Clinicians’ Perspectives on Barriers and Facilitators for the Adoption of Non-Invasive Liver Tests for NAFLD: A Mixed-Method Study
Abstract
:1. Introduction
2. Materials and Methods
2.1. Study Design and Registration
2.2. Theoretical Framework
2.3. Sampling and Consent to Participate
2.4. Data Collection
2.4.1. Scoping Phase
Selected Tests
- PRO-C3: This procollagen-based marker is a relatively new serum biomarker with limited availability outside clinical trials. The procollagen type III N-terminal peptide (P3NP) is a by-product of the cleavage of procollagen III to produce collagen III [35].
2.4.2. Data Collection Phase
Qualitative Data Collection
Quantitative Data Collection
2.5. Data Analysis
2.5.1. Qualitative Data Analysis
2.5.2. Quantitative Data Analysis
3. Results
3.1. Identified Factors Affecting Tests’ Adoption
3.1.1. The Condition
“In our more complex diseases, where the decision and treatment depends a little bit on the assessment of [the] fibrosis, FibroScan alone will not be sufficient and have to be complemented with something else.”(Hepatologist)
3.1.2. The Technology
“So, there is this greyish area where the accuracy is not good enough. And the real low values give you a fair accuracy, there’s absence of significant fibrosis and certainly cirrhosis, and this higher limit where you’re sure that there is significant fibrosis and possibly even close to cirrhosis. And then there’s this greyish area where you’re not certain.”(Gastroenterologist)
“More important is how you interpret the results. And interpreting the result is a bit more complicated, and it requires knowledge of the tool and its pitfalls, particularly where you are likely to get false-positive results, and what to do when you suspect and therefore what to do as a result.”(Hepatologist)
“At this stage, I don’t know how FIB-4, PRO-C3, and ELF perform in relation to each other and in different patient groups. I can imagine that advanced stages of NASH in certain patients such as morbidly obese patients or patients with diabetes will be better identified with the ELF test than with a FIB-4 test. This is something that we should investigate. We have very good data from the UK and other countries. But for example, we have no data in the Netherlands, our population could be different than the UK population. So we need to do more research and to establish the sensitivity and specificity in our population.”(Internist)
3.1.3. The Value Proposition
“So they could be cost-effective, but I don’t think they will beat using only FIB-4. The problem with all these cost-effectiveness analyses is that they are heavily influenced by what you put into them. And it depends on who you talk to how you really should count these costs. So even though cost-effectiveness analysis are very, very important, they are sometimes skewed, depending on which researcher that does them. But compared to the more normal or ordinary tests, both ELF and PRO-C3 are quite expensive. So that’s a barrier.”(Hepatologist)
3.1.4. The Adopters
“[as a clinician] if you come up with evidence, and as a group, or maybe even two clinics, in our case, vascular medicine, and hepatology, if you say this is important, then we’re going to have to be there in order to follow this development, or maybe even be leading in the development in the Netherlands, in order to convince boards of directors and insurance companies to provide financial support.”(Endocrinologist)
“[as a clinician] if you just come up with evidence, and as a group… in our case, vascular medicine, and hepatology, if you say this is important, then we’re going to have to be there in order to follow this development, or maybe even be leading in the development….[as] you’d have to convince [the] boards of directors to provide this funding.”(Endocrinologist)
3.1.5. The Organization
“It was initiated by clinicians, who really wanted something to identify patients with these disorders, NAFLD and NASH, and we realized that the echography [Conventional ultrasound] was not sufficient, and that the usual algorithms are not sensitive enough. So we wanted a more precise measurement [such as] the FibroScan to take better care of our patients. So it was initiated by clinicians. And then we started talking to management. Together, we organized the money to buy the machine and it was very easily implemented in our center…”(Internist)
“That will be mainly at the level of the clinical lab where all the technical things needs to happen. So it should be integrated in the machinery of the lab and in the protocols of the lab. And there should be knowledge of the technical staff at the lab, if there is any specific manipulation needed, which is not done automatically by the machine. So it’s mainly a question of looking into the technical aspects of the lab and the training of staff at the clinical lab.”(Hepatologist)
“And what we have put out there in primary care is some very clear [guidance], there’s a big box that says ELF [score] below this; fine reassure [the patient], ELF at this level; fine refer [the patient onwards]. So it’s quite prescriptive in the sense, they don’t have to think too much about what the ELF components are and what it’s telling them. They’re just being guided by the result.”(Endocrinologist)
3.1.6. The Wider System
“So cost-effectiveness are performed by people who aren’t even in that specialty area. So it’s a group of people who just look at the data: statisticians. And then there might be one advisor on the group who is from that area. It’s hard for them to argue sometimes against all these numbers.”(Hepatologist)
3.1.7. The Future Outlook
“Ultrasound elastography is an elastography technique incorporated into regular ultrasound machines, which are available in all hospitals. I think this technique has the best chance to become the first line [test for] measuring fibrosis in NAFLD.”(Gastroenterologist)
4. Discussion
4.1. Strengths and Limitations
4.2. Implications for Practice and Research
5. Conclusions
Supplementary Materials
Author Contributions
Funding
Institutional Review Board Statement
Informed Consent Statement
Data Availability Statement
Acknowledgments
Conflicts of Interest
References
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Questionnaire Respondents (N = 27) | Interview Respondents (N = 16) | |
---|---|---|
Age (Years) | ||
Mean (Range) | 43 (30–68) | 46 (30–68) |
Country of practice | ||
Belgium | 6 | 3 |
UK | 6 | 4 |
France | 4 | 3 |
Germany | 3 | 0 |
Greece | 1 | 0 |
Italy | 2 | 1 |
Netherlands | 5 | 4 |
Sweden | 0 | 1 |
Specialty | ||
Endocrinology | 2 | 2 |
Gastroenterology | 5 | 2 |
Hepatology | 15 | 8 |
Internal medicine | 5 | 4 |
Years of experience (Years) | ||
Mean (Range) | 16 (3–36) | 19 (3–36) |
Domain | Barriers | Facilitators |
---|---|---|
1.The condition | Multisystem disease linked with other extra-hepatic chronic diseases | |
2.The technology | Difficult interpretation | Robust clinical evidence |
Long-time interval between measurement and access to the test’s result | Proved better performance in detecting the target condition compared to other available tests | |
Need for extra training | Quick measurement process and data generation process | |
Availability in different clinical settings | No need for specialist to perform the test | |
Usage for research purposes | Easy access to the test in the clinical setting | |
Lack of empirical evidence | Availability of the test for the research purposes in an academic clinical setting | |
Low performance as a single biomarker-based test | Knowledge needed for proper interpretation of the test results | |
Inter operator variability | Possibility of using test for other target conditions in clinical pathway | |
3.The value proposition | Non-existence of a therapeutic intervention | Comprehensible results for patients |
Higher costs compared to existing tests | Lower costs compared to existing tests | |
Doubting quality and appropriateness of the test for specific population or health setting | No need for extra sampling- possibility of measuring the biomarker using the samples collected for routine measurements | |
4.The adopters | Involvement of multiple adopters in the implementation process | Local champions-interested clinicians or lab professional |
Inconsistent Acceptance | Small workflow changes-simple ordering method for the clinicians | |
Acceptance of a new test and changing the routine clinical approach by clinicians | ||
No sufficient awareness about non-alcoholic fatty liver disease (NAFLD) and non-invasive tests | ||
5.The organization | Available funding | Sufficient intra-organizational financial support |
Support from management team | ||
Already implemented similar devices | ||
6.The wider system | Lack of reimbursement | Proper reimbursement system |
Health system local differences | Local and national disease specialist group and scientific consortiums | |
Absence of practical national guidelines | ||
7.The future outlook | Complicated, costly and time consuming process for future implementations |
ELF (N = 27) | FibroScan (N = 27) | PRO-C3 (N = 27) | |
---|---|---|---|
The Condition | |||
The complexity of NAFLD as a disease hinders the adoption of the test in clinical setting | |||
Agree | 7 | 6 | 8 |
Neutral | 9 | 4 | 10 |
Disagree | 11 | 17 | 9 |
If NAFLD cases weren’t as diverse as they are, adoption of the test in clinical setting would be easier | |||
Agree | 8 | 7 | 8 |
Neutral | 9 | 7 | 9 |
Disagree | 10 | 13 | 10 |
The Technology | |||
A lot of training and support is needed to use this test * | |||
Agree | 4 | 12 | 3 |
Neutral | 8 | 5 | 9 |
Disagree | 14 | 10 | 13 |
The data generated by this test are not always used for decision making in NAFLD clinical practice * | |||
Agree | 8 | 6 | 11 |
Neutral | 12 | 3 | 10 |
Disagree | 6 | 18 | 4 |
The data generated by this test are not always sufficient for decision making in NAFLD clinical practice * | |||
Agree | 15 | 15 | 13 |
Neutral | 7 | 3 | 8 |
Disagree | 4 | 9 | 4 |
The data generated by this test are always trusted * | |||
Agree | 3 | 6 | 3 |
Neutral | 7 | 5 | 7 |
Disagree | 16 | 16 | 15 |
Overall, this test is easy to use | |||
Agree | 13 | 21 | 9 |
Neutral | 8 | 4 | 9 |
Disagree | 6 | 2 | 9 |
ELF (N = 27) | FibroScan (N = 27) | PRO-C3 (N = 27) | |
---|---|---|---|
The Value Proposition | |||
This test is not a cost-effective option for the organization I work at * | |||
Agree | 5 | 4 | 6 |
Neutral | 13 | 2 | 16 |
Disagree | 9 | 21 | 4 |
From my perspective, this test is more advantageous regarding patient management over existing NAFLD clinical practice (i.e., liver biopsy) * | |||
Agree | 10 | 20 | 7 |
Neutral | 11 | 5 | 12 |
Disagree | 5 | 2 | 6 |
This test has an added value for me as a clinician * | |||
Agree | 13 | 26 | 9 |
Neutral | 11 | 1 | 14 |
Disagree | 3 | 0 | 3 |
This test has an added value for the patient * | |||
Agree | 12 | 25 | 10 |
Neutral | 13 | 1 | 14 |
Disagree | 2 | 1 | 2 |
The Adopters | |||
The use of this test changes the usual practice of my work as a clinician for NAFLD care in a positive way * | |||
Agree | 6 | 25 | 3 |
Neutral | 15 | 1 | 16 |
Disagree | 6 | 1 | 7 |
Patients are not always willing to cooperate with this test * | |||
Agree | 5 | 3 | 4 |
Neutral | 10 | 2 | 11 |
Disagree | 12 | 22 | 10 |
There is not enough understanding of the use of this test in the pathway of decision making for NAFLD care * | |||
Agree | 13 | 5 | 16 |
Neutral | 6 | 6 | 7 |
Disagree | 7 | 16 | 3 |
ELF (N = 27) | FibroScan (N = 27) | PRO-C3 (N = 27) | |
---|---|---|---|
The Organization | |||
There is not enough support and advocacy in the organization for the adoption of this test * | |||
Agree | 12 | 3 | 13 |
Neutral | 9 | 2 | 11 |
Disagree | 5 | 21 | 2 |
There are enough time and resources in the organization for the adoption of this test | |||
Agree | 12 | 18 | 8 |
Neutral | 4 | 0 | 9 |
Disagree | 11 | 9 | 10 |
here is not enough allocated budget in the organization for adoption of this test | |||
Agree | 18 | 10 | 14 |
Neutral | 8 | 5 | 12 |
Disagree | 1 | 12 | 1 |
There is a shared vision in the organization between management and clinicians regarding adoption of this test* | |||
Agree | 3 | 12 | 2 |
Neutral | 13 | 9 | 16 |
Disagree | 11 | 6 | 8 |
Extensive work is needed to properly adopt this test in clinical practice | |||
Agree | 14 | 9 | 17 |
Neutral | 8 | 3 | 7 |
Disagree | 5 | 15 | 3 |
The Wider System | |||
The qualification requirements and regulatory landscape for this test are well-defined in my country * | |||
Agree | 2 | 15 | 0 |
Neutral | 9 | 6 | 8 |
Disagree | 16 | 6 | 18 |
Currently, there are no rigorous clinical guidelines for use of this test in my country | |||
Agree | 16 | 7 | 20 |
Neutral | 3 | 1 | 3 |
Disagree | 8 | 19 | 4 |
There is enough reimbursement available for this test in my country * | |||
Agree | 7 | 6 | 6 |
Neutral | 9 | 6 | 10 |
Disagree | 11 | 15 | 10 |
The Future Outlook | |||
The test has the potential to be adopted at larger scale for NAFLD care in the future * | |||
Agree | 15 | 26 | 14 |
Neutral | 7 | 1 | 10 |
Disagree | 5 | 0 | 3 |
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Vali, Y.; Eijk, R.; Hicks, T.; Jones, W.S.; Suklan, J.; Holleboom, A.G.; Ratziu, V.; Langendam, M.W.; Anstee, Q.M.; Bossuyt, P.M.M., on behalf of the LITMUS Investigators. Clinicians’ Perspectives on Barriers and Facilitators for the Adoption of Non-Invasive Liver Tests for NAFLD: A Mixed-Method Study. J. Clin. Med. 2022, 11, 2707. https://doi.org/10.3390/jcm11102707
Vali Y, Eijk R, Hicks T, Jones WS, Suklan J, Holleboom AG, Ratziu V, Langendam MW, Anstee QM, Bossuyt PMM on behalf of the LITMUS Investigators. Clinicians’ Perspectives on Barriers and Facilitators for the Adoption of Non-Invasive Liver Tests for NAFLD: A Mixed-Method Study. Journal of Clinical Medicine. 2022; 11(10):2707. https://doi.org/10.3390/jcm11102707
Chicago/Turabian StyleVali, Yasaman, Roel Eijk, Timothy Hicks, William S. Jones, Jana Suklan, Adriaan G. Holleboom, Vlad Ratziu, Miranda W. Langendam, Quentin M. Anstee, and Patrick M. M. Bossuyt on behalf of the LITMUS Investigators. 2022. "Clinicians’ Perspectives on Barriers and Facilitators for the Adoption of Non-Invasive Liver Tests for NAFLD: A Mixed-Method Study" Journal of Clinical Medicine 11, no. 10: 2707. https://doi.org/10.3390/jcm11102707
APA StyleVali, Y., Eijk, R., Hicks, T., Jones, W. S., Suklan, J., Holleboom, A. G., Ratziu, V., Langendam, M. W., Anstee, Q. M., & Bossuyt, P. M. M., on behalf of the LITMUS Investigators. (2022). Clinicians’ Perspectives on Barriers and Facilitators for the Adoption of Non-Invasive Liver Tests for NAFLD: A Mixed-Method Study. Journal of Clinical Medicine, 11(10), 2707. https://doi.org/10.3390/jcm11102707