Monitoring treatment harm in myalgic encephalomyelitis/chronic fatigue syndrome: A freedom-of-information study of National Health Service specialist centres in England

Abstract

The use of graded exercise therapy and cognitive behavioural therapy for myalgic encephalomyelitis/chronic fatigue syndrome has attracted considerable controversy. This controversy relates not only to the disputed evidence for treatment efficacy but also to widespread reports from patients that graded exercise therapy, in particular, has caused them harm. We surveyed the National Health Service–affiliated myalgic encephalomyelitis/chronic fatigue syndrome specialist clinics in England to assess how harms following treatment are detected and to examine how patients are warned about the potential for harms. We sent 57 clinics standardised information requests under the United Kingdom’s Freedom of Information Act. Data were received from 38 clinics. Clinics were highly inconsistent in their approaches to the issue of treatment-related harm. They placed little or no focus on the potential for treatment-related harm in their written information for patients and for staff. Furthermore, no clinic reported any cases of treatment-related harm, despite acknowledging that many patients dropped out of treatment. In light of these findings, we recommend that clinics develop standardised protocols for anticipating, recording, and remedying harms, and that these protocols allow for therapies to be discontinued immediately whenever harm is identified.

Full text

Harm detection in ME/CFS treatment 1
MONITORING TREATMENT HARM IN MYALGIC
ENCEPHALOMYELITIS/CHRONIC FATIGUE SYNDROME:
A FREEDOM-OF-INFORMATION STUDY OF NATIONAL HEALTH SERVICE
SPECIALIST CENTRES IN ENGLAND
Graham McPhee, Independent Scholar, Crowborough, UK
Adrian Baldwin, Independent Scholar, Bristol, UK
Tom Kindlon, Irish ME/CFS Association, Dublin, Ireland
Brian M. Hughes*, National University of Ireland, Galway, Ireland
*Address for correspondence:
School of Psychology
National University of Ireland, Galway
University Road
Galway
H91 TK33
Ireland.
Email: brian.hughes@nuigalway.ie

Harm detection in ME/CFS treatment 2
Abstract
The use of graded exercise therapy (GET) and cognitive behavioural therapy (CBT) for
myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) has attracted considerable
controversy. This controversy relates not only to the disputed evidence for treatment efficacy,
but also to widespread reports from patients that GET, in particular, has caused them harm.
We surveyed all NHS-affiliated ME/CFS specialist clinics in England to assess how harms
following treatment are detected, and to examine how patients are warned about the potential
for harms. We sent 57 clinics standardised information requests under the UK’s Freedom of
Information Act. Data were received from 38 clinics. Clinics were highly inconsistent in their
approaches to the issue of treatment-related harm. They placed little or no focus on the
potential for treatment-related harm in their written information for patients and for staff.
Furthermore, no clinic reported any cases of treatment-related harm, despite acknowledging
that many patients dropped out of treatment. In light of these findings, we recommend that
clinics develop standardised protocols for anticipating, recording, and remedying harms, and
that these protocols allow for therapies to be discontinued immediately whenever harm is
identified.
Key words: chronic fatigue syndrome; clinics; cognitive behavioural therapy; graded
exercise therapy; myalgic encephalomyelitis; therapeutic harm; therapeutic risk

Harm detection in ME/CFS treatment 3
In 2007, the United Kingdom’s National Institute for Health and Care Excellence
(NICE) published treatment guidelines for myalgic encephalomyelitis/chronic fatigue
syndrome (ME/CFS). The guidelines recommended three therapies aimed at rehabilitating
patients by having them gradually increase their activity levels: “activity management”;
graded exercise therapy (GET); and a form of cognitive behavioural therapy (CBT) intended
to persuade patients to increase their activity (NICE, 2007). NICE guidelines are formally
directed at National Health Service (NHS) specialist ME/CFS clinics in England, but are also
used in the rest of the UK and have influenced practice recommendations in several other
countries. However, despite their status as officially recommended treatments, the use of GET
and CBT for ME/CFS has attracted considerable controversy. Critics argue: (a) that the
evidence that these therapies are effective for ME/CFS is flawed and that any apparently
positive effects could be due to methodological bias (McPhee, 2017; Vink & Vink-Niese,
2018; Wilshire et al., 2018); and (b) that GET in particular seems harmful to patients
(Geraghty, Hann, & Kurtev, 2017). Against this background, the United States Centers for
Disease Control and Prevention removed GET and CBT from their own ME/CFS treatment
guidelines in 2017 (ME Association, 2017). NICE is now reviewing its guidelines for the UK
(NICE, 2017).
When treating patients, all therapies carry some element of risk. A treatment is
therefore usually recommended only when a cost-benefit-risk analysis shows that the
likelihood and extent of benefits clearly outweigh those of the risks. In clinical research, harm
is more likely to be investigated for pharmacological treatments than for non-
pharmacological ones (Duggan et al., 2014; Meister et al., 2016). However, the cost-benefit
principle applies as much to non-pharmaceutical therapies, such as exercise, as to any others

Harm detection in ME/CFS treatment 4
(Cooper et al., 2007). For GET and CBT in ME/CFS, the evidence for treatment efficacy is
disputed and the likely treatment gains are unclear. This means that there should be a strong
focus on the therapies’ costs in any cost-benefit analyses.
A common limitation seen in clinical trials across medicine is that the reporting of
harms frequently receives much less attention than that of efficacy outcomes (e.g., Ioannidis
& Lau, 2001). Some empirical studies of CBT and GET in ME/CFS have reported no
apparent safety concerns, although the reporting of harms in such trials has been widely
recognised as being poor, with often no data on adverse events being published at all
(Chambers et al., 2006; Kindlon, 2011; Marques et al., 2015; Price et al., 2008; Smith et al.,
2015). Advocacy groups for ME/CFS patients regularly report concern about the potential for
harms arising from these treatments (e.g., ME Association, 2015). A number of surveys by
patients’ associations have suggested that CBT and GET can trigger significant deterioration
in ME/CFS patients.
Across 11 such surveys, involving nearly 8,000 patients in the UK, Norway, and the
Netherlands, cumulative totals of 57% and 20% of all patients surveyed reported
deterioration after GET and CBT respectively (Geraghty, Hann, & Kurtev, 2017). GET was
associated with a higher proportion of patients deteriorating than CBT in every survey that
examined both. A subsequent survey of patients’ experiences over the past ten years was
commissioned by Forward ME (ME Association, 2019) at the request of NICE. The survey
reached a sample of over 2,000 patients, roughly a quarter of the number of patients seen in
UK NHS ME/CFS clinics each year (BACME, 2019). Symptom deterioration was reported
by 81% of patients who received GET and 47% who received CBT, further confirming the
pattern seen by Geraghty, Hann and Kurtev. The deterioration does not appear to be restricted
to potentially substandard therapy being provided outside the NHS. One survey (Kindlon,
2011) compared the proportion of patients reporting deterioration following GET and found

Harm detection in ME/CFS treatment 5
no difference whether the therapy was provided by NHS specialists or by non-NHS therapists
(31% vs 33%).
A multi-site cohort study by Collin and Crawley (2017) confirmed that significant
levels of deterioration are reported by patients attending NHS ME/CFS specialist clinics in
England. Among 418 patients who were followed up one year after baseline, 20% reported
that their ME/CFS had worsened; from a subset of 383 who were followed up after two or
more years, 30% reported worsening. The authors reported these findings as reflecting the
often treatment-resistant nature of ME/CFS. However, the prevalence of deterioration from
baseline after years of being treated by specialists according to NICE guidelines raises the
question of whether practitioners (or researchers) are paying enough attention to the risk of
harm in this population, or are equipped to recognise harm when it happens.
A recent service audit conducted by the British Association for CFS/ME (2019), an
organisation that supports clinical professionals, suggested that service approaches vary
considerably across the UK health system. Tellingly, this report emphasised that, as the area
of CFS/ME “does not yet have the advantage of an accepted evidence base for diagnosis or
treatment” (p. 34), service design and delivery depend greatly on choices made by clinicians
based on their experiences. As such, it is likely that the way clinics deal with the issue of
treatment-related harm will be similarly variable.
In the present research, we surveyed all NHS-affiliated ME/CFS specialist clinics in
England to assess how harms following treatment are detected, and to identify practices for
warning patients about the potential for harms during, after, or arising from treatment. We
requested information from individual clinics to gain insight into their readiness to deal with
harms.

Harm detection in ME/CFS treatment 6
Method
Sampling frame and contact
Based on an online directory publicly posted by the ME Association (a registered UK
charity) as of November 2018 (ME Association, 2018), we identified 57 separate specialist
NHS centres in England providing services to adult ME/CFS patients. During the period
November 2018 to January 2019, we sent each clinic (or the NHS Trust that provided it, as
listed in the ME Association’s directory) a standardised freedom-of-information request
asking about information and data relating to harms (see next section). The UK’s Freedom of
Information Act (FOIA) requires public authorities to provide recorded information in
response to requests, but authorities do not need to respond to questions that cannot be
answered with recorded data (Information Commissioner’s Office, 2019). Nonetheless, we
also asked each centre to send us any verbal information about harm that it gave to ME/CFS
patients and staff if it did not provide them with written information.
We sent a single reminder to any clinic that had not responded within the 20-working-
day period set out in the FOIA. We closed data collection when each clinic had had at least 30
working days to reply to our original request.
We established that 11 of the 57 centres no longer functioned at the time they were
contacted. Two further clinics told us that they did not provide rehabilitative therapies (such
as GET or CBT) to ME/CFS patients. This left a final target sample of 44 centres in the
present study.
Information requested
Information for patients and staff about risks and harms. The first two questions in
our freedom-of-information requests related to information given to patients and staff about
safety, risk and harm in relation to rehabilitative therapies.

Harm detection in ME/CFS treatment 7
The first question was: ‘Please provide the information that you give ME/CFS
patients about the safety and risks of the rehabilitative therapies (e.g. CBT, graded exercise
therapy, activity management) provided by your service. If information is only provided
verbally, we would be grateful for a brief summary. If you do not give patients such
information in any form, please say so.’
The second question was: ‘Please provide us with any written guidance that you use
to determine whether an ME/CFS patient has been harmed by the rehabilitative therapies (e.g.
CBT, graded exercise therapy, activity management) provided by your service. This may
include training material that you use to help your staff recognise harms. If you use unwritten
criteria to determine whether a patient has been harmed, we would be grateful for a brief
summary. If you have no criteria for judging whether a patient has been harmed, please say
so. If you used different guidance for the patients in the time period dealt with in [the
subsequent questions], please provide that also.’
Quantitative data requests. The remaining five questions were numerical, and related
to data on the patients who began treatment in 2016 (or, if data for this period were not
available, for the nearest earlier one-year period starting on any calendar date). 2016 was
chosen to be long enough ago for post-treatment harms to be detected and follow-up to have
taken place.
The questions asked: (i) how many patients began therapy; (ii) how many dropped out
because their condition worsened, because they experienced harm from the therapy, or
because of an unknown reason; (iii) how many reported an increase in symptoms that had
lasted for more than a few days and/or that their symptoms had become severe or distressing
(according to the NICE guidelines [NICE, 2007], healthcare professionals should advise
ME/CFS patients to contact them if this happens); (iv) how many patients were recorded as

Harm detection in ME/CFS treatment 8
having been harmed by their therapy; and (v) how long any follow-up period was, and how
many patients had been lost to follow-up.
Data extraction and analysis. Two members of the research group, who had coding
experience, independently extracted 22 items of data from each clinic’s responses. For the
responses to the first question, about the information given to patients about risks and harms,
the coders used a list of statements such as “Symptoms may worsen temporarily”. The coders
judged whether the clinics had made each statement – or something that meant the same – to
any of their patients (see Table 1 for the full list). For the second question, the coders judged
whether the clinic had criteria to determine whether a patient has been harmed, and for the
quantitative questions, the coders attempted to extract the quantitative data and some
summary information about how any follow-up of patients was conducted.
There were two disagreements that could not be resolved between the coders and
these were resolved by a third party (also from the research group). For each data item, we
calculated the percentage of clinics for which the two coders agreed on the data. Median
agreement across items was 95% (IQR 89% to 97%).
Results
Response rate
Four of the 44 clinics eligible for inclusion did not respond by the cut-off date. Also,
two centres that contracted their services out to private providers declined to take part on the
basis that private providers are exempt from the FOIA. Thus, responses were received from a
total of 38 eligible clinics, giving a response rate of 86%.
Guidance for patients about safety and risks

Harm detection in ME/CFS treatment 9
Table 1 shows information that clinics reported giving ME/CFS patients about the
safety and risks of the rehabilitative therapies, as classified by our coders. (Warnings about
symptoms not directly related to ME/CFS, such as chest pain during exercise or emotional
distress from facing the reality of symptoms, were not included.) The most commonly
reported guidance from clinics was that ‘setbacks’ or ‘relapses’ were possible (N = 15; 40%).
A second common piece of advice was that ‘symptoms may worsen temporarily’ (N = 12;
32%). Only one of the 38 clinics reported telling patients that the safety of the rehabilitative
therapies is disputed.
-----------------------------------
Insert Table 1 here
-----------------------------------
Guidance for staff about safety and risks
Just one of the 38 clinics reported having guidance for determining whether a patient
had been harmed during or after ME/CFS treatment. They described their approach as
follows:
Harm may be defined by the patient as [it] could take different forms.... If patients
rate their health as worse or much worse we review the written information to assess
if this is related to the treatment or to other causes, such as a deterioration in co-
morbidities or a life event.
A number of other clinics reported that they used scales such as the SF-36 (Ware &
Sherbourne, 1992) to measure improvement and deterioration. However, no clinic said how
or whether they used any such measure to determine whether a patient had been, or might
have been, harmed.

Harm detection in ME/CFS treatment 10
Eighteen clinics (47%) responded that they gave no written guidance to staff about
harm-detection, nor did they report giving any verbal guidance. Nineteen clinics (50%) gave
responses that did not address the question.
Quantitative data requests
Twenty-three of the 38 clinics (61%) provided at least some quantitative data for a
specified one-year period in response to our data request. Fifteen clinics gave information for
patients starting treatment in 2016, with the rest giving information for one-year periods in
the range of 2015 to 2018. Fifteen clinics made it clear how many patients began treatment
during the year; the median number of patients in these clinics was 132 (full range 26-450;
IQR 58-212).
Table 2 summarises the clinics’ responses relating to harms. Given the small number
of cases, individual values are presented rather than summary statistics.
-----------------------------------
Insert Table 2 here
-----------------------------------
Altogether, it was clear for 12 clinics that they followed up all patients once treatment was
completed. The number of follow-ups ranged from one to four. For two of these clinics,
follow-up was 12 months after initial assessment of the patient; for nine clinics, follow-up
was timed from the patient’s final treatment session, and was between three and twelve
months later. The remaining clinic did not specify its follow-up timing.

Harm detection in ME/CFS treatment 11
Discussion
The present study was conducted to assess how NHS ME/CFS clinics in England deal
with the possibility of treatment-related harm. Overall, our findings suggest that such clinics
place little focus on dealing with such harms, with a general pattern of centres not addressing
the issue of harm with patients or staff and, ultimately, reporting no harm.
It is certainly notable that no clinic at all reported any harm for any patient. It is
equally notable that all seven of the 38 clinics that provided dropout rates (18%) reported that
patients dropped out of treatment, including for reasons that were unclear. As noted above,
previous research has shown that significant numbers of patients receiving rehabilitative
therapies report deterioration, both within NHS centres in England (e.g., Collin and Crawley,
2017) and internationally (Geraghty, Hann, & Kurtev, 2017). Against the backdrop of these
findings, the centres we sampled seem overly optimistic in reporting zero harms.
We consider three explanations for why centres reported zero treatment-related harms
for their services. Firstly, it could just be that no harms occurred in the 17 centres that gave us
data. But the Collin and Crawley (2017) and Geraghty, Hann and Kurtev (2017) work
suggests that harms are not rare. We would have expected to see harms in our dataset and it
seems implausible that they would all be concentrated in the 21 clinics that did not report
harm rates.
A second possibility is that patients attending the clinics in our dataset did indeed
experience harm (which might account for the dropout rates reported), but did not report their
harm to the clinics, thus preventing the clinics from recording it. In relation to this, it is worth
noting the clinics’ descriptions of their advice to patients. No clinic reported telling patients
explicitly that they could be worse after therapy than before. Having not been primed about
harm, patients who deteriorated might have been reluctant to report it to their clinic, or might
have attributed their deterioration to other causes.

Harm detection in ME/CFS treatment 12
For example, one clinic gives the following text to patients in the ‘Frequently Asked
Questions’ section of an information leaflet about GET:
I’ve looked on the internet and someone who has done GET has ended up in a
wheelchair, will it harm me?
There are many sources of information available on the internet; however it is not
always easy to see if this information is factual and correct. Many people have
concerns with GET making their condition worse. If GET is correctly undertaken it
will not harm you. Many controversies occur when people have undertaken what they
feel was GET but this is often not the case. For example we know of cases where it
has been a general exercise programme that has been carried out and increased too
quickly, leading people to do too much too quickly, thereby having a detrimental
effect.
Rather than telling patients that treatment-related harm is possible, this message encourages
patients to take personal responsibility for any deterioration (because of not having ‘correctly
undertaken’ their therapy), and discourages them from reporting it to their clinic as ‘harm’.
Even without priming, patients providing feedback on medical treatment are frequently
influenced by socially desirable responding bias (Epstein et al., 2005). Patients may be
particularly influenced when clinics tell them that the treatments are effective. A related issue
concerns the way therapies such as CBT might teach patients to reframe their negative
experiences, further discouraging them from reporting harms (Kindlon, 2017). In
combination, such factors are likely to lead to a misinformation ‘loop’, where clinics are
reinforced in believing no harms have occurred by the very fact that patients do not report
them.

Harm detection in ME/CFS treatment 13
A third possible reason for the reported zero-harm rate is that patients did indeed
report harm, or try to do so, but that clinics did not formally record it. As noted above, only
one clinic reported any kind of criteria for determining harm. It is unclear how the rest of the
clinics would have recorded explicit reports of harm by patients. This matter could be
clarified by directly surveying the experiences that patients and staff have had in relation to
harm-reporting. We note that therapies such as GET and CBT are not covered by existing
national harm-reporting systems (such as the ‘Yellow Card Scheme’ operated by the UK’s
Medicines and Healthcare Products Regulatory Agency). This means that if patients cannot
report their harms to the clinics, then no agency at a national level will be aware of these data.
Some comments made by clinics seemed to suggest an institutional scepticism about
whether approved therapies for ME/CFS could cause harm. For example, one clinic
responded to our request for harms data by stating:
This data is not available. This is making an assumption that treatments we provide
are harmful. If any treatment is contraindicated we would not provide it.
ME/CFS is a variable condition, and any patient’s judgement of whether they have been
harmed by their treatment must therefore be based on context. They must decide whether any
deterioration is beyond the usual variation in their symptoms, fits the timing, and happens in
the absence of other possible triggers. However, the complexity of this judgement leaves
room for clinics to attribute harm to other causes, and if clinics presume that treatments are
harmless, they will inevitably fail to record harms accurately.
The NICE guidelines for ME/CFS explicitly recommend that clinics tell patients to
contact them, once they have started therapy, if they experience an increase in symptoms that
lasts more than a few days, or if symptoms become severe or distressing (NICE, 2007).

Harm detection in ME/CFS treatment 14
However, only two clinics in the present study were able to provide us with the number of
patients who had reported such concerns. It therefore seems that few NHS ME/CFS clinics in
England are equipped to track these experiences in a formal way. This is concerning, given
that NICE appear to consider them important indicators of current or impending harm.
Limitations of the present study
The present study offers some initial insights into the issue of harm during or after
rehabilitative therapy for ME/CFS, but is limited in several respects. Because we surveyed
institutions rather than people, the information gathered is at a macro-level rather than micro-
level. It represents the clinics’ official approaches to harm, as outlined by the staff responsible
for dealing with the freedom-of-information requests. However, the responses are unlikely to
fully capture how frontline clinical staff view or deal with harms in daily practice. As such, it
is important to interpret our findings as mainly reflecting institution-level matters. Further
research would be needed to examine what the first-hand experiences of patients and their
therapists have been. Additional insights could be gained from objective patient-level data on
harms.
One related limitation is the fact that clinics may vary in how they define a “dropout”.
Where clinics allow a patient to stop a particular therapeutic approach – such as GET – while
continuing to see a therapist, it is possible that this patient will not be classified as having
“dropped out” of therapy. As above, future research that focuses on first-hand patient
experiences would clarify whether this has happened.
In addition, the data that we gathered reflect the limitations of making freedom-of-
information requests. Such requests are, by their nature, more restricted than the questions
used in typical surveys or psychometric research. The FOIA obliges public bodies to supply
recorded data that they hold, but does not oblige them to answer questions about what

Harm detection in ME/CFS treatment 15
information or material they do not hold. Also, public bodies do not have to respond to
questions about experiences and attitudes, such as whether a therapist would record a harm
when a patient said they had been made worse by the therapy even if the therapist disagreed.
Nor do such bodies have to answer direct questions about procedure, and so we did not ask
the clinics whether they warned patients about the controversy surrounding the safety of CBT
and GET. The best that we could do was to note such information if it was volunteered.
Finally, it is also possible that one or more of the clinics chose to withhold information that
we requested, but that would have been against the FOIA, and so we think it unlikely.
Conclusions
The present study aimed to get initial insights about how prepared English NHS
ME/CFS clinics are to deal with adverse outcomes during or after rehabilitative therapies.
Harms may be a decisive factor when weighing up costs and benefits of the therapies, given
the controversy over the therapies’ efficacy and the disputes about the quality of the evidence
that underpins them.
In that regard, it is striking that among the ME/CFS clinics surveyed in the present
study there was an almost universal absence of criteria for detecting harm, and that no clinic
reported any harm as having occurred in their patients. Four-fifths of the dataset did not give
any information about patients dropping out: of those that did, all of them reported that some
patients had dropped out during treatment, with one clinic reporting that as many as 44% of
patients did so. However, no clinic reported that they attributed any of this patient dropout to
treatment-related harm.
A related point is that clinics mainly reported providing little information to patients
about the possibility of harm, although several advised patients that setbacks or relapses
could happen. It may be useful for patients to be provided with information about the

Harm detection in ME/CFS treatment 16
prevalence of deterioration previously found in NHS CFS clinics (Collin & Crawley, 2017) or
reported in other surveys (Geraghty, Hann, & Kurtev, 2017), as well as information about the
relative pattern of harms reported for different treatments. Such information will be especially
important when seeking to obtain informed consent from patients prior to ME/CFS treatment.
Further, there would appear to be clear benefits to a national system for collecting
information from patients who believe they have been harmed by rehabilitative therapies,
similar to the UK’s Yellow Card Scheme for collecting information about adverse effects
arising from medical drugs or devices.
In the absence of any evidence that clinics systematically record or even screen for
harms that might arise from treatment for ME/CFS, clinics should ideally avoid making
assumptions that the therapies they offer are harmless because of their nature. This seems a
particularly pressing concern given the significant controversy over the evidence for the
efficacy of the rehabilitative therapies, and the widespread view among patients and
advocates that these therapies can cause harm. Instead, clinics should develop standardised
protocols for anticipating, preventing, and, where necessary, recording and remedying harms
for those patients affected by them. Such protocols should also provide for therapies to be
discontinued immediately wherever they are identified as causing patient harm.
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Harm detection in ME/CFS treatment 20
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Harm detection in ME/CFS treatment 21
Table 1
Information provided by ME/CFS clinics (N = 38) to patients regarding safety and risks of
rehabilitative therapies
Information n%
‘Setbacks’ or ‘relapses’ may happen. 15 40
Symptoms may worsen temporarily. 12 32
The therapy is safe as long as the increase in activity is gradual
or ‘done properly’ or ‘properly supervised’.
5 13
Patients are given criteria for when they should report worsening
symptoms to the therapist/clinic (e.g. new symptoms, worsening
that is serious/prolonged/worrying).
2 5
There is controversy or disagreement about the safety/risks of
the therapies.
1 3
Patients may be worse after the course of therapy than before. 0 0
Patients may be worse after the course of therapy than before:
‘long-term’ or for months or years.
0 0

Harm detection in ME/CFS treatment 22
Table 2.
Data provided by ME/CFS clinics (N = 38) relating to treatment harm
Information N of clinics that
provided data
Proportion of patients
for each clinic that
provided data
Patients recorded as harmed 17 0% for all
Patients recorded as having dropped out of
treatment
- overall 7 4%, 11%, 14%, 18%,
23%, 33%, 44%
- because of worsening or harm 5 0% for all
- for an unknown reason 7 4%, 5%, 7%, 14%,
17%, 18%, 26%
Patients reporting increase in symptoms for more
than a few days, and/or symptoms that have
become severe/distressing
2 0%, 65%
Patients lost to follow-up 4 4%, 27%, 64%, 75%