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.

Determinants of satisfaction with acute pain therapy during and after childbirth.

BACKGROUND: An important task in obstetrics is to offer patients adequate pain management after vaginal delivery (VD) and after cesarean section (CS). The aim of the present analysis was to assess pain intensity at the day after childbirth, after 3 and 6 months in women after VD and after CS. Additionally, it was planned to identify determinants of maternal satisfaction with acute pain therapy following VD and CS. METHODS: This secondary analysis of a single-center prospective cohort study included 210 parturients. The women gave birth in the University Hospital of Wuerzburg. They completed a survey before childbirth (P), on the first day (D1), 3 and 6 months after VD and CS. The survey included questions about the expected pain, the experienced pain, the birth, the pain afterwards and also psychological questionnaires. In addition, information was collected from the patient records. Women with planned CS received spinal anesthesia. A secondary CS was performed with an epidural, spinal or general anesthesia. Pain therapy on the ward was standardized. The primary outcomes were acute and chronic pain intensity at rest, during movement, determinants of satisfaction with pain therapy and the wish to have received more pain medication during and after VD and CS (D1). RESULTS: A total of 175 women completed the survey at all time points and were available for the analysis (drop-out 16.8%). The results confirmed high pain levels at D1 after CS (median pain intensity during movement: 8 NRS points, interquartile range, IQR 6-9 points). After VD pain scores were much lower (median pain intensity during movement: 4 points, IQR 2-5 points). Of the mothers 7.4% reported pain at rest at all time points after VD or CS but pain intensity was low after 3 and 6 months (median pain intensity at rest: 2 points, IQR 0-3 points), 28% received extended-release opioids after CS and 33% of women (VD and CS) had an epidural. The most important influencing factor for lower satisfaction with pain therapy after CS or VD was inadequate pain relief. Women with VD who had an epidural, were more satisfied during delivery than women without but there was no difference at D1. DISCUSSION: This study confirmed high acute pain levels following CS and an incidence of chronic pain of around 7% but pain intensity was low and one third received strong opioids after CS. Around 11% of women after primary CS (8% epidural, 3% combined spinal/epidural) and around 55% of women after secondary CS had an epidural, which could be used for pain therapy after birth. Women without an epidural or without opioids may not have had good pain management. The received pain relief appeared to be the most relevant predictor for satisfaction and the wish to have received more pain medication. Mothers having a VD with an epidural catheter were more satisfied with pain therapy during birth than those without. Therefore, a better multimodal pain management (including opioids, epidural and nonopioids) might provide better pain relief and might improve overall satisfaction with pain treatment following CS. Finally, the received pain relief might be a better patient-related outcome measure for satisfaction with pain treatment after childbirth than pain intensity alone.

Patient Reported Outcome Measures in Chronic Neuropathic Pain Clinical Trials - A Systematic Literature Review.

In neuropathic pain clinical trials, the patient's perspective is often insufficiently reflected focusing mainly on pain intensity. Comparability of outcome assessment is limited due to heterogenous patient reported outcome measures (PROMs). The MEDLINE, CENTRAL, and Embase databases and reference lists of published meta-analyses were searched. Randomized controlled studies assessing treatment efficacy of drugs for chronic neuropathic pain were included. PROMs were assigned to recommended IMMPACT/NeuPSIG domains: pain intensity, pain other aspects, physical functioning, emotional functioning, global improvement and satisfaction, adverse events, participant disposition. Domains and PROMs were compared regarding the publication year and methodological quality of the studies. Within the 251 included studies 200 PROMs were used with 27 being recommended by IMMPACT/NeuPSIG. The number of domains was higher in high/moderate quality studies. The (sub-) domains 'physical functioning', 'global improvement and satisfaction', and 'neuropathic pain quality' were assessed more frequently in high/moderate quality studies and those published after 2011. Recent studies and those of better quality more often used the recommended PROMs. Although neuropathic assessment via PROMs has improved, there is still a high heterogeneity. A standardized core set of outcome domains and should be defined to improve neuropathic pain treatment and to achieve better comparability of clinical trials. Perspective: This systematic literature review assesses the use of patient reported outcome measures (PROMs) in chronic neuropathic pain. The results show that there is still a high heterogeneity, highlighting the need for a standardized core set of outcome domains and PROMs to improve comparability of clinical trials and neuropathic pain treatment.

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.

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.