Recruiting patients with persistent physical symptoms and no specific diagnosis for clinical trials in primary care: ... 2025 Rosendal et al

[Andy]

Full title: Recruiting patients with persistent physical symptoms and no specific diagnosis for clinical trials in primary care: a qualitative study of four scenarios

Abstract​

Aim:
To investigate how to recruit patients rigosrously [sic] in general practice for trials based on symptoms as predefined inclusion criteria rather than a well-defined diagnosis. We used persistent physical symptoms (PPS) as a target condition.

Background:
Conducting randomized controlled trials (RCTs) in general practice is crucial for evidence-based decision-making and treatment in frontline healthcare. However, recruitment is often challenged in general practice because many patients have vaguely defined conditions, such as PPS.

Methods:
We used qualitative semi-structured interviews to explore the perspectives of general practitioners (GPs) on different recruitment scenarios, while paying particular attention to the logistics and feasibility in routine care. A total of 11 GPs from seven clinics were strategically recruited. The GPs were presented with one recruitment scenario (pre-consultation screening) and encouraged to suggest other scenarios. We conducted a thematic framework analysis of the interview material.

Findings:
To ensure valid intervention research, one predefined scenario was discussed, and three additional scenarios were co-created during the interviews: (1) opportunistic screening, (2) pre-consultation screening, (3) audit (retrospective and prospective), and (4) random sample screening of the practice population. These scenarios differ with respect to logistical complexity, comparability to daily clinical practice, and entailed selection bias. Every scenario requires individual adaptation and implementation support to be feasible in routine care in general practice. The present study provides approaches for rigorous primary care research based on RCTs for frequent and vaguely defined conditions, but it also highlights a need to develop research methods better suited to frontline healthcare interventions.

Open access

 

[Utsikt]

I truly don’t understand the purpose of this. Why would they even ask about recruitment scenarios with a substantial risk of bias?

About their perception of the patients?

Some GPs found that a large number of patients present symptoms with no biomedical explanation, whereas others would confine PPS to severely affected individuals only, i.e. functional disorders. One GP described these patients with terms like ‘hiking trophies’, ‘regular guests’, ‘problem patients’, and ‘heart-sink patients’. She did not know of any patients with PPS who were still relatively well-functioning. Another GP knew of well-functioning patients with PPS, but these patients were likely to go unrecognized:

I think that this is a new observation for general practice (…). Those staying under the radar are the almost well-functioning [patients], who just keep on returning again and again and are somewhat health anxious and feel themselves a little too much. (GP G)

They have to have become completely desensitised to their own views to be able to say stuff like this out loud.

Several GPs mentioned that it took some time before being assured that PPS in a patient were not signs of an underlying disease. One GP said that she would often have done multiple consultations before suspecting PPS. Others explained that − before voicing any hypotheses about PPS to the patients − they had to be quite sure that the patient did not have a physical disease:

Often you need to just sweep in front of the somatic door before excluding a psychiatric or functional diagnosis. You must be quite sure that you haven’t missed anything because they show up with something that might raise a slightly red flag. But then along the way, I think you can begin to explain that it’s your nervous system that is overloaded, it is your body that makes noise, but you have been carefully examined. (GP G)

In line with this, the GPs said that they would usually conduct a medical assessment of the patient (possibly involving specialized care) before recommending an intervention addressing PPS. They chose this approach for two reasons. First, the GP had to be sure that a physical disease was not present. Second, the GP wanted to maintain a good relationship with the patient. Some GPs explained that conducting physical examinations could also serve to make the patient feel taken seriously.

About pre-consultation screening:

One GP was so critical of the screening approach that she would refuse to follow this scenario. She argued that screening patients might create new health concerns and thereby disturb the consultation:

Some of my patients…they don’t need to be reminded of all the conditions that you could possibly suffer from. They need to focus on what they actually experience in their body and in their life and then talk to the GP about it, and if they are presented with this [BDS checklist], then their mind will go somewhere else, and we don’t get the conversation we need. I believe it would harm the consultation process. (GP D)

Using population screening:

The GPs suggesting this scenario said that it might be too much work for some GPs to go through the patient lists. They also acknowledged that there might be a risk to include patients who had not thought of contacting their GP due to the symptoms. GPs G and H were not supportive of the scenario; they believed it would create a lot of extra work by stirring a need for consultations, which did not exist before the questionnaires were sent out:

This would induce some sort of need that might not have been there already […], and this would cause a lot of extra activities in the clinic. (GP H)

In line with GPs G and H, GP K found this scenario to be extremely remote from routine clinical practice because it holds a risk of including patients solely on the basis of their symptoms, although they may have no intention of seeking healthcare.

In another clinic, GPs I and J supported this point made by GPs G and H. However, GP J added that many of the patients to be offered a consultation would be patients attending relatively often anyway:

I just think that very many of the patients that you wish to find come here relatively often anyway. So, if they obtained a different understanding of how to handle their symptoms, then perhaps they wouldn’t need to come here so often. (GP J)

Thus, GP J believed that if the patients agreed to accept the intervention, they might learn to manage their symptoms better, and their need for GP consultations might thus decrease accordingly.

It looks to me like these GPs don’t really want anything to do with these patients, and would welcome anything that makes it less likely that they seek help.

The author’s discussions demonstrate that these are people that really don’t care about doing science properly, they’d rather do it in a way that’s convenient for them. I guess we already knew that, but it’s nice to have it spelled out by them:

Implications​

This study shows that researchers need to strike a difficult balance between scientific standards for recruitment (consecutive, uniform, and unbiased recruitment), practical feasibility in the clinic, and possible burdens placed on GPs and patients when selecting a recruitment procedure for trials aimed at vaguely defined conditions, such as PPS.

 

[rvallee]

I have no idea what or who this is for or what it aims to accomplish. All it shows is that health problems that medicine doesn't understand are mishandled disastrously, the profession has made zero progress and is not about to, not with this nonsense. Reeks of even worse than amateurism, at least with amateurs things wouldn't fail this hard. We would be better served by homeopaths, and we wouldn't be served at all. This is how awful this ideology is, it's so much worse than nothing. Their perception of patients is truly awful.

The insistence, many times throughout the paper, to assert that there is no disease, not that the disease is unknown but that there isn't one at all, is about the only useful thing, as it reveals the standard bullshit but of course this happens quite a lot and it never makes any difference.

None of this is honest, and so it can't ever work out. They're not honest with us, with themselves and with the facts. It's impossible to imagine things ever improving on this front without medicine being completely transformed by AI. This is human failure at its most fundamental level.

 

[Liie]

Aha:

Affiliation:
Research Clinic for Functional Disorders, Aarhus University Hospital

The authors are all from the same institution as our old friend Per Fink.