RADHIKa: Ratio-based analysis deriving basis for comparison of historical, parallel or interdependent reported ken of studies - a novel method for comparing interconnected and disconnected data sets
Background: Control arm selection is difficult for devices clinical trial due to the complexity and uniqueness of every device. Therefore, we propose RADHIKa - ratio-based analysis deriving basis for comparison of historical or parallel interdependent reported ken of studies that can be used to compare the relative performance or safety of independent studies.
Methods: A ken (set of studies) has four basic prerequisites to qualify for RADHIKa. Comparison and calculations are based upon assessment of two major factors, effect and influence. RADHIKa is a three step methodology that includes construction of ken, ratio calculations, and plotting box plots.
Results: Inferences of RADHIKa has ratio and box plot interpretation. When the RADHIKa ratio is 1 or close to 1, both the control arm and the evaluation arm are equal. The box plot indicates the tendency of the parameter along with the difference in two arms. When the dark box is above line of unity, it indicates that the evaluation arm has performed better or if it’s vice versa the predicate has performed better. The tails of the box indicate significance of the outcome in each direction.
Conclusions: RADHIKa method is a useful tool to compare the relative performance or safety of independent studies, especially single arm device studies.
Vercellini P, Frontino G, De Giorgi O, Aimi G, Zaina B, Crosignani PG. Comparison of a levonorgestrel-releasing intrauterine device versus expectant management after conservative surgery for symptomatic endometriosis: a pilot study. Fertil Steril. 2003;80(2):305-9.
Du ZD, Hijazi ZM, Kleinman CS, Silverman NH, Larntz K, Amplatzer Investigators. Comparison between transcatheter and surgical closure of secundum atrial septal defect in children and adults: results of a multicenter nonrandomized trial. J Am Coll Cardiol. 2002;39(11):1836-44.
Michaels AD, Chatterjee K. Cardiology Patient Pages. Angioplasty versus Bypass Surgery for Coronary Artery Disease. Circulation. 2002;106(23):187-90.
White AJ, Kedia G, Mirocha JM, Lee MS, Forrester JS, Morales WC, et al. Comparison of coronary artery bypass surgery and percutaneous drug-eluting stent implantation for treatment of left main coronary artery stenosis. JACC Cardiovasc Interv. 2008;1(3):236-45.
Grube E. Biolimus A9 Drug-Eluting Stents: The Biosensors STEALTH I Results. Angioplasty Summit, Korea 2005. Available at https://www.yumpu.com/en/document/view/26894895/biolimus-a9-drug-eluting-stents-the-biosensors-summitmdcom/1. Accessed on 20-07-2016.
Luis Gruberg, MD. RAVEL: Sirolimus-Eluting Stent vs Bare-Metal Stent in Simple Lesions -5-Year Clinical Follow-up. Medscape. Dec 26, 2006. Available at http://www.medscape.com/viewarticle/
Accessed on 20-07-2016.
Comparison of Harmonic Scalpel and Ligasure Devices in Laparoscopic Morbid Obesity Surgery. Available at https://clinicaltrials.gov/ct2/show/NC
T02538328. Accessed on 20 July 2016.
Serruys PW, Onuma Y, Garg S, Sarno G, van den Brand M, Kappetein AP, et al. Assessment of the SYNTAX score in the Syntax study. Euro Intervention. 2009;5(1):50-6.
Geneletti S, Richardson S, Best N. Adjusting for selection bias in retrospective, case-control studies. Biostatistics. 2009;10(1):17-31.
Tjak JG, Davis ML, Morina N, Powers MB, Smits JA, Emmelkamp PM. A meta-analysis of the efficacy of acceptance and commitment therapy for clinically relevant mental and physical health problems. Psychother Psychosom. 2015;84(1):30-6.
Kinga WR, Heb J. A meta-analysis of the technology acceptance model. Information & Management. 2006;43(6):740–55.
Yousafzai SY, Foxall GR, Pallister JG. Technology acceptance: a meta-analysis of the TAM: Part 1, l is available at www.emeraldinsight.com/1746-5664.ht
m. Accessed on 20 August 2016.
Kandzari DE, Bhatt DL, Sobotka PA, O'Neill WW, Esler M, Flack JM, et al. Catheter‐based renal denervation for resistant hypertension: rationale and design of the SYMPLICITY HTN‐3 Trial. Clin cardiol. 2012;35(9):528-35.
Sancheti KH, Laud NS, Bhende H, Reddy G, Pramod N, Mani JN. The INDUS knee prosthesis - Prospective multicentric trial of a posteriorly stabilized high-flex design: 2 years period follow-up. Indian J Orthop. 2009;43(4):367-74.
Ruel A, Pui C, Westrich G. Design Modifications May Improve Range of Motion Following Posteriorly Stabilized Total Knee Replacement: a Matched Pair Study. HSS Journal. 2014;10(3):256-9.