Year 2023, Volume 39 - Issue 1

Recruitment of adequate number of healthy volunteers is vital for success of clinical trials but there is limited research on factors motivating the healthy volunteers to participate in clinical trials especially in developing countries. Pakistani researchers also faced the problems in enrollment of enough healthy volunteers during COVID-19 pandemic when a number of clinical trials began in Pakistan. Around 117 research proposals were processed by the National Bioethics Committee (NBC) of Pakistan in last two years. A major proportion of these clinical research studies target healthy populations as primary research subjects or as controls.

Numerous studies have investigated factors such as motives, barriers, risks. benefits and ethical values affecting recruitment and participation of healthy volunteers in clinical trials. We have reviewed the literature to learn about factors that motivate or prevent the healthy persons to volunteer along with the pertaining ethical issues.

Financial incentive is the principal motive for healthy volunteers to participate in clinical trials along with altruism, contribution to sciences, research and other people’s health, desire to take part in something important, learning more about science and medicine, access to healthcare & free medical checkup and prospects of one’s social network expansion whereas time inconvenience, confidentiality, possible side effects & route of administration of drug and fear of contacting the disease were identified as important barriers.

Application of knowledge of these motives and barriers will help Pakistani researchers to enroll adequate number of healthy volunteer for their clinical trials.

Background and Objective: Dengue fever (DF) has been a major health concern globally. Pakistan is also combating this infection for the last decade. Cytokine genes play an important role in DF pathogenesis. This study aimed to analyze dendritic cell-specific intercellular adhesion molecule-3-grabbing non-integrin (DC-SIGN) and tumor necrosis factor α (TNF-α) genes promoter polymorphisms in DF patients.

Methods: A total of 140 (n = 140) dDF patients were recruited for study at the Department of Human Genetics and Molecular Biology of University of Health Sciences, Lahore, Pakistan over a period of 3 years. Simple DF was noted in 105 patients (75%) while 35 (25%) showed bleeding complications. All patients were found positive for dengue non-structural protein or dengue IgM. All patients were tested for two polymorphisms in TNF-α (-238G/A, and -308G/A) and one polymorphism in DC-SIGN (-336G/A) using restriction fragment length polymorphism technique. A single nucleotide polymorphism stats program was used for statistical analysis.

Results: Susceptibility to develop dengue infection in the presence of -336G allele odds ratio (OR = 27.95, p = <0.0001) and GG genotype (OR = 183.77, p = <0.0001) was found to be significantly associated in this study. Presence of a combination of alleles -336G/-238A/-308A was noted in 59.4% of DF cases and 7.6% healthy controls, a difference with statistical significance (OR = 31.46, p = <0.0001). Moreover, prevalence of DF symptoms showed a trend higher in G-carriers versus non-G-carriers of DC-SIGN -336 polymorphism.

Conclusion: This work suggests a potential association of DC-SIGN -336 polymorphism with susceptibility to develop symptomatic dengue illness. However, no potential association was found between TNF-α promoter polymorphisms and dengue infection in this study.

ABSTRACT

Background and Objective: A global increase in the prevalence of diabetes mellitus (DM) is associated with increased morbidity and mortality. Oxidative stress is a fundamental component in the pathogenesis of DM Ajwa dates are known to have a high antioxidant content, especially in their seeds. Hence this study was designed to determine the preventive effects of Ajwa date fruit on alloxan-induced diabetes in an experimental rat model.

Methods: This experimental study was conducted at the Post Graduate Medical Institute, Lahore, Pakistan. A total of forty Sprague-Dawley rats were divided into five groups with eight animals in each. Rats in group A were normal control, whereas rats in group B were induced with intraperitoneal alloxan (160 mg/kg body weight) to develop diabetes. Groups C, D, and E rats were fed on a diet supplemented with Ajwa flesh, seed, and whole Ajwa respectively for 1 week. Blood and urine glucose levels were measured on days 0, 7 (pre-alloxan) and 11, 14, 19 (post-alloxan). Serum insulin, homeostatic model assessment (HOMA) for β-cell function (HOMA-β), and insulin resistance (HOMA[1]IR) were estimated terminally.

Results: Diabetes was induced successfully in animals of all experimental groups except the normal control group. Rats of the Ajwa-seed group (D) showed relative resistance to diabetes induction with three non-diabetic rats on day 19. In group E, rats had lower blood sugar levels than rats in group C (p = 0.010). Serum insulin, HOMA-β and HOMA-IR, revealed partial beta cells restoration in the experimental animals of groups D and C. Insulin resistance was significantly higher, despite the highest insulin level (3.77 µIU/ml; p value <0.001) in group C.

Conclusion: Ajwa date seed powder appears to provide relative protection against the development of diabetes in rats induced by alloxan.

Background and Objective: Plastic surgeons face challenging conditions when dealing with soft tissue injuries or defects involving the lower part of the leg and the proximal part of the foot. The objective of the current study is to compare single-staged reverse sural artery flaps with two-staged interpolated flaps in distal lower limb injuries.

Methods: It was a prospective study carried out at the Department of Plastic Surgery, Allama Iqbal Memorial Teaching Hospital, Sialkot, Pakistan, over 5 years from 2015 to 2020. Sixty-eight (n = 68) patients with distal lower limb soft-tissue defects were enrolled and randomly allotted a two-stage interpolated flap design (group A) or single-stage reverse sural artery flap design (group B). The measured outcomes included the frequency of flap-tip necrosis, epidermolysis, partial or total flap loss, and additional procedures needed for managing these complications.

Results: Out of all the patients, 72% were of male gender and 28% were females with a mean age of 38.38 ± 10.76 years. In group A, there were 6% of the cases where tip necrosis was the only impediment as compared to 17% in group B. In patients of group A, epidermolysis was seen in 12% as compared to 35% in group B whereas only 6% of patients in group A required secondary procedures for flap tip necrosis as compared to group B (47%). Paired t-test was used to calculate the statistical significance of the outcome between the two groups (p-value of 0.0491).

Conclusion: The two-staged interpolated flap procedure results in fewer complications as compared to a single-staged reverse sural artery flap procedure. However, the shorter hospital stay in single-staged flap design is satisfying for the patients who did not report any complications with this procedure.

Background and Objectives: Poliomyelitis still remains a significant public health concern in developing countries though it has been eradicated from most of the world. Illiteracy, cultural constraints, and skepticism of the general public regarding vaccination are considered major impediments to its successful eradication from developing countries. In this study, the authors aimed to evaluate parental knowledge and attitudes about poliomyelitis and its immunization in a local population as well as to elucidate the determinants and barriers relating to the immunization process.

Methods: This mixed-method study was conducted on 350 consenting parents who accompanied their children under 5 years of age at the pediatric outdoors of a tertiary care hospital in Sialkot, Pakistan. Parents of only those children were included for the study who had failed to receive a polio dose during the last two supplementary immunization activities The parents were interviewed on a pre-tested, semi structured questionnaire. Statistical Package for the Social Sciences was used for statistical analysis considering p-value <0.05 as significant.

Results: Among 350 parents, 91.7% lacked knowledge about polio vaccination and 82% reported a negative attitude towards the disease and its immunization. A total of 11.4% of subjects completely refused to get their child vaccinated. The socioeconomic status, religious myths, level of literacy, and occupation of the parents significantly influenced their level of knowledge and attitude toward the disease and its vaccination (p < 0.05).

Conclusion: Poor knowledge and negative attitudes of parents towards poliomyelitis vaccination were observed. Fear of side effects and religious beliefs were identified as the most common barriers to immunization toward achieving polio eradication.

Background and Objective: The contagious and invasive nature has made coronavirus disease-19 (COVID-19) a critical health issue for the community. The lower respiratory tract is the major site of inflammation seen in COVID-19-positive individuals. Vitamin D (Vit D) has been proposed to have a positive role in immunomodulation, hence, this study aimed to determine the association between Vit D levels and the severity of COVID-19 in infected pediatric patients presenting at a secondary healthcare hospital in Pakistan.

Methods: This cross-sectional analytical study was conducted on 100 pediatric patients of the age range 1-18 years from March to December 2021. These patients were hospitalized and diagnosed with coronavirus disease with confirmed results on a real‐time reverse transcription-polymerase chain reaction. Blood samples of the patients were taken to monitor the baseline levels of markers of acute infection and Vit D levels. Patients with serum Vit D levels ≤ 20ng/ml were labeled with deficiency, those with levels 21-29ng/ml were presumed to have Vit D insufficiency whereas levels ≥30 ng/ml were considered normal.

Results: There were 57 (57%) males and 43 (43%) female pediatric patients. The mean age of the patients was 10.46 ± 4.25 years (1-18 years). The deficient Vit D level group had a greater frequency of pyrexia, weakness, cough, anosmia, headache, myalgia, and diarrhea. The levels of Vit D and severity of the disease were significantly associated (p-value = 0.027).

Conclusion: Pediatric patients with COVID-19 having optimum levels of Vit D were less likely to develop complications associated with the severity of the disease.

Background and Objective: Manual therapy is a treatment approach by physical therapists where different techniques are applied to patients with hands for rehabilitation purposes. The objective of the study was to find the frequency of De’Quervain tenosynovitis and thumb and wrist pain in physical therapists working in different rehabilitation centers in relation to age, body mass index (BMI), and working hours.

Methods: A cross-sectional study was conducted on 135 physical therapists working in different settings in Lahore, Pakistan. Physiotherapists were enrolled by convenience sampling. Data were recorded on a questionnaire form. Finkelstein test was performed to check De Quervain’s tenosynovitis. A numeric pain rating scale was sued to measure pain. The data were tested for significance using statistical tests.

Results: On the dominant hand, 99 (73.3%) physical therapists had no wrist pain, 104 (77%) had no thumb pain, 28 (20.7%) had mild wrist pain and 20 (14.8%) had mild thumb pain. Only 21 (15.6%) physiotherapists were tested positive for Finkelstein (De Quervain’s tenosynovitis). Finkelstein test reported 100% negative result on the non-dominant side. There is a negative correlation between thumb pain with the age (r = -0.005), BMI (r = -0.110) and working hours (r = -0.033) of the physical therapists.

Conclusion: The study concluded that the prevalence of De Quervain’s tenosynovitis, thumb, and wrist pain was more on the dominant hand than on the non-dominant side. The majority of the physical therapists reported mild to no pain in the wrist and thumb. There is a negative correlation of thumb pain with age, BMI and working hours.