The suitability of patient-reported outcome measures used to assess the impact of hypoglycaemia on quality of life in people with diabetes: a systematic review using COSMIN methods.

Publisher: Springer Verlag Country of Publication: Germany NLM ID: 0006777 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1432-0428 (Electronic) Linking ISSN: 0012186X NLM ISO Abbreviation: Diabetologia Subsets: MEDLINE

Original Publication: Berlin Springer Verlag

Blood Glucose* ; Quality of Life*; Diabetes Mellitus, Type 1/*blood ; Diabetes Mellitus, Type 2/*blood ; Hypoglycemia/*blood; Humans ; Patient Reported Outcome Measures ; Reproducibility of Results

Aims/hypothesis: It is generally accepted that hypoglycaemia can negatively impact the quality of life (QoL) of people living with diabetes. However, the suitability of patient-reported outcome measures (PROMs) used to assess this impact is unclear. The aim of this systematic review was to identify PROMs used to assess the impact of hypoglycaemia on QoL and examine their quality and psychometric properties.
Methods: Systematic searches (MEDLINE, EMBASE, PsycINFO, CINAHL and The Cochrane Library databases) were undertaken to identify published articles reporting on the development or validation of hypoglycaemia-specific PROMs used to assess the impact of hypoglycaemia on QoL (or domains of QoL) in adults with diabetes. A protocol was developed and registered with PROSPERO (registration no. CRD42019125153). Studies were assessed for inclusion at title/abstract stage by one reviewer. Full-text articles were scrutinised where considered relevant or potentially relevant or where doubt existed. Twenty per cent of articles were assessed by a second reviewer. PROMS were evaluated, according to COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) guidelines, and data were extracted independently by two reviewers against COSMIN criteria. Assessment of each PROM's content validity included reviewer ratings (N = 16) of relevance, comprehensiveness and comprehensibility: by researchers (n = 6); clinicians (n = 6); and adults with diabetes (n = 4).
Results: Of the 214 PROMs used to assess the impact of hypoglycaemia on QoL (or domains of QoL), seven hypoglycaemia-specific PROMS were identified and subjected to full evaluation: the Fear of Hypoglycemia 15-item scale; the Hypoglycemia Fear Survey; the Hypoglycemia Fear Survey version II; the Hypoglycemia Fear Survey-II short-form; the Hypoglycemic Attitudes and Behavior Scale; the Hypoglycemic Confidence Scale; and the QoLHYPO questionnaire. Content validity was rated as 'inconsistent', with most as '(very) low' quality, while structural validity was deemed 'unsatisfactory'. Other measurement properties (e.g. reliability) varied, and evidence gaps were apparent across all PROMs. None of the identified studies addressed cross-cultural validity or measurement error. Criterion validity and responsiveness were not assessed due to the lack of a 'gold standard' measure of the impact of hypoglycaemia on QoL against which to compare the PROMS.
Conclusions/interpretation: None of the hypoglycaemia-specific PROMs identified had sufficient evidence to demonstrate satisfactory validity, reliability and responsiveness. All were limited in terms of content and structural validity, which restricts their utility for assessing the impact of hypoglycaemia on QoL in the clinic or research setting. Further research is needed to address the content validity of existing PROMs, or the development of new PROM(s), for the purpose of assessing the impact of hypoglycaemia on QoL.
Prospero Registration: CRD42019125153.

Erratum in: Diabetologia. 2022 Jun;65(6):1063. (PMID: 35320374)

Hendrieckx C, Ivory N, Singh H, Frier BM, Speight J (2019) Impact of severe hypoglycaemia on psychological outcomes in adults with type 2 diabetes: a systematic review. Diabet Med 36(9):1082–1091. https://doi.org/10.1111/dme.14067. (PMID: 10.1111/dme.1406731271669)
Wieringa TH, de Wit M, Twisk JWR, Snoek FJ (2018) Does hypoglycaemia affect the improvement in QoL after the transition to insulin in people with type 2 diabetes? J Endocrinol Investig 41(2):249–258. https://doi.org/10.1007/s40618-017-0744-5. (PMID: 10.1007/s40618-017-0744-5)
LaManna J, Litchman ML, Dickinson JK et al (2019) Diabetes education impact on hypoglycemia outcomes: a systematic review of evidence and gaps in the literature. Diabetes Educ 45(4):349–369. https://doi.org/10.1177/0145721719855931. (PMID: 10.1177/014572171985593131210091)
Barendse S, Singh H, Frier BM, Speight J (2012) The impact of hypoglycaemia on quality of life and related patient-reported outcomes in type 2 diabetes: a narrative review. Diabet Med 29(3):293–302. https://doi.org/10.1111/j.1464-5491.2011.03416.x. (PMID: 10.1111/j.1464-5491.2011.03416.x21838763)
Lundkvist J, Berne C, Bolinder B, Jönsson L (2005) The economic and quality of life impact of hypoglycaemia. Eur J Health Econ 6:197–202. https://doi.org/10.1007/s10198-005-0276-3. (PMID: 10.1007/s10198-005-0276-315761775)
Jacobson AM, Braffett MS, Cleary PA, Gubitosi-Klug RA, Larkin ME, the DCCT/EDIC Research Group (2013) A 23-year follow-up of the diabetes control and complications/epidemiology of diabetes interventions and complications cohort. Diabetes Care 36(10):3131–3138. https://doi.org/10.2337/dc12-2109. (PMID: 10.2337/dc12-2109238356933781542)
Rossi MC, Nicolucci A, Ozzello A et al (2019) Impact of severe and symptomatic hypoglycemia on quality of life and fear of hypoglycemia in type 1 and type 2 diabetes: results of the Hypos-1 Observational Study. Nutr Metab Cardiovasc Dis 29(7):736–743. https://doi.org/10.1016/j.numecd.2019.04.009. (PMID: 10.1016/j.numecd.2019.04.00931153746)
Heindrieckx C, Gonder-Frederick L, Heller SR, Snoek FJ, Speight J (2020) How has psycho-behavioural research advanced our understanding of hypoglycaemia in type 1 diabetes? Diabet Med 37:411–419.
Speight J, Reaney MD, Barnard KD (2009) Not all roads lead to Rome—a review of quality of life measurement in adults with diabetes. Diabet Med 26(4):315–327. https://doi.org/10.1111/j.1464-5491.2009.02682.x. (PMID: 10.1111/j.1464-5491.2009.02682.x19388959)
Reaney M, Gwaltney C (2014) Measuring and interpreting patient-reported outcome data from clinical trials of diabetes medication. J Diabetes Res Clin Metab 3:7. https://doi.org/10.7243/2050-0866-3-7. (PMID: 10.7243/2050-0866-3-7)
Mokkink LB, Terwee CB, Patrick DL et al (2010) The COSMIN study reached international consensus on taxonomy, terminology, and definitions of measurement properties for health-related patient-reported outcomes. J Clin Epidemiol 63(7):737–745. https://doi.org/10.1016/j.jclinepi.2010.02.006. (PMID: 10.1016/j.jclinepi.2010.02.00620494804)
Terwee CB, Prinsen CAC, Chiarotto A et al (2018) COSMIN methodology for evaluating the content validity of patient-reported outcome measures: a Delphi study. Qual Life Res 27:1159–1170. https://doi.org/10.1007/s11136-018-1829-0. (PMID: 10.1007/s11136-018-1829-0295509645891557)
Chiarotto A, Ostelo RW, Boers M, Terwee CB (2018) A systematic review highlights the need to investigate the content validity of patient-reported outcome measures for physical functioning in patients with low back pain. J Clin Epidemiol 95:73–93. https://doi.org/10.1016/j.jclinepi.2017.11.005. (PMID: 10.1016/j.jclinepi.2017.11.00529154811)
Craxford S, Deacon C, Myint Y, Ollivere B (2019) Assessing outcome measures used after rib fracture: a COSMIN systematic review. Injury 50(11):1816–1825. https://doi.org/10.1016/j.injury.2019.07.002. (PMID: 10.1016/j.injury.2019.07.00231353094)
Rezai M, Kolne K, Bui S, Lindsay S (2020) Measures of workplace inclusion: a systematic review using the COSMIN methodology. J Occup Rehabil 30:420–454. https://doi.org/10.1007/s10926-020-09872-4. (PMID: 10.1007/s10926-020-09872-431939009)
Ortega-Avila AB, Cervera-Garvi P, Ramos-Petersen L, Chicharro-Luna E, Gijon-Nogueron G (2019) Patient-reported outcome measures for patients with diabetes mellitus associated with foot and ankle pathologies: a systematic review. J Clin Med 8(2):146. https://doi.org/10.3390/jcm8020146. (PMID: 10.3390/jcm80201466407033)
Powell PA, Carlton J, Buckley Woods H, Mazzone P (2020) Measuring quality of life in Duchenne muscular dystrophy: a systematic review of the content and structural validity of commonly used instruments. Health Qual Life Outcomes 18:263. (PMID: 10.1186/s12955-020-01511-z)
Speight J, Holmes-Truscott E, Hendrieckx C, Skovlund S, Cooke D (2020) Assessing the impact of diabetes on quality of life: what have the past 25 years taught us? Diabet Med 37(3):483–492. https://doi.org/10.1111/dme.14196. (PMID: 10.1111/dme.1419631797443)
McGee HM, O’Boyle CA, Hickey A, O’Malley K, Joyce CR (1991) Assessing the quality of life of the individual: The SEIQoL with a healthy and a gastroenterology unit population. Psychol Med 21(3):749–759.
Schipper HC, Clinch JJ, Olweny CLM (1996) Quality of life studies: definitions and conceptual issues. In: Spilker B (ed) Quality of life and pharmacoeconomics in clinical trials. Lippincott-Raven Publishers, Philadelphia, pp 11–23.
de Galan BE, McCrimmon RJ, Ibberson M, for the Hypo-RESOLVE Consortium et al (2020) Reducing the burden of hypoglycaemia in people with diabetes through increased understanding: design of the Hypoglycaemia REdefining SOLutions for better liVEs (Hypo-RESOLVE) project. Diabet Med 37(6):1066–1073. https://doi.org/10.1111/dme.14240. (PMID: 10.1111/dme.14240319708147317819)
Terwee CB, Mokkink LB, Knol DL, Ostelo RW, Bouter LM, de Vet HC (2012) Rating the methodological quality in systematic reviews of studies on measurement properties: a scoring system for the COSMIN checklist. Qual Life Res 21:651–657. https://doi.org/10.1007/s11136-011-9960-1. (PMID: 10.1007/s11136-011-9960-121732199)
Mokkink L, Prinsen C, Patrick D et al (2018) COSMIN methodology for systematic reviews of patient-reported outcome measures (PROMs)—user manual. Available from https://www.cosmin.nl/wp-content/uploads/COSMIN-syst-review-for-PROMs-manual_version-1_feb-2018.pdf . Accessed 1 Dec 2018.
Prinsen CAC, Mokkink LB, Bouter LM et al (2018) COSMIN guideline for systematic reviews of patient-reported outcome measures. Qual Life Res 27(5):1147–1157. https://doi.org/10.1007/s11136-018-1798-3. (PMID: 10.1007/s11136-018-1798-3294358015891568)
Carlton J, Leaviss J, Clowes M, Hendrieckx C, Pouwer F, Speight J (2020) Psychometric characteristics of patient-reported outcome measures of the impact of hypoglycaemia on quality of life (QoL) in people with diabetes (PwD): a systematic review using COSMIN. PROSPERO 2019 CRD42019125153 Available from https://www.crd.york.ac.uk/prospero/display_record.php?ID=CRD42019125153 . Registered 27 Feb 2020.
Terwee CB, Jansma EP, Riphagen II, de Vet HCW (2009) Development of a methodological PubMed search filter for finding studies on measurement properties of measurement instruments. Qual Life Res 18(8):1115–1123. https://doi.org/10.1007/s11136-009-9528-5. (PMID: 10.1007/s11136-009-9528-5197111952744791)
U.S Department of Health and Human Services Food and Drug Administration (FDA) (2009) Guidance for industry: patient-reported outcome measures: use in medicinal product development to support labelling claims. Available from https://www.fda.gov/media/77832/download . Accessed 1 Dec 2018.
Terwee CB, Prinsen CAC, Chiarotto A et al (2018) COSMIN methodology for assessing the content validity of PROMs: user manual. Available from https://www.cosmin.nl/wp-content/uploads/COSMIN-methodology-for-content-validity-user-manual-v1.pdf . Accessed 1 Dec 2018.
Guyatt GH, Oxman AD, Vist GE et al (2008) GRADE: an emerging consensus on rating quality of evidence and strength of recommendations. BMJ 336:924–926. https://doi.org/10.1136/bmj.39489.470347.AD. (PMID: 10.1136/bmj.39489.470347.AD184369482335261)
Terwee CB, Prinsen CAC, Ricci Garotti MG, Suman A, de Vet HCW, Mokkink LB (2016) The quality of systematic reviews of health-related outcome measurement instruments. Qual Life Res 25:767–779. https://doi.org/10.1007/s11136-015-1122-4. (PMID: 10.1007/s11136-015-1122-426346986)
Grabman J, Vajda Bailey K, Schmidt K et al (2017) An empirically derived short form of the Hypoglycaemia Fear Survey II. Diabet Med 34(4):500–504. https://doi.org/10.1111/dme.13162. (PMID: 10.1111/dme.1316227278467)
Cox DJ, Irvine A, Gonder-Frederick L, Nowacek G, Butterfield J (1987) Fear of hypoglycemia: quantification, validation, and utilization. Diabetes Care 10(5):617–621. https://doi.org/10.2337/diacare.10.5.617. (PMID: 10.2337/diacare.10.5.6173677982)
Orozco-Beltràn D, Artola S, Jansa M, Lopez de la Torre-Casares M, Fuster E (2018) Impact of hypoglycemic episodes on health-related quality of life of type-2 diabetes mellitus patients: development and validation of a specific QoLHYPO© questionnaire. Health Qual Life Outcomes 16(1):52. (PMID: 10.1186/s12955-018-0875-1)
Brod M, Højbjerre L, Bushnell DM, Hansen CT (2015) Assessing the impact of non-severe hypoglycemic events and treatment in adults: development of the Treatment-Related Impact Measure-Non-severe Hypoglycemic Events (TRIM-HYPO). Qual Life Res 24(12):2971–2984. https://doi.org/10.1007/s11136-015-1023-6.
Anderbro T, Amsberg S, Wredling R et al (2008) Psychometric evaluation of the Swedish version of the Hypoglycaemia Fear Survey. Patient Educ Couns 73(1):127–131. https://doi.org/10.1016/j.pec.2008.03.022.
Tasende C, Rubio JA, Alvarez J (2018) Spanish translation, adaptation and validation of the Hypoglycemia Fear Survey in adults with type 1 diabetes in the Community of Madrid. Endocrinol Diabetes Nutr 65(5):287–296. https://doi.org/10.1016/j.endinu.2017.12.003. (PMID: 10.1016/j.endinu.2017.12.003)
Graue M, Iversen MM, Wentzel-Larsen T, Rokne B, Haugstvedt A (2013) Assessing fear of hypoglycemia among adults with type 1 diabetes - psychometric properties of the Norwegian version of the Hypoglycemia Fear Survey II questionnaire. Norsk Epidemiologi 23(1):75–81. (PMID: 10.5324/nje.v23i1.1605)
Lam AYR, Xin X, Tan WB, Gardner DSL, Goh SY (2017) Psychometric validation of the Hypoglycemia Fear Survey-II (HFS-II) in Singapore. BMJ Open Diabetes Res Care 5(1):e000329. https://doi.org/10.1136/bmjdrc-2016-000329. (PMID: 10.1136/bmjdrc-2016-000329287616465530240)
Anarte Ortiz MT, Caballero FF, Ruiz de Adana MS et al (2011) Development of a new fear of hypoglycemia scale: FH-15. Psychol Assess 23(2):398–405. https://doi.org/10.1037/a0021927. (PMID: 10.1037/a002192721381839)
Gonder-Frederick LA, Schmidt KM, Vajda KA et al (2011) Psychometric properties of the Hypoglycemia Fear Survey-II for adults with type 1 diabetes. Diabetes Care 34(4):801–806. https://doi.org/10.2337/dc10-1343. (PMID: 10.2337/dc10-1343213461823064031)
Pinhas-Hamiel O, Tisch E, Levek N et al (2017) Sexual lifestyle among young adults with type 1 diabetes. Diabetes Metab Res Rev 33(2):e2837. https://doi.org/10.1002/dmrr.2837. (PMID: 10.1002/dmrr.2837)
Polonsky WH, Fisher L, Hessler D, Edelman SV (2015) Development of a new measure for assessing insulin delivery device satisfaction in patients with type 1 and type 2 diabetes. Diabetes Technol Ther 17(11):773–779. https://doi.org/10.1089/dia.2015.0140. (PMID: 10.1089/dia.2015.014026167948)
Polonsky WH, Fisher L, Hessler D, Edelman SV (2017) Investigating hypoglycemic confidence in type 1 and type 2 diabetes. Diabetes Technol Ther 19(2):131–136. https://doi.org/10.1089/dia.2016.0366. (PMID: 10.1089/dia.2016.036627997217)
Terwee CP, Prinsen CAC, Chiarotto A et al (2018) COSMIN standards and criteria for evaluating the content validity of health-related patient-reported outcome measures: a Delphi study. Qual Life Res 27:1159–1170. https://doi.org/10.1007/s11136-018-1829-0. (PMID: 10.1007/s11136-018-1829-0295509645891557)
Hendrieckx C, Halliday JA, Bowden JP et al (2014) Severe hypoglycaemia and its association with psychological well-being in Australian adults with type 1 diabetes attending specialist tertiary clinics. Diabetes Res Clin Pract 103:430–436. https://doi.org/10.1016/j.diabres.2013.12.005. (PMID: 10.1016/j.diabres.2013.12.00524513121)
Miller KM, Foster NC, Beck RW, T1D Exchange Clinic Network et al (2015) Current state of type 1 diabetes treatment in the U.S.: updated data from the T1D Exchange clinic registry. Diabetes Care 38:971–978. https://doi.org/10.2337/dc15-0078. (PMID: 10.2337/dc15-007825998289)
Walker J, Bradley C (2002) Assessing the quality of life of adolescents with diabetes: using the SEIQoL, DQoL, patient and diabetes specialist nurse ratings. Pract Diab Int 19(5):141–144. https://doi.org/10.1002/pdi.348. (PMID: 10.1002/pdi.348)
Wild D, Grove A, Martin M et al (2005) Principles of good practice for the translation and cultural adaptation process for patient-reported outcomes (PRO) measures: Report of the ISPOR task force for translation and cultural adaptation. Value Health 8(2):94–104. https://doi.org/10.1111/j.1524-4733.2005.04054.x. (PMID: 10.1111/j.1524-4733.2005.04054.x15804318)
International Consortium for Health Outcomes Measurement. Measuring results that matter: type 1 and type 2 diabetes in adults data collection reference guide. Version 1.0.0. ICHOM Diabetes in Adults Working Group, Type 1 and Type 2 Diabetes in Adults, November 2018. Available from https://ichom.org/files/medical-conditions/diabetes-in-adults/dia-reference-guide.pdf . Accessed 1 Dec 2019.
Carlton J, Peasgood T, Khan S, Barber R, Bostock J, Keetharuth AD (2020) An emerging framework for fully incorporating public involvement (PI) into patient-reported outcome measures (PROMs). J Patient Rep Outcomes 4:4. https://doi.org/10.1186/s41687-019-0172-8. (PMID: 10.1186/s41687-019-0172-8319330056957651)

Keywords: COSMIN; Diabetes; Hypoglycaemia; Patient-reported outcome measures; Psychometric properties; Quality of life; Questionnaire; Systematic review

0 (Blood Glucose)

Date Created: 20210202 Date Completed: 20220222 Latest Revision: 20240522

20240522

PMC8099839

10.1007/s00125-021-05382-x

33528625