{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,2,27]],"date-time":"2026-02-27T05:07:26Z","timestamp":1772168846725,"version":"3.50.1"},"update-to":[{"DOI":"10.12688\/f1000research.149264.1","type":"new_version","label":"New version","source":"publisher","updated":{"date-parts":[[2025,9,12]],"date-time":"2025-09-12T00:00:00Z","timestamp":1757635200000}},{"DOI":"10.12688\/f1000research.149264.2","type":"new_version","label":"New version","source":"publisher","updated":{"date-parts":[[2025,9,12]],"date-time":"2025-09-12T00:00:00Z","timestamp":1757635200000}},{"DOI":"10.12688\/f1000research.149264.3","type":"new_version","label":"New version","source":"publisher","updated":{"date-parts":[[2025,9,12]],"date-time":"2025-09-12T00:00:00Z","timestamp":1757635200000}},{"DOI":"10.12688\/f1000research.149264.4","type":"new_version","label":"New version","source":"publisher","updated":{"date-parts":[[2025,9,12]],"date-time":"2025-09-12T00:00:00Z","timestamp":1757635200000}}],"reference-count":12,"publisher":"F1000 Research Ltd","license":[{"start":{"date-parts":[[2025,9,12]],"date-time":"2025-09-12T00:00:00Z","timestamp":1757635200000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":["f1000research.com"],"crossmark-restriction":false},"short-container-title":["F1000Res"],"abstract":"\n Background Urinary tract infection (UTI) is a frequent bacterial infection among women of reproductive age. Inappropriate and irrational prescribing of antibiotics\n \u2014such as the use of unapproved fixed-dose combinations or empirical broad-spectrum therapy\u2014<\/ns3:bold>\n has contributed to growing antimicrobial resistance. Adverse drug reactions (ADRs) further complicate treatment outcomes, yet remain underreported, especially in routine outpatient practice. Therefore, an assessment of current prescribing patterns is essential to promote rational drug use. Additionally, evaluation of adverse drug reactions remains important for patient safety and pharmacovigilance. Objectives\n \n \n \u2022 To describe the prescribing patterns of drugs used for urinary tract infections (UTIs) among women of reproductive age (15\u201344 years).<\/ns3:p>\n <\/ns3:list-item>\n \n \u2022 To evaluate the incidence, type, and severity of adverse drug reactions (ADRs) as documented in hospital records.<\/ns3:p>\n <\/ns3:list-item>\n \n \u2022 To assess the prescription of fixed-dose combinations (FDCs) and combination antimicrobial therapy in relation to standard treatment guidelines (WHO, NLEM 2022).<\/ns3:p>\n <\/ns3:list-item>\n <\/ns3:list>\n Methods This is a retrospective observational study based on outpatient department (OPD) prescriptions for women aged 15\u201344 years diagnosed with community-acquired, uncomplicated UTIs at a tertiary care hospital in Central India. Data from 139 prescription records\n will be retrieved from the medical record section and analyzed.<\/ns3:bold>\n Prescribing indicators, documented ADRs, and use of FDCs will be assessed against national guidelines using descriptive statistics, chi-square tests, and logistic regression analysis.\n <\/ns3:p>","DOI":"10.12688\/f1000research.149264.5","type":"journal-article","created":{"date-parts":[[2025,9,12]],"date-time":"2025-09-12T15:55:08Z","timestamp":1757692508000},"page":"417","update-policy":"https:\/\/doi.org\/10.12688\/f1000research.crossmark-policy","source":"Crossref","is-referenced-by-count":0,"title":["Analysis of prescription pattern and adverse drug reactions of drugs used in Urinary Tract Infection in reproductive age group (15-44 years) women in a Tertiary Care Hospital in Central India: An observational retrospective study"],"prefix":"10.12688","volume":"13","author":[{"ORCID":"https:\/\/orcid.org\/0009-0005-6737-9144","authenticated-orcid":false,"given":"Gayatri","family":"Patil","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Sushil","family":"Varma","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"2560","published-online":{"date-parts":[[2025,9,12]]},"reference":[{"key":"ref1","doi-asserted-by":"publisher","first-page":"1756287219832172","DOI":"10.1177\/1756287219832172","article-title":"An introduction to the epidemiology and burden of urinary tract infections.","volume":"11","author":"M Medina","year":"2019","journal-title":"Ther Adv Urol."},{"key":"ref2","doi-asserted-by":"publisher","first-page":"S5-S13","DOI":"10.1016\/s0002-9343(02)01054-9","article-title":"Epidemiology of urinary tract infections: incidence, morbidity, and economic costs.","volume":"113","author":"B Foxman","year":"2002","journal-title":"Am J Med."},{"key":"ref3","doi-asserted-by":"publisher","first-page":"269-284","DOI":"10.1038\/nrmicro3432","article-title":"Urinary tract infections: epidemiology, mechanisms of infection and treatment options.","volume":"13","author":"A Flores-Mireles","year":"2015","journal-title":"Nat Rev Microbiol."},{"key":"ref4","first-page":"1-5","article-title":"Study of prescribing patterns of antimicrobial agents in urinary tract infection.","volume":"1","author":"L Mahadevamma","year":"2011","journal-title":"Int J Pharm Bio Sci."},{"key":"ref5","doi-asserted-by":"publisher","first-page":"890-891","DOI":"10.1001\/jama.2019.11652","article-title":"Trends in antibiotic prescribing for urinary tract infections in women, 2000\u20132016.","volume":"322","author":"G Chiang","year":"2019","journal-title":"JAMA."},{"key":"ref6","doi-asserted-by":"publisher","first-page":"354-358","DOI":"10.3855\/jidc.218","article-title":"Antibiotic resistance in pathogens causing community-acquired urinary tract infections in India: a multicenter study.","volume":"2","author":"A Kothari","year":"2008","journal-title":"J Infect Dev Ctries."},{"key":"ref7","first-page":"85-88","article-title":"Occurrence of ESBL and AmpC \u03b2-lactamases and susceptibility to newer antimicrobial agents in complicated UTI.","volume":"127","author":"N Taneja","year":"2008","journal-title":"Indian J Med Res."},{"key":"ref8","doi-asserted-by":"publisher","first-page":"1219-1228","DOI":"10.1016\/j.cmi.2015.09.021","article-title":"Safety of nitrofurantoin in renal impairment: a systematic review.","volume":"21","author":"A Huttner","year":"2015","journal-title":"Clin Microbiol Infect."},{"key":"ref9","doi-asserted-by":"publisher","first-page":"1600-1608","DOI":"10.1056\/NEJM199512143332404","article-title":"Medication use and the risk of Stevens\u2013Johnson syndrome or toxic epidermal necrolysis.","volume":"333","author":"J Roujeau","year":"1995","journal-title":"N Engl J Med."},{"key":"ref11","doi-asserted-by":"publisher","first-page":"205031212110251","DOI":"10.1177\/20503121211025174","article-title":"Irrational drug use and its associated factors at Debre Markos Referral Hospital\u2019s outpatient pharmacy in East Gojjam, Northwest Ethiopia.","volume":"9","author":"L Melku","year":"2021","journal-title":"SAGE Open Med."},{"key":"ref12","doi-asserted-by":"publisher","first-page":"358","DOI":"10.4081\/jphia.2014.358","article-title":"Prescribing patterns and perceptions of health care professionals about rational drug use in a specialist hospital clinic.","volume":"5","author":"M Ojo","year":"2014","journal-title":"J Public Health Afr."},{"key":"ref13","doi-asserted-by":"publisher","first-page":"1-12","DOI":"10.1016\/j.ucl.2007.09.004","article-title":"Uncomplicated urinary tract infection in adults including uncomplicated pyelonephritis.","volume":"35","author":"L Nicolle","year":"2008","journal-title":"Urol Clin North Am."}],"container-title":["F1000Research"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/f1000research.com\/articles\/13-417\/v5\/xml","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/f1000research.com\/articles\/13-417\/v5\/pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/f1000research.com\/articles\/13-417\/v5\/iparadigms","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,11,20]],"date-time":"2025-11-20T19:05:11Z","timestamp":1763665511000},"score":1,"resource":{"primary":{"URL":"https:\/\/f1000research.com\/articles\/13-417\/v5"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2025,9,12]]},"references-count":12,"URL":"https:\/\/doi.org\/10.12688\/f1000research.149264.5","relation":{"has-version":[{"id-type":"doi","id":"10.12688\/f1000research.149264.4","asserted-by":"subject"},{"id-type":"doi","id":"10.12688\/f1000research.149264.3","asserted-by":"subject"},{"id-type":"doi","id":"10.12688\/f1000research.149264.2","asserted-by":"subject"},{"id-type":"doi","id":"10.12688\/f1000research.149264.1","asserted-by":"subject"}],"has-review":[{"id-type":"doi","id":"10.5256\/f1000research.188018.r413764","asserted-by":"subject"},{"id-type":"doi","id":"10.5256\/f1000research.188018.r413764","asserted-by":"object"}]},"ISSN":["2046-1402"],"issn-type":[{"value":"2046-1402","type":"electronic"}],"subject":[],"published":{"date-parts":[[2025,9,12]]},"assertion":[{"value":"Indexed","URL":"https:\/\/f1000research.com\/articles\/13-417\/v5#article-reports","order":0,"name":"referee-status","label":"Referee status","group":{"name":"current-referee-status","label":"Current Referee Status"}},{"value":"10.5256\/f1000research.185974.r402774, Niels Frimodt-Moller, Copenhagen University Hospital, Copenhagen, 13 Aug 2025, version 3, 1 approved, 2 not approved","URL":"https:\/\/f1000research.com\/articles\/13-417\/v3#referee-response-402774","order":0,"name":"referee-response-402774","label":"Referee Report","group":{"name":"article-reports","label":"Article Reports"}},{"value":"10.5256\/f1000research.163709.r297784, Vineetha Menon, Gulf Medical University, Ajman, 13 Jul 2024, version 1, 2 not approved","URL":"https:\/\/f1000research.com\/articles\/13-417\/v1#referee-response-297784","order":1,"name":"referee-response-297784","label":"Referee Report","group":{"name":"article-reports","label":"Article Reports"}},{"value":"DR. GAYATRI PATIL <\/b>; \nPosted: 16 Dec 2024<\/i>; \n1. Abstract:<\/b> The abstract is too brief; lacks specificity and content.  \nResponse:<\/u><\/b>    Changes done in the abstract. \n2. Introduction:<\/b> 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.  \nResponse:<\/u><\/b>   Now, I have mentioned the information regarding the previous study. It is mentioned in the discussion part. i.e. 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. \n3. Method:<\/b> 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. \n Response:<\/u><\/b> I have now added these parameters in my annexure 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 \nb. What does the author mean by "Study reference: Pritam Pardeshi"?<\/b> \nResponse:<\/u> <\/b>This was the reference for my sample size calculation for the study. \nc. Statistical methods: There is a lack of information on how statistical methods were applied.<\/b> \nResponse:<\/u> <\/b>We will use the student\u2019s t-test and Chi-square Test. \nd. Data collection: The data collection process is not detailed enough. <\/b> \nResponse<\/u><\/b>: I will be collecting the data from the medical record section and then I will analyze the prescription for the given parameters which were given in the data collection section in my protocol. \ne. Study setting: The study setting does not mention in which institution the study was done<\/b>.  \nResponse:<\/u>  <\/b>This study will be carried out in the Rural Tertiary Care Hospital in Central India \nf. Overall there are a lot of inconsistencies in the methodology. It's also stating that the study will be done- what does that mean?<\/b> \nResponse:<\/u>  <\/b>We haven\u2019t started this study yet that\u2019s why I wrote the study will be done. It\u2019s my protocol for my study. \n4. Results: No results are available for review. <\/b> \nResponse:<\/u>  <\/b>As this study is not started yet we can\u2019t predict the result of this analysis. That\u2019s why I didn\u2019t mention the results. \n5. Discussion: The discussion lacks depth and specificity. There is also a repetition of information previously mentioned. No clear conclusion or limitations were stated.<\/b> \nResponse:<\/u>  <\/b>I have made the changes in the discussion part according to your comments.   \nIs the rationale for, and objectives of, the study clearly described?<\/b> No, now I have made the changes to the objective. \nIs the study design appropriate for the research question?<\/b> Yes \nAre sufficient details of the methods provided to allow replication by others?<\/b> No   \nResponse:<\/u>  <\/b> Changes were made in the data collection section. \nAre the datasets clearly presented in a useable and accessible format?<\/b> No  \nResponse:<\/u>  <\/b>  I have mentioned the parameters in this ANNEXURE. 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","URL":"https:\/\/f1000research.com\/articles\/13-417\/v5#referee-comment-12974","order":2,"name":"referee-comment-12974","label":"Referee Comment","group":{"name":"article-reports","label":"Article Reports"}},{"value":"10.5256\/f1000research.188018.r413764, Abayeneh Girma, Mekdela Amba University, Tulu Awlya, South Wollo Zone, 16 Sep 2025, version 5, indexed","URL":"https:\/\/f1000research.com\/articles\/13-417\/v5#referee-response-413764","order":3,"name":"referee-response-413764","label":"Referee Report","group":{"name":"article-reports","label":"Article Reports"}},{"value":"DR. GAYATRI PATIL <\/b>; \nPosted: 16 Sep 2025<\/i>; \nCOMMENT 1 :<\/b> \nThe rationale for focusing on the reproductive age group (15\u201344 years) is not strongly justified. While anatomical factors are mentioned, a clearer link to unique prescribing challenges or ADR profiles in this group (e.g., teratogenicity concerns, interaction with contraceptives) would strengthen the argument. Again, some references are quite old (e.g., Roujeau 1995, Foxman 2002, and more than 2 studies conducted in 2008). Incorporating more recent literature on Indian prescribing patterns and resistance trends would better contextualize the study.<\/i> \nRESPONSE :<\/b> We thank the reviewer for this valuable observation. The rationale for focusing on the reproductive age group was primarily due to the higher prevalence of UTIs in this population, influenced by anatomical and physiological factors. We agree that teratogenicity and drug\u2013contraceptive interactions are important issues in this group; however, our study was observational and aimed at evaluating prescribing and ADR patterns, hence we chose not to elaborate further on these aspects to maintain conciseness in the introduction. With respect to references, we cited some earlier landmark studies to provide historical context. At the same time, we have also included and discussed findings from more recent Indian literature on prescribing practices and antimicrobial resistance trends to ensure that the results are appropriately contextualized. We believe this balance of classical and contemporary evidence supports the rationale for our study design. \nCOMMENT 2 :<\/b> \nThe description is insufficient for replication. There is no detail on which specific covariates will be included in the logistic regression model to "identify predictors of ADRs." How missing data will be handled (beyond exclusion). How model assumptions will be checked.<\/i> \nRESPONSE :<\/b> We thank the reviewer for raising this important point. In our analysis, the covariates considered for inclusion in the logistic regression model were: Demographic characteristics (age, sex) Clinical factors (presence of co-morbidities, type of infection) Treatment-related variables (number of drugs prescribed, duration of therapy) Cases with incomplete information were excluded from analysis. Standard diagnostic checks were carried out in SPSS to ensure model validity, including assessment of multicollinearity and model fit statistics (Hosmer\u2013Lemeshow test). We confirm that established statistical protocols were followed throughout.","URL":"https:\/\/f1000research.com\/articles\/13-417\/v5#referee-comment-14605","order":4,"name":"referee-comment-14605","label":"Referee Comment","group":{"name":"article-reports","label":"Article Reports"}},{"value":"10.5256\/f1000research.187324.r411054, Sandip Mukhopadhyay, Epidemiology - Pharmacology, ICMR-National Institute for Research in Bacterial Infections, Kolkata, West Bengal, 09 Sep 2025, version 4, 1 approved, 1 approved with reservations, 2 not approved","URL":"https:\/\/f1000research.com\/articles\/13-417\/v4#referee-response-411054","order":5,"name":"referee-response-411054","label":"Referee Report","group":{"name":"article-reports","label":"Article Reports"}},{"value":"DR. GAYATRI PATIL <\/b>; \nPosted: 10 Sep 2025<\/i>; We sincerely thank the reviewer for the constructive and valuable comments. We have carefully revised the manuscript to address each point as detailed below. \nComment 1:<\/b> Therefore, an assessment of current prescribing patterns and ADRs is essential to promote rational drug use may be re-phrased after removing the ADR from the sentence. \nResponse:<\/b> We agree. The abstract has been revised to: Therefore, an assessment of current prescribing patterns is essential to promote rational drug use. Additionally, evaluation of adverse drug reactions remains important for patient safety and pharmacovigilance. \nComment 2:<\/b> Objectives 1 & 3 are feasible through a cross-sectional\/record-based design. Objective 2 on ADRs is less feasible in this design. \nResponse:<\/b> We acknowledge this point. Objectives 1 (prescription patterns) and 3 (FDC adherence) are indeed fully aligned with a retrospective design. Objective 2 has been clarified as: To evaluate the incidence, type, and severity of adverse drug reactions (ADRs) \nas documented in hospital records<\/b>. This limits ADR assessment only to available records. \nComment 3:<\/b> Retrospective ADR data collection may lead to bias and missing data; this objective is best suited for prospective studies. \nResponse:<\/b> We agree. We have emphasized in the \nMethods<\/b> that only physician-documented ADRs will be captured from OPD records, and in the \nDiscussion,<\/b> we explicitly highlight the limitation of under-reporting in retrospective data. The ADR objective will therefore remain exploratory. \nComment 4:<\/b> Operational definition of uncomplicated UTI is too abstract; should include urinalysis and microbiology. \nResponse:<\/b> We thank the reviewer. The definition has been revised to: Diagnosis of community-acquired uncomplicated UTI was based on documented clinical symptoms (e.g., dysuria, urgency, frequency, suprapubic pain), with or without supporting urine analysis or culture reports. Table 1 has been updated accordingly. \nComment 5:<\/b> Sample size estimation should be based on the primary objective (prescription pattern), not ADR prevalence. \nResponse:<\/b> We acknowledge this. While the calculation was based on an assumed ADR prevalence, we have clarified in the \nSample Size section<\/b> that the sample is primarily adequate for the primary objective (prescription pattern analysis). ADR analysis is exploratory. \nComment 6:<\/b> Statistics section should come at the end of Methods. \nResponse:<\/b> Accepted. The \nStatistical Analysis<\/b> subsection has been moved to the last part of the Methods for improved logical flow. We thank the reviewer once again for the valuable feedback, which has helped us to improve the clarity and scientific rigor of our manuscript.","URL":"https:\/\/f1000research.com\/articles\/13-417\/v5#referee-comment-14544","order":6,"name":"referee-comment-14544","label":"Referee Comment","group":{"name":"article-reports","label":"Article Reports"}},{"value":"The author(s) declared that no grants were involved in supporting this work","order":7,"name":"grant-information","label":"Grant Information"},{"value":"This is an open access article distributed under the terms of the Creative Commons Attribution Licence, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.","order":0,"name":"copyright-info","label":"Copyright"}]}}