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Randomisation and group allocation | Centres were randomly allocated to either the intervention (menu box delivery) or comparison (menu planning) group after baseline data collection was complete. Centres were stratified into two equal groups matched for centre size (based on child attendance numbers) and centre socio-economic status using Socio-Economic Indexes for Areas | PMC10755420 | ||
The menu box delivery intervention | Centres allocated to the intervention received a weekly menu box delivery service that included all ingredients and recipes required for morning snack, lunch and afternoon snack for the week, tailored to the number of children attending the centre. Intervention centres were provided with menu packs that included information about the delivery process, copies of tailored recipes and ingredient lists for each week of the 4-week menu. Ingredients were delivered weekly to centres by a local grocery supplier. The cost of the menu box delivery service, including ingredients, menus/recipes and delivery, was covered by the research team. Centres were asked to apply standard practices and policies to manage the preferences and dietary requirements of children in their care.Comparison centres were provided with a self-paced online menu planning training and an online menu assessment tool designed for LDC cooks to support the implementation of a centre menu that met Menu Planning Guidelines
Intervention flow and data collection points. | PMC10755420 | ||
Data collection and entry | Data were collected on two occasions: (i) at baseline, pre-intervention between July and October 2020 and (ii) at follow-up, in weeks 11 and 12 of the intervention implementation period (between November and December 2020). The primary outcomes were child food provision and child dietary intake. Secondary outcomes were menu compliance and intervention acceptability by staff. Due to COVID-19 restrictions at the time, modifications were made to the collection of dietary data at the follow-up time point. Due to differences in methods at baseline and follow-up, only follow-up dietary data were analysed and compared between groups. | PMC10755420 | ||
Centre, staff and child socio-demographic characteristics | At baseline, operational data for the centres were collected, including average attendance and nutrition policies. Baseline cook characteristics including age, experience, hours worked/week and relevant qualifications were collected. Age and gender were collected for all children involved in dietary data collection. | PMC10755420 | ||
Primary outcomes: food provision and child dietary intake | The primary outcomes assessed were child food provision (what children were served at mealtimes) and child dietary intake assessed against the Victorian Menu Planning Guidelines for five food groups (vegetables and legumes; fruit; cereals and breads; dairy and alternatives and meat and alternatives) and discretionary food and drinks (foods and drinks that do not fit in the five food groups as they are nutrient poor and typically higher in kilojoules, saturated fat, added sugars and/or added salt) as classified in the Australian Dietary GuidelinesChildren’s food provision and intake were measured using the standardised weighed plate wastage method for lunch and two mid-meal snacks. To adapt to COVID-19 restrictions at follow-up data collection, measurement of plate waste was modified to incorporate a hybrid use of photography and weight measures, as researchers were not permitted to enter rooms during mealtimesAll foods were entered into Excel, and an eight-digit food code was assigned to individual food items (e.g. raw carrot) using the AUSNUT 2011–2013 database | PMC10755420 | ||
Secondary outcomes: menu compliance and intervention acceptability, fidelity and cost | Menu compliance was measured by assessing two consecutive weeks of centre menus against the Victorian Menu Planning GuidelinesCook and director feedback was obtained through structured interviewer-administered questionnaires to evaluate cooks’ acceptability of intervention components and to collect feedback on training material at follow-up. The purpose-designed questionnaires included four items for menu box delivery acceptability, four items for online cook training acceptability and four items for menu assessment tool acceptability for both directors and cooks (see Table
Overall acceptability and satisfaction of the menu box delivery service, online cook training and menu assessment tool reported by centre cooks and directors at follow-up (=8) | PMC10755420 | ||
Statistical analysis | All statistical analyses were performed using SPSS 24.0 statistical software. Data were checked and cleaned prior to analyses and visually assessed for normality using frequency histograms, which were then compared with the results of Kolmogorov–Smirnov and Shapiro–Wilk tests of normality. As child food provision and intake data were not normally distributed, data are reported as median and inter-quartile range (IQR). Socio-demographic data are reported as frequency (%) or mean (The effect of the intervention on children’s food provision and intake was determined using a linear mixed-effects model, adjusting for clustering of centres (random effect) and controlling for child age and gender, socio-economic status of centre location and centre size (fixed effects). Only children with complete data for all measured eating occasions including lunch and morning and afternoon snacks were included in the analyses. Log-transformation was performed for variables that did not fit model assumptions. Estimates for transformed variables are reported as the ratio of geometric means, whereas non-transformed variables are reported as geometric means. Statistical significance was considered at | PMC10755420 | ||
Results | PMC10755420 | |||
Sample characteristics | Eight of 11 LDC centres approached to participate in the study agreed to participate (four intervention, four comparison: Fig.
CONSORT flow diagram of centres and children through the study.
Demographic characteristics of comparison and intervention; centres, centre cooks and children included in follow up data analysisIQR, inter-quartile range.Data presented as Three socio-economic status categories, low, mid and high, were formed using Socio-Economic Indexes for Areas determined by centre postcode. Indices of 1–3 were categorised as indicating ‘low’ SES, 4–7 as ‘mid’ and 8–10 as ‘high’
| PMC10755420 | ||
Child food provision and dietary intake | At follow-up, median (IQR) child daily vegetable provision within intervention centres was 0·9 (0·7–1·2) serves/d, compared with 0·8 (0·5–1·3) serves/d in the comparison centres (Table
Daily food group provision and intake to 2–5-year-old children at follow-up as assessed by plate waste in serves (IQR, inter-quartile range.Data presented as median (IQR).Targets using Victorian Menu planning guidelines for long day careFits within the vegetable, and meat and alternatives groups, no specific target.
Impact of intervention on differences in child food group provision and consumption in serves at follow-up, linear mixed model outputs, in children present at follow-up (Log-transformed data, exponentiated coefficients reported (ratio of geometric means).Heteroscedasticity present in model. | PMC10755420 | ||
Menu compliance | At follow-up, half of the intervention centres (
Number of centres meeting or exceeding menu planning guidelines at baseline and follow-up (Targets using Victorian Menu planning guidelines for long day care | PMC10755420 | ||
Staff acceptability | Overall, all intervention centre directors (four out of four) agreed that they would continue to use the menu box delivery service if able to, whereas only half of the cooks (two out of four) agreed (Table | PMC10755420 | ||
Fidelity | All intervention centre cooks (4/4) reported using the menu box delivery service and recipes over the 8-week intervention period. Intervention centre cooks reported modifying recipes to speed up preparation times and serving meals to children in ways they believed to be more preferable to children. For example, pasta and pasta sauce are being served separately. Adherence to and use of the online cook training and menu assessment tool was low among cooks from comparison centres. Three (out of four) completed the training, but no cook reported assessing more than one of the 4-week menus using the menu assessment tool. | PMC10755420 | ||
Cost | In total, 59/64 invoices were collected from centres over the 8-week intervention period. Five invoices (8 %) were missing across two comparison centres. Missing invoices were assumed to be non-biased and missing completely at random as missingness resulted from cooks misplacing invoices. Mean intervention centre menu expenditure was AUD$4·62 (95 % CI ($4·58, $4·67)) per child/d, compared with AUD$2·28 (95 % CI ($2·27, $2·30)) per child/d in comparison centres. | PMC10755420 | ||
Discussion | This study evaluated the impact of a menu box delivery service to support menu compliance and improve food provision and children’s dietary intakes in the ECEC setting. While intervention centre menus showed greater compliance with food group guidelines at follow-up, the impact observed was similar between the intervention and comparison centres in regard to child food provision and intake, including vegetable intake. Satisfaction and acceptability of the intervention were low for cooks but greater for directors, albeit pilot process data (Evaluations in the literature of childcare centre menu compliance with Australian menu guidelines demonstrate that the provision of vegetables and legumes, as well as meat and alternatives, is consistently least likely to meet menu planning guidelines of all food groupsImportantly, however, the impact of the menu box delivery service intervention on food provision and child intake was equivalent to, but not superior to comparison centres following usual practice. These findings are similar to those reported in previous studies. For example, Bell Previous literature, both in Australia and internationally, has found that effective interventions to promote healthy eating in children within the age group attending ECEC settings (2–5 years) are those that target both environmental- and individual-level factors through multicomponent interventionsDespite acceptability of the menu box delivery service intervention being low for cooks (similar to that for cooks in the comparison group), director acceptability was high amongst pilot questionnaire data with intervention centre cooks and directors (Food budget restrictions can play a role in centre-level food provision decisions in childcare centres, particularly related to types or quality of foods providedStrengths of this study include the novelty of the intervention being the first study to explore a menu box delivery concept outside the commercial household environment, the cluster randomised controlled study design and staff (director and cook) feedback. However, a number of limitations exist. First, the 8-week intervention implementation period may not have been an adequate duration to observe changes in children’s dietary intake given the variability in day-to-day child attendance in care. Healthy eating interventions in child care are recommended to have a minimum 12-month duration, or ideally 2 to 4 yearsFinally, the methodology used for measuring plate waste differed between baseline and follow-up, due to the implications of COVID-19 restrictions. This affected the capacity to draw a direct comparison between baseline and follow-up data. The methodology used to analyse child food provision and consumption follow-up data may have also impacted the reliability of the plate waste measures, as both child dietary provision and consumption were estimated from photographs. The findings of this novel study, which piloted the application of a menu box delivery service in the LDC setting, suggest that this is a viable model. Study findings showed that although menu compliance can be improved via a menu box delivery service, impacts on food provision and consumption in children were similar for the intervention and comparison groups. The innovative combination of sector guidelines and an emerging food service model could support longer-term, sustainable improvements in centre menu compliance, which may improve children’s food provision and intakes in the longer term. Following refinement of the menu box delivery service to improve cook acceptability, future trials are recommended to be conducted in larger samples of cooks to ensure in-depth staff feedback and with longer follow-up periods to determine the long-term effect on child dietary intake. Future opportunities should seek to continue to harness benefits of a meal kit subscription services such as its popularity and convenience | PMC10755420 | ||
Acknowledgements | MANSON | The authors acknowledge the contributions of Nutrition Australia (Victoria) for providing the menu box delivery service menus and Paul Capobianco and Luca Caristo for their input into the menu box delivery service design. The authors would also like to acknowledge the contributions of Robyn Dustchke and Alexandra Manson in dietary data collection, Brenda Tay for her support in plate-waste photography analysis and Shalem Leemaqz for his contribution to the dietary intake modelling analysis design. | PMC10755420 | |
Financial support | SK is supported by the Flinders University Research Scholarship and Healthy Development Adelaide PhD Excellence Award. This study was conducted as part of the VegKIT project ( | PMC10755420 | ||
Conflicts of interest | There are no conflicts of interest. | PMC10755420 | ||
Authorship | R.K.G. is a principal investigator of this study. D.N.C. and R.K.G. conceived the study and obtained funding. R.K.G., D.Z. and S.K. led the design of the study. V.B. developed the cost analysis and design. J.C.A. contributed to the design and preparation of the intervention components. S.K., D.Z. and R.K.G. led implementation of the study. S.K. led the manuscript draft, and all authors contributed interpretation of result, writing and editing of the manuscript. | PMC10755420 | ||
Ethics of human subject participation | This study was conducted according to the guidelines laid down in the Declaration of Helsinki, and all procedures involving research study participants were approved by the Flinders University Human Research Ethics Committee (HREC project number 8566). Written informed consent was obtained from all subjects. | PMC10755420 | ||
References | PMC10755420 | |||
Background | Intimate partner violence and abuse (IPVA) is a pervasive societal issue that impacts many women globally. Web-based help options are becoming increasingly available and have the ability to eliminate certain barriers in help seeking for IPVA, especially in improving accessibility. | PMC10337397 | ||
Objective | This study focused on the quantitative evaluation of the SAFE eHealth intervention for women IPVA survivors. | PMC10337397 | ||
Methods | depression, anxiety | A total of 198 women who experienced IPVA participated in a randomized controlled trial and quantitative process evaluation. Participants were largely recruited on the internet and signed up through self-referral. They were allocated (blinded for the participants) to (1) the intervention group (N=99) with access to a complete version of a help website containing 4 modules on IPVA, support options, mental health, and social support, and with interactive components such as a chat, or (2) the limited-intervention control group (N=99). Data were gathered about self-efficacy, depression, anxiety, and multiple feasibility aspects. The primary outcome was self-efficacy at 6 months. The process evaluation focused on themes, such as ease of use and feeling helped. In an open feasibility study (OFS; N=170), we assessed demand, implementation, and practicality. All data for this study were collected through web-based self-report questionnaires and automatically registered web-based data such as page visits and amount of logins. | PMC10337397 | |
Results | depression, anxiety | We found no significant difference over time between groups for self-efficacy, depression, anxiety, fear of partner, awareness, and perceived support. However, both study arms showed significantly decreased scores for anxiety and fear of partner. Most participants in both groups were satisfied, but the intervention group showed significantly higher scores for suitability and feeling helped. However, we encountered high attrition for the follow-up surveys. Furthermore, the intervention was positively evaluated on multiple feasibility aspects. The average amount of logins did not significantly differ between the study arms, but participants in the intervention arm did spend significantly more time on the website. An increase in registrations during the OFS (N=170) was identified: the mean amount of registrations per month was 13.2 during the randomized controlled trial and 56.7 during the OFS. | PMC10337397 | |
Conclusions | Our findings did not show a significant difference in outcomes between the extensive SAFE intervention and the limited-intervention control group. It is, however, difficult to quantify the real contribution of the interactive components, as the control group also had access to a limited version of the intervention for ethical reasons. Both groups were satisfied with the intervention they received, with the intervention study arm significantly more so than the control study arm. Integrated and multilayered approaches are needed to aptly quantify the impact of web-based IPVA interventions for survivors. | PMC10337397 | ||
Trial Registration | Netherlands Trial Register NL7108 NTR7313; https://trialsearch.who.int/Trial2.aspx?TrialID=NTR7313 | PMC10337397 | ||
Introduction | Intimate partner violence and abuse (IPVA) is a type of domestic violence and abuse (DVA) that affects many women. It consists of various types of violence between current or former partners: physical, sexual, psychological, and economic [While Van Rosmalen-Nooijens and colleagues [All the aforementioned outcomes for eHealth interventions in the IPVA context originate from Australia, Canada, the United States, and New Zealand. In Europe, our team in the Netherlands developed the first eHealth intervention for female IPVA survivors that was scientifically evaluated through a randomized controlled trial (RCT), a process evaluation (PE), and an open feasibility study (OFS). The Dutch web-based intervention SAFE [Secondary research questions are: “Is SAFE an effective intervention to increase awareness and perceived support and to lower symptoms of mental health problems in women exposed to IPVA?” and “Is SAFE a feasible tool in the real-world setting for providing information and support to women exposed to IPVA?” | PMC10337397 | ||
Methods | PMC10337397 | |||
Ethics Approval | Nijmegen | All research components, including 2 amendments, covering a clarification of the inclusion criteria for fear of partner scores and the introduction of the OFS, were approved by the Medical Ethics Committee from Arnhem and Nijmegen (NL68268.091.18; dossier 2018-5009) and the RCT was registered at the Netherlands Trial Register NL7108 (NTR7313). The SAFE study was conducted in compliance with the Declaration of Helsinki, and this study is described based on the CONSORT-EHEALTH (Consolidated Standards of Reporting Trials of Electronic and Mobile HEalth Applications and onLine TeleHealth) guidelines and the CHERRIES (Checklist for Reporting Results of Internet E-surveys) [ | PMC10337397 | |
Framework of RCT | The RCT is a parallel-group design with 2 arms and stratified (block size of 4) automated randomization in 2 age groups (18-30 years and 31-50 years). The eHealth developer and a statistician generated the random allocation sequence. The randomization was single-blinded for the participants. The researchers could track which participant was part of the control or intervention group but could not influence the randomization process. The RCT intervention group received the complete intervention, that is, access to a website with support for IPVA survivors with interactive components. The control group received minimal intervention with only the most essential static information (The participants for the RCT were largely recruited on the internet between April 1, 2019, and October 1, 2020, and signed up through self-referral or a DVA, social, or mental health care professional. Women in the RCT were between 18 and 50 years of age who had a sufficient comprehension of Dutch, experienced IPVA no longer than 1 year ago or were still experiencing significant fear of their partner. All participants digitally received an information letter and signed an informed consent form by checking a box. Through the information letter and a statement on the intervention website, participants were made aware that this study was conducted by researchers from the Radboudumc. Subsequently, we enforced a mandatory 24-hour waiting period to ensure participants had sufficient time to contemplate their decision to participate. Participants then provided digital consent again, filled out the M0 (baseline) questionnaires, and were randomized in the control or intervention arm. The intervention was frozen during the RCT, meaning no major changes to the intervention were made during the trial.The sample size was calculated based on the primary outcome measure, self-efficacy at 6 months, as described in the study protocol [ | PMC10337397 | ||
SAFE modules and functionalities during randomized controlled trial (boldfaced: available to the control and intervention group; not boldfaced: only available to the intervention group) and open feasibility study (in italics: not available or applicable during OFS). OFS: open feasibility study. | stress reduction |
Information on physical health (issues).Information on mental health (issues).Information on coping strategies and stress reduction.
Information on social support.Information on disclosing IPVA.Information on contact options.
Exercises for creating awareness and to stimulate reflecting on their situation and help seeking process.Short videos by women survivors of IPVA and by professionals.Stories and quotes from women survivors of IPVA.
| PMC10337397 | |
Framework of PE and OFS | PE consists of surveys at several time points. We also conducted a qualitative PE (interviews), described in a separate article (van Gelder NE, et al, unpublished data, 2023). The OFS tests the intervention in a real-world setting while gathering feasibility data that are combined with additional data from the RCT on specific feasibility measures: acceptability, demand, implementation, practicality, adaptation, integration, expansion, and limited-efficacy testing [For the OFS, the complete version of the intervention (The Web Evaluation Questionnaire data were analyzed by comparing the mean differences between the 2 RCT study arms. The log data were analyzed with descriptive statistics, and the PE data were compared to the OFS data. | PMC10337397 | ||
Results | PMC10337397 | |||
Feasibility: Level of Need and Use | This intervention scored high on demand, implementation, and practicality. We saw an increase in registrations during the OFS (N=170; RCT and OFS means per month are 13.2 and 56.7, respectively; Furthermore, the costs of this intervention have been higher in the development phase than in the implementation phase, and it costs relatively little to maintain (Randomized controlled trial (RCT; 2019-2021) and open feasibility study (OFS; 2021) registrations per month. For the RCT: all women who completed their registrations, regardless of inclusion or exclusion in the RCT study. For the OFS: all women who completed their registrations, anonymous (N=152) and registered accounts (N=18; mean age 36 years). | PMC10337397 | ||
Discussion | PMC10337397 | |||
Principal Findings | SECONDARY | This study quantitatively evaluated the effectiveness and feasibility of the first Dutch self-support eHealth intervention (SAFE) for women exposed to IPVA. This study did not provide statistically significant evidence that the extensive SAFE intervention was more effective than the minimal intervention in increasing self-efficacy (primary outcome), awareness, and perceived support, and in decreasing mental health problems (secondary outcomes). It did provide evidence for SAFE’s adequate feasibility on multiple levels, such as acceptability and demand, and for participants’ satisfaction and appreciation. | PMC10337397 | |
Comparison to Previous Work | depression, anxiety | In line with the findings of Hegarty and colleagues [Both groups showed significant improvements for anxiety and fear of partner but no significant effect for depression. Since anxiety was not included as an outcome in other studies, a comparison was not possible. Other studies have not found a significant impact on fear of partner [With regard to feasibility, the SAFE intervention scores high on acceptability, demand, implementation, practicality, adaptation, integration, and expansion. It also shows promise for certain aspects of limited efficacy testing as the intervention shows signs of being successful among the target group [The SAFE eHealth intervention appears as a feasible tool to provide information and support to women who experience IPVA. Our corresponding qualitative evaluation (van Gelder NE, et al, unpublished data, 2023) shows that while the intervention did not always explicitly improve self-efficacy or mental health problems or show significant statistical differences, women did find it helpful in terms of awareness, support, and acknowledgment, and they were satisfied with the provided information and help options. | PMC10337397 | |
Strengths and Limitations | First, a strength of this study is the extensive study design, using 3 evaluation methods to assess the intervention’s effectiveness on multiple levels. Second, the IPVA experiences within the study sample represent all 4 types of IPVA (psychological, physical, economic, and sexual) that survivors can endure. Third, for diversity in cultural background and sexual orientation, this study is quite representative of the general Dutch female population. In 2020, overall, 93.2% of the general Dutch female population has the Dutch nationality [There are also several limitations to this study. First, we noticed the extensive registration procedure for the RCT study was a barrier for women to sign up for the intervention. Also, unlike other studies [Second, the reliance on self-reports for all outcomes and thus the risk of self-reporting bias are limitations. Furthermore, as the study partially took place during the COVID-19 pandemic, this external circumstance could have decreased or delayed progress or improvement in some outcomes, for example, with regard to increasing mental health problems [Third, for the measure on awareness (contemplation ladder), a lower score at M6 compared to M0 could mean that awareness became lower over time but also that they did not experience IPVA anymore or had left the abusive relationship, as scoring 0 was answering: “I don’t think of leaving my partner and/or seeking help. The relationship is not violent (anymore).” Thus, this impedes the interpretation of this outcome.Last, in terms of diversity and equity, this study has some limitations as well [ | PMC10337397 | ||
Implications | SECONDARY, RECRUITMENT | With regard to improving self-efficacy and mental health in women IPVA survivors, we could conclude that while some studies found significant improvements for both groups [Overall, the feasibility of this intervention is high, with survivors expressing a demand for web-based options and professionals expressing interest in implementing this type of support. Hence, in addition to the direct use by IPVA survivors, professionals have the option to refer clients or patients to the platform as an additional means of support, as a bridging tool when waitlisted for an in-person intervention, or as part of a blended care approach [We thank all of the participants in the SAFE study and all the survivors (and bystanders) who put their trust in us and reached out to us, either by registering for the SAFE intervention or by contacting us for advice. We also thank all the professionals, survivor-professionals (in Dutch: Authors' Contributions: NEG, SOP, SAL, KAWLRN, and JBP designed the research. NEG developed and promoted the SAFE intervention and supported the recruitment of study participants. NEG analyzed the data with help from Reinier Akkermans (statistician) and under supervision of SAL, SOP, KAWLRN, and JBP. NEG wrote the manuscript. SAL, SOP, KAWLRN, and JBP reviewed the manuscript for important intellectual content. All authors read and approved the final manuscript.Conflicts of Interest: The SAFE intervention that was evaluated in this study was designed by the authors and built by an eHealth developer (Ippo) outside the Radboudumc.Primary and secondary outcome measures and measurement timepoints.Check for selective attrition bias at the M6 survey on self-efficacy.Login prerequisites for the intervention during the OFS.User data from the RCT study arms and OFS group.Feasibility data from Matomo and SAFE’s social media accounts and messages.Information on the eHealth developer costs of the SAFE intervention.CONSORT-eHEALTH checklist (V 1.6.1). | PMC10337397 | |
Abbreviations | analysis of covarianceAbused Women’s Active Response EmergencyChecklist for Reporting Results of Internet E-surveysConsolidated Standards of Reporting Trials of Electronic and Mobile HEalth Applications and onLine TeleHealthdomestic violence and abuseGeneral Data Protection RegulationGeneral Self-Efficacy Scaleintimate partner violence and abuseMedical Outcomes Survey Social Support-5open feasibility studyprocess evaluationrandomized controlled trial | PMC10337397 | ||
Data Availability | The data sets generated and analyzed during this study are available on reasonable request from the DANS repository [ | PMC10337397 | ||
1. Introduction | LEMS, cognitive deficits | FEMINIZATION | This study aims to investigate the effects of dual-task physical–cognitive the training on body balance (BB), gait performance (GP), lower limb muscle strength (LEMS), and cognitive performance (CP) in a group of cognitively normal older adult women (Aging brings a series of biological, psychological, and functional changes [Cognitive changes caused by aging are characterized by a reduction in synaptic density and the dendritic arborization of cortical neurons [The relationship between motor tasks such as GP and BB with cognition is controlled by muscle modulation processes, known as muscle synergy [In the clinical area, the use of simultaneous tasks that compete for limited resources (i.e., dual-task interference) is presented as a strategy to identify cognitive deficits [In general, a low CP and GP [The purpose of this study was to examine the effect of a 12-week physical–cognitive DT training program on GP, BB, LEMS, and cognition in a group of cognitively normal older adult women. We hypothesized that, after 12 weeks of intervention, members of the physical–cognitive DT training would indicate better performance in all tests. In turn, comparatively, members of the DT group would present better results in the evaluations after 12 weeks of follow-up than members of the control group. We justify the single inclusion of older adult women in the study because both in Brazil, as well as in the city where this investigation was carried out, there is a multifaceted phenomenon called the feminization of aging [ | PMC10139030 |
2. Materials and Methods | This is a randomized experimental study with a double-blind design. Those responsible for the evaluations in all phases of the study were blinded. After assessments of all participants at baseline (T1), study members were randomly assigned (1:1) into a dual-task (DT) or control (CG) group. Single-sequence randomization was generated by a web-based search randomizer ( | PMC10139030 | ||
2.1. Sample Size | Sample size and power calculations were performed with G* Power3, based on a previous study. Thus, a priori repeated measure ANOVA suggested that a total sample size of 44 was needed to reach 0.80% power to detect the interaction effect size of 0.20 at the 0.05 level of significance. Considering possible sample loss, 50 individuals were evaluated and allocated into the two groups in the proportion of 1:1. | PMC10139030 | ||
2.2. Participants and Eligibility | FEMINIZATION | Participants were recruited through dissemination in WhatsApp, Facebook, radio, and older adult groups in the city. Initially, the intention was to include individuals of both sexes, however, 98% of those interested were women. Thus, the investigation was composed exclusively of older women. It is worth noting that in Brazil, the location of this investigation, a multifaceted phenomenon called the feminization of aging has been observed [ | PMC10139030 | |
2.3. Intervention | PMC10139030 | |||
2.3.1. Dual-Task Training | DT physical–cognitive training was structured based on the principle of variable priority, when the focus of attention is divided between two or more tasks [The training load was implemented by the progression of tasks, more specifically, through the variation in motor exercises and increased difficulty of cognitive tasks. This strategy was modified every two weeks, more specifically, after four training sessions. Thus, we seek to intensify neuroplasticity, reducing the interference of competitive demands at the neural level, and favoring the exercise of allocation simultaneously from two or more tasks. | PMC10139030 | ||
2.3.2. Education Control Group | The CG activities consisted of a set of thematic workshops developed by the interdisciplinary team of the University of Third Age. The activities were under the responsibility of professionals from different areas (Physical Education, Medicine, Pharmacy, Nursing, Physiotherapy, History, Literature, English, Politics, Sociology, Informatics, and Arts). The methodology used was guided by the pedagogical principles of permanent education specific to the adult older population [ | PMC10139030 | ||
2.4. Control of Procedures and Adherence | Members of both groups attended at least 75% of training sessions [ | PMC10139030 | ||
2.5. Outcome Measures | Before randomization, participants answered a standardized questionnaire to collect sociodemographic data (e.g., age, education), history of falls, medications, and comorbidities. Secondly, anthropometric data (weight, height) were collected, and the Body Mass Index (BMI) was determined. Finally, we used the Mini-Mental State Examination (MMSE) [ | PMC10139030 | ||
2.5.1. Primary Outcomes | VF | The instruments used in this study are part of the list of tests commonly applied to assess mobility [In the TUGm, participants were asked to travel the 3 m-round trip carrying a paper tray (25 cm in diameter) with a dominant hand. On the tray, there was a glass (6.9 cm in diameter and 8.4 cm high) containing 200 mL of water (1 cm below the edge). In the TUGc, the patients were instructed to repeat the days of the week in reverse order, starting on Sunday. The performance of static and dynamic balance was evaluated by the Gleich Gewichsttest, validated by Wydra [The VF test examined the phonemic fluency and semantic memory system’s ability to strategize, organize, process, and retrieve information stored in long-term memory [ | PMC10139030 | |
2.5.2. Secondary Outcomes | LEMS | STS | LEMS was performed using the sit-to-stand (STS) test [ | PMC10139030 |
2.6. Covariates | Considering possible confounding factors, the analyses were controlled by a set of variables recognized as a potential for falls among the older adult population, namely: sex and age [ | PMC10139030 | ||
2.7. Statistical Analysis | Normality was tested with the Shapiro–Wilk test. Categorical variables (medications, education, and comorbidities) were presented by several cases, and the frequency was analyzed using the chi-square test. Considering that all scalar variables (age, BMI, falls, MMSE, BB, GP, VF) presented a normal distribution, they were acquired through means and standard deviations and were analyzed using the t-test for independent samples, while categorical data were analyzed using the chi-square test. The estimation of between- and within-group differences at baseline, post-training, and 12-week follow-up was performed by three-way repeated measures ANOVA. For this purpose, we considered the intervention DT versus CG as a factor between groups, and the measurement of time as a factor within the group (2 × 3 comparison). Data processing took place after checking all assumptions (homoscedasticity and normal distribution). Using partial eta-square, intergroup effect sizes were calculated according to the following categorization: small ( | PMC10139030 | ||
3. Results | Seventy-five people were selected for the study ( | PMC10139030 | ||
3.1. Sample Characteristic | Forty-four women participated in the study (66.20 ± 4.05 years). No significant difference between the groups was found in the baseline assessments ( | PMC10139030 | ||
3.2. Descriptive Statistics | PMC10139030 | |||
3.2.1. Gait, Body Balance, and Lower Extremity Muscle Strength | The comparative results obtained by both groups in the motor assessments at baseline, post-tests, and follow-up are presented in | PMC10139030 | ||
3.2.2. Cognition | Concerning the result of the VF-total, there were significant time–effect differences [F(2.96) = 6.301, | PMC10139030 | ||
4. Discussion | VF, lower extremity muscle strength, age-related deterioration, LEMS, visual, auditory, and somatosensory systems, cognitive and motor tests | This study investigated the effects of a 12-week dual-task physical–cognitive training on gait performance, balance, lower extremity muscle strength, and cognitive performance in a group of cognitively normal older adult women compared to a control group, who participated only in educational activities. Our two assumptions were confirmed. First, we found that DT training was able to generate significant time–group interaction effects after the 12-week intervention on the performance of BB, GP, LEMS, and EFs, except for the VF-category. Second, members of the DT training also reported better results on these same variables at the end of the 12-week follow-up. Thus, our findings were in line with previous investigations that showed concurrent physical–cognitive training as being capable for neutralizing age-related deterioration in physical and cognitive functions [A strength of our study was the training protocol. When it comes to DT training, the type of exercise applied is decisive for the creation of internal interference factors [It is noteworthy that although the performance of the CG members on all outcome variables (T2 and T3 assessments) was lower than the results of the DT group, except for BB, their performance levels were adequate for an age group between 60 and 79 years. In our study, while DT group members indicated an improvement in gait performance in a single task, motor dual task, and cognitive dual task, CG participants maintained gait speed in the three different conditions unchanged. Walking is a complex task that requires a mutual work of the sensorial and cognitive systems [In this study, the benefits of DT training became more evident after the follow-up period, when lasting effects (retention gains: Δ = T3 − T1) were revealed. Thus, members of the DT group indicated in the gait condition a single task (gain of 23.3%), motor dual task (gain of 20.9%), and cognitive dual task (gain of 12.2%). Similar results of DT training in GP among older adults have also been reported in previous experimental studies [In the present study, the greatest power effect revealed by DT training was observed in the BB test. The improvement in balance control can be attributed to the set of tasks experienced by the older adults in the DT group, which improved the functioning of the sensory system organs responsible for regulating postural control (i.e., visual, auditory, and somatosensory systems). Thus, over 24 weeks, while the CG members maintained their balance performance unchanged, those who participated in the DT training increased the efficiency of this motor skill by up to 300.0% from T1 to T2, and were able to retain the gains (Δ = T3 − T1) by up to 200% after follow-up. Our findings are in line with previous studies [The improvement in the BB performance was in agreement with a previous review study [Another positive effect of DT training was for LEMS. With aging, there is a gradual loss of related muscle strength that can compromise performance in ADLs, even reducing perceived quality of life [Regarding cognition—more specifically, a subcomponent of executive functions, which is verbal fluency—we found that, except for the VF category, while the cognitive performance of the CG members remained unchanged over 24 weeks, the members of the DT training indicated improvement in the performance of phonemic fluency and semantic memory functions. The effective gain can be verified after follow-up through retention effects (Δ = T3 − T1) of up to 26.6%, 176.7%, and 116.6%, respectively, in the categories VF-total, VF-category, and VF-grouping. The literature has highlighted the benefits of physical exercise under the principles of DT to increase the cognitive reserve of the older adult population [It is worth noting that, based on the MMSE test, all of our study population had a preserved cognitive state. Therefore, they experienced natural aging [The present study has some limitations. First, findings from the present study can only be generalized to a specific group of older adult women, and only for those who meet the same selection criteria adopted in this investigation. Second, considering that the cognitive and motor tests were applied three times over a period of six months, it is possible that some participants memorized the tasks, generating bias in the results. Third, neuroimaging techniques were not added to further monitor the neural changes caused by DT training. Thus, it must be considered that it is possible that the clinical instruments used did not offer an in-depth analysis of the underlying brain mechanisms that benefited from DT training. Fourth, the levels of complexity, specificity, and prioritization of the motor and cognitive task limit the comparability with previous studies. Thus, the effect sizes generated by our physical–cognitive DT training protocol may vary considerably from those presented by other studies. Fifth, the use of only one cognitive test is a limitation of this investigation. Therefore, it is suggested that future studies, in addition to the verbal fluency test, add other instruments to verify the effects of physical–cognitive DT training on executive functions. The measure can broaden the understanding of the underlying mechanisms of neural plasticity generated by this type of training. Finally, it is encouraged to carry out a longitudinal follow-up of the evaluated population in order to state more precisely the effects of DT training and natural aging on GP, BB, LEMS, and EFs. | PMC10139030 | |
5. Conclusions | The findings provided evidence for the effectiveness of 12 weeks of dual-task physical–cognitive training in counteracting age-related changes in gait performance (single- and dual-task conditions), also improving static and dynamic balance performance, and increasing lower limb strength. A strong point of our study was the non-requirement of expensive equipment in the training protocol, which also ensured the participants’ adherence over the 12 weeks. In turn, admitting that physiological aging is responsible for changes in cognitive functions, enhancing the loss of autonomy and vulnerability of the individual, DT training proved to be capable of inducing neural plasticity (i.e., search and retrieval of data, ability for organization, self-regulation, and operational memory). Our results can serve as a reference for new investigations focused on the prevention of falls in cognitively normal older adult women. | PMC10139030 | ||
Author Contributions | Conceptualization, M.d.M.N.; methodology, M.d.M.N., P.A.M. and A.I.; software, M.d.M.N.; validation P.M.B.R., P.A.M., L.d.S.N., C.N.S. and A.I.; data curation, M.d.M.N. and P.A.M.; writing—original draft preparation, M.d.M.N., M.K. and A.I.; writing—review and editing, P.M.B.R., P.A.M., L.d.S.N. and C.N.S.; visualization, M.d.M.N., P.A.M., P.M.B.R., L.d.S.N. and C.N.S.; supervision, P.A.M., M.K. and A.I.; project administration, M.d.M.N., M.K. and A.I. All authors have read and agreed to the published version of the manuscript. | PMC10139030 | ||
Institutional Review Board Statement | The study was conducted according to the guidelines of the Declaration of Helsinki and had been approved by the local ethics committee before the start of the data collection. The actions were approved by the Human Research Ethics Committee of the Federal University of Vale do São Francisco in Brazil (number 2,866,845, Brazil Platform). | PMC10139030 | ||
Informed Consent Statement | Informed consent was obtained from all subjects involved in the study before participation. | PMC10139030 | ||
Data Availability Statement | The data presented in this study are available upon request from the corresponding author. | PMC10139030 | ||
Conflicts of Interest | The authors declare no conflict of interest. | PMC10139030 | ||
References | lower extremity muscle strength | Study design and flow of participants.Results of the time × group interaction analysis, according to the groups. (Description of training components and task specificity.Strategies to increase DT training load during gait and balance tasks.Main characteristics of participants in the baseline.Note: Data are expressed as mean (M) ± standard deviation (SD) or frequency (f); kg = Kilograms; cm = centimeters; MMSE = Mini-Mental State Examination; BMI = Body Mass Index; kg/mResults between the dual-task and control groups for gait, balance, lower extremity muscle strength, and cognitive performance.Note: Values are presented as mean (M) ± standard deviation (SD); s = second; TUG = Timed Up & Go; TUGm = Timed Up & Go (manual); TUGc = Timed Up & Go (cognitive); TEC = Balance Test; LEMS = c; VF = Verbal Fluency; | PMC10139030 | |
Introduction | ANTIBODY-MEDIATED REJECTION | The presence of donor-specific antibody (DSA) and antibody-mediated rejections are poor prognostic factors for graft survival and a major cause of graft failure in kidney transplant (KT) patientsThe allograft survival rate was poorer in patients with de novo (dnDSA) than in those with preexisting DSA, although antibody-mediated rejection can occur in both patients with preexisting DSA and dnDSATherefore, it is important to actively control dnDSA and accompanying antibody-mediated rejection to improve kidney allograft outcomes. In previous studies, dnDSA reduction was identified only after intravenous immunoglobulin (IVIG) or rituximab use during desensitization | PMC10175554 | |
Methods | PMC10175554 | |||
Trial design | This study was an open-label, randomized, controlled clinical trial conducted at two large tertiary academic medical centers (Severance Hospital and Seoul National University Hospital) in Korea between January 2019 and October 2021. This study was approved by the Institutional Review Board (IRB) of Yonsei University Health System (IRB No. 4–2018-0359) and Seoul National University Hospital (IRB No. H-1712–158-912). The protocol was registered on ClinicalTrials.gov (Identifier: NCT04033276, first trial registration 26/07/2019) and conducted in accordance with the principles of the Declaration of Istanbul and the Declaration of Helsinki. All patients provided informed consent. The requirement for informed consent of patients who were retrospectively recruited from Severance Hospital was waived by IRB of Yonsei University Health System (IRB No. 4–2022-1125) because of the retrospective nature of the study. | PMC10175554 | ||
Participants, randomization, and intervention | KT patients with subclinical class II dnDSA were screened. Participants who met the following criteria were included: (i) age ≥ 19 years; (ii) estimated glomerular filtration rate (eGFR) > 20 ml/min/1.73 mEligible participants who offered consent were randomly assigned to receive rituximab (IVIG–) or rituximab combined with IVIG (IVIG +) at a ratio of 1:1 (stratified by dnDSA peak level: < 10,000 MFI or ≥ 10,000 MFI and participating center). Both groups received rituximab (Roche, Basel, Switzerland) at a dose of 375 mg/m | PMC10175554 | ||
Data collection and follow-up | ADVERSE EVENTS | The clinical and laboratory findings of the patients were assessed at baseline and 3 and 12 months. Assessment of general health status, medication use, and the occurrence of adverse events were performed at every visit. Laboratory measurements were performed at every visit, including DSA, serum creatinine, complete blood count, routine chemistry tests, electrolytes, and urinalysis. The presence of DSA was assessed using LABScreen Single Antigen Class I/Class II (One Lambda, Canoga Park, CA, USA). CD19 levels were measured at baseline and 3 months. The date of the last follow-up was August 2021. | PMC10175554 | |
Study outcome | CHRONIC KIDNEY DISEASE, SECONDARY | The primary endpoint was the change in dnDSA titer at 3 and 12 months after preemptive treatment. The dnDSA titer was determined using either strength of immune-dominant class II dnDSA (MFI) or sum of class II dnDSA (MFI). Immune-dominant dnDSA was defined as DSA with the highest MFI at baseline. The sum of class II dnDSA was calculated by adding the MFI values of all class II dnDSAs. The secondary outcomes were changes in eGFR estimated by the Chronic Kidney Disease Epidemiology Collaboration equation | PMC10175554 | |
Statistical analyses | Continuous variables were presented as means with standard deviations (SD) for normally distributed data and medians with interquartile ranges (IQRs) for non-normally distributed data. Categorical variables were expressed as numbers with percentages. Between-group comparisons were tested for statistical significance using the Pearson chi-square test, Fisher exact test, unpaired t-test, Mann–Whitney U test, one-way ANOVA test, or Kruskal–Wallis test, as appropriate. Bonferroni correction was used for P-values to correct for the problem of multiple testing. Generalized estimating equation (GEE) models were used to examine the effect of the treatment on dnDSA titer between the IVIG + and IVIG- groups at 3 and 12 months with baseline. Detailed information about GEE model can be found in the | PMC10175554 | ||
Results | PMC10175554 | |||
Change in the sum of dnDSA titer | The sum of dnDSA also decreased at 3 and 12 months after treatment in the IVIG + and IVIG − groups (Fig. Generalized estimating equation analysis for comparing the treatment effect of IVIG/rituximab with that of rituximab alone on class II dnDSA sum.
Visit was treated as a categorical variable. The MFI values were log-transformed. β refers to the coefficient estimated from the multivariate generalized estimating equation model. The β coefficients of the group × time interaction terms represent the difference in mean changes in MFI values at each time point with respect to the baseline between the IVIG + and IVIG − groups (mean change in IVIG + group − mean change in IVIG − group). | PMC10175554 | ||
Change in kidney function | proteinuria | There was no significant difference in eGFR or proteinuria change between the IVIG + and IVIG– groups at either 3 or 12 months compared to baseline (Table | PMC10175554 | |
Adverse events and antibody-mediated rejection | ADVERSE EVENTS | During the study period, 36 and 41 adverse events occurred in the IVIG + and IVIG − groups, respectively, and there was no difference between the two groups ( | PMC10175554 | |
Comparison between treatment group and no treatment group | To verify the effect of treatment on dnDSA, patients who had subclinical dnDSA but did not receive any treatment (rituximab or IVIG) were retrospectively enrolled as a control group and compared with patients participating in the present study. The two treatment groups' demographic and baseline laboratory findings were generally similar (Table | PMC10175554 | ||
Discussion | microangiopathy | GRAFT LOSS, ANTIBODY-MEDIATED REJECTION, VASCULAR INFLAMMATION, MICROANGIOPATHY | In this open-label randomized controlled trial, we found that preemptive treatment in patients with dnDSA was associated with a reduction in dnDSA MFI. However, compared with the use of rituximab alone, combination of IVIG to rituximab did not provide additional benefit for dnDSA reduction. dnDSA-induced vascular inflammation and microangiopathy play a major role in antibody-mediated rejection, leading to kidney allograft lossMost previous studies examined the reduction of DSA titer in pre-transplant desensitization of highly sensitized recipientsNo randomized controlled study has investigated the effectiveness of pre-emptive treatment in kidney transplant patients with dnDSA. Therefore, it is not established whether preemptive treatment for dnDSA could be useful or which treatment is better in kidney transplant patients. This randomized clinical trial showed that rituximab alone or combination therapy of rituximab and high-dose IVIG treatment reduced dnDSA MFI. However, our study did not demonstrate clear additional benefits of IVIG combination compared to rituximab alone. As clinical antibody-mediated rejection was not observed in either treatment group during the study period, we could not assess impact of each treatment on the occurrence of antibody-mediated rejection.Among class II dnDSA, anti-DQ dnDSA showed poorer response to treatment than anti-DR dnDSA. In the previous study, most of the immune-dominant DSAs detected in patients with late rejection were anti-DQ DSA and their titer did not respond well to the rejection treatmentConsidering the poor prognosis of dnDSA and the accompanying antibody-mediated rejection, early detection, and preemptive treatment of dnDSA with or without subclinical rejection could be important. Furthermore, preventive strategies are of course more important. Since class II eplet mismatch is an important immunologic risk factor for dnDSA, good eplet matching can be an important method to reduce the development of DSAThis study has several limitations. First, this study enrolled a relatively small number of patients and most of the patients had living-related kidney transplant. Therefore, the potential selection bias could not be ruled out. In addition, the short follow-up duration made it impossible to investigate preemptive treatment's effect on antibody-mediated rejection, kidney function, and graft loss. To overcome this limitation, MFI change was defined as primary endpoint in this study. Based on this study, further large-scale studies with long-term follow-up are needed to assess the long-term benefits of preemptive treatment for dnDSA. Secondly, the lack of allograft biopsy findings at the time of dnDSA detection in this study could not determine the presence of subclinical antibody-mediated rejection. However, the necessity for allograft biopsy in patients with subclinical dnDSAs has not been established in large clinical trialsNevertheless, this study is the first, randomized, controlled study to assess effectiveness of preemptive therapy for subclinical dnDSA and determine a better treatment regimen for subclinical dnDSA in kidney transplant patients. This study could contribute to the field by providing baseline data for establishing effective preemptive treatment of subclinical dnDSA.In conclusion, the preemptive administration of high-dose IVIG combined with rituximab did not show an additional benefit in reducing dnDSA compared to the administration of rituximab alone, although both treatments reduced dnDSA. | PMC10175554 |
Supplementary Information |
Supplementary Information. | PMC10175554 | ||
Supplementary Information | The online version contains supplementary material available at 10.1038/s41598-023-34804-6. | PMC10175554 | ||
Author contributions | J.Y. and K.H.H. designed the study. H.W.K. and J.L. wrote the manuscript. H.W.K. and S.-J.H. analyzed the data. J.Y. reviewed and edited the manuscript. H.W.K., J.L., B.S.K., K.H.H., and J.Y. analyzed the data and contributed to the discussion. J.Y. is the guarantor of this work and takes responsibility for the integrity of the data. All authors critically revised the manuscript for key intellectual content and approved the final version. | PMC10175554 | ||
Funding | This study was supported by a grant from GC Biopharma, which was not involved in the study design or analysis. | PMC10175554 | ||
Data availability | The datasets generated and/or analyzed during the current study are not publicly available due privacy but are available from the corresponding author on reasonable request. | PMC10175554 | ||
Competing interests | The authors declare no competing interests. | PMC10175554 | ||
References | PMC10175554 | |||
Background | BREAST CANCER | Diphereline is a Gonadotropin-Releasing Hormone agonist commonly used in patients with breast cancer. This study aimed to compare the efficacy and safety of one-month and three-month Microrelin injections produced by Homa Pharmed Company with three-month Diphereline injections manufactured by IPSEN, France. | PMC10638790 | |
Methods | ’ menopausal symptoms | The study was a non-inferiority randomized clinical trial conducted between 2019 and 2023 on premenopausal women candidates for endocrine therapy. The participants were randomly assigned in blocks of six to one of three groups named A (Diphereline 11.25 mg), B (Microrelin 11.25 mg), and C (Microrelin 3.75 mg). The participants’ menopausal symptoms, estradiol, and FSH serum levels were recorded in three-month intervals for one year. The efficacy of each medication and its side effects were compared among the three groups by statistical analysis during the one-year follow-up. | PMC10638790 | |
Results | BREAST CANCER | The study included 133 patients with breast cancer. A decreasing trend in the serum levels of FSH and estradiol and an increasing trend of menopausal symptoms were recorded during the study. No specific side effects leading to drug disruption, hospitalization, or exclusion from the study were observed. Adjusting the effect of study group and time showed no significant changes in estradiol levels between groups B (p = 0.506) and C (p = 0.607) and group A. Also, serum FSH changes between groups B (p = 0.132) and C (p = 0.104) compared to group A were not significant. Moreover, the menopausal symptoms during the one-year follow-up did not significantly increase in group B (p = 0.108) and C (p = 0.113) compared to group A. | PMC10638790 | |
Conclusions | It can be concluded that injections of both Microrelin 11.25 mg and 3.75 mg, produced by Homa Pharmed, Iran, are non-inferior in terms of effectiveness and incidence of menopausal symptoms compared to Diphereline, manufactured by IPSEN, France. | PMC10638790 | ||
Trial registration | IRCT.ir, IRCT20201227049847N1; Registered on 09/01/2021. | PMC10638790 | ||
Keywords | PMC10638790 | |||
Background | Breast cancer, cancers, breast cancer | BREAST CANCER, RECURRENCE, CANCERS, BREAST CANCER | Breast cancer ranks among the most frequently detected cancers in women globally, with an approximate occurrence of 2.3 million new cases [Estrogen is an important factor in breast cancer development and prognosis. In primary treatments of breast cancer, luteinizing hormone-releasing hormone agonist (LHRHa) can be used to reduce estrogen levels in patients with positive hormone receptors [The TEXT-SOFT trial showed that the combination of aromatase inhibitors such as Exemestane with ovarian inhibitors significantly reduces the chance of recurrence compared to Tamoxifen plus ovarian inhibitors [Triptorelin is a GnRH analog which initially stimulates the pituitary gland. After continuous contact with its receptor, triptorelin can inhibit gonadotropin release by reducing the sensitivity or reducing the production of receptors [ | PMC10638790 |
Methods | MCI, Cancer | CANCER | This study is a non-inferiority RCT conducted at Motamed Cancer Research Institute (MCI) between 2019 and 2023. The primary objective was to examine the effectiveness, benefits, and side effects of a domestically produced medication called Microrelin, available in one-month and three-month formulations by Homa Pharmed pharmaceutical company, and compare them with a similar foreign brand, Diphereline 11.25 mg. | PMC10638790 |
Eligibility criteria | non-metastatic breast cancer | The study included premenopausal patients over the age of 18 with non-metastatic breast cancer and positive hormone receptor status who met the criteria for endocrine therapy All of the patients received chemotherapy regimen of AC4T4 (Adriamycin 60 mg/m2, Cyclophosphamide 600 mg/m2 – Docetaxel 75 mg/m2), and Tamoxifen for endocrine therapy. The exclusion criteria included the need to hysterectomy and oophorectomy, and participant’s unwillingness to continue participation. | PMC10638790 | |
Method | Cancer | DRUG SIDE EFFECTS, CANCER | Throughout the treatment, all patients were monitored for their menstrual status. Patients with inclusion criteria who did not experience cessation of menstruation were recruited in the study. Menopausal status in the three groups was evaluated by examining the trends in serum estradiol and FSH levels as well as the changes in menopausal symptoms over a one-year period.Since all patients had normal menstruation periods before the start of the study, estradiol levels were not measured at baseline. In all three groups, serum estradiol and FSH levels were measured after 3, 6, 9, 12 months of drug administration. Menopausal symptoms and drug side effects were assessed using the Heinemann questionnaire at start of the study and the following 3, 6, 9, and 12 months.At the outset of this study, we provided patients with sufficient explanation about the procedures involved and a written informed consent was obtained from all eligible participants. We emphasized that patients could withdraw from the study whenever they wanted. The prescribed drugs were free of charge. This study was approved by the Ethics Committee of Motamed Cancer Research Institute (IR.ACECR.IBCRC.REC.1397.003). | PMC10638790 |
Instruments | menopause-related complaints | MRS |
Demographic and clinical characteristics of the participants were registered in a checklist.Serum estradiol and FSH titers were obtained from laboratory reports and recorded.The severity of menopause-related complaints was assessed using the Menopause Rating Scale (MRS) designed by Heinemann et al. in 2003 [ | PMC10638790 |
Randomization | RECRUITMENT | Recruited patients were randomly assigned to one of the three treatment groups using a block randomization with a block size of six. A statistician created the blocks in sets of six using Excel software, resulting in 35 sets of different states (e.g., BBCAAC, BCAACB, CCAABB). The letters A, B, and C represented each of the three intervention groups, and each set of six random codes was placed in a sealed envelope. In recruitment phase, an envelope was randomly selected and the patients were assigned to one of the study groups based on the order of the letters (Fig.
Consort diagram: recruitment, eligibility screening, randomization, follow-up, and analysis | PMC10638790 |
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