Standards for reporting randomized controlled trials in neurosurgery: A review

Journal of Neurosurgery

Volumn 114, Issue 2, 2011, Pages 280-285

  Kiehna, Erin N ^a   Starke, Robert M ^a   Pouratian, Nader ^a   Dumont, Aaron S ^a  

^a UNIVERSITY OF VIRGINIA HEALTH SYSTEM   (United States)

Author keywords

Clinical trial design; Consolidated standards for reporting of trials; Jadad score; Randomized controlled trial

Indexed keywords

BRAIN SURGERY; HUMAN; MEDICAL DECISION MAKING; MEDICAL LITERATURE; NEUROSURGERY; PRACTICE GUIDELINE; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL (TOPIC); REVIEW;

HUMANS; NEUROSURGERY; PERIODICALS AS TOPIC; RANDOMIZED CONTROLLED TRIALS AS TOPIC; UNITED STATES;

EID: 79551692787     PISSN: 00223085     EISSN: 19330693     Source Type: Journal    
DOI: 10.3171/2010.8.JNS091770     Document Type: Review

References (50)

1. Abouzari M, Rashidi A, Rezaii J, Esfandiari K, Asadollahi M, Aleali H, et al: The role of postoperative patient posture in the recurrence of traumatic chronic subdural hematoma after burr-hole surgery. Neurosurgery 61:794-797, 2007 (Pubitemid 350073294)
2. Al-Rawi PG, Turner CL, Waran V, Ng I, Kirkpatrick PJ: A randomized trial of synthetic patch versus direct primary closure in carotid endarterectomy. Neurosurgery 59:822-829, 2006
3. Altman DG, Bland JM: Absence of evidence is not evidence of absence. BMJ 311:485, 1995
4. Angevine PD, McCormick PC: Wrong science: the SPORT trial and its potential impact on neurosurgery. Clin Neurosurg 51:120-125, 2004
5. Aoyama H, Shirato H, Tago M, Nakagawa K, Toyoda T, Hatano K, et al: Stereotactic radiosurgery plus whole-brain radiation therapy vs stereotactic radiosurgery alone for treatment of brain metastases: a randomized controlled trial. JAMA 295:2483-2491, 2006 (Pubitemid 43854963)
6. Balasubramanian SP, Wiener M, Alshameeri Z, Tiruvoipati R, Elbourne D, Reed MW: Standards of reporting of randomized controlled trials in general surgery: can we do better? Ann Surg 244:663-667, 2006 (Pubitemid 44629937)
7. Balch CM: Randomized clinical trials in surgery: why do we need them? J Thorac Cardiovasc Surg 132:241-242, 2006
8. Barrow DL: Bad science ISAT: the impact on neurosurgical practice. Clin Neurosurg 51:126-131, 2004
9. Barth M, Capelle HH, Münch E, Thomé C, Fiedler F, Schmiedek P, et al: Effects of the selective endothelin A (ET(A)) receptor antagonist Clazosentan on cerebral perfusion and cerebral oxygenation following severe subarachnoid hemorrhage-preliminary results from a randomized clinical series. Acta Neurochir (Wien) 149:911-918, 2007 (Pubitemid 47319143)
10. Begg C, Cho M, Eastwood S, Horton R, Moher D, Olkin I, et al: Improving the quality of reporting of randomized controlled trials. The CONSORT statement. JAMA 276:637-639, 1996 (Pubitemid 26278070)
11. Biggs M, Curtis JA: Randomized, prospective study comparing ulnar neurolysis in situ with submuscular transposition. Neurosurgery 58:296-304, 2006
12. Blackstone EH: CONSORT and beyond. J Thorac Cardiovasc Surg 132:229-232, 2006
13. Bracken MB, Shepard MJ, Collins WF, Holford TR, Young W, Baskin DS, et al: A randomized, controlled trial of methyl-prednisolone or naloxone in the treatment of acute spinal-cord injury. Results of the Second National Acute Spinal Cord Injury Study. N Engl J Med 322:1405-1411, 1990 (Pubitemid 20152525)
14. Brown JA, Lutsep HL, Weinand M, Cramer SC: Motor cortex stimulation for the enhancement of recovery from stroke: a prospective, multicenter safety study. Neurosurgery 58:464-473, 2006
15. Chang SM, Reynolds SL, Butowski N, Lamborn KR, Buckner JC, Kaplan RS, et al: GNOSIS: guidelines for neuro-oncology: standards for investigational studies-reporting of phase 1 and phase 2 clinical trials. Neuro Oncol 7:425-434, 2005 (Pubitemid 41555615)
16. Cho DY, Chen CC, Chang CS, Lee WY, Tso M: Endoscopic surgery for spontaneous basal ganglia hemorrhage: comparing endoscopic surgery, stereotactic aspiration, and craniotomy in noncomatose patients. Surg Neurol 65:547-556, 2006
17. Deuschl G, Schade-Brittinger C, Krack P, Volkmann J, Schäfer H, Bötzel K, et al: A randomized trial of deep-brain stimulation for Parkinson's disease. N Engl J Med 355:896-908, 2006 (Pubitemid 44315982)
18. Devereaux PJ, Manns BJ, Ghali WA, Quan H, Lacchetti C, Montori VM, et al: Physician interpretations and textbook definitions of blinding terminology in randomized controlled trials. JAMA 285:2000-2003, 2001
19. Elgmark Andersson E, Emanuelson I, Björklund R, Stålhammar DA: Mild traumatic brain injuries: the impact of early intervention on late sequelae. A randomized controlled trial. Acta Neurochir (Wien) 149:151-160, 2007
20. Fehlings MG: Editorial: recommendations regarding the use of methylprednisolone in acute spinal cord injury: making sense out of the controversy. Spine 26 (24 Suppl):S56-S57, 2001
21. Hatton J, Kryscio RK, Ryan M, Ott L, Young B: Systemic metabolic effects of combined insulin-like growth factor-I and growth hormone therapy in patients who have sustained acute traumatic brain injury. J Neurosurg 105:843-852, 2006 (Pubitemid 44917386)
22. Hopewell S, Altman DG, Moher D, Schulz KF: Endorsement of the CONSORT Statement by high impact factor medical journals: a survey of journal editors and journal 'Instructions to Authors'. Trials 9:20, 2008
23. Jacquier I, Boutron I, Moher D, Roy C, Ravaud P: The reporting of randomized clinical trials using a surgical intervention is in need of immediate improvement: a systematic review. Ann Surg 244:677-683, 2006 (Pubitemid 44629939)
24. Jadad AR, Moore RA, Carroll D, Jenkinson C, Reynolds DJ, Gavaghan DJ, et al: Assessing the quality of reports of randomized clinical trials: is blinding necessary? Control Clin Trials 17:1-12, 1996 (Pubitemid 26120810)
25. Kassell NF, Dumont AS: Randomized controlled trials in surgery: comic opera no more? J Thorac Cardiovasc Surg 132:243-244, 2006 (Pubitemid 44092838)
26. Keime-Guibert F, Chinot O, Taillandier L, Cartalat-Carel S, Frenay M, Kantor G, et al: Radiotherapy for glioblastoma in the elderly. N Engl J Med 356:1527-1535, 2007 (Pubitemid 46588417)
27. Kuhn MJ, Picozzi P, Maldjian JA, Schmalfuss IM, Maravilla KR, Bowen BC, et al: Evaluation of intraaxial enhancing brain tumors on magnetic resonance imaging: intraindividual crossover comparison of gadobenate dimeglumine and gadopentetate dimeglumine for visualization and assessment, and implications for surgical intervention. J Neurosurg 106:557-566, 2007 (Pubitemid 46536450)
28. Kupsch A, Benecke R, Müller J, Trottenberg T, Schneider GH, Poewe W, et al: Pallidal deep-brain stimulation in primary gen eralized or segmental dystonia. N Engl J Med 355:1978-1990, 2006
29. Lauer MS: Believability of clinical trials: a diagnostic testing perspective. J Thorac Cardiovasc Surg 132:249-251, 2006
30. Maciunas RJ, Maddux BN, Riley DE, Whitney CM, Schoenberg MR, Ogrocki PJ, et al: Prospective randomized double-blind trial of bilateral thalamic deep brain stimulation in adults with Tourette syndrome. J Neurosurg 107:1004-1014, 2007 (Pubitemid 350255216)
31. Mas JL, Chatellier G, Beyssen B, Branchereau A, Moulin T, Becquemin JP, et al: Endarterectomy versus stenting in patients with symptomatic severe carotid stenosis. N Engl J Med 355:1660-1671, 2006 (Pubitemid 44583956)
32. Moher D, Jones A, Lepage L: Use of the CONSORT statement and quality of reports of randomized trials: a comparative before-and-after evaluation. JAMA 285:1992-1995, 2001
33. Moher D, Schulz KF, Altman DG: The CONSORT statement: revised recommendations for improving the quality of reports of parallel-group randomised trials. Lancet 357:1191-1194, 2001 (Pubitemid 32378696)
34. Myburgh J, Cooper DJ, Finfer S, Bellomo R, Norton R, Bishop N, et al: Saline or albumin for fluid resuscitation in patients with traumatic brain injury. N Engl J Med 357:874-884, 2007 (Pubitemid 47347321)
35. Okun MS, Mann G, Foote KD, Shapira NA, Bowers D, Springer U, et al: Deep brain stimulation in the internal capsule and nucleus accumbens region: responses observed during active and sham programming. J Neurol Neurosurg Psychiatry 78:310-314, 2007 (Pubitemid 46579673)
36. Pantazis G, Tsitsopoulos P, Mihas C, Katsiva V, Stavrianos V, Zymaris S: Early surgical treatment vs conservative management for spontaneous supratentorial intracerebral hematomas: a prospective randomized study. Surg Neurol 66:492-502, 2006
37. Sade RM: Reports of clinical trials: ethical aspects. J Thorac Cardiovasc Surg 132:245-246, 2006
38. Saitoh Y, Hirayama A, Kishima H, Shimokawa T, Oshino S, Hirata M, et al: Reduction of intractable deafferentation pain due to spinal cord or peripheral lesion by high-frequency repetitive transcranial magnetic stimulation of the primary motor cortex. J Neurosurg 107:555-559, 2007 (Pubitemid 47451039)
39. Scheller C, Richter HP, Engelhardt M, Köenig R, Antoniadis G: The influence of prophylactic vasoactive treatment on cochlear and facial nerve functions after vestibular schwannoma surgery: a prospective and open-label randomized pilot study. Neurosurgery 61:92-98, 2007
40. Schmid-Elsaesser R, Kunz M, Zausinger S, Prueckner S, Briegel J, Steiger HJ: Intravenous magnesium versus nimodipine in the treatment of patients with aneurysmal subarachnoid hemorrhage: a randomized study. Neurosurgery 58:1054-1065, 2006
41. SPACE Collaborative Group, Ringleb PA, Allenberg J, Brückmann H, Eckstein HH, Fraedrich G, et al: 30 day results from the SPACE trial of stent-protected angioplasty versus carotid endarterectomy in symptomatic patients: a randomised noninferiority trial. Lancet 368:1239-1247, 2006 (Erratum in Lancet 368:1238, 2006)
42. Springborg JB, Møller C, Gideon P, Jørgensen OS, Juhler M, Olsen NV: Erythropoietin in patients with aneurysmal subarachnoid haemorrhage: a double blind randomised clinical trial. Acta Neurochir (Wien) 149:1089-1101, 2007
43. Tiruvoipati R, Balasubramanian SP, Atturu G, Peek GJ, Elbourne D: Improving the quality of reporting randomized controlled trials in cardiothoracic surgery: the way forward. J Thorac Cardiovasc Surg 132:233-240, 2006 (Pubitemid 44092827)
44. Tseng MY, Hutchinson PJ, Turner CL, Czosnyka M, Richards H, Pickard JD, et al: Biological effects of acute pravastatin treatment in patients after aneurysmal subarachnoid hemorrhage: a double-blind, placebo-controlled trial. J Neurosurg 107:1092-1100, 2007 (Pubitemid 350255169)
45. Turner CL, Wilkinson IB, Kirkpatrick PJ: Use of antihypertension agents for the suppression of arterial pulse pressure waveforms in patients with intracranial aneurysms. J Neurosurg 104:531-536, 2006
46. Uetani K, Nakayama T, Ikai H, Yonemoto N, Moher D: Quality of reports on randomized controlled trials conducted in Japan: evaluation of adherence to the CONSORT statement. Intern Med 48:307-313, 2009
47. van den Bergh WM, MASH Study Group, Algra A, Dorhout Mees SM, van Kooten F, Dirven CM, et al: Randomized controlled trial of acetylsalicylic acid in aneurysmal subarachnoid hemorrhage: the MASH Study. Stroke 37:2326-2330, 2006
48. Vandenbroucke JP: STREGA, STROBE, STARD, SQUIRE, MOOSE, PRISMA, GNOSIS, TREND, ORION, COREQ, QUOROM, REMARK... and CONSORT: for whom does the guideline toll? J Clin Epidemiol 62:594-596, 2009
49. Weinstein JN, Tosteson TD, Lurie JD, Tosteson AN, Hanscom B, Skinner JS, et al: Surgical vs nonoperative treatment for lumbar disk herniation: the Spine Patient Outcomes Research Trial (SPORT): a randomized trial. JAMA 296:2441-2450, 2006 (Pubitemid 44791200)
50. Wu JS, Zhou LF, Tang WJ, Mao Y, Hu J, Song YY, et al: Clinical evaluation and follow-up outcome of diffusion tensor imaging-based functional neuronavigation: a prospective, controlled study in patients with gliomas involving pyramidal tracts. Neurosurgery 61:935-949, 2007