메뉴 건너뛰기




Volumn 90, Issue , 2017, Pages 99-107

Series: Pragmatic trials and real world evidence: Paper 6. Outcome measures in the real world

Author keywords

Generalizability; Outcome measurement; Pragmatic trial; Real world evidence

Indexed keywords

ARTICLE; CLINICAL PRACTICE; CLINICAL TRIAL (TOPIC); DECISION MAKING; FEASIBILITY STUDY; FUNCTIONAL STATUS; HUMAN; MORBIDITY; MORTALITY; OUTCOME ASSESSMENT; PATIENT-REPORTED OUTCOME; PRIORITY JOURNAL; STANDARDIZATION; WELLBEING; BIOASSAY; EVIDENCE BASED MEDICINE; METHODOLOGY; RANDOMIZED CONTROLLED TRIAL (TOPIC); STANDARDS;

EID: 85021190910     PISSN: 08954356     EISSN: 18785921     Source Type: Journal    
DOI: 10.1016/j.jclinepi.2016.12.022     Document Type: Article
Times cited : (36)

References (62)
  • 1
    • 63649136121 scopus 로고    scopus 로고
    • Explanatory and pragmatic attitudes in therapeutical trials
    • Schwartz, D., Lellouch, J., Explanatory and pragmatic attitudes in therapeutical trials. J Clin Epidemiol 62 (2009), 499–505.
    • (2009) J Clin Epidemiol , vol.62 , pp. 499-505
    • Schwartz, D.1    Lellouch, J.2
  • 2
    • 80052383955 scopus 로고    scopus 로고
    • Explanatory and pragmatic clinical trials: a primer and application to a recent asthma trial
    • Sackett, D.L., Explanatory and pragmatic clinical trials: a primer and application to a recent asthma trial. Pol Arch Med Wewn 121 (2011), 259–263.
    • (2011) Pol Arch Med Wewn , vol.121 , pp. 259-263
    • Sackett, D.L.1
  • 5
    • 84895030346 scopus 로고    scopus 로고
    • Systematic review of the Hawthorne effect: new concepts are needed to study research participation effects
    • McCambridge, J., Witton, J., Elbourne, D.R., Systematic review of the Hawthorne effect: new concepts are needed to study research participation effects. J Clin Epidemiol 67 (2014), 267–277.
    • (2014) J Clin Epidemiol , vol.67 , pp. 267-277
    • McCambridge, J.1    Witton, J.2    Elbourne, D.R.3
  • 6
    • 57349108691 scopus 로고    scopus 로고
    • Improving the reporting of pragmatic trials: an extension of the CONSORT statement
    • Zwarenstein, M., Treweek, S., Gagnier, J.J., Altman, D.G., Tunis, S., Haynes, B., et al. Improving the reporting of pragmatic trials: an extension of the CONSORT statement. BMJ, 337, 2008, a2390.
    • (2008) BMJ , vol.337 , pp. a2390
    • Zwarenstein, M.1    Treweek, S.2    Gagnier, J.J.3    Altman, D.G.4    Tunis, S.5    Haynes, B.6
  • 7
    • 84902549977 scopus 로고    scopus 로고
    • Developing core outcome measurement sets for clinical trials: OMERACT Filter 2.0
    • Boers, M., Kirwan, J.R., Wells, G., Beaton, D., Gossece, L., d'Agostino, M.A., et al. Developing core outcome measurement sets for clinical trials: OMERACT Filter 2.0. J Clin Epidemiol 67 (2014), 745–753.
    • (2014) J Clin Epidemiol , vol.67 , pp. 745-753
    • Boers, M.1    Kirwan, J.R.2    Wells, G.3    Beaton, D.4    Gossece, L.5    d'Agostino, M.A.6
  • 8
    • 85032272565 scopus 로고    scopus 로고
    • EUnetHTA: Endpoints used for relative effectiveness assessment of pharmaceuticals. Available at Accessed May 29.
    • EUnetHTA: Endpoints used for relative effectiveness assessment of pharmaceuticals. Available at http://www.eunethta.eu/eunethta-guidelines. Accessed May 29, 2017.
    • (2017)
  • 9
    • 67651193711 scopus 로고    scopus 로고
    • Initial national priorities for comparative effectiveness research
    • The National Academies Press Washington, DC
    • Institute of Medicine. Initial national priorities for comparative effectiveness research. 2009, The National Academies Press, Washington, DC.
    • (2009)
  • 10
    • 84940771419 scopus 로고    scopus 로고
    • The Salford Lung Study protocol: a pragmatic, randomised phase III real-world effectiveness trial in chronic obstructive pulmonary disease
    • Bakerly, N.D., Woodcock, A., New, J.P., Gibson, J.M., Wu, W., Leather, D., et al. The Salford Lung Study protocol: a pragmatic, randomised phase III real-world effectiveness trial in chronic obstructive pulmonary disease. Respir Res, 16, 2015, 101.
    • (2015) Respir Res , vol.16 , pp. 101
    • Bakerly, N.D.1    Woodcock, A.2    New, J.P.3    Gibson, J.M.4    Wu, W.5    Leather, D.6
  • 11
    • 0034802767 scopus 로고    scopus 로고
    • Considerations in the evaluation of surrogate endpoints in clinical trials. Summary of a National Institutes of Health Workshop
    • De Gruttola, V.G., Clax, P., DeMets, D.L., Downing, G.J., Ellenberg, S.S., Friedman, L., et al. Considerations in the evaluation of surrogate endpoints in clinical trials. Summary of a National Institutes of Health Workshop. Contemp Clin Trials 22 (2001), 485–502.
    • (2001) Contemp Clin Trials , vol.22 , pp. 485-502
    • De Gruttola, V.G.1    Clax, P.2    DeMets, D.L.3    Downing, G.J.4    Ellenberg, S.S.5    Friedman, L.6
  • 12
    • 79952115940 scopus 로고    scopus 로고
    • Designing comparative effectiveness research on prescription drugs: lessons from the clinical trial literature
    • Chokshi, D.A., Avorn, J., Kesselheim, A.S., Designing comparative effectiveness research on prescription drugs: lessons from the clinical trial literature. Health Aff 29 (2010), 1842–1848.
    • (2010) Health Aff , vol.29 , pp. 1842-1848
    • Chokshi, D.A.1    Avorn, J.2    Kesselheim, A.S.3
  • 13
    • 79956191863 scopus 로고    scopus 로고
    • Individuals with diabetes preferred that future trials use patient-important outcomes and provide pragmatic inferences
    • Murad, M.H., Shah, N.D., Van Houten, H.K., Ziegenfuss, J.Y., Deming, J.R., Beebe, T.J., et al. Individuals with diabetes preferred that future trials use patient-important outcomes and provide pragmatic inferences. J Clin Epidemiol 64 (2011), 743–748.
    • (2011) J Clin Epidemiol , vol.64 , pp. 743-748
    • Murad, M.H.1    Shah, N.D.2    Van Houten, H.K.3    Ziegenfuss, J.Y.4    Deming, J.R.5    Beebe, T.J.6
  • 14
    • 0034632793 scopus 로고    scopus 로고
    • Human immunodeficiency virus type 1 RNA level and CD4 count as prognostic markers and surrogate end points: a meta-analysis. HIV Surrogate Marker Collaborative Group
    • Human immunodeficiency virus type 1 RNA level and CD4 count as prognostic markers and surrogate end points: a meta-analysis. HIV Surrogate Marker Collaborative Group. AIDS Res Hum Retroviruses 16 (2004), 1123–1133.
    • (2004) AIDS Res Hum Retroviruses , vol.16 , pp. 1123-1133
  • 15
    • 84927768820 scopus 로고    scopus 로고
    • Impact of low-level viremia on clinical and virological outcomes in treated HIV-1-infected patients
    • Antiretroviral Therapy Cohort Collaboration (ART-CC), Vandenhende, M.A., Ingle, S., May, M., Chene, G., Zangerle, R., Van Sighem, A., et al. Impact of low-level viremia on clinical and virological outcomes in treated HIV-1-infected patients. AIDS 29 (2015), 373–383.
    • (2015) AIDS , vol.29 , pp. 373-383
    • Vandenhende, M.A.1    Ingle, S.2    May, M.3    Chene, G.4    Zangerle, R.5    Van Sighem, A.6
  • 16
    • 84901482905 scopus 로고    scopus 로고
    • New frontiers in patient-reported outcomes: adverse event reporting, comparative effectiveness, and quality assessment
    • Basch, E., New frontiers in patient-reported outcomes: adverse event reporting, comparative effectiveness, and quality assessment. Annu Rev Med 65 (2014), 307–317.
    • (2014) Annu Rev Med , vol.65 , pp. 307-317
    • Basch, E.1
  • 17
    • 36849021996 scopus 로고    scopus 로고
    • Patient-reported outcomes assessment in cancer trials: taking stock, moving forward
    • Lipscomb, J., Reeve, B.B., Clauser, S.B., Abrams, J.S., Bruner, D.W., Burke, L.B., et al. Patient-reported outcomes assessment in cancer trials: taking stock, moving forward. J Clin Oncol 25 (2007), 5133–5140.
    • (2007) J Clin Oncol , vol.25 , pp. 5133-5140
    • Lipscomb, J.1    Reeve, B.B.2    Clauser, S.B.3    Abrams, J.S.4    Bruner, D.W.5    Burke, L.B.6
  • 18
    • 33749264114 scopus 로고    scopus 로고
    • Meaningful differences
    • P. Fayers R.D. Hays Oxford Press New York, NY
    • Osoba, D., King, M., Meaningful differences. Fayers, P., Hays, R.D., (eds.) Assessing quality of life in clinical trials, 2005, Oxford Press, New York, NY, 244–257.
    • (2005) Assessing quality of life in clinical trials , pp. 244-257
    • Osoba, D.1    King, M.2
  • 19
    • 84939469660 scopus 로고    scopus 로고
    • Pragmatic characteristics of patient-reported outcome measures are important for use in clinical practice
    • Kroenke, K., Monahan, P.O., Kean, J., Pragmatic characteristics of patient-reported outcome measures are important for use in clinical practice. J Clin Epidemiol 68 (2015), 1085–1092.
    • (2015) J Clin Epidemiol , vol.68 , pp. 1085-1092
    • Kroenke, K.1    Monahan, P.O.2    Kean, J.3
  • 20
    • 84880202219 scopus 로고    scopus 로고
    • Measure once, cut twice adding patient-reported outcome measures to the electronic health record for comparative effectiveness research
    • Wu, A.W., Kharrazi, H., Boulware, L.E., Snyder, C.F., Measure once, cut twice adding patient-reported outcome measures to the electronic health record for comparative effectiveness research. J Clin Epidemiol 66:8 Suppl (2013), S12–S20.
    • (2013) J Clin Epidemiol , vol.66 , Issue.8 , pp. S12-S20
    • Wu, A.W.1    Kharrazi, H.2    Boulware, L.E.3    Snyder, C.F.4
  • 21
    • 85032283776 scopus 로고    scopus 로고
    • Available at Accessed May 29.
    • Available at www.comet-initiative.org. Accessed May 29, 2017.
    • (2017)
  • 22
    • 84959264761 scopus 로고    scopus 로고
    • Standardizing patient outcomes measurement
    • Porter, M.E., Larsson, S., Lee, T.H., Standardizing patient outcomes measurement. N Engl J Med 374 (2016), 504–506.
    • (2016) N Engl J Med , vol.374 , pp. 504-506
    • Porter, M.E.1    Larsson, S.2    Lee, T.H.3
  • 23
    • 85032276385 scopus 로고    scopus 로고
    • Available at Accessed May 29.
    • Available at https://www.linkedin.com/company-beta/2760048/. Accessed May 29, 2017.
    • (2017)
  • 24
    • 85032277491 scopus 로고    scopus 로고
    • Available at Accessed May 29.
    • Available at http://www.healthmeasures.net/. Accessed May 29, 2017.
    • (2017)
  • 25
    • 85032286394 scopus 로고    scopus 로고
    • Available at Accessed May 29.
    • Available at https://www.nihcollaboratory.org/cores/Pages/default.aspx. Accessed May 29, 2017.
    • (2017)
  • 26
    • 85032297599 scopus 로고    scopus 로고
    • Available at Accessed May 29.
    • Available at http://www.cosmin.nl. Accessed May 29, 2017.
    • (2017)
  • 27
    • 84868269353 scopus 로고    scopus 로고
    • Health care system information sharing: a step toward better health globally
    • Eldessouki, R., Smith, M.D., Health care system information sharing: a step toward better health globally. Value Health Reg Issues 1 (2012), 118–129.
    • (2012) Value Health Reg Issues , vol.1 , pp. 118-129
    • Eldessouki, R.1    Smith, M.D.2
  • 28
    • 85032299713 scopus 로고    scopus 로고
    • Available at Accessed May 29.
    • Available at http://www.ispor.org/HTARoadmaps/Default.asp. Accessed May 29, 2017.
    • (2017)
  • 29
    • 85032291027 scopus 로고    scopus 로고
    • Available at Accessed May 29.
    • Available at http://www.ispor.org/peguidelines/index.asp. Accessed May 29, 2017.
    • (2017)
  • 31
    • 0035049158 scopus 로고    scopus 로고
    • Adjusting for multiple testing—when and how
    • Bender, R., Lange, S., Adjusting for multiple testing—when and how. J Clin Epidemiol 54 (2001), 343–349.
    • (2001) J Clin Epidemiol , vol.54 , pp. 343-349
    • Bender, R.1    Lange, S.2
  • 32
    • 84861531594 scopus 로고    scopus 로고
    • Joint hypothesis testing and gatekeeping procedures for studies with multiple endpoints
    • Mascha, E.J., Turan, A., Joint hypothesis testing and gatekeeping procedures for studies with multiple endpoints. Anesth Analg 114 (2012), 1304–1317.
    • (2012) Anesth Analg , vol.114 , pp. 1304-1317
    • Mascha, E.J.1    Turan, A.2
  • 33
    • 85032257796 scopus 로고    scopus 로고
    • Available at Accessed May 29.
    • General Considerations for Clinical Trials (ICH Topic E 8). Available at http://www.ema.europa.eu/ema/. Accessed May 29, 2017.
    • (2017)
  • 34
    • 85032294697 scopus 로고    scopus 로고
    • Reflection paper on the regulatory guidance for the use of health related quality of life (HRQL) measures in the evaluation of medicinal products. EMA 2005, Guidance document ref nr: CPMP/EWP/139391/04, Available at
    • Reflection paper on the regulatory guidance for the use of health related quality of life (HRQL) measures in the evaluation of medicinal products. EMA 2005, Guidance document ref nr: CPMP/EWP/139391/04, Available at http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/general/general_content_001238.jsp&mid=WC0b01ac0580032ec4.
  • 36
    • 0037132574 scopus 로고    scopus 로고
    • Health-related quality-of-life assessments and patient-physician communication
    • Detmar, S.B., Muller, M.J., Schornagel, J.H., Wever, L.D., Aaronson, N.K., Health-related quality-of-life assessments and patient-physician communication. JAMA 288 (2008), 3027–3034.
    • (2008) JAMA , vol.288 , pp. 3027-3034
    • Detmar, S.B.1    Muller, M.J.2    Schornagel, J.H.3    Wever, L.D.4    Aaronson, N.K.5
  • 37
    • 84891616455 scopus 로고    scopus 로고
    • Patient-physician communication about health-related quality-of-life problems: are non-Hodgkin lymphoma survivors willing to talk?
    • Arora, N.K., Jensen, R.E., Sulayman, N., Hamilton, A.S., Potosky, A.L., Patient-physician communication about health-related quality-of-life problems: are non-Hodgkin lymphoma survivors willing to talk?. J Clin Oncol 31 (2013), 3964–3970.
    • (2013) J Clin Oncol , vol.31 , pp. 3964-3970
    • Arora, N.K.1    Jensen, R.E.2    Sulayman, N.3    Hamilton, A.S.4    Potosky, A.L.5
  • 38
    • 33646412290 scopus 로고    scopus 로고
    • Assessing health-related quality of life in palliative care: comparing patient and physician assessments
    • Petersen, M.A., Larsen, H., Pedersen, L., Sonne, N., Groenvold, M., Assessing health-related quality of life in palliative care: comparing patient and physician assessments. Eur J Cancer 42 (2006), 1159–1166.
    • (2006) Eur J Cancer , vol.42 , pp. 1159-1166
    • Petersen, M.A.1    Larsen, H.2    Pedersen, L.3    Sonne, N.4    Groenvold, M.5
  • 39
    • 84940023578 scopus 로고    scopus 로고
    • Assessing patient preferences in heart failure using conjoint methodology
    • Pisa, G., Eichmann, F., Hupfer, S., Assessing patient preferences in heart failure using conjoint methodology. Patient Prefer Adherence 9 (2015), 1233–1241.
    • (2015) Patient Prefer Adherence , vol.9 , pp. 1233-1241
    • Pisa, G.1    Eichmann, F.2    Hupfer, S.3
  • 40
    • 34248648440 scopus 로고    scopus 로고
    • Patient perspective: fatigue as a recommended patient-centred outcome measure in rheumatoid arthritis
    • Kirwan, J., Minnock, P., Adebajo, A., Bresnihan, B., Choy, E., de Wit, M., et al. Patient perspective: fatigue as a recommended patient-centred outcome measure in rheumatoid arthritis. J Rheumatol 34 (2007), 1174–1177.
    • (2007) J Rheumatol , vol.34 , pp. 1174-1177
    • Kirwan, J.1    Minnock, P.2    Adebajo, A.3    Bresnihan, B.4    Choy, E.5    de Wit, M.6
  • 42
    • 84942293174 scopus 로고    scopus 로고
    • ISPOR TASK FORCE report clinical outcome assessments: conceptual foundation—report of the ISPOR clinical outcomes assessment—emerging good practices for Outcomes Research Task Force
    • Walton, M.K., Powers, J.H., Hobart, J., Patrick, D., Marquis, P., Vamvakas, S., et al. ISPOR TASK FORCE report clinical outcome assessments: conceptual foundation—report of the ISPOR clinical outcomes assessment—emerging good practices for Outcomes Research Task Force. Value Health 18 (2015), 741–752.
    • (2015) Value Health , vol.18 , pp. 741-752
    • Walton, M.K.1    Powers, J.H.2    Hobart, J.3    Patrick, D.4    Marquis, P.5    Vamvakas, S.6
  • 43
    • 77952511914 scopus 로고    scopus 로고
    • International consensus on taxonomy, terminology, and definitions of measurement properties for health-related patient-reported outcomes: results of the COSMIN study
    • Mokkink, L.B., Terwee, C.B., Patrick, D.L., Alonso, J., Stratford, P.W., Knol, D.L., et al. International consensus on taxonomy, terminology, and definitions of measurement properties for health-related patient-reported outcomes: results of the COSMIN study. J Clin Epidemology 63 (2010), 737–745.
    • (2010) J Clin Epidemology , vol.63 , pp. 737-745
    • Mokkink, L.B.1    Terwee, C.B.2    Patrick, D.L.3    Alonso, J.4    Stratford, P.W.5    Knol, D.L.6
  • 44
    • 84889078530 scopus 로고    scopus 로고
    • ISOQOL recommends minimum standards for patient-reported outcome measures used in patient-centered outcomes and comparative effectiveness research
    • Reeve, B.B., Wyrwich, K.W., Wu, A.W., Velikova, G., Terwee, C.B., Snyder, C.F., et al. ISOQOL recommends minimum standards for patient-reported outcome measures used in patient-centered outcomes and comparative effectiveness research. Qual Life Res 22 (2013), 1889–1905.
    • (2013) Qual Life Res , vol.22 , pp. 1889-1905
    • Reeve, B.B.1    Wyrwich, K.W.2    Wu, A.W.3    Velikova, G.4    Terwee, C.B.5    Snyder, C.F.6
  • 45
  • 46
    • 85020759003 scopus 로고    scopus 로고
    • Series: Pragmatic trials and real world evidence: Paper 2. Setting, sites, and investigator selection
    • Worsley, S.D., Oude Rengerink, K., Irving, E., Lejeune, S., Mol, K., Collier, S., et al. Series: Pragmatic trials and real world evidence: Paper 2. Setting, sites, and investigator selection. J Clin Epidemiol 88 (2017), 14–20.
    • (2017) J Clin Epidemiol , vol.88 , pp. 14-20
    • Worsley, S.D.1    Oude Rengerink, K.2    Irving, E.3    Lejeune, S.4    Mol, K.5    Collier, S.6
  • 47
    • 84942091352 scopus 로고    scopus 로고
    • Determining the minimally important difference in the clinical disease activity index for improvement and worsening in early rheumatoid arthritis patients
    • Curtis, J.R., Yang, S., Chen, L., Pope, J.E., Keystone, E.C., Haraoui, B., et al. Determining the minimally important difference in the clinical disease activity index for improvement and worsening in early rheumatoid arthritis patients. Arthritis Care Res (Hoboken) 67 (2015), 1345–1353.
    • (2015) Arthritis Care Res (Hoboken) , vol.67 , pp. 1345-1353
    • Curtis, J.R.1    Yang, S.2    Chen, L.3    Pope, J.E.4    Keystone, E.C.5    Haraoui, B.6
  • 48
    • 84941426655 scopus 로고    scopus 로고
    • Introducing the concept of the minimally important difference to determine a clinically relevant change on patient-reported outcome measures in patients with intermittent claudication
    • Conijn, A.P., Jonkers, W., Rouwet, E.V., Vahl, A.C., Reekers, J.A., Koelemay, M.J., Introducing the concept of the minimally important difference to determine a clinically relevant change on patient-reported outcome measures in patients with intermittent claudication. Cardiovasc Intervent Radiol 38 (2015), 1112–1118.
    • (2015) Cardiovasc Intervent Radiol , vol.38 , pp. 1112-1118
    • Conijn, A.P.1    Jonkers, W.2    Rouwet, E.V.3    Vahl, A.C.4    Reekers, J.A.5    Koelemay, M.J.6
  • 49
    • 33646486740 scopus 로고    scopus 로고
    • The cost of dichotomising continuous variables
    • Altman, D.G., Royston, P., The cost of dichotomising continuous variables. BMJ, 332, 2006, 1080.
    • (2006) BMJ , vol.332 , pp. 1080
    • Altman, D.G.1    Royston, P.2
  • 50
    • 84909590798 scopus 로고    scopus 로고
    • Automated estimation of disease recurrence in head and neck cancer using routine healthcare data
    • Ricketts, K., Williams, M., Liu, Z.W., Gibson, A., Automated estimation of disease recurrence in head and neck cancer using routine healthcare data. Comput Methods Programs Biomed 117 (2014), 412–424.
    • (2014) Comput Methods Programs Biomed , vol.117 , pp. 412-424
    • Ricketts, K.1    Williams, M.2    Liu, Z.W.3    Gibson, A.4
  • 51
    • 84964584033 scopus 로고    scopus 로고
    • Identification of nonresponse to treatment using narrative data in an electronic health record inflammatory bowel disease cohort
    • Ananthakrishnan, A.N., Cagan, A., Cai, T., Gainer, V.S., Shaw, S.Y., Savova, G., et al. Identification of nonresponse to treatment using narrative data in an electronic health record inflammatory bowel disease cohort. Inflamm Bowel Dis 22 (2016), 151–158.
    • (2016) Inflamm Bowel Dis , vol.22 , pp. 151-158
    • Ananthakrishnan, A.N.1    Cagan, A.2    Cai, T.3    Gainer, V.S.4    Shaw, S.Y.5    Savova, G.6
  • 52
    • 84931287731 scopus 로고    scopus 로고
    • Use of electronic health records to ascertain, validate and phenotype acute myocardial infarction: a systematic review and recommendations
    • Rubbo, B., Fitzpatrick, N.K., Denaxas, S., Daskalopoulou, M., Yu, N., Patel, R.S., et al. Use of electronic health records to ascertain, validate and phenotype acute myocardial infarction: a systematic review and recommendations. Int J Cardiol 187 (2015), 705–711.
    • (2015) Int J Cardiol , vol.187 , pp. 705-711
    • Rubbo, B.1    Fitzpatrick, N.K.2    Denaxas, S.3    Daskalopoulou, M.4    Yu, N.5    Patel, R.S.6
  • 53
    • 84856003959 scopus 로고    scopus 로고
    • Tradeoffs between accuracy measures for electronic health care data algorithms
    • Chubak, J., Pocobelli, G., Weiss, N.S., Tradeoffs between accuracy measures for electronic health care data algorithms. J Clin Epidemiol 65 (2012), 343–349.e2.
    • (2012) J Clin Epidemiol , vol.65 , pp. 343-349.e2
    • Chubak, J.1    Pocobelli, G.2    Weiss, N.S.3
  • 54
    • 35348821297 scopus 로고    scopus 로고
    • The intention-to-treat approach in randomized controlled trials: are authors saying what they do and doing what they say?
    • Gravel, J., Opatrny, L., Shapiro, S., The intention-to-treat approach in randomized controlled trials: are authors saying what they do and doing what they say?. Clin Trials 4 (2007), 350–356.
    • (2007) Clin Trials , vol.4 , pp. 350-356
    • Gravel, J.1    Opatrny, L.2    Shapiro, S.3
  • 55
    • 79955736485 scopus 로고    scopus 로고
    • Pragmatic trials—guides to better patient care?
    • Ware, J.H., Hamel, M.B., Pragmatic trials—guides to better patient care?. N Engl J Med 364 (2011), 1685–1687.
    • (2011) N Engl J Med , vol.364 , pp. 1685-1687
    • Ware, J.H.1    Hamel, M.B.2
  • 56
    • 84904179088 scopus 로고    scopus 로고
    • The opportunities and challenges of pragmatic point-of-care randomised trials using routinely collected electronic records: evaluations of two exemplar trials
    • van Staa, T.P., Dyson, L., McCann, G., Padmanabhan, S., Belatri, R., Goldacre, B., et al. The opportunities and challenges of pragmatic point-of-care randomised trials using routinely collected electronic records: evaluations of two exemplar trials. Health Technol Assess 18 (2014), 1–146.
    • (2014) Health Technol Assess , vol.18 , pp. 1-146
    • van Staa, T.P.1    Dyson, L.2    McCann, G.3    Padmanabhan, S.4    Belatri, R.5    Goldacre, B.6
  • 57
    • 79953890884 scopus 로고    scopus 로고
    • Blind outcome assessment: the development and use of procedures to maintain and describe blinding in a pragmatic physiotherapy rehabilitation trial
    • Minns Lowe, C.J., Wilson, M.S., Sackley, C.M., Barker, K.L., Blind outcome assessment: the development and use of procedures to maintain and describe blinding in a pragmatic physiotherapy rehabilitation trial. Clin Rehabil 25 (2011), 264–274.
    • (2011) Clin Rehabil , vol.25 , pp. 264-274
    • Minns Lowe, C.J.1    Wilson, M.S.2    Sackley, C.M.3    Barker, K.L.4
  • 58
    • 84868653173 scopus 로고    scopus 로고
    • Measurement error and outcomes defined by exceeding a threshold: biased findings in comparative effectiveness trials
    • Buzkova, P., Measurement error and outcomes defined by exceeding a threshold: biased findings in comparative effectiveness trials. Pharm Stat 11 (2012), 429–441.
    • (2012) Pharm Stat , vol.11 , pp. 429-441
    • Buzkova, P.1
  • 59
    • 33644617812 scopus 로고    scopus 로고
    • The role of measurement reliability in clinical trials
    • Lachin, J.M., The role of measurement reliability in clinical trials. Clin Trials 1 (2004), 553–566.
    • (2004) Clin Trials , vol.1 , pp. 553-566
    • Lachin, J.M.1
  • 60
    • 67649383249 scopus 로고    scopus 로고
    • Evaluating the benefit of event adjudication of cardiovascular outcomes in large simple RCTs
    • Pogue, J., Walter, S.D., Yusuf, S., Evaluating the benefit of event adjudication of cardiovascular outcomes in large simple RCTs. Clin Trials 6 (2009), 239–251.
    • (2009) Clin Trials , vol.6 , pp. 239-251
    • Pogue, J.1    Walter, S.D.2    Yusuf, S.3
  • 61
    • 68249114452 scopus 로고    scopus 로고
    • Multiple imputation for missing data in epidemiological and clinical research: potential and pitfalls
    • Sterne, J.A., White, I.R., Carlin, J.B., Spratt, M., Royston, P., Kenward, M.G., et al. Multiple imputation for missing data in epidemiological and clinical research: potential and pitfalls. Br Med J, 338, 2009, b2393.
    • (2009) Br Med J , vol.338 , pp. b2393
    • Sterne, J.A.1    White, I.R.2    Carlin, J.B.3    Spratt, M.4    Royston, P.5    Kenward, M.G.6
  • 62
    • 11844302840 scopus 로고    scopus 로고
    • Treating individuals 2. Subgroup analysis in randomized controlled trials: importance, indications, and interpretation
    • Rothwell, P.M., Treating individuals 2. Subgroup analysis in randomized controlled trials: importance, indications, and interpretation. Lancet 365 (2005), 176–186.
    • (2005) Lancet , vol.365 , pp. 176-186
    • Rothwell, P.M.1


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.