Professional Documents
Culture Documents
Pinto Carral2018
Pinto Carral2018
2 82
3 83
4 84
5 85
PM R XXX (2018) 1-12
6 www.pmrjournal.org 86
7 87
8 Original Research 88
9 89
10 90
11
12
Validity, Reliability, and Responsiveness of the Spanish Version of 91
92
13
14
the OPTIMAL Instrument 93
94
15 95
16 96
17 Q4 Arrate Pinto-Carral, PhD, Tania Fernández-Villa, PhD, Andrew A. Guccione, PhD, 97
18 a 98
19 Federico Montero Cuadrado, PhD, José M Cancela, PhD, Antonio José Molina, PhD 99
20 100
21 101
22 102
23 103
24 104
25 Abstract 105
26 106
27 Background: The Outpatient Physical Therapy Improvement in Movement Assessment Log (OPTIMAL) is a self-report instrument 107
28 108
29
developed to measure the ability to perform mobility actions. 109
30 Objective: To validate a Spanish version of the OPTIMAL instrument. 110
31 Design: Cross-cultural adaptation and validation study. 111
32 112
Setting: Primary and specialized outpatient care settings.
33 113
34 Participants: Three hundred seven patients beginning physical therapy treatment and 30 subjects from the general population. 114
35 Methods: A 2-part study was designed based on guidelines for cultural adaptation of patient-reported outcome measures. 115
36 Outcomes: Reliability was estimated by internal consistency (Cronbach a), SE of measurement, and test-retest reliability 116
37 117
38 (intraclass correlation coefficient) at 2 weeks. Confirmatory factor analysis was performed to examine structural validity. The 118
39 association with the Physical Functioning Subscale was assessed with Spearman correlation coefficients. OPTIMAL scores across 119
40 different groups were compared with Mann-Whitney U and Kruskal-Wallis tests. Effect size, standardized response mean, and 120
41 121
42
minimal detectable change were determined for responsiveness. 122
43 Results: The Spanish version of the OPTIMAL instrument showed a similar structure to the original English questionnaire. Cronbach 123
44 a was 0.95 for the difficulty and confidence scales. Intraclass correlation coefficient was 0.91 (95% CI 0.87-0.94) for the difficulty 124
45 scale and 0.90 (95% CI 0.85-0.93) for the confidence scale. The SE of measurement was 5.11 for the difficulty scale and 6.54 for the 125
46 126
47 confidence scale. The association with the Physical Functioning Subscale was strong and significant (P < .001). The 2 scales 127
48 showed significantly different scores for each of the established patient groups. The effect size was 0.61 (95% CI 0.48-0.74) for the 128
49 difficulty scale and 0.53 (95% CI 0.38-0.69) for the confidence scale. The standardized response mean was 0.97 (95% CI 0.78-1.13) 129
50 130
51
for the difficulty scale and 0.76 (95% CI 0.48-1.01) for the confidence scale. The minimal detectable change, of a possible score of 131
52 100, was 14.2 for the difficulty scale and 18.1 for the confidence scale. 132
53 Conclusion: The Spanish version of the OPTIMAL has appropriate reliability, validity, and responsiveness and it is an adequate self- 133
54 134
report instrument for the assessment of mobility actions.
55 135
56 Level of Evidence: III 136
57 137
58 138
59 139
60 140
61 141
62 Introduction mobility. Cronbach a coefficients were 0.85-0.95 in 142
63 143
64 these subscales [1]. Each scale consists of 22 items 144
65 The Outpatient Physical Therapy Improvement in related to the mobility domain within the activities and 145
66 146
67
Movement Assessment Log (OPTIMAL) is a self-report participation component of the International Classifi- 147
68 instrument developed to measure the ability to cation of Functioning, Disability and Health [2]. Two 148
69 perform mobility actions in the adult physical therapy more questions ask the patient to indicate which 3 ac- 149
70 150
71 population [1]. It consists of 2 scales, difficulty and tivities the patient would like to be able to do without 151
72 confidence, that respectively assess difficulty and con- any difficulty and to mark which of those 3 the patient 152
73 153
74 fidence in performing movements. The original study of considers the most important. These 2 questions allow 154
75 the OPTIMAL identified 3 factors in the 2 scales: trunk the formulation of patient-centered functional goals as 155
76 156
77
mobility, lower extremity mobility, and upper extremity currently demanded in rehabilitation [3-6]. 157
78 158
79 1934-1482/$ - see front matter ª 2018 by the American Academy of Physical Medicine and Rehabilitation 159
80 https://doi.org/10.1016/j.pmrj.2018.05.021 160
321 cognitive methodology that combined the think- be converted to a percentage, which allows for com- 401
322 402
323 aloud technique with the semistructured interview. parisons across subjects [37]. Scores approaching 403
324 Review of cognitive debriefing results and finaliza- 0 represent good mobility and scores approaching 100 404
325 405
326
tion. The results of the pilot test were pooled with indicate poor mobility (greater physical disability). 406
327 those of the translation group and the main author of 407
328 the original version of the questionnaire. 408
329
Data Collection 409
330 Proofreading. With the resolution of any doubts and For data collection, a physiotherapy coordinator was 410
331 conflicts detected during the pilot test, the final appointed at each of the 7 participating centers. All 411
332 412
333
questionnaire was drafted. patients completed the data collection form on at least 413
334 Final report. 1 occasion during their first or second physical therapy 414
335 415
336 session. For test-retest reliability, in addition to the 30 416
337 individuals from the general population, a subsample of 417
338 Phase 2: Psychometric Testing 418
339
patients completed the questionnaires on 2 occasions 419
340 separated by a 1-week interval. The 2 data collections 420
341 After adapting the instrument, its measurement were conducted by the same physical therapist and 421
342 422
343
properties were analyzed according to the Consensus- under the same conditions. Subjects did not undergo 423
344 based Standards for the Selection of Health Measure- any treatment between the 2 measurements. A 424
345 ment Instruments checklist [33] and the criteria of the 425
346
different subsample of patients participated in data 426
347 Scientific Advisory Committee of the Medical Outcomes collection for responsiveness analyses. The baseline 427
348 Trust [34,35]. measurement was taken at the first or second physical 428
349 429
350 therapy session and the final measurement was taken 430
351 Subjects after 4 weeks or at discharge (if sooner than 4 weeks) 431
352 Three hundred twenty-two patients who were 432
353
from physical therapy into the clinical setting. This 433
354 beginning physical therapy at 7 public rehabilitation 4-week period was used in accordance with the results 434
355 centers in the northwestern region of Spain were invited cited in the original validation of the English version [1]. 435
356 436
357
to participate in the study. One was a specialized care 437
358 center and the others were primary care centers. As Analyses 438
359 inclusion criteria, individuals had to be outpatients 439
360 Patients’ diagnoses were classified according to 4 440
361 older than 18 years and able to read Spanish. A conve- groups: upper limb, lower limb, trunk and spine, and 441
362 nience sample of 30 individuals from the general pop- 442
363 general (cardiopulmonary, neurologic, or systemic con- 443
364 ulation was used for the analysis of test-retest reliability ditions). The scales and subscales of the OPTIMAL 444
365 and known-groups validity. questionnaire were scored up to value of 100, with 445
366 446
367 higher scores indicating greater disability, according to 447
368 Instruments the following formula [37]: 448
369 After providing written informed consent, each 449
370 450
371 participant completed some sociodemographic and ftotal score total number of items scoredg 100 451
372 health questions, the Spanish version of the Physical 452
373 ftotal possible score total number of items scoredg 453
374
Functioning Subscale (PF-10) [36], and the Spanish- 454
375 adapted version of the OPTIMAL instrument. 455
376 The PF-10 scale contains 10 items and offers 3 The Shapiro-Wilk test and quantiles of normal distri- 456
377 457
378 response options for each item. It is scored from 0 to bution plots were applied to examine the normality of 458
379 100, with a higher score indicating higher functionality. OPTIMAL and PF-10 scores [38]. Mean SD and median 459
380 460
381
The Spanish version of this scale yielded an intraclass and first and third quartiles were calculated for each 461
382 correlation coefficient of 0.83 and a Cronbach a coef- measure. Missing data and those recorded as “not 462
383 ficient of 0.84 in the study by Alonso et al [36]. applicable” were scored as 0 and were weighted in 463
384 464
385 The OPTIMAL instrument, as described in the Intro- accordance with the formula used to score the OPTIMAL 465
386 duction, includes 2 scales, difficulty and confidence, instrument. 466
387 467
388 each of which contains 22 items. The response options To determine the structural validity, a confirmatory 468
389 of the items include 5-point Likert scales plus a “not factor analysis was carried out for the difficulty scale 469
390 470
391
applicable” option. The total score for each scale can and for the confidence scale. The starting model was 471
392 be calculated by summing all applicable responses, with the one proposed in the original validation of the English 472
393 a result of 22-110 when the respondent completes all version [1]. Given the ordinal nature of the data and the 473
394 474
395 items. If 1 activity included in the OPTIMAL is marked lack of normal distribution of the items, we used the 475
396 “not applicable,” then it is completely deleted from the robust weighted least squares mean and variance- 476
397 477
398
total score and the maximum possible score is lower. adjusted estimation [39]. The root mean square error 478
399 However, this total score can be expressed as a pro- of approximation (RMSEA) and its CI of 90%, comparative 479
400 portion based on the number of answered items that can fit index (CFI), and Tucker-Lewis index (TLI) were 480
961 1041
962 1042
963 1043
964 1044
965 1045
966 1046
967 1047
968 1048
969 1049
970 1050
971 1051
972 1052
973 1053
974 1054
975 1055
976 1056
977 1057
978 1058
979 1059
980 1060
981 1061
982 1062
983 1063
984 1064
985 1065
986 1066
987 1067
988 1068
989 1069
990 1070
991 1071
992 1072
993 1073
994 1074
995 1075
996 1076
997 1077
998 1078
999 1079
1000 1080
1001 1081
1002 1082
1003 1083
1004 1084
1005 1085
1006 1086
1007 1087
1008 1088
1009 1089
1010 1090
1011 1091
1012 1092
1013 1093
1014 1094
1015 1095
1016 1096
1017 1097
1018 1098
1019 Figure 2. Results of confirmatory factor analysis for the difficulty scale. Covariates between items 5-8 and items 14-15 were found. OPTIMAL ¼ 1099
1020 Outpatient Physical Therapy Improvement in Movement Assessment Log. 1100
1021 1101
1022 1102
1023 1103
1024 1104
1025 Known-Groups Validity patients plus the 30 individuals from the general popu- 1105
1026 As expected, the general population group obtained lation), of which 38.1% were men and 61.9% were 1106
1027 1107
1028 significantly lower results on the OPTIMAL instrument women with a mean age SD of 47.5 11.3 years. 1108
1029 than the patient group (P < .001; Table 3). Patients with However, 3 subjects had missing data on the confidence 1109
1030 1110
1031
chronic health problems and those with mobility prob- scale at retest. Table 6 presents internal consistency, 1111
1032 lems during the past week obtained higher scores than test-retest reliability, and SE of measurement values. 1112
1033 the other groups, with significant differences for these 2 1113
1034 1114
1035 groups (P < .001; Table 5). Responsiveness 1115
1036 In the analysis of responsiveness, a subsample of 92 1116
1037 1117
1038
Reliability patients consisted of 33.7% men and 66.3% women with 1118
1039 In the analysis of test-retest reliability, the data from a mean age SD of 55.7 15.4 years. The mean time 1119
1040 84 individuals were analyzed (a subsample of 54 between the 2 data collections was 27.6 1.7 days. 1120
1121 1201
1122 1202
1123 1203
1124 1204
1125 1205
1126 1206
1127 1207
1128 1208
1129 1209
1130 1210
1131 1211
1132 1212
1133 1213
1134 1214
1135 1215
1136 1216
1137 1217
1138 1218
1139 1219
1140 1220
1141 1221
1142 1222
1143 1223
1144 1224
1145 1225
1146 1226
1147 1227
1148 1228
1149 1229
1150 1230
1151 1231
1152 1232
1153 1233
1154 1234
1155 1235
1156 1236
1157 1237
1158 1238
1159 1239
1160 1240
1161 1241
1162 1242
1163 1243
1164 1244
1165 1245
1166 1246
1167 1247
1168 1248
1169 1249
1170 1250
1171 1251
1172 1252
1173 1253
1174 1254
1175 1255
1176 1256
1177 1257
1178 1258
1179 Figure 3. Results of confirmatory factor analysis for the confidence scale. Covariates between items 5-8, 14-15, and 21-22 were found. OPTIMAL ¼ 1259
1180 1260
Outpatient Physical Therapy Improvement in Movement Assessment Log.
1181 1261
1182 1262
1183 Data were missing from 3 subjects at follow-up. The improvement of 15.9 points in the total raw would be 1263
1184 1264
1185 differences between baseline and 4-week follow-up necessary to determine a real change in mobility. The 1265
1186 scores were significant (P < .001) for the OPTIMAL and proportion of MDC was 37% in the difficulty scale and 1266
1187 1267
1188
the PF-10 (Table 7). The ES was 0.61 (95% CI 0.48-0.74) 32.6% in the confidence scale. The correlation between 1268
1189 for the OPTIMAL difficulty scale and 0.53 (95% CI 0.38- the change measured for the OPTIMAL instrument and 1269
1190 0.69) for the OPTIMAL confidence scale. The standard- that measured with the PF-10 was 0.78 for difficulty 1270
1191 1271
1192 ized response mean was 0.97 (95% CI 0.78-1.13) for the and 0.64 for confidence (P < .001). 1272
1193 difficulty scale and 0.76 (95% CI 0.48-1.01) for the con- 1273
1194 1274
1195 fidence scale. The MDC for the difficulty scale was 14.2 Discussion 1275
1196 of 100, indicating an improvement of 12.5 points in the 1276
1197 1277
1198
total raw score of the scale (22-110) would be necessary The OPTIMAL instrument measures the difficulty and 1278
1199 to determine a real change in mobility. For the confi- confidence in performing movements. According to 1279
1200 dence scale, the MDC was 18.1 of 100, indicating an Riddle et al [26], the 2 scales overlap with each other, 1280
1441 Table 6 increases [62]. In our study, we also calculated the MDC, 1521
1442 Reliability of the Spanish version of the OPTIMAL instrument (n ¼ 84) 1522
1443 a datum that had not been calculated in previous 1523
1444 Cronbach a ICC (95% CI) SEM studies regarding the OPTIMAL questionnaire and that is 1524
1445 1525
1446 OPTIMAL difficulty of great interest in physical therapy [46]. 1526
1447 Total 0.95 0.91 (0.87-0.94) 5.11 1527
1448 Trunk subscale 0.89 0.83 (0.76-0.89) Limitations 1528
1449 Lower extremity 0.95 0.92 (0,88-0.95) 1529
1450 subscale 1530
1451 The main limitation of our study is the lower 1531
1452
Upper extremity 0.91 0.87 (0.80-0.91) 1532
1453 subscale adjustment obtained in most analyses for the confi- 1533
1454 OPTIMAL confidence dence scale. To calculate convergent validity and 1534
1455 Total 0.95 0.90 (0.85-0.93) 6.54 1535
1456
external responsiveness, the PF-10 was used in our study 1536
Trunk subscale 0.91 0.83 (0.74-0.88)
1457
Lower extremity 0.94 0.91 (0.88-0.94)
for the comparison of the difficulty scale and the con- 1537
1458 fidence scale. This instrument was chosen because it 1538
1459 subscale 1539
1460 Upper extremity 0.94 0.89 (0.83-0.93) had been used as a comparison instrument to determine 1540
1461 subscale the convergent validity of several instruments [63,64], 1541
1462 1542
1463 OPTIMAL ¼ Outpatient Physical Therapy Improvement in Movement including the English version of the OPTIMAL [1]. It 1543
1464 Assessment Log; ICC ¼ intraclass correlation coefficient; SEM ¼ SE of would have been interesting to use another instrument 1544
1465 measurement. to specifically measure the construct of confidence or 1545
1466 1546
1467 self-efficacy. Another limitation is the fact that no 1547
1468 pain. This could explain in part why the dimension of external criteria were used on the improvement (or not) 1548
1469 1549
1470 trunk mobility has a greater weight in the confidence of the patients; therefore, the clinically meaningful 1550
1471 scale. change was not determined [62]. Future studies should 1551
1472 consider these 2 aspects with regard to the OPTIMAL 1552
1473
In our study, the estimated reliability was appro- 1553
1474 priate for the difficulty and confidence scales, given instrument. 1554
1475 reliability coefficients of at least 0.90 [43], similar to 1555
1476 1556
1477 those from Vanti et al [28] in the Italian version of the Conclusion 1557
1478 OPTIMAL. 1558
1479 1559
1480
The Spanish adaptation of the OPTIMAL instrument is This study of cultural adaptation and psychometric 1560
1481 sensitive to change over time, but with a moderate ES validation indicates that the Spanish version of the 1561
1482 (<0.80). However, this ES is larger than the one cited in OPTIMAL instrument has a functional equivalence with 1562
1483 1563
1484 the original validation of the English version [1]. Diverse its original English version and that it is a reliable, valid, 1564
1485 studies have granted more responsiveness to specific and responsive instrument for the assessment of 1565
1486 1566
1487 instruments compared with generic ones [57,58], mobility. 1567
1488 whereas others [59-61] have suggested that the 2 in- 1568
1489 1569
1490
strument types can measure change over time in a Acknowledgments 1570
1491 similar manner. Furthermore, it is necessary to take into 1571
1492 account that ES is a statistic that depends on the SD of We greatly appreciate the work done by the physio- 1572
1493 1573
1494 the sample and, hence, that ES decreases as SD therapists who collaborated in this study. The 1574
1495 1575
1496 1576
1497 Table 7 1577
1498 Responsiveness of the Spanish version of the OPTIMAL instrument (n ¼ 92) 1578
1499 1579
1500
Change scores 1580
1501 Mean SD Median (IQR) P value* ES (95% CI) SRM (95% CI) MDC† 1581
1502 1582
1503 OPTIMAL difficulty 1583
1504 Total 13.7 14.1 10.2 (5.1-18.8) <.001 0.61 (0.48-0.74) 0.97 (0.78-1.13) 14.2 1584
1505 Trunk subscale 10.0 16.6 6.26 (0-18.75) <.001 1585
1506 1586
Lower extremity subscale 14.1 14.9 9.4 (4.2-24.8) <.001
1507 1587
1508 Upper extremity subscale 16.1 19.3 12.5 (0-25) <.001 1588
1509 OPTIMAL confidence 1589
1510 Total 13.1 17.3 12.5 (2.3-21.2) <.001 0.53 (0.38-0.69) 0.76 (0.48-1.01) 18.1 1590
1511 Trunk subscale 13.6 20.6 8.3 (0-25) <.001 1591
1512 Lower extremity subscale 16.6 19.6 11.1 (1.4-22.2) <.001 1592
1513 1593
1514
Upper extremity subscale 14.6 23.3 8.3 (0-33.3) <.001 1594
1515 PF-10 20.3 22.0 15 (0-35) <.001 1595
1516 1596
OPTIMAL ¼ Outpatient Physical Therapy Improvement in Movement Assessment Log; ES ¼ effect size; SRM ¼ standardized response mean; MDC ¼
1517 1597
1518 minimal detectable change; IQR ¼ interquartile range; PF-10 ¼ Physical Functioning Subscale. 1598
1519 * By Wilcoxon signed rank test. 1599
†
1520 Score 0-100. 1600
1601 Outpatient Physical Therapy Improvement in Movement 15. Alghwiri AA, Whitney SL, Baker CE, et al. The development and 1681
1602 validation of the vestibular activities and participation measure. 1682
1603 Assessment Log is copyrighted by the American Physical 1683
Arch Phys Med Rehabil 2012;93:1822-1831.
1604 Therapy Association and used with permission. The 16. Bandura A. Self-efficacy mechanism in human agency. Am Psychol
1684
1605 1685
1606
sublicense to use the Physical Functioning Subscale was 1982;37:122-147. 1686
1607 obtained from QualityMetric through Bibliopro. This 17. Schwarzer R, Jerusalem M. Generalized Self-Efficacy Scale. In: 1687
1608 study was funded in part by the Professional College of Johnston M, Weinman J, Wright SC, eds. Measures in Health Psy- 1688
1609 chology: A User’s Portfolio. Causal and Control Beliefs. Windsor, 1689
1610 Physiotherapists of Castilla y León, Spain (research aid 1690
UK: NFER-NELSON; 1995; 35-37.
1611 number INV2014-1). 1691
1612 18. Sherer M, Maddux JE, Mercandante B, Prentice-Dunn S, Jacobs B, 1692
1613 Rogers RW. The Self-Efficacy Scale: Construction and validation. 1693
1614 Psychol Rep 1982;51:663-671. 1694
1615 Supplementary Data 19. Lorig K, Chastain RL, Ung E, Shoor S, Holman HR. Development and 1695
1616 evaluation of a scale to measure perceived self-efficacy in people 1696
1617 1697
1618 Supplementary data associated with this article can with arthritis. Arthritis Rheum 1989;32:37-44. 1698
1619 20. Tannenbaum C, Brouillette J, Korner-Bitensky N, et al. Creation 1699
be found in the online version at https://doi.org/
1620 and testing of the Geriatric Self-Efficacy Index for Urinary Incon- 1700
1621 10.1016/j.pmrj.2018.05.021. tinence. J Am Geriatr Soc 2008;56:542-547. 1701
1622 21. Gage M, Noh S, Polatajko HJ, Kaspar V. Measuring perceived self- 1702
1623 1703
efficacy in occupational therapy. Am J Occup Ther 1994;48:
1624 1704
1625
References 783-790. 1705
1626 22. Resnick B, Jenkins LS. Testing the reliability and validity of the 1706
1627 1. Guccione AA, Mielenz TJ, De Vellis RF, et al. Development and Self-Efficacy for Exercise Scale. Nurs Res 2000;49:154-159. 1707
1628 testing of a self-report instrument to measure actions: Outpatient 23. Williams RM, Myers AM. Functional Abilities Confidence Scale: A 1708
1629 clinical measure for injured workers with acute low back pain. 1709
1630
Physical Therapy Improvement in Movement Assessment Log 1710
(OPTIMAL). Phys Ther 2005;85:515-530. Phys Ther 1998;78:624-634.
1631 1711
1632 2. World Health Organization. International Classification of Func- 24. Kyte DG, Calvert M, van der Wees PJ, Ten Hove R, Tolan S, Hill JC. 1712
1633 tioning, Disability and Health (ICF). Geneva: World Health Orga- An introduction to patient-reported outcome measures (PROMs) in 1713
1634 nization; 2001. physiotherapy. Physiotherapy 2015;101:119-125. 1714
1635 25. Deshpande PR, Rajan S, Sudeepthi BL, Abdul Nazir CP. Patient- 1715
3. Randall KE, McEwen IR. Writing patient-centered functional goals.
1636 reported outcomes: A new era in clinical research. Perspect Clin 1716
1637 Phys Ther 2000;80:1197-1203. 1717
1638 4. Leach E, Cornwell P, Fleming J, Haines T. Patient centered goal- Res 2011;2:137-144. 1718
1639 setting in a subacute rehabilitation setting. Disabil Rehabil 2010; 26. Riddle DL, Stratford PW, Carter TL, Cleland JA. Psychometric 1719
1640 32:159-172. properties of the Outpatient Physical Therapy Improvement in 1720
1641 5. Gardner T, Refshauge K, McAuley J, Goodall S, Huebsher M, Movement Assessment Log (OPTIMAL) in patients with musculo- 1721
1642 skeletal disorders: A replication study with additional findings. 1722
Smith L. Patient led goal setting: A pilot study investigating a
1643 1723
promising approach for the management of chronic low back pain. Phys Ther 2013;93:672-680.
1644 1724
1645 Spine (Phila Pa 1976) 2016;41:1405-1413. 27. Elston B, Goldstein M, Makambi KH. Item response theory analysis 1725
1646 6. Friedly J, Akuthota V, Amtmann D, Patrick D. Why disability and of the Outpatient Physical Therapy Improvement in Movement 1726
1647 rehabilitation specialists should lead the way in patient-reported Assessment Log (OPTIMAL). Phys Ther 2013;93:661-671. 1727
1648 outcomes. Arch Phys Med Rehabil 2014;95:1419-1422. 28. Vanti C, Villafañe JH, Branchini M, et al. The Italian version of the 1728
1649 Outpatient Physical Therapy Improvement in Movement Assess- 1729
1650
7. Stratford P. Assessing disability and change on individual patients: 1730
A report of a patient specific measure. Physiother Can 1995;47: ment Log: Cross-cultural adaptation and psychometric properties.
1651 1731
1652 258-263. Int J Rehabil Res 2017;41:28-34. 1732
1653 8. Ruta DA, Garratt AM, Leng M, Russell IT, MacDonald LM. A new 29. Guillemin F, Bombardier C, Beaton D. Cross-cultural adaptation of 1733
1654 approach to the measurement of quality of life: The Patient- health-related quality of life measures: Literature review and 1734
1655 proposed guidelines. J Clin Epidemiol 1993;46:1417-1432. 1735
Generated Index. Med Care 1994;32:1109-1126.
1656 1736
9. Kopec JA, Esdaile JM, Abrahamowicz M, et al. The Quebec Back 30. Beaton DE, Bombardier C, Guillemin F, Ferraz MB. Guidelines for
1657 1737
1658 Pain Disability Scale: Conceptualization and development. J Clin the process of cross-cultural adaptation. Spine 2000;25:3186- 1738
1659 Epidemiol 1996;49:151-161. 3191. 1739
1660 10. Binkley JM, Stratford PW, Lott SA, Riddle DL. The Lower Extremity 31. Wild D, Grove A, Martin M, et al. Principles of good practice for 1740
1661 Functional Scale (LEFS): Scale development, measurement prop- the translation and cultural adaptation process for patient- 1741
1662 reported outcomes (PRO) measures: Report of the ISPOR task 1742
erties, and clinical application. Phys Ther 1999;79:371-383.
1663 1743
1664 11. Haley SM, Jette AM, Coster WJ, et al. Late Life Function and force for translation and cultural adaptation. Value Health 2005; 1744
1665 Disability Instrument II: Development and evaluation of the func- 2:94-104. 1745
1666 tion component. J Gerontol A Biol Sci Med Sci 2002;57:M217-M222. 32. Patient Reported Outcomes Measurement Information System 1746
1667 12. Cook KF, Roddey TS, Gartsman GM, Olson SL. Development and (PROMIS) Network. National Institute of Heath EU. PROMIS in- 1747
1668 psychometric evaluation of the Flexilevel Scale of Shoulder strument development and validation scientific standards: Version 1748
1669 1749
Function. Med Care 2003;41:823-835. 2.0 (revised May 2013). Available at: http://www.nihpromis.org/
1670 1750
1671 13. Medina-Mirapeix F, Navarro-Pujalte E, Escolar-Reina P, Montilla- Documents/PROMIS_Standards_050212.pdf. Accessed February 1751
1672 Herrador J, Valera-Garrido F, Collins SM. Mobility Activities Mea- 23, 2015. 1752
1673 surement for outpatient rehabilitation settings. Arch Phys Med 33. Mokkink LB, Terwee CB, Patrick DL, et al. The COSMIN checklist for 1753
1674 Rehabil 2011;92:632-639. assessing the methodological quality of studies on measurement 1754
1675 properties of health status measurement instruments: An inter- 1755
14. Medina-Mirapeix F, Gacto-Sánchez M, Navarro-Pujalte E, Montilla-
1676 1756
1677 Herrador J, Lillo-Navarro C, Escolar-Reina P. Development and national Delphi study. Qual Life Res 2010;19:539-549. 1757
1678 initial psychometric evaluation of the Mobility Activities Measure 34. Lohr KN, Aaronson NK, Alonso J, et al. Evaluating quality-of-life 1758
1679 for Inpatient Rehabilitation Settings (Mobam-in). Arch Phys Med and health status instruments: development of scientific review 1759
1680 Rehabil 2014;95:2367-2375. criteria. Clin Ther 1996;18:979-992. 1760
1761 35. Aaronson N, Alonso J, Burnam A, et al. Assessing health status and 52. Buitenhuis J, de Jong PJ. Fear avoidance and illness beliefs in post- 1846
1762 quality-of-life instruments: Attributes and review criteria. Qual traumatic neck pain. Spine (Phila Pa 1976) 2011;36(suppl): 1847
1763 1848
1764 Life Res 2002;11:193-205. S238-S243. 1849
1765 36. Alonso J, Prieto L, Antó JM. [The Spanish version of the SF-36 53. Andersen TE, Karstoft KI, Brink O, Elklit A. Pain-catastrophizing 1850
1766 Health Survey (the SF-36 health questionnaire): An instrument and fear-avoidance beliefs as mediators between post-traumatic 1851
1767 for measuring clinical results]. Med Clin (Barc) 1995;104:771-776. stress symptoms and pain following whiplash injury: A prospec- 1852
1768 1853
1769 37. American Physical Therapy Association (APTA). OPTIMAL 1.1 Data tive cohort study. Eur J Pain 2016;20:1241-1252. 1854
1770 Collection Instrument. Available at: http://www.apta.org/ 54. Elfving B, Andersson T, Grooten WJ. Low levels of physical activity 1855
1771 optimal/. Accessed May 13, 2015. in back pain patients are associated with high levels of fear- 1856
1772 avoidance beliefs and pain catastrophizing. Physiother Res Int 1857
38. Miller RG Jr. Beyond ANOVA: Basics of Applied Statistics. London:
1773 1858
1774 Chapman & Hall; 1997. 2007;12:14-24. 1859
1775 39. Muthén LK, Muthén BO. Mplus User’s Guide. 7th ed. Los Angeles: 55. Grotle M, Vøllestad NK, Veierød MB, Brox JI. Fear-avoidance be- 1860
1776 Muthén & Muthén; 2012. liefs and distress in relation to disability in acute and chronic low 1861
1777 back pain. Pain 2004;112:343-352. 1862
40. Batista-Foguet JM, Coenders G, Alonso J. Análisis factorial con-
1778 1863
1779 firmatorio: Su utilidad en la validación de cuestionarios relacio- 56. Poiraudeau S, Rannou F, Baron G, et al. Fear-avoidance beliefs 1864
1780 nados con la salud. Med Clin (Barc) 2004;122(suppl 1):21-27. about back pain in patients with subacute low back pain. Pain 1865
1781 41. Kelley K, Lai K. Accuracy in parameter estimation for the root 2006;124:305-311. 1866
1782 57. Bessette L, Sangha O, Kuntz KM, et al. Comparative responsiveness 1867
mean square error of approximation: Sample size planning for
1783 1868
1784 narrow confidence intervals. Multivariate Behav Res 2011;46:1-32. of generic versus disease-specific and weighted versus unweighted 1869
1785 42. Weir JP. Quantifying test-retest reliability using the intraclass health status measures in carpal tunnel syndrome. Med Care 1998; 1870
1786 correlation coefficient and the SEM. J Strength Cond Res 2005;19: 36:491-502. 1871
1787 58. Giesinger K, Hamilton DF, Jost B, Holzner B, Giesinger JM. 1872
231-240.
1788 1873
1789 43. Terwee CB, Bot SD, de Boer MR, et al. Quality criteria were pro- Comparative responsiveness of outcome measures for total knee 1874
1790 posed for measurement properties of health status questionnaires. arthroplasty. Osteoarthritis Cartilage 2014;22:184-189. 1875
1791 J Clin Epidemiol 2007;60:34-42. 59. Walsh TL, Hanscom B, Lurie JD, Weinstein JN. Is a condition- 1876
1792 specific instrument for patients with low back pain/leg symp- 1877
44. Husted JA, Cook RJ, Farewell VT, Gladman DD. Methods for
1793 1878
1794 assessing responsiveness: a critical review and recommendations. toms really necessary? The responsiveness of the Oswestry 1879
1795 J Clin Epidemiol 2000;53:459-468. Disability Index, MODEMS, and the SF-36. Spine (Phila Pa 1976) 1880
1796 45. Cohen J. Statistical Power Analysis for the Behavioral Sciences. 2003;28:607-615. 1881
1797 60. Pan SL, Liang HW, Hou WH, Yeh TS. Responsiveness of SF-36 and 1882
2nd ed. Hillsdale, NJ: Lawrence Erlbaum Associates; 1988.
1798 1883
1799 46. Haley SM, Fragala-Pinkham MA. Interpreting change scores of tests Lower Extremity Functional Scale for assessing outcomes in trau- 1884
1800 and measures used in physical therapy. Phys Ther 2006;86:735-743. matic injuries of lower extremities. Injury 2014;45:1759-1763. 1885
1801 47. Guccione AA, Mielenz TJ. On “Psychometric properties of the 61. Angst F, Verra ML, Lehmann S, Gysi F, Benz T, Aeschlimann A. 1886
1802 Responsiveness of the cervical Northern American Spine Society 1887
Outpatient Physical Therapy Improvement in Movement Assess-
1803 1888
1804 ment Log”. Phys Ther 2013;93:705-707. questionnaire (NASS) and the Short Form 36 (SF-36) in chronic 1889
1805 48. Luszczynska A, Scholz U, Schwarzer R. The general self-efficacy whiplash. Clin Rehabil 2012;26:142-151. 1890
1806 scale: multicultural validation studies. J Psychol 2005;139:439-457. 62. Crosby RD, Kolotkin RL, Williams GR. Defining clinically meaningful 1891
1807 change in health-related quality of life. J Clin Epidemiol 2003;56: 1892
49. Lackner JM, Carosella AM, Feuerstein M. Pain expectancies, pain,
1808 1893
1809 and functional self-efficacy expectancies as determinants of 395-407. 1894
1810 disability in patients with chronic low back disorders. J Consult 63. de Vreede PL, Samson MM, van Meeteren NL, Duursma SA, 1895
1811 Clin Psych 1996;64:212-220. Verhaar HJ. Reliability and validity of the Assessment of Daily 1896
1812 Activity Performance (ADAP) in community-dwelling older women. 1897
50. Costa Lda C, Maher CG, McAuley JH, Hancock MJ, Smeets RJ. Self-
1813 1898
1814 efficacy is more important than fear of movement in mediating the Aging Clin Exp Res 2006;18:325-333. 1899
1815 relationship between pain and disability in chronic low back pain. 64. Roaldsen KS, Halvarsson A, Sarlija B, Franzen E, Ståhle A. Self- 1900
1816 Eur J Pain 2011;15:213-219. reported function and disability in late life: Cross-cultural adap- 1901
1817 tation and validation of the Swedish version of the late-life 1902
51. Woby SR, Urmston M, Watson PJ. Self-efficacy mediates the rela-
1818 1903
1819 tion between pain-related fear and outcome in chronic low back function and disability instrument. Disabil Rehabil 2014;36: 1904
1820 pain patients. Eur J Pain 2007;11:711-718. 813-817. 1905
1821 1906
1822 1907
1823 1908
1824 1909
1825
Disclosure 1910
1826 1911
1827 1912
A.P.-C. SALBIS Research Group, School of Health Science, Universidad de León, F.M.C. Pain Unit, Rı́o Hortega University Hospital, Valladolid, Spain
1828 1913
1829 Av Astorga s/n 24401, Ponferrada, León, Spain. Address correspondence to: Disclosures: none 1914
1830 A.P.-C.; e-mail: apinc@unileon.es 1915
1831 Disclosures: none J.M.C. Galicia Sur Health Research Institute (IIS Galicia Sur), Sergas-UVIGO, 1916
1832 HealthyFit Research Group; Faculty of Education and Sport Sciences, University 1917
1833 T.F.-V. Research Group on Gene-Environment Interactions and Health (GIIGAS), of Vigo, Pontevedra, Spain 1918
1834 Institute of Biomedicine (IBIOMED), Universidad de León, León Spain Disclosures: none 1919
1835 1920
Disclosures: none
1836 1921
1837 A.J.M. Research Group on Gene-Environment Interactions and Health (GIIGAS), 1922
1838 A.A.G. Department of Rehabilitation Science, George Mason University, Fairfax, Institute of Biomedicine (IBIOMED), Universidad de León, León, Spain 1923
1839 VA Disclosures: none 1924
1840 Disclosures: none 1925
1841 Submitted for publication March 20, 2018; accepted May 26, 2018. 1926
1842 1927
1843 1928
1844 1929
1845 1930