Treating obesity in individuals and populations
BMJ 2005; 331 doi: https://doi.org/10.1136/bmj.331.7529.1387 (Published 08 December 2005) Cite this as: BMJ 2005;331:1387
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At the end of last year Anjali Jain reviewed the highly emotive
subject of obesity. (1) This may well be top of the medical and
critically, political agenda for many years. Several differing viewpoints
were offered in the BMJ 'rapid responses' from diverse fields; often
disagreeing with the conclusions offered. The real answer may have
arrived.
This January we saw the publication of the draft version (2) of the
training and curriculum document for the new Faculty of Sport and Exercise
Medicine (SEM) UK, guardians of the newest medical speciality. This
document describes the proposed aims and responsibilities of the
speciality for the first time, as well as the specialist training syllabus
for, initially, a chosen few.
The next stage of development is to educate the general populous, the
profession, and those allied to us, exactly what service Sports and
Exercise Physicians can provide.
The name perhaps betrays the true potential and scope of a field that if
handled well has the chance to impact on every subsection of society, no
matter what age, race or medical history.
At a time when the Western World is besieged by the accumulating
consequences of obesity and under activity, new interventions and a whole
new way of thinking is surely required.
These lifestyle challenges are widely accepted as expensive to manage
if given room to develop, only this week the National Institue of Health
and Clinical Excellence (NICE) approved gastric stapling in children. If
the metabolic consequences of endemic obesity are allowed to develop as
they have in the USA over a short time period, obesity may go down in
history as the expediter of the demise of our health care system. Consider
these issues in light of the historical reaction to self inflicted health
problems; it took us 50 years to decide that the unquestionable findings
of Doll and Hill required significant Government action. (3) However, the
greatest slur on our management of health in the UK may come sooner than
expected, when we live to see the first generation that has a lower life
expectancy than its parents.
The message is simple; the application of increased levels of activity to
virtually any member of society has the potential to improve quality of
life, and longevity. It has always been the challenge of the athletic
coach to design activities that are safe, simple, affordable, and
critically, measurably effective. These same principles are fast being
gelled with knowledge of general medical conditions, sports biomechanics,
and the recent explosion of advance in molecular physiology (and
nutrition) to form a robust evidence base as the foundation for Sports and
Exercise Medicine.
Unlike many specialities, this one is formed from personnel who have a
broad experience base; surgeons, cardiologists, general practitioners and
biological scientists. They also have the shared interest in advancing
methods of optimising athletic and sporting ability. These may be the
drives that keep them together in the close community they have
unofficially resided for years, adding to their cohesion and impact as a
group. If the general health issues described become the focus of much of
the energy of the new speciality it begs the question: What are the
potential benefits for the elite British sportsperson?
Hopefully, with central coordination, hospital bases, and secured funding,
we will rapidly see the development and application of evidence-based
therapies for the common injuries that afflict so many of us, yet until
now have had no obvious foci for coordinated treatment within the NHS.
These improvements are only possible in the care of a strong, modern
speciality with the ability to design and benefit from quality clinical
trials.
The birth of a new speciality is a time for optimism. The best scenario I
envisage is a speciality that will grow in strength alongside the diverse
specialities that have supported its development this far. In time SEM may
become the force that leads a paradoxical charge at both ends of the
spectrum of physical ability. A new proactive dimension to the concept of
preventative medicine should live comfortably alongside improved 21st
century care for the sporting elite; our example of what can be achieved.
1. Anjali Jain .Treating obesity in individuals and populations. BMJ
2005; 331: 1387-1390
2. Sport and Exercise Medicine Training and Curriculum (January 2006)
(http://www.rcsed.ac.uk/site/CMD=VIEW/DOCID=fa278801-50cc-4231-8092-
83cfc888980d/596/default.aspx)
3. Doll R, Bradford Hill A. Smoking and carcinoma of the lung:
preliminary report. British medical journal, 1950, 2: 739–748.
Competing interests:
None declared
Competing interests: No competing interests
I read with interest the recent article by Anjali Jain
(1) discussing the issue of obesity. The author is to be congratulated for
preparing such a comprehensive, well-referenced and timely publication. It
very nicley describes the burden of obesity and its associated health
hazards.
The emerging issue however is however the early control of
obesity.Childhood obesity has reached epidemic proportion; worldwide,
approximately 22 million children under five years of age are
overweight(2). Large number of epidemiological studies proved obesity as a
significant risk factor for cardiovascular diseases. Pathogenesis of
atherosclerosis, the underlying cause of cardiovascular disease, begins in
early childhood, although it clinically manifests in adulthood.(3) It is
also evident that risk factors for cardiovascular diseases can best be
modified at young ages, as in childhood, thus improve the health outcomes
in adult life.
In context of direct and indirect cost, the impact of obesity on the
lives of people is devastating when measured in terms of premature
morbidity, mortality and disabilities. Poor countries which already has
poor health and economic indicators cannot afford the emerging costly
epidemic of obesity. Thus, every effort should be made to prevent and
modify unhealthy lifestyle by increasing health promotion and disease
prevention measures while the condition still is in the early phase.
In this regard, it is important for Family Physicians to play a
leading role, as they understand the natural history and disease process
and are engaged to provide comprehensive preventive and curative health
care to all family members including children and adolescents. To promote
healthy lifestyle among individuals and families, family physicians should
intervene earlier in life thus beating the epidemic of obesity and other
lifestyle risk factors for cardiovascular diseases in later life. At the
same time, it is important to educate and encourage parents (being a role
model) to personally adopt and practice a healthy lifestyle, especially
with regard to diet and regular physical activity. There is also an
immense need for more research to explore this issue in more details and
to find and implement more cost-effective intervention programs in
accordance to cultures and needs.
References:
1.Anjali Jain .Treating obesity in individuals and populations.BMJ
2005; 331: 1387-1390
2.Rocchini AP. Childhood obesity and diabetes epidemic. N Engl J Med
2002; 346(11):584-5
3. Ucar B, Kilic Z, Colak O, Oner S, Kalyoncu C. Coronary risk
factors in Turkish schoolchildren: Randomized cross-sectional study.
Pediatrics International 2000; 42:259-67
Competing interests:
None declared
Competing interests: No competing interests
Obesity is now a Quality indicator in the Quality and Outcomes
framework for GPs. We are required to "produce a register of patients aged
16 years and over with a BMI greater than or equal to 30 in the last 15
months." (1)
"The following principles relating to the Quality and Outcomes Framework
were agreed ....Indicators should, where possible, be based on the best
available evidence.
Only data which are useful in patient care should be collected." (2)
There was nothing in Jain's timely Clinical Review of Treating obesity in
individuals and populations to indicate that creating a register of obese
patients has any value in the treatment of Obesity. (3) Can the government
please publish the evidence that justifies the time and money that this
will cost? Or, have they decided that evidence and principles are
irrelevant when it comes to government policy?
Patrick Bower
(1)www.nhsemployers.org/pay-conditions/pay-conditions-656.cfm
(2)www.nhsconfed.org/docs/quality_ and_outcomes_framework_guidance.pdf
(3)Anjali Jain
Treating obesity in individuals and populations
BMJ 2005; 331: 1387-1390
Competing interests:
None declared
Competing interests: No competing interests
Submitted on behalf of Dietitians working in Obesity Management (UK),
a specialist group of the British Dietetic Association.
Whilst we would agree with Anjali Jain [1] that there is a need to
focus on public health interventions to combat the obesity epidemic, this
should not be done at the expense of offering effective treatment
interventions to those already affected by this condition. The WHO has
classified obesity as a chronic disease and it needs to be managed as
such. There are numerous co-morbidities associated with obesity [2]. It
reduces life expectancy, impacts on quality of life and may account for as
much as 65 % of cases of type 2 diabetes[3]. While prevention strategies
are clearly required, it seems unthinkable to ignore the treatment of
individuals, whose numbers currently amount to over 20% of the population.
We would also agree with Soljak’s response (17/12/05) regarding
Jain’s neglect of the evidence for the clinical benefits of modest weight
loss as demonstrated by trials such as the Diabetes Prevention Program [4]
and the Finnish Diabetes Prevention Study [5]. In addition, given Jain’s
aim of summarizing the evidence relating to the treatment of obesity we
find it surprising that she did not make reference to the recent Health
Technology Assessment systematic review of the long-term effects and
economic consequences of treatments for obesity and implications for
health improvement [6]. As with the earlier NIH review published in the US
[7], this review highlighted that what does work most effectively is a
combination of strategies, incorporating diet, physical activity and
behaviour modification. In relation to pharmacotherapy, a recent study has
demonstrated the excellent results which can be achieved when a more
comprehensive lifestyle programme is combined with medication [8]. The
results underscore the importance of prescribing weight-loss medications
in combination with, and not in lieu of lifestyle modification.
We would agree with Jain that interventions focusing on weight loss
maintenance, require particular attention. As healthcare professionals, it
is interesting to note that we do not question the need for lifelong care
of other chronic conditions such as diabetes or CHD and yet often expect
obesity to be ‘cured’ by the briefest of interventions or those
interventions requiring the least effort.
Perhaps an even greater challenge for health care professionals is to
overcome some of our own assumptions regarding the futility of treatments
when approaching this topic area.
References
1. Jain A. Treating obesity in individuals and populations. BMJ 2005;
331: 1388-1390.
2. Jung RT. Obesity the disease. Br Med Bull 1997; 53(2): 307-321
3. Bray GA. Medical Consequences of obesity. J Clin End Met 2004; 89:
2583-2589.
4. Diabetes Prevention Program Research Group. Reduction in the
incidence of type 2 diabetes with lifestyle intervention or metformin. N
Engl J Med 2002; 346: 393-403.
5. Tuomilehto J, Lindstrom J, Eriksson JG et al. Prevention of type 2
diabetes mellitus by changes in lifestyle among subjects with impaired
glucose tolerance. N Engl J Med 2001; 343:1341-1351.
6. Avenell A, Broom J, Brown TJ, et al. Systematic review of the long
term effects and economic consequences of treatments for obesity and
implications for health improvement. Health Technol Assess 2004; 8:1-458.
7. National Institutes of Health (1998). Clinical Guidelines on the
Identification, Evaluation, and Treatment of Overweight and Obesity in
Adults: The Evidence Report. Washington DC: National Heart Lung and Blood
Institute in cooperation with the National Institute of Diabetes and
Digestive kidney Diseases.
8. Wadden TA, Berkowitz RI, Womble LG et al. Randomized trial of
lifestyle modification and pharmacotherapy for obesity. N Engl J Med 2005;
353: 2111-2120.
Competing interests:
None declared
Competing interests: No competing interests
Overweight and obesity is now one of the major threats to the health
of the world’s populations.1 Effective strategies to increase energy
expenditure and reduce energy intake are being sought by countless
agencies.
An important component of any program will be strategies to enhance
health literacy among members of the population so they are able to easily
understand the energy density of the available foods and drinks. Many
countries require that food packaging includes information on the
composition of the food in terms of nutrients, fats, sugars (or overall
energy density) and other constituents. However, this information is
usually provided in fairly technical language which many people find
difficult to interpret in terms of the behaviours required to maintain a
healthy weight or to achieve fat reduction.2
Presenting information on the energy density of foods and drinks
which is quickly and easily understood by most people, regardless of their
educational background, could make a very helpful contribution to
population health literacy. One approach may be to represent the energy
density of the food or drink in terms of the amount of activity required
to expend the energy contained in a typical serve. For example, the label
may state “Walk 30”, “Cycle 50” or “Football 20” indicating that 30
minutes of walking, 50 minutes of cycling or 20 minutes of football are
typically required to expend the energy consumed in one serve of the food
or drink. The consumer will then have an immediate understanding of the
behavioural implications of purchasing a particular product and of the
impact of consuming a particular food or drink compared with the
alternatives. Of course, the details of how this might best be done need
to be considered, but in the context of the health problems accumulating
from the obesity epidemic, it warrants serious consideration.
References
1 Lobstein T, Baur L, Uauy R. Obesity in children and young people: a
crisis in public health. Obes Rev 2004;5(Suppl. 1):4-104.
2 Cowburn G, Stockley L. Consumer understanding and use of nutrition
labelling: a systematic review. Public Health Nutr 2005;8(1):21-8.
Competing interests:
None declared
Competing interests: No competing interests
Anjali Jain’s recent review of obesity treatment summarized dozens of
studies for which the key outcome was a change in measured weight.1
However, measuring changes in weight, body mass index (BMI, kg/m2), or BMI
percentiles may not be the best way to prove that our communities are more
or less healthy. By way of illustration, I cite a report on 128
overweight and obese women who volunteered for a 14-week regimen of low-
calorie diet and regular exercise.2 At the end of this regimen, the
participants had mean reductions of 27% in trunk fat (assessed with dual-
energy x-ray absorptiometry), 33% in intra-abdominal fat area (assessed
with computerized tomography), and 37% in fasting triglyceride
concentration. By contrast, their mean BMI and body weight decreased by
only 12% each. One might imagine that an intervention conducted among
less enthusiastic participants would have failed to produce a significant
reduction in BMI or body weight despite substantial mean reductions in the
lipid content of their blood and their high-risk intra-abdominal depot.
Are we helping our patients (and our communities) if we evaluate
their progress solely by measuring their BMI or weight? Among adults, low
-cost anthropometric indices such as waist-to-hip circumference ratio3 or
the waist circumference alone might be more appropriate ways to estimate
obesity-related risk. Among youth, there is reason to think that risk
could be better assessed by the ratio of their waist circumference-to-
height than by their BMI percentiles.4 We could possibly improve on the
BMI or waist circumference by monitoring their “lipid accumulation
product” (defined for adults by both their waist circumference and fasting
triglyceride concentration).5 In short, for the price of a fasting blood
sample we may be better able to evaluate obesity-related health risks and
also the success of interventions designed to reduce those risks.
[The findings and conclusions in this commentary those of the author
and do not necessarily represent the views of the Centers for Disease
Control and Prevention.]
References
1 Jain A. Treating obesity in individuals and populations. BMJ 2005;
331: 1387-90.
2 Okura T, Nakata Y, Yamabuki K, Tanaka K. Regional body composition
changes exhibit opposing effects on coronary heart disease risk factors.
Arterioscler Thromb Vasc Biol 2004; 24: 923-9.
3 Yusuf S, Hawken S, Ounpuu S, Bautista L, Franzosi MG, Commerford
P, et al. Obesity and the risk of myocardial infarction in 27 000
participants from 52 countries: a case-control study. The Lancet 2005;
366: 1640-9.
4 Kahn HS, Imperatore G, Cheng YJ. A population-based comparison of
BMI percentiles and waist-to-height ratio for identifying cardiovascular
risk in youth. J Pediatr 2005; 146: 482-8.
5 Kahn HS. The "lipid accumulation product" performs better than the
body mass index for recognizing cardiovascular risk: a population-based
comparison. BMC Cardiovasc Disord 2005; 5: 26 (available on-line at
http://www.biomedcentral.com/1471-2261/5/26 ).
Competing interests:
None declared
Competing interests: No competing interests
As the review highlights a population approach is vital to decrease
obesity. This without doubt involves continued lifestyle adaptations of
the whole population. However the traditional interventions we are
familiar with may not be the only way.
The question why are some people not obese in an obese promoting
environment? Is a question that we can all answer. To be a role model we
each have a personal perspective of how to overcome the barriers. If we
were to unify in this approach as health professionals; the active
individuals who comprise the NHS body, then the combination of experience
could provide great depth and an invaluable living ‘database’. There are
over 1million contacts with people via the NHS everyday, surely a unified
NHS role model could only have a positive impact. GPs in the action or
maintenance stage of the transtheoretical model of change [1] with regards
to physical activity are three times more likely to promote the same
behaviour in their patients than those in other stages. For Practice
Nurses the same difference quadruples the likelihood of them promoting
physical activity.[2]
Recently I conducted a pilot study on a General ward of a Liverpool
Hospital. 97% agree or strongly agree that hospitals should be an example
in promoting cardiovascular health and 67% agree or strongly agree that as
an employee of the NHS they should be a role model of cardiovascular
health. The Choosing Health White Paper describes the NHS as an example
of a health promoting environment. [3] The NHS and other collaborative
health environments are those that each of us can modify by our daily
individual action, whilst evidence for interventions is being defined and
understood.
Specifically concerning the inactivity risk factor; we all have no
excuse, we know the facts that 30mins, 5-7times a week of moderate
activity is significantly beneficial to health.[4] If we don’t make time
for it as health professionals how can we expect the rest of the
population? Have we forgotten the power of the role model? A role model
serves as an ideal to which one can aspire.[5] A positive role model will
clearly have positive implications on those observing. Is it on this
level that we need more focus?
Competing interest: none declared
Madeleine McCutcheon
md0u40e6@liv.ac.uk
BSc Hons Sports Science & Physiology
Medical Student
Exercise Referral Programme Consultant
1. Ogden J. Health Beliefs. Health Psychology a Textbook.
Maidenhead:Open University Press, 2004:22-23.
2. McKenna J, Naylor PJ, McDowell H. Barriers to physical activity
promotion by general practitioners and practice nurses. Br J Sports Med
1998:32:242-247.
3. Department of Health. Chapter 8. Choosing Health Making healthy
choices easier. HM Government: Crown Copyright, 2004.
4. Whaley MH, Brubaker PH, Otto RM. Benefits and risks associated
with physical activity. ACSM’s Guidelines for Exercise Testing and
Prescription. Maryland:Lippincott Williams & Wilkins, 2006:7-9.
5. Reynolds PP, Reaffirming Professionalism through the Education
Community. Annals of Internal Medicine 1994:120(7):609-614.
Competing interests:
None declared
Competing interests: No competing interests
In her insightful and thought-provoking review Jain (1) advocates to
focus on public health interventions rather than individual interventions
to tackle the obesity epidemic. It may be worth considering that
overweight and obesity are serious health issues that will only worsen
without thoughtful interventions that address individual and societal
attitudes alike as well as their environmental context.
In a multidimensional approach to tackle the obesity pandemia
physicians and other health care professionals are called to play a key
role. However, it has been reported that, in general, obesity management
is minimal and inconsistent (2). Some clinicians may not have the skills
or time to address this complex heterogenous problem in the short
consultation time available in the out-patient setting (3). Gaps in
screening as well as in providing treatment recommendations or in
executing appropriate patient referral may be signs of what has been
described as "clinical inertia", a phenomenon ocurring predominantly due
to three problems: overestimation of care provided; use of "soft" reasons
to avoid intensification of therapy; and lack of education, training, and
practice organization focused on achieving therapeutic goals (4).
Interestingly, obesity has not until recently featured strongly in medical
training with medical school curricula not even addressing obesity as a
disease.
Lack of motivation to work with overweight and obese patients owing
to negative perceptions of the efficacy of treatments or adherence to
treatment may be an important barrier to successfully implement
interventions in the health care setting. There is no ethical validity to
sustain the “futility and recidivism” arguments. In overweight and obesity
treatment any intervention which causes a negative energy balance is
guaranteed to be efficacious in producing a health benefit. It has been
estimated that affecting energy balance by only 100 kcal/d, an easily
attainable target, could prevent weight gain in most of the population
(5).
In spite of the unprecedented advances in the knowledge and
understanding of systems biology related to energy balance regulation,
these have not translated into improved medical care of obesity. This
paradox poses the need for a new vision and impetus for efficient
translational and clinical reasearch. The final aim of alleviating human
suffering will remain elusive as long as scientific advances do not drive
changes in everyday clinical practice fostered by a robust, bidirectional
information flow between clinicians and basic scientists.
1. Jain A. Treating obesity in individuals and populations. BMJ
2005;331:1388-90.
2. Cleator J, Richman E, Leong KS, Mawdsley L, White S, Wilding J.
Obesity: under-diagnosed and under-treated in hospital outpatient
departments. Int J Obesity 2002;26:581-4.
3. Pi-Sunyer X. A clinical view of the obesity problem. Science
2003;299:859-60.
4. Phillips LS, Branch WT Jr, Cook CB, et al. Clinical inertia. Ann
Intern Med 2001;135:825-34.
5. Hill JO, Wyatt HR, Reed GW, Peters JC. Obesity and the
environment: where do we go from here? Science 2003;299:853-5.
Competing interests:
None declared
Competing interests: No competing interests
Jain's Clinical Review of obesity treatments (BMJ 9/12/05) makes some
sweeping and incorrect statements about the ineffectiveness of treating
individuals. She states that "these (individual) interventions have
resulted in only small amounts of permanent weight loss with marginal
clinical relevance". However she ignores a body of recent research in a
sub-group of obese or overweight patients- those with prediabetes.
A recent sytematic review of weight-loss interventions in this group
(1) showed that the incidence of diabetes was significantly lower in the
intervention groups in three of five studies examining this outcome after
3-6 years followup. In the US Diabetes Prevention Program, after an
average followup of 2.8 years, the lifestyle intervention
reduced diabetes incidence by 58 percent (2). Other CVD risk factors were
also improved (3). If these benefits are maintained, there is every
reason to believe that CVD endpoints will improve. Similar results were
obtained in the Finnish Diabetes Prevention Study, and an intervention
based on it is now national policy there (4).
The obesity epidemic is a daunting prospect for health professionals,
and unfortunately the blind eye turned by Jain is a frequent, but flawed,
response. As a public health doctor I agree entirely with Jain in hoping
that evidence-based public health interventions emerge quickly. However
health professionals will also need to fully engage with the epidemic to
ensure that their overweight and obese patients receive appropriate
treatment and referral, where it is justified by the evidence. They will
have increasing support to do this- for example, from health trainers.
One hopes that this message will be received not just by primary
healthcare teams but also by those negotiating the new Quality and
Outcomes Framework of the GP Contract.
References
1. Norris SL, Zhang X, Avenell A. Long-term effectiveness of weight-
loss interventions in adults with pre-diabetes. Am J Prev Med 2005; 28:
126-139.
2. Diabetes Prevention Program Research Group. Reduction in the
incidence of Type 2 diabetes with lifestyle intervention or metformin. N
Engl J Med 2002; 346: 393-403.
3. Diabetes Prevention Program Research Group. Impact of Intensive
Lifestyle and Metformin Therapy on Cardiovascular
Disease Risk Factors in the Diabetes Prevention Program. Diabetes Care
2005; 28: 888-894.
4. Tuomilehto J, Lindstrom J, Eriksson JG et al. Prevention of
type 2 diabetes mellitus by changes in lifestyle among subjects with
impaired glucose tolerance. N Engl J Med 2001; 343: 1343-1351.
Competing interests:
None declared
Competing interests: No competing interests
Obesity in Children and adults
Dr. Jain's clinical review of treating obesity in individuals and
populations is a well written and careful review of the 'state of the art'
of the clinical treatment of obesity. I must agree with her that the
current medical approaches are disappointing and the bariatric approaches,
although encouraging in weight loss results, are somewhat 'barbaric'.
Unfortunately, as Dr. Jain points out, the current evidence does seem to
point in the direction of a multi-faceted 'public health' and
environmental approach to the growing epidemic of overweight and obese.
But before examining the 'public health' approaches, let us discuss the
'success' of the surgical approach and the evidence behind it (almost
solely observational studies to date).
Clinical trials in children have been conducted in the U.S., U.K.,
and worldwide for decades. The history of the improvement in survival
rates for children newly diagnosed with the most common childhood
leukemia, acute lymphocytic leukemia (ALL), from approximately 40 percent
several decades ago to the current 80 percent, to a great extent the
result of multi-center clinical trials, is frequently cited a one of the
great pediatric clinical science successes.(1, 2) Trials of surgical
interventions in children are conducted much less frequently than those
for medical therapies.(3) Issues of decisiveness versus equipoise in
addition to a resistant culture of surgical training seem to be the major
issues limiting the initiative, design, and interest in surgical trials in
children in the United States.(3-5) Indeed, less than 0.5% of the
published pediatric surgical literature has been shown to utilize the
prospective, randomized trial methodology.(4) Despite the cultural,
psychologic, technical, and logistical barriers to controlled trials of
surgical innovations, such trials have been conducted.
One of the more remarkable evaluations of a common surgical procedure
in U.S. adults, arthroscopic surgery for degenerative joint disease of the
knee, was conducted at the Houston Veteran’s Administration Hospital (6)
Participants were randomized to a sham incision under light anesthesia
(control), an arthroscopic saline flush of the knee joint, and
conventional arthroscopy including debridement, repair, and removal of
damaged cartilaginous surfaces. Remarkably, there was no difference in
functional outcomes, pain, or quality of life 24 months from surgery.
Recently, trials addressing the effectiveness of the insertion of
pneumatic eustachian tubes in children with persistent middle ear
effusions, the most common surgical procedure in U.S. children performed
approximately 500,000 times annually, have yielded surprising and
disappointing results.(7) This surgical intervention in otherwise healthy
US children less than 3 years of age, whether instituted earlier compared
to 6-9 months later in the course of an effusion persistent for at least 3
months, did not have significant effects on speech, language, or cognitive
outcomes up to 4 years of age.(8-10) Furthermore, contrary to commonly
accepted theorizing until now, insertion of pneumatic eustachian tubes
actually appears to result in persistent anatomic changes and small but
statistically significant hearing deficits compared with children who do
not undergo the procedure.(11) Despite the disappointing results of these
trials, it is likely the adults and children included in these evaluations
of common surgical procedures experienced an inclusion benefit which
enhanced their outcomes, intensity and quality of care, extending beyond
that which they otherwise would have experienced outside of a clinical
trial.(12) Indeed, in a randomized controlled trial of anti-thrombin III
in sick pre-mature infants with respiratory distress syndrome, the control
infants had significantly decreased days on a ventilator and lengths of
stay compared to those eligible whose parent’s refused participation in
the trial.(13) This ‘inclusion benefit’ may be due to placebo effect,
trial effect, enhanced quality of care, or other undefined benefits of the
more careful, regimented care likely to be provided within the context of
a clinical trial.(12)
Variations and disparities in medical interventions in the U.S.
proven effective in children are likely to be a result of access to
healthcare and subspecialty care and differential re-imbursement between
private insurers, the Medicaid program, and uninsured interventions.(14,
15) Fisher, et.al. have shown that access to care, especially adult
subspecialty care results in more frequent testing and increased use of
hospital resources without improvement in quality of care and other
outcome measures (eg survival) in higher-spending regions compared with
lower spending regions of the U.S..
Given the above and Dr. Jain's careful review, consideration should
be given to the manner in which calories are supplied to our children and
the environments available to them for physical activity. Multi-faceted
trials of the social, dietary, and built environments of children at risk
for overweight and obesity are needed. Furthermore, controlled trials of
bariartric surgery in children and adults are desparately needed to ensure
that this approach does not become 'standard of care' with sub-standard
evidence to support it.
1. Pui CH, Campana D, Evans WE. Childhood acute lymphoblastic
leukaemia--current status and future perspectives. Lancet Oncol. 2001
2001;2(10):597-607.
2. Rivera DK, Pinkel D, Simone JV, Hancock ML, Crist WM. Treatment of
acute lymphoblastic leukemia. 30 years' experience at St. Jude Children's
Research Hospital. NEJM. 1993;329(18):1289-1295.
3. Moss LR, Henry MC, Dimmitt RA, Rangel S, Geraghty N, Skarsgard ED.
The role of prospective randomized clinical trials in pediatric surgery:
state of the art? J. Pediatr. Surg. 2001;36(8):1182-1186.
4. Hardin WD, Stylianos S, Lally KP. Evidence-based practice in
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Competing interests:
None declared
Competing interests: No competing interests