421
Views
11
CrossRef citations to date
0
Altmetric
Articles

Consolidated Standards of Reporting Trials (CONSORT): Considerations for Neuropsychological Research

, &

References

  • Abraha, I., & Montedori, A. (2010). Modified intention to treat reporting in randomised controlled trials: systematic review. BMJ, 340, c2697. doi:10.1136/bmj.c2697
  • Agha, R., Cooper, D., & Muir, G. (2007). The reporting quality of randomised controlled trials in surgery: A systematic review. International Journal of Surgery, 5(6), 413–422. doi:10.1016/j.ijsu.2007.06.002
  • Al-Marzouki, S., Roberts, I., Evans, S., & Marshall, T. (2008). Selective reporting in clinical trials: Analysis of trial protocols accepted by The Lancet. Lancet, 372(9634), 201. doi:10.1016/s0140-6736(08)61060-0
  • Alshurafa, M., Briel, M., Akl, E. A., Haines, T., Moayyedi, P., Gentles, S. J., … Guyatt, G. H. (2012). Inconsistent definitions for intention-to-treat in relation to missing outcome data: Systematic review of the methods literature. PLoS One, 7(11), e49163. doi:10.1371/journal.pone.0049163
  • Altman, D. G., & Dore, C. J. (1990). Randomisation and baseline comparisons in clinical trials. Lancet, 335(8682), 149–153.
  • Altman, D. G., & Moher, D. (2013). Declaration of transparency for each research article. BMJ, 347, f4796. doi:10.1136/bmj.f4796
  • Alvarez, F., Meyer, N., Gourraud, P. A., & Paul, C. (2009). CONSORT adoption and quality of reporting of randomized controlled trials: A systematic analysis in two dermatology journals. British Journal of Dermatology, 161(5), 1159–1165. doi:10.1111/j.1365-2133.2009.09382.x
  • Barry, H. C., Ebell, M. H., Shaughnessy, A. F., Slawson, D. C., & Nietzke, F. (2001). Family physicians’ use of medical abstracts to guide decision making: Style or substance? Journal of the American Board of Family Practice, 14(6), 437–442.
  • Basso, M. R., Bornstein, R. A., & Lang, J. M. (1999). Practice effects on commonly used measures of executive function across twelve months. The Clinical Neuropsychologist, 13(3), 283–292. doi:10.1076/clin.13.3.283.1743
  • Basso, M. R., Lowery, N., Ghormley, C., & Bornstein, R. A. (2001). Practice effects on the Wisconsin Card Sorting Test-64 Card version across 12 months. The Clinical Neuropsychologist, 15(4), 471–478. doi:10.1076/clin.15.4.471.1883
  • Begg, C., Cho, M., Eastwood, S., Horton, R., Moher, D., Olkin, I., … Stroup, D. F. (1996). Improving the quality of reporting of randomized controlled trials. The CONSORT statement. JAMA, 276(8), 637–639.
  • Bilder, R. M. (2011). Neuropsychology 3.0: Evidence-based science and practice. J Int Neuropsychol Soc, 17(1), 7–13. doi:10.1017/s1355617710001396
  • Bossuyt, P. M., Reitsma, J. B., Bruns, D. E., Gatsonis, C. A., Glasziou, P. P., Irwig, L. M., … de Vet, H. C. (2003). Towards complete and accurate reporting of studies of diagnostic accuracy: The STARD initiative. BMJ, 326(7379), 41–44.
  • Boutron, I., Moher, D., Altman, D. G., Schulz, K. F., & Ravaud, P. (2008a). Extending the CONSORT statement to randomized trials of nonpharmacologic treatment: Explanation and elaboration. Annals of Internal Medicine, 148(4), 295–309.
  • Boutron, I., Moher, D., Altman, D. G., Schulz, K. F., & Ravaud, P. (2008b). Methods and processes of the CONSORT Group: Example of an extension for trials assessing nonpharmacologic treatments. Annals of Internal Medicine, 148(4), W60–66.
  • Bowden, S. C., Harrison, E. J., & Loring, D. W. (2013). Evaluating research for clinical significance: Using critically appraised topics to enhance evidence-based neuropsychology. The Clinical Neuropsychologist. doi:10.1080/13854046.2013.776636
  • Calvert, M., Blazeby, J., Altman, D. G., Revicki, D. A., Moher, D., & Brundage, M. D. (2013). Reporting of patient-reported outcomes in randomized trials: The CONSORT PRO extension. JAMA, 309(8), 814–822. doi:10.1001/jama.2013.879
  • Campbell, M. K., Elbourne, D. R., & Altman, D. G. (2004). CONSORT statement: Extension to cluster randomised trials. BMJ, 328(7441), 702–708. doi:10.1136/bmj.328.7441.702
  • Chan, A. W., Hrobjartsson, A., Haahr, M. T., Gotzsche, P. C., & Altman, D. G. (2004). Empirical evidence for selective reporting of outcomes in randomized trials: Comparison of protocols to published articles. JAMA, 291(20), 2457–2465. doi:10.1001/jama.291.20.2457
  • Chappell, R. (2012). Non-inferiority trials. In B. Ravina, J. L. Cummings, M. P. McDermott, & R. M. Poole (Eds.), Clinical trials in neurology. New York, NY: Cambridge University Press.
  • Chelune, G. J. (2010). Evidence-based research and practice in clinical neuropsychology. The Clinical Neuropsychologist, 24(3), 454–467. doi:10.1080/13854040802360574
  • Chelune, G. J., Naugle, R. I., Luders, H., Sedlak, J., & Awad, I. A. (1993). Individual change after epilepsy surgery: Practice effects and base-rate information. Neuropsychology, 7(1), 41–52. doi:10.1037/0894-4105.7.1.41
  • Cooper, H., Appelbaum, M., Maxwell, S., Stone, A., & Sher, K. J. (2008). Reporting standards for research in psychology: Why do we need them? What might they be? American Psychologist, 63(9), 839–851. doi:10.1037/0003-066x.63.9.839
  • Couillet, J., Soury, S., Lebornec, G., Asloun, S., Joseph, P. A., Mazaux, J. M., & Azouvi, P. (2010). Rehabilitation of divided attention after severe traumatic brain injury: A randomised trial. Neuropsychological Rehabilitation, 20(3), 321–339. doi:10.1080/09602010903467746
  • Craft, S., Baker, L. D., Montine, T. J., Minoshima, S., Watson, G. S., Claxton, A., …Gerton, B. (2012). Intranasal insulin therapy for Alzheimer disease and amnestic mild cognitive impairment: A pilot clinical trial. Archives of Neurology, 69(1), 29–38. doi:10.1001/archneurol.2011.233
  • Davidson, K. W., Goldstein, M., Kaplan, R. M., Kaufmann, P. G., Knatterud, G. L., Orleans, C. T., … Whitlock, E. P. (2003). Evidence-based behavioral medicine: What is it and how do we achieve it? Annals of Behavioral Medicine, 26(3), 161–171.
  • Des Jarlais, D. C., Lyles, C., & Crepaz, N. (2004). Improving the reporting quality of nonrandomized evaluations of behavioral and public health interventions: The TREND statement. American Journal of Public Health, 94(3), 361–366.
  • Duff, K. (2012). Evidence-based indicators of neuropsychological change in the individual patient: Relevant concepts and methods. Archives of Clinical Neuropsychology, 27(3), 248–261. doi:10.1093/arclin/acr120
  • Dwan, K., Gamble, C., Williamson, P. R., & Altman, D. G. (2008). Reporting of clinical trials: A review of research funders’ guidelines. Trials, 9, 66. doi:10.1186/1745-6215-9-66
  • Edwards, J. D., Hauser, R. A., O’Connor, M. L., Valdes, E. G., Zesiewicz, T. A., & Uc, E. Y. (2013). Randomized trial of cognitive speed of processing training in Parkinson disease. Neurology, 81(15), 1284–1290. doi:10.1212/WNL.0b013e3182a823ba
  • Egger, M., Juni, P., & Bartlett, C. (2001). Value of flow diagrams in reports of randomized controlled trials. JAMA, 285(15), 1996–1999.
  • Folkes, A., Urquhart, R., & Grunfeld, E. (2008). Are leading medical journals following their own policies on CONSORT reporting? Contemporary Clinical Trials, 29(6), 843–846. doi:10.1016/j.cct.2008.07.004
  • Fontelo, P. (2011). Consensus abstracts for evidence-based medicine. Evidence Based Medicine, 16(2), 36–38. doi:10.1136/ebm20003
  • Franck, N., Duboc, C., Sundby, C., Amado, I., Wykes, T., Demily, C., … Vianin, P. (2013). Specific vs general cognitive remediation for executive functioning in schizophrenia: a multicenter randomized trial. Schizophrenia Research, 147(1), 68–74. doi:10.1016/j.schres.2013.03.009
  • Grant, S. P., Mayo-Wilson, E., Melendez-Torres, G. J., & Montgomery, P. (2013). Reporting quality of social and psychological intervention trials: A systematic review of reporting guidelines and trial publications. PLoS One, 8(5), e65442. doi:10.1371/journal.pone.0065442
  • Gravel, J., Opatrny, L., & Shapiro, S. (2007). The intention-to-treat approach in randomized controlled trials: Are authors saying what they do and doing what they say? Clinical Trials, 4(4), 350–356. doi:10.1177/1740774507081223
  • Greenfield, M. L., Mhyre, J. M., Mashour, G. A., Blum, J. M., Yen, E. C., & Rosenberg, A. L. (2009). Improvement in the quality of randomized controlled trials among general anesthesiology journals 2000 to 2006: A 6-year follow-up. Anesthesia & Analgesia, 108(6), 1916–1921. doi:10.1213/ane.0b013e31819fe6d7
  • Hampstead, B. M., Stringer, A. Y., Stilla, R. F., Giddens, M., & Sathian, K. (2012). Mnemonic strategy training partially restores hippocampal activity in patients with mild cognitive impairment. Hippocampus, 22(8), 1652–1658. doi:10.1002/hipo.22006
  • Han, C., Kwak, K. P., Marks, D. M., Pae, C. U., Wu, L. T., Bhatia, K. S., … Patkar, A. A. (2009). The impact of the CONSORT statement on reporting of randomized clinical trials in psychiatry. Contemporary Clinical Trials, 30(2), 116–122. doi:10.1016/j.cct.2008.11.004
  • Hanks, R. A., Rapport, L. J., Wertheimer, J., & Koviak, C. (2012). Randomized controlled trial of peer mentoring for individuals with traumatic brain injury and their significant others. Archives of Physical Medicine and Rehabilitation, 93(8), 1297–1304. doi:10.1016/j.apmr.2012.04.027
  • Haynes, R. B., McKibbon, K. A., Walker, C. J., Ryan, N., Fitzgerald, D., & Ramsden, M. F. (1990). Online access to MEDLINE in clinical settings. A study of use and usefulness. Annals of Internal Medicine, 112(1), 78–84.
  • Hopewell, S., Clarke, M., Moher, D., Wager, E., Middleton, P., Altman, D. G., & Schulz, K. F. (2008). CONSORT for reporting randomized controlled trials in journal and conference abstracts: Explanation and elaboration. PLoS Med, 5(1), e20. doi:10.1371/journal.pmed.0050020
  • Hopewell, S., Hirst, A., Collins, G. S., Mallett, S., Yu, L. M., & Altman, D. G. (2011). Reporting of participant flow diagrams in published reports of randomized trials. Trials, 12, 253. doi:10.1186/1745-6215-12-253
  • Ioannidis, J. P. (2005). Why most published research findings are false. PLoS Med, 2(8), e124. doi:10.1371/journal.pmed.0020124
  • Ioannidis, J. P., Evans, S. J., Gotzsche, P. C., O’Neill, R. T., Altman, D. G., Schulz, K., & Moher, D. (2004). Better reporting of harms in randomized trials: An extension of the CONSORT statement. Annals of Internal Medicine, 141(10), 781–788.
  • Jacobson, N. S., & Truax, P. (1991). Clinical significance: A statistical approach to defining meaningful change in psychotherapy research. Journal of Consulting and Clinical Psychology, 59(1), 12–19.
  • Jadad, A. R., Moore, R. A., Carroll, D., Jenkinson, C., Reynolds, D. J., Gavaghan, D. J., & McQuay, H. J. (1996). Assessing the quality of reports of randomized clinical trials: Is blinding necessary? Controlled Clinical Trials, 17(1), 1–12.
  • Kaufman, D. A. S., Boxer, O., & Bilder, R. M. (Eds.). (2013). Evidence based science and practice in neuropsychology: A review. New York, NY: Oxford University Press.
  • Keefe, R. S., Bilder, R. M., Davis, S. M., Harvey, P. D., Palmer, B. W., Gold, J. M., … Lieberman, J. A. (2007). Neurocognitive effects of antipsychotic medications in patients with chronic schizophrenia in the CATIE Trial. Archives of General Psychiatry, 64(6), 633–647. doi:10.1001/archpsyc.64.6.633
  • Kraemer, H. C., & Kupfer, D. J. (2006). Size of treatment effects and their importance to clinical research and practice. Biological Psychiatry, 59(11), 990–996. doi:10.1016/j.biopsych.2005.09.014
  • Lezak, M. D., Howieson, D. B., & Loring, D. W. (Eds.). (2004). Neuropsychological assessment (4th ed.). New York, NY: Oxford University Press.
  • Loring, D. W., & Bowden, S. C. (2013). The STROBE statement and neuropsychology: Lighting the way toward evidence-based practice. The Clinical Neuropsychologist. doi:10.1080/13854046.2012.762552
  • Maassen, G. H. (2004). The standard error in the Jacobson and Truax Reliable Change Index: The classical approach to the assessment of reliable change. Journal of the International Neuropsychological Society, 10(6), 888–893.
  • Maassen, G. H., Bossema, E., & Brand, N. (2009). Reliable change and practice effects: Outcomes of various indices compared. Journal of Clinical and Experimental Neuropsychology, 31(3), 339–352. doi:10.1080/13803390802169059
  • Mahncke, H. W., Connor, B. B., Appelman, J., Ahsanuddin, O. N., Hardy, J. L., Wood, R. A., … Merzenich, M. M. (2006). Memory enhancement in healthy older adults using a brain plasticity-based training program: A randomized, controlled study. Proceedings of the National Academy of Science USA, 103(33), 12523–12528. doi:10.1073/pnas.0605194103
  • Marcelo, A., Gavino, A., Isip-Tan, I. T., Apostol-Nicodemus, L., Mesa-Gaerlan, F. J., Firaza, P. N., … Fontelo, P. (2013). A comparison of the accuracy of clinical decisions based on full-text articles and on journal abstracts alone: A study among residents in a tertiary care hospital. Evidence Based Medicine, 18(2), 48–53. doi:10.1136/eb-2012-100537
  • Masur, D., Shinnar, S., Cnaan, A., Shinnar, R. C., Clark, P., Wang, J., … Glauser, T. A. (2013). Pretreatment cognitive deficits and treatment effects on attention in childhood absence epilepsy. Neurology, 81(18), 1572–1580. doi:10.1212/WNL.0b013e3182a9f3ca
  • Moher, D. (1998). CONSORT: An evolving tool to help improve the quality of reports of randomized controlled trials. Consolidated Standards of Reporting Trials. JAMA, 279(18), 1489–1491.
  • Moher, D., Hopewell, S., Schulz, K. F., Montori, V., Gotzsche, P. C., Devereaux, P. J., & Altman, D. G. (2012). CONSORT 2010 explanation and elaboration: Updated guidelines for reporting parallel group randomised trials. International Journal of Surgery, 10(1), 28–55. doi:10.1016/j.ijsu.2011.10.001
  • Moher, D., Jones, A., & Lepage, L. (2001). Use of the CONSORT statement and quality of reports of randomized trials: A comparative before-and-after evaluation. JAMA, 285(15), 1992–1995.
  • Moher, D., Pham, B., Jones, A., Cook, D. J., Jadad, A. R., Moher, M., … Klassen, T. P. (1998). Does quality of reports of randomised trials affect estimates of intervention efficacy reported in meta-analyses? Lancet, 352(9128), 609–613. doi:10.1016/s0140-6736(98)01085-x
  • Moher, D., Schulz, K. F., & Altman, D. G. (2001). The CONSORT statement: Revised recommendations for improving the quality of reports of parallel-group randomized trials. Journal of the American Podiatric Medical Association, 91(8), 437–442.
  • Piaggio, G., Elbourne, D. R., Pocock, S. J., Evans, S. J., & Altman, D. G. (2012). Reporting of noninferiority and equivalence randomized trials: Extension of the CONSORT 2010 statement. JAMA, 308(24), 2594–2604. doi:10.1001/jama.2012.87802
  • Piantadosi, S. (2005). Treatment effects monitoring. In Clinical Trials: A methodologic perspective. Hoboken, NK: John Wiley & Sons Inc.
  • Plint, A. C., Moher, D., Morrison, A., Schulz, K., Altman, D. G., Hill, C., & Gaboury, I. (2006). Does the CONSORT checklist improve the quality of reports of randomised controlled trials? A systematic review. Medical Journal of Australia, 185(5), 263–267.
  • Pocock, S. J., Hughes, M. D., & Lee, R. J. (1987). Statistical problems in the reporting of clinical trials. A survey of three medical journals. New England Journal of Medicine, 317(7), 426–432. doi:10.1056/nejm198708133170706
  • Rapport, L. J., Axelrod, B. N., Theisen, M. E., Brines, D. B., Kalechstein, A. D., & Ricker, J. H. (1997). Relationship of IQ to verbal learning and memory: test and retest. Journal of Clinical and Experimental Neuropsychology, 19(5), 655–666. doi:10.1080/01688639708403751
  • Sackett, D. L., Rosenberg, W. M., Gray, J. A., Haynes, R. B., & Richardson, W. S. (1996). Evidence based medicine: What it is and what it isn’t. BMJ, 312(7023), 71–72.
  • Saint, S., Christakis, D. A., Saha, S., Elmore, J. G., Welsh, D. E., Baker, P., & Koepsell, T. D. (2000). Journal reading habits of internists. Journal of General Internal Medicine, 15(12), 881–884.
  • Sawrie, S. M., Chelune, G. J., Naugle, R. I., & Luders, H. O. (1996). Empirical methods for assessing meaningful neuropsychological change following epilepsy surgery. Journal of the International Neuropsychological Society, 2(6), 556–564.
  • Schriger, D. L., Chehrazi, A. C., Merchant, R. M., & Altman, D. G. (2011). Use of the Internet by print medical journals in 2003 to 2009: A longitudinal observational study. Annals of Emergency Medicine, 57(2), 153–160 e153. doi:10.1016/j.annemergmed.2010.10.008
  • Schulz, K. F., Altman, D. G., & Moher, D. (2010). CONSORT 2010 statement: Updated guidelines for reporting parallel group randomised trials. PLoS Med, 7(3), e1000251. doi:10.1371/journal.pmed.1000251
  • Schulz, K. F., Chalmers, I., Altman, D. G., Grimes, D. A., & Dore, C. J. (1995). The methodologic quality of randomization as assessed from reports of trials in specialist and general medical journals. The Online Journal of Current Clinical Trials, Doc No 197, [ 81 paragraphs].
  • Smith, G. S., Laxton, A. W., Tang-Wai, D. F., McAndrews, M. P., Diaconescu, A. O., Workman, C. I., & Lozano, A. M. (2012). Increased cerebral metabolism after 1 year of deep brain stimulation in Alzheimer disease. Archives of Neurology, 69(9), 1141–1148. doi:10.1001/archneurol.2012.590
  • Straus, E., Sherman, E. M. S., & Spreen, O. (Eds.). (2006). A compendium of neuropsychological tests: Administration, norms, and commentary (3rd ed.). New York, NY: Oxford University Press.
  • Stuifbergen, A. K., Becker, H., Perez, F., Morison, J., Kullberg, V., & Todd, A. (2012). A randomized controlled trial of a cognitive rehabilitation intervention for persons with multiple sclerosis. Clinical Rehabilitation, 26(10), 882–893. doi:10.1177/0269215511434997
  • Turner, L., Shamseer, L., Altman, D. G., Schulz, K. F., & Moher, D. (2012). Does use of the CONSORT Statement impact the completeness of reporting of randomised controlled trials published in medical journals? A Cochrane review. Syst Rev, 1, 60. doi:10.1186/2046-4053-1-60
  • Uman, L. S., Chambers, C. T., McGrath, P. J., Kisely, S., Matthews, D., & Hayton, K. (2010). Assessing the quality of randomized controlled trials examining psychological interventions for pediatric procedural pain: recommendations for quality improvement. Journal of Pediatric Psychology, 35(7), 693–703. doi:10.1093/jpepsy/jsp104
  • von Elm, E., Altman, D. G., Egger, M., Pocock, S. J., Gotzsche, P. C., & Vandenbroucke, J. P. (2008). The Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) statement: Guidelines for reporting observational studies. Journal of Clinical Epidemiology, 61(4), 344–349. doi:10.1016/j.jclinepi.2007.11.008
  • Wechsler, D. (2008). Wechsler Memory Scale (4th ed.). San Antonio, TX: Pearson Education.
  • Wieseler, B., Wolfram, N., McGauran, N., Kerekes, M. F., Vervolgyi, V., Kohlepp, P., … Grouven, U. (2013). Completeness of reporting of patient-relevant clinical trial outcomes: Comparison of unpublished clinical study reports with publicly available data. PLoS Med, 10(10), e1001526. doi:10.1371/journal.pmed.1001526
  • Wolinsky, F. D., Mahncke, H., Vander Weg, M. W., Martin, R., Unverzagt, F. W., Ball, K. K., … Tennstedt, S. L. (2010). Speed of processing training protects self-rated health in older adults: Enduring effects observed in the multi-site ACTIVE randomized controlled trial. International Psychogeriatrics, 22(3), 470–478. doi:10.1017/s1041610209991281
  • Wolinsky, F. D., Vander Weg, M. W., Howren, M. B., Jones, M. P., & Dotson, M. M. (2013). A randomized controlled trial of cognitive training using a visual speed of processing intervention in middle aged and older adults. PLoS One, 8(5), e61624. doi:10.1371/journal.pone.0061624
  • Zwarenstein, M., Treweek, S., Gagnier, J. J., Altman, D. G., Tunis, S., Haynes, B., … Moher, D. (2008). Improving the reporting of pragmatic trials: An extension of the CONSORT statement. BMJ, 337, a2390. doi:10.1136/bmj.a2390

Reprints and Corporate Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

To request a reprint or corporate permissions for this article, please click on the relevant link below:

Academic Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

Obtain permissions instantly via Rightslink by clicking on the button below:

If you are unable to obtain permissions via Rightslink, please complete and submit this Permissions form. For more information, please visit our Permissions help page.