PACE Trial and PACE Trial Protocol

[Dolphin]

http://www.goodmedicine.org.uk/stre...emotion-processing-chronic-fatigue-syndrome-c

I'm not sure if this has been posted before. It's one of the few references I've seen to the step test, the results of which have so far not been published. The walking test is presumably the six-minute walking test.

Leeds BABCP conference: workshop on emotion processing in chronic fatigue syndrome - current CBT treatment results (2nd post)

[..]4.) Encouraging & monitoring increases in activity are central to this therapy approach. See the GET manual for more information on exercise assessment and the CBT manual or books like Trudie's "Overcoming chronic fatigue: a self help guide"for more general comments. Cella, Sharpe & Trudie published a paper last year - "Measuring disability in patients with chronic fatigue syndrome: reliability and validity of the Work and Social Adjustment Scale" - highlighting the potential value of the widely used WSAS as a disability measure in chronic fatigue (and as a tool to help in discussion of activity targets). Initial WSAS scores in two fatigue cohorts treated at specialist centres were 27.2 (SD 6.3) and 26.9 (SD 8.5). The scores decreased significantly in severity and did so at approximately the same (fairly slow) rate that the Chalder Fatigue scores decreased - with the final WSAS ratings getting to the high teens by one year follow-up. Interestingly correlation with objective measures of physical activity improvement (e.g. walking & step tests) was only weak, highlighting how disability assessment is likely to be quite strongly coloured by factors like anxiety & depression. The WSAS is downloadable from the "Increasing access to psychological therapies (IAPT) outcomes toolkit" page of this website, where you'll also find other helpful measures.

 

[Simon]

http://www.goodmedicine.org.uk/stre...emotion-processing-chronic-fatigue-syndrome-c

I'm not sure if this has been posted before. It's one of the few references I've seen to the step test, the results of which have so far not been published. The walking test is presumably the six-minute walking test.

Leeds BABCP conference: workshop on emotion processing in chronic fatigue syndrome - current CBT treatment results (2nd post)

[..]4.) Encouraging & monitoring increases in activity are central to this therapy approach. See the GET manual for more information on exercise assessment and the CBT manual or books like Trudie's "Overcoming chronic fatigue: a self help guide"for more general comments. Cella, Sharpe & Trudie published a paper last year - "Measuring disability in patients with chronic fatigue syndrome: reliability and validity of the Work and Social Adjustment Scale" - highlighting the potential value of the widely used WSAS as a disability measure in chronic fatigue (and as a tool to help in discussion of activity targets). Initial WSAS scores in two fatigue cohorts treated at specialist centres were 27.2 (SD 6.3) and 26.9 (SD 8.5). The scores decreased significantly in severity and did so at approximately the same (fairly slow) rate that the Chalder Fatigue scores decreased - with the final WSAS ratings getting to the high teens by one year follow-up. Interestingly correlation with objective measures of physical activity improvement (e.g. walking & step tests) was only weak, highlighting how disability assessment is likely to be quite strongly coloured by factors like anxiety & depression.

Initially I thought this was new info from the Leeds conference, but I'm pretty sure the weak correlation of walking/step testis with WSAS is was from that Cella paper. In Table 1 it gives the correlations with the WSAS as:

6MWT: -0.261 [which is weak]​

Step test: 0.128 [which is trivial]​

both results are significant (p<0.001), but that's presumably because of the huge sample size (600+)

Would be very interesting to see how these objective measures correlated with the self-rated physical function scores.

 

[Dolphin]

Additions (this week?) to the PACE Trial manuals page:

I happened to go back to the PACE Trial manuals page and noticed Word files which I think are recent additions - indeed I was looking at this page last week and don't recall seeing them, but could be wrong on that. But they weren't in a folder I have on my PC for the official PACE Trial manuals so I presume that means they weren't there at the start.

http://www.pacetrial.org/trialinfo/

[..]

CBT treatment manual
*Appendix to (3): http://www.pacetrial.org/docs/CBT PACE final therapists landscape appendices-mrec 2.doc
CBT participant manual NB copyright © Constable and Robinson
*Appendix to (4) http://www.pacetrial.org/docs/CBT PACE final participants landscape charts-MREC 2.doc

* parts I think are new

 

[Dolphin]

user9876

I came across this note to myself to try to get this paper. As I know you are interested in scales, I thought I'd post it. However I hope you weren't the original source!

More recent studies using item response theory (IRT) have shown strong linear associations between the original SF-36 simple summated ratings scores and those derived from IRT models, except at the extremes, as would be expected (Haley, McHorney, & Ware, 1994; McHorney, Haley, & Ware, 1997; Raczek, Ware, Bjorner, Gandek, Haley, Aaronson, Apolone, Bech, Brazier, Bullinger, & Sullivan, 1998). Results from these IRT studies have also suggested that improvements in scales and scoring algorithms are possible, especially for the PF scale. These models have also revealed substantial increases in the range of scale levels measured by both of the SF-36v2 role functioning scales in comparison with the original versions of those scales (Ware et al., 2000). Among the practical implications are greater score precision and reduced concentrations of scores at the “ceiling” and “floor”.

3 "mild" criticisms of the SF-36 PF scale:

J Clin Epidemiol. 1994 Jun;47(6):671-84.

Evaluation of the MOS SF-36 physical functioning scale (PF-10): I. Unidimensionality and reproducibility of the Rasch item scale.

**Haley SM, McHorney CA, Ware JE Jr.

Source Health Institute, New England Medical Center Hospitals, Boston, MA 02111, USA.

Abstract

Indexes developed to measure physical functioning as an essential component of general health status are often based on sets of hierarchically-structured items intended to represent a broad underlying concept.

Rasch Item Response Theory (IRT) provides a methodology to examine the hierarchical structure, unidimensionality, and reproducibility of item positions (calibrations) along a scale.

Data gathered on the 10-item Physical Functioning Scale (PF-10) from a large sample of Medical Outcomes Study patients (N = 3445) were used to examine the hierarchical order, unidimensionality, and reproducibility of item calibrations.

Rasch-IRT analyses generated an empirical item hierarchy, confirmed the unidimensionality of the PF-10 for most patients, and established the reproducibility of item calibrations across patient populations and repeated tests.

These findings support the content validity of the PF-10 as a measure of physical functioning and suggest that valid Rasch-IRT summary scores could be generated as an alternative to the current Likert summative scores.

Unidimensionality and reproducibility of the item scale are essential prerequisites for the development of Rasch-based person measures of physical functioning that can be used across populations and over repeated tests. PMID: 7722580 [PubMed - indexed for MEDLINE]

(ii) J Clin Epidemiol. 1997 Apr;50(4):451-61.

Evaluation of the MOS SF-36 Physical Functioning Scale (PF-10): II. Comparison of relative precision using Likert and Rasch scoring methods.

** McHorney CA, Haley SM, Ware JE Jr.

Source

Department of Preventive Medicine, University of Wisconsin-Madison Medical School, USA.

Abstract

This study examined the relative precision (RP) of two methods of scoring the 10-item Physical Functioning Scale (PF-10) from a large sample of patients (n = 3445) of the Medical Outcomes Study.

Based on a Likert scaling model, the PF-10 summated scoring method was compared with a Rasch Item Response Theory (IRT) scaling model in which raw scores were transformed into a latent trait variable of physical functioning.

Potential differences between scoring methods were hypothesized to be attributed to: (1) the logarithmic nature of the Rasch transformation; (2) the unevenness of the PF-10 item distributions; and (3) reduction of within-group variance.

RP ratios favored the Rasch model in discriminating between patients who differed in disease severity.

The Rasch and Likert scoring models performed similarly for tests involving sensitivity to change over a two-year follow-up period.

In all comparisons, differences between methods were most apparent in clinical groups whose scores most approximated the extremes of the score distribution.

Further research is necessary to test for differences between scoring models in discrimination and sensitivity to change among clinical groups whose scores are sufficiently spread across the continuum of physical functioning, in particular patients with either very high or low physical functioning.

The Rasch model of scoring may have important implications for the clinical interpretation of individual scores at all ranges of the scale.

PMID: 9179104 [PubMed - indexed for MEDLINE]

Comparison of Rasch and summated rating scales constructed from SF-36 physical functioning items in seven countries: results from the IQOLA Project. International Quality of Life Assessment.

**Raczek AE, Ware JE, Bjorner JB, Gandek B, Haley SM, Aaronson NK, Apolone G, Bech P, Brazier JE, Bullinger M, Sullivan M.

Source

School of Education, Boston College, Chestnut Hill, Massachusetts, USA.

Abstract

Rasch models for polytomous items were used to assess the scaling assumptions and compare item response patterns in the 10-item SF-36 physical functioning scale (PF-10) for general population respondents in Denmark, Germany, Italy, the Netherlands, Sweden, the United Kingdom, and the United States.

The Rasch model of physical functioning developed in the United States was compared to models for other countries, and each country was compared to a multinational composite.

Strong scale congruence across the seven countries was demonstrated; items that varied between countries and from the composite may reflect unique cultural response patterns or differences in translation.

Scoring algorithms based on the Rasch model for each country were superior to the current Likert scoring in tests of relative validity (RV) in discriminating among age groups in all countries.

In relation to the Likert PF-10 scoring (RV = 1.00), scores estimated using the Rasch rating scale model achieve a median RV of 1.31 (range: 1.01-1.59), while the Rasch partial credit model attained a median RV of 1.44 (range: 1.01-2.23).

Rasch models hold good potential for improving health status measures, estimating individual scores when responses to scale items are missing, and equating scores across countries.

PMID: 9817138 [PubMed - indexed for MEDLINE] ------

IIRC, Ware was involved in designing the SF36 so he may be biased.

 

[Dolphin]

I don't think that this point has been made before:

(I've copied it from this post: http://forums.phoenixrising.me/inde...ronic-fatigue-sabes-figura.22388/#post-341565 )

This is from this paper:

Cost-effectiveness of counselling, graded-exercise and usual care for chronic fatigue: evidence from a randomised trial in primary care.

BMC Health Serv Res. 2012 Aug 20;12:264. doi: 10.1186/1472-6963-12-264.
Sabes-Figuera R, McCrone P, Hurley M, King M, Donaldson AN, Ridsdale L.
Free at: http://www.biomedcentral.com/1472-6963/12/264

The most interesting thing in this paper to me doesn't in fact really relate to this trial specifically, but more to trials in general that use the Chalder fatigue scale, particularly when they use a threshold to signify significant or important changes. For example, the PACE Trial claimed 2 points would be sufficient for a clinically useful difference with large percentages in all groups (incl. the SMC no therapy group) achieving this.

This paper says:

Outcomes

Assessments were made at baseline with follow-up at six and twelve months. The primary clinical outcome was the Chalder fatigue scale [9], which consists of 13 items assessed using Likert scales (0,1,2,3) producing a total score ranging between 0 and 33. For the purpose of the economic evaluation we calculated the amount of clinically significant change by the six-month follow-up given that use of services data was not available for the twelve months follow-up. This was obtained by dividing the actual change in the Chalder fatigue scale total score by four. Thus a value of one in the change in fatigue outcome corresponds to a difference of four in the original Chalder fatigue scale, assuming that a change of that magnitude was clinically significant (CSI)[6]. This was based in a consensus reached by clinicians in a previous trial [10].



6. McCrone P, Ridsdale L, Darbishire L, Seed P: Cost-effectiveness of cognitive behavioural therapy, graded exercise and usual care for patients with chronic fatigue in primary care.
Psychol Med2004,34(6):991-999.

10. Ridsdale L, Godfrey E, Seed P:Chronic Fatigue in general practice: authors reply.
Br J Gen Pract2001,51:317-318.

Here's the relevant part of their letter (reference 10):

Because the Chalder fatigue scale6 is relatively new, there is no published definition of equivalence. The researchers in this trial include several of those involved in developing and testing the instrument. Our consensus view was that a difference of less than four, using a Likert scale, is not important. We found that the apparent advantage six months after therapy of CBT over counselling was only 1.04 points with a 95% confidence interval from -1.7 to 3.7. Arriving at this estimate was always the main aim of the trial. Jones et al7 (on whom Underwood and Eldridge rely) state ‘If every point within this range (i.e. the confidence interval) corresponds to a difference of no clinical importance then the treatments may be considered to be equivalent.’ We conclude that the treatments are clinically equivalent.

A clinician that was concerned about differences of two or three points could legitimately claim that the question is still open.

 

[Graham]

Thanks Dolphin. I haven't seen that before.

The results from our survey suggest that, in practice, a change of one point in the bimodal scale is equivalent to two points in the Likert scale.

 

[Tom Kindlon]

From Tate Mitchell:
Refs for 6MWT graph-

PACE 6MWT results before and after treatment- APT 314m>334m, CBT

333m>354m, GET 312m>379m, SMC 326m>348m

Kadikar, 1997- Recommended for lung transplant= 400m
Lipkin, 1986- Class III heart failure= 402m, Class II heart failure= 558m, healthy controls= 683m
Steffen, 2002- Ages 60-69= 572m, ages 70-79= 527m, ages 80-89= 417m
Ross, 2010- Various cardiopulmonary disorders. Mean distance for the different disease groups, comprising over 1000 patients, was 393m.

 

[Graham]

In the PACE race video, I said that a distance of less than 300 metres was medically grim. I didn't want to be too specific there, but in fact I read that that was a big indicator on the likelihood of living another year for patients with heart disease: less than 300 the majority died, more than 300 the majority lived (from memory, we are talking of more than three-quarters).

In the UK, the slowest speed allowed to cross the road at crossings controlled by lights (pelican crossings with the green man) would correspond to a distance of 432 metres. OK, it doesn't take 6 minutes to cross a road, but it is an indication of how poor this speeds are.

 

[Bob]

Here's a similar graph, in case helpful for anyone.

The CBT group achieved no average improvement beyond the SMC control group.
The GET group made a modest average improvement (35.3 m) (adjusted difference from SMC) beyond the SMC control group after 52 weeks.
The average distance that the GET group achieved, of 379m at 52 weeks, is still far from what might be considered a common healthy average distance, as shown in the graph.


References:
(1) The 6-min walk distance in healthy subjects: reference standards from seven countries.
Casanova C, Celli BR, Barria P, Casas A, Cote C, de Torres JP, Jardim J, Lopez MV, Marin JM, Montes de Oca M, Pinto-Plata V, Aguirre-Jaime A; Six Minute Walk Distance Project (ALAT).
1 January 2010
European Respiratory Journal 2011 Jan;37(1):150-6. Epub 2010 Jun 4.
doi: 10.1183/09031936.00194909
http://www.ncbi.nlm.nih.gov/pubmed/20525717
http://erj.ersjournals.com/content/early/2010/06/04/09031936.00194909.full.pdf html
Adults without chronic disease, aged 40 to 80 years, across seven countries = 571m

(2) Six minute walk distance in healthy subjects aged 55–75 years
Bernadine Camarri, Peter R. Eastwood, Nola M. Cecins, Philip J. Thompson, Sue Jenkins
Respiratory Medicine, Volume 100, Issue 4 , Pages 658-665, April 2006
http://www.resmedjournal.com/article/S0954-6111(05)00326-4/abstract
Healthy subjects aged 55-75yrs = 659m

(3) Six minute walking distance in healthy elderly subjects
T. Troosters, R. Gosselink, M. Decramer
Eur Respir J 1999; 14: 270±274
http://www.ersj.org.uk/content/14/2/270.full.pdf
Healthy elderly subjects (50-85 yrs) = 631m

(4) Inspiratory Capacity, Dynamic Hyperinflation, Breathlessness, and Exercise Performance during the 6-Minute-Walk Test in Chronic Obstructive Pulmonary Disease
José M. Marin, Santiago J. Carrizo, Manuel Gascon, Andres Sanchez, Begoña Gallego And Bartolomé R. Celli
Am. J. Respir. Crit. Care Med. May 1, 2001 vol. 163 no. 6 1395-1399
http://171.66.122.149/content/163/6/1395.full
Patients with Chronic Obstructive Pulmonary Disorder = 439m

(5) Six minute walking test for assessing exercise capacity in chronic heart failure
D P Lipkin, A J Scriven, T Crake, P A Poole-Wilson
British Medical Journal Volume 292 8 March 1986
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC1339640/pdf/bmjcred00224-0015.pdf
Patients with class III heart failure = 402m

 

[Valentijn]

The most objective measure used in the PACE Trial to assess the effectiveness of the interventions, was the Six Minute Walking Distance Test.
The CBT group achieved no average improvement beyond the SMC control group.
The GET group made a modest average improvement (35.3 m) (adjusted difference from SMC) beyond the SMC control group after 52 weeks.
The average distance that the GET group achieved, of 379m at 52 weeks, is still far from what might be considered a common healthy average distance, as shown in the graph.

Shocking how the 6MWD didn't make it into the determination of "recovery", eh?

 

[Valentijn]

So Hitler wasn't joking when he said someone's 90 year old grandma could run circles around him

 

[Bob]

After seeing Tate's graph, I decided to change some of the comparison data that I used in my graph, to improve its consistency. I've also added an extra category of severe MS.
I don't know which of my graphs is most helpful, but I thought I'd post this one, as I've done the work.

References:

(1) Six minute walking test for assessing exercise capacity in chronic heart failure
D P Lipkin, A J Scriven, T Crake, P A Poole-Wilson
British Medical Journal Volume 292 8 March 1986
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC1339640/pdf/bmjcred00224-0015.pdf
Healthy Controls = 683m
Patients with class III heart failure = 402m

(2) Six minute walk distance in healthy subjects aged 55–75 years
Bernadine Camarri, Peter R. Eastwood, Nola M. Cecins, Philip J. Thompson, Sue Jenkins
Respiratory Medicine, Volume 100, Issue 4 , Pages 658-665, April 2006
http://www.resmedjournal.com/article/S0954-6111(05)00326-4/abstract
Healthy subjects aged 55-75yrs = 659m

(3) Inspiratory Capacity, Dynamic Hyperinflation, Breathlessness, and Exercise Performance during the 6-Minute-Walk Test in Chronic Obstructive Pulmonary Disease
José M. Marin, Santiago J. Carrizo, Manuel Gascon, Andres Sanchez, Begoña Gallego And Bartolomé R. Celli
Am. J. Respir. Crit. Care Med. May 1, 2001 vol. 163 no. 6 1395-1399
http://171.66.122.149/content/163/6/1395.full
Patients with Chronic Obstructive Pulmonary Disorder = 439m

(4) Evaluation of the six-minute walk in multiple sclerosis subjects and healthy controls
Myla D Goldman, Ruth Ann Marrie, Jeffrey A Cohen
2008
Multiple Sclerosis, April 2008; vol. 14, 3: pp. 383-390., first published on October 17, 2007
DOI:10.1177/1352458507082607
http://msj.sagepub.com/content/14/3/383.abstract
http://pocketknowledge.tc.columbia.edu/home.php/viewfile/download/65399/The six-minute walk test.pdf
Patients with severe MS = 389m


Note 1:

The CBT group achieved no average improvement beyond the SMC control group.
The GET group made a modest average improvement (35.3 m) (adjusted difference from SMC) beyond the SMC control group after 52 weeks.
The average distance that the GET group achieved, of 379m at 52 weeks, is still far from what might be considered a common healthy average distance, as shown in the graph.


Note 2:

Fewer patients/controls were studied in the categories that I've added to this graph (i.e. 'healthy controls', and 'severe MS'), so perhaps some of the data is not quite as robust as in my previous graph.
Having said that, the top entry that I used in the previous graph was not demographically representative, because it was taken from a review of research carried out in a number of different countries, including some non-European and developing nations, and they used slightly older adults.
But, as seen in the graphs, all the data I've used seems consistent, and perhaps the new graph might make more intuitive sense to a casual reader.

 

[Bob]

Does anyone have a helpful citation to use when stating that it's bad scientific practice not to publish trial outcomes that were outlined in a trial protocol?

 

[Esther12]

Does anyone have a helpful citation to use when stating that it's bad scientific practice not to publish trial outcomes proposed in a trial protocol?

Something like this: http://www.bmj.com/content/346/bmj.f105

There have been a few things like this recently, but I've not been saving references for them (so many things that might be useful someday, it's difficult to keep track of them all).

 

[Bob]

Something like this: http://www.bmj.com/content/346/bmj.f105

There have been a few things like this recently, but I've not been saving references for them (so many things that might be useful someday, it's difficult to keep track of them all).

Thanks Esther. That's very helpful, and interesting. And very strongly worded!
I'm looking for something that specifically refers to trial protocols.
I haven't got access to the full article, so I don't know if it refers to protocols.
Specifically, I want something that says, or implies, that it is bad practise not to publish trial protocol outcomes.

 

[Esther12]

Not sure Bob - I thought that one did, and assumed the 'registering' in the title referred to registering outcome measures, but I didn't check before posting. I think that this used to be open access, but I could probably find a copy now. I think that it was prompted by the Sense about Science campaign for protocols to be registered and results made available in the manner laid out there. Haveyou looked at any of the things related to that? It's something I've only been semi-following. There have been papers in journals about this, but I'm not certain of the references.

[edit - here's the paper, looks like it does mention a problem with a failure to release protocol defined data, although I expect the PACE researchers would try to wiggle around this: http://www.anzctr.org.au/docs/Chalm...st be registered and published_BMJ 9Jan13.pdf ]

I did a quick google and found this paragraph in a letter related to the campaign, so it is in the right area:

The Clinical Trials Regulation is currently being debated in the European Parliament. We
want you to put in place measures to ensure that the protocols for all clinical trials from
now on - and all clinical trials since the 1980s – are posted on a public register; and that the
summary results, the “primary and secondary outcomes” measured in all these trials and
the Clinical Study Reports are published.

http://www.alltrials.net/wp-content...m-clinical-trial-participants-2013-Jan-18.pdf

These quotes could be helpful:

Dr Richard Lehman: “It is a scandal that doctors like myself often prescribe treatments without knowing their true benefits and harms, because research evidence from human trials has been withheld.”​

Richard Stephens, Chair of the NIHR Cancer Consumer Liaison Group: 20% of cancer patients in the UK take part in clinical trials as part of their treatment options. We expect that the results of trials will be made freely available to researchers”​

Tracey Brown, Director, Sense About Science: “We expect doctors and researchers to have access to the best available evidence, not half of it. But there have been years of foot-dragging and non-compliance with requirements.”​

Carl Heneghan, Director, Centre for Evidence-Based Medicine, University of Oxford : “The missing results from the last 20 years represent lost opportunities to replicate results and learn from all that research, and to develop some of it in light of new discoveries.”​

Fiona Godlee Editor in Chief BMJ: “The evidence that much research goes unreported is overwhelming, putting patients at risk and wasting healthcare resources.”​

http://www.alltrials.net/supporters/

Links to a couple of things here:

http://www.alltrials.net/blog-2/

 

[Esther12]

Another Trish Groves thing:

• When submitting clinical trial papers to journals: be prepared to also submit the protocol and trial registration details and to explain any deviations from these; and be ready to state what plans you have, if any, for sharing patient level data from the trial. The BMJ now requires authors submitting any drug or device trial to the journal to commit to making the relevant anonymised patient level data available on reasonable request3. Other journals may well follow suit.

Some of the AllTrials campaigners have been patients in trials and, along with other trial participants, they’ve written an open letter to the EMA asking the agency to ensure that “the protocols for all clinical trials from now on – and all clinical trials since the 1980s – are posted on a public register; and that the summary results, the “primary and secondary outcomes” measured in all these trials and the Clinical Study Reports are published. They are also urging people who are thinking of taking part in a clinical trial to agree to participate only in those trials that have been registered and that promise to publish the results in full4.

http://www.pharmaphorum.com/2013/01/30/data-transparency-clinical-trials-bmj/

 

[Bob]

Thanks for all the info Esther.

 

[Esther12]

No probs. Just edited in the link to the Groves thing above as I forgot it first time. Happy reading!

 

[user9876]

http://www.alltrials.net/supporters/

Links to a couple of things here:

http://www.alltrials.net/blog-2/

There is also a quote from the medical research council
http://www.alltrials.net/supporters/

Medical Research Council: The MRC is pleased to sign up to this campaign and has, for many years, strongly supported the position that clinical trial results must be published in a timely manner. At the end of 2012, we made both the requirement to publish, and the need for MRC-funded researchers to share data, even more explicit: “results of MRC-funded clinical studies (whether positive or negative) must be published within a reasonable period (generally within a year of completion) following the conclusion of the study. Results should be reported in accordance with the recommendations in the CONSORT statement [Schulz et al. BMJ 2010; 340: c332]. Data should be made available in line with the MRC Policy on Data Sharing” The MRC celebrates its centenary this year and it would be surprising if, in our one hundred year history, there were no unreported or unpublished skeletons in our cupboards. However, tools such as e-Val (developed by the MRC and the precursor of ResearchFish) and Gateway to Research will mean funders such as ourselves will find it far easier to monitor adherence to the policy.

They seem to find it easy to make such statements but don't actually enforce them.