ABSTRACT
Investigating the contribution of mindfulness training to psychological well-being and quality of life in the university setting is of interest. The objective of the study is to present a comparative analysis of the scores in the variables of self-efficacy, resilience, coping strategies, and communication skills before and after the application of an intervention program based on mindfulness. An ex post facto cross-sectional design and a convenience sample of participants were adopted. The participants were students belonging to Education Sciences who benefited from the activities of the program. Instruments were administered to assess mindfulness, self-efficacy, resilience, coping strategies, and communication skills. The correlations of the mindfulness variable with the other psychoeducational variables evaluated were also analyzed. The results indicate an increase in the scores in the selected variables of mindfulness, resilience, communication skills, and some of the coping strategies considered productive or functional such as problem solving, self-criticism, emotional expression, desiderative thinking, social support, and cognitive restructuring. Statistically significant correlations were also observed between the variable mindfulness and those of perceived self-efficacy, resilience, coping strategies, and communication skills. The development of mindfulness training programs in the university setting is necessary to contribute to the improvement of more adaptive coping skills and the promotion of resilience.
ABSTRACT
Placental leptin may impact foetal development. Maternal overnutrition has been linked to increased plasma leptin levels and adverse effects on offspring, whereas choline, an essential nutrient for foetal development, has shown promise in mitigating some negative impacts of maternal obesity. Here, we investigate whether a maternal obesogenic diet alters foetal growth and leptin levels in the foetal stomach, amniotic fluid (AF), and placenta in late gestation and explore the potential modulating effects of maternal choline supplementation. Female rats were fed a control (CD) or a western diet (WD) four weeks before mating and during gestation, half of them supplemented with choline (pregnancy days 11-17). Leptin levels (in foetal stomach, AF, and placenta) and leptin gene expression (in placenta) were assessed on gestation days 20 and 21. At day 20, maternal WD feeding resulted in greater leptin levels in foetal stomach, placenta, and AF. The increased AF leptin levels were associated with a premature increase in foetal weight in both sexes. Maternal choline supplementation partially prevented these alterations, but effects differed in CD dams, causing increased AF leptin levels and greater weight in male foetuses at day 20. Maternal choline supplementation effectively mitigates premature foetal overgrowth induced by an obesogenic diet, potentially linked to increased AF leptin levels. Further research is needed to explore the sex-specific effects.
Subject(s)
Amniotic Fluid , Choline , Dietary Supplements , Leptin , Animals , Female , Leptin/blood , Leptin/metabolism , Pregnancy , Choline/administration & dosage , Amniotic Fluid/metabolism , Rats , Male , Placenta/metabolism , Placenta/drug effects , Fetal Development/drug effects , Obesity/metabolism , Obesity/etiology , Fetal Weight/drug effects , Rats, Sprague-Dawley , Diet, Western/adverse effectsSubject(s)
Schistosomiasis haematobia , Transients and Migrants , Humans , Female , Africa South of the Sahara/ethnology , Transients and Migrants/statistics & numerical data , Prospective Studies , Schistosomiasis haematobia/epidemiology , Europe/ethnology , Europe/epidemiology , Adult , Middle Aged , Anthelmintics/therapeutic use , Anthelmintics/administration & dosage , Schistosoma haematobium/isolation & purificationABSTRACT
One approach to reduce the side effects of chemotherapy in cancer treatment is photodynamic therapy (PDT), which allows spatiotemporal control of the cytotoxicity. We have used the strategy of coordinating π-expansive ligands to increase the excited state lifetimes of Ir(III) half-sandwich complexes in order to facilitate the generation of 1O2. We have obtained derivatives of formulas [Cp*Ir(Câ§N)Cl] and [Cp*Ir(Câ§N)L]BF4 with different degrees of π-expansion in the Câ§N ligands. Complexes with the more π-expansive ligand are very effective photosensitizers with phototoxic indexes PI > 2000. Furthermore, PI values of 63 were achieved with red light. Time-dependent density functional theory (TD-DFT) calculations nicely explain the effect of the π-expansion. The complexes produce reactive oxygen species (ROS) at the cellular level, causing mitochondrial membrane depolarization, cleavage of DNA, nicotinamide adenine dinucleotide (NADH) oxidation, as well as lysosomal damage. Consequently, cell death by apoptosis and secondary necrosis is activated. Thus, we describe the first class of half-sandwich iridium cyclometalated complexes active in PDT.
Subject(s)
Antineoplastic Agents , Photochemotherapy , Photosensitizing Agents/pharmacology , Photosensitizing Agents/therapeutic use , Antineoplastic Agents/pharmacology , Ligands , Cell Line, Tumor , Iridium/pharmacologySubject(s)
Humans , Male , Female , Primary Health Care , Pedigree , Electronic Health Records , Rare Diseases , Genetic Privacy , Physicians, FamilyABSTRACT
Suicidal behavior among young people has become an increasingly relevant topic after the COVID-19 pandemic and constitutes a public health problem. This study aimed to examine the variables associated with suicide risk and determine their predictive capacity. The specific objectives were: (1) to analyze the relationship between suicide risk and model variables and (2) to design an artificial neural network (ANN) with predictive capacity for suicide risk. The sample comprised 337 youths aged 18-33 years. An ex post facto design was used. The results showed that emotional attention, followed by problem solving and perfectionism, were variables that contributed the most to the ANN's predictive capacity. The ANN achieved a hit rate of 85.7%, which is much higher than chance, and with only 14.3% of incorrect cases. This study extracted relevant information on suicide risk and the related risk and protective factors via artificial intelligence. These data will be useful for diagnosis as well as for psycho-educational guidance and prevention. This study was one of the first to apply this innovative methodology based on an ANN design to study these variables.
ABSTRACT
We report two, genotypically identical but phenotypically distinct cases of Schaaf-Yang syndrome and propose the early use of Genome Sequencing in patients with nonspecific presentations to facilitate the early diagnosis of children with rare genetic diseases and improve overall health care outcomes.
ABSTRACT
In the treatment of hormone-dependent cancers, aromatase inhibitors (AI) are receiving increased attention due to some undesirable effects such as the risk of endometrial cancer and thromboembolism of SERMs (selective estrogen receptor modulators). Letrozole is the most active AI with 99% aromatase inhibition. Unfortunately, this compound also exhibits some adverse effects such as hot flashes and fibromyalgias. Therefore, there is an urgent need to explore new types of AIs that retain the same-or even increased-antitumor ability. Inspired by the letrozole structure, a set of new derivatives has been synthesized that include a ferrocenyl moiety and different heterocycles. The derivative that contains a benzimidazole ring, namely compound 6, exhibits a higher aromatase inhibitory activity than letrozole and it also shows potent cytostatic behavior when compared to other well-established aromatase inhibitors, as demonstrated by dose-response, cell cycle, apoptosis and time course experiments. Furthermore, 6 promotes the inhibition of cell growth in both an aromatase-dependent and -independent fashion, as indicated by the study of A549 and MCF7 cell lines. Molecular docking and molecular dynamics calculations on the interaction of 6 or letrozole with the aromatase binding site revealed that the ferrocene moiety increases the van der Waals and hydrophobic interactions, thus resulting in an increase in binding affinity. Furthermore, the iron atom of the ferrocene fragment can form a metal-acceptor interaction with a propionate fragment, and this results in a stronger coupling with the heme group-a possibility that is consistent with the strong aromatase inhibition of 6.
Subject(s)
Breast Neoplasms , Cytostatic Agents , Humans , Female , Letrozole/pharmacology , Aromatase Inhibitors/pharmacology , Aromatase Inhibitors/chemistry , Aromatase/metabolism , Metallocenes , Molecular Docking Simulation , Nitriles/pharmacology , Triazoles/pharmacology , MCF-7 CellsABSTRACT
BACKGROUND: Congenital thrombotic thrombocytopenic purpura (cTTP) is an ultra-rare, life-threatening hereditary disorder that causes patients to experience significant morbidity and decreased health-related quality of life (HRQoL). A cTTP disease-specific patient-reported outcome (PRO) instrument that is reflective of patients' experiences with the disorder does not currently exist. The objective of this study was to evaluate and validate the psychometric properties of the Congenital Thrombotic Thrombocytopenic Purpura-Patient Experience Questionnaire (cTTP-PEQ), developed using a literature review, interviews with expert clinicians, and qualitative concept elicitation and cognitive debriefing interviews. METHODS: This prospective, observational study (NCT03519672) was conducted with patients diagnosed with cTTP currently receiving treatment. Patients were enrolled through investigator sites and direct-to-patient recruitment. Individuals completed electronic self-administered PRO measures, including the cTTP-PEQ, at baseline and Day 14 (+ up to 10 days). The cTTP-PEQ consisted of five multi-item domains (Pain/Bruising, Cognitive Impairment, Visual Impairment, Mood, Treatment Burden) and three single-item domains (Fatigue, Headache, Activity Limitation), and assessed symptoms and impact of cTTP in the previous 24 h, 7 days, and 2 weeks. Convergent and discriminant validity were evaluated using Spearman's rank correlation coefficients. Known-groups validity was assessed between patient groups separated by Patient Global Impression of Severity (PGI-S; normal vs. mild/moderate/severe). Internal reliability was assessed using Cronbach's alpha. Test-retest reliability was assessed using intraclass correlation coefficients (ICCs). RESULTS: Thirty-six patients participated in this study. Convergent validity was confirmed with high-to-moderate correlations (r ≥ 0.4) for 12/15 hypothesized relationships between pairs of domains and/or total scores. Discriminant validity was confirmed with low correlations (r < 0.3) observed for 5/7 hypothesized relationships. Known-groups validity was confirmed with significant differences (p ≤ 0.05) in mean cTTP-PEQ scores between the two PGI-S groups for most domains and items at both timepoints. Cronbach's alpha was 0.88 at baseline and 0.91 at Day 14, confirming internal consistency of the instrument. Test-retest reliability was also confirmed with a high ICC (0.96). CONCLUSION: This study validates the psychometric properties of the novel cTTP-PEQ for use in research and clinical practice to assess HRQoL among patients with cTTP. This instrument will be particularly useful when assessing cTTP disease burden and the impact of new treatments.
Subject(s)
Purpura, Thrombotic Thrombocytopenic , Humans , Purpura, Thrombotic Thrombocytopenic/diagnosis , Quality of Life , Reproducibility of Results , Prospective Studies , Psychometrics , Patient Reported Outcome Measures , Observational Studies as TopicABSTRACT
A new series of donor-acceptor-donor (D-A-D) structures derived from arylethynyl 1H-benzo[d]imidazole was synthesized and processed into single crystals with the goal of testing such crystals' ability to act as optical waveguides. Some crystals displayed luminescence in the 550-600 nm range and optical waveguiding behavior with optical loss coefficients around 10-2 dB/µm, which indicated a notable light transport. The crystalline structure, confirmed by X-ray diffraction, contains internal channels that are important for light propagation, as we previously reported. The combination of a 1D assembly, a single crystal structure, and notable light emission properties with low losses from self-absorption made 1H-benzo[d]imidazole derivatives appealing compounds for optical waveguide applications.
ABSTRACT
BACKGROUND: Nen UnkUmbi/EdaHiYedo ("We Are Here Now," or NE) is an intervention to prevent STIs, HIV, HCV, and teen pregnancy among Assiniboine and Sioux youth of the Fort Peck Reservation in the state of Montana in the USA. A cluster-randomized stepped-wedge design (SWD) trial is used to evaluate NE, where clusters are schools. The purpose of this study is to evaluate whether there is evidence of a secular trend associated with the COVID-19 pandemic. METHODS: The original study design is a cluster-randomized stepped-wedge design (SWD), in which five schools that youth from Fort Peck attend are the clusters to be randomized into the intervention one at a time, with all schools eventually being randomized to the intervention across three steps. N/E is a 5-year study involving 456 15- to 18-year-old youth. For this study, we use a mixed quantitative and qualitative methods approach to understand how the COVID-19 pandemic may have been associated with the study's primary outcome variables. Data were drawn from the first cluster exposed to the intervention and one control cluster that did not yet receive the intervention during the period in which COVID-19 mitigation efforts were being implemented. A pre-post COVID questionnaire was added to core measures administered, and semistructured qualitative interviews were conducted with youths regarding their perceptions of how the pandemic altered their sexual behaviors. RESULTS: One hundred eighteen youth responded to the questionnaire and 31 youth participated in semistructured qualitative interviews. Youth reporting having sex with less people due to COVID-19 reported more sex acts (incident rate ratio (IRR)=3.6, 95% CI 1.6-8.1) in comparison to those who did not report having sex with less people, and youth who reported having sex with the same amount of people due to COVID-19 reported less sex acts (IRR=0.31, 95% CI 0.14-0.7) in comparison to those who did not report having sex with the same amount of people. Youth reporting having sex less times due to COVID-19 experienced a greater number of sex acts in comparison to those who did not report having sex less times (IRR=2.7, 1.2-6.4). Results suggest that more sexually active individuals reported perceiving having sex with less people and less frequent engagement in sex during the pandemic. It is possible that the COVID-19 pandemic period was associated with a truncation in the distribution of sexual activity that would bias an estimate of the intervention's effect. CONCLUSION: Findings suggest evidence of a secular trend. This trend must be accounted for at trial end, and sensitivity analyses are recommended. Documenting and reporting on these findings encourages transparent reporting during the implementation of a SWD trial during a global pandemic, and informs endline analyses. TRIAL REGISTRATION: This trial is registered with the Clinical trials registry of the US National Library of Medicine at the National Institutes of Health (NIH). It was registered on October 1, 2018. The study presented in this manuscript is funded by NIH National Institute on Minority Health and Health Disparities (NIMHD), Award # R01MD012761-01, Elizabeth Rink (Principal Investigator). The study's ClinicalTrials.gov number is NCT03694418.
Subject(s)
COVID-19 , Sexually Transmitted Diseases , Pregnancy , Female , Humans , Adolescent , Pandemics , Reproductive Health , Sexual Behavior , Sexually Transmitted Diseases/prevention & controlABSTRACT
OBJECTIVE: The purpose of this study was to describe the feasibility of respiratory oscillometry (RO) in schoolchildren with asthma, and the concordance of its results with those of spirometry, to determine its clinical usefulness. METHODS: RO and spirometry were performed in 154 children (6 to 14-year-old) with asthma, following strict quality criteria for the tests. Their feasibility (probability of valid test, time of execution, number of maneuvers needed to achieve a valid test, and perceived difficulty) was compared. The factors that influence feasibility were analyzed with multivariate methods. FEV1, FEV1/FVC, FVC and FEF25-75 for spirometry, and R5, AX and R5-19 for RO, were converted into z-scores and their concordance was investigated through intraclass correlation coefficients (ICC) and kappa indices for normal/abnormal values. RESULTS: There were no differences in the probability of obtaining a valid RO or spirometry (83.1% vs. 81.8%, p = 0.868). RO required a lower number of maneuvers [mean (SD) 4.2 (1.8) versus 6.0 (1.6), p < 0.001] and less execution time [5.1 (2.7) versus 7.6 (2.4) minutes, p < 0.001], and patients considered it less difficult. Age increased the probability of obtaining valid RO and spirometry. The concordance of results between RO and spirometry was low, and only between zFEV1 and zAX could it be considered moderate (ICC = 0.412, kappa = 0.427). CONCLUSION: RO and spirometry are feasible in children with asthma. RO has some practical advantages, but the concordance of its results with spirometry is low.
Subject(s)
Asthma , Child , Humans , Adolescent , Oscillometry/methods , Feasibility Studies , Asthma/diagnosis , Spirometry/methods , Forced Expiratory VolumeABSTRACT
Presbyopia can be defined as the refractive state of the eye in which, due to a physiological decrease in the ability to accommodate, it is not possible to sustain vision without fatigue in a prolonged manner, along with difficulty focusing near vision. It is estimated that its prevalence in 2030 will be approximately 2.1 billion people. Corneal inlays are an alternative in the correction of presbyopia. They are implanted beneath a laser-assisted in situ keratomileusis (LASIK) flap or in a pocket in the center of the cornea of the non-dominant eye. The purpose of this review is to provide information about intraoperative and postoperative KAMRA inlay complications in the available scientific literature. A search was conducted on PubMed, Web of Science, and Scopus with the following search strategy: ("KAMRA inlay" OR "KAMRA" OR "corneal inlay pinhole" OR "pinhole effect intracorneal" OR "SAICI" OR "small aperture intracorneal inlay") AND ("complication" OR "explantation" OR "explanted" OR "retired"). The bibliography consulted shows that the insertion of a KAMRA inlay is an effective procedure that improves near vision with a slight decrease in distance vision. However, postoperative complications such as corneal fibrosis, epithelial iron deposits, and stromal haze are described.
ABSTRACT
Antecedentes y objetivosLas principales guías de práctica clínica recomiendan un adecuado manejo periprocedimiento de los fármacos antitrombóticos en caso de realización de técnicas invasivas. El principal objetivo de este estudio fue evaluar si existe mayor riesgo de eventos tromboembólicos por la supresión o la disminución de la dosis de anticoagulantes o antiagregantes en pacientes sometidos a una colangiopancreatografía retrógrada endoscópica (CPRE). Pacientes y métodos: Se realizó un estudio observacional prospectivo que incluyó 644CPRE realizadas con intención terapéutica durante el año 2019 en el Hospital Universitario Reina Sofía con un seguimiento de 30días posprocedimiento. Resultados: Seis pacientes presentaron un evento tromboembólico, no hallando diferencias entre la incorrecta retirada/reintroducción del tratamiento antitrombótico y una mayor proporción de eventos tromboembólicos o hemorrágicos tras el procedimiento (p>0,05). La incidencia de eventos trombóticos fue significativamente mayor en pacientes en tratamiento con heparina o apixabán (p=0,001), así como con antecedente de fibrilación auricular (p=0,05), valvulopatía reumática (p=0,037) y tromboembolismo pulmonar recurrente (p=0,035), siendo este además un factor de riesgo independiente. Asimismo, la incidencia de hemorragia en los 30días postesfinterotomía fue significativamente menor en aquellos con implantación de prótesis biliar (p=0,04).Conclusiones: El inadecuado manejo periprocedimiento de la terapia antitrombótica no se asocia a un aumento significativo de la incidencia de eventos tromboembólicos en los 30días posteriores a la CPRE. No obstante, se aconseja seguir las recomendaciones para una adecuada suspensión/reintroducción de fármacos antitrombóticos, realizando una vigilancia y un seguimiento estrechos tras el procedimiento en pacientes con factores que aumenten el riesgo trombótico.(AU)
Background and objectives: The main clinical practice guidelines recommend adequate periprocedural withdrawal and reintroduction of antithrombotic drugs in case of invasive techniques. The main objective of this study was to assess whether, in patients receiving anticoagulant or antiplatelet therapy, the suppression or reduction of the pharmacological dose for the performance of endoscopic retrograde cholangiopancreatography (ERCP) implies a greater risk of thromboembolic events. Patients and methods: A prospective observational study was carried out, which included 644ERCP performed with therapeutic intention during 2019 at the Reina Sofía University Hospital with follow-up during the 30days after the endoscopic intervention. Results: Six patients presented a thromboembolic event, finding no differences between the incorrect withdrawal/reintroduction of antithrombotic treatment and a higher proportion of thromboembolic or hemorrhagic events after the procedure (P>.05). The incidence of thrombotic events was significantly higher in patients treated with heparin or apixaban (P=.001), as well as with a history of atrial fibrillation (P=.05), rheumatic valve disease (P=.037) and recurrent pulmonary embolism (P=.035), this being also an independent risk factor. Likewise, the incidence of hemorrhage in the 30days post-sphincterotomy was significantly lower in those with implantation of a biliary prosthesis (P=.04). Conclusions: Inadequate periprocedural management of antithrombotic therapy is not associated with a significant increase in the incidence of thromboembolic events in the 30days after ERCP. However, close follow-up and surveillance during the days after this is essential in those patients with a condition that significantly increases the risk of thrombosis.(AU)
Subject(s)
Humans , Male , Aged , Cholangiopancreatography, Endoscopic Retrograde , Thromboembolism , Platelet Aggregation Inhibitors , Anticoagulants/therapeutic use , Sphincterotomy , Gastroenterology , Gastrointestinal DiseasesABSTRACT
BACKGROUND AND OBJECTIVES: The main clinical practice guidelines recommend adequate periprocedural withdrawal and reintroduction of antithrombotic drugs in case of invasive techniques. The main objective of this study was to assess whether, in patients receiving anticoagulant or antiplatelet therapy, the suppression or reduction of the pharmacological dose for the performance of endoscopic retrograde cholangiopancreatography (ERCP) implies a greater risk of thromboembolic events. PATIENTS AND METHODS: A prospective observational study was carried out, which included 644ERCP performed with therapeutic intention during 2019 at the Reina Sofía University Hospital with follow-up during the 30days after the endoscopic intervention. RESULTS: Six patients presented a thromboembolic event, finding no differences between the incorrect withdrawal/reintroduction of antithrombotic treatment and a higher proportion of thromboembolic or hemorrhagic events after the procedure (P>.05). The incidence of thrombotic events was significantly higher in patients treated with heparin or apixaban (P=.001), as well as with a history of atrial fibrillation (P=.05), rheumatic valve disease (P=.037) and recurrent pulmonary embolism (P=.035), this being also an independent risk factor. Likewise, the incidence of hemorrhage in the 30days post-sphincterotomy was significantly lower in those with implantation of a biliary prosthesis (P=.04). CONCLUSIONS: Inadequate periprocedural management of antithrombotic therapy is not associated with a significant increase in the incidence of thromboembolic events in the 30days after ERCP. However, close follow-up and surveillance during the days after this is essential in those patients with a condition that significantly increases the risk of thrombosis.
Subject(s)
Thromboembolism , Thrombosis , Humans , Anticoagulants/adverse effects , Cholangiopancreatography, Endoscopic Retrograde/adverse effects , Cholangiopancreatography, Endoscopic Retrograde/methods , Fibrinolytic Agents/adverse effects , Thromboembolism/epidemiology , Thromboembolism/etiology , Thromboembolism/prevention & control , Hemorrhage/etiology , Thrombosis/etiologyABSTRACT
Introducción: La Atención Primaria (AP) es el primer contacto entre el paciente y el médico, por lo que es fundamental tener claro los criterios de sospecha de una enfermedad genética y dónde se debe remitir para su estudio. Material y métodos: Cuatro sociedades científicas: la Sociedad Española de Medicina Familiar y Comunitaria (semFYC), la Asociación Española de Genética Humana (AEGH), la Asociación Española de Pediatría (AEP) y la Sociedad Española de Oncología Médica (SEOM), han revisado los criterios de derivación a los servicios de genética clínica de las diferentes guías publicadas, con el objetivo de elaborar unas recomendaciones para AP. Conclusiones: Con este Documento de Consenso el médico de familia y el pediatra de AP conocerán cuándo, cómo y dónde derivar a sus pacientes con patología hereditaria y/o genética a los servicios de genética clínica.(AU)
Introduction: Primary care (PC) is the first contact between the patient and the doctor, so it is essential to be clear about the criteria for suspecting a genetic disease and where it should be referred for study. Material and methods: Four scientific societies: the Spanish Society of Family and Community Medicine (semFYC), the Spanish Association of Human Genetics (AEGH), the Spanish Association of Pediatrics (AEP) and the Spanish Society of Medical Oncology (SEOM), have reviewed the criteria for referral to the clinical genetics services of the different published guidelines with the purpose of define the recommendations for PC. Conclusions: With this consensus document, the PC doctor and pediatrician will know when, how and where to refer their patients with hereditary and/or genetic pathology to clinical genetics services.(AU)
Subject(s)
Societies, Scientific , Consensus , Referral and Consultation , Primary Health Care , SpainABSTRACT
INTRODUCTION: Primary care (PC) is the first contact between the patient and the doctor, so it is essential to be clear about the criteria for suspecting a genetic disease and where it should be referred for study. MATERIAL AND METHODS: Four scientific societies: the Spanish Society of Family and Community Medicine (semFYC), the Spanish Association of Human Genetics (AEGH), the Spanish Association of Pediatrics (AEP) and the Spanish Society of Medical Oncology (SEOM), have reviewed the criteria for referral to the clinical genetics services of the different published guidelines with the purpose of define the recommendations for PC. CONCLUSIONS: With this consensus document, the PC doctor and pediatrician will know when, how and where to refer their patients with hereditary and/or genetic pathology to clinical genetics services.
Subject(s)
Community Medicine , Referral and Consultation , Humans , Child , Consensus , Primary Health Care , SpainABSTRACT
Importance: Patient-reported outcome instruments are key in assessing COVID-19-related symptoms and associated burden. However, a valid and reliable instrument to assess symptom severity and progression among outpatients with COVID-19 is not yet available. Objectives: To assess the extent to which the Symptoms Evolution of COVID-19 (SE-C19) instrument is valid, reliable, and able to detect symptom changes in outpatients with COVID-19, as well as to establish a definition of symptom resolution. Design, Setting, and Participants: In this diagnostic/prognostic study, psychometric properties of SE-C19 were assessed in participants recruited into an ongoing, adaptive, phase 1/2/3, randomized, double-blind, placebo-controlled clinical trial, during 2020 to 2022. Adult outpatients with symptomatic COVID-19 were randomized 1:1:1 to receive 2.4 g or 8.0 g intravenous casirivimab and imdevimab or placebo, in outpatient centers at 114 sites, from 2 countries (US and Mexico). Main Outcomes and Measures: Reliability, validity, and sensitivity to change of the SE-C19 were assessed. SE-C19 and Patient Global Impression of Severity (PGIS) were administered daily from predose at day 1 to day 29. Results: Analysis was conducted on 657 adult outpatients (342 female patients [52.1%], 562 White patients [85.5%]), and 337 non-Hispanic patients [51.3%]. At baseline, patients reported a mean (SD) of 6.6 (3.9) symptoms (ie, rated as at least mild) with a mean (SD) of 3.8 (3.3) of these symptoms being rated as moderate or severe. Stable patients according to PGIS showed scores with intraclass correlation values indicating moderate-to-good test-retest reliability (ie, 0.50-0.90). At baseline, 20 item scores (87%) varied significantly across PGIS-defined groups, supporting the validity of the SE-C19. A symptom-resolution end point was defined after excluding the item sneezing due to its low ability to discriminate severity levels, and excluding confusion, rash, and vomiting, due to their low prevalence in this population. Symptom resolution required complete absence of all remaining items, except cough, fatigue, and headache, which could be mild or moderate in severity. A total of 19 of 23 items from the SE-C19 instrument were identified as valid and reliable to measure disease-related symptoms in outpatients with COVID-19. Conclusions and Relevance: This study identified 19 items that are valid and reliable to measure disease-related symptoms in outpatients with COVID-19, and proposed a definition of symptom resolution for potential use in future clinical trials.
Subject(s)
COVID-19 , Adult , Humans , Female , COVID-19/diagnosis , Outpatients , Reproducibility of Results , Patient Reported Outcome MeasuresABSTRACT
Life-history calendars (LHCs) can produce retrospective data regarding numerous events, exposures, and sequences that have occurred across participants' lifespans. In this mixed-quantitative-and-qualitative-methods study, processes of LHC administration were evaluated in two populations experiencing health disparities: foreign-born agricultural workers (n = 41) and Indigenous people who used injection drugs (IPWIDS) (n = 40). LHC administrator and participant perspectives were elicited during follow-up survey activities. In both agricultural workers and IPWIDs, over half of participants reported that the LHC made it easier to remember things about the past, and participant age was associated with cumulative experience in different domains of interest. Qualitative findings suggested that data-collector training and the development of concise interview guides are critical for improving LHC data quality. Participants described ethical themes, including utilitarian, cathartic, and reflective aspects, of LHC participation. Future iterations of the LHC may benefit from providing free-form and open-ended spaces for participants to reflect on the LHC activity following LHC administration.