Facilitators and challenges to ICD-11 implementation: a qualitative study using the consolidated framework for implementation science

Abstract

Background

The eleventh version of ICD (ICD-11) is the latest version of ICD adopted by the 72nd World Health Assembly in 2019. Worldwide, countries are piloting the ICD-11 and conducting relevant feasibility studies. ICD-11 implementation was not a straightforward initiative, requiring the involvement of various stakeholders. The challenges and facilitators beyond the pilot implementation settings were less well understood. There is a need to understand the perspective of implementers who have experienced ICD-11 implementation involving heterogeneous systems.

Methods

We used primary data gathered between April and May 2024 via semi-structured interviews with the implementers (n = 15) who were members of Malaysia’s national-level ICD-11 implementation committee. We collected and analyzed the qualitative data using the Consolidated Framework for Implementation Research (CFIR) 2022 to understand how the key informants implemented ICD-11. Permission was obtained to record the interviews, which were transcribed and coded using NVivo 12. We used conventional qualitative content analysis to identify key facilitators and challenges to ICD-11 implementation.

Results

By applying CFIR 2022, we determined the relevant factors influencing the implementation of ICD-11 in Malaysia. Defining the facilitators and challenges provided direction on areas of focus and improvement in the ICD-11 implementation context. The facilitators included the lead organizations’ reputation, fulfilment of existing use case, extensive content with terminology service, trialability, lower cost, collaboration with external agencies, improvement of existing laws, clear roles within the organization, effective communication, emerging needs, suitability with existing workflow, easy access to knowledge, motivated team, availability of existing frameworks, and engaging team. The challenges were ICD-11’s complexity, customization, support by top management, vendor’s steep learning curve, inadequate documentation, outdated infrastructure, data duplication and validity, workforce, impact on work processes, funding, and technical expertise.

Conclusions

This study identified key facilitators and challenges in nationwide ICD-11 adoption, providing critical insights for implementation across heterogeneous systems. Successful adoption requires addressing coding, technical and policy aspects. Future research should evaluate user perspectives and the adaptability of implementation strategies in diverse settings.

Clinical trial number

Not applicable.

Supplementary Information

The online version contains supplementary material available at 10.1186/s12911-025-03157-7.

Background

The International Statistical Classification of Diseases (ICD) is a disease classification system that facilitates data storage, retrieval, and analysis [1]. For over a century, ICD has been the basis for comparison of mortality and morbidity statistics worldwide [2]. The eleventh version of ICD (ICD-11) is the latest version of ICD adopted by the 72nd World Health Assembly (WHA) in 2019 [3]. From the latest update in the 77th WHA, about 120 countries are in various stages of ICD-11 implementation [4]. For clarity and brevity, the term ICD-11 used in this article referred to the Mortality and Morbidity Statistics (ICD-11 MMS) linearization.

The findings of global ICD-11 implementation studies

At the time of writing, countries such as Kuwait, China, and Iran successfully piloted ICD-11 [5–7]. At the same time, countries such as the USA conducted ICD-11 feasibility and impact studies [8–10]. Current literature showed that the advantages of ICD-11 include its capability to capture broader coverage of diseases with deeper details and training at a lower cost [6, 11]. Enablers for ICD-11 implementation included influence from the top management, a holistic team approach, user-tailored training, social media use for education, on-site assistance, and vendor experience [5, 6]. Conversely, implementation challenges included generating outputs in downstream systems, documentation incompleteness, IT-related issues, training, and limitations in data comparability [5, 6, 9, 10].

ICD-11 implementers

Based on the worldwide ICD-11 adoption in 2019, the national-level Malaysian ICD-11 Implementation Committee was established that same year. This committee comprised implementers with backgrounds in Information Technology (IT), Health Informatics, health department representatives from within and outside the MOH. The committee coordinated the decision-makers, users, and system owners in ICD-11 implementation. In other words, their roles were essential to facilitate and reduce the challenges of using ICD-11 in Malaysia by setting strategies to coordinate training sessions, conduct promotional activities, and facilitate access to related materials.

Current progress in Malaysia

Various transitional activities have been undertaken since 2019 involving WHO’s ICD-10 2010 Edition used previously to ICD-11. The MOH collaborated with a local university focusing on training [12]. Since January 1, 2024, systems such as the Health Management Information System (HMIS), National Health Data Warehouse (NHDW), and a Hospital Information System (HIS) commenced data collection and reporting using ICD-11 [13]. These systems were used in all 149 MOH hospitals. As of now, ICD-11 implementation in Malaysia is still ongoing, particularly with respect to the remaining hospital information systems (HIS) and systems within the private sector. Nevertheless, the morbidity and mortality reporting for the reference year 2024 was planned to be in ICD-11, leveraging data captured from systems already equipped with ICD-11 and available tools such as the ICD-10 to ICD-11 mapping Table [14]. Besides the system’s transition, data quality monitoring was ongoing, with efforts to improve the existing laws and legislation to promote the use of ICD-11 in the private sector [15].

Consolidated framework for implementation research (CFIR)

Guided by the CFIR 2022 [16], a systematic framework for evaluating potential and current implementation challenges and enablers is suitable for specific contexts such as ICD-11. Insights gained from this framework may guide current efforts and address issues related to ICD-11 implementation. CFIR has been adopted in numerous health-related initiatives, such as efforts reported by the US Department of Veterans Affairs (VA) for performance monitoring and postpartum navigation involving patients with limited resources [17–20].

CFIR stipulated five areas associated with various factors of influence interacting with one another, for example – (1) innovation domain; (2) outer setting; (3) inner setting; (4) individuals domain; and (5) implementation process domain [21]. Recognizing the growing importance of technology-related implementation endeavors, CFIR incorporated elements of health digitalization relevant to ICD-11 implementation in health services [16].

Study aims

In this study, we aim to explore the facilitators and challenges of ICD-11 implementation, provide practical strategies to address the challenges, and leverage the facilitators of ICD-11 implementation. Based on previous studies, the challenges and facilitators beyond the settings of pilot implementation were less well understood. There was a gap in understanding the perspective of implementers who experienced ICD-11 implementation involving heterogeneous systems.

Methods

Study design and setting

Using the qualitative approach, we used the CFIR framework for data collection and analysis [21]. A total of 15 interviews were conducted. Seven sessions were conducted face-to-face, while the remaining eight interviews were conducted online. This study was assessed and reviewed by the Research Ethics Committee, National University of Malaysia (UKM PPI/111/8/JEP-2023-080) and the Medical Research & Ethics Committee, MOH Malaysia (NMRR ID-23-00756-KIH (IIR)).

Sampling and recruitment

Purposive sampling was used to choose key informants among the national-level implementation committee members. The sampling process was carried out until the key informants provided no new information in which the data had achieved saturation. In this study, implementers were from diverse backgrounds, including information technology (IT), clinical coders, and health informaticians.

Site selection

For this study, we identified MOH facilities active in the healthcare sector during the ICD-11 implementation [22]. At the time of data collection, the web-based HMIS and NHDW, equipped with ICD-11 functionalities, were used in all MOH facilities. Based on the criteria set by the MOH on ICD-11 implementation, facilities or systems are deemed to have implemented ICD-11 when the facilities or systems publish reports or capture data using ICD-11.

Data collection

At the respondents’ request, interviews were conducted either face-to-face or via video teleconferencing software Google Meet between April and May 2024. The interview guide consisted of semi-structured questions on the domains and constructs adapted from the CFIR online kit [21]. For example, the interview guide based on CFIR 2022 included domains related to individual characteristics, innovation, outer setting, inner setting, and innovation process that may influence ICD-11 implementation.

Supplementary File 1 contains sample questions matched to the CFIR constructs adapted from Yan et al. (2023) [23]. Its operational definitions were pilot tested among the implementers, not in the sample, and were further improved. The average duration of each interview was from 40 to 50 min. With participants’ consent, the interviews were recorded and transcribed. Table 1 depicts the interview guide topics and the associated constructs.

Table 1.

CFIR 2022 domains and interview guide topics

CFIR domain	Interview guide topic
Innovation	• Implementer’s credibility • Facilitators or challenges to implementing ICD-11 • Assessing implementers’ needs
Outer setting	• Role of MOH agencies • International partnerships • Policies and regulations • Show-stoppers potentially disrupting the implementation
Inner setting	• Implementing ICD-11 in the MOH • Training and guidance
Characteristics of individuals	• Key informants’ background • Self-efficacy
Implementation process	• Background of implementation • Thoughts and reflections on improving implementation

Data analysis

Following transcription, data analysis was completed immediately. The interviews were transcribed verbatim into Microsoft Word and then imported into the NVivo 12 software for data management and coding procedure. Using the conventional qualitative content analysis (QCA), insights and knowledge of the subject were obtained [24, 25]. Upon reading the transcripts, text fragments were examined and matched to the pertinent codes.

We combined inductive and deductive category methods to create the coding system. The inductive subcategories emerged during the interview, whereas the deductive categories were extracted from the semi-structured interview guide using the CFIR domains and constructs. Thus, interviews were utilized to investigate more categories and find topics pertinent to a broader range of studies. We examined the interviews multiple times to ensure the code framework was complete. When extracting any other categories from the transcripts was impossible, the coding framework was used to conduct a line-by-line analysis of each of the 15 interviews [24–26].

Results

The results include implementers’ insights on their roles, the enablers, and the impediments they face while implementing ICD-11 in Malaysia. Tables 2 and 3 show CFIR 2022 domains with the corresponding facilitators and challenges and sample quotes from qualitative interviews.

Table 2.

Facilitators to ICD-11 implementation and corresponding CFIR 2022 domain and constructs, and ERIC-aligned implementation strategies

CFIR domain	CFIR construct	Facilitator	Implementation strategies
ICD-11	Source	Reputable organizations oversee the implementation	• Identify and prepare champions • Conduct educational meetings
	Evidence-base	Identical to how ICD is crucial for current use cases
	Relative advantage	ICD-11 has extensive content and a terminology service in comparison to ICD-10
	Trialability	Can be piloted to understand user needs and related deficiencies
	Innovation cost	Use of ICD-11 is free of charge.
Outer setting	Partnership and connections	Collaboration with external organizations like universities, the private sector, and WHO	• Involve stakeholders • Obtain and use stakeholders’ feedback
	Policies & Laws	• Directive for ICD-11 implementation from 2024 onwards • Enhancement of current legislation regarding ICD-11 reporting
Inner setting	Relational connections	Centralized and clearly defined roles among all MOH agencies	• Conduct local consensus discussions • Assess for readiness and identify challenges and facilitators
	Communications	• Content that is customized according to professions and roles in the organization • Formal and informal platforms for communication
	Tension for change	• Need to provide answers to specific business and research questions • Consider the complexity and broader range of diseases
	Compatibility	ICD-11 fits with existing systems and workflows
	Access to knowledge & information	• Capacity for self-directed learning • Availability of coding guide
Individuals	Implementation Leads and Team Members	Highly motivated to implement ICD-11	• Conduct ongoing training • Make training dynamic • Provide ongoing consultation
Implement -ation process	Planning	References for steps and milestones related to: • Policies by ICD-11 Implementation or Transition Guide • Systems transition by the Systems’ Development Life Cycle	• Develop a formal implementation blueprint • Develop and implement tools for quality monitoring
	Engaging	Champions involved in nationwide roadshows and attended invitations for talks and training.

Table 3.

Challenges to ICD-11 implementation identified by key informants and corresponding CFIR 2022 domain and constructs, and ERIC-aligned implementation strategies

CFIR domain	CFIR construct	Challenges	Implementation strategies
ICD-11	Complexity	Rigorous coding process	• Promote adaptability
	Adaptability	Partial customization of ICD-11 Embedded Coding Tool based on local needs
Outer setting	Critical incidents	Lack of support by decision-makers	• Alter incentive/ allowance structures
	Local conditions	• Potential high transition cost for proprietary systems • Physician’s inadequate documentation
Inner setting	Structural characteristics	• Outdated infrastructure • Potential for data duplication • Lack of data validity • Inadequate personnel • Adjustments to the current workflow	• Access new funding
	Available resources	Insufficient funding for ICD-11 transitions of all systems
Individuals	Implementation Leads and Team Members	Lack of technical expertise on ICD-11-related matters	• Identify and prepare champions • Make training dynamic

Role of implementers

Implementers described how the work committee formation process is initiated through recommendations from their supervisors or their appointment as national expert coders: “My supervisor nominated my name to join the committee as my job scope entails ICD codes and Casemix” [I-12]. As another implementer put it, “I am a Medical Officer at the Casemix department scored considerably well in the course enough to be appointed as the national ICD-11 expert and subsequently joined this committee” [I-1].

In the working committee, the implementers were tasked to contribute to ICD-11 implementation priorities:

We meet every two months usually, given updates by the secretariat and any proposals will be put up as a committee, we look through the proposals and suggest improvements that can be done before being submitted to the higher-ups” [I-9].

Facilitators of ICD-11 implementation

The ICD-11 implementers have identified facilitators (Table 2) that influence the implementation effort in Malaysia mapped to the CFIR constructs.

ICD-11 domain

Within the innovation domain in CFIR, we defined the innovation source as how dependable the organizations involved were in developing and implementing ICD-11, such as the WHO and MOH [16]. The key informants described that the organizations associated with ICD-11 were reputable and felt no hesitations to embrace the ICD-11 use:

WHO developed ICD-11, and the Health Informatics Centre is the lead in its implementation here. There is no question of its importance; it is a need. [I-5]

The evidence base on ICD-11 was described as the extent to which ICD-11 has substantial evidence establishing its effectiveness [16]. The implementers responded that ICD-11’s implementation was expected to fulfil the existing use cases related to ICD-10, like reporting and casemix.

ICD-11 is important for MOH. The importance of ICD-11 is like that of ICD-10 in terms of data comparison, casemix, and costing. [I-9]

Additionally, the relative advantage of ICD-11 represented that ICD-11 outperformed existing practices and other available innovations [16]. Implementers reported that, compared to ICD-10, ICD-11 is more advantageous because it has a terminology service with concepts in ontological relationships. The ICD-11 Embedded Coding Tool can recognize terminology concepts like postcoordination and synonyms.

ICD-10 is purely a statistical classification. On the other hand, ICD-11 is equipped with terminology service. It has ontological relationships between concepts. It also has a coding tool that can consider terminology concepts like synonyms and word combinations through postcoordination. [I-3]

Trialability was also an applicable concept under the Innovation domain, defined as the ability to use ICD-11 on a small scale and undo it at the end of the pilot phase [16]. The implementers opined that the piloting use of ICD-11 was possible and that some gaps and issues were discovered:

On pilot use, it can be considered a success, identified deficiencies here and there but is not a disadvantage but for us to prepare better before the implementation. [I-6]

Innovation cost was illustrated as the reasonable cost for operating and purchasing ICD-11 [16]. One implementer remarked that ICD-11 was free except for the one-off cost to fit ICD-11 in local systems: “… no need to pay to use ICD-11. However, we must pay the contractors to use it in our system. It is the only cost, and there is no subscription fee after that.” [I-5].

Outer setting domain

Within the Outer Setting [16], partnerships & connections represented the external networks connected to the Inner setting, such as professional organization networks, university affiliations, and referral networks [16]. The implementers reported that collaboration with relevant external agencies facilitated the ICD-11 implementation in Malaysia:

We worked closely with the IT contractors for this. WHO also gave their timely feedback whenever we approached them. During training, we worked closely with the university, where they covered the private personnel and our own personnel using the same materials. [I-9]

Policies & laws were another important construct identified. It is defined as using ICD-11 supported by laws, rules, professional group guidelines, recommendations, or accreditation [16]. The key informants described that one of the key enablers for the ICD-11 implementation was the decision made by the MOH’s top management:

We do it because of the directive from the top management. [I-1]

… official letter to use ICD-11. [I-10]

Inner setting domain

Related to the Inner Setting domain, structural characteristics were the infrastructure that enable the Inner Setting [16]. The implementers noted that previous arrangements and infrastructure related to a central system for the collation of reports across were beneficial in facilitating ICD-11 implementation in Malaysia:

Fortunately, there is direct oversight by the MOH. There is even a good partnership with the private sector in a centralized manner. We have an existing central data repository system used nationwide in ICD-10. [I-3]

In addition, relational connections that were high-caliber teams, networks, and partnerships within the Inner Setting aided in the ICD-11 implementations [16]. The key informants responded that the centralized structure within the MOH and the clearly defined roles of the agencies set the stage for ICD-11 implementation:

HQ needs to have a clear direction. If you want to use ICD-11, you need to facilitate. Other agencies need to agree, too. Others, like the states and districts, will follow suit if there is a clear direction. [I-2]

Relevant to the communications construct, excellent formal and informal information sharing among MOH agencies facilitated the implementation effort [16]. In short, the implementers informed us that the content was customized to the roles of the users during engagements. Besides that, formal communications in the form of official meetings and informal via social messaging applications were important for timely clarification of issues and doubts:

We communicate formally and informally. Both positively impact the users and us. WhatsApp is fast, but we must ensure the information is accurate. We normally use it to pre-empt the users before the meeting. Formally, via meetings. [I-14]

Tension for change was also applicable in this context. It was characterized as the current situation, like the use of ICD-10, must be changed because it was untenable [16]. The implementers confirmed that there was an increasing need to answer questions of higher specificities, complexities, and a wider range of diseases:

We want to analyze more; therefore, we need good data. Some information is only captured in ICD-11. Users get annoyed when they cannot find specific codes for the diagnosis. In the end, the system captures only vague and unspecified information. [I-2]

ICD-11 has also been found to be compatible with Malaysian systems, procedures, and workflows [16]. As the implementers put it: “I think ICD-11 fits in our setting; granted, some changes need to be made, but no one is made redundant. We need the people that we have now more than ever. System-wise, modifications must be made. As best as possible, we try to use ICD-11 to lessen paperwork and improve the current workflow” [I-8].

Likewise, easy access to knowledge & information related to ICD-11 was helpful in the implementation effort [16]. It was possible to get training via the e-learning platforms, and there was a coding guide for reference:

Education-wise, we have an ICD-11 module in our e-learning platform that can be accessed anytime. The reference manual for ICD-11 diagnosis coding is helpful as the guide suggests codes for common diagnoses in the MOH. [I-10]

Individuals’ domain

Under the Individuals domain, applying to both the Implementation Leads and Team Members, motivation was a concept of their commitment to ensuring the effort’s success [16]. The key informants described the importance of setting achievable milestones, and with each success, stakeholders can stay motivated:

With the top management’s directive, our aim is clear: to ensure the reporting is in ICD-11, so we focused on that first. [I-2]

Implementation process domain

Within the Implementation process domain, planning was about establishing objectives and metrics for the implementation beforehand, as well as roles, duties, steps, and milestones [16]. The implementers mentioned that several existing references were used to aid in the planning and setting milestones of ICD-11 implementation:

Policy-wise and other non-technical goals, we adapted the tasks from the ICD-11 Guide published by WHO. [I-7]

We treat systems transition like the usual IT projects, starting with user requirements and other tasks in the SDLC. [I-14]

Engaging was an encouragement to draw stakeholders to participate in ICD-11 implementation [16]. The key informants noted that every opportunity was taken to spread awareness of ICD-11:

We did what we could, took up invitations, and organized nationwide roadshows to spread awareness to anyone who would listen. [I-7]

Related to the reflecting & evaluating construct, it was defined as gathering and discussing information regarding the ICD-11 implementation progress [16]. The implementers have noted that, in general, it was not a straightforward endeavor, but current progress may be considered a success:

Implementation… we are on the right track; we were ambitious to implement it from data collection to downstream systems. [I-3]

All in all, I am quite happy now we have gone live. Hiccups regarding data quality and analytics are here and there, but they are manageable. We can be better, nevertheless. [I-2]

Challenges to ICD-11 implementation

The ICD-11 implementers identified challenges (Table 3) that influenced the implementation effort in Malaysia mapped to the CFIR constructs.

ICD-11 domain

ICD-11 complexity was the multifaceted nature of ICD-11 in terms of its extent, nature, and quantity of linkages and coding steps [16]. Implementers described the intricate coding process involved due to the nature of ICD-11, which is a classification system with terminology services:

Users need to understand the coding tool, which has considerably more functions and is detailed. Users find it difficult to identify the right codes and understand the need to choose the right terms. [I-4]

The key informants also raised the challenges related to ICD-11’s adaptability. In the context of this study, adaptability was ICD-11’s ability to adjust, customize, or refine to suit local requirements [16]. The implementers discussed that the ICD-11 Embedded Coding Tool (ICD-11 ECT) still allows the coding process to proceed without the required postcoordinated codes:

For sepsis codes and codes related to injuries, I can still proceed even though I did not provide the cause of sepsis and the external causes related to it. It would be good to have a pop-up to remind users to provide it. [I-15]

Outer setting domain

Critical incidents delineated how unexpected large-scale events may interfere with ICD-11 implementation [16]. The implementers noted that dwindling support from decision-makers could be the largest challenge to implementation:

If bosses think that we do not need ICD-11, we must stop. [I-2]

In the Outer setting domain, local conditions were the technological, political, and environmental conditions that support the ICD-11 implementation [16]. The implementers described the challenges associated with ICD-11 being a new initiative, and IT contractors may take some time to adopt ICD-11 and that the incompleteness of documentation may not allow users to realize the full potential of ICD-11:

Off-the-shelf products may not be easily switch to ICD-11 and may require higher costs. [I-2]

Documentation is still not yet satisfactory. Clinicians, too, need to be aware of ICD-11. [I-9]

Inner setting domain

In contrast, some challenges described by the key informants were related to structural characteristics construct, namely, outdated infrastructure, data duplication, data validity, inadequate personnel, and impact on current workflows:

Most computers are old and need replacement so implementation can be done completely. [I-7]

During the pilot and post-implementation stages, some users made mistakes when entering the old and new systems. So this caused some data duplication in our database. [I-2]

Some systems allow data to be submitted by physicians without checking, and the validity of the data may be affected negatively, especially since some are being trained. [I-9]

Change the existing workflow for clinical coding-related tasks. [I-3]

In the Inner setting domain, available resources were illustrated as the resources that needed to implement ICD-11. Of the resources, insufficient funding and staffing were considered challenges in implementing ICD-11 across all systems:

Lack of funding to expand the use of ICD-11. [I-4]

Lack of workforce, especially to improve the awareness of users. If we have a bigger team, I think things will be better. [I-11]

Individuals’ domain

Within the construct of Implementation leads and team leaders, there was a lack of technical expertise on the use of ICD-11:

We were not technically trained to undertake the implementation. WHO provides available documentation but requires some HTML and JSON knowledge to communicate our requirements to the vendor. [I-7]

Implementation process domain

Finally, the need to adapt existing systems to use ICD-11 may hinder ICD-11 implementation. The challenges related to the adapting construct were defined as the best fit and integration of ICD-11 into existing workflows [16]. The implementers described that additional modifications had to be made to the system to suit the use of ICD-11:

Hand in hand with the ICD-11 implementation, we added the save functionality to our system to reduce the data entry burden for our personnel. For example, all fields except ICD coding can be entered by the clerk and saved. Then, the clinical coder will search for the patient information, proceed with ICD coding, and submit the form. [I-8]

Discussion

We identified facilitators and challenges to implementing ICD-11 in Malaysia. Mapping these factors to CFIR 2022 [16] enabled us to pinpoint strategies in the Expert Recommendations for Implementing Change with the way forward to improve the ICD-11 implementation intervention. These implementation strategies should be able to tackle the difficulties implementers had when implementing ICD-11 in the respective local settings. Tables 2 and 3 suggested strategies to guide ongoing ICD-11 implementation initiatives, as outlined below.

Implications

ICD-11 domain

Facilitators related to the ICD-11 domain identified by the implementers included the reputation of the lead organization, suitability with existing use cases, extensive content, ability to be piloted, and long-term cost. The implementers also discussed challenges, such as ICD-11’s rigorous coding process and partial customization based on local needs. Findings from the implementers supported the following from existing literature [7], highlighting the critical need for champions such as those from the WHO, the Ministry of Health (MOH), or local universities to guide and sustain the implementation effort [12].

Via the champions, educational meetings can be organized with different foci like on systems or clinical coding [5, 27]. In Malaysia, engagements related to ICD-11 coding have been frequently delivered by the champions [12]. Regular meetings to discuss the correct coding method and techniques may improve the coding speed and accuracy [28, 29]. Zhang et al. (2024) and Ibrahim et al. (2022) emphasized extending the ICD-11 education to IT personnel [5, 6]. This is because education promoted the adaptability of the ICD-11 software to the local systems to suit or improve existing work processes. From our experience, the added functionality to save entries in the system that were not there before the ICD-11 implementation eased the workflow and improved user acceptance.

Outer setting domain

The implementers described that having close partnerships with external agencies and non-punitive laws and policies may facilitate ICD-11 implementation. At the same time, challenges such as local conditions and critical incidents such as the lack of support from stakeholders may be challenges to implementation efforts, such as involvement and obtaining feedback from relevant stakeholders like users and decision-makers. In the US and Kuwait, engagements with the stakeholders by the national agencies on the use of ICD-11 were already underway [6, 30].

Regarding laws and policies, taking a leaf from the USA’s Health Information Technology for Economic and Clinical Health (HITECH) Act, incentivizing users and system developers to use or build systems that comply with data standards may facilitate ICD-11 implementation [31]. As for now, the MOH has commenced efforts to improve the relevant regulations related to disease reporting under the Private Healthcare Facilities and Services Act 1998. Principles relating to the HITECH Act and the revision of the list of recommended standards can be the basis for future revisions associated with ICD-11.

Inner setting domain

The implementers identified facilitators such as connections, communications, and data needs within the MOH. Also, enablers such as ICD-11’s compatibility and stakeholders’ access to learning materials aid in the implementation effort. For challenges, the implementers raised issues like outdated infrastructure, data duplication, validity, workforce, impact on current workflow, and inadequate funding.

Overall, it was imperative to assess readiness and identify the challenges and facilitators related to it. One of the ways to determine this was via the pilot implementation and acceptance studies of ICD-11 in specific local settings [5–7]. Furthermore, the challenges raised by the implementers suggest the need to access new funding for the implementation effort. While the necessary funding application was underway, existing systems must be maintained, and ICD-10 ICD-11 crosswalk was sufficient in the transition phase to ensure standardized reporting [32]. Next, conducting regular local consensus discussions was imperative to identify the grouses and needs related to ICD-11 implementation. In the context of coding issues, regular team meetings were emphasized to obtain agreement on ICD-11 coding [27]. The ICD-11 coding reference manual could be improved regularly based on the latest coding consensus in Malaysia [33].

Individuals’ domain

The key informants described that having the motivation to implement ICD-11 was essential to ensure its success. Despite that, among the challenges faced by the implementers was the initial lack of technical expertise on ICD-11 in the country. Nevertheless, the documentation provided by the WHO and existing knowledge of local systems was sufficient to ensure the implementation of ICD-11 systems and to decide on relevant ICD-11 coding policy [34, 35].

Potential implementation strategies included conducting dynamic and ongoing training, involving continuous consultation to tailor stakeholders’ needs and implementers’ strengths. Ongoing and dynamic training have been described in Kuwait on the use of applications like YouTube and social messaging applications to spread the intended messages [6]. Not only that, but on-site support was also advocated during the implementation [6]. Similar training in Malaysia was organized through formal talks and via e-learning platforms [12].

Innovation process

For the final innovation process domain, the implementers pointed out that planning using existing frameworks and regular engagements in talks and training facilitated the ICD-11 implementation. The implementation document by WHO [36] was helpful as a guide to plan the tasks and set an achievable timeline for ICD-11 implementation [15]. On quality monitoring, existing literature showed that cluster codes have lower levels of agreement [5, 37]. The MOH could identify the criteria for quality assessment to improve the ICD-11 implementation efforts in Malaysia continually.

Study strengths

Our study has a few noteworthy strengths. To our knowledge, little was known about the facilitators and barriers to implementing ICD-11 beyond the scope of pilot implementation [5–7]. It is essential to understand these factors, especially given the heterogeneity across healthcare systems. This study closes a significant gap and addresses the needs related to the ICD-11 implementation. Using qualitative research techniques (such as in-person interviews), we pinpointed several facilitators and challenges that influence the implementation in the context of this study. We conducted interviews with a representative sample of participants, comprising implementers who were directly involved in the implementation of ICD-11. This allowed us to gather various perspectives regarding the ICD-11 implementation in different settings. Furthermore, the findings of our study added to the expanding body of work in implementation science that used CFIR to assess particularly in the field of ICD-11 implementation.

Study limitations

This study has some limitations, which included the findings’ generalizability. The implementers interviewed were drawn from various sites and had experienced implementing ICD-11 across multiple systems and vendors in different use cases, such as casemix and the reporting system. However, all were affiliated with a single health system, the MOH. However, most of the issues raised were generic to ICD-11 and thus apply to other settings or countries. Social desirability bias may be possible because the interviews were audio recorded, and implementers’ opinions and perceptions might not accurately represent the process. We ensured the key informants were informed of the confidentiality agreements before conducting the interviews and provided them with information outlining the anonymity of the data. Lastly, the CFIR-ERIC matching tool’s proposed implementation strategies were determined by expert consensus. Therefore, their mechanisms of effectiveness may be vague. We attempted to include a variety of stakeholders in the study and adapted the general strategies to practical strategies.

Conclusions

Facilitators and challenges identified, and its corresponding strategies must be considered while planning for ICD-11 implementation. Implementers should be ready to focus not only on the coding aspects but also on the technical and policy aspects of the implementation. Future research should delve into the users’ perspectives concerning ICD-11 and assess the suitability of the implementation strategies in other contexts.

Supplementary Information

Below is the link to the electronic supplementary material.

Abbreviations

ICD-11

International Statistical Classification of Diseases 11th Version

ICD

International Statistical Classification of Diseases

CFIR

Consolidated Framework for International Research

WHA

World Health Assembly

IT

Information Technology

HMIS

Health Management Information System

NHDW

National Health Data Warehouse

HIS

Hospital Information System

VA

US Department of Veterans Affairs

QCA

Qualitative Content Analysis

HITECH

Health Information Technology for Economic and Clinical Health

Author contributions

ECOW, ASAF, AA, HMS and MFK contributed to the collection and analysis of data. MNM, NMM and SAS provided input on methods and overall study design. ECOW, ZMI and MRAM designed the study and provided input on the analysis. All authors provided input on the manuscript development, read and approved the final manuscript.

Funding

None.

Data availability

The data generated and analyzed during the current study are not publicly available but are available from the corresponding author on reasonable request.

Declarations

Ethics approval and consent to participate

This study was assessed and reviewed by the Research Ethics Committee, National University of Malaysia (UKM PPI/111/8/JEP-2023-080) and the Medical Research & Ethics Committee, MOH Malaysia (NMRR ID-23-00756-KIH (IIR)). The Research & Ethics Committee approved information and consent statement was read aloud at the start of each interview, following which verbal consent was obtained from all participants. The interviewer documented verbal consent in secure study records.

Consent for publication

Not applicable.

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