ABSTRACT
Objectives: Patients with brain tumors are prone to develop deep venous thrombosis (DVT) following neurosurgical excision of tumor. However, there is a deficiency of knowledge about the screening method, optimum frequency, and duration of the surveillance to diagnose DVT in the post-operative period. The primary objective was to find the incidence of DVT and associated risk factors. The secondary objectives were to find the optimum duration and frequency of surveillance venous ultrasonography (V-USG) in patients undergoing neurosurgery. Materials and Methods: Hundred consecutive adult patients undergoing neurosurgical excision of brain tumors were included after their consent, over a period of 2 years. The risk factors for DVT were assessed in all the patients preoperatively. All patients underwent surveillance duplex V-USG of the upper and lower limbs at pre-planned time intervals in the perioperative period, by experienced radiologists and anesthesiologists. The occurrence of DVT was noted using the objective criteria. The association between the perioperative variables and the incidence of DVT was assessed using univariate logistic regression analysis. Results: The most common prevalent risk factors were - malignancy (97%), major surgery (100%), and age >40 years (30%). Asymptomatic DVT was detected in the right femoral vein in one patient who underwent suboccipital craniotomy for high-grade medulloblastoma, on the 4th and 9th postoperative day, making the incidence of DVT 1%. The study found no association with perioperative risk factors and could not suggest the optimum duration and frequency of surveillance V-USG. Conclusion: A low incidence of DVT (1%) was detected in patients undergoing neurosurgeries for brain tumors. Prevalent thromboprophylaxis practices and a shorter period of post-operative surveillance could be the reasons for the low incidence of DVT.
ABSTRACT
Context: A failure to obtain continued Institutional Ethics Committee (IEC) approval for the study before the expiry date assigned by the IEC is considered as "lapse of the IEC approval" to continue the study at the site by the Investigator. Considering this, we had conducted an audit of principal investigators (PI ') compliance for Continuing Review Application (CRA) submission timelines and decision taken on the lapses in the validity of IEC approval continuation. Aim: The aim of this study is to assess the pre- and post-policy trends of non-compliance management of delayed CRA submission and compare the PI's compliance for submission of CRA between Investigator Initiated trial (IIT) and Pharma studies. Setting and Design: The present study was a retrospective audit of CRAs of ongoing projects submitted by PIs to IEC, ACTREC. Materials and Methods: The data from total 199 CRAs submitted for review to the IEC between the year January 2016 and December-2017 were collected and maintained in Microsoft Excel sheet, and later, the data were exported into the SPSS software version 21 for the analysis. Statistical Analysis: All categorical data were presented in numbers and percentage. The first primary objective was assessed by calculating the duration between the dates of approval for any study to the date of next CRA submission. The CRAs submitted after the project expiry date were considered as a lapse in following the IEC SOP. Results: This retrospective audit revealed that CRA reminder sent by the IEC to the PI played an important role in compliance w. r. t timely in following the IEC SOPof the CRA by the PI. As a result, overall, 90% of CRAs showed compliance in submitting CRAs to IEC in both IIT and Pharma study. The number of lapses were reduced to 7 in the postpolicy period as compared to 15 lapses in the prepolicy period. Conclusion: This retrospective audit reveals that CRA reminder sent by the IEC to the PI played an important role in improving the compliance of PIs in submitting CRA to IEC. Each IEC should develop the policy to minimize the delays in CRA submission by the PI and prevent lapses in following the IEC SOP.
ABSTRACT
CONTEXT: Adherence to good clinical practice (GCP) guidelines by the researcher provides public confidence that the rights, safety and well-being of human participants involved in research are protected. It has been observed that researchers require basic GCP training. Considering this, we had decided to conduct a training session on overview of GCP. AIMS: To strengthen the knowledge and awareness regarding GCP. SETTINGS AND DESIGN: The design of the study was quasi-experimental one group, pre-test and post-test design and the study was conducted at ACTREC among healthcare professionals at Tata Memorial Centre. METHODS AND MATERIAL: A semi-structured questionnaire was used to collect the data in pre and post-test. A total of 138 participants were participated in the study. The training session was pre-planned which included a lecture followed by the question-answer session. STATISTICAL ANALYSIS USED: Wilcoxon Signed Rank test was used to assess the effect of the planned teaching programme. Macnemar test was used for item wise comparison of pre and post-test scores. Mann Whitney test was used to determine the significant difference between knowledge scores and selected demographic variables. RESULTS: This study has resulted in overall improvement of knowledge with a median difference of 5 with P-value <0.001. There was a statistically significant improvement of knowledge between pre and post-test of those having GCP training in the past, working group and education. CONCLUSIONS: The exercise of holding training program was found to be significant in improving the knowledge base of participants, especially investigators and study coordinators.