Factors that Influence Coping with Chronic Noncancer Pain in European Countries: A Systematic Review of Measuring Instruments

Factors that influence coping with chronic non-cancer pain in European countries. A systematic review of measuring instruments Running Head: Assessment of coping with chronic non-cancer pain Rocío Cáceres-Matos, PhD student1 Eugenia Gil-García, PhD (corresponding author)1 Andrés Cabrera-León, PhD2 Ana María Porcel-Gálvez, PhD1 Sergio Barrientos-Trigo, PhD1 1. Department of Nursing, University of Seville, Spain 2. Andalusian School of Public Health (Escuela Andaluza de Salud Pública), Spain Correspondence author: Eugenia Gil-García Address: C/ Avenzoar 6, 41009, Seville, Spain Tel.: +34 954 555 953 E-mail: [email protected] Category for which the manuscript is being submitted: Systematic Review Funding sources: This research did not receive any specific grant from funding agencies in the public, commercial, or not-for-profit sectors. Conflicts of interest disclosures: None declared Keywords: Chronic pain, instruments, systematic review, validation studies Key Practice Points: The present paper is part of a Doctoral Thesis within the framework of the Inter-University Doctoral Program in Health Sciences of the University of Seville, the University of Jaen, and the Andalusian School of Public Health, registered at the Laboratory of Chronic Non-Cancer Pain Care. The main author benefits from a grant for training university professors (FPU) from the Ministry of Education, Culture and Sports of the Government of Spain. 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 Introduction Chronic pain is characterized as a personal, sensory, and emotional experience, composed of biological, psychological, and socio-cultural processes of more than three months’ duration (International Association for the Study of Pain, 1986). When chronic pain is not associated with an oncologic condition, it is referred to as Chronic Non- Cancer Pain or CNCP (Cunha et al., 2016). Chronic pain is a health condition affecting 1.5 billion people worldwide (Global Industry Analysts, 2011). The estimated prevalence of chronic pain in Europe is 19% of the population (Bushnell et al., 2013). Spain has the lowest prevalence of CNCP, at 17% (Fricker, 2010; Cabrera-León, Rueda & Cantero-Braojos, 2017). The cost of chronic pain in Europe exceeds 300 trillion euros, about 1.5-3% of the Gross Domestic Product (Torralba, Miquel & Darba, 2014). Individuals with CNCP generate adaptive and coping responses different from those of individuals with neurodegenerative diseases or oncological conditions. In these cases, coping is determined by expectations for prognosis, aggressiveness of treatment, and level of dependence (Ferrer-Peña, Gil-Martinez & Pardo-Montero, 2016). Coping is defined as the cognitive and behavioral efforts that individuals make in situations they consider to be stressful (Lazarus & Folkman, 1984). Due to its complexity and subjectivity, coping requires an integrative understanding of the resources influencing it (Carvajal, Centeno, Watson, Martínez & San-Rubiales, 2011; Ferrer-Peña et al., 2016). Coping is influenced by biological, psychological, and sociocultural resources that individuals learn and develop throughout their lives. Research shows that different resources can hinder and/or improve coping. High levels of pain intensity, disability (Ferrer-Peña et al., 2016), stress (Catalano et al., 2011), anxiety/depression (Bushnell et al., 2013), and pain catastrophizing (Tsang et al., 2008) act as resources that hinder adaptation to pain. In contrast, resilience (Catalano et al., 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 2011), self-esteem (Hegarty, 2014), high levels of perceived quality of life (Von Korff, 2011), and social support act as resources that favor coping with CNCP (Cabrera-Leon & Cantero-Braojos, 2017; De Sola, Salazar, Dueñas, Ojeda & Failde, 2016; Norrefalk, 2011). Due to the high prevalence of chronic pain, the limitations that chronic pain creates for people who suffer from it, and the high healthcare costs it causes (Registered Nurses’ Association of Ontario, 2013), many authors and organizations call for a change of perspective and approach (Breivik et al., 2013; Wranker et al., 2014). Thus, the Pain Proposal initiative, endorsed by the European Pain Federation (EFIC), proposed that the assessment be carried out in a comprehensive manner (Torralba, Miquel & Darba, 2014). A few years later, the Registered Nurses’ Association of Ontario stressed the importance for healthcare professionals to be aware of the tools available to assess resources that influence coping (Registered Nurses’ Association of Ontario, 2013). For all of these reasons, the two principal aims of this systematic review were to: (a) identify instruments, developed and tested in Europe, that measure coping with CNCP; and (b) assess the reported psychometric properties of the instruments identified. The literature search attempted to answer the following two research questions: (a) What are the instruments, developed and tested in Europe, that measure coping with CNCP in non-hospitalized adults?; and (b) what are the quality criteria of the instruments assessed on the basis of their psychometric properties? 60 61 62 63 64 65 66 67 68 69 70 71 72 73 74 75 76 77 78 79 80 81 82 83 84 85 86 87 88 89 90 91 92 93 94 95 96 97 98 99 100 101 102 103 104 105 106 107 108 109 110 111 112 113 114 115 116 117 118 Methods Design The systematic review was conducted in accordance with the PRISMA guidelines (Urrutia & Bonfill, 2010) and the Joanna Briggs Institute methodological framework (Aromataris & Munn, 2017). The review protocol was registered in PROSPERO under the registration number CRD42017059693, available at: http://www.crd.york.ac.uk/PROSPERO/display_record.php?ID=CRD42017059693 Literature search strategy The literature search was carried out in four international databases (the Web of Science, CINAHL, PubMed, and Scopus) between January and February 2017. Two reviewers conducted the search independently and discussed their results with a third reviewer. All studies, regardless of the year of publication, were considered in the search. Table 1 shows the terms used. [Table 1] Study selection. Eligibility criteria The studies that met the following inclusion criteria were considered to be eligible for the review: (a) psychometric studies of some of the biological, psychological, and/or socio-cultural resources that influence coping; (b) in adults with CNCP; (c) who are not hospitalized; and (d) developed and tested in a European setting. The exclusion criteria were the following: (a) validated studies in adult patients with CNCP with co-occurring neurodegenerative diseases; (b) chronic infectious diseases, or (c) cognitive impairment. 119 120 121 122 123 124 125 126 127 128 129 130 131 132 133 134 135 136 137 138 139 140 141 142 143 144 145 146 147 148 149 150 151 152 153 154 155 156 157 158 159 160 161 162 163 164 165 166 167 168 169 170 171 172 173 174 175 176 177 The titles and abstracts of all of the identified studies were reviewed. Duplicate citations, articles that did not meet each of the inclusion criteria, as well as articles the full texts of which were not available to the authors were eliminated. The full-text articles were then read and, finally, the studies that met all the inclusion criteria and that had been published in a European context were included. Any discrepancies among the reviewers were resolved by team consensus. Data collection A double-entry table was designed with the following sections: instrument name, version and year, sample, content, criterion validity, reliability, construct validity. Two reviewers conducted the data collection independently and discussed their results with a third reviewer. Assessment of psychometric properties The psychometric properties of the validation studies included were analyzed using the COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) checklist. Each of the included studies was assessed for internal consistency, reliability, measurement error, validity, and responsiveness (Terwee, 2011): Internal consistency is defined as the degree of interrelation between items; reliability is understood as the proportion of total variance in measurements that is between patients; and measurement error is the systematic and random error of patient scores. To measure validity, we took into account content validity, construct validity, and criterion validity. Content validity is the degree to which an instrument reflects the 178 179 180 181 182 183 184 185 186 187 188 189 190 191 192 193 194 195 196 197 198 199 200 201 202 203 204 205 206 207 208 209 210 211 212 213 214 215 216 217 218 219 220 221 222 223 224 225 226 227 228 229 230 231 232 233 234 235 236 theoretical construct that it is supposed to measure; construct validity measures the characteristic to be assessed, and criterion validity measures the degree to which the scores of an instrument reflect the “gold standard.” Finally, responsiveness, which is defined as the ability of an instrument to detect changes over time in the construct to be measured, was also assessed. A standard template was drawn up to collect the scores obtained by the instruments for each of the psychometric properties analyzed. Each psychometric property was assigned the lowest score attained: “Excellent” (+++), “Good” (++), “Fair” (+), or “Poor” (0) (Mokkink et al., 2012). This process was independently carried out by two reviewers, who discussed their results with a third reviewer. Risk of bias In systematic reviews, it is necessary to analyze risk of bias due to the heterogeneous results obtained on some occasions (Whiting, Rutjes, Reitsma, Bossuyt & Kleijnen, 2003). The QUADAS-2 tool assesses both risk of bias and applicability: (a) systematic flaws or limitations in the design or conduct of a study which distort the results; and (b) the extent to which primary studies are applicable to the research question of the review (Whiting et al., 2011). This tool analyzes four domains (Ciapponi, 2015): 1. Definition of the review question: evaluation of the authors’ descriptions of the diagnostic test, the reference test, and the illness or situation under study. 2. Tailoring of the tool: evaluation of the instrument’s adaptation to the study that is being carried out. 237 238 239 240 241 242 243 244 245 246 247 248 249 250 251 252 253 254 255 256 257 258 259 260 261 262 263 264 265 266 267 268 269 270 271 272 273 274 275 276 277 278 279 280 281 282 283 284 285 286 287 288 289 290 291 292 293 294 295 3. Revision of the flow diagram published for the primary study: revision of the flow diagram of each primary study to determine the method used for including patients. 4. Judgment of bias and applicability of the first three domains: assessing the risk of bias and applicability of the study by addressing four areas: patient selection, interpretation of the test under study, use of gold standard, and patient flow and timing. Each study is assigned the lowest score obtained for each domain (“low,” “high” and “unclear”). If a study is judged as “low” on all domains relating to bias or applicability, the overall study is considered to have a “low risk of bias.” If judgments are “high” or “unclear,” the study is considered to be “at risk of bias” or as having “concerns regarding applicability,” respectively. Risk of bias was assessed by two reviewers independently. Results Study selection Titles and abstracts from 9,850 studies were reviewed and duplicate citations and studies that met the exclusion criteria were eliminated. One-hundred-and-six full-text articles were read, which eventually resulted in 36 studies involving 24 different instruments that assessed coping mechanisms. The selection process is shown in figure 1. [Figure 1] Study characteristics Two studies were published in the 1990s. The number of studies published per year has been increasing since the beginning of the 2000s until present, with 2004 and 2016 being the years of highest scientific output. 296 297 298 299 300 301 302 303 304 305 306 307 308 309 310 311 312 313 314 315 316 317 318 319 320 321 322 323 324 325 326 327 328 329 330 331 332 333 334 335 336 337 338 339 340 341 342 343 344 345 346 347 348 349 350 351 352 353 354 The studies reviewed addressed pain intensity, anxiety, resilience, fear-avoidance, catastrophizing, self-esteem, disability, or dependence. The Fear-Avoidance Beliefs Questionnaire (FABQ), the Roland Morris Disability Questionnaire (RMDQ), and the Quebec Back Pain Disability Scale (QBPDS) are the instruments for which the highest quantity of translations into other languages have been validated. Spain, Germany, the United Kingdom, and France have the highest number of psychometric studies published. Table 2 presents the main characteristics of the studies included. [Table 2] Assessment of psychometric properties Table 3 shows the results obtained by applying the COSMIN checklist to the included studies. Reliability, validity, and responsiveness have been analyzed. [Table 3] Reliability The reliability analysis assessed internal consistency and inter-rater reliability. Internal consistency was assessed in 32 studies (89%). All of them used the overall Cronbach’s alpha coefficient of the instrument, and 10 of them (28%) also showed the value for each subscale, which had to be greater than 0.70. The assessment conducted with the COSMIN checklist showed that 19 studies (59%) had “good” or “excellent” scores in terms of internal consistency. The rest of studies scored low, either because they did not calculate internal consistency for each subscale or because the sample size was too small. 355 356 357 358 359 360 361 362 363 364 365 366 367 368 369 370 371 372 373 374 375 376 377 378 379 380 381 382 383 384 385 386 387 388 389 390 391 392 393 394 395 396 397 398 399 400 401 402 403 404 405 406 407 408 409 410 411 412 413 Inter-rater reliability was assessed in 21 studies (58%) by calculating the Intraclass Correlation Coefficient. Eleven of them (52%) scored “excellent” or “good.” Measurement error was assessed in 36 studies, of which 13 (36%) showed “excellent” or “good” scores. The instruments which showed the best reliability scores were the Spanish versions of the Graded Chronic Pain Scale (GCPS) (Ferrer-Peña, 2016), the Pain Catastrophizing Scale (PCS) (García-Campayo, 2007), the Pain Self-Perceptions Scale (PSPS-Spanish) (García-Campayo, 2010), and the Roland-Morris Questionnaire (RMQ) (Kovacs, 2002); the Swiss and Italian validations of the Fear-Avoidance Beliefs Questionnaire (FABQ) (Staerkle, 2004; Pruneti, 2014); and the Avoidance-Endurance Questionnaire (AEQ) (Hasenbring, 2009), the Pain Beliefs and Perceptions Inventory (PBPI) (Azevedo, 2016), and the Pain Disability Index (PDI) (Soer, 2013) validated in Germany, Portugal, and the Netherlands, respectively. Validity Among the properties related to validity, no studies included the hypothesis test. Content validity was analyzed in two studies (6%), one of which scored “good.” In contrast, measurement error and construct validity were assessed in all of the studies, with 13 (36%) scoring “good” or “excellent” for measurement error and 26 (72%) for construct validity. Construct validity was assessed in 29 (81%) studies. In 10 of them (28%), construct validity was assessed using Exploratory Factor Analysis (EFA), while in 19 of them (53%) it was assessed using Confirmatory and Exploratory Factor Analysis. Cross-cultural validity was assessed in 26 of the studies (72%), with 8 (31%) scoring “good” or “excellent.” Criterion validity was assessed in 21 studies (58.3%). In 8 of them (22.2%) “excellent” or “good” scores were obtained. 414 415 416 417 418 419 420 421 422 423 424 425 426 427 428 429 430 431 432 433 434 435 436 437 438 439 440 441 442 443 444 445 446 447 448 449 450 451 452 453 454 455 456 457 458 459 460 461 462 463 464 465 466 467 468 469 470 471 472 Catalano, D., Chan, F., Wilson, L., Chiu, C., & Muller, V. (2011). The buffering effect of resilience on depression among individuals with spinal cord injury: a structural equation model. Rehabilitation Psychology. 56, 200-211. Chaory, K., Fayad, F., Rannou, F., Lefèvre-Colau, M.M., Fermanian, J., Revel, M., & Poiraudeau, S. (2004). Validation of the French version of the Fear Avoidance Belief Questionnaire. Spine. 29, 908-913. Ciapponi, A. (2015). QUADAS-2: instrumento para la evaluación de la calidad de estudios de precisión diagnóstica. Evidencia. 18, 22–6. Cunha, C.O., Pinto-Fiamengui, L.M.S., Sampaio, F.A., & Conti, P.C.R. Is aerobic exercise useful to manage chronic pain? (2016). Revista dor. 17, 61-64. De Sola, H., Salazar, A., Dueñas, M., Ojeda, B., & Failde, I. (2016). A nationwide study of the impact of chronic pain on the patient’s employment. Relationship with the family and social support. BMJ Open. 6, 1-12. Esteve, R., Ramírez-Maestre, C., Peters, M.L., Serrano-Ibáñez, E.R., Ruiz-Párraga, G.T., & López-Martínez, A.E. (2016). Development and initial validation of the Activity Patterns Scale in Patients with chronic pain. J Pain. 17, 451-461. Fernandes, L., Storheim, K., Lochting, I., & Grotle, M. (2012). Cross-cultural adaptation and validation of the Norwegian pain catastrophizing scale in patients with low back pain. BMC Musculoskeletal Disorder. 13, 1-9. Ferrer-Peña, R., Gil-Martínez, A., & Pardo-Montero, J. (2016). Adaptation and validation of the Spanish version of the Graded Chronic Pain Scale. Reumatología Clínica. 12, 130-138. 827 828 829 830 831 832 833 834 835 836 837 838 839 840 841 842 843 844 845 846 847 848 849 850 851 852 853 854 855 856 857 858 859 860 861 862 863 864 865 866 867 868 869 870 871 872 873 874 875 876 877 878 879 880 881 882 883 884 885 Fricker, J. (2010). Pain in Europe -a report. García-Campayo, J., Rodero, B., Alda, M., Sobradiel, N., Montero, J., & Moreno, S. (2007). Validación de la versión española de la escala de la catastrofización ante el dolor en la Fibromialgia. Medicina Clínica. 13, 487–493. García-Campayo, J., Rodero, B., López del Hoyo, Y., Luciano, J.V., Alda, M., & Gili, M. (2010). Validation of a Spanish language version of the pain selfperception scale in patients with fibromyalgia. BMC Musculoskeletal Disorders.11:255. George, S.Z., Valencia, C., & Beneciuk, J.M. (2010). A Psychometric investigation of fear avoidance model measures in patients with chronic low back pain. Journal of Orthopedic Sports Physical Therapy. 40, 197–205. Georgoudis, G., Watson, P.J., & Oldham, J.A. (2000). The development and validation of a Greek version of the short-form McGill Pain Questionnaire. European Journal of Pain. 4, 275-281. Global Industry Analysts. (2011). Global pain management market to reach US$60 billion by 2015. Gómez-Pérez, L., López-Martínez, A.E., & Ruiz-Párraga, G.T. (2011). Psychometric properties of the Spanish Version of the Tampa Scale for Kinesiophobia. J Pain 12, 425-435. González-Escalada, J.R., Camba, A., Muriel, C., Rodríguez, M., Contreras, & D., Barutell, C. (2012). Validation of the Lattinen Index for the assessment of chronic pain patients. Revista dela Sociedad Española del Dolor. 19, 181–188. 886 887 888 889 890 891 892 893 894 895 896 897 898 899 900 901 902 903 904 905 906 907 908 909 910 911 912 913 914 915 916 917 918 919 920 921 922 923 924 925 926 927 928 929 930 931 932 933 934 935 936 937 938 939 940 941 942 943 944 González-Menéndez, A., Fernández-García, P., & Torres-Viejo, I. (2010). Aceptación del dolor crónico en pacientes con fibromialgia: adaptación del Chronic Pain Acceptance Questionnaire (CPAQ). Psicothema. 4, 997–1003. Grotle, M., Brox, J., & Vøllestad, N. (2006). Reliability, validity and responsiveness of the fear-avoidance beliefs questionnaire: methodological aspects of the Norwegian version. Journal of Rehabilitation Medicine. 38, 346-353. Hasenbring, M.I., Hallner, D., & Rusu, A.C. (2009). Fear-avoidance- and endurancerelated responses to pain: Development and validation of the Avoidance- Endurance Questionnaire. European Journal of Pain. 13, 620-628. Hegarty, D., & Wall, M. (2014). Prevalence of stigmatization and poor self-esteem in chronic pain patients. J Pain Relief 3, 3–6. Higgins, J.P.T, & Green, S. (2011). Cochrane Handbook for Systematic Reviews of Interventions Version 5.1.0. International association for the study of pain. (1986). Classification of chronic pain. Kemani, M.K., Zettergvist, V., Kanstrup, M., Holmström, L., & Wicksell, R.K. (2016). A validation of the pain interference index in adults with longstanding pain. Acta Anaesthesiologica Scandinavica. 60, 250-258. Klasen, B.W., Hallner, D., Schaub, C., Willburger, R., & Hasenbring, M. (2004). Validation and reliability of the German version of the Chronic Pain Grade questionnaire in primary care back pain patients. Psycho-Social Medicine. 14, 1- 12. 945 946 947 948 949 950 951 952 953 954 955 956 957 958 959 960 961 962 963 964 965 966 967 968 969 970 971 972 973 974 975 976 977 978 979 980 981 982 983 984 985 986 987 988 989 990 991 992 993 994 995 996 997 998 999 1000 1001 1002 1003 Kovacs, F.M., Llobera, J., Gil del Real, M.T., Abraira, V., Gestoso, M., & Fernández, C. (2002). Validation of the Spanish version of the Roland-Morris Questionnaire. Spine. 27, 538-542. Lacasse, A., Bourgault, P., Tousignant-Laflamme, Y., Courtemanche-Harel, & R., Choinière, M. (2015). Development and validation of the French-Canadian chronic pain self-efficacy scale. Pain Research & Management. 20, 75-83. Lazarus, R.S., & Folkman, S. (1984). Stress, Appraisal & Coping. New York:Springer, Lumley, M.A., Cohen, J.L., Borszcz, G.G., Cano, A., Radcliffe, A.M., Porter, L.S.,… Keefe, F.J. (2011). Pain and emotion: a biopsychosocial review of recent research. Journal of Clinical Psychology. 67, 942–968. Mannion, A.F., Junge, A., Fairbank, J.C.T., Dvorak, J., & Grob, D. (2006). Development of a German version of the Oswestry Disability Index. Part 1: cross-cultural adaptation, reliability, and validity. European Spine Journal. 15, 55-65. Mason, V.L., Skevington, S.M., & Osborn, M. (2009). A measure for quality of life assessment in chronic pain: preliminary properties of the WHOQOL-pain. Journal of Behavioral Medicine. 32, 162-173. McCracken, L.M., & Dhingra, L. (2002). A short version of the Pain Anxiety Symptoms Scale (PASS-20): preliminary development and validity. Pain Research & Management. 7, 45-50. Meyer, K., Sprott, H., & Mannion, A.F. (2008). Cross-cultural adaptation, reliability, and validity of the German version of the Pain Catastrophizing Scale. Journal of Psychosomatic Research. 64, 469-478. 1004 1005 1006 1007 1008 1009 1010 1011 1012 1013 1014 1015 1016 1017 1018 1019 1020 1021 1022 1023 1024 1025 1026 1027 1028 1029 1030 1031 1032 1033 1034 1035 1036 1037 1038 1039 1040 1041 1042 1043 1044 1045 1046 1047 1048 1049 1050 1051 1052 1053 1054 1055 1056 1057 1058 1059 1060 1061 1062 Ministerio de Sanidad, Servicios Sociales e Igualdad. Documento Marco para la mejora del abordaje del dolor en el Sistema Nacional de Salud. (2014). Mokkink, L.B., Terwee, C.B., Patrick, D.L., Alonso, J., Stratford, P.W., Knol, D.K.,… De Vet, H.C.W. (2012). The COSMIN checklist manual. Norrefalk, J. (2011). Improving the current and future management of chronic pain: A European Consensus Report. Notario-Pacheco, B., Martínez-Vizcaíno, V., Trillo-Calvo, E., Pérez-Yus, M.C., Serrano-Parra, D., & García-Campayo, J. (2014). Validity and reliability of the Spanish version of the 10- item CD-RISC in patients with fibromyalgia. Health Quality of Life Outcomes. 12, 1-9. Pruneti, C., Sgromo, D., Bicchieri, L., Fontana, F., Franceschini, M., & Ferraro, F. (2014). Contribution to the validation of Italian version of Fear Avoidance Beliefs Questionnaire. Acta Biomedica. 85, 8-17. Registered Nurses’ Association of Ontario. (2013). Valoración y manejo del dolor. Riecke, J., Holzapfel, S., Rief, W., Lachnit, H., & Glombiewski, J.A. (2016). Crosscultural adaption of the German Quebec back pain disability scale: An exposurespecific measurement for back pain patients. Journal of Pain Research. 9, 9-15. Roelofs, J., McCracken, L., Peters, M.L., Crombez, G., van Breukelen, G., & Vlaeyen, J.W.S. (2004). Psychometric evaluation of the Pain Anxiety Symptoms Scale (PASS) in chronic pain patients. Journal of Behavioral Medicine. 27, 167-183. 1063 1064 1065 1066 1067 1068 1069 1070 1071 1072 1073 1074 1075 1076 1077 1078 1079 1080 1081 1082 1083 1084 1085 1086 1087 1088 1089 1090 1091 1092 1093 1094 1095 1096 1097 1098 1099 1100 1101 1102 1103 1104 1105 1106 1107 1108 1109 1110 1111 1112 1113 1114 1115 1116 1117 1118 1119 1120 1121 Ruiz-Párraga, G.T., López-Martínez, A.E., & Gómez-Pérez, L. (2012). Factor structure and psychometric properties of the Resilience Scale in a Spanish chronic musculoskeletal pain sample. Journal of Pain. 13, 1090-1098. Sandborgh, M., Lindberg, P., & Denison, E. (2008). The Pain Belief Screening Instrument (PBSI): predictive validity for disability status in persistent musculoskeletal pain. Disability Rehabilitation. 30, 1123-1130. Schoppink L.E., van Tulder, M.W., Koes, B.W., Beurskens, S.A., & De Bie, R.A. (1996). Reliability and validity of the Dutch adaptation of the Quebec Back Pain Disability Scale. Physical Therapy. 76, 268-275. Staerkle, R., Mannion, A.F., Elfering, A., Junge, A., Semmer, N.K., Jacobshagen, N.,… Boos, N. (2007). Longitudinal validation of the Fear-Avoidance Beliefs Questionnaire (FABQ) in a Swiss-German sample of low back pain patients. European Spine Journal. 13, 1750-1751. Soer, R., Köke, A.J., Vroomen, P.C., Stegeman, P., Smeets, R.J., & Coppes, M.H. (2013). Extensive validation of the pain disability index in 3 groups of patients with musculoskeletal pain. Spine. 38, 562-568. Soriano, J., & Monsalve, V. (2004). Validation of the reduced chronic pain coping questionnaire (CAD-R). Revista de la Sociedad Española del Dolor. 11, 27-34. Terwee, C.B. (2011). COSMIN checklist with 4-point scale. Cosmin. Torralba, A., Miquel, A., & Darba, J. (2014). Situación actual del dolor crónico en España: iniciativa Pain Proposal. Revista de la Sociedad Española del Dolor. 21, 16-22. 1122 1123 1124 1125 1126 1127 1128 1129 1130 1131 1132 1133 1134 1135 1136 1137 1138 1139 1140 1141 1142 1143 1144 1145 1146 1147 1148 1149 1150 1151 1152 1153 1154 1155 1156 1157 1158 1159 1160 1161 1162 1163 1164 1165 1166 1167 1168 1169 1170 1171 1172 1173 1174 1175 1176 1177 1178 1179 1180 Tsang, A., Von Korff, M., Lee, S., Alonso, J., Karam, E., Angermeyer, M.C.,… Watanabe, M. (2008). Common chronic pain conditions in developed and developing countries: gender and age differences and comorbidity with Depression-Anxiety disorders. Journal of Pain. 9, 883–891. Ueberall, M.A., & Mueller-Schwefe, G.H.H. (2012). Low-dose 7-day transdermal buprenorphine in daily clinical practice - perceptions of elderly patients with moderate non-malignant chronic pain. Current Medicine Research Opinion. 28, 1585-1595. Urrútia, G., & Bonfill, X. (2010). Declaración PRISMA: una propuesta para mejorar la publicación de revisiones sistemáticas y metaanálisis. Medicina Clinica 135, 507-511. Von Korff, M. (2011). Assessment of chronic pain in epidemiological and health services research. In: Turk, D., Melzack, R. (Eds.), Handbook of Pain Assessment (pp.455-473). New York, United States: Guilford Press. Waddell, G., Newton, M., Henderson, I., Somerville, D., & Main, C.J. (1993). A Fear- Avoidance Beliefs Questionnaire (FABQ) and the role of fear-avoidance beliefs in chronic low back pain and disability. Pain. 52, 157-168. Whiting, P., Rutjes, A.W., Reitsma, J.B., Bossuyt, P.M., Kleijnen, J. (2003). The development of QUADAS: a tool for the quality assessment of studies of diagnostic accuracy included in systematic reviews. BMC Medical Research Methodology. 3, 25. Whiting, P., Rutjes, A.W., Westwood, M.E., Mallett, S., Deeks, J.J., Reitsma, J.B.,… Bossuyt, P.M.M. (2011). QUADAS-2: A Revised Tool for the Quality 1181 1182 1183 1184 1185 1186 1187 1188 1189 1190 1191 1192 1193 1194 1195 1196 1197 1198 1199 1200 1201 1202 1203 1204 1205 1206 1207 1208 1209 1210 1211 1212 1213 1214 1215 1216 1217 1218 1219 1220 1221 1222 1223 1224 1225 1226 1227 1228 1229 1230 1231 1232 1233 1234 1235 1236 1237 1238 1239 Assessment of Diagnostic Accuracy Studies. Annals of Internal Medicine Research and Reporting Methods. 155, 529-536 Wicksell, R.K., Renöfält, J., Olsson, G.L., Bond, F.W., & Melin, L. (2008). Avoidance and cognitive fusion - central components in pain related disability? Development and preliminary validation of the Psychological Inflexibility in Pain Scale (PIPS). European Journal of Pain. 12, 491-500. Wranker, L.S., Rennemark, M., Berglund, J., & Elmståhl, S. (2014). Relationship between pain and Quality of Life-Findings from the Swedish National Study on Aging and Care-Blekinge study. Scandinavian Journal of Pain, 5(4), 270–275. Yvanes-Thomas, M., Calmels, P., Béthoux, F., Richard, A., Nayme, P., Payre, D., & Laurent, B. (2002). Validity of the French-language version of the Quebec back Pain Disability Scale in low back pain patients in France. Journal of Bone Spine. 69, 397-405. Zerkak, D., Métivier, J.C., Fouquet, B., & Beaudreuil, J. (2013). Validation of a French version of Roland-Morris questionnaire in chronic low back pain patients. Annals of Physical Rehabilitation Medicine. 56, 613-620. Author contributions: RCM designed the research methodology, carried out the database search and data extraction, selected the eligible studies, and drafted the first version of the manuscript. EGG devised the main idea of the systematic review, designed the research methodology, and verified the methodological quality of the documents included, performed the database search, and reviewed the final manuscript. ACL and AMPG both participated in the methodological design of the systematic 1240 1241 1242 1243 1244 1245 1246 1247 1248 1249 1250 1251 1252 1253 1254 1255 1256 1257 1258 1259 1260 1261 1262 1263 1264 1265 1266 1267 1268 1269 1270 1271 1272 1273 1274 1275 1276 1277 1278 1279 1280 1281 1282 1283 1284 1285 1286 1287 1288 1289 1290 1291 1292 1293 1294 1295 1296 1297 1298 review and in the review of the final manuscript. SBT designed the systematic review methodology, carried out the database search and data extraction, and drafted the first version of the manuscript. The manuscript has been translated from Spanish into English by a professional translator and revised by a native English speaker. 1299 1300 1301 1302 1303 1304 1305 1306 1307 1308 1309 1310 1311 1312 1313 1314 1315 1316 1317 1318 1319 1320 1321 1322 1323 1324 1325 1326 1327 1328 1329 1330 1331 1332 1333 1334 1335 1336 1337 1338 1339 1340 1341 1342 1343 1344 1345 1346 1347 1348 1349 1350 1351 1352 1353 1354 1355 1356 1357 1 Figure 1. Flow diagram Records identified through database searching (n = 9,850) Screening Included Eligibility Identification Potentially relevant articles (n = 210) Records excluded, with reasons (n = 104) Titles which did not assess pain in adults (n = 59) Titles which assessed pain in hospitalized adults (n = 37) Full-text non available (n = 8) Full-text articles assessed for eligibility (n = 106) Full-text articles excluded, with reasons (n = 70) Full-text articles which did not meet the eligibility criteria (n = 35) Studies validated in non-European countries (n = 35) Studies included in qualitative synthesis (n = 36) Records excluded, with reasons (n = 9,640) Titles which were repeated (n = 1,887) Titles which did not asses biological, psychological and/or socio-cultural resources of pain (n = 7,753) Topics: a = Biological resources. b = Psychological resources. c = Socio-cultural resources. α = Cronbach’s alpha coefficient. KMO = Kaiser-Meyer-Olkin. EFA = Exploratory Factor Analysis. CFA = Confirmatory Factor Analysis. ICC = Intraclass Correlation Coefficient. FABQ-PA = Fear-Avoidance Beliefs Questionnaire - Psychological Assessment. FABQ-W = Fear-Avoidance Beliefs Questionnaire - Work. HADS = Hospital Anxiety and Depression Scale. HADS-d = Hospital Anxiety and Depression Scale - Depression. HADS-a = Hospital Anxiety and Depression Scale - Anxiety. NRS = Numerical Rating Scale. VAS = Visual Analogue Scale. FIQ = Fibromyalgia Impact Questionnaire. PC = Pain Catastrophizing. SF12-P = Medical Outcome Study Short Form 12 Health Survey - Psychological. PPDS = Pain Persistence and Distraction. IPS = Inflexibility Pain Scale. HS = Humor Scale. FAR = Fear-Avoidance Responses. ER = Endurance-related responses. DPQ = Dallas Pain Questionnaire. Roland-Morris Questionnaire (RMQ) Zerzak (2008) French version n = 58 patients with chronic low back pain (38 men and 20 women) France 24 items - ICC = 0.89 n = 58 patients 2 days DPQ: r = 0.514 QBPDS: r = 0.713 α = 0.84 c Resilience Scale (RS-18) Ruiz-Párraga (2010) Spanish version n = 300 patients with chronic musculoskeletal pain Spain 18 items KMO: 0.93 Bartlett’s sphericity test: p < 0.001 EFA: 2 factors account for 52.43% of the variance n = 102 patients 180 days - α = 0.92 b Tampa Scale for Kinesiophobia (TSK) Gómez-Pérez (2011) Spanish version n = 125 patients with chronic pain (29 men and 45 women) Spain 11 items 2 factors EFA: 2 factors - - α = 0.79 c WHOQOL-pain Mason (2009) British version n = 133 patients with chronic low back pain (47 men and 86 women) United Kingdom 100 items 5-point Likert scale 4 domains - - - α = 0.88 Facets: Anger and frustration: α = 0.81 Uncertainty: α = 0.79 Pain relief: α = 0.66 b 206 207 208 209 210 211 212 213 214 215 216 217 218 219 220 221 222 223 224 225 226 227 228 229 230 231 232 233 234 235 236 237 238 239 240 241 242 243 244 245 246 Table 3. Scores of the psychometric properties after applying the COSMIN criteria. AUTHOR (YEAR) / COUNTRY INSTRUMENTS IRT or CTT A B C D E F G H I Hasenbring (2009) / Germany Avoidance-Endurance Questionnaire (AEQ) CTT +++ ++ ++ +++ +++ Esteve (2016) / Spain Activity Patterns Scale (APS) CTT +++ 0 0 +++ ++ Ruiz-Párraga (2015) / Spain Avoidance-Endurance Questionnaire (AEQ) CTT 0 0 0 +++ 0 ++ Notario-Pacheco (2014) / Spain Connor-Davidson Resilience Scale (CD-RISC) CTT +++ 0 0 +++ 0 + + Klasen (2004) / Germany Chronic Pain Grade Questionnaire (CPG) CTT 0 0 0 0 0 + 0 Ferrer-Peña (2016) / Spain Graded Chronic Pain Scale (CPGS) CTT ++ +++ ++ ++ ++ ++ +++ Lacasse (2015) / France Chronic Pain Self-Efficacy Scale (FC-CPSES) CTT 0 0 0 0 0 0 Waddell (1993) / United Kingdom Fear-Avoidance Beliefs Questionnaire (FABQ) CTT +++ 0 0 +++ Chaory (2004) / France Fear Avoidance Belief Questionnaire (FABQ) CTT 0 ++ ++ ++ 0 +++ Staerkle (2004) / Switzerland Fear-Avoidance Beliefs Questionnaire (FABQ) CTT ++ ++ ++ +++ 0 +++ Grotle (2006) / Norway Fear-Avoidance Beliefs Questionnaire (FABQ) CTT 0 0 0 ++ ++ +++ Pruneti (2014) / Italy Fear-avoidance beliefs questionnaire (FABQ) CTT ++ ++ ++ ++ 0 +++ George (2010) / United Kingdom Fear-Avoidance Model Measures (FAM) CTT 0 + + ++ González-Escalada (2012) / Spain Lattinen Index (LI) CTT 0 + + 0 + 0 Georgoudis (2000) / Greece Short-Form McGill Pain Questionnaire (MPQ) CTT 0 0 0 0 0 + 0 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 Mannion (2006) / Switzerland Oswestry Disability Index (ODI) CTT 0 + + 0 0 + +++ McCracken (2002) / United Kingdom Pain Anxiety Symptoms Scale (PASS-20) CTT ++ 0 0 ++ 0 Roelofs (2004) / The Netherlands Pain Anxiety Symptoms Scale (PASS) CTT 0 0 0 +++ 0 0 Azevedo (2016) / Portugal Pain Beliefs and Perceptions Inventory (PBPI) CTT +++ ++ ++ +++ +++ Sandborgh (2008) / Sweden Pain Belief Screening Instrument (PBSI) CTT ++ 0 0 ++ 0 + Meyer (2007) / Switzerland Pain Catastrophizing Scale (PCS) CTT 0 0 0 +++ +++ ++ García-Campayo (2008) / Spain Pain Catastrophizing Scale (PCS) CTT +++ ++ ++ +++ 0 +++ Fernandes (2012) / Norway Pain Catastrophizing Scale (PCS) CTT + ++ ++ + 0 ++ Soer (2013) / The Netherlands Pain Disability Index (PDI) CTT ++ ++ ++ ++ 0 +++ Kemani (2016) / Sweden Pain Interference Index (PII) CTT +++ 0 0 +++ +++ Wicksell (2007) / Sweden Psychological Inflexibility Pain Scale (PIPS) CTT +++ 0 0 +++ +++ 0 García-Campayo (2010) / Spain Pain Self-Perception Scale (PSPS-Spanish) CTT ++ ++ ++ ++ ++ ++ ++ Schoppink (1996) / The Netherlands Quebec Back Pain Disability Scale (QBPDS) CTT 0 0 ++ ++ 0 Yvanes-Thomas (2002) / France Quebec Back Pain Disability Scale (QBPDS) CTT 0 0 0 0 0 0 Riecke (2016) / Germany Quebec Back Pain Disability Scale (QBPDS) CTT ++ 0 0 ++ ++ ++ Buchanan (2007) / Germany Roland Morris Disability Questionnaire (RMDQ) CTT 0 0 0 0 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60 61 62 63 64 65 66 67 68 69 70 71 72 73 74 75 76 77 78 79 80 81 82 Kovacs (2002) / Spain Roland-Morris Questionnaire (RMQ) CTT ++ ++ ++ ++ ++ Zerzak (2008) / France Roland-Morris Questionnaire (RMQ) CTT 0 0 0 0 0 +++ ++ Ruiz-Párraga (2010) / Spain Resilience Scale (RS-18) CTT +++ 0 ++ +++ 0 +++ Gómez-Pérez (2011) / Spain Tampa Scale for Kinesiophobia (TSK) CTT +++ 0 0 +++ 0 Mason (2009) / United Kingdom WHOQOL-pain CTT 0 0 0 0 COSMIN psychometric property boxes: A = internal consistency, B = reliability, C = measurement error, D = content validity, E = structural validity, F = hypothesis testing, G = cross-cultural validity, H = criterion validity. 4-point scale rating: +++ = excellent, ++ = good, + = fair, 0 = poor, empty space = COSMIN rating not applicable. IRT = item response theory; CTT = classical test theory. 83 84 85 86 87 88 89 90 91 92 93 94 95 96 97 98 99 100 101 102 103 104 105 106 107 108 109 110 111 112 113 114 115 116 117 118 119 120 121 122 123 Table 4. QUADAS-2 analysis RISK OF BIAS APPLICABILITY CONCERNS AUTHOR (YEAR) / COUNTRY INSTRUMENTS PATIENT SELECTION INDEX TEST REFERENCE STANDARD FLOW AND TIMING PATIENT SELECTION INDEX TEST REFERENCE STANDARD Hasenbring (2009) / Germany Avoidance-Endurance Questionnaire (AEQ) Low Low Low Low Low Low Low Esteve (2016) / Spain Activity Patterns Scale (APS) ? ? Low Low Low Low Low Ruiz-Párraga (2015) / Spain Avoidance-Endurance Questionnaire (AEQ) High High Low Low Low Low ? Notario-Pacheco (2014) / Spain Connor-Davidson Resilience Scale (CD-RISC) Low Low Low Low Low Low Low Klasen (2004) / Germany Chronic Pain Grade Questionnaire (CPG) High High Low Low Low Low Low Ferrer-Peña (2016) / Spain Graded Chronic Pain Scale (CPGS) High High Low Low Low Low Low Lacasse (2015) / France Chronic Pain Self-Efficacy Scale (FC-CPSES) High High Low Low Low Low Low Waddell (1993) / United Kingdom Fear-Avoidance Beliefs Questionnaire (FABQ) Low Low Low Low Low Low Low Chaory (2004) / France Fear-Avoidance Belief Questionnaire (FABQ) Low Low Low Low Low Low Low Staerkle (2004) / Switzerland Fear-Avoidance Beliefs Questionnaire (FABQ) ? ? ? ? Low Low Low 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 Grotle (2006) / Norway Fear-Avoidance Beliefs Questionnaire (FABQ) Low Low Low Low Low Low Low Pruneti (2014) / Italy Fear-Avoidance Beliefs Questionnaire (FABQ) ? Low Low Low Low Low High George (2010) / United Kingdom Fear-Avoidance Model Measures (FAM) Low High ? High Low High ? González-Escalada (2012) / Spain Lattinen Index (LI) Low Low Low Low High High Low Georgoudis (2000) / Greece Short-Form McGill Pain Questionnaire (MPQ) ? ? Low Low ? ? Low Mannion (2006) / Switzerland Oswestry Disability Index (ODI) Low Low Low Low Low Low Low McCracken (2002) / United Kingdom Pain Anxiety Symptoms Scale (PASS-20) ? ? Low Low Low Low Low Roelofs (2004) / The Netherlands Pain Anxiety Symptoms Scale (PASS) ? ? Low Low Low Low Low Azevedo (2016) / Portugal Pain Beliefs and Perceptions Inventory (PBPI) Low Low Low Low Low Low ? Sandborgh (2008) / Sweden Pain Belief Screening Instrument (PBSI) ? ? Low Low Low Low Low Meyer (2007) / Switzerland Pain Catastrophizing Scale (PCS) ? Low Low Low Low Low ? García-Campayo (2008) / Spain Pain Catastrophizing Scale (PCS) Low Low Low Low ? ? Low 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60 61 62 63 64 65 66 67 68 69 70 71 72 73 74 75 76 77 78 79 80 81 82 Fernandes (2012) / Norway Pain Catastrophizing Scale (PCS) ? ? Low Low Low Low ? Soer (2013) / The Netherlands Pain Disability Index (PDI) Low Low Low Low ? ? ? Kemani (2016) / Sweden Pain Interference Index (PII) Low Low Low Low Low Low High Wicksell (2007) / Sweden Psychological Inflexibility Pain Scale (PIPS) ? ? Low Low Low Low Low García-Campayo (2010) / Spain Pain Self-Perception Scale (PSPS-Spanish) High High Low Low Low Low Low Schoppink (1996) / The Netherlands Quebec Back Pain Disability Scale (QBPDS) ? ? Low Low ? ? ? Yvanes-Thomas (2002) / France Quebec Back Pain Disability Scale (QBPDS) Low Low Low Low ? ? ? Riecke (2016) / Germany Quebec Back Pain Disability Scale (QBPDS) Low Low Low Low ? ? ? Buchanan (2007) / Germany Roland Morris Disability Questionnaire (RMDQ) High High Low Low ? ? High Kovacs (2002) / Spain Roland-Morris Questionnaire (RMQ) High High Low Low Low Low ? Zerzak (2008) / France Roland-Morris Questionnaire (RMQ) ? ? Low Low Low Low ? Ruiz-Párraga (2010) / Spain Resilience Scale (RS-18) Low Low Low Low Low Low Low Gómez-Pérez (2011) / Spain Tampa Scale for Kinesiophobia (TSK) ? ? Low Low Low Low Low 83 84 85 86 87 88 89 90 91 92 93 94 95 96 97 98 99 100 101 102 103 104 105 106 107 108 109 110 111 112 113 114 115 116 117 118 119 120 121 122 123 Mason (2009) / United Kingdom WHOQOL-pain Low Low Low Low Low Low Low 124 125 126 127 128 129 130 131 132 133 134 135 136 137 138 139 140 141 142 143 144 145 146 147 148 149 150 151 152 153 154 155 156 157 158 159 160 161 162 163 164