Reporting of Harms Associated with Graded Exercise Therapy and Cognitive Behavioural Therapy in Myalgic Encephalomyelitis/CFS (Kindlon, 2011)

Tom Kindlon · Dec 9, 2018

Free full text:
http://iacfsme.org/PDFS/Reporting-of-Harms-Associated-with-GET-and-CBT-in.aspx

Reporting of Harms Associated with Graded Exercise Therapy and Cognitive Behavioural Therapy in Myalgic Encephalomyelitis/Chronic Fatigue Syndrome

Tom Kindlon

ABSTRACT

Across different medical fields, authors have placed a greater emphasis on the reporting of efficacy measures than harms in randomised controlled trials (RCTs), particularly of nonpharmacologic interventions.

To rectify this situation, the Consolidated Standards of Reporting Trials (CONSORT) group and other researchers have issued guidance to improve the reporting of harms.

Graded Exercise Therapy (GET) and Cognitive Behavioural Therapy (CBT) based on increasing activity levels are often recommended for Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS).

However, exercise-related physiological abnormalities have been documented in recent studies and high rates of adverse reactions to exercise have been recorded in a number of patient surveys.

Fifty-one percent of survey respondents (range 28-82%, n=4338, 8 surveys) reported that GET worsened their health while 20% of respondents (range 7-38%, n=1808, 5 surveys) reported similar results for CBT.

Using the CONSORT guidelines as a starting point, this paper identifies problems with the reporting of harms in previous RCTs and suggests potential strategies for improvement in the future.

Issues involving the heterogeneity of subjects and interventions, tracking of adverse events, trial participants’ compliance to therapies, and measurement of harms using patient-oriented and objective outcome measures are discussed.

The recently published PACE (Pacing, graded activity, and cognitive behaviour therapy: a randomised evaluation) trial which explicitly aimed to assess “safety”, as well as effectiveness, is also analysed in detail.

Healthcare professionals, researchers and patients need high quality data on harms to appropriately assess the risks versus benefits of CBT and GET.
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https://twitter.com/user/status/1071568742818213888

Tom Kindlon · Dec 9, 2018

https://twitter.com/user/status/1071727218727026688

Sly Saint · Mar 2, 2019

Am posting this here rather than in the Parliamentary questions thread because the question/debate (in the House of Lords) was not on ME per se but on the Safety of Medicines and medical devices.

In it they discussed the reporting of harms or lack of.
Am quoting the contribution by Baroness Finlay of Llandaff (Vice chair of the NICE guideline committee) but others contributions may also be of interest.

I will focus in this debate on the role of the National Institute for Health and Care Excellence, which is building on its 20 years of experience, and will look forward to what needs to be done. I declare that I am vice-chair of a guideline review group on ME and chronic fatigue syndrome, a review that was precipitated by patient voices and has good patient representation on it. I should also declare that my husband has done a great deal of work on patient and family-reported outcome measures, which may be relevant here.
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NICE has now gone into formal partnership with the MHRA to try to share intelligence and understanding, and to monitor key issues. However, adverse event reporting is a major problem for them in this work because it relies on clinicians notifying such events, as through the yellow card scheme. As with any voluntary reporting system, reporting is incomplete—sometimes woefully so.
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There is an inherent bias to report the positive benefits of interventions in research papers and underreport adverse effects. There were 62,000 adverse incidents reported over the last three years, a third of which had serious repercussions. However, this is only a small number compared with those that have happened across Europe.
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In recognition of this, NICE rigorously reviews its current guidelines and seeks the sources of adverse events. Unfortunately, safety outcomes are poorly addressed in randomised trials; large numbers of treated patients are needed to reliably detect uncommon yet serious events from sources such as large case series, surveys, registers and individual case reports. Sometimes unpublished evidence is the sole source of such information.
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It is essential that safety information and evidence of harm are collected and rapidly disseminated.
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Changes to NHS structures in recent years have made dissemination more difficult because responsibility for the implementation of such guidance does not fall to any single body—hence NICE’s agreement with the four nations, a document on safely introducing new procedures. But we need to do much more to strengthen this. All NHS providers should ensure their governance structures require reporting of outcomes, including adverse events, as well as dissemination of information. Clinicians undertaking any interventional procedure, and the suppliers of devices and equipment, should be routinely asked whether any complications have arisen in the short or longer term rather than just leaving it up to them to decide whether such complications are serious enough to report. Patients must be asked too.
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All this data can be entered on a mandatory relevant national register, maintained to a sufficiently high standard to deliver evidence to clinicians for decision-making and for informed funding decisions. The quality of registers at the moment seems to be disappointingly variable. Without efficacy and safety information, problems will continue to go undetected and unpublicised.
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full debate can be seen here:
https://www.theyworkforyou.com/lords/?id=2019-02-28a.326.2&s=Chronic+Fatigue+Syndrome#g348.0

relevant to the NICE committee members
@adambeyoncelowe @Keela Too @Jonathan Edwards

Jonathan Edwards · Mar 2, 2019

Interesting comments.

Tom Kindlon · Dec 9, 2019

It's now at a new link following a reorganisation of the IACFS/ME website.
https://www.iacfsme.org/reporting-o...ncephalomyelitis-chronic-fatigue-syndrome-tom

I also just plugged it again on its anniversary:
https://twitter.com/user/status/1204022559370612737

Sly Saint · Dec 9, 2019

let's hope that you won't need to plug it again next year

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Reporting of Harms Associated with Graded Exercise Therapy and Cognitive Behavioural Therapy in Myalgic Encephalomyelitis/CFS (Kindlon, 2011)

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Reporting of Harms Associated with Graded Exercise Therapy and Cognitive Behavioural Therapy in Myalgic Encephalomyelitis/CFS (Kindlon, 2011)

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