Health related quality of life in patients with Charcot arthropathy of the foot and ankle

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1 Foot and Ankle Surgery 14 (2008) infection, and amputation. Clinical observation indicates that Charcot arthropathy may have devastating consequences on the quality of life of neuropathic patients, particularly those with diabetes, and this has been corroborated by recent studies with standardized quality of life surveys [2 4]. The frequency of diabetes-related lower extremity amputation varies between different national and ethnic groups [5 7]. In the Canadian province of Manitoba, the indigenous (Aboriginal) peoples comprise 13.6% of the population [8]. The age-adjusted prevalence of diagnosed diabetes is 2.86-fold greater in Aboriginal than nonwww.elsevier.com/locate/fas Health related quality of life in patients with Charcot arthropathy of the foot and ankle Michael P. Sochocki M.D. a, Shawn Verity M.D. a, Pamela J. Atherton M.S. b, Jefrey L. Huntington M.P.H. c, Jeff A. Sloan Ph.D. b, John M. Embil M.D., FRCPC d,e, Elly Trepman M.D. e,f,g, * a Faculty of Medicine, University of Manitoba, Canada b Department of Health Sciences Research, Mayo Clinic, Rochester, MN, USA c Intermountain Healthcare, Salt Lake City, UT, USA d Section of Infectious Diseases, Department of Internal Medicine, University of Manitoba, Canada e Department of Medical Microbiology, University of Manitoba, Canada f Department of Surgery, University of Manitoba, Canada g Department of Orthopaedic Surgery, Grand Itasca Clinic & Hospital, Grand Rapids, MN, USA Received 5 March 2007; received in revised form 9 July 2007; accepted 17 July 2007 Abstract Background: Clinical observation suggests that Charcot arthropathy of the foot and ankle has major negative consequences on the quality of life of neuropathic patients, particularly those with diabetes. We hypothesized that the quality of life in patients with Charcot arthropathy may be aggravated by Aboriginal ethnicity and rural residence because of limited access to timely specialty healthcare. Methods: Sixty patients with Charcot arthropathy were interviewed with the Short Form 36 (SF-36) Health Survey. Results: Mean Physical Component Summary (PCS) score was 31 8 points and mean Mental Component Summary (MCS) score was points. Mean PCS and MCS scores were not affected by gender, ethnicity, residence, or Charcot stage. Mean PCS score was significantly lower in non-employed (unemployed or retired) than employed patients and in patients who did not use alcohol than those who used alcohol; MCS score was not affected by employment status or alcohol use. Conclusions: Charcot arthropathy has a major negative effect on quality of life. The SF-36 survey was sensitive to the physical effects, but not to mental effects, of Charcot arthropathy. # 2007 European Foot and Ankle Society. Published by Elsevier Ltd. All rights reserved. Keywords: Diabetes mellitus; Neuropathy; Health survey; SF Introduction Charcot arthropathy is a condition that affects joints of the foot and ankle in diabetic and non-diabetic patients with peripheral neuropathy, and is manifested by bony fragmentation, fracture, and dislocation resulting in foot deformity, bony prominence, and instability [1]. This may limit the ability to use standard footwear and result in ulceration, deep * Corresponding author at: Health Sciences Centre, MS Sherbrook Street, Winnipeg, Man. R3A 1R9, Canada. Tel.: ; fax: /$ see front matter # 2007 European Foot and Ankle Society. Published by Elsevier Ltd. All rights reserved. doi: /j.fas

2 12 M.P. Sochocki et al. / Foot and Ankle Surgery 14 (2008) Aboriginal men and 4.64-fold greater in Aboriginal than non-aboriginal women [9]. The frequency of lower extremity amputation in Manitoba is greater in Aboriginal people than the representation of Aboriginal people in the overall population (frequency of amputations: Aboriginal, 16%; non-aboriginal, 84%) [10]. Non-urban residence, especially in remote communities of Manitoba, may contribute to poor outcome because of limited access to specialty health care that may contribute to delay in diagnosis and morbidity [11 15]. We hypothesized that the quality of life in patients with Charcot arthropathy may be aggravated by Aboriginal ethnicity and rural residence because of limited access to timely specialty healthcare. The purpose of this study is to evaluate quality of life of patients with Charcot arthropathy and identify risk factors that may contribute to poor quality of life. 2. Materials and methods 2.1. Subjects All patients who were being treated for Charcot foot and ankle at a tertiary care multispecialty diabetic foot and ankle clinic from July to August, 2002 were approached to participate in the study, and consent was obtained; no patient declined to participate. The study was part of a larger project assessing quality of life associated with diabetic foot problems that was approved by the Health Research Ethics Board of the University of Manitoba Demographics and clinical features Demographic and clinical information was obtained from questions to the patients and review of medical records and radiographic studies. There were 60 patients with Charcot foot and ankle who participated in the study, and the majority demographic characteristics included male gender, Caucasian ethnicity, urban place of residence, and nonemployed status (either unemployed or retired) (Table 1). The majority of patients had type 2 diabetes, insulin treatment, and foot numbness; one third of patients had a history of ulcer (Table 2). The most frequent natural history and anatomic site of Charcot arthropathy were stage 3 (consolidation) [16] and type 1 (Lisfranc) [17], respectively (Table 2) Quality of life assessment The Medical Outcomes Survey (MOS) Short Form 36 (SF-36) Health Survey was administered as previously described, including the 36 items that yielded two summary measures: Physical Health Component Summary (PCS) and Mental Health Component Summary (MCS) [18]. The component summary scales were scored as previously Table 1 Demographic and clinical features of subjects with Charcot arthropathy Feature No. (%) subjects or average a Total no. (%) subjects 60 (100) Age (year) Gender Male 32 (53) Female 28 (47) Height (cm) Weight (kg) BMI (kg/m 2 ) b 29 9 Ethnicity Caucasian 42 (70) Aboriginal 11 (18) Other c 7 (12) Residence d Urban 37 (62) Rural 23 (38) Primary employment activity Sitting 9 (15) Standing 8 (13) Physical labor 6 (10) Not employed e 37 (62) Smoke 8 (13) Alcohol use 22 (37) a Data reported as number (%) subjects or mean std dev. b BMI = Body mass index = weight/(height) 2. c Other: 1 African, 1 East Indian, 1 Philippine, 4 unknown. d Urban = city; rural = small town, reservation, or rural. e Not employed: unemployed or retired. described, with physical and mental regression weights and a constant for both measures obtained from published SF-36 data of the general United States population [19]. Both the PCS and the MCS scales were transformed to have a mean of 50 points and a standard deviation of 10 points, with a possible range of points, in the general United States population [19] Data analysis Statistical analysis was done using database (SAS Institute Inc., Cary, NC) and statistical (SPSS Inc., Chicago, IL) software. Both parametric and non-parametric procedures were employed. Chi-squared analysis was performed to analyze categorical variables. Student s one-tailed t-test and analysis of variance were used to compare average values, which were reported as mean standard deviation. Pearson s correlation coefficients were determined to evaluate potential correlation between select variables and SF-36 component scores. Differences between the average PCS and MCS scores of different subgroups of greater than 10 points (on the transformed point scale) were considered clinically meaningful [20]. Significant differences were defined by P 0.05.

3 M.P. Sochocki et al. / Foot and Ankle Surgery 14 (2008) Table 2 Profile of diabetes and foot complications in subjects with Charcot arthropathy Parameter No. (%) subjects or average a Diabetes type Type 1 18 (30) Type 2 38 (63) Non-diabetic 4 (7) Diabetes duration (year) Hemoglobin A 1c (%) b 9 2 Diabetes treatment b Insulin 37 (66) Oral hypoglycemic 25 (45) Diet and exercise 8 (14) Numbness in feet 56 (93) Duration of numbness (year) 7 5 Ulcer history Deep 10 (17) Infected 6 (10) Superficial 4 (7) Charcot stage Stage 1 7 (12) Stage 2 17 (28) Stage 3 33 (55) Unknown 3 (5) Charcot location c Lisfranc 35 (58) Hindfoot 17 (28) Forefoot 9(15) Ankle 8 (13) Calcaneus 3 (5) a Data reported as mean std dev or number (%) subjects. b N = 56 subjects with diabetes; some subjects had more than one treatment type. c Charcot location: some feet had more than one site of involvement. 3. Results For all patients surveyed, mean PCS score was significantly lower, and mean MCS was similar, to the mean value of 50 points for the general United States Population [19] (Table 3). Mean PCS and MCS scores were not affected by gender, ethnicity, residence, or Charcot stage (Table 3). Mean PCS score was significantly lower in nonemployed (unemployed or retired) than employed patients and in patients who did not use alcohol than those who used alcohol; MCS score was not affected by employment status or alcohol use (Table 3). Body mass index, diabetes treatment, or presence of numbness had no significant effect on mean PCS or MCS scores (data not shown). There was no significant correlation between selected variables (age, height, weight, diabetes duration, duration of numbness) and the PCS or MCS scores (data not shown). The majority of patients had limitations of varied activities including work or daily activities because of impaired physical or emotional health (Table 4). Table 3 Short Form 36 (SF-36) component scores in subjects with Charcot arthropathy Number (%) SF-36 component scores a subjects PCS PCSag MCS MCSag All subjects 60 (100) Gender Male 32 (53) Female 28 (47) Ethnicity Caucasian 42 (70) Aboriginal 11 (18) Other b 7 (12) Residence **** Urban 37 (62) Rural 23 (38) Employment Sitting 9 (15) Standing 8 (13) Physical labor 6 (10) Not employed c 37 (62) P 0.03 NS NS NS Alcohol use Yes 22 (37) No 38 (63) P NS NS Charcot stage Stage 1 7 (12) Stage 2 17 (28) Stage 3 33 (55) Unknown 3 (5) **** Urban = city; rural = small town, reservation, or rural. a Reported as mean S.D.; PCS, physical component summary; PCSag, physical component summary (age- and gender-adjusted); MCS, mental component summary; MCSag, mental component summary (age- and gender-adjusted); NS = not significant, P > b Other: 1 African, 1 East Indian, 1 Phillipine, 4 Unknown. c Not employed: unemployed or retired. 4. Discussion The results demonstrate that Charcot arthropathy has a major effect in decreasing quality of life, evidenced by the low mean PCS score (Table 3) which was significantly less than PCS values for patients with type 2 diabetes (45 points) [19], the general Canadian population (51 points) [21], and the general United States population (50 points) [18]. This confirms the findings of other recent studies using the SF-36 in smaller groups of patients with Charcot arthropathy [2,3] and in a recent larger multicenter study [4]. The mean PCS score in patients with Charcot arthropathy was similar to that in patients with unhealed diabetic foot ulcers (35 points) [22], which underscores the profound physical limitations present in the patient with Charcot arthropathy. However, the

4 14 M.P. Sochocki et al. / Foot and Ankle Surgery 14 (2008) Table 4 Response frequency to selected questions from the health survey Question from health survey Number (%) subjects Health limits these activities a lot Vigorous activities 51 (89) Moderate activities 35 (58) Lifting or carrying groceries 31 (52) Climbing several flights of stairs 47 (78) Climbing one flight of stairs 25 (42) Bending, kneeling, stooping 29 (48) Walking more than one mile 53 (88) Walking several hundred yards 36 (60) Walking one hundred yards 31 (52) Bathing or dressing self 7 (12) Any limitation during past 4 weeks in work or daily activities because of physical health Decreased time 48 (89) Accomplished less than desired 53 (90) Type of work or other activity limited 53 (90) Difficulty performing 56 (93) Any limitation during past 4 weeks in work or daily activities because of emotional health Decreased time 38 (69) Accomplished less than desired 46 (77) Less careful than usual 33 (55) During the past 4 weeks, experienced severe or very severe Interference with social activities because of health 18 (30) Bodily pain 23 (38) Interference with normal work because of pain 12 (20) data did not support the hypothesis that quality of life in patients with Charcot arthropathy is aggravated by Aboriginal ethnicity or rural residence (Table 3). The mean MCS score for patients with Charcot arthropathy was similar (within 10 points) to previously published scores for patients with type 2 diabetes (52 points) [19], the general Canadian population (52 points) [21], the general United States population (50 points) [18], and patients with unhealed diabetic foot ulcers (50 points) [22]. Therefore, the mental component of the SF-36 was not sensitive to the presence of Charcot arthropathy, and recently developed disease-specific surveys may provide a more realistic quantitative measure of the negative emotional effects of the morbidity associated with Charcot arthropathy as demonstrated with diabetic foot ulcers and peripheral neuropathy [23 26]. Limitations of the study include the small sample size, which precluded comparative evaluation of potentially important variables such as treatment methods for Charcot arthropathy [1] and presence of other comorbidities such as kidney and eye disease. The SF-36 survey, which is a general health survey, has previously been shown to be sensitive to the development of diabetic renal and neuropathic complications [27], increased symptom severity in diabetes [28], and the number of complications in type 2 diabetic patients treated with insulin [29]. However, the SF-36 may be less sensitive than disease-specific questionnaires [23 26,29] and less able than diabetes-specific health surveys to screen out differences due to non-diabetic comorbidities [30]. Furthermore, a follow-up survey may be useful in determining responsiveness to treatment [31] such as reconstruction of deformity [32]. Acknowledgements The authors are grateful to Brent Diekmann for technical assistance. This study was generously supported by a grant from the Manitoba Orthopaedic Foundation. References [1] Trepman E, Nihal A, Pinzur MS. Charcot neuroarthropathy of the foot and ankle. Foot Ankle Int 2005;26: [2] Willrich A, Pinzur M, McNeil M, Juknelis D, Lavery L. Health related quality of life, cognitive function, and depression in diabetic patients with foot ulcer or amputation. A preliminary study. Foot Ankle Int 2005;26: [3] Pinzur MS, Evans A. Health-related quality of life in patients with Charcot foot. Am J Orthop 2003;32: [4] Dhawan V, Spratt KF, Pinzur MS, Baumhauer J, Rudicel S, Saltzman CL. Reliability of AOFAS diabetic foot questionnaire in Charcot arthropathy: stability, internal consistency, and measurable difference. Foot Ankle Int 2005;26: [5] Nelson RG, Gohdes DM, Everhart JE, Hartner JA, Zwemer FL, Pettitt DJ, Knowler WC. Lower-extremity amputations in NIDDM. 12-yr follow-up study in Pima Indians. Diab Care 1988;11:8 16. [6] Most RS, Sinnock P. The epidemiology of lower extremity amputations in diabetic individuals. Diab Care 1983;6: [7] Lee JS, Lu M, Lee VS, Russell D, Bahr C, Lee ET. Lower-extremity amputation. Incidence, risk factors, and mortality in the Okahoma Indian Diabetes Study. Diabetes 1993;42: [8] Statistics Canada, Census of Population, May 15, accessed May 22, [9] Green C, Blanchard JF, Young TK, Griffith J. The epidemiology of diabetes in the Manitoba-registered First Nation population. Diab Care 2003;26: [10] Blanchard JF. Manitoba Health, unpublished data. [11] Katz SJ, Zemencuk JK, Hofer TP. Breast cancer screening in the United States and Canada, 1994: socioeconomic gradients persist. Am J Public Health 2000;90: [12] Badgley RF. Social and economic disparities under Canadian health care. Int J Health Serv 1991;21: [13] Newbold KB. Problems in search of solutions: health and Canadian aboriginals. J Commun Health 1998;23: [14] Veugelers PJ, Yip AM. Socioeconomic disparities in health care use: Does universal coverage reduce inequalities in health? J Epidemiol Commun Health 2003;57: [15] Kapral MK, Wang H, Mamdani M, Tu JV. Effect of socioeconomic status on treatment and mortality after stroke. Stroke 2002;33: [16] Eichenholtz SN. Charcot joints. Springfield, IL: Charles C. Thomas; [17] Brodsky JW. The diabetic foot. In: Coughlin MJ, Mann RA, editors. Surgery of the foot and ankle. 7th ed., St. Louis: Mosby; p [18] Ware JE, Kosinski M, Keller SD. SF-12: How to score the SF-12 Physical and Mental Health Summary Scales, 3rd ed., Lincoln, RI: QualityMetric Inc.; 1998.

5 M.P. Sochocki et al. / Foot and Ankle Surgery 14 (2008) [19] Ware JE, Snow KK, Kosinski M, Gandek B. SF-36 health survey: manual and interpretation guide. Boston, MA: The Health Institute; 1993 [second printing, 1997]. [20] Sloan JA, Cella D, Frost MH, Guyatt G, Osoba D. Quality of life III: translating the science of quality-of-life assessment into clinical practice an example-driven approach for practicing clinicians and clinical researchers. Clin Ther 2003;25(suppl. D):D1 5. [21] Hopman WM, et al. Canadian normative data for the SF-36 health survey. CMAJ 2000;163: [22] Goodridge D, Trepman E, Sloan J, Guse L, Strain LA, McIntyre J, Embil JM. Quality of life of adults with unhealed and healed diabetic foot ulcers. Foot Ankle Int 2006;27: [23] Goodridge D, Trepman E, Embil JM. Health-related quality of life in diabetic patients with foot ulcers. J Wound Ostomy Cont Nurs 2005;32: [24] Vileikyte L, Peyrot M, Bundy C, Rubin RR, Leventhal H, Mora P, Shaw JE, Baker P, Boulton AJM. The development and validation of a neuropathy- and foot ulcer-specific quality of life instrument. Diab Care 2003;26: [25] Abetz L, Sutton M, Brady L, McNulty P, Gagnon DD. The Diabetic Foot Ulcer Scale (DFS): a quality of life instrument for use in clinical trials. Pract Diab Int 2002;19: [26] Bann CM, Fehnel SE, Gagnon DD. Development and validation of the Diabetic Foot Ulcer Scale-Short Form (DFS-SF). Pharmacoeconomics 2003;21: [27] Ahroni JH, Boyko EJ. Responsiveness of the SF-36 among veterans with diabetes mellitus. J Diab Complic 2000;14:31 9. [28] Gulliford MC, Mahabir D. Relationship of health-related quality of life to symptom severity in diabetes mellitus: a study in Trinidad and Tobago. J Clin Epidemiol 1999;52: [29] Anderson RM, Fitzgerald JT, Wisdom K, Davis WK, Hiss RG. A comparison of global versus disease-specific quality-of-life measures in patients with NIDDM. Diab Care 1997;20: [30] Woodcock AJ, Julious SA, Kinmonth AL, Campbell MJ. Diabetes Care From Diagnosis Group. Problems with the performance of the SF-36 among people with type 2 diabetes in general practice. Qual Life Res 2001;10: [31] Garratt AM, Ruta DA, Abdalla MI, Russell IT. SF 36 health survey questionnaire: II. Responsiveness to changes in health status in four common clinical conditions. Qual Health Care 1994;3: [32] Schon LC. Chronic midfoot Charcot rocker-bottom reconstruction. In: Nunley JA, Pfeffer GB, Sanders RW, Trepman E, editors. Advanced Reconstruction Foot and Ankle. Rosemont, IL: American Academy of Orthopaedic Surgeons; p

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