An audit of the knowledge and attitudes of doctors towards Surgical Informed Consent (SIC)

Background: The Surgical Informed Consent (SIC) is a comprehensive process that establishes an information- based agreement between the patient and his doctor to undertake a clearly outlined medical or surgical intervention. It is neither a casual formality nor a casually signed piece of paper. The present study was designed to audit the current knowledge and attitudes of doctors towards SIC at a tertiary care teaching hospital in Pakistan. Methods: This cross-sectional qualitative investigation was conducted under the auspices of the Department of Medical Education (DME), Pakistan Institute of Medical Sciences (PIMS), Shaheed Zulfiqar Ali Bhutto Medical University (SZABMU), Islamabad over three months period. A 19-item questionnaire was employed for data collection. The participants were selected at random from the list of the surgeons maintained in the hospital and approached face-to-face with the help of a team of junior doctors detailed for questionnaire distribution among them. The target was to cover over 50% of these doctors by convenience sampling. Results: Out of 231 respondents, there were 32 seniors while 199 junior doctors, constituting a ratio of 1:6.22. The respondents variably responded to the questions regarding various attributes of the process of SIC. Overall, the junior doctors performed poorer compared to the seniors. Conclusion: The knowledge and attitudes of our doctors particularly the junior ones, towards the SIC are less than ideal. This results in their failure to avail this golden opportunity of doctor-patient communication to guide their patients through a solidly informative and legally valid SIC. They are often unaware of the essential preconditions of the SIC; provide incomplete information to their patients; and quite often do not ensure direct involvement of their patients in the process. Additionally they lack an understanding of using interactive computer-based programs as well as the concept of nocebo effect of informed consent

Effect of early tranexamic acid administration on mortality, hysterectomy, and other morbidities in women with post-partum haemorrhage (WOMAN): an international, randomised, double-blind, placebo-controlled trial

Background Post-partum haemorrhage is the leading cause of maternal death worldwide. Early administration of tranexamic acid reduces deaths due to bleeding in trauma patients. We aimed to assess the effects of early administration of tranexamic acid on death, hysterectomy, and other relevant outcomes in women with post-partum haemorrhage. Methods In this randomised, double-blind, placebo-controlled trial, we recruited women aged 16 years and older with a clinical diagnosis of post-partum haemorrhage after a vaginal birth or caesarean section from 193 hospitals in 21 countries. We randomly assigned women to receive either 1 g intravenous tranexamic acid or matching placebo in addition to usual care. If bleeding continued after 30 min, or stopped and restarted within 24 h of the first dose, a second dose of 1 g of tranexamic acid or placebo could be given. Patients were assigned by selection of a numbered treatment pack from a box containing eight numbered packs that were identical apart from the pack number. Participants, care givers, and those assessing outcomes were masked to allocation. We originally planned to enrol 15 000 women with a composite primary endpoint of death from all-causes or hysterectomy within 42 days of giving birth. However, during the trial it became apparent that the decision to conduct a hysterectomy was often made at the same time as randomisation. Although tranexamic acid could influence the risk of death in these cases, it could not affect the risk of hysterectomy. We therefore increased the sample size from 15 000 to 20 000 women in order to estimate the effect of tranexamic acid on the risk of death from post-partum haemorrhage. All analyses were done on an intention-to-treat basis. This trial is registered with ISRCTN76912190 (Dec 8, 2008); ClinicalTrials.gov, number NCT00872469; and PACTR201007000192283. Findings Between March, 2010, and April, 2016, 20 060 women were enrolled and randomly assigned to receive tranexamic acid (n=10 051) or placebo (n=10 009), of whom 10 036 and 9985, respectively, were included in the analysis. Death due to bleeding was significantly reduced in women given tranexamic acid (155 [1·5%] of 10 036 patients vs 191 [1·9%] of 9985 in the placebo group, risk ratio [RR] 0·81, 95% CI 0·65–1·00; p=0·045), especially in women given treatment within 3 h of giving birth (89 [1·2%] in the tranexamic acid group vs 127 [1·7%] in the placebo group, RR 0·69, 95% CI 0·52–0·91; p=0·008). All other causes of death did not differ significantly by group. Hysterectomy was not reduced with tranexamic acid (358 [3·6%] patients in the tranexamic acid group vs 351 [3·5%] in the placebo group, RR 1·02, 95% CI 0·88–1·07; p=0·84). The composite primary endpoint of death from all causes or hysterectomy was not reduced with tranexamic acid (534 [5·3%] deaths or hysterectomies in the tranexamic acid group vs 546 [5·5%] in the placebo group, RR 0·97, 95% CI 0·87-1·09; p=0·65). Adverse events (including thromboembolic events) did not differ significantly in the tranexamic acid versus placebo group. Interpretation Tranexamic acid reduces death due to bleeding in women with post-partum haemorrhage with no adverse effects. When used as a treatment for postpartum haemorrhage, tranexamic acid should be given as soon as possible after bleeding onset. Funding London School of Hygiene & Tropical Medicine, Pfizer, UK Department of Health, Wellcome Trust, and Bill & Melinda Gates Foundation

An Audit of the Knowledge and Attitudes of Doctors towards Surgical Informed Consent (SIC)

Background: The Surgical Informed Consent (SIC) is a comprehensive process that establishes an informationbased agreement between the patient and his doctor to undertake a clearly outlined medical or surgical intervention. It is neither a casual formality nor a casually signed piece of paper. The present study was designed to audit the current knowledge and attitudes of doctors towards SIC at a tertiary care teaching hospital in Pakistan. Methods:This cross-sectional qualitative investigation was conducted under the auspices of the Department of Medical Education (DME), Pakistan Institute of Medical Sciences (PIMS), Shaheed Zulfiqar Ali Bhutto Medical University (SZABMU), Islamabad over three months period. A 19-item questionnaire was employed for data collection. The participants were selected at random from the list of the surgeons maintained in the hospital and approached face-to-face with the help of a team of junior doctors detailed for questionnaire distribution among them. The target was to cover over 50% of these doctors by convenience sampling. Results:Out of 231 respondents, there were 32 seniors while 199 junior doctors, constituting a ratio of 1:6.22. The respondents variably responded to the questions regarding various attributes of the process of SIC. Overall, the junior doctors performed poorer compared to the seniors. Conclusion:The knowledge and attitudes of our doctors particularly the junior ones, towards the SIC are less than ideal. This results in their failure to avail this golden opportunity of doctor-patient communication to guide their patients through a solidly informative and legally valid SIC. They are often unaware of the essential preconditions of the SIC; provide incomplete information to their patients; and quite often do not ensure direct involvement of their patients in the process. Additionally they lack an understanding of using interactive computer-based programs as well as the concept of nocebo effect of informed consent