http://informahealthcare.com/dre ISSN 0963-8288 print/ISSN 1464-5165 online Disabil Rehabil, 2015; 37(5): 464 ! 2014 Informa UK Ltd. DOI: 10.3109/09638288.2014.952455
LETTER TO THE EDITOR
Response to Gladwell et al.: concerns about safety for GET Anna Sheridan Glasgow, UK
It is commendable that Gladwell et al. [1] have sought to understand the discrepancy between randomised controlled trials (RCT) data and survey data in the rehabilitation of people with chronic fatigue syndrome/myalgic encephalomyelitis (CFS/ME). Survey data from multiple countries consistently demonstrates high rates of adverse reactions similar to those obtained in the Action for ME survey and are an important indication of how patients experience a treatment ‘‘on the ground’’ outside the confines of a clinical trial [2]. However, I have a number of concerns regarding the conclusions that the authors make about these discrepancies. Firstly, the authors seem to consider that only methodological differences, such as how the treatment is administered, could account for the different outcomes observed. The extent to which findings from RCTs can be reliably generalised to larger patient populations has been questioned [3,4]. It is possible for example that participants and clinicians alter their behaviour as a result of being part of a study, which may lead to better outcomes from RCTs compared to outcomes from treatment that takes place in the community. Even with the expected benefits of being part of a non-blinded medical trial, the addition of GET to patient’s medical care only led to an additional 15% of patients reporting improvements in subjectively measured fatigue [and 12% for subjectively measured physical function]. Secondly, the demographic covered in surveys is likely to be different to those who take part in the RCTs. In particular the severely affected, who are estimated to make up between 10% and 25% of the patient population [5], are generally excluded from trials, such as PACE which focused on mild to moderate patients able to attend a clinic. However one exception is the FINE trial [6], which found that rehabilitation strategies (which included elements of GET) resulted in no improvement for those house or bed bound. Others who are unable to take part in RCTs include those for whom travelling is difficult either due to additional medical problems (such as postural orthostatic tachycardia syndrome) or lack of access to transport. RCTs therefore only provide results for a subset of the patient population. This raises important questions about the safety of these treatments; perhaps the discrepancies observed between RCT and survey data simply indicate that the patient populations who have not taken part in the RCT are those most likely to be adversely affected by those treatments. This relates to my main concern about this paper. The authors suggest that changing therapist training and developing quality
Address for correspondence: Anna Sheridan, Glasgow, UK. E-mail: [email protected]
criteria for rehabilitation interventions will be sufficient to guarantee treatment safety for patients. It is not clear that this would be the case, and is of particular concern given the poor reporting of harms in this types of treatment discussed in detail by Kindlon [2]. The action for ME survey studied in this paper reports that 60% of those citing GET as their most recent form of rehabilitation and 26% citing GAT reported feeling worse following the treatment. The deterioration rates from the PACE trial have not yet been released, however it seems unlikely that the measures outlined by Gladwell et al. [1] will ever be able to guarantee patient safety. The PACE trial [7] was carried out in carefully controlled conditions which would be hard to replicate in a clinical setting. If outcomes are extremely sensitive to the exact implementation protocol, the likelihood of administering this treatment without causing harm to a significant proportion of patients seems low. A better conclusion from this analysis might be that it is imperative for a wide range of subjective and objective measures to be used whenever these treatments are carried out. This would enable us to determine not only the efficacy of the treatments but also any adverse reactions, both long and short term. In addition, such data should include follow-up for at least two years after the treatment has finished. Finally such data should be made publicly available, so that independent analyses can be undertaken.
References 1. Gladwell PW, Pheby D, Rodriguez T, Poland F. Use of an online survey to explore positive and negative outcomes of rehabilitation for people with CFS/ME. Disabil Rehabil 2014;36:387–94. 2. Kindlon T. Reporting of harms associated with graded exercise therapy and cognitive behavioural therapy in myalgic encephalomyelitis/chronic fatigue syndrome. Bull IACFS/ME 2011;19: 59–111. 3. Rawlins M. De Testimonio: on the evidence for decisions about the use of therapeutic interventions. Clin Med 2008;8:579–88. 4. Rawlins MD. De testimonio. London: Royal College of Physicians; 2008. 5. NICE. ‘‘Chronic fatigue syndrome/myalgic encephalomyelitis (or encephalopathy) Costing report Implementing NICE guidance’’; 2007. 6. Wearden AJ, Riste L, Dowrick C, et al. Fatigue Intervention by Nurses Evaluation – The FINE Trial. A randomised controlled trial of nurse led self-help treatment for patients in primary care with chronic fatigue syndrome: study protocol. BMC Med 2006;4:9. 7. White PD, Goldsmith KA, Johnson AL, et al. Comparison of adaptive pacing therapy, cognitive behaviour therapy, graded exercise therapy, and specialist medical care for chronic fatigue syndrome (PACE): a randomised trial. Lancet 2011;377:823–36.
Copyright of Disability & Rehabilitation is the property of Taylor & Francis Ltd and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use.
LETTER TO THE EDITOR
Response to Gladwell et al.: concerns about safety for GET Anna Sheridan Glasgow, UK
It is commendable that Gladwell et al. [1] have sought to understand the discrepancy between randomised controlled trials (RCT) data and survey data in the rehabilitation of people with chronic fatigue syndrome/myalgic encephalomyelitis (CFS/ME). Survey data from multiple countries consistently demonstrates high rates of adverse reactions similar to those obtained in the Action for ME survey and are an important indication of how patients experience a treatment ‘‘on the ground’’ outside the confines of a clinical trial [2]. However, I have a number of concerns regarding the conclusions that the authors make about these discrepancies. Firstly, the authors seem to consider that only methodological differences, such as how the treatment is administered, could account for the different outcomes observed. The extent to which findings from RCTs can be reliably generalised to larger patient populations has been questioned [3,4]. It is possible for example that participants and clinicians alter their behaviour as a result of being part of a study, which may lead to better outcomes from RCTs compared to outcomes from treatment that takes place in the community. Even with the expected benefits of being part of a non-blinded medical trial, the addition of GET to patient’s medical care only led to an additional 15% of patients reporting improvements in subjectively measured fatigue [and 12% for subjectively measured physical function]. Secondly, the demographic covered in surveys is likely to be different to those who take part in the RCTs. In particular the severely affected, who are estimated to make up between 10% and 25% of the patient population [5], are generally excluded from trials, such as PACE which focused on mild to moderate patients able to attend a clinic. However one exception is the FINE trial [6], which found that rehabilitation strategies (which included elements of GET) resulted in no improvement for those house or bed bound. Others who are unable to take part in RCTs include those for whom travelling is difficult either due to additional medical problems (such as postural orthostatic tachycardia syndrome) or lack of access to transport. RCTs therefore only provide results for a subset of the patient population. This raises important questions about the safety of these treatments; perhaps the discrepancies observed between RCT and survey data simply indicate that the patient populations who have not taken part in the RCT are those most likely to be adversely affected by those treatments. This relates to my main concern about this paper. The authors suggest that changing therapist training and developing quality
Address for correspondence: Anna Sheridan, Glasgow, UK. E-mail: [email protected]
criteria for rehabilitation interventions will be sufficient to guarantee treatment safety for patients. It is not clear that this would be the case, and is of particular concern given the poor reporting of harms in this types of treatment discussed in detail by Kindlon [2]. The action for ME survey studied in this paper reports that 60% of those citing GET as their most recent form of rehabilitation and 26% citing GAT reported feeling worse following the treatment. The deterioration rates from the PACE trial have not yet been released, however it seems unlikely that the measures outlined by Gladwell et al. [1] will ever be able to guarantee patient safety. The PACE trial [7] was carried out in carefully controlled conditions which would be hard to replicate in a clinical setting. If outcomes are extremely sensitive to the exact implementation protocol, the likelihood of administering this treatment without causing harm to a significant proportion of patients seems low. A better conclusion from this analysis might be that it is imperative for a wide range of subjective and objective measures to be used whenever these treatments are carried out. This would enable us to determine not only the efficacy of the treatments but also any adverse reactions, both long and short term. In addition, such data should include follow-up for at least two years after the treatment has finished. Finally such data should be made publicly available, so that independent analyses can be undertaken.
References 1. Gladwell PW, Pheby D, Rodriguez T, Poland F. Use of an online survey to explore positive and negative outcomes of rehabilitation for people with CFS/ME. Disabil Rehabil 2014;36:387–94. 2. Kindlon T. Reporting of harms associated with graded exercise therapy and cognitive behavioural therapy in myalgic encephalomyelitis/chronic fatigue syndrome. Bull IACFS/ME 2011;19: 59–111. 3. Rawlins M. De Testimonio: on the evidence for decisions about the use of therapeutic interventions. Clin Med 2008;8:579–88. 4. Rawlins MD. De testimonio. London: Royal College of Physicians; 2008. 5. NICE. ‘‘Chronic fatigue syndrome/myalgic encephalomyelitis (or encephalopathy) Costing report Implementing NICE guidance’’; 2007. 6. Wearden AJ, Riste L, Dowrick C, et al. Fatigue Intervention by Nurses Evaluation – The FINE Trial. A randomised controlled trial of nurse led self-help treatment for patients in primary care with chronic fatigue syndrome: study protocol. BMC Med 2006;4:9. 7. White PD, Goldsmith KA, Johnson AL, et al. Comparison of adaptive pacing therapy, cognitive behaviour therapy, graded exercise therapy, and specialist medical care for chronic fatigue syndrome (PACE): a randomised trial. Lancet 2011;377:823–36.
Copyright of Disability & Rehabilitation is the property of Taylor & Francis Ltd and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use.
