Recommendations for Methodology of Virtual Reality Clinical Trials in Health Care by an International Working Group: Iterative Study

Brandon Birckhead, Carine Khalil, Xiaoyu Liu, Samuel Conovitz, Albert Rizzo, Itai Danovitch, Kim Bullock, Brennan Spiegel, Brandon Birckhead, Carine Khalil, Xiaoyu Liu, Samuel Conovitz, Albert Rizzo, Itai Danovitch, Kim Bullock, Brennan Spiegel

Abstract

Background: Therapeutic virtual reality (VR) has emerged as an efficacious treatment modality for a wide range of health conditions. However, despite encouraging outcomes from early stage research, a consensus for the best way to develop and evaluate VR treatments within a scientific framework is needed.

Objective: We aimed to develop a methodological framework with input from an international working group in order to guide the design, implementation, analysis, interpretation, and communication of trials that develop and test VR treatments.

Methods: A group of 21 international experts was recruited based on their contributions to the VR literature. The resulting Virtual Reality Clinical Outcomes Research Experts held iterative meetings to seek consensus on best practices for the development and testing of VR treatments.

Results: The interactions were transcribed, and key themes were identified to develop a scientific framework in order to support best practices in methodology of clinical VR trials. Using the Food and Drug Administration Phase I-III pharmacotherapy model as guidance, a framework emerged to support three phases of VR clinical study designs-VR1, VR2, and VR3. VR1 studies focus on content development by working with patients and providers through the principles of human-centered design. VR2 trials conduct early testing with a focus on feasibility, acceptability, tolerability, and initial clinical efficacy. VR3 trials are randomized, controlled studies that evaluate efficacy against a control condition. Best practice recommendations for each trial were provided.

Conclusions: Patients, providers, payers, and regulators should consider this best practice framework when assessing the validity of VR treatments.

Keywords: clinical trials; consensus; virtual reality.

Conflict of interest statement

Conflicts of Interest: BS was the Principal Investigator of a 2016 Virtual Reality (VR) research grant (#CSR211835), administered by his academic institution, from AppliedVR (Los Angeles, California). He is currently the Principal Investigator of a VR research grant (#CSR212943), administered by his academic institution, from Traveler’s Insurance (New York City, NY) and Samsung Electronics (Suwon, South Korea). AR’s research relating to this paper has been funded by the National Institutes of Health (NIH), National Science Foundation, US Army Research Office, Telemedicine and Advanced Technology Research Center, US Army Medical Research Acquisition Activity, Department of Veterans Affairs, and Kesseler Foundation. All other authors (BB, CK, XL, SC, ID, and KB) have no conflicts of interest. Regarding the other Virtual Reality Clinical Outcomes Research Experts members, Dr Rothbaum owns equity in Virtual Better, Inc, which is developing products related to virtual reality research related to this paper. The terms of this arrangement have been approved by Emory University in accordance with its conflict of interest policies. Dr Johnson receives funding through the NIH to study virtual environments. Some of Dr van Rooijen’s VR research has been funded by Phillips, Inc (Amsterdam, Netherlands). All other members of the committee (Tom Caruso, Ali Fardinpour, Diane Gromala, Rafael Grossmann, Kate Hardy, Ted Jones, Kate Laver, Sheila Parinas, Les Posen, David Thomas, Herve Rosay, Earl Scott, and Andrea Stevenson Won) have no conflicts of interest.

©Brandon Birckhead, Carine Khalil, Xiaoyu Liu, Samuel Conovitz, Albert Rizzo, Itai Danovitch, Kim Bullock, Brennan Spiegel. Originally published in JMIR Mental Health (http://mental.jmir.org), 31.01.2019.

Figures

Figure 1
Figure 1
Summary of VR1, VR2, VR3. VR: virtual reality.

References

    1. Dascal J, Reid M, IsHak WW, Spiegel B, Recacho J, Rosen B, Danovitch I. Virtual Reality and Medical Inpatients: A Systematic Review of Randomized, Controlled Trials. Innov Clin Neurosci. 2017;14(1-2):14–21.
    1. Mahrer NE, Gold JI. The use of virtual reality for pain control: a review. Curr Pain Headache Rep. 2009 Apr;13(2):100–9.
    1. Valmaggia LR, Latif L, Kempton MJ, Rus-Calafell M. Virtual reality in the psychological treatment for mental health problems: An systematic review of recent evidence. Psychiatry Res. 2016 Feb 28;236:189–95. doi: 10.1016/j.psychres.2016.01.015.
    1. Wismeijer AAJ, Vingerhoets AJJM. The use of virtual reality and audiovisual eyeglass systems as adjunct analgesic techniques: a review of the literature. Ann Behav Med. 2005 Dec;30(3):268–78. doi: 10.1207/s15324796abm3003_11.
    1. Lohse KR, Hilderman CGE, Cheung KL, Tatla S, Van der Loos HFM. Virtual reality therapy for adults post-stroke: a systematic review and meta-analysis exploring virtual environments and commercial games in therapy. PLoS One. 2014;9(3):e93318. doi: 10.1371/journal.pone.0093318.
    1. Botella C, Serrano B, Baños RM, Garcia-Palacios A. Virtual reality exposure-based therapy for the treatment of post-traumatic stress disorder: a review of its efficacy, the adequacy of the treatment protocol, and its acceptability. Neuropsychiatr Dis Treat. 2015;11:2533–45. doi: 10.2147/NDT.S89542. doi: 10.2147/NDT.S89542.
    1. Gonçalves R, Pedrozo AL, Coutinho ESF, Figueira I, Ventura P. Efficacy of virtual reality exposure therapy in the treatment of PTSD: a systematic review. PLoS One. 2012;7(12):e48469. doi: 10.1371/journal.pone.0048469.
    1. de Carvalho MR, Dias TRDS, Duchesne M, Nardi AE, Appolinario JC. Virtual Reality as a Promising Strategy in the Assessment and Treatment of Bulimia Nervosa and Binge Eating Disorder: A Systematic Review. Behav Sci (Basel) 2017 Jul 09;7(3) doi: 10.3390/bs7030043.
    1. Chirico A, Lucidi F, De Laurentiis M, Milanese C, Napoli A, Giordano A. Virtual Reality in Health System: Beyond Entertainment. A Mini-Review on the Efficacy of VR During Cancer Treatment. J Cell Physiol. 2016 Feb;231(2):275–87. doi: 10.1002/jcp.25117.
    1. da Costa RMEM, de Carvalho LAV. The acceptance of virtual reality devices for cognitive rehabilitation: a report of positive results with schizophrenia. Comput Methods Programs Biomed. 2004 Mar;73(3):173–82. doi: 10.1016/S0169-2607(03)00066-X.
    1. Macedo M, Marques A, Queirós C. Virtual reality in assessment and treatment of schizophrenia: a systematic review. J Bras Psiquiatr. 2015 Mar;64(1):70–81. doi: 10.1590/0047-2085000000059.
    1. Luque-Moreno C, Ferragut-Garcías A, Rodríguez-Blanco C, Heredia-Rizo AM, Oliva-Pascual-Vaca J, Kiper P, Oliva-Pascual-Vaca A. A Decade of Progress Using Virtual Reality for Poststroke Lower Extremity Rehabilitation: Systematic Review of the Intervention Methods. Biomed Res Int. 2015;2015:342529. doi: 10.1155/2015/342529. doi: 10.1155/2015/342529.
    1. Malloy KM, Milling LS. The effectiveness of virtual reality distraction for pain reduction: a systematic review. Clin Psychol Rev. 2010 Dec;30(8):1011–8. doi: 10.1016/j.cpr.2010.07.001.
    1. Parsons TD, Rizzo AA. Affective outcomes of virtual reality exposure therapy for anxiety and specific phobias: a meta-analysis. J Behav Ther Exp Psychiatry. 2008 Sep;39(3):250–61. doi: 10.1016/j.jbtep.2007.07.007.
    1. Powers MB, Emmelkamp PMG. Virtual reality exposure therapy for anxiety disorders: A meta-analysis. J Anxiety Disord. 2008;22(3):561–9. doi: 10.1016/j.janxdis.2007.04.006.
    1. Rodrigues-Baroni JM, Nascimento LR, Ada L, Teixeira-Salmela LF. Walking training associated with virtual reality-based training increases walking speed of individuals with chronic stroke: systematic review with meta-analysis. Braz J Phys Ther. 2014;18(6):502–12. doi: 10.1590/bjpt-rbf.2014.0062.
    1. de Rooij IJM, van de Port IGL, Meijer JG. Effect of Virtual Reality Training on Balance and Gait Ability in Patients With Stroke: Systematic Review and Meta-Analysis. Phys Ther. 2016 Dec;96(12):1905–1918. doi: 10.2522/ptj.20160054.
    1. Triberti S, Repetto C, Riva G. Psychological factors influencing the effectiveness of virtual reality-based analgesia: a systematic review. Cyberpsychol Behav Soc Netw. 2014 Jun;17(6):335–45. doi: 10.1089/cyber.2014.0054.
    1. Rus-Calafell M, Garety P, Sason E, Craig TJK, Valmaggia LR. Virtual reality in the assessment and treatment of psychosis: a systematic review of its utility, acceptability and effectiveness. Psychol Med. 2018 Dec;48(3):362–391. doi: 10.1017/S0033291717001945.
    1. Girard B, Turcotte V, Bouchard S, Girard B. Crushing virtual cigarettes reduces tobacco addiction and treatment discontinuation. Cyberpsychol Behav. 2009 Oct;12(5):477–83. doi: 10.1089/cpb.2009.0118.
    1. Kuntze MF, Stoermer R, Mager R, Roessler A, Mueller-Spahn F, Bullinger AH. Immersive virtual environments in cue exposure. Cyberpsychol Behav. 2001 Aug;4(4):497–501. doi: 10.1089/109493101750527051.
    1. Bordnick PS, Traylor AC, Carter BL, Graap KM. A Feasibility Study of Virtual Reality-Based Coping Skills Training for Nicotine Dependence. Res Soc Work Pract. 2012 May;22(3):293–300. doi: 10.1177/1049731511426880.
    1. Carter BL, Bordnick P, Traylor A, Day SX, Paris M. Location and longing: the nicotine craving experience in virtual reality. Drug Alcohol Depend. 2008 May 01;95(1-2):73–80. doi: 10.1016/j.drugalcdep.2007.12.010.
    1. Thompson-Lake DGY, Cooper KN, Mahoney JJ, Bordnick PS, Salas R, Kosten TR, Dani JA, De La Garza R. Withdrawal Symptoms and Nicotine Dependence Severity Predict Virtual Reality Craving in Cigarette-Deprived Smokers. Nicotine Tob Res. 2015 Jul;17(7):796–802. doi: 10.1093/ntr/ntu245.
    1. Bordnick PS, Traylor A, Copp HL, Graap KM, Carter B, Ferrer M, Walton AP. Assessing reactivity to virtual reality alcohol based cues. Addict Behav. 2008 Jun;33(6):743–56. doi: 10.1016/j.addbeh.2007.12.010.
    1. Maples-Keller JL, Price M, Rauch S, Gerardi M, Rothbaum BO. Investigating Relationships Between PTSD Symptom Clusters Within Virtual Reality Exposure Therapy for OEF/OIF Veterans. Behav Ther. 2017 Dec;48(2):147–155. doi: 10.1016/j.beth.2016.02.011.
    1. Maples-Keller JL, Bunnell BE, Kim S, Rothbaum BO. The Use of Virtual Reality Technology in the Treatment of Anxiety and Other Psychiatric Disorders. Harv Rev Psychiatry. 2017;25(3):103–113. doi: 10.1097/HRP.0000000000000138.
    1. Meyerbröker K, Emmelkamp PMG. Virtual reality exposure therapy in anxiety disorders: a systematic review of process-and-outcome studies. Depress Anxiety. 2010 Oct;27(10):933–44. doi: 10.1002/da.20734.
    1. Emmelkamp PMG, Krijn M, Hulsbosch AM, de Vries S, Schuemie MJ, van der Mast CA. Virtual reality treatment versus exposure in vivo: a comparative evaluation in acrophobia. Behav Res Ther. 2002 May;40(5):509–16.
    1. Bouchard S, Dumoulin S, Robillard G, Guitard T, Klinger E, Forget H, Loranger C, Roucaut FX. Virtual reality compared with exposure in the treatment of social anxiety disorder: a three-arm randomised controlled trial. Br J Psychiatry. 2017 Dec;210(4):276–283. doi: 10.1192/bjp.bp.116.184234.
    1. Morina N, Ijntema H, Meyerbröker K, Emmelkamp PM. Can virtual reality exposure therapy gains be generalized to real-life? A meta-analysis of studies applying behavioral assessments. Behav Res Ther. 2015 Nov;74:18–24. doi: 10.1016/j.brat.2015.08.010.
    1. Rizzo AA, Difede J, Rothbaum BO, Johnston S, McLay RN, Reger G, Gahm G, Parsons T, Graap K, Pair J. VR PTSD exposure therapy results with active duty OIF/OEF combatants. Stud Health Technol Inform. 2009;142:277–82.
    1. Maples-Keller JL, Yasinski C, Manjin N, Rothbaum BO. Virtual Reality-Enhanced Extinction of Phobias and Post-Traumatic Stress. Neurotherapeutics. 2017 Jul;14(3):554–563. doi: 10.1007/s13311-017-0534-y.
    1. Difede J, Cukor J, Jayasinghe N, Patt I, Jedel S, Spielman L, Giosan C, Hoffman HG. Virtual reality exposure therapy for the treatment of posttraumatic stress disorder following September 11, 2001. J Clin Psychiatry. 2007 Nov;68(11):1639–47.
    1. Freeman D. Studying and treating schizophrenia using virtual reality: a new paradigm. Schizophr Bull. 2008 Jul;34(4):605–10. doi: 10.1093/schbul/sbn020.
    1. Kim K, Kim J, Kim J, Park D, Jang HJ, Ku J, Kim C, Kim IY, Kim SI. Characteristics of social perception assessed in schizophrenia using virtual reality. Cyberpsychol Behav. 2007 Apr;10(2):215–9. doi: 10.1089/cpb.2006.9966.
    1. Sorkin A, Weinshall D, Modai I, Peled A. Improving the accuracy of the diagnosis of schizophrenia by means of virtual reality. Am J Psychiatry. 2006 Mar;163(3):512–20. doi: 10.1176/appi.ajp.163.3.512.
    1. Veling W, Pot-Kolder R, Counotte J, van Os J, van der Gaag M. Environmental Social Stress, Paranoia and Psychosis Liability: A Virtual Reality Study. Schizophr Bull. 2016 Dec;42(6):1363–1371. doi: 10.1093/schbul/sbw031.
    1. Ferrer-Garcia M, Gutiérrez-Maldonado J, Riva G. Virtual Reality Based Treatments in Eating Disorders and Obesity: A Review. J Contemp Psychother. 2013 Jun 25;43(4):207–221. doi: 10.1007/s10879-013-9240-1.
    1. Cesa GL, Manzoni GM, Bacchetta M, Castelnuovo G, Conti S, Gaggioli A, Mantovani F, Molinari E, Cárdenas-López G, Riva G. Virtual reality for enhancing the cognitive behavioral treatment of obesity with binge eating disorder: randomized controlled study with one-year follow-up. J Med Internet Res. 2013 Jun 12;15(6):e113. doi: 10.2196/jmir.2441.
    1. Riva G. The key to unlocking the virtual body: virtual reality in the treatment of obesity and eating disorders. J Diabetes Sci Technol. 2011 Mar 01;5(2):283–92. doi: 10.1177/193229681100500213.
    1. Gutiérrez-Maldonado J, Ferrer-García M, Caqueo-Urízar A, Moreno E. Body image in eating disorders: the influence of exposure to virtual-reality environments. Cyberpsychol Behav Soc Netw. 2010 Oct;13(5):521–31. doi: 10.1089/cyber.2009.0301.
    1. Ferrer-García M, Gutiérrez-Maldonado J. The use of virtual reality in the study, assessment, and treatment of body image in eating disorders and nonclinical samples: a review of the literature. Body Image. 2012 Jan;9(1):1–11. doi: 10.1016/j.bodyim.2011.10.001.
    1. Marco JH, Perpiñá C, Botella C. Effectiveness of cognitive behavioral therapy supported by virtual reality in the treatment of body image in eating disorders: one year follow-up. Psychiatry Res. 2013 Oct 30;209(3):619–25. doi: 10.1016/j.psychres.2013.02.023.
    1. Gutiérrez-Maldonado J, Pla-Sanjuanelo J, Ferrer-García M. Cue-exposure software for the treatment of bulimia nervosa and binge eating disorder. Psicothema. 2016 Nov;28(4):363–369. doi: 10.7334/psicothema2014.274.
    1. Subramanian SK, Lourenço CB, Chilingaryan G, Sveistrup H, Levin MF. Arm motor recovery using a virtual reality intervention in chronic stroke: randomized control trial. Neurorehabil Neural Repair. 2013 Jan;27(1):13–23. doi: 10.1177/1545968312449695.
    1. Crosbie JH, Lennon S, McGoldrick MC, McNeill MDJ, McDonough SM. Virtual reality in the rehabilitation of the arm after hemiplegic stroke: a randomized controlled pilot study. Clin Rehabil. 2012 Sep;26(9):798–806. doi: 10.1177/0269215511434575.
    1. Bergeron M, Lortie CL, Guitton MJ. Use of Virtual Reality Tools for Vestibular Disorders Rehabilitation: A Comprehensive Analysis. Adv Med. 2015;2015:916735. doi: 10.1155/2015/916735. doi: 10.1155/2015/916735.
    1. You SH, Jang SH, Kim Y, Kwon Y, Barrow I, Hallett M. Cortical reorganization induced by virtual reality therapy in a child with hemiparetic cerebral palsy. Dev Med Child Neurol. 2005 Sep;47(9):628–35.
    1. Rothbaum BO, Hodges LF, Kooper R, Opdyke D, Williford JS, North M. Effectiveness of computer-generated (virtual reality) graded exposure in the treatment of acrophobia. Am J Psychiatry. 1995 Apr;152(4):626–8. doi: 10.1176/ajp.152.4.626.
    1. Hoffman HG, Richards TL, Bills AR, Van Oostrom T, Magula J, Seibel EJ, Sharar SR. Using FMRI to study the neural correlates of virtual reality analgesia. CNS Spectr. 2006 Jan;11(1):45–51.
    1. Hoffman HG, Richards TL, Coda B, Bills AR, Blough D, Richards AL, Sharar SR. Modulation of thermal pain-related brain activity with virtual reality: evidence from fMRI. Neuroreport. 2004 Jun 07;15(8):1245–8.
    1. Li A, Montaño Z, Chen VJ, Gold JI. Virtual reality and pain management: current trends and future directions. Pain Manag. 2011 Mar;1(2):147–157. doi: 10.2217/pmt.10.15.
    1. McCaul KD, Malott JM. Distraction and coping with pain. Psychol Bull. 1984 May;95(3):516–33.
    1. U.S Food & Drug Administration. [2017-10-09]. Step 3: Clinical Research .
    1. Laine L, Spiegel B, Rostom A, Moayyedi P, Kuipers EJ, Bardou M, Sung J, Barkun AN. Methodology for randomized trials of patients with nonvariceal upper gastrointestinal bleeding: recommendations from an international consensus conference. Am J Gastroenterol. 2010 Mar;105(3):540–50. doi: 10.1038/ajg.2009.702.
    1. Grade Working Group. [2006-04-07]. GRADE .
    1. Slack. [2018-12-13].
    1. Ericsson AKS, Simon H. Protocol Analysis: Verbal Reports as Data. Cambridge, Massachusetts: MIT Press; 1993.
    1. Mummah SA, Robinson TN, King AC, Gardner CD, Sutton S. IDEAS (Integrate, Design, Assess, and Share): A Framework and Toolkit of Strategies for the Development of More Effective Digital Interventions to Change Health Behavior. J Med Internet Res. 2016 Dec 16;18(12):e317. doi: 10.2196/jmir.5927.
    1. Field Guide to Human-Centered Design. Palo Alto, California: Kit; 2015.
    1. Brown T. Design thinking. Harv Bus Rev. 2008 Jun;86(6):84–92, 141.
    1. Jerald J. The VR Book: Human-centered Design For Virtual Reality. New York, NY: Morgan & Claypool Publishers; 2015.
    1. Carr S, Halliday A, King A, Liedtka J, Lockwood T. The Influence of Design Thinking in Businessome Preliminary Observations. Design Management Review. 2010;21:58–63.
    1. Oculus. 2017. [2018-07-09]. Introducing Chromecast for Gear VR: Step into VR and Stream to Your Flatscreen Internet
    1. Github. [2017-07-05].
    1. Mosadeghi S, Reid MW, Martinez B, Rosen BT, Spiegel BMR. Feasibility of an Immersive Virtual Reality Intervention for Hospitalized Patients: An Observational Cohort Study. JMIR Ment Health. 2016 Jun 27;3(2):e28. doi: 10.2196/mental.5801.
    1. Stanney KM, Kennedy RS, Drexler JM. Cybersickness is not simulator sickness. In Proceedings of the Human Factors and Ergonomics Society annual meeting; September 22-26, 1997; Albuquerque, New Mexico. SAGE Publications; 1997.
    1. Bruck S, Watters PA. Estimating cybersickness of simulated motion using the simulator sickness questionnaire (SSQ): A controlled study. International Conference on Computer Graphics, Imaging and Visualization; Aug 11-14, 2009; Tianjin, China. 2009. pp. 486–488.
    1. Porcino TM, Clua E, Trevisan D, Vasconcelos CN, Valente L. Minimizing cyber sickness in head mounted display systems: design guidelines and applications. IEEE 5th International Conference; April 2-4, 2017; Perth, Western Australia. 2017. Apr, pp. 1–6.
    1. Yao R, Heath T, Davies A, Forsyth T, Mitchell N, Hoberman P. Oculus. 2014. [2018-10-22]. Oculus VR Best Practices Guide .
    1. Mazloumi Gavgani A, Hodgson DM, Nalivaiko E. Effects of visual flow direction on signs and symptoms of cybersickness. PLoS One. 2017;12(8):e0182790. doi: 10.1371/journal.pone.0182790.
    1. Lin J, Abi-Rached H, Lahav M. Virtual guiding avatar: An effective procedure to reduce simulator sickness in virtual environments. Proceedings of the SIGCHI conference on Human factors in computing systems; ACM; April 24-29, 2004; Vienna, Austria. 2004. pp. 719–726.
    1. Budhiraja P, Miller MR, Modi AK, Forsyth D. ARXIV. 2017. Oct 06, [2018-12-13]. Rotation Blurring: Use of Artificial Blurring to Reduce Cybersickness in Virtual Reality First Person Shooters .
    1. Gavgani AM, Nesbitt KV, Blackmore KL, Nalivaiko E. Profiling subjective symptoms and autonomic changes associated with cybersickness. Auton Neurosci. 2017 Mar;203:41–50. doi: 10.1016/j.autneu.2016.12.004.
    1. Tyrrell R, Sarig-Bahat H, Williams K, Williams G, Treleaven J. Simulator sickness in patients with neck pain and vestibular pathology during virtual reality tasks. Virtual Reality. 2017 Sep 22;22(3):211–219. doi: 10.1007/s10055-017-0324-1. doi: 10.1007/s10055-017-0324-1.
    1. Park WD, Kim YS, Jang SW, Kim GA, Kim YH, Son W. A study on cyber sickness reduction by oculo-motor exercise performed immediately prior to viewing virtual reality (VR) content on head mounted display (HMD) JVE Journals. 2017;(14):260–264. doi: 10.21595/vp.2017.19170. doi: 10.21595/vp.2017.19170.
    1. Russell MEB, Hoffman B, Stromberg S, Carlson CR. Use of controlled diaphragmatic breathing for the management of motion sickness in a virtual reality environment. Appl Psychophysiol Biofeedback. 2014 Dec;39(3-4):269–77. doi: 10.1007/s10484-014-9265-6.
    1. Dworkin RH, Turk DC, Farrar JT, Haythornthwaite JA, Jensen MP, Katz NP, Kerns RD, Stucki G, Allen RR, Bellamy N, Carr DB, Chandler J, Cowan P, Dionne R, Galer BS, Hertz S, Jadad AR, Kramer LD, Manning DC, Martin S, McCormick CG, McDermott MP, McGrath P, Quessy S, Rappaport BA, Robbins W, Robinson JP, Rothman M, Royal MA, Simon L, Stauffer JW, Stein W, Tollett J, Wernicke J, Witter J, IMMPACT Core outcome measures for chronic pain clinical trials: IMMPACT recommendations. Pain. 2005 Jan;113(1-2):9–19. doi: 10.1016/j.pain.2004.09.012.
    1. Cella D, Yount S, Rothrock N, Gershon R, Cook K, Reeve B, Ader D, Fries JF, Bruce B, Rose M, PROMIS Cooperative Group The Patient-Reported Outcomes Measurement Information System (PROMIS): progress of an NIH Roadmap cooperative group during its first two years. Med Care. 2007 May;45(5 Suppl 1):S3–S11. doi: 10.1097/01.mlr.0000258615.42478.55.
    1. Hoffmann TC, Glasziou PP, Boutron I, Milne R, Perera R, Moher D, Altman DG, Barbour V, Macdonald H, Johnston M, Lamb SE, Dixon-Woods M, McCulloch P, Wyatt JC, Chan A, Michie S. Better reporting of interventions: template for intervention description and replication (TIDieR) checklist and guide. BMJ. 2014 Mar 07;348:g1687. doi: 10.1136/bmj.g1687.
    1. Saghaei Mahmoud. An overview of randomization and minimization programs for randomized clinical trials. J Med Signals Sens. 2011 Jan;1(1):55–61.
    1. Tashjian VC, Mosadeghi S, Howard AR, Lopez M, Dupuy T, Reid M, Martinez B, Ahmed S, Dailey F, Robbins K, Rosen B, Fuller G, Danovitch I, IsHak W, Spiegel B. Virtual Reality for Management of Pain in Hospitalized Patients: Results of a Controlled Trial. JMIR Ment Health. 2017 Mar 29;4(1):e9. doi: 10.2196/mental.7387.
    1. Jaeschke R, Singer J, Guyatt GH. Measurement of health status. Ascertaining the minimal clinically important difference. Control Clin Trials. 1989 Dec;10(4):407–15.
    1. Norman GR, Sloan JA, Wyrwich KW. Interpretation of changes in health-related quality of life: the remarkable universality of half a standard deviation. Med Care. 2003 May;41(5):582–92. doi: 10.1097/01.MLR.0000062554.74615.4C.
    1. Curran PJ, Bauer DJ. The disaggregation of within-person and between-person effects in longitudinal models of change. Annu Rev Psychol. 2011;62:583–619. doi: 10.1146/annurev.psych.093008.100356.
    1. Begg C, Cho M, Eastwood S, Horton R, Moher D, Olkin I, Pitkin R, Rennie D, Schulz KF, Simel D, Stroup DF. Improving the quality of reporting of randomized controlled trials. The CONSORT statement. JAMA. 1996 Aug 28;276(8):637–9.

Source: PubMed

スポンサーと協力者

医学的状態

薬物療法

3
購読する