Abstract
Purpose of Review
Patient-reported outcome measures (PROMs) and patient registries both play important roles in assessing patient outcomes. However, no study has examined the use of PROMs among registries involving patients with type 2 diabetes mellitus (T2DM). Our objective is twofold: first, to review the range of PROMs used in registry-based studies of patients with T2DM; second, to describe associations between these PROMs, T2DM and its complications.
Recent Findings
The International Consortium for Health Outcomes Measurement (ICHOM) Diabetes Standard Set recommended routine usage of PROMs to assess psychological well-being, diabetes distress, and depression among patients with T2DM.
Summary
A wide variety of PROMs were used among the 15 studies included in this review. Quality of life, depressive symptoms and treatment adherence were the most common aspects of T2DM that utilised PROMs for assessment. Adoption of PROMs among registries of patients with T2DM remains uncommon, non-routine and with few that are validated before use.
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References
Papers of particular interest, published recently, have been highlighted as: • Of importance
Black N. Patient reported outcome measures could help transform healthcare. BMJ. 2013;346:f167. https://doi.org/10.1136/bmj.f167.
Callahan LF. The history of patient-reported outcomes in rheumatology. Rheum Dis Clin N Am. 2016;42(2):205–17. https://doi.org/10.1016/j.rdc.2016.01.012.
Froud R, Patel S, Rajendran D, Bright P, Bjørkli T, Buchbinder R, et al. A systematic review of outcome measures use, analytical approaches, reporting methods, and publication volume by year in low back pain trials published between 1980 and 2012: Respice, adspice, et prospice. PLoS One. 2016;11(10):e0164573-e. https://doi.org/10.1371/journal.pone.0164573.
Weldring T, Smith SMS. Patient-reported outcomes (PROs) and patient-reported outcome measures (PROMs). Health Serv Insights. 2013;6:61–8. https://doi.org/10.4137/HSI.S11093.
Patrick, Donald L, Gordon H Guyatt, and Catherine Acquardro. Patient-Reported Outcomes. In: Cochrane Handbook For Systematic Reviews Of Interventions Version 5.1.0. The Cochrane Collaboration. 2011. https://handbook-5-1.cochrane.org/. Accessed 01 Sep 2019.
Nelson EC, Eftimovska E, Lind C, Hager A, Wasson JH, Lindblad S. Patient reported outcome measures in practice. BMJ (Clinical research ed). 2015;350:g7818. https://doi.org/10.1136/bmj.g7818.
• Greenhalgh J, Dalkin S, Gooding K. Patient-reported outcome measures as a tool to support patients in raising or sharing concerns with clinicians. In: Functionality and feedback: a realist synthesis of the collation, interpretation and utilisation of patient-reported outcome measures data to improve patient care. NIHR Journals Library: Southampton; 2017. This book chapter provides a comprehensive overview of the clinical importance and benefits of PROM utilization in a wide range of health settings.
EuroQol Research Foundation. Introduction. In: EQ-5D-3L User Guide: Basic information on how to use the EQ-5D-3L instrument. 2018. https://euroqol.org/wp-content/uploads/2019/10/EQ-5D-3L-User-Guide_version-6.0.pdf. Accessed 01 Sep 2019.
Nelson EC, Dixon-Woods M, Batalden PB, Homa K, Van Citters AD, Morgan TS, et al. Patient focused registries can improve health, care, and science. BMJ (Clinical research ed). 2016;354:i3319. https://doi.org/10.1136/bmj.i3319.
National Academies of Sciences. The National Academies Collection: reports funded by National Institutes of Health. Real-World Evidence Generation and Evaluation of Therapeutics: Proceedings of a Workshop. Washington (DC): National Academies Press (US) Copyright 2017 by the National Academy of Sciences. All rights reserved.; 2017.
Gliklich RE, Dreyer NA, Leavy MB. Use of patient-reported outcomes in registries. Registries for evaluating patient outcomes: a user’s guide. Rockville: Agency for Healthcare Research and Quality (US); 2014.
Prodinger B, Taylor P. Improving quality of care through patient-reported outcome measures (PROMs): expert interviews using the NHS PROMs Programme and the Swedish quality registers for knee and hip arthroplasty as examples. BMC Health Serv Res. 2018;18(1):87. https://doi.org/10.1186/s12913-018-2898-z.
Breckenridge K, Bekker HL, Gibbons E, van der Veer SN, Abbott D, Briançon S, et al. How to routinely collect data on patient-reported outcome and experience measures in renal registries in Europe: an expert consensus meeting. Nephrol Dial Transplant. 2015;30(10):1605–14. https://doi.org/10.1093/ndt/gfv209.
Zamora NV, Christensen R, Goel N, Klokker L, Lopez-Olivo MA, Kristensen LE, et al. Critical outcomes in longitudinal observational studies and registries in patients with rheumatoid arthritis: an OMERACT Special Interest Group Report. J Rheumatol. 2017;44(12):1894–8. https://doi.org/10.3899/jrheum.161108.
Speight J, Reaney MD, Barnard KD. Not all roads lead to Rome-a review of quality of life measurement in adults with diabetes. Diabet Med. 2009;26(4):315–27. https://doi.org/10.1111/j.1464-5491.2009.02682.x.
Liberati A, Altman DG, Tetzlaff J, Mulrow C, Gotzsche PC, Ioannidis JP, et al. The PRISMA statement for reporting systematic reviews and meta-analyses of studies that evaluate health care interventions: explanation and elaboration. PLoS Med. 2009;6(7):e1000100. https://doi.org/10.1371/journal.pmed.1000100.
NIH National Heart, Lung and Blood Institute. Study quality assessment tools: quality assessment tool for observational cohort and cross-sectional studies. https://www.nhlbi.nih.gov/health-topics/study-quality-assessment-tools. Accessed 22 Aug 2019.
Kikuchi Y, Iwase M, Fujii H, Ohkuma T, Kaizu S, Ide H, et al. Association of severe hypoglycemia with depressive symptoms in patients with type 2 diabetes: the Fukuoka Diabetes Registry. BMJ Open Diabetes Res Care. 2015;3(1):e000063. https://doi.org/10.1136/bmjdrc-2014-000063.
Tsujii S, Hayashino Y, Ishii H. Diabetes distress, but not depressive symptoms, is associated with glycaemic control among Japanese patients with type 2 diabetes: Diabetes Distress and Care Registry at Tenri (DDCRT 1). Diabet Med. 2012;29(11):1451–5. https://doi.org/10.1111/j.1464-5491.2012.03647.x.
Rathmann WK, Kuß O, Anderson D, Busch S, Hahn M, Engelhard J, et al. Increased depression symptom score in newly diagnosed type 2 diabetes patients. Psychiatry Res. 2018;261:259–63. https://doi.org/10.1016/j.psychres.2017.12.091.
Hayashino Y, Mashitani T, Tsujii S, Ishii H. Elevated levels of hs-CRP are associated with high prevalence of depression in japanese patients with type 2 diabetes: the Diabetes Distress and Care Registry at Tenri (DDCRT 6). Diabetes Care. 2014;37(9):2459–65. https://doi.org/10.2337/dc13-2312.
Hayashino Y, Okamura S, Tsujii S, Ishii H. Association between diabetes distress and all-cause mortality in Japanese individuals with type 2 diabetes: a prospective cohort study (Diabetes Distress and Care Registry in Tenri [DDCRT 18]). Diabetologia. 2018;61(9):1978–84. https://doi.org/10.1007/s00125-018-4657-4.
Fumagalli S, Said SA, Laroche C, Gabbai D, Boni S, Marchionni N, et al. Management and prognosis of atrial fibrillation in diabetic patients: an EORP-AF General Pilot Registry report. Eur Heart J Cardiovasc Pharmacother. 2018;4(3):172–9. https://doi.org/10.1093/ehjcvp/pvx037.
Hayashino Y, Tsujii S, Ishii H. Association of diabetes therapy-related quality of life and physical activity levels in patients with type 2 diabetes receiving medication therapy: the Diabetes Distress and Care Registry at Tenri (DDCRT 17). Acta Diabetol. 2018;55(2):165–73. https://doi.org/10.1007/s00592-017-1080-0.
Mashitani T, Hayashino Y, Okamura S, Kitatani M, Furuya M, Iburi T, et al. Diabetes treatment-related quality of life is associated with levels of self-care activities in insulin injection among Japanese patients with type 2 diabetes: Diabetes Distress and Care Registry at Tenri (DDCRT 8). Acta Diabetol. 2015;52(4):639–47. https://doi.org/10.1007/s00592-015-0725-0.
Wasem JB, Bramlage P, Gitt AK, Binz C, Krekler M, Deeg E, et al. Co-morbidity but not dysglycaemia reduces quality of life in patients with type-2 diabetes treated with oral mono- or dual combination therapy--an analysis of the DiaRegis registry. Cardiovasc Diabetol. 2013;12:47. https://doi.org/10.1186/1475-2840-12-47.
von Arx LBG, Gydesen H, Skovlund S. Treatment beliefs, health behaviors and their association with treatment outcome in type 2 diabetes. BMJ Open Diabetes Res Care. 2016;4(1):e000166. https://doi.org/10.1136/bmjdrc-2015-000166.
Mashitani TH, Hayashino Y, Okamura S, Kitatani M, Furuya M, Matsunaga S, et al. Patient-reported adherence to insulin regimen is associated with glycemic control among Japanese patients with type 2 diabetes: Diabetes Distress and Care Registry at Tenri (DDCRT 3). Diabetes Res Clin Pract. 2013;100(2):189–94. https://doi.org/10.1016/j.diabres.2013.03.006.
Shigaki CK, Kruse RL, Mehr D, Sheldon KM, Bin G, Moore C, et al. Motivation and diabetes self-management. Chronic Ill. 2010;6(3):202–14. https://doi.org/10.1177/1742395310375630.
Woo V, Bell A, Clement M, Noronha L, Tsoukas MA, Camacho F, et al. CANadian CAnagliflozin REgistry: patient-reported outcomes of canagliflozin in the treatment of type 2 diabetes mellitus in canadian clinical practice. Can J Diabetes. 2019. https://doi.org/10.1016/j.jcjd.2019.04.004.
Berkowitz SA, Karter AJ, Lyles CR, Liu JY, Schillinger D, Adler NE, et al. Low socioeconomic status is associated with increased risk for hypoglycemia in diabetes patients: the Diabetes Study of Northern California (DISTANCE). J Health Care Poor Underserved. 2014;25(2):478–90. https://doi.org/10.1353/hpu.2014.0106.
Philpot LM, Barnes SA, Brown RM, Austin JA, James CS, Stanford RH, et al. Barriers and benefits to the use of patient-reported outcome measures in routine clinical care: a qualitative study. Am J Med Qual. 2018;33(4):359–64. https://doi.org/10.1177/1062860617745986.
• International Consortium for Health Outcomes Measurement. Type 1 and Type2 Diabetes in Adults: DATA COLLECTION REFERENCE GUIDE 2019. This report identified a core, standard set of outcomes which matter most to people with diabetes, and recommended psychological well-being, diabetes distress and depression to be routinely assessed among patients with diabetes.
Tang TS, Yusuf FLA, Polonsky WH, Fisher L. Assessing quality of life in diabetes: II - deconstructing measures into a simple framework. Diabetes Res Clin Pract. 2017;126:286–302. https://doi.org/10.1016/j.diabres.2016.10.007.
Woodcock AJ, Julious SA, Kinmonth AL, Campbell MJ. Problems with the performance of the SF-36 among people with type 2 diabetes in general practice. Qual Life Res. 2001;10(8):661–70.
Zettler ME, SANDOVAL R. Patient-reported outcome labeling for antidiabetic agents approved in the United States, 2011–2017. Diabetes. 2018;67(Supplement 1):1284. https://doi.org/10.2337/db18-1284-P.
U.S. Department of Health & Human Services. Registry Of Patient Registries. Agency For Healthcare Research And Quality. 2019. https://www.ahrq.gov/ropr/index.html. Accessed 29 Aug 2019.
Haverman L, van Oers HA, van Muilekom MM, Grootenhuis MA. Options for the Interpretation of and recommendations for acting on different PROMs in daily clinical practice using KLIK. Med Care. 2019;57(Suppl 5 Suppl 1):S52–s8. https://doi.org/10.1097/mlr.0000000000001061.
Grossman LV, Feiner SK, Mitchell EG, Masterson Creber RM. Leveraging patient-reported outcomes using data visualization. Appl Clin Inform. 2018;9(3):565–75. https://doi.org/10.1055/s-0038-1667041.
Radloff LS. The CES-D Scale: A Self-Report Depression Scale for research in the general population. Appl Psychol Meas. 1977;1(3):385–401.
Jahn R, Baumgartner JS, van den Nest M, Friedrich F, Alexandrowicz RW, Wancata J. Criterion Validity of the German Version of the CES-D in the General Population. Psychiatr Prax. 2018;45(8):434–42. https://doi.org/10.1055/a-0584-9803.
Wada K, Tanaka K, Theriault G, Satoh T, Mimura M, Miyaoka H, et al. Validity of the Center for Epidemiologic Studies Depression Scale as a screening instrument of majosr depressive disorder among Japanese workers. Am J Ind Med. 2007;50(1):8–12. https://doi.org/10.1002/ajim.20403.
RAND Health Care. 36-Item Short Form Survey (SF-36) Scoring Instructions. https://www.rand.org/health-care/surveys_tools/mos/36-item-short-form/scoring.html. Accessed 21 Aug 2019.
Ware JEKM, Dewey JE, Gandek B. How to score and interpret single-item health status measures: a manual for users of the SF-8 Health Survey. Boston: QualityMetric, Inc; 2001.
Tokuda Y, Okubo T, Ohde S, Jacobs J, Takahashi O, Omata F, et al. Assessing items on the SF-8 Japanese version for health-related quality of life: a psychometric analysis based on the nominal categories model of item response theory. Value Health. 2009;12(4):568–73. https://doi.org/10.1111/j.1524-4733.2008.00449.x.
Konerding U, Elkhuizen SG, Faubel R, Forte P, Malmström T, Pavi E, et al. The validity of the EQ-5D-3L items: an investigation with type 2 diabetes patients from six European countries. Health Qual Life Outcomes. 2014;12:181. https://doi.org/10.1186/s12955-014-0181-5.
Bradley C, Todd C, Gorton T, Symonds E, Martin A, Plowright R. The development of an individualized questionnaire measure of perceived impact of diabetes on quality of life: the ADDQoL. Qual Life Res. 1999;8:79–91.
Wee HL, Tan CE, Goh SY, Li SC. Usefulness of the Audit of Diabetes-Dependent Quality-of-Life (ADDQoL) Questionnaire in Patients with Diabetes in a Multi-Ethnic Asian Country. PharmacoEconomics. 2006;24(7):673–82.
IPAQ Group. Protocol for IPAQ Short Form. In: Guidelines for Data Processing and Analysis of the International Physical Activity Questionnaire (IPAQ) – Short and Long Forms. International Physical Activity Questionnaire. 2005. https://sites.google.com/site/theipaq/scoring-protocol. Accessed 24 Aug 2019.
Tomioka K, Iwamoto J, Saeki K, Okamoto N. Reliability and validity of the International Physical Activity Questionnaire (IPAQ) in elderly adults: the Fujiwara-kyo Study. J Epidemiol. 2011;21(6):459–65. https://doi.org/10.2188/jea.je20110003.
Ainsworth BE, Haskell WL, Whitt MC, Irwin ML, Swartz AM, Strath SJ, et al. Compendium of physical activities: an update of activity codes and MET intensities. Med Sci Sports Exerc. 2000;32(9 Suppl):S498–504.
Spitzer RL WJ, Kroenke K. Coding and Scoring. In: Instruction Manual: Instructions for Patient Health Questionnaire (PHQ) and GAD-7 Measures. Patient Health Questionnaire (PHQ) Screeners. n.d. https://www.phqscreeners.com/select-screener. Accessed 16 Aug 2019.
Doi S, Ito M, Takebayashi Y, Muramatsu K, Horikoshi M. Factorial validity and invariance of the Patient Health Questionnaire (PHQ)-9 among clinical and non-clinical populations. PLoS One. 2018;13(7):e0199235. https://doi.org/10.1371/journal.pone.0199235.
Ishii H. Psycho-behavioral problems in diabetes treatment. J Jpn Diab Soc. 2000;43(1):13–6.
Traina SB, Colwell HH, Crosby RD, Mathias SD. Pragmatic measurement of health satisfaction in people with type 2 diabetes mellitus using the Current Health Satisfaction Questionnaire. Patient Relat Outcome Meas. 2015;6:103–15. https://doi.org/10.2147/prom.S79368.
Traina SB, McQuarrie K, Barrett A, DiBenedetti D, McLeod L. Content Validity of the Current Health Satisfaction Questionnaire (Ches-Q) Among People Living with Type 2 Diabetes Mellitus (T2 dm) and Comorbid Chronic Kidney Disease (Ckd). Value Health. 2015;18(7):A710–A1. https://doi.org/10.1016/j.jval.2015.09.2675.
Arribas F, Ormaetxe JM, Peinado R, Perulero N, Ramirez P, Badia X. Validation of the AF-QoL, a disease-specific quality of life questionnaire for patients with atrial fibrillation. Europace. 2010;12(3):364–70. https://doi.org/10.1093/europace/eup421.
Ishii H. Development and psychometric validation of the Diabetes Therapy-Related QOL (DTR-QOL) questionnaire. J Med Econ. 2012;15(3):556–63. https://doi.org/10.3111/13696998.2012.665111.
Ishii H, Suzaki Y, Miyata Y, Matsui S. Randomized multicenter evaluation of quality of life and treatment satisfaction in type 2 diabetes patients receiving once-weekly trelagliptin versus a daily dipeptidyl peptidase-4 inhibitor. Diabetes Ther. 2019;10(4):1369–80. https://doi.org/10.1007/s13300-019-0643-1.
Ishii H, Kim HR, Crawford B. The revalidation of the diabetes treatment-related quality-of-life (DTR-QOL) questionnaire in Japan. Diabetol Int. 2019;10(2):93–101. https://doi.org/10.1007/s13340-018-0371-1.
Ji L, Zhang P, Weng J, Lu J, Guo X, Jia W, et al. Observational Registry of Basal Insulin Treatment (ORBIT) in Patients with type 2 diabetes uncontrolled by oral hypoglycemic agents in China--study design and baseline characteristics. Diabetes Technol Ther. 2015;17(10):735–44. https://doi.org/10.1089/dia.2015.0054.
Toobert DJ, Hampson SE, Glasgow RE. The summary of diabetes self-care activities measure: results from 7 studies and a revised scale. Diabetes Care. 2000;23(7):943–50. https://doi.org/10.2337/diacare.23.7.943.
Levesque CS, Williams GC, Elliot D, Pickering MA, Bodenhamer B, Finley PJ. Validating the theoretical structure of the Treatment Self-Regulation Questionnaire (TSRQ) across three different health behaviors. Health Educ Res. 2006;22(5):691–702. https://doi.org/10.1093/her/cyl148.
RAND Health Care. Social Support Survey Instrument Scoring Instructions. n.d. https://www.rand.org/health-care/surveys_tools/mos/social-support/scoring.html. Accessed 21 Aug 2019.
Hayashino Y, Tsujii S, Ishii H. High frequency of non-nocturnal hypoglycemia was associated with poor sleep quality measure by Pittsburg Sleep Quality Index in patients with diabetes receiving insulin therapy: Diabetes Distress and Care Registry at Tenri (DDCRT 4). Exp Clin Endocrinol Diabetes. 2013;121(10):628–34. https://doi.org/10.1055/s-0033-1355424.
Kobayashi S, Honda S, Murakami K, Sasaki S, Okubo H, Hirota N, et al. Both comprehensive and brief self-administered diet history questionnaires satisfactorily rank nutrient intakes in Japanese adults. J Epidemiol. 2012;22(2):151–9. https://doi.org/10.2188/jea.je20110075.
Merola A, Sturchio A, Hacker S, Serna S, Vizcarra JA, Marsili L, et al. Technology-based assessment of motor and nonmotor phenomena in Parkinson disease. Expert Rev Neurother. 2018;18(11):825–45. https://doi.org/10.1080/14737175.2018.1530593.
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Chen, Y.T., Tan, Y.Z., Cheen, M. et al. Patient-Reported Outcome Measures in Registry-Based Studies of Type 2 Diabetes Mellitus: a Systematic Review. Curr Diab Rep 19, 135 (2019). https://doi.org/10.1007/s11892-019-1265-8
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DOI: https://doi.org/10.1007/s11892-019-1265-8