Feasibility Study and Design of the ICU Infection Registry System for Patients Admitted to the Alzahra University Hospital in Isfahan: A Methodology Study
Soodabeh Rostami1, Setayesh Sindarreh2, Amirhossein Akhavan Sigari2, Marzieh Salimi Bani3, Behjat Taheri2, Saeed Abbasi4
1 Infectious Diseases and Tropical Medicine Research Center, Isfahan University of Medical Sciences, Isfahan, Iran
2 Anesthesiology and Critical Care Research Center, Isfahan University of Medical Sciences, Isfahan, Iran
3 Alzahra Medical Center, Isfahan University of Medical Sciences, Isfahan, Iran
4 Infectious Diseases and Tropical Medicine Research Center, Isfahan University of Medical Sciences; Anesthesiology and Critical Care Research Center, Isfahan University of Medical Sciences, Isfahan, Iran
|Date of Submission||09-Aug-2022|
|Date of Acceptance||22-Oct-2022|
|Date of Web Publication||31-Aug-2023|
Al-Zahra University Hospital, Soffe Blvd, Isfahan
Source of Support: None, Conflict of Interest: None
Background: Data gathering and bioinformatics play a significant role in the management and treatment of patients, especially of critically ill patients. This study assesses the feasibility and design of a registration system for nosocomial infections and sepsis in the intensive care unit of Alzahra university hospital in Isfahan.
Methods: The members of the registration system consisting of physicians and nurses of the ICU, infectious disease and pulmonary specialists, microbiologists, infection control supervisors, and librarians. The data collection tool was a researcher-made checklist. To design the framework of the tool, researchers investigated various tools and indices in references and databases such as PubMed, Scopus, Web of Science, and national databases regarding ICU infection and disease registration systems. Essential items in this field were selected and a preliminary draft was prepared to record the data of patients with ICU-related infections. After applying experts' opinions, the checklist was reviewed, and the final approval of the checklist was obtained.
Results: The final version of the checklist is prepared in three parts consisting of demographic data, principle variables (data required for registration of a patient), and the extended variables including details of the principle variables, and the data used to diagnose and treat.
Conclusion: The ICU infection registration system can predict the prevalence of infection, monitor services and treatment of patients, analyze survival, assess clinical care outcomes, and investigate drug-related interventions. Reducing hospitalization costs by stratifying patients, providing a database for research studies, assessing the cost-effectiveness of interventions, are other advantages that resulted from the design of this system.
Keywords: Healthcare-associated infections, intensive care units, registries
|How to cite this article:|
Rostami S, Sindarreh S, Sigari AA, Bani MS, Taheri B, Abbasi S. Feasibility Study and Design of the ICU Infection Registry System for Patients Admitted to the Alzahra University Hospital in Isfahan: A Methodology Study. Adv Biomed Res 2023;12:218
|How to cite this URL:|
Rostami S, Sindarreh S, Sigari AA, Bani MS, Taheri B, Abbasi S. Feasibility Study and Design of the ICU Infection Registry System for Patients Admitted to the Alzahra University Hospital in Isfahan: A Methodology Study. Adv Biomed Res [serial online] 2023 [cited 2023 Sep 26];12:218. Available from: https://www.advbiores.net/text.asp?2023/12/1/218/384991
| Introduction|| |
Nosocomial infections are a global problem in hospitals, especially in developing countries. Nosocomial infections are infections that spread in a limited way and are caused by pathogenic responses to infectious agents and toxins in the hospital, provided that it occurs at least 48–72 h after admission to the hospital., Such infections increase hospital stays, cost, and mortality of patients. Millions of dollars are spent around the world each year diagnosing, treating, and compensating for the effects of this infection. Costs such as absenteeism, disability, reduced efficiency, occupancy of hospital beds, and the injury of other patients are other indirect costs associated with such infection. The prevalence of nosocomial infection worldwide is between 5% and 25%. Based on available studies, in North America and Europe, and sub-Saharan Africa and Asia, 5%–10% and 40% of hospitalized patients acquired nosocomial infections, respectively.
Predictors such as invasive measures, extended hospital stay, overuse of antibiotics, and severe diseases cause intensive care unit (ICU) patients to suffer from nosocomial infections several times more often than other hospitalized patients. The prevalence of ICU nosocomial infections in Europe is approximately 20%, and most of such infections are associated with the use of invasive devices and interventions. The most common types of nosocomial infections are ventilator-induced pneumonia (VAP), catheter-dependent sepsis-associated urinary tract infections, and surgical site infections.
By controlling such infections, mortality, treatment-related complications, average hospital stay, and hospital costs will be reduced. The proper delivery of health requires the utilization of clinical tools that guarantee the improvement of services in the long run. One of these tools is the disease registration system. Disease registration is an organized system for collecting, storing, retrieving, analyzing, and disseminating data about patients with particular diseases or in the face of known and suspected substance adverse effects on a population and geographical area. This tool is used to develop clinical studies on various diseases. The launch of this system will lead to improved patient care and planning to provide health services and increase the quality and productivity of the health service delivery system and patient satisfaction. This tool is also suitable for collecting critical data on patients' history and following up on clinical trials.
Disease registration has been on the agenda of the Deputy Minister of Research and Technology of the Ministry of Health since 2014. The data collected through this system have been used to manage and organize diseases and conduct research. Disease registration plays an effective role in diagnosing and measuring the prevalence of a particular disease and/or a health event in society and enables the health system to better and more effectively monitor the quality of health services provided. This system also provides a good source for diagnosing patients for further research studies such as cohort studies and clinical trials. Currently, there is an Iranian Nosocomial Infection Surveillance System (INIS) in the country, and data on nosocomial infection is entered online. Despite the growing activity of this system, its pitfalls are the incompleteness of the variables studied in some hospitals, and the lack of complete and adequate monitoring of the data entered. Also, the lack of relationship between this system and hospital data entry systems is another weakness, and therefore, the patient's clinical and laboratory data cannot be analyzed simultaneously with the healthcare system data. On the other hand, no specific registration system for nosocomial infections in ICUs in Iran has been developed yet. Therefore, this study was conducted to design a registration system for nosocomial infections and sepsis in the ICU for the promotion of the quality of treatment protocols and easy application of the results obtained from treatment decisions.
| Materials and Methods|| |
The present study is a research action study aimed to record and monitor interventional activities and control and manage the data of patients with ICU infection at Alzahra Medical Center. Given that Alzahra Educational and Medical Center with about 120 ICU beds is one of the largest educational and medical centers in the province and the country, which also provides services to patients in neighboring provinces (Shahrekord, Khuzestan, Ilam, Yazd, etc.), the study population consisted of patients admitted to this center.
First, a meeting was held with the hospital officials regarding the need to fully record patients' data in the files and confirm their cooperation regarding the familiarity and use of data forms designed by the hospital personnel.
The panel of specialists in the present study consisted of clinical team members (10 members) (hospital triage physicians, infectious disease specialists, pulmonologists, ICU specialists, epidemiologists, librarians, and medical informants).
The data collection tool was a researcher-made checklist by the Delphi method. The given approach for compiling the checklist was to produce a tool that, while having a uniform and one-handed structure, includes various dimensions of patients' treatment and care needs and can be implemented and uploaded to the hospital's electronic file. Hence, in addition to the main data about ICU infection, more subdata was collected to design a checklist to design a relatively comprehensive tool and assist in the treatment process at all stages. Therefore, the checklist of this study was designed by the Delphi method in three parts: demographic data, specialized data about the patient's clinical symptoms, and extended specialized data.
Checklist design stages
To design checklist and its contents, criteria and various indices were investigated in databases such as PubMed, Scopus, UptoDate, Science Direct, Web of Science, and national databases of Magiran and SID regarding ICU infection and disease registration systems.
The most important variables related to patients with ICU infection including demographic data, drug history, laboratory data, symptoms, epidemiology, risk factors, lifestyle, prognosis, complications, and treatments were selected.
Then, the selected variables for designing a checklist were investigated by a panel of experts including hospital triage physicians, infectious disease specialists, pulmonologists, ICU specialists, microbiologist, epidemiologists, librarians, and medical informants who were asked to study the selected variables scientifically (based on the items in scientific references), and express their opinions in this regard. They were also asked about the content of the checklist in terms of appearance, choice of words, sentences, and comprehensibility. Finally, according to the opinions of specialists, the variables were reviewed and corrected and a new edition was prepared. Then, an initial draft was prepared to record the data of patients with ICU infection.
After applying the opinion of the board of specialists, the checklist was provided to them again, and this time, more detailed variables (a subset of the main variables) were surveyed in the checklist. Finally, after collecting comments in the second stage and applying them, the final approval in terms of science, appearance, and writing of the checklist was obtained.
In the last stage, after preparing the checklist for the pilot project, 10 residents of the field of infectious diseases, lung, and ICU were given the necessary training on how to fill in the questionnaire and its terms and variables. Then, 50 questionnaires were completed by trained residents to identify their pitfalls in which they were asked to identify any existing problems. After collecting the questionnaires, the pitfalls were raised again by the board of specialists. In the end, the final version of the checklist was prepared by applying the opinions of pulmonologists, infectious disease, and ICU specialists.
A manual in Persian including a definition of variables, and how the checklists should be completed has been prepared for all users. The data of all patients referred to Alzahra Hospital, including the details and history of patients were provided based on the designed data collection form, and the data were checked for accuracy by an infectious, pulmonary, or internal resident. After the patient enters the ICU, and in case of any symptoms pointing to infection after 72 h in the ICU, the patient data will be recorded in the relevant form and additional data will be added if the patient's culture result is positive.
Each month, a training session was held to update the team specialists and nurses, reassess the questionnaires, and address potential problems regarding data entry and submission.
In this study, the researcher observed all the principles related to research ethics, such as obtaining informed consent from patients participating in the study, explaining the research and its objectives, observing confidentiality, and providing the opportunity to leave the study at any time; and the rights of authors in the use of printed and electronic texts.
To use the registration data, according to the instructions provided by the Ministry of Health, permission was obtained from the Research Ethics Committee.
| Results|| |
The collected variables were classified into three parts:
- Demographic information: The first part of the checklist is patients' demographic data including name and surname, father's name, national/ID number, date of birth, gender, pregnancy, contact number, residence, occupation, date of hospitalization, the reason for hospitalization, final diagnosis, ward name, history of hospitalization in the past 3 months, date of hospitalization in the ICU, the reason for transfer to the ICU, and emergency surgery.
- Main variables: The second part of the checklist includes specialized data about the patient's clinical symptoms. These variables are designed as the minimum data a person needs to record in a checklist (patient's clinical symptoms). The data about these variables were collected in both direct and indirect ways. Directly, the necessary data will be recorded by interviewing the patient, and indirectly, data will be collected from the patient's file.
The main variables included 11 major fields of vital symptoms at the time of ICU admission, diagnosis of infection, laboratory data at ICU admission and infection diagnosis, drugs used, underlying disease or risk factors, radiological results, type of infection, microbiology results, and infection history.
It should be noted that vital symptoms and laboratory data are measured and recorded twice (at the time of entry into the ICU and at the time of diagnosis of the infection, which is described in [Table 1]).
- Extended main variables
The details of the main variables are recorded in the extended variables and data is used to diagnose, treat, and follow-up on the patient at later stages.
|Table 1: Data related to the nosocomial infection checklist registry in the ICU|
Click here to view
| Discussion|| |
Nosocomial infections are one of the most important global health issues imposing direct and indirect costs on the health system. Predictors such as invasive measures, increased hospital stay, antibiotic overuse, and severe disease impose patients admitted to the ICU at a higher risk of developing nosocomial infections compared with other hospitalized patients. Continuous monitoring of risk factors for the development of such infections is very important to improve the quality of healthcare. Therefore, this study was conducted to design a registration system for nosocomial infections and sepsis in the ICU of Alzahra Medical Center in Isfahan, Iran.
The first infection registration system was developed in 1994 in Spain, called the ENVIN-HELICS. This system has been designed to collect data on infections related to invasive devices used during the patient's hospitalization in the ICU. This registry contains patients' data from admission to the time of discharge from the ICU. A study by López-Pueyo et al. reported that the data in the ENVIN-HELICS registry in 2008 were accurate and reliable.
Moreover, a study by Agodi et al. showed that Italy's infection registration and monitoring system is called SPIN-UTI, in which nosocomial infection in the ICU is registered. This system is successful because it has the power to communicate with other European registration systems.
Another example is the infection registration system in the ICU in western China collecting and assessing data from recording and using a variety of data references, including patients' electronic medical records, the ICU information system, and the system designed to register nosocomial infections in the ICU. Chinese researchers have assessed this registration system as successful so that it can fill the knowledge gap in infection control in ICUs both in China and in other parts of the world and act as a model for other registration systems.
On the other hand, consistent with the present study, a study conducted by Eibposh and Ashrati investigated the healthcare system for nosocomial infection in Iran. This system was officially established in the country in 2006 with the participation of 100 hospitals, and in 2017, the number of covered hospitals increased to 555 hospitals (56%) with more than 100 beds. Infections studied in this system consisted of pneumonia, blood, urinary tract, and surgery room infections. However, in the registration system of the present study, ventilator-dependent pneumonia, sepsis, septic shock, catheter-dependent urinary tract, blood infection, and surgical wound infection had been recorded.
Moreover, the principal variables of the Nosocomial Infection Care System include demographic data (patient name, age, gender, and weight1), type of infection, individual factors, patient outcome, and the microorganism(s) causing the infection and its sensitivity/antibiotic resistance. Recently, data on the duration of hospital stay and the number of invasive devices used have also been collected, which makes it possible to calculate the raw and relative incidence rate of invasive tools. The results of these studies indicate the effectiveness of the program in improving the awareness, attitude, and performance of its partners. The program has been increasing in terms of diagnosis and the number of hospitals covered. However, the small number of patients remains a challenge. There are challenges in the scientific and executive dimensions such as inadequate support from universities to hospitals to implement the system, a slow process of updating the guidelines, and a lack of coordination between departments.
Another point is that the variables collected in the Nosocomial Infection Care System are very limited for patients admitted to the ICU. While in the current registration system modeled on similar successful registration systems in Italy, Spain, and China, in addition to the variables listed in the system, variables specific to patients admitted to the ICU are collected such as clinical symptoms and related scores, as well as imaging data currently available by a separate software. This system makes it possible to give a wider dimension to data analysis.
In addition, according to the results of the present study, the system for patients with sepsis has been registered in Masih Daneshvari Research Medical Center, Shahid Beheshti University of Medical Sciences. Although it records and considers all cases of sepsis in this system, this registration system does not focus on patients in the ICU, and on the other hand, this system has not been officially launched yet.
| Conclusion|| |
According to the results of the present study, the nosocomial infection registration system in the ICU can lead to measuring the prevalence and incidence of the disease, monitoring patient services and treatment, analyzing survival and assessing clinical care outcomes and finding patients at higher risk for emergency treatment measures.Also, this registration system can create a database for conducting research studies, a reference for clinical trials, case-control, and cohort studies, assessing the cost-effectiveness of interventions and estimating costs, allocating funds, and taking effective steps to achieve research objectives.
We thank the Ethics Committee of the Isfahan University of Medical Sciences and Health Services for the approved proposal. Also, we would like to thank Isfahan University of Medical Sciences for supporting this study.
This study was approved by the Iran National Committee for Ethics in Biomedical Research with an ethical code (IR.MUI.MED.REC.1399.1105) and proposal was approved by Isfahan University of medical science with code 199589.
Financial support and sponsorship
The Research Review board of Isfahan University of Medical Sciences.
Conflicts of interest
There are no conflicts of interest.
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