Hospital-Based Surveillance System Development in Patients with Hematological Malignancies undergoing Bone Marrow Transplant in Middle-Income Countries- the Case of Iran experience: Research Protocol

Hospital-Based Surveillance System Development in Patients with Hematological Malignancies undergoing Bone Marrow Transplant in Middle-Income Countries- the Case of Iran experience: Research Protocol | Research Square window.SnipcartSettings = { analytics: { enabled: false } }; (function() { var accessVector = localStorage.getItem('access_vector') || ''; window.dataLayer = window.dataLayer || []; if (accessVector) { window.dataLayer.push({ user: { profile: { profileInfo: { snid: accessVector } } } }); } })(); (function(w,d,s,l,i){w[l]=w[l]||[];w[l].push({'gtm.start':new Date().getTime(),event:'gtm.js'});var f=d.getElementsByTagName(s)[0],j=d.createElement(s),dl=l!='dataLayer'?'&l='+l:'';j.async=true;j.src='https://www.googletagmanager.com/gtm.js?id='+i+dl;f.parentNode.insertBefore(j,f);})(window,document,'script','dataLayer','GTM-K279D39R'); Browse Preprints In Review Journals COVID-19 Preprints AJE Video Bytes Research Tools Research Promotion AJE Professional Editing AJE Rubriq About Preprint Platform In Review Editorial Policies Our Team Advisory Board Help Center Sign In Submit a Preprint Cite Share Download PDF Study protocol Hospital-Based Surveillance System Development in Patients with Hematological Malignancies undergoing Bone Marrow Transplant in Middle-Income Countries- the Case of Iran experience: Research Protocol Sima Oshnouei, Mohamad Jebraeily, Mohsen Asadi-Lari, Aarefeh Jafarzadeh-Kohneloo, and 2 more This is a preprint; it has not been peer reviewed by a journal. https://doi.org/ 10.21203/rs.3.rs-4450602/v1 This work is licensed under a CC BY 4.0 License Status: Posted Version 1 posted You are reading this latest preprint version Abstract Background In patients with hematological malignancies undergoing bone marrow transplants, both cancer surveillance programs and cancer registries play crucial roles in monitoring and improving patient outcomes. This research protocol aims to establish a hospital-based surveillance system for patients with hematological malignancies undergoing bone marrow transplantation (BMT) in Iran, utilizing a mixed-methods approach. Methods The study will involve quantitative data collection through medical record reviews and qualitative data collection through action research. To evaluate the feasibility and acceptability of the surveillance system among healthcare providers and patients, an assessment was conducted. This involved organizing an expert panel and conducting focus groups. Given the absence of a standardized data collection format for the patients under study, we are taking steps to develop a Bone Marrow Transplantation Registry Electronic System in educational hospitals. Results We utilized a standardized format developed by the EBMT and CIBMTR, along with input from expert panels and focus groups, to review the literature on hematological malignancies. We have created a Bone Marrow Transplant Registry Checklist, designed as a tool for data collection. It incorporates validated MDS elements tailored to five distinct types of hematological malignancies. We utilized a passive data collection method to continuously gather pertinent information and created a web-based data collection tool for continuous monitoring and evaluation of treatments. Analytical reports were generated in the form of operational dashboards, providing valuable feedback on analyses during the surveillance process. A pilot test of the registry surveillance system was conducted to ensure alignment with standard procedures and to identify and address any systematic or random errors. Conclusions This research protocol outlines the methodology for establishing a system and emphasizes the importance of implementing standardized monitoring protocols in middle-income countries to enhance the evaluation of treatment outcomes among patients with hematological malignancies undergoing HSCT. This system can help identify gaps in available data and treatment modalities during procedures like HSCT. It can facilitate quality improvement and ultimately enhance patient outcomes by engaging with other decision-makers and supporting the growing efforts in middle-income countries in the concept of action research. Hospital-Based registry Surveillance developing Bone Marrow Transplant cancer system Introduction Hematological malignancy (HM) is a life-threatening disorder that increases susceptibility to other cancers. Despite the increased risk of cancer, there are no widely accepted guidelines for the development of cancer surveillance protocols for individuals affected by hematological malignancies. Hematologic/Oncologic Malignancies study was initiated in 2000 as part of the treatment program for these patients to improve outcomes. Bone marrow transplantation is commonly used to treat patients diagnosed with leukemia, aplastic anemia, lymphoma, multiple myeloma, immune deficiency disorders, and some solid tumors [ 1 – 2 ]. Bone marrow transplantation surveillance systems have been developed to monitor the status of hematopoietic stem cell transplantation (HSCT), and chimerism analysis is a well-established method for monitoring the condition of HSCT [ 3 – 4 ]. Cancer registries are an example of this kind of surveillance and have been established in all states. The methods used for cancer registration have been well-documented. Cancer registries collect information about individuals diagnosed with cancer through reports from physicians and diagnostic laboratories. Depending on the available resources, the information may include not only basic demographic data on the individual and type of tumor but also detailed data on the anatomic site of the tumor, the stage at diagnosis, the cell type of the cancer, and treatment and follow-up clinical information. When a person is diagnosed with more than one type of cancer, information is obtained for each separate tumor in a case report. Most registries include reports of all malignant cancers [ 5 ]. Specific examples of important registries available to collect information on bone marrow transplantation include the EBMT, CIBMTR, and APBMT [ 6 ]. Current knowledge on systematic surveillance systems in hematological malignancies is limited, especially in developing countries. In China, the Chinese Blood and Marrow Transplantation Registry Group (CBMTRG) reported 18,110 HSCTs in a single year (2021), contributing to a total of 90,436 HSCTs since 2008. To date, 174 medical centers have been registered as having a certificate to perform HSCT [ 7 ]. The first bone marrow transplant center in Iran was established in 1992 at Shariati Hospital in Tehran, with subsequent expansions to accommodate the increasing demand for HSCT [ 8 ]. The current state of bone marrow transplantation in hematological malignancies in Iran reflects significant progress and advancements in the field. Over the past two decades, the rates of HSCT have increased significantly, with 49.4 transplants per one million inhabitants being performed. Recent advancements include the utilization of double cord blood and haploidentical transplantation to treat various life-threatening conditions [ 9 ]. Cancer surveillance systems differ among countries due to various factors such as the extent of data collection, registry quality, and population coverage. In developed nations such as the U.S., these systems rely on established cancer registries to gather detailed information on new cancer cases, disease severity, and treatment outcomes. They incorporate hospital registries from cancer centers and population-based registries linked to state health departments to compile extensive data on cancer diagnoses and outcomes across regions. Conversely, lower-income countries face challenges due to inadequate surveillance systems resulting from insufficient vital statistics and population-based registries [ 10 ]. Survival data in the East Mediterranean region (EMR) are limited. Iranian cancer patients experience a relatively poor prognosis compared to those in high-income countries. Implementation of early detection programs and improving the quality of care are required to enhance cancer survival rates among Iranian patients. Further studies are needed to monitor the outcomes of cancer patients in Iran and other EMR countries [ 11 ]. Analysis of data extracted from the Surveillance, Epidemiology, and End Results database shows a growing trend of improved long-term survival rates among prevalent hematologic malignancies. However, persistent concerns exist regarding late mortality. Therefore, additional research is warranted to investigate the long-term outcomes of treatable malignancies in order to map the factors contributing to the observed declines in survival rates over time [ 12 – 13 ]. In Iran, the follow-up of patients with hematological malignancies is currently not feasible. Establishing a registry system within a surveillance system can play an important role in the follow-up of patients. In patients with hematological malignancies undergoing bone marrow transplants, both cancer surveillance programs and cancer registries play crucial roles in monitoring and improving patient outcomes. While there is no single nationwide surveillance and registry system in Iran, our aim is to develop a hospital-based cancer registry surveillance for the five most common hematological malignancies at the national level. As part of the surveillance system development, secondary objectives include designing and implementing a Bone Marrow Transplantation Registry Electronic System in educational hospitals to provide actionable data to these patients in near real-time. With the availability of this large dataset, it is possible to make more efficient use of current resources, increase data security, build new services that can be shared, create more consistent data reporting connections, and provide interactive data visualization dashboards that update the platform as needed. Materials/Subjects and Methods Study population and setting: The study population would include patients with hematological malignancies who are undergoing bone marrow transplants at Urmia Imam Khomeini Hospital in Iran. The hospital serves as the primary site for patient care, treatment, and medical procedures related to hematological malignancies and bone marrow transplants. Since March 2015, bone marrow transplantation for hematological malignancies has been initiated at Urmia Imam Khomeini Hospital in Iran, located in northwestern Iran. Over the past eight years, the annual number of patients undergoing bone marrow transplantation has increased from around 15 to 40. Developing a robust Bone Marrow Transplantation surveillance and registry system that integrates action research principles with expert guidance involves following these key steps: Literature review : A systematic review was conducted to examine the available documentation in the patient files of individuals with hematological malignancies who had undergone hematopoietic stem cell transplantation (HSCT). This review involved exploring the Bone Marrow Transplantation worldwide surveillance and similar cancer registries, various analytical methods, and tools for processing and interpreting patients' data to address key aspects: 1. identifying cases. 2. Minimum data requirements 3. Determining data sources, 4. Understanding data collection mechanisms, and their important function related to future analyses. 5. Defining the objectives of a Disease Registry and Performance Indicators or Key Performance Indicators (KPIs) to evaluate the success of a surveillance system. Expert Panel Organization : To ensure a comprehensive and well-rounded approach to conducting high-quality systematic reviews in various fields, we first identified and formed an expert panel committee. The committee is responsible for establishing surveillance and registry objectives, developing action plans and protocols for program implementation, evaluating its effectiveness, and securing essential support. The expert panel must meet the following criteria: each member should have at least 5 years of experience in practice or research, with 3 years specifically related to the project's focus [ 14 ]. A qualitative study focused on action research : Action research methodology was utilized to actively engage key stakeholders, researchers, and patients in the design and implementation of the surveillance system. In developing the surveillance system, conducting action research is crucial to enhance all processes of the surveillance system. This work involves an iterative approach that includes planning, acting, observing, and reflecting for system improvement. The system is refined based on feedback from the committee and stakeholders. Additionally, as part of the design, focus group methodology was selected to explore clinicians' knowledge and reasons for specific patterns of thinking. This process involves a comprehensive and evolving approach that encompasses the following key steps: 1. Establish objectives,2. Develop case definitions, 3. Determine the data source or data collection mechanism (type of system), 4. Develop data collection instruments, 5. Field-test methods ,6. Develop and test an analytic approach, 7. Develop a dissemination mechanism, 8. Ensure the use of analysis and interpretation [ 15 ]. Ethic Access to this information is granted with the approval of the Ethics Committee at Urmia University of Medical Sciences (IR.IUMS.REC.1402.763). Ethical considerations regarding patient confidentiality and data protection were strictly adhered to throughout the data extraction and analysis processes; therefore, informed consent is not required in this case. Results 1. For hematological malignancies, literature reviews indicate that the EBMT (European Blood and Marrow Transplantation), CIBMTR (Center for International Blood and Marrow Transplant Research), and APBMT (Asia-Pacific Blood and Marrow Transplantation Group) are the three most prominent international communities involved in clinical blood and marrow transplantation and cellular therapy. These communities almost had a harmonized and uniform language of definitions, which is crucial for collaborative work and data sharing between registries at the international level for future endeavors. Additionally, one of the noteworthy features in developing the bone marrow transplantation surveillance system is determining essential data sources and collection mechanisms. The primary basis for this was the standard format developed by EBMT, CIBMTR, and APBMT, which are prominent organizations in the field. 2. The expert panel members had at least 5 years of experience in practice or research, with 3 years specifically related to the project's focus. The panel included oncologists, BMT unit staff (including secretaries, head nurse), nurses providing services to hematological malignancy patients, and the registry director located in this hospital. 3. During the expert panel consultation, a decision was made to include a variety of data elements after consulting and addressing other important issues related to the design and development of the surveillance system. This was the first step in designing the surveillance system, determining case definitions, and defining surveillance system purposes. 4. During the first six months of the project, each work group met at least once a month, either via phone or during a one-day face-to-face meeting. The classification of malignancy types, procedures related to BMT transplantation, associated complications, and treatments outlined in the case definitions were identified through a comprehensive literature review. These were deeply discussed by an expert panel to incorporate their opinions and ensure national validity. This comprehensive approach aimed to enhance diagnostic precision beyond what could be achieved solely through diagnostic ICD codes. In collaboration with an expert panel, the purpose of establishing a surveillance system was determined to develop a hospital-based cancer registry surveillance focusing on the five most common hematological malignancies. The aim was to provide high-quality data for evaluating strategies related to hematopoietic stem cell transplantation. The mission included conducting follow-up to identify clinical outcomes in two hospitals with improved results in bone marrow transplant patients, which constituted the primary goal of designing the surveillance system. 5. During focus groups with oncologists, the BMT unit staff (including secretaries and head nurses), and other nurses specializing in providing services to patients with hematological malignancies, appropriate data collection methods were discussed. Various approaches and significant issues related to data collection methods for the patients under study were evaluated. The summarized comments from the focus group are as follows: “In our country, there is currently no standardized format for collecting data on the patients under study. Clinical data on these patients are typically collected as part of their BMT and treatment approaches. It is gathered from various sources, including laboratory analyses such as HLA typing, Complete Blood Count (CBC), Peripheral Blood Smear, Blood Chemistry Tests, Coagulation Tests, Flow Cytometry, Cytogenetic Analysis, Bone Marrow Aspiration, and Biopsy, along with medical history, physical examination, and imaging. None of these variables are patient-reported outcomes. However, this data is often unstructured or presented as narrative text in the patients' medical records of the BMT unit and Blood unit following HSCT admission. In this research, patient data, including information about individuals eligible for bone marrow transplant treatment and their medical history, was utilized. Moreover, these applied data sources may also require support from clinical informaticists to clean and standardize the data before uploading it into the registry system. To investigate post-HSCT outcomes in the first 100 days after HSCT, it is necessary to follow up with HSCT patients. Based on the oncologist's experience in the expert panel, almost all post-transplant patients consult the oncologist to evaluate potential adverse effects and treatment outcomes, considering the high severity of hematological malignancies. " 6. In the subsequent stage, it is crucial to build an initial platform for MDS to design a data collection instrument. Following suggestions from an expert panel, we utilized a minimal dataset consisting of validated elements for HSCT registry. This dataset had been previously validated at a national level in a study conducted in Iran by Taheriyan et al. Additionally, before implementing the surveillance registry model to evaluate the regional feasibility of the registry model at Urmia's Imam Khomeini Hospital, a focus group discussion was conducted with oncologists, the BMT unit staff (including secretaries and head nurses), and other nurses involved in the BMT specializing in providing services to patients with hematological malignancies. Subsequently, the paper-based form was structured into seven key sections, including pre-HSCT status, leukemia, lymphoma, plasma cell disorders like multiple myeloma, and post-HSCT information. It specifically focused on the data up to day 100 post-transplantation. In summary, the Bone Marrow Transplant registry checklist functions as a surveillance data collection tool that includes validated MDS elements specific to five hematological malignancies studied. 7. Passive data collection methodology was employed to continuously gather relevant information, rather than intermittently. Verified items derived from validated Minimum Data Set (MDS) components were compiled into paper-based forms in collaboration with the knowledgeable Head nurse from the BMT unit. These data would be input into the registry's computer system using standardized codes that are confirmed by an expert panel. 8. Following this, a web-based data collection instrument was developed to establish a robust disease registry surveillance mechanism for the ongoing monitoring and evaluation of treatments. 9. Finally, the designed model of the disease registry surveillance system was pilot-tested to ensure alignment with standard procedures and to prevent or reduce systematic or random errors. Users' suggestions were implemented to enhance the data collection process. A pilot test was conducted at the BMT section of Urmia Imam Khomeini Hospital. A WhatsApp group was established with both the project team and expert members. The forms were shared in the group, and members were asked to provide feedback on them. After a comprehensive review of the members' comments, the approved feedback was integrated into the forms. Twenty transplants were prospectively registered, and the registry was created from MED forms provided by all consecutive patients. All data were regularly recorded and updated. 10. In the next phase, during the expert panel deliberation, it was decided that the designed web-based registry system should possess the following analytical capabilities to generate aggregate analytical reports: 10.1- The registry surveillance system can be utilized to analyze and report the frequency of autologous and allogeneic hematopoietic stem cell transplantation (HSCT) for hematologic malignancies such as multiple myeloma (MM), acute lymphoblastic leukemia (ALL), acute myeloid leukemia (AML), Hodgkin lymphoma (HL), and non-Hodgkin lymphoma (NHL). 10.2- The frequency of relevant outcome measures, such as mortality, the first 100-day survival post-HSCT, relapse, remission, rejection, complete remission, and the acute incidence of Graft-versus-Host Disease (GVHD), can be analyzed and documented within the surveillance framework, taking into account gender and age distributions. 10.3- Risk assessment and reporting for the analyzed hematologic malignancies can be carried out within the surveillance system. These analytic reports are presented in the form of lists, graphs, and operational dashboards. 11. After reviewing related articles and recommendations from a collaborative expert panel, it has been decided to disseminate semiannual analytical reports in validated formats. These reports will be distributed to policymakers and stakeholders, including oncologists who conduct bone marrow transplants in the BMT units of this region. 12. Based on the suggestions of the focus group, the regional surveillance system should be able to utilize disseminated surveillance information for improvement and informed decision-making when evaluating therapeutic outcomes. In other words, it ensures the analysis and interpretation of the data within the surveillance system, offering valuable feedback on analyses during the surveillance process. This feedback guides therapeutic decisions, improves patient outcomes, helps stakeholders identify areas for improvement, and facilitates informed decision-making based on surveillance data. Discussion The cancer surveillance system for hematological malignancies worldwide is a critical aspect of public health and medical research. Hematological malignancies are a diverse group of disorders that affect the blood and its components, including anemia, bleeding disorders, and hematologic malignancies. These conditions have a significant impact on global health, posing challenges for healthcare systems worldwide [ 16 ]. Designing surveillance protocols for hematological malignancies undergoing bone marrow transplantation presents several challenges that need to be addressed to ensure effective monitoring and management of these patients. Consequently, these patients are often exposed to cytoreductive conditioning regimens that can lead to significant toxicities, such as mucositis, dermatitis, and pulmonary, hepatic, and renal toxicities. Managing these toxicities while ensuring effective surveillance is crucial [ 17 ]. Infections due to compromised immune systems are other important challenges in these patients [ 18 ]. Implementing genetic counseling and tailored surveillance protocols for these patients is a challenge that needs to be addressed. Patients with genetic predispositions to hematologic malignancies require specialized surveillance strategies to detect early signs of disease progression or relapse [ 19 ]. Overcoming resource limitations to ensure effective surveillance is crucial for patient outcomes. Developing surveillance protocols in resource-limited settings can be challenging due to the substantial investments required in infrastructure, equipment, medical supplies, and the training of healthcare professionals [ 20 ]. Surveillance for hematological malignancies in patients undergoing bone marrow transplantation requires a multidisciplinary approach involving various specialties such as radiation oncology, infectious disease, cardiology, and more. Careful monitoring of minimal residual disease (MRD) and prompt application of preemptive strategies in the post-transplant setting have become imperative [ 21 ]. One-time treatment approaches are crucial for patients affected by hematological malignancies who are candidates for HSCT due to their disease status. Implementing one-time interventions can significantly impact patient outcomes and quality of life during the complex process of HSCT, especially in a population sensitive to financial concerns [ 22 – 23 ]. This complex surveillance system requires careful planning and execution to ensure comprehensive monitoring. The challenge in the cancer surveillance system that is similar to bone marrow transplant in hematological malignancy in a regional hospital is the requirement for precise and thorough data collection and reporting. Just as bone marrow transplants in hematological malignancies require precise matching and monitoring. Surveillance systems also serve to gather valuable information about treatment efficacy and safety, contributing to the improvement of treatment process and outcomes over time [ 24 ]. Additionally, they facilitate communication among members of the multi-disciplinary BMT team at the national level to Creates more consistent data reporting connections, reduce waiting time of patients ensuring that each patient receives the fastest treatment in suitable time. Considering the mission of the surveillance system, activities worldwide focusing on population-based initiatives can be highlighted. The Surveillance, Epidemiology, and End Results (SEER) program, initiated by the U.S. National Cancer Institute allows for cohort analyses and establishes a global benchmark for cancer registries by employing standardized practices for data collection and coding [ 25 ]. The HOLA study focuses on patient characteristics and treatment outcomes for hematological malignancies in Latin American countries. This observational registry study aims to fill the gap in real-world data on diseases such as chronic lymphocytic leukemia (CLL), multiple myeloma (MM), and non-Hodgkin lymphoma (NHL) in the region, offering valuable insights for healthcare professionals and policymakers [ 26 ]. A robust surveillance system will facilitate the monitoring, assessment, and enhancement of policies, initiatives, and services. It will also help optimize resource allocation, support advocacy and education efforts, and serve as a reference point for healthcare professionals. These goals rely on various elements, including data quality, systematic data collection, analysis, and interpretation, utilization of results for prevention and control strategies, and consistent feedback from end users to enhance fulfilling the system's mission to guide actions and policies to improve treatment outcomes [ 27 ]. In the process of data collection in our study, similar to many other developing nations, we encounter several challenges and obstacles such as staff attitudes, deficiencies in health system infrastructure, and operational issues. Particularly, the data collection process is hindered by a lack of adequate documentation. The development of hospital-based surveillance systems in middle-income countries faces diverse challenges, as highlighted in the referenced literature. These challenges include the operational feasibility of hospital-based cancer registries [ 28 ]. and the necessity for digital transformation to electronic medical records for enhanced data management [ 29 ]. Furthermore, inadequate or non-existent healthcare infrastructures, absence of accurate records and population data, complexities arising from cultural norms, and challenges stemming from political and economic instability present additional obstacles. To comprehensively register all cancer cases, data must be sourced from various outlets, including hospitals, laboratories, and death certificates within healthcare networks. Poorly established communication channels among different stakeholders and the lack of a standardized method for uniquely identifying individuals further complicate the collection of this data [ 30 ]. Based on the issues highlighted regarding the availability of data for patients undergoing HSCT, as mentioned in the results section, it is evident that there is currently no standardized format or registry functionality in our country that records detailed treatment profiles of the studied patients. As part of the data collection sources for monitoring information related to this protocol, a new computer system is being developed to establish patient registries accessible on the Internet. Prior steps in developing this new computer system involve expanding the minimum data requirements for electronic health records to enhance core elements specific to the HSCT patients in validated, interoperable ways to elevate the quality of surveillance data concerning these medical conditions. Furthermore, these core datasets strike a balance between national reliability and alignment with international standards. This research focused on establishing a fundamental dataset for the HSCT registration system at Tehran Imam Khomeini Hospital, which was later validated to streamline system development. The Minimum Data Set (MDS) comprises nine sections covering pre-HSCT, leukemia, lymphoma, myelodysplastic syndrome, myeloproliferative neoplasms, combined myelodysplastic syndrome and myeloproliferative neoplasms, plasma cell disorders including multiple myeloma, hemoglobinopathy, and post-HSCT data. Data elements were sourced from the Center for International Blood and Marrow Transplant Research (CIBMTR) and the European Society for Blood and Marrow Transplantation (EBMT) essential datasets. These data were then analyzed in collaboration with an expert panel [ 31 ]. After validating the delivered registry model dataset, our research paper in paper-based form was reviewed by a panel of research experts to identify functional components for utilizing the surveillance system in future stages. By developing an electronic surveillance system, it will be possible to link follow-up information to pre-treatment data for patients undergoing HSCT in BMT units and medical records throughout the BMT procedure. Research expert panels have recommended that, since almost all patients treated in the BMT units at Imam Hospital visit the oncologist's office for follow-up appointments to assess the outcomes of their HSCT treatment, and follow-up data is systematically collected from their clinical and paraclinical examinations post-HSCT, which are not available in the BMT unit at Imam Hospital, using paper-based charts in the doctor's office seems to be the most appropriate option for monitoring this data. To prevent missing information, the current optimal solution would involve digitally transforming the patients' charts from the doctors' offices into electronic medical records using specialized registry software. This transition could be facilitated by providing BMT oncologists with access and passwords to use in their offices. In brief, this system aims to deliver actionable and standardized data to patients in almost real-time, optimize current resources, enhance data security, and introduce new services for shared use. It will standardize interfaces, create more consistent data reporting connections, provide interactive data visualization dashboards, update the platform as necessary, and serve as a foundation for future system development if required. Quality assurance activities in design should be complemented by pretesting and pilot testing. The findings from pretests and pilot studies help refine and enhance these procedures to increase their effectiveness, validity, and reliability. The feasibility and efficiency of the study procedures are assessed through pretests and pilot studies. Pilot studies also provide an opportunity to assess different strategies for participant recruitment and data collection methods to address any potential issues before the project encounters failure [ 32 ]. In our research, after implementing the model, the data collection system underwent pilot testing to ensure compliance with standard procedures, minimize systematic or random errors, and uphold quality control. In other words, the aim is to assess the functional aspects of specific procedures, pinpoint significant flaws, implement necessary improvements, and effectively store data from the study of hematologic malignancies undergoing HSCT. The training of head nurses in our research focused on ensuring that they were informed about procedures, standardizing data collection, and highlighting the importance of adhering to the procedures outlined in the operational manuals. This involves a variety of approaches to guarantee the accuracy, completeness, and timeliness of data collection and reporting, as well as the key features of the registry software. It facilitates the implementation of feasible systems and minimizes the need for changes as systems are implemented on a broad scale. To underscore this, quality assurance, quality control, and quality improvement are crucial aspects to consider when designing a robust surveillance system to ensure effective surveillance protocols. These are essential components to ensure the accuracy, reliability, and integrity of data collected in various monitoring activities. These processes are crucial for maintaining high-quality standards and minimizing errors in surveillance protocols that require a cyclical approach to ensure high-quality data in a high-volume cancer registry within the surveillance system. The fundamental characteristics of high-quality data in public health surveillance include completeness, accuracy, and timeliness, which are summarized in the acronym CAT [ 33 ]. In the context of designing a surveillance system for hematopoietic stem cell transplants to improve outcomes, it is important to note that the model for improvement is a robust tool for redesigning healthcare processes in transplant and cellular therapy. This model uses a series of components to organize and critically evaluate improvement activities. Unlike other health sciences clinical research, quality improvement projects are based on evolving hypotheses that lead to observable, sequential tests of change, with constant collection and feedback of performance data to stakeholders [ 34 ]. Most importantly, in designing a surveillance system, it is crucial to recognize that it involves action research. Only focusing on a systematic review during setup can lead to bias, impeding the development of a robust and sensitive surveillance system. This approach may not yield the qualitative information necessary for providing effective feedback to improve the surveillance process and achieve its intended goals. Therefore, action research is essential in shaping surveillance systems by developing a reflective and iterative method where practitioners actively participate in research to instigate positive change and enhancement. Moreover, it emphasizes the significance of ongoing reflection, collaborative engagement, and empowering individuals, all essential for creating responsive surveillance systems that meet community needs and can adapt to evolving situations. Being flexible to adapt in response to identified needs, a surveillance system is important while considering all the recommendations mentioned above [ 35 ]. Finally, the dissemination of surveillance data plays a crucial role in improving data collection within surveillance systems. In the public health field, the usefulness of surveillance data can be categorized as immediate, annual, and archival, depending on the public health interventions that can be implemented. Periodic information dissemination for decision-makers in a timely manner is crucial to strengthen evidence-based decision-making using a surveillance system [ 36 – 37 ]. Unfortunately, we do not currently have a detailed report available for this specific purpose. As per the oncologists in the expert panel, the current patient information report for individuals undergoing bone marrow transplants, which includes the frequency of allogeneic and autologous transplant cases for various hematological malignancies, along with mortality data, is shared monthly in the BMT telegram group in Excel format. Designing the surveillance system and expanding the electronic registry system, while considering the dimensions of a capable care system and employing exploratory approaches to expand it, and following the principle of quality improvement, can be an important step in providing high-quality information for evaluating treatment outcomes in patients, particularly in the context of low- and middle-income countries. In line with the aforementioned, information technology and informatics can streamline the dissemination process of analytical reports of surveillance data [ 38 ]. This is crucial for regularly reporting surveillance data findings to ensure that decision-makers and oncologists involved in patient treatments receive updated information promptly. Incorporating data visualization in the reports can present complex data clearly and concisely, aiding in better understanding and interpretation by the recipients [ 39 ]. Similar to many other health and therapeutic issues highlighted and affected by evidence, global disparities in hematological malignancies such as multiple myeloma in the areas of patient surveillance are clearly observed [ 40 ]. Limitations of the surveillance system in hematological malignancies in northwestern Iran include insufficient data in flow cytometry and molecular marker examination for all patients. The lack of data in these diagnostic technologies hinders the ability to accurately categorize and characterize various types of hematological malignancies, potentially resulting in misdiagnoses and suboptimal treatment outcomes. Additionally, the absence of comprehensive data can hinder the discovery of new biomarkers and therapeutic targets that have the potential to enhance patient care and outcomes. It is important to note that while the current surveillance system may be limited, research efforts such as the one conducted in this study can serve as a crucial preliminary step towards providing more comprehensive diagnostic and treatment options for patients with hematological malignancies in the future. By engaging with policymakers at higher levels and advocating for increased resources and support for advanced diagnostic technologies, researchers can help address these limitations and improve the overall management of hematological cancers in Iran. Additionally, collaborating with international partners in research and clinical trials can help bridge the gap in access to advanced diagnostic tools and treatments for patients with hematological malignancies in northwestern Iran. By sharing knowledge, resources, and expertise, researchers and healthcare providers can collaborate to overcome the limitations of the current surveillance system and ultimately enhance patient outcomes. In conclusion, this study protocol describes the design and methods used in implementing a Hospital-Based Surveillance System for Patients with Hematological Malignancies undergoing Bone Marrow Transplant in the northwest of Iran. It is valuable to keep in mind that surveillance systems are necessary but not sufficient for improving cancer therapeutic approaches. They are an essential component of global cancer control, especially in ensuring access to suitable and timely cancer treatment in low- and middle-income countries. A comprehensive comprehension of the impact of bone marrow transplants on hematological malignancies is crucial for public health practitioners, researchers, health insurers, and policymakers. In recent years, various researchers have recognized the necessity for improved data collection as a key priority in bone marrow transplantation. Developing a hospital-based surveillance system for bone marrow transplantation represents a significant contribution to enhancing the timely acquisition of crucial information. This is especially important given the inherent complexity of this therapeutic approach and the significance of risk stratification and precision in classifying patients based on their risk level. Surveillance is essentially a dynamic process, not a static picture. It aims to improve treatment outcomes through intelligent evaluation rather than relying solely on natural progression. This offers expert guidance to the Special Diseases Department of the Ministry of Health, facilitating the optimization of drug distribution, resource allocation, and quality control of transplant procedures at the national level. Moreover, this effort involves establishing a comprehensive hematologic malignancy surveillance system. This system informs policy decisions related to expanding drug and equipment supply and improving healthcare centers. The ultimate goal is to ensure the highest standards of care delivery at both national and local levels. Abbreviations Cancer Surveillance System (CSS); Hematopoietic Stem Cell Transplantation (HSCT); Multiple Myeloma (MM); Acute Lymphoblastic Leukemia (ALL); Acute Myeloid Leukemia (AML); Non-Hodgkin Lymphoma (NHL); Hodgkin Lymphoma (HL); Human Leukocyte Antigen (HLA) ; HOLA ; Hemato-Oncology Latin America Observational Registry ; Surveillance, Epidemiology, and End Results (SEER) Declarations Acknowledgements: This article and its results were extracted from the dissertation of Oshnouei S, a Ph.D. candidate in Epidemiology, which was supported by Iran University of Medical Sciences and the Prevention and Oncopathology Research Center. We gratefully acknowledge the assistance of the following individuals: Dr. Motevalian SA, Dr. Rimaz Sh, Dr. Solaymani-Dodaran M, Dr. Niakan Kalhori Sh, Dr. Karami M, and Dr. Hagdoost AA , Dr.Roosta Y ,Dr faghisolouk F for their contributions to improving the methodological aspects of this research. We gratefully acknowledge the Clinical Research Development Unit of Urmia Imam Khomeini Hospital . Author Contributions: B.E was responsible for designing the review protocol, while S.O was responsible for writing the protocol and report, conducting the literature review, and updating reference lists. She contributed to writing the manuscripts, creating summaries of findings from expert panel decisions and focus groups, and interpreting the results of the expert panel decision. B.E and R.A improved the interpretation of the results of the expert panel decision. A.J. provided feedback on the manuscripts. M.J. contributed technical expertise by providing comments to expand the registry system and improve data collection procedures. M.A.L contributed technical expertise and comments to enhance surveillance system procedures. Competing Interests: The authors declare no conflict of interest. Data Availability Statement: not applicable Funding: Funding for a research project was provided by the Oncopathology Research Center at Iran University of Medical Sciences in Tehran, Iran. References Alexander T, Greco R. Hematopoietic stem cell transplantation and cellular therapies for autoimmune diseases: overview and future considerations from the Autoimmune Diseases Working Party (ADWP) of the European Society for Blood and Marrow Transplantation (EBMT). Bone Marrow Transplant. 2022; 57:1055-62 Khaddour K, Hana CK, Mewawalla P. Hematopoietic Stem Cell Transplantation. [Updated 2023 May 6]. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2024 Jan-. Available from: https://www.ncbi.nlm.nih.gov/books/NBK536951/ Xu LP, Lu DP, Wu DP, Jiang EL, Liu DH, Huang H, et al . Hematopoietic Stem Cell Transplantation Activity in China 2020-2021 During the SARS-CoV-2 Pandemic: A Report From the Chinese Blood and Marrow Transplantation Registry Group. Transplant Cell Ther. 2023;29(2):136.e1-136.e7. Caparso C, Ozkan G, Kluge M, Salim H, Khaghany A, Blok A, et al. Mobile Technology to Monitor and Support Health and Well-Being: Qualitative Study of Perspectives and Design Suggestions from Patients Undergoing Hematopoietic Cell Transplantation. JMIR Form Res. 2023;7:e49806. Birkhead, Guthrie S., and Christopher M. Maylahn, 'State and Local Public Health Surveillance in the United States', in Lisa M. Lee, and others (eds), Principles & Practice of Public Health Surveillance, 3rd edn (2010; online edn, Oxford Academic, 1 Sept. 2010). Bernstein AB, Sweeney MH, Centers for Disease Control and Prevention. Public health surveillance data: legal, policy, ethical, regulatory, and practical issues. MMWR Surveill Summ. 2012;61:30-4. Wang X, Huang R, Zhang X, Zhang X. Current status and prospects of hematopoietic stem cell transplantation in China. Chin Med J. 2022;135(12):1394-1403. Bahoush G. Outcome of Patients Treated with Hematopoietic Stem Cell Transplantation: Results from A Single Center. Asia Pac J Oncol Nurs. 2021;8(2):218-223. Ghavamzadeh A, Alimoghaddam K, Ghaffari F, Derakhshandeh R, Jalali A, Jahani M. Twenty years of experience on stem cell transplantation in iran. Iran Red Crescent Med J. 2013;15(2):93-100. Walters S, Maringe C, Butler J, Brierley JD, Rachet B, Coleman MP. Comparability of stage data in cancer registries in six countries: lessons from the International Cancer Benchmarking Partnership. Int J Cancer. 2013;132(3):676-85. Nemati S, Saeedi E, Lotfi F, Nahvijou A, Mohebbi E, Ravankhah Z, et al. National surveillance of cancer survival in Iran (IRANCANSURV): Analysis of data of 15 cancer sites from nine population‐based cancer registries. International Journal of Cancer. 2022;151(12):2128-35. Pulte D, Jansen L, Brenner H. Changes in long term survival after diagnosis with common hematologic malignancies in the early 21st century. Blood Cancer J. 2020 ;10(5):56. Atkinson K, Champlin R, Ritz J, Fibbe W, Ljungman P, Brenner MK (eds). Clinical Bone Marrow and Blood Stem Cell Transplantation. 3rd ed. Cambridge University Press, Cambridge, 2004. Coulter I, Elfenbaum P, Jain S, Jonas W. SEaRCH™ expert panel process: streamlining the link between evidence and practice. BMC Res Notes. 2016;9:16. Lisa M. Lee (ed.),Steven M. Teutsch (ed.),Stephen B. Thacker (ed.),Michael E. St. Louis (ed.). Principles & Practice of Public Health Surveillance, 3rd edn (2010; online edn, Oxford Academic, 1 Sept. 2010) Houpert R, Almont T, Belahreche R, Faro M, Okouango J, Vestris M, et al. A population-based analysis of hematological malignancies from a French-West-Indies cancer registry's data (2009-2018). BMC Cancer. 2023;23(1):1197. Pastorczak A, Attarbaschi A, Bomken S, Borkhardt A, van der Werff Ten Bosch J, Elitzur S, et al. Consensus Recommendations for the Clinical Management of Hematological Malignancies in Patients with DNA Double Stranded Break Disorders. Cancers (Basel). 2022;14(8):2000. Mahar UR, Ahsan B, Ahmad U, Bokhari SW. Developing an Allogeneic Hematopoietic Progenitor Cell Transplant Service in a Resource-Limited Country: Challenges and Outcomes. Cureus. 2023;15(9):e44818. Tang L, Huang Z, Mei H, Hu Y. Immunotherapy in hematologic malignancies: achievements, challenges and future prospects. Signal Transduct Target Ther. 2023;8(1):306. Mahar UR, Ahsan B, Ahmad U, Bokhari SW. Developing an Allogeneic Hematopoietic Progenitor Cell Transplant Service in a Resource-Limited Country: Challenges and Outcomes. Cureus. 2023 ;15(9):e44818. Leotta S, Condorelli A, Sciortino R, Milone GA, Bellofiore C, Garibaldi B, et al. Prevention and Treatment of Acute Myeloid Leukemia Relapse after Hematopoietic Stem Cell Transplantation: The State of the Art and Future Perspectives. Journal of Clinical Medicine. 2022; 11(1):253. Sharma SK, Choudhary D, Doval D, Khandelwal V, Setia R, Dadu T, et al. Hematopoietic Stem Cell Transplant for Hematological Malignancies: Experience from a Tertiary Care Center in Northern India and Review of Indian Data. South Asian J Cancer. 2021;11(1):62-67. Knight TG, Aguiar M, Robinson M, Morse A, Chen T, Bose R, et al. Financial Toxicity Intervention Improves Outcomes in Patients With Hematologic Malignancy. JCO Oncol Pract. 2022;18(9):e1494-e1504. Granot N, Storb R. History of hematopoietic cell transplantation: challenges and progress. Haematologica. 2020;105(12):2716-2729. Cancer Surveillance System (CSS), available online 29 Feb 2024 [https://www.fredhutch.org/en/research/divisions/public-health-sciences-division/research/epidemiology/cancer-surveillance-system.html] Tietsche de Moraes Hungria V, Chiattone C, Pavlovsky M, Abenoza LM, Agreda GP, Armenta J, Arrais C, et al. Epidemiology of Hematologic Malignancies in Real-World Settings: Findings From the Hemato-Oncology Latin America Observational Registry Study. J Glob Oncol. 2019;5:1-19. Institute of Medicine (US) Committee on a National Surveillance System for Cardiovascular and Select Chronic Diseases. A Nationwide Framework for Surveillance of Cardiovascular and Chronic Lung Diseases. Washington (DC): National Academies Press (US); 2011. 7, Using Surveillance Data for Action. Available from: https://www.ncbi.nlm.nih.gov/books/NBK83171/ Jena S, Sahoo KC, Samantaray K, Satpathy N, Epari V. Operational Feasibility of Hospital-Based Cancer Registries in Low- and Middle-Income Countries: A Systematic Review. Cureus. 2023;15(7):e42126. Tiangco B, Daguit SEJ, Astrologo NC, Flores L, Parma RN, Celi LA. Challenges in the maintenance of an open hospital-based cancer registry system in a low-to-middle-income country (LMIC): 2017-2022 experience. PLOS Digit Health. 2024;3(1):e0000328. Tervonen HE, Bray F, Foliaki S, Roder D. Cancer registration challenges in low- and middle-income countries-the case of the Pacific Islands. Eur J Cancer Care (Engl). 2017;26(1). Taheriyan M, Dabiri MZ, Nodehi SRS, Kalhori SRN, Mohammadzadeh N . Minimum Dataset Development for Hematopoietic Stem Cell Transplantation (HSCT) Recipient Registry in Iran. Adv Appl Sci Res.2023; 14(2):13. Quality Assurance. In: Szklo M, Nieto FJ . Epidemiology: beyond the basics. 4 th ed. Jones & Bartlett learning Publishers, Burlington, MA . 2019. pp 351-354. Centers for Disease Control and Prevention.7.5 Key Characteristics of Data Quality in Public Health Surveillance. Page last reviewed: November 23, 2020 Division of Birth Defects and Developmental Disabilities, NCBDDD, Centers for Disease Control and Prevention. available online[https://www.cdc.gov/ncbddd/birthdefects/surveillancemanual/chapters/chapter-7/chapter7.5.html]. Kapadia M, Lehmann L, Auletta J, Beatty L, Bhatt N, Blacken R, Demmel K, Dodd T, Desmond C, Fitch T, Flesch L. Quality improvement in hematopoietic stem cell transplant and cellular therapy: using the Model for Improvement to impact outcomes. Transplantation and Cellular Therapy. 2022;28(5):233-41. Lindsay AC, Sussner KM, Greaney ML, Mierzwa S, Rich-Edwards J, Wiecha J, Peterson K. Understanding the data-action cycle of surveillance: A qualitative study of federal and state stakeholders. Health Promotion Practice. 2010;11(2):188-96. Bernstein AB, Sweeney MH, Centers for Disease Control and Prevention. Public health surveillance data: legal, policy, ethical, regulatory, and practical issues. MMWR Surveill Summ. 2012 ; 61(03):30-34. Nsubuga P, White ME, Thacker SB, et al. Public Health Surveillance: A Tool for Targeting and Monitoring Interventions. In: Jamison DT, Breman JG, Measham AR, et al., editors. Disease Control Priorities in Developing Countries. 2nd edition. Washington (DC): The International Bank for Reconstruction and Development / The World Bank; 2006. Chapter 53. Available from: https://www.ncbi.nlm.nih.gov/books/NBK11770/ Co-published by Oxford University Press, New York. Shah HA, Househ M. Concepts, objectives and analysis of public health surveillance systems. Computer Methods and Programs in Biomedicine Update. 2024;5:100136. Schulze A, Brand F, Geppert J, Böl GF. Digital dashboards visualizing public health data: a systematic review. Front Public Health. 2023;11:999958. Mateos MV, Ailawadhi S, Costa LJ, Grant SJ, Kumar L, Mohty M, Aydin D, Usmani SZ. Global disparities in patients with multiple myeloma: a rapid evidence assessment. Blood Cancer J. 2023;13(1):109. Additional Declarations No competing interests reported. Cite Share Download PDF Status: Posted Version 1 posted You are reading this latest preprint version Research Square lets you share your work early, gain feedback from the community, and start making changes to your manuscript prior to peer review in a journal. As a division of Research Square Company, we’re committed to making research communication faster, fairer, and more useful. We do this by developing innovative software and high quality services for the global research community. Our growing team is made up of researchers and industry professionals working together to solve the most critical problems facing scientific publishing. Also discoverable on Platform About Our Team In Review Editorial Policies Advisory Board Help Center Resources Author Services Accessibility API Access RSS feed Manage Cookie Preferences © Research Square 2026 | ISSN 2693-5015 (online) Privacy Policy Terms of Service Do Not Sell My Personal Information {"props":{"pageProps":{"initialData":{"identity":"rs-4450602","acceptedTermsAndConditions":true,"allowDirectSubmit":true,"archivedVersions":[],"articleType":"Study protocol","associatedPublications":[],"authors":[{"id":308521990,"identity":"501ed8a0-e6ff-497c-9cae-0e06a0f07ffa","order_by":0,"name":"Sima Oshnouei","email":"","orcid":"","institution":"Iran University of Medical Sciences","correspondingAuthor":false,"prefix":"","firstName":"Sima","middleName":"","lastName":"Oshnouei","suffix":""},{"id":308521992,"identity":"264c6a54-3e5f-47d5-adaa-0d33a662093a","order_by":1,"name":"Mohamad Jebraeily","email":"","orcid":"","institution":"Urmia University of Medical Sciences","correspondingAuthor":false,"prefix":"","firstName":"Mohamad","middleName":"","lastName":"Jebraeily","suffix":""},{"id":308521995,"identity":"e0d1c72f-af61-49cb-8793-e40bbff12373","order_by":2,"name":"Mohsen Asadi-Lari","email":"","orcid":"","institution":"Iran University of Medical Sciences","correspondingAuthor":false,"prefix":"","firstName":"Mohsen","middleName":"","lastName":"Asadi-Lari","suffix":""},{"id":308521997,"identity":"0281a410-e082-4c83-a915-2ca4eb75d805","order_by":3,"name":"Aarefeh Jafarzadeh-Kohneloo","email":"","orcid":"","institution":"Tabriz University of Medical Sciences","correspondingAuthor":false,"prefix":"","firstName":"Aarefeh","middleName":"","lastName":"Jafarzadeh-Kohneloo","suffix":""},{"id":308522000,"identity":"bf9c660d-2191-40be-a4fb-3de8696ed0b0","order_by":4,"name":"Babak Eshrati","email":"data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAZAAAAAyAQMAAABI0h/eAAAABlBMVEX///8AAABVwtN+AAAACXBIWXMAAA7EAAAOxAGVKw4bAAAA9klEQVRIiWNgGAWjYBACAwYeBsYGMAMIEiqABDNzA9FaGBsSzoC0MJKihbENJEZAizn72YMfZzDY2JtLH37+4OG82mj+dqCWHxXbcGqx7MlLltzAkJa4sy/NsCFx2/HcGYeBtvWcuY3bYQdyDCQfMBxOMDjDANJyLLcBqIWZsQ2PlvNvjH8+YPhvb3CG/WND4pxjufMJarmRYwZ02AHGDWd4gLY01ORuIKTFcsa7NMsZBsmJQC2FMxKOHcjdCNRyEJ9fzPlzD9/sqbADOWzDxx81dbnzzh8++OBHBW4tUOfBWYfB5AEC6lFAHSmKR8EoGAWjYIQAAAhwYU+6/9ttAAAAAElFTkSuQmCC","orcid":"","institution":"Iran University of Medical Sciences","correspondingAuthor":true,"prefix":"","firstName":"Babak","middleName":"","lastName":"Eshrati","suffix":""},{"id":308522001,"identity":"7d51417f-e21c-4748-904b-e57d947e1cbf","order_by":5,"name":"Rahim Asghari","email":"","orcid":"","institution":"Imam Khomeini Hospital, Urmia University of Medical Sciences","correspondingAuthor":false,"prefix":"","firstName":"Rahim","middleName":"","lastName":"Asghari","suffix":""}],"badges":[],"createdAt":"2024-05-20 18:12:06","currentVersionCode":1,"declarations":"","doi":"10.21203/rs.3.rs-4450602/v1","doiUrl":"https://doi.org/10.21203/rs.3.rs-4450602/v1","draftVersion":[],"editorialEvents":[],"editorialNote":"","failedWorkflow":false,"files":[{"id":64090861,"identity":"adfe830e-ad69-4ecf-8ca0-6a9996f95bd5","added_by":"auto","created_at":"2024-09-06 14:31:41","extension":"pdf","order_by":0,"title":"","display":"","copyAsset":false,"role":"manuscript-pdf","size":393357,"visible":true,"origin":"","legend":"","description":"","filename":"manuscript.pdf","url":"https://assets-eu.researchsquare.com/files/rs-4450602/v1/77dc43c4-f9a5-4f0d-aa6f-f91d30c6872d.pdf"}],"financialInterests":"No competing interests reported.","formattedTitle":"Hospital-Based Surveillance System Development in Patients with Hematological Malignancies undergoing Bone Marrow Transplant in Middle-Income Countries- the Case of Iran experience: Research Protocol","fulltext":[{"header":"Introduction","content":"\u003cp\u003eHematological malignancy (HM) is a life-threatening disorder that increases susceptibility to other cancers. Despite the increased risk of cancer, there are no widely accepted guidelines for the development of cancer surveillance protocols for individuals affected by hematological malignancies. Hematologic/Oncologic Malignancies study was initiated in 2000 as part of the treatment program for these patients to improve outcomes. Bone marrow transplantation is commonly used to treat patients diagnosed with leukemia, aplastic anemia, lymphoma, multiple myeloma, immune deficiency disorders, and some solid tumors [\u003cspan citationid=\"CR1\" class=\"CitationRef\"\u003e1\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR2\" class=\"CitationRef\"\u003e2\u003c/span\u003e].\u003c/p\u003e \u003cp\u003eBone marrow transplantation surveillance systems have been developed to monitor the status of hematopoietic stem cell transplantation (HSCT), and chimerism analysis is a well-established method for monitoring the condition of HSCT [\u003cspan citationid=\"CR3\" class=\"CitationRef\"\u003e3\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR4\" class=\"CitationRef\"\u003e4\u003c/span\u003e].\u003c/p\u003e \u003cp\u003eCancer registries are an example of this kind of surveillance and have been established in all states. The methods used for cancer registration have been well-documented. Cancer registries collect information about individuals diagnosed with cancer through reports from physicians and diagnostic laboratories. Depending on the available resources, the information may include not only basic demographic data on the individual and type of tumor but also detailed data on the anatomic site of the tumor, the stage at diagnosis, the cell type of the cancer, and treatment and follow-up clinical information. When a person is diagnosed with more than one type of cancer, information is obtained for each separate tumor in a case report. Most registries include reports of all malignant cancers [\u003cspan citationid=\"CR5\" class=\"CitationRef\"\u003e5\u003c/span\u003e].\u003c/p\u003e \u003cp\u003eSpecific examples of important registries available to collect information on bone marrow transplantation include the EBMT, CIBMTR, and APBMT [\u003cspan citationid=\"CR6\" class=\"CitationRef\"\u003e6\u003c/span\u003e]. Current knowledge on systematic surveillance systems in hematological malignancies is limited, especially in developing countries. In China, the Chinese Blood and Marrow Transplantation Registry Group (CBMTRG) reported 18,110 HSCTs in a single year (2021), contributing to a total of 90,436 HSCTs since 2008. To date, 174 medical centers have been registered as having a certificate to perform HSCT [\u003cspan citationid=\"CR7\" class=\"CitationRef\"\u003e7\u003c/span\u003e].\u003c/p\u003e \u003cp\u003eThe first bone marrow transplant center in Iran was established in 1992 at Shariati Hospital in Tehran, with subsequent expansions to accommodate the increasing demand for HSCT [\u003cspan citationid=\"CR8\" class=\"CitationRef\"\u003e8\u003c/span\u003e]. The current state of bone marrow transplantation in hematological malignancies in Iran reflects significant progress and advancements in the field. Over the past two decades, the rates of HSCT have increased significantly, with 49.4 transplants per one million inhabitants being performed. Recent advancements include the utilization of double cord blood and haploidentical transplantation to treat various life-threatening conditions [\u003cspan citationid=\"CR9\" class=\"CitationRef\"\u003e9\u003c/span\u003e].\u003c/p\u003e \u003cp\u003eCancer surveillance systems differ among countries due to various factors such as the extent of data collection, registry quality, and population coverage. In developed nations such as the U.S., these systems rely on established cancer registries to gather detailed information on new cancer cases, disease severity, and treatment outcomes. They incorporate hospital registries from cancer centers and population-based registries linked to state health departments to compile extensive data on cancer diagnoses and outcomes across regions. Conversely, lower-income countries face challenges due to inadequate surveillance systems resulting from insufficient vital statistics and population-based registries [\u003cspan citationid=\"CR10\" class=\"CitationRef\"\u003e10\u003c/span\u003e]. Survival data in the East Mediterranean region (EMR) are limited. Iranian cancer patients experience a relatively poor prognosis compared to those in high-income countries. Implementation of early detection programs and improving the quality of care are required to enhance cancer survival rates among Iranian patients. Further studies are needed to monitor the outcomes of cancer patients in Iran and other EMR countries [\u003cspan citationid=\"CR11\" class=\"CitationRef\"\u003e11\u003c/span\u003e].\u003c/p\u003e \u003cp\u003eAnalysis of data extracted from the Surveillance, Epidemiology, and End Results database shows a growing trend of improved long-term survival rates among prevalent hematologic malignancies. However, persistent concerns exist regarding late mortality. Therefore, additional research is warranted to investigate the long-term outcomes of treatable malignancies in order to map the factors contributing to the observed declines in survival rates over time [\u003cspan citationid=\"CR12\" class=\"CitationRef\"\u003e12\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR13\" class=\"CitationRef\"\u003e13\u003c/span\u003e].\u003c/p\u003e \u003cp\u003eIn Iran, the follow-up of patients with hematological malignancies is currently not feasible. Establishing a registry system within a surveillance system can play an important role in the follow-up of patients. In patients with hematological malignancies undergoing bone marrow transplants, both cancer surveillance programs and cancer registries play crucial roles in monitoring and improving patient outcomes. While there is no single nationwide surveillance and registry system in Iran, our aim is to develop a hospital-based cancer registry surveillance for the five most common hematological malignancies at the national level. As part of the surveillance system development, secondary objectives include designing and implementing a Bone Marrow Transplantation Registry Electronic System in educational hospitals to provide actionable data to these patients in near real-time. With the availability of this large dataset, it is possible to make more efficient use of current resources, increase data security, build new services that can be shared, create more consistent data reporting connections, and provide interactive data visualization dashboards that update the platform as needed.\u003c/p\u003e"},{"header":"Materials/Subjects and Methods","content":"\u003cdiv id=\"Sec3\" class=\"Section2\"\u003e \u003ch2\u003eStudy population and setting:\u003c/h2\u003e \u003cp\u003eThe study population would include patients with hematological malignancies who are undergoing bone marrow transplants at Urmia Imam Khomeini Hospital in Iran. The hospital serves as the primary site for patient care, treatment, and medical procedures related to hematological malignancies and bone marrow transplants. Since March 2015, bone marrow transplantation for hematological malignancies has been initiated at Urmia Imam Khomeini Hospital in Iran, located in northwestern Iran. Over the past eight years, the annual number of patients undergoing bone marrow transplantation has increased from around 15 to 40.\u003c/p\u003e \u003cp\u003eDeveloping a robust Bone Marrow Transplantation surveillance and registry system that integrates action research principles with expert guidance involves following these key steps:\u003c/p\u003e \u003cp\u003e \u003col\u003e \u003cspan\u003e \u003cli\u003e \u003cp\u003e \u003cb\u003eLiterature review\u003c/b\u003e: A systematic review was conducted to examine the available documentation in the patient files of individuals with hematological malignancies who had undergone hematopoietic stem cell transplantation (HSCT). This review involved exploring the Bone Marrow Transplantation worldwide surveillance and similar cancer registries, various analytical methods, and tools for processing and interpreting patients' data to address key aspects: 1. identifying cases. 2. Minimum data requirements 3. Determining data sources, 4. Understanding data collection mechanisms, and their important function related to future analyses. 5. Defining the objectives of a Disease Registry and Performance Indicators or Key Performance Indicators (KPIs) to evaluate the success of a surveillance system.\u003c/p\u003e \u003c/li\u003e \u003c/span\u003e \u003cspan\u003e \u003cli\u003e \u003cp\u003e \u003cb\u003eExpert Panel Organization\u003c/b\u003e: To ensure a comprehensive and well-rounded approach to conducting high-quality systematic reviews in various fields, we first identified and formed an expert panel committee. The committee is responsible for establishing surveillance and registry objectives, developing action plans and protocols for program implementation, evaluating its effectiveness, and securing essential support. The expert panel must meet the following criteria: each member should have at least 5 years of experience in practice or research, with 3 years specifically related to the project's focus [\u003cspan citationid=\"CR14\" class=\"CitationRef\"\u003e14\u003c/span\u003e].\u003c/p\u003e \u003c/li\u003e \u003c/span\u003e \u003cspan\u003e \u003cli\u003e \u003cp\u003e \u003cb\u003eA qualitative study focused on action research\u003c/b\u003e: Action research methodology was utilized to actively engage key stakeholders, researchers, and patients in the design and implementation of the surveillance system. In developing the surveillance system, conducting action research is crucial to enhance all processes of the surveillance system. This work involves an iterative approach that includes planning, acting, observing, and reflecting for system improvement. The system is refined based on feedback from the committee and stakeholders. Additionally, as part of the design, focus group methodology was selected to explore clinicians' knowledge and reasons for specific patterns of thinking. This process involves a comprehensive and evolving approach that encompasses the following key steps: 1. Establish objectives,2. Develop case definitions, 3. Determine the data source or data collection mechanism (type of system), 4. Develop data collection instruments, 5. Field-test methods ,6. Develop and test an analytic approach, 7. Develop a dissemination mechanism, 8. Ensure the use of analysis and interpretation [\u003cspan citationid=\"CR15\" class=\"CitationRef\"\u003e15\u003c/span\u003e].\u003c/p\u003e \u003c/li\u003e \u003c/span\u003e \u003c/ol\u003e \u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec4\" class=\"Section2\"\u003e \u003ch2\u003eEthic\u003c/h2\u003e \u003cp\u003e \u003cdiv class=\"BlockQuote\"\u003e \u003cp\u003eAccess to this information is granted with the approval of the Ethics Committee at Urmia University of Medical Sciences (IR.IUMS.REC.1402.763). Ethical considerations regarding patient confidentiality and data protection were strictly adhered to throughout the data extraction and analysis processes; therefore, informed consent is not required in this case.\u003c/p\u003e \u003c/div\u003e \u003c/p\u003e \u003c/div\u003e"},{"header":"Results","content":"\u003cp\u003e1. For hematological malignancies, literature reviews indicate that the EBMT (European Blood and Marrow Transplantation), CIBMTR (Center for International Blood and Marrow Transplant Research), and APBMT (Asia-Pacific Blood and Marrow Transplantation Group) are the three most prominent international communities involved in clinical blood and marrow transplantation and cellular therapy. These communities almost had a harmonized and uniform language of definitions, which is crucial for collaborative work and data sharing between registries at the international level for future endeavors. Additionally, one of the noteworthy features in developing the bone marrow transplantation surveillance system is determining essential data sources and collection mechanisms. The primary basis for this was the standard format developed by EBMT, CIBMTR, and APBMT, which are prominent organizations in the field.\u003c/p\u003e\n\u003cp\u003e2. The expert panel members had at least 5 years of experience in practice or research, with 3 years specifically related to the project\u0026apos;s focus. The panel included oncologists, BMT unit staff (including secretaries, head nurse), nurses providing services to hematological malignancy patients, and the registry director located in this hospital.\u003c/p\u003e\n\u003cp\u003e3. During the expert panel consultation, a decision was made to include a variety of data elements after consulting and addressing other important issues related to the design and development of the surveillance system. This was the first step in designing the surveillance system, determining case definitions, and defining surveillance system purposes.\u003c/p\u003e\n\u003cp\u003e4. \u0026nbsp;During the first six months of the project, each work group met at least once a month, either via phone or during a one-day face-to-face meeting. The classification of malignancy types, procedures related to BMT transplantation, associated complications, and treatments outlined in the case definitions were identified through a comprehensive literature review. These were deeply discussed by an expert panel to incorporate their opinions and ensure national validity. This comprehensive approach aimed to enhance diagnostic precision beyond what could be achieved solely through diagnostic ICD codes.\u003c/p\u003e\n\u003cp\u003eIn collaboration with an expert panel, the purpose of establishing a surveillance system was determined to develop a hospital-based cancer registry surveillance focusing on the five most common hematological malignancies. The aim was to provide high-quality data for evaluating strategies related to hematopoietic stem cell transplantation. The mission included conducting follow-up to identify clinical outcomes in two hospitals with improved results in bone marrow transplant patients, which constituted the primary goal of designing the surveillance system.\u003c/p\u003e\n\u003cp\u003e5. During focus groups with oncologists, the BMT unit staff (including secretaries and head nurses), and other nurses specializing in providing services to patients with hematological malignancies, appropriate data collection methods were discussed. Various approaches and significant issues related to data collection methods for the patients under study were evaluated.\u003c/p\u003e\n\u003cp\u003eThe summarized comments from the focus group are as follows:\u003c/p\u003e\n\u003cp\u003e\u0026ldquo;In our country, there is currently no standardized format for collecting data on the patients under study. Clinical data on these patients are typically collected as part of their BMT and treatment approaches. It is gathered from various sources, including laboratory analyses such as HLA typing, Complete Blood Count (CBC), Peripheral Blood Smear, Blood Chemistry Tests, Coagulation Tests, Flow Cytometry, Cytogenetic Analysis, Bone Marrow Aspiration, and Biopsy, along with medical history, physical examination, and imaging. None of these variables are patient-reported outcomes. However, this data is often unstructured or presented as narrative text in the patients\u0026apos; medical records of the BMT unit and Blood unit following HSCT admission. In this research, patient data, including information about individuals eligible for bone marrow transplant treatment and their medical history, was utilized. Moreover, these applied data sources may also require support from clinical informaticists to clean and standardize the data before uploading it into the registry system. To investigate post-HSCT outcomes in the first 100 days after HSCT, it is necessary to follow up with HSCT patients. Based on the oncologist\u0026apos;s experience in the expert panel, almost all post-transplant patients consult the oncologist to evaluate potential adverse effects and treatment outcomes, considering the high severity of hematological malignancies.\u003cstrong\u003e\u0026quot;\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003e6. In the subsequent stage, it is crucial to build an initial platform for MDS to design a data collection instrument. Following suggestions from an expert panel, we utilized a minimal dataset consisting of validated elements for HSCT registry. This dataset had been previously validated at a national level in a study conducted in Iran by Taheriyan et al. Additionally, before implementing the surveillance registry model to evaluate the regional feasibility of the registry model at Urmia\u0026apos;s Imam Khomeini Hospital, a focus group discussion was conducted with oncologists, the BMT unit staff (including secretaries and head nurses), and other nurses involved in the BMT specializing in providing services to patients with hematological malignancies. Subsequently, the paper-based form was structured into seven key sections, including pre-HSCT status, leukemia, lymphoma, plasma cell disorders like multiple myeloma, and post-HSCT information. It specifically focused on the data up to day 100 post-transplantation. In summary, the Bone Marrow Transplant registry checklist functions as a surveillance data collection tool that includes validated MDS elements specific to five hematological malignancies studied.\u003c/p\u003e\n\u003cp\u003e7. Passive data collection methodology was employed to continuously gather relevant information, rather than intermittently. Verified items derived from validated Minimum Data Set (MDS) components were compiled into paper-based forms in collaboration with the knowledgeable Head nurse from the BMT unit. These data would be input into the registry\u0026apos;s computer system using standardized codes that are confirmed by an expert panel.\u003c/p\u003e\n\u003cp\u003e8. Following this, a web-based data collection instrument was developed to establish a robust disease registry surveillance mechanism for the ongoing monitoring and evaluation of treatments.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e9. Finally, the designed model of the disease registry surveillance system was pilot-tested to ensure alignment with standard procedures and to prevent or reduce systematic or random errors. Users\u0026apos; suggestions were implemented to enhance the data collection process. A pilot test was conducted at the BMT section of Urmia Imam Khomeini Hospital. A WhatsApp group was established with both the project team and expert members. The forms were shared in the group, and members were asked to provide feedback on them. After a comprehensive review of the members\u0026apos; comments, the approved feedback was integrated into the forms. Twenty transplants were prospectively registered, and the registry was created from MED forms provided by all consecutive patients. All data were regularly recorded and updated.\u003c/p\u003e\n\u003cp\u003e10. In the next phase, during the expert panel deliberation, it was decided that the designed web-based registry system should possess the following analytical capabilities to generate aggregate analytical reports:\u003c/p\u003e\n\u003cp\u003e\u0026nbsp;10.1- The registry surveillance system can be utilized to analyze and report the frequency of autologous and allogeneic hematopoietic stem cell transplantation (HSCT) for hematologic malignancies such as multiple myeloma (MM), acute lymphoblastic leukemia (ALL), acute myeloid leukemia (AML), Hodgkin lymphoma (HL), and non-Hodgkin lymphoma (NHL).\u003cspan dir=\"RTL\"\u003e\u0026nbsp;\u003c/span\u003e\u003c/p\u003e\n\u003cp\u003e10.2- The frequency of relevant outcome measures, such as mortality, the first 100-day survival post-HSCT, relapse, remission, rejection, complete remission, and the acute incidence of Graft-versus-Host Disease (GVHD), can be analyzed and documented within the surveillance framework, taking into account gender and age distributions.\u003c/p\u003e\n\u003cp\u003e10.3- Risk assessment and reporting for the analyzed hematologic malignancies can be carried out within the surveillance system. These analytic reports are presented in the form of lists, graphs, and operational dashboards.\u003c/p\u003e\n\u003cp\u003e11. After reviewing related articles and recommendations from a collaborative expert panel, it has been decided to disseminate semiannual analytical reports in validated formats. These reports will be distributed to policymakers and stakeholders, including oncologists who conduct bone marrow transplants in the BMT units of this region.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e12.\u0026nbsp;\u003c/strong\u003eBased on the suggestions of the focus group, the regional surveillance system should be able to utilize disseminated surveillance information for improvement and informed decision-making when evaluating therapeutic outcomes. In other words, it ensures the analysis and interpretation of the data within the surveillance system, offering valuable feedback on analyses during the surveillance process. This feedback guides therapeutic decisions, improves patient outcomes, helps stakeholders identify areas for improvement, and facilitates informed decision-making based on surveillance data.\u003c/p\u003e\n"},{"header":"Discussion","content":"\u003cp\u003eThe cancer surveillance system for hematological malignancies worldwide is a critical aspect of public health and medical research. Hematological malignancies are a diverse group of disorders that affect the blood and its components, including anemia, bleeding disorders, and hematologic malignancies. These conditions have a significant impact on global health, posing challenges for healthcare systems worldwide [\u003cspan citationid=\"CR16\" class=\"CitationRef\"\u003e16\u003c/span\u003e].\u003c/p\u003e \u003cp\u003eDesigning surveillance protocols for hematological malignancies undergoing bone marrow transplantation presents several challenges that need to be addressed to ensure effective monitoring and management of these patients. Consequently, these patients are often exposed to cytoreductive conditioning regimens that can lead to significant toxicities, such as mucositis, dermatitis, and pulmonary, hepatic, and renal toxicities. Managing these toxicities while ensuring effective surveillance is crucial [\u003cspan citationid=\"CR17\" class=\"CitationRef\"\u003e17\u003c/span\u003e]. Infections due to compromised immune systems are other important challenges in these patients [\u003cspan citationid=\"CR18\" class=\"CitationRef\"\u003e18\u003c/span\u003e]. Implementing genetic counseling and tailored surveillance protocols for these patients is a challenge that needs to be addressed. Patients with genetic predispositions to hematologic malignancies require specialized surveillance strategies to detect early signs of disease progression or relapse [\u003cspan citationid=\"CR19\" class=\"CitationRef\"\u003e19\u003c/span\u003e]. Overcoming resource limitations to ensure effective surveillance is crucial for patient outcomes. Developing surveillance protocols in resource-limited settings can be challenging due to the substantial investments required in infrastructure, equipment, medical supplies, and the training of healthcare professionals [\u003cspan citationid=\"CR20\" class=\"CitationRef\"\u003e20\u003c/span\u003e]. Surveillance for hematological malignancies in patients undergoing bone marrow transplantation requires a multidisciplinary approach involving various specialties such as radiation oncology, infectious disease, cardiology, and more. Careful monitoring of minimal residual disease (MRD) and prompt application of preemptive strategies in the post-transplant setting have become imperative [\u003cspan citationid=\"CR21\" class=\"CitationRef\"\u003e21\u003c/span\u003e]. One-time treatment approaches are crucial for patients affected by hematological malignancies who are candidates for HSCT due to their disease status. Implementing one-time interventions can significantly impact patient outcomes and quality of life during the complex process of HSCT, especially in a population sensitive to financial concerns [\u003cspan citationid=\"CR22\" class=\"CitationRef\"\u003e22\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR23\" class=\"CitationRef\"\u003e23\u003c/span\u003e]. This complex surveillance system requires careful planning and execution to ensure comprehensive monitoring. The challenge in the cancer surveillance system that is similar to bone marrow transplant in hematological malignancy in a regional hospital is the requirement for precise and thorough data collection and reporting. Just as bone marrow transplants in hematological malignancies require precise matching and monitoring. Surveillance systems also serve to gather valuable information about treatment efficacy and safety, contributing to the improvement of treatment process and outcomes over time [\u003cspan citationid=\"CR24\" class=\"CitationRef\"\u003e24\u003c/span\u003e]. Additionally, they facilitate communication among members of the multi-disciplinary BMT team at the national level to Creates more consistent data reporting connections, reduce waiting time of patients ensuring that each patient receives the fastest treatment in suitable time.\u003c/p\u003e \u003cp\u003eConsidering the mission of the surveillance system, activities worldwide focusing on population-based initiatives can be highlighted. The Surveillance, Epidemiology, and End Results (SEER) program, initiated by the U.S. National Cancer Institute allows for cohort analyses and establishes a global benchmark for cancer registries by employing standardized practices for data collection and coding [\u003cspan citationid=\"CR25\" class=\"CitationRef\"\u003e25\u003c/span\u003e]. The HOLA study focuses on patient characteristics and treatment outcomes for hematological malignancies in Latin American countries. This observational registry study aims to fill the gap in real-world data on diseases such as chronic lymphocytic leukemia (CLL), multiple myeloma (MM), and non-Hodgkin lymphoma (NHL) in the region, offering valuable insights for healthcare professionals and policymakers [\u003cspan citationid=\"CR26\" class=\"CitationRef\"\u003e26\u003c/span\u003e].\u003c/p\u003e \u003cp\u003eA robust surveillance system will facilitate the monitoring, assessment, and enhancement of policies, initiatives, and services. It will also help optimize resource allocation, support advocacy and education efforts, and serve as a reference point for healthcare professionals. These goals rely on various elements, including data quality, systematic data collection, analysis, and interpretation, utilization of results for prevention and control strategies, and consistent feedback from end users to enhance fulfilling the system's mission to guide actions and policies to improve treatment outcomes [\u003cspan citationid=\"CR27\" class=\"CitationRef\"\u003e27\u003c/span\u003e].\u003c/p\u003e \u003cp\u003eIn the process of data collection in our study, similar to many other developing nations, we encounter several challenges and obstacles such as staff attitudes, deficiencies in health system infrastructure, and operational issues. Particularly, the data collection process is hindered by a lack of adequate documentation. The development of hospital-based surveillance systems in middle-income countries faces diverse challenges, as highlighted in the referenced literature. These challenges include the operational feasibility of hospital-based cancer registries [\u003cspan citationid=\"CR28\" class=\"CitationRef\"\u003e28\u003c/span\u003e]. and the necessity for digital transformation to electronic medical records for enhanced data management [\u003cspan citationid=\"CR29\" class=\"CitationRef\"\u003e29\u003c/span\u003e]. Furthermore, inadequate or non-existent healthcare infrastructures, absence of accurate records and population data, complexities arising from cultural norms, and challenges stemming from political and economic instability present additional obstacles. To comprehensively register all cancer cases, data must be sourced from various outlets, including hospitals, laboratories, and death certificates within healthcare networks. Poorly established communication channels among different stakeholders and the lack of a standardized method for uniquely identifying individuals further complicate the collection of this data [\u003cspan citationid=\"CR30\" class=\"CitationRef\"\u003e30\u003c/span\u003e].\u003c/p\u003e \u003cp\u003eBased on the issues highlighted regarding the availability of data for patients undergoing HSCT, as mentioned in the results section, it is evident that there is currently no standardized format or registry functionality in our country that records detailed treatment profiles of the studied patients. As part of the data collection sources for monitoring information related to this protocol, a new computer system is being developed to establish patient registries accessible on the Internet. Prior steps in developing this new computer system involve expanding the minimum data requirements for electronic health records to enhance core elements specific to the HSCT patients in validated, interoperable ways to elevate the quality of surveillance data concerning these medical conditions. Furthermore, these core datasets strike a balance between national reliability and alignment with international standards. This research focused on establishing a fundamental dataset for the HSCT registration system at Tehran Imam Khomeini Hospital, which was later validated to streamline system development. The Minimum Data Set (MDS) comprises nine sections covering pre-HSCT, leukemia, lymphoma, myelodysplastic syndrome, myeloproliferative neoplasms, combined myelodysplastic syndrome and myeloproliferative neoplasms, plasma cell disorders including multiple myeloma, hemoglobinopathy, and post-HSCT data. Data elements were sourced from the Center for International Blood and Marrow Transplant Research (CIBMTR) and the European Society for Blood and Marrow Transplantation (EBMT) essential datasets. These data were then analyzed in collaboration with an expert panel [\u003cspan citationid=\"CR31\" class=\"CitationRef\"\u003e31\u003c/span\u003e]. After validating the delivered registry model dataset, our research paper in paper-based form was reviewed by a panel of research experts to identify functional components for utilizing the surveillance system in future stages.\u003c/p\u003e \u003cp\u003eBy developing an electronic surveillance system, it will be possible to link follow-up information to pre-treatment data for patients undergoing HSCT in BMT units and medical records throughout the BMT procedure. Research expert panels have recommended that, since almost all patients treated in the BMT units at Imam Hospital visit the oncologist's office for follow-up appointments to assess the outcomes of their HSCT treatment, and follow-up data is systematically collected from their clinical and paraclinical examinations post-HSCT, which are not available in the BMT unit at Imam Hospital, using paper-based charts in the doctor's office seems to be the most appropriate option for monitoring this data. To prevent missing information, the current optimal solution would involve digitally transforming the patients' charts from the doctors' offices into electronic medical records using specialized registry software. This transition could be facilitated by providing BMT oncologists with access and passwords to use in their offices. In brief, this system aims to deliver actionable and standardized data to patients in almost real-time, optimize current resources, enhance data security, and introduce new services for shared use. It will standardize interfaces, create more consistent data reporting connections, provide interactive data visualization dashboards, update the platform as necessary, and serve as a foundation for future system development if required.\u003c/p\u003e \u003cp\u003eQuality assurance activities in design should be complemented by pretesting and pilot testing. The findings from pretests and pilot studies help refine and enhance these procedures to increase their effectiveness, validity, and reliability. The feasibility and efficiency of the study procedures are assessed through pretests and pilot studies. Pilot studies also provide an opportunity to assess different strategies for participant recruitment and data collection methods to address any potential issues before the project encounters failure [\u003cspan citationid=\"CR32\" class=\"CitationRef\"\u003e32\u003c/span\u003e]. In our research, after implementing the model, the data collection system underwent pilot testing to ensure compliance with standard procedures, minimize systematic or random errors, and uphold quality control. In other words, the aim is to assess the functional aspects of specific procedures, pinpoint significant flaws, implement necessary improvements, and effectively store data from the study of hematologic malignancies undergoing HSCT. The training of head nurses in our research focused on ensuring that they were informed about procedures, standardizing data collection, and highlighting the importance of adhering to the procedures outlined in the operational manuals. This involves a variety of approaches to guarantee the accuracy, completeness, and timeliness of data collection and reporting, as well as the key features of the registry software. It facilitates the implementation of feasible systems and minimizes the need for changes as systems are implemented on a broad scale.\u003c/p\u003e \u003cp\u003eTo underscore this, quality assurance, quality control, and quality improvement are crucial aspects to consider when designing a robust surveillance system to ensure effective surveillance protocols. These are essential components to ensure the accuracy, reliability, and integrity of data collected in various monitoring activities. These processes are crucial for maintaining high-quality standards and minimizing errors in surveillance protocols that require a cyclical approach to ensure high-quality data in a high-volume cancer registry within the surveillance system. The fundamental characteristics of high-quality data in public health surveillance include completeness, accuracy, and timeliness, which are summarized in the acronym CAT [\u003cspan citationid=\"CR33\" class=\"CitationRef\"\u003e33\u003c/span\u003e].\u003c/p\u003e \u003cp\u003eIn the context of designing a surveillance system for hematopoietic stem cell transplants to improve outcomes, it is important to note that the model for improvement is a robust tool for redesigning healthcare processes in transplant and cellular therapy. This model uses a series of components to organize and critically evaluate improvement activities. Unlike other health sciences clinical research, quality improvement projects are based on evolving hypotheses that lead to observable, sequential tests of change, with constant collection and feedback of performance data to stakeholders [\u003cspan citationid=\"CR34\" class=\"CitationRef\"\u003e34\u003c/span\u003e].\u003c/p\u003e \u003cp\u003eMost importantly, in designing a surveillance system, it is crucial to recognize that it involves action research. Only focusing on a systematic review during setup can lead to bias, impeding the development of a robust and sensitive surveillance system. This approach may not yield the qualitative information necessary for providing effective feedback to improve the surveillance process and achieve its intended goals. Therefore, action research is essential in shaping surveillance systems by developing a reflective and iterative method where practitioners actively participate in research to instigate positive change and enhancement. Moreover, it emphasizes the significance of ongoing reflection, collaborative engagement, and empowering individuals, all essential for creating responsive surveillance systems that meet community needs and can adapt to evolving situations. Being flexible to adapt in response to identified needs, a surveillance system is important while considering all the recommendations mentioned above [\u003cspan citationid=\"CR35\" class=\"CitationRef\"\u003e35\u003c/span\u003e].\u003c/p\u003e \u003cp\u003eFinally, the dissemination of surveillance data plays a crucial role in improving data collection within surveillance systems. In the public health field, the usefulness of surveillance data can be categorized as immediate, annual, and archival, depending on the public health interventions that can be implemented. Periodic information dissemination for decision-makers in a timely manner is crucial to strengthen evidence-based decision-making using a surveillance system [\u003cspan citationid=\"CR36\" class=\"CitationRef\"\u003e36\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR37\" class=\"CitationRef\"\u003e37\u003c/span\u003e]. Unfortunately, we do not currently have a detailed report available for this specific purpose. As per the oncologists in the expert panel, the current patient information report for individuals undergoing bone marrow transplants, which includes the frequency of allogeneic and autologous transplant cases for various hematological malignancies, along with mortality data, is shared monthly in the BMT telegram group in Excel format. Designing the surveillance system and expanding the electronic registry system, while considering the dimensions of a capable care system and employing exploratory approaches to expand it, and following the principle of quality improvement, can be an important step in providing high-quality information for evaluating treatment outcomes in patients, particularly in the context of low- and middle-income countries. In line with the aforementioned, information technology and informatics can streamline the dissemination process of analytical reports of surveillance data [\u003cspan citationid=\"CR38\" class=\"CitationRef\"\u003e38\u003c/span\u003e]. This is crucial for regularly reporting surveillance data findings to ensure that decision-makers and oncologists involved in patient treatments receive updated information promptly. Incorporating data visualization in the reports can present complex data clearly and concisely, aiding in better understanding and interpretation by the recipients [\u003cspan citationid=\"CR39\" class=\"CitationRef\"\u003e39\u003c/span\u003e].\u003c/p\u003e \u003cp\u003eSimilar to many other health and therapeutic issues highlighted and affected by evidence, global disparities in hematological malignancies such as multiple myeloma in the areas of patient surveillance are clearly observed [\u003cspan citationid=\"CR40\" class=\"CitationRef\"\u003e40\u003c/span\u003e]. Limitations of the surveillance system in hematological malignancies in northwestern Iran include insufficient data in flow cytometry and molecular marker examination for all patients. The lack of data in these diagnostic technologies hinders the ability to accurately categorize and characterize various types of hematological malignancies, potentially resulting in misdiagnoses and suboptimal treatment outcomes. Additionally, the absence of comprehensive data can hinder the discovery of new biomarkers and therapeutic targets that have the potential to enhance patient care and outcomes. It is important to note that while the current surveillance system may be limited, research efforts such as the one conducted in this study can serve as a crucial preliminary step towards providing more comprehensive diagnostic and treatment options for patients with hematological malignancies in the future. By engaging with policymakers at higher levels and advocating for increased resources and support for advanced diagnostic technologies, researchers can help address these limitations and improve the overall management of hematological cancers in Iran. Additionally, collaborating with international partners in research and clinical trials can help bridge the gap in access to advanced diagnostic tools and treatments for patients with hematological malignancies in northwestern Iran. By sharing knowledge, resources, and expertise, researchers and healthcare providers can collaborate to overcome the limitations of the current surveillance system and ultimately enhance patient outcomes.\u003c/p\u003e \u003cp\u003eIn conclusion, this study protocol describes the design and methods used in implementing a Hospital-Based Surveillance System for Patients with Hematological Malignancies undergoing Bone Marrow Transplant in the northwest of Iran. It is valuable to keep in mind that surveillance systems are necessary but not sufficient for improving cancer therapeutic approaches. They are an essential component of global cancer control, especially in ensuring access to suitable and timely cancer treatment in low- and middle-income countries. A comprehensive comprehension of the impact of bone marrow transplants on hematological malignancies is crucial for public health practitioners, researchers, health insurers, and policymakers. In recent years, various researchers have recognized the necessity for improved data collection as a key priority in bone marrow transplantation. Developing a hospital-based surveillance system for bone marrow transplantation represents a significant contribution to enhancing the timely acquisition of crucial information. This is especially important given the inherent complexity of this therapeutic approach and the significance of risk stratification and precision in classifying patients based on their risk level. Surveillance is essentially a dynamic process, not a static picture. It aims to improve treatment outcomes through intelligent evaluation rather than relying solely on natural progression. This offers expert guidance to the Special Diseases Department of the Ministry of Health, facilitating the optimization of drug distribution, resource allocation, and quality control of transplant procedures at the national level. Moreover, this effort involves establishing a comprehensive hematologic malignancy surveillance system. This system informs policy decisions related to expanding drug and equipment supply and improving healthcare centers. The ultimate goal is to ensure the highest standards of care delivery at both national and local levels.\u003c/p\u003e"},{"header":"Abbreviations","content":"\u003cp\u003eCancer Surveillance System (CSS); Hematopoietic Stem Cell Transplantation (HSCT); Multiple Myeloma (MM); Acute Lymphoblastic Leukemia (ALL); Acute Myeloid Leukemia (AML); Non-Hodgkin Lymphoma (NHL); Hodgkin Lymphoma (HL); Human Leukocyte Antigen (HLA) ; HOLA ; Hemato-Oncology Latin America Observational Registry ; Surveillance, Epidemiology, and End Results (SEER)\u003c/p\u003e\n"},{"header":"Declarations","content":"\u003cp\u003e\u003cstrong\u003eAcknowledgements:\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThis article and its results were extracted from the dissertation of Oshnouei S, a Ph.D. candidate in Epidemiology, which was supported by Iran University of Medical Sciences and the Prevention and Oncopathology Research Center. We gratefully acknowledge the assistance of the following individuals: Dr. Motevalian SA, Dr. Rimaz Sh, Dr. Solaymani-Dodaran M, Dr. Niakan Kalhori Sh, Dr. Karami M, and Dr. Hagdoost AA , Dr.Roosta Y ,Dr faghisolouk F \u0026nbsp;for their contributions to improving the methodological aspects of this research. We gratefully acknowledge the Clinical Research Development Unit of Urmia Imam Khomeini Hospital .\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAuthor Contributions:\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eB.E was responsible for designing the review protocol, while S.O was responsible for writing the protocol and report, conducting the literature review, and updating reference lists. She contributed to writing the manuscripts, creating summaries of findings from expert panel decisions and focus groups, and interpreting the results of the expert panel decision. B.E and R.A improved the interpretation of the results of the expert panel decision. A.J. provided feedback on the manuscripts. M.J. contributed technical expertise by providing comments to expand the registry system and improve data collection procedures. M.A.L contributed technical expertise and comments to enhance surveillance system procedures.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eCompeting Interests:\u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe authors declare no conflict of interest.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eData Availability Statement:\u0026nbsp;\u003c/strong\u003enot applicable \u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eFunding:\u003c/strong\u003e Funding for a research project was provided by the Oncopathology Research Center at Iran University of Medical Sciences in Tehran, Iran.\u003c/p\u003e\n\u003cp\u003e\u0026nbsp;\u003c/p\u003e"},{"header":"References","content":"\u003col\u003e\n\u003cli\u003eAlexander T, Greco R. 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JCO Oncol Pract. 2022;18(9):e1494-e1504.\u003c/li\u003e\n\u003cli\u003eGranot N, Storb R. History of hematopoietic cell transplantation: challenges and progress. Haematologica. 2020;105(12):2716-2729.\u003c/li\u003e\n\u003cli\u003eCancer Surveillance System (CSS), available online 29 Feb 2024 [https://www.fredhutch.org/en/research/divisions/public-health-sciences-division/research/epidemiology/cancer-surveillance-system.html]\u003c/li\u003e\n\u003cli\u003eTietsche de Moraes Hungria V, Chiattone C, Pavlovsky M, Abenoza LM, Agreda GP, Armenta J, Arrais C, et al. Epidemiology of Hematologic Malignancies in Real-World Settings: Findings From the Hemato-Oncology Latin America Observational Registry Study. J Glob Oncol. 2019;5:1-19.\u003c/li\u003e\n\u003cli\u003eInstitute of Medicine (US) Committee on a National Surveillance System for Cardiovascular and Select Chronic Diseases. A Nationwide Framework for Surveillance of Cardiovascular and Chronic Lung Diseases. 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Quality improvement in hematopoietic stem cell transplant and cellular therapy: using the Model for Improvement to impact outcomes. Transplantation and Cellular Therapy. 2022;28(5):233-41.\u003c/li\u003e\n\u003cli\u003eLindsay AC, Sussner KM, Greaney ML, Mierzwa S, Rich-Edwards J, Wiecha J, Peterson K. Understanding the data-action cycle of surveillance: A qualitative study of federal and state stakeholders. Health Promotion Practice. 2010;11(2):188-96.\u003c/li\u003e\n\u003cli\u003eBernstein AB, Sweeney MH, Centers for Disease Control and Prevention. Public health surveillance data: legal, policy, ethical, regulatory, and practical issues. MMWR Surveill Summ. 2012 ; 61(03):30-34.\u003c/li\u003e\n\u003cli\u003eNsubuga P, White ME, Thacker SB, et al. Public Health Surveillance: A Tool for Targeting and Monitoring Interventions. In: Jamison DT, Breman JG, Measham AR, et al., editors. Disease Control Priorities in Developing Countries. 2nd edition. Washington (DC): The International Bank for Reconstruction and Development / The World Bank; 2006. Chapter 53. Available from: https://www.ncbi.nlm.nih.gov/books/NBK11770/ Co-published by Oxford University Press, New York.\u003c/li\u003e\n\u003cli\u003eShah HA, Househ M. Concepts, objectives and analysis of public health surveillance systems. Computer Methods and Programs in Biomedicine Update. 2024;5:100136.\u003c/li\u003e\n\u003cli\u003eSchulze A, Brand F, Geppert J, B\u0026ouml;l GF. Digital dashboards visualizing public health data: a systematic review. Front Public Health. 2023;11:999958.\u003c/li\u003e\n\u003cli\u003eMateos MV, Ailawadhi S, Costa LJ, Grant SJ, Kumar L, Mohty M, Aydin D, Usmani SZ. Global disparities in patients with multiple myeloma: a rapid evidence assessment. Blood Cancer J. 2023;13(1):109.\u003c/li\u003e\n\u003c/ol\u003e"}],"fulltextSource":"","fullText":"","funders":[],"hasAdminPriorityOnWorkflow":false,"hasManuscriptDocX":true,"hasOptedInToPreprint":true,"hasPassedJournalQc":"","hasAnyPriority":false,"hideJournal":true,"highlight":"","institution":"","isAcceptedByJournal":false,"isAuthorSuppliedPdf":false,"isDeskRejected":"","isHiddenFromSearch":false,"isInQc":false,"isInWorkflow":false,"isPdf":false,"isPdfUpToDate":true,"isWithdrawnOrRetracted":false,"journal":{"display":true,"email":"[email protected]","identity":"researchsquare","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":true,"externalIdentity":"","sideBox":"","snPcode":"","submissionUrl":"/submission","title":"Research Square","twitterHandle":"researchsquare","acdcEnabled":true,"dfaEnabled":false,"editorialSystem":"","reportingPortfolio":"","inReviewEnabled":false,"inReviewRevisionsEnabled":true},"keywords":"Hospital-Based registry, Surveillance developing, Bone Marrow Transplant, cancer, system","lastPublishedDoi":"10.21203/rs.3.rs-4450602/v1","lastPublishedDoiUrl":"https://doi.org/10.21203/rs.3.rs-4450602/v1","license":{"name":"CC BY 4.0","url":"https://creativecommons.org/licenses/by/4.0/"},"manuscriptAbstract":"\u003ch2\u003eBackground\u003c/h2\u003e \u003cp\u003eIn patients with hematological malignancies undergoing bone marrow transplants, both cancer surveillance programs and cancer registries play crucial roles in monitoring and improving patient outcomes. This research protocol aims to establish a hospital-based surveillance system for patients with hematological malignancies undergoing bone marrow transplantation (BMT) in Iran, utilizing a mixed-methods approach.\u003c/p\u003e\u003ch2\u003eMethods\u003c/h2\u003e \u003cp\u003eThe study will involve quantitative data collection through medical record reviews and qualitative data collection through action research. To evaluate the feasibility and acceptability of the surveillance system among healthcare providers and patients, an assessment was conducted. This involved organizing an expert panel and conducting focus groups. Given the absence of a standardized data collection format for the patients under study, we are taking steps to develop a Bone Marrow Transplantation Registry Electronic System in educational hospitals.\u003c/p\u003e\u003ch2\u003eResults\u003c/h2\u003e \u003cp\u003eWe utilized a standardized format developed by the EBMT and CIBMTR, along with input from expert panels and focus groups, to review the literature on hematological malignancies. We have created a Bone Marrow Transplant Registry Checklist, designed as a tool for data collection. It incorporates validated MDS elements tailored to five distinct types of hematological malignancies. We utilized a passive data collection method to continuously gather pertinent information and created a web-based data collection tool for continuous monitoring and evaluation of treatments. Analytical reports were generated in the form of operational dashboards, providing valuable feedback on analyses during the surveillance process. A pilot test of the registry surveillance system was conducted to ensure alignment with standard procedures and to identify and address any systematic or random errors.\u003c/p\u003e\u003ch2\u003eConclusions\u003c/h2\u003e \u003cp\u003eThis research protocol outlines the methodology for establishing a system and emphasizes the importance of implementing standardized monitoring protocols in middle-income countries to enhance the evaluation of treatment outcomes among patients with hematological malignancies undergoing HSCT. This system can help identify gaps in available data and treatment modalities during procedures like HSCT. It can facilitate quality improvement and ultimately enhance patient outcomes by engaging with other decision-makers and supporting the growing efforts in middle-income countries in the concept of action research.\u003c/p\u003e","manuscriptTitle":"Hospital-Based Surveillance System Development in Patients with Hematological Malignancies undergoing Bone Marrow Transplant in Middle-Income Countries- the Case of Iran experience: Research Protocol","msid":"","msnumber":"","nonDraftVersions":[{"code":1,"date":"2024-06-03 21:13:21","doi":"10.21203/rs.3.rs-4450602/v1","editorialEvents":[{"type":"communityComments","content":0}],"status":"published","journal":{"display":true,"email":"[email protected]","identity":"researchsquare","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":true,"externalIdentity":"","sideBox":"","snPcode":"","submissionUrl":"/submission","title":"Research Square","twitterHandle":"researchsquare","acdcEnabled":true,"dfaEnabled":false,"editorialSystem":"","reportingPortfolio":"","inReviewEnabled":false,"inReviewRevisionsEnabled":true}}],"origin":"","ownerIdentity":"999e7b87-8dc6-4f4e-945a-9880d1291a62","owner":[],"postedDate":"June 3rd, 2024","published":true,"recentEditorialEvents":[],"rejectedJournal":[],"revision":"","amendment":"","status":"posted","subjectAreas":[],"tags":[],"updatedAt":"2024-09-06T14:23:35+00:00","versionOfRecord":[],"versionCreatedAt":"2024-06-03 21:13:21","video":"","vorDoi":"","vorDoiUrl":"","workflowStages":[]},"version":"v1","identity":"rs-4450602","journalConfig":"researchsquare"},"__N_SSP":true},"page":"/article/[identity]/[[...version]]","query":{"redirect":"/article/rs-4450602","identity":"rs-4450602","version":["v1"]},"buildId":"qtupq5eGEP_6zYnWcrvyt","isFallback":false,"isExperimentalCompile":false,"dynamicIds":[84888],"gssp":true,"scriptLoader":[]}