TITLE: Minimizing Antibiotic Usage for Poorly localizable fevers of short duration in Adults using a Check List and Temperature Monitoring.
PLACE OF STUDY: The study was conducted in Medicine, Peoples Hospital, PCMS & RC, Bhopal, M.P.
STUDY DESIGN – It was Prospective Observational Study.
STUDY PERIOD – over one year
SAMPLE SIZE - 500 patients
SAMPLE POPULATION -Patients of age 14-50 yrs attending Medicine Department in PCMS & RC, Bhanpur, Bhopal.
INCLUSION CRITERIA:
Written informed consent from each patient or legal guardian prior to enrollment.
Patients Age 14 to 50 years
Recent-onset fever (within one to five days) when the diagnostic uncertainty is high.
Symptoms commonly suggestive of self-limiting flu like illnesses such as myalgia, arthralgia with commonly known symptoms indicating involvement of upper respiratory tract such as cough, rhinorrhoea, frontal headache etc.
EXCLUSION CRITERIA:
Obvious clinical localization for fever such as pneumonia, meningitis, urinary tract infection etc.
Clinical diagnosis suggesting important clinical localizations such as spontaneous bacterial peritonitis in cirrhotic patients with ascitis.
Elderly, underlying immunosuppression or any associated conditions predisposing to severe infections such as diabetes.
CONSENT:
Written and informed consent in local language was obtained prior to enrollment in study.
ETHICAL APPROVAL:
Institutional Ethical clearance for this study was obtained from Institutional Ethics Committee at Peoples Hospital, Barkatullah University, Bhopal.
METHOD OF STUDY:
Five hundred clinically matched patients over one year presenting with recent-onset fever to the Peoples Hospital PCMS & RC, Bhopal, was prospectively monitored for fever, duration of illness and satisfaction levels.
In fever patients presenting to PCMS&RC we had used a check list to allocate suitable patients to just antipyretics and/or antibiotics and temperature charting for 2 days (extended to 4 days if fever persists but lesser number of fever episodes per day and temperature spikes <1030F) and study their health care outcomes. After monitoring for two days if the fever shows a progression only then antibiotics been instituted. (depending on the judgment of the treating physician).
Two groups were studied:
Group A –
This group comprise of patients encountered by investigators (not blinded to the patient’s inclusion status in the study), they waited two days before taking a decision on antibiotics after selecting patients for the above on the basis of inclusion criteria and continue to encourage monitoring of their fever patterns over two days.
Group B –
This group comprise of patients encountered by Physicians delivering their usual care for fever (as per their prevailing clinical judgment). They remained blinded to the patient’s status in the study.
Patient’s recruitment was done through OPD attender from OPD and was alternately allocated in each group. Patients been recruited such that to cover all seasons in a year. OPD Patients were advised Temperature charting 8 hourly and also during fever episodes for 2 days (duration been extended for 4 days if fever persists but with lesser number of fever episodes per day and temperature spikes <1030F). Patients who were admitted in hospital, their temperature been monitored by patient itself or by his/her relative or by nursing staff.
Patient reviewed after 2 days by personal appearance or Phone call for follow up about temperature charting, fever pattern, duration of illness/time to recovery, events inbetween two days if any, check list score and satisfaction level on VAS. A Check List being provided for deciding whether to use antibiotic or not during the course of illness or to explain whether Antibiotic need was there or not. VAS (Visual Analogue Scale) being used before and after the illness to access the satisfaction level of Patient’s. Patient was advised to report immediately for any urgent need.
STUDY TOOLS –
Mercury Thermometer.
Check List.
VAS (Visual Analogue Scale)
CHECK LIST
(To decide whether to use Antibiotics or Not)
- Cough with sputum production/ haemoptysis
/ Breathlessness 0 1
- Chest pain, palpitation 0 1
- Tachypnoea, Hypotension 0 1
- Epigastric or right hypochondrial or
right iliac fossa (abdominal) pain / jaundice 0 1
-Vomiting and/or constipation or diarrhoea 0 1
- Burning micturition/pain during micturition and
Low back pain/ Urinary dysuria 0 1
- Yellow discolouration of sclera 0 1
- Confusion, altered sensorium 0 1
- Black coloured stool (malena) and/or blood 0 1
In vomiting
- Immunosuppressive conditions like 0 1
Diabetes/CRF (kidney failure)/Malignancy/HIV
/Any chronic illness
VISUAL ANALOUGE SCALE (VAS) –
A Visual Analogue Scale (VAS) is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured.
READING AT THE TIME OF PRESENTATION-
1 2 3 4 5 6 7 8 9 10
☹ ☺
The symbols indicate patient’s level of satisfaction/well-being with their current health.
READING AFTER RECOVERY –
1 2 3 4 5 6 7 8 9 10
☹ ☺
The symbols indicate patient’s level of satisfaction/well-being with their current health
STATISTICAL ANALYSIS:
Statistical analysis were done using SPSS software version 20. Average/median duration of fever will be ascertained. Dispersion in terms of range and standard deviation will be calculated. Antibiotic/ antipyretics consumptions will be associated/correlated by duration of fever by using Student T-test, and patient satisfaction through Mann-Whitney Test and appropriate statistical test.
OBSERVATION
The present study was conducted in Department of Medicine, Peoples Hospital PCMS & RC, Bhopal - a tertiary care centre from June 2012- May 2013. Ethical approval for this study was obtained from Institutional Ethics Committee at Peoples Hospital, Barkatullah University, Bhopal.
. A total of 500 subjects (246 males, 254 females) were recruited in the study.
SEX | FREQUENCY | PERCENT |
MALE | 246 | 49.2 |
FEMALE | 254 | 51.8 |
TOTAL | 500 | 100.0 |
Group |
|
GROUP | Gender | Total |
MALE | FEMALE |
| NO ANTIBIOTIC | 118 | 132 | 250 |
| ANTIBOITIC | 128 | 122 | 250 |
Total | 246 | 254 | 500 |
|
T-Test –
Group Statistics |
| Group | N | Mean | Std. Deviation | Std. Error Mean |
DURATION OF ILLNESS | NO ANTIBIOTIC | 250 | 2.57 | 1.008 | .064 |
ANTIBOITIC | 250 | 2.58 | 1.070 | .068 |
NO. OF FEVER SPIKES | NO ANTIBIOTIC | 250 | 2.13 | 1.607 | .102 |
ANTIBOITIC | 250 | 2.13 | 1.513 | .096 |
