Identifying Possible Outcome Domains from Existing Outcome Measures to Inform an OMERACT Core Domain Set for Safety in Rheumatology Trials

REFERENCES

1. 1.↵
   1. Zorzela L,
   2. Loke YK,
   3. Ioannidis JP,
   4. Golder S,
   5. Santaguida P,
   6. Altman DG,
   7. et al;
   8. PRISMAHarms Group

   . PRISMA harms checklist: improving harms reporting in systematic reviews. BMJ 2016;352:i157.

   OpenUrlAbstract/FREE Full Text
2. 2.↵
   1. Guyatt GH,
   2. Oxman AD,
   3. Kunz R,
   4. Atkins D,
   5. Brozek J,
   6. Vist G,
   7. et al.

   GRADE guidelines: 2. Framing the question and deciding on important outcomes. J Clin Epidemiol 2011;64:395–400.

   OpenUrlCrossRefPubMed
3. 3.↵
   1. Ioannidis JP,
   2. Evans SJ,
   3. Gotzsche PC,
   4. O’Neill RT,
   5. Altman DG,
   6. Schulz K,
   7. et al;
   8. CONSORT Group

   . Better reporting of harms in randomized trials: an extension of the CONSORT statement. Ann Intern Med 2004;141:781–8.

   OpenUrlCrossRefPubMed
4. 4.↵
   1. Ethgen M,
   2. Boutron I,
   3. Baron G,
   4. Giraudeau B,
   5. Sibilia J,
   6. Ravaud P

   . Reporting of harm in randomized, controlled trials of nonpharmacologic treatment for rheumatic disease. Ann Intern Med 2005;143:20–5.

   OpenUrlCrossRefPubMed
5. 5.↵
   1. Hadi MA,
   2. McHugh GA,
   3. Conaghan PG

   . Quality of reporting of harms in randomised controlled trials of pharmacological interventions for rheumatoid arthritis: a systematic review. Evid Based Med 2017;22:170–7.

   OpenUrl
6. 6.↵
   1. Saini P,
   2. Loke YK,
   3. Gamble C,
   4. Altman DG,
   5. Williamson PR,
   6. Kirkham JJ

   . Selective reporting bias of harm outcomes within studies: findings from a cohort of systematic reviews. BMJ 2014;349:g6501.

   OpenUrlAbstract/FREE Full Text
7. 7.↵
   1. Klokker L,
   2. Tugwell P,
   3. Furst DE,
   4. Devoe D,
   5. Williamson P,
   6. Terwee CB,
   7. et al.

   Developing an OMERACT core outcome set for assessing safety components in rheumatology trials: the OMERACT safety working group. J Rheumatol 2017;44:1916–9.

   OpenUrlAbstract/FREE Full Text
8. 8.↵
   1. Boers M,
   2. Kirwan JR,
   3. Tugwell P,
   4. Beaton D,
   5. Bingham CO III,
   6. Conaghan PG,
   7. et al.

   The OMERACT Handbook. [Internet. Accessed February 18, 2019.] Available from: https://omeract.org/resources
9. 9.↵
   1. Macefield RC,
   2. Jacobs M,
   3. Korfage IJ,
   4. Nicklin J,
   5. Whistance RN,
   6. Brookes ST,
   7. et al.

   Developing core outcomes sets: methods for identifying and including patient-reported outcomes (PROs). Trials 2014;15:49.

   OpenUrlCrossRefPubMed
10. 10.↵
    1. McNair AG,
    2. Whistance RN,
    3. Forsythe RO,
    4. Rees J,
    5. Jones JE,
    6. Pullyblank AM,
    7. et al;
    8. CONSENSUS-CRC (Core Outcomes and iNformation SEts iN SUrgical Studies - ColoRectal Cancer) Working Group

    . Synthesis and summary of patient-reported outcome measures to inform the development of a core outcome set in colorectal cancer surgery. Colorectal Dis 2015;17:O217–29.

    OpenUrl
11. 11.↵
    1. Arksey H,
    2. O’Malley L

    . Scoping studies: towards a methodological framework. Int J Soc Res Methodol 2005;8:19–32.

    OpenUrlCrossRef
12. 12.↵
    1. Tricco AC,
    2. Lille E,
    3. Zarin W,
    4. O’Brien KK,
    5. Colquhoun H,
    6. Levac D,
    7. et al.

    PRISMA Extension for Scoping Reviews (PRISMA-ScR): Checklist and explanation. Ann Intern Med 2018;169:467–73.

    OpenUrlCrossRef
13. 13.↵
    1. Kane M,
    2. Trochim W

    . Concept mapping for planning and evaluation. London: Sage Publications Inc.; 2007.
14. 14.↵
    1. Fries JF,
    2. Spitz PW,
    3. Williams CA,
    4. Bloch DA,
    5. Singh G,
    6. Hubert HB

    . A toxicity index for comparison of side effects among different drugs. Arthritis Rheum 1990;33:121–30.

    OpenUrlCrossRefPubMed
15. 15.↵
    1. Welch V,
    2. Singh G,
    3. Strand V,
    4. Fries J,
    5. Boers M,
    6. Ramey D,
    7. et al.

    Patient based method of assessing adverse events in clinical trials in rheumatology: the revised Stanford Toxicity Index. J Rheumatol 2001;28:1188–91.

    OpenUrlAbstract/FREE Full Text
16. 16.↵
    1. Woodworth TG,
    2. Furst DE,
    3. Strand V,
    4. Kempeni J,
    5. Fenner H,
    6. Lau CS,
    7. et al.

    Standardizing assessment of adverse effects in rheumatology clinical trials. Status of OMERACT Toxicity Working Group March 2000: towards a common understanding of comparative toxicity/safety profiles for antirheumatic therapies. J Rheumatol 2001;28:1163–9.

    OpenUrlAbstract/FREE Full Text
17. 17.↵
    1. Lassere MN,
    2. Johnson KR,
    3. Van Santen S,
    4. Carlton K,
    5. Rappo J,
    6. Michael R,
    7. et al.

    Generic patient self-report and investigator report instruments of therapeutic safety and tolerability. J Rheumatol 2005;32:2033–6.

    OpenUrlAbstract/FREE Full Text
18. 18.↵
    1. Woodworth T,
    2. Furst DE,
    3. Alten R,
    4. Bingham CO 3rd,
    5. Yocum D,
    6. Sloan V,
    7. et al.

    Standardizing assessment and reporting of adverse effects in rheumatology clinical trials II: the Rheumatology Common Toxicity Criteria v.2.0. J Rheumatol 2007;34:1401–14.

    OpenUrlAbstract/FREE Full Text
19. 19.↵
    1. Boers M,
    2. Brooks P,
    3. Fries JF,
    4. Simon LS,
    5. Strand V,
    6. Tugwell P

    . A first step to assess harm and benefit in clinical trials in one scale. J Clin Epidemiol 2010;63:627–32.

    OpenUrlCrossRefPubMed
20. 20.↵
    1. Gossec L,
    2. Fautrel B,
    3. Flipon E,
    4. Lecoq d’Andre F,
    5. Marguerie L,
    6. Nataf H,
    7. et al.

    Safety of biologics: elaboration and validation of a questionnaire assessing patients’ self-care safety skills: the BioSecure questionnaire. An initiative of the French Rheumatology Society Therapeutic Education section. Joint Bone Spine 2013;80:471–6.

    OpenUrl
21. 21.↵
    1. Thanou A,
    2. Chakravarty E,
    3. James JA,
    4. Merrill JT

    . How should lupus flares be measured? Deconstruction of the safety of estrogen in lupus erythematosus national assessment-systemic lupus erythematosus disease activity index flare index. Rheumatology 2014;53:2175–81.

    OpenUrlCrossRefPubMed
22. 22.↵
    1. Miloslavsky EM,
    2. Naden RP,
    3. Bijlsma JW,
    4. Brogan PA,
    5. Brown ES,
    6. Brunetta P,
    7. et al.

    Development of a Glucocorticoid Toxicity Index (GTI) using multicriteria decision analysis. Ann Rheum Dis 2016;76:543–6.

    OpenUrl
23. 23.↵
    1. Basch E,
    2. Reeve BB,
    3. Mitchell SA,
    4. Clauser SB,
    5. Minasian LM,
    6. Dueck AC,
    7. et al.

    Development of the National Cancer Institute’s patient-reported outcomes version of the common terminology criteria for adverse events (PRO-CTCAE). J Natl Cancer Inst 2014;106.