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Abstract
Objectives Atrial fibrillation (AF) screening may increase early detection and reduce complications of AF. European, Australian and World Heart Federation guidelines recommend opportunistic screening, despite a current lack of clear evidence supporting a net benefit for systematic screening. Where screening is implemented, the most appropriate approaches are unknown. We explored the views of European stakeholders about opportunities and challenges of implementing four AF screening scenarios.
Design Telephone-based semi-structured interviews with results reported using Consolidated criteria for Reporting Qualitative research guidelines. Data were thematically analysed using the framework approach.
Setting AF screening stakeholders in 11 European countries.
Participants Healthcare professionals and regulators (n=24) potentially involved in AF screening implementation.
Intervention Four AF screening scenarios: single time point opportunistic, opportunistic prolonged, systematic single time point/prolonged and patient-led screening.
Primary outcome measures Stakeholder views about the challenges and feasibility of implementing the screening scenarios in the respective national/regional healthcare system.
Results Three themes developed. (1) Current screening approaches: there are no national AF screening programmes, with most AF detected in symptomatic patients. Patient-led screening exists via personal devices, creating screening inequity. (2) Feasibility of screening: single time point opportunistic screening in primary care using single-lead ECG devices was considered the most feasible. Software algorithms may aid identification of suitable patients and telehealth services have potential to support diagnosis. (3) Implementation requirements: sufficient evidence of benefit is required. National screening processes are required due to different payment mechanisms and health service regulations. Concerns about data security, and inclusivity for those without primary care access or personal devices must be addressed.
Conclusions There is an overall awareness of AF screening. Opportunistic screening appears the most feasible across Europe. Challenges are health inequalities, identification of best target groups for screening, streamlined processes, the need for evidence of benefit and a tailored approach adapted to national realities.
- cardiac epidemiology
- general medicine (see internal medicine)
- quality in health care
- risk management
- stroke
- preventive medicine
Data availability statement
Data are available on reasonable request. The data underlying this article were provided by the AFFECT-EU Consortium by permission. Data will be shared on request to the corresponding author with permission of the AFFECT-EU Consortium is also expected but not yet confirmed.
This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.
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- cardiac epidemiology
- general medicine (see internal medicine)
- quality in health care
- risk management
- stroke
- preventive medicine
Strengths and limitations of this study
Telephone interviews were conducted by members of a multilingual research group, allowing engagement with a diverse sample of healthcare professionals and regulators from 11 European countries.
This study focuses on process considerations for implementation of atrial fibrillation (AF) screening to understand whether AF screening can work in practice and how, because if ongoing studies and individual patient meta-analyses provide strong evidence for screening, it is important to have already considered implementation strategies.
Purposive sampling was used to invite potential participants who were knowledgeable about or influential in decisions about AF screening, and those who responded may have been biased in favour of screening.
Introduction
Atrial fibrillation (AF) is the most common arrhythmia of clinical importance in the general population worldwide.1 The prevalence rises to >1 in 10 in older adults.2 Due to rapid ageing in the population and survival from underlying conditions closely related to AF, recent projections indicate that the prevalence will more than double in the next decades.3–5 AF is therefore very likely to impose a substantial and growing economic and societal burden on the different healthcare systems across Europe. Importantly, compared with individuals free of AF, the presence of stroke in individuals with AF is nearly fivefold higher6 and one-tenth of patients who have an ischaemic stroke are first diagnosed with AF at the time of the stroke event.7 Currently, the initial diagnosis of AF is often related to symptoms that lead to rhythm monitoring. However, AF often is paucisymptomatic or asymptomatic.8 Detection of AF by screening before symptoms or complications occur, could initiate treatment with oral anticoagulants to reduce the risk and the severity of stroke.1 9 Opportunistic screening for AF by pulse taking or ECG in patients ≥65 years of age or systematic ECG screening in aged individuals ≥75 years, or those at high risk, is recommended by the European Society of Cardiology (ESC).1 Despite these recommendations, whom and how to screen and the optimal setting with the highest efficiency remain uncertain among experts.10 There is ongoing controversy about cost-effectiveness and a lack of evidence about AF screening.11 Based on the lack of evidence from randomised studies on the stroke reduction efficacy of systematic AF screening and on the lack of data on stroke risk of shorter asymptomatic AF episodes, the United States Preventive Services Task Force have given an ‘I’ recommendation (inadequate evidence) for AF screening.11 Consequently, appropriate risk-based screening and systematic screening programmes at a comprehensive national healthcare level do not currently exist in any of the European countries nor in the USA. However, in the near future, data from ongoing studies and individual patient meta-analyses will enrich our insights into the merits and pitfalls of the AF screening process.
A range of new technologies has been developed that may improve the feasibility, accuracy and rates of AF detection.12 However, the best approach to AF screening remains uncertain. In this study, we undertook semi-structured interviews with experts in the field including various healthcare professionals (HCP) and regulatory authorities in order to identify obstacles and opportunities of different possible AF screening scenarios across Europe.
Methods
This qualitative study used semi-structured telephone interviews to explore the feasibility of different approaches to screening for primary detection of AF across 11 European countries. Results were reported using the Consolidated criteria for Reporting Qualitative research guidelines.13 Overarching themes, encompassing current practice, the feasibility of the different AF screening approaches and implementation requirements were established.
Patient and public involvement
Patients and the public were not involved in the choice of topic, assisting in the study design, advising on the project or in carrying out the research.
Sample
We recruited a purposive sample of key informants,14 who were identified of as being knowledgeable about AF and/or influential in the implementation of health screening policies across 11 European countries via a panel of AF experts involved in the EU-funded AFFECT-EU (affect-eu.eu),15 Digital, Risk-based Screening for Atrial Fibrillation in the European Community study between June and May 2021. Eligible participants were (i) HCP with experience in screening and clinical expertise in AF detection and management (nurses, general practitioners, pharmacists, cardiologists); (ii) regulators (individuals with insights into processes for the implementation of disease screening programmes, developing health technology assessments for political decision-making or with expertise of reimbursement procedures and detailed knowledge of (cost)-effectiveness of screening programmes). Email invitations explaining the aim of the study and that the research/researchers were part of a wider pan-European project about AF screening, were sent to potential participants (n=40). Participants gave consent to register for the study.
Data collection
The AFFECT-EU research group developed two interview guides, one for each professional group. We used an iterative process of expert review and with reference to AF screening literature. Topics included current national approaches to AF screening, other national disease screening programmes and discussion about four AF screening scenarios (figure 1) developed specifically for the interview guide: single time point opportunistic screening, prolonged opportunistic screening, systematic single time point or prolonged screening and patient-led screening (online supplemental file 1). We defined opportunistic screening as any screening programme that did not systematically invite patients or members of the public to take part (eg, screening a patient in primary care while they were attending an appointment for another reason, or a member of the public shopping at a pharmacy and being offered the opportunity to take part in AF screening).
Supplemental material
Atrial fibrillation (AF) screening programmes: current approaches, feasibility and implementation challenges. GP, general practitioner.
Lead experts in the field (RS, HH) guided the development of the scenarios and the interview questionnaire. Six researchers (DE, CLH, LD, GB, EP, TSP), arranged interviews in their country of residence and conducted telephone interviews at convenient times for participants in their native language. In countries with no resident researcher, interviews were conducted in English. Prior to interviews, participants were provided with the questions and visual representations of the four screening scenarios. Interviews took place between July 2020 and May 2021 with consistent application of the interview guide. Interviews were conducted in private, recorded on an encrypted audio recorder and transcribed verbatim. All transcripts were translated into English by the researcher who conducted the interview.
Data analysis
Interview transcripts were imported into NVivo V.12 (QSR International, Melbourne, Australia) for analysis and used a unique identification code to protect participant identities. Data were analysed using thematic analysis16 with a framework approach.17 One researcher (CLH), a research fellow with 8 years’ experience of qualitative research, read and re-read all transcripts in the familiarisation phase. She independently created open codes (n=53) identifying relationships, similarities or dissimilarities for the first three transcripts. During identification, CLH presented data at a workshop, with four other researchers, one male and three females (DE, LD, LN and RS) acting as ‘critical friends’ to provide critical input and outline sources of bias. In our initial framework, we identified 10 categories (current approaches to screening, evidence of effectiveness, feasibility of AF screening, screenee identification, screening location, timing, use of technology, interpretation of screening results, potential inequity and remuneration). During indexing, CLH coded six more transcripts. LN, a professor with 10 years’ experience of qualitative research, checked coding and category accuracy before CLH and DE coded all remaining transcripts. In a second workshop with all researchers, we explored and rearranged the data according to the themes and compared these within and across all cases. Prior to final analysis, five researchers (CLH, DE, LD, LN and RS) reviewed the framework and agreed to 3 final overarching themes and 10 subthemes.
Results
We recruited 24 participants from 11 European countries (table 1). Sixteen people who were invited to take part did not respond to the invitation email. Median interview length was 54 (range 36–78) min.
Participant characteristics
Three main themes developed: (1) current approaches to screening, (2) the feasibility of AF screening approaches and (3) implementation requirements (figure 2). We present data in tables that summarise participants’ views of the status within each theme and how these relate to the opportunities and challenges for future AF screening programmes across Europe. Indicative quotes are provided.
Opportunities and challenges for the implementation of atrial fibrillation (AF) screening in Europe.
Current approaches to screening
The majority of AF detection currently takes place in primary care when patients present with symptoms, during workup for other conditions or during a routine follow-up consultation. Those who do not routinely visit healthcare services are excluded from potential detection of AF. National screening programmes exist across all 11 European countries for various cancers and some cardiovascular diseases. Many participants considered that AF screening could be integrated into cardiovascular check-ups (eg, systematic screening of blood pressure, body mass index and lifestyle factors or opportunistic approaches to screening these factors) but not into current cancer screening programmes. The latter was because of the inappropriate age of those screened (cervical cancer) or remote sample collection (bowel cancer). Population awareness-raising programmes exist for lifestyle (smoking, physical activity and diet) and some cardiovascular diseases but only in exception for AF. Participants reported that these programmes increased health inequalities (table 2).
Current approaches to screening
The feasibility of AF screening approaches
There was some support for all screening scenarios, but participants considered that single time point opportunistic AF screening using single-lead ECG devices was the most appropriate and feasible approach if proven effective.
Some of the participants stated that software systems in primary care had the potential to identify suitable patients for screening but that algorithms did not currently exist for this. Telehealth centres were reported to be a potential solution to support ECG interpretation and AF training, although there were conflicting views about where such a service should be located. Participants in central, northern and Nordic areas of Europe suggested that patients who are more affluent increasingly present with potential AF diagnoses from privately owned wearables, creating pressure for medical investigations, data protection issues and increasing health inequalities (table 3).
The feasibility of AF screening approaches
Implementation requirements for AF screening
Primary care was considered the most appropriate location for AF screening by the majority of participants, with mixed views about the suitability of pharmacies. Participants reported that GPs could be relieved of some of the burden for AF screening with alternative staff training. Most participants agreed that there was a need for advocates for national AF screening programmes who must present evidence of effectiveness and produce clear protocols for implementation to national review committees in order to build a case for screening. Where screening is introduced, country/local payment mechanisms must be agreed (table 4).
Implementation requirements for AF screening
Discussion
This study explored the views of 24 expert HCP and regulators across Europe about the opportunities and challenges of AF screening implementation and on four specific AF screening scenarios using thematic analysis. Three major themes developed that are related to opportunities and challenges for AF screening: (1) current approaches to screening, (2) the feasibility of AF screening approaches and (3) implementation requirements. Our study participants reported that AF is mainly diagnosed via symptomatic patient presentation in primary care across all the European countries involved. Structured approaches for AF screening on a national or regional level (besides research projects) do not exist. There is a perceived need to implement AF screening; however, the participants considered a lack of evidence for effectiveness as the main barrier to implementing AF screening across the European healthcare systems. This is despite clear recommendations with class I/IIa evidence in the latest AF management guidelines.1
Previous AF screening studies have largely used non-randomised, cross-sectional study designs that render it difficult to compare AF detection with usual care in the same population.18 Recent studies, some of them ongoing, applied more intensive screening approaches.19–23 Assessment of Remote Heart Rhythm Sampling Using the AliveCor Heart Monitor to Screen for Atrial Fibrillation: The REHEARSE-AF study randomised ambulatory patients ≥65 years of age with stroke risk factors to twice-weekly single-lead iECG for 1 year and demonstrated the acceptance of this screening method and a possible benefit for stroke risk.19 The partly randomised mHealth Screening to Prevent Strokes (mSToPS) study suggested that active monitoring with a rhythm patch in high-risk individuals with AF without symptoms may reduce adverse outcomes over 3 years follow-up.24 Outcome data of the currently published systematic screening trials Systematic ECG Screening for Atrial Fibrillation Among 75 Year Old Subjects in the Region of Stockholm and Halland, Sweden (STROKESTOP)20 and Danish Atrial Fibrillation Detected by Continuous ECG Monitoring (LOOP) show controversial results.25 Ongoing studies examine stroke rates, major bleeding, and mortality with different AF screening approaches. These data will help to establish evidence of the relative risks and benefits of AF screening and concomitant anticoagulation.20 22 25 Thus, healthcare providers and decision-makers like those in the current study who cited the need for more evidence, will soon have much more data at hand to assess the effectiveness of AF screening.
Opportunistic single time point screening (online supplemental file 1: scenario 1) is one of the guideline-recommended ways of AF screening1 and in our study was considered as the most feasible approach. Primary care was suggested as the most efficient setting for implementation. The most frequently mentioned advantage for scenario 1 was ease of implementation and lower costs for the healthcare system compared with the other screening approaches. This was partly due to the use of single-lead ECG devices as outlined in scenario 1, which have been previously identified as presenting a good alternative to 12-lead ECGs for initial screening in a primary care setting.26 A recent study showed controversial results regarding the effectiveness of single time point measurement.27 28 This is possibly because effectiveness may be determined by what happens in the comparator of usual care. The usual care arm was particularly effective in the Netherlands general practice setting inside the large Detecting and Diagnosing Atrial Fibrillation (D2AF) study28 and similarly in the VITALS AF study in the USA.22 Where usual care is already good at detecting AF, an increase in opportunistic screening would be neither effective nor cost-effective. The situation of such high prevalence and incidental detection is unlikely to be widespread in Europe, therefore more randomised clinical trials to examine this approach are needed.
Besides primary care, other locations such as pharmacies, dentists or podiatrists were suggested by the participants to have the potential for AF screening. A current pharmacy-based AF screening study including 7100 patients showed a relatively high detection rate of 3.6% for unknown AF when using a single time point measurement with a hand-held ECG.29 Another study determined that screening with iECG in pharmacies with an automated algorithm were feasible and cost-effective.30 A recent study with a follow-up of 17 years report a significant association of periodontal disease and AF that possibly explain the cardioembolic stroke risk with periodontal disease.31 However, dentist and podiatrists are not a focus for AF screening by current research and could be considered for further investigations of appropriate screening settings. Other possibilities not covered include patient self-screening in GP waiting rooms.32
The interview participants stated that the most effective approach to detect new AF cases would possibly be prolonged screening (online supplemental file 1: scenario 2 or 3). Continuous 2-week patches as in (mSToPS study),24 or intermittent ECG snapshot screening over a few weeks as used in the STROKESTOP20 and Screening for Atrial Fibrillation with ECG to Reduce stroke (SAFER) studies could be applied in primary care. However, these approaches were considered too expensive to implement with existing resources in healthcare settings across European regions. This indicates a need to include cheaper reusable devices. For example, new affordable devices such as an electrocardiographic (ECG) patch that was used in a recent randomised clinical trial that screened high-risk individuals aged ≥75 years for 2 weeks continuously showed a relatively high detection rate of 5.3% compared with standard of care (0.5%) with an accuracy of 87% for AF diagnosis. The device was also well tolerated by the patients.33
Our results suggest that patient-led screening already exists in all participating countries. This type of approach has the potential to increase AF detection rate if screening is driven by the use of wearables for prolonged self-measurement in the general population, as demonstrated by the Apple Heart and Huawei studies.34–37 However, interviewees suggested that this approach also presented challenges for data management and follow-up of false positive cases in younger age individuals who do not fall into the targeted group for AF screening. In the Apple Heart Study, which included >400 000 participants, 52% were <40 years of age. Among those individuals, only 341 (0.16%) were notified of an irregular finding, and of these, only 9 (0.004%) had AF. Therefore, 97% of participants <40 years of age received false positive alerts that could possibly lead to adverse effects such as anxiety, medical counselling and potential further workup. Patient-led screening was also considered to create potential pressure for individuals with a lower socioeconomic status to invest and buy such wearables. The experts were concerned that this approach could contribute to increasing a general health inequality problem. This is consistent with other research where older age, low health literacy and low socioeconomic status are factors associated with lower uptake of digital health solutions.38 39 Higher educated individuals use this kind of technology more often or are more likely to benefit from the usage of such technologies,39 and the spread of digital devices could possibly result in even more inequalities in health.40 41 A general concern of using wearables for AF screening was also highlighted by a survey conducted among HCP, in which ~70% felt we were not yet ready for this approach.42 Thus, current approaches have to focus on and develop mitigation strategies to overcome health inequalities due to the use of wearables to detect AF.
General population-based promotion programmes seem to exist more commonly in Nordic and northern/central European countries with a focus on lifestyle modifications and cardiovascular disease. Unequal health promotion programmes guided though different national healthcare policies in the European countries to address cardiovascular disease have been reported in other studies.43 Large social disparities and inadequate government health expenditure are major barriers to clinical prevention of cardiovascular disease in Eastern Europe.44
Our study highlighted that the development of standardised implementation structures for AF screening across Europe is rather unlikely due to different payment mechanisms and regional or national healthcare regulations within each country. Action plans such as the World Heart Federation’s Roadmap for Nonvalvular Atrial Fibrillation45 or publicly funded screening implementation research such as the EU-funded AFFECT-EU consortium (affect-eu.eu) have the potential to engage decision-makers and could serve as a model for countries to develop AF policies and update their national disease action plans.46
The interviewees suggested that costs for telehealth provision were not covered by current reimbursement systems and could create potential conflicts between primary care and the new service providers of the second or third healthcare market. However, telehealth presents a possible solution in particular for low-income and middle-income areas with a large territory and an acute deficit of HCP to increase the integration of low-cost medical services.47 In addition, the impact of the COVID-19 public health emergency has created an unprecedented opportunity for regulatory changes with regard to telehealth provision.48 These changes could help to address the current telehealth provision for targeted screening solutions in Europe.49 Some experts suspected that if AF screening is implemented, primary care physicians would need to be prepared to take the responsibility for diagnosis and treatment. Nevertheless, studies showed a lack of accurate detection of AF on an ECG by primary care professionals. Therefore, training and education would need to be provided, possibly supported by telehealth applications.50
Methodological considerations
AF is an established risk marker for clinical outcomes such stroke and heart failure. It is increasingly recognised that AF frequently is undetected until complications occur, which has given rise to an interest in detecting AF earlier in a preventive healthcare setting. Recent studies vindicate the recommendation for opportunistic screening as set out in the ESC guidelines.51 52 However, the evidence to support more systematic wide-spread screening remains extremely limited and larger randomised trials of the different approaches versus no screening and individual-patient data meta-analysis of these studies53 to prevent stroke or other adverse outcomes are needed. However, general technical advances such as digital wearables are driving forces for screening and are increasingly applied whether recommended or not. In this qualitative feasibility study, we investigated positions towards the most promising screening approaches that are currently of interest, and in some settings recommended by a variety of professional societies and organisations. Our study addresses the question of whether AF screening can work in practice and how. As, such, it focused on process considerations rather than outcomes evidence.
HCP experts outside the consortium were invited to avoid selection bias. However, as experts with strong opinions on screening may have been more likely to agree to participate, some selection bias is possible. In addition, we invited regulators of each respective country specifically because they have experience evaluating screening implementation for other conditions in their regional context, and we assume that these stakeholders have an objective perspective to AF screening approaches. Diverse aspects and approaches were reported, suggesting that severe selection bias is unlikely. In the majority of cases, the interviews were conducted in participants’ native language and translated into English, therefore translation bias is possible. Nevertheless, the interviewees were able to express their thoughts very clearly within this study design. The sampling strategy aimed to maximise experience of AF screening and regulatory knowledge of implementing national screening programmes rather than be representative of HCP and health regulators across Europe.
Qualitative analysis is inherently subjective as it is influenced by the assumptions, beliefs and biases of the researcher.54 In this study, the majority of researchers had a special interest in AF screening, with the exception of the main data analyst (CLH), which may have reduced biases due to preconceived ideas about results. Potential biases were explored during data workshops and group discussions with all authors. The study identified a range of themes and possible opportunities for screening implementation, but large-scale work is warranted to see whether the identified feasible approaches of the suggested screenings are robust, and whether they explain the patterns of opportunities and obstacles for screening implementation across Europe.
A major strength of this study includes a heterogeneous sample of both HCP and healthcare regulators with a wide range of backgrounds.
Conclusion
Qualitative data based on stakeholder knowledge across Europe indicate that there is an overall awareness of AF as a relevant disease, and an acknowledgement of the need for screening. In contrast to other healthcare promotion efforts, AF screening programmes have not been implemented in any of the countries or regions. Opportunistic screening is deemed to be the scenario most likely be realised in the near future, probably at GP offices, but other settings can be considered. Obstacles, in particular the lack of evidence for effectiveness of screening from randomised trials, appear to be surmountable. Information from our interviews can inform the design and implementation of AF screening programmes. Thus, the obvious gap between guideline recommendations and AF screening reality may be closed.
Data availability statement
Data are available on reasonable request. The data underlying this article were provided by the AFFECT-EU Consortium by permission. Data will be shared on request to the corresponding author with permission of the AFFECT-EU Consortium is also expected but not yet confirmed.
Ethics statements
Patient consent for publication
Ethics approval
Hamburg Medical Association Ethics Committee reviewed this study and deemed it service evaluation. The investigation conforms to the principles outlined in the Declaration of Helsinki.
Acknowledgments
We thank the participants and dedicated study staff of the AFFECT-EU studies for their generous contribution of time and efforts.
References
Supplementary materials
Supplementary Data
This web only file has been produced by the BMJ Publishing Group from an electronic file supplied by the author(s) and has not been edited for content.
Footnotes
Twitter @HansonCoral, @lisneubeck
Collaborators AFFECT-EU investigators (all collaborators are named in the title).
Contributors CLH and DE have originally designed the study both are guarantors of the research project. LD, GB, EP, TSP, DE and CLH have acquired the data. CLH, DE, LN and RS have analysed the data. CLH, DE, LN, RS, HH and LD have interpreted the data. CLH and DE have drafted the article and BF, HW and the other authors have critically revised it. All authors undertake to give final approval of the version to be published and agree to be accountable for all aspects of the work.
Funding RS has received funding from the European Research Council under the European Union’s Horizon 2020 research and innovation program (grant agreement no. 648131); the German Center for Cardiovascular Research (DZHK) (81Z1710103); the European Union’s Horizon 2020 research and innovation programme (grant agreement no. 847770, AFFECT-EU) and ERACoSysMed3 (031L0239).
Competing interests RS has received speaker and advisory board honoraria by BMS/Pfizer outside this work. BF reports research grants to institution for investigator initiated studies from BMS/Pfizer alliance, and speaker fees and non-financial support from BMS/Pfizer, Daiichi Sankyo and OMRON. GB reported speaker’s fees of small amount from Bayer, Boehringer, Boston, Biotronik and Medtronic. HH did receive personal fees from Biotronik and BMS/Pfizer. He received unconditional research grants through the University of Antwerp and/or the University of Hasselt from Bayer, Boehringer-Ingelheim, Bracco Imaging Europe, Abbott, Medtronic, Biotronik, Daiichi Sankyo, BMS/Pfizer and Boston Scientific, all outside the scope of this work. SZD is a part-time employee of Vital Beats without relation to the current work. TSP: consultancy (no fee) and small speaker fee from Bayer and BMS/Pfizer outside this work.
Patient and public involvement Patients and/or the public were not involved in the design, or conduct, or reporting, or dissemination plans of this research.
Provenance and peer review Not commissioned; externally peer reviewed.
Supplemental material This content has been supplied by the author(s). It has not been vetted by BMJ Publishing Group Limited (BMJ) and may not have been peer-reviewed. Any opinions or recommendations discussed are solely those of the author(s) and are not endorsed by BMJ. BMJ disclaims all liability and responsibility arising from any reliance placed on the content. Where the content includes any translated material, BMJ does not warrant the accuracy and reliability of the translations (including but not limited to local regulations, clinical guidelines, terminology, drug names and drug dosages), and is not responsible for any error and/or omissions arising from translation and adaptation or otherwise.