title stringlengths 1 1.19k | keywords stringlengths 0 668 | concept stringlengths 0 909 | paragraph stringlengths 0 61.8k | PMID stringlengths 10 11 |
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AUTHOR CONTRIBUTIONS | M.R.G., S.L.L., W.B.F, M.A.W., and D.L.K. conceptualized and designed the experiments. M.R.G., M.R.A., K.E.K., and A.J.L. performed the experiments. M.R.G and S.L.L. analyzed and interpreted the data. M.R.G. drafted the original manuscript. M.R.G., S.L.L., and A.J.L. contributed to the statistical analysis. All authors... | PMC10727961 | ||
FUNDING INFORMATION | This research was supported, in part, by a National Institutes of Health (NIH) grant HL145055 and P20 GM113125. | PMC10727961 | ||
ETHICS STATEMENT | Each participant provided written informed consent as approved by the University of Delaware Institutional Review Board. | PMC10727961 | ||
Supporting information |
Table S1
Click here for additional data file.
Table S2
Click here for additional data file. | PMC10727961 | ||
ACKNOWLEDGMENTS | We would like to thank our nurse, Wendy Nichols, our undergraduate students, Paige Kutler and Daniel Himsworth, and our study dietitian, Kristina Krieger, for their help during collection and analysis of the data. | PMC10727961 | ||
DATA AVAILABILITY STATEMENT | Data are available upon reasonable request to the principal investigator after institutional data transfer agreement approvals. | PMC10727961 | ||
REFERENCES | PMC10727961 | |||
Background | Recommendations for health care digitization as issued with the Riyadh Declaration led to an uptake in telemedicine to cope with the COVID-19 pandemic. Evaluations based on clinical data are needed to support stakeholders’ decision-making on the long-term implementation of digital health. | PMC10775022 | ||
Objective | trauma | This health economic evaluation aims to provide the first German analysis of the suitability of video consultations in the follow-up care of patients in orthopedic and trauma surgery, investigate the financial impact on hospital operations and personnel costs, and provide a basis for decisions on digitizing outpatient ... | PMC10775022 | |
Methods | trauma | We conducted a randomized controlled trial that evaluated video consultations versus face-to-face consultations in the follow-up care of patients in orthopedic and trauma surgery at a German university hospital. We recruited 60 patients who had previously been treated conservatively or surgically for various knee or sh... | PMC10775022 | |
Results | After 4 withdrawals in each arm, data from a total of 52 patients (telemedicine group: n=26; control group: n=26) were used for our analyses. In the telemedicine group, 77% (20/26) of all patients agreed that telemedicine provided for their health care needs, and 69% (18/26) found telemedicine an acceptable way to rece... | PMC10775022 | ||
Conclusions | trauma | Our study supports stakeholders’ decision-making on the long-term implementation of digital health by demonstrating that video consultations in the follow-up care of patients in orthopedic and trauma surgery result in cost savings and productivity gains for clinics with no negative impact on patient utility. | PMC10775022 | |
Trial Registration | German Clinical Trials Register DRKS00023445; https://drks.de/search/en/trial/DRKS00023445 | PMC10775022 | ||
Introduction | trauma | The adoption of digital technologies has progressed only gradually in health care systems, and uncertainty, especially with respect to the suitability and financial effects, has often acted as a drag on the broader use of digital health applications such as telemedicine [To support stakeholders’ decision-making on the ... | PMC10775022 | |
Methods | PMC10775022 | |||
Study Design | Trauma, trauma | We conducted an RCT to examine the use of telemedicine in the follow-up care of patients in orthopedic and trauma surgery at the University Hospital of Giessen, Germany, between September 2020 and April 2021. Our study design had 3 main goals: evaluation of patient and physician satisfaction, evaluation of economic and... | PMC10775022 | |
Ethical Considerations | A detailed study protocol for the planned RCT was submitted and approved by the local ethics committee of the University of Giessen before the start of the study (AZ 73/20). Furthermore, the RCT was registered with the German Clinical Trials Register (DRKS00023445). Patients received comprehensive information about the... | PMC10775022 | ||
Analysis of Telemedicine Suitability and its Economic Effects | trauma | The consideration of the health provider’s perspective comprised a bilateral analysis. In the first step, it was investigated whether telemedicine is suitable for hospitals in the follow-up care of patients in orthopedic and trauma surgery. As suggested by current literature, the investigation of video consultations’ s... | PMC10775022 | |
Results | PMC10775022 | |||
General Findings | knee disorder, shoulder disorder | The health economic evaluation was based on data from 26 patients in the intervention group and 26 patients in the control group after the withdrawal of 4 study participants in both treatment groups. In the telemedicine group, 42% (11/26) of participants were female, and 58% (15/26) were male. In addition, 27% (7/26) o... | PMC10775022 | |
Discussion | PMC10775022 | |||
Principal Results | trauma | This health economic analysis from a health provider’s perspective showed important insights for stakeholder decision-making on the long-term use of telemedicine in the follow-up care of patients in orthopedic and trauma surgery by examining both the suitability of video consultations and the associated financial and p... | PMC10775022 | |
Limitations | There are 3 main limitations. On the one hand, the treatment duration was not measured precisely but was collected from the physicians by means of a questionnaire. However, individual deviations should compensate for each other in total. Furthermore, the technical equipment, the internet connection, and the clinical pr... | PMC10775022 | ||
Conclusions | trauma | The first health economic evaluation based on data from a German RCT demonstrated that the use of telemedicine might be suitable for the follow-up care of patients in orthopedic and trauma surgery regarding the physician-patient communication and service provided and that video consultations are less time-consuming for... | PMC10775022 | |
Abbreviations | face-to-faceOrganization for Economic Cooperation and Developmentrandomized controlled trialTelemedicine Satisfaction Questionnaire | PMC10775022 | ||
Data Availability | The data sets generated and analyzed during this study are available from the corresponding author on reasonable request. | PMC10775022 | ||
Background | various B-cell malignancies, RCC, CRC | ADVANCED RENAL CELL CARCINOMA, COLORECTAL ADENOCARCINOMA, CHRONIC GRAFT-VERSUS-HOST DISEASE, RCC | Ibrutinib, a first-in-class inhibitor of Bruton’s tyrosine kinase, is approved for the treatment of various B-cell malignancies and chronic graft-versus-host disease. Based on encouraging preclinical data, safety and efficacy of ibrutinib combined with companion drugs for advanced renal cell carcinoma (RCC), gastric/ga... | PMC10623721 |
Methods | RCC | RCC | Ibrutinib 560 mg or 840 mg once daily was administered with standard doses of everolimus for RCC, docetaxel for GC, and cetuximab for CRC. Endpoints included determination of the recommended phase 2 dose (RP2D) of ibrutinib in phase 1b and efficacy (overall response rate [ORR] for GC and CRC; progression-free survival ... | PMC10623721 |
Results | RCC | RCC | A total of 39 (RCC), 46 (GC), and 50 (RCC) patients were enrolled and received the RP2D. Safety profiles were consistent with the individual agents used in the study. Confirmed ORRs were 3% (RCC), 21% (GC), and 19% (CRC). Median (90% CI) PFS was 5.6 (3.9–7.5) months in RCC, 4.0 (2.7–4.2) months in GC, and 5.4 (4.1–5.8)... | PMC10623721 |
Conclusions | SOLID TUMOUR | Clinically meaningful increases in efficacy were not observed compared to historical controls; however, the data may warrant further evaluation of ibrutinib combinations in other solid tumours. | PMC10623721 | |
Trial registration | ClinicalTrials.gov, NCT02599324. | PMC10623721 | ||
Supplementary Information | The online version contains supplementary material available at 10.1186/s12885-023-11539-1. | PMC10623721 | ||
Keywords | PMC10623721 | |||
Background | CRC, urothelial carcinoma, UC, various B-cell malignancies, RCC, gastric adenocarcinoma, chronic graft-versus-host disease, RCC | SOLID TUMOUR, UROTHELIAL CARCINOMA, COLORECTAL ADENOCARCINOMA, CHRONIC GRAFT-VERSUS-HOST DISEASE, DISEASES, RCC | Ibrutinib, a first-in-class, once-daily covalent inhibitor of Bruton’s tyrosine kinase (BTK), is approved for the treatment of various B-cell malignancies and chronic graft-versus-host disease following the failure of one or more lines of systemic therapy and remains under investigation in these settings and for other ... | PMC10623721 |
Materials and methods | PMC10623721 | |||
Study design and patients | DLTs, hematologic adverse, toxicities, non-hematologic, Tumors, tumour, RCC | DISEASE PROGRESSION, DISEASE, TUMORS, TUMOUR, ONCOLOGY, RCC | This was an open-label phase 1b/2 multicenter study (ClinicalTrials.gov; NCT02599324) conducted between December 2015 and March 2020, to determine the recommended phase 2 dose (RP2D) of ibrutinib combined with everolimus in RCC, docetaxel in GC, and cetuximab in CRC for previously treated patients. The data cutoff date... | PMC10623721 |
Study treatment | tumour, RCC | TUMOUR, RCC | In phase 1b, the starting dose level for ibrutinib was 560 mg orally once daily. Ibrutinib 560 mg was combined with everolimus 10 mg orally once daily (RCC cohort), docetaxel 60‒75 mg/mFollowing the determination of the RP2D by a Dose Level Review Committee (DLRC), additional patients were enrolled and treated in phase... | PMC10623721 |
Study objectives | SD, RCC | DISEASE, RCC | The primary objectives of phase 1b were to determine the RP2D for ibrutinib in each cohort: in combination with everolimus in RCC, docetaxel in GC, and cetuximab in CRC. Secondary objectives in phase 1b of each cohort included evaluation of the preliminary safety and tolerability, overall response rate (ORR) per RECIST... | PMC10623721 |
Assessments and analyses | Tumour | TUMOUR | Tumour response was assessed using computed tomography (CT) or magnetic resonance imaging (in the case of CT contraindication). Imaging was performed at baseline and every 6 weeks thereafter, per the investigator using RECIST v1.1 guidelines, including confirmation of complete and PRs at least 28 days after the criteri... | PMC10623721 |
Statistical considerations and analysis populations | tumour, RCC | DISEASE, EVENT, TUMOUR, RCC | For phase 1b, data were summarised by dose level for each cohort separately. For Phase 2, efficacy and safety data were summarised by RP2D dose level of ibrutinib for each cohort. The safety population included all patients who received at least one dose of any study drug. The DLT-evaluable population was defined as pa... | PMC10623721 |
Results | PMC10623721 | |||
RCC Cohort | PMC10623721 | |||
Phase 1b | RCC | RCC | A total of 10 patients were enrolled in the RCC cohort in phase 1b; patients received everolimus with either 560 mg ibrutinib ( | PMC10623721 |
GC Cohort | PMC10623721 | |||
Phase 1b | DLTs, leukopenia | LEUKOPENIA | Twenty-one patients were enrolled in the GC cohort in phase 1b; all patients received 560 mg ibrutinib with docetaxel; median duration of ibrutinib exposure was 2.7 months and median docetaxel exposure was 1.4 months. Fourteen patients were DLT-inevaluable due to dose interruptions. Seven patients were DLT-evaluable. T... | PMC10623721 |
Phase 1b/2 | DISEASE | A total of 46 patients were enrolled in the GC cohort and were treated at the RP2D in phase 1b/2. Twelve patients (26%) had received at least two prior lines of therapy and 15 (33%) had > 2 metastatic sites of disease (Table Among patients who received the RP2D in the efficacy-evaluable population (All 46 patients in t... | PMC10623721 | |
CRC Cohort | PMC10623721 | |||
Phase 1b | DLTs | Twenty patients were enrolled in the CRC cohort in phase 1b; 8 and 12 patients, respectively, received 560 mg and 840 mg ibrutinib with cetuximab. Median duration of ibrutinib exposure was 2.7 months and median cetuximab exposure was 2.3 months. Eleven patients were DLT-inevaluable, 10 due to dose interruption because ... | PMC10623721 | |
Phase 1b/2 | dermatitis acneiform | DISEASE | A total of 50 patients were enrolled in the CRC cohort in phase 1b/2. All patients had received at least two prior lines of therapy and 27 (54%) had > 2 metastatic sites of disease (Table Among patients who received the RP2D in the efficacy-evaluable population (All 50 patients treated at the RP2D experienced a TEAE of... | PMC10623721 |
Pharmacokinetics | Ibrutinib was rapidly absorbed with a median time to maximum concentration (t | PMC10623721 | ||
Discussion | tumours, gastrointestinal and skin toxicity, tumour, RCC | TUMOURS, TUMOUR, RCC | This multicenter, open-label, phase 1b/2 study of ibrutinib combination therapy in patients with RCC (ibrutinib plus everolimus), GC (ibrutinib plus docetaxel), or CRC (ibrutinib plus cetuximab) demonstrated acceptable safety in patients with advanced tumours. Overall, results presented here suggest that administration... | PMC10623721 |
Acknowledgements | We thank the patients who participated in the study and their supportive families, as well as the investigators and clinical research staff from the study centers. The authors thank Harisha Atluri, PhD (employed with AbbVie), for assistance with pharmacokinetic data analysis; and Gary Acton, MD (contracted with AbbVie)... | PMC10623721 | ||
Authors’ contributions | MWS, FM | D-YO collaborated with the study sponsors to design the study; MAM, DIQ, PJO, IC, SYK, ID, DC, JB, BM, SKW, K-WL, FM, PM, MWS, DW, and HTA collected the study data; EC performed the data analyses; EC, JHR, and JPD confirmed the accuracy of the data and compiled it for analysis; all authors had access to the data and we... | PMC10623721 | |
Funding | This study was sponsored by Pharmacyclics LLC, an AbbVie Company. | PMC10623721 | ||
Availability of data and materials | Requests for access to individual participant data from clinical studies conducted by Pharmacyclics LLC, an AbbVie Company, can be submitted through Yale Open Data Access (YODA) Project site at | PMC10623721 | ||
Declarations | PMC10623721 | |||
Ethics approval and consent to participate | DEL | The protocol was approved by the institutional review boards or independent ethics committees of all participating institutions. The study was approved by the following institutional review boards or independent ethics committees: Asan Medical Center Institutional Review Board 88; CEIm Hospital Universitario Ramon y Ca... | PMC10623721 | |
Consent for publication | Not applicable. | PMC10623721 | ||
Competing interests | Pancreatic Cancer, MWS, Novocure | ONCOLOGY, PANCREATIC CANCER, CROSS, EMD | D-YO: consulting/advisory role with AstraZeneca, Novartis, Genentech/Roche, Merck Serono, Bayer, Taiho, ASLAN, Halozyme, Zymeworks, Bristol Myers Squibb/Celgene, BeiGene, Basilea, and Turning Point Therapeutics; and research funding from AstraZeneca, Novartis, Array BioPharma, Eli Lilly, Servier, BeiGene, Merck Sharp &... | PMC10623721 |
References | PMC10623721 | |||
Objectives | TG | HIGH TRIGLYCERIDES | Eicosapentaenoic acid in its ethyl ester form is the single active component of icosapent ethyl (IPE). This study was a phase III, multi-center trial assessing the safety and efficiency of IPE for treating very high triglyceride (TG) in a Chinese cohort. | PMC10257163 |
Methods | TG | Patients having TG levels (5.6–22.6 mmol/L) were enrolled and randomly assigned to receive a treatment of oral intake of 4 g or 2 g/day of IPE, or placebo. Before and after 12 weeks of treatment, TG levels were assessed and the median was calculated to determine the change between the baseline and week 12. In addition ... | PMC10257163 | |
Results | TG | Random assignments were performed on 373 patients (mean age 48.9 years; 75.1% male). IPE (4 g/day) lowered TG levels by an average of 28.4% from baseline and by an average of 19.9% after correction for placebo (95% CI: 29.8%-10.0%, | PMC10257163 | |
Conclusions | high-TG | IPE at 4 g/day dramatically lowered other atherogenic lipids without a noticeable increase in LDL-C, thereby decreasing TG levels in an exceptionally high-TG Chinese population. | PMC10257163 | |
Keywords | PMC10257163 | |||
Introduction | death | ATHEROSCLEROTIC CARDIOVASCULAR DISEASE, HIGH TRIGLYCERIDES, ASCVD | Atherosclerotic cardiovascular disease, also referred to as ASCVD, was responsible for almost 2.4 million fatalities in China in 2016, making it the primary cause of death globally [Consuming higher amounts of omega-3 fatty acids, such as eicosapentaenoic acid (EPA) or docosahexaenoic acid (DHA), has been demonstrated ... | PMC10257163 |
Materials and methods | PMC10257163 | |||
Study design and participants | TG | Forty-nine Chinese institutions participated in this phase III clinical investigation. This research was carried out at many sites utilizing a randomized, placebo-controlled, double-blind trial design. The research followed the rules and guidelines set out by local and/or national independent ethics committees, as well... | PMC10257163 | |
Randomization | By using computerized data collection and minimum dynamic randomization, patients were segregated into three groups, with an equal distribution of patients in each group, resulting in a 1:1:1 ratio. According to the baseline plasma TG levels (less than or more than 8.5 mmol/L), gender, and whether or not they had previ... | PMC10257163 | ||
Procedures | The framework of the study design was provided (Fig. Study design. Abbreviation: IPE = icosapent ethylFor patients who had not received any other lipid-altering treatment and had been on a stable dosage of statin therapy for more than four weeks (with or without ezetimibe), this screening and stabilization phase lasted... | PMC10257163 | ||
Study outcomes | TG | SECONDARY | The median percentage difference in TG levels from the start to the end of the trial, after accounting for the placebo, was the major outcome measure (week 12). The TG baseline was determined using the mean TG value from visit 5 (week 0) as well as the value from the visit before that (one week earlier, visit 4 or visi... | PMC10257163 |
Safety assessments | treatment-emergent adverse | ADVERSE EVENTS | Evaluations of safety were performed using information gathered from clinical laboratory tests, abdominal ultrasonography, vital signs, electrocardiograms, and physical examinations, as well as from reports of adverse events (AEs). AEs that appeared for the first time or were worse during the double-blind phase were kn... | PMC10257163 |
Statistical analysis | The primary objective was to determine the placebo-adjusted median percentage difference in fasting TG levels between weeks 0 and 12 of treatment. According to data from the MARINE trial, the difference in effectiveness between IPE 4 g/day and placebo was estimated to be 30% (51% standard deviation). With 100 patients ... | PMC10257163 | ||
Results | PMC10257163 | |||
Safety | abnormal hepatic function, diarrhea, TEAEs, urticaria, TEAE | PANCREATITIS, URTICARIA | In all therapy groups, the occurrence of TEAE was typically modest and comparable. Most TEAEs were modest and were unrelated to study medications. Drug-related TEAEs with a greater incidence (> 2%) included diarrhea (9.7%, 2.4%, and 5.6% in IPE 2 g/day, 4 g/day and placebo, respectively). Serious TEAEs were recorded wi... | PMC10257163 |
Discussion | ASCVD, TG, Vascepa | PILES, EVENTS, RECRUITMENT, PATHOGENESIS, ATHEROSCLEROTIC CARDIOVASCULAR DISEASE, ASCVD, ENDOTHELIAL DYSFUNCTION | Triglyceride-rich lipoproteins (TGRLs) are closely associated with the pathogenesis and progression of atherosclerotic cardiovascular disease (ASCVD) via direct arterial wall deposition, endothelial dysfunction, recruitment of monocytes and subsequent foam cell formation, stimulation of inflammatory cytokines, and acti... | PMC10257163 |
Comparisons with other studies and what does the current work add to the existing knowledge | nonfatal stroke, cardio-cerebrovascular disease, unstable angina, nonfatal myocardial infarction, TG | UNSTABLE ANGINA | According to previously published analyses in a non-Chinese population, the MARINE study demonstrated that 4 g/day IPE reduced within-group TG concentrations by 26.6% in patients with extremely high TG levels (5.6—22.6 mmol/L) without significant increases in LDL-C levels compared to placebo. Our results were consisten... | PMC10257163 |
Strengths and limitations | EVENTS, HIGH TRIGLYCERIDES | This work included comprehensive analyses of data in Chinese patients, which allowed for a more targeted evaluation of IPE's effectiveness and safety in this population. These data indicated that IPE was effective for the treatment of very high triglyceride condition in Chinese patients, and that it was well-tolerated.... | PMC10257163 | |
Acknowledgements | We appreciated the contributions from participants in this study and all the investigators. This study was sponsored by EDDING. Clinical operation, data management and statistical analysis were supported by Tigermed (contract research organization). The manuscript was developed and its content was contributed by all au... | PMC10257163 | ||
Authors’ contributions | P. | Z.W., X. Z., Y. Q., S. Z., Y. C., X. C., X. Q., P. L., S. L., S. J., R. M., L. H., L. W., Z. L., Y. S., Z. Q., F. L., C. X. and C. L. collected the data. J. G. design the study and wrote the main manuscript text. All authors reviewed the manuscript. The author(s) read and approved the final manuscript. | PMC10257163 | |
Funding | This study was supported by EDDING. | PMC10257163 | ||
Availability of data and materials | The entirety of the data featured in this work is made accessible to interested parties through the author of correspondence. | PMC10257163 | ||
Declarations | PMC10257163 | |||
Ethics approval and consent to participate | This multi-center, placebo-controlled, randomized, double-blinded, phase III clinical trial was conducted in 39 research centers in China. The research protocol adhered to the International Conference on Harmonization Guidelines for Good Clinical Practice, and regulations and directives set forth by autonomous local an... | PMC10257163 | ||
Competing interests | The authors declare no competing interests. | PMC10257163 | ||
References | PMC10257163 | |||
Background | inadequate HIV testing rate. | Men who have sex with men (MSM) in China hold a low-risk perception of acquiring HIV. This has resulted in an inadequate HIV testing rate. | PMC10504623 | |
Objective | This study aims to investigate whether administering HIV risk self-assessments with tailored feedback on a gay geosocial networking (GSN) app could improve HIV testing rates and reduce sexual risk behaviors in Chinese MSM. | PMC10504623 | ||
Methods | SECONDARY | We recruited MSM from Beijing, China, who used the GSN platform Blued in October 2017 in this 12-month double-blinded randomized controlled trial. From October 2017 to September 2018, eligible participants were randomly assigned to use a self-reported HIV risk assessment tool that provided tailored feedback according t... | PMC10504623 | |
Results | In total, 9280 MSM were recruited from baseline and were randomly assigned to group 1 (n=3028), group 2 (n=3065), or controls (n=3187). After follow-up, 1034 (34.1%), 993 (32.4%), and 1103 (34.6%) remained in each group, respectively. Over 12 months, group 1 took 391 tests (mean of 2.51 tests per person), group 2 took ... | PMC10504623 | ||
Conclusions | MSM | Repeated HIV risk assessments coupled with tailored feedback through GSN apps improved HIV testing. Such interventions should be considered a simple way of improving HIV testing among MSM in China and increasing awareness of HIV status. | PMC10504623 | |
Trial Registration | ClinicalTrials.gov NCT03320239; https://clinicaltrials.gov/study/NCT03320239 | PMC10504623 | ||
Introduction | HIV infections, HIV risk perception, MSM | HIV INFECTIONS | Consistent with global trends, China has experienced an increase in HIV prevalence among men who have sex with men (MSM), with the national HIV prevalence estimated to be 5.7% across 2001-2018 [Despite the high burden of HIV infections within MSM communities, HIV testing rates among MSM are low in China, and only half ... | PMC10504623 |
Methods | PMC10504623 | |||
Study Design and Participants | MSM | This double-blinded, triple-arm RCT was conducted among MSM in Beijing, China, between October 2017 and September 2018. Participants were recruited in October 2017 through the popular Chinese gay dating app Blued, which has approximately 480,000 monthly active users in Beijing [ | PMC10504623 | |
Randomization and Masking | Participants were simply randomized in a 1:1:1 ratio by a computerized randomization algorithm with SAS 9.3 (SAS Institute, Inc.) into 3 groups (group 1, group 2, and the control group). The assignment of group allocations was masked to both the study staff and participants to ensure double-blinding. | PMC10504623 | ||
Procedures | HIV infection, sexual behaviors | HIV INFECTION, RECRUITMENT | Recruitment messages were privately sent through the app to Blued users from a Blued administrative account. The message briefly introduced the study and provided a link to participate. MSM who clicked the link were directed to eligibility screening, the consent form, and the baseline survey. The baseline questionnaire... | PMC10504623 |
Outcomes | SECONDARY | The primary outcome of interest was the cumulative number of rapid HIV tests taken over 12 months, described as the mean number of HIV tests per person who attended Blued testing sites for testing per year. The secondary outcome was self-reported UAI at each follow-up, which was assessed by asking “In the past three mo... | PMC10504623 | |
Statistical Analysis | REGRESSION | The primary outcome of this study was the mean number of rapid HIV tests per person per year. We estimated a sample size of 1500 participants (500 per group) was needed to detect a difference of 10% or more in the intervention groups, achieving 90% power at a 2-sided significance of 0.05. The sample size calculation as... | PMC10504623 | |
Role of the Funding Source | The study funders had no role in the study design, data collection, data analysis, explanation of results, or manuscript drafting. The corresponding authors had full access to all study data and had final responsibility for the decision to submit it for publication. | PMC10504623 |
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