Responsiveness of multiple patient-reported outcome measures for acute postsurgical pain: primary results from the international multi-centre PROMPT NIT-1 study.

BACKGROUND: Postsurgical outcome measures are crucial to define the efficacy of perioperative pain management; however, it is unclear which are most appropriate. We conducted a prospective study aiming to assess sensitivity-to-change of patient-reported outcome measures assessing the core outcome set of domains pain intensity (at rest/during activity), physical function, adverse events, and self-efficacy. METHODS: Patient-reported outcome measures were assessed preoperatively, on day 1 (d1), d3, and d7 after four surgical procedures (total knee replacement, breast surgery, endometriosis-related surgery, and sternotomy). Primary outcomes were sensitivity-to-change of patient-reported outcome measures analysed by correlating their changes (d1-d3) with patients' global impression of change and patients' specific impression of change items as anchor criteria. Secondary outcomes included identification of baseline and patient characteristic variables explaining variance in change for each of the scales and descriptive analysis of various patient-reported outcome measures from different domains and after different surgeries. RESULTS: Of 3322 patients included (18 hospitals, 10 countries), data from 2661 patients were analysed. All patient-reported outcome measures improved on average over time; the median calculated sensitivity-to-change for all patient-reported outcome measures (overall surgeries) was 0.22 (range: 0.07-0.31, scale: 0-10); all changes were independent of baseline data or patient characteristics and similar between different procedures. CONCLUSIONS: Pain-related patient-reported outcome measures have low to moderate sensitivity-to-change; those showing higher sensitivity-to-change from the same domain should be considered for inclusion in a core outcome set of patient-reported outcome measures to assess the effectiveness and efficacy of perioperative pain management.

[Interdisciplinary multimodal assessment : Interprofessional interaction in team meetings and final talks]. / Interdisziplinäres Multimodales Assessment : Interprofessionelle Interaktion in Teamsitzung und Abschlussgespräch.

BACKGROUND: In PAIN2020 (Innovation Fund, 01NVF17049), an outpatient interdisciplinary multimodal assessment (IMA) was introduced early in the course of the disease. The central quality feature is the close interdisciplinary collaboration of pain medicine, physiotherapy and psychology, which requires a complex organizational and coordination process, especially in team meetings and final discussions. OBJECTIVES: The (different) views of the professional groups involved are brought together in the team process as a common consensus. The process of shaping the interaction of the professional groups among each other in the team meeting and final discussion as well as with the patients is examined (qualitatively) and discussed. METHODS: In PAIN2020, a workshop on IMA was held to jointly reflect on the insights and experiences gained in the process so far through monitoring with staff or teams of the PAIN2020 centers. In one of three work phases, interprofessionally composed groups gathered statements from participants on the design of the interaction in team meeting and final discussion in three rotating rounds within the framework of a World Café. RESULTS: It was possible to identify conducive and obstructive factors for the design of interdisciplinary collaboration in team meetings and final discussions, which were brought together in a superordinate framework model. DISCUSSION: The provision of the new care service as an interdisciplinary task in a team goes beyond existing structural and process parameters in the definition of framework conditions in interdisciplinary multimodal pain therapy and should therefore also take personal competencies and professional competencies into account. Therefore, new dimensions arise for the implementation of the IMA, which should be discussed in the future.

[Feasibility of the interdisciplinary multimodal assessment-The team perspective]. / Umsetzbarkeit des interdisziplinären multimodalen Assessments ­ die Teamperspektive.

BACKGROUND: Secondary preventive outpatient diagnostic services for patients with pain and risk factors for chronification have not yet been sufficiently established. In the PAIN2020 project (Innovation Fund, 01NVF17049) an outpatient interdisciplinary multimodal assessment (IMA) was introduced for the first time early in the course of the disease. OBJECTIVE: For the implementation of the IMA procedures for team cooperation and decision criteria were developed, which were implemented by a team of medical, physiotherapeutic and psychological therapists. These procedures and decision criteria are to be discussed against the background of clinical experience and examined with respect to their feasibility (qualitative). METHODS: In PAIN2020 a workshop on IMA was held in September 2021 to jointly reflect on the findings and experiences gained in the process so far through monitoring and structuring documentation in the implementation with staff or teams of PAIN2020 centers on the feasibility of implementing a structured interdisciplinary multimodal assessment. In three work phases, occupational group-specific and cross-occupational group topics were addressed. RESULTS: In the decision-making processes of the occupational groups, in addition to profession-specific focal points within the framework of the assessment of findings (somatic, functional or psychosocial core criteria), overarching core criteria within the professions as well as complementary patient-related aspects are evident, which are included in the integrative team process. With respect to team collaboration, the implementation of the team meeting and the final discussion can be used to identify structural and process parameters that promote or inhibit implementation, which are also accompanied by interactional factors. DISCUSSION: For the implementation of the IMA, there were (1) adaptations of the IMA, which is currently implemented as A­IMA in the selective agreement with BARMER and (2) new dimensions or task fields and ideas for evidence-based concepts for the content design of integrative diagnostics as well as for the feedback of the results to the patients, which should be discussed in the future.

[Emotional competence of patients with chronic pain : A self- and third-party assessment]. / Emotionale Kompetenzen bei Menschen mit chronifizierten Schmerzen : Ein Selbst- und Fremdbild.

RESEARCH QUESTION: The aim of the study is to assess the status quo of emotional competence in people with chronic pain. How do patients experience themselves regarding to their ability to perceive, express, and regulate emotions? And does this assessment coincide with the assessment of emotional competence (EC) by mental health professionals? METHODS: The study took place in the context of interdisciplinary multimodal pain therapy at an outpatient clinic in N = 184 adult German-speaking individuals with non-cancer-related chronic pain. EC was assessed at the end of therapy using the self- and third-party assessment scales of the Emotional Competence Questionnaire. The external assessment was performed by the mental health team. Standard scores were created using the norm sample provided by questionnaires. These were analyzed descriptively and inferentially. RESULTS: Self-perceived EC was average (Mself_total = 99.31; SD = 7.78). The mental health professionals predominantly rated the emotional competence of the patients significantly lower (Mexternal_total = 94,70; SD = 7,81; F(1.179) = 35,73; p < 0.001; η2 = 0.17). Emotional expressivity, as a component of EC, was externally rated as below average (Mexpressivity_external = 89.14, SD = 10.33). DISCUSSION: Patients with chronic pain rate themselves as unimpaired in terms of their daily emotional awareness, expression, and regulation abilities. At the same time, mental health professionals rate these same individuals as significantly less emotionally competent. The question remains open as to what extent the divergent assessments can be explained by assessment bias.

[Emotions in chronic pain : Changes in the course of day clinic interdisciplinary multimodal pain therapy]. / Emotionen bei chronifiziertem Schmerz : Veränderungen im Verlauf einer tagesklinischen interdisziplinären multimodalen Schmerztherapie.

RESEARCH QUESTION: The present study examined the extent to which emotional experience and emotional competence (EC) change in people with chronic pain during interdisciplinary multimodal pain treatment (IMPT). METHODS: The study included N = 184 adult German-speaking individuals with non-cancer-related chronic pain. They completed a day clinic IMPT. The frequency of specific emotions (anger, etc.) and EC was assessed at three measurement time points using the Questionnaire for Emotion-Specific Self-Assessment of Emotional Competencies (ERSQ-ES) and the Emotional Competency Questionnaire (ECQ). The course results were analyzed descriptively, inferentially, and using linear regression. RESULTS: Positive emotions were experienced more frequently (effect size r = 0.40; p < 0.001) and negative emotions less frequently (r = 0.39, p < 0.001) at end of therapy. The experience of anger decreased particularly strongly (r = 0.52; p < 0.001). Self-assessed EC did not change during the IMPT (χ2ECQ_total (2) = 0.09; p = 0.956). EC largely explained the variance in the frequency experience of positive (R2 = 0.468) and negative emotions (R2 = 0.390). DISCUSSION: Improvements in patient-reported frequencies of positive and negative emotions during IMPT were demonstrated. Further research should validate these results using a control group. Even though no explicit increase in competence was perceivable for the studied subjects, EC had a high predictive value for emotion frequency. Future therapy designs and evaluations should focus more on changes of emotional experience.

[Development of two outpatient interdisciplinary group modules in the treatment of patients with pain and risk of chronification]. / Entwicklung zweier ambulanter gruppentherapeutischer interdisziplinärer Therapiemodule in der Behandlung von Patienten mit Schmerzen und Chronifizierungsrisiko.

BACKGROUND AND OBJECTIVE: An early treatment of patients who suffer from pain and show risk factors for chronification is meaningful as these patients can benefit from an early interdisciplinary multimodal pain treatment (IMST). In view of the insufficient treatment, two outpatient treatment modules for the secondary prevention of pain chronification are developed within the framework of PAIN2020: the educative and accompanying IMST (E­IMST and B­IMST). MATERIAL AND METHODS: The developmental process of both IMSTs is presented. In this context two target groups of patients were defined for which 1 session (E­IMST) or 10 intervention appointments (B­IMST) were planned, depending on the chronification, impairment and complexity of the disorder. The conception was carried out in five steps: development of the objectives, development of the main contents, workshop on the content and conceptional design (contents, mediation, exercises), preparation of a time schedule and processing of the results (manual, presentations, worksheets, handbook). The B­IMST was initially developed from which the contents for the E­IMST were subsequently extracted. Additionally, a concept for testing the feasibility and a working model for a pilot study were developed. RESULTS: The objectives for both forms of IMST are improvement of the understanding of pain and contributing factors, the increase of the experience of control and self-efficacy and the increase in self-responsibility with respect to strategies to reduce pain. Differences between the two treatment modules arise from the needs and framework conditions. Medical, physiotherapeutic and psychotherapeutic contents and schedules were organized for both IMST modules. The B­IMST consists of five modules each with two sessions as group interventions (biopsychosocial model, activation planning, regulation of needs, sleep and medication, routine transfer). The 3­h E­IMST group intervention mainly intends to mediate knowledge on pain and the biopsychosocial pain model. Theoretical and practical interventions, empirical knowledge and experience-oriented methods are employed. CONCLUSION: There are now two interdisciplinary structured manuals for the secondary preventive treatment of patients with recurrent pain and a risk profile for chronification. These approaches must now prove themselves with respect to feasibility and effectiveness.

[Psychosocial factors in pain and pain management : A statement]. / Psychosoziale Faktoren bei Schmerz und Schmerzbehandlung : Eine Positionsbestimmung.

Although psychosocial factors have a profound impact on the experience of pain and pain recovery, the transfer to clinical application has so far been insufficient. With this article, a task force of the special interest group "Psychosocial Aspects of Pain" of the German Pain Society (Deutsche Schmerzgesellschaft e. V.) would like to draw attention to the considerable discrepancy between existing scientific evidence on the importance of psychosocial factors in the development of chronic pain disorders and the translation of these findings into the care of pain patients. Our objective is a stronger integration of psychological and psychosomatic expertise in pain treatment and research, as well as the improvement of structural and institutional conditions, to achieve an increased consideration of psychosocial aspects. In this way, modern, integrative and complex pain concepts can reach the patient. Based on these fundamental findings on the importance of psychosocial factors in pain and pain treatment, implications for the transfer to clinic and further research will be shown.

[Prevention of chronic pain in the German healthcare system : Current state and perspective]. / Vermeidung chronischer Schmerzen in der deutschen Gesundheitsversorgung : Derzeitiger Stand und Ausblick.

The current healthcare provision in Germany is established, in particular, for the diagnostics and treatment of chronic pain conditions; however, the current aim is to initiate the diagnostic and therapeutic approaches oriented towards the biopsychosocial pain model in the early stages of pain, i.e. before the onset of chronification, for patients with pain and a risk of chronification in order to actively avoid chronification processes. In this context, multiple risk factors play an important role for the diagnostic and therapeutic approaches as well as for the interdisciplinary multimodal pain therapy developed for this purpose. The Global Year of the International Association for the Study of Pain (IASP) 2020 addressed the prevention of (chronic) pain, a welcome opportunity to provide a short review of the evidence for and clinical experiences with timely diagnostic and therapeutic options and to summarize the current framework conditions and scientific recommendations for Germany. At the end of this article the implications for future research are summarized, particularly for the treatment of patients with pain and risk of chronification.

[Evaluation of an early interdisciplinary multimodal assessment for patients with pain : Protocol of a randomized controlled study (PAIN2020)]. / Evaluation eines frühen interdisziplinären multimodalen Assessments für Patienten mit Schmerzen : Protokoll einer randomisierten kontrollierten Studie (PAIN2020).

Health care provision for patients with pain and risk factors for chronicity is still insufficient and characterized in particular by over-, under- and misuse of existing approaches. The PAIN2020 project is funded by the German Federal Ministry of Health Care (Innovationsfonds 01NVF17049) and aims to improve health care delivery for this group of patients by implementing an early ambulatory diagnostic approach by a pain specialist, resulting in an improvement in pain and restored or maintained function. A randomized clinical trial in 31 facilities Germany-wide will identify eligible patients and guide them into early specialized pain diagnostics. The interventional arm provides an interdisciplinary multimodal assessment, delivered by pain medicine specialists, physiotherapists and clinical psychologists. The control arm contains a single assessment by a pain specialist. Patients and caregivers receive detailed recommendations for evidence-based interventions tailored to the needs of the individual patient. Two evaluation approaches will be merged. The first requires a net sample size of 3840 patients, assessed (admission) and followed-up (3 and 6 months) by clinical data (German Pain Questionnaire, additional scales) and analyzed by a multi-level approach. In a second evaluation arm the clinical data of the included patients will be supplemented by secondary data from a statutory health insurance (BARMER) and compared to a sample of policyholders not addressed by the study. Data analyses will be performed by an external evaluation institute. The project started in April 2018.

[Early Interdisciplinary Assessment for Secondary Prevention of Chronic Pain - Scientific Background, Concept of Delivery, Target Population and Status of Health Care Provision]. / Frühes interdisziplinäres Assessment zur Sekundärprävention chronischer Schmerzen.

Pain is agreed to be understood as a multi-causal, biopsychosocial phenomenon. A sufficient health care delivery shall therefore contain a corresponding interdisciplinary approach in diagnostic and therapy, respectively. Factors contributing to the process of chronification should be considered early in treating patients suffering from recurrent or persistent pain. Close collaboration of multidisciplinary protagonists in health care as well as interdisciplinary comprehensive medical treatment offer are two of the prerequisites for good practice in health care treating patients with pain.The article introduces into existing knowlegde about pain and risk factors for chronicity. The background (evidence and theoretical) of corresponding health care approaches and a detailed concept of interdisciplinary pain diagnostic by a multiprofessional team consisting of pain physician, physiotherapist and clinical psychologist are described and discussed.

Patient-reported outcome measures for acute and chronic pain: current knowledge and future directions.

PURPOSE OF REVIEW: During the past years, patient-reported outcomes (PROs) and patient-reported outcome measures (PROMs) have become of growing awareness and importance in medical research and practice. This review summarizes recent developments concerning PROs and PROMs related to pain in the acute postoperative as well as chronic settings and indicates gaps and challenges relevant for future research and clinical applications. RECENT FINDINGS: There are core outcome sets (COSs) of PROs and PROMs developed for specific pain conditions but patients' perception is not sufficiently considered in the development of corresponding concepts and instruments. SUMMARY: COSs of PRO and PROMs are crucial in the field of research to enhance the comparability of results and reducing outcome reporting bias. In clinical practice PROs and PROMs are important for allocation of treatment. Concerning the development and implementation of PROs and PROMs patients' perspective should be thoroughly considered. Relating to acute as well as chronic pain there are some attempts to create COSs of PROs and PROMs but validity and reliability for both are still missing.

PAIN2.0: study protocol for a multicentre randomised controlled trial to evaluate the efficacy of a 10-week outpatient interdisciplinary multimodal pain therapy to manage recurrent pain for patients with risk factors of developing chronic pain in Germany.

BACKGROUND: Up to 27% of the German population suffers from recurrent or persistent pain (lasting more than three months). Therefore, prevention of chronic pain is one major object of pain management interventions. The aim of this nationwide, multicentre, randomised controlled trial is to evaluate the efficacy of a 10-week ambulatory (outpatient) interdisciplinary multimodal pain therapy (A-IMPT) for patients with recurrent pain and at risk of developing chronic pain. This project was initiated by the German Pain Society (Deutsche Schmerzgesellschaft e.V.) and the public health insurance provider BARMER. It is currently funded by the German Innovation Fund (01NVF20023). The study PAIN2.0 focuses on reducing pain intensity and pain-related disability and investigates whether this intervention can improve physical activity, psychological well-being, and health literacy. METHODS: PAIN2.0 is designed as a multicentre 1:1 randomised controlled trial with two parallel groups (randomisation at the patient level, planned N = 1094, duration of study participation 12 months, implemented by 22 health care facilities nationwide). After 6 months, patients within the control group also receive the intervention. The primary outcomes are pain intensity and pain-related impairment, measured as Characteristic Pain Intensity (PI) and Disability Score (DS) (Von Korff), as well as patient-related satisfaction with the intervention. Secondary outcomes are the number of sick leave days, sickness allowance, treatment costs, psychological distress, health-related quality of life, and catastrophizing. The effects of the intervention will be analysed by a parallel-group comparison between the intervention and control groups. In addition, the long-term effects within the intervention group will be observed and a pre-post comparison of the control group before and after the intervention will be performed. DISCUSSION: Recurrent or persistent pain is common in the German population and causes high costs for patients and society. The A-IMPT aims to improve pain and pain-related impairments in pain patients at risk of chronification, thereby reducing the risk of developing chronic pain with its high socioeconomic burden. This new therapy could easily be integrated into existing therapy programs if positively evaluated. TRIAL REGISTRATION: The trial PAIN2.0 has been registered in the German Clinical Trials Register (DRKS) since 21/11/2022 with the ID DRKS00030773 .

Developing consensus on core outcome sets of domains for acute, the transition from acute to chronic, recurrent/episodic, and chronic pain: results of the INTEGRATE-pain Delphi process.

Background: Pain is the leading cause of disability worldwide among adults and effective treatment options remain elusive. Data harmonization efforts, such as through core outcome sets (COS), could improve care by highlighting cross-cutting pain mechanisms and treatments. Existing pain-related COS often focus on specific conditions, which can hamper data harmonization across various pain states. Methods: Our objective was to develop four overarching COS of domains/subdomains (i.e., what to measure) that transcend pain conditions within different pain categories. We hosted a meeting to assess the need for these four COS in pain research and clinical practice. Potential COS domains/subdomains were identified via a systematic literature review (SLR), meeting attendees, and Delphi participants. We conducted an online, three step Delphi process to reach a consensus on domains to be included in the four final COS. Survey respondents were identified from the SLR and pain-related social networks, including multidisciplinary health care professionals, researchers, and people with lived experience (PWLE) of pain. Advisory boards consisting of COS experts and PWLE provided advice throughout the process. Findings: Domains in final COS were generally related to aspects of pain, quality of life, and physical function/activity limitations, with some differences among pain categories. This effort was the first to generate four separate, overarching COS to encourage international data harmonization within and across different pain categories. Interpretation: The adoption of the COS in research and clinical practice will facilitate comparisons and data integration around the world and across pain studies to optimize resources, expedite therapeutic discovery, and improve pain care. Funding: Innovative Medicines Initiative 2 Join Undertaking; European Union Horizon 2020 research innovation program, European Federation of Pharmaceutical Industries and Associations (EFPIA) provided funding for IMI-PainCare. RDT acknowledges grants from Esteve and TEVA.

Longitudinal outcome evaluations of Interdisciplinary Multimodal Pain Treatment programmes for patients with chronic primary musculoskeletal pain: A systematic review and meta-analysis.

BACKGROUND AND OBJECTIVES: Although Interdisciplinary Multimodal Pain Treatment (IMPT) programmes share a biopsychosocial approach to increase the wellbeing of patients with chronic pain, substantial variation in content and duration have been reported. In addition, it is unclear to what extent any favourable health outcomes are maintained over time. Therefore, our first aim was to identify and analyse the change over time of patient-related outcome measures in cohorts of patients who participated in IMPT programmes. Our second aim was to acquire insight into the heterogeneity of IMPT programmes. DATABASES AND DATA TREATMENT: The study protocol was registered in Prospero under CRD42018076093. We searched Medline, Embase, PsycInfo and Cinahl from inception to May 2020. All study selection, data extraction and risk of bias assessments were independently performed by two researchers. Study cohorts were eligible if they included adult patients with chronic primary musculoskeletal pain for at least 3 months. We assessed the change over time, by calculating pre-post, post-follow-up and pre-follow-up contrasts for seven different patient-reported outcome domains. To explore the variability between the IMPT programmes, we summarized the patient characteristics and treatment programmes using the intervention description and replication checklist. RESULTS: The majority of the 72 included patient cohorts significantly improved during treatment. Importantly, this improvement was generally maintained at follow-up. In line with our expectations and with previous studies, we observed substantial methodological and statistical heterogeneity. CONCLUSIONS: This study shows that participation in an IMPT programme is associated with considerable improvements in wellbeing that are generally maintained at follow-up. The current study also found substantial heterogeneity in dose and treatment content, which suggests different viewpoints on how to optimally design an IMPT programme. SIGNIFICANCE: The current study provides insight into the different existing approaches regarding the dose and content of IMPT programs. This analysis contributes to an increased understanding of the various approaches by which a biopsychosocial perspective on chronic pain can be translated to treatment programs. Furthermore, despite theoretical and empirical assertions regarding the difficulty to maintain newly learned health behaviors over time, the longitudinal analysis of health outcomes did not find a relapse pattern for patients who participated in IMPT programs.

Developing consensus on core outcome domains for assessing effectiveness in perioperative pain management: results of the PROMPT/IMI-PainCare Delphi Meeting.

ABSTRACT: Postoperative pain management is still insufficient, leading to major deficits, including patient suffering, impaired surgical recovery, long-term opioid intake, and postsurgical chronic pain. Yet, identifying the best treatment options refers to a heterogeneous outcome assessment in clinical trials, not always reflecting relevant pain-related aspects after surgery and therefore hamper evidence synthesis. Establishing a core outcome set for perioperative pain management of acute pain after surgery may overcome such limitations. An international, stepwise consensus process on outcome domains ("what to measure") for pain management after surgery, eg, after total knee arthroplasty, sternotomy, breast surgery, and surgery related to endometriosis, was performed. The process, guided by a steering committee, involved 9 international stakeholder groups and patient representatives. The face-to-face meeting was prepared by systematic literature searches identifying common outcome domains for each of the 4 surgical procedures and included breakout group sessions, world-café formats, plenary panel discussions, and final voting. The panel finally suggested an overall core outcome set for perioperative pain management with 5 core outcome domains: physical function (for a condition-specific measurement), pain intensity at rest, pain intensity during activity, adverse events, and self-efficacy. Innovative aspects of this work were inclusion of the psychological domain self-efficacy, as well as the specific assessment of pain intensity during activity and physical function recommended to be assessed in a condition-specific manner. The IMI-PROMPT core outcome set seeks to improve assessing efficacy and effectiveness of perioperative pain management in any clinical and observational studies as well as in clinical practice.

Assessing outcome in postoperative pain trials: are we missing the point? A systematic review of pain-related outcome domains reported in studies early after total knee arthroplasty.

ABSTRACT: The management of acute postoperative pain remains suboptimal. Systematic reviews and Cochrane analysis can assist with collating evidence about treatment efficacy, but the results are limited in part by heterogeneity of endpoints in clinical trials. In addition, the chosen endpoints may not be entirely clinically relevant. To investigate the endpoints assessed in perioperative pain trials, we performed a systematic literature review on outcome domains assessing effectiveness of acute pain interventions in trials after total knee arthroplasty. We followed the Cochrane recommendations for systematic reviews, searching PubMed, Cochrane, and Embase, resulting in the screening of 1590 potentially eligible studies. After final inclusion of 295 studies, we identified 11 outcome domains and 45 subdomains/descriptors with the domain "pain"/"pain intensity" most commonly assessed (98.3%), followed by "analgesic consumption" (88.8%) and "side effects" (75.3%). By contrast, "physical function" (53.5%), "satisfaction" (28.8%), and "psychological function" (11.9%) were given much less consideration. The combinations of outcome domains were inhomogeneous throughout the studies, regardless of the type of pain management investigated. In conclusion, we found that there was high variability in outcome domains and inhomogeneous combinations, as well as inconsistent subdomain descriptions and utilization in trials comparing for effectiveness of pain interventions after total knee arthroplasty. This points towards the need for harmonizing outcome domains, eg, by consenting on a core outcome set of domains which are relevant for both stakeholders and patients. Such a core outcome set should include at least 3 domains from 3 different health core areas such as pain intensity, physical function, and one psychological domain.

[Opioids in the management of chronic pain and driving ability]. / Chronische Schmerzen: Fahrsicherheitsrelevante Aspekte beim Einsatz von Opioiden.

Opioids are important in pain management of patients suffering from chronic pain. However, opioid use is associated with several concerns, such as opioid induced impairment of cognitive and psychomotor performance. Several studies could demonstrate that opioid treatment in stable doses does not necessarily impair complex activities such as driving ability. But due to intraindividual variability to opioid response and other confounding factors (e.g. pain intensity, co-morbidity) judgements have to be made on an individual basis only.

Developing consensus on core outcome domains and measurement instruments for assessing effectiveness in perioperative pain management after sternotomy, breast cancer surgery, total knee arthroplasty, and surgery related to endometriosis : The IMI-PainCare PROMPT protocol for achieving a consensus on core outcome domains.

INTRODUCTION: Evidence synthesis of clinical trials requires consistent outcome assessment. For pain management after surgery, inconsistency of effectiveness assessment is still observed. A subproject of IMI-PainCare (Innovative Medicine Initiatives, www.imi-paincare.eu ) aims for identifying core outcome domains and measurement instruments for postoperative pain in four surgical fields (sternotomy, breast cancer surgery, total knee arthroplasty, and surgery related to endometriosis) in order to harmonize outcome assessment for perioperative pain management. METHODS: A multifaceted process will be performed according to existing guidelines (Core Outcome Measures in Effectiveness Trials (COMET), COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN)). In a first step, outcome domains will be identified via systematic literature review and consented on during a 1-day consensus meeting by 10 stakeholder groups, including patient representatives, forming an IMI PROMPT consensus panel. In a second step, outcome measurement instruments regarding the beforehand consented core outcome domains and their psychometric properties will be searched for via systematic literature review and approved by COSMIN checklist for study quality and scale quality separately. In a three-step online survey, the IMI PROMPT consensus panel will vote for most suitable measurement instruments. The process is planned to be conducted between 11/2017 (systematic literature review on common outcome domains) and 3/2022 (final voting on core outcome measurement).

Pain Measurement in Rheumatic and Musculoskeletal Diseases: Where To Go from Here? Report from a Special Interest Group at OMERACT 2018.

OBJECTIVE: Establishing a research agenda on standardizing pain measurement in clinical trials in rheumatic and musculoskeletal diseases (RMD). METHODS: Discussion during a meeting at the Outcome Measures in Rheumatology (OMERACT) 2018, prepared by a systematic review of existing core outcome sets and a patient online survey. RESULTS: Several key questions were debated: Is pain a symptom or a disease? Are pain core (sub)domains consistent across RMD? How to account for pain mechanistic descriptors (e.g., central sensitization) in pain measurement? CONCLUSION: Characterizing and assessing the spectrum of pain experience across RMD in a standardized fashion is the objective of the OMERACT Pain Working Group.

The OMERACT-OARSI Core Domain Set for Measurement in Clinical Trials of Hip and/or Knee Osteoarthritis.

OBJECTIVE: To update the 1997 OMERACT-OARSI (Outcome Measures in Rheumatology-Osteoarthritis Research Society International) core domain set for clinical trials in hip and/or knee osteoarthritis (OA). METHODS: An initial review of the COMET database of core outcome sets (COS) was undertaken to identify all domains reported in previous COS including individuals with hip and/or knee OA. These were presented during 5 patient and health professionals/researcher meetings in 3 continents (Europe, Australasia, North America). A 3-round international Delphi survey was then undertaken among patients, healthcare professionals, researchers, and industry representatives to gain consensus on key domains to be included in a core domain set for hip and/or knee OA. Findings were presented and discussed in small groups at OMERACT 2018, where consensus was obtained in the final plenary. RESULTS: Four previous COS were identified. Using these, and the patient and health professionals/researcher meetings, 50 potential domains formed the Delphi survey. There were 426 individuals from 25 different countries who contributed to the Delphi exercise. OMERACT 2018 delegates (n = 129) voted on candidate domains. Six domains gained agreement as mandatory to be measured and reported in all hip and/or knee OA clinical trials: pain, physical function, quality of life, and patient's global assessment of the target joint, in addition to the mandated core domain of adverse events including mortality. Joint structure was agreed as mandatory in specific circumstances, i.e., depending on the intervention. CONCLUSION: The updated core domain set for hip and/or knee OA has been agreed upon. Work will commence to determine which outcome measurement instrument should be recommended to cover each core domain.