Search

Background and Objectives Chronological age is invariably used as a categorizing tool for spaces, collections, and programs in public libraries. With age-based conceptions of human experience in library practice, education, and scholarship primarily focused on those under the age 18, little is known how age-based classifications are implemented in public libraries, and with what impacts, for older library patrons. Research Design and Methods Stemming from a larger project that seeks to bring attention to the ways in which public libraries engage with community-dwelling older adults, this paper explores 51 older patrons' perspectives on the numbers and language (e.g. 55+, older adult, seniors, adult) assigned to older adults in library programs and which label best (or least) suits their sense of identity and, in turn, what language encourages or deters their engagement with library programs. Results Findings illustrate that age-based language describing older adult library programs is often at odds with patrons' perceptions of how library programming relevant to them ought to be labeled. Common to all participants was a clear dislike for the term "elderly." While most participants preferred "older adult" to "senior," others voiced no preference, as long as they felt heard and valued. Many participants linked the use of language used to describe library programs to being excluded from and treated differently from other (younger) library patrons. Discussion and Implications The language used to group and describe different library populations directly shapes feelings of belonging (or exclusion) in library programs. Insights from this research contribute to our evolving understandings of the ways in which language connected to age can shape one's sense of identity. Results also serve to cultivate a more sensitive and critical approach to the question of age within library science, and, by extension, the experiences of older adults who frequent the library. [ABSTRACT FROM AUTHOR]

Background and Objectives Ageism is oftentimes sugarcoated within humor. Paper birthday cards are 1 delivery approach in which ageist messages are perpetuated and reinforced through humor. Research Design and Methods A convenience sample of birthday cards (k = 227), all indicating a decade of age, were acquired from 7 national retail stores in Colorado Springs, CO. The decades sampled ranged from 21 to 100. With a predeveloped codebook, 3 raters coded the decade birthday cards on various variables, including age group, ageist tone, and humor. Results Birthday cards intended for age 30–60 contained significantly more ageist messages compared to cards intended for age 21 and age 70–100, which did not show a significant difference from each other. Additionally, birthday cards with humor showed more ageist messages than cards without humor. Characteristics of decade birthday cards were also explored. Discussion and Implications Consumers need to learn to evaluate these ageist messages in birthday cards to reduce the perpetuation of damaging stereotypes. [ABSTRACT FROM AUTHOR]

Aims Cardiovascular magnetic resonance parametric mapping enables non-invasive quantitative myocardial tissue characterization. Human myocardium has normal ranges of T1 and T2 values, deviation from which may indicate disease or change in physiology. Normal myocardial T1 and T2 values are affected by biological sex. Consequently, normal ranges created with insufficient numbers of each sex may result in sampling biases, misclassification of healthy values vs. disease, and even misdiagnoses. In this study, we investigated the impact of using male normal ranges for classifying female cases as normal or abnormal (and vice versa). Methods and results One hundred and forty-two healthy volunteers (male and female) were scanned on two Siemens 3T MR systems, providing averaged global myocardial T1 and T2 values on a per-subject basis. The Monte Carlo method was used to generate simulated normal ranges from these values to estimate the statistical accuracy of classifying healthy female or male cases correctly as 'normal' when using sex-specific vs. mixed-sex normal ranges. The normal male and female T1- and T2-mapping values were significantly different by sex, after adjusting for age and heart rate. Conclusion Using 15 healthy volunteers who are not sex specific to establish a normal range resulted in a typical misclassification of up to 36% of healthy females and 37% of healthy males as having abnormal T1 values and up to 16% of healthy females and 12% of healthy males as having abnormal T2 values. This paper highlights the potential adverse impact on diagnostic accuracy that can occur when local normal ranges contain insufficient numbers of both sexes. Sex-specific reference ranges should thus be routinely adopted in clinical practice. [ABSTRACT FROM AUTHOR]

Background Non-pharmaceutical interventions (NPIs) decrease COVID-19 transmission. Reliability and validity of adherence to NPIs in accordance with normalization process theory (NPT) in coherent and convenient social subgroups using reflective measurement model assessment has not been evaluated. Methods In February 2021, a sample of medical students and people with substance use disorders in treatment as coherent (based on continuous probability distribution) vs. convenient groups (based on convenience, not equal probability) composed of travellers and COVID-19 suspected persons from Split-Dalmatia County (SDC) (n  = 656) in the Mediterranean completed self-administered surveys. Partial least squares structural equation modelling (PLS-SEM) was used to measure reflective model assessment of adherence to NPIs according to NPT. Results PLS-SEM reflective model assessment provided two-group specific factors in inverse relationships which determined adherence to NPIs with excellent goodness-of-fit [ χ 2 = 1.292, df = 1; P  = 0.297, CFI = 1, TLI = 0.997, RMSEA = 0.011 (90% CI 0–0.105), RMSEA P  = 0.604, SRMR = 0.008, Hoelter CN (α = 0.05) = 2322.757]. Significant negative factors covariance estimate (−0.716) revealed an inverse relationship between first (adherence to NPIs and internal locus of control (LoC) (0.640)) and second factor; young adulthood age (≤25) and highest level of education (1362). As the first factor increased the second tended to decrease. LoC is expected potential mechanism by which sex (MLsex = −0.017, SE = 0.007, P  < 0.016) and belonging to coherent subgroups (MLgroup = −0.008, SE = 0.003, P  = 0.015) can produce indirect effect of adherence to NPIs. Conclusions Coherent subgroups had a more pronounced tendency toward integration of NPIs in everyday life. Group factors that facilitate the normalization were higher educated younger adults with a tendency toward external LoC. [ABSTRACT FROM AUTHOR]

Background Consumption of alcohol is a risk factor for non-communicable and infectious diseases, mental health problems, and can lead injuries and violence. The aim of this study was to evaluate the prevalence of alcohol-involved deaths among decedents who died of external causes and underwent autopsy in Lithuania. Methods Study includes age persons of any age (from 0 to 110 years) who died and were autopsied in Lithuania from 1 January 2017 to 31 December 2020. Data were obtained from the Lithuanian State Register of Deaths and Their Causes. Results Among external causes of death, the presence of alcohol was detected in 55.0% of cases. Male decedents had a significantly higher number of positive BAC level recorded, at 46.6%, compared with female decedents (32.1%; P  < 0.001). The highest incidence of deaths where the alcohol was detected in the deceased's blood was found when the decedent was listed as being in the victims of assault group (71.5%, 95% CI 65.4–77.2). However, the highest median BAC score was found for those in the accidents group (59.7%, 95% CI: 58.2–61.2, BAC 2.42 ‰, IQR 1.86). Conclusions The findings of this study suggest that alcohol use may be a contributing factor in a wide range of fatal incidents, including accidents, injuries, and cases of violent intent. Inequalities between males and females were identified, with a higher proportion of males with alcohol detected in blood at the time of death. [ABSTRACT FROM AUTHOR]

A joint spatio–temporal distribution model of mackerel (ages 3–10) was developed to investigate the age-based responses of mackerel to three environmental drivers: sea surface temperature (SST), mixed layer depth, and chlorophyll-a concentration during the summer months 2010–20 in the Nordic Seas. The study showed that SST was the most important variable amongst the ones tested and had the strongest impact on the distribution of the younger age classes (3–5), which had a narrower range of favourable SST and a stronger aversion to cold temperatures than older individuals. Consequently, the impact of SST differed regionally; in the polar front regions, SST explained up to 61% of the variability in the observed density of young individuals, where Arctic water masses likely acted as a barrier to these young individuals. That said, part of it could be confounded with the limited migration capability of young mackerels, which could not reach the furthest frontal regions. In warmer southern waters, the same environmental variables had less explanatory power for mackerel of all ages. Individuals in the south were likely not constrained by temperature and perhaps more influenced by other variables, such as food availability or ocean current (throughout their migration path), for which appropriate data are lacking. Moreover, the model showed that older mackerel were distributed more to the north and west, and their migration pattern changed when the 2013 year-class no longer migrated to the west compared to previous year-classes. Additionally, all-year classes started migrating more eastward from summer 2018. [ABSTRACT FROM AUTHOR]

In this paper, we analyse the metallicity structure of the Magellanic Clouds using parameters derived from the Gaia Data Release 3 (DR3) low-resolution XP (for Blue/Red Photometer) spectra, astrometry, and photometry. We find that the qualitative behaviour of the radial metallicity gradients in the Large Magellanic Cloud (LMC) and Small Magellanic Cloud (SMC) is quite similar, with both of them having a metallicity plateau at intermediate radii and a second at larger radii. The LMC has a first metallicity plateau at [M/H] ≈ −0.8 for 3–7°, while the SMC has one at [M/H] ≈ −1.1 for 3–5°. The outer LMC periphery has a fairly constant metallicity of [M/H] ≈ −1.0 (10–18°), while the outer SMC periphery has a value of [M/H] ≈ −1.3 (6–10°). The sharp drop in metallicity in the LMC at ∼8° and the marked difference in age distributions in these two regions suggest that there were two important evolutionary phases in the LMC. In addition, we find that the Magellanic periphery substructures, likely Magellanic debris, are mostly dominated by LMC material stripped off in old interactions with the SMC. This presents a new picture in contrast with the popular belief that the debris around the clouds had been mostly stripped off from the SMC due to having a lower mass. We perform a detailed analysis for each known substructure and identify its potential origin based on metallicities and motions with respect to each galaxy. [ABSTRACT FROM AUTHOR]

Background The Nordic countries represent a unique case study for the COVID-19 pandemic due to socioeconomic and cultural similarities, high-quality comparable administrative register data and notable differences in mitigation policies during the pandemic. We aimed to compare weekly excess mortality in the Nordic countries across the three full pandemic years 2020–2022. Methods Using data on weekly all-cause mortality from official administrative registers in Denmark, Finland, Norway and Sweden, we employed time series regression models to assess mortality developments within each pandemic year, with the period 2010–2019 used as reference period. We then compared excess mortality across the countries in 2020–2022, taking differences in population size and age- and sex-distribution into account. Results were age- and sex-standardized to the Danish population of 2020. Robustness was examined with a variety of sensitivity analyses. Results While Sweden experienced excess mortality in 2020 [75 excess deaths per 100 000 population (95% prediction interval 29–122)], Denmark, Finland and Norway experienced excess mortality in 2022 [52 (14–90), 130 (83–177) and 88 (48–128), respectively]. Weekly death data reveal how mortality started to increase in mid-2021 in Denmark, Finland and Norway, and continued above the expected level through 2022. Conclusion Although the Nordic countries experienced relatively low pandemic excess mortality, the impact and timing of excess mortality differed substantially. These estimates—arguably the most accurate available for any region in capturing pandemic-related excess deaths—may inform future research and policy regarding the complex mortality dynamics in times of a health crisis such as the COVID-19 pandemic. [ABSTRACT FROM AUTHOR]

Background Although the global chronic morbidity indicator (GCMI) of the Minimum European Health Module (MEHM) was not specifically designed to monitor chronic disease in the population, it is increasingly used for this purpose in Europe and elsewhere. However, its metrological characteristics have seldom been examined, with various sensitivity issues being raised. The present study investigated the metrological performances of the GCMI and analyzed its implications in terms of prevalence and demographic and socioeconomic gradients of chronic conditions in the population. Methods We used data from two large French nationwide representative surveys with cross-sectional and longitudinal data conducted between 2010 and 2021. The surveys used MEHM and collected data on numerous chronic conditions and socioeconomic indicators. Criterion and predictive validity of the GCMI regarding chronic conditions and the resultant socioeconomic gradients were compared with indicators based on reports of individual chronic conditions. Results GCMI sensitivity to capture chronic conditions varied from <20 to 80% depending on the chronic condition. Number of chronic conditions, gender, age and education were also associated with GCMI endorsement. However, the GCMI was predictive of mortality and activity limitations independently of individual conditions. Conclusion The varying lack of sensitivity depending on the chronic condition and the respondent's sociodemographic status may bias estimates of demographic and socioeconomic gradients compared with indicators based on reports of individual chronic conditions. Differences between GCMI and list-based approaches should be more cautiously considered when monitoring chronic conditions in the population. These approaches should be viewed as complementary rather than contradictory or interchangeable. [ABSTRACT FROM AUTHOR]

Background Resilience of national health systems in Europe remains a major concern in times of multiple crises and as more evidence is emerging relating to the indirect effects of the COVID-19 pandemic on health care utilization (HCU), resulting from de-prioritization of regular, non-pandemic healthcare services. Most extant studies focus on regional, disease specific or early pandemic HCU creating difficulties in comparing across multiple countries. We provide a comparatively broad definition of HCU across multiple countries, with potential to expand across regions and timeframes. Methods Using a cross-country federated research infrastructure (FRI), we examined HCU for acute cardiovascular events, elective surgeries and serious trauma. Aggregated data were used in forecast modelling to identify changes from predicted European age-standardized counts via fitted regressions (2017–19), compared against post-pandemic data. Results We found that elective surgeries were most affected, universally falling below predicted levels in 2020. For cardiovascular HCU, we found lower-than-expected cases in every region for heart attacks and displayed large sex differences. Serious trauma was the least impacted by the COVID-19 pandemic. Conclusion The strength of this study comes from the use of the European Population Health Information Research Infrastructure's (PHIRI) FRI, allowing for rapid analysis of regional differences to assess indirect impacts of events such as pandemics. There are marked differences in the capacity of services to return to normal in terms of elective surgery; additionally, we found considerable differences between men and women which requires further research on potential sex or gender patterns of HCU during crises. [ABSTRACT FROM AUTHOR]

Objective This study compared adults with peripheral vestibular hypofunction (VH) to healthy controls and assessed the sensitivity and specificity of the Cervical Torsion Test (CTT) and the Head-Neck Differentiation Test (HNDT). This study aimed to determine whether neck problems affected primary outcomes. Methods This cross-sectional study included adults from a specialist consultation for dizziness. VH had been diagnosed with the video Head Impulse Test. Exclusion criteria were conditions following head or neck trauma and diseases of the central nervous system. The sensitivity and specificity of the index tests were calculated, and regression analyses were performed to test for contributing factors. Results A total of 19 patients with VH and a historical cohort of 19 matched healthy controls were included. Most patients with VH (84.2%) experienced symptoms in at least 1 test component, compared to 5.2% of the control group. Of patients with VH, 78.9% had symptoms during the HNDT "en bloc" (en bloc = head and trunk rotated together), whereas only 26.3% reported symptoms during the CTT en bloc. The best discriminatory validity was found for the HNDT en bloc, with a sensitivity of 0.79 (95% CI = 0.54–0.94), a specificity of 0.86 (95% CI = 0.65–0.97), and a positive likelihood ratio of 5.79 (95% CI = 1.97–17.00). The number of symptoms of CTT "in torsion" (in torsion = trunk rotated actively with fixed head) was increased by a factor of 1.13 (95% CI = 1.01–1.27) for every additional point on the Neck Disability Index. Conclusion The CTT and HNDT can serve as non-laboratory tests for patients with dizziness. The HNDT en bloc has the best discriminatory validity, finding those with and those without VH. Symptom reproduction during torsion may help to identify when neck problems may contribute to dizziness. Impact The HNDT en bloc may be useful for ruling VH in or out in patients with dizziness. Positive CTT and HNDT in torsion components may verify the likelihood of additional neck involvement. [ABSTRACT FROM AUTHOR]

This study investigated the acquisition of early expressive vocabulary among young children who are deaf and hard-of-hearing (DHH; n  = 68) using auditory technology (hearing aids and cochlear implants). Parents completed a standardized vocabulary checklist, which allowed analyses of (i) the size of their child's spoken vocabulary; (ii) composition of the expressive lexicon (e.g. parts of speech such as nouns and verbs; semantic categories such as routines and body parts); and (iii) demographic and audiologic factors (e.g. chronologic age, degree of hearing access) potentially associated with these metrics. Young children who are DHH and use auditory technology acquired fewer spoken words than peers with typical hearing (TH) matched for chronologic age but more spoken words than peers with TH matched for listening experience. Action verbs—not nouns—significantly increased the odds of a child who is DHH achieving a vocabulary quotient within the normative range. These findings support the exploration of early expressive vocabulary size and composition—especially the number of active verbs—to guide clinical management and decision-making for young children who are DHH. [ABSTRACT FROM AUTHOR]

Background Although biobanks have become fundamental to many research centers and contribute to medical development, they generate many ethical and legal issues that may discourage patients from donating. Materials and Methods To understand patients' perception of ethical and legal issues related to biobanks we conducted a survey among 548 Polish patients with cancer. Results While 93.1% of patients with cancer declared themselves willing to donate biospecimens left over after a medical procedure to a biobank, most opted for one-time consent or study-specific consent, blanket consent being less frequently preferred. Many patients believed that future use of previously collected tissues require second contact. Most patients preferred pseudonymization over anonymization of the data, and supported donors' right to withdraw informed consent at any given moment. Finally, while personal health information was the most expected form of compensation for donation, most patients suggested that all parties, including the biobank concerned, the sponsors of the research, and the donors, should own the rights to cancer tissues donated and profit from the biobank research. Patients' opinions on the ethical and legal issues related to biobank research were associated with age, sex, religiosity, education level, and place of residence. Conclusions Since biobanks generate ethical and legal issues related to informed consent, data protection and storage, as well as the sharing of biosamples, tissue ownership, and profit sharing, that may discourage patients from donation, when asking a patient for a donation, healthcare professionals should communicate in a donor-centered manner and address patients' ethical and moral concerns related to donation and offer resources to help manage these concerns. [ABSTRACT FROM AUTHOR]

Background Complementary feeding has long-term effects on health but there is heterogeneity in recommendations across Europe. Recommendations include responsive feeding practices and nutritional needs but there is a debate in primary paediatricians as to which one should be the main criterion for complementary feeding. This pilot study investigated (i) the factors affecting the recommendations of paediatricians in Cyprus for starting complementary feeding, (ii) whether their main criterion is the developmental readiness or the nutritional needs of the infant and (iii) how this priority influences recommendations. Methods The 11-item questionnaire was completed by 73 Cypriot paediatricians. Results Approximately 66% of paediatricians recommended starting complementary feeding between 5 and 6 months, 29% between 4 and 5 and 3% between 6 and 7 months. Predefined schemes were recommended by ∼25% of paediatricians, baby-led weaning by 14% and 58% of paediatricians recommended either modality depending on the family circumstances whilst 4% involve the mother in the decision process. Approximately 64% of paediatricians recommended the introduction of parent's diet after the first year of life. Approximately 55% of paediatricians chose developmental readiness and 45% nutritional needs of the infant as their primary criterion for starting complementary feeding. Paediatricians who prioritized developmental readiness were more likely to be younger, less likely to advice on meat quantity and less likely to follow good nutritional practice. Conclusions The younger the paediatrician the more likely they are to prioritize developmental readiness over nutritional needs of the infant for complementary feeding. Paediatricians who prioritized developmental readiness were also less likely to provide nutritional advice. [ABSTRACT FROM AUTHOR]

Background Socioeconomic inequalities constitute an important focus area for public health, and it has long been established that higher educational level and longer lifespan are correlated. Little is known about decennial time trends in poor self-rated health and mental distress. Methods This study linked decennial cross-sectional survey data on self-rated health and mental distress from the Trøndelag Health Study (HUNT) from 1984 to 2019 with educational registry data using personal identification numbers. Survey participation ranged from 50 807 to 77 212. Slope index of inequality (SII) and relative index of inequality (RII) were calculated using generalized linear models in Stata. Analyses were stratified by sex and age, using the age categories of 30–59 years and 60–80 years. Results Absolute inequalities in self-rated health and mental distress between educational groups have stayed relatively stable throughout all rounds of HUNT. Relative inequalities in self-rated health and mental distress have generally increased, and both men and women with the lowest education level were more likely to experience poor self-rated health and mental distress relative to those with the highest education level. RII in self-rated health increased over time for both sexes and both age groups. RII for mental distress increased in both sexes and both age groups, except for men and women aged 60–80. Discussion This study shows that relative inequalities in self-rated and mental health in the Norwegian population are still persistent and have increased. Further knowledge about groups with a disadvantageous health situation should have implications for health care resource allocation. [ABSTRACT FROM AUTHOR]

Objective The objective of this study was to conduct a systematic and comprehensive review of qualitative research to examine the physical and psychological needs, as well as work experiences, of patients undergoing total knee replacement and total hip replacement surgeries during their process of returning to work. Methods A systematic review and meta-synthesis of qualitative literature was conducted. A systematic search was conducted across 8 databases to identify qualitative or mixed-methods research on the needs and experiences of individuals with total knee replacement and total hip replacement who have returned to work. The search period extended from the inception of each database to March 2023. Two researchers independently utilized a predetermined search strategy to retrieve relevant English-language studies published in any year. The included studies were assessed for quality using the Critical Appraisal Skills Program appraisal tool. Findings from the studies were then summarized and integrated using the pooled integration method. Results There were 10 studies in total. Three key themes were identified from the original research: needs during the return to work process and rehabilitation training, faith and support to return to work, and constraints and challenges at work. Conclusion Health care professionals and employers should conscientiously consider the physical and psychological requirements of patients who have undergone total knee replacement and total hip replacement when they are resuming work, taking into account the specific constraints and challenges that may arise in the workplace. To ensure a seamless transition back to work, it is essential to develop tailored occupational interventions, implement comprehensive return to work programs, and offer patients sufficient understanding and support. Impact The findings of this study offer valuable insights into the physical and psychological needs, as well as the work experiences, of patients who have undergone total knee replacement and total hip replacement during their reintegration into the workforce. These findings have the potential to assist health care professionals and employers in providing enhanced support to facilitate successful return-to-work outcomes for patients. [ABSTRACT FROM AUTHOR]

Motivation Major improvements in sequencing technologies and genome sequence assembly have led to a huge increase in the number of available genome sequences. In turn, these genome sequences form an invaluable source for evolutionary, ecological, and comparative studies. One kind of analysis that has become routine is the search for traces of ancient polyploidy, particularly for plant genomes, where whole-genome duplication (WGD) is rampant. Results Here, we present a major update of a previously developed tool wgd, namely wgd v2, to look for remnants of ancient polyploidy, or WGD. We implemented novel and improved previously developed tools to (a) construct K S age distributions for the whole-paranome (collection of all duplicated genes in a genome), (b) unravel intragenomic and intergenomic collinearity resulting from WGDs, (c) fit mixture models to age distributions of gene duplicates, (d) correct substitution rate variation for phylogenetic placement of WGDs, and (e) date ancient WGDs via phylogenetic dating of WGD-retained gene duplicates. The applicability and feasibility of wgd v2 for the identification and the relative and absolute dating of ancient WGDs is demonstrated using different plant genomes. Availability and implementation wgd v2 is open source and available at https://github.com/heche-psb/wgd. [ABSTRACT FROM AUTHOR]

Background: Transport injuries are a major cause of mortality among adolescents. Our aim was to evaluate the circumstances and trauma associated with fatal accidents involving adolescents and two-wheeled vehicles. Methods: We analyzed retrospective data from the Finnish Crash Data Institute from 2008 to 2019 involving 10- to 24-year-old victims of fatal traffic accidents who were injured while riding a bicycle, moped or motorcycle. We collected data on patient characteristics, accident circumstances and possible treatment. These fatalities were compared with national mortality rates among the respective age groups. Results: We identified 147 fatalities over the 12-year period involving 20 bicycle, 50 moped and 77 motorcycle riders. Most accidents involved males (n=121, 82%). Less than half of vehicles were in good condition (46%); motorized vehicles were often illegally tuned (37%) or had tire problems (31%). Most of the accidents were collisions with another vehicle (n=99, 67%) or other objects (n=35, 24%). In 94% of cases, the Injury Severity Score was >25. Head injury was the most common cause of death (62%). Among 15-year-olds, every fifth death was due to accidents on two-wheeled vehicles. Conclusions: Fatal transport accidents among adolescents comprise several elements that should be incorporated into driver's education and in case of minors, also communicated to parents. These include the condition of the vehicle, proper helmet use and effects of speed on both control of the vehicle and the consequences of a possible collision. [ABSTRACT FROM AUTHOR]

Background Fatigue is common in patients undergoing radiotherapy (RT) and can significantly impact quality of life. Melatonin, a safe inexpensive natural supplement, may improve symptoms and attenuate the side effects of RT. The purpose of this randomized double-blind placebo-controlled phase III trial was to assess the effects of melatonin for preventing fatigue and other symptoms in patients with breast cancer undergoing RT. Methods Female early stage or Ductal carcinoma in situ patients with breast cancer ≥18 years of age with Eastern Cooperative Oncology Group (ECOG) performance status <3, hemoglobin ≥9 g/dL, planned for outpatient RT treatment with curative intent, were randomized 1:1 to melatonin 20 mg or placebo, orally, starting the night before RT initiation until 2 weeks post-RT. Randomization was stratified according to treatment duration (<3 weeks, ≥3 weeks) and prior chemotherapy. The primary endpoint was the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue scale), and secondary endpoints were FACIT-F subscales, Edmonton Symptom Assessment Scale (ESAS), and Patient-Reported Outcomes Measurement Information System (PROMIS) scores obtained at baseline, and 2 and 8 weeks post-RT. A 2-sided ANOVA F -test at a 4.5% significance level for the primary endpoint was used. Secondary analyses were reported using an F -test at a 5% significance level. The goal was to recruit approximately 140 patients with interim analysis planned mid-recruitment. Results Eighty-five patients were screened for eligibility; 79 patients were randomized: 40 to melatonin and 39 to placebo; 78 patients were treated and included in the interim analysis at the mid-recruitment point. Baseline patient characteristics of age, race, and ECOG performance status were similar in both arms. The treatment effect was studied using a longitudinal mixed effects model with the effect of treatment over time (treatment × time) as the primary outcome parameter. The treatment × time for FACIT-Fatigue did not demonstrate statistical significance (P -value.83) in the melatonin group compared to placebo. In addition, secondary analyses of FACIT physical, social, emotional, and functional well-being scores did not demonstrate statistical significance (P -values of.35,.06,.62, and.71, respectively). Total PROMIS scores, collected as secondary outcome reported by patients, did not demonstrate statistically significant change over time either (P -value is.34). The other secondary scale, ESAS, was analyzed for each individual item and found to be nonsignificant, anxiety (P  = .56), well-being (.82), drowsiness (.83), lack of appetite (.35), nausea (.79), pain (.50), shortness of breath (.77), sleep (.45), and tiredness (.56). Depression was the only item demonstrating statistical significance with a decrease of 0.01 unit in the placebo group, a change not considered clinically significant. Melatonin was well-tolerated with no grade 3 or 4 adverse events reported. The most common side effects were headache, somnolence, and abdominal pain. No patients died while participating in this study. Two patients died within a year of study completion from breast cancer recurrence. Sixteen patients withdrew prior to study completion for various reasons including adverse events, hospitalizations unrelated to study drug, RT discontinuation, and COVID-19 precautions. Conclusions In this double-blind placebo-controlled phase III trial, melatonin did not prevent or significantly improve fatigue and other symptoms in patients with early stage breast cancer undergoing RT. The analysis, showing little evidence of an effect, at mid-recruitment, assured early termination of the trial. [ABSTRACT FROM AUTHOR]