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临床试验/CTRI/2024/03/064343
CTRI/2024/03/064343尚未招募不适用

A Descriptive Study of the Prescribing Pattern of Drugs in Chronic Suppurative Otitis Media and Impact of Disease on Health-Related Quality of Life in Patients Attending Otorhinolaryngology Out Patient Department at Sawai Man Singh Hospital, Jaipur

未提供1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2024年3月29日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
100
试验地点
1
主要终点
Active aural discharge

研究概览

简要总结

Chronic suppurative otitis media (CSOM) is a chronic infective, inflammatory disorder of the middle ear characterized by recurrent otorrhea for at least   2–6 weeks, through tympanic membrane perforation.1 It causes a myriad of intermittent or persistent symptoms across all age groups like ear discharge, hearing loss, tinnitus, and vertigo. CSOM has emerged as one of the most common causes of acquired hearing loss.2 It is a common condition encountered in the Ear, Nose, and Throat (ENT) department worldwide. A systematic analysis done by Vos et al. revealed that worldwide approximately 4.4% of the human population is affected by chronic suppurative otitis media (CSOM).3 The World Health Organization (WHO) estimates CSOM incidence between 65-330 million with, 50% of individuals with hearing impairment.3

 CSOM can lead to significant morbidities, including hearing loss, recurrent infections, and potential complications such as mastoiditis, cholesteatoma, and intracranial infections.4 The management of CSOM typically involves a combination of medical and surgical interventions. Antibiotics play an important role in controlling infection and promoting healing of the middle ear infection. However, the irrational and inappropriate use of antibiotics can contribute to the emergence and spread of antimicrobial drug resistance, which is a global public health concern.5

 WHO defined Drug Utilization Research as, “Studies of the marketing, distribution, prescription, and use of drugs in a society, with special emphasis on the resulting medical, social, and economic consequences”. This study aims to critically analyse the prescriptions issued at the  ENT outpatient department of the hospital. This study is to find out areas that need improvement in the overall interest of the patient and the healthcare system.6

 Drug utilization monitoring can be used to assess the Rational use of drug therapy, outcome of treatment, and quality of life care. CSOM can also a produce significant impact on the quality of life of the affected individuals. In many cases, CSOM patients suffer from many complications like hearing loss, emotional impact, impact on day-to-day activities, social impact, and its impact on sleep. The present study was planned to evaluate the prescribing pattern of drugs along with the study of the impact of disease on health-related quality of life (QOL) in patients suffering from CSOM.7

WHO defined Rational use of drugs as “A state in which medications are received by patients appropriately according to their clinical needs and individual requirements, for an adequate period at the lowest cost”. The various repercussions of irrational drug use include polypharmacy, increased use of branded drugs, increased drug cost per person, drug interactions, adverse effects, irrational antibiotic prescribing, and antibiotic resistance and it may lead to a post-antibiotic era, then it will be very difficult to treat even mild infections. This justifies the need for an antibiotic policy that comprises microbiological data and prescription auditing in any geographical area.Rational use of antimicrobial agents requires proper clinical evaluation, judgment, and a comprehensive understanding of microbiological and pharmacological factors, and only through the rational prescribing practices of the clinician, the overuse and misuse of antibiotics issues can be resolved globally.8

Due to the irrational use of antibiotics, Antimicrobial Resistance (AMR) is also increasing among the pathogens causing CSOM. This necessitates the evaluation of antimicrobial drug susceptibility patterns in these patients on the basis of culture and sensitivity.9 Antimicrobial Stewardship is defined as “The careful and responsible management of something entrusted to one’s care”. It was originally applied in the healthcare setting as a tool for optimizing antimicrobial use, termed “Antimicrobial stewardship” (AMS). Stewardship has been applied in the context of governance of the health sector as a whole, taking responsibility for the health and well-being of the population and guiding health systems at the national and global levels.

AMS principles also apply to the use of antimicrobials in the animal and agriculture sectors, typically with an emphasis on the responsible and prudent use of these agents. Core Elements of Outpatient Antibiotic Stewardship provides guidance for antibiotic stewardship in outpatient settings and is applicable to any entity interested in improving outpatient antibiotic prescribing and use.10

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 80.00 Year(s)(—)
性别
All

入选标准

  • Patient diagnosed with CSOM with or without active recurrent otorrhea and visible tympanic membrane perforation, visiting OPD of Otorhinolaryngology department.
  • Adult patient of either sex.
  • Patients willing to give written informed consent for the study.

排除标准

  • Patients with non-infective conditions, E.g., Malignancy and Road traffic accidents.
  • Patients with aural discharge with any cause other than CSOM.
  • E.g., foreign body, furunculosis, and post-operative patients of CSOM.
  • Patients with co-morbid conditions like cancer, HIV, hepatitis.
  • Patients are part of any other study.
  • Non corporative patients.

结局指标

主要结局

Active aural discharge

时间窗: 6 month

次要结局

  • 1. Average number of drugs per encounter(2. Percentage of drugs prescribed with the generic name)

研究者

发起方
未提供
责任方
Principal Investigator
主要研究者

DR. Prateek Saini

department of pharmacology, SMS Medical College

研究点 (1)

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