The effects of a structured communication tool in patients with medically unexplained physical symptoms: a cluster randomized trial 2023 Abrahamsen

It really is extraordinary stuff. They seem quite upfront about presenting a non-evidenced based story to explain the patient's condition. I don't know how that gets through an ethics committee.
It was even given an award:
The evaluation committee for the travel grant consisted of Anette Fosse, Anja Brænd and Trygve Skonnord. They write this in the justification for the award:

"Based on her own practice and her own perceived inadequacy towards a common patient group, the prize winner has developed a structured conversation tool that she is exploring the effect of in her PhD project. The results of the intervention are convincing, with effects on function, symptoms, quality of life and sick leave, and the study was published in a highly ranked international journal. The project has obvious general medical relevance, maintains high quality and originality, and the prize winner has a good ability to pedagogically communicate the tool and the research."
Does anyone in Norway know if this laminated manual with its 'deliberately created' story is still in use?
It’s very much in use. Abrahamsen is in the news what feels like every month and I think the latest number from earlier this year was that >40 % of GPs have been through her course, and some of the counties appear to be offering it to all their GPs.
The thing with hours worked is that on sickleave in Norway you can be on 50% sickleave but have 100% attendance, you just do less in the workplace. I’m not quite sure in what type of job this works but that’s the idea at least.
Yes, the sick leave refers to productivity, not hours spent in the workplace.
 
@Hutan : I'm not really sure what they did for the sick leave measure. It's pretty opaque.

"The GPs recorded sick leave from the participants’ medical records at baseline, after the final session of the study, and at the 11-week follow-up. At each time point, a participant could either be assigned a value for full time sick leave (yes or no) or a value for partial sick leave. The latter was quantified in percentage points. Both variables were unrelated to the number of hours worked per week. We then defined a joint variable, “sickness absence adjusted for partial sick leave” (SAAPSL), where the scale for full time sick leave was aligned with the percentage scale for partial sick leave (i.e., yes = 100%, no = 0%). Thus, each participant was assigned a value ranging from 0% to 100% for the joint variable. Therefore, "Full-time sick leave" and "Partial sick leave" mentioned in Table 2 are variables that are not further analyzed. Consequently, when we subsequently refer to "sick leave," it specifically pertains to the SAAPSL variable."

I'm not sure that hours actually worked is considered or compared at any point.


I haven't read the method and instructions of said 'course' but isn't this point exactly where the con is:

GPs are in charge of whether or not someone gets sick leave. If they so no I'm not giving you another sicknote then there is no sickleave? And yet this is 'the measure' they are trying to parade as success. That isn't the same as attendance at work or ability to do it once there.

Is this really an unbelieveably major con where the measure could actually even be 'a snapshot measure' of sick leave status at points bsaeline, 1, 2 comparing a group with no inside information (usual care) with those put on a plan that tells the GP to send people back to work at certain points. Is it really like a manual saying 'remove sicknotes at 10weeks' then uses a measure of 'were they on sickleave last week' taken at week 11, as the measure for controls vs subjects?

And those in control of those assessments, and coercive levers are 'believers in ideology' vs GPs who aren't? ANd what the participants fill in questionnaires that pass thru those GPs hands (GPs who control everything for that patient - NAV and employer info)

More to the point it could just be about one group following a set timing for 'sending back to work' that coordinates with when they want the measures done to tick the box for the study and could have had their patients on sick leave until week 10 vs the controls could have been forced to try and carry on for those 10 weeks so by week 11 collapse out. And by week 12 both are disabled. So 1. what a farce, but 2. what's it got to do with health rather than manipulation of workplace policy over a short period of time - with no measure checking whether anyone longer term ends up more or less disabled.

Indeed part 3 of 'the plan' is explicitly

When the topic of work participation and sick leave arises, GPs generate a "job list" using four targeted Socratic questions, for example: “What aspects of work would be helpful for you given your current situation?” The participant’s' responses are documented in their medical records as a “job list”. This "job list" can be shared with supervisors for workplace support instead of sick leave. If sick leave is needed, the list is included in the note to guide necessary workplace adjustments. This approach provides a comprehensive assessment of the patient's work abilities to the Norwegian Labor and Welfare Agency (NAV), focusing on capabilities rather than limitations.

There is an ambiguous para talking about GPs being free to schedule appointments (sorry it says participants, but in what land do patients actually have control of this - if people get one a week with the same GP then it is because the GP decided to 'put them in their schedule') and not a prescribed number of sessions, but there are 3 parts to the plan and homework for the patient after each and apparently a required 2 sessions to adress homework after the plan has been signed off. After the initial sessions apparently validating them, then telling them about allostatic load theory then running thru these 3 parts as 'the plan'.

I don't know when 'the final session of the study' is but given there is then 11week follow-up, is that after the end has been done with, or after baseline and therefore theoretically people might still have not completed the homework yet unless the GP is actually making sure they do it in 6 weeks etc?

A questionnaire was administered to all participants at baseline and at follow-up after the last consultation within a 14-day time frame. Each participant was registered by the GPs who used a registration form that included symptoms and relevant diagnoses, and the participant's sick leave status at baseline, the last session, and at the end of the 11-week study period.

So apparently if the 'measure' is some BS interpretation of 'baseline' taken out of context, because is there specification of what counts or doesn't count ie is it just the 11 weeks before? or the year - how do they justify such assessments as equivalent? Because we all know that taking a day off after you've already had 4 weeks this year is more serious than being the type who gets to take a day off with a slight cold 'because I must be wonderful as I never take one (because they are never unfortunate enough to be ill)'.

And the term they use is 'sick leave status' at the baseline, last session, 11 weeks could then just mean 'have you been sent back to work by your GP this week' not whether you are actually well enough, or any measure of leave for the last 3 months etc.


We know from people with or without ME/CFS of varying severity that we are generally a lot that are indeed vulnerable ie 'made vulnerable' by each and every individual in the system (time they take responsibility for their actions not someone on the receiving end of them be made responsible for their actions) and also keen to get their lives back/not 'demotivated'.

But also that if someone is coercing us, whether they kid themselves or not that is what they are playing a role in doing, by threats of financial ruin and inciting supporters around us or worse then we will prioritise absolutely everything just like (because we are) someone who has had to choose short-term survival over long-term survival because there is no long term either way anymore (you don't have it if you don't get thru the short-term by fawning to the threat, you won't ever get long-term because their actions will ruin you but you can't get thru the short term by worrying about that).
 
I haven't read the method and instructions of said 'course' but isn't this point exactly where the con is:

GPs are in charge of whether or not someone gets sick leave. If they so no I'm not giving you another sicknote then there is no sickleave? And yet this is 'the measure' they are trying to parade as success. That isn't the same as attendance at work or ability to do it once there.

Is this really an unbelieveably major con where the measure could actually even be 'a snapshot measure' of sick leave status at points bsaeline, 1, 2 comparing a group with no inside information (usual care) with those put on a plan that tells the GP to send people back to work at certain points. Is it really like a manual saying 'remove sicknotes at 10weeks' then uses a measure of 'were they on sickleave last week' taken at week 11, as the measure for controls vs subjects?

And those in control of those assessments, and coercive levers are 'believers in ideology' vs GPs who aren't? ANd what the participants fill in questionnaires that pass thru those GPs hands (GPs who control everything for that patient - NAV and employer info)

More to the point it could just be about one group following a set timing for 'sending back to work' that coordinates with when they want the measures done to tick the box for the study and could have had their patients on sick leave until week 10 vs the controls could have been forced to try and carry on for those 10 weeks so by week 11 collapse out. And by week 12 both are disabled. So 1. what a farce, but 2. what's it got to do with health rather than manipulation of workplace policy over a short period of time - with no measure checking whether anyone longer term ends up more or less disabled.

Indeed part 3 of 'the plan' is explicitly



There is an ambiguous para talking about GPs being free to schedule appointments (sorry it says participants, but in what land do patients actually have control of this - if people get one a week with the same GP then it is because the GP decided to 'put them in their schedule') and not a prescribed number of sessions, but there are 3 parts to the plan and homework for the patient after each and apparently a required 2 sessions to adress homework after the plan has been signed off. After the initial sessions apparently validating them, then telling them about allostatic load theory then running thru these 3 parts as 'the plan'.

I don't know when 'the final session of the study' is but given there is then 11week follow-up, is that after the end has been done with, or after baseline and therefore theoretically people might still have not completed the homework yet unless the GP is actually making sure they do it in 6 weeks etc?



So apparently if the 'measure' is some BS interpretation of 'baseline' taken out of context, because is there specification of what counts or doesn't count ie is it just the 11 weeks before? or the year - how do they justify such assessments as equivalent? Because we all know that taking a day off after you've already had 4 weeks this year is more serious than being the type who gets to take a day off with a slight cold 'because I must be wonderful as I never take one (because they are never unfortunate enough to be ill)'.

And the term they use is 'sick leave status' at the baseline, last session, 11 weeks could then just mean 'have you been sent back to work by your GP this week' not whether you are actually well enough, or any measure of leave for the last 3 months etc.


We know from people with or without ME/CFS of varying severity that we are generally a lot that are indeed vulnerable ie 'made vulnerable' by each and every individual in the system (time they take responsibility for their actions not someone on the receiving end of them be made responsible for their actions) and also keen to get their lives back/not 'demotivated'.

But also that if someone is coercing us, whether they kid themselves or not that is what they are playing a role in doing, by threats of financial ruin and inciting supporters around us or worse then we will prioritise absolutely everything just like (because we are) someone who has had to choose short-term survival over long-term survival because there is no long term either way anymore (you don't have it if you don't get thru the short-term by fawning to the threat, you won't ever get long-term because their actions will ruin you but you can't get thru the short term by worrying about that).

OK so

Secondary outcomes​


The GPs recorded sick leave from the participants’ medical records at baseline, after the final session of the study, and at the 11-week follow-up. At each time point, a participant could either be assigned a value for full time sick leave (yes or no) or a value for partial sick leave.

The latter was quantified in percentage points. Both variables were unrelated to the number of hours worked per week.

We then defined a joint variable, “sickness absence adjusted for partial sick leave” (SAAPSL), where the scale for full time sick leave was aligned with the percentage scale for partial sick leave (i.e., yes = 100%, no = 0%). Thus, each participant was assigned a value ranging from 0% to 100% for the joint variable. Therefore, "Full-time sick leave" and "Partial sick leave" mentioned in Table 2 are variables that are not further analyzed. Consequently, when we subsequently refer to "sick leave," it specifically pertains to the SAAPSL variable.

and there is another strange concern in the footnote of table 2
a Participants with full or partial long-term benefits due to a disability. A participant can receive long term benefits while being employed. Among the 324 employed participants, some received partial long-term benefits (>50% work disability), with a total of 275 participants (86.2%) reporting that they did. Of those, 129 participants (82%) were in the usual care group and 146 participants (91%) were in the intervention group.

I'm sorry but that means that before anything happened 17 more people assigned to the intervention received partial long-term benefits

Which could mean all sorts, but basically means if their GP is being instructed to send suggestions to NAV based on a bas***ised 'CBT' these people are extremely vulnerable and have a lot to lose so there is no way that this could be called a therapy vs just the coercion 'working', given to repeat the quote in the comment above, the final part of the 'plan' given to people is:

When the topic of work participation and sick leave arises, GPs generate a "job list" using four targeted Socratic questions, for example: “What aspects of work would be helpful for you given your current situation?” The participant’s' responses are documented in their medical records as a “job list”.

This "job list" can be shared with supervisors for workplace support instead of sick leave. If sick leave is needed, the list is included in the note to guide necessary workplace adjustments. This approach provides a comprehensive assessment of the patient's work abilities to the Norwegian Labor and Welfare Agency (NAV), focusing on capabilities rather than limitations.

ie the plan isn't healthcare , it is telling a group of GPs who will be 'measured' by a snapshot of whether their patient is on sickleave at certain points to take them off sick leave and report this 'initiative' to NAV (which I guess affects all financial support?) at almost the exact point people will be measured.

I'd personally also like to have the stats and info on ill-health retirement that could be unrelated to NAV/not impacted by that as it was split across control vs non-control , the age stats shows 46.9yrs (12.9) for control vs 45.3 (13.2) for non-control which isn't 'the same' either and could easily mean they slipped in a few more people who were near retirement anyway into the control.
 
OK so



and there is another strange concern in the footnote of table 2


I'm sorry but that means that before anything happened 17 more people assigned to the intervention received partial long-term benefits

Which could mean all sorts, but basically means if their GP is being instructed to send suggestions to NAV based on a bas***ised 'CBT' these people are extremely vulnerable and have a lot to lose so there is no way that this could be called a therapy vs just the coercion 'working', given to repeat the quote in the comment above, the final part of the 'plan' given to people is:





ie the plan isn't healthcare , it is telling a group of GPs who will be 'measured' by a snapshot of whether their patient is on sickleave at certain points to take them off sick leave and report this 'initiative' to NAV (which I guess affects all financial support?) at almost the exact point people will be measured.

I'd personally also like to have the stats and info on ill-health retirement that could be unrelated to NAV/not impacted by that as it was split across control vs non-control , the age stats shows 46.9yrs (12.9) for control vs 45.3 (13.2) for non-control which isn't 'the same' either and could easily mean they slipped in a few more people who were near retirement anyway into the control.

The chart of 'flow of participants through the study' is revealing too: https://www.thelancet.com/cms/10.10...fce-87eb-ac0d078a7f86/main.assets/gr1_lrg.jpg

for controls 231 participants completed baseline measures and 7 didn't = 238

for participants 278 did and 25 didn't = 303

And so the usual drop-out trend continues

for controls, (from 231) 223 completed measures (96%), 8 didn't, 1 withdrew

for participants (from 278) 236 completed measures (85%), 42 didn't, 1 withdrew

But actually if it was from the enrolled then it is for controls: 223/238 (94%) vs participants 236/303 (78%)
 
This was the primary measures:

Primary outcome​

The Patient Global Impression of Change (PGIC) was utilized as the primary outcome measure of the study, which evaluates changes in clinical status based on patient-reported experiences of changes in function, symptoms, and quality of life from baseline to follow-up, and involved posing one question: "Describe the changes in function, symptoms, and overall quality of life since you received treatment by your GP."

Except the treatment plan by this point has involved that last step regarding work, but before that the following 2 steps:
1. Collaboratively, the patient and GP prioritize the problems, distinguishing those that can be addressed immediately from those beyond the patient's control. Subsequently, the patient selects one problem to focus on, and with the help of the GP a suggested solution is registered as an activity plan in the patient's medical record.

I'm just guessing but given the GP is actually in control of what they (given CBT is combative) will agree is 'controllable' and therefore on the list of things 'to choose to focus on' could mean picking eg hayfever knowing that antihistamines will work vs you know fixing the OI/exhaustion preventing showering most days. But maybe it really is CBT heavy and suggesting someone 'sorts out that disorganised kitchen that's being begging to be tidied up'.

2. Addressing low energy and reduced self-confidence: The ICIT recommends the use of the "list of opportunity." Within this framework, GPs utilize a predetermined set of Socratic questions to explore how the patient's ailments impact their daily life. The aim is to collaboratively create an activity plan in the patient's medical record, focusing on feasible goals as perceived by the patient. For instance, one question may involve assisting the patient in planning and organizing periods of rest to regain sufficient energy, enabling them to participate in social activities they had previously withdrawn from due to their symptoms.

Isn't this basically 'teaching to the test'?

Particularly after you've done the literal magician's trick of diversoin of attention by directing people explicitly to focus on the one symptom/'challenge' that has apparently been addressed - when filling in this one question PGIC (of course don't forget what a disaster this time of year used to be like with your hayfever/how much time you spent trying to find things in that kitchen?)

vs not having the manipulative prompt if you are in the control group.

Plus of course telling people who have a condition where they get PEM to build in rest periods, and taking a measure after they've tried that is kind of asking for the answer to be at worst 'I need a bit more, but it is better than it was with no rest'.

So timing of taking this measure just after people have had a number of weeks of this, and before they've had to actually feel the impact of adding in workplace demands...

well it seems like tosh doesn't it?

If you put a 'oh life is so busy' person on this vs a person with a degenerative disease they'd both experience the same given the manipulative timings are intended to produce that.

SO the control is BS pretence isn't it? All it measures is how if you don't coerce to control what people can do at certain times then you don't get the snapshot answers to your liking.

It's a bit like measuring what a difference access to air conditioning makes to someone's life and putting one group on a 'programme' that means that measure is taken well before and mid/after the summer time then calling the 'control' a group when the measures are taken just x weeks apart but any time of the year?
 
SO on the secondary outcomes

Sick leave is a measure that is entirely controlled and coerced by what the GPs are ordered to 'do to' and the most vulnerable patients (on disability) being loaded into the intervention group in larger numbers.

Worse, the write-up and appendix document uses the following as justification of their use of this measure in the way the have:

Power calculation

The power calculation was conducted using a 7-point scale that ranged from "very much better" (1) to "very much worse" (7). Despite the absence of prior studies examining the use of PGIC to evaluate MUPS patients, a previous investigation on chronic pain patients and their PGIC scores at 12 months was employed 7.
Unless I have read this incorrectly (?) this means they've used one study as justification that might well be rubbish anyway, but at least did follow-up at 12months, as justification of using the same calculations on data taken at 11weeks?


I do not think the work efficacy survey can be seen as an uncoerced measure because they have not clarified that the GP who is writing a report to NAV isn't being given sight of the questionnaire, and the person who is being forced into the workplace by their sick leave being withdrawn is also finding that the same person has written to NAV and their employer regarding capability and adjustments. Both of which they must absolutely have to complete their questionnaire answers in correspondence with 'because they agreed'. Apparently. That has been dictated to them. BY someone with all the power for everything

Patient experience with intervention questionnaire

Specifically, they reported more effective use of time, productive conversations, and high levels of confidence in their GPs. The intervention group reported feeling well-cared for, receiving adequate help, and understanding from their GPs. They experienced less worry and more positive affect than the usual care group, feeling strengthened, cheerful, and relaxed.

Except again is this not polluted by the questionnaire not being guaranteed not to get back to the GP who will be writing to their employer and NAV?

Oh and ahem... the drop-out rate for the intervention group was actually 303-232 by the end (74%) compared to just 8/9 dropping out (96% completion) in the control. Isn't it downright weird that 71 people dropped out of this 'fantastic experience' and reporting back vs 8/9 who just had a normal one to report on ? And therefore isn't it totally false to count the claims above without noting all those who didn't feel comfortable to fill it in?

So really.. there is only one measure in the lot where it is even worth taking any look - the RAND quality of life measure , and I haven't looked at the issues there yet. But I'm not too happy about it only being reported in some coefficient, and then 'adjusted' measure of that in the table: https://www.thelancet.com/journals/eclinm/article/PIIS2589-5370(23)00439-X/fulltext#tbl3
 
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