Background
Methods
Researchers’ characteristics
Participants
Data collection tool and process
Data analysis
Ethics
Results
Characteristics of participants interviewed | Number |
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Number of interviews | 12 |
Gender (female/male) | 11/1 |
Participants with a medical background | 6 |
Participants with a nursing background | 5 |
The participant with formal training in research methods | 10 |
The median number of PVGs each participant had participated up to the interview day | 1.25 (range 1–4) |
Interview duration | 30-60 min |
Roles in PVG development* | |
Lead person Methodologist External review expert | 8 11 1 |
Themes
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1. Understanding of PVGs
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1.1 PVGs is a new type of health education material, that is developed with a rigorous method and should be based on patients’ needs
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1.2 Differences and connections between PVGs, general health education materials, clinical practice guidelines, and decision aids
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→ 1.2.1 PVG and CPG: PVG should be developed based on the needs of patients, while CPG should be developed based on the needs of clinical medical staff |
→ 1.2.2 PVG and general health education material: PVG is designed with a more rigorous method and provides recommendations |
→ 1.2.3 PVG and PDA: PDA helps patients make decisions, PVG not |
2. Current practice
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2.1 Three models of PVG development
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→ 2.1.1 Model 1, PVG development based on one CPG (with translation) |
→ 2.1.2 Model 2, PVG development based on multiple CPGs (with adaptation) |
→ 2.1.3 Model 3, de novo development of PVGs |
2.2 Methodologies followed
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→ 2.2.1 GIN Public guidance |
→ 2.2.2 MC-PCGs |
→ 2.2.3 Evidence synthesis methodology to deal with a recommendation from different CPGs |
→ 2.2.4 Guideline adaptations guidance to deal with recommendations from a different context |
→ 2.2.5 WHO handbook to guide the de novo development |
3. Challenges for developing PVGs
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3.1 The lack of standardized and native methodology to develop PVGs
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→ 3.1.1 Team (Contributors and their role in PVG development) |
• Lack of standards for team composition (what roles are needed, the number of people for each role, qualifications for each role) |
• Limited capabilities for PVG development |
→ 3.1.2 Identifying patient’s needs |
• Lack of standards for identifying what types of patient needs |
• The conflict between limited resources and identifying patient’s needs from different background |
→ 3.1.3 Evidence retrieval, evidence synthesis, and forming recommendations |
• Framing the right clinical questions is challenging |
• Lack of evidence |
• No framework to guide PVG development groups to make judgments on recommendations from different source CPGs |
• Lack of standards for making the decision between comprehensive search and target search for CPGs |
→ 3.1.4 Contents |
• The disparity in patients’ educational levels |
• The conflict between the function of PVG in aiding patients’ decision making and incomprehensibility of the draft which confuses patients’ understandings |
• No framework to guide the presentation of the recommendation |
• Incorrespondence between patients’ need and their reading preferences |
→ 3.1.5 Test and evaluation |
• Lack of a standard PVG evaluation tool, to define a good PVG |
3.2 Challenges in patient engagement
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→ 3.3.1 Lack of standard methodological guidance on how patients should be involved in the development of PVG → Patients lack knowledge of PVGs |
3.3 Other challenges
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→ 3.4.1 Lack of publicly known and trusted platform that could disseminate PVGs |
→ 3.4.2 Resources required for developing PVGs |
→ 3.4.3 Conflicting interests of all parties |
Understanding of PVGs
Patient versions of guidelines | |
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General health education materials |
Participant I: I think from the content level, in my opinion, the general educational material is just to inform, the content in it may be some background knowledge, but not necessarily operational, but the PVGs must be operational, because the content in the PVGs is translated from recommendations, which are operational, or it can’t be written as a recommendation, right? But I don’t think there’s a clear boundary between the two, because the PVG is just one health education material, right? I understand it’s also health education material, it can be a video, a leaflet, a book or something like that, for patients, they are just health education materials.
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Clinical practice guidelines | The patient version of the guideline are guidelines for patients which address patients’ questions. Clinical practice guidelines are primarily to address healthcare professionals’ questions raised in the clinical setting. Patients’ question is relevant to their lives and has a different focus from that of physicians. Therefore, PVGs developers should first identify the needs of patients. |
Patient decision aids | Compared with the patient version of the guideline, decision aids require patients to participate in decision-making, which is not feasible
Participant I:… I think it’s the reason why I didn’t want to develop decision aids at that time because I think it’s complicated. Secondly, I think the communication between doctors and patients in Guangdong province is not up to this level. That is to say, people still rely more on doctors to make decisions for them. If you show them, for example, we often tell them a lot of evidence like shared decision making, and then how much benefit is, how much harm is, and let them balance and so on. I think it’s very difficult to understand for 80 or 90 per cent of the patients. After telling that information to patients, he would actually ask me in return, “Doctor, what do you think is the best choice for me to do?“, “. So don’t think it’s feasible to let patients make the final choice anyway, so I never want to do it at all
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Current practice
Three models of PVG development
Participant A: I think the first scenario is that maybe this clinical practice guideline is almost completed, and then they did surveys and found that the patients also need some recommendations in this guideline, and I think this is the first model of PVG development which is based on a clinical practice guideline…And then, there is another situation where no single clinical practice guideline could address all patients’ questions. This is precisely what happened to us; there are no single clinical practice guidelines for stroke and physical dysfunction (but patients need them). And then, we need to do a synthesise of many guidelines. Those are the two models of PVG development.
Participant D: I think, for example, to translate the guideline I developed into the patient version. I feel that it doesn’t work; why not? Because the questions that patients raised are not necessarily included in the guideline. It’s not necessarily the questions that the clinical practice guidelines will address. For example, our clinical practice guidelines mentioned glycosylated haemoglobin-related questions and recommendations, but none of our patients asked these questions in the interviews.
Application of existing methods for PVG Development
Methodologies | Inapplicability |
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GIN Public guidance | 1. Problem: Only describes the methodology for PVG development based on one CPG Solution: adopted evidence synthesis methodology
Participant A: Because our PVG is not based on one guideline, but on multiple guidelines, it may not be quite in line with the GIN Public guidance and MC-PCGs, so we used evidence synthesis methodology.
2. Problem: There is no guidance on whether recommendations in clinical practice guidelines need to be adjusted when they are translated into patient versions
Participant A: GIN and MC-PCGs both mentioned how should we present the recommendations. But they didn’t mention if we should change the strength of the recommendations when they are presented in PVGs. For example, the strength of a recommendation in the clinical practice guidelines is relatively low because of the low certainty of the evidence, but it may be particularly practical for patients at home and patients may have a strong preference for it, and then if we could change the strength of this recommendation to be strong? For example, the recommendation of acupressure for stroke patients is weak in the evidence summary we included, but I found that patients are very positive about acupressure, and it is very convenient to use. So, I’m thinking when we present this recommendation in this PVG, should we redefine the recommendation level? Moreover, if the patient finds the recommendation weak, why it is weak? Is this because this intervention may cause bad effects on my health? So, I am afraid the presence of weak may make patients misunderstood.
Solution: No solution. 3. Problem: Only provided the general principles, lack of a clear process
Participant A: GIN is not particularly detailed, it lacks detailed process guidance, that is, it only provided the relevant principles or standards, but he did not tell you what steps we need to take for the PVG development
Solution: Follow the process provided in MC-PCGs, WHO handbook, guideline adaptation methodologies
Participant A: we followed the process included in the guideline adaptations guideline and MC-PCGs
Participant B: We are still referring to the 2015 GIN manual, then we also referred to the development process in the WHO handbook, that is, we took the steps mostly for the development of clinical practice guidelines.
4. Problem: Lack of clear criteria on how to define a good PVG
Participant A: In fact, GIN actually did not mention how we should translate recommendations in the clinical practice guideline into a version that patients can understand, and patients may prefer, it is not clear, that is, this is the lack of a standard, that is, how do you determine your phraseology, your expression is the best for readers.
Solution: Combined GIN Public guidance and general health information assessment tool
Participant A: Like us, we have adopted an American patient education material assessment tool as one of the criteria in the translation process. We combined the GIN and the American FAMT patient education materials and assessment tools to refine and translate the recommendations.
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MC-PCGs | Problem: MC-PCGs are inapplicable in our country to some extent
Participant A: The MC-PCGs are currently the only standard tool for PVG, but they may not be suitable for our national situation. For example, it mentioned in it that a draft of PVG should be given to the relevant patient’s representative association or a professional association. However, in our country, there is basically no such association, especially for patients, thus this development process criteria may not be suitable.
Solution: Adapted MC-PCGs in some items, such as in the process of “approval” 2. Problem: There is no guidance on whether recommendations in clinical practice guidelines need to be adjusted when they are translated into patient versions Same as GIN Public guidance 3. Problem: Lack of publicly available detailed guidance, not easy to understand and apply
Participant A: Like MC-PCGs, it mentioned that the team should have an independent chair and a process support member/secretary… Because they did not tell what his qualifications should be, what is the qualification for the chair? Thus, we divide our team into two groups directly, into two groups, that is, one is responsible for drafting, and the other group may be specialized in providing recommendations, which we think may be more suitable. Yes, more suitable for our current environment, right?
Solution: No solution. 4. Problem: Lack of clear criteria on how to define a good PVG Same as GIN Public guidance |
WHO handbook
| There are differences between clinical practice guidelines and patient versions of guidelines regarding the process and methodology of development, because of their differences in target population: 1. Problem: PVG focus on addressing questions raised by patients, not health professionals
Participant B: Because at present, one of the biggest differences between clinical practice guidelines and PVG is that their audiences are different, maybe the audience of practice guidelines is clinicians, and the audience of PVG is patients. Hence, their purpose is not the same, the starting point must be different, and fundamental questions that need to be addressed in PVG are not the same, which must be raised or cared for by patients.
Solution: WHO handbook was used as a compensatory methodology. They adapted some processes and methodology in the WHO handbook, such as the method of identifying clinical questions, and combined them with GIN Public guidance in guiding the presentation of PVG 2. Problem: The mostly used method of Delphi expert consultation to identify clinical questions in CPG is less applicable to PVG
Participant D: Delphi expert consultation method could be used to identify problems during CPG development, but we certainly cannot use this approach, why? I said the problems we are looking for are questions raised by patients, right? But if we take the Delphi approach, which means we need to invite experts to determine which questions we need to solve in the PVG, do you think it is appropriate? It seems inappropriate, you originally want to know which issues are the patients most concerned about, but now we did an interview with patients, and if we then ask experts to give the final decision, then why did we need to interview pregnant women at the beginning, I said it is very unsuitable to formulate questions by means of Delphi method
Solution: use the social function method to determine the final set of questions 3. Problem: The requirement for team composition in CPG development is different from PVG development Solution: formed a patient and public group, and involved policymakers, editors and illustrator
Participant B: One of the things that the Patient and Public Group are responsible for, in its roles is to identify clinical questions on the one hand, and on the other hand, to identify the preferences and values of patients and the public when we form our recommendations. We may need to include some government policymakers in the steering committee, patients with some medical backgrounds and other such things, so that it may be more reflective of the patient’s own voice, right?
4. Problem: the requirement for the presentation of PVG is different from CPG Solution: combined with GIN Public guidance in guiding the presentation of PVG
Participant B: Another is that after we form the recommendation, we need to do the user test to see if the patients can accept, and understand the recommendation…
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Challenges for developing PVGs
The lack of standardized and native methodology to develop PVGs
Participant G: Sometimes, if you are given the rules and requirements and straightforward advice, you do it with less effort. When you do it according to the standards and requirements, you will have more confidence in it (the PVG you produced).
Participant H: There is no standard, and then I am not sure if this is the right way or not, so I am just feeling my way.
“Due to our professional scope is limited, we also have limited ability (to develop PVGs), we actually believe if there are more excellent teams or individuals joining us here, more authoritative, and more experienced experts to join in, it will be better.”
Challenges in patient engagement
Participate A: Which development process would be better for patients and editors to be involved in PVG development? Should they be involved in the whole development process, but can this really make a difference? Because they (patients) may not have as much time as we do, so we can’t invite them every time.
Participate C: because we look for some patients in the hospital, of course, we need to find some patients, and parents who are more cooperative, because parents of low cooperation will not participate. Then, we did find some of the parents with a high degree of cooperation, however, they are less likely to say, less likely to raise different voices, they are less likely to tell us there are problems existing in our PVG.