University Research Ethics Committee Research Articles

Abstract PO5-17-10: PERFORMANCE AND OUTCOMES OF THE 70-GENES SIGNATURE (MAMMAPRINT™) IN A POPULATION WITH MIDDLE INCOME – REAL WORLD STUDY (AGEMA-BRA)

Abstract INTRODUCTION – Breast cancer remains the most frequent tumor in the female population and the fourth in mortality in the world population (GLOBOCAN 2020). With the aim of reducing mortality and at the same time de-escalating treatment, avoiding overtreatment, individualized therapy is increasingly being applied. The genomic signature of 70-genes, when stratifying patients into high and low risk of relapse, makes it possible to withdraw part of the cases of high clinical risk from chemotherapy treatment. However, the MINDACT study, which validated this signature, was carried out only in the European population, with no data on performance and outcomes in other populations with greater miscegenation. OBJECTIVE – To study the performance and outcomes of the 70-gene genomic signature (MammaPrint™) in a Brazilian population with a high ethnic miscegenation. METHODOLOGY – A retrospective cohort study was conducted in 953 women with breast cancer at high clinical risk, who underwent genomic analysis with the 70-gene platform (MammaPrint™), from January 2016 to December 2020. For the statistical evaluation, a descriptive analysis of the data with absolute and relative frequencies of the variables was performed. To verify the association between qualitative variables, the chi-square test was used. All analyzes were performed in the R 4.1.0 environment (R Core Team, 2021). Study approved by the Research Ethics Committee of the State University of Ponta Grossa (PR) - (CAAE: 12194219.4.0000.0105). RESULTS – The analysis of 955 cases from the AGEMABRA cohort (all at high clinical risk) showed 546 cases (57.2%) with low genomic risk and 409 cases (42.8%) with high genomic risk to MammaPrint™ (MP); when compared with data from the MINDACT study (46.2% low risk and 53.8% high risk) a significant difference was observed in the distribution for high and low risk in the two populations (p.< 0.001). After excluding patients with missing data, 409 cases of low- and high-risk MP were studied. The variables regarding age group, tumor diameter, number of affected lymph nodes, hormone receptors and HER2 overexpression showed no significant difference; within this same analysis, the tumor grade showed a higher incidence of grade 1 in the population with low genomic risk (6.6%) compared to high risk (2.9%) and grade 3 in high risk (13%) compared to low risk (5%) with p.< 0.001 (table 1). With an average follow-up of 40 months, the DMFS (disease metastatic free survival) found was 97.2%, being 97.8% for low risk and 96.2% for high risk (p.0.54). All patients with high-risk MP who progressed had used adjuvant chemotherapy, and all patients with low-risk MP who relapsed received only endocrine therapy. When compared to the MINDACT population, the AGEMA-BRA has more elderly patients, and smaller tumors with a lower histological grade (p.=< 0.001). CONCLUSION – The analysis of the Brazilian population submitted to the 70-gene genomic signature showed a greater proportional number of tumors with low genomic risk than in the test approval study, favoring its application with the aim of de-escalating systemic treatment in this population. Despite the low rate of disease progression in the AGEMA-BRA study, probably determined by the population with the best prognosis disease and the short follow-up, recurrence was similar in the high and low genomic risk groups, demonstrating the adequate selection of systemic therapy following the results of the MP. An increase in the sample size and longer follow-up are necessary to confirm the results found. Table 1. Characteristics of patients and tumor according to risk (AGEMA-BRA) Citation Format: Fabio Mansani, Ruffo Freitas-Junior. PERFORMANCE AND OUTCOMES OF THE 70-GENES SIGNATURE (MAMMAPRINT™) IN A POPULATION WITH MIDDLE INCOME – REAL WORLD STUDY (AGEMA-BRA) [abstract]. In: Proceedings of the 2023 San Antonio Breast Cancer Symposium; 2023 Dec 5-9; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2024;84(9 Suppl):Abstract nr PO5-17-10.

The Political Life of Research Ethics Committees And What It Means for Ethnographic Research

This review discusses three pieces of work, that is, a conference panel and two books, that deal with the role of research ethics committees (RECs) in regulating biomedical research and medical anthropological research. We summarise the papers and conversations of a panel we convened on this topic during the 2020 European Association for Social Anthropologists (EASA) conference. We review two relatively recent books which discuss the role of RECs in biomedical research: Adam Hedgecoe’s (2020) Trust in the System: Research Ethics Committees and the Regulation of Biomedical Research, and Salla Sariola and Bob Simpson’s (2019) Research as Development: Biomedical Research, Ethics, and Collaboration in Sri Lanka. Finally, we consider how the review that RECs outside academic institutions perform is inadequate for ethnographic research, including that involving prospective participants who may lack capacity to consent. We conclude that undertaking the research ethics review internally (i.e., under university RECs) would be a first step forward in reclaiming ethnographic research ethical conversations.

Combination of pregabalin and Amitriptyline in management of chronic idiopathic pain following penile prosthesis implantation: a pilot study

BackgroundChronic post-penile prosthesis pain is de novo pain persisting > 2 months post-operatively. This pain is inadequately reported, poorly understood and undermanaged. The purpose of this current pilot study was to improvise a medical approach to alleviate the condition and assess the combination of Pregabalin and Amitriptyline in its management.ResultsThe study enrolled 9 patients complaining of idiopathic penile, pelvic, or scrotal pain persisting > 2 months after penile prosthesis implantation. Patients were prescribed pregabalin 75mg/12h (escalated after 1 week to 150mg/12h upon demand) and Amitriptyline 25mg once daily for 3 months. The pain was reassessed after 10, 30 and 100 days. The dose of pregabalin required and the side effects of the medication were noted. Findings revealed a significant decrease in pain duration (p = 0.007), frequency (p < 0.001), and intensity (p < 0.001); in glanular (p = 0.008), shaft pain (p = 0.046) but not scrotal (p = 0.112). Moreover, a significant decrease was found in sharp pain (p = 0.003) and pain aggravated by touch (p = 0.008) but not aching pain (p = 0.277). Additionally, significant improvement was reported in QoL (p < 0.001) and dose escalation of pregabalin to 150mg/12h was required in only 1 case (11%).ConclusionThe combination of pregabalin and amitriptyline is very effective in the management of chronic idiopathic pain following penile prosthesis implantation. However, due to the ambiguity and lack of reporting of the condition, we recommend a multicentric contribution to acknowledge the condition, and weigh its prevalence accurately, whilst evaluating the efficacy of our approach.This study received ethical approval from Ain Shams University Research Ethics Committee (REC) FWA 000017585, on 04/13/2023 (REC-FMASU@med.asu.edu.eg). Trial registrationno FMASU R98/2023.

Occupational burnout and job satisfaction among community pharmacists

IntroductionCommunity pharmacists (CPs) are the most accessible healthcare professionals in primary care due to pharmacies' open-door policy and convenience, resulting in high patient and prescription volumes, and numerous free-of-charge consultations. Therefore, they are at high risk for burnout. ObjectivesThe primary objective of this study was to assess the levels of burnout among community pharmacists in Greece, marking the first investigation of its kind within the country. Additionally, this study aimed to explore potential correlations between demographic variables and other health-related factors with burnout scores. MethodsThis study used a quantitative cross-sectional design involving two validated questionnaires(the Greek version of Maslach (MBI) questionnaire and the SF-36 questionnaire). Prior to data collection, all the relevant documentation was approved by the Metropolitan College Research Ethics Committee and was adopted under the auspices of the Panhellenic Pharmaceutical Association. Random sampling was used. Data collection period was July to August 2022. ResultsA total of 368 responses were included in the analysis, with the majority being pharmacy-owners (n = 292, 79.3%). Notably, a significant proportion of respondents were female practitioners working within community pharmacy settings (n = 230, 62.5%). Analysis revealed that the sample exhibited low levels of personal achievement (M = 30.99, SD = 6.41), high levels of emotional exhaustion (M = 41.73, SD = 6.94), and moderate levels of depersonalization (M = 23.38, SD = 3.78), indicative of substantial occupational burnout. Furthermore, gender had a discernible impact on depersonalization, with women scoring higher than men (t = −3.29, p < 0.01). Pharmacists who identified medicine shortages as their primary challenge in daily practice reported lower emotional burnout and depersonalization, albeit with a diminished sense of accomplishment (t = −2.62, p < 0.01). ConclusionsThis study sheds light on burnout levels and health-related quality of life among community pharmacists in Greece.

Ethical challenges in global research on health system responses to violence against women: a qualitative study of policy and professional perspectives

BackgroundStudying global health problems requires international multidisciplinary teams. Such multidisciplinarity and multiculturalism create challenges in adhering to a set of ethical principles across different country contexts. Our group on health system responses to violence against women (VAW) included two universities in a European high-income country (HIC) and four universities in low-and middle-income countries (LMICs). This study aimed to investigate professional and policy perspectives on the types, causes of, and solutions to ethical challenges specific to the ethics approval stage of the global research projects on health system responses to VAW.MethodsWe used the Network of Ethical Relationships model, framework method, and READ approach to analyse qualitative semi-structured interviews (n = 18) and policy documents (n = 27). In March-July 2021, we recruited a purposive sample of researchers and members of Research Ethics Committees (RECs) from the five partner countries. Interviewees signposted policies and guidelines on research ethics, including VAW.ResultsWe developed three themes with eight subthemes summarising ethical challenges across three contextual factors. The global nature of the group contributed towards power and resource imbalance between HIC and LMICs and differing RECs’ rules. Location of the primary studies within health services highlighted differing rules between university RECs and health authorities. There were diverse conceptualisations of VAW and vulnerability of research participants between countries and limited methodological and topic expertise in some LMIC RECs. These factors threatened the timely delivery of studies and had a negative impact on researchers and their relationships with RECs and HIC funders. Most researchers felt frustrated and demotivated by the bureaucratised, uncoordinated, and lengthy approval process. Participants suggested redistributing power and resources between HICs and LMICs, involving LMIC representatives in developing funding agendas, better coordination between RECs and health authorities and capacity strengthening on ethics in VAW research.ConclusionsThe process of ethics approval for global research on health system responses to VAW should be more coordinated across partners, with equal power distribution between HICs and LMICs, researchers and RECs. While some of these objectives can be achieved through education for RECs and researchers, the power imbalance and differing rules should be addressed at the institutional, national, and international levels. Three of the authors were also research participants, which had potential to introduce bias into the findings. However, rigorous reflexivity practices mitigated against this. This insider perspective was also a strength, as it allowed us to access and contribute to more nuanced understandings to enhance the credibility of the findings. It also helped to mitigate against unequal power dynamics.

What Protects At-Risk Young People in India From Using and Abusing Substances? A Photo-Led Study of Lived Experience

Youth substance abuse is widespread in India. Data is needed to inform the focus of prevention approaches. Our aim was to understand the perspectives of Indian young people about what protects them from substance (ab)use, and our study followed protocols approved by UK and Indian university research ethics committees. We recruited 15 Indian adolescents from Assam (seven males, eight females) aged 15 to 18 years at elevated risk because they had family/friends who were substance addicts. Participants took part in a photo-led interview in which they represented visually and narratively their experience of resisting substances (ab)use. Data were analyzed by a UK-India team using reflexive thematic analysis. Seven dominant protective factors were expressed by young people, including nurturing and communicative relationships with parents; up close and personal observations around addiction which left participants fearful of substances; protective mindsets and resolutions emerging from participants’ reflection on drug culture; staying away from “bad” company; being repulsed by substances; having healthy ways to cope at difficult times; and having something that mattered more than using substances. Findings show the resilience of Indian adolescents and suggest that prevention approaches in India should focus on augmenting individual, school and family mechanisms which appear dynamic and cumulative.

CLINICAL PROFILE OF PTOSIS PATIENTS IN DR. M. DJAMIL HOSPITAL PADANG

Abstract&#x0D; Introduction &amp; Objectives : Ptosis is one of the most common upper eyelid abnormalities. Ptosis surgery is indicated when there is visual compromise. Patient clinical profile is important in diagnosing and planning treatment for ptosis correction. The aim of this study is to describe the clinical profile of ptosis surgery patient in Dr. M. Djamil Hospital Padang.&#x0D; Methods : This study was conducted in descriptive and retrospective manner. This research has been approved by the Medical Faculty of Andalas University research ethics committee No: 332/UN.16.2/KEP- FK/2021. All patients that were diagnosed with ptosis in Dr. M. Djamil Hospital Padang from January 2016 to December 2021 were included.&#x0D; Results : There were 33 patients included in this study. Most common age range was 11-20 years old (51.5%), patients were dominantly female (51.5%). According to laterality, the most common was unilateral ptosis, 21 cases (63.6%). Congenital ptosis comprises 51.5% of the cases with myogenic as the most common etiology. Severe ptosis was found in 20 cases (57.6%), poor levator function was found in 17 cases (51.5%). Levator resection was performed in 19 cases (57.6%). Thirty patients (90.9%) had MRD1 ≥2 mm post-surgery.&#x0D; Conclusion : Levator function is important in determining the surgical method. In severe ptosis with poor levator function, frontalis suspension is the surgery of choice. Appropriate surgical procedure in accordance to accurate pre-operative evaluation will show a good surgical result.

EPIDEMIOLOGICAL PROFILE OF CONFIRMED CASES OF COVID-19 IN THE PERIOD FROM APRIL TO MAY 2020 IN THE STATE OF MARANHÃO

Brazil was the first South American country to report a confirmed case of Coronavirus Disease 2019 (COVID-19), on February 26, 2020, in the state of São Paulo. Maranhão was one of the states in Brazil where the pandemic picked up speed early. Thus, the objective of this study is to report the initial experience regarding the epidemiological and clinical aspects of COVID-19 in the State of Maranhão. This is a cross-sectional study and the data used come from a database provided by the Central Laboratory of the State of Maranhão – LACEN, with the approval of the Research Ethics Committee of the State University of Maranhão according to CAAE: 32171220.0.0000.5087. The initial sample included data from 2,336 individuals, but 646 patients were excluded because they did not contain information about epidemiological data, thus totaling a final sample of 1,690 individuals. For data archiving and statistical analysis, SPSS ® version 25.0 software was used. The final sample consisted of 1690 individuals, of whom 64.9% (n=1098) tested positive for COVID-19, 52.2% (n=882) were women, 82.8% (n=1374) came from the public health sector and 82.3% (n=1400) from the metropolitan region of the state. The highest prevalence of positive cases for COVID-19 was in the state capital, with 86.5% (n=950). It was found that most patients depended directly on the unified health system as a form of priority care, which led to a strong collapse since they were not prepared for the demand arising from the pandemic. Emphasizing the importance of investments in the Unified Health System, as well as the supervision of these resources.

Patient's best interest as viewed by nursing students.

In recent years, patient advocacy has emerged as a prominent concept within healthcare. How nursing students decide what is best for their patients is not well understood. The objective is to examine nursing students' views on doing what is best for patients during their clinical experiences and how they seek to establish patient interests when providing care. Research questions guiding the interview were as follows: (1) What are nursing students' perceptions of patient interests? (2) What factors influence nursing students' perceptions of advocating for patient's interests? Qualitative descriptive research using thematic analysis. Data was collected through individual online interviews with nine nursing students with clinical experience. The study was approved by the University Research Ethics Committee. Participants provided digital informed consent. The students asserted that they are able to understand the patients' interests by placing emphasis on the patients' needs. They believe that it is crucial to adopt a collaborative strategy for the provision of care to meet these requirements. In addition, some of them expressed concern over the most effective methods of advocating for the interests of patients. Three themes were identified. (1) Focussing on patient needs first, (2) taking a collective approach, and (3) learning how to advocate. Students understand and value the ethical commitments associated with advocating for the patient's best interest by considering factors such as prioritising the patient's needs, adopting a strategy that involves everyone, and acquiring the ability to undertake the advocacy role. Additionally, nursing education strategies in clinical contexts require additional study to inspire students to do what is in their patient's best interests.

Narrative Identities of Center-based Filipino Children in Conflict with the Law

This study examined the narrative identities of 10 male, center-based, Filipino children in conflict with the law (CICL) from their stories of their experiences before entering the youth rehabilitation center, during their commitment at the center, and their perception of the future after they leave the center. Participants were minors when they were charged with the commission of an offense, but were 18 to 22 years old at the time of the interviews. Multiple in-depth, face-to-face, semi-structured interviews were conducted using an adapted life story interview guide to elicit participants’ self-defining memories and views of the past, present, and future, following protocols approved by the University Research Ethics Committee and research guidelines for juvenile justice populations. Data were analyzed inductively using thematic narrative analysis and revealed three depicted identities across time points, manifesting a sense of sameness and continuity in the CICL’s views of themselves. In particular, the CICL depicted the self as a young person in need, with capabilities, and demonstrating concern for others. The study contributes to the development of a theory and program framework that can support the positive development of CICL, before, during, and after their stay in the youth rehabilitation center by identifying important elements for focus.

The Intersection of Cross-Border Migration and the Reconciliation of Work and Family: Chinese-Speaking Immigrant Women in Australia

The Intersection of Cross-Border Migration and the Reconciliation of Work and Family: Chinese-Speaking Immigrant Women in Australia

To explore clinical pharmacists’ opinions, and their perceived barriers and facilitators, to supporting clinical research delivery in secondary care

Abstract Introduction The National Health Service (NHS) is confronted with significant challenges in facilitating clinical research delivery.1 Clinical pharmacists were instrumental in ensuring patient safety while conducting urgent public health studies, such as the RECOVERY trial, during the COVID-19 pandemic.2 Numerous studies have reported the positive impact of pharmacy workforce in supporting clinical research delivery3. However, it remains unclear whether pharmacists are willing to take on this extra responsibility. Aim To explore the opinions of UK clinical pharmacists towards facilitating the delivery of clinical research in secondary care. Objectives include understanding the level of knowledge of clinical research among clinical pharmacists; assessing levels of interest among clinical pharmacists towards supporting clinical research delivery; identifying clinical pharmacists’ perceived barriers and facilitators to supporting clinical research delivery; and developing recommendations to facilitate pharmacists’ engagement in research delivery. Methods This study employed a qualitative research approach and utilised convenience sampling based on the researcher’s professional network. Eight pharmacists from two secondary care NHS Trusts participated. Individual semi-structured interviews were conducted using questions adapted from the Research Capacity and Culture (RCC) tool which was validated by two clinical trial pharmacists. Keele University Research Ethics Committee provided a favourable ethical opinion. Interview transcripts were analysed to identify emerging themes by using framework analysis. Results The findings revealed that participants possessed limited knowledge of clinical research in general. The key themes identified were categorised into three domains: individual, professional, and organisational, which corresponded with the RCC tool. In the individual domain, pharmacists demonstrated interest in clinical research delivery but lacked confidence. They acknowledged clinical research as contributing to evidence-based practice and enhancing professional development. However, they expressed concerns about patient harm resulting from trial interventions and poorly designed studies generating misleading data. Within the professional domain, pharmacists' capability to support clinical research delivery was limited by inadequate training in clinical research, their clinical skills, and their disease knowledge. They perceived internal and external barriers to participation. It has been suggested to improve the research culture within the profession and promote the role pharmacists can play in delivering research among other healthcare professionals. In the organisational domain, the workplace environment was perceived to present obstacles due to competing priorities and clinical research not being seen to be a core duty by managers. Additionally, awareness of clinical research opportunities was limited and exposure to clinical research-related activities within the workplace was minimal. Discussion/Conclusion Recommendations to address these barriers include promoting clinical research training, developing mentorship programs, creating platforms to connect clinical pharmacists with research opportunities, and identifying roles that allow pharmacists to incorporate clinical research into their routine practice. This research project has several limitations, including the use of a convenience sampling method, a small sample size and potential interviewer bias due to research participants all being known to the researcher. In summary, the pharmacy workforce possesses the potential to support the challenges in clinical research delivery faced by the NHS. However, addressing the perceived barriers is critical to enhancing pharmacist involvement in this field.

Developing an exercise intervention to improve bone mineral density in traumatic amputees: protocol for a Delphi study

IntroductionLower limb amputation results in reduced bone mineral density (BMD) on the amputated side. Exercise interventions have proven effective in improving BMD. However, such interventions have not been attempted in...

In-vitro Synergistic Antimicrobial Activity of Melia azedarach and Solanum incanum Ethanolic Leaf Extracts Against the Staphylococcus aureus

The increasing challenges of adverse drug reactions, costly medicines, and antimicrobial resistance necessitate the exploration of safe and effective antimicrobial agents. This study aimed to evaluate the antimicrobial activity of ethanol leaf extracts from Melia azedarach and Solanum incanum against Staphylococcus aureus, a clinically significant pathogen known for its resistance to conventional antibiotics. The research design employed was an experimental study with three concentrations of the plant extracts (1g/ml, 1.4g/ml, and 2g/ml) tested against Staphylococcus aureus, and the standard antimicrobial agent, ciprofloxacin, served as a positive control, while ethanol served as a solvent control. The samples were prepared, and the experiments were conducted in triplicate, following established protocols. The choice of Melia azedarach and Solanum incanum was scientifically justified based on their well-documented traditional medicinal uses and previous reports of antimicrobial activity. Ethical approval was obtained from the Kabarak University Research Ethics Committee (KUREC), and a research permit was obtained from the National Commission for Science, Technology, and Innovation (NACOSTI). The results demonstrated significant anti-staphylococcal activity for both extracts, with Melia azedarach exhibiting superior efficacy compared to Solanum incanum at all concentrations tested. Moreover, the combined extracts displayed enhanced antimicrobial effects against Staphylococcus aureus compared to the individual extracts. Phytochemical analysis revealed the presence of tannins, coumarins, flavonoids, and anthraquinones in both extracts, with higher levels of steroidal glycosides in Solanum incanum. We recommend further phytochemical and pharmacological investigations to identify the active antimicrobial constituents in these plants. These findings hold promise in the development of novel therapeutic agents to combat infectious diseases, offering Melia azedarach and Solanum incanum as potential sources for drug development.

Multisystem recovery after sport-related concussion in adolescent rugby players: a prospective study protocol

IntroductionSport-related concussion is one of the most common injuries in adolescent rugby players with evidence of prolonged recovery in some concussed athletes. Concussion is a complex pathophysiological process that can...

Multicohort cross-sectional study of cognitive and behavioural digital biomarkers in neurodegeneration: the Living Lab Study protocol

Introduction and aimsDigital biomarkers can provide a cost-effective, objective and robust measure for neurological disease progression, changes in care needs and the effect of interventions. Motor function, physiology and behaviour...

Students' Perceptions on Online Clinical Learning amid the COVID-19 Pandemic in an Institution of Higher Learning: A Qualitative Inquiry.

Institutions of learning have been disrupted globally with serious implications for clinical teaching for students of health professions. The purpose of our study was to explore the perceptions of students towards online clinical teaching during the COVID-19 pandemic at Fatima College of Health Sciences. This was a descriptive qualitative study conducted on a purposive sample of 25 students from 24 June to 30 August 2020. The sample size was determined by data saturation. These were mainly nursing students in their 2nd to the 4th years of study. Students are required to have experiences, of stipulated nature and duration, in various specialty clinical settings throughout the clinical years of their programs. Approval for the study was granted by the Fatima College Research Ethics Committee (approval number: INTSTF010BSN20). The research was conducted according to the requirements of the Declaration of Helsinki. Data were collected through online semistructured questionnaires. Prospective participants were sent a soft copy of the informed consent document, and consent was indicated by clicking an "agree" link on the page that took them to the questionnaire. All participants were informed of their freedom to either participate in the study or not, without any penalty and were assured of their confidentiality. The questionnaires were kept in a password-protected file to which the researchers had sole access. Manual thematic analysis was done following the stages of organisation, familiarisation, transcription, coding, developing a thematic framework, indexing, displaying, and reporting. The major themes identified were the unfamiliar experience, challenges of online clinical learning, and possible solutions. Challenges of online clinical learning are multifaceted and require concerted multidisciplinary efforts to resolve. Nursing institutions, ours included, must develop flexible education systems that will be able to thrive in crisis and other unforeseeable circumstances.

The impact of fatigue on people with Fibromyalgia Syndrome: A survey.

Fibromyalgia syndrome (FMS) is a common pain syndrome associated with fatigue and anxiety. The aim of this survey was to determine the impact of fatigue on the quality of life (QoL) of people with FMS and to explore the relationships between fatigue, pain, and anxiety. A postal survey was conducted among support groups. Demographic data were collected and participants were asked to complete the Multi-dimensional Assessment of Fatigue Scale (MAF) and two visual analog scales (VAS) measuring pain and anxiety. Data were analysed using descriptive statistics, and relationships between variables were explored using Pearson's correlation coefficient and Fisher's Exact Probability Test. Ethical approval was granted from Ulster University's research ethics committee. A response rate of 52.5% was achieved (105/200). Fatigue was found to severely impact the QoL of those with FMS. From the MAF, a mean Global Fatigue Index score of 40.7 (range 1=no fatigue-50=severe fatigue) was calculated. Fatigue was significantly associated with both pain (r=0.674) and anxiety (r=0.546) (both p values<0.0001), and no significant relationship was found between the duration of FMS and fatigue (r=0.106; p=0.320). Fatigue has a major impact on the QoL of patients with FMS. There is a strong relationship between fatigue and other variables such as pain and anxiety. However, there is no relationship between the time since diagnosis and fatigue experienced. Fatigue management should feature highly in any treatment programme for those with FMS.

Family role in paediatric safety incidents: a retrospective study protocol

IntroductionHealthcare-associated harm is an international public health issue. Children are particularly vulnerable to this with 15%–35% of hospitalised children experiencing harm during medical care. While many factors increase the risk...

Follicular homocysteine as a marker of oocyte quality in PCOS and the role of micronutrients

PurposeDoes follicular homocysteine predict the reproductive potential of oocytes following FSH stimulation in PCOS women? Can it be modulated by dietary interventions?MethodsThis was a prospective, randomized, interventional clinical study. Forty-eight PCOS women undergoing in vitro fertilization at a private fertility clinic were randomized for a dietary supplementation providing micronutrients involved in homocysteine clearance or no treatment. The supplement was assumed 2 months before stimulation until pick-up day. Monofollicular fluids were collected and frozen. After embryo transfer, the fluids from the follicles generating the transferred embryos were thawed and analyzed.ResultsFollicular homocysteine showed a negative correlation with clinical pregnancy both in the whole population (r = − 0.298; p = 0.041) and in controls (r = − 0.447, p = 0.053). The support achieved a non-significantly lower concentration of follicular homocysteine (median [IQR]–7.6 [13.2] vs 24.3 [22.9]). Supplemented patients required far less FSH for stimulation (1650 [325] vs 2250 [337], p = 0.00002) with no differences in the number of oocytes collected, MII rate, and fertilization rate. Supplemented patients enjoyed higher blastocyst rate (55% [20.5] vs 32% [16.5]; p = 0.0009) and a trend for improved implantation rate (64% vs 32%; p = 0.0606). Clinical pregnancy rates were 58% vs 33% in controls (p = ns).ConclusionFollicular homocysteine is a suitable reporter that might be investigated as a tool for oocyte-embryo selection. A diet enriched with methyl donors may be useful in PCOS and supplements may also help. These findings may be also true for non-PCOS women, which warrants investigation.The study was approved by the Acibadem University Research Ethics Committee (2017–3-42). Clinical trial retrospective registration number ISRCTN55983518.