12_EBC_PP_Appraisal_RCTs

12_EBC_PP_Appraisal_RCTs - Appraisal of Two Randomized...

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© 2006 Appraisal of Two Randomized Clinical Trials
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Evidence-based © 2006 2 Low Back Pain RCT Meade T, et al. Randomised comparison of chiropractic and hospital outpatient management for low back pain: results from extended follow up . BMJ 1995; 311(7001): 349-351. One of the strongest studies to date supporting chiropractic care of LBP
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Evidence-based © 2006 3 T. W. Meade Director of the Medical Research Council Epidemiology and Medical Care Unit, Wolfson Institute of Preventive Medicine, Medical College of St Bartholomew's Hospital, London
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Evidence-based © 2006 4 Introduction The authors previously reported that LBP patients treated with chiropractic did better than those receiving hospital outpatient management (followed for 6 months) This paper presented results for the same group, but three years later Oswestry questionnaires and pain scales were the outcome measures
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Evidence-based © 2006 5 Methods Patients presenting either to a chiropractic clinic or hospital were randomly allocated to either chiropractic or in hospital treatment Chiropractors used chiropractic manipulation in most patients Hospital staff most commonly used Maitland mobilization or manipulation
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Evidence-based © 2006 6 Methods Cont. 741 patients started treatment Progress was measured with the Oswestry questionnaire At six weeks, 95% of chiropractic and 89% of hospital were returned At three years by 77% and 70%
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Evidence-based © 2006 7 Methods Cont. At the three year follow up patients were asked whether they thought their allocated treatment had helped their back pain Results were analyzed on an intention to treat basis All patients entering the study were included in the statistical analysis, even if they dropped out
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Evidence-based © 2006 8 Intention to Treat Whatever the reason for people failing to complete follow up or not adhering to the protocol, everyone should be analyzed according to the group they were initially allocated to, in other words the group in which they were intended to remain Dropouts are impossible to include in an intention to treat analysis
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Evidence-based © 2006 9 Methods Cont. Differences between group means were tested by unpaired t tests X 2 was used to test for differences in proportions between the two treatment groups
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Evidence-based © 2006 10 Results Cont. Mean (SD) Oswestry scores before treatment were 29.8 (14.2) in chiropractic and 28.5 (14.1) in hospital treatment group 20-40% = moderate disability There was a 3.18 percentage point difference at three years – a 29% greater improvement in patients treated with chiropractic
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Evidence-based © 2006 11 Results Cont. TABLE I - Differences (95% confidence intervals) between mean changes in Oswestry scores* ----------------------------------------------------------------------------------------------------------- Time of No of patients No of patients follow up undergoing undergoing Treatment Difference Chiropractic Hospital ----------------------------------------------------------------------------------------------------------- Six weeks 1.69 (-0.74 to 4.12) 357 309 Six months 3.31 (0.51 to 6.11) 325 282 One year 2.04 (-0.71 to 4.79) 314 265 Two years 3.02 (0.08 to 5.96) 285 256 Three years 3.18 (0.16 to 6.20) 290 239 ----------------------------------------------------------------------------------------------------------- *Positive differences indicate greater improvement in patients treated with chiropractic.
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12_EBC_PP_Appraisal_RCTs - Appraisal of Two Randomized...

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