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Table 2 Summary of information gained from the survey and cohort study

From: Contributions of a survey and retrospective cohort study to the planning of a randomised controlled trial of corticosteroids in the treatment of paediatric septic shock

Information needed

Information obtained from each study design

Information gained by doing both

Effect of information obtained on RCT protocol

 

Survey study

Cohort study

  

Overall frequency of steroid use for fluid resistant septic shock

Wide variation in individual physician responses within and between centres

Overall steroid use varied from 35.3% to 71.4% between centres

Despite survey responses to the contrary, one centre had a high rate of empiric corticosteroid administration

Centres with a high rate of steroid administration and centres with ≥50% of respondent physicians stating they often or always administer steroids for septic shock were not included in the RCT

Use of steroids in patients who received 60 cm3/kg of fluid and were on two or more vasoactive agents

95.6% of physicians surveyed stated they would administer steroids to such patients

50.8% of such patients actually received steroids

The discrepancy between the survey and cohort study findings suggests that physicians believe there may be benefit to corticosteroids but do not always administer them

This discrepancy provided support for the existence of community equipoise, which was needed as justification for the grant to fund the RCT

Performance of adrenal testing

The majority of physicians stated that they sometimes, often or always perform adrenal testing prior to steroid use

Only 5.1% of patients had adrenal testing performed prior to steroid use

The discrepancy between what physicians say they do versus what they did regarding adrenal testing suggests that physicians may believe that adrenal testing should be performed but rarely do

We identified barriers to conducting adrenal testing including delays in obtaining results, difficulty in interpreting results and the cost of conducting the test. Due to these findings, adrenal testing was not required as part of the protocol

Physician willingness to randomise patients

84.3% would be willing to randomise patients on one high dose of vasoactive medication. However, 74.3% would start open-label steroids in patients requiring two high doses of vasoactive medication

It was not possible to determine willingness to randomise but we observed a lower rate of steroid use (50.8%) in the patient group for which 74.3% of respondents said they would administer steroids

The lower rate of actual steroid administration suggests that physicians might be open to randomisation and protocol adherence in the target population but that open-label steroid use would be a significant threat to the feasibility of the study

This finding emphasised the need for a pilot RCT with close monitoring of both the frequency and reported reasons for open-label steroid use

Dose of hydrocortisone therapy

65.2% reported using the equivalent of 1 mg/kg/dose q6h and 26.1% used 2 mg/kg/dose q6h

56.3% of patients received 1 mg/kg/dose q6h and 26.7% received 2 mg/kg/dose q6h

The majority of physicians used 1 mg/kg/dose of hydrocortisone with 2 mg/kg/dose being a common second choice

The paediatric literature varies significantly regarding the dose of hydrocortisone for septic shock. However, given the consistency of the survey and cohort study data, we opted to use an initial bolus of 2 mg/kg/dose followed by 1 mg/kg/dose q6h

  1. RCT randomised controlled trial