Institutional Review Board Research Articles

Stressbusters: a plot study investigating the effects of OMT on stress management in medical students.

Medical students report high levels of perceived stress and burnout, especially during the preclinical years. The combination of physical stressors from poor posture, poor sleep quality, and mental stressors from the rigorous curriculum stimulates the sympathetic nervous system (SNS) to secrete cortisol. Previous studies have shown that persistent elevated cortisol levels are associated with negative health outcomes. We conducted an Institutional Review Board (IRB)-approved study to determine if regular osteopathic manipulative treatments (OMTs) could impact the stress levels of first-year osteopathic medical students (OMSs) at Touro College of Osteopathic Medicine (TouroCOM) Harlem campus by measuring physiologic stress through changes in weekly salivary cortisol levels, perceived emotional and psychological stress levels, and cognitive function. We recruited 10 first-year OMSs who were not currently receiving external OMT outside of weekly coursework; other forms of external stress management, such as yoga or meditation, were not controlled for in this study. Utilizing a random number generator, the 10 student respondents were split into a control group that received no treatment and a treatment group that received 15 min of weekly OMT for 6weeks. The treatment consisted of condylar decompression, paraspinal inhibition, and supine rib raising, which are techniques that are known to balance the SNS and parasympathetic nervous system (PNS). Cortisol levels were quantified by enzyme-linked immunosorbent assay (ELISA) cortisol immunoassay via salivary samples collected at the beginning of each weekly session, prior to treatment for the treatment group, at the same time of day each week. We also measured participants' weekly subjective perception of stress utilizing the College Student Stress Scale (CSSS) and cognitive function utilizing the Lumosity Performance Index (LPI). We conducted a two-tailed, unpaired t-test as well as a U test for the cortisol levels, given the smaller sample size and potential for a nonnormal distribution. A lower cortisol level was correlated to a higher optical density (OD), the logarithmic measure of percent transmission of light through a sample; analysis of our data from the ELISA cortisol immunoassay showed an average weekly change in OD (∆OD) for the treatment group of 0.0215 and an average weekly ∆OD of-0.0044 in the control group. The t-test showed p=0.0497, and our U test showed a p=0.0317. Both tests indicated a statistically significant decrease across the weekly salivary cortisol levels in the treatment group utilizing a p<0.05. An additional effect-size analysis supported our finding of a significant decrease in weekly cortisol levels in the treatment group, Cohen's d=1.460. Based on the CSSS responses, there was no significant difference in perceived stress between the control and treatment groups (p=0.8655, two-tailed). Analysis of the LPI revealed no statistically significant difference in cognitive performance (p=0.9265, two-tailed). Our study supports the claim that OMT that targets the SNS and PNS has a significant impact on cortisol levels. While the reduction in cortisol levels was statistically significant, the broader physiological impact remains unclear. Further research is necessary to determine whether this reduction translates to meaningful clinical benefits.

Transophthalmic Artery Embolization of Anterior Skull Base Meningiomas: Technical Case Series.

Preoperative embolization of anterior skull base meningiomas can facilitate surgical resection by reducing tumor vascularity. However, transophthalmic artery embolization carries risks of visual complications. This study aimed to evaluate the safety and efficacy of this technique using modern endovascular tools. This retrospective study included patients with anterior skull base meningiomas who underwent preoperative transophthalmic artery embolization followed by surgical resection between January 2022 and April 2024. Patient demographics, tumor characteristics, embolization details, surgical outcomes, and complications were analyzed. Seven patients (median age 57 years; 6 male) underwent embolization for tumors located primarily at the planum sphenoidale (58%). Unilateral embolization was performed in most cases, with one bilateral transophthalmic approach. Commonly embolized branches included the anterior and posterior ethmoidal arteries. Polyvinyl alcohol particles were the primary embolic agent (71%). Angiographic devascularization was achieved in all cases without complications. Gross total resection was achieved in 71%, with a median blood loss of 427 cc. At a 9-month follow-up, the median modified Rankin Scale score was 1. With careful patient selection, advanced microcatheter technology, and meticulous technique, preoperative transophthalmic artery embolization can be safely performed to facilitate resection of anterior skull base meningiomas. These results suggest it is a viable option for well-selected patients at experienced centers, though larger prospective studies are needed. Fr = French (unit of measurement for catheter diameter); IQR = Interquartile range; IRB = Institutional Review Board; PVA = Polyvinyl alcohol; TOAE = Transophthalmic artery embolization; WHO = World Health Organization.

Patient Centered, Clinical, Radiographic, and Biochemical comparative evaluation of Transgingival and Conventional Flapped Implant surgical technique: A randomized controlled trial.

A multifaceted study compared transgingival (flapless) implant placement with conventional flapped placement, which employed clinical, radiographic, biochemical, and patient-centered parameters. The study was approved by the institutional ethics committee and was conducted according to the ethical standards in the 1964 Declaration of Helsinki and its amendments. Seventy-five implants were placed, 37 by flapless method (group 1) and 38 by flapped method (group 2). The Group 1 subjects underwent flapless implant placement, while Group 2 underwent flapped implant placement. The modified plaque index was significantly higher in group 2 at 6 weeks (Mann Whitney test, z = -3.08, p = .002). Modified sulcus bleeding index was also significantly higher in group 2, up to the 12-week follow-up (Mann Whitney test, z = -4.63, p < .001). Crestal bone loss revealed no significant intergroup difference. Under biochemical evaluation, matrix metalloproteinase-8 (MMP-8) was significantly higher in flapped implants up to the 6-week follow-up. The patient-reported questionnaire-based acceptability assessment showed that the flapless technique is better regarding the perceived duration of the surgery and post-operative comfort.

Local Context Review by Single Institutional Review Boards: Results from a Modified Delphi Process

Local Context Review by Single Institutional Review Boards: Results from a Modified Delphi Process

Accuracy of Contrast-Enhanced Ultrasound for Hepatocellular Carcinoma Post-Transcatheter Arterial Embolization

Background/Objectives: Contrast-enhanced ultrasound (CEUS) is a non-invasive imaging technique with similar accuracy to CT and MRI for the diagnosis of hepatocellular carcinoma (HCC). CEUS offers several advantages in patient populations who have contraindications for CT or MRI. There are limited prospective studies in the United States evaluating the diagnostic equivalence of CEUS following transcatheter arterial chemoembolization (TACE) with same-day CT/MRI. This prospective pilot study compared CEUS and CT/MRI in patients with HCC following TACE in a United States population using Lumason® contrast agent and the Liver Reporting and Data System (LI-RADS). Methods: Following institutional review board protocols, adult patients with a diagnosis of HCC were included. Follow-up CT/MRI was directed by referring clinicians, and CEUS was performed on the same day. CEUS was used to evaluate for treated lesion(s), new lesion(s), and portal vein thrombus before and after Lumason®. Any subsequent follow-up imaging was reviewed. Results: In 26 enrolled patients, 33 target lesions were identified (size range 0.9–16.8 cm), and 26 were LI-RADS-5 or -M. CEUS identified 19 cases of residual tumor, 12 with no viable disease; CT/MRI identified 17 cases of residual tumor, 16 with no viable disease (p = 0.617). Both CEUS and CT/MRI identified five portal vein thrombi. Two lesions were missed or miscategorized on CEUS, while six were missed or miscategorized on CT/MRI (p = 0.289). Six new lesions were identified on both CEUS and CT/MRI. Of these new lesions, four were identified only by CT/MRI and three only by CEUS. Conclusions: CEUS is comparable to CT/MRI performed at identical follow-up intervals in evaluating for residual versus treated HCC following first-time TACE.

Is medical school culture conducive to women’s academic success? a survey on faculty perceptions and experiences of gender equity

BackgroundIn academic medicine, the lack of gender equity hinders the career progression of women academics. This can often affect scientific productivity and widen the gender gap that exists in this field. As such, this study aimed to understand how full-time faculty members in academic medicine perceive the climate for women academics and identify target areas for interventions supporting gender equity.MethodsThis study adopted an embedded mixed-methods design. Data collection was done from November 2022 to January 2023, at the National University of Singapore (NUS) School of Medicine. The participants comprised academic clinicians and non-clinician faculty members who were either currently employed full-time at the NUS School of Medicine or had recently resigned. They completed an adapted version of the Culture Conducive to Women’s Academic Success (CCWAS) questionnaire, which assessed their perceptions of the faculty climate across four domains: equal access, work-life balance, freedom from gender bias, and supportive leadership. Quantitative findings were complemented by qualitative data gathered through open-ended survey questions. ANOVA and t-test were used to analyse the quantitative data, and content analysis was used to analyse the qualitative data.ResultsCompared to female participants (M = 140.0, SD = 57.9), male participants perceived greater gender equity (M = 158.7, SD = 62.9). Personal experiences of gender inequity were described by some female participants. Participants also raised various suggestions to improve work-life balance for both male and female faculty members, mitigate structural gender bias and increasing support for women faculty.ConclusionsFemale faculty members tend to have a less favourable view of the working climate for women in academic medicine, compared to their male counterparts. This might be attributed to differences in awareness of gender inequity and understanding of gender bias. Findings of this study provided further insight into the perceptions of faculty members regarding workplace gender equity and interventions that can be implemented to support them in their career.Trial registrationEthical approval was obtained from the National University of Singapore Institutional Review Board (NUS-IRB-2022-325).

Sub-Tenon’s Block in Patients with Previous Encircling Band Surgery—A Feasibility Study

Introduction: During the COVID-19 pandemic, reducing aerosol-generating procedures became fundamental, particularly in ophthalmic surgeries traditionally performed under general anesthesia (GA). Regional anesthesia, such as sub-Tenon’s block (STB), is widely used in vitreoretinal surgeries, offering a safer alternative by avoiding airway manipulation. However, the altered orbital anatomy in patients with previous scleral explant surgery creates unique challenges to STB application. This study aims to evaluate the effectiveness, safety, and feasibility of STB in patients after encircling band surgery. Methods: This retrospective analysis included 46 patients with a history of scleral explant surgery, undergoing vitreoretinal procedures at the Bern University Hospital. All procedures were conducted under STB with either analgosedation or GA for additional support when required. An ophthalmic surgeon or an experienced anesthesiologist performed the STBs. Data collected included block success rate, procedural difficulty, incidence of chemosis, and patient satisfaction. The Institutional Ethics Committee approved this study, and all participants provided informed consent. Results: STB was successfully administered in 93.5% of cases, with only three unsuccessful blocks. Block placement was rated as easy in 55% of cases, moderately difficult in 28%, and difficult in 17%. Chemosis was observed in 24% of patients, with severe cases in only 4%. Patient satisfaction scores were high, with most patients expressing satisfaction with the STB procedure. Conversion to GA was required in only one case due to alcohol withdrawal-related agitation. Discussion: The high success rate and minimal complications suggest that STB is a feasible and safe alternative to GA in patients with prior scleral buckling surgery. The altered orbital anatomy presents potential challenges, including scar tissue and compartmentalization, which may lead to patchy anesthesia. However, the use of STB avoids the risks associated with GA and may be especially beneficial for elderly or frail patients. Future studies should further investigate the hemodynamic implications of STB in these cases and the potential for ultrasound-guided techniques to improve accuracy and safety.

A novel model of age estimation in mixed dentition population in Western India – A retrospective study

Objectives: Age estimation is an integral part of legal investigations for forensic purposes. When the chronological age of the individual is not documented or he/she is under the conflict of the law, age estimation comes into play. The need for age estimation may arise in various legal incidences involving children, and juveniles, for civil aspects such as adoption, child labor, or other criminal proceedings such as rape, kidnapping, and illegal immigration. An accurate and dependable method, that can estimate age with high probability, can aid in narrowing down the list of possible victims or even play a decisive role in such cases. The reliability of the method and the probability of correct age estimation play a decisive role in the court of law. Bedek et al’s model (2019) was recently developed and tested in Croatian and South Indian populations with satisfactory results. As there is no evidence of study in the Western Indian population, looking into the accessibility of the population group, the present study aims to evaluate the validity and reliability of the Bedek method in the Western Indian population. Materials and Methods: Approval was sought from the Institutional Ethical Committee. Five hundred and twenty-five orthopantomographs (OPG) of patients aged 5–15 were obtained. A double-blinded study was done, where the radiographs were analyzed using ImageJ software, independently by two investigators. The data were tabulated and subjected to statistical analysis for accuracy of age estimation and intra- as well as inter-observer reliability. Results: There was an underestimation by a range of −1.3038 to −0.74536. There was underestimation in all the models of Bedek with P &lt; 0.005, for all the teeth models except, the three- and two-teeth model (P &gt; 0.005). Conclusion: In our study, we found that the accuracy of age estimation increases significantly with the number of teeth used. Seven four-teeth models were the most suitable for age estimation on OPG. All models except the three-teeth model and two-teeth model were found to be more accurate.

Analysis of the epidemiological profile of men who have sex with men as blood donors

Introduction: In May 2020, the Brazilian Supreme Court ruled that men who have sex with men (MSM) should be eligible to donate blood. Objectives: This study aims to describe the epidemiological, sociodemographic, and serological profile of MSM donors in the haemotherapy centre of a university hospital. Methodology and Resources: A cross-sectional study was conducted between June 2020 and June 2023. The study was approved by the Ethics Review Board of the Pedro Ernesto University Hospital. Results: There was a predominance of young people, single, and with higher education (complete or incomplete). Regarding gender specification, 46 (92%) identified as cis. In the sample, 64% (32) of candidates had taken at least one rapid test in the 12-month period. Most of the individuals analysed were donor eligible (90%), non-reactive for the serology of interest in the research (91.3%). Discussion: Among MSM donors, the prevalence of homosexual orientation and the regular use of condoms were observed. Even with the prior restriction of Resolution No. 399/2020, a proportion of these candidates donated blood. The reactivity for syphilis (6%) among the volunteers is below expectations, while for hepatitis B (2%) it is above the target, considering that the indicator presented by the state blood bank network, and there was no HIV reactivity. Conclusions: The importance of using risky sexual behaviour, rather than sexual orientation, as a criterion for donor eligibility was observed. This change allowed for the possibility of including minorities in the blood donation process.

Fearsome four- Fungal infections in renal transplant recipients

To study the clinical presentation, diagnostic methods, treatment and outcomes of Invasive Aspergillosis Cryptococcal infection, Mucormycosis and Histoplasmosis in renal transplant recipients. : We performed a retrospective analysis of renal transplant recipients with four major fungal infections from January 2000 until December 2022 at a tertiary care centre in Southern India. This study was approved by the institutional ethical committee. We have identified these cases from the electronic records of the microbiology department and renal transplant outpatient clinic. A total of 1970 patients underwent renal transplantation at this institute during study period. A total of 25 patients were diagnosed as having invasive Aspergillosis - 20 patients had pneumonia, three had right maxillary sinusitis, one each had left chronic suppurative otitis media, and skull base osteomyelitis). There were 20 patients with cryptococcal infection of which eight had disseminated infection, seven had meningitis, four had cutaneous cryptococcosis and one had pulmonary cryptococcosis. Mucormycosis was diagnosed in 14 patients, twelve of which had pulmonary mucormycosis, one had oculo-cerebral mucormycosis and one patient had acute invasive fungal maxillarysinusitis. Histoplasmosis was diagnosed in four patients, two of whom had disseminated histoplasmosis and two had cutaneous histoplasmosis. In this study, mortality was highest with mucormycosis (57%) followed by 33.3% with invasive Aspergillosis and 20% with Cryptococci infection. Currently, there is no standard serological test available for the routine identification of invasive fungal infections in patients. Initial cultures may yield negative results due to slow fungal growth and variations in colony appearance. Therefore, it is essential to pursue aggressive sampling methods when fungal infection is suspected. Invasive procedures such as bronchoscopic lavage and abscess aspiration play a crucial role in reaching a diagnosis. In summary, maintaining a high level of suspicion and employing thorough investigations in post-renal transplant recipients are vital for early diagnosis, prompt treatment initiation, prevention of disease spread, and reduction of mortality risk.

Fructosamine as an Indicator forGlycemic Control inthe Veteran Community.

Glycemic monitoring via Hemoglobin A1(HbA1c) proves to be inaccurate when a patient is diagnosed with a hemoglobinopathy/erythrocyte disorder. Moreover, any acute changes of glycemic intake within 6 weeks of blood sampling have been noted to impart a greater effect on HbA1c than the remaining days of the supposed overall 3-to-4-month average of glycemic control. Fructosamine, an alternative to HbA1c, allows physicians to analyze glycemic control in the presence of an underlying hemoglobinopathy/erythrocyte disorder. Fructosamine analyzes glycemic control over a two-to-three week period, compared to a 3-to-4-month period with HbA1c. Studies indicate that fructosamine is significantly correlated with HbA1c in various population types. Given the increased likelihood of hemaglobinopathies/erythrocyte disorders in the veteran population accompanied by the the necessity for tighter glycemic evaluation, fructosamine offers an assay for physician when analyzing glycemic control in veterans. The aim of our study was to evaluate the correlation of HbA1c and fructosamine in the veteran community. We hypothesize that fructosamine is significantly correlated with HbA1c in the veteran community and therefore can be used as an alternative assay in the Veterans Affairs. Following institutional review board review and exemption, a retrospective chart review was conducted at the Northport Veterans Affairs between the dates of December 2007 and December 2018. Inclusion criteria consisted of veterans above the age of 18 years with a HbA1c and fructosamine assay drawn from the same blood sample. Exclusion criteria consisted of veterans with an underlying hemoglobinopathy, erythrocyte disorder, or serum protein altering pathology. Linear regression analysis was conducted between HbA1c and fructosamine values. Linear regression equation, correlation coefficient, and coefficient of variance were reported. A paired t-test was conducted between assay HbA1c and predicted HbA1c from the determined regression equation. A total of 156 veterans were included in this study. A correlation coefficient and coefficient of variance of 0.75 and 0.56 were calculated from regression analysis (P < 0.05). A regression equation of the following was determined: HbA1c{%} = 0.0154*Fructosamine (mmol/L)+ 3.121. Paired t-test of assay HbA1c (M = 8.17, standard deviation = 1.64) and predicted HbA1c (M = 8.21, standard deviation = 1.53) returned without significance for difference of paired values. Given that both correlation coefficient and coefficient of variance were considered significantly strong and the paired t-test indicated no significant difference between assay HbA1c and predicted HbA1c, fructosamine can be considered as an alternative assessment of glycemic control compared to HbA1c in the veteran community. We advise physicians at the Veterans Affairs to use fructosamine as an assessment of glycemic control when a veteran is diagnosed with an underlying hemoglobinopathy/erythrocyte disorder or requires stringent analysis of glycemic control. Yet, at this point of time, fructosamine does not have the necessary data to indicate complete replacement of HbA1c with fructosamine.

Efficacy of combining aspirin with hydroxychloroquine in pregnancies at high risk for pre-eclampsia: a prospective, multicentre, open-label, single-arm clinical trial, investigator-initiated study (HUGS study)

IntroductionThe use of hydroxychloroquine (HCQ) during pregnancies complicated by systemic lupus erythematosus or refractory antiphospholipid antibody syndrome has demonstrated a significant ability to prevent pre-eclampsia (PE). As such, the potential...

Augmenting research consent: should large language models (LLMs) be used for informed consent to clinical research?

The integration of artificial intelligence (AI), particularly large language models (LLMs) like OpenAI’s ChatGPT, into clinical research could significantly enhance the informed consent process. This paper critically examines the ethical implications of employing LLMs to facilitate consent in clinical research. LLMs could offer considerable benefits, such as improving participant understanding and engagement, broadening participants’ access to the relevant information for informed consent and increasing the efficiency of consent procedures. However, these theoretical advantages are accompanied by ethical risks, including the potential for misinformation, coercion and challenges in accountability. Given the complex nature of consent in clinical research, which involves both written documentation (in the form of participant information sheets and informed consent forms) and in-person conversations with a researcher, the use of LLMs raises significant concerns about the adequacy of existing regulatory frameworks. Institutional Review Boards (IRBs) will need to consider substantial reforms to accommodate the integration of LLM-based consent processes. We explore five potential models for LLM implementation, ranging from supplementary roles to complete replacements of current consent processes, and offer recommendations for researchers and IRBs to navigate the ethical landscape. Thus, we aim to provide practical recommendations to facilitate the ethical introduction of LLM-based consent in research settings by considering factors such as participant understanding, information accuracy, human oversight and types of LLM applications in clinical research consent.

Conventional curettage adenoidectomy vs endoscopic microdebrider adenoidectomy - A comparative study.

Adenoidectomy is a frequently done ENT procedure. The purpose of the current article is to assess endoscopic powered adenoidectomy as a potential replacement for the traditional curettage approach. Two hundred forty consecutive adenoidectomy cases were randomly divided into two groups of one hundred twenty each. Between August 2020 to February 2023 after getting ethical clearance from Institutional Ethical Committee, Group I underwent Conventional Curettage Adenoidectomy (CA), while Group II underwent Endoscopic Micro-debrider Adenoidectomy (EMA). Average operative time in CA Group was 31.4min and in EMA group was 55.7min. In CA group, mean intraoperative blood loss was 64.4 mL, however, in EMA group, mean blood loss was 86.7 mL (p 0.001). In EMA Group, the resection was consistently complete, with 112 out of 120 cases having an adenoid grade of less than I in post-op. However in the CA group, in 44 (36.7%) of the patients, there was more than 25% remaining adenoid tissue postoperatively and more than 50% remnant adenoid tissue was found in 12 cases (10%) post-op. Post-operative pain was studied with the CA Group demonstrating an average 7 days' postoperative pain score of 3.90 whereas EMA Group demonstrating an average 7 days' postoperative pain score of 0.9. It was observed that EMA was a secure and reliable tool for adenoidectomy. Endoscopic powered adenoidectomy performed better in the completion of resection, accuracy of resection under vision, collateral damage, and post-operative pain. Contrarily, conventional Curettage adenoidectomy scored higher in terms of shorter surgery times and less intraoperative hemorrhage.

Nonscientific Members of Institutional Review Boards

Nonscientific Members of Institutional Review Boards

EVALUATION OF EFFICACY AND SAFETY OF AZITHROMYCIN AND DOXYCYCLINE IN TREATMENT OF ACNE VULGARIS WITH DIFFERENT LEVELS OF SERUM TESTOSTERONE: A PROSPECTIVE, RANDOMIZED, CONTROLLED, COST-EFFECTIVE, COMPARATIVE STUDY

Objectives: The objectives of this study are to compare the therapeutic efficacy, safety, quality of life (QoL), and cost-effectiveness of azithromycin and doxycycline in patients with acne vulgaris and the correlation of serum testosterone levels with the severity of acne. Methods: A prospective, randomized, open-label study was conducted at a tertiary care hospital in South India, according to the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use Guideline for Good Clinical Practice principles. After institutional ethics committee approval, 100 patients aged 15–40 with moderate-to-severe acne were enrolled, excluding those with a history of gastritis, drug hypersensitivity, pregnancy, or under 12 years old. Participants were randomized to receive either oral azithromycin 500 mg daily for three consecutive days each week for 4 weeks, or doxycycline 100 mg daily for 28 days, along with topical treatments. Efficacy was measured by the type and number of acne lesions, graded according to standardized criteria. QoL was assessed using the Cardiff Acne Disability Index (CADI). Serum testosterone levels were correlated with acne severity. Results: Of the 96 patients (42 males, 54 females) who completed the study, 49 were in the azithromycin group and 47 in the doxycycline group. The mean age was 23.5 years in the azithromycin group and 22.1 years in the doxycycline group. Significant reductions in acne severity and number of lesions were observed in both groups (p&lt;0.0001), with azithromycin showing superior improvement (p&lt;0.01). At baseline, most patients had Grade 3 or 4 acne, which improved significantly post-treatment. QoL improvements were also significant in both groups, with mean CADI scores reducing from around 8 to below 4 (p&lt;0.0001). A weak positive correlation (r=0.24) was found between serum testosterone levels and acne severity. Adverse events were mild and did not necessitate discontinuation. To achieve a 1 unit decrease in CADI, azithromycin treatment costed an additional rupees of 264.5 over doxycycline. Conclusion: Azithromycin and doxycycline are effective treatments for moderate-to-severe acne vulgaris, with significant improvements in clinical and QoL outcomes. While azithromycin offers better clinical efficacy, doxycycline provides a more cost-effective option. Further studies could explore long-term outcomes and the impact of hormonal variations on treatment efficacy.

Perceptions of clinicians and research ethics boards regarding ethical issues in investigator-initiated trials: a multicenter qualitative study in China

PurposeThis multicenter qualitative study aimed to explore the perceptions of clinicians and research ethics boards (REBs) regarding ethical issues in Investigator Initiated Trials (IITs).MethodsBetween February and April 2024, semi-structured interviews were conducted with 27 participants from 15 tertiary hospitals, including clinical doctors and members of REBs. Responses were grouped and analyzed using a descriptive phenomenological approach.ResultsClinicians expressed challenges in navigating the formal review process due to limited access to information and unclear guidelines. Academic review highlighted a deficiency in research literacy among clinical investigators, leading to flawed study design. Ethical review revealed concerns about inadequate ethical awareness among clinicians, resulting in failed ethical approvals. Moreover, delays in review processes and resource shortages were noted, hindering the efficient conduct of IITs.ConclusionThe findings underscore the need for comprehensive training programs to enhance clinicians’ research literacy and ethical awareness. Establishing a comprehensive system to support IITs, including enhanced guidance and support from REBs, is essential to ensure the quality and integrity of IITs in China.

Pharmacovigilance: A Comprehensive Review of Drug Safety Monitoring Practices

Pharmacovigilance, a crucial aspect of healthcare, encompasses the science and activities related to detecting, assessing, understanding, and preventing adverse drug reactions and other drug-related problems1. Its significance has grown considerably, especially following the 1961 thalidomide tragedy, which underscored the need for comprehensive drug safety monitoring. This field plays a vital role in improving patient safety and quality of life, while also safeguarding public health. emphasizes the expanding scope of pharmacovigilance beyond spontaneous reporting and marketed drug evaluation. It now includes ensuring patient safety during clinical trials through informed consent and ethical review boards, developing safety profiles for new drugs, and communicating this information to stakeholders2. Further highlights the importance of pharmacovigilance by discussing consumer reporting of adverse drug reactions and the challenges of early detection. This abstract provides a concise overview of the importance and evolving role of pharmacovigilance in ensuring drug safety

BARRIERS TO BREAST CANCER SCREENING AMONG WOMEN IN THIRUVALLUR DISTRICT

Introduction: Breast cancer screening is a critical public health issue where various barriers hinder women's participation in screening programs. Understanding these barriers is essential for developing effective interventions to improve screening rates and ultimately reduce breast cancer mortality. This study aims to assess the barriers to breast cancer screening among women in Tiruvallur district.Methods: A cross-sectional research design was used for this study. The sample consisted of 50 women randomly selected from villages under the Rural Health Training Center (RHTC) of a medical college in Thiruvallur district. The study received approval from the Institutional Ethics Committee. Women above 20 years of age who provided consent were included in the study, while women with a prior diagnosis of breast cancer or currently undergoing treatment were excluded.Results: The result showed that about 50% of women are aware of breast cancer screening, though 16.7% are unsure of where to access services. Psychological barriers include anxiety about results 33.3% and fear of pain 35%. Accessibility barriers include cost 38.3% and time constraints 35%. Social and cultural influences are minimal, with only 16.6% discouraged by family and 26.7% citing cultural beliefs. Health system barriers include service quality 36.7% and long waiting times 31.6%. Age group (Chi-square = 10.123, p = 0.015) and education (Chi-square = 9.456, p = 0.022) are significantly associated with screening barriers, while marital status, employment, and family history of breast cancer are not. Age and education level notably influence perceived barriers to breast cancer screening.Conclusions: The study concluded that psychological barriers, particularly anxiety about results and fear of pain, are prevalent among the women surveyed, indicating the need for supportive counseling and reassurance to encourage participation in screening programs.

Spontaneous walking characteristics of patients with peripheral arterial disease.

Background: Walking rehabilitation is the cornerstone of patients with peripheral arterial disease (PAD) treatment. In order to propose a personalised walking rehabilitation program to each patient, it is important to know the PAD-patients walking characteristics. Such data are lacking in the literature. The aim of this study was to analyse the spontaneous walking characteristics of PAD patients. Patients and Methods: This study was conducted between May 2016 and March 2018. Walking characteristics (cadence, stride, number of daily walking episodes, duration of an episode, distance covered during an episode, daily total walking duration and distance, walking speed) were recorded by Withings Pulse O2® activity trackers for one week in patients with asymptomatic or symptomatic PAD. Walking intensity was classified as ambling pace (<2 METs), slow walking (2-3 METs) and active walking (>3 METs). Study protocol has been approved by an independent ethics committee. Results: Eighty-seven patients were included (males 87%, mean age 66 ± 9 years, intermittent claudication 86%, right ankle brachial index (ABI) = 0.80 ± 0.19 and left ABI = 0.79 ± 0.15). The mean recording duration was 8 ± 1.2 days. Most of the steps were shuffling pace (shuffling pace 55.7%, active walking 32.8%, slow walking 11.5%). There was no significant difference between weekdays and weekend days nor for cadence, stride, episode duration, distance covered during an episode, number of daily walking episodes, daily total walking duration and distance. The average duration of active walking episodes was 3 minutes. Duration of active walking was less than 3 minutes in 66% of patients with a mean duration of 1 minute and 55 seconds. Conclusion: Analysis of PAD patients spontaneous walking characteristics with an activity tracker can get the maximum active walking duration achieved by each patient and be useful to offer a personalised walking rehabilitation program.