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BACKGROUND: Despite its excellent screening effectiveness and sensitivity for breast cancer (BC), digital breast tomosynthesis (DBT) is controversial due to its high radiation exposure and long reading time. This study examines the diagnostic accuracy of DBT and digital mammography (DM) for BC screening and diagnosis in women with dense or non-dense breast tissue. MATERIAL AND METHODS: PRISMA-compliant searches were performed on Medline, Embase, PubMed, Web of Science, and the Cochrane databases for articles comparing DBT and DM for BC screening until March 2023. Meta-analysis was performed using RevMan sofware, and the Cochrane Risk of Bias Assessment Tool was employed to assess study quality. RESULTS: This meta-analysis included 11 trials with a total of 2,124,018 individuals. Screening with DBT resulted in a greater cancer detection rate, as demonstrated by a risk ratio (RR) of 1.27 (95% confidence interval (95% CI): 1.14-1.41). Digital breast tomosynthesis also had a reduced recall rate, with a RR of 0.88 (95% CI: 0.78-0.99), higher sensitivity and specificity values (pooled sensitivity of 0.91 (95% CI: 0.59-0.99)) and pooled specificity of 0.90 (95% CI: 0.42-1.0)) than DM (pooled sensitivity of 0.86 (95% CI: 0.52-1.0) and pooled specificity of 0.81 (95% CI: 0.12-1.0)). All acquired data exhibited reliability, lack of bias and statistical significance (p < 0.05). CONCLUSION: Digital breast tomosynthesis is a more effective screening and diagnostic assessment tool for women with dense or non-dense breasts than DM in terms of incremental cancer detection, sensitivity and recall rate.
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Story recall is an episodic memory paradigm that is popular among researchers interested in the effects of aging, disease, and/or injury on memory functioning; it is less popular among individual-differences researchers studying neurotypical young adults. One reason differential psychologists may favor other episodic memory paradigms is that the prospect of scoring story recall is daunting, as it typically requires manually scoring hundreds or thousands of freely recalled narratives. In this study, I investigated two questions related to scoring story recall for individual differences research. First, whether there is anything to gain by scoring story recall for memory of central and peripheral details or if a single score is sufficient. Second, I investigated whether scoring can be automated using computational methods - namely, BERTScore and GPT-4. A total of 235 individuals participated in this study. At the latent variable level, central and peripheral factors were highly correlated (r = .99), and the two factors correlated with external factors (viz., fluid intelligence, crystallized intelligence, and working memory capacity) similarly. Regarding automated scoring, both BERTScore and GPT-4 derived scores were strongly correlated with manually derived scores (r ≥ .97); additionally, factors estimated from the various scoring methods all showed a similar pattern of correlations with the external factors. Thus, differential psychologists may be able to streamline scoring by disregarding detail type and by using automated approaches. Further research is needed, particularly of the automated approaches, as both BERTScore and GPT-4 derived scores were occasionally leptokurtic while manual scores were not.
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The dynamic evolution of SARS-CoV-2 variants necessitates ongoing advancements in therapeutic strategies. Despite the promise of monoclonal antibody (mAb) therapies like bebtelovimab, concerns persist regarding resistance mutations, particularly single-to-multipoint mutations in the receptor-binding domain (RBD). Our study addresses this by employing interface-guided computational protein design to predict potential bebtelovimab-resistance mutations. Through extensive physicochemical analysis, mutational preferences, precision-recall metrics, protein-protein docking, and energetic analyses, combined with all-atom, and coarse-grained molecular dynamics (MD) simulations, we elucidated the structural-dynamics-binding features of the bebtelovimab-RBD complexes. Identification of susceptible RBD residues under positive selection pressure, coupled with validation against bebtelovimab-escape mutations, clinically reported resistance mutations, and viral genomic sequences enhances the translational significance of our findings and contributes to a better understanding of the resistance mechanisms of SARS-CoV-2.
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This report explores the 24-hour dietary recall (24HDR) form used for the Expanded Food and Nutrition Education Program (EFNEP). Dietary supplement use, amount of money spent on food, time being physically active, portion size consumed, foods reported by meals, and preparation of the meal were common components collected among 61 EFNEP programs. Components not included were instructions for the peer educator, use of food models/measuring cups, examples of foods/beverages, time food/beverages were consumed, color coding, and a prompt to review what was written. A standardized 24-hour dietary recall form with training protocols is recommended to uphold the integrity of data collection.
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BACKGROUND: Time spent in sleep, sedentary behaviour (SB), and physical activity are exhaustive and mutually exclusive parts of a 24-h day that need to be considered in a combination. The aim of this study was to identify validated self-reported tools for assessment of movement behaviours across the whole 24-h day, and to review their attributes and measurement properties. METHODS: The databases PubMed, Scopus, and SPORTDiscus were searched until September 2023. Inclusion criteria were: (i) published in English language, (ii) per-reviewed paper, (iii) assessment of self-reported time spent in sleep, SB, and physical activity, (iv) evaluation of measurement properties of all estimates across the full 24-h day, and (v) inclusion of adolescents, adults, or older adults. The methodological quality of included studies was assessed using the Consensus-based Standards for the selection of health Measurement Instruments checklist. RESULTS: Our search returned 2064 records. After studies selection, we included 16 articles that reported construct validity and/or test-retest reliability of 12 unique self-reported tools - eight questionnaires, three time-use recalls, and one time-use diary. Most tools enable assessment of time spent in sleep, and domain-specific SB and physical activity, and account that sum of behaviours should be 24 h. Validity (and reliability) correlation coefficients for sleep ranged between 0.22 and 0.69 (0.41 and 0.92), for SB between 0.06 and 0.57 (0.33 and 0.91), for light-intensity physical activity between 0.18 and 0.46 (0.55 and 0.94), and for moderate- to vigorous-intensity physical activity between 0.38 and 0.56 (0.59 and 0.94). The quality of included studies being mostly fair-to-good. CONCLUSIONS: This review found that only a limited number of validated self-reported tools for assessment of 24-h movement behaviours are currently available. Validity and reliability of most tools are generally adequate to be used in epidemiological studies and population surveillance, while little is known about adequacy for individual level assessments and responsiveness to behavioural change. To further support research, policy, and practice, there is a need to develop new tools that resonate with the emerging 24-h movement paradigm and to evaluate measurement properties by using compositional data analysis. SYSTEMATIC REVIEW REGISTRATION: PROSPERO CRD42022330868.
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Ejercicio Físico , Conducta Sedentaria , Autoinforme , Sueño , Humanos , Reproducibilidad de los Resultados , Encuestas y Cuestionarios , Adulto , Adolescente , Conductas Relacionadas con la SaludRESUMEN
Acoustic keyword spotting (KWS) plays a pivotal role in the voice-activated systems of artificial intelligence (AI), allowing for hands-free interactions between humans and smart devices through information retrieval of the voice commands. The cloud computing technology integrated with the artificial neural networks has been employed to execute the KWS tasks, which however suffers from propagation delay and the risk of privacy breach. Here, we report a single-node reservoir computing (RC) system based on the CuInP2S6 (CIPS)/graphene heterostructure planar device for implementing the KWS task with low computation cost. Through deliberately tuning the Schottky barrier height at the ferroelectric CIPS interfaces for the thermionic injection and transport of the electrons, the typical nonlinear current response and fading memory characteristics are achieved in the device. Additionally, the device exhibits diverse synaptic plasticity with an excellent separation capability of the temporal information. We construct a RC system through employing the ferroelectric device as the physical node to spot the acoustic keywords, i.e., the natural numbers from 1 to 9 based on simulation, in which the system demonstrates outstanding performance with high accuracy rate (>94.6%) and recall rate (>92.0%). Our work promises physical RC in single-node configuration as a prospective computing platform to process the acoustic keywords, promoting its applications in the artificial auditory system at the edge.
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BACKGROUND: Early detection of Alzheimer's disease (AD) is one of the critical components of the global response to the growing dementia crisis. Analysis of serial position performance in story recall tests has yielded sensitive metrics for the prediction of AD at low cost. In this study, we examined whether serial position markers in two story recall tests (the logical memory test, LMT, and the Craft Story 21 test, CST) were sensitive to cross-sectional biomarker-based assessment of in vivo neuropathology. METHODS: Participants were selected from the Wisconsin Registry of Alzheimer's Prevention (n = 288; WRAP) and the Alzheimer's Disease Research Center (n = 156; ADRC), both from the University of Wisconsin-Madison. Average age at PET was 68.9 (6.7) and 67.0 (8.0), respectively. Data included tau and PiB PET, and LMT for WRAP participants and CST for ADRC participants. Two sets of Bayesian analyses (logistic regressions and ANCOVAs) were conducted within each cohort, separately. RESULTS: Results indicated that the A+T+ classification was best predicted, cross-sectionally, by the recency ratio (Rr), indexing how much of the end of the story was forgotten between initial learning and delayed assessment. Rr outperformed traditional scores and discriminated between A+T+ and A+T-/A-T-, in both cohorts. CONCLUSIONS: Overall, this study confirms that serial position analysis of LMT and CST data, and particularly Rr as an index of recency loss, is a valuable tool for the identification of in vivo tau pathology in individuals free of dementia. Diagnostic considerations are discussed.
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Enfermedad de Alzheimer , Recuerdo Mental , Tomografía de Emisión de Positrones , Humanos , Masculino , Femenino , Enfermedad de Alzheimer/diagnóstico por imagen , Anciano , Tomografía de Emisión de Positrones/métodos , Recuerdo Mental/fisiología , Persona de Mediana Edad , Estudios Transversales , Pruebas Neuropsicológicas , Proteínas tau/metabolismo , Encéfalo/diagnóstico por imagenRESUMEN
Dairy, especially cheese, is associated with high levels of greenhouse gas emissions. Accurate estimates of dairy consumption are therefore important for monitoring dietary transition targets. Previous studies found that disaggregating the meat out of composite foods significantly impacts estimates of meat consumption. Our objective was to determine whether disaggregating the dairy out of composite foods impacts estimates of dairy consumption in Scotland. Approximately 32% of foods in the UK Nutrient Databank contain some dairy. In the 2021 Scottish Health Survey, mean daily intakes of dairy with and without disaggregation of composite foods were 238.6 and 218.4 g, respectively. This translates into an 8% underestimation of dairy consumption when not accounting for dairy in composite foods. In particular, milk was underestimated by 7% and cheese and butter by 50%, whereas yogurt was overestimated by 15% and cream by 79%. Failing to disaggregate dairy from composite foods may underestimate dairy consumption.
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BACKGROUND: Previous studies have shown that Japanese dietary patterns are associated with high nutrient density. However, these studies were limited to the Japanese population. We examined this association in the US population. METHODS: A cross-sectional analysis was conducted using data from the National Health and Nutrition Examination Survey (NHANES) 2017-2018. We included 3138 people aged 20-79 years. Food and nutrient intake data were based on the 24 h recall method. Three Japanese diet indices were used: (1) Japanese Diet Index (JDI, based on 9 food items), (2) modified JDI (mJDI, based on 12 food items), and (3) weighted JDI (wJDI, selected and weighted from mJDI food items). The nutrient density (ND) score was calculated based on the Nutrient-Rich Food Index 9.3. Spearman's rank correlation coefficients were calculated. RESULTS: The correlation coefficients with the ND score were 0.24 (p < 0.001) for the JDI and 0.38 (p < 0.001) for the mJDI. The correlation coefficient between the wJDI and ND score was 0.48 (p < 0.001). The three Japanese diet indices were correlated with the ND score in all racial groups (p < 0.001). CONCLUSIONS: Even among the US population, higher degrees of Japanese diet defined by the JDI or mJDI were associated with higher nutrient density.
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Dieta , Encuestas Nutricionales , Adulto , Anciano , Femenino , Humanos , Masculino , Persona de Mediana Edad , Adulto Joven , Estudios Transversales , Dieta/estadística & datos numéricos , Conducta Alimentaria , Japón , Nutrientes/análisis , Valor Nutritivo , Estados UnidosRESUMEN
There is growing evidence that false memories can occur in working memory (WM) tasks with only a few semantically related words and seconds between study and test. Abadie and Camos (2019) proposed a new model to explain the formation of false memories by describing the role of articulatory rehearsal and attentional refreshing, the two main mechanisms for actively maintaining information in WM. However, this model has only been tested in recognition tasks. In the present study, we report four experiments testing the model in recall tasks in which the active maintenance of information in WM plays a more important role for retrieval. Short lists of semantically related items were held for a short retention interval filled with a concurrent task that either impaired or not the use of each of the WM maintenance mechanisms. Participants were asked to recall the items immediately after the concurrent task (immediate test) or later, at the end of a block of several trials (delayed test). In the immediate test, semantic errors were more frequent when WM maintenance was impaired. Specifically, rehearsal prevented the occurrence of semantic errors in the immediate test, while refreshing had no effect on their occurrence in this test, but increased semantic errors produced only in the delayed test. These results support Abadie and Camos (2019) model and go further by demonstrating the role of active information maintenance in WM in the emergence of false memories. The implications of these findings for understanding WM-LTM relationships are discussed.
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OBJECTIVES: EQ-5D-5L with its recall time of "today" may limit its ability to capture episodic symptoms and exacerbations in chronic obstructive airway diseases (OAD). We examined whether longer time frames and changing the intensity response scales to frequency scales could improve the measurement properties of EQ-5D-5L. METHODS: We used a mixed-method design starting with in-depth interviews with 20 patients and clinicians to elicit preferred time frames using concept elicitation techniques and content analyses. We then administered the top 4 preferred variants using 1- and 4-weeks' time frames with the original intensity or an alternative frequency response scale alongside EQ-5D-5L and St George Respiratory Questionnaire to OAD patients during 2 different visits. We compared the ceiling effects and construct validity by testing a priori hypotheses in relation to St George Respiratory Questionnaire and clinical outcomes via correlation and receiver operating characteristic (ROC) analyses, respectively. Follow-up patients were categorized into "better," "stable," and "worse" groups to assess reliability using intraclass correlation coefficient (ICC) or Cohen's Kappa (k) and responsiveness using ROC analysis. RESULTS: A total of 184 patients (mean [SD] age: 54[18]; female: 37.0%) completed baseline assessments. A total of 120 patients also completed follow-up assessments (mean [SD] interval: 2.8 [1.7] months). The ceilings were lower in the variants compared with EQ-5D-5L (P < .001). Reliability of the variants were comparable to or higher than EQ-5D-5L. The c-statistic values derived from ROC analyses of the variants were consistently higher than EQ-5D-5L. CONCLUSIONS: Use of longer time frames with the original intensity or the frequency response scales may improve EQ-5D-5L's psychometric properties in OAD patients.
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As we navigate our day-to-day lives, we regularly adapt our behaviour according to what we predict may happen next in a given context. When an unexpected event occurs, our predictions about the world are disrupted and must be updated. Unexpected, isolated events, particularly with high emotionality, are also better recalled. In the present work, we investigated how oddballs affect recall dynamics. Seventy young, healthy participants encoded word lists containing either emotional or perceptual oddballs at varying stimulus onset asynchronies followed by free recall. It is well established that after recalling an item, we have a higher probability of recalling items encoded nearby, particularly those that were encoded after the item was recalled, a phenomenon known as forward contiguity of recall. We tested how novelty (oddballs versus control words) modulated forward contiguity as a function of salience type (emotional versus perceptual). The present results provide empirical evidence of forward contiguity modulation selectively by emotional salience and suggest that recall patterns after presenting emotional and perceptual oddballs are mediated by different mechanisms.
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INTRODUCTION: Radiation recall reaction (RRR) is a rare inflammatory reaction developing in a previously irradiated field after a triggering agent. In pediatric patients, it is poorly understood and deficiently studied. Gemcitabine-docetaxel (G/D) in childhood cancer is mainly used as a salvage regimen for sarcomas. We aim to describe RRR triggered by G/D in children. PATIENTS AND METHODS: Retrospective review of 21 patients receiving G/D along with radiotherapy at two hospitals from 2010 until 2022. RRR was considered as any toxicity occurring after G/D administration in a previously irradiated field. RRR features were described. Fisher's and Mann-Whitney tests were utilized to analyze the risk factors involved. RESULTS: Sixteen episodes of RRR developed in 16 (76.2%) patients. RRR mainly involved deep layers of the skin (58%) and occurred predominantly after two G/D cycles. The mean time between radiotherapy and chemotherapy was 28.5 days (0-1359 days), and the mean radiation volume 391 mL (157-1810 mL) for RRR. RRR treatment was mainly systemic steroids, with partial responses in six of 11 (58%) patients. Re-exposure to G/D was associated with a high rate of recurrence in nine of 15 (56.2%), prompting drug discontinuation. The major risk factors for RRR after G/D include, without statistical significance, a larger volume of the irradiated field and a shorter interval between chemotherapy and radiotherapy. CONCLUSIONS: The incidence of RRR after G/D in the pediatric population is higher than previously reported. Drug re-exposure is usually followed by recurrence. Higher irradiated volumes and a shorter time to the start of chemotherapy could be related with an increased risk of RRR.
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Protocolos de Quimioterapia Combinada Antineoplásica , Desoxicitidina , Docetaxel , Gemcitabina , Humanos , Estudios Retrospectivos , Masculino , Femenino , Niño , Desoxicitidina/análogos & derivados , Desoxicitidina/efectos adversos , Docetaxel/efectos adversos , Docetaxel/administración & dosificación , Adolescente , Factores de Riesgo , Preescolar , Protocolos de Quimioterapia Combinada Antineoplásica/efectos adversos , Protocolos de Quimioterapia Combinada Antineoplásica/uso terapéutico , Neoplasias/tratamiento farmacológico , Neoplasias/radioterapia , Estudios de Seguimiento , Lactante , Radiodermatitis/etiología , Radiodermatitis/patología , PronósticoRESUMEN
Background: Training schoolchildren in basic life support ('Kids-Save-Lives' training) is widely believed to improve outcomes from out-of-hospital cardiac arrest. Numerous programmes have been launched, but to our knowledge, neither children nor schoolteachers have been directly involved in designing these courses. This is unfortunate, as it is well-known that children (as the target goup of training) learn differently from adults. We therefore sought to explore the view of schoolchildren and their teachers on the design of a 'Kids-Save-Lives' course. Methods: We designed a state-of-the-art, 90-min BLS training and delivered it to all 13 classes of a secondary community school (children aged 12-16). Directly after each training, we performed Video-Stimulated Recall (VSR) with 2 children and 2 schoolteachers. For VSR, we presented video sequences from defined sections of the training and related semi-structured questions to these sections. The interviews were audio-recorded, transcribed, and analysed using qualitative content analysis. Results: Twenty-four children and 24 teachers participated in the VSR. The overall satisfaction with the training was very high. Participants especially appreciated the brief theoretical introduction using a video, the high practical involvement, and the final scenario. Children suggested the program could be improved by better linking the video to the children's world, increasing excitement and action, and limiting the group size in the final scenario. Teachers suggested incorporating more theoretical background, using terms and language more consistently, and better integrating the program into the school curriculum. Conclusions: Although very satisfied with a state-of-the-art 'Kids-Save-Lives' training, children and teachers made important suggestions for improvement.
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In the present study, two experiments were conducted to examine whether thematic relation can produce recognition without cued-recall effect and whether the direction of the association has an influence on this effect. The participants provided higher familiarity ratings for studied items than for unstudied items during target retrieval failure. Additionally, the thematic relation-elicited recognition without cued-recall effect was larger in the forward association than in the backward association. Collectively, these results indicated that thematic relations can elicit the recognition without cued-recall effect, and this effect is asymmetrical. The current findings support the features overlap hypothesis described in the global match model.
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Objective: To explore the activation patterns in the frontal cortex of patients with post-stroke cognitive impairment during the execution of working memory tasks. Methods: 15 patients with post-stroke cognitive impairment, 17 patients without cognitive impairment, and 15 healthy controls of similar age and sex were included. All participants under-went immediate recall task testing and near-infrared spectroscopy imaging to measure frontal cortex activation during the task. Results: The healthy control group performed the best in the immediate recall task, followed by the post-stroke non-cognitive impairment group. The post-stroke cognitive impairment group had the poorest performance. The near-infrared spectroscopy results revealed that during the immediate recall task, the healthy control group primarily activated the left frontal lobe region. In contrast, post-stroke patients exhibited reduced activation in the left frontal lobe and increased activation in the right frontal cortex, particularly in the right frontopolar and orbitofrontal regions, with the post-stroke cognitive impairment group displaying the most pronounced changes. Conclusion: Patients with post-stroke cognitive impairment exhibit reduced activation in the left prefrontal cortex during the working memory tasks. They rely on compensatory activation in the right prefrontal cortex, particularly in the frontopolar and orbitofrontal cortex, to successfully complete the task.
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Multiple studies have explored the factor structure of working memory (WM) tasks, yet few have done so controlling for both the domain and category of the memory items in a single study. In the current pre-registered study, we conducted a large-scale latent variable analysis using variant forms of n-back and backward recall tasks to test whether they measured a single underlying construct, or were distinguished by stimuli-, domain-, or paradigm-specific factors. Exploratory analyses investigated how the resulting WM factor(s) were linked to fluid intelligence. Participants (N = 703) completed a fluid reasoning test and multiple n-back and backward recall tasks containing memoranda that varied across (spatial or verbal material) and within (verbal digits or letters) domain, allowing the variance specific to task content and paradigm to be assessed. Two distinct but related backward recall and n-back constructs best captured the data, in comparison to other plausible model constructions (single WM factor, two-factor domain, and three-factor materials models). Common variance associated with WM was a stronger predictor of fluid reasoning than a residual n-back factor, but the backward recall factor predicted fluid reasoning as strongly as the common WM factor. These data emphasise the distinctiveness between backward recall and n-back tasks.
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OBJECTIVE: To compare the differences in estimated food, energy, and nutrient intakes between the consecutive 3 days 24-hour dietary recall(24HR)(referred to as the 3-day method) and consecutive 2 days 24HR(referred to as the 2-day method) to provide a basis for the use of consecutive 2 days 24HR in China nutrition surveillance. METHODS: Using objective sampling to select participants in northern and southern provinces, dietary data were obtained through consecutive 3 days 24HR, and the average intakes of food, energy and nutrients were calculated for three days from Thursday to Saturday and two days on Friday and Saturday, respectively. The 3-day method was considered as the reference standard method to evaluate the performance of the 2-day method for estimating food, energy and nutrient intakes. RESULTS: Among 778 participants aged 18-60 years in urban and rural areas of two provinces, the errors of the mean and median of 2-day method for estimating the intake of four major food categories less than 6% compared with the 3-day method, and there were significant equivalencies(P<0.025) and no significant differences in four major food categories group(P>0.05). Of the 24 food groups estimated by the 2-day method, 17 had mean errors within 5%, the largest error was in animal offal(13.45%) and the smallest in fruit(0.15%), and there were significant equivalencies(P<0.025) and no significant differences in seven food groups(P>0.05). For energy and nutrients, the mean and median errors of energy were less than 0.5% and there were significant equivalencies(P<0.025) and no significant differences for energy(P>0.05). Among the 25 nutrients, except sodium, iodine and vitamin E, the mean and median errors of the other 22 nutrients were less than 5%, and there were significant equivalencies(P<0.025) and no significant differences in 16 nutrients(P>0.05). CONCLUSION: There was little difference between the two survey method in assessing the intake of high consumption frequency foods, energy and most nutrients at group level, the 2-day method can be used as an alternative to the 3-day method to collect dietary intake data with high consumption rates in the population.
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Ingestión de Energía , Recuerdo Mental , Nutrientes , Humanos , Adulto , Persona de Mediana Edad , Femenino , Masculino , Adolescente , Adulto Joven , China , Nutrientes/análisis , Encuestas sobre Dietas/métodos , Dieta/estadística & datos numéricos , Registros de DietaRESUMEN
Assessing dietary habits with validated questionnaires is crucial for achieving reliable results in health research. The aim of this study was the development and validation of a semi-quantitative food frequency questionnaire (FFQ) in an 18-30-year-old Serbian population. A total of 93 participants completed the FFQ and three 24 h dietary recalls (24 hR). Pearson and intraclass correlations between FFQ and 24 hR intakes were assessed and were de-attenuated and energy-adjusted. Bland-Altman plots were generated, and quintiles of energy, water, fiber, and macronutrient intake were analyzed with contingency tables. Adjustments for sex differences were included. The validity of the FFQ varied, with significant correlations for energy, carbohydrates, cholesterol, and vitamin B12, vitamin C and vitamin D. Misclassification rates were generally low. Bland-Altman plots indicated good agreement between methods. It can be concluded that the validated FFQ is a promising tool for dietary assessment in the Serbian population. Results for several nutrients align closely with previous studies. The new FFQ is a useful tool for dietary assessment in the Serbian population.
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Encuestas sobre Dietas , Conducta Alimentaria , Humanos , Serbia , Femenino , Masculino , Adulto , Reproducibilidad de los Resultados , Adulto Joven , Adolescente , Encuestas sobre Dietas/normas , Encuestas sobre Dietas/métodos , Encuestas y Cuestionarios/normas , Dieta/estadística & datos numéricos , Evaluación Nutricional , Ingestión de EnergíaRESUMEN
BACKGROUND: Efficacy assessments in clinical trials of treatments for female sexual arousal disorder (FSAD) and other female sexual dysfunction (FSD) diagnoses rely on various patient-reported outcomes (PROs). AIMS: We sought to compare 1-month recall PRO measures among participants enrolled in a clinical trial who provided these data without (test population) vs with (control population) use of an at-home, 24-hour recall electronic diary (eDiary), capturing similar data. METHODS: Preplanned subset analysis as performed during a phase 2b, exploratory, randomized, placebo-controlled, double-blind study of sildenafil cream, 3.6% (sildenafil cream) among healthy premenopausal women with FSAD. Preliminary product efficacy was assessed via 1-month recall and 24-hour recall questionnaires. A subset of the participants, the Evaluation of Recall Subset [ERS] provided PROs via the 1-month recall instruments but did not provide data via the 24-hour recall eDiary. OUTCOMES: Responses to the 1-month recall instruments were compared among ERS (test) vs non-ERS (control) participants. Among the non-ERS population, correlations between 1-month and 24-hour recall endpoints were calculated. RESULTS: There were no significant differences in the study co-primary 1-month recall efficacy endpoints, the Arousal Sensation (AS) domain of the 28-item Sexual Function Questionnaire (SFQ28) and the Female Sexual Distress Scale - Desire, Arousal, Orgasm question 14, among ERS vs non-ERS participants during the initial 1-month no-drug run-in period or the 1-month single-blind placebo run-in period (P values > .47). Scores on these 1-month recall PROs continued to be similar after randomization for sildenafil cream (P values > .30) and placebo cream (P values > .20) assigned ERS and non-ERS participants during the 3-month double-blind dosing period. There were strong correlations between the SFQ28 AS and eDiary AS scores during the no-drug run-in (R = 0.79, P < .01) and the single-blind run-in (R = 0.73 P < .001). During the double-blind dosing period, the SFQ28 AS score continued to be highly correlated with the eDiary AS score among sildenafil cream users (R = 0.83; P < .001) and placebo cream users (R = 0.8; 2 P < .001). CLINICAL IMPLICATIONS: There was no evidence that 1-month recall PRO instruments introduce recall bias; assessing arousal sensations with 24-hour vs 1-month PRO instruments is similar and either method could be used to assess efficacy depending on study objectives. STRENGTHS AND LIMITATIONS: This preplanned subset analysis compared efficacy of PROs based on recall duration. While the subset was preplanned, the study was powered to detect significant differences in the primary efficacy objectives, not among this subset analyses. CONCLUSION: These data will be used in planning future efficacy assessments of sildenafil cream for FSAD. CLINICAL TRIAL REGISTRATION: This clinical trial was registered with ClinicalTrials.gov, NCT04948151.