[version 1; peer review: 2 not approved]
No competing interests were disclosed.
Urinary tract infection is considered a common bacterial infection. Nowadays there is an increase in the irrational and inappropriate use of drugs.
Adverse drug reactions have been reported to be a main cause of morbidity, hospital admission, and sometimes death. For this, it is very important to do the analysis of prescriptions and to see the adverse drug reactions due to the prescribed drugs.
To determine the prescribing pattern of drugs used in urinary tract infections of the reproductive age group (15-44). To identify adverse reactions due to drugs used for UTI of reproductive age group (15-44). To observe the pattern of combination therapy for urinary tract patients of reproductive age group. To analyze the Fixed Drug Combination.
It is a retrospective observational study. Data will be collected from 175 prescription papers. Data will be collected from the medical record section. The study will include prescriptions of UTI for Females of the reproductive age group (15-44 years).
Urinary tract infection occurs when microbial pathogens are present in the urinary tract. It affects both genders but it is more common in women and it affects the females of the reproductive age group (15-44 years) mostly. It may be because of their anatomy and reproductive physiology. Women get urinary tract infections more often because their urethra is shorter than men's and it may be due to delay in micturition, use of contraceptives, and sexual activity.
The kidneys and the ureter are involved in upper urinary tract infections, while the bladder and urethra are involved in lower urinary tract infections.
Clinically urinary tract infection is classified into – Complicated/uncomplicated and primary/recurrent.
Treatment of urinary tract infections may vary according to location, age of patient, and severity of presentation in the community. After the urine culture sensitivity test, empiric therapy for UTI should be initiated. The choice of medication should be determined by identifying the pathogen, assessing sensitivity through urine culture, and considering the patient's comorbid conditions.
Uncomplicated cystitis:
Nitrofurantoin 100mg - 5 days is the 1 st line treatment and
2 nd line treatment for uncomplicated cystitis: Trimethoprim/Sulfamethoxazole - 3 days,
oral Cephalexin 500mg - 3-7 days, or Fosfomycin 3 g -1 day.
Complicated cystitis:
Nitrofurantoin 100mg - 7 days is the 1 st line treatment and
Trimethoprim/Sulfamethoxazole -7 days, or oral Cephalexin 500 mg - 7 days, or Fosfomycin 3g every 48 hours for 3 doses is the 2nd line treatment.
Most commonly Nitrofurantoin and Sulfonamides are used in the treatment of UTI in reproductive age groups and pregnant women.
RELATED ADVERSE DRUG REACTIONS:
(1) Adverse drug reactions of Nitrofurantoin:
Nausea, loss of appetite, vomiting and diarrhea
Severe adverse reactions are:
Pulmonary toxicity (acute, subacute, chronic pulmonary reaction)
liver injuries due to nitrofurantoin
Peripheral neuropathy – is rare and it is mostly seen in patients with poor renal function and on prolonged use.
(2) Adverse drug reactions of Sulfonamides:
Sulfonamide-induced liver injury- it can be hepatocellular or cholestatic hypersensitivity reactions include fever, facial edema, lymphadenopathy, arthralgias, rash, eosinophilia, or atypical lymphocytosis (or both).
diarrhea, nausea, headaches, and dizziness, skin rash.
Rare adverse reactions:
severe allergic skin rashes, aplastic anemia, pancreatitis, serum sickness, Stevens-Johnson syndrome, agranulocytosis, nephritis, confusion seizures, and ataxia.
Nowadays, it is necessary to evaluate prescriptions due to the rapid changes in the prescriptions of diseases.
To analyze the irrational and inappropriate use of drugs this study is necessary.
For the improvement of patient compliance and to find out what type of adverse reactions are seen in reproductive age group female (15-44yrs) UTI patients due to prescribed drugs.
To analyze the prescription pattern and adverse drug reactions of drugs used in urinary tract infections of reproductive age group (15-44).
To determine the prescribing pattern of drugs used in urinary tract infections of the reproductive age group (15-44). To identify adverse reactions due to drugs used for UTI of reproductive age group (15-44).
To observe the pattern of combination therapy for urinary tract patients of reproductive age group. To analyze the Fixed Drug Combination.
The study will include prescriptions of UTI for Females of the reproductive age group (15-44 years).
ICU patients
Incomplete case files.
This research study will be carried out in the Department of Pharmacology.
Daniel Formula:
Z = statistic for a level of confidence =1.96
P = Prevalence of urinary tract infection =33.54% = 0.3354
d = Desired error of margin = 7% = 0.07
We will collect recorded files of patients from the medical record section. And Analyze prescriptions and adverse drug reactions of patients.
| NAME | AGE/SEX | MRD NO. | OPD NO. | DIAGNOSIS | DRUGS USED | DOSE OF THE DRUG | ANY IRRATIONAL IN PRESCRIPTION | DURATION OF DRUG THERAPY | ADVERSE DRUG REACTIONS |
|---|---|---|---|---|---|---|---|---|---|
The findings of this study will be used for metanalysis.
The study is yet to be started
Nowadays irrational and inappropriate use of drugs is a major concern. Irrational drug use may cause adverse consequences including drug resistance and adverse drug reactions
.
This analysis is for the use of evidence-based medicine in tertiary care centers, to fulfill the drug information needs of the physician and also for improvement in the quality of healthcare by giving feedback to prescribers. This is an observational, retrospective study that will aim at the analysis of drug patterns and adverse drug reactions due to drug prescription in urinary tract infections at tertiary health care centers.
1. Ethical Committee approval is obtained.
Consent to participate:
As it is a retrospective there is no requirement asked from our institutional Ethical committee for getting the data of the past patient it is waived off for this study, Also we have taken proper permission and a letter from the concerned faculty of Hospital (CMS) from the medical record section for the previous data.
No data are associated with this article.
AVBRH HOSPITAL, HMIS
1. Abstract: The abstract is too brief; lacks specificity and content.
2. Introduction: The introduction lacks smooth flow and transitions between sections. There is some redundancy of information, grammatical errors, and formatting issues. There is no information given on the findings from previous studies done in this area. Also, there is a lack of focus on the significance of the study.
3. Method:
a. Study criteria: Study criteria is missing out on several vital elements. For example, details of treatment settings, time frame, presence of comorbidities, pregnancy status, or recurrent infections had not been addressed in the study criteria.
b. What does the author mean by "
c. Statistical methods: There is a lack of information on how statistical methods were applied.
d. Dala collection: The data collection process is not detailed enough.
e. Study setting: The study setting does not mention in which institution the study was done.
f. Overall there are a lot of inconsistencies in the methodology. It's also stating that the study will be done- what does that mean?
4. Results: No results are available for review.
5. Discussion: The discussion lacks depth and specificity. There is also repetition of information previously mentioned. No clear conclusion or limitations were stated.
Is the study design appropriate for the research question?
Yes
Is the rationale for, and objectives of, the study clearly described?
No
Are sufficient details of the methods provided to allow replication by others?
No
Are the datasets clearly presented in a useable and accessible format?
No
Reviewer Expertise:
Geriatrics, Medication safety management
I confirm that I have read this submission and believe that I have an appropriate level of expertise to state that I do not consider it to be of an acceptable scientific standard, for reasons outlined above.
This analysis is for the use of evidence-based medicine in tertiary care centers, to fulfill the drug information needs of the physician and also for improvement in the quality of healthcare by giving feedback to prescribers. This is an observational, retrospective study that will aim at the analysis of drug prescription patterns and adverse drug reactions due to drug prescription in urinary tract infections at tertiary health care centers.
a. Study criteria: Study criteria is missing out on several vital elements. For example, details of treatment settings, time frame, presence of comorbidities, pregnancy status, or recurrent infections had not been addressed in the study criteria.
NAME, AGE/SEX, MRD NO., OPD NO., DIAGNOSIS, DRUGS USED, DOSE OF THE DRUG, ANY IRRATIONAL IN PRESCRIPTION, DURATION OF DRUG THERAPY, ADVERSE DRUG REACTIONS, DURATION OF ILLNESS, COMORBIDITIES, PREGNANCY STATUS, RECURRENT INFECTIONS
No, now I have made the changes to the objective.
Yes
No
No
NAME, AGE/SEX, MRD NO., OPD NO., DIAGNOSIS, DRUGS USED, DOSE OF THE DRUG, ANY IRRATIONAL IN PRESCRIPTION, DURATION OF DRUG THERAPY, ADVERSE DRUG REACTIONS, DURATION OF ILLNESS, COMORBIDITIES, PREGNANCY STATUS, RECURRENT INFECTIONS
The protocol by Patil et al concerns an interesting subject regarding antibiotic use in urinary tract infection (UTI) in women, but the protocol needs revision particluarly to be more strict and prescise.
1. It is not clear, whether the investigation partakes on nosocomial (hospital derived) UTI or community associated UTI, or both? Define.
2. Define how a UTI is going to be defined through the retrospective approach (symptoms, urine culture, biochemical issue etc), if it is going to be analysed, whether the antibiotic treatment was correct i.e. administered for UTI.
3. Define which adverse effects are searched for, not only for nitrofurantoin and sulfonamides? it is often the case, that hospital records do not monitor adverse effects - this is always better done in a prospective study, where such effects are defined and the investigators asked to record them.
4. The calculation of sample size is performed according to prevalence of UTI; since all subjects searched for are supposed to have UTI, this is not correct. The sample size should be based upon the theoretical prevalence of adveres effects, since this is main objective. This is usually in the range of 5-10%, why the sample size must be much larger.
5. What is meant by combination therapy and fixed combinations? describe which e.g. trimethoprim-sulphamethoxazole, amoxicilin-clavulanic acid etc. Is combination therapy meant to be two drugs both intended for UTI?
Is the study design appropriate for the research question?
No
Is the rationale for, and objectives of, the study clearly described?
No
Are sufficient details of the methods provided to allow replication by others?
No
Are the datasets clearly presented in a useable and accessible format?
No
Reviewer Expertise:
Clinical microbiology, urinary tract infections, E.coli pathogenesis, antibiotic activity in vitro and in vivo
I confirm that I have read this submission and believe that I have an appropriate level of expertise to state that I do not consider it to be of an acceptable scientific standard, for reasons outlined above.
Ex. Trimethoprim + Sulfamethoxazole (Co-trimoxazole)
Amoxicillin + Clavulanic Acid
Nitrofurantoin + Vitamin B6
Hence both the terminologies are different.
No
No
No
No
NAME, AGE/SEX, MRD NO., OPD NO., DIAGNOSIS, DRUGS USED, DOSE OF THE DRUG, ANY IRRATIONAL IN PRESCRIPTION, DURATION OF DRUG THERAPY, ADVERSE DRUG REACTIONS, DURATION OF ILLNESS, COMORBIDITIES, PREGNANCY STATUS, RECURRENT INFECTIONS