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.

Cost-effectiveness of the Perioperative Pain Management Bundle a registry-based study.

Introduction: The Perioperative Pain Management Bundle was introduced in 10 Serbian PAIN OUT network hospitals to improve the quality of postoperative pain management. The Bundle consists of 4 elements: informing patients about postoperative pain treatment options; administering a full daily dose of 1-2 non-opioid analgesics; administering regional blocks and/or surgical wound infiltration; and assessing pain after surgery. In this study, we aimed to assess the cost-effectiveness of the Bundle during the initial 24 h after surgery. Materials and methods: The assessment of cost-effectiveness was carried out by comparing patients before and after Bundle implementation and by comparing patients who received all Bundle elements to those with no Bundle element. Costs of postoperative pain management included costs of the analgesic medications, costs of labor for administering these medications, and related disposable materials. A multidimensional Pain Composite Score (PCS), the effectiveness measurement, was obtained by averaging variables from the International Pain Outcomes questionnaire evaluating pain intensity, interference of pain with activities and emotions, and side effects of analgesic medications. The incremental cost-effectiveness ratio (ICER) was calculated as the incremental change in costs divided by the incremental change in PCS and plotted on the cost-effectiveness plane along with the economic preference analysis. Results: The ICER value calculated when comparing patients before and after Bundle implementation was 181.89 RSD (1.55 EUR) with plotted ICERs located in the northeast and southeast quadrants of the cost-effectiveness plane. However, when comparing patients with no Bundle elements and those with all four Bundle elements, the calculated ICER was -800.63 RSD (-6.82 EUR) with plotted ICERs located in the southeast quadrant of the cost-effectiveness plane. ICER values differ across surgical disciplines. Conclusion: The proposed perioperative pain management Bundle is cost-effective. The cost-effectiveness varies depending on the number of implemented Bundle elements and fluctuates across surgical disciplines.

The Perioperative Pain Management Bundle is Feasible: Findings From the PAIN OUT Registry.

OBJECTIVES: The quality of postoperative pain management is often poor. A "bundle," a small set of evidence-based interventions, is associated with improved outcomes in different settings. We assessed whether staff caring for surgical patients could implement a "Perioperative Pain Management Bundle" and whether this would be associated with improved multidimensional pain-related patient-reported outcomes (PROs). METHODS: "PAIN OUT," a perioperative pain registry, offers tools for auditing pain-related PROs and obtaining information about perioperative pain management during the first 24 hours after surgery. Staff from 10 hospitals in Serbia used this methodology to collect data at baseline. They then implemented the "Perioperative Pain Management Bundle" into the clinical routine and collected another round of data. The bundle consists of 4 treatment elements: (1) a full daily dose of 1 to 2 nonopioid analgesics (eg, paracetamol and/or nonsteroidal anti-inflammatory drugs), (2) at least 1 type of local/regional anesthesia, (3) pain assessment by staff, and (4) offering patients information about pain management. The primary endpoint was a multidimensional pain composite score (PCS), evaluating pain intensity, interference, and side effects that was compared between patients who received the full bundle versus not. RESULTS: Implementation of the complete bundle was associated with a significant reduction in the PCS ( P < 0.001, small-medium effect size [ES]). When each treatment element was evaluated independently, nonopioid analgesics were associated with a higher PCS (ie, poorer outcome, and negligible ES), and the other elements were associated with a lower PCS (all negligible small ES). Individual PROs were consistently better in patients receiving the full bundle compared with 0 to 3 elements. The PCS was not associated with the surgical discipline. DISCUSSION: We report findings from using a bundle approach for perioperative pain management in patients undergoing mixed surgical procedures. Future work will seek strategies to improve the effect.

Following Evidence-Based Recommendations for Perioperative Pain Management after Cesarean Section Is Associated with Better Pain-Related Outcomes: Analysis of Registry Data.

Women who have had a Cesarean Section (CS) frequently report severe pain and pain-related interference. One reason for insufficient pain treatment might be inconsistent implementation of evidence-based guidelines. We assessed the association between implementing three elements of care recommended by guidelines for postoperative pain management and pain-related patient-reported outcomes (PROs) in women after CS. The analysis relied on an anonymized dataset of women undergoing CS, retrieved from PAIN OUT. PAIN OUT, an international perioperative pain registry, provides clinicians with treatment assessment methodology and tools for patients to assess multi-dimensional pain-related PROs on the first postoperative day. We examined whether the care included [i] regional anesthesia with a neuraxial opioid OR general anesthesia with wound infiltration or a Transvesus Abdominis Plane block; [ii] at least one non-opioid analgesic at the full daily dose; and [iii] pain assessment and recording. Credit for care was given only if all three elements were administered (= "full"); otherwise, it was "incomplete". A "Pain Composite Score-total" (PCStotal), evaluating outcomes of pain intensity, pain-related interference with function, and side-effects, was the primary endpoint in the total cohort (women receiving GA and/or RA) or a sub-group of women with RA only. Data from 5182 women was analyzed. "Full" care was administered to 20% of women in the total cohort and to 21% in the RA sub-group. In both groups, the PCStotal was significantly lower compared to "incomplete" care (p < 0.001); this was a small-to-moderate effect size. Administering all three elements of care was associated with better pain-related outcomes after CS. These should be straightforward and inexpensive for integration into routine care after CS. However, even in this group, a high proportion of women reported poor outcomes, indicating that additional work needs to be carried out to close the evidence-practice gap so that women who have undergone CS can be comfortable when caring for themselves and their newborn.

Status quo of pain-related patient-reported outcomes and perioperative pain management in 10,415 patients from 10 countries: Analysis of registry data.

BACKGROUND: Postoperative pain is common at the global level, despite considerable attempts for improvement, reflecting the complexity of offering effective pain relief. In this study, clinicians from Mexico, China, and eight European countries evaluated perioperative pain practices and patient-reported outcomes (PROs) in their hospitals as a basis for carrying out quality improvement (QI) projects in each country. METHODS: PAIN OUT, an international perioperative pain registry, provided standardized methodology for assessing management and multi-dimensional PROs on the first postoperative day, in patients undergoing orthopaedic, general surgery, obstetric & gynaecology or urological procedures. RESULTS: Between 2017 and 2019, data obtained from 10,415 adult patients in 105 wards, qualified for analysis. At the ward level: 50% (median) of patients reported worst pain intensities ≥7/10 NRS, 25% spent ≥50% of the time in severe pain and 20-34% reported severe ratings for pain-related functional and emotional interference. Demographic variables, country and surgical discipline explained a small proportion of the variation in the PROs, leaving about 88% unexplained. Most treatment processes varied considerably between wards. Ward effects accounted for about 7% and 32% of variation in PROs and treatment processes, respectively. CONCLUSIONS: This comprehensive evaluation demonstrates that many patients in this international cohort reported poor pain-related PROs on the first postoperative day. PROs and treatments varied greatly. Most of the variance of the PROs could not be explained. The findings served as a basis for devising and implementing QI programmes in participating hospitals. SIGNIFICANCE: In preparation for quality improvement projects, we comprehensively evaluated pain-related patient-reported outcomes (PROs) and treatment practices of 10,415 adult patients spanning 10 countries. PROs were generally poor. Demographics, country and surgical discipline explained a small proportion of variation for the PROs, about 88% remained unexplained. Treatment practices varied considerably between wards. Ward effects accounted for about 7% and 32% of variation in PROs and treatment processes, respectively. Future studies will aim to identify treatments which are associated with improved outcomes.

Rethinking the definition of chronic postsurgical pain: composites of patient-reported pain-related outcomes vs pain intensities alone.

ABSTRACT: Chronic postsurgical pain (CPSP) is defined by pain intensity and pain-related functional interference. This study included measures of function in a composite score of patient-reported outcomes (PROs) to investigate the incidence of CPSP. Registry data were analyzed for PROs 1 day and 12 months postoperatively. Based on pain intensity and pain-related interference with function, patients were allocated to the groups " CPSPF " (at least moderate pain with interference), " mixed " (milder symptoms), and " no CPSPF ". The incidence of CPSPF was compared with CPSP rates referring to published data. Variables associated with the PRO-12 score (composite PROs at 12 months; numeric rating scale 0-10) were analyzed by linear regression analysis. Of 2319 patients, 8.6%, 32.5%, and 58.9% were allocated to the groups CPSPF , mixed , and no CPSPF , respectively. Exclusion of patients whose pain scores did not increase compared with the preoperative status, resulted in a 3.3% incidence. Of the patients without pre-existing pain, 4.1% had CPSPF. Previously published pain cutoffs of numeric rating scale >0, ≥3, or ≥4, used to define CPSP, produced rates of 37.5%, 9.7%, and 5.7%. Pre-existing chronic pain, preoperative opioid medication, and type of surgery were associated with the PRO-12 score (all P < 0.05). Opioid doses and PROs 24 hours postoperatively improved the fit of the regression model. A more comprehensive assessment of pain and interference resulted in lower CPSP rates than previously reported. Although inclusion of CPSP in the ICD-11 is a welcome step, evaluation of pain characteristics would be helpful in differentiation between CPSPF and continuation of pre-existing chronic pain.

Postoperative Pain and Age: A Retrospective Cohort Association Study.

BACKGROUND: As the population ages, the number of elderly people undergoing surgery increases. Literature on the incidence and intensity of postoperative pain in the elderly is conflicting. This study examines associations between age and pain-related patient reported outcomes and perioperative pain management in a dataset of surgical patients undergoing four common surgeries: spinal surgery, hip or knee replacement, or laparoscopic cholecystectomy. Based on the authors' clinical experience, they hypothesize that pain scores are lower in older patients. METHODS: In this retrospective cohort, study data were collected between 2010 and 2018 as part of the international PAIN OUT program. Patients filled out the International Pain Outcomes Questionnaire on postoperative day 1. RESULTS: A total of 11,510 patients from 26 countries, 59% female, with a mean age of 62 yr, underwent one of the aforementioned types of surgery. Large variation was detected within each age group for worst pain, yet for each surgical procedure, mean scores decreased significantly with age (mean Numeric Rating Scale range, 6.3 to 7.3; ß = -0.2 per decade; P ≤ 0.001), representing a decrease of 1.3 Numeric Rating Scale points across a lifespan. The interference of pain with activities in bed, sleep, breathing deeply or coughing, nausea, drowsiness, anxiety, helplessness, opioid administration on the ward, and wish for more pain treatment also decreases with age for two or more of the procedures. Across the procedures, patients reported being in severe pain on postoperative day one 26 to 38% of the time, and pain interfered moderately to severely with movement. CONCLUSIONS: The authors' findings indicate that postoperative pain decreases with increasing age. The change is, however, small and of questionable clinical significance. Additionally, there are still too many patients, at any age, undergoing common surgeries who suffer from moderate to severe pain, which interferes with function, supporting the need for tailoring care to the individual patient.

Associations between early postoperative pain outcome measures and late functional outcomes in patients after knee arthroplasty.

INTRODUCTION/AIM: Early rehabilitation, return to daily life activities and function are the ultimate goals of perioperative care. It is unclear which pain-related patient-reported outcome measures (PROM) mirror treatment effects or are related with early and late functional outcomes. METHODS: We examined associations between two approaches of pain management (scheduled vs 'on demand') and PROMs on post-operative days one and five (POD1, 5) with function on POD5 and 3 months after surgery in patients undergoing Total Knee Arthroplasty (TKA) in a single centre. The scheduled pain management consisted of pain assessment and routine administration of non-opioid drugs, and a weak opioid based on severity of pain reported by patients. The 'on demand' group received non-opioids and/or a weak opioid only when asking 'on demand' for analgesics. RESULTS: On POD1, patients in the scheduled treatment group reported reduced severity of worst pain, less interference of pain with activities in-bed and sleep, and a higher proportion got out of bed. On POD5, these patients reported as well significantly less worst pain, spent significantly less time in severe pain, experienced less interference of pain with activities in bed, and felt less helpless. Furthermore, tests of function, extension and flexion ranges, Barthel index and 6 minutes walking test on POD5, and the Knee Injury and Osteoarthritis Outcome Score (KOOS) 3 months later were significantly better in the scheduled treatment group compared to the 'on demand' treatment group. Pain related PROMs assessed at POD1 and especially at POD5 are associated with better knee range of motion, better performance in activities of daily living, and faster gait speed, as well as less pain, better performance in activities of daily living, as well as higher knee-related quality of life 3 months postoperatively. CONCLUSIONS: Our study demonstrates that severe postoperative pain after TKA might have long lasting consequences, and even small improvements in treatment, although being far from optimal, are accompanied by improved outcomes.

Chronic Breast Pain Prior to Breast Cancer Surgery Is Associated with Worse Acute Postoperative Pain Outcomes.

Acute postoperative pain is associated with adverse short and long-term outcomes among women undergoing surgery for breast cancer. Previous studies identified preexisting pain as a predictor of postoperative pain, but rarely accounted for pain location or chronicity. This study leveraged a multinational pain registry, PAIN OUT, to: (1) characterize patient subgroups based on preexisting chronic breast pain status and (2) determine the association of preexisting chronic pain with acute postoperative pain-related patient-reported outcomes and opioid consumption following breast cancer surgery. The primary outcome was a composite score comprising the mean of pain intensity and pain interference items from the International Pain Outcomes Questionnaire. The secondary outcome was opioid consumption in the recovery room and ward. Among 1889 patients, we characterized three subgroups: no preexisting chronic pain (n = 1600); chronic preexisting pain elsewhere (n = 128) and; chronic preexisting pain in the breast with/without pain elsewhere (n = 161). Controlling for covariates, women with preexisting chronic breast pain experienced more severe acute postoperative pain and pain interference (ß = 1.0, 95% CI = 0.7-1.3, p < 0.001), and required higher doses of opioids postoperatively (ß = 2.7, 95% CI = 0.6-4.8, p = 0.013). Preexisting chronic breast pain may be an important risk factor for poor pain-related postoperative outcomes. Targeted intervention of this subgroup may improve recovery.

Towards Better Perioperative Pain Management in Mexico: A Study in a Network of Hospitals Using Quality Improvement Methods from PAIN OUT.

OBJECTIVE: This was a pre-post study in a network of hospitals in Mexico-City, Mexico. Participants developed and implemented Quality Improvement (QI) interventions addressing perioperative pain management. METHODS: PAIN OUT, an international QI and research network, provided tools for web-based auditing and feedback of pain management and patient-reported outcomes (PROs) in the clinical routine. Ward- and patient-level factors were evaluated with multi-level models. Change in proportion of patients reporting worst pain ≥6/10 between project phases was the primary outcome. RESULTS: Participants created locally adapted resources for teaching and pain management, available to providers in the form of a website and a special issue of a national anesthesia journal. They offered teaching to anesthesiologists, surgeons, including residents, and nurses. Information was offered to patients and families. A total of 2658 patients were audited in 9 hospitals, between July 2016 and December 2018. Participants reported that the project made them aware of the importance of: training in pain management; auditing one's own patients to learn about PROs and that QI requires collaboration between multi-disciplinary teams. Participants reported being unaware that their patients experienced severe pain and lacked information about pain treatment options. Worst pain decreased significantly between the two project phases, as did PROs related to pain interfering with movement, taking a deep breath/coughing or sleep. The opportunity of patients receiving information about their pain treatment options increased from 44% to 77%. CONCLUSIONS: Patients benefited from improved care and pain-related PROs. Clinicians appreciated gaining increased expertise in perioperative pain management and methods of QI.

A survey of postoperative pain treatments and unmet needs.

More than 300 million patients undergo surgery worldwide each year. Pain associated with these procedures is associated with short- and long-term negative sequelae for patients, healthcare providers, and healthcare systems. The following chapter is a review of the reality of postoperative pain management in everyday clinical routine based on survey- and registry-derived data with a focus on care in adults. Between 30% and up to 80% of patients report moderate to severe pain in the days after surgery. Structures, processes, and outcomes vary widely between hospitals and indicate gaps between evidence-based findings and practice. Pain assessment is not effectively implemented in many hospitals and should consider cultural differences. Few data exist on the situation of pain management in low- and middle-income countries, indicating lack of resources and available medication in many of these areas. Certain types of surgery as well as demographic and clinical factors are associated with increased risk of severe postoperative pain.

Improving perioperative pain management: a preintervention and postintervention study in 7 developing countries.

INTRODUCTION: The burden of untreated postoperative pain is high. OBJECTIVE: This study assessed feasibility of using quality improvement (QI) tools to improve management of perioperative pain in hospitals in multiple developing countries. METHODS: The International Pain Registry and Developing Countries working groups, from the International Association for the Study of Pain (IASP), sponsored the project and PAIN OUT, a QI and research network, coordinated it, and provided the research tools. The IASP published a call about the project on its website. Principal investigators (PIs) were responsible for implementing a preintervention and postintervention study in 1 to 2 surgical wards in their hospitals, and they were free to choose the QI intervention. Trained surveyors used standardized and validated web-based tools for collecting findings about perioperative pain management and patient reported outcomes (PROs). Four processes and PROs, independent of surgery type, assessed effectiveness of the interventions. RESULTS: Forty-three providers responded to the call; 13 applications were selected; and PIs from 8 hospitals, in 14 wards, in 7 countries, completed the study. Interventions focused on teaching providers about pain management. Processes improved in 35% and PROs in 37.5% of wards. CONCLUSIONS: The project proved useful on multiple levels. It offered PIs a framework and tools to perform QI work and findings to present to colleagues and administration. Management practices and PROs improved on some wards. Interpretation of change proved complex, site-dependent, and related to multiple factors. PAIN OUT gained experience coordinating a multicentre, international QI project. The IASP promoted research, education, and QI work.

Topical application of morphine for wound healing and analgesia in patients with oral lichen planus: a randomized, double-blind, placebo-controlled study.

OBJECTIVE: The objective of this study was to investigate the effect of topical morphine on erosive/ulcerative lesions in patients with oral lichen planus (OLP). Previous studies reported on an enhanced remission of skin wounds when morphine was applied topically. MATERIALS AND METHODS: This was single-center, prospective, double-blind, placebo-controlled, randomized, multi-arm (3), phase II study (RCT). Patients diagnosed with erosive and/or ulcerative OLP applied 0.2 or 0.4 mg morphine dissolved in glycerine, three times a day for 5 days. The primary outcome was the extent of healing. Secondary outcomes were as follows: (1) effect on pain, (2) presence and severity of opioid-related central and local side effects, (3) whether patients required 'rescue medication' for treatment of pain, and (4) total intake of test substance. RESULTS: A total of 123 patients were screened for eligibility, 45 patients were recruited into the study, and 43 completed it. Patients applied a solution of either placebo or 0.2 or 0.4% morphine in groups of n = 12, n = 15, and n = 16, respectively. Extent of healing was similar in the three groups. Severity of pain was minor pre-treatment and throughout the course of the study. Only minor adverse events were reported (dry mouth, burning sensation). CONCLUSION: Morphine did not enhance wound healing compared to placebo-treated patients. Healing was observed in all groups, which may be attributed to an effect of glycerine or to the natural course of the disease. Patients experienced only mild levels of pain, rendering the model insensitive for assessing pain. CLINICAL RELEVANCE: OLP is a chronic disease and current treatment options are limited. Healing occurred in all three study groups, an effect we attribute to the carrier.

Implementing a pain management nursing protocol for orthopaedic surgical patients: Results from a PAIN OUT project.

AIMS AND OBJECTIVES: To investigate the effect of introducing a standardised pain management nursing protocol in orthopaedic patients undergoing surgery. BACKGROUND: Postoperative pain is a common phenomenon but is still undertreated in hospitalised patients. Nurses' lack of sufficient knowledge and skills about pain management may be a contributing factor to poor outcomes. DESIGN: An interventional, separate sample pre- and post-test. METHODS: A pain management nursing protocol was introduced and a handbook and training sessions regarding management of postsurgical pain were provided to the nurses on a Joint Orthopaedic ward at a university-affiliated general hospital in Guangzhou, China. Before and after the intervention, nurses' knowledge about pain management and attitudes were assessed, and perioperative management practices and pain-related patient-reported outcomes were evaluated. RESULTS: Sixteen and 15 registered nurses, and 77 and 71 patients participated in the study before and after the intervention, respectively. Nurses' scores related to knowledge and skills increased significantly after the protocol was introduced but were still insufficient with regard to pharmacological-related items. The proportion of patients receiving a combined opioid and nonopioid increased after the intervention. Clinically significant changes were observed in some patient-reported outcomes, such as worst pain since surgery, percentage of time experiencing severe pain, and pain interference with activities out of bed. There were significant changes in nonpharmacological methods administered by nurses to patients or used by patients to relieve pain. CONCLUSIONS: Implementation of a pain management nursing protocol combined with education in one surgical ward was associated with nurses' increased knowledge and attitudes regarding pain, a change in some management practices, and improvement in a number of pain-related patient-reported outcomes. RELEVANCE TO CLINICAL PRACTICE: It was feasible to develop and implement a standardised pain management nursing protocol and use it in the clinical routine. The intervention had an effect on changing some features of care, with an improvement in patient-reported outcomes. Support by leaders and medical team facilitated the process of the implementation.

Chronic postsurgical pain in Europe: An observational study.

BACKGROUND: Chronic postsurgical pain (CPSP) is an important clinical problem. Prospective studies of the incidence, characteristics and risk factors of CPSP are needed. OBJECTIVES: The objective of this study is to evaluate the incidence and risk factors of CPSP. DESIGN: A multicentre, prospective, observational trial. SETTING: Twenty-one hospitals in 11 European countries. PATIENTS: Three thousand one hundred and twenty patients undergoing surgery and enrolled in the European registry PAIN OUT. MAIN OUTCOME MEASURES: Pain-related outcome was evaluated on the first postoperative day (D1) using a standardised pain outcome questionnaire. Review at 6 and 12 months via e-mail or telephonic interview used the Brief Pain Inventory (BPI) and the DN4 (Douleur Neuropathique four questions). Primary endpoint was the incidence of moderate to severe CPSP (numeric rating scale, NRS ≥3/10) at 12 months. RESULTS: For 1044 and 889 patients, complete data were available at 6 and 12 months. At 12 months, the incidence of moderate to severe CPSP was 11.8% (95% CI 9.7 to 13.9) and of severe pain (NRS ≥6) 2.2% (95% CI 1.2 to 3.3). Signs of neuropathic pain were recorded in 35.4% (95% CI 23.9 to 48.3) and 57.1% (95% CI 30.7 to 83.4) of patients with moderate and severe CPSP, respectively. Functional impairment (BPI) at 6 and 12 months increased with the severity of CPSP (P < 0.01) and presence of neuropathic characteristics (P < 0.001). Multivariate analysis identified orthopaedic surgery, preoperative chronic pain and percentage of time in severe pain on D1 as risk factors. A 10% increase in percentage of time in severe pain was associated with a 30% increase of CPSP incidence at 12 months. CONCLUSION: The collection of data on CPSP was feasible within the European registry PAIN OUT. The incidence of moderate to severe CPSP at 12 months was 11.8%. Functional impairment was associated with CPSP severity and neuropathic characteristics. Risk factors for CPSP in the present study were chronic preoperative pain, orthopaedic surgery and percentage of time in severe pain on D1. TRIAL REGISTRATION: Clinicaltrials.gov identifier: NCT01467102.

PAIN OUT: an international acute pain registry supporting clinicians in decision making and in quality improvement activities.

RATIONALE, AIMS AND OBJECTIVES: Management of post-operative pain is unsatisfactory worldwide. An estimated 240 million patients undergo surgery each year. Forty to 60% of these patients report clinically significant pain. Discrepancy exists between availability of evidence-based medicine (EBM)-derived knowledge about management of perioperative pain and increased implementation of related practices versus lack of improvement in patient-reported outcomes (PROs). We aimed to assist health care providers to optimize perioperative pain management by developing and validating a medical registry that measures variability in care, identifies best pain management practices and assists clinicians in decision making. METHODS: PAIN OUT was established from 2009 to 2012 with funding from the European Commission. It now continues as a self-sustaining, not-for-profit project, targeting health care professionals caring for patients undergoing surgery. RESULTS: The growing registry includes data from 40 898 patients, 60 hospitals and 17 countries. Collaborators upload data (demographics, clinical, PROs) from patients undergoing surgery in their hospital/ward into an Internet-based portal. Two modules make use of the data: (1) online, immediate feedback and benchmarking compares PROs across sites while offline analysis permits in-depth analysis; and (2) the case-based clinical decision support system offers practice-based treatment recommendations for individual patients; it is available now as a prototype. The Electronic Knowledge Library provides succinct summaries on perioperative pain management, supporting knowledge transfer and application of EBM. CONCLUSION: PAIN OUT, a large, growing international registry, allows use of 'real-life' data related to management of perioperative pain. Ultimately, comparative analysis through audit, feedback and benchmarking will improve quality of care.