Inappropriate use of randomised trials to evaluate complex phenomena: case study of vaginal breech delivery
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improvement projects. Qual Saf Health Care 2003;12:210-4. Inappropriate use of randomised trials to evaluate complex phenomena: case study of vaginal breech delivery Andrew Kotaska
As randomised trials continue to ascend in the evolution of evidence based medicine, we mustrecognise and respect their limitations when examining complex phenomena in heterogeneouspopulations
Randomised controlled trials have greatly improved
the quality of evidence guiding clinical practice, but
when applied to complex phenomena, they have
important limitations. Complex patient populations
with poorly quantifiable variations between individuals
present one area of difficulty; complex procedures
requiring skill and clinical judgment present another.
A large, well designed, and well executed randomised
controlled trial of breech presentation at term, the
“term breech trial,” by Hannah et al rapidly dictated a
new standard of care for the management of breechdeliveries around the world.1 Yet this trial failed to
adequately appreciate both the complex nature of
vaginal breech delivery and the complex mix of opera-
tor variables necessary for its safe conduct. Widespread
acceptance of this trial’s results has breached the limits
Hannah et al’s trial showed a significant increase in
perinatal mortality and morbidity in women ran-domised to a trial of labour compared with electivecaesarean section.1 The trial’s methodological flaws
have been examined,2–4 but the intrinsic limitations of
applying large scale randomisation to complexphenomena have received little attention. These
limitations are the focus of this paper. Bias of licence
Vaginal breech delivery is a complex procedure
Many of the term breech trial’s 121 centres were inNorth America, where 13% of breech presentations atterm were delivered vaginally.5 The study achieved a
breech delivery at baseline were not reported, but
successful vaginal delivery rate of 57% by asking those
many would have tripled their vaginal delivery rate
centres with vaginal birth rates under 40% in the
labour group to increase the rate or withdraw from
The vaginal delivery of a breech baby involves risk.
participation.6 Individual centres rates of vaginal
Cord prolapse and trapped fetal parts are unpredict-
BMJ VOLUME 329 30 OCTOBER 2004
able complications. Every practitioner knows this; and
surgery and because some surgeons lack the skill or
the literature, the courts, and the low baseline rate of
experience to support a safe, high vaginal hysterec-
such deliveries in North America highlight caution.
tomy rate. Case selection depends on diagnosis, parity,
Maternity units with interest and skill in delivering
size and mobility of the uterus, and operator skill,
breech babies vaginally have achieved higher rates:
which together determine a safe baseline rate. Increas-
24% in the United States, 36% in Sweden, 38% in
ing the rate arbitrarily and randomising such a
Israel, 38% in Switzerland, 39% in France, and 53% in
complex mix of patient and operator characteristics
would compromise safety, yet this is what happened in
selected women for a trial of labour using various
safety criteria and showed lower mortality and morbid-ity associated with vaginal breech delivery than in the
Homogenising populations and
term breech trial. Few obstetrical units other than Løv-
set’s have published vaginal delivery rates as high as theterm breech trial.12
Randomisation improves the internal validity of trials
Statistical power required a high vaginal delivery
by homogenising study and control populations
rate to enhance the trial’s ability to detect small differ-
thereby avoiding bias from differences between the
ences in outcome. With this aim, the researchers
two. Clinically important factors that are variable
encouraged practitioners to increase their vaginal
within populations are, however, homogenised as well.
breech delivery rate beyond their previous comfort
Their importance to the outcome is lost, and the trial
level. Despite being difficult to quantify, comfort level
loses external validity for individuals within subsets of
(or “practitioner comfort level”) plays a pivotal part in
the population. Results represent the mean outcome
the safety of complex procedures. Protected from
for all participants and are not applicable to subgroups
medicolegal liability by the equipoise of a randomised
at lower risk. Although subgroup analysis, found in the
trial, some practitioners must have pushed their
term breech trial, can potentially identify subpopula-
comfort levels with vaginal breech delivery. This
tions in which a procedure may be safer, it is statistically
constitutes a significant bias: one of licence. The trial
weak. When phenomena are complex, many patient
protocol’s liberal labour guidelines allowed 0.5 cm
and practitioner characteristics influence outcome,
dilation/h and 3.5 hours for the second stage. This is
rendering individual subgroups small and meaningful
considerable licence, and few obstetricians from
centres with proved safety in vaginal breech delivery
A major limit of evidence based medicine is the dif-
ficulty in applying the results of randomised trials toindividual patients. For example, most would agree that
A discriminating procedure
a multiparous woman in advanced labour at 38 weekswith a 3000 g fetus in a frank breech presentation with
Human skill varies. This is particularly evident when
flexed head and no nuchal cord represents a low risk
tasks are complex, require careful judgment, and have
subgroup of all breech presentations. By studying a
narrow margins for error. Increasingly complex tasks
heterogeneous group of women, the term breech trial
are discriminating, with more effort and skill required
lacks the external validity needed to guide us with the
to master them. The safe vaginal delivery of a breech
management of such women. Yet experienced
baby requires considerable skill and is a discriminating
obstetricians will now press for an emergency
obstetrical procedure. Skill is required in multiple are-
caesarean, not trusting their clinical judgment to
nas: not just in the delivery technique, but in
discern low risk situations, because all women with a
ultrasound assessment, the selection of cases, intra-
breech presentation have been assigned a similar risk
partum fetal surveillance, the conduct of labour, and
status by a randomised controlled trial.
paediatric support. A coordinated, well functioning
Multicentre trials can also lead to homogenisation
of the intervention. Previous randomised trials of
breech presentations were too small to detect clinically
include carotid endarterectomy, where surgical skill is
meaningful differences in outcome, so a large
one of the strongest predictors of the operation’s
multicentre trial was required to improve statistical
utility;13 14 surgery for cancer, where additional surgical
power. Yet despite the interest, altruism, and self refer-
training improves outcome;15 16 and vaginal hysterec-
ential experience of the practitioners, the involvement
tomy. Rates of vaginal hysterectomy vary greatly
of 121 centres resulted in an average level of care.
among surgeons, and the learning curve to increase an
Encouraging practitioners to exceed their comfort
individual surgeon’s rate takes years.17 It has been sug-
level with vaginal breech delivery lowered that
gested that “encouraging more surgeons to perform
more vaginal hysterectomies may result initially in an
If generic levels of care had always been accepted as
increasing complication rate because it is technically
the ideal, none of the surgical subspecialties would
have arisen. The standard of care shown by the term
In the United Kingdom and in North America, the
breech trial is not the best we can offer. Although
baseline vaginal hysterectomy rate for non-malignant
breech deliveries commonly occur under average con-
disease is 20%. Encouraging a group of surgeons to
ditions, it does not mean that committed centres are
suddenly increase their rate from 20% to 60% would
unable to offer better than average care. Collectively we
not be a meaningful way to evaluate the safety of the
have been improving our “mean” level of care for years,
procedure compared with abdominal hysterectomy.
and the perinatal risk associated with breech delivery
Nor should all women have an abdominal hysterec-
has continued to drop despite stabilisation of the
tomy because some are poor candidates for vaginal
BMJ VOLUME 329 30 OCTOBER 2004 Simplified risk reduction
Historically, the greatest decrease in perinatal mortality
from vaginal breech deliveries was reported by Brachtin 1938.20 Other techniques recommended to enhance
the safety of vaginal breech delivery include routine
randomised trials have important limitations
determination of fetal weight, head attitude, andnuchal or presenting cord using ultrasonography; con-
Vaginal breech delivery is a complex procedure
tinuous fetal monitoring; radiological pelvimetry; cau-
that is poorly amenable to the methods of large
tious attention to the progress of labour; and
preparing for emergency symphysiotomy should fetalparts become trapped.21 Although poorly amenable to
One randomised controlled trial has dictated a
scientific analysis, some of these techniques are likely
new standard of care for vaginal breech deliveries
to be important for safe vaginal breech delivery. None
were included in the term breech trial.
The use of a short term combined end point
It is impractical for a large, multicentre trial to use
overstated any true risk of planned vaginal
complex risk reducing strategies. Meaningful quality
delivery to longer term neurodevelopmental
control in 121 centres is impossible, and more caution
would have meant fewer vaginal deliveries, increasingthe number of participants needed to achieve similarstatistical power. Therefore, the researchers chose asimple labour protocol with few risk avoidance
deliveries and 0.4% of women undergoing elective
strategies. The lack of proved effectiveness of other
caesareans. Mortality was not significantly different
strategies ostensibly justified their exclusion; yet our
(3 of 511 or 0.6%) in the planned vaginal delivery
current inability to analyse safe vaginal breech delivery
group compared with zero in the planned caesarean
does not preclude its existence. The resulting standard
group. One of these deaths, included in the intention
of care, arguably reasonable for a large, multicentre
to treat analysis, occurred before the onset of labour in
trial, falls short of its designation as the definitive study
a cephalic twin weighing 1150 g, highlighting
concerns about the adequacy of case selection and
Since publication of the term breech trial, the onus
raising questions about the appropriateness of
has been placed on individual obstetrical units to ret-
intention to treat analysis at all cost. Regardless, the
rospectively examine their experience with vaginal
impact of the trial’s results was due primarily to an
breech delivery and to show safety. Several have done
excess of short term morbidity in the planned vaginal
so and continue to offer vaginal breech delivery.11 22 23
Safety in these specific centres is due to heterogeneity
Long term outcomes in breech babies are hard to
of human skill, not to statistical anomaly, and vaginal
assess epidemiologically, but were retrospectively
breech delivery in those units should be studied and
shown to be equivalent in 1645 children, irrespective
emulated. For complex phenomena, a large, ran-
of the planned mode of delivery.25 Researchers
domised, multicentre trial does not overrule demon-
from the term breech trial have published details on
death or abnormal neurodevelopment over two years
In the case of carotid endarterectomy, it should ide-
in a subgroup of 923 children from the term breech
ally be performed at a centre and by a surgeon with a
trial.26 They found a similar incidence: 2.8% in the
perioperative stroke rate of 3%, not 6%. If unavailable,
planned vaginal delivery group and 3.1% in the
a patient might elect medical treatment, as the risks
elective caesarean section group. The use of a short
could outweigh the benefits. Similarly, a woman with
term combined end point seems to have been
an average breech presentation and access to average
care may decide that a caesarean section is safer than atrial of labour; yet even that conclusion is potentiallyflawed: without a bias of licence, the maternity unit car-
The limits of evidence based medicine
ing for her may well have a low, safe, baseline vaginal
Delivering a breech presentation vaginally is a skill:
guided by science, its safety relies on the experience ofpractitioners and caution. In the term breech trial,
Short term combined end points
large scale randomisation, which homogenised boththe study population and clinical intervention,
Randomised trials often utilise short term end points
resulted in an average level of care in an average
because they are easier to measure than longer term
population, limiting the trial’s external validity in cen-
outcomes. It is also easier to show a statistical
tres showing above average skill and in women of
difference in a combined end point rather than a sin-
below average risk. Encouraging practitioners to
gle end point. Yet combined end points can be
exceed their comfort level ensured a high vaginal
misleading.24 In the term breech trial, the end point
delivery rate and adequate statistical power, but intro-
included perinatal mortality and various short term
duced a bias of licence and compromised safety. Using
morbidities, including hypotonia, transient brachial
a combined short term end point overstated any true
plexus injury, and isolated low arterial cord pH or
effect on long term neurodevelopment.
base excess, whose lasting significance is unclear. In
The philosophical limits of evidence based
countries with low perinatal mortality, this combined
medicine include failing to appreciate and cultivate the
end point occurred in 5.7% of planned vaginal
complex nature of sound clinical judgment, failing to
BMJ VOLUME 329 30 OCTOBER 2004
appreciate the relevance of poorly quantifiable clinical
11 Kayem G, Goffinet F, Clement D, Hessabi M, Cabrol D. Breech presenta-
tion at term: morbidity and mortality according to the type of delivery at
phenomena that are obscured by randomisation, and
Port Royal Maternity hospital from 1993 through 1999. Eur J Obstet
devaluing the intangible differences between individu-
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12 Albrechtsen S, Rasmussen S, Reigstad H, Markestad T, Irgens LM,
Dalaker K. Evaluation of a protocol for selecting fetuses in breech
providers).27 The condemnation of vaginal breech
presentation for vaginal delivery or cesarean section. Am J Obstet Gynecol
delivery by one randomised controlled trial and its
13 Tu JV, Hannan EL, Anderson GM, Iron K, Wu K, Vranizan K, et al. The
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14 Barnett HJ, Taylor DW, Eliasziw M, Fox AJ, Ferguson GG, Haynes RB, et
al. Benefit of carotid endarterectomy in patients with symptomatic mod-
The author thanks Ewart Woolley, whose skill in vaginal breech
erate or severe stenosis. North American Symptomatic Carotid Endarter-
deliveries inspired him, and Robert Liston and Michael Klein
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15 Mayer AR, Chambers SK, Graves E, Holm C, Tseng PC, Nelson BE, et al.
Ovarian cancer staging: does it require a gynecologic oncologist. Gynecol
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Hannah ME, Hannah WJ, Hewson SA, Hodnett ED, Saigal S, Willan AR. Obstet Gynecol 2001;97:613-6.
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18 Maresh M, Metcalfe M, McPherson K, Overton C, Hall V, Hargreaves J, et
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al. The VALUE national hysterectomy study: description of the patients
Collaborative Group. Lancet 2000;356:1375-83.
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Hauth JC, Cunningham FG. Vaginal breech delivery is still justified. Obstet
19 Albrechtsen S, Rasmussen S, Irgens LM. Secular trends in peri- and neo-
natal mortality in breech presentation; Norway 1967-1994. Acta Obstet
Keirse MJ. Evidence-based childbirth only for breech babies? BirthGynecol Scand 2000;79:508-12.
20 Bracht E. Zur Behandlung der Steisslage. Zentralblatt Gynaecol 1938;
Halmesmaki E. Vaginal term breech delivery—a time for reappraisal?
Acta Obstet Gynecol Scand 2001;80:187-90.
21 Menticoglou SM. Symphysiotomy for the trapped aftercoming parts of
Lee KS, Khoshnood B, Sriram S, Hsieh HL, Singh J, Mittendorf R. Rela-
the breech: a review of the literature and a plea for its use. Aust NZ J Obstet
tionship of cesarean delivery to lower birth weight-specific neonatal mor-
tality in singleton breech infants in the United States. Obstet Gynecol
22 Giuliani A, Schoell W, Basver A, Tamussino K. Mode of delivery and out-
come of 699 term singleton breech deliveries at a single center. Am J
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23 Alarab M, Regan C, O’Connell MP, Keane DP, O’Herlihy C, Foley ME.
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tive cesarean section: a study of singleton term breech presentations. Br JObstet Gynaecol 1998;105:710-7. Effect of postnatal depression on other members of the mother’s family Question
In a situation of mild stress (the threat of losing a deal in a
Does anyone know of any journals or sites with information on
competitive children’s card game), 5 year old children of
how postnatal depression affects the rest of the family, not just the
depressed mothers were more likely to express depressive
cognitions (hopelessness, pessimism, and low self worth) than
Oliver Mallon, student nurse, Queens University, Belfast
children of well mothers. The association between depressivecognitions and recent exposure to maternal depression was in
part accounted for by current maternal hostility to the child.
Different effects appear at different stages of child development.
Sinclair D, Murray L. Effects of postnatal depression on children’s
The leading figure in UK research in Professor Lynn Murray. Shehas been publishing in the area of effects of postnatal depression
adjustment to school. Teacher’s reports. Br J Psychiatry 1998;172:
on child development for about 15 years. Here are details of three
of her characteristic studies. Murray L. The impact of postnatal depression on infant
Family social class and the child’s sex had the greatest influences
development. J Child Psychol Psychiatry 1992;33:543-61.
on 5 year old children’s behavioural adjustment. However, bothpostnatal and recent maternal depression were associated with
Infants of postnatally depressed mothers performed worse on
significantly raised levels of child disturbance, particularly among
object concept tasks, were more insecurely attached to their
boys and those from lower social class families.
mothers, and showed more mild behavioural difficulties. Postnatal
Woody Caan, professor of public health, APU, Chelmsford
depression had no effect on general cognitive and languagedevelopment, but seemed to make infants more vulnerable toadverse effects of lower social class and male sex. http://bmj.bmjjournals.com/cgi/qa-display/short/bmj_el;69637
Murray L, Woolgar M, Cooper P, Hipwell A. Cognitive
This exchange was posted on the Q&A section of bmj.com. If you want to
vulnerability to depression in 5-year-old children of depressed
respond to the question, or ask a new question of your own, follow the
mothers. J Child Psychol Psychiatry 2001;42:891-9. link above or go to http://bmj.com/q&a
BMJ VOLUME 329 30 OCTOBER 2004
13 Rasbash J, Browne W, Goldstein H. A user’s guide to MLwiN Version 2.1.
London: Institute of Education, University of London, 2000.
Funding: Medical Research Council (research costs); NHS in
14 Fenwick E, Claxton K, Sculpher M. Representing uncertainty: the role of
England, Northern Ireland, Scotland, and Wales (excess
cost-effectiveness acceptability curves. Health Econ 2001;10:779-87.
treatment and service support costs).
15 Fenwick E, O’Brien BJ, Briggs AH. Cost-effectiveness acceptability
Competing interests: LL, JM, MU, MV, and KW have received
curves—facts, fallacies and frequently asked questions. Health Econ2004;13:405-15.
salaries from the MRC. MU has received fees for speaking from
16 Raftery J. NICE: faster access to modern treatments? Analysis of guidance
Menarini Pharmaceuticals, the manufacturers of dexketoprofen
on health technologies. BMJ 2001;323:1300-3.
and ketoprofen, and Pfizer, the manufacturers of celecoxib and
valdecoxib. The other 12 authors have nothing to declare.
Ethical approval: The Northern and Yorkshire multicentreresearch ethics committee and 41 local research ethics commit-tees approved the trial protocol. Corrections and clarifications
Klaber Moffett J, Torgerson D, Bell-Syer S, Jackson D, Llewlyn-Phillips H,Farrin A, et al. Randomised controlled trial of exercise for low back pain:
Inappropriate use of randomised trials to evaluate
clinical outcomes, costs, and preferences. BMJ 1999;319:279-83. complex phenomena: case study of vaginal breech
Malmivaara A, Hakkinen U, Heinrichs M, Koskenniemi L, Kuosma E,
Lappi S, et al. The treatment of acute low back pain—bed rest, exercises,
In the final stage of production of this Education
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Skargren EI, Carlsson PG, Oberg BE. One-year follow-up comparison of
and Debate article by Andrew Kotaska, human
the cost and effectiveness of chiropractic and physiotherapy as primary
error conspired with an electronic glitch to
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produce two correspondence addresses—only one
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of which was correct (30 October, pp 1039-42). As
mechanical origin: randomised comparison of chiropractic and hospitaloutpatient treatment. BMJ 1990;300:1431-7.
well as publishing Kotaska’s email address, we
UK BEAM Trial Team. United Kingdom back pain exercise and manipu-
wrongly inserted the email address for the
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corresponding author (P Garner) of the preceding
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article (although that email address also appeared
Kind P. The EuroQoL instrument: an index of health-related quality oflife. In: Spilker B, ed. Quality of life and pharmacoeconomics in clinical trials.
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Philadelphia: Lippincott-Raven, 1996.
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We failed to spot a spelling mistake and an
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Bajwa (27 November, p 1271). It should be carpal
Canterbury: Personal Social Services Research Unit, University of Kent,
recommended international non-proprietary name
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12 Gold MR, Siegel JE, Russell LB, Weinstein MC. Cost-effectiveness in healthand medicine. New York: Oxford University Press, 1996. Serendipity
In retrospect, my belief in serendipity began in the summer of
Subsequent distractions of examinations and surgical training
1951. I was between my first and second years as a clinical
meant that I knew little of him again until I became a consultant in
medical student at the Welsh National School of Medicine when I
Cardiff in 1966 and was able to meet him on more equal terms. By
was attracted to a medical secretary working in the MRC unit at
this time he had become an international figure on healthcare
policy, which was later crystallised in his 1972 classic monograph
She told me that the unit was looking for two medical students
Effectiveness and Efficiency: Random Reflections on Health Services. To
who, for a modest stipend, would assist in an MRC survey of coal
my mind, this remains the definitive work on the functioning of the
miners’ chest diseases in one of the South Wales mining valleys.
NHS and, at only 92 pages, should be compulsory reading for all
Apart from the attractions of the secretary, no stipend was too
clinicians and managers who work in it.
modest for me at that time, and I applied. Having been
I cannot now remember much about the medical secretary, but
interviewed by Archie Cochrane, who was running the survey, I
I remain most grateful to her for telling me about that holiday job
was the third choice of the four who applied. One of the first two
in 1951. Because of it, I came to know a really remarkable man
and, to a certain extent, to understand what made him tick. He
During that long distant summer, I cannot recall having been
given any important duties beyond arranging x ray envelopes in
died in 1988. I feel sure that all the current talk of “integrated
alphabetical order. But I do remember many hours in the
medicine” must be making him turn in his grave.
company of Archie Cochrane. It was a small team, and we spent
David Crosby retired surgeon, University Hospital of Wales, Cardiff
long hours classifying chest x rays and poring over the data,which were well beyond my comprehension. We also spent time
We welcome articles up to 600 words on topics such as
in his Jaguar car, of which he was quite proud, visiting individual
A memorable patient, A paper that changed my practice, My most
miners in their homes who for many diverse and interesting
unfortunate mistake, or any other piece conveying instruction,
reasons did not wish to be x rayed. Considerable energy was
pathos, or humour. Please submit the article on http://
expended in ensuring that the survey should be 100%.
submit.bmj.com Permission is needed from the patient or a
Once or twice he had a migraine, which meant a longer session
relative if an identifiable patient is referred to. We also welcome
the next day. To me, he was kind and quizzical. I doubt that I ever
contributions for “Endpieces,” consisting of quotations of up to
gave him any of the answers he wanted, but he tried hard to make
80 words (but most are considerably shorter) from any source,
ancient or modern, which have appealed to the reader. BMJ VOLUME 329 11 DECEMBER 2004
SemEval-2010 Task 8: Multi-Way Classificationof Semantic Relations Between Pairs of NominalsIris Hendrickx∗ , Su Nam Kim† , Zornitsa Kozareva‡ , Preslav Nakov§ ,O S´eaghdha¶, Sebastian Pad´o , Marco Pennacchiotti∗∗,Lorenza Romano††, Stan Szpakowicz‡‡dataset for each of seven relations. We have definedSemEval-2010 Task 8 as multi-way classification,where the label for ea
Peter H Andersen Department of Dermatology Marselisborg Hospital P.P Orumsgade 11 DK-8000 Ärhus C. Title: Treatment of recurrent herpes labialis (cold sores) using trans-cutaneous electrical nerve stimulation Purpose: To investigate if recurrent attacks of herpes labialis may be prevented or the severity diminished using trans-cutanneous electrical nerve stimulation (TCNS)