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FACT
Focus on Alternative and Complementary Therapies

Development and reliability of a methodological quality scale for assessment of randomised controlled trials of acupuncture

Gagnier JJ1,2, Ed Mills1, Ping Wu1
1Faculty of Medicine, Department of Health Policy Management and Evaluation, University of Toronto, Toronto, Ontario, Canada
2Research Department, Canadian College of Naturopathic Medicine, Toronto, Ontario, Canada

Introduction

Randomised controlled trials are considered the best method to test treatment efficacy. Recently, the Standards for Reporting Interventions in Controlled Trials of Acupuncture (STRICTA) were published, which suggest information necessary in reports of acupuncture trials. These standards ensure reporting quality. There is currently no accepted methodological quality scale for controlled trials of acupuncture. The purpose of the present study was the development of a methodological quality scale that combines generic methodological quality items with the STRICTA items.

Methods

One individual isolated the most widely used methodological quality scale: the Jadad scale. Three individuals converted the STRICTA criteria the their operational definitions into methodological quality criteria and combined them with the Jadad criteria into a single scale. Five individuals independently assessed 14 controlled trials of acupuncture. Kappa scores were calculated for each item (P < 0.05). Ease of use was rated on an 11-point Likert scale.

Results

The scale consisted of seven items. Items 1–3 reflect methodological quality and items 4–7 reflect treatment adequacy. Operational definitions were modified to clarify item operational definitions. The average score for ease of use of the preliminary scale was 7 (range: 4–8). Kappa scores for the individual criteria ranged from –0.1480 to 0.6208.

Conclusion

Inter-rater reliability was poor for five items and good for two others. Assessors require training in the use of methodological scales. This scale will prove useful in assessing randomised controlled trials of acupuncture for readers, editors and reviewers.

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