Perspectives in Clinical Research最新文献

Background: Pharmacotherapy of chronic kidney disease (CKD) consists of prescribing myriad of drugs such as antihypertensives, antidiabetics, and phosphate binders to delay disease progression and control the comorbidities, resulting in inherent variability in prescriptions. In addition, tendency to self-medicate may further aggravate the condition. Hence, the present study was planned to assess self-medication practices and variability in prescription patterns in CKD patients.

Methodology: A cross-sectional, questionnaire-based study approved by the ethics committee was conducted in CKD patients attending the nephrology outpatient department. The prescription details which included drug name, dosage form, dose, frequency, duration, and dosage instructions were recorded and prescription completeness was checked. To assess the tendency of CKD patients to self-medicate, each patient was administered a prevalidated [Content Validity Ratio (CVR) = 0.76] 8-item questionnaire which had dichotomous responses "Yes" and "No" and was scored as 2 and 0, respectively (total score 16).

Results: Three hundred CKD patients (150 on hemodialysis and 150 nondialysis) yielded 300 prescriptions with 1272 drugs. It was evident that 33% of patients did self-medicate themselves with analgesics, and the mean score (7.81 ± 3.01) of self-medication practices was perceived significantly higher in the nondialysis group (8.41 ± 3.46). The most common classes of drugs prescribed in CKD patients were calcium channel blockers (41%), antidiabetic drugs (39%), diuretics (35%), gastrointestinal drugs (35%), and multivitamins (27%), with the average number of drugs being 5.84 ± 0.51.

Conclusion: Nearly one-third of CKD patients were self-medicating with paracetamol, nonsteroidal anti-inflammatory drugs; more in the nondialysis group emphasizing reinforcement of patient education programs. The most common drugs prescribed were amlodipine, followed by metformin, and the average number of drugs was less in our setting, indicating vigilant dose prescribing in CKD patients.

Aim: The study aimed to determine the incidence of adverse drug reactions (ADRs) among newly diagnosed tuberculosis (TB) patients receiving daily drug regimen with fixed-dose combination treatment under the National Tuberculosis Elimination Program.

Materials and methods: A community-based prospective cohort study was carried out in the Udupi district. Over 12 months, all newly diagnosed TB patients of either gender were included from 63 primary health centers and 6 community health centers, and ADRs were recorded by personal interviews.

Results: A total of 710 patients were enrolled, among whom 453 (63.8%), were males, and 257 (36.2%) were females. Pulmonary TB was diagnosed among 510 (71.8%) and 200 (28.2%) were extrapulmonary cases. During the intensive phase (IP) of treatment, 480 (67.6%) patients reported at least one ADR and 79 (11.1%) experienced two ADRs during IP and 31 (6.5%) had ADRs during the continuation phase. Out of 480, 140 (29.2%) had gastritis, 132 (27.5%) had vomiting, 105 (21.9%) had nausea, 60 (12.5%) had skin rashes, 27 (5.6%) had drug-induced hepatitis, and 16 (3.3%) had vision problems. Among 480 patients with ADRs, 462 (96.3%) had successful treatment outcomes, the remaining 17 patients (3.5%) died, and one (0.2%) had treatment failure.

Conclusions: Adverse events were more common in the 1^st few months of treatment than in subsequent months. All mild-to-moderate ADRs were effectively managed, and most had successful treatment outcomes.

Conventional trial designs are resource and time-intensive. To accelerate the process of testing new interventions, we now have several novel research trial designs. This article focuses on master protocol trials, which allow several therapies to be tested within a single larger trial.

Background: Antibiotics are among the most commonly prescribed drugs. Unnecessary use of antibiotics is particularly concerning because antibiotics may be associated with a number of adverse drug events.

Aim: The study was designed to detect the association between pulmonary embolism and antibiotics by disproportionality analysis in the Food and Drug Administration database of Adverse Event Reporting System (FAERS) using data mining algorithms (DMAs).

Materials and methods: A retrospective case/noncase disproportionality analysis was performed in the FAERS database. This study was based on adverse events (AEs) reported to FAERS from 2004 Q1 to 2022 Q3. Reporting odds ratio (ROR), proportional reporting ratio (PRR), and information component (IC) were applied to measure the disproportionality in reporting. A positive signal of increased AE risk was defined as ROR >1, Chi-square >4, PRR R2 with the number of cases >3, and IC >0.

Results: Total AEs in the FAERS database from 2004 Q1 to 2022 Q3 were found to be 26,555,430. Among which 80,809 reports of pulmonary embolism were considered. The same were selected for further analysis which showed that 11 antibiotics were reported for pulmonary embolism. The number of reports for minocycline, chloramphenicol, and moxifloxacin was found to be 113, 14, and 179. A significant potential signal was noted for minocycline (ROR - 2.87, Chi-square - 135.95, IC - 1.22), chloramphenicol (ROR - 3.35, Chi-square - 22.80, IC - 0.77), and moxifloxacin (ROR - 2.08, Chi-square - 99.37, IC - 0.83).

Conclusion: This study found a statistically significant increased risk of reporting pulmonary embolism with minocycline, chloramphenicol, and moxifloxacin, although a causal relation cannot be definitively established.

Stem cell research is a major focus for scientific and medical communities worldwide due to the potential for stem cells to restore function lost due to disease, trauma, congenital abnormalities, and aging. Stem cells can repair, replace, or regenerate damaged cells, tissues, or organs, making them an important area of research in regenerative medicine. India is emerging as a prominent hub for the development of stem cell therapy (SCT), and it is important to assess the current state of stem cell research in India and the potential for advancement to promote stem cell-based therapy. However, several barriers exist in India that are hindering the rapid expansion of SCT. This article examines the existing regulations that govern SCT in India, comparing them with regulations in developed nations, particularly for patients with unmet clinical needs. It also highlights the importance of public education in dispelling myths, addressing concerns, and promoting the benefits of stem cell research. The article concludes with recommendations for enhancing safety measures in SCT applications to ensure ethical practices and patient well-being.

Post-COVID-19, the emergence of newer technologies has taken center stage. One such technology is metaverse, which is an extension of existing technologies such as virtual reality (VR) and augmented reality (AR) that enables a fully immersive communication platform through the utilization of digital twins and avatars in a three-dimensional digital space. Literature review has shown that the adoption of such technologies in the field of clinical trials can help in improving the therapeutic outcomes in patients while having numerous other benefits. Despite its early stages of adoption, the application of metaverses in clinical trials through the use of AR, VR, and digital twins holds the ability to revolutionize key tasks in clinical trials, such as patient enrollment, engagement, monitoring, and counseling, by removing barriers to study participation. This review article focuses on the concepts of metaverse, its use in clinical trials, its inherent benefits, and limitations and serves as a starting point for clinical research organizations, pharmaceutical companies, and technology firms to conceptualize and develop metaverse solutions that stand to significantly benefit the broader landscape of clinical trials.

Introduction: Informed consent documents (ICDs) are integral to a research project and must provide all required information to the participant. We undertook a 6-year retrospective cross-sectional analysis of ICDs to assess the same.

Methods: We accessed 300 ICDs from studies submitted to institutional ethics committee. Studies were selected using random proportional-to-size sampling across years and study types (thesis, pharma, government, investigator initiated [OA] studies). We used the Flesch-Kincaid Reading Ease Score (FRES), estimated reading time (ERT) and scored ICDs out of 13 points on the basis of the Indian Council of Medical Research (ICMR)-mandated headings (ICD Quality Score [IQS]). Information pertaining to the consent refusal rate (CRR) of each study was correlated with FRES, ERT, and other parameters. P <0.05 was considered statistically significant.

Results: Two hundred and ninety-three ICDs had complete information. Median FRES was 48.3 (interquartile range [IQR] = 7), median ERT was 4.5 min (IQR = 1.3), the median expected duration of participation was 35 min (IQR = 40); compensation was provided by 23 projects and median compensation was Rs. 2500 (IQR = Rs. 4750). Mean IQS improved from 11.95 to 12.60 in 6 years (Kruskal-Wallis test, P < 0.001). FRES was weakly negatively correlated to the CRR (r = -0.120, P = 0.039), while the expected duration of participation was weakly positively correlated (r = 0.144, P = 0.014).

Conclusion: Pharma studies performed better and ICDs have improved in their readability and ICMR guidelines compliance.