Background
Study setting: the MSF clinics for Syrian refugees in Abdeh and Dar Al Zahara (DAZ), Lebanon
Methods
Data collection
Construct | Meaning |
---|---|
Affective attitude | How an individual feels about the intervention |
Burden | The perceived amount of effort that is required to participate in the intervention |
Ethicality | The extent to which the intervention has good fit with an individual’s value system |
Intervention coherence | The extent to which the participant understands the intervention and how it works |
Opportunity costs | The extent to which benefits, profits, or values must be given up to engage in the intervention |
Perceived effectiveness | The extent to which the intervention is perceived to be likely to achieve its purpose |
Self-efficacy | The participant’s confidence that they can perform the behaviour(s) required to participate in the intervention |
Data analysis
Results
Participant group | Number (%, for patient group) |
---|---|
Patients | 32 (100%) |
Male | 22 (69%) |
Secondary education or above (vs Primary or none) | 9 (28%) |
Non-switcher or discontinued | 7 (21%) |
MSF Staff (Roles included: general practitioner, clinic manager, NCD nurse, NCD referent doctor, mission pharmacist, project pharmacist, medical co-ordinator) | 11 |
Construct | Theme | ||
---|---|---|---|
Patients | MSF staff | External stakeholders | |
ACCEPTABILITY | |||
Affective attitude | Makes life easier Among those who did not switch or discontinued: Fear of unfamiliar Lack of control | Treatment improvement | Perception of high risk Ok for the poor/uninsured |
Intervention coherence | Attribution of side effects | Clarity regarding pill and how it works | |
Burden | Easier than previous treatment | Early effort, long-term reward | |
Self-efficacy | High capability to execute | Empowered by information | |
Ethicality | Helps achieve patient goals | Fit with values/patient welfare | |
Opportunity costs | Sacrifices treatment flexibility | ||
Perceived effectiveness | Make patients feel better | High efficiency Improved efficiency | |
Other | Trust in (MSF) doctors | ||
SUSTAINABILITY | |||
Challenges | Dependence on MSF/lack of faith in external system Financial barriers | Inconsistent supply of drugs to clinic Lack of coherence Lack of transition plan | Background context (i.e. political, social, health system factors outside of MSF control) Changing established practice of clinicians Lack of commercial interest outside MSF |
Supporting factors | Time investment Contextualisation of intervention within local health system and political circumstances. Intervention as advocacy | MSF as catalyst/precedent for change Stakeholder engagement Integration into health system Price/economic crisis as opportunity |
Patients - acceptability
One prominent theme that explained FDC acceptability among patients that did not fit well with any constructs from the Theoretical Framework on Acceptability is a strong trust in doctors, and specifically MSF doctors, and what they prescribe. This trust seemed to be as important for acceptability as (or perhaps even linked to) how patients feel about the drug itself, and seemed to even override some patients’ attribution of any unpleasant side effects to the FDC. The following two examples from patient interviews demonstrate this trust:“100%. I’ll tell you why. Because, I’m feeling very well with it, I’m not complaining at all from any side effects or pain or anything like that at all. I’m very comfortable with it. If I weren’t comfortable, I would have stopped it. I would have come here and told them to remove it.” [Patient 10]
“I don’t know anything at all. I will take whatever you give me.” [Patient 5]
Among the small group of non-switchers, (i.e. those patients who declined to switch to Trinomia, [n = 11, 2.4%] in the overall study), there appeared to be fear or reluctance related to an unfamiliar drug. They felt secure about the medications they were currently on and didn’t want to introduce any risk of side effects from a new drug. In one example, this fear was related to a previous experience of hair loss that a patient had attributed to a blood pressure medication he had been prescribed. In response to being asked whether he was told Trinomia consisted of the same three drugs he was already on, he replied:“You know, you explained to us from the beginning … and if it weren’t good, you wouldn’t have explained it or even given it to us.” [Patient 19]
Patient: (yes), they told me … I didn’t test the medication, but they told me it has 3 types in 1 pill … But with this experience I didn’t dare. The blood pressure medication I know it, the diabetes medication I know it, the blood thinner I know it and the lipid [ … ]
Interviewer: so you trust the medication you are currently taking and you wouldn’t change them?
And among those who discontinued Trinomia (n = 34, [8.1%] in the overall study), there seemed to be a similar attribution of side effects to Trinomia and a preference for a drug regimen with which they were familiar and that they felt “worked better” for them.Patient: yes I don’t want to change them [Patient 15]
Patient: I started to worry about having to swallow this pill today. It became a burden (laughs) … because once I swallow it, it means 2-3 hours later I would get these disturbances in my body … I wouldn’t be normal … What do I want with this medication, I don’t want it anymore …
Interviewer: do you think that these symptoms are caused by something specific in the medication or it might be because of something else?
Patient: no, it might because it’s one mass
Interviewer: you mean one combined pill?
Patient: yes, this is my belief. Because originally … there wasn’t one pill I swallowed, except the blood thinner and another one, the regulator, I swallowed them together. Other than that, there were hours between one pill and another.
Interviewer: when the doctor here prescribed again the blood thinner, blood pressure and lipid medication separately, did these symptoms go away or did they persist?
Other non-switchers described FDCs as something that resulted in a lack of control. They raised concerns that FDCs did not allow them the flexibility to adjust their blood pressure medication in response to fluctuations in their blood pressure readings, which they were monitoring regularly themselves.Patient: not at all, I went back to normal, as if nothing’s wrong. [Patient 11]
“What I’m afraid about this combined medication, is that … one doesn’t know how the blood pressure is going to be like … If it’s low and you take the pills altogether like this... it will be difficult” [Patient 32]
Patients - sustainability
Also emerging as a challenge to sustainability of the intervention was the dependence on MSF for health care and for medicines, especially financially.“I’ll tell you something. If a doctor from outside, tells me there this combined medication, I would never take it, because honestly there is no trust at all. But in Doctors without Borders [MSF], I trust them, so I accepted the idea. That’s why as an experience, I accepted it. But be sure, that if it was from outside, even if it was a doctor, I would have refused.” [Patient 10]
“Now if you tell me MSF will stop providing me with the medication, I will stop taking the medication, I don’t have money at all to buy it, honestly. My wife and I are living in a (warehouse). There is only god. If MSF stops giving the medication, I will have to stop.” [Patient 4]
MSF staff - acceptability
What also emerged as crucial to acceptability was a theme related to self-efficacy, the sense of empowerment that staff felt due to the training and support provided to them about the FDC. This highlighted how important it was to hold early training sessions with staff that would allow them to ask questions and become comfortable with the new drug and with prescribing it.“Of course, after we started with Trinomia, things changed a bit … I had to focus on this medication, provide proper education to the patient … After that, even in the simplest things, like writing on the file, rather than writing simvastatin, and so on, you just put Trinomia … It saves our time, saves the patient’s time … . all these things helped honestly.” [Staff Member 6]
Hesitation regarding the acceptability of FDC treatment among staff appeared to be related not to the pill itself but to the ethicality of introducing a new treatment that could not be guaranteed once MSF closed its clinics (a theme that arises again when considering sustainability of FDCs). Staff expressed a feeling of discomfort with introducing a switch to patients’ treatment regime only to have to likely switch it back once discharged from MSF. As one staff member described:“Honestly the first training … we were like the patients, we didn’t know anything about it … we had a lot of questions: “What would the patient ask me?” … “How would I answer?” … “What if the patient refused?” … they told us everything about it and that it’s approved by the authorities and the Ministry of Health, so it was reassuring that I’m not giving the patient a medication where he’d go to the neighbours and they’d ask him “what are you taking?” or something … so in a way I’m protected, legally speaking. And when we knew everything about it, it was okay, we didn’t feel there was a problem anymore … we were convinced … we should be convinced as well to be able to convince the patient.”[Staff Member 5]
To alleviate their concerns around ethicality and to accept FDCs as in line with their values, staff seemed to make a conscious decision to view the FDC intervention as part of a larger effort to advocate for use of FDCs for Syrian refugees and Lebanese more generally. Several staff discussed framing the study and the introduction of FDCs as working together with patients to generate evidence that would support the use of FDCs as a standard treatment option, and thus lead to longer-term treatment improvement.“The only thing I’d say I didn’t like about this is, first, it’s still a newly introduced drug. So, the problem is when I want to introduce a drug to a patient, I want to make sure it’s sustainable. In case I will no longer be available to give it to him for free, the study stops … I don’t know how accessible this is for people with low income or no income like the refugees. So yeah mainly this is the compromise. Yes, it’s a nice combination and its very convenient but how accessible is it? Is this going to affect the patient? Can he get it later? Can he afford it later? These are the things that I think contradict what I believe in.” [Staff Member 8]
“ … there was a clear need to clarify our position, to explain the rationale of the decision (to introduce FDCs despite imminent MSF departure) … … Finally we got something in the middle … we explain to the people that we saw, that we keep seeing the added value to push for a fixed dose combination feasibility study in a context like Lebanon … we saw that maybe our patients will not be benefitting in the long term, or (it’s) not a very sustainable decision, but that (it) will contribute to general evidence to keep advocating for a change … You know, so basically, we frame in that sense, and after that, we … we shift a little bit this approach and we take … we create accountability … we start to treat the patient as a partner.” [Staff Member 9]
MSF staff - sustainability
“In general, I think it (FDC) is easy and effective but you need everyone to be committed to it … we’re not staying forever.. MSF is going to close … so is it something other doctors would follow? I feel there are many difficulties and challenges because every doctor works with a specific company that markets medication … It will also be very difficult for MoPH to impose it … so I feel there are a lot of difficulties for later on … For our work (at MSF), it’s easy, but maybe for later on, it’s difficult.” [Staff Member 5]
External stakeholders - acceptability
“I was telling you that we rather keep our … some kind of freedom to tailor the treatment because statins in cardiac patients are important and we have to reach a very low level of LDL cholesterol, which is not very easy to handle with a fixed dose, because we may start with 10 mg, 20, but we might end up with 40 mg and add another treatment on top of the statin. For this reason, we are a little bit … not at ease to use the fixed dose, the polypill [ … .] … I think this (public dispensaries) is the first place to use it … in these kinds of facilities … the second is the GPs, and the third is the specialists, maybe at the end because certainly the scope of its use there (in specialist facilities) will be very very poor.” [Stakeholder 4]
External stakeholders - sustainability
On the other hand, a key emergent theme that could support sustainability is that of MSF’s opportunity to act as a precedent for innovative treatment approaches, including FDCs. This seemed to be an opportunity that could only be exploited if MSF engaged stakeholders at an early stage and throughout the process, especially clinicians whose “hearts and minds” would have to be changed, and formally integrated interventions as much as possible into the existing health system’s circumstances. The below quotations demonstrate this theme.“MSF do a very good job, but it’s outside this logic … I mean, they have their clinics which are not very sustainable in the long run because they will not be integrated in the national system … Because you know, for example, the clinic of MSF, they create new clinics...and these clinics are not belonging to this country.” [Stakeholder 1]
“Then it’s good to organize a meeting with the Ministry of Public Health, invite donors, and stakeholders and then to do follow up. Not just to organize one meeting and it’s forgotten. Advocacy is something that is in the long run … say okay, we pilot, I don’t know in two clinics … this is the result, we invite you to pilot this. Then go to the donors and say okay why don’t you pilot this in another. And then organize a joint meeting with the Ministry of Public Health and a joint meeting with the UN and WHO, why not, to discuss technicalities. Because if you don’t push push push, nothing will move forward.”[Stakeholder 1]
Stakeholders also seemed to perceive the financial crisis in Lebanon as a “window of opportunity” in which to advocate for FDCs, given their potential for being cost-saving, but that advocacy would still be required to support their use.“It needs to be clear who will manufacture the product and how you will integrate it within the existing supply chain of the country, who should basically be on board when you get their buy in … the Ministry of Public Health, their technical department, the Primary Healthcare Department, definitely the Secretary General, also embedded within the guidelines of the Ministry of Health … then how … there’s any governance issue related for instance to the standard operating procedures and the clinical guidelines because there is a chronic disease guideline, for example for the diagnosis, treatment, what would be the dosage and so on, so there is this layer of how it will fit into that.”[Stakeholder 3]
“Particularly in these days with the financial crisis, I think that it’s not really hard to convince the cardiologist of the necessity to adopt such a drug. But of course they will argue, they like to argue.” [Stakeholder 6]