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Study protocol | A copy of the protocol for this study was submitted as an additional file to the journal. | PMC10731830 | ||
Authors’ contributions | Conceptualization: NE, Experimental work: NE, and YO, Interpretation of data: NE and MA writing original draft: NE. prepared tables: YO Review and editing: NE and MA All authors have read and reviewed the manuscript. | PMC10731830 | ||
Funding | This study was funded by the Deanship of Academic Research at the University of Jordan, Amman, Jordan. | PMC10731830 | ||
Availability of data and materials | This article has all the data that were collected or analyzed during this study. | PMC10731830 | ||
Declarations | PMC10731830 | |||
Ethics approval and consent to participate | dry dentures, denture | The study was conducted in accordance with the World Medical Declaration of Helsinki.The protocol of this study was reviewed and approved by the Deanship of Academic Research at the University of Jordan Hospital (IRB number: 42–2022).All participants involved in this study signed the consent form provided before the be... | PMC10731830 | |
Consent for publication | Not applicable. | PMC10731830 | ||
Competing interests | The authors declare no competing interests. | PMC10731830 | ||
References | PMC10731830 | |||
Significance: | toxicity, tumor, DLTs | TUMOR, PROLIFERATION, SOLID TUMORS, ADVERSE EVENT, TUMOR ANGIOGENESIS | Methionine aminopeptidase 2 (MetAP2) is essential to endothelial cell growth and proliferation during tumor angiogenesis. M8891 is a novel orally bioavailable, potent, selective, reversible MetAP2 inhibitor with antiangiogenic and antitumor activity in preclinical studies. The safety, tolerability, pharmacokinetics, an... | PMC10448909 |
Introduction | tumor | PROLIFERATION, TUMOR, SOLID TUMORS, TUMOR ANGIOGENESIS | Methionine aminopeptidase 2 (MetAP2) is one of two cytoplasmic methionine aminopeptidases ubiquitously expressed in mammalian cells. MetAPs catalyze N-terminal methionine excision from newly formed proteins, an essential step in cotranslational protein maturation ensuring protein stability and functionality. MetAP2 has... | PMC10448909 |
Materials and Methods | PMC10448909 | |||
Study Design | REGRESSION, SOLID TUMORS | This was a first-in-human (FIH), phase I, open-label, multicenter, single-arm, dose-escalation study designed to determine the maximum tolerated dose (MTD), recommended phase II dose (RP2D), safety, tolerability, pharmacokinetic, and pharmacodynamic profiles of M8891 in patients with advanced solid tumors (NCT03138538)... | PMC10448909 | |
Patient Eligibility | cancer, tumor | ONCOLOGY, CANCER, TUMOR, SOLID TUMORS | Eligible patients were ≥18 years of age and provided written informed consent; had histologically confirmed advanced solid tumors, refractory to or intolerant of existing cancer therapies, with no surgical, radiation, or systemic anticancer therapies available after at least one prior systemic anticancer therapy; had a... | PMC10448909 |
Treatment | toxicity, overdose | Patients received oral M8891 in 21-day cycles at doses of 7–80 mg once daily. The starting dose of 7 mg once daily was based on the dog highest non-severely toxic dose of 0.75 mg/kg/day divided by a safety factor of 6, which equated to a human dose of 7.5 mg (rounded to 7 mg) for a participant of 60 kg bodyweight. Safe... | PMC10448909 | |
Assessments and Endpoints | nausea or vomiting, death, DLTs, bleeding, neutropenia, fever, fatigue, toxicity, Tumor, thrombocytopenia, TEAEs, SD, rash, treatment-emergent adverse events, hypertension | BLEEDING, NEUTROPENIA, TUMOR, ADVERSE EVENTS, BLOOD, THROMBOCYTOPENIA, DISEASE, EVENTS, HYPERTENSION, HEPATOCELLULAR INJURY | The primary endpoint was DLTs during the first 21-day treatment cycle of M8891, based on a predefined set of treatment-emergent adverse events (TEAE) with the aim to determine the MTD of M8891. At each dose level, the first patient was observed for DLTs for ≥7 days before the dosing of 2 subsequent patients was commenc... | PMC10448909 |
Statistical Analyses | toxicity, tumor, DLTs, overdose | EVENTS, TUMOR | No formal significance level was defined for this study and all analyses were considered descriptive. Five analysis sets were defined: the dose-escalation set included all patients treated in the dose-escalation cohorts who did not miss >4 cumulative days of planned M8891 doses in the first cycle unless they experience... | PMC10448909 |
Data Availability | For all new products or new indications approved in both the European Union and the United States after January 1, 2014, the healthcare business of Merck KGaA, Darmstadt, Germany will share patient-level and study-level data after deidentification as well as redacted study protocols and clinical study reports from clin... | PMC10448909 | ||
Results | PMC10448909 | |||
Patient Demographics and Disposition | ONCOLOGY, DISEASE | Baseline and disease history characteristics of all 27 patients enrolled are presented in Patient demographics and dispositionAbbreviations: ECOG, Eastern Cooperative Oncology Group; Max, maximum; Min, minimum; StD, standard deviation.
Thirteen of 27 patients (48.1%, | PMC10448909 | |
Safety | bleeding, DLTs, thrombocytopenia, TEAEs, decreased appetite | DISEASE PROGRESSION, BLEEDING, DEEP VEIN THROMBOSIS, THROMBOCYTOPENIA, ADVERSE EVENT, EVENTS | Overall, most patients (96.3%, 26/27) experienced a TEAE, with 21 (77.8%) reporting at least one TEAE considered related to M8891 by investigators (Overview of TEAEs for M8891Abbreviations: TEAE, treatment-emergent adverse event; QD, once daily.
TEAEs occurring in ≥15% patients are presented by dose level and overall, ... | PMC10448909 |
Pharmacokinetics | The pharmacokinetic parameters for M8891 for cycle 1, days 1 and 15 are presented with summary statistics in Pharmacokinetic parameters of M8891 in plasma by treatment after single (cycle 1, day 1) and multiple dosing (cycle 1, day 15)Abbreviations: AUC
Except for a few subjects (Peak and total exposures (Plasma conce... | PMC10448909 | ||
Pharmacodynamics | tumor, tumors | TUMOR, TUMORS | Met-EF1α accumulation in tumors was observed at 7 mg once daily and tended to increase up to 35 mg once daily in a dose-dependent manner in line with the observed increase of exposure (Met-EF1α/protein levels in tumor on cycle 2, day 1 (individual patient dot plot). Open symbols show the pretreatment Met-EF1α levels, a... | PMC10448909 |
Efficacy | BOR of SD | DISEASE | Although no objective responses were observed in this heavily pretreated study population, 7 (25.9%) patients had a BOR of SD (Percentage change from baseline of the sum of longest target lesion diameters. The dashed lines show thresholds for progressive disease and PR. Dose levels are represented by different colors a... | PMC10448909 |
Discussion | bleeding, DLTs, tumor, neurotoxicity, tumors | BLEEDING, TUMOR, SOLID TUMORS, DRUG EFFECT, EVENTS, TUMOR GROWTH, TUMORS | In this phase I study, orally administered M8891 was clinically manageable in patients with advanced solid tumors. Among the 27 patients enrolled into the study, only two DLTs were observed, and, after enrolling a confirmatory cohort, the RP2D was determined as 35 mg once daily based on the absence of DLTs at doses ≤35... | PMC10448909 |
Acknowledgments | The authors would like to thank the patients, investigators, co-investigators, and the study teams at each of the participating centers and the healthcare business of Merck KGaA, Darmstadt, Germany. The trial was sponsored by the healthcare business of Merck KGaA, Darmstadt, Germany (CrossRef Funder ID: 10.13039/100009... | PMC10448909 | ||
Authors’ Disclosures | P. | ONCOLOGY, EMD | M.A. Carducci reports personal fees from Pfizer, Sanofi Genzyme, and AstraZeneca outside the submitted work. C. Habermehl reports personal fees from Merck KGaA outside the submitted work. F. Rohdich reports other. O. Karpenko reports personal fees from Merck healthcare KGaA, during the conduct of the study; personal fe... | PMC10448909 |
Authors’ Contributions | PMC10448909 | |||
References | PMC10448909 | |||
ABSTRACT. | malaria, parasitemia, infections | MALARIA, PARASITEMIA, INFECTIONS, FETAL GROWTH RESTRICTION | Financial support: This work was funded by grants from the Academy of Finland (79787 and 207010), the Foundation for Pediatric Research in Finland, and the Medical Research Fund of Tampere University Hospital.Disclosures: The azithromycin and its placebo used in the study were provided free of charge by Pfizer Inc (New... | PMC10077022 |
INTRODUCTION | LBW, malaria, microscopy-diagnosed, parasitemia, infections | MALARIA, PARASITEMIA, INFECTIONS | Low birth weight (LBW) is an important risk factor of childhood mortality, morbidity, and lower intellectual ability later in life.Typical interventions aimed to reduce LBW incidence focus on improving maternal nutrition, managing maternal infections, encouraging a healthy life style, and providing health services to p... | PMC10077022 |
METHODS | PMC10077022 | |||
Background/study design. | PCR-diagnosed malaria parasitemia | PRETERM DELIVERY, SECONDARY | This study is a secondary analysis of maternal PCR-diagnosed malaria parasitemia throughout pregnancy and ultrasound-assessed fetal growth as part of Lungwena Antenatal Intervention Study. The trial was a single-center, randomized, partially placebo-controlled, outcome assessor–blinded, three-arm clinical trial in rura... | PMC10077022 |
Participants and follow-up. | Details of the inclusion and exclusion criteria and randomization are available in the original trial publication.All participants were seen at the health center at 4-week intervals until 36 completed gestation weeks and weekly thereafter. At each visit, the mothers underwent an interview, a routine antenatal investiga... | PMC10077022 | ||
Outcomes. | parasitemia, PCR-diagnosed malaria parasitemia, PCR-diagnosed | MALARIA, PARASITEMIA | To identify maternal malaria parasitemia status, all DBS samples were run on an ABI 7900 Real-Time System (Applied Biosystems, Foster City, CA). Samples were considered positive if both cycle threshold values were below 45. We aimed at high sensitivity and specificity and therefore analyzed all samples in duplicate. Re... | PMC10077022 |
Statistical analysis. | peripheral blood malaria parasitemia, parasitemia | MALARIA, PARASITEMIA, REGRESSIONS, SECONDARY, REGRESSION, PRETERM DELIVERY | The sample size of 440 pregnant women per group was planned to give 80% power at a 5% level of significance to detect a 40% reduction in the rate of preterm delivery, which was the trial’s main hypothesis.Treatment allocation for the study was broken for the analysis of the trial’s main hypothesis. The statistician for... | PMC10077022 |
Ethics committee approval. | Both the original trial and the follow-up were performed according to Good Clinical Practice and the ethical standards of the Declaration of Helsinki. The protocol was approved by the College of Medicine Research and Ethics Committee, Malawi, and the Ethical Committee of Pirkanmaa Hospital District, Finland. This trial... | PMC10077022 | ||
RESULTS | PMC10077022 | |||
Enrollment and background. | parasitemia | MALARIA, PARASITEMIA | Between December 1, 2003, and October 11, 2006, 1,320 women were enrolled in the study and randomized to control (436), monthly SP (441), and AZI-SP groups (443). At enrollment the intervention groups were similar except for small differences in the prevalence of microscopic malaria parasitemia and mean number of previ... | PMC10077022 |
Maternal malaria parasitemia. | malaria, parasitemia | MALARIA, REGRESSION, PARASITEMIA | The overall proportion (Proportion of malaria parasitemia positive samples, using the locally weighted scatterplot smoothing technique with bandwidth (0.2). AZI-SP = intervention group with monthly sulfadoxine-pyrimethamine (SP) and two doses of azithromycin.Proportion of maternal malaria parasitemia by intervention gr... | PMC10077022 |
Fetal growth. | SE, parasitemia | REGRESSION, PARASITEMIA, MALARIA | The mean (SD) biparietal diameter of the fetuses was 41.8 mm (7.4) at enrollment, 77.1 mm (4.6) at 28–32 weeks of pregnancy, and 90.7 mm (4.3) at 37–38 weeks of pregnancy. Corresponding values for femur length were 22.5 mm (6.1), 52.0 mm (4.0), and 63.3 mm (4.3), respectively. The mean biparietal diameter was close to ... | PMC10077022 |
DISCUSSION | LBW, stunting, malaria, parasitemia, weight gain, PCR-diagnosed malaria parasitemia | MALARIA, PRETERM BIRTH, PARASITEMIA | The aim of this study was to determine the impact of antenatal monthly SP with or without two doses of azithromycin on maternal PCR-diagnosed malaria parasitemia and fetal biparietal diameter and femur length growth velocity in the second and third trimesters of pregnancy compared with two doses of SP. In a sample of 1... | PMC10077022 |
ACKNOWLEDGMENTS | We thank the study participants, the people of Lungwena, the staff at the Lungwena Training Health Centre and the Malindi and Mangochi Hospitals, and our research nurses and assistants. | PMC10077022 | ||
REFERENCES | PMC10077022 | |||
Background | This study updated 3-year analyses to further characterize the impact of docetaxel, cisplatin, and fluorouracil (TPF) chemotherapy followed by surgery. | PMC10761379 | ||
Methods | cancer | PRIMARY TUMOR, CANCER, OESOPHAGEAL SQUAMOUS CELL CARCINOMA | This study was a single-center phase 2 clinical trial. Patients with a diagnosis of borderline resectable esophageal squamous cell carcinoma (BR-ESCC) because of the primary tumor or bulky lymph node that potentially invaded adjacent organs were eligible. The treatment started with TPF chemotherapy followed by surgery ... | PMC10761379 |
Results | Surgery was performed for 27 patients (57.4%), and R0 resection was confirmed in 25 patients (53.2%). Pathologic complete response was confirmed in four patients (8.5%). The median follow-up time for the surviving patients was 44.8 months (range, 3.4–74.6 months). The median OS for all the patients was 41.9 months (95%... | PMC10761379 | ||
Patients and Methods | Cancer | CANCER | The study was approved by the ethics committee of Sun Yat-sen University Cancer Center. All patients included in the study provided written informed consent before enrollment. The study was registered at ClinicalTrials.gov (NCT02976909). | PMC10761379 |
Patients | As previously reported, | PMC10761379 | ||
Study Design and End Points | The NEOCRTEC-1601 study was a single-center phase 2 clinical trial. The details of the borderline resectable criteria and clinical staging were described in our previous report. | PMC10761379 | ||
Treatment Procedure | tumor, tumors | TUMOR, POSTOPERATIVE COMPLICATIONS, TUMOR PROGRESSION, PRIMARY TUMOR, TUMORS | The protocol therapy started with two or three cycles of TPF-induction chemotherapy (intravenous [IV] paclitaxel 135 mg/mAfterward, if curative resection was considered possible on multidisciplinary consultation reassessment, the patient was scheduled for conversion surgery 3–4 weeks after induction therapy. McKeown es... | PMC10761379 |
Pathologic Analysis | TRG, tumor, Cancer | TUMOR, DEGENERATION, RESIDUAL TUMOR, REGRESSION, CANCER | Evaluations of residual tumor (R) were classified as follows: R0 resection (no microscopic and macroscopic residual tumor), R1 resection (only microscopic residual tumor), and R2 resection (macroscopic residual tumor). A condition without grossly and microscopically viable tumor in the entire surgical specimen, includi... | PMC10761379 |
Statistical Analysis | According to the retrospective data from our center, the R0 resection rate for BR-ESCC with surgery alone was approximately 20% (3/12) and expected to increase to 40%. With a one-sided alpha significance level of 0.05 and a statistical power of 80%, the inclusion of 40 patients was required for evaluation of the R0 res... | PMC10761379 | ||
Results | PMC10761379 | |||
Survival | The median follow-up time for the surviving patients was 44.8 months (range, 3.4–74.6 months). The median OS for all the patients was 41.9 months (95% CI, 18.6–65.3 months), and the median PFS for all the patients was 38.7 months (95% CI, 23.5–53.9 months). The 3-year survival rate was 54.4% (95% CI, 40.2–69.5 %), and ... | PMC10761379 | ||
Acknowledgment | This study was supported by the National Natural Science Foundation of China (grant nos. 81972614 and 82273032) and the Natural Science Foundation of Guangdong Province, China (grant no.2022A1515012217). | PMC10761379 | ||
Funding | National Natural Science Foundation of China, 81972614, 82273032, Natural Science Foundation of Guangdong Province, No.2022A1515012217. | PMC10761379 | ||
Disclosures | There are no conflicts of interest. | PMC10761379 | ||
References | PMC10761379 | |||
BACKGROUND: | heart failure, death | HEART FAILURE, LEFT VENTRICULAR SYSTOLIC DYSFUNCTION | Percutaneous coronary intervention (PCI) is frequently undertaken in patients with ischemic left ventricular systolic dysfunction. The REVIVED (Revascularization for Ischemic Ventricular Dysfunction)-BCIS2 (British Cardiovascular Society-2) trial concluded that PCI did not reduce the incidence of all-cause death or hea... | PMC10782932 |
METHODS: | heart failure, left ventricular systolic dysfunction | HEART FAILURE, LEFT VENTRICULAR SYSTOLIC DYSFUNCTION, REGRESSION | REVIVED-BCIS2 was a prospective, multicenter UK trial, which randomized patients with severe ischemic left ventricular systolic dysfunction to either PCI+OMT or OMT alone. Health care resource use (including planned and unplanned revascularizations, medication, device implantation, and heart failure hospitalizations) a... | PMC10782932 |
RESULTS: | Between 2013 and 2020, 700 patients were recruited (mean age: PCI+OMT=70 years, OMT=68 years; male (%): PCI+OMT=87, OMT=88); median follow-up was 3.4 years. Over all follow-ups, patients undergoing PCI yielded similar health benefits at higher costs compared with OMT alone (PCI+OMT: 4.14 QALYs, £22 352; OMT alone: 4.16... | PMC10782932 | ||
CONCLUSIONS: | left ventricular systolic dysfunction | LEFT VENTRICULAR SYSTOLIC DYSFUNCTION | A minimal difference in total QALYs was identified between arms, and PCI+OMT was not cost-effective compared with OMT, given its additional cost. A strategy of routine PCI to treat ischemic left ventricular systolic dysfunction does not seem to be a justifiable use of health care resources in the United Kingdom. | PMC10782932 |
REGISTRATION: | URL: | PMC10782932 | ||
WHAT IS KNOWN | heart failure, death, left ventricular systolic dysfunction | HEART FAILURE, LEFT VENTRICULAR SYSTOLIC DYSFUNCTION | Percutaneous coronary intervention (PCI) is frequently utilized in patients with ischemic left ventricular systolic dysfunction.The REVIVED (Revascularization for Ischemic Ventricular Dysfunction)-BCIS2 (British Cardiovascular Society-2)trial demonstrated that PCI did not decrease all-cause death or heart failure hospi... | PMC10782932 |
WHAT THE STUDY ADDS | Heart failure, HF, coronary artery disease, left ventricular systolic dysfunction | HEART FAILURE, LEFT VENTRICULAR SYSTOLIC DYSFUNCTION, CORONARY ARTERY DISEASE | This study evaluates the economic implications associated with PCI in ischemic left ventricular systolic dysfunction patients, filling a crucial knowledge gap.Results indicate that although PCI provides similar health benefits, it comes at a higher cost when compared with optimal medical therapy alone.Most health resou... | PMC10782932 |
METHODS | PMC10782932 | |||
Trial Design and Patient Population | HEART | REVIVED was a prospective, multicenter, randomized, open-label trial involving 700 patients with ILVDThe patients enrolled had a median age of 69 years, 12% were female, the median British Cardiovascular Intervention Society jeopardy score was 10, the mean baseline LVEF was 27%±6.8%, and 26% had New York Heart Associat... | PMC10782932 | |
Economic Analysis | The analysis follows the preferred methods of the UK National Institute for Health and Care Excellence | PMC10782932 | ||
Estimation of Costs | coronary artery disease | CORONARY ARTERY DISEASE | Health care resources used by each participant in the trial were obtained from the trial case report forms completed by trial investigators. The case report form captured the health resource consumption at baseline, 6 months, 12 months, and then on a yearly basis, with only postrandomization consumption included for an... | PMC10782932 |
Health-Related Quality of Life | In the REVIVED trial, health-related quality of life was assessed using the KCCQ and the EQ-5D-5L questionnaires. | PMC10782932 | ||
Multiple Imputation | Missing responses to the EuroQol 5-dimension (EQ-5D) instrument were imputed using multiple imputations by chained equations. | PMC10782932 | ||
Regression Analysis | REGRESSION | Generalized linear models were used to estimate independently predicted total costs and QALYs over the follow-up period. Adjustment for clinically relevant and validated covariates was performed, consistent with the primary outcome analysis.To consider the potential interdependence and correlation between costs and out... | PMC10782932 | |
Cost-Effectiveness Analysis | SENSITIVITY | Incremental cost-effectiveness analysis was conducted based on differences in mean costs and QALYs between the 2 randomized groups. In the context of 1 group having higher mean costs and QALYs, incremental cost-effectiveness was estimated as the relevant intervention’s incremental cost per additional QALY. Judgments on... | PMC10782932 | |
RESULTS | Between 2013 and 2020, 347 patients were randomized to PCI+OMT and 353 to OMT alone. A total of 225 patients (32%) died during the median trial follow-up of 41 months. The KCCQ overall summary score at 6 months increased by 6.5 points more in the PCI+OMT arm (+11.2 versus +4.7). However, by 24 months, the difference wa... | PMC10782932 | ||
DISCUSSION | left ventricle systolic dysfunction, Angioplasty, coronary artery disease | REGRESSION, DISEASE, CORONARY ARTERY DISEASE, STABLE ANGINA | In this prospective within-trial cost-effectiveness analysis of the REVIVED trial, no appreciable difference in total QALYs was identified between arms, but the PCI+OMT strategy was substantially more expensive than OMT alone, largely due to the upfront cost of PCI. Consequently, PCI+OMT was economically dominated and ... | PMC10782932 |
APPENDIX | Rocchiccioli, Donna Exley, Natalia, Claudia | HEART, MARION, WRIGHT, MOORE, EDWARDS, WELLS, CROSS, STUART, HORTON, FRASER, BROWN | REVIVED Sites and Investigators: Guy’s and St Thomas’ Hospital: Prof Divaka Perera (principal investigator); Prof Amedeo Chiribiri, Prof Gerry Carr-White, Dr Antonis Pavlidis, Prof Simon Redwood, Dr Brian Clapp, Prof Aldo Rinaldi, Dr Haseeb Rahman, Dr Natalia Briceno (coinvestigators); Sophie Arnold, Amy Raynsford, Kar... | PMC10782932 |
ARTICLE INFORMATION | PMC10782932 | |||
Sources of Funding | arrhythmia | HEART, ARRHYTHMIA | This trial was sponsored by King’s College London and funded by the National Institute for Health and Care Research Health Technology Assessment Program (10/57/67). The arrhythmia analyses were supported by the British Heart Foundation (fellowship FS/CRTF/21/24190 and the King’s British Heart Foundation Center of Resea... | PMC10782932 |
Disclosures | None. | PMC10782932 | ||
Supplemental Material | Supplemental MethodsTables S1–S10References | PMC10782932 | ||
Supplementary Material | PMC10782932 | |||
Nonstandard Abbreviations and Acronyms | Cardiomyopathy | HEART FAILURE, CARDIOMYOPATHY, APPENDIX, HEART | coronary artery bypass graftingEuroQol 5-dimensionEuroQol 5 dimension 5 levelheart failureischemic left ventricular systolic dysfunctionKansas City Cardiomyopathy Questionnairemedical therapyoptimal medical therapypercutaneous coronary interventionquality-adjusted life-yearRevascularization for Ischemic Ventricular Dys... | PMC10782932 |
REFERENCES | PMC10782932 | |||
Background | Pulse oximetry as a home or remote monitoring tool accelerated during the pandemic for patients with COVID-19, but evidence on its use is lacking. | PMC9926282 | ||
Aim | cardiovascular comorbidity | To assess the feasibility of home monitoring by pulse oximetry of patients aged ≥40 years with cardiovascular comorbidity and moderate-to-severe COVID-19. | PMC9926282 | |
Design and setting | A primary care-based, open, pilot randomised controlled trial, with nested process evaluation, was undertaken in the Netherlands. | PMC9926282 | ||
Method | From November 2020 to June 2021, eligible patients presenting to one of 14 participating Dutch general practices were randomly allocated to regular measurement of peripheral oxygen saturation (at least three SpO | PMC9926282 | ||
Results | Hypoxemia | All 41 participants (21 intervention, 20 usual care) completed the 45-day follow-up period. Overall, the intervention group performed 97.6% of protocolised measurements; the median daily measurement per participant was 2.7 (interquartile range 1–4). Hypoxemia (SpO | PMC9926282 | |
Conclusion | Home monitoring of patients with moderate-to-severe COVID-19 by pulse oximetry appeared feasible; adherence was high, patients reported a high feeling of safety, while the number of primary care consultations remained similar to usual care. | PMC9926282 | ||
INTRODUCTION | cardiovascular comorbidity, fits | A pulse oximeter is a small, easy-to-operate, non-invasive tool to measure the peripheral oxygen saturation (SpOTherefore, a primary care-based, open, pilot randomised controlled trial (RCT) was conducted. The aim was to assess the feasibility of a trial of home monitoring by pulse oximetry for patients aged ≥40 years ... | PMC9926282 | |
METHOD | PMC9926282 | |||
Trial design | Between November 2020 and June 2021, an open-label, individually randomised (one-to-one) controlled pilot trial, with nested process evaluation, was conducted in Dutch primary care. | PMC9926282 | ||
Public and patient involvement | chronic or oncologic disease | Patients of the Patient and Family Advisory Council from the ZonMw institution in the Netherlands provided input in defining research questions, outcomes, and data collection at the design stage of the study. This group consisted of middle-aged patients with chronic or oncologic disease who received structured care via... | PMC9926282 | |
Participants | cardiovascular comorbidity, anaemia, shortness of breath | RESPIRATORY TRACT INFECTION, ANAEMIA | Patients were aged ≥40 years with cardiovascular comorbidity who presented to the GP with moderate-to-severe COVID-19 symptoms. Moderate-to-severe symptoms were defined as at least 3 days with a body temperature ≥37.5°C and either a) new onset of symptoms of respiratory tract infection; b) a feeling of shortness of bre... | PMC9926282 |
Intervention | All participants in the intervention group received an FDA-approved for medical use pulse oximeter (Nonin 3230); together with verbal, written, and visual instructions to measure their SpOBefore distribution, all pulse oximeters were registered, checked, and released by the Department of Medical Technology and Clinical... | PMC9926282 | ||
Data collection | disability | At baseline, a short interviewer-administered questionnaire was completed, including demographic data and the 12-item WHODAS 2.0 (World Health Organization Disability Assessment Schedule 2.0), which is a generic assessment instrument developed by the WHO to measure health and disability (scale: 0 = no disability to 48 ... | PMC9926282 | |
Outcomes | The primary outcome was feasibility of a trial of home monitoring by pulse oximetry defined as successful inclusion of approximately 50 participants within 6 months who were willing to a) be randomised; and b) adhere to study procedures.Secondary outcomes included quantitative data about the use of pulse oximetry in pr... | PMC9926282 | ||
Process evaluation | In a process evaluation alongside the trial, the study examined how the intervention was used in practice in terms of fidelity (intervention carried out as planned), dose (intervention was used as long and frequently as planned), adjustments (whether made to the intervention and why), and reach (whether the intended au... | PMC9926282 | ||
Sample size considerations | A formal sample-size calculation was not performed for this feasibility pilot trial. It was initially aimed to randomise approximately 50 participants, a number deemed to be sufficient to assess the feasibility of the trial. | PMC9926282 |
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