Introduction

More and more children and adolescents successfully survive cancer into adulthood due to improvements in childhood cancer treatment [,]. There are currently around 500,000 childhood cancer survivors in Europe [-], with around 8000-10,000 new survivors each year []. However, despite the increasing survival rates, childhood cancer survivors remain at risk of impaired quality of life and extensive morbidity and mortality due to disease relapse or late health complications caused by cancer treatments (late effects) [-]. Late effects can include physical as well as psychological and social conditions, ranging from subsequent neoplasms and cardiotoxicity to chronic pain and poor psychological well-being [-]. To improve or preserve the quality of life of childhood cancer survivors, long-term follow-up (LTFU) care focusing on late-effects surveillance and timely intervention is essential []. However, comprehensive LTFU programs are lacking in many pediatric cancer centers []. In particular, the coordination of LTFU care between health care providers (HCPs), care managers, and childhood cancer survivors, as well as the available knowledge about late effects and the transition from pediatric to adult health care services, often call for improvement [-].

Previous studies have highlighted the need for a treatment summary and care plan for childhood cancer survivors as part of successful LTFU care [-]. To increase knowledge among HCPs and childhood cancer survivors and optimize long-term survivorship care, the Survivorship Passport (SurPass) was developed by the Pan-European Network for Care of Survivors after Childhood and Adolescent Cancer (PanCare), a multidisciplinary and international association of professionals, childhood cancer survivors, and their families, aiming to reduce the impact of late health effects for childhood cancer survivors [-]. The SurPass summarizes cancer and treatment-related data of childhood cancer survivors and, thanks to built-in algorithms, suggests personalized follow-up recommendations based on evidence-based surveillance guidelines developed by the International Late Effects of Childhood Cancer Guideline Harmonization Group and consensus-based recommendations formulated within several PanCare projects (PanCareSurFup and PanCareFollowUp) [,]. In addition, the SurPass provides plain language information on late effects and self-care. All in all, the SurPass supports personalized follow-up care and can improve understanding of late effects among HCPs and childhood cancer survivors. Over the years, multiple versions of SurPass have been developed. At the Istituto Giannina Gaslini, Italy, the SurPass (version 1.2) was found to have an overall positive impact on survivors and their families []. Ultimately, the SurPass has the potential to be used throughout Europe and beyond to improve LTFU care and empower childhood cancer survivors to take charge of their own health [].

Previously developed versions of the SurPass require manual entry of individual treatment data to be entered manually into the SurPass database, making its use in daily clinical practice rather time-consuming []. As a result, SurPass is currently being upgraded to a semiautomated and interoperable version (SurPass version 2.0) as part of the European Horizon 2020-funded PanCareSurPass (PCSP) project []. Like previous versions of SurPass (version 2.0) will generate a survivor-specific treatment summary and survivorship care plan (SCP) using algorithms that link treatment data with available follow-up recommendations. Unlike previous versions, SurPass (version 2.0; hereafter referred to as SurPass) will facilitate semiautomated data entry from electronic health information systems (EHISs) and integration of SurPass into national or regional electronic health records (EHRs). A high level of interoperability and data protection or security are essential to achieve semiautomated data transfer. The development and harmonization of interfaces is required to enable data exchange between systems and the storage of information in different systems (eg, hospital systems, clinical trials, and cancer registries). Interoperability between EHISs and EHRs and the SurPass platform is facilitated by the Health Level Seven (HL7) Fast Healthcare Interoperability Resources (FHIR) interoperability standard []. HL7 FHIR supports the exchange of data between health care software systems and combines the hallmarks of the established HL7 (version 2 and 3) and Clinical Document Architecture (CDA) standards while leveraging current web standards such as XML, JSON, HTTP, and the OAuth (Open Authorization Standard) []. In addition, HL7’s international patient summary (IPS) standard specifies an EHR extract containing essential health information intended for use in cross-border care scenarios. IPS models support continuity of care for patients and coordination of care across health systems []. Specifically, the treatment summary variables in SurPass are linked according to the IPS. Finally, SurPass has been certified as a Class 1 medical device and must guarantee data security in terms of availability, confidentiality, and data integrity by the General Data Protection Regulation (GDPR) [] and national data protection and privacy requirements.

Upon successful implementation of SurPass throughout 3 European health system scenarios (national EHISs, regional EHISs, and cancer registries or hospital-based EHISs), the PCSP project must focus on the three main challenges described above: (1) semiautomation of data input, (2) interoperability, and (3) data protection or privacy and cybersecurity. To support the most appropriate implementation strategy for SurPass throughout the 3 health system scenarios and overcome the 3 main challenges, a digital survey study was designed. The results of the first part of the survey, which addressed barriers and facilitators related to the care process and ethical, legal, social, and economic aspects of implementation, are described elsewhere []. This report describes the results of the second part of the survey, with which we aimed to identify IT-related barriers and facilitators to SurPass implementation. Subsequently, we aimed to derive insights that could be broadly applied to countries with similar types of health systems interested in implementing SurPass.

MethodsStudy Design and Participants

The PCSP project representatives were asked to provide the email addresses of all the IT specialists working in their center who are responsible for the management of IT systems used to document the treatment of patients with cancer and the future implementation of SurPass (N=20). Specifically, the IT specialists invited were based in 6 LTFU care centers (hereafter referred to by their country name): 1 IT specialist from Austria (Children’s Cancer Research Institute St Anna Kinderkrebsforschung), 1 from Belgium (Katholieke Universiteit Leuven and University Hospitals Leuven), 5 from Germany (University Medical Center Mainz [German Childhood Cancer Registry] and Universität zu Lübeck), 7 from Italy (Istituto Giannina Gaslini), 2 from Lithuania (Viesoji Istaiga Vilniaus Universiteto Ligonine Santaros Klinikos), and 4 from Spain (Fundación para la Investigación del Hospital Universitario la Fe de la Comunidad Valenciana). The participating centers represented the 3 European health system scenarios, including (1) nationally based EHISs or EHRs (Austria and Lithuania), (2) institutional or regional EHISs or EHRs (Italy and Spain), and (3) national cancer registries and hospital-based EHISs or EHRs (Germany and Belgium).

Survey Development

The survey was designed using the input from 6 earlier semistructured interviews with IT specialists from each of the participating centers, conducted by researchers from HL7 Europe []. The interviews were conducted to build up a picture of the relevant issues to be explored in the survey. In turn, the survey aimed to collect detailed data on the health system scenarios represented by the centers. First, we inquired about individual respondent characteristics, such as country of residence and organization of the IT department, followed by questions about which systems could be accessed by survivorship care staff; whether the information could be downloaded, entered, or updated; whether the information was integrated transparently, via common identifiers, or by other means; and whether the systems could exchange information using application programming interfaces (APIs). Second, respondents were asked to indicate which health data exchange (HDE) standards or interoperability frameworks were used or currently implemented in their institution. Third, the availability of childhood cancer survivor information (eg, medical history, diagnostic imaging, or pathology laboratories) and its format (eg, hardcopy, PDF, or HL7 CDA) and accessibility were examined. Similar questions about availability and format were asked about cancer diagnosis and treatment (eg, histology-cytology reports, cumulative doses of chemotherapy or radiotherapy, and types of immunotherapy) and noncancer medical information (eg, comorbidities, surgical procedures, and hereditary syndromes). Lastly, respondents were asked about data protection, data storage, and available resources related to the implementation of SurPass. The survey concluded with open-ended questions about barriers and facilitators to the implementation of the interoperable SurPass. The full survey is presented in .

Ethical Considerations

Ethical review board or institutional approvals were required and obtained in Belgium (Ethics Committee Research UZ Leuven; S65576), Italy (Comitato Etico Regionale della Liguria; 385/2021, databank ID 11633), Germany (Ethik-Komission Universität zu Lübeck; 21-257), and Spain (Comité de Ética de la Investigación con medicamentos; 2019-170-1). Ethical approval was not required in Austria and Lithuania. Institutional approval for pseudonymized data collection, analysis, and storage was granted by the Princess Máxima Center, the Netherlands (Clinical Research Committee Princess Máxima Center). This study was performed in line with the principles of the Declaration of Helsinki. Written informed consent was obtained from all participants included in this study. All responses to the survey were pseudonymized. Participants were informed that by participating in this study, they consented to the publication of their pseudonymized responses.

Data Collection

Survey distribution and data collection were conducted using the cloud-based central data management platform Castor electronic data capture, a GDPR-compliant digital survey tool. The survey was conducted in English. On-site language assistance was provided to participants with limited English proficiency. The survey was launched on August 16, 2021, and closed on October 4, 2021. The results were sent to the centers for validation, which took place from December 2021 to March 2022.

Data Analysis

Pseudonymized survey data were exported from Castor electronic data capture and processed and analyzed using SPSS (version 25.0, IBM Corp). The survey results were categorized and analyzed per health system scenario and according to the three main challenges: (1) semiautomation of data input, (2) interoperability, and (3) data protection or privacy and cybersecurity. Additionally, the availability of sufficient resources (ie, staff, funding, and knowledge) to implement SurPass was considered separately for each center.

Predefined barriers to semiautomated data input and interoperability included: unaligned EHIS infrastructures without the availability of a personalized EHR or structured centralized clinical trial database from which (clinical) data could be transferred; the availability or accessibility of less than half of the requested health data information sources and patient data; the nonuse of HL7 FHIR; and the use of proprietary (noninteroperable) coding systems. Barriers to data protection or privacy and cybersecurity included not being able to privacy-protect SurPass record linkage (in line with GDPR), less than half of the IT specialists (per center) being able to guarantee data protection, and less than half of the IT specialists (per center) being familiar with data retention regulations. Finally, the unavailability of sufficient resources as indicated by at least half of the IT specialists (per center), was also considered a barrier.

Predefined facilitators for semiautomation of data input and interoperability included having a standardized and structured HDE process; the availability of a personalized EHR or structured centralized clinical trial database from which (clinical) data could be transferred in the case of nonaligned EHISs; the availability or accessibility of at least half of the requested health data information sources and patient data, ideally with the possibility to download, enter, update, and integrate the data using APIs; the use of HL7 FHIR; and the use of international coding systems such as the Anatomical Therapeutic Chemical (ATC) code system, the International Classification of Diseases for Oncology, 3rd Edition (ICD-O-3), and the International Classification for Childhood Cancer, 3rd Edition (ICCC-3) as used in SurPass. Facilitators for data protection or privacy and cybersecurity included pseudonymization of personal health data per the European Regulation 2016/679 of the European Parliament and of the Council of April 27, 2016, on the protection of natural persons per the processing of personal data and the free movement of such data, at least half of the IT specialists (per center) being able to ensure data protection, and at least half of the IT specialists (per center) being familiar with data retention regulations. Similarly, the availability of sufficient resources, as indicated by at least half of the IT specialists (per center), was considered to facilitate the implementation of SurPass.

Furthermore, we used the fit-viability model (FVM) as described by Liang et al [] to assess the successful implementation of SurPass across the 3 unique health system scenarios. Specifically, the FVM evaluates the technological factors and organizational readiness essential for implementing information technology. Liang et al [] defined “fit” as the match between task requirements and technology capabilities and “viability” as the economic feasibility, IT infrastructure maturity, and organizational support. In our study, we used the FVM to assess how well SurPass fits into the 3 health system scenarios and the extent to which SurPass is feasible, sustainable, and likely to be successfully integrated into the existing EHIS in the different health system scenarios, taking into account the system-specific barriers and facilitators.

ResultsSurvey Participants

A total of 13 IT specialists (1 from Austria and Belgium, 2 from Lithuania and Spain, 3 from Germany, and 4 from Italy) responded to the survey invitation. Further, 3 IT specialists represented the first scenario (national EHISs), 5 IT specialists represented the second scenario (regional or local EHISs), and 4 IT specialists represented the third scenario (cancer registries and hospital-based EHISs). The overall response rate was 65%. The response rates per country were 100% for Austria (1/1), Belgium (1/1), and Lithuania (2/2); 60% (3/5) for Germany; 57% (4/7) for Italy, and 50% (2/4) for Spain.

Barriers and Facilitators per Health System ScenarioOverview of Available Data Systems and Resources

Inherent to the 3 health system scenarios, there are barriers and facilitators relevant to the implementation of SurPass. The characteristics of these scenarios, categorized according to the 3 main implementation challenges, are described below. The availability of data systems and resources in each center is discussed accordingly (see also -). The center-specific HDE standards, interoperability frameworks, and coding systems for each center are described separately by Chronaki et al []. A general overview of all the identified barriers and facilitators to the implementation of the SurPass is provided in .

Table 1. Information system sources in each health system scenario and center.Accessible data systemsScenario 1Scenario 2Scenario 3
LithuaniaAustriaItalySpainBelgiumGermanyNational EHRaYesYesYesYesYesNo
Possibility to download dataYesYesYesYesYesNo
Possibility to enter dataYesmbYesNoYesNo
Possibility to update dataYesYesYesNoNoNo
Integrated transparentlyNomYesNoNoNo
APIsc available to integrateYesYesYesNoYesNoRegional EHR?dm~eYesNoNo
Possibility to download data?mYesNoNoNo
Possibility to enter data?mYesYesNoNo
Possibility to update data?mYesYesNoNo
Integrated transparently?m?~NoNo
APIs available to integrate?mYes~NoNoCancer registryYesYesYesYesYesYes
Possibility to download dataNoYesYes?YesNo
Possibility to enter dataNoYesYesYesYesYes
Possibility to update dataNoYesYesYesNoYes
Integrated transparently?m?YesNo?
APIs available to integrateNoYes?NoYesNoHospital EMRfYesmYesYesYesYes
Possibility to download dataYesmYesYesYesNo
Possibility to enter dataYesmYesYesYes?
Possibility to update dataYesmYesYesYes?
Integrated transparentlyYesmYesYesYes?
APIs available to integrateYesmYesYesNo?Patient records at LTFUg care centerYesmYesYesYes?
Possibility to download dataYesmYesYesYes?
Possibility to enter dataYesmYesYesYes?
Possibility to update dataYesmYesYesYes?
Integrated transparentlymmYesNoYes?
APIs available to integratemmYesNoNo?Patient records at other outpatient centerYesmNoNoYes?
Possibility to download dataYesmNoNoYes?
Possibility to enter dataYesmNoNoNo?
Possibility to update dataYesmNoNoNo?
Integrated transparentlyYesmNoNoYes?
APIs available to integrateYesmNoNoNo?Appointment scheduling systemYesYesYesYesYesYes
Possibility to download dataYesmYesYesYes?
Possibility to enter dataYesYesYesYesYes?
Possibility to update dataYesYesYesYesYes?
Integrated transparently?mYesYesYes?
APIs available to integrateYesmYesYesNo?PharmacyYesmYesYesYesYes
Possibility to download data?mYesYesYes?
Possibility to enter data?mYesYesYes?
Possibility to update data?mYesYesYes?
Integrated transparentlyYesmYesYesYes?
APIs available to integrate?mYesYesYes?LaboratoriesYesYesYesYesYesYes
Possibility to download dataYesYesYesYesYes?
Possibility to enter dataNoNoYesYesYes?
Possibility to update dataNoNoYesYesYes?
Integrated transparently?mYesYesYes?
APIs available to integrate?mYesYesYes?RadiologyYesYesYesYesYes?
Possibility to download dataYesYesYesYesYes?
Possibility to enter dataYesNoYesYesYes?
Possibility to update dataYesNoYesYesYes?
Integrated transparently?mYesYesYes?
APIs available to integrate?mYesYesYes?Clinical trial systemsYesmNoNoYesYes
Possibility to download dataYesmNoNoNo?
Possibility to enter dataYesmNoNoNo?
Possibility to update dataYesmNoNoNo?
Integrated transparentlyYesmNoNoYes?
APIs available to integrateYesmNoNoNo?Primary health care information systemYesYesNoYesNoYes
Possibility to download datamYesNoYesNoNo
Possibility to enter datamYesNoYesNo?
Possibility to update datamYesNoYesNo?
Integrated transparentlymmNoYesNo?
APIs available to integratemmNoYesNo?

aEHR: electronic health record.

bm: Answers missing.

cAPI: application programming interface.

d?: Respondents did not know.

e~: Unclear, for example, 1 × “yes” and 1 × “no.”

fEMR: electronic medical record.

gLTFU: long-term follow-up.

Table 2. Patient data that is electronically available in each health system scenario and centera.CharacteristicsScenario 1Scenario 2Scenario 3
LithuaniaItalySpainBelgiumGermanyPatient data type
Patient summary or medical historyYesYesYesYesYes
Hospital admissionsYesYesYesYesYes
Diagnostic imaging (images)YesYesYesYesYes
Diagnostic imaging (reports)YesYesYesYesYes
Biochemical laboratoriesYesYesYesYesYes
Pathology laboratoriesYesYesYesYesYes
CCb treatment summaryYesYesYes?cYes
LTFUd care visit report?YesNo??
SurPasseNoYesNoNoNo
LTFU center appointmentsYes????
Other medical databases??NoYesYes

aAn earlier version of the Survivorship Passport has been implemented and evaluated previously in Italy. Austria was intentionally left out of the table because all answers were missing.

bCC: childhood cancer.

cRespondents did not know.

dLTFU: long-term follow-up.

eSurPass: Survivorship Passport.

Table 3. Overview of accessible patient data formats in each health system scenario and center. Austria was intentionally left out of the table because all answers were missing.Patient data typeScenario 1Scenario 2Scenario 3
LithuaniaItalySpainBelgiumGermanyGeneral medical history
Comorbidities****a****?b?***c
Allergies*******************
Medication (noncancer related)*****************d
Surgical procedures (noncancer related)*****************
Admissions***************
Trauma************No
Hereditary syndromes***No*****NoCancer diagnosis
Cancer diagnosis****?*********
Cancer diagnosis date*****e***f****
Histology-cytology report***************
Imaging reports*************
Laboratory reports***************Cancer treatment
Surgical interventions**************
Stem cell or bone marrow transplantations*****?**No
Chemotherapy start or end date?**********
Chemotherapy type?************
Chemotherapy cumulative dose********??
Chemotherapy treatment complications?********?
Immunotherapy start or end date???**?
Immunotherapy type???**?
Immunotherapy cumulative dose?????
Immunotherapy treatment complications?????
Hormonal therapy start or end date???**?
Hormonal therapy type???**?
Hormonal therapy cumulative dose?????
Hormonal therapy treatment complications?????
Radiotherapy start or end date********?
Radiotherapy type?******?
Radiotherapy cumulative dose?****??
Radiotherapy site?****??
Radiotherapy treatment complications?****??

aElectronically available, coded, and interconnected.

bRespondents did not know.

cYes, electronically available and coded.

dYes, electronically available.

eYes, hardcopy available (awarded when at least one respondent mentioned “yes”).

fElectronically available, free text, and interconnected.

Table 4. Scarcity of resources in each health system scenario and center. The table shows the number of IT specialists per country that indicated either having (yes) or not having (no) sufficient staff, time, funds, and knowledge.Resource type lacking, nScenario 1Scenario 2Scenario 3
LithuaniaAustriaItalySpainBelgiumGermanyStaff
Yes011102
No20311
Time
Yes012102
No202111Funds
Yes012101
No202112Knowledge
Yes012001
No202212Table 5. Summary of the identified barriers and facilitators to the implementation of the SurPassa (version 2.0) throughout all 3 health care system scenarios.CharacteristicsBarriersFacilitatorsScenario 1: national EHISsb
AustriacUncertainty about data retention
Lack of resources
Standardized and structured data exchange
Straightforward GDPRd compliance using pseudonymization
Data protection can be guaranteed
Use of ATCe code system for medication
Use of ICD-O-3f for histology