Peripartal pain perception and pain therapy: introduction and validation of a questionnaire as a quality instrument.

BACKGROUND: Labor pain is difficult to measure. The aim of this proof-of-concept study is to implement and test a questionnaire assessing pain sensation during and after vaginal deliveries. Its key aspect is a highly standardized survey of patient-reported outcome (PRO) by staff not involved in routine care. METHODS: Between January and November 2015 339 women were assessed 24-48 h after spontaneous or operative-vaginal delivery of a singleton. German language skills were a prerequisite to participate. The test-retest reliability was calculated in 38 women 24-36 and 48-72 h postpartum between July and October 2017. Primiparae after spontaneous delivery and multiparae with no history of operative deliveries were compared in a subgroup analysis. RESULTS: Maximum labor pain and post-partum pain were reported a median of 9 [8-10] and 4 [3-6]. Higher ratings were associated with younger age, higher gestational ages, infant's biometrics, and the duration of laboring. Only regional analgesia tended to reduce pain perception (NRS 8 vs. 9). Higher-degree injuries were associated with less pain postpartum. The questionnaire proved to be reliable in most aspects (Cronbach's α > 0.6 for 19/21 questions) and showed an acceptable content and criterion validity (Cohen correlation > ± 0.3, interrelation between items). CONCLUSION: Labor is a very painful experience, irrespective of previous obstetric history. Ratings indicate inadequateness of treatment except for patients receiving preventive postoperative pain management. Systematic postpartum pain assessment, hence, is still a pending issue. Adjustments will be made concerning language skills and specific questions on effectiveness of analgesia otherwise good reliability and validity of the questionnaire were proven.

PAIN OUT: the making of an international acute pain registry.

BACKGROUND: About 240 million patients undergo surgery every year, worldwide. Roughly 50% of these patients report clinically significant pain. Numerous barriers impede provision of adequate management. Lack of evidence about appropriateness and effectiveness of interventions is one. A registry can provide such information, eventually facilitating better management. This paper reports the development and feasibility of PAIN OUT, the first international acute pain registry, established with funds from the European Commission, and presents preliminary analysis to illustrate the nature of investigations that registry data make possible. METHODS: On the first postoperative day, 6347 adult patients undergoing orthopaedic or general surgery, in 11 medical centres in Europe and Israel, provided Patient Reported Outcomes (PROs) using a validated questionnaire. Clinical data were abstracted from the patient's chart. RESULTS: Feasibility worked well. Over a period of 1 year, surveyors accrued targeted data sets and entered them into an online browser. Collaborators could receive online feedback comparing their findings about PROs against anonymized findings from other centres. Missing data for the majority of variables were low. Despite considerable variability between institutions, a large number of patients were treated according to the generic, evidence-based recommendations we assessed. However, this was not sufficient to result in acceptable outcomes for the majority of patients. CONCLUSION: The initial development of PAIN OUT has been achieved. From 2013, it continues as a not-for-profit academic project, open to clinicians and researchers worldwide. The International Association for Study of Pain and PAIN OUT will work together to maintain, disseminate and develop the registry.

[External validity of pain-linked functional interference: are we measuring what we want to measure?]. / Externe Validität der schmerzbedingten Funktionsbeeinträchtigung : Messen wir, was wir messen wollen?

BACKGROUND: Measurement of functional interference (FI) of pain is crucial for postoperative pain management. This study examined the external validity of three FI items (respiration, mobilization and sleep) within the framework of the German quality improvement in postoperative pain management (QUIPS) project. MATERIAL AND METHODS: A total of 380 patients undergoing trauma/orthopedic or abdominal surgery were asked to complete the QUIPS outcome questionnaire. Criteria to determine external validity of FI assessment were tolerance to a continuous passive motion (CPM) machine for FI with mobilization, the pre-postoperative difference of peak flow for FI with respiration and sleep quality measured with actigraphy for FI with sleep. RESULTS: The QUIPS outcome questionnaire achieved satisfactory reliability (r(tt) =0 .783-0.954, internal consistency 0.597-0.941). The three FI items under examination achieved a significant correlation (r =0 .407-0.469) with the external criteria.

Feasibility of international data collection and feedback on post-operative pain data: proof of concept.

Post-operative pain exacts a high toll from patients, families, healthcare professionals and healthcare systems worldwide. PAIN-OUT is a research project funded by the European Union's 7th Framework Program designed to develop effective, evidence-based approaches to improve pain management after surgery, including creating a registry for feedback, benchmarking and decision support. In preparation for PAIN-OUT, we conducted a pilot study to evaluate the feasibility of international data collection with feedback to participating sites. Adult orthopaedic or general surgery patients consented to participate between May and October 2008 at 14 collaborating hospitals in 13 countries. Project staff collected patient-reported outcomes and process data from 688 patients and entered the data into an online database. Project staff in 10 institutions met the enrolment criteria of collecting data from at least 50 patients. The completeness and quality of the data, as assessed by rate of missing data, were acceptable; only 2% of process data and 0.06% of patient-reported outcome data were missing. Participating institutions received access to select items as Web-based feedback comparing their outcomes to those of the other sites, presented anonymously. We achieved proof of concept because staff and patients in all 14 sites cooperated well despite marked differences in cultures, nationalities and languages, and a central database management team was able to provide valuable feedback to all.

Determination of moderate-to-severe postoperative pain on the numeric rating scale: a cut-off point analysis applying four different methods.

BACKGROUND: Cut-off points (CPs) of the numeric rating scale (NRS 0-10) are regularly used in postoperative pain treatment. However, there is insufficient evidence to identify the optimal CP between mild and moderate pain. METHODS: A total of 435 patients undergoing general, trauma, or oral and maxillofacial surgery were studied. To determine the optimal CP for pain treatment, four approaches were used: first, patients estimated their tolerable postoperative pain intensity before operation; secondly, 24 h after surgery, they indicated if they would have preferred to receive more analgesics; thirdly, satisfaction with pain treatment was analysed, and fourthly, multivariate analysis was used to calculate the optimal CP for pain intensities in relation to pain-related interference with movement, breathing, sleep, and mood. RESULTS: The estimated tolerable postoperative pain before operation was median (range) NRS 4.0 (0-10). Patients who would have liked more analgesics reported significantly higher average pain since surgery [median NRS 5.0 (0-9)] compared with those without this request [NRS 3.0 (0-8)]. Patients satisfied with pain treatment reported an average pain intensity of median NRS 3.0 (0-8) compared with less satisfied patients with NRS 5.0 (2-9). Analysis of average postoperative pain in relation to pain-related interference with mood and activity indicated pain categories of NRS 0-2, mild; 3-4, moderate; and 5-10, severe pain. CONCLUSIONS: Three of the four methods identified a treatment threshold of average pain of NRS≥4. This was considered to identify patients with pain of moderate-to-severe intensity. This cut-off was indentified as the tolerable pain threshold.

Room for improvement: nurses' and physicians' views of a post-operative pain management program.

BACKGROUND: The practice of post-operative pain therapy continues to be a problem. We conducted a survey among nurses and physicians about their views of an established post-operative pain management program. METHODS: A questionnaire was sent to all nurses and physicians of nine surgical wards (general, trauma, cardio-thoracic and oromaxillofacial surgery and gynecology). Questions were developed from qualitative interviews with staff. Patient data were derived from a post-operative pain registry. RESULTS: Seventy-eight physicians and nurses answered; the overall response rate was 23%. Post-operative pain therapy had high personal priority on an 11-point numeric rating scale (mean 9.08+/-1.27 standard deviation), but the success of pain management on the ward was rated as 7.32+/-1.37. Staff rating of success tended to correspond with patients' actual pain ratings. Knowledge of pain therapy was assessed as 6.85+/-1.82; nurses consistently rated levels higher than physicians. Staff over- or underestimated the painfulness of typical procedures and females rated procedures as more painful than men. There was considerable confusion about responsibilities and duties. 10.7% of staff perceived time delays exceeding 6 h between a request for acute pain services (APS) consultation and administration of medication to the patient. Invited comments suggested improvement in personnel education, team coordination, communication with patients and speed of action to increase the quality of pain therapy. CONCLUSION: Despite staff's high personal priority and well-established APS and pain management program, post-operative pain therapy still leaves room for improvement. Considerable confusion about responsibilities and duties underlines the importance of better organizational approaches.