BMC family practice integrated GP care for patients with persistent physical symptoms, 2020, Chalder et al

[Andy]

Full title: BMC family practice integrated GP care for patients with persistent physical symptoms: feasibility cluster randomised trial
[Worth noting that the intended study title was probably "Integrated GP care for patients with persistent physical symptoms: feasibility cluster randomised trial", i.e. the title minus the name of the journal, BMC family practice, it was printed in.]

Part of the PRINCE gobbledegook.

Background
Patients continue to suffer from medically unexplained symptoms otherwise referred to as persistent physical symptoms (PPS). General practitioners (GPs) play a key role in the management of PPS and require further training. Patients are often frustrated with the care they receive. This study aims to assess the acceptability of an ‘integrated GP care’ approach which consists of offering self-help materials to patients with PPS and offering their GPs training on how to utilise cognitive behavioural skills within their consultations, as well as assessing the feasibility of conducting a future trial in primary care to evaluate its benefit.

Methods
A feasibility cluster randomised controlled trial was conducted in primary care, South London, UK. GP practices (clusters) were randomly allocated to ‘integrated GP care plus treatment as usual’ or ‘treatment as usual’. Patients with PPS were recruited from participating GP practices before randomisation. Feasibility parameters, process variables and potential outcome measures were collected at pre-randomisation and at 12- and 24-weeks post-randomisation at cluster and individual participant level.

Results
Two thousand nine hundred seventy-eight patients were identified from 18 GP practices. Out of the 424 patients who responded with interest in the study, 164 fully met the eligibility criteria. One hundred sixty-one patients provided baseline data before cluster randomisation and therefore were able to participate in the study. Most feasibility parameters indicated that the intervention was acceptable and a future trial feasible. 50 GPs from 8 GP practices (randomised to intervention) attended the offer of training and provided positive feedback. Scores in GP knowledge and confidence increased post-training. Follow-up rate of patients at 24 weeks was 87%. However estimated effect sizes on potential clinical outcomes were small.

Conclusions
It was feasible to identify and recruit patients with PPS. Retention rates of participants up to 24 weeks were high. A wide range of health services were used. The intervention was relatively low cost and low risk. This complex intervention should be further developed to improve patients’/GPs’ utilisation of audio/visual and training resources before proceeding to a full trial evaluation.

Open access, https://bmcfampract.biomedcentral.com/articles/10.1186/s12875-020-01269-9

ETA: Added note about the title of the study.

 

[Hoopoe]

A quick look at whether there was outcome switching.

The planned primary outcome measures

1. Willingness of clinicians to participate in the study
   
2. Willingness of patients to use the provided material given in 'integrated GP care' (self-help material).
   
3. Willingness of practices and participants to be contacted about the study
   
4. Willingness of practices to be randomised
   
5. Willingness of GP practices to be consent and be randomized as assessed
   
6. Follow-up rates and response rates to questionnaires
   
7. Rate of eligible trial participants (Consort). The number of patients per practice that are initially screened for eligibility and the number per practice meeting the inclusion and exclusion criteria.
   
8. Availability of data required and the usefulness and limitations of GP databases assessed qualitatively
   
9. Willingness of participants to be consented and randomised

The published primary outcome measures

1. Willingness of GP practices to be contacted about PRINCE Primary
2. Willingness of GP practices to consent and be randomised
3. Availability of data needed and the usefulness and limitations of the general practice databases
4. Interest of patients to be contacted about the study
5. Rate of eligible participants
6. Willingness of patients to consent to participate in PRINCE Primary
7. Willingness of participants to complete baseline measures before randomisation
8. Interest of GPs to attend the GP training (intervention arm only)
9. Participants follow-up rates to questionnaires per group

Several of these outcomes appear to have been split or eliminated or reworded in a confusing way. If I was a reviewer I would demand clarification.

Some examples

Willingness of practices and participants to be contacted about the study

This appears to have been split into two outcomes "Willingness of GP practices to be contacted about PRINCE Primary" and "Interest of patients to be contacted about the study".

Follow-up rates and response rates to questionnaires

In the publication this is now referred to as "Participants follow-up rates to questionnaires per group" which no longer mentions response rates.

Willingness of patients to use the provided material given in 'integrated GP care' (self-help material)

This appears to have been dropped.

That said to be sure one would have to do a more careful analysis looking at the published data to make sure that there was a substantial deviation and not merely a confusing change in wording.

The secondary outcomes seem to have changed substantially as well. The registered trial lists 10, in the publication there are only 6.

 

[Trish]

What a waste of everyone's time and money. Thousands of patients contacted, very few completed the process and there were no benefits from it.

 

[Amw66]

What a waste of everyone's time and money. Thousands of patients contacted, very few completed the process and there were no benefits from it.

No benefits for patients
Doubtless benefits for others

 

[Hoopoe]

Looking at use of health services by trial arm there don't seem to be important difference between the groups. If anything the control group seems to receive less testing (wasn't the idea to reduce healthcare costs?) and has better work outcomes (but am not sure if this is statistically significant). The intervention also appears to make people more likely to see a mental health care professional.

 

[NelliePledge]

They keep churning out the tripe.

 

[NelliePledge]

Looking at use of health services by trial arm there don't seem to be important difference between the groups. If anything the control group seems to receive less testing (wasn't the idea to reduce healthcare costs?) and has better work outcomes (but am not sure if this is statistically significant). The intervention also appears to make people more likely to see a mental health care professional.

I think you’ve written the skeleton of a @dave30th blog.

 

[rvallee]

The fact that these people are still doing feasibility trials for things that have been used in practice, uselessly, for years is beyond absurd. It's a complete failure of oversight. They basically just keep doing the first few steps, then back again. Over and over and over again. It's a level of failure that simply should not exist and in fact does not exist in most professions.

This money needs to be reimbursed, taken off the future budgets of whoever made the absurd decision to spend money on yet another copy-paste piece of useless study. And all oversight decision-makers frankly need to account for why they keep allowing for identical copy-paste tripe of zero usefulness to be done over and over for years, identical, always the first few tentative steps, always on things that have long been used in practice, without oversight or accountability of course, thanks to these very people.

This is a jobs program. Nothing else. It serves no purpose other than providing easy jobs for people who can't actually do it.

 

[Hoopoe]

I think you’ve written the skeleton of a @dave30th blog.

I wish I did. I wanted to write more and find out if the primary outcomes were really switched or not but ran out of stamina and then lost motivation.

 

[NelliePledge]

I wish I did. I wanted to write more and find out if the primary outcomes were really switched or not but ran out of stamina and then lost motivation.

Hopefully @dave30th will agree and use what you’ve done. Then you can claim an assist as they call it in sport these days when you set up the other player to score a goal

 

[Arnie Pye]

This must be one of my brain fog days. I don't even understand the title.

 

[dave30th]

I think you’ve written the skeleton of a @dave30th blog

Ha! I was going to look at this over the weekend. someone sent it to me yesterday and I've been tied up. Sounds like another Chalder clunker. How many can one person have?

 

[Snowdrop]

As I see the problem of how this gets funding: too many privileged people with little (if any) real experience using a 'top-down' model for thinking about how to approach health issues.

 

[Hoopoe]

MUS is not one problem, it's a hundred or a thousand problems put into the same category for no other reason than being unexplained and difficult. It needs many solutions.

 

[NelliePledge]

Sounds like another Chalder clunker. How many can one person have?

100%

 

[Sean]

MUS is not one problem, it's a hundred or a thousand problems put into the same category for no other reason than being unexplained and difficult. It needs many solutions.

Removing the BPS clinicians/researchers from the equation would probably be enough of a solution on its own.

 

[James Morris-Lent]

They keep churning out the tripe.

Sounds like another Chalder clunker. How many can one person have?

It might genuinely be worth quantifying and creating some sort of visualization of just how many of these things they churn out.

If you have the real Tabasco there is no need to disgorge the same paper every six weeks about the same 'breakthrough' in treatment and the same 'need' for more research. Even just a list of all the spam that they've put out should shock anybody with two discerning brain cells.

 

[Trish]

It might genuinely be worth quantifying and creating some sort of visualization of just how many of these things they churn out.

And how much it's cost.

 

[Arnie Pye]

This must be one of my brain fog days. I don't even understand the title.

Okay, this is annoying me and I want to understand the hodgepodge of nouns and verbs in the following title to try and make sense of it.

Title of article : "BMC family practice integrated GP care for patients with persistent physical symptoms"

"BMC Family Practice" is the name of the journal this was published in. BMC appears to be the initials of "BioMedCentral" - another meaningless mess.

So, my translation has come up with the following :

1) The article referred to is published in a journal with a name containing some meaningless initials.

2) GP care for patients with persistent physical symptoms was integrated with something but I don't know what.

3) I think there should be a colon between practice and integrated in the title. But it is still meaningless. So my final attempt at understanding this is :

4) Change the title to "BMC Family Practice : GP Care For Persistent Physical Symptoms Has Been Integrated With Something But I Don't Know What"

 

[Snowdrop]

It might genuinely be worth quantifying and creating some sort of visualization of just how many of these things they churn out.

If you have the real Tabasco there is no need to disgorge the same paper every six weeks about the same 'breakthrough' in treatment and the same 'need' for more research. Even just a list of all the spam that they've put out should shock anybody with two discerning brain cells.

Agree completely though I would add that the people who fund this stuff need to also be held to account.

Absolutely nothing of any concrete value in terms of recovering from illness and going back to one's previous life come out of this (and the anecdotes that get sponsored as such need investigating). The hallmark of good medicine here is returning to full health (that's what the BPS model promised initially--not coping strategies). So why fund endless papers that fail to provide any real life benefits.