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We thank Dr Innes and his colleagues for their response. We are in the process of analysing data for admissions and mortality for subgroups defined by the three long-term conditions and predictive risk score. The trial was not powered for these subgroup analyses, although they were pre-specified. We will apply a checklist to assess the credibility of any effects [1].
References
[1] Sun X, Briel M, Busse JW, You JJ, Akl EA, Mejza F, et al. Credibility of claims of subgroup effects in randomised controlled trials: a systematic review. BMJ 2012;344:e1553 doi:10.1136/bmj.e1553
Competing interests: None declared
The Nuffield Trust, 59 New Cavendish Street, London W1G 7LP
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+We thank Professor Greenhalgh for her response. We agree with her about the importance of non-randomised studies. Yet at the same time, many commentators agree that randomised trials have an important role to play, and we hope that this trial will provide valuable information about telehealth.
Our analysis was conducted and written up in line with published recommendations [1] and our original protocol. Dissemination policies were governed by the standard contractual terms for projects funded by the DH Policy Research Programme [2]. The terms specified that permission to submit findings for publication cannot be withheld. Draft copies of proposed publications were sent to Department of Health in advance of submission for publication and clearance was given in line the contract. We favoured publication of the articles in the peer-reviewed press, so that the draft articles could be extensively examined.
As you note, the Department of Health published several documents during the peer review process [3]. The research team was not involved in these interpretations of the findings and the resulting documents. Our role has been to design and conduct a relevant and high-quality evaluation and to report the findings clearly and transparently. We believe we have done this with the peer-reviewed material.
References
[1] Campbell MK, Elbourne DR, Altman DG. CONSORT statement: extension to cluster randomised trials. BMJ 2004; 328:702-708
[2] Department of Health (2012). Policy Research Programme Guidance for Applicants. Available at: http://prp.dh.gov.uk
[3] Department of Health (2011). Whole system demonstrator programme: Headline findings – December 2011. Available at: www.dh.gov.uk/health/2011/12/wsd-headline-findings.
Competing interests: None declared
The Nuffield Trust, 59 New Cavendish Street, London W1G 7LP
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+We welcome this high quality randomised control trial1 as it fulfils the need for more robust evaluation of telehealth interventions with evidence to inform our commissioning decisions.
The outcomes of the research reducing secondary care, reductions in mortality are pertinent to primary commissioning outcomes. However the evidence for actual clinical effect of the hospital day’s difference on its own is reported to be not significant enough. Also, the conclusion that the study is not generalisable puts a limitation on local use of the findings to transfer the knowledge directly into our telehealth work.
Two things we noted of relevance to our work locally are firstly, for pathway design that the mechanism for avoiding emergency admissions is not yet clear and there is no indication of which end of risk stratification yields the best outcomes. Secondly, the study is not powered to pick up anything meaningful regarding dementia and their specific carers. We know dementia is going to be one of the biggest Long Term Conditions we need to deal with in the coming years. Early indications from local evaluation work with service providers and patients using telehealth interventions shows benefits for people with long term conditions including dementia. The main problem is the need to have the findings from cost effectiveness and quality of life studies to give us evidence on the outcomes for patients receiving telehealth and whether the studies collectively strengthens the evidence; we need the complete picture.
1. Steventon et al, Effect of telehealth on use of secondary care and mortality: findings from the Whole System Demonstrator cluster randomised trial. BMJ, 2012. 344.
Competing interests: None declared
Sandwell PCT , Kingston House, High Street, West Bromwich B70 9LD
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+Steventon et al present interesting data that raise more questions than are answered.
Telehealth takes many forms, and outcomes should not merely be in terms of mortality and pounds saved. In the North of Scotland we have used a combination of video conferencing and telephone consultations to consult with patients in our dispersed population who have chronic kidney disease.
We have seen an improvement in quality of service we can provide, and little or no reduction in our cost, but taking a wider view a reduction in costs to society in terms of patient travel, and time off work for patients and or carers.
We can see more patients in their locality by selecting patients for VC and telephone consultation which frees up out patient clinic space. In our practice this frequently prevents the need for a patient from making a 250 mile round trip, saving their time and reducing CO2 emissions. The feedback from our patients has been positive, and as a sceptical bunch of clinicians we have been pleasantly surprised to find that the quality of our consultations is not diminished.
The bigger picture needs to be seen and rural areas may have the most to benefit from from telehealth solutions.
BMJ2012;344:e3874
Competing interests: None declared
NHS Highland, Raigmore Hospital, Inverness,IV2 6XG
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+2 July 2012
In Steventon et al ‘s report on the effect of telehealth on use of secondary care and mortality the apparent benefits in the intervention arm appear to be driven largely by an unexplained increase in adverse events in the control arm following entry to the study.1 A possible explanation for this is that although this was intended to be a “usual care” arm the resources available to deliver usual care had in fact been diverted to provide the trial intervention. The methods state that the telehealth monitoring centres were “staffed by specialist nurses and community matrons from local health organisations” which must mean that they had been diverted from previous roles.
A particular anxiety in COPD has been that resources will be diverted towards unproven telehealth interventions at the expense of high-value interventions with a strong evidence base, specifically pulmonary rehabilitation which remains significantly under-provided in the UK. 2 3 Preliminary findings from the Whole System Demonstrator program presented at the King's Fund suggested the cost per quality adjusted life year (QALY) was in the region of £80,000. As outlined in the accompanying editorial,4 the evaluation of telehealth interventions is complex and needs to be considered within the wider health context. This must include the opportunity costs of investment of finite healthcare resources in this area.
1. Steventon A, Bardsley M, Billings J, Dixon J, Doll H, Hirani S, et al. Effect of telehealth on use of secondary care and mortality: findings from the Whole System Demonstrator cluster randomised trial. BMJ 2012;344.
2. Lacasse Y, Goldstein R, Lasserson TJ, Martin S. Pulmonary rehabilitation for chronic obstructive pulmonary disease. Cochrane Database Syst Rev 2006(4):CD003793.
3. Dodd JW, Hogg L, Nolan J, Jefford H, Grant A, Lord VM, et al. The COPD assessment test (CAT): response to pulmonary rehabilitation. A multicentre, prospective study. Thorax 2011;66(5):425-29.
4. Car J, Huckvale K, Hermens H. Telehealth for long term conditions. BMJ 2012;344.
Competing interests: None declared
NIHR Biomedical Research Unit at Royal Brompton Hospital and Imperial College, London, Royal Brompton Hospital, Fulham Rd, London SW3 6NP
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+We read with interest the recent report of the whole system demonstrator randomised controlled trial (WSD)[1]. This was a much needed study of the impact of an increasingly frequent intervention which until now has been deployed with relatively little evidence of efficacy. The headline reduction of an approximate halving of mortality within the intervention group is both impressive and surprising. This is mirrored by the reduction in hospital admissions of 5.3%. Figure 2 reveals this apparent intervention-related reduction in admissions is in fact an early increase in admissions in the control group when compared to baseline. As inferred by the authors this may be due to an increase in anxiety-related requests for admission as a consequence of the denial of telehealth in the control group. It is known that hospital admission can be associated with an increase in subsequent mortality[2, 3]. In particular, in patients with COPD (the largest group included in the trial) the recent Cochrane review comparing hospital at home with inpatient care suggested that the risk ratio for death is 0.65 in those managed at home[4]. Hospital admission appears to be bad for your health!
If hospital admission is the main reason for the greater mortality seen in the WSD control group then this should occur irrespective of the original inclusion diagnosis. We challenge the authors to present the relative risk of admission and death in their three diagnostic categories. If there is no difference then whilst the WSD demonstrates a significant impact on admissions, whether this is due to the intervention, or the unfulfilled expectation of telehealth, is a moot point.
1. Steventon et al, Effect of telehealth on use of secondary care and mortality: findings from the Whole System Demonstrator cluster randomised trial. BMJ, 2012. 344.
2. Shepperd, S.D., H. Angus, RM. Illiffe, S. Kaira, L Ricauda, NA. WIlson, AD., Hospital at home admission avoidance. Cochrane review, 2010.
3. Bell, C.R., MD,Mortality of patients admitted to hospital on weekends as compared with weekdays. New England Journal of Medicine, 2001. 345(9): p. 663-8.
4. Jeppesen E, B.K., Vist GE, Wedzicha JA, Wright JJ, Greenstone M, Walters JAE, Hospital at home for acute exacerbations of chronic obstructive pulmonary disease. Cochrane review, 2012.
Competing interests: None declared
Department of Academic Respiratory Medicine, Castle Hill Hospital, Cottingham, Hull HU16 5JQ
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+Limitations listed for this trial did not include close involvement of the funder in its design and execution. Under ‘Finances’, the authors state: “The Department of Health reviewed the protocol … and provided project manager support”.[1]
The Department of Health makes greater claims for its own involvement in the trial. In January 2012 it signed a ‘concordat’ with the technology industry, which referred to “a randomised controlled trial funded and run by the Department of Health” (paragraph 1).2
The authors have not commented formally on the substantial mismatch between their findings and conclusions (which were measured and cautious[1]) and those used by the Department of Health to inform policy (which were one-sided and sensationalist[2,3]), though individual WSD researchers have expressed misgivings.[4]
Randomised trials, which ‘control for’ context, have limited purchase for evaluating politically driven e-Health programmes.[5] The Department of Health’s cherry-picking of unanalysed data to put on its website before the trial had finished recruiting was scientifically inappropriate but politically expedient.[6]
The BMJ has led the field in exposing how the pharmaceutical industry’s conflicts of interest distort research. In failing to require the WSD’s authors to consider conflicts of interest by the state (whose intention to implement telehealth was enshrined in policy before the WSD results were analysed[7]), and in privileging randomised trials over study designs that allow analysis of political influences,[8] the BMJ has let itself to be used as a pawn by an increasingly powerful industrial-political complex.
1. Steventon A, Bardsley M, Billings J, Dixon J, Doll H, Hirani S, et al. Effect of telehealth on use of secondary care and mortality: findings from the Whole System Demonstrator cluster randomised trial. BMJ 2012;344:e3874.
2. Department of Health. A concordat between the Department of Health and the telehealth/telecare industry. http://www.3millionlives.co.uk/pdf/Concordat - FINAL.pdf. London: Department of Health, 2012.
3. Department of Health. Whole Systems Demonstrator: Headline findings December 2011. London: Stationery Office, 2011.
4. Praities N. Telehealth 'unlikely to be cost effective', admit researchers leading DH pilot. Pulse 2012;http://www.pulsetoday.co.uk/newsarticle-content/-/article_display_list/13585495/telemedicine-unlikely-to-be-cost-effective-admit-researchers-leading-dh-pilot.
5. Greenhalgh T, Russell J. Why Do Evaluations of eHealth Programs Fail? An Alternative Set of Guiding Principles. PLoS Med 2010;7(11):e1000360.
6. Greenhalgh T. Whole System Demonstrator: Desperately seeking peer-reviewed papers (rapid response). BMJ 2011:http://www.bmj.com/rapid-response/2011/11/03/whole-system-demonstrator-desperately-seeking-peer-reviewed-papers
7. Department of Health. Operating Framework 2012-13. London: Stationery Office, 2011.
8. Greenhalgh T, Procter R, Wherton J, Sugarhood P, Shaw S. The organising vision for telehealth and telecare: discourse analysis. BMJ Open 2012;in press.
Competing interests: None declared
Queen Mary University of London, 58 Turner St London E1 2AB
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