[Patient-reported outcomes and quality of care in specialized palliative home care: a nationwide, prospective longitudinal cohort trial]. / Symptomverlauf, Betreuungsqualität und Zufriedenheit mit der spezialisierten ambulanten Palliativversorgung (SAPV) aus Patient*innenperspektive: eine bundesweite prospektive Längsschnittstudie.

INTRODUCTION: Since 2007, patients receiving palliative care have been entitled to specialised outpatient palliative care (SAPV). Until now, the quality of care of the SAPV was only regionally focussed or in relation to individual SAPV teams. A nationwide analysis of outcome quality is still awaited. The organisation and design of structures and processes vary greatly from region to region, which complicates a comparative assessment of implementation. One way to measure the quality of the heterogeneous structures and processes is to collect patient-reported outcomes. Here, it is possible to use symptom burden, quality of care and patient satisfaction with SAPV care, since patients' quality of life is a central focus of SAPV care. This article is part of the research project SAVOIR, which is funded by the G-BA Innovation Fund. METHODS: For this prospective longitudinal survey of the outcome quality of SAPV, structured data were collected at two measurement points (t1 and t2 [4-10 days after t1]). A nationwide, representative sample of SAPV teams was targeted. These teams performed consecutive recruitment of patients included in SAPV. Two questionnaire instruments were used: the IPOS (Integrated Palliative Outcome Scale) at t1 and t2, and the QUAPS (quality control in specialized palliative home care) questionnaire at t2. Patient-reported outcomes measured improvement in symptom burden, patient satisfaction, and quality of care from the patient perspective. In addition, an exploratory stepwise regression analysis of factors associated with satisfaction was conducted. RESULTS: 42 SAPV teams agreed to participate in the study. They recruited a total of 964 patients at measurement time t1 (t2: 690 patients). The analyses show that the number and intensity of symptoms from the patient perspective decreased significantly during the course of SAPV treatment, especially pain, gastrointestinal symptoms, but also psychological complaints. 74.7 % of the patients reported a high level of satisfaction with SAPV. Also, the quality of care was considered to be high by the patients. Exploratively, five factors were extracted that explain 55 % of the satisfaction with SAPV: respect for the patient's decision, quality of communication, support with practical problems, and referral to care measures as well as symptom relief between the two measurement points. CONCLUSIONS: The SAPV patients recruited from a total of nine KV regions reported a reduced symptom burden and a high level of satisfaction with SAPV and rated the quality of care provided by SAPV as high.

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.

Correlates of satisfaction with pain treatment in the acute postoperative period: results from the international PAIN OUT registry.

Patient ratings of satisfaction with their postoperative pain treatment tend to be high even in those with substantial pain. Determinants are poorly understood and have not previously been studied in large-scale, international datasets. PAIN OUT, a European Union-funded acute pain registry and research project, collects patient-reported outcome data on postoperative day 1 using the self-reported International Pain Outcome Questionnaire (IPO), and patient, clinical, and treatment characteristics. We investigated correlates of satisfaction and consistency of effects across centres and countries using multilevel regression modelling. Our sample comprised 16,868 patients (median age 55 years; 55% female) from 42 centres in 11 European countries plus Israel, USA, and Malaysia, who underwent a wide range of surgical procedures, for example, joint, limb, and digestive tract surgeries. Median satisfaction was 9 (interquartile range 7-10) on a 0-10 scale. Three IPO items showed strong associations and explained 35% of the variability present in the satisfaction variable: more pain relief received, higher allowed participation in pain treatment decisions, and no desire to have received more pain treatment. Patient factors and additional IPO items reflecting pain experience (eg, worst pain intensity), pain-related impairment, and information on pain treatment added little explanatory value, partially due to covariate correlations. Effects were highly consistent across centres and countries. We conclude that satisfaction with postoperative pain treatment is associated with the patients' actual pain experience, but more strongly with impressions of improvement and appropriateness of care. To the degree they desire, patients should be provided with information and involved in pain treatment decisions.

Patients' perception of postoperative pain management: validation of the International Pain Outcomes (IPO) questionnaire.

UNLABELLED: PAIN OUT is a European Commission-funded project aiming at improving postoperative pain management. It combines a registry that can be useful for quality improvement and research using treatment and patient-reported outcome measures. The core of the project is a patient questionnaire-the International Pain Outcomes questionnaire-that comprises key patient-level outcomes of postoperative pain management, including pain intensity, physical and emotional functional interference, side effects, and perceptions of care. Its psychometric quality after translation and adaptation to European patients is the subject of this validation study. The questionnaire was administered to 9,727 patients in 10 languages in 8 European countries and Israel. Construct validity was assessed using factor analysis. Discriminant validity assessment used Mann-Whitney U tests to detect mean group differences between 2 surgical disciplines. Internal consistency reliability was calculated as Cronbach's alpha. Factor analysis resulted in a 3-factor structure explaining 53.6% of variance. Cronbach's alpha at overall scale level was high (.86), and for the 3 subscales was low, moderate, or high (range, .53-.89). Significant mean group differences between general and orthopedic surgery patients confirmed discriminant validity. The psychometric quality of the International Pain Outcomes questionnaire can be regarded as satisfactory. PERSPECTIVE: The International Pain Outcomes questionnaire provides an instrument for postoperative pain assessment and improvement of quality of care, which demonstrated good psychometric quality when translated into a variety of languages in a large European and Israeli patient population. This measure provides the basis for the first comprehensive postoperative pain registry in Europe and other countries.

How simple can it get? Measuring pain with NRS items or binary items.

OBJECTIVES: In the postoperative setting, functional interference of pain is an important outcome parameter. It can be measured by numerical rating scales (NRS) and by binary items (yes/no). For implementation, dissemination, and practicability in clinical routine, not only psychometric characteristics but also patients' acceptance of assessment methods is important but has not been studied so far. To compare these 2 answer formats, the pain interference questions of the German initiative Quality Improvement in Postoperative Pain Management, a multicentric pain registry project, were used. METHODS: Psychometric quality, clinical significance, and patients' preferences were analyzed in NRS and binary formats of pain interference assessments. Responses from 430 patients in 3 surgical disciplines (abdominal, orthopedic/trauma, and oromaxillofacial surgery) were examined. RESULTS: The results indicate a satisfactory reliability and validity of both answer formats. They achieve equal test-retest reliability (0.724 to 0.885) and construct validity (identifying significant differences between the 3 surgical disciplines). The binary "no interference" answer consistently corresponds to NRS values of 0 to 2. The means in 3 pain intensity measures differ significantly for the groups of patients with or without pain interference. Two third of the patients prefer to answer to binary items. DISCUSSION: Binary answer format was proven to be a practical alternative to the NRS format for a screening instrument. Comparison of binary answers with NRS answers can improve our understanding of the clinical relevance of patients' statements. Most patients prefer the use of the binary answer format.

The impact of early postoperative pain on health-related quality of life.

OBJECTIVES: To examine how the severity of postoperative pain affects patient's health-related quality of life (HRQoL) at 1 week following surgery and to compare two generic validated HRQoL instruments. METHODS: Patients undergoing general or orthopaedic surgery at the Royal London Hospital were randomly sampled. The following patient outcome data were collected EQ-5D (EuroQoL) pre-operatively and the Revised American Pain Society Patient Outcome Questionnaire (APS-POQ-R) at 24 hours postoperation; and EQ-5D, Short-Form-12 (SF-12) and APS-POQ-R at 7 days postoperation. The degree of association between pain and HRQoL was assessed using Pearson's correlation coefficient and multivariate generalized linear regression models. RESULTS: Of the 228 patients included, 166 patients provided data at 7 days. Sixteen percent reported severe pain ≥ 50% of the day at 7 days. The severity of pain on both the APS-POQ-R pain severity and interference and affective impairment domains at 7 days was highly correlated with a decrease in HRQoL as assessed by the SF-12 Physical Component Score (PCS), SF-12 Mental Component Score (MCS), and EQ-5D scores (r = -0.34 to -0.61, P < 0.0001). Multivariate regression analyses showed that irrespective of confounding factors (eg, age, gender, and pre-operative HRQoL) patients with severe postoperative pain experience important reductions in both physical and mental well-being domains of their HRQoL. CONCLUSIONS: A proportion of patients continue to experience severe pain at 7 days postoperatively, even after minor surgery. HRQoL is strongly associated with the level of pain and provides additional data on the impact of postsurgery pain on patient's function and well-being. Additional studies are needed to elucidate the interaction between pain severity and HRQoL during the peri-operative period.

Quality improvement in postoperative pain management: results from the QUIPS project.

INTRODUCTION: Acute postoperative pain management is still far from satisfactory despite the availability of high-quality guidelines and advanced pain management techniques. METHODS: An outcome-oriented project called QUIPS (Quality Improvement in Postoperative Pain Management) was developed, consisting of standardized data acquisition and an analysis of quality and process indicators. RESULTS: After validation of the questionnaire, a total of 12 389 data sets were collected from 30 departments in six participating hospitals. Improved outcomes (reduction in pain intensity) were observed in four of the six hospitals. The most painful operations, in the patients' judgment, were traumatological and orthopedic procedures, as well as laparoscopic appendectomy. Traditional process indicators, such as routine pain documentation, were only poorly correlated with outcomes. DISCUSSION: QUIPS shows that outcomes in postoperative pain management can be measured and compared in routine clinical practice. This may lead to improved care. QUIPS reveals which operations are the most painful. Quality improvement initiatives should use as few resources as possible, measure the quality of the outcomes, and provide rapid feedback. Structural and process parameters should be continuously reevaluated to determine their suitability as indicators of quality.