Influence of Priming on Patient-Reported Outcome Measures: A Randomized Controlled Trial, 2016, Claessen et al.

Abstract
Background: Patient-reported outcome measures (PROMs) are influenced by psychosocial factors, but it is unknown whether we can influence PROM scores by modifying the mindset of the patient.

Purpose: We assessed whether priming affects scores on PROMs.

Methods: In all, 168 patients with musculoskeletal illness participated in this double-blinded, randomized, controlled, parallel study between July 2014 and October 2014 in a level I trauma center. Inclusion criteria were patients aged 18 years or older with English fluency and literacy and the ability to provide informed consent. Priming was performed by means of the Pain Catastrophizing Scale (PCS). The patients were randomized (1:1:1) into 3 groups: intervention group I was negatively primed with the original PCS; intervention group II was positively primed with a positively phrased PCS group; and control group III was not primed. Assessments were performed using PROMs on the domain of physical function, depression, and pain. Bivariate and multivariable regression analyses were conducted.

Results: The intervention and control groups were well balanced in demographic and condition-specific characteristics. The positive PCS was independently associated with higher PROM scores in the physical function domain (Patient-Reported Outcome Measurement Information System Upper Extremity Function: coefficient = 4.7, partial R(2) = 0.042; CI: 1.2-8.2; p < 0.010).

Conclusions: Patients primed with a positively phrased version of the PCS reported less functional disability as compared with patients who were either negatively primed or not primed at all. This suggests that by influencing the mindset, PROMs can be influenced, resulting in better outcome if positively primed.

Level of evidence: Level 1 therapeutic study.

Trial registration: NCT02209259.

Full text at: https://www.sciencedirect.com/science/article/abs/pii/S0033318215001541?via=ihub

 

This study is an example of how easily patients' reporting of symptoms can be influenced by investigators.

Priming is sort of the minimum influence you can do, much less than what usually happens in trials on behavioral interventions.

 

Does the paper show the normal and the positive PCS?

 

The normal PCS is a Likert scale with 13 items scored from 0 ("not at all") to 4 ("all the time").

The total score ranges from 0-52 with >= 30 representing a "clinically relevant level of catastrophizing": "A total PCS score of 30 corresponds to the 75th percentile of the distribution of PCS scores in clinic samples of chronic pain patients".

It is broken down into three subscales: rumination about pain ("I can't stop thinking about how much it hurts"), pain magnification ("I'm afraid that something serious might happen"), helplessness ("There is nothing I can do to reduce the intensity of my pain").

When I'm in pain...

1. I worry all the time about whether the pain will end.
   
2. I feel I can’t go on.
   
3. It’s terrible and I think it’s never going to get any better.
   
4. It’s awful and I feel that it overwhelms me.
   
5. I feel I can’t stand it anymore.
   
6. I become afraid that the pain will get worse.
   
7. I keep thinking of other painful events.
   
8. I anxiously want the pain to go away.
   
9. I can’t seem to keep it out of my mind.
   
10. I keep thinking about how much it hurts.
    
11. I keep thinking about how badly I want the pain to stop.
    
12. There’s nothing I can do to reduce the intensity of the pain.
    
13. I wonder whether something serious may happen.

The "posively-adjusted PCS" devised by the investigators of this study is as follows:

When I'm in pain...

1. I go about my business, without concern about whether the pain will end.
2. I feel I can carry on.
3. It's manageable and I think it will get better.
4. It's tolerable and I can push it to the background.
5. I feel I'll be OK.
6. I am confident that the pain will diminish.
7. I think about how things have worked out in the past and I move on.
8. I realize it may take some time for the pain to go away.
9. I have learned how to take my mind off of the pain.
10. I am able to stay focused on daily tasks regardless of pain.
11. I have a sense that I'll be OK with or without pain.
12. There are some things I can do to reduce the intensity of the pain.
13. I trust everything will be all right.

 

That positively adjusted PCS appears to have been written by someone who has led a charmed life, has never felt pain, and has never even stubbed their toe. If I saw a doctor or therapist who asked me those questions I would probably get up and leave because I would assume the person was making fun of me and disbelieving me for sadistic reasons of their own.

 

as i have mentioned before this whole fraud has always been nothing more than marketing .heavily weighted questionaire giving the answers that the creators want . not the way any kind of serious researchers or scientist would operate .

 

Pain (even when it's centralized--nothing 'wrong' with body, just the brain and lack of dampening ascending and descending pathways),

Pain's function is to get your attention.

Sometimes pain is not mild, is not susceptible to being ignored by distraction, denial, or positive thinking or distraction.

Sometimes pain is at the high end of moderate or severe and is not amenable to much intervention other than medication.

 

I haven't read the paper. Are the researchers seeking to expose this sort of priming as a concern?

 

I can't see the full paper, but I get the impression from the stuff in post #1 that the researchers believe they have achieved wonderful results with positive priming.

And no, I don't think they are even slightly concerned about what they are doing. They appear to think that influencing scoring with positive priming gives them the kind of "improvements" in subject's PROM scores that are absolutely wonderful.

The whole idea of manipulating patients like this and then declaring the results to be desirable (and presumably they think they are valid as well) is absurd.

Edit : In case people hadn't noticed I wanted to point out that this paper has been available online since the 1st October 2015, and has a 2016 copyright notice.

 

Another paper we can add to the pile of dodgy priming research, which according to this site is a trainwreck:

https://replicationindex.com/2017/0...wreck-how-priming-research-went-of-the-rails/

 

Well that whole PCS thing, normal or otherwise, seems to me to be utterly stupid. Just completely facile. I cant even believe that anyone with a modicum of intelligence would use it. I mean the answer to every question, on both the normal & altered form, is "it depends how bad it is". The pain of say, childbirth, cannot be ignored, distracted from or normal tasks got on with. A mild headache shouldnt get in the way of anything.

This entirely about people making assessments of how severe the pain that someone else is experiencing, is.

You're not in my body therefore you have no business judging that.

I'd have thought that the (normal) PCS could be used much more effectively to assess the severity of someone's pain, rather than their mental approach to it - ie if they cant ignore it, then it must be bad, so lets help them.
But instead, in a particularly sick & perverse twisting, it is used to assume that if someone cant ignore it & it worries them, it cant be because it's bad (unless we've got a number from a test that proves it's bad), then it must be because they are too weak or silly to be able to get on with things in spite of said pain. It's so insulting

ETA sorry to go off topic, i know this thread is about priming, but i dont think i ever saw the PCS in all it's 'glory' before. We really are though the ruddy looking glass

 

The primary outcome of this study didn't seem to reach the level of statistical significance. In the discussion it says: "In this 3-arm, single-blind, random-ized (1:1:1), controlled trial we found evidence of priming in patients with musculoskeletal illness. Patients assessed themselves as more physically capable after their mindset was positively primed using a positively phrased version of the PCS compared with the original PCS. However, no significant differences between either of these groups and the control group, which did not complete a PCS, were found."

The "p < 0.010" in the abstract is based on a multivariable analysis, not the primary outcome. However I think it's difficult to draw firm conclusions based on that for a few reasons. This study also seems to be published in a not particularly good journal, so there are probably other limitations to this study too.

Neglecting to mention that the study didn't find a significant difference in the primary outcome in the abstract seems questionable to me.