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jha 2025, 28(3): 13-27 |
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Frokh Eslamlo S, Jebraeily M, Ghasemnejad Berenji H, Moghaddam Tabrizi F, Ayatollahi H. Minimum data set for implementing a registry for women infected with human papillomavirus. jha 2025; 28 (3) :13-27
URL: http://jha.iums.ac.ir/article-1-4707-en.html
URL: http://jha.iums.ac.ir/article-1-4707-en.html
Shima Frokh Eslamlo1 
, Mohammad Jebraeily2 , Hojat Ghasemnejad Berenji3 , Fatemeh Moghaddam Tabrizi4 , Haleh Ayatollahi5
, Mohammad Jebraeily2 , Hojat Ghasemnejad Berenji3 , Fatemeh Moghaddam Tabrizi4 , Haleh Ayatollahi5
1- Student Research Committee, Urmia University of Medical Sciences, Urmia, Iran.
2- Department of Health Information Technology, School of Allied Medical Sciences, Urmia University of Medical Sciences, Urmia, Iran. ,jabraily@gmail.com
3- Reproductive Health Research Center, Clinical Research Institute, Urmia University of Medical Sciences, Urmia, Iran.
4- School of Nursing and Midwifery, Urmia University of Medical Sciences, Urmia, Iran.
5- Department of Obstetrics and Gynecology, School of Medicine, Urmia University of Medical Sciences, Urmia, Iran.
2- Department of Health Information Technology, School of Allied Medical Sciences, Urmia University of Medical Sciences, Urmia, Iran. ,
3- Reproductive Health Research Center, Clinical Research Institute, Urmia University of Medical Sciences, Urmia, Iran.
4- School of Nursing and Midwifery, Urmia University of Medical Sciences, Urmia, Iran.
5- Department of Obstetrics and Gynecology, School of Medicine, Urmia University of Medical Sciences, Urmia, Iran.
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Table 2. Minimum HPV registry data elements reviewed in the first and second stages of Delphi
Table 2. Continue
Table 2. Continued
× Indicates a consensus of 50% or less ü Indicates a consensus of 75% or more
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Introduction
Human papillomavirus (HPV) is the most common sexually transmitted viral infection worldwide. Approximately, 80% of sexually active individuals will acquire an HPV infection during their lifetime, most of them within a few years following sexual debut ]1[. According to the most recent meta-analysis conducted on Iranian healthy female and female subjects with cervical cancer, the prevalence of HPV infection was 9.4% and 77.4%, respectively ]2[.
The HPV vaccine reduces the risk of cervical cancer and protects against other HPV-related vaginal and anal cancers. The vaccine was approved by the US Food and Drug Administration in 2006 ]3.[ Despite the availability of the Gardasil vaccine in Iran, the high cost of HPV vaccination has limited its use, and there is no national program to vaccinate girls and boys in the country ]4,2[. However, most developed countries, such as Australia, Hungary, and the United Kingdom, have included HPV vaccination in their national vaccination programs ]5 .[Cervical cytology screening is the second-standard method for the early detection of cervical cancer and has led to a sharp reduction in the incidence of this disease. Furthermore, national cervical cancer screening (CCS) program in Sweden showed that the risk of cervical cancer in women who were not screened was higher than in women who were previously screened ]6،4.[ In Iran, a national program for the prevention and early detection of cervical cancer using HPV testing is currently being implemented. However, a large number of women do not participate in the screening program, and this low level of participation leads to the late identification of women infected with HPV and those with cervical cancer ]4 .[Therefore, it is necessary to implement control strategies through prevention, diagnosis, and treatment programs ]7[.
A disease registry system is an information system designed for the collection, storage, retrieval, analysis, and dissemination of information related to a specific disease. Such a system can play a crucial role in examining disease incidence and prevalence trends, identifying at-risk populations, evaluating the effectiveness of health intervention programs, monitoring and follow-up of patients, improving the quality of healthcare, and facilitating medical research]8-10.[ One of the key steps in developing disease registry systems is the determination of the minimum data set (MDS), which involves identifying standardized data for a specific population with a particular disease or condition and is utilized for scientific, clinical, and health policy purposes within the registry system ]11-13[. The MDS is a standard method to gather, store and distribute key standardized data elements ]13.[
It seems that no registry system has been established in Iran to track women infected with HPV. Therefore, the creation and development of a registry system for women affected by HPV can play a vital role in monitoring and improving the quality of care for these patients, as well as in the early detection and treatment of cervical cancer. For the design of a registry system, it is essential to first identify the necessary data elements. This study was conducted with the aim of determining the MDS for the implementation of an HPV registry system.
Methods
This descriptive cross-sectional study was conducted in 2025 in three phases. At first, a review of scientific literature published between 2014 and 2024 was conducted using the Scopus, PubMed, and ScienceDirect databases ]14-18[. The search strategy included the keywords “human papillomavirus,” “minimum data set,” and “registry.” In addition, 100 medical records of women diagnosed with HPV, who were followed during the first half of 2025 at the Gynecologic Oncology Clinic of Kosar Hospital in Urmia, were reviewed using a convenience sampling method to identify and extract relevant data elements. In the second phase, based on a review of scientific literature and examination of patients’ medical records, the minimum data set was developed during a focus group session attended by five experts, including two gynecologic oncologists, two reproductive health specialists, and one health information management specialist. Following the incorporation of their feedback, the data elements were classified accordingly.
In the third phase, after preparing the list of data elements, expert opinions were surveyed using the Delphi method. The first round questionnaire consisted of two main parts in the form of open and closed questions. The first part included the personal characteristics of the experts (four questions) and the second part included five sub-categories of MDS: demographic (17 questions), patient history (80 questions), clinical information (19 questions), laboratory information (34 questions), and follow-up (10 questions). The data elements related to the minimum data set for HPV (160 questions) were specified as closed questions labeled "necessary" or "not necessary". The experts were asked to specify their opinion on the necessity of each data element.
The validity of the questionnaire was evaluated and confirmed by seven experts, including four gynecologic oncologists, two reproductive health specialists, and one health information management professional. To assess the reliability of the questionnaire, the test-retest method was employed. Initially, the questionnaire was distributed among 10 participants from the study population. Two weeks later, the same questionnaire was re-administered to the same individuals, resulting in an internal consistency coefficient of 81% for the entire questionnaire and a Pearson correlation coefficient of 85%, indicating good reliability between the two administrations.
In each round of the Delphi process, the questionnaires were distributed to the experts either in person or via email. After collecting the questionnaires in the first Delphi round, the data were analyzed using descriptive statistics (frequency and percentage) in Microsoft Excel. The decision to accept or reject each data element was as follows: data elements with a consensus of 50% or less among experts were excluded from the final MDS; elements achieving a consensus of 75% or higher were included in the final MDS; and elements with a consensus between 50% and 75% were re-evaluated in the second Delphi round. Consequently, the 27 data elements that did not meet the required threshold in the first round were sent back to the same group of experts.
In each Delphi round, 20 experts were purposefully selected, including gynecologic oncologists with clinical experience in managing patients with HPV and familiarity with the protocols for diagnosis, treatment, and follow-up of these patients; reproductive health specialists with sufficient experience in collecting and monitoring clinical data related to HPV; and health information management specialists with experience in designing and managing disease registry systems.
Results
After reviewing various studies, articles, and patients' medical records, all HPV-related data elements were extracted. In this study, a two-stage Delphi questionnaire was sent to 20 specialists. The demographic information of these specialists in the first and second rounds of Delphi is presented in Table 1. Most of the participants (80%) were female and fell within the age range of 40 to 49 years (45%). More than half of the participants (55%) had 10-15 years of work experience. Most participants were gynecological oncologists (50%).
Table 1. Characteristics of the participants
.PNG)
The results of the expert survey on the data elements related to women infected with HPV are shown in Table 2. Of the 160 data elements in the initial MDS, 110 achieved more than 75 percent agreement in the first Delphi round and 20 achieved the same threshold in the second Delphi round and were included in the final MDS. Moreover, 30 data elements were removed from the proposed MDS due to less than 50 percent agreement. Finally, 130 data elements were included in the final MDS. These data elements were organized into several categories as follows: demographic information (11 data elements); patient history, including vaccination history (five data elements), sexual activity history (five data elements), history of HPV-related diseases (10 data elements), other specific medical conditions (three data elements), blood transfusion history (two data elements), social history (eight data elements), psychological history (12 data elements), family medical history (three data elements), and pregnancy and contraceptive history (eight data elements); clinical information (15 data elements); marriage information (four data elements); diagnostic and laboratory information (34 data elements); and follow-up information (10 data elements)
Human papillomavirus (HPV) is the most common sexually transmitted viral infection worldwide. Approximately, 80% of sexually active individuals will acquire an HPV infection during their lifetime, most of them within a few years following sexual debut ]1[. According to the most recent meta-analysis conducted on Iranian healthy female and female subjects with cervical cancer, the prevalence of HPV infection was 9.4% and 77.4%, respectively ]2[.
The HPV vaccine reduces the risk of cervical cancer and protects against other HPV-related vaginal and anal cancers. The vaccine was approved by the US Food and Drug Administration in 2006 ]3.[ Despite the availability of the Gardasil vaccine in Iran, the high cost of HPV vaccination has limited its use, and there is no national program to vaccinate girls and boys in the country ]4,2[. However, most developed countries, such as Australia, Hungary, and the United Kingdom, have included HPV vaccination in their national vaccination programs ]5 .[Cervical cytology screening is the second-standard method for the early detection of cervical cancer and has led to a sharp reduction in the incidence of this disease. Furthermore, national cervical cancer screening (CCS) program in Sweden showed that the risk of cervical cancer in women who were not screened was higher than in women who were previously screened ]6،4.[ In Iran, a national program for the prevention and early detection of cervical cancer using HPV testing is currently being implemented. However, a large number of women do not participate in the screening program, and this low level of participation leads to the late identification of women infected with HPV and those with cervical cancer ]4 .[Therefore, it is necessary to implement control strategies through prevention, diagnosis, and treatment programs ]7[.
A disease registry system is an information system designed for the collection, storage, retrieval, analysis, and dissemination of information related to a specific disease. Such a system can play a crucial role in examining disease incidence and prevalence trends, identifying at-risk populations, evaluating the effectiveness of health intervention programs, monitoring and follow-up of patients, improving the quality of healthcare, and facilitating medical research]8-10.[ One of the key steps in developing disease registry systems is the determination of the minimum data set (MDS), which involves identifying standardized data for a specific population with a particular disease or condition and is utilized for scientific, clinical, and health policy purposes within the registry system ]11-13[. The MDS is a standard method to gather, store and distribute key standardized data elements ]13.[
It seems that no registry system has been established in Iran to track women infected with HPV. Therefore, the creation and development of a registry system for women affected by HPV can play a vital role in monitoring and improving the quality of care for these patients, as well as in the early detection and treatment of cervical cancer. For the design of a registry system, it is essential to first identify the necessary data elements. This study was conducted with the aim of determining the MDS for the implementation of an HPV registry system.
Methods
This descriptive cross-sectional study was conducted in 2025 in three phases. At first, a review of scientific literature published between 2014 and 2024 was conducted using the Scopus, PubMed, and ScienceDirect databases ]14-18[. The search strategy included the keywords “human papillomavirus,” “minimum data set,” and “registry.” In addition, 100 medical records of women diagnosed with HPV, who were followed during the first half of 2025 at the Gynecologic Oncology Clinic of Kosar Hospital in Urmia, were reviewed using a convenience sampling method to identify and extract relevant data elements. In the second phase, based on a review of scientific literature and examination of patients’ medical records, the minimum data set was developed during a focus group session attended by five experts, including two gynecologic oncologists, two reproductive health specialists, and one health information management specialist. Following the incorporation of their feedback, the data elements were classified accordingly.
In the third phase, after preparing the list of data elements, expert opinions were surveyed using the Delphi method. The first round questionnaire consisted of two main parts in the form of open and closed questions. The first part included the personal characteristics of the experts (four questions) and the second part included five sub-categories of MDS: demographic (17 questions), patient history (80 questions), clinical information (19 questions), laboratory information (34 questions), and follow-up (10 questions). The data elements related to the minimum data set for HPV (160 questions) were specified as closed questions labeled "necessary" or "not necessary". The experts were asked to specify their opinion on the necessity of each data element.
The validity of the questionnaire was evaluated and confirmed by seven experts, including four gynecologic oncologists, two reproductive health specialists, and one health information management professional. To assess the reliability of the questionnaire, the test-retest method was employed. Initially, the questionnaire was distributed among 10 participants from the study population. Two weeks later, the same questionnaire was re-administered to the same individuals, resulting in an internal consistency coefficient of 81% for the entire questionnaire and a Pearson correlation coefficient of 85%, indicating good reliability between the two administrations.
In each round of the Delphi process, the questionnaires were distributed to the experts either in person or via email. After collecting the questionnaires in the first Delphi round, the data were analyzed using descriptive statistics (frequency and percentage) in Microsoft Excel. The decision to accept or reject each data element was as follows: data elements with a consensus of 50% or less among experts were excluded from the final MDS; elements achieving a consensus of 75% or higher were included in the final MDS; and elements with a consensus between 50% and 75% were re-evaluated in the second Delphi round. Consequently, the 27 data elements that did not meet the required threshold in the first round were sent back to the same group of experts.
In each Delphi round, 20 experts were purposefully selected, including gynecologic oncologists with clinical experience in managing patients with HPV and familiarity with the protocols for diagnosis, treatment, and follow-up of these patients; reproductive health specialists with sufficient experience in collecting and monitoring clinical data related to HPV; and health information management specialists with experience in designing and managing disease registry systems.
Results
After reviewing various studies, articles, and patients' medical records, all HPV-related data elements were extracted. In this study, a two-stage Delphi questionnaire was sent to 20 specialists. The demographic information of these specialists in the first and second rounds of Delphi is presented in Table 1. Most of the participants (80%) were female and fell within the age range of 40 to 49 years (45%). More than half of the participants (55%) had 10-15 years of work experience. Most participants were gynecological oncologists (50%).
Table 1. Characteristics of the participants
The results of the expert survey on the data elements related to women infected with HPV are shown in Table 2. Of the 160 data elements in the initial MDS, 110 achieved more than 75 percent agreement in the first Delphi round and 20 achieved the same threshold in the second Delphi round and were included in the final MDS. Moreover, 30 data elements were removed from the proposed MDS due to less than 50 percent agreement. Finally, 130 data elements were included in the final MDS. These data elements were organized into several categories as follows: demographic information (11 data elements); patient history, including vaccination history (five data elements), sexual activity history (five data elements), history of HPV-related diseases (10 data elements), other specific medical conditions (three data elements), blood transfusion history (two data elements), social history (eight data elements), psychological history (12 data elements), family medical history (three data elements), and pregnancy and contraceptive history (eight data elements); clinical information (15 data elements); marriage information (four data elements); diagnostic and laboratory information (34 data elements); and follow-up information (10 data elements)
Table 2. Minimum HPV registry data elements reviewed in the first and second stages of Delphi
| Category | Delphi round | Consensus | Data elements (Frequency, Percentage) |
| Demographic information | First |
ü | Patient file number (18, 90%), First two letters of first name (19, 95%), First two letters of last name (19, 95%), Last four digits of national ID (19, 95%), Patient code (17, 85%), Insurance type (16, 80%), Marital status (20, 100%). |
| First |
× |
Father’s name (3, 15%), Place of birth (6, 30%), Email (3,15%), Number of family members (5,25%), Number of dependents (5,25%), Number of people living with (4,20%). | |
| Second | ü | Age (17, 85%), Religion (14, 70%), Place of residence (16, 80%), Mobile number (17, 85%). |
Table 2. Continue
| Category | Delphi round | Consensus | Data elements (Frequency, Percentage) |
| Immunization history | First | ü | HPV immunization (20, 100%), Age of first dose (20, 100%), Type of vaccine (19, 95%), Number of doses (19, 95%), Spouse immunization history (18, 90%). |
| First | × |
Hepatitis B immunization (9, 45%). | |
| Sexual activity history | First | ü | Sexual activity with a high-risk partner (20, 100%), Types of sexual contact during past 12 months (20, 100%), Multiple sexual partners (20, 100%), Condom use during intercourse (19, 95%), Unsatisfactory sexual history (19, 95%). |
| History of HPV-related diseases | First | ü | History of precancerous lesions or cervical cancer (19, 95%), History of treatment (18, 90%), Type of treatment (18, 90%), HIV (17, 85%), Herpes (19, 95%), Chlamydia (19, 95%), Gonorrhea (19, 95%), Syphilis (19, 95%), Warts (19, 95%), Trichomoniasis (19, 95%). |
| First | × |
Cervical cryotherapy (7, 35%), Cervical cauterization (7, 35%), IUD removal under anesthesia (6, 30%), Cervical polyp history (5, 25%), Pelvic inflammatory disease (6, 30%), Staphylococcus (7, 35%), Genital mycoplasma (6, 30%). | |
| Special disease history | First | ü | History of specific disease(s) (16, 80%), History of treatment (16, 80%), Type of treatment (16, 80%). |
| Family medical history | First | ü | Family history of disease (17, 85%), Name of diseases (17, 85%), Family history of genital warts (19, 95%). |
| History of blood transfusion | First | ü | Blood transfusion history (16, 80%), Reaction to blood transfusion (16, 80%). |
| Social history | First |
ü | Education level (17, 85%), Patient’s occupation (19, 95%), Workplace (19, 95%), Spouse’s occupation (18, 90%), Socioeconomic status (16, 80%), Smoking history (17, 85%), Hookah (17, 85%), Alcohol (17, 85%). |
| First | × | House ownership/rent (5, 25%), Monthly family income (3, 15%). | |
| Psychiatric and behavioral history | First Second |
ü |
Patient appearance (16, 80%), Patient behavior (16, 80%), History of psychotropic drug use (17, 85%), Drug names (17, 85%).
Suicide attempt (17, 85%), Number of self-harm incidents (17, 85%), Harm to others (17, 85%), Number of harm to others (17, 85%), Psychiatric hospitalization (16, 80%), Number of hospitalizations (16, 80%), Use of psychiatric medications (16, 80%), Name & dosage of drugs (16, 80%). |
| Pregnancy and contraception history | First |
ü | Pregnancy history (17, 85%), Number of pregnancies (17, 85%), Number of deliveries (17, 85%), Number of children (16, 80%), Contraception method (20, 100%). |
| First |
ü | Multiple pregnancy (5, 25%), Pregnancy after IVF (5, 25%), Ectopic pregnancy (6, 30%), Premature rupture of membranes (8, 40%), Age at first childbirth (7, 35%), Type of delivery (6, 30%), Induced abortion (4, 20%), Medical/technical abortion (4, 20%), Spontaneous abortion (3, 15%), Infertility history (9, 45%). | |
| Second | ü | Number of abortions (16, 80%), Current pregnancy (16, 80%), Current breastfeeding (16, 80%). | |
| Clinical information | First | ü | Date of visit (16, 80%), Reason for visit (19, 95%), Age at menarche (18, 90%), Age at first sexual intercourse (18, 90%), Date of last menstrual period (LMP) (18, 90%), Abnormal vaginal bleeding (19, 95%), Type of bleeding (19, 95%), Menstrual cycle (15, 75%), BMI (16, 80%), Blood group (18, 90%). |
| First |
× |
Drug allergy (5, 25%), Dysuria (7, 35%), Cervical pain during exam (9, 45%), Abdominal pain (9, 45%). | |
| Second | ü | Dyspareunia (17, 85%), Abnormal vaginal discharge (17, 85%), Vaginal itching/burning (16, 80%), Urinary burning (16, 80%), Urinary frequency (16, 80%). |
Table 2. Continued
| Category | Delphi round | Consensus | Data elements (Frequency, Percentage) |
| Marriage information | First | ü | Age at marriage (17, 85%), Patient’s marriage order (19, 95%), Spouse’s marriage order (19, 95%), Polygamy (20, 100%). |
| Laboratory information (Pap smear) | First | ü | Date of last Pap smear (20, 100%), Sample type (20, 100%), Sample adequacy (20, 100%), Presence of intraepithelial lesion/malignancy (20, 100%), Organism (20, 100%), Inflammation (20, 100%), Non-neoplastic findings (19, 95%), Epithelial cell abnormalities (19, 95%), Recommendation (19, 95%). |
| Laboratory information (HPV Test) | First | ü | HPV test result (20, 100%), Sample type (20, 100%), Sampling method (20, 100%), HPV diagnosis date (20, 100%), HPV type (20, 100%), HPV subtype (20, 100%). |
| Laboratory information (Colposcopy) | First | ü | Reason for referral (19, 95%), Normal appearance of perianal/ vulva / vagina (20, 100%), Lesion detected (20, 100%), SCJ (Squamous-Columnar Junction) observed (20, 100%). |
| Laboratory information (Pathology) | First | ü | Sample type (20, 100%), Lesion color (20, 100%), Chronic cervicitis (20, 100%), Chronic cervicitis with squamous metaplasia (19, 95%), Chronic cervicitis with reactive atypia (19, 95%), Chronic cervicitis with koilocytosis (19, 95%), Endometrial tissue in sample (19, 95%), Endometrial phase (19, 95%), Final pathology result (20, 100%), P16 (20, 100%), Ki-67 (20, 100%), Final recommendation (19, 95%), Sampling date (19, 98%), Pathology center (19, 98%), Pathologist name (19, 98%). |
| Follow-up information | First | ü | Next visit date (17, 85%), HPV vaccination (19, 98%), Colposcopy (19, 98%), Biopsy (19, 98%), LEEP (Loop Electrosurgical Excision Procedure) (19, 98%), ECC (18, 90%), Con biopsy (18, 90%), Hysterectomy (19, 95%), Recovery (13, 65%), Death (16, 80%). |
Discussion
The present study aimed to identify the MDS for a registry of women infected with HPV. To determine the essential data elements, a two-round Delphi method was employed, through which the final data elements were established based on expert consensus. Accordingly, 130 data elements were selected out of the initial 160 elements proposed in the preliminary MDS. These elements were categorized into five main domains: demographic information, medical history, clinical symptoms, laboratory data, and follow-up information.
Most of the data elements in this MDS available in two sections: demographic and clinical. Demographic information is collected to recognize and communicate with patients, and it is considered necessary for identifying, contacting, and following up with patients. Regarding clinical data, it should be acknowledged that these data are obtained during the process of diagnosis and treatment; in addition, forming the basis of direct patient care, they aid in reimbursement, planning, and research in healthcare ]19،20[. Based on our results, similar to other disease registry systems in the world, the necessary data elements for designing a registry for HPV can be classified into five groups: demographic, history, clinical, laboratory, diagnostic, and follow-up, all of which were agreed upon by experts.
In 2022, the University Medical Centre Maribor in Slovenia collected a minimum data set on patients treated for cervical cancer. For this purpose, a computer program called Cervix-Online was developed, which enabled the rapid and reliable collection, processing, and analysis of 116 data elements from patients with cervical cancer. These included general information, medical history, diagnostic procedures, histopathological examination results, treatment methods, and post-treatment follow-up]14 .[In that study, data elements related to treatment methods were included as a subcategory; however, in the present study, these elements were excluded based on expert consensus. Moreover, the data elements related to laboratory tests and diagnosis in that study were fully consistent with our findings.
In a study conducted by Mariam et al. ]15 [ in Canada to investigate the HPV prevalence infection among sexually active couples, a web-based information system was utilized. This system included demographic information, sexual activity history, pregnancy history, contraceptive history, clinical records, and HPV vaccination data. The set of data elements used in that study is consistent with our findings. Data elements related to sexual activity history, such as age at first sexual intercourse and having multiple sexual partners, were similar in both studies. Additionally, in the Canadian study, patient identifiers such as name, surname, national identification number, and father’s name were not recorded; instead, a unique identifier was used. Similarly, in our study, to protect patient confidentiality, each individual was identified using a composite code derived from the first two letters of the first name, the first two letters of the surname, and the last four digits of the national identification number.
In 2025, a study entitled “minimum dataset and metadata for active vaccine safety surveillance” was conducted, which proposed core data elements for vaccine safety monitoring systems, including demographic information and vaccine details (name, dose, and administration date). This study specifically emphasized that for HPV vaccines, these data should be integrated with clinical screening and pathology information ]21[. In the present study, the same approach was applied, utilizing these elements to enable accurate and integrated monitoring of HPV vaccination outcomes. In another study conducted in Malaysia in 2025, a program called ROSE was launched, which incorporates HPV self-sampling at the primary healthcare level. In this program, primary HPV testing replaces conventional Pap smears in certain regions, and data are systematically recorded and monitored ]17[. However, unlike this program, the minimum data set in our study does not include self-sampling procedures. A study conducted in China in 2025 examined data systems related to HPV, including information on HPV vaccination, screening, HPV-related diseases, and sexual behaviors. The main variables in these systems included the type of vaccine and doses administered, HPV screening data, Pap smear results, and precancerous lesions]22[. The present study also referred to all these data elements; however, unlike the Chinese study—which integrated vaccination and screening data—our study presented these data elements separately.
Limitations
The present study had several limitations. During the resource search and retrieval stage, a systematic review was not conducted, and only available scientific literature was examined. In addition, full-text access to some of the selected articles was not available. These limitations may affect the generalizability of the results to other settings or populations. Furthermore, since the participants in this study were limited to specialists in oncology, reproductive health, and health information management from Urmia University of Medical Sciences, this represents another limitation of the research. Future studies could include experts from more diverse geographical regions to enhance the generalizability of the findings.
Conclusion
The development of a comprehensive minimum data set for HPV can enable the assessment of virus transmission patterns, identification of at-risk populations, and monitoring of key aspects related to prevention and patient care. It can also serve as a valuable resource for conducting epidemiological research and clinical trials. Given the sensitivity of HPV-related data, particular attention must be paid to key issues such as confidentiality and data security. Identifiable patient information should be converted into encrypted identifiers. Considering the high prevalence of HPV in Iran, it appears essential to establish a national HPV registry system to identify infected women and monitor their treatment status. Moreover, it is recommended that this registry be capable of interoperability and information exchange with other existing systems in various healthcare centers, including laboratory systems, to facilitate the receipt of Pap smear, HPV test results, and pathology reports.
Declarations
Ethical considerations: This study was conducted under the ethical approval code IR.UMSU.REC.1403.039 issued by the Ethics Committee in Biomedical Research at Urmia University of Medical Sciences.
Funding: This research was funded and supported by Urmia University of Medical Sciences (Project Code:3420). The funder had no role in data collection, analysis and manuscript preparation.
Conflicts of interests: The authors declared that there is no conflict of interest.
Authors’ contribution: Sh.E: Study design, data curation, data analysis, writing–original draft, methodology, final approval. M.J: Conceptualization, study design, writing– original draft, writing review & editing, supervision, project administration, methodology, validation, final approval. H.GH: Study design, data analysis, writing–original draft, methodology, final approval. F.M: Study design, data curation, data analysis, writing–original draft, methodology, final approval. H.A: Study design, data curation, data analysis, writing–original draft, methodology, final approval. All authors have read and approved the final text of the article.
Consent for publication: Not Applicable.
Data availability: The data used in this study are available from the corresponding author upon reasonable request via email
AI deceleration: The authors used Grammarly for editing the English section of the manuscript. All edited content was reviewed and approved by the authors.
Acknowledgements: This article is derived from a portion of a Master’s thesis in Health Information Technology, entitled “Development and Evaluation of a Registration System for Women Infected with Human Papillomavirus in Iran,” conducted at Urmia University of Medical Sciences. The thesis was approved on 8 April 2024 with code 3420.
The present study aimed to identify the MDS for a registry of women infected with HPV. To determine the essential data elements, a two-round Delphi method was employed, through which the final data elements were established based on expert consensus. Accordingly, 130 data elements were selected out of the initial 160 elements proposed in the preliminary MDS. These elements were categorized into five main domains: demographic information, medical history, clinical symptoms, laboratory data, and follow-up information.
Most of the data elements in this MDS available in two sections: demographic and clinical. Demographic information is collected to recognize and communicate with patients, and it is considered necessary for identifying, contacting, and following up with patients. Regarding clinical data, it should be acknowledged that these data are obtained during the process of diagnosis and treatment; in addition, forming the basis of direct patient care, they aid in reimbursement, planning, and research in healthcare ]19،20[. Based on our results, similar to other disease registry systems in the world, the necessary data elements for designing a registry for HPV can be classified into five groups: demographic, history, clinical, laboratory, diagnostic, and follow-up, all of which were agreed upon by experts.
In 2022, the University Medical Centre Maribor in Slovenia collected a minimum data set on patients treated for cervical cancer. For this purpose, a computer program called Cervix-Online was developed, which enabled the rapid and reliable collection, processing, and analysis of 116 data elements from patients with cervical cancer. These included general information, medical history, diagnostic procedures, histopathological examination results, treatment methods, and post-treatment follow-up]14 .[In that study, data elements related to treatment methods were included as a subcategory; however, in the present study, these elements were excluded based on expert consensus. Moreover, the data elements related to laboratory tests and diagnosis in that study were fully consistent with our findings.
In a study conducted by Mariam et al. ]15 [ in Canada to investigate the HPV prevalence infection among sexually active couples, a web-based information system was utilized. This system included demographic information, sexual activity history, pregnancy history, contraceptive history, clinical records, and HPV vaccination data. The set of data elements used in that study is consistent with our findings. Data elements related to sexual activity history, such as age at first sexual intercourse and having multiple sexual partners, were similar in both studies. Additionally, in the Canadian study, patient identifiers such as name, surname, national identification number, and father’s name were not recorded; instead, a unique identifier was used. Similarly, in our study, to protect patient confidentiality, each individual was identified using a composite code derived from the first two letters of the first name, the first two letters of the surname, and the last four digits of the national identification number.
In 2025, a study entitled “minimum dataset and metadata for active vaccine safety surveillance” was conducted, which proposed core data elements for vaccine safety monitoring systems, including demographic information and vaccine details (name, dose, and administration date). This study specifically emphasized that for HPV vaccines, these data should be integrated with clinical screening and pathology information ]21[. In the present study, the same approach was applied, utilizing these elements to enable accurate and integrated monitoring of HPV vaccination outcomes. In another study conducted in Malaysia in 2025, a program called ROSE was launched, which incorporates HPV self-sampling at the primary healthcare level. In this program, primary HPV testing replaces conventional Pap smears in certain regions, and data are systematically recorded and monitored ]17[. However, unlike this program, the minimum data set in our study does not include self-sampling procedures. A study conducted in China in 2025 examined data systems related to HPV, including information on HPV vaccination, screening, HPV-related diseases, and sexual behaviors. The main variables in these systems included the type of vaccine and doses administered, HPV screening data, Pap smear results, and precancerous lesions]22[. The present study also referred to all these data elements; however, unlike the Chinese study—which integrated vaccination and screening data—our study presented these data elements separately.
Limitations
The present study had several limitations. During the resource search and retrieval stage, a systematic review was not conducted, and only available scientific literature was examined. In addition, full-text access to some of the selected articles was not available. These limitations may affect the generalizability of the results to other settings or populations. Furthermore, since the participants in this study were limited to specialists in oncology, reproductive health, and health information management from Urmia University of Medical Sciences, this represents another limitation of the research. Future studies could include experts from more diverse geographical regions to enhance the generalizability of the findings.
Conclusion
The development of a comprehensive minimum data set for HPV can enable the assessment of virus transmission patterns, identification of at-risk populations, and monitoring of key aspects related to prevention and patient care. It can also serve as a valuable resource for conducting epidemiological research and clinical trials. Given the sensitivity of HPV-related data, particular attention must be paid to key issues such as confidentiality and data security. Identifiable patient information should be converted into encrypted identifiers. Considering the high prevalence of HPV in Iran, it appears essential to establish a national HPV registry system to identify infected women and monitor their treatment status. Moreover, it is recommended that this registry be capable of interoperability and information exchange with other existing systems in various healthcare centers, including laboratory systems, to facilitate the receipt of Pap smear, HPV test results, and pathology reports.
Declarations
Ethical considerations: This study was conducted under the ethical approval code IR.UMSU.REC.1403.039 issued by the Ethics Committee in Biomedical Research at Urmia University of Medical Sciences.
Funding: This research was funded and supported by Urmia University of Medical Sciences (Project Code:3420). The funder had no role in data collection, analysis and manuscript preparation.
Conflicts of interests: The authors declared that there is no conflict of interest.
Authors’ contribution: Sh.E: Study design, data curation, data analysis, writing–original draft, methodology, final approval. M.J: Conceptualization, study design, writing– original draft, writing review & editing, supervision, project administration, methodology, validation, final approval. H.GH: Study design, data analysis, writing–original draft, methodology, final approval. F.M: Study design, data curation, data analysis, writing–original draft, methodology, final approval. H.A: Study design, data curation, data analysis, writing–original draft, methodology, final approval. All authors have read and approved the final text of the article.
Consent for publication: Not Applicable.
Data availability: The data used in this study are available from the corresponding author upon reasonable request via email
AI deceleration: The authors used Grammarly for editing the English section of the manuscript. All edited content was reviewed and approved by the authors.
Acknowledgements: This article is derived from a portion of a Master’s thesis in Health Information Technology, entitled “Development and Evaluation of a Registration System for Women Infected with Human Papillomavirus in Iran,” conducted at Urmia University of Medical Sciences. The thesis was approved on 8 April 2024 with code 3420.
Type of Study: Research |
Subject:
Health Information Management
Received: 2025/08/29 | Accepted: 2025/11/27 | Published: 2025/12/9
Received: 2025/08/29 | Accepted: 2025/11/27 | Published: 2025/12/9
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