Open AccessAssessment of Methodologic Quality of Randomized Trials of Interventional Techniques: Development of an Interventional Pain Management Specific Instrument
Author(s) -
Laxmaiah Manchikanti,
Joshua A Hirsch,
Steven P. Cohen,
James E. Heavner,
Frank J E Falco,
Sudhir Diwan,
Mark V. Boswell,
Kenneth D. Candido,
Obi Onyewu,
Jie Zhu,
Nalini Sehgal,
Alan D. Kaye,
Ramsin Benyamin,
Standiford Helm,
Vijay Singh,
Sukdeb Datta,
Sala Hadin Abdi,
Paul J. Christo,
Haroon Hameed,
Mariam Hameed,
Ri Cardo Vallejo,
Vidyasagar Pampati,
Gabor B. Racz,
Prithvi Raj
Publication year - 2014
Publication title -
pain physician
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.31
H-Index - 99
eISSN - 2150-1149
pISSN - 1533-3159
DOI - 10.36076/ppj.2014/17/e263
Subject(s) - medicine , interventional pain management , randomized controlled trial , medical physics , reliability (semiconductor) , gold standard (test) , systematic review , quality (philosophy) , medline , physical therapy , pain management , surgery , radiology , power (physics) , philosophy , physics , epistemology , quantum mechanics , political science , law
Background: A major component of a systematic review is an assessment of the methodological qualityand bias of randomized trials. The most commonly utilized methodological quality assessment and biasassessment for randomized trials is by the Cochrane Review Group. While this is not a “gold standard,” it isan indication of the current state-of-the-art review methodology. There is, however, no specific instrumentto assess the methodological quality of manuscripts published for interventional techniques.Objectives: Our objective was to develop an instrument specifically for interventional pain management,to assess the methodological quality of randomized trials of interventional techniques.Methods: Item generation for the instrument was based on a definition of quality, to the extent towhich the design and conduct of the trial were congruent with the objectives of the trial. Applicabilitywas defined as the extent to which the trial produced procedures could be applied with contemporaryinterventional pain management techniques. Multiple items based on Cochrane review criteria wereutilized along with specific requirements for interventional techniques.Results: A total of 22 items were developed which formed IPM-QRB or Interventional Pain ManagementTechniques – Quality Appraisal of Reliability and Risk of Bias Assessment tool. This included 9 of the 12items from the Cochrane review criteria with deletion of some items that were repetitive or duplicate,and the addition of 13 new items.The results were compared for inter-rater reliability of Cochrane review criteria and IPM-QRB, and interinstrument reliability.The assessment was performed in multiple stages with an initial learning curve. The final assessment wasfor 4 randomized controlled trials (RCTs) utilizing both Cochrane review criteria and IPM-QRB criteria.The inter-rater agreement for Cochrane review criteria with overall intra-class correlation coefficient was0.407 compared to an intra-class correlation coefficient of 0.833 for IPM-QRB criteria. The inter-rateragreement was superior for IPM-QRB criteria compared to Cochrane review criteria despite twice theitems of Cochrane review criteria as IPM-QRB criteria with the detailed nature of assessment.Limitations: Limited validity or accuracy assessment of the instrument and the large number of itemsto be scored.Conclusion: We have developed a new comprehensive instrument to assess the methodologicalquality of randomized trials of interventional techniques. This instrument is superior to Cochrane reviewmethodology criteria in that it provides more extensive and specific information for interventionaltechniques that will be useful in assessing the methodologic quality and bias of interventional techniques.Key words: Methodological quality assessment, evidence-based medicine, comparative effectivenessresearch, Cochrane Reviews, interventional techniques, risk of bias assessment