Convergent and Discriminant Validity of the Barthel Index and the EQ-5D-3L When Used on Older People in a Rehabilitation Setting
Abstract
:1. Introduction
2. Materials and Methods
2.1. Study Design and Recruitment
- A range of intermediate care services operational for at least 2–3 years.
- Reasonable throughput into the intermediate care system (at least 1000 cases per annum).
- A mix of urban and rural sites.
- Senior management support for the collection of routine data by services themselves.
- Clinical and managerial support for participation in the national evaluation.
2.2. Instruments
2.2.1. Barthel Index (BI)
2.2.2. EuroQol-5-Dimensions 3 Level (EQ-5D-3L)
2.3. Conceptual Overlap between Instruments and Hypotheses
2.4. Statistical Analysis
3. Results
3.1. Participant Characteristics
3.2. Conceptual Overlap between Instruments
3.3. Convergent Validity
3.4. Discriminant Validity
4. Discussion
5. Conclusions
Author Contributions
Funding
Institutional Review Board Statement
Informed Consent Statement
Data Availability Statement
Conflicts of Interest
References
- Khanna, D.; Tsevat, J. Health-related quality of life--an introduction. Am. J. Manag. Care 2007, 13 (Suppl. S9), S218–S223. [Google Scholar]
- Bierman, A.S. Functional Status: The Sixth Vital Sign. J. Gen. Intern. Med. 2001, 16, 785–786. [Google Scholar] [CrossRef] [Green Version]
- Beswick, A.D.; Rees, K.; Dieppe, P.; Ayis, S.; Gooberman-Hill, R.; Horwood, J.; Ebrahim, S. Complex interventions to improve physical function and maintain independent living in elderly people: A systematic review and meta-analysis. Lancet 2008, 371, 725–735. [Google Scholar] [CrossRef] [Green Version]
- Halvorsrud, L.; Kirkevold, M.; Diseth, A.; Kalfoss, M. Quality of life model: Predictors of quality of life among sick older adults. Res. Theory Nurs Pr. 2010, 24, 241–259. [Google Scholar] [CrossRef]
- Simone, P.M.; Haas, A.L. Frailty, Leisure Activity and Functional Status in Older Adults: Relationship With Subjective Well Being. Clin. Gerontol. 2013, 36, 275–293. [Google Scholar] [CrossRef]
- Sims, J. Healthy ageing. Aust. Fam. Phys. 2017, 46, 26–29. [Google Scholar] [PubMed]
- World Health Organisation Rehabilitation: Key Facts. Available online: https://www.who.int/news-room/fact-sheets/detail/rehabilitation (accessed on 24 August 2021).
- Stolov, W.C.; Clowers, M.R. Handbook of Severe Disability: A Text. for Rehabilitation Counselors, Other Vocational Practitioners, and Allied Health Professionals; U.S. Government Printing Office: Washington, DC, USA, 1981.
- Cohen, M.E.; Marino, R.J. The tools of disability outcomes research functional status measures. Arch. Phys. Med. Rehabil. 2000, 81, S21–S29. [Google Scholar] [CrossRef] [PubMed]
- Hall, W.J. Update in geriatrics. Ann. Intern. Med. 1997, 127, 557–564. [Google Scholar] [CrossRef] [PubMed]
- Mahoney, F.I.; Barthel, D.W. Functional Evaluation: The Barthel Index. Md. State Med. J. 1965, 14, 61–65. [Google Scholar] [PubMed]
- National Institute for Health and Care Excellence Guide to the Methods of Technology Appraisal 2013; NICE: London, UK, 2013.
- Makai, P.; Brouwer, W.B.; Koopmanschap, M.A.; Stolk, E.A.; Nieboer, A.P. Quality of life instruments for economic evaluations in health and social care for older people: A systematic review. Soc. Sci. Med. 2014, 102, 83–93. [Google Scholar] [CrossRef] [PubMed]
- Bulamu, N.B.; Kaambwa, B.; Ratcliffe, J. A systematic review of instruments for measuring outcomes in economic evaluation within aged care. Health Qual. Life Outcomes 2015, 13, 179. [Google Scholar] [CrossRef] [Green Version]
- Brazier, J.E.; Deverill, M.; Green, C.; Harper, R.; Booth, A. A review of the use of health status measures in economic evaluation. Health Technol. Assess. 1999, 3, 1–164. [Google Scholar] [CrossRef]
- Furlong, W.; Barr, R.D.; Feeny, D.; Yandow, S. Patient-focused measures of functional health status and health-related quality of life in pediatric orthopedics: A case study in measurement selection. Health Qual. Life Outcomes 2005, 3, 3. [Google Scholar] [CrossRef] [Green Version]
- Royal College of Physicians Report of Joint Workshops of the Research Unit of the Royal College of Physicians and the British Geriatrics Society. Standardised Assessment Scales for Elderly People; Royal College of Physicians: London, UK, 1992. [Google Scholar]
- Wilkinson, P.R.; Wolfe, C.D.; Warburton, F.G.; Rudd, A.G.; Howard, R.S.; Ross-Russell, R.W.; Beech, R. Longer term quality of life and outcome in stroke patients: Is the Barthel index alone an adequate measure of outcome? Qual. Health Care 1997, 6, 125–130. [Google Scholar] [CrossRef]
- Barton, P.; Bryan, S.; Glasby, J.; Hewitt, G.; Jagger, C.; Kaambwa, B.; Martin, G.; Nancarrow, S.A.; Parker, S.; Regen, E.; et al. A National Evaluation of the Costs and Outcomes of Intermediate Care for Older People; Intermediate Care National Evaluation Team (ICNET): Birmingham, UK, 2006. [Google Scholar]
- Lu, W.S.; Huang, S.L.; Yang, J.F.; Chen, M.H.; Hsieh, C.L.; Chou, C.Y. Convergent validity and responsiveness of the EQ-5D utility weights for stroke survivors. J. Rehabil Med. 2016, 48, 346–351. [Google Scholar] [CrossRef] [Green Version]
- Kaambwa, B.; Bryan, S.; Barton, P.; Parker, H.; Martin, G.; Hewitt, G.; Parker, S.; Wilson, A. Costs and health outcomes of intermediate care: Results from five UK case study sites. Health Soc. Care Community 2008, 16, 573–581. [Google Scholar] [CrossRef]
- Della Pietra, G.L.; Savio, K.; Oddone, E.; Reggiani, M.; Monaco, F.; Leone, M.A. Validity and reliability of the Barthel index administered by telephone. Stroke A J. Cereb. Circ. 2011, 42, 2077–2079. [Google Scholar] [CrossRef]
- Bouwstra, H.; Smit, E.B.; Wattel, E.M.; van der Wouden, J.C.; Hertogh, C.; Terluin, B.; Terwee, C.B. Measurement Properties of the Barthel Index in Geriatric Rehabilitation. J. Am. Med. Dir. Assoc. 2019, 20, 420–425.e1. [Google Scholar] [CrossRef] [PubMed]
- Hormozi, S.; Alizadeh-Khoei, M.; Sharifi, F.; Taati, F.; Aminalroaya, R.; Fadaee, S.; Angooti-Oshnari, L.; Saghebi, H. Iranian Version of Barthel Index: Validity and Reliability in Outpatients’ Elderly. Int. J. Prev. Med. 2019, 10, 130. [Google Scholar] [PubMed]
- Green, J.; Forster, A.; Young, J. A test-retest reliability study of the Barthel Index, the Rivermead Mobility Index, the Nottingham Extended Activities of Daily Living Scale and the Frenchay Activities Index in stroke patients. Disabil. Rehabil. 2001, 23, 670–676. [Google Scholar] [CrossRef]
- Taghizadeh, G.; Martinez-Martin, P.; Meimandi, M.; Habibi, S.A.H.; Jamali, S.; Dehmiyani, A.; Rostami, S.; Mahmuodi, A.; Mehdizadeh, M.; Fereshtehnejad, S.M. Barthel Index and modified Rankin Scale: Psychometric properties during medication phases in idiopathic Parkinson disease. Ann. Phys. Rehabil. Med. 2020, 63, 500–504. [Google Scholar] [CrossRef]
- Brazier, J.E.; Ratcliffe, J.; Salomon, J.A.; Tsuchiya, A. Measuring and Valuing Health Benefits for Economic Evaluation, 2nd ed.; Oxford University Press: Oxford, UK, 2017. [Google Scholar]
- Dolan, P. Modeling valuations for EuroQol health states. Med. Care 1997, 35, 1095–1108. [Google Scholar] [CrossRef]
- Coast, J.; Peters, T.J.; Richards, S.H.; Gunnell, D.J. Use of the EuroQoL among elderly acute care patients. Qual. Life Res. 1998, 7, 1–10. [Google Scholar] [CrossRef] [PubMed]
- Brazier, J.E.; Walters, S.J.; Nicholl, J.P.; Kohler, B. Using the SF-36 and Euroqol on an elderly population. Qual. Life Res. 1996, 5, 195–204. [Google Scholar] [CrossRef]
- Lyons, R.A.; Crome, P.; Monaghan, S.; Killalea, D.; Daley, J.A. Health status and disability among elderly people in three UK districts. Age Ageing 1997, 26, 203–209. [Google Scholar] [CrossRef] [Green Version]
- van den Bos, G.A.; Triemstra, A.H. Quality of life as an instrument for need assessment and outcome assessment of health care in chronic patients. Qual. Health Care 1999, 8, 247–252. [Google Scholar] [CrossRef] [Green Version]
- World Health Organization. Towards a Common Language for Functioning, Disability and Health ICF: The International Classification of Functioning, Disability and Health; World Health Organization: Geneva, Switzerland, 2002. [Google Scholar]
- Tucker, C.A.; Cieza, A.; Riley, A.W.; Stucki, G.; Lai, J.S.; Bedirhan Ustun, T.; Kostanjsek, N.; Riley, W.; Cella, D.; Forrest, C.B. Concept analysis of the patient reported outcomes measurement information system (PROMIS((R))) and the international classification of functioning, disability and health (ICF). Qual. Life Res. Int. J. Qual. Life Asp. Treat. Care Rehabil. 2014, 23, 1677–1686. [Google Scholar] [CrossRef]
- Tucker, C.A.; Escorpizo, R.; Cieza, A.; Lai, J.S.; Stucki, G.; Ustun, T.B.; Kostanjsek, N.; Cella, D.; Forrest, C.B. Mapping the content of the Patient-Reported Outcomes Measurement Information System (PROMIS(R)) using the International Classification of Functioning, Health and Disability. Qual. Life Res. Int. J. Qual. Life Asp. Treat. Care Rehabil. 2014, 23, 2431–2438. [Google Scholar] [CrossRef] [Green Version]
- Domino, G.; Domino, M.L. Psychological Testing: An. Introduction, 2nd ed.; Cambridge University Press: Cambridge, UK, 2006. [Google Scholar]
- Kendall, M.G. A New Measure of Rank Correlation. Biometrika 1938, 30, 81–93. [Google Scholar] [CrossRef]
- Tinetti, M.E.; Doucette, J.; Claus, E.; Marottoli, R. Risk factors for serious injury during falls by older persons in the community. J. Am. Geriatr. Soc. 1995, 43, 1214–1221. [Google Scholar] [CrossRef] [PubMed]
- Kline, R.B. Exploratory and confirmatory factor analysis. In Applied Quantitative Analysis in the Social Sciences; Petscher, Y., Schatsschneider, C., Eds.; Routledge: New York, NY, USA, 2013; Chapter 6; pp. 171–207. [Google Scholar]
- Holgado–Tello, F.P.; Chacón–Moscoso, S.; Barbero–García, I.; Vila–Abad, E. Polychoric versus Pearson correlations in exploratory and confirmatory factor analysis of ordinal variables. Qual. Quant. 2008, 44, 153. [Google Scholar] [CrossRef]
- Kline, R. Principles and Practice of Structural Equation Modeling, 4th ed.; The Guilford Press: London, UK, 2015. [Google Scholar]
- Tabachnick, B.G.; Fidell, L.S. Using multivariate statistics, 5th ed.; Allyn & Bacon: Boston, MA, USA, 2007. [Google Scholar]
- Yong, A.E.; Pearce, S. A Beginner’s Guide to Factor Analysis: Focusing on Exploratory Factor Analysis. Tutor. Quant. Methods Psychol. 2013, 9, 79–94. [Google Scholar] [CrossRef]
- Krippendorff, K. Computing Krippendorff’s Alpha-Reliability. 2011. Available online: http://repository.upenn.edu/asc_papers/43 (accessed on 20 July 2021).
- De Swert, K.; Calculating Inter-Coder Reliability in Media Content Analysis Using Krippendorff’s Alpha. Working Paper. 2012. Available online: http://www.polcomm.org/wp-content/uploads/ICR01022012.pdf (accessed on 20 July 2021).
- van Hateren, K.J.; Alkhalaf, A.; Kleefstra, N.; Groenier, K.H.; de Jong, P.E.; de Zeeuw, D.; Gans, R.O.; Struck, J.; Bilo, H.J.; Gansevoort, R.T.; et al. Comparison of midregional pro-A-type natriuretic peptide and the N-terminal pro-B-type natriuretic peptide for predicting mortality and cardiovascular events. Clin. Chem. 2012, 58, 293–297. [Google Scholar] [CrossRef] [Green Version]
- Campbell, D.T.; Fiske, D.W. Convergent and discriminant validation by the multitrait-multimethod matrix. Psychol. Bull. 1959, 56, 81–105. [Google Scholar] [CrossRef] [Green Version]
- Hubley, A.M. Discriminant Validity. In Encyclopedia of Quality of Life and Well-Being Research; Michalos, A.C., Ed.; Springer Netherlands: Dordrecht, The Netherlands, 2014; pp. 1664–1667. [Google Scholar]
- Henseler, J.; Ringle, C.M.; Sarstedt, M. A new criterion for assessing discriminant validity in variance-based structural equation modeling. J. Acad. Mark. Sci. 2015, 43, 115–135. [Google Scholar] [CrossRef] [Green Version]
- Gefen, D.; Straub, D.; Boudreau, M.-C. Structural equation modeling and regression: Guidelines for research practice. Commun. AIS 2000, 4, 1–78. [Google Scholar] [CrossRef] [Green Version]
- Herdman, M.; Gudex, C.; Lloyd, A.; Janssen, M.; Kind, P.; Parkin, D.; Bonsel, G.; Badia, X. Development and preliminary testing of the new five-level version of EQ-5D (EQ-5D-5L). Qual. Life Res. 2011, 20, 1727–1736. [Google Scholar] [CrossRef] [Green Version]
- Lu, Y.; Fang, J. Advanced Medical Statistics; World Scientific Publishing, Co., Pte. Ltd.: Singapore, 2003. [Google Scholar]
- Coast, J.; Peters, T.; Natarajan, L.; Sproston, K.; Flynn, T. An assessment of the construct validity of the descriptive system for the ICECAP capability measure for older people. Qual. Life Res. 2008, 17, 967. [Google Scholar] [CrossRef] [Green Version]
- Keeley, T.; Coast, J.; Nicholls, E.; Foster, N.E.; Jowett, S.; Al-Janabi, H. An analysis of the complementarity of ICECAP-A and EQ-5D-3 L in an adult population of patients with knee pain. Health Qual. Life Outcomes 2016, 14, 36. [Google Scholar] [CrossRef] [Green Version]
- Kaambwa, B.; Gill, L.; McCaffrey, N.; Lancsar, E.; Cameron, I.D.; Crotty, M.; Gray, L.; Ratcliffe, J. An empirical comparison of the OPQoL-Brief, EQ-5D-3 L and ASCOT in a community dwelling population of older people. Health Qual. Life Outcomes 2015, 13, 164. [Google Scholar] [CrossRef] [Green Version]
- Kaambwa, B.; Mpundu-Kaambwa, C.; Adams, R.; Appleton, S.; Martin, S.; Wittert, G. Suitability of the Epworth Sleepiness Scale (ESS) for Economic Evaluation: An Assessment of Its Convergent and Discriminant Validity. Behav. Sleep Med. 2018, 16, 448–470. [Google Scholar] [CrossRef] [PubMed]
- Kaambwa, B.; Ratcliffe, J. Predicting EuroQoL 5 dimensions 5 levels (EQ-5D-5L) utilities from Older People’s Quality of Life brief questionnaire (OPQoL-brief) scores. Patient Patient-Cent. Outcome Res. 2018, 11, 39–54. [Google Scholar] [CrossRef] [PubMed]
- Chren, M.M.; Lasek, R.J.; Quinn, L.M.; Covinsky, K.E. Convergent and discriminant validity of a generic and a disease-specific instrument to measure quality of life in patients with skin disease. J. Investig. Dermatol. 1997, 108, 103–107. [Google Scholar] [CrossRef] [PubMed] [Green Version]
- Guyatt, G.H.; Deyo, R.A.; Charlson, M.; Levine, M.N.; Mitchell, A. Responsiveness and validity in health status measurement: A clarification. J. Clin. Epidemiol. 1989, 42, 403–408. [Google Scholar] [CrossRef]
- Drummond, M.F.; Sculpher, M.; O’Brien, B.; Stoddart, G.L.; Torrance, G.W. Methods for the Economic Evaluation of Health Care Programmes; Oxford University Press: Oxford, UK, 2005. [Google Scholar]
- Coast, J.; Flynn, T.N.; Natarajan, L.; Sproston, K.; Lewis, J.; Louviere, J.J.; Peters, T.J. Valuing the ICECAP capability index for older people. Soc. Sci. Med. 2008, 67, 874–882. [Google Scholar] [CrossRef] [PubMed] [Green Version]
- Coast, J.; Smith, R.; Lorgelly, P. Should the capability approach be applied in health economics? Health Econ. 2008, 17, 667–670. [Google Scholar] [CrossRef] [PubMed]
International Classification of Functioning, Disability and Health (ICF) Classifications | Instrument Dimensions | |||
---|---|---|---|---|
Domains | ICF Chapter | Specific ICF Chapters and Categories | EQ-5D-3L a | Barthel Index |
Body Functions |
| Chapter: Mental Functions
| Anxiety/ depression | |
Chapter: Sensory Functions and Pain
| Pain/ discomfort | |||
Chapter: Functions of the Digestive, Metabolic, Endocrine Systems
| Bowels | |||
Chapter: Functions of the Digestive, Metabolic, Endocrine Systems
| Bladder | |||
Body structure |
| N/A | N/A | N/A |
Activities and Participation |
| Chapter: Mobility
| Mobility | Mobility Stairs Transfer |
Chapter: Self-Care
| Self-care | Bathing Grooming Feeding Dressing Toilet use | ||
Chapter: Domestic
| Usual activities | |||
Chapter: Interpersonal Interactions and Relationships
| Usual activities | |||
Chapter: Major Life Areas
| Usual activities | |||
Chapter: Community, Social and Civic Life
| Usual activities | |||
Environmental Factors |
| N/A | N/A | N/A |
Characteristic a | Mean (SD) b | Median (IQR) b |
---|---|---|
Age | 78 (11) | 80 (73, 86) |
EQ-5D-3L utility score | 0.499 (0.351) | 0.587 (0.26, 0.743) |
BI total score | 79.32 (19.465) | 85 (70, 95) |
EQ-5D-3L utility Z-score c | −0.002 (0.999) | 0.248 (−0.684, 0.692) |
BI total Z-score c | 0.001 (1) | 0.292 (−0.479, 0.806) |
Characteristic | n (%) | |
Gender | ||
Male | 515 (30) | |
Female | 1175 (70) | |
Living Arrangements | ||
No | 748 (44) | |
Yes | 942 (56) | |
Type of Intermediate care rehabilitation service d | ||
Acute Admission avoidance | 659 (39) | |
Supported Discharge | 961 (57) | |
Residential | 70 (4) |
EQ-5D-3L b Dimensions | Barthel b Items | |||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Mobility | Self-Care | Usual Activities | Pain/Discomfort | Anxiety/Depression | Feeding | Bathing | Grooming | Dressing | Bowels | Bladder | Toilet Use | Transfers | Mobility | Stairs | ||
EQ-5D-3L Dimensions | Mobility | - | −0.17 | −0.20 | −0.22 | −0.25 | −0.14 | −0.16 | −0.28 | −0.31 | −0.31 | −0.28 | ||||
Self-care | 0.45 | - | −0.29 | −0.35 | −0.42 | −0.54 | −0.17 | −0.20 | −0.39 | −0.40 | −0.36 | −0.29 | ||||
Usual activities | 0.39 | 0.46 | - | −0.22 | −0.29 | −0.28 | −0.37 | −0.09 | −0.12 | −0.30 | −0.32 | −0.30 | −0.26 | |||
Pain | 0.35 | 0.27 | 0.28 | - | −0.12 | −0.11 | −0.14 | −0.17 | −0.06 | −0.06 | −0.16 | −0.20 | −0.19 | −0.17 | ||
Anxiety | 0.28 | 0.32 | 0.28 | 0.32 | - | −0.11 | −0.16 | −0.20 | −0.24 | −0.11 | −0.14 | −0.24 | −0.25 | −0.26 | −0.15 | |
Barthel Index Items | Feeding | - | ||||||||||||||
Bathing | 0.21 | - | ||||||||||||||
Grooming | 0.38 | 0.38 | - | |||||||||||||
Dressing | 0.40 | 0.42 | 0.64 | - | ||||||||||||
Bowels | 0.19 | 0.10 | 0.24 | 0.19 | - | |||||||||||
Bladder | 0.24 | 0.18 | 0.32 | 0.31 | 0.38 | - | ||||||||||
Toilet use | 0.44 | 0.30 | 0.53 | 0.55 | 0.26 | 0.35 | - | |||||||||
Transfers | 0.40 | 0.28 | 0.50 | 0.54 | 0.26 | 0.34 | 0.74 | - | ||||||||
Mobility | 0.36 | 0.28 | 0.46 | 0.50 | 0.24 | 0.32 | 0.70 | 0.74 | - | |||||||
Stairs | 0.18 | 0.40 | 0.33 | 0.38 | 0.19 | 0.22 | 0.34 | 0.34 | 0.38 | - |
Variable | Factor1 | Factor2 | Uniqueness |
---|---|---|---|
Barthel Index Dimensions | |||
Feeding | 0.6565 | 0.5210 | |
Bathing | 0.6571 | 0.4804 | |
Grooming | 0.8207 | 0.2606 | |
Dressing | 0.7982 | −0.3522 | 0.2388 |
Bowels | 0.5767 | 0.6592 | |
Bladder | 0.6418 | 0.5853 | |
Toilet use | 0.8563 | −0.3604 | 0.1369 |
Transfers | 0.7934 | −0.4303 | 0.1853 |
Mobility | 0.7433 | −0.4334 | 0.2597 |
Stairs | 0.5859 | −0.3066 | 0.5628 |
EQ-5D-3L b dimensions | |||
Mobility | 0.7277 | 0.3899 | |
Self-care | −0.4931 | 0.6432 | 0.3431 |
Usual activities | −0.3105 | 0.6496 | 0.4816 |
Pain/Discomfort | 0.6402 | 0.5871 | |
Anxiety/Depression | 0.5723 | 0.6431 | |
Variance explained by factors | 64.96% | 35.04% | |
Average variance extracted (AVE) c | 0.3791 | ||
Correlation between factors | 0.0001 | ||
Determinant | 0.003 | ||
Bartlett test of sphericity | χ2 = 9781.303, p < 0.001 | ||
Kaiser-Meyer-Olkin Measure d | 0.899 |
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Kaambwa, B.; Bulamu, N.B.; Mpundu-Kaambwa, C.; Oppong, R. Convergent and Discriminant Validity of the Barthel Index and the EQ-5D-3L When Used on Older People in a Rehabilitation Setting. Int. J. Environ. Res. Public Health 2021, 18, 10314. https://doi.org/10.3390/ijerph181910314
Kaambwa B, Bulamu NB, Mpundu-Kaambwa C, Oppong R. Convergent and Discriminant Validity of the Barthel Index and the EQ-5D-3L When Used on Older People in a Rehabilitation Setting. International Journal of Environmental Research and Public Health. 2021; 18(19):10314. https://doi.org/10.3390/ijerph181910314
Chicago/Turabian StyleKaambwa, Billingsley, Norma B. Bulamu, Christine Mpundu-Kaambwa, and Raymond Oppong. 2021. "Convergent and Discriminant Validity of the Barthel Index and the EQ-5D-3L When Used on Older People in a Rehabilitation Setting" International Journal of Environmental Research and Public Health 18, no. 19: 10314. https://doi.org/10.3390/ijerph181910314