SYSTEMATIC REVIEW
A systematic review of the outcomes reported in multimodal pain therapy for chronic pain S. Deckert1, U. Kaiser2, C. Kopkow1, F. Trautmann1, R. Sabatowski2,3, J. Schmitt1 1 Center for Evidence-Based Healthcare,Medizinische Fakult€at Carl Gustav Carus,TU Dresden,Germany 2 Comprehensive Pain Center,Universit€atsklinikum Carl Gustav Carus,Dresden,Germany 3 Department of Anesthesiology and Intensive Care,Universit€atsklinikum Carl Gustav Carus,Dresden,Germany
Correspondence Stefanie Deckert E-mail: stefanie.deckert@uniklinikum-dresden. de Funding sources The study is funded by the German Federal Ministry of Education and Research (BMBF 01GY1326). Conflicts of interest None declared.
Accepted for publication 16 March 2015 doi:10.1002/ejp.721
Abstract Background and objective: There are no recommendations provided for the outcome domains of chronic pain that should be explicitly considered in each clinical trial to describe the efficacy and effectiveness of multimodal pain therapy (MPT). Our aims were to summarize all reported outcome domains in studies assessing the effects of MPT for chronic pain, and to subsequently inform a consensus-based development of a core outcome set of domains in this field. Database and data treatment: Medline, Embase and AMED were searched for studies reporting on chronic pain for at least 3 months that applied MPT and investigated outcome domains. All reported outcome domains were extracted from eligible articles. The patient-reported outcome measurement information system (PROMIS) was applied for conceptual classification. Results: From 3626 potentially relevant titles, 70 studies were included. The median and maximal numbers of outcome domains were 8 and 34, respectively. Although most studies (n = 45/70) assessed a combination of all three core health areas, i.e. physical, mental and social health, there was great variation in the specific domains chosen to address these core health areas. No outcome domain was measured consistently in all studies. After selection of all outcome domains which were reported in at least 10% of all studies included, we identified 14 different outcome domains, mostly operationalized through the domains pain intensity (n = 56/70) and depressive symptoms (n = 42/70). Conclusions: The current lack of standardization of outcome domains in MPT studies hinders to readily compare interventions from different trials and is a barrier towards evidence-based decision making. Based on these results, the development of a core outcome set of domains for MPT has been initiated.
1. Introduction A multidisciplinary approach in pain management (syn. multimodal pain therapy (MPT) or functional restoration) addresses chronic pain as a bio-psychosocial condition and consists of physical exercises, a behavioural-psychological principle and medical © 2015 European Pain Federation - EFICâ
treatment provided by a physician specialized in pain management (Mayer and Gatchel, 1988; Arnold et al., 2009). Therefore, effects of MPT should be measureable by using bio-psycho-social outcome domains. Although the efficacy and effectiveness of MPT approaches have been investigated in various clinical trials (Guzm an et al., 2001; Waterschoot et al., 2014), comparisons of the benefits of different Eur J Pain 20 (2016) 51--63
51
Outcome reporting in multimodal pain therapy
Database • Medline, Embase and AMED. What does this review add?
• Outcome domains in multimodal pain therapy studies were generally very heterogeneous and no outcome domain was measured consistently in all studies. • The review underlines the necessity of an accepted core outcome set of domains and measurement instruments to be able to summarize the results in meta-analyses for evidence-based decision making in multimodal pain therapy.
interventions is hardly possible due to the lack of standardization and comparability of study endpoints. This current situation constitutes a significant barrier towards evidence-based decision making in MPT (Kaiser et al., 2014). The development of ‘core outcome sets’ (COS) is a powerful strategy to overcome problems related to the use of different, frequently incomparable and unvalidated outcome measures. A COS is a consented minimum set of outcome domains (‘core outcome set of domains’) and outcome measures (‘core outcome set of measurement instruments’) to be used in every trial or study in a medical field. The Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials (IMMPACT) recommended the following core outcome domains that should be measured in each clinical trial evaluating efficacy and effectiveness of any pain treatment: (1) pain, (2) physical functioning, (3) emotional functioning, (4) participant ratings of improvement and satisfaction with treatment, (5) symptoms and adverse events and (6) participation disposition (Turk et al., 2003). Nevertheless, the situation is not as clear as it seems to be because the characteristic of chronic pain and also of pain patients is as heterogeneous as the diversity of therapy approaches to chronic pain syndromes. In case that the target population and setting are not clearly enough described in the scope of the COS of domains, content and face validity of the specific outcome domains cannot be ensured. Thus, core outcome domains have to be relevant for patients in MPT as a specific population in pain therapy approaches, and furthermore be able to illustrate therapy effects of the special bio-psycho-social character of MPT. For
52 Eur J Pain 20 (2016) 51--63
S. Deckert et al.
example, while reduction in pain intensity is a typical therapy goal of medication intake, MPT primarily aims to restore physical and psychological functioning, whereas pain reduction is a secondary objective (Mayer and Gatchel, 1988). These methodological weaknesses are applicable to IMMPACT recommendations and also to COS which do not focus on MPT in particular (e.g. Reneman et al., 2013). Based on IMMPACT we still need to verify whether already recommended outcome domains for chronic pain are applicable and relevant for MPT trials or not. It might be possible that an additional or adapted COS of domains for especially MPT trials is required. Hence, we prepared a systematic review to (1) identify and present the reported outcome domains measured in Randomized Controlled Trials (RCTs) and longitudinal non-randomized studies focusing on MPT in chronic pain and to (2) prepare a selection of most reported outcome domains for a subsequent consensus-based process.
2. Methods/Design A comprehensive study (VAPAIN – Validation and Application of a patient relevant core outcome set to assess effectiveness of multimodal pain therapy) (http://www.comet-initiative.org/studies/details/392? result=true) was conceptualized to develop an evidence-based consensus on a COS for MPT. As presented here, the first step in this process was a systematic review (without a registration of a review protocol) on outcome domains of MPT.
2.1 Inclusion and exclusion criteria Eligibility criteria were predefined and utilized for literature search and study selection procedures (Table 1). Only publications reporting on persons suffering from chronic pain for at least 3 months (population), which applied MPT (intervention), and investigated endpoints (outcome) on the basis of RCTs and longitudinal non-randomized studies (study design) were considered eligible. Chronic pain of at least 3 months (according to the International Association for the Study of Pain S.o.T, 1986) has to be strictly formulated as study inclusion criteria. The intervention had to be performed by at least physical therapists and psychotherapists/psychologist, and the profession had to be stated by the authors (e.g. it has to be stated clearly, that physical therapy was conducted by physical therapists). The outcomes had to be clearly stated and described (i.e. definition and/or
© 2015 European Pain Federation - EFICâ
S. Deckert et al.
Outcome reporting in multimodal pain therapy
Table 1 Eligibility criteria. Inclusion
Exclusion
Population
Persons with chronic pain (duration of pain ≥3 months) Persons of all ages (children, adolescents, adults and elderly)
Intervention
Approaches using at least two aspects of multimodal therapy consisting of physiotherapeutic (e.g. exercising, aerobic) and psychotherapeutic components (e.g. problem solving) Functional restoration or rehabilitation program Not implicitly necessary All patient-reported and external assessed (e.g. by physicians or spouses) outcome domains Randomized Controlled Trials, longitudinal (prospective and retrospective) non-randomized studies Full text articles German, English
Persons with acute (duration
A systematic review of the outcomes reported in multimodal pain therapy for chronic pain S. Deckert1, U. Kaiser2, C. Kopkow1, F. Trautmann1, R. Sabatowski2,3, J. Schmitt1 1 Center for Evidence-Based Healthcare,Medizinische Fakult€at Carl Gustav Carus,TU Dresden,Germany 2 Comprehensive Pain Center,Universit€atsklinikum Carl Gustav Carus,Dresden,Germany 3 Department of Anesthesiology and Intensive Care,Universit€atsklinikum Carl Gustav Carus,Dresden,Germany
Correspondence Stefanie Deckert E-mail: stefanie.deckert@uniklinikum-dresden. de Funding sources The study is funded by the German Federal Ministry of Education and Research (BMBF 01GY1326). Conflicts of interest None declared.
Accepted for publication 16 March 2015 doi:10.1002/ejp.721
Abstract Background and objective: There are no recommendations provided for the outcome domains of chronic pain that should be explicitly considered in each clinical trial to describe the efficacy and effectiveness of multimodal pain therapy (MPT). Our aims were to summarize all reported outcome domains in studies assessing the effects of MPT for chronic pain, and to subsequently inform a consensus-based development of a core outcome set of domains in this field. Database and data treatment: Medline, Embase and AMED were searched for studies reporting on chronic pain for at least 3 months that applied MPT and investigated outcome domains. All reported outcome domains were extracted from eligible articles. The patient-reported outcome measurement information system (PROMIS) was applied for conceptual classification. Results: From 3626 potentially relevant titles, 70 studies were included. The median and maximal numbers of outcome domains were 8 and 34, respectively. Although most studies (n = 45/70) assessed a combination of all three core health areas, i.e. physical, mental and social health, there was great variation in the specific domains chosen to address these core health areas. No outcome domain was measured consistently in all studies. After selection of all outcome domains which were reported in at least 10% of all studies included, we identified 14 different outcome domains, mostly operationalized through the domains pain intensity (n = 56/70) and depressive symptoms (n = 42/70). Conclusions: The current lack of standardization of outcome domains in MPT studies hinders to readily compare interventions from different trials and is a barrier towards evidence-based decision making. Based on these results, the development of a core outcome set of domains for MPT has been initiated.
1. Introduction A multidisciplinary approach in pain management (syn. multimodal pain therapy (MPT) or functional restoration) addresses chronic pain as a bio-psychosocial condition and consists of physical exercises, a behavioural-psychological principle and medical © 2015 European Pain Federation - EFICâ
treatment provided by a physician specialized in pain management (Mayer and Gatchel, 1988; Arnold et al., 2009). Therefore, effects of MPT should be measureable by using bio-psycho-social outcome domains. Although the efficacy and effectiveness of MPT approaches have been investigated in various clinical trials (Guzm an et al., 2001; Waterschoot et al., 2014), comparisons of the benefits of different Eur J Pain 20 (2016) 51--63
51
Outcome reporting in multimodal pain therapy
Database • Medline, Embase and AMED. What does this review add?
• Outcome domains in multimodal pain therapy studies were generally very heterogeneous and no outcome domain was measured consistently in all studies. • The review underlines the necessity of an accepted core outcome set of domains and measurement instruments to be able to summarize the results in meta-analyses for evidence-based decision making in multimodal pain therapy.
interventions is hardly possible due to the lack of standardization and comparability of study endpoints. This current situation constitutes a significant barrier towards evidence-based decision making in MPT (Kaiser et al., 2014). The development of ‘core outcome sets’ (COS) is a powerful strategy to overcome problems related to the use of different, frequently incomparable and unvalidated outcome measures. A COS is a consented minimum set of outcome domains (‘core outcome set of domains’) and outcome measures (‘core outcome set of measurement instruments’) to be used in every trial or study in a medical field. The Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials (IMMPACT) recommended the following core outcome domains that should be measured in each clinical trial evaluating efficacy and effectiveness of any pain treatment: (1) pain, (2) physical functioning, (3) emotional functioning, (4) participant ratings of improvement and satisfaction with treatment, (5) symptoms and adverse events and (6) participation disposition (Turk et al., 2003). Nevertheless, the situation is not as clear as it seems to be because the characteristic of chronic pain and also of pain patients is as heterogeneous as the diversity of therapy approaches to chronic pain syndromes. In case that the target population and setting are not clearly enough described in the scope of the COS of domains, content and face validity of the specific outcome domains cannot be ensured. Thus, core outcome domains have to be relevant for patients in MPT as a specific population in pain therapy approaches, and furthermore be able to illustrate therapy effects of the special bio-psycho-social character of MPT. For
52 Eur J Pain 20 (2016) 51--63
S. Deckert et al.
example, while reduction in pain intensity is a typical therapy goal of medication intake, MPT primarily aims to restore physical and psychological functioning, whereas pain reduction is a secondary objective (Mayer and Gatchel, 1988). These methodological weaknesses are applicable to IMMPACT recommendations and also to COS which do not focus on MPT in particular (e.g. Reneman et al., 2013). Based on IMMPACT we still need to verify whether already recommended outcome domains for chronic pain are applicable and relevant for MPT trials or not. It might be possible that an additional or adapted COS of domains for especially MPT trials is required. Hence, we prepared a systematic review to (1) identify and present the reported outcome domains measured in Randomized Controlled Trials (RCTs) and longitudinal non-randomized studies focusing on MPT in chronic pain and to (2) prepare a selection of most reported outcome domains for a subsequent consensus-based process.
2. Methods/Design A comprehensive study (VAPAIN – Validation and Application of a patient relevant core outcome set to assess effectiveness of multimodal pain therapy) (http://www.comet-initiative.org/studies/details/392? result=true) was conceptualized to develop an evidence-based consensus on a COS for MPT. As presented here, the first step in this process was a systematic review (without a registration of a review protocol) on outcome domains of MPT.
2.1 Inclusion and exclusion criteria Eligibility criteria were predefined and utilized for literature search and study selection procedures (Table 1). Only publications reporting on persons suffering from chronic pain for at least 3 months (population), which applied MPT (intervention), and investigated endpoints (outcome) on the basis of RCTs and longitudinal non-randomized studies (study design) were considered eligible. Chronic pain of at least 3 months (according to the International Association for the Study of Pain S.o.T, 1986) has to be strictly formulated as study inclusion criteria. The intervention had to be performed by at least physical therapists and psychotherapists/psychologist, and the profession had to be stated by the authors (e.g. it has to be stated clearly, that physical therapy was conducted by physical therapists). The outcomes had to be clearly stated and described (i.e. definition and/or
© 2015 European Pain Federation - EFICâ
S. Deckert et al.
Outcome reporting in multimodal pain therapy
Table 1 Eligibility criteria. Inclusion
Exclusion
Population
Persons with chronic pain (duration of pain ≥3 months) Persons of all ages (children, adolescents, adults and elderly)
Intervention
Approaches using at least two aspects of multimodal therapy consisting of physiotherapeutic (e.g. exercising, aerobic) and psychotherapeutic components (e.g. problem solving) Functional restoration or rehabilitation program Not implicitly necessary All patient-reported and external assessed (e.g. by physicians or spouses) outcome domains Randomized Controlled Trials, longitudinal (prospective and retrospective) non-randomized studies Full text articles German, English
Persons with acute (duration
