antiangiogenic factors, did not lead to a reduction in preterm birth.Interestingly, there was a large discrepancy between the 2 models combined (fullPIERS and sFlt-1/PlGF). A high majority (97.8%) of patients enrolled into the trial were classified as low risk for adverse maternal outcomes according to the fullPIERS criterion alone. However, 59.6% of these women had sFlt-1/PlGF ratio >38, indicating a nonreassuring result in the initial risk assessment.There was increased knowledge mobilization on preeclampsia by clinicians participating in the study, with an abnormal sFlt-1/PlGF ratio leading to a higher possibility of identifying preeclampsia with severe features, with reduction in cases of eclampsia in the intervention group.Although the potential role of angiogenic imbalance in risk identification, there is no consensus on a specific cutoff to identify patients at higher risk for adverse outcomes or whether a pattern of elevation of the sFlt-1/PlGF ratio could be useful to define timing of delivery to improve either maternal or perinatal outcomes. Equally, there is still no clear consensus on the threshold of the fullPIERS algorithm that best determines need for delivery, particularly at gestational ages <37 weeks.Therefore, our results will encourage future researches to evaluate the impact of using different test thresholds on maternal and perinatal outcomes, focusing on optimizing timing of delivery in low- and middle-income settings. | PMC10510842 |
ARTICLE INFORMATION | PMC10510842 |
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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 & Melinda Gates Foundation (OPP1142172) and Conselho Nacional de Desenvolvimento Científico e Tecnológico—CNPq and the Brazilian Ministry of Health Brazil (401718/2015-8) to M.A.B. Dias. Roche Diagnostics provided the kits for sFlt-1 (soluble fms-like tyrosine kinase-1) and PlGF (placental growth factor) measurement (Elecsys Preeclampsia Platform). The authors thank all patients who participated in the PREPARE trial (Prematurity Reduction by Preeclampsia Care). | 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 report. | PMC10510842 |
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