Skip to main content
Top
Published in: Archives of Orthopaedic and Trauma Surgery 2/2014

01-02-2014 | Trauma Surgery

Methodological challenges in the use of hip-specific composite outcomes: linking measurements from hip fracture trials to the International Classification of Functioning, Disability and Health Framework

Authors: Amy Hoang-Kim, Emil Schemitsch, Abhaya V. Kulkarni, Dorcas Beaton

Published in: Archives of Orthopaedic and Trauma Surgery | Issue 2/2014

Login to get access

Abstract

Introduction

The prevalence of hip-specific outcome measures in randomized trials reflects what directs our outcome assessment following a hip fracture. The present study provides an overview on the most commonly-used hip-specific outcome instruments used for postoperative assessment of hip fracture with respect to their covered contents. This can facilitate the selection of appropriate items for specific purposes in clinical as well as research settings.

Methods

We used the International Classification of Functioning, Disability and Health (ICF) model to distinguish concepts within the instrument. All items from the questionnaires were categorized into one of three categories using the ICF linking rules for a standardized approach. The hip-specific composites measures were also compared to other types of prevalent measures: generic and patient-based instruments.

Results

All of the items in the instruments could be mapped to the ICF. We report the highest frequency of ICF activity and participation (71 %) within the Harris hip score (HHS) which is similar to the frequency of ICF content found in the generic measures (82 %). Hip-specific composites focused mostly on walking and moving long and short distances, while in patient-reported measures there was a concentration on the concept of sensation of pain and pain in body parts.

Discussion and conclusion

The prevalent use of the HHS, over the other hip-specific instruments, could be attributed to its likeness in concept to other generic measures. The dominance of the ICF category of activity and participation reflects what is important to clinicians treating a hip fracture. Composite scores remain problematic as they cut across different ICF concepts. As long as the popularity of composite scoring systems continues, an overall score may not represent the true patient preferences and concerns in clinical trials. Future studies could apply the results from this study for the creation of an ICF category-based item banking or investigators could operationalize the ICF categories within these candidate measures for specific interventions.
Literature
1.
go back to reference Arts DGT, Keizer NF, Scheffer G (2002) Defining and improving data quality in medical registries: a literature review, case study and generic framework. J Am Med Inform Assoc 9:600–611PubMedCentralPubMedCrossRef Arts DGT, Keizer NF, Scheffer G (2002) Defining and improving data quality in medical registries: a literature review, case study and generic framework. J Am Med Inform Assoc 9:600–611PubMedCentralPubMedCrossRef
2.
go back to reference Beaton D, Schemitsch E (2003) Measures of health-related quality of life and physical function. Clin Orthop Relat Res 413:90–105PubMedCrossRef Beaton D, Schemitsch E (2003) Measures of health-related quality of life and physical function. Clin Orthop Relat Res 413:90–105PubMedCrossRef
3.
go back to reference Bellamy N, Kirwan J, Bowers M et al (1997) Recommendations for a core set of outcome measures for future phase II clinical trials in knee, hip and hand osteoarthritis. Consensus development at OMERACT III. J Rheumatol 24:799–802PubMed Bellamy N, Kirwan J, Bowers M et al (1997) Recommendations for a core set of outcome measures for future phase II clinical trials in knee, hip and hand osteoarthritis. Consensus development at OMERACT III. J Rheumatol 24:799–802PubMed
4.
go back to reference Blomfeldt R et al (2005) Comparison of internal fixation with total hip replacement for displaced femoral neck fractures. Randomized controlled trial performed at four years. J Bone Jt Surg 87:1680–1688CrossRef Blomfeldt R et al (2005) Comparison of internal fixation with total hip replacement for displaced femoral neck fractures. Randomized controlled trial performed at four years. J Bone Jt Surg 87:1680–1688CrossRef
5.
go back to reference Blomfeldt R et al (2007) Internal fixation versus hemiarthroplasty for displaced fractures of the femoral neck in elderly patients with severe cognitive impairment. J Bone Jt Surg 89:160–165CrossRef Blomfeldt R et al (2007) Internal fixation versus hemiarthroplasty for displaced fractures of the femoral neck in elderly patients with severe cognitive impairment. J Bone Jt Surg 89:160–165CrossRef
6.
go back to reference Busse J, Bhandari M, Ferreira-González I et al (2012) Use and interpretation of composite end points in orthopaedic trials. J Bone Jt Surg Am 94:65–69CrossRef Busse J, Bhandari M, Ferreira-González I et al (2012) Use and interpretation of composite end points in orthopaedic trials. J Bone Jt Surg Am 94:65–69CrossRef
7.
go back to reference Charnley J (1972) The long-term results of low-friction arthroplasty of the hip performed as a primary intervention. J Bone Jt Surg Br 54:61–76 Charnley J (1972) The long-term results of low-friction arthroplasty of the hip performed as a primary intervention. J Bone Jt Surg Br 54:61–76
8.
go back to reference Chi GY (2005) Some issues with composite endpoints in clinical trials. Fundam Clin Pharmacol 19:609–619PubMedCrossRef Chi GY (2005) Some issues with composite endpoints in clinical trials. Fundam Clin Pharmacol 19:609–619PubMedCrossRef
9.
go back to reference Cieza A, Brockow T, Ewert T et al (2002) Linking health-status measurements to the international classification of functioning, disability and health. J Rehab Med 34:205–210CrossRef Cieza A, Brockow T, Ewert T et al (2002) Linking health-status measurements to the international classification of functioning, disability and health. J Rehab Med 34:205–210CrossRef
10.
go back to reference Cieza A, Gey S, Chatterji S et al (2005) ICF linking rules: an update based on lessons learned. J Rehab Med 37:212–218CrossRef Cieza A, Gey S, Chatterji S et al (2005) ICF linking rules: an update based on lessons learned. J Rehab Med 37:212–218CrossRef
11.
go back to reference Coons SJ, Rao S, Keininger DL et al (2000) A comparative review of generic quality-of-life instruments. Pharmacoeconomics 17:13–35PubMedCrossRef Coons SJ, Rao S, Keininger DL et al (2000) A comparative review of generic quality-of-life instruments. Pharmacoeconomics 17:13–35PubMedCrossRef
12.
go back to reference Dawson J, Fitzpatrick R, Carr A (1996) Questionnaire on the population of patients about total hip replacement. J Bone Jt Surg 76-B:185–190 Dawson J, Fitzpatrick R, Carr A (1996) Questionnaire on the population of patients about total hip replacement. J Bone Jt Surg 76-B:185–190
13.
go back to reference Euroqol Group (1990) Euroqol—a new facility for the measurement of health related quality of life. Health Policy 16:199–208CrossRef Euroqol Group (1990) Euroqol—a new facility for the measurement of health related quality of life. Health Policy 16:199–208CrossRef
14.
go back to reference Freemantle N, Calvert M, Wood J et al (2003) Composite outcomes in randomized trials: greater precision but with greater uncertainty? JAMA 289:2554–2559PubMedCrossRef Freemantle N, Calvert M, Wood J et al (2003) Composite outcomes in randomized trials: greater precision but with greater uncertainty? JAMA 289:2554–2559PubMedCrossRef
15.
go back to reference Gent M (1997) Discussion: some issues in the construction and use of clusters of outcome events. Control Clin Trials 18:546–549CrossRef Gent M (1997) Discussion: some issues in the construction and use of clusters of outcome events. Control Clin Trials 18:546–549CrossRef
16.
go back to reference Gill TM, Feinstein AR (1994) A critical appraisal of the quality of quality of life measurements. JAMA 272:619–626PubMedCrossRef Gill TM, Feinstein AR (1994) A critical appraisal of the quality of quality of life measurements. JAMA 272:619–626PubMedCrossRef
17.
go back to reference Goldhahn J, Little D, Mitchell P et al (2010) ISFR-IOF working group in publication evidence for anti-osteoporosis therapy in acute fracture situations–recommendations of a multidisciplinary workshop of the International Society for Fracture Repair. Bone 46:267–271PubMedCrossRef Goldhahn J, Little D, Mitchell P et al (2010) ISFR-IOF working group in publication evidence for anti-osteoporosis therapy in acute fracture situations–recommendations of a multidisciplinary workshop of the International Society for Fracture Repair. Bone 46:267–271PubMedCrossRef
18.
19.
go back to reference Guyatt GH, Feeeny DH, Patrick DL (1993) Measuring health-related quality of life. Ann Int Med 118:622–629PubMedCrossRef Guyatt GH, Feeeny DH, Patrick DL (1993) Measuring health-related quality of life. Ann Int Med 118:622–629PubMedCrossRef
20.
go back to reference Harris WH (1969) Traumatic arthritis of the hip after dislocation and acetabular fractures: treatment by mold arthroplasty. J Bone Joint Surg 51:737–755PubMed Harris WH (1969) Traumatic arthritis of the hip after dislocation and acetabular fractures: treatment by mold arthroplasty. J Bone Joint Surg 51:737–755PubMed
21.
go back to reference Hays RD, Sherbourne CD, Mazel RM (1993) The RAND 36-item Health Survey 1.0. Health Econ 2:217–227PubMedCrossRef Hays RD, Sherbourne CD, Mazel RM (1993) The RAND 36-item Health Survey 1.0. Health Econ 2:217–227PubMedCrossRef
22.
go back to reference Hays RD, Marshall GN, Wang EYI et al (1994) Four-year cross-lagged associations between physical and mental health in the medical outcomes study. J Consult Clin Psychol 62:441–449PubMedCrossRef Hays RD, Marshall GN, Wang EYI et al (1994) Four-year cross-lagged associations between physical and mental health in the medical outcomes study. J Consult Clin Psychol 62:441–449PubMedCrossRef
23.
go back to reference Hoang-Kim A (2010) The first international society for fracture repair and international osteoporosis foundation ‘Osteoporosis: from evidence to action’ combined symposium & working groups. Adv Orthop 2:15–18 Hoang-Kim A (2010) The first international society for fracture repair and international osteoporosis foundation ‘Osteoporosis: from evidence to action’ combined symposium & working groups. Adv Orthop 2:15–18
24.
go back to reference Hoang-Kim A, Beaton D, Bhandari M et al (2013) The need to standardize functional outcome in randomized trials of hip fracture: a review using the ICF framework. J Orthop Trauma 27:e1–e8PubMedCrossRef Hoang-Kim A, Beaton D, Bhandari M et al (2013) The need to standardize functional outcome in randomized trials of hip fracture: a review using the ICF framework. J Orthop Trauma 27:e1–e8PubMedCrossRef
25.
go back to reference Huque MF, Alosh M, Bhore R (2011) Addressing multiplicity issues of a composite endpoint and its components in clinical trials. J Biopharma Stat 21:610–634CrossRef Huque MF, Alosh M, Bhore R (2011) Addressing multiplicity issues of a composite endpoint and its components in clinical trials. J Biopharma Stat 21:610–634CrossRef
26.
go back to reference Jette AM, Keysor JJ (2003) Disability models: implications for arthritis exercise and physical activity interventions. Arthritis Car eRes 49:114–120CrossRef Jette AM, Keysor JJ (2003) Disability models: implications for arthritis exercise and physical activity interventions. Arthritis Car eRes 49:114–120CrossRef
27.
go back to reference Johanson NA et al (1992) A self-administered hip-rating questionnaire for the assessment of outcome after total hip replacement. J Bone Joint Surg 74-A:587–597 Johanson NA et al (1992) A self-administered hip-rating questionnaire for the assessment of outcome after total hip replacement. J Bone Joint Surg 74-A:587–597
28.
go back to reference Judet R, Judet J (1952) Technique and results with acrylic femoral head prosthesis. J Bone Jt Surg 34-B:173–180 Judet R, Judet J (1952) Technique and results with acrylic femoral head prosthesis. J Bone Jt Surg 34-B:173–180
29.
go back to reference Kind P (1996) The EuroQol instrument: an index of health-related quality of life. In: Spilker B (ed) Quality of life and pharmacoeconomics in clinical trials, 2nd edn. Lippincott-Raven Publishers, Philadelphia (PA), pp 191–201 Kind P (1996) The EuroQol instrument: an index of health-related quality of life. In: Spilker B (ed) Quality of life and pharmacoeconomics in clinical trials, 2nd edn. Lippincott-Raven Publishers, Philadelphia (PA), pp 191–201
30.
go back to reference Liang MH, Katz JN, Phillips C, The American Academy of Orthopaedic Surgeons Task Force on Outcome Studies et al (1991) The total hip arthroplasty outcome evaluation form of the American Academy of Orthopaedic Surgeons. Results of a nominal group process. J Bone Jt Surg 73-A:639–646 Liang MH, Katz JN, Phillips C, The American Academy of Orthopaedic Surgeons Task Force on Outcome Studies et al (1991) The total hip arthroplasty outcome evaluation form of the American Academy of Orthopaedic Surgeons. Results of a nominal group process. J Bone Jt Surg 73-A:639–646
31.
go back to reference McDowell I (2006) Measuring health: A guide to rating scales and questionnaires. Oxford University Press, Incorporated, United KingdomCrossRef McDowell I (2006) Measuring health: A guide to rating scales and questionnaires. Oxford University Press, Incorporated, United KingdomCrossRef
32.
go back to reference Merle d’Aubigne R, Cauchoix J, Ramadier JV (1949) Evaluation chiffré de la function de la hanche. Application a l’étude des resultants des operations mobilatrices de la hanche. Rev Chir Orthop Reparatrice Appar Mot 35:5–12 Merle d’Aubigne R, Cauchoix J, Ramadier JV (1949) Evaluation chiffré de la function de la hanche. Application a l’étude des resultants des operations mobilatrices de la hanche. Rev Chir Orthop Reparatrice Appar Mot 35:5–12
33.
go back to reference Miedel R et al (2005) The standard gamma nail or the medoff sliding plate for unstable trochanteric and subtrochanteric fractures. A randomised, controlled trial. J Bone Jt Surg 87:68–75 Miedel R et al (2005) The standard gamma nail or the medoff sliding plate for unstable trochanteric and subtrochanteric fractures. A randomised, controlled trial. J Bone Jt Surg 87:68–75
34.
go back to reference Montori VM, Permanyer-Miralda G, Ferreira-González I et al (2005) Validity of composite end points in clinical trials. BMJ 330:594–596PubMedCrossRef Montori VM, Permanyer-Miralda G, Ferreira-González I et al (2005) Validity of composite end points in clinical trials. BMJ 330:594–596PubMedCrossRef
35.
go back to reference Moyé LA (2003) Multiple analyses in clinical trials: fundamentals for investigators. Springer-Verlag, New York Moyé LA (2003) Multiple analyses in clinical trials: fundamentals for investigators. Springer-Verlag, New York
36.
go back to reference Neaton JD, Gray G, Zuckermann BD et al (2005) Key issues in endpoint selection for heart failure trials: composite end points. J Card Fail 11:567–575PubMedCrossRef Neaton JD, Gray G, Zuckermann BD et al (2005) Key issues in endpoint selection for heart failure trials: composite end points. J Card Fail 11:567–575PubMedCrossRef
37.
go back to reference Patrick DL, Chiang YP (2000) Measurement of health outcomes in treatment effectiveness evaluations: conceptual and methodological challenges. Med Care 38(suppl II):14–25 Patrick DL, Chiang YP (2000) Measurement of health outcomes in treatment effectiveness evaluations: conceptual and methodological challenges. Med Care 38(suppl II):14–25
38.
go back to reference Perenboom RJM, Chorus AMJ (2003) Measuring participation according to the International Classification of Functioning, Disability and Health (ICF). Disabil Rehabil 25:577–587PubMedCrossRef Perenboom RJM, Chorus AMJ (2003) Measuring participation according to the International Classification of Functioning, Disability and Health (ICF). Disabil Rehabil 25:577–587PubMedCrossRef
39.
go back to reference Pollard B, Johnston M, Dieppe P (2006) What do osteoarthritis health outcome instruments measure? Impairment, activity limitation, or participation restriction? J Rheum 33:757–763PubMed Pollard B, Johnston M, Dieppe P (2006) What do osteoarthritis health outcome instruments measure? Impairment, activity limitation, or participation restriction? J Rheum 33:757–763PubMed
40.
go back to reference Salvati EA, Wilson PD Jr (1973) Long-term results of femoral head replacement. J Bone Jt Surg 55A:516–524 Salvati EA, Wilson PD Jr (1973) Long-term results of femoral head replacement. J Bone Jt Surg 55A:516–524
41.
go back to reference Stinchfield FE, Cooperman B (1957) Replacement of the femoral head by Judet or Austin Moore prosthesis. J Bone Jt Surg Am 39-A:1043–1058 Stinchfield FE, Cooperman B (1957) Replacement of the femoral head by Judet or Austin Moore prosthesis. J Bone Jt Surg Am 39-A:1043–1058
42.
go back to reference Stucki G (2005) International Classification of Functioning, Disability, and Health (ICF): a promising framework and classification for rehabilitation medicine. Am J Phys Med Rehabil 84:733–740PubMedCrossRef Stucki G (2005) International Classification of Functioning, Disability, and Health (ICF): a promising framework and classification for rehabilitation medicine. Am J Phys Med Rehabil 84:733–740PubMedCrossRef
43.
go back to reference Thomas VS, Rockwood K, McDowell I (1998) Multidimensionality in instruments and basic activities of daily living. J Clin Epidemiol 51:315–321PubMedCrossRef Thomas VS, Rockwood K, McDowell I (1998) Multidimensionality in instruments and basic activities of daily living. J Clin Epidemiol 51:315–321PubMedCrossRef
44.
go back to reference Tidermark J et al (2003) Internal fixation compared with total hip replacement for displaced femoral neck fractures in the elderly. A randomised, controlled trial. J Bone Jt Surg Br 85:380–388CrossRef Tidermark J et al (2003) Internal fixation compared with total hip replacement for displaced femoral neck fractures in the elderly. A randomised, controlled trial. J Bone Jt Surg Br 85:380–388CrossRef
45.
go back to reference Ware JE Jr, Sherbourne CD (1992) The MOS 36-item short form health survey (SF-36). Conceptual framework and item selection. Med Care 30:473–483PubMedCrossRef Ware JE Jr, Sherbourne CD (1992) The MOS 36-item short form health survey (SF-36). Conceptual framework and item selection. Med Care 30:473–483PubMedCrossRef
46.
go back to reference Weigl M, Cieza A, Harder M et al (2003) Linking osteoarthritis-specific health status measures to the International Classification of Functioning, Disability, and Health (ICF). Osteoarthritis Cartilage 11:519–523PubMedCrossRef Weigl M, Cieza A, Harder M et al (2003) Linking osteoarthritis-specific health status measures to the International Classification of Functioning, Disability, and Health (ICF). Osteoarthritis Cartilage 11:519–523PubMedCrossRef
47.
go back to reference Wilkie R, Peat G, Thomas E et al (2004) Measuring the consequences of osteoarthritis and joint pain in population-based studies: can existing health measurement instruments capture levels of participation? Arthritis Rheum-Arthritis Care Res 51:755–762CrossRef Wilkie R, Peat G, Thomas E et al (2004) Measuring the consequences of osteoarthritis and joint pain in population-based studies: can existing health measurement instruments capture levels of participation? Arthritis Rheum-Arthritis Care Res 51:755–762CrossRef
48.
go back to reference Witkop L, Smith C, Fox Z et al (2010) Methodological issues in the use of composite endpoints in clinical trials: examples from the HIV field. Clin Trials 7:19CrossRef Witkop L, Smith C, Fox Z et al (2010) Methodological issues in the use of composite endpoints in clinical trials: examples from the HIV field. Clin Trials 7:19CrossRef
49.
go back to reference World Health Organization (2001) International Classification of Functioning, Disability and Health ICF. World Health Organization, Geneva World Health Organization (2001) International Classification of Functioning, Disability and Health ICF. World Health Organization, Geneva
Metadata
Title
Methodological challenges in the use of hip-specific composite outcomes: linking measurements from hip fracture trials to the International Classification of Functioning, Disability and Health Framework
Authors
Amy Hoang-Kim
Emil Schemitsch
Abhaya V. Kulkarni
Dorcas Beaton
Publication date
01-02-2014
Publisher
Springer Berlin Heidelberg
Published in
Archives of Orthopaedic and Trauma Surgery / Issue 2/2014
Print ISSN: 0936-8051
Electronic ISSN: 1434-3916
DOI
https://doi.org/10.1007/s00402-013-1824-4

Other articles of this Issue 2/2014

Archives of Orthopaedic and Trauma Surgery 2/2014 Go to the issue