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Background and Aims: Cardiovascular diseases are the leading causes of morbidity and mortality in chronic kidney disease (CKD) patients. Our aim was to derive predictors of cardiac morbidity, mortality, cardiac complications and to develop/validate a scoring tool in patients with CKD undergoing non-cardiac surgery. Methods: A prospective observational multicentre study was done on 770 patients with CKD. The primary outcome ("Event") was one or more than one of sudden cardiac death, pulmonary oedema, acute coronary syndrome, arrhythmia and 30-day mortality. Secondary outcome was hypertension and hypotension. Predictors of cardiac risk were identified. A scoring tool was developed on the 2018 dataset and was validated on the 2019 dataset. Results: The overall incidence of cardiac events was 290 (37.66%) whereas the incidence of major adverse cardiac and cerebrovascular events was 15.04%. Mortality due to cardiac cause was 13 (1.68%). On multivariate regression analysis, seven perioperative variables had significant association with increased risk of events: age > 65 years (P = 0.004), metabolic equivalents (METS) ≤4 (P≤0.032), emergency surgery (P =0.032), mean arterial pressure >119 (P = 0.001), echocardiographic scoring (P = 0.054), type of anaesthesia (P ≤ 0.0001) and type of surgery (P = 0.056). Using these variables, a risk stratification tool was developed. C statistics showed favourable predictive accuracy (0.714) and the model showed good calibration. Conclusion: This risk scoring tool based on preoperative variables will help to predict the risk of events in high-risk CKD patients undergoing non-cardiac surgery. This will help in better counselling and optimisation. [ABSTRACT FROM AUTHOR]

Aim To conduct a systematic review to summarize the outcome of adult patients with history of type II DM after renal transplantation [RTx] in following category of patients: (1) type 2 DM; (2) type 2 DM vs Non-DM; (3) type 2 DM vs Dialysis; (4) Preemptive Kidney Transplant (prekTx) vs non prekTx. Method MEDLINE, EMBASE, Renal transplant registries were searched for observational/cohort/case-control studies from 1980 to 2015. Results We identified 10 studies reporting outcome of kidney transplantation in patients with type 2 DM [type 2 DM (2), type2 DM vs Non-DM (6), type 2 DM vs Dialysis (1), prekTx vs non-prekTx (1)]. One and five year graft survival ranged from 76% to 100% and 53% to 96% respectively. 8, 4, 8, and 2 studies showed 1, 3, 5 and 10 yr patient survival respectively. Recent study with type 2 DM patients showed at 10 yrs, graft survival did not differ between Non-DM and type 2 DM but Non-DM patient survival was better ( p < .001) than type 2 DM patients after RTx. At 5 yrs, patient survival ranged from 29% to 97%. Graft and patient survival did not differ between type 2 DM and Non-DM patients in three and two studies respectively. A study showed at 10 yrs, survival after RTx was significantly ( p < .001) better than patients on dialysis. Preemptive transplant study reported lower adjusted graft failure and mortality risk for type 2 DM transplant recipients from living donors compared to deceased donors. Conclusion Results from these few single center studies demonstrate the need for multicenter rigorous studies to look at long term survival of type 2 diabetes patients after renal transplant. [ABSTRACT FROM AUTHOR]

Context: Studies have reported that clinical research has experienced tremendous growth during past few decades with many multinational pharmaceutical companies recruiting millions of Indians in clinical trials (CTs). However, there is hardly any literature that talks about the participants, their knowledge, and awareness of CTs. It is important that the general public is aware about CTs so that they can take their own informed decision to participate in CTs. Aim: To assess public awareness, perceptions, and attitudes toward CTs and their views on various methods to create awareness about CTs. Materials and Methods: Cross sectional survey was conducted with 200 non trial participants (NTPs) and 40 trial participants (TPs). Results: TPs were significantly (P < 0.0001) older than NTPs. More than 80% of both TPs and NTPs mentioned participation in CT helps advance medical science and strongly felt that there is a need to create awareness about CTs. Nearly 70% of TPs could not remember the phase of the trial while 20% did not know which type of trial they had participated. The main reason for participation in the trial was physician's advice. About 80% of both TPs and NTPs felt that participation in CT will increase with free medications and advice from friends/relatives who had good experience with trial. Conclusion: Results of this pilot study revealed need to create CT awareness among the general public. However, considering ethno-cultural, regional, and literacy-level differences throughout the country, a nationwide study would be appropriate to provide reliable results about awareness of CTs among Indians. [ABSTRACT FROM AUTHOR]

Context: Medical expertise combined with availability of patients with varied diseases have resulted in rapid increase in number of clinical trials (CTs) recruiting millions of patients in India. Yet, few researchers have tried to understand if the public in India is aware of CTs. Aims: To explore the awareness, perceptions of and attitude towards participating in CTs among general public in Pune. Materials and Methods: Focus group discussions (FGDs) and interviews were conducted by contacting people in the community of various age groups and socio economic status with 7 Trial participants (TPs) and 17 Non Trial Participants (NTPs). The survey tool consisted of open-ended questions that assessed the awareness and attitudes of the individuals regarding the CTs. Interview were recorded on paper and translated from (Marathi) local language to English for analysis. Qualitative analysis was used to report the findings. Results: Most participants could associate CTs with medicine or development of new medicine; however they did not have a good understanding of the manner and safeguards with which CTs are conducted. Participants were not aware about different types of CTs and phases of the CTs. CTs were felt to be of benefit to the community and advancement of science. However, due to fear of adverse effects, 80% of the respondents were not ready to participate in the CTs. Conclusions: The Indian Pharmaceutical company is the world's 3rd largest by volume as per Dr. Shivathanu Pillai's report 17th March 2010, in spite of that it has been noticed that the awareness about CTs is very low; therefore there is a need to create awareness about CTs which helps the participants to participate in CTs based on their own decision. These FGD findings require validation in a lar ger sample. [ABSTRACT FROM AUTHOR]

A letter to the editor is presented on the need for transparency in recruitment of patients during clinical trials (CTs).