ETHICAL ISSUES IN RANDOMIZED CONTROL TRIALS: A REVIEW

Randomized Control Trials (RCTs) are scientific experiments that are used to investigate the effectiveness of various interventions in the field of Medicine and public health. As a result of complexity of the process, even the competent individuals are not able to understand the process of randomization with anticipated consequences associated with it. There is rise in trend of research and conduct of RCTs in developing countries; hence, there is a need to review all ethical issues confronted by the researchers during conduct of such trials. An Online literature search was carried out in April 2015 to May 2015 from Google Scholar, BioMed Central Ethics and PubMed using the key term “Trials”, “Randomized Control Trials”, “Ethical issues” and various synonymous terms from the titles of the articles. This resulted in 25 articles. Following, which these articles were scrolled down, and all articles with ethical issues encountered with different type of trials, were included. Avoiding the duplication of issues, 13 articles were finally selected for review. From the review narrates that ethical issues of patient autonomy, informed consent, therapeutic misconceptions, state of equipoise for individuals, clinicians and researchers, controversies between placebo and active control orthodoxies, design biases, role of gate keepers, benefit verses risk assessment and protection of vulnerable groups are the important ethical issues highlighted by various researchers. There can be issues related to some surgeries, early cessation of RCTs due to some apparent benefits and conduct of trials in third world countries. It is imperative that institutional review boards should consider all such issues during ethical assessment of such trials. Keywords:Benefit verses risk assessment Institutional review board (IRB), Randomized Control Trials (RCTs), vulnerable groups

Gender-Based Motivational Factors For Choosing Dentistry As A Career By First Year Dental Students Of College Of Pakistan

Abstract Objective: Dentistry, also known as “Dental Medicine” is opted for various reasons like prestige, socioeconomic status or personal desire. However, some join dentistry just to fulfil the wishes of their parents. Students who choose dentistry by their own choice excel better in this field. Another general impression is that mostly female students prefer it. To have a true picture of these impressions in our society, we planned this study to identify the reasons and motives of undergraduate dental surgeons for joining dentistry. Methods: A cross-sectional study, was conducted on 278 students at Margalla College of Dentistry, from December 2020 to April 2021 after the approval of the Ethical review committee of the institute. - The probability judgmental sampling technique was used. Students who consented were included in the study. A self-administered questionnaire was used to collect data which was analyzed using SPSS 21. Results: In this study, about 48.4% of students selected dentistry as their first choice but out of these only 48.9% did prior career planning. Female students 76 (49.6%) opted for dentistry as compared to male students 12 (30.7%). However, there was an insignificant difference regarding career choice between both genders (p=0.591). Prominent motivating factors were flexible work patterns (63.5%), self-employment (63%), financial security (44.8%) and parents wish (25%). Conclusion: Students chose Dentistry not only due to their interests but also because of flexible work patterns, financial security and self-employment. Both genders have more or less the same inclination towards dentistry.

Acute High Dose Reprotoxic Effects of Bisphenol-A on the Testicles of Adult Rodents.

Objectives: To evaluate the acute effects of high dose of bisphenol-A (BPA) induced in the testicles of adult rats.Methodology: An Experimental study was conducted at Anatomy Department, University of Health Sciences, Lahore, from January 2015 to December 2015.Twelve adult Wistar albino rats were weighed and divided into three groups of four rats each. Group A (control) was given corn oil (2ml/kg/day). Group B (BPA-100) was given BPA 100mg/kg/day dissolved in corn oil (2ml/kg/day). Group C (BPA-200) was given BPA 200mg/kg/day dissolved in corn oil (2ml/kg/day). The animals were sacrificed on the 8th day after weighing. Testis were weighed and fixed in Buoin’s solution. Johnson scoring was done in H&E stained slides. Basement membrane integrity was observed in PAS stained slides.Results: Group A rats showed normal parameters. Group B (BPA-100) showed a significant decrease in Johnson score and an increase in basement membrane disruption while the changes in body weight of animals and paired weight of testis was statistically insignificant. Group C (BPA 200) rats died within 3-4 days and the experiment was limited to two groups.Conclusion: The results of the present study indicate that a high dosage of Bisphenol A in rats causes significant disruption of the testicular histology and proves to be a significant reprotoxin even with a short duration of exposure

ASSOCIATION BETWEEN RESPIRATORY DISEASES AND ORAL HEALTH: A SYSTEMATIC REVIEW STUDY

Background: The purpose of this review was to investigate evidence for a possible etiological association between oral health and pneumonia or other respiratory diseases. Methods: The following data sources were used: Ovid MEDLINE Cumulative Index to Nursing & Allied Health Literature; Evidence Based Medicine of Cochrane Central Register of Controlled Trials; Cochrane Database of Systematic Reviews; Database of Abstracts of Reviews of Effects; EMBASE; Health and Psychosocial Instruments; Health STAR; International Pharmaceutical Abstracts; PubMed; and Google Scholar from the earliest record until July 2018. Results: A total of 728 articles were searched for relevancy, determined by article title, abstract, and full copy, resulting in a yield of 19 studies that met our inclusion criteria.: 1) the potential risk factors for pneumonia were identified as the presence of cariogenic and periodontal pathogens, dental decay, and poor oral hygiene in five studies; 2) there was a weak association identified in four poor to fair studies between periodontal disease and chronic obstructive pulmonary disease (COPD) and 3) 10 studies providing evidence that interventions aiming to improve oral health reduced the progression or occurrence of pneumonia. Conclusions: 1) There is fair evidence (II-2, grade B recommendation) of an association of pneumonia with oral health (odds ratio [OR] = 1.2 to 9.6 depending on oral health indicators). 2) There is poor evidence of a weak association (OR <2.0) between COPD and oral health (II-2/3, grade C recommendation). 3) There is good evidence (I, grade a recommendation) that the reduction in progression or occurrence of respiratory diseases among high-risk elderly adults living in nursing homes and especially those in intensive care units could be improved with oral hygiene and frequent professional oral health care. Key words: Dental plaque; oral health; oral hygiene; periodontal diseases; pneumonia; pulmonary disease, chronic obstructive

Oral Ulcers Presentation in Systemic Diseases: An Update

BACKGROUND: Diagnosis of oral ulceration is always challenging and has been the source of difficulty because of the remarkable overlap in their clinical presentations. AIM: The objective of this review article is to provide updated knowledge and systemic approach regarding oral ulcers diagnosis depending upon clinical picture while excluding the other causative causes. METHODS: For this, specialised databases and search engines involving Science Direct, Medline Plus, Scopus, PubMed and authentic textbooks were used to search topics related to the keywords such as oral ulcer, oral infections, vesiculobullous lesion, traumatic ulcer, systematic disease and stomatitis. Associated articles published from 1995 to 2019 in both dental and medical journals including the case reports, case series, original articles and reviews were considered. RESULTS: The compilation of the significant data reveals that ulcers can be classified according to (i) duration of onset, (ii) number of ulcers and (iii) etiological factors. Causation of oral ulcers varies from slight trauma to underlying systemic diseases and malignancies. CONCLUSION: Oral manifestations must be acknowledged for precise diagnosis and appropriate treatment

Prevalence of clinical spectrum of cutaneous adverse drug reactions in patients presenting at a tertiary care hospital in Pakistan

Introduction: Cutaneous adverse drug reactions (CADRs) are the most common adverse drug reactions reported in the literature. CADRs have resulted in disabling infirmities during hospitalization and complications following outdoor drug therapy. The pattern of CADRs and the responsible drugs usually changes with the introduction of newer drugs and evolving clinical practices. Moreover, several international studies showed variable prevalence, emphasizing the need for local data in light of different socioeconomic and demographic practices. Therefore, the purpose of this study is to evaluate the prevalence of adverse cutaneous drug reactions and identify the clinical spectrum and any potential risk factors.Methodology: The current study is a descriptive cross-sectional study conducted at Aga Khan University Hospital, Pakistan. One hundred ninety-three patients who met the study inclusion criteria were included. Data were collected from patients on a proforma after taking informed consent. Quantitative data were presented as simple descriptive statistics giving mean and standard deviation, while qualitative variables were presented as frequency and percentages. Effect modifiers were controlled through stratification to highlight the effect of these on the outcome variable. The post-stratification chi-square test was applied and the p-value of ≤0.05 was statistically significant.Results: A total of 193 patients who had cutaneous adverse drug reactions were included in the study. The mean age in this study was 47.78±8.33 years. One hundred eight (56%) were male and 85 (44%) were female. Out of 193 patients, 135 (69.9%), 50 (25.9%), 24 (12.4%), 12 (6.2%), 20 (10.4%), 11 (5.7%) and six (3.1%) had maculopapular rash, acneiform eruptions, Stevens-Johnson syndrome, erythema multiform, urticaria, fixed drug eruptions and toxic epidermal necrolysis, respectively.Conclusion: CADRs are a common clinical presentation and awareness and knowledge about their diagnosis and prevention is important. It can be assumed that in our local setup, the clinical trends and medications causing ADRs are strikingly similar to those found in other countries. Physicians commonly come across these cases and they should be well aware of the clinical spectrum of skin reactions to enable early diagnosis and management

Efficiency of Crystal Violet Stain to Study Mitotic Figures in Oral Epithelial Dysplasia

AIM: To evaluate mitotic activity in the different grades of oral epithelial dysplasia using 1% crystal violet stain. MATERIAL AND METHODS: A descriptive study was conducted in the Department of Histopathology of the Post Graduate Medical Institute, Lahore on a total of thirty-three cases of the Oral Epithelial Dysplasia (OED). Fresh, frozen paraffin-embedded archival tissue blocks were collected from Lahore General Hospital, Lahore &amp; Oral &amp; Maxillofacial Surgery Department of Nawaz Sharif Hospital, Yakki Gate, Lahore. The representative sections were taken and, after processing, mounted on glass slides and stained with H&amp;E and crystal violet stains. The stained slides were then examined under an optical microscope. The efficacy of 1% crystal violet stain to identify mitotic figures in the different grades of oral epithelial dysplasia was assessed with the sample t-test. A difference of p &lt; 0.05 was considered to be significant. RESULTS: A comparison of the mitotic figure count in two categories in sections stained with both stains showed a statistically significant difference. An increase in the mean mitotic count was noted in the sections of OED stained with crystal violet in comparison to the sections of OED stained with H&amp;E which was statistically significant (p = 0.00). CONCLUSION: Counting of mitotic cell is the rapid and simplest way of evaluating the proliferative activity of cells. Crystal violet stain can be a rationalised step in the staining of mitotic figures compared to the usual H&amp;E staining and can be employed as a selective stain during routine histopathological procedures

A Remarkable Case of Acute Motor-Sensory Axonal Polyneuropathy (AMSAN) Variant of Guillain Barré Syndrome, in a Diabetic Patient Infected With COVID-19: A Case Report and Review of the Literature

BackgroundSevere acute respiratory syndrome coronavirus 2 (SARS-CoV-2), which causes coronavirus disease- 2019 (COVID-19), has been a global epidemic in our healthcare system. SARS-CoV-2 primarily affects the respiratory system, but neurological involvement has also been reported, including Guillain–Barré syndrome (GBS) development.Case PresentationA 58-year-old male with known co-morbid hypertension and type 2 diabetes mellitus presented to the emergency room with complaints of worsening shortness of breath, dry cough, and fever for the past 10 days. On day 20 of hospitalization, he developed neurological symptoms after being tested positive for COVID-19. A neuroelectrophysiology study was conducted to evaluate neurological symptoms and suggested that the patient suffers from acute motor-sensory axonal polyneuropathy (AMSAN). CSF analysis showed elevated protein levels that confirmed the diagnosis of GBS. He was subsequently treated with oral prednisolone and IVIG, which improved neurological symptoms.ConclusionEver since the emergence of COVID-19, GBS has surfaced as to its potentially dangerous outcome. Healthcare professionals should be mindful of GBS and should rule it out in anyone having sensory symptoms or weakness during or after a COVID-19 infection. Its early detection and treatment can result in improved clinical outcomes

Primary Amebic Meningoencephalitis Caused by Naegleria fowleri, Karachi, Pakistan

We report 13 cases of Naegleria fowleri primary amebic meningoencephalitis in persons in Karachi, Pakistan, who had no history of aquatic activities. Infection likely occurred through ablution with tap water. An increase in primary amebic meningoencephalitis cases may be attributed to rising temperatures, reduced levels of chlorine in potable water, or deteriorating water distribution systems

Global, regional, and national burden of colorectal cancer and its risk factors, 1990–2019: a systematic analysis for the Global Burden of Disease Study 2019

Funding: F Carvalho and E Fernandes acknowledge support from Fundação para a Ciência e a Tecnologia, I.P. (FCT), in the scope of the project UIDP/04378/2020 and UIDB/04378/2020 of the Research Unit on Applied Molecular Biosciences UCIBIO and the project LA/P/0140/2020 of the Associate Laboratory Institute for Health and Bioeconomy i4HB; FCT/MCTES through the project UIDB/50006/2020. J Conde acknowledges the European Research Council Starting Grant (ERC-StG-2019-848325). V M Costa acknowledges the grant SFRH/BHD/110001/2015, received by Portuguese national funds through Fundação para a Ciência e Tecnologia (FCT), IP, under the Norma Transitória DL57/2016/CP1334/CT0006.proofepub_ahead_of_prin