- Email: [email protected]
Evidence base for interventions in complex emergencies
Correspondence
Ben Aris
American Academy of Neurology issued a practice parameter recommending that gastrostomy be done before the FVC fell below this level.4 Since then, investigators seem to have made significant progress: several groups have assessed other techniques for detecting early respiratory insufficiency, including measurement of sniff nasal pressure and oximetry. Although there are still no randomised trials of gastrostomy, safety seems to have been improved in people with advanced ALS by a combination of careful preoperative assessment and the use of percutaneous radiological techniques, which avoid sedation and general anaesthesia.5 If we are to avoid the same problems when assessing future surgical treatments, it will be helpful to consider the experience with gastrostomy carefully. Huang might have done much to avoid postoperative mortality by injecting cells under local anaesthetic. Nevertheless, we need more information about the safety of this technique. It would be particularly important to describe the events that led to the deaths of two patients, and autopsy data might provide some evidence of OEC viability. An estimate of the postoperative survival rate would also be of interest. These preliminary results might allow people with ALS and their physicians to reach tentative conclusions about the short-term risks of intracerebral injections of OEC treatment and could inform the design of future surgical trials to assess efficacy. I declare that I have no conflict of interest.
R J Swingler [email protected] Department of Neurology, Ninewells Hospital, Dundee DD1 9SY, UK 1 2
3
4
842
Watts J. Controversy in China. Lancet 2005; 365: 109–10. Mazzini L, Fagioli F, Boccaltetti R. Stem-cell therapy in amyotrophic lateral sclerosis. Lancet 2004; 364: 1936–37. Freed CR, Greene PE, Breeze RE, et al. Transplantation of embryonic dopamine neurons for severe Parkinson’s disease. N Engl J Med 2001; 344: 710–19. Miller RG, Rosenberg JA, Gelinas DF, et al. Practice parameter: the care of the patient with
5
amyotrophic lateral sclerosis (an evidencebased review). Report of the Quality Standards Subcommittee of the American Academy of Neurology: ALS Practice Parameters Task Force. Neurology 1999; 52: 1311–23. Leigh PN, Abrahams S, Al-Chalabi A, et al, and the King’s MND Care and Research Team. The management of motor neurone disease. J Neurol Neurosurg Psychiatry 2003; 74 (suppl IV): iv32–47.
The Kozijavkin method: giving parents false hope? In his Nov 27 World Report (p 1927),1 Ben Aris describes Vladimir Kozijavkin’s method for the treatment of children with cerebral palsy. We certainly appreciate Kozijavkin’s efforts to improve life for children with cerebral palsy, but we are concerned that Aris’ account might give many parents false hope. Cerebral palsy is a serious developmental disorder with a high prevalence—it affects about one per 500 liveborn babies.2 The condition has a great effect on the daily life of the child and his or her family. No wonder that people through the ages have tried to improve the functional outcome in children with cerebral palsy. Various methods of physiotherapeutical treatment have been developed, such as neurodevelopmental treatment, treatment according to Vojta, or conductive education according to Petö. These methods are based on varying views on developmental principles of the nervous system and varying views on basic principles in education. There is no evidence to suggest any of these methods are effective.3,4 The basic idea of Kozijavkin’s treatment is the provision of proprioceptive stimuli and unlocking of vertebral column segments. These stimuli are assumed to trigger central nervous circuitries, a process which is in turn thought to facilitate the development of motor skills. A large part of the treatment consists of passive procedures— ie, procedures that do not improve functional outcome.3 Results of studies5 indicate that active and intensive training of functional and mean-
ingful skills is the most promising principle for physiotherapeutical guidance of children with cerebral palsy. Our worry is that publication of the Kozijavkin method in The Lancet will give many parents of children with cerebral palsy the hope that this magic method is an effective treatment. However, we are not aware of any evidence of the effectiveness of the Kozijavkin method. We therefore advise our Ukrainian colleagues to report their results in a peer-reviewed journal. Only then can your readers be reassured the technique works. We declare that we have no conflict of interest.
*Mijna Hadders-Algra, Tineke Dirks, Cornill Blauw-Hospers, Victorine de Graaf-Peters [email protected] University of Groningen, Department of Neurology/Developmental Neurology, Hanzeplein 1, 9713 GZ Groningen, Netherlands 1 2
3
4
5
Aris B. The Kozijavkin method. Lancet 2004; 364: 1927–28. Stanley F, Blair E, Alberman E. Cerebral palsies: epidemiology and causal pathways. London: Mac Keith Press, 2000. Butler C, Darrah J. Effects of neurodevelopmental treatment (NDT) for cerebral palsy: an AACPDM evidence report. Dev Med Child Neurol 2001; 43: 778–90. Darrah J, Watkins B, Chen L, Bonin C. Conductive education intervention for children with cerebral palsy: an AACPDM evidence report. Dev Med Child Neurol 2004; 46: 187–204. Ketelaar M, Vermeer A, Hart H, et al. Effects of a functional physiotherapy program on motor abilities of children with cerebral palsy. Phys Ther 2001; 81: 1534–45.
Evidence base for interventions in complex emergencies R F Mollica and colleagues (Dec 4, p 2058)1 state that “public health experts have called for all health interventions in complex emergencies to be evidence-based”. Although the call may have gone out, we fear it has not been heeded. Indeed, The Lancet’s Series on complex emergencies largely fails to acknowledge this acute lack of an evidence base.2,3 We have reviewed published papers to assess the impact and www.thelancet.com Vol 365 March 5, 2005
Correspondence
Impact assessment General ration distribution 9 Supplementary feeding programmes 15 Therapeutic feeding programmes 16 Vitamin A supplementation 0 Bed-nets 0 Measles vaccination programmes 0
Economic evaluation 0 1 1 0 1 0
Table: Number of published impact and economic evaluation studies undertaken on various interventions during emergencies
1
2
3
4
cost-effectiveness of six health-related emergency interventions.4 The interventions reviewed were: general rations, supplementary feeding, therapeutic feeding, measles vaccination, vitamin A supplementation, and bed-nets. Given the large amount of funds being spent on these types of interventions in emergencies, we were astonished to find so little information in the public domain about their impact and cost-effectiveness (table). The lack of published impact and cost-effectiveness information, particularly in relation to emergency feeding and food security support programmes, is of much concern. There are key areas of uncertainty about the relative usefulness of certain types of intervention— eg, expanded general ration distribution versus general ration distribution in conjunction with targeted supplementary feeding programmes—and over issues of design within programme types—eg, community versus administrative targeting in general ration programmes. There are also rapidly emerging new types of programming at the interface of HIV and nutrition for which impact and cost information is urgently needed. There are several understandable reasons for the dearth of published information, including the ethical difficulties of undertaking research in emergencies.5 However, one over-arching key factor is the absence of an agency with responsibility for taking an overview of the effectiveness of different types of intervention. This lack of corporate accountability has allowed the institutional status quo to prevail. Thus agencies that have built up expertise and mandates around certain types of www.thelancet.com Vol 365 March 5, 2005
intervention (or intervention design) will continue to practise these interventions in emergencies without serious examination or challenge. Given the multiplicity of stakeholders and vested interests in this sector, we believe that an independent body or institutional mechanism should be created with responsibility for increasing information on impact and cost-effectiveness in this sector. Without establishing such a body, little is likely to change. This body would take responsibility for identifying key gaps in knowledge about impact and costeffectiveness. It will develop and coordinate mechanisms for making greater use of the grey literature and promoting impact studies. The agency would also have an advocacy role where emerging evidence indicates a need for change in implementation practice. There is an urgent need to generate this evidence base for planning and decision-making. Limited resources are available to respond to sometimes immense initial requirements and competing needs. Under these circumstances, resources are easily wasted. However, to date, cost-effectiveness has seldom been considered in the prioritisation and assessment of emergency interventions. We declare that we have no conflict of interest.
Arabella Duffield, Garth Reid, *Jeremy Shoham, Damian Walker [email protected] Save the Children, London, UK (AD); Department of Public Health, University of Aberdeen, School of Medicine, Aberdeen, UK (GR); *Emergency Nutrition Netword, Unit 13, Standingford House, Cave Street, Oxford OX4 1BA, UK (JS); Health Policy Unit, London School of Hygiene and Tropical Medicine, London, UK (DW)
5
Mollica RF, Lopez Cardozo B, Osofsky HJ, Raphael B, Ager A, Salama P. Mental health in complex emergencies. Lancet 2004; 364: 2058–67. Connolly MA, Gayer M, Ryan MJ, Salama P, Spiegel P, Heyman DL. Communicable diseases in complex emergencies: impact and challenges. Lancet 2004; 364: 1974–83. Young H, Borrel A, Holland D, Salama P. Public nutrition in complex emergencies. Lancet 2004; 364: 1899–909. Duffield A, Reid G, Shoham J, Walker D. Review of the published literature for the impact and cost effectiveness of 6 nutrition related emergency interventions. Report prepared by the Emergency Nutrition Network, Dec 2004. http://www. ennonline.net. Leaning J. Ethics of research in refugee populations. Lancet 2001; 357: 1432–33.
Procurement of organs from executed prisoners In his 2004 Supplement article (p s30),1 Thomas Diflo encourages the western transplant community to put political, economical, scientific, and educational pressure on the Chinese authorities to halt the barbaric procurement of organs from executed prisoners. Diflo is right, but for his views not to be interpreted as paternalistic neocolonialist lectures, we must acknowledge that organs were also harvested in this way in western democracies not so long ago. The first cadaver kidney transplants in France were obtained from guillotined prisoners2,3 and similar practices also occurred in the USA.4 Diflo is also right when he states that “the complicity of the surgeon who will do the transplantation is needed”. What he does not mention, however, is that a willing recipient is also needed, as well as a follow-up transplant clinic in the west. It follows that in all the countries that condemn the practice, any potential organ recipient should be formally informed that if he or she accepts abroad an organ from an executed prisoner or of illegal or non-traceable origin, he or she will be denied access to transplant follow-up clinics. Such a policy may seem hard and uncharitable but, after 843
Ben Aris
American Academy of Neurology issued a practice parameter recommending that gastrostomy be done before the FVC fell below this level.4 Since then, investigators seem to have made significant progress: several groups have assessed other techniques for detecting early respiratory insufficiency, including measurement of sniff nasal pressure and oximetry. Although there are still no randomised trials of gastrostomy, safety seems to have been improved in people with advanced ALS by a combination of careful preoperative assessment and the use of percutaneous radiological techniques, which avoid sedation and general anaesthesia.5 If we are to avoid the same problems when assessing future surgical treatments, it will be helpful to consider the experience with gastrostomy carefully. Huang might have done much to avoid postoperative mortality by injecting cells under local anaesthetic. Nevertheless, we need more information about the safety of this technique. It would be particularly important to describe the events that led to the deaths of two patients, and autopsy data might provide some evidence of OEC viability. An estimate of the postoperative survival rate would also be of interest. These preliminary results might allow people with ALS and their physicians to reach tentative conclusions about the short-term risks of intracerebral injections of OEC treatment and could inform the design of future surgical trials to assess efficacy. I declare that I have no conflict of interest.
R J Swingler [email protected] Department of Neurology, Ninewells Hospital, Dundee DD1 9SY, UK 1 2
3
4
842
Watts J. Controversy in China. Lancet 2005; 365: 109–10. Mazzini L, Fagioli F, Boccaltetti R. Stem-cell therapy in amyotrophic lateral sclerosis. Lancet 2004; 364: 1936–37. Freed CR, Greene PE, Breeze RE, et al. Transplantation of embryonic dopamine neurons for severe Parkinson’s disease. N Engl J Med 2001; 344: 710–19. Miller RG, Rosenberg JA, Gelinas DF, et al. Practice parameter: the care of the patient with
5
amyotrophic lateral sclerosis (an evidencebased review). Report of the Quality Standards Subcommittee of the American Academy of Neurology: ALS Practice Parameters Task Force. Neurology 1999; 52: 1311–23. Leigh PN, Abrahams S, Al-Chalabi A, et al, and the King’s MND Care and Research Team. The management of motor neurone disease. J Neurol Neurosurg Psychiatry 2003; 74 (suppl IV): iv32–47.
The Kozijavkin method: giving parents false hope? In his Nov 27 World Report (p 1927),1 Ben Aris describes Vladimir Kozijavkin’s method for the treatment of children with cerebral palsy. We certainly appreciate Kozijavkin’s efforts to improve life for children with cerebral palsy, but we are concerned that Aris’ account might give many parents false hope. Cerebral palsy is a serious developmental disorder with a high prevalence—it affects about one per 500 liveborn babies.2 The condition has a great effect on the daily life of the child and his or her family. No wonder that people through the ages have tried to improve the functional outcome in children with cerebral palsy. Various methods of physiotherapeutical treatment have been developed, such as neurodevelopmental treatment, treatment according to Vojta, or conductive education according to Petö. These methods are based on varying views on developmental principles of the nervous system and varying views on basic principles in education. There is no evidence to suggest any of these methods are effective.3,4 The basic idea of Kozijavkin’s treatment is the provision of proprioceptive stimuli and unlocking of vertebral column segments. These stimuli are assumed to trigger central nervous circuitries, a process which is in turn thought to facilitate the development of motor skills. A large part of the treatment consists of passive procedures— ie, procedures that do not improve functional outcome.3 Results of studies5 indicate that active and intensive training of functional and mean-
ingful skills is the most promising principle for physiotherapeutical guidance of children with cerebral palsy. Our worry is that publication of the Kozijavkin method in The Lancet will give many parents of children with cerebral palsy the hope that this magic method is an effective treatment. However, we are not aware of any evidence of the effectiveness of the Kozijavkin method. We therefore advise our Ukrainian colleagues to report their results in a peer-reviewed journal. Only then can your readers be reassured the technique works. We declare that we have no conflict of interest.
*Mijna Hadders-Algra, Tineke Dirks, Cornill Blauw-Hospers, Victorine de Graaf-Peters [email protected] University of Groningen, Department of Neurology/Developmental Neurology, Hanzeplein 1, 9713 GZ Groningen, Netherlands 1 2
3
4
5
Aris B. The Kozijavkin method. Lancet 2004; 364: 1927–28. Stanley F, Blair E, Alberman E. Cerebral palsies: epidemiology and causal pathways. London: Mac Keith Press, 2000. Butler C, Darrah J. Effects of neurodevelopmental treatment (NDT) for cerebral palsy: an AACPDM evidence report. Dev Med Child Neurol 2001; 43: 778–90. Darrah J, Watkins B, Chen L, Bonin C. Conductive education intervention for children with cerebral palsy: an AACPDM evidence report. Dev Med Child Neurol 2004; 46: 187–204. Ketelaar M, Vermeer A, Hart H, et al. Effects of a functional physiotherapy program on motor abilities of children with cerebral palsy. Phys Ther 2001; 81: 1534–45.
Evidence base for interventions in complex emergencies R F Mollica and colleagues (Dec 4, p 2058)1 state that “public health experts have called for all health interventions in complex emergencies to be evidence-based”. Although the call may have gone out, we fear it has not been heeded. Indeed, The Lancet’s Series on complex emergencies largely fails to acknowledge this acute lack of an evidence base.2,3 We have reviewed published papers to assess the impact and www.thelancet.com Vol 365 March 5, 2005
Correspondence
Impact assessment General ration distribution 9 Supplementary feeding programmes 15 Therapeutic feeding programmes 16 Vitamin A supplementation 0 Bed-nets 0 Measles vaccination programmes 0
Economic evaluation 0 1 1 0 1 0
Table: Number of published impact and economic evaluation studies undertaken on various interventions during emergencies
1
2
3
4
cost-effectiveness of six health-related emergency interventions.4 The interventions reviewed were: general rations, supplementary feeding, therapeutic feeding, measles vaccination, vitamin A supplementation, and bed-nets. Given the large amount of funds being spent on these types of interventions in emergencies, we were astonished to find so little information in the public domain about their impact and cost-effectiveness (table). The lack of published impact and cost-effectiveness information, particularly in relation to emergency feeding and food security support programmes, is of much concern. There are key areas of uncertainty about the relative usefulness of certain types of intervention— eg, expanded general ration distribution versus general ration distribution in conjunction with targeted supplementary feeding programmes—and over issues of design within programme types—eg, community versus administrative targeting in general ration programmes. There are also rapidly emerging new types of programming at the interface of HIV and nutrition for which impact and cost information is urgently needed. There are several understandable reasons for the dearth of published information, including the ethical difficulties of undertaking research in emergencies.5 However, one over-arching key factor is the absence of an agency with responsibility for taking an overview of the effectiveness of different types of intervention. This lack of corporate accountability has allowed the institutional status quo to prevail. Thus agencies that have built up expertise and mandates around certain types of www.thelancet.com Vol 365 March 5, 2005
intervention (or intervention design) will continue to practise these interventions in emergencies without serious examination or challenge. Given the multiplicity of stakeholders and vested interests in this sector, we believe that an independent body or institutional mechanism should be created with responsibility for increasing information on impact and cost-effectiveness in this sector. Without establishing such a body, little is likely to change. This body would take responsibility for identifying key gaps in knowledge about impact and costeffectiveness. It will develop and coordinate mechanisms for making greater use of the grey literature and promoting impact studies. The agency would also have an advocacy role where emerging evidence indicates a need for change in implementation practice. There is an urgent need to generate this evidence base for planning and decision-making. Limited resources are available to respond to sometimes immense initial requirements and competing needs. Under these circumstances, resources are easily wasted. However, to date, cost-effectiveness has seldom been considered in the prioritisation and assessment of emergency interventions. We declare that we have no conflict of interest.
Arabella Duffield, Garth Reid, *Jeremy Shoham, Damian Walker [email protected] Save the Children, London, UK (AD); Department of Public Health, University of Aberdeen, School of Medicine, Aberdeen, UK (GR); *Emergency Nutrition Netword, Unit 13, Standingford House, Cave Street, Oxford OX4 1BA, UK (JS); Health Policy Unit, London School of Hygiene and Tropical Medicine, London, UK (DW)
5
Mollica RF, Lopez Cardozo B, Osofsky HJ, Raphael B, Ager A, Salama P. Mental health in complex emergencies. Lancet 2004; 364: 2058–67. Connolly MA, Gayer M, Ryan MJ, Salama P, Spiegel P, Heyman DL. Communicable diseases in complex emergencies: impact and challenges. Lancet 2004; 364: 1974–83. Young H, Borrel A, Holland D, Salama P. Public nutrition in complex emergencies. Lancet 2004; 364: 1899–909. Duffield A, Reid G, Shoham J, Walker D. Review of the published literature for the impact and cost effectiveness of 6 nutrition related emergency interventions. Report prepared by the Emergency Nutrition Network, Dec 2004. http://www. ennonline.net. Leaning J. Ethics of research in refugee populations. Lancet 2001; 357: 1432–33.
Procurement of organs from executed prisoners In his 2004 Supplement article (p s30),1 Thomas Diflo encourages the western transplant community to put political, economical, scientific, and educational pressure on the Chinese authorities to halt the barbaric procurement of organs from executed prisoners. Diflo is right, but for his views not to be interpreted as paternalistic neocolonialist lectures, we must acknowledge that organs were also harvested in this way in western democracies not so long ago. The first cadaver kidney transplants in France were obtained from guillotined prisoners2,3 and similar practices also occurred in the USA.4 Diflo is also right when he states that “the complicity of the surgeon who will do the transplantation is needed”. What he does not mention, however, is that a willing recipient is also needed, as well as a follow-up transplant clinic in the west. It follows that in all the countries that condemn the practice, any potential organ recipient should be formally informed that if he or she accepts abroad an organ from an executed prisoner or of illegal or non-traceable origin, he or she will be denied access to transplant follow-up clinics. Such a policy may seem hard and uncharitable but, after 843