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HEAD TO HEAD: C Seth Landefeld, Kaveh G Shojania, and Andrew D Auerbach Should we use large scale healthcare interventions without clear evidence that benefits outweigh costs and harms? No BMJ 2008; 336: 1277 [Full text]

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The same coercive forces govern the need of large-scale health-care interventions

Grazyna T Adamiak   (11 June 2008)

Evidence or Action?

Arun Sivanandam, Mahendra Bhandari, MS, MCho(Uro), FAMS, DSc (Hon)   (12 June 2008)

The Parachute Approach

Bahaeddin A Shabaneh, MD, MBA, FACC   (7 September 2008)

The same coercive forces govern the need of large-scale health-care interventions 11 June 2008
Grazyna T Adamiak, PhD, MA, MH&W Unemployed Send response to journal: Re: The same coercive forces govern the need of large-scale health-care interventions	With regard to the need for evidence for conducting large-scale health care interventions, both Authors appear to agree that any intervention should be monitored and successively evaluated. They disagree what regards the conception of health care and the organizational layers contributing to the delivery of health care. Separation between organisation at a population, functional and institutional level and the individual or group practices of health care professionals at the technical or operational level. While Crumb on the Yes-side, having an experience from a publicly financed and governed health care system clearly separates between clinical or biological evidence regarding the human body and the evidence from social sciences on the social, construct organisation and political institutions, the No-side represents a view that the various kinds of evidence are not separable and they provide examples of interventions aimed at individual patients with consequences for parts of the health care system. While Crumb starts from the top-down or a whole, system or institutional managerial view on healthcare the No-side represents the bottom-up view on the same. The coercive forces they do not mention are the economic situation, epidemiology of diseases and the ongoing technological changes, and following, the need of every health care organisation to adjust to the changing and dynamic environment when the changes are so comprehensive that they have significant implications for the policy. These kinds of adjustments have the same driving forces, economy and technology, both in the private and in the publicly financed health systems independently of the mode of the delivery. Both kinds and organisation have to adjust to changing health care needs of populations. While tuberculosis was, a large health care problem in the 40-50-ies, later on large-scale vaccination programs eliminated the need of some parts of the health care services to the advantage of others even if these services were efficacious. The same occurred in the case of the day-surgery eliminating the need of excess inpatient beds in hospitals. The driving or coercive forces are market forces, or, with other words, the dynamics of the institutional environment. Competing interests: None declared
Evidence or Action? 12 June 2008
Arun Sivanandam, Research Assistant Vattikuti Urology Institute, Henry Ford Hospital, Detroit, MI, Mahendra Bhandari, MS, MCho(Uro), FAMS, DSc (Hon) Send response to journal: Re: Evidence or Action?	This head to head debate on large interventions in the absence of clear evidence has little scope for extreme positions. A growing trend of overemphasis on high level evidence has accorded an iconic status to Randomized Control Trials (RCTs) by journals, editors and readers alike. However, truth holds that neither are all RCTs worth that amount of respect nor are all Level 2-3 evidences worthless. In fact, RCTs can suffer from poor randomization and tend to exaggerate treatment effects by up to 41% (1). Additional bias from journals not willing to publish negative outcomes, even when the studies fulfill CONSORT criteria, dilutes the foregone sanctity of the term “Level 1 evidence”. As such, in the absence of available RCTs, assessment of the best available alternative evidence at that point is appropriate. The physician would always be the interface to implement the outcome of the study. Rather than interventions based on level of evidence alone, physicians should make a balanced judgment on the gravity of the situation weighing risks/benefits, independent of possible underlying academia- industrial nexus. Medicine has always pushed the frontiers on the basis of sound judgment sans evidence. If Murray and Merill had waited for Level 1 evidence, humanity would never have benefited from organ transplantation (2). Hence, high level evidence should not be a security blanket that impedes the growth of medicine. Considering that inaction may actually prove to be expensive for a situation, we are not recommending a rash approach. In absence of evidence, a combined judgment of patients and physicians as stakeholders is called for, following the principle: primum non nocere. References: 1. Adetugbo K, and Williams H. How well are Randomized Controlled Trials reported in the Dermatology literature? Arch Dermatol. 2000; 136:381-5. 2. Merril JP, Murray JE, Harrison JH and Guild WR. Successful homotransplantation of the human kidney between identical twins. J Am Med Assoc. 1956; 160:277-82. Competing interests: None declared
The Parachute Approach 7 September 2008
Bahaeddin A Shabaneh, MD, MBA, FACC, Cardiologist Oconee Medical Ctr , Seneca, South Carolina Send response to journal: Re: The Parachute Approach	The approach advocated by Crump (2008) is often referred to as the Parachute approach . This terminology was suggested by Smith and Bell (BMJ 2003;327:1459-1461 ) who concluded in their article “ … We think that everyone might benefit if the most radical protagonists of evidence based medicine organised and participated in a double blind, randomised, placebo controlled, crossover trial of the parachute” . Potts et al from UC Berkeley ( Potts et al 2006) advocated the Parachute approach in certain circumstances in underdeveloped countries where resources are limited. They used examples to support their argument like oral rehydration therapy in diarrhea, circumcision of males to decrease risks of HIV and misoprostol in postpartum hemorrhage. Parachute approach has created controversy among researchers. I personally believe that this approach might be needed in few exceptions as described above especially when conducting a large controlled trial is difficult and where waiting for it might be unethical. On the other hand evidence based medicine should be the standard and should be strongly encouraged in most situations. Although double blinded randomized trials are not completely perfect but they are the best way available to show the benefit of a test, procedure or a medicine. ( Pocock 1983: pp1-13) References: 1) Bernard Crump. Should we use large scale healthcare interventions without clear evidence that benefits outweigh costs and harms? Yes. BMJ 2008;336:1276 (7 June), doi:10.1136/bmj.a145. Available from : http://www.bmj.com/cgi/content/full/336/7656/1276 2) C Seth Landefeld, Kaveh G Shojania, and Andrew D Auerbach. Should we use large scale healthcare interventions without clear evidence that benefits outweigh costs and harms? No. BMJ 2008;336:1277 (7 June), doi:10.1136/bmj.a144. Available from: http://www.bmj.com/cgi/content/full/336/7656/1277 3) Smith G, Pell JP. Parachute use to prevent death and major trauma related to gravitational challenge: systematic review of randomised controlled trials. BMJ 2003;327: 1459-61 4) Potts M, Prata N, Walsh J, Grossman A. Parachute approach to evidence based medicine. BMJ 2006; 333: 701-3. 5) Pocock, S.J. (1983) ‘The rationale of clinical trials’. In: Pocock, S.J. Clinical trials: a practical approach. Chichester: John Wiley & Sons, pp.1−13 Competing interests: None declared