Medical Research Ethics Committee Research Articles

Cardiovascular calcification in hemodialysis patients: A Qatar-based prevalence and risk factors study.

Patients with end-stage kidney disease on hemodialysis (HD) have an increased risk of death due to the high prevalence of cardiovascular disease. Vascular calcification (VC) is predictive of cardiovascular disease and mortality. We conducted a study to evaluate the prevalence and risk factors for VC in dialysis patients in Qatar. This is a retrospective nationwide study including all chronic ambulatory dialysis patients in Qatar from 2020 to 2022. We used our national electronic medical record to track demographics, clinical characteristics, comorbidities, laboratory values, and diagnostic data for each patient. Calcifications were assessed by echocardiography (routinely done for all our dialysis population per national protocol), computed tomography, X-ray, and ultrasound. The study protocol was approved by the local medical research ethics committee (MRC-01-20-377). 842 HD patients were included in this study. Vascular calcifications (VC) were prevalent in 52.6% of patients. The main site of VC was Mitral valve calcifications in 55.5% of patients. Patients with VC were significantly older and had more prevalence of diabetes mellitus (p = 0.001 and p = 0.006, respectively). There was no statistically significant difference between patients with calcifications and patients without calcifications regarding serum calcium, phosphorus, and PTH level. In multivariate analysis, age and diabetes significantly increased the risk factor for calcification (95% CI 1.033-1.065, p < 0.0001, and 95% CI 1.128-2.272, p < 0001, respectively). Moreover, higher vitamin D levels and higher doses of IV Alfacalcidol were significant risk factors for calcifications (95% CI 1.005-1.030, p < 0.007, and 95% CI 1.092-1.270, p < 0.0001, respectively). Our study found that vascular calcification was widespread among our dialysis population in Qatar. Implementing the practice of echocardiography in dialysis patients was extremely helpful and the most productive in detecting vascular calcification. Diabetes mellitus almost doubles the risk for vascular calcifications in dialysis patients. These results are beneficial in identifying risk factors for vascular calcification, which can help stratify dialysis patients' risk of cardiovascular disease and optimize prevention efforts.

Peroperative administration of tranexamic acid in Roux-en-Y and one-anastomosis gastric bypass to reduce haemorrhage in patients with morbid obesity: protocol for randomised controlled trial (PATRY trial)

IntroductionBy implementation of Enhanced Recovery After Bariatric Surgery protocols and day-care surgery, early discharge poses a challenge if excessive bleeding occurs after bariatric surgery. Tranexamic acid (TXA) has demonstrated efficacy...

Efficacy of patient education and duloxetine, alone and in combination, for patients with multisystem functional somatic disorder: Study protocol for the EDULOX trial

BackgroundMultisystem functional somatic disorder is characterized by specific patterns of persistent physical symptoms with a complex biopsychosocial etiology. The disorder can lead to disability and personal suffering. Current treatment options require specialized settings, therefore patients often wait a long time to receive specific treatment.Patient education is considered important in most treatment programs, but has only been investigated sparsely as a stand-alone treatment. Pharmacological treatment is limited to tricyclic antidepressants in low doses with no antidepressant properties. Duloxetine has been found effective in single organ functional disorders. As a treatment for multisystem functional somatic disorder, duloxetine could reduce symptoms and treat comorbid anxiety and depression. It may furthermore enhance the effect of patient education through a hypothesized effect on cognitive functioning. The purpose of the EDULOX trial is to study psycho-EDUcation and duLOXetine alone and in combination. MethodsThis is a nested study design. The parent trial “EDULOX1” (n = 424) will compare a patient education program with enhanced usual care in an open-labelled, randomized controlled trial. In addition to this, eligible participants will furthermore receive either duloxetine or active placebo in the nested, double-blinded, randomized controlled trial, “EDULOX2” (n = 212). Patient and clinician reported outcomes will be collected through questionnaires. ConclusionThe EDULOX trial may establish evidence for treatments applicable for the majority of patients with multisystem functional somatic disorder. If effective, duloxetine would be a more tolerable pharmacological treatment option that can target comorbid depression and anxiety, and potentially boost the effect of patient education.Trial registration numberThe study is registered at www.clinicaltrials.gov (NCT06232473) and the internal list of research projects at the Region of Central Denmark (Case number 1-16-02-305-23). Approval from the Danish Medical Research Ethics Committees (Case number: 2212291) and the Danish Medicines Agency was obtained under EudraCT Number: 2022-002780-30 and Sponsor's Protocol Code Number: 9515.

Shared decision-making for non-operative management versus operative management of hip fractures in selected frail older adults with a limited life expectancy: a protocol for a nationwide implementation study

Background and purposeRecent research has highlighted non-operative management (NOM) as a viable alternative for frail older adults with hip fractures in the final phase of life. This study aims to...

Frequency of self-directed dying in the Netherlands: research protocol of a cross-sectional mixed-methods study

IntroductionIn the Netherlands, assisting in suicide is allowed for physicians and regulated by the Termination of Life on Request and Assisted Suicide (review procedures) Act. However, some people decide to...

Evaluation of heroin-assisted treatment in Norway: protocol for a mixed methods study

BackgroundOpioid agonist treatment (OAT) for patients with opioid use disorder (OUD) has a convincing evidence base, although variable retention rates suggest that it may not be beneficial for all. One of the options to include more patients is the introduction of heroin-assisted treatment (HAT), which involves the prescribing of pharmaceutical heroin in a clinical supervised setting. Clinical trials suggest that HAT positively affects illicit drug use, criminal behavior, quality of life, and health. The results are less clear for longer-term outcomes such as mortality, level of function and social integration. This protocol describes a longitudinal evaluation of the introduction of HAT into the OAT services in Norway over a 5-year period. The main aim of the project is to study the individual, organizational and societal effects of implementing HAT in the specialized healthcare services for OUD.MethodsThe project adopts a multidisciplinary approach, where the primary cohort for analysis will consist of approximately 250 patients in Norway, observed during the period of 2022–2026. Cohorts for comparative analysis will include all HAT-patients in Denmark from 2010 to 2022 (N = 500) and all Norwegian patients in conventional OAT (N = 8300). Data comes from individual in-depth and semi-structured interviews, self-report questionnaires, clinical records, and national registries, collected at several time points throughout patients’ courses of treatment. Qualitative analyses will use a flexible inductive thematic approach. Quantitative analyses will employ a wide array of methods including bi-variate parametric and non-parametric tests, and various forms of multivariate modeling.DiscussionThe project’s primary strength lies in its comprehensive and longitudinal approach. It has the potential to reveal new insights on whether pharmaceutical heroin should be an integral part of integrated conventional OAT services to individually tailor treatments for patients with OUD. This could affect considerations about drug treatment even beyond HAT-specific topics, where an expanded understanding of why some do not succeed with conventional OAT will strengthen the knowledge base for drug treatment in general. Results will be disseminated to the scientific community, clinicians, and policy makers.Trial registrationThe study was approved by the Norwegian Regional Committee for Medical and Health Research Ethics (REK), ref.nr.:195733.

Issues in Clinical Studies Leading to Medical Research Ethics Committee (MREC) Negative Decisions

The rationale behind a Medical Research Ethics Committee (MREC) negative decision is always shared directly with the applicants. However, insight into the review process and common reasons for a negative decision may also be valuable for other researchers, clinical research organizations and people with an interest in MREC processes. To our knowledge Medical Research Ethics Committees (MRECs) do generally not report on the negative decisions they issue and on the underlying rationale for such decisions. Here we give insight into the MREC review process by briefly describing procedures and discussing the negative decisions issued by MREC NedMec in the past five years.

Tailored anticoagulant treatment after a first venous thromboembolism: protocol of the Leiden Thrombosis Recurrence Risk Prevention (L-TRRiP) study - cohort-based randomised controlled trial

IntroductionPatients with a first venous thromboembolism (VTE) are at risk of recurrence. Recurrent VTE (rVTE) can be prevented by extended anticoagulant therapy, but this comes at the cost of an...

A new minimally invasive, nonexcisional, surgical browlift technique with minimal scarring: a protocol for a prospective observational study.

The aim of this study is to prospectively evaluate the new minimal invasive (MINE) browlift technique with possibly superior results and minimal visible scarring. A prospective observational study will be performed on all available data from patients who will undergo a browlift procedure in the HMC from 1 June 2021 till 31 May 2024. Our goal is to include at least 50 patients. Inclusion criteria are: patients with medical (i.e. brow ptosis and facial paralysis) or cosmetic indication, patients with sufficient understanding of the Dutch or English language and willingness to participate in extra study specific follow-up moments and filling in of questionnaires. Exclusion criteria are: less than 18 years of age and patients with previous brow or eyelid surgery. Patients will be photographed preoperatively and postoperatively using the VECTRA camera. Scarring after procedure; functionality of eyebrow movement; amount of correction in brow ptosis, measured in VECTRA; longevity of procedure in months; aesthetic result as assessed by questionnaires and adverse effects of procedure will be measured. The database management software 'Castor' will be used to store and collect the data from the questionnaire. The Medical Research Ethics Committee found this study not eligible to be submitted to the Dutch Medical Research Involving Human Subjects Acts (WMO). Written consent will be obtained from all patients.

Web-based guided self-help cognitive behavioral therapy-enhanced versus treatment as usual for binge-eating disorder: a randomized controlled trial protocol.

Binge-eating disorder (BED) is a psychiatric disorder characterized by recurrent episodes of eating a large amount of food in a discrete period of time while experiencing a loss of control. Cognitive behavioral therapy-enhanced (CBT-E) is a recommended treatment for binge-eating disorder and is typically offered through 20 sessions. Although binge-eating disorder is highly responsive to CBT-E, the cost of treating these patients is high. Therefore, it is crucial to evaluate the efficacy of low-intensity and low-cost treatments for binge-eating disorder that can be offered as a first line of treatment and be widely disseminated. The proposed noninferiority randomized controlled trial aims to determine the efficacy of web-based guided self-help CBT-E compared to treatment-as-usual CBT-E. Guided self-help will be based on a self-help program to stop binge eating, will be shorter in duration and lower intensity, and will require fewer therapist hours. Patients with binge-eating disorder (N = 180) will be randomly assigned to receive guided self-help or treatment-as-usual. Assessments will take place at baseline, mid-treatment, at the end of treatment, and at 20- and 40-weeks post-treatment. Treatment efficacy will be measured by examining the reduction in binge-eating days in the previous 28 days between baseline and the end of treatment between groups, with a noninferiority margin (Δ) of 1 binge-eating day. Secondary outcomes will include full remission, body shape dissatisfaction, therapeutic alliance, clinical impairment, health-related quality of life, attrition, and an economic evaluation to assess cost-effectiveness and cost-utility. The moderators examined will be baseline scores, demographic variables, and body mass index. It is expected that guided self-help is noninferior in efficacy compared to treatment-as-usual. The proposed study will be the first to directly compare the efficacy and economically evaluate a low-intensity and low-cost binge-eating disorder treatment compared to treatment-as-usual. If guided self-help is noninferior to treatment-as-usual in efficacy, it can be widely disseminated and used as a first line of treatment for patients with binge-eating disorder. The Dutch trial register number is R21.016. The study has been approved by the Medical Research Ethics Committees United on May 25th, 2021, case number NL76368.100.21.

Immune regulation and blood–brain barrier permeability in cerebral small vessel disease: study protocol of the INflammation and Small Vessel Disease (INSVD) study – a multicentre prospective cohort study

IntroductionThe INflammation and Small Vessel Disease (INSVD) study aims to investigate whether peripheral inflammation, immune (dys)regulation and blood–brain barrier (BBB) permeability relate to disease progression in cerebral small vessel disease...

Association between perioperative glucose profiles assessed by the continuous glucose monitoring (CGM) system and prognosis in patients with ST-segment elevation myocardial infarction (STEMI): protocol for a cohort study

IntroductionST-segment elevation myocardial infarction (STEMI) presents a serious cardiovascular condition requiring prompt intervention. Dysglycaemia has been identified as a significant risk factor impacting STEMI prognosis. However, limited research has focused...

Awareness and level of digital literacy among students receiving health-based education

BackgroundBeing digitally literate allows health-based science students to access reliable, up-to-date information efficiently and expands the capacity for continuous learning. Digital literacy facilitates effective communication and collaboration among other healthcare providers. It helps to navigate the ethical implications of using digital technologies and aids the use of digital tools in managing healthcare processes. Our aim in this study is to determine the digital literacy level and awareness of our students receiving health-based education in our university and to pave the way for supporting the current curriculum with courses on digital literacy when necessary.MethodStudents from Acibadem University who were registered undergraduate education for at least four years of health-based education, School of Medicine, Nutrition and Dietetics, Nursing, Physiotherapy and Rehabilitation, Psychology, Biomedical Engineering, Molecular Biology, and Genetics were included. The questionnaire consisted of 24 queries evaluating digital literacy in 7 fields: software and multimedia, hardware and technical problem solving, network and communication/collaboration, ethics, security, artificial intelligence (A.I.), and interest/knowledge. Two student groups representing all departments were invited for interviews according to the Delphi method.ResultsThe survey was completed by 476 students. Female students had less computer knowledge and previous coding education. Spearman correlation test showed that there were weak positive correlations between the years and the “software and multimedia,” “ethics,” “interest and knowledge” domains, and the average score. The students from Nursing scored lowest in the query after those from the Nutrition and Dietetics department. The highest scores were obtained by Biomedical Engineering students, followed by the School of Medicine. Participants scored the highest in “network” and “A.I.” and lowest in “interest-knowledge” domains.ConclusionIt is necessary to define the level of computer skills who start health-based education and shape the curriculum by determining which domains are weak. Creating an educational environment that fosters females’ digital knowledge is recommended. Elective courses across faculties may be offered to enable students to progress and discuss various digital literacy topics. The extent to which students benefit from the digital literacy-supported curriculum may be evaluated. Thus, health-based university students are encouraged to acquire the computer skills required by today’s clinical settings.RegistrationThis study was approved by Acıbadem University and Acıbadem Healthcare Institutions Medical Research Ethics Committee (ATADEK) (11 November 2022, ATADEK registration: 2022-17-138) All methods were carried out in accordance with relevant guidelines and regulations. Informed consent was obtained from the participants.

Blunt Cerebrovascular Injury: Our Experience and Review of Current Practice

Abstract Background: Blunt cerebrovascular injury (BCVI) is an injury to the carotid or vertebral artery that is nonpenetrating and results from stretching or impingement of the vessel walls due to sudden head movement. Recent studies showed that the incidence of BCVI is around 1%–9%, with stroke being the most dreaded complication. Methodology: This retrospective study was conducted after approval by the medical research ethics committee at our tertiary care center, including all consecutive neck computed tomography angiography scans for blunt trauma patients from January 2017 to December 2020. The patient demographics, symptoms, and signs at presentation and imaging were reviewed through the electronic patient records for the presence of BCVI using the modified Denver scoring and Biffl criteria. Patients younger than 18 years, those with penetrating trauma, and patients with no head-and-neck scans were excluded from the study. The treatment and outcome of the positive cases were studied. Results: There were 871 patients with blunt trauma during the study. Of this number, 16 patients were identified with BCVI (1.83%). Most of the patients were male (75%), and the mean age of the cohort was 31 years (18–45 years). Among those with BCVI, five had carotid artery injuries (31%), and 11 had vertebral artery injuries (68.8%). BCVI Grades 2 and 4 were the most prevalent injuries. Ischemic infarction was seen in three patients (18%). Five patients (31.3%) with BCVI received antiplatelet therapy. None of the patients underwent endovascular or surgical treatment. Moreover, there was no BCVI-related mortality. There was a statistically significant between the Biffl grading, type of artery injury, and the presence of neurological deficit at the time of initial presentation, which both turned to be significant with a P = 0.017 and P = 0.049, respectively. Conclusion: BCVI is a serious injury with the potential for neurological complications. The artery involved and Biffl grading influence the presentation. Initiation of therapy with antithrombotic medications for stroke prevention is essential in all patients. The patients with positive findings need follow-up imaging, and an internationally recognized guideline is essential to manage this cohort.

Dietary intervention with edible film-coated multistrain probiotic Lacticaseibacilli in nondairy food matrices significantly increased the recovery of fecal viable Lacticaseibacilli and improved the performance of several colonic biomarkers among slightly malnourished preschool children.

Probiotic enriched dairy products are widely consumed in Western countries for their beneficial effects on the gastrointestinal tract and overall health. The present study aims to investigate the beneficial effects of probiotic Lacticaseibacilli (LAB) strains in non-dairy food matrices. A blend of edible film-coated probiotic LAB, L. plantarum, L. paracasei, and L. rhamnosus, were incorporated into plain biscuits and dry dates. Design of the randomized controlled study: Children of both sexes (mean age 55.7 ± 14.5 months) attending kindergarten in Tersa, a poor urban Giza district, were recruited and randomized into 5 groups of equal numbers. Treatment groups: (1) placebo biscuits, (2) functional probiotic biscuits (0.18 billion colony forming units (cfu) of LAB) (3) functional probiotic + inulin biscuits (0.2 billion cfu of LAB + 2 g of chicory inulin); (4) placebo dates and (5) functional probiotic dates (0.3 billion cfu of viable multistrain LAB). The supplements were served 5 days a week and each child had to consume 21 servings of the supplement. The primary outcome was an increase in the fecal recovery of viable LAB after the intake of 21 servings (T1) compared to the respective baseline counts (T0). The secondary outcomes include the determination of fecal short-chain fatty acids (SCFA) and secretory immunoglobulin A (s-Ig A) using ELISA and fecal ammonia excretion. Results: Statistically significant % increases in the recoveries of fecal viable LAB were found among the children consuming 21 servings of supplements 2, 3, and 5 compared to the respective count at T0. Similar significant increases were found in the fecal concentrations of SCFA and s-Ig A among the children consuming 21 servings of supplements 2, 3 and 5 compared to the respective counts at T0. On the other hand, the concentration of toxic ammonia excretion decreased significantly in the feces of all children consuming probiotic-containing supplements (groups 2, 3, and 5) at T1 compared to the respective concentrations obtained at T0. Conclusion: Multistrain microencapsulated probiotic Lacticaseibacilli in functional biscuits and dry dates successfully tolerated the acidic gastric transit and exerted their bioactive action on the colonic microbiome. The synbiotic supplement exhibited a higher production rate of colonic SCFA. Probiotic-enriched products that confer definitive health benefits are convenient and do not need to be kept under refrigeration. Manipulating the composition and function of the microbiome in childhood through probiotic/+ prebiotic interventions is cost-effective with long-term beneficial health outcomes. This study was approved by the Medical Research Ethics Committee, National Research Center and registered as Clinical Trial 16/422. Written informed consent was obtained from the mothers of all participating children.

‘Effects of a home-based bimodal lifestyle intervention in frail patients with end-stage liver disease awaiting orthotopic liver transplantation’: study protocol of a non-randomised clinical trial

IntroductionPatients with end-stage liver disease awaiting orthotopic liver transplantation (OLT) are generally classified as frail due to disease-related malnutrition and a progressive decline in musculoskeletal and aerobic fitness, which is...

Artificial intelligence-supported diabetic retinopathy screening in Tanzania: rationale and design of a randomised controlled trial

IntroductionGlobally, diabetic retinopathy (DR) is a major cause of blindness. Sub-Saharan Africa is projected to see the largest proportionate increase in the number of people living with diabetes over the...

Hubungan Antara Tingkat Pengetahuan dan Ketepatan Apoteker Dalam Mengelola Obat Sisa, Obat Rusak, dan Obat Kedaluwarsa di Apotek Malang Raya

Medicine is an important pharmaceutical component in health care field, the quality of medicine must be kept in a good condition until it used by patients. In this case the pharmacist has a stake in maintaining medicine’s quality through a proper drugs management. Pharmacists should have the knowledge and the appropriateness in the management of leftover, damaged and expired medicines to prevent the cumulation of medicine waste in the pharmacies and the community environment. Therefore, this research was conducted with the aim to find out the Correlation Between Pharmacists’ Level of Knowledge and Management of Unused, Damaged or Expired Medicines at Malang Raya Pharmacies. Analytical observational research method with cross sectional approach was carried out to 106 pharmacists who worked in the pharmacy of Malang Raya region. Sampling was carried out using clustered random sampling technique. Questionnaires that have passed the validity and reliability test were used as a measurement of the level of knowledge and the drugs management of the pharmacist. This study was approved by the Medical Research Ethics Committee of the Medical Faculty of Brawijaya University. Result of the average level of pharmacists’ knowledge was in the category of "good" with a value of 81.6%, but result of the appropriateness questionnaire with “how to store medicines properly” and “how to eliminate drugs properly” indicators, showed that there 100% of respondent were not appropriate. Correlation analysis between the level of knowledge and drugs management of the pharmacist, showed a significance value of 0.425. It was concluded from this study, that there was no correlation between the level of pharmacist knowledge with the management of unused drugs, damaged drugs and expired drugs in the Pharmacy area of Malang Raya Keywords: pharmacist, knowledge, leftover medicine, damage medicine, expired medicine

Effect of transvaginal Lactobacillus supplementation on reversing lower genital tract dysbiosis and improving perinatal outcomes in PCOS patients after IVF-FET: a study protocol for a multicenter randomized controlled trial

BackgroundSignificant lower genital tract (LGT) dysbiosis and an associated lower rate of clinical pregnancy after in vitro fertilization–frozen embryo transfer (IVF-FET) among polycystic ovary syndrome (PCOS) patients have been previously reported by our group. We aimed to assess whether transvaginal Lactobacillus supplementation can reverse LGT dysbiosis and further improve perinatal outcomes in PCOS patients after IVF-FET.Methods/designThis is a protocol for a multicenter, open-label, randomized controlled trial in China. Women diagnosed with PCOS who are undergoing IVF-FET treatment will be recruited. Allocation to the intervention/control arms at a ratio of 1:1 will be executed by an electronic randomization system. Participants in the intervention arm will receive the live Lactobacillus capsule vaginally for 10 consecutive days before embryo transfer, while those in the control arm will receive standard individualized care. The primary outcomes will be the clinical pregnancy rate, implantation rate, and live birth rate. 16S rRNA sequencing and liquid chromatography–mass spectrometry will be conducted to evaluate the LGT microbiome and systemic metabonomics before and after the intervention. A sample of 260 participants will provide 95% power to detect a 20% increase in the rate of clinical pregnancy (α = 0.025, one-tailed test, 15% dropout rate). A total of 300 participants will be recruited.DiscussionThis is the first large and multicenter randomized controlled trial aimed at assessing the efficacy of transvaginal Lactobacillus supplementation on restoring the LGT microbiome and improving perinatal outcomes in PCOS patients after IVF-FET. This pragmatic trial is promising for increasing the rates of clinical pregnancy and live birth in PCOS patients after IVF-FET.Ethics and disseminationEthical review approval was obtained from the Medical Research Ethics Committees of the International Peace Maternity and Child Health Hospital of Shanghai Jiao Tong University (15 October 2020, GKLW 2020-29). To maximize dissemination, these findings will be reported in open access publications in journals with high impact, and oral and poster conference presentations will be performed.Trial registrationChiCTR ChiCTR2000036460. Registered on 13 September 2020, https://www.chictr.org.cn/showproj.html?proj=59549.

Development of an international core outcome set for treatment trials in paediatric inguinal hernia: protocol for a three-phase study including a systematic review and Delphi survey

IntroductionIn children, open inguinal hernia repair has been the gold standard for treatment, but with recent technical advancements in laparoscopy, laparoscopic hernia repair is gaining popularity. Despite available results from...