Perspectives in Clinical Research最新文献

Background: Increasing incidence of tuberculosis is intensifying the posttubercular obstructive airway disease (PTOAD) in developing countries. Currently, there are no standard treatment guidelines for the management of PTOAD patients. The present study aims to evaluate the prescribing pattern, adherence, adverse drug reactions (ADRs), and quality of life (QoL) in PTOAD patients.

Materials and methods: A prospective observational study was conducted to evaluate the prescriptions of PTOAD patients, estimating the medical adherence using Morisky 8-Item Medication Adherence Questionnaire, assessing ADRs using Hartwig's Severity Assessment Scale and assessing QoL using St. George's respiratory Questionnaire. Chi-square test, analysis of variance, paired t-test were used to compare the data. The significance of change in adherence status was assessed by Wilcoxon signed-rank test.

Results: A total of 94 prescriptions of PTOAD were analyzed. Inhaled long-acting muscarinic antagonist was prescribed to 31.9% of patients. The most common inhaled fixed dose combination was long-acting beta-2 agonist with corticosteroid, prescribed to 52.1% of patients. At final follow-up, maximum percentage of patients were found to be highly adherent, i.e. 56.4%. Overall, 34% of patients have complained about mild category of ADRs. A significant improvement in QoL was observed. At baseline, mean forced expiratory volume in 1 (FEV₁) was 64.66% ±23.61%, which increased significantly to 73.34% ±21.60% on final follow-up (P < 0.001).

Conclusion: Bronchodilators are the mainstay of treatment of PTOAD patients, since both the QoL and FEV1 were improved with treatments. However, to have good treatment outcome, strict adherence along with safety of the medications must be assured.

Background: Managing of SAE by all stakeholders i.e. principal investigator (PI), sponsor, and Institutional Ethics Committee (IEC), in an ethical manner is the most important indicator of participant safety during clinical trial. The present study was conducted with the objectives to assess the extent of regulatory compliance in reporting SAEs, relatedness and financial compensation given/recommended by various stakeholders.

Methods: This was a retrospective observational study which involved analysis of SAE's reviewed by IEC. Administrative approval for accessing the documents was obtained and complete confidentiality was maintained. A total of 66 SAE of 34 regulatory clinical trials reported from January 2014 to March 2020 were analyzed.

Result: When analyzed for relatedness, 16 (24.24%) of the reported SAEs were found related to the clinical trial and out of these, 7 were SAE of death. Among the remaining 50 SAEs, 48 (72.7 %) were not related to clinical trial .65 (98.48%) SAEs, initial report and final report were submitted to EC within timelines. All the 66 SAE reports were sent by EC within stipulated time as required by regulation.

Conclusion: The study concludes that 66 SAE reports were identified and there was no deviation in reporting timelines in initial reporting and due analysis report by PI and initial review by IEC in 65 SAE's. Similarly, analysis of SAE by IEC for relatedness, and provision of compensation to participant was achieved in majority of SAE. The study is unique in a way that qualitative and quantitative analysis of SAE reports was performed.

Context: Management of asthma and chronic obstructive pulmonary disease (COPD) includes use of inhalers as an integral component of drug delivery. Awareness about inhaler devices along with demonstration of the usage of inhaler technique aids in the optimization of therapeutic outcome.

Aim: This study aimed to assess the correct use of inhaler technique following pre- and posttraining sessions for the management of COPD and asthma among pulmonary outpatients at a tertiary care hospital.

Settings: This prospective cross-sectional study was carried out among patients diagnosed with asthma or COPD and prescribed with inhaler medication in the form of pressurized metered-dose inhaler (pMDI), MDI with spacer, or dry powder inhaler (DPI).

Subjects and methods: The inhaler device use by the patients was assessed initially, followed by a demonstration on inhaler device technique, and reassessed post training using a checklist.

Statistical analysis: Comparison of the median total score of pretraining and posttraining inhaler technique was analyzed by Wilcoxon signed rank test. P < 0.05 was considered statistically significant.

Results: Out of 144 patients, 55.6%, 27.7%, and 16.7% of them were prescribed pMDI, MDI with spacer, and DPI, respectively. Post inhaler technique training, about 79.2% of the patients were able to demonstrate the inhaler technique correctly compared to 52.1% prior to training. A statistically significant difference in the median score of inhaler technique has been observed before and after training.

Conclusions: This study reports a significant improvement in the correct use of inhaler technique post training. In addition, the most frequent error among inhaler users was revealed to be in the breath actuation.

Context: Clinical Trials (CTs) are the key when it comes to informing clinical decision-making processes. There is a very low number of CTs conducted in Togo, and there is no study that assessed the willingness of Togolese to participate in CTs.

Aims: The aim of this study was to assess public awareness and willingness to participate in CTs in Togo.

Subjects and methods: We designed a cross-sectional study, using an online survey with Google Form in the general population, carried out from December 2019 to March 2020.

Statistical analysis used: An Excel sheet was generated from the Google Form, and we performed a descriptive analysis using IBM SPSS Statistics 21. All variables were presented as frequencies and percentages.

Results: This study involved 210 participants. The findings of this study are showing that Togolese are reasonably aware about CTs, and they have a positive intention to participate, but they are ignorant of national CTs regulations. Although unawareness and unwillingness may be universally common, one challenge in Togo is the lack of communication.

Conclusions: The findings of this study are encouraging. The National Bioethics Committee for Health needs to be better communicative, and providing training in clinical research is essential.

Objectives: The objective was to estimate the proportion of adverse drug reactions (ADRs) to daily regimen antituberculosis treatment (ATT) among the ADRs received in the ADR monitoring center (AMC) of the institution and to describe its pattern.

Materials and methods: This was a descriptive study conducted in the Department of Pharmacology of a Government Medical College in Central Kerala and the period under study was October 2017-June 2020. The data on ADR were entered into a structured pro forma and data were analyzed using SPSS for Windows Version 16.0 (SPSS Inc., Chicago, USA).

Results: Of the 643 ADRs, 98 (15.24%) were suspected to be due to the daily regimen of ATT. The most common organ system affected was hepatobiliary 46 (46.9%) namely hepatitis in 35 and asymptomatic elevated liver enzymes in 11 followed by eye with 26 reports of decreased vision. In 96 (97.95%), the suspected ADR had probable causality and in 2 (2.04%) it was possible. Seventy-seven (78.6%) ADR reports were serious as well as moderate-level 4b in severity and 57 (58.16%) were probably preventable. The mean days of onset of ADR after starting the ATT regimen were 56.40 ± 58.29 days (range 1-180). Decrease in vision with a mean duration of 125.23 ± 55.46 days had the longest latency in onset among all the ADRs.

Conclusions: Of all the ADRs reported to AMC 15.24% were due to the daily regimen of ATT. Hepatitis was the most common ADR encountered followed by decrease in vision. The majority of the ADRs were probable in causality, serious, moderate-level 4b in severity, and probably preventable.

Introduction: Prescription of drugs should always be done in a judicious manner and with a satisfactory risk/benefit ratio. Pharmacotherapeutic agents are one of the important causes of adverse effects starting from mere inconvenience to permanent disability and death. Studies suggest that about 0.2%-24% of patients with adverse drug reactions (ADRs) are subjected to hospital admission in India as well as in several highly developed industrialized countries. India contributes below 1% in terms of ADR reporting against the world rate of 5%. To enhance the reporting rate, it is important to improve the knowledge, attitude, and practice (KAP) of all the health-care professionals with regard to the ADR reporting and the pharmacovigilance (PV).

Aim: The aim of the study was to evaluate the basic KAP of the postgraduate (PG) students at Meenakshi Medical College and Hospital, Enathur, Kanchipuram, Tamilnadu, India, regarding ADR monitoring and PV.

Materials and methods: This was a before and after comparison study with an educational intervention. A knowledge-, attitude-, and practice-based questionnaire on ADR reporting and PV program was prepared and administrated.

Results: Participants had good theoretical knowledge regarding PV, but their attitudes and practical knowledge increased significantly after an educational intervention. The overall scores observed between pretest and posttest were found to be statistically significant.

Conclusion: Educational intervention had proven to be an effective tool in improving the KAP of PV in the present study. Lack of motivation and training toward ADR reporting discourages PGs from reporting. Revisions are needed to include the clinical application of PV in the present academic curriculum. Ensuring a better safety profile for drugs can be done only through PV.