Peer approaches to self-management (PALS): comparing a peer mentoring approach for disease self-management in African American women with lupus with a social support control: study protocol for a randomized controlled trial

Edith M Williams, Leonard Egede, Jim C Oates, Clara L Dismuke, Viswanathan Ramakrishnan, Trevor D Faith, Hetlena Johnson, Jillian Rose, Edith M Williams, Leonard Egede, Jim C Oates, Clara L Dismuke, Viswanathan Ramakrishnan, Trevor D Faith, Hetlena Johnson, Jillian Rose

Abstract

Background: Systemic lupus erythematosus (SLE or lupus) is a chronic autoimmune disease that is associated with increased morbidity, mortality, healthcare costs and decreased quality of life. African Americans in the USA have three to four times greater prevalence of SLE, risk of developing SLE at an earlier age, and SLE-related disease activity, damage, and mortality compared with Caucasians, with the highest rates experienced by African American women. There is strong evidence that patient-level factors are associated with outcomes, which justifies targeting them with intervention. While evidence-based self-management interventions that incorporate both social support and health education have reduced pain, improved function, and delayed disability among patients with SLE, African Americans and women are still disproportionately impacted by SLE. Peer mentoring interventions are effective in other chronic conditions that disproportionately affect minorities, such as diabetes mellitus, HIV, and kidney disease, but there is currently no empirically tested peer mentoring intervention developed for patients with SLE. Preliminary data from our group suggest that peer mentoring improves self-management, reduces disease activity, and improves health-related quality of life (HRQOL) in African American women with SLE.

Methods: This study will test an innovative, manualized peer mentorship program designed to provide modeling and reinforcement by peers (mentors) to other African American women with SLE (mentees) to encourage them to engage in activities that promote disease self-management. Through a randomized, "mentored" or "support group" controlled design, we will assess the efficacy and mechanism(s) of this intervention in self-management, disease activity, and HRQOL.

Discussion: This is the first study to test peer mentorship as an alternative strategy to improve outcomes in African American women with SLE. This could result in a model for other programs that aim to improve disease self-management, disease activity, and HRQOL in African American women suffering from chronic illness. The peer mentoring approach is uniquely fitted to African Americans, and this intervention has the potential to lead to health improvements for African American women with SLE that have not been attainable with other interventions. This would significantly reduce disparities and have considerable public health impact.

Trial registration: ClinicalTrials.gov, NCT03734055 . Registered on 27 November 2018.

Keywords: African American; Behavioral intervention; Peer mentoring; Self-management; Systemic lupus erythematosus; Women.

Conflict of interest statement

The authors declare that they have no competing interests.

Figures

Fig. 1
Fig. 1
SPIRIT figure of participant activity within one cohort
Fig. 2
Fig. 2
Procedural flow chart for mentors, mentored participants, and controls

References

    1. Rahman A, Isenberg D. Systemic lupus erythematosus. New Engl J Med. 2008;358(9):929–939. doi: 10.1056/NEJMra071297.
    1. Pons-Estel G, Ugarte-Gil M, Alarcón G. Epidemiology of systemic lupus erythematosus. Expert Rev Clin Immu. 2017;13(8):799–814. doi: 10.1080/1744666X.2017.1327352.
    1. Giffords E. Understanding and managing systemic lupus erythematosus (SLE) J Soc Work Health Care. 2003;37(4):57–72. doi: 10.1300/J010v37n04_04.
    1. Sehlo M, Bahlas S. Perceived illness stigma is associated with depression in female patients with systemic lupus erythematosus. J Psychosom Res. 2013;74(3):248–251. doi: 10.1016/j.jpsychores.2012.09.023.
    1. Hanly J, Su L, Urowitz M, et al. Mood disorders in systemic lupus erythematosus: results from an international inception cohort study. Arthritis Rheumatol. 2015;67(7):1837–1847. doi: 10.1002/art.39111.
    1. Kulczycka L, Sysa-Jędrzejowska A, Robak E. The influence of clinical manifestations and treatment on satisfaction with life together with positive and negative emotions in systemic lupus erythematosus patients. Acta Dermatovenerol Croat. 2011;19(1):6–12.
    1. Jolly M. How does quality of life of patients with systemic lupus erythematosus compare with that of other common chronic illnesses? J Rheumatol. 2005;32(9):1706–1708.
    1. Beckerman N. Living with lupus: a qualitative report. Soc Work Health Care. 2011;50(4):330–343. doi: 10.1080/00981389.2011.554302.
    1. McElhone K, Abbott J, Gray J, Williams A, Teh L-S. Patient perspective of systemic lupus erythematosus in relation to health related quality of life concepts. A qualitative study. Lupus. 2010;19(14):1640–1647. doi: 10.1177/0961203310378668.
    1. Macejová Z, Záriková M, Oetterová M. Systemic lupus erythematosus–disease impact on patients. Cent Eur J Public Health. 2013;21(3):171–173. doi: 10.21101/cejph.a3818.
    1. Campbell RJ, Cooper G, Gilkeson G. The impact of systemic lupus erythematosus on employment. J Rheumatol. 2009;36(11):2470–2475. doi: 10.3899/jrheum.080586.
    1. Williams E, Bruner L, Adkins A, Vrana C, Logan A, Kamen D, et al. I too, am America: a review of research on systemic lupus erythematosus (SLE) in African Americans. Lupus Sci Med. 2015;3(1):E000144. doi: 10.1136/lupus-2015-000144.
    1. Fernández M, Alarcón G, Calvo-Alén J, et al. A multiethnic, multicenter cohort of patients with systemic lupus erythematosus (SLE) as a model for the study of ethnic disparities in SLE. Arthritis and Rheum. 2007;57(4):576–584. doi: 10.1002/art.22672.
    1. Lau C, Yin G, Mok M. Ethnic and geographical differences in systemic lupus erythematosus: an overview. Lupus. 2006;15(11):715–719. doi: 10.1177/0961203306072311.
    1. Ow M, Ho P, Thumboo J, Wee H. Factors associated with health services utilization in patients with systemic lupus erythematosus: a systematic review. Clin Exp Rheumatol. 2010;28(6):892–904.
    1. Cooper G, Parks C, Treadwell E, St. Clair E, Gilkeson G, Cohen P, et al. Differences by race, sex and age in the clinical immunologic features of recently diagnosed systemic lupus erythematosus patients in the southeastern United States. Lupus. 2002;11(3):161. doi: 10.1191/0961203302lu161oa.
    1. Alarcon G, Beasley T, Roseman J. Ethnic disparities in health and disease: the need to account for ancestral admixture when estimating the genetic contribution to both (LUMINA XXVI) Lupus. 2005;14(10):867–868. doi: 10.1191/0961203305lu2184xx.
    1. Williams E, Egede L, Oates J. Effective self-management interventions for patients with lupus: potential impact of peer mentoring. Am J Med Sci. 2017;353(6):580–592. doi: 10.1016/j.amjms.2017.01.011.
    1. Lorig K, Ritter P, Plant K. A disease-specific self-help program compared with a generalized chronic disease self-help program for arthritis patients. Arthritis Rheum. 2005;53(6):950–957. doi: 10.1002/art.21604.
    1. Lorig K, Ritter P, Laurent D, Fries J. Long-term randomized controlled trials of tailored-print and small-group arthritis self-management interventions. Med Care. 2004;42(4):346–354. doi: 10.1097/01.mlr.0000118709.74348.65.
    1. Lorig K, Ritter P, Laurent D, Plant K. The Internet-based arthritis self-management program: a one-year randomized trial for patients with arthritis or fibromyalgia. Arthritis Rheum. 2008;59(7):1009–1017. doi: 10.1002/art.23817.
    1. Greco C, Rudy T, Manzi S. Effects of a stress-education program on psychological function, pain, and physical function of systemic lupus erythematosus patients: a randomized controlled trial. Arthritis Rheum. 2004;51(4):625–634. doi: 10.1002/art.20533.
    1. Edworthy S, Dobkin P, Clarke A, Da Costa D, Dritsa M, Fortin P, et al. Group psychotherapy reduces illness intrusiveness in systemic lupus erythematosus. J Rheumatol. 2003;30(5):1011–1016.
    1. Brady T, Kruger J, Helmick C, Callahan L, Boutaugh M. Intervention programs for arthritis and other rheumatic diseases. Health Educ Behav. 2003;30(1):44–63. doi: 10.1177/1090198102239258.
    1. Drenkard C, Bao G, Dennis G, Kan H, Jhingran P, Molta C, et al. Burden of systemic lupus erythematosus on employment and work productivity: data from a large cohort in the southeastern United States. Arthritis Care Res. 2014;66(6):878–887. doi: 10.1002/acr.22245.
    1. Wallace R. Systemic lupus erythematosus in African-American women: cognitive physiological modules, autoimmune disease, and structured psychosocial stress. Adv Complex Syst. 2003;6(4):599–629. doi: 10.1142/S0219525903001092.
    1. Barnado A, Wheless L, Meyer A, Gilkeson G, Kamen D. Quality of life in patients with systemic lupus erythematosus (SLE) compared with related controls within a unique African American population. Lupus. 2012;21(5):563–569. doi: 10.1177/0961203311426154.
    1. Chae D, Drenkard C, Lewis T, Lim S. Discrimination and cumulative disease damage among African American women with systemic lupus erythematosus. Am J Public Health. 2015;105(10):2099–2107. doi: 10.2105/AJPH.2015.302727.
    1. Feldman C, Bermas B, Zibit M, Fraser P, Todd D, Fortin P, et al. Designing an intervention for women with systemic lupus erythematosus from medically underserved areas to improve care: a qualitative study. Lupus. 2013;22(1):52–62. doi: 10.1177/0961203312463979.
    1. Sutanto B, Singh-Grewal D, McNeil H, O'Neill S, Craig J, Jones J, et al. Experiences and perspectives of adults living with systemic lupus erythematosus: thematic synthesis of qualitative studies. Arthritis Care Res. 2013;65(11):1752–1765. doi: 10.1002/acr.22032.
    1. Danoff-Burg S, Friedberg F. Unmet needs of patients with systemic lupus erythematosus. Behav Med. 2009;35(1):5–13. doi: 10.3200/BMED.35.1.5-13.
    1. Martin L, Williams S, Haskard K, DiMatteo M. The challenge of patient adherence. Ther Clin Risk Manag. 2005;1(3):189–199.
    1. Julian L, Yelin E, Yazdany J, Panopalis P, Trupin L, Criswell L, et al. Depression, medication adherence, and service utilization in systemic lupus erythematosus. Arthritis Rheum. 2009;61(2):240–246. doi: 10.1002/art.24236.
    1. de Achaval S, Suarez-Almazor M. Improving treatment adherence in patients with rheumatologic disease. J Musculoskelet Med. 2010;27(10):1691476.
    1. Korbet S, Schwartz M, Evans J, Lewis E. Severe lupus nephritis: racial differences in presentation and outcome. J Am Soc Nephrol. 2007;18(1):244–254. doi: 10.1681/ASN.2006090992.
    1. Moses N, Wiggers J, Nicholas C, Cockburn J. Prevalence and correlates of perceived unmet needs of people with systemic lupus erythematosus. Patient Educ Couns. 2005;57(1):30–38. doi: 10.1016/j.pec.2004.03.015.
    1. Law G, Pope J, Lalani S, Silverman E, Cooper G, Fortin P, et al. Barriers To healthcare in a multiethnic cohort of systemic lupus erythematosus (SLE) patients: patient and physician perceptions. Rom J Rheum. 2010;19(1):12–19.
    1. Mosley-Williams A, Lumley M, Gillis M, Leisen J. D G. Barriers to treatment adherence among African-American and white women with systemic lupus erythematosus. Arthritis Rheum. 2002;47(6):630–638. doi: 10.1002/art.10790.
    1. Heisler M. Different models to mobilize peer support to improve diabetes self-management and clinical outcomes: evidence, logistics, evaluation considerations and needs for future research. Fam Pract. 2010;27(Suppl 1):i23–i32. doi: 10.1093/fampra/cmp003.
    1. Heisler M. Building peer support programs to manage chronic disease: seven models for success. Oakland: California Healthcare Foundation; 2006.
    1. Rotheram-Borus M, Richter L, van Heerden A, van Rooyen H, Tomlinson M, Harwood J, et al. A cluster randomized controlled trial evaluating the efficacy of peer mentors to support South African women living with HIV and their infants. PLoS One. 2014;9(1):e84867. doi: 10.1371/journal.pone.0084867.
    1. Jerson B, D'Urso C, Arnon R, Miloh T, Iyer K, Kerkar N, et al. Adolescent transplant recipients as peer mentors: a program to improve self-management and health-related quality of life. Pediatr Transplant. 2013;17(7):612–620.
    1. Tracy K, Burton M, Nich C, Rounsaville B. Utilizing peer mentorship to engage high recidivism substance-abusing patients in treatment. Am J Drug Alcohol Abuse. 2011;37(6):525–531. doi: 10.3109/00952990.2011.600385.
    1. Anderson A, Damio G, Chapman D, Perez-Escamilla R. Differential response to an exclusive breastfeeding peer counseling intervention: the role of ethnicity. J Hum Lact. 2007;23(1):16–23. doi: 10.1177/0890334406297182.
    1. Spencer R, Bower J, Kirk S, Hancock FC. Peer mentoring is associated with positive change in physical activity and aerobic fitness of grades 4, 5, and 6 students in the heart healthy kids program. Health Promot Pract. 2014;15(6):803–811. doi: 10.1177/1524839914530402.
    1. Thomas R, Lorenzetti D, Spragins W. Systematic review of mentoring to prevent or reduce tobacco use by adolescents. Acad Pediatr. 2013;13(4):300–307. doi: 10.1016/j.acap.2013.03.008.
    1. Dorgo S, Robinson K, Bader J. The effectiveness of a peer-mentored older adult fitness program on perceived physical, mental, and social function. J Am Acad Nurse Pract. 2009;21(2):116–122. doi: 10.1111/j.1745-7599.2008.00393.x.
    1. Eskicioglu P, Halas J, Senechal M, Wood L, McKay E, Villeneuve S, et al. Peer mentoring for type 2 diabetes prevention in first nations children. Pediatrics. 2014;133(6):e1624–e1e31. doi: 10.1542/peds.2013-2621.
    1. Keyserling T, Samuel-Hodge C, Ammerman A, Ainsworth B, Henriquez-Roldan C, Elasy T, et al. A randomized trial of an intervention to improve self-care behaviors of African-American women with type 2 diabetes: impact on physical activity. Diabetes Care. 2002;25(9):1576–1583. doi: 10.2337/diacare.25.9.1576.
    1. Heisler M, Piette J. “I help you, and you help me”: facilitated telephone peer support among patients with diabetes. Diabetes Educ. 2005;31:869–879. doi: 10.1177/0145721705283247.
    1. Sazlina S, Browning C, Yasin S. Effectiveness of personalized feedback alone or combined with peer support to improve physical activity in sedentary older Malays with type 2 diabetes: a randomized controlled trial. Front Public Health. 2015;3:178. doi: 10.3389/fpubh.2015.00178.
    1. Knox L, Huff J, Graham D, Henry M, Bracho A, Henderson C, et al. What peer mentoring adds to already good patient care: implementing the Carpeta Roja peer mentoring program in a well-resourced health care system. Ann Fam Med. 2015;13(Suppl 1):S59–565. doi: 10.1370/afm.1804.
    1. Woodbury M, Botros M, Kuhnke J, Greene J. Evaluation of a peer-led self-management education programme PEP talk: diabetes, healthy feet and you. Int Wound J. 2013;10(6):703–711. doi: 10.1111/iwj.12188.
    1. Philis-Tsimikas A, Fortmann A, Lleva-Ocana L, Walker C, Gallo L. Peerled diabetes education programs in high-risk Mexican Americans improve glycemic control compared with standard approaches: a Project Dulce promotora randomized trial. Diabetes Care. 2011;34:1926–1931. doi: 10.2337/dc10-2081.
    1. Long J, Jahnle E, Richardson D, Loewenstein G, Volpp K. Peer mentoring and financial incentives to improve glucose control in African American veterans: a randomized trial. Ann Intern Med. 2012;156(6):416–424. doi: 10.7326/0003-4819-156-6-201203200-00004.
    1. Williams E, Hyer M, Voronca D, Ramakrishnan V, Faith T, Gebregziabher M, et al. Peer-to-peer mentoring for African American women with lupus: a feasibility pilot. Arthritis Care Res. 2018;70(6):908–917. doi: 10.1002/acr.23412.
    1. Williams E, Hyer J, Ramakrishnan V, Faith T, Egede L, Oates J, et al. Cytokine balance and behavioral intervention; findings from the Peer Approaches to Lupus Self-Management (PALS) project. Hum Immunol. 2017;78(9):574–581. doi: 10.1016/j.humimm.2017.07.005.
    1. Bellg A, Borrelli B, Resnick B, Hecht J, Minicucci D, Ory M, et al. Enhancing treatment fidelity in health behavior change studies: best practices and recommendations from the NIH Behavior Change Consortium. Health Psychol. 2004;23(5):443–451. doi: 10.1037/0278-6133.23.5.443.
    1. Hochberg M. Updating the American College of Rheumatology revised criteria for the classification of systemic lupus erythematosus (letter) Arthritis Rheum. 1997;40(9):1725. doi: 10.1002/art.1780400928.
    1. Peterson M, Horton R, Engelhard E, Lockshin M, Abramson T. Effect of counselor training on skills development and psychosocial status of volunteers with systemic lupus erythematosus. Arthritis Care Res. 1993;6(1):38–44. doi: 10.1002/art.1790060108.
    1. Allen L, Tsao J, Hayes L, Zeltzer L. Peer mentorship to promote effective pain management in adolescents: study protocol for a randomised controlled trial. Trials. 2011;12:132. doi: 10.1186/1745-6215-12-132.
    1. Horton R, Peterson M, Powell S, Engelhard E, Paget S. Users evaluate LupusLine, a telephone peer counseling service. Arthritis Care Res. 1997;10(4):257–263. doi: 10.1002/art.1790100407.
    1. Sandhu S, Veinot P, Embuldeniya G, Brooks S, Sale J, Huang S, et al. Peer-to-peer mentoring for individuals with early inflammatory arthritis: feasibility pilot. BMJ Open. 2013;3(3):e002267. doi: 10.1136/bmjopen-2012-002267.
    1. Kang M, Ragan B, Park J. Issues in outcomes research: an overview of randomization techniques for clinical trials. J Athl Train. 2008;43(2):215–221. doi: 10.4085/1062-6050-43.2.215.
    1. Arthritis Foundation. The Systemic Lupus Erythematosus Self-Help Course: program guidelines and procedures manual: Atlanta: Arthritis Foundation; 1987.
    1. Williams E, Penfield M, Kamen D, Oates J. An intervention to reduce psychosocial and biological indicators of stress in african american lupus patients: the Balancing Lupus Experiences with Stress Strategies Study. Open J Prev Med. 2014;4(1):22–31. doi: 10.4236/ojpm.2014.41005.
    1. Chinman M, McCarthy S, Mitchell-Miland C, Daniels K, Youk A, Edelen M. Early stages of development of a peer specialist fidelity measure. Psychiatr Rehabil J. 2016;39(3):256–265. doi: 10.1037/prj0000209.
    1. MUSC Office of Public Relations. Patients, families with lupus receive support. The Catalyst. 2011 Friday, November 25, 2011.
    1. Queen Quet. St. Helena Island, SC 2017. [cited 2017]. Available from: .
    1. Flournoy-Floyd M, Ortiz K, Oates J, Egede L, Williams E. “We Would Still Find Things to Talk About”: assessment of mentor perspectives in a systemic lupus erythematosus intervention ( Peer Approaches to Lupus Self-management-PALS), empowering SLE patients. J Natl Med Assoc. 2018;110(2):182–189. doi: 10.1016/j.jnma.2017.05.003.
    1. Egede L, Strom J, Durkalski V, Mauldin P, Moran W. Rationale and design: telephone-delivered behavioral skills interventions for blacks with type 2 diabetes. Trials. 2010;11:35. doi: 10.1186/1745-6215-11-35.
    1. Williams J, Lynch C, Knapp R, Egede L. Technology-Intensified Diabetes Education Study (TIDES) in African Americans with type 2 diabetes: study protocol for a randomized controlled trial. Trials. 2014;15:460. doi: 10.1186/1745-6215-15-460.
    1. Matthews B, Baker F, Hann D, Denniston M, Smith T. Health status and life satisfaction among breast cancer survivor peer support volunteers. Psychooncology. 2002;11(3):199–211. doi: 10.1002/pon.550.
    1. Stewart A, Hays R, Ware J. Measuring functioning and well-being: the Medical Outcomes Study approach. In: Stewart A, Ware J, editors. Health Perceptions, Energy/Fatigue, and Health Distress Measures. Durham: Duke University Press; 1991.
    1. Webster K, Cella D, Yost K. The Functional Assessment of Chronic Illness Therapy (FACIT) measurement system: properties, application, and interpretation. Health Qual Life Out. 2003;16(1):79. doi: 10.1186/1477-7525-1-79.
    1. Toloza S, Jolly M, Alarcón G. Quality-of-life measurements in multiethnic patients with systemic lupus erythematosus: cross-cultural issues. Curr Rheumatol Rep. 2010;12(4):237–249. doi: 10.1007/s11926-010-0110-5.
    1. Hibbard J, Stockard J, Mahoney E, Tusler M. Development of the Patient Activation Measure (PAM): conceptualizing and measuring activation in patients and consumers. Health Serv Res. 2004;39(4 Pt 1):1005–1026. doi: 10.1111/j.1475-6773.2004.00269.x.
    1. Hibbard J, Mahoney E, Stockard J, Tusler M. Development and testing of a short form of the patient activation measure. Health Serv Res. 2005;40(6 Pt 1):1918–1930. doi: 10.1111/j.1475-6773.2005.00438.x.
    1. Lorig K, Stewart A, Ritter P, Gonzalez V, Laurent D, Lynch J. Outcome measures for health educaiton and other health care interventions. Thousand Oaks: Sage Publications; 1996.
    1. Lorig K, Sobel D, Ritter P, Laurent D, Hobbs M. Effect of a self-managment program on patients with chronic disease. Effective Clinical Practice. 2001;4(6):256–262.
    1. Ortiz K, Flournoy-Floyd M, Williams E. Systemic Lupus Erythematosus Observations of Travel Burden (SLEOTB): a qualitative inquiry. Int J Rheum Dis. 2015;18(7):751–760. doi: 10.1111/1756-185X.12614.
    1. Williams EM, Bruner L, Ortiz K, Zhang J, Zhou J, Kamen D. The Systemic Lupus Erythematosus Travel Burden Survey: baseline data among a South Carolina cohort. BMC Res Notes. 2016;9:246. doi: 10.1186/s13104-016-2060-0.
    1. Hays R, Cunningham W, Sherbourne C, Wilson I, Wu A, Cleary P, et al. Health-related quality of life in patients with human immunodeficiency virus infection in the United States: results from the HIV Cost and Services Utilization Study. Am J Med. 2000;108(9):714–722. doi: 10.1016/S0002-9343(00)00387-9.
    1. Lorig K, Chastain R, Ung E, Shoor S, Holman H. Development and evaluation of a scale to measure perceived self-efficacy in people with arthritis. Arthritis Rheum. 1989;32(1):37–44. doi: 10.1002/anr.1780320107.
    1. Kroenke K, Spitzer R. The PHQ-9: a new depression and diagnostic severity measure. Psychiat Ann. 2002;32(9):509–521. doi: 10.3928/0048-5713-20020901-06.
    1. Spitzer R, Kroenke K, Williams J, Löwe B. A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med. 2006;166(10):1092–1097. doi: 10.1001/archinte.166.10.1092.
    1. Cohen S, Kamarck T, Mermelstein R. A global measure of perceived stress. J Health Soc Behav. 1983;24(4):385–396. doi: 10.2307/2136404.
    1. Baker D, Williams M, Parker R, Gazmararian J, Nurse J. Development of a brief test to measure functional health literacy. Patient Educ Couns. 1999;38(1):33–42. doi: 10.1016/S0738-3991(98)00116-5.
    1. Sherbourne C, Stewart A. The MOS social support survey. Soc Sci Med. 1991;32(6):705–714. doi: 10.1016/0277-9536(91)90150-B.
    1. Egede L, Ellis C. Development and testing of the Multidimensional Trust in Health Care Systems Scale. J Gen Intern Med. 2008;23(6):808–815. doi: 10.1007/s11606-008-0613-1.
    1. Karlson E, Daltroy L, Rivest C, et al. Validation of a systemic lupus activity questionnaire (SLAQ) for population studies. Lupus. 2003;12(4):280–286. doi: 10.1191/0961203303lu332oa.
    1. Bombardier C, Gladman D, Urowitz M, Caron D, Chang C, Austin A, et al. Derivation of the SLEDAI. A disease activity index for lupus patients. Arthritis Rheum. 1992;35(5):630–640. doi: 10.1002/art.1780350606.
    1. American College of Rheumatology Ad Hoc Committee on Systemic Lupus Erythematosus Response Criteria The American College of Rheumatology response criteria for systemic lupus erythematosus clinical trials: measures of overall disease activity. Arthritis Rheum. 2004;50(11):3418–3426. doi: 10.1002/art.20628.
    1. Lu Q, You J, Man J, Loh A, Young L. Evaluating a culturally tailored peer-mentoring and education pilot intervention among Chinese breast cancer survivors using a mixed-methods approach. Oncol Nurs Forum. 2014;41(6):629–637. doi: 10.1188/14.ONF.629-637.
    1. Collings R, Swanson V, Watkins R. The impact of peer mentoring on levels of student wellbeing, integration and retention: a controlled comparative evaluation of residential students in UK higher education. High Educ. 2014;68(6):927–942. doi: 10.1007/s10734-014-9752-y.
    1. Chung M, Moser D, Lennie T, Frazier S. Perceived social support predicted quality of life in patients with heart failure, but the effect is mediated by depressive symptoms. Qual Life Res. 2013;22(7):1555–1563. doi: 10.1007/s11136-012-0294-4.
    1. Merianos A, King K, Vidourek R, Nabors L. Mentoring and peer-led interventions to improve quality of life outcomes among adolescents with chronic illnesses. Appl Res Qual Life. 2016;11(3):1009–1023. doi: 10.1007/s11482-015-9415-x.
    1. Keefe R, Kraemer H, Epstein R, Frank E, Haynes G, Laughren T, et al. Defining a clinically meaningful effect for the design and interpretation of randomized controlled trials. Innov Clin Neurosci. 2013;10(5–6 Suppl A):4S–19S.
    1. Donner A. Sample size requirements for the comparison of two or more coefficients of interobserver agreement. Stat Med. 1998;17(10):1157. doi: 10.1002/(SICI)1097-0258(19980530)17:10<1157::AID-SIM792>;2-W.
    1. Eldridge S, Ashby D, Kerry S. Sample size for cluster randomized trials: effect of coefficient of variation of cluster size and analysis method. Int J Epidemiol. 2006;35(5):1292–1300. doi: 10.1093/ije/dyl129.
    1. Wilson E, Jayne R, Dellow E. Fordham. The cost-effectiveness of mycophenolate mofetil as firstline therapy in active lupus nephritis. Rheumatology. 2007;46(7):1096–1101. doi: 10.1093/rheumatology/kem054.
    1. Pierotti F, Palla I, Treur M, Pippo L, Turchetti G. Assessment of the economic impact of belimumab for the treatment of systemic lupus erythematosus in the Italian setting: a cost-effectiveness analysis. PLoS One. 2015;10(10):e0140843. doi: 10.1371/journal.pone.0140843.
    1. Nichol M, Sengupta N, Globe D. Evaluating quality-adjusted life years: estimation of the health utility index (HUI2) from the SF −36. Med Decis Mak. 2001;21(2):105–112. doi: 10.1177/02729890122062352.
    1. Owens D, Qaseem A, Chou R, Shekelle P. High-value, cost-conscious health care: concepts for clinicians to evaluate the benefits, harms, and costs of medical interventions. Ann Intern Med. 2011;154(3):174–180. doi: 10.7326/0003-4819-154-3-201102010-00007.
    1. Dixon P, Hollinghurst S, Edwards L, Thomas C, Foster A, Davies B, et al. Cost-effectiveness of telehealth for patients with depression: evidence from the Healthlines randomised controlled trial. BJPsych Open. 2016;2:262–269. doi: 10.1192/bjpo.bp.116.002907.
    1. Pyne J, Fortney J, Tripathi S, Maciejewski M, Edlund M, Williams D. Cost-effectiveness analysis of a rural telemedicine collaborative care intervention for depression. Arch Gen Psychiatry. 2010;67(8):812–821. doi: 10.1001/archgenpsychiatry.2010.82.

Source: PubMed

スポンサーと協力者

医学的状態

薬物療法

3
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