Chapter 6 Contextual Ethics in Risk Management Decision Making; Intrapersonal and interpersonal contexts
Environmental and societal contexts, which I examine in the next chapter
The use of prophylactic antibiotics is effective in reducing infective complications following transrectal prostate biopsy.
There was no significant difference in infective complications between the two groups of patients studied. The finding suggests that in selected patients without obvious pre-existing risk factors for infection, a 1-day regimen is as effective as a 5-day regimen for antibiotic prophylaxis in transrectal prostate biopsy
In almost all cases, the bacterial isolates were resistant to ciprofloxacin and as such prolongation of antimicrobial therapy would have been of no added value.
Despite being more expensive, prolonged antibiotic administration was not more effective in preventing infections after biopsy. Therefore, for antibiotic prophylaxis a 1-day regimen seems simple, effective and practicable in this setting.
On account of the above, the author recommends a 1-day prophylactic regimen for transrectal prostate biopsyin selected patients.
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APPENDIX A PROFORMA
NAME --- DATE --- HOSPITAL NUMBER ---
AGE --- SYMPTOMS
[ ] Lower Urinary Tract Symptoms [ ] Bone Pains
[ ] Weight Loss [ ] Haematuria [ ] Paraparesis
[ ] Others --- --- PROSTATE:
Prostate Specific Antigen (PSA) Level---ng/ml Prostate size on ultrasound scan---g REASON FOR BIOPSY:
[ ] Elevated PSA
[ ] Abnormal Digital Rectal Examination (DRE) Findings [ ] Others---
PROPHYLACTIC GROUP:
[ ] I 1-day prophylaxis [ ] II 5-day prophylaxis
PRE- BIOPSY URINE CULTURE
[ ] Positive growth [ ] No growth INFECTIVE COMPLICATIONS:
[ ] Fever
[ ] Positive post biopsy urine culture (UTI)
[ ] Others--- NON INFECTIVE COMPLICATIONS:
[ ] Retention of urine [ ] Haematuria
[ ] Rectal bleeding [ ] Haematospermia [ ] Perineal pain
[ ] Others --- POST BIOPSY URINE CULTURE:
[ ] Positive growth [ ] No growth
Organism --- Sensitivity ---
POST BIOPSY BLOOD CULTURE:
[ ] Positive growth [ ] No growth
Organism --- Sensitivity ---
HOSPITAL ADMISSION DUE TO COMPLICATIONS [ ] Yes
[ ] No
ESTIMATED COST OF ANTIBIOTICS Group I ---
Group II --- HISTOLOGY:
[ ] Benign [ ] Malignant
[ ] Others ---
APPENDIX B CONSENT FORM
I, Dr Jude Agbugui of the department of Surgery, University of Benin Teaching Hospital wish to carry out a research titled “antibiotic prophylaxis for transrectal prostate biopsy; a prospective study of 1- day versus 5- day antibiotic regimen”.
Before you decide to take part or not, it is important for you to understand why the research is being done, what it will involve and the possible benefits and discomfort. Please take time to read the information carefully.
WHAT IS THE STUDY ABOUT?
The study is aimed at determining whether the use of antibiotics for 1 day would be as effective as that for 5 days in preventing infections following prostate biopsy. Prostate biopsy may be associated with complications like fever and urinary tract infections. Antibiotics are usually given to prevent such infections but there is no agreement amongst doctors on how long this should be. Today, antibiotics are being overused. This is associated with heavy financial burden on patients and increased risk of side effects. As a result of the above, limiting the length of antibiotic administration in prostate biopsy has been considered.
WHAT WILL BE DONE IF YOU PARTICIPATE IN THIS STUDY?
You will be randomly assigned to either one of 2 groups. If you are in group 1, you will receive antibiotics for 1 day. If you are in group 2, you will be given antibiotics for 5 days. You will be required to provide urine and blood samples when necessary for investigations. These investigations will be done for you at no extra cost. It is important to know that if you decide not to take part in the study it will not affect your relationship with your doctors in any way. However, if you decide to participate, you will be expected to sign the consent form provided. You can also leave the study at any point even after giving consent.
WILL THE INFORMATION BE CONFIDENTIAL?
The information obtained during the study will be stored and analysed. The results may be published in Medical journals but your identity will not be revealed.