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Tanısal görüntüleme teknikleri kullanılan randomize kontrollü çalışmaların istatistiksel anlamlılığının kırılganlık indeksi ile değerlendirilmesi

Year 2019, Volume: 44 Issue: 4, 1310 - 1316, 29.12.2019
https://doi.org/10.17826/cumj.512585

Abstract

Amaç:
Randomize
kontrollü çalışmalar (RKÇ), kanıt değerinin altın standardı olarak kabul
edilmekte olup, karıştırıcı etkenlerin kontrol altında tutulması ve olası
yanlılığın minimize edilmesini sağlayarak yöntem etkinliğini değerlendirdiği
için önerilmektedir. Geleneksel olarak, RKÇ'lerde belirli bir yöntemin,
tedavinin veya müdahalenin istatistiksel etkinliğini göstermek için kesim
noktası 0.05 olan p değerinden yararlanılmaktadır. Ancak çalışma sonuçlarının güvenilirliği
ile ilgili sıkıntı vardır. Kırılganlık İndeksi (Kİ) p değerinin
kısıtlılıklarına çözüm getirmek için ortaya atılmıştır. Bu çalışmanın amacı
tanı amaçlı görüntüleme yöntemlerinden yararlanarak yapılmış RKÇ’lerin
güvenilirliğini Kırılganlık İndeksinden yararlanarak değerlendirmektir. 

Gereç ve Yöntem:
Pubmed
veri tabanında “Randomize Kontrollü Çalışma”, “Kesin Test” ve “Tanısal
Görüntüleme” terimlerini içeren bir sistematik araştırma yapılmıştır. İki
araştırmacı birbirinden bağımsız olarak özetleri ve çalışmaları seçim
kriterlerine göre incelemiştir.

Bulgular:

medyan değeri 4.0 [1.0-4.0] ve örnek genişliğinin medyan değeri 83.5[36.0-148.0]
olarak bulunmuştur. Dahil edilen çalışmaların %50’sinin p değeri 0.001 ile 0.05
arasında yer almaktadır. Bir kişi daha eklendiği durumda çalışmaların
%94,4’ünün p değeri anlamsız hale gelmiştir. Kİ ile örnek genişliği ve
ilgilenilen olayın gözlendiği kişi sayısı arasında anlamlı bir ilişki
yoktur.  (r=0.144, p=0.570; r=0.169,
p=0.504) Rapor edilen p değeri grupları arasında Kİ değerleri bakımından
istatistiksel olarak anlamlı bir farklılık vardır. (p<0.001)







Sonuç:
İkili
sonuç değişkenleri için Kİ değeri, p değeri ile birlikte verilmelidir. Araştırmacılar
Kİ değerini  yorumlarken dikkatli olmalıdır çünkü Kİ değeri sadece çalışmanın kanıt değerini
ve istatistiksel gücünü göstermektedir.

References

  • Masic I, Miokovic M, Muhamedagic B. Evidence Based Medicine-New Approaches and Challenges. Professional Paper 2008;16(4):219-225.
  • Bowers A, Meyer C, Tritz D, Cook C, Fuller K, Smith C, et al. Assessing quality of randomized trials supporting guidelines for laparoscopic and endoscopic surgery. Journal of Surgical Research 2018; 224:233-239.
  • Lalumera E, Fanti S. Randomized Controlled Trials for Diagnostic Imaging: Conceptual and Pratical Problems. Topoi 2017;1-6.
  • Chakkera HA, Schold JD, Kaplan B. P value: significance is not all black and white. Transplantation 2016;100(8):1607-1609.
  • Pocock SJ, Stone GW. The primary outcome is positive is that good enough? N Engl J Med 2016; 375:971–979.
  • Shen Y, Cheng X, Zhang W. The fragility of randomized controlled trials in intracranial hemorrhage. Neurosurg Rev 2017;1-6. (DOI: 10.1007/s10143-017-0870-8)
  • Wilson YG, Davies AH, Currie IC, McGrath C, Morgan M, Baird RN, et al. Angioscopically-assisted in situ saphenous vein bypass for infrainguinalrevascularisation. Eur J VascEndovascSurg 1996;12(2):223-229.
  • Hu X, Zhang W, Fan M, Mulder J, Frencken JE. Frequency of remnants of sealants left behind in pits and fissures of occlusal surfaces after 2 and 3 years. Clin Oral Investig 2017; 21(1):143-149.
  • Frenkel RE, Shapiro H, Stoilov I. Predicting vision gains with anti-VEGF therapy in neovascular age-related macular degeneration patients by using low-luminance vision. Br J Ophthalmol 2016; 100(8): 1052-1057.
  • Rud E, Baco E, Klotz D, Rennesund K, Svindland A, Berge V, et al. Does preoperative magnetic resonance imaging reduce the rate of positive surgical margins at radical prostatectomy in a randomised clinical trial? EurUrol 2015;68(3):487-496.
  • Hurwitz MD, Ghanouni P, Kanaev SV, Iozeffi D, Gianfelice D, Fennessy FM, et al. Magnetic resonance-guided focused ultrasound for patients with painful bone metastases: phase III trial results. J Natl Cancer Inst. 2014; 106(5):1-9.
  • Neethling WM, Strange G, Firth L, Smith FE. Evaluation of a tissue-engineered bovine pericardial patch in paediatric patients with congenital cardiac anomalies: initial experience with the ADAPT-treated CardioCel(R) patch. Interact CardiovascThorac Surg. 2013; 17(4):698-702.
  • Beaudoin FL, Haran JP, Liebmann O. A comparison of ultrasound-guided three-in-one femoral nerve block versus parentenal opioids alone for analgesia in emergency department patients with hip fractures: a randomized controlled trial. AcadEmerg Med. 2013;20(6):584-91.
  • Gerdesmeyer L, Wagenpfeil S, Birkenmaier C. Percutaneous epidural lysis of adhesions in chronic lumbar radicular pain: a randomized, double-blind, placebo-controlled trial. Pain Physician 2013; 16(3):185-196.
  • Jin GY, Lynch D, Chawla A. Interstitial lung abnormalities in a CT lung cancer screening population: prevalence and progression rate. Radiology 2013; 268(2): 563-571.
  • Conde A, Mainieri V, Mota EG, Oshima HM. Influence of ultrasound and diamond burs treatments on microtensile bond strength. Indian J Dent Res 2012;23(3):373-377.
  • Kawaguchi Y, Ogawa M, Omata F, Hiroyuki I, Shimosegawa T, Mine T. Randomized controlled trial of pancreatic stenting to prevent pancreatitis after endoscopic retrograde cholangiopancreatography. World J Gastroenterol 2012;18(14):1635-1641.
  • Berra L, Coppadoro A, Bittner EA, Kolobow T, Laquerriere P, Pohlmann JR, et al. A clinical assessment of the Mucus Shaver: a device to keep the endotracheal tube free from secretions. Crit Care Med 2012;40(1):119-124.
  • Sasaki RT, Arcanjo AJ, Florio FM, Basting RT. Micromorphology and microhardness of enamel after treatment with home-use bleaching agents containing 10% carbamide peroxide and 7.5% hydrogen peroxide. J Appl Oral Sci 2009;17(6):611-616.
  • Carandina S, Mari C, De Palma M,Marcellino MG, Cisno C, Legnaro A, et al. Varicose vein stripping vs haemodynamic correction (CHIVA): a long term randomised trial. Eur J VascEndovascSurg 2008;35(2):230-237.
  • Ruan HJ, Fan CY, Liu JJ, Big-fang Z. A comparative study of internal fixation and prosthesis replacement for radial head fractures of Mason type III. IntOrthop 2009;33(1):249-253.
  • Zografos GC, Zagouri F, Sergentanis TN,Koulocheri D, Nonni A, Oikonomou V, et al. Is zero underestimation feasible? Extended Vacuum-Assisted Breast Biopsy in solid lesions - a blind study. World J SurgOncol 2007; 5:53.
  • Wanders A, Heijde DV, Landewe R,Behier JM, Calin A, Oliveri I, et al. Nonsteroidal antiinflammatory drugs reduce radiographic progression in patients with ankylosing spondylitis: a randomized clinical trial.Arthirits Rheum 2005;52(6):1756-1765.
  • Rashid ST, Salman M, Myint F, Baker DM, Agarwal S, Sweny P, et al. Prevention of contrast-induced nephropathy in vascular patients undergoing angiography: a randomized controlled trial of intravenous N-acetylcysteine. J VascSurg 2004;40(6):1136-1141.
  • Kim HY. Statistical notes for clinical researchers: Chi-squared test and Fisher’s Exact test. Restor Dent Endod. 2017;42(2):152-155.
  • Walsh M, Srinathan SK, McAuley DF, Mrkobrada M, Levine O, Ribic C, et al. The statistical significance of randomized controlled trial results is frequently fragile: a case for a Fragility Index. Journal of Clinical Epidemiology 2014; 67:622-628.
  • Evaniew N, Files C, Smith C,Bhandari M, Ghert M, Walsh M, et al. The fragility of statistically significant findings from randomized trials in spine surgery: a systematic survey. The Spine Journal 2015;15:2188-2197.
  • Pocock SJ. Current issues in the design and interpretation of clinical trials. Statistics in Medicine 1985;290(6461):39-42.
  • Narayan VM, Gandhi S, Chrouser K,Evaniew N, Dahm P. The fragility of statistically significant findings from randomized controlled trials in the urologic literature. BJU Int. 2018; 122(1):160-166.
  • Checketts JX, Scott JT, Meyer C, Horn J, Jones J, Vassar M. The Robustness of Trials That Guide Evidence-Based OrthopaedicSurgery.J Bone Joint Surg Am. 2018;100:e85(1-10)
  • Mazzinari G, Ball L, SerpaNeto A,Errando CL, Dondorp AM, Bos LD, et al. The fragility of statistical significant findings in randomised controlled anaesthesiology trials: systematic review of the medical literature. British Journal of Anaesthesia 2018;120(5):935-941.
  • Berti A, Cornec D, Medina Inojosa JR, Matteson EL, Murad MH. Treatments for giant cell arteritis: Meta-analysis and assessment of estimates reliability using the fragility index Seminars in Arthritis and Rheumatism 2018 (Article in press)
  • Thorlund K, Imberger G, Walsh M, Chu R, Gluud C, Wetterslev J, et al. The number of patients and events required to limit the risk of overestimation of intervention effects in meta-analysisea simulation study. PLoS One 2011;6(10):e25491. [Electronic Resource].
  • Carter RE, McKie PM, Storlie CB. The Fragility Index: a P-value in sheep’s clothing? European Heart Journal 2017;38:346-348.

Evaluation of statistical significance of randomized controlled trials using diagnostic imaging techniques with fragility index

Year 2019, Volume: 44 Issue: 4, 1310 - 1316, 29.12.2019
https://doi.org/10.17826/cumj.512585

Abstract

Amaç: Bu çalışmanın amacı kırılganlık indeksinin  (Kİ) başarısını, tanı amaçlı görüntüleme yöntemleri kullanılan randomize kontrollü çalışmalar (RKÇ) için değerlendirmektir.  

Gereç ve Yöntem: Pubmed veri tabanında “Randomize Kontrollü Çalışma”, “Kesin Test” ve “Tanısal Görüntüleme” terimlerini içeren bir sistematik araştırma yapılmıştır. İki araştırmacı birbirinden bağımsız olarak özetleri ve çalışmaları seçim kriterlerine göre incelemiştir.

Bulgular: Kİ medyan değeri 4.0 [1.0-4.0] ve örnek genişliğinin medyan değeri 83.5[36.0-148.0] olarak bulunmuştur. Dahil edilen çalışmaların %50’sinin p değeri 0.001 ile 0.05 arasında yer almaktadır. Bir kişi daha eklendiği durumda çalışmaların %94,4’ünün p değeri anlamsız hale gelmiştir. Kİ ile örnek genişliği ve ilgilenilen olayın gözlendiği kişi sayısı arasında anlamlı bir ilişki yoktur.  (r=0.144, p=0.570; r=0.169, p=0.504) Rapor edilen p değeri grupları arasında Kİ değerleri bakımından istatistiksel olarak anlmalı bir farklılık vardır. (

Sonuç: İkili sonuç değişkenleri için Kİ p değeri ile birlikte verilmelidir. Araştırmacılar Kİ’yi yorumlarken dikkatli olmalıdır çünkü Kİ sadece çalışmanın kanıt değerini ve istatistiksel gücünü göstermektedir. 


References

  • Masic I, Miokovic M, Muhamedagic B. Evidence Based Medicine-New Approaches and Challenges. Professional Paper 2008;16(4):219-225.
  • Bowers A, Meyer C, Tritz D, Cook C, Fuller K, Smith C, et al. Assessing quality of randomized trials supporting guidelines for laparoscopic and endoscopic surgery. Journal of Surgical Research 2018; 224:233-239.
  • Lalumera E, Fanti S. Randomized Controlled Trials for Diagnostic Imaging: Conceptual and Pratical Problems. Topoi 2017;1-6.
  • Chakkera HA, Schold JD, Kaplan B. P value: significance is not all black and white. Transplantation 2016;100(8):1607-1609.
  • Pocock SJ, Stone GW. The primary outcome is positive is that good enough? N Engl J Med 2016; 375:971–979.
  • Shen Y, Cheng X, Zhang W. The fragility of randomized controlled trials in intracranial hemorrhage. Neurosurg Rev 2017;1-6. (DOI: 10.1007/s10143-017-0870-8)
  • Wilson YG, Davies AH, Currie IC, McGrath C, Morgan M, Baird RN, et al. Angioscopically-assisted in situ saphenous vein bypass for infrainguinalrevascularisation. Eur J VascEndovascSurg 1996;12(2):223-229.
  • Hu X, Zhang W, Fan M, Mulder J, Frencken JE. Frequency of remnants of sealants left behind in pits and fissures of occlusal surfaces after 2 and 3 years. Clin Oral Investig 2017; 21(1):143-149.
  • Frenkel RE, Shapiro H, Stoilov I. Predicting vision gains with anti-VEGF therapy in neovascular age-related macular degeneration patients by using low-luminance vision. Br J Ophthalmol 2016; 100(8): 1052-1057.
  • Rud E, Baco E, Klotz D, Rennesund K, Svindland A, Berge V, et al. Does preoperative magnetic resonance imaging reduce the rate of positive surgical margins at radical prostatectomy in a randomised clinical trial? EurUrol 2015;68(3):487-496.
  • Hurwitz MD, Ghanouni P, Kanaev SV, Iozeffi D, Gianfelice D, Fennessy FM, et al. Magnetic resonance-guided focused ultrasound for patients with painful bone metastases: phase III trial results. J Natl Cancer Inst. 2014; 106(5):1-9.
  • Neethling WM, Strange G, Firth L, Smith FE. Evaluation of a tissue-engineered bovine pericardial patch in paediatric patients with congenital cardiac anomalies: initial experience with the ADAPT-treated CardioCel(R) patch. Interact CardiovascThorac Surg. 2013; 17(4):698-702.
  • Beaudoin FL, Haran JP, Liebmann O. A comparison of ultrasound-guided three-in-one femoral nerve block versus parentenal opioids alone for analgesia in emergency department patients with hip fractures: a randomized controlled trial. AcadEmerg Med. 2013;20(6):584-91.
  • Gerdesmeyer L, Wagenpfeil S, Birkenmaier C. Percutaneous epidural lysis of adhesions in chronic lumbar radicular pain: a randomized, double-blind, placebo-controlled trial. Pain Physician 2013; 16(3):185-196.
  • Jin GY, Lynch D, Chawla A. Interstitial lung abnormalities in a CT lung cancer screening population: prevalence and progression rate. Radiology 2013; 268(2): 563-571.
  • Conde A, Mainieri V, Mota EG, Oshima HM. Influence of ultrasound and diamond burs treatments on microtensile bond strength. Indian J Dent Res 2012;23(3):373-377.
  • Kawaguchi Y, Ogawa M, Omata F, Hiroyuki I, Shimosegawa T, Mine T. Randomized controlled trial of pancreatic stenting to prevent pancreatitis after endoscopic retrograde cholangiopancreatography. World J Gastroenterol 2012;18(14):1635-1641.
  • Berra L, Coppadoro A, Bittner EA, Kolobow T, Laquerriere P, Pohlmann JR, et al. A clinical assessment of the Mucus Shaver: a device to keep the endotracheal tube free from secretions. Crit Care Med 2012;40(1):119-124.
  • Sasaki RT, Arcanjo AJ, Florio FM, Basting RT. Micromorphology and microhardness of enamel after treatment with home-use bleaching agents containing 10% carbamide peroxide and 7.5% hydrogen peroxide. J Appl Oral Sci 2009;17(6):611-616.
  • Carandina S, Mari C, De Palma M,Marcellino MG, Cisno C, Legnaro A, et al. Varicose vein stripping vs haemodynamic correction (CHIVA): a long term randomised trial. Eur J VascEndovascSurg 2008;35(2):230-237.
  • Ruan HJ, Fan CY, Liu JJ, Big-fang Z. A comparative study of internal fixation and prosthesis replacement for radial head fractures of Mason type III. IntOrthop 2009;33(1):249-253.
  • Zografos GC, Zagouri F, Sergentanis TN,Koulocheri D, Nonni A, Oikonomou V, et al. Is zero underestimation feasible? Extended Vacuum-Assisted Breast Biopsy in solid lesions - a blind study. World J SurgOncol 2007; 5:53.
  • Wanders A, Heijde DV, Landewe R,Behier JM, Calin A, Oliveri I, et al. Nonsteroidal antiinflammatory drugs reduce radiographic progression in patients with ankylosing spondylitis: a randomized clinical trial.Arthirits Rheum 2005;52(6):1756-1765.
  • Rashid ST, Salman M, Myint F, Baker DM, Agarwal S, Sweny P, et al. Prevention of contrast-induced nephropathy in vascular patients undergoing angiography: a randomized controlled trial of intravenous N-acetylcysteine. J VascSurg 2004;40(6):1136-1141.
  • Kim HY. Statistical notes for clinical researchers: Chi-squared test and Fisher’s Exact test. Restor Dent Endod. 2017;42(2):152-155.
  • Walsh M, Srinathan SK, McAuley DF, Mrkobrada M, Levine O, Ribic C, et al. The statistical significance of randomized controlled trial results is frequently fragile: a case for a Fragility Index. Journal of Clinical Epidemiology 2014; 67:622-628.
  • Evaniew N, Files C, Smith C,Bhandari M, Ghert M, Walsh M, et al. The fragility of statistically significant findings from randomized trials in spine surgery: a systematic survey. The Spine Journal 2015;15:2188-2197.
  • Pocock SJ. Current issues in the design and interpretation of clinical trials. Statistics in Medicine 1985;290(6461):39-42.
  • Narayan VM, Gandhi S, Chrouser K,Evaniew N, Dahm P. The fragility of statistically significant findings from randomized controlled trials in the urologic literature. BJU Int. 2018; 122(1):160-166.
  • Checketts JX, Scott JT, Meyer C, Horn J, Jones J, Vassar M. The Robustness of Trials That Guide Evidence-Based OrthopaedicSurgery.J Bone Joint Surg Am. 2018;100:e85(1-10)
  • Mazzinari G, Ball L, SerpaNeto A,Errando CL, Dondorp AM, Bos LD, et al. The fragility of statistical significant findings in randomised controlled anaesthesiology trials: systematic review of the medical literature. British Journal of Anaesthesia 2018;120(5):935-941.
  • Berti A, Cornec D, Medina Inojosa JR, Matteson EL, Murad MH. Treatments for giant cell arteritis: Meta-analysis and assessment of estimates reliability using the fragility index Seminars in Arthritis and Rheumatism 2018 (Article in press)
  • Thorlund K, Imberger G, Walsh M, Chu R, Gluud C, Wetterslev J, et al. The number of patients and events required to limit the risk of overestimation of intervention effects in meta-analysisea simulation study. PLoS One 2011;6(10):e25491. [Electronic Resource].
  • Carter RE, McKie PM, Storlie CB. The Fragility Index: a P-value in sheep’s clothing? European Heart Journal 2017;38:346-348.
There are 34 citations in total.

Details

Primary Language English
Subjects Health Care Administration
Journal Section Research
Authors

Didem Derici Yıldırım 0000-0001-7709-6133

Bahar Taşdelen 0000-0001-8146-4912

Publication Date December 29, 2019
Acceptance Date April 3, 2019
Published in Issue Year 2019 Volume: 44 Issue: 4

Cite

MLA Derici Yıldırım, Didem and Bahar Taşdelen. “Evaluation of Statistical Significance of Randomized Controlled Trials Using Diagnostic Imaging Techniques With Fragility Index”. Cukurova Medical Journal, vol. 44, no. 4, 2019, pp. 1310-6, doi:10.17826/cumj.512585.