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| Mike Saks and Judith Allsop |
Chapter 12 - Randomized Controlled
Trials
George Lewith and Paul Little |
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| Contributor
biography |
| George Lewith is Reader in the Complementary
Medicine Research Unit, University of Southampton, UK.
He leads an international complementary and alternative
medicine research group within the university. He has
raised over £4 million in research funds in the
last 10 years and has published over 100 peer reviewed
articles since 2001. The research group is focused on
differentiating the specific from the non-specific effects
of CAM and developing models that will help to explain
the patient perceived benefits of these interventions.
It is are currently investigating the effects of acupuncture,
healing, homeopathy and herbal medicines and exploring
pain, arthritis and cancer as illness models |
| Paul Little is Professor in the School
of Medicine at the University of Southampton, UK. He has
raised over £5 million in funds and published more
than 60 articles in peer reviewed journals in the past
8 years. He has developed pragmatic trial methodology,
and run several trials utilising a variety of designs
in the areas of self limiting illness, antibiotic use,
back pain, and health promotion in primary care. |
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| Chapter overview |
| This chapter outlines underlying principles
and concepts that govern all randomized controlled trials
(RCTs) and defines their place within clinical research.
It examines the different types of RCT and the practical
issues that arise when carrying out a trial in a clinical
setting. |
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| Chapter links |
| Chapter
15 - Governance and Ethics in Health Research |
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| Suggested
Online Readings |
| Clark,
M.S., Rubenach, S. and Winsor, A. (2003) ‘A Randomized
Controlled Trial of an Education and Counselling Intervention
for Families after Stroke’, Clinical Rehabilitation,
17 (7): 703-12. |
| The paper discusses a two-group randomized
controlled trial to determine whether education and counselling
after stroke leads to improved family functioning and
psychosocial outcomes for the spouses of stroke patients
and better functional and social outcomes for patients.
Data were collected on admission to and discharge from
rehabilitation units in two Australian hospitals. Sixty-two
stroke patients and their spouses were recruited, 32 in
the intervention group and 30 in the control group. The
intervention group received a stroke information package
and three visits from a social worker trained in family
counselling. Various outcome measures to assess family
functioning are discussed. At six months the intervention
group had better family functioning for both patients
and spouses and patients had better social recovery. |
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| Jacob,
K.S., Bhugra, D. and Mann, A.H. (2002) ‘A Randomised
Controlled Trial of an Educational Intervention for Depression
among Asian Women in Primary Care in the United Kingdom’,
International Journal of Social Psychiatry, 48
(2): 139-48. |
| This paper discusses a randomised
clinical trial of ‘patient education’ versus
‘usual care’ outcomes for the treatment of
depression in a sample of 70 Asian women in primary care.
Thirty-five were randomly allocated to receive education
about the nature, causes, prevalence and treatment of
depression, 35 did not receive such information. There
were no statistical differences between the two groups
on baseline characteristics. Sixty-six subjects were followed
up at two months. The paper concludes that patients with
common mental disorders, especially those with milder
forms of the condition, who received the educational material,
had a higher recovery rate than patients who do not receive
such education. |
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| Plant,
H., Bredin, M., Krishnasamy, M. and Corner, J. (2000)
‘Working with Resistance, Tension and Objectivity:
Conducting a Randomised Controlled Trial of a Nursing
Intervention for Breathlessness’, Journal of
Research in Nursing, 5 (6): 426-34. |
| The paper examines the experience
of nurses collaborating in a multi-centre randomised controlled
trial which evaluated a nursing intervention for the management
of breathlessness in patients with lung cancer. An analysis
of the process of conducting a randomised controlled trial
produced valuable insights that indicated the kind of
support required to undertake research and successfully
implement a new intervention into clinical practice. The
study also highlighted the problems associated with asking
ill people to complete standard measurement tools, particularly
when such instruments might not be sensitive to the reality
of the patient(s) problem, in this case, the experience
of breathlessness. |
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| Further Reading |
| Grimes, D. and Schulz, K. (2002) A
series of articles in The Lancet on research design (359:
57-61; 145-49; 248-52; 341-45; 515-19; 614-18; 781-85;
881-84; 966-70). |
| These articles in the epidemiology
series give a wonderfully concise introduction to research
design. |
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| Lewith, G.T., Walach, H., Jonas, W.B.
(eds.) (2002) Clinical Research in Complementary Therapies.
Edinburgh: Churchill Livingstone. |
| This book draws on the best of conventional
research methods, including randomized controlled trials,
and adapts them to the needs of complementary and alternative
medicine. |
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