Pain management quality assurance programs (PMQP) have been successfully implemented in numerous hospitals across Europe. We aimed to evaluate the medium-term sustainability of a PMQP implemented at intensive care units (ICUs).Two surveys, the first in 2012, immediately after introduction of the PMQP, and the second in 2015, were carried out amongst patients, physicians and nurses. Demographic parameters of all participants were assessed. Patients were asked after their pain levels during ICU stay. Staff members answered a questionnaire regarding familiarity with standards and processes of PMQP and self-perception of their knowledge as well as contentment with interdisciplinary communication.In total (2012/2015), 267 (125/142) patients, 113 (65/48) physicians and 510 (264/246) members of the nursing staff participated. Minimum and maximum pain levels of patients did not differ between both surveys. Patients’ tolerance of pain 24 hours before the survey was better (p = 0.023), and vomiting occurred less often (p = 0.037) in 2015. Physicians’ and nurses’ contentment with the own knowledge about pharmacological pain treatment had increased from 2012 to 2015 (p = 0.002 and 0.004). Satisfaction with communication between nurses and physicians was better in 2015 (p<0.001 and p = 0.002). Familiarity with PMQP standards and processes remained stable in both collectives.The implementation of our PMQP achieved a high standard of care, guarantying a high patient and staff member satisfaction. Continuous education, ongoing training, regular updates and implementation of feedback-loops ensure continuity, in some parameters even an increase in knowledge and competencies. This is mirrored in high patient and staff member satisfaction. Quality management concepts for acute pain therapy have successfully been implemented in numerous hospitals in Europe recently –6. EvideFollowing a process of evaluation, a pain management quality assurance program (PMQP) was introduced in all 16 departments of the hospital of the Medical University of Graz between 2009 and 2012 according to the certification criteria of “Certkom”, Germany. Before that, pain management, including assessment and subsequent therapeutic measures, was carried out unstructured and more or less according to the individual experience and preferences of the attending physicians and nurses, resulting in vast differences in the treatment of pain conditions. Our PMQP included the implementation of interdisciplinary working groups for pain management, of evidence-based clinical practice guidelines for pain treatment, of comprehensive advanced educational curricula and trainings and of thorough assessment, documentation and treatment of patients’ pains. The established regimens for pain treatment were adapted considering the pathophysiology of the underlying disease and accompanying illnesses, plus the type and extent of any given medical intervention. Our pharmacological pain regimens included both baseline and on-demand-medication. Treatment of side effects like discomfort, constipation, dyspnoea, nausea or vomiting also followed a particular regimen adapted to the individual patient’s needs .In critically ill patients adequate management of pain is crucial to ensure best possible clinical outcomes . The aimThe study has been approved by the institutional review board of the Medical University of Graz (vote#: 28–235 ex 15/16). As approved by the review board, written informed consent was obtained from all participants.http://www.certkom.com) and included following dimensions of care quality:The PMQP strictly followed the certification criteria from “Certkom” ○development of advanced educational curricula, and training as well as○comprehensive patient informationdevelopment of therapeutic standards and templates for pain-management documentationwere implemented and certified by”Certkom”.To address all these aspects within the university hospital four main initiatives, namelyThe development of therapeutic standards and corresponding SOPs were performed by a multidisciplinary work group consisting of physicians, nurses and therapists and were led by an expert on pain management from the anesthesiological department and moderated by Executive Department for Quality and Risk Management. Therapeutic standards followed the WHO model analgesic ladder , and werAccompanying SOPs were developed and trained to all healthcare professionals and included i) admission and discharge of patients, ii) information, guidance and training of patients’ pain, iii) administration of opioids, iv) pain management measurement, v) documentation of pain, vi) non-pharmacological options of pain management as well as vii) standard treatment of nausea and vomiting.Alongside, an educational curriculum for all healthcare professionals group was developed in order to guarantee concomitant education of SOPs and from time to time refreshing of pain therapy knowledge. These curricula are offered each year and physicians and nurses are obliged once in two years to take part. For new employees, additional enrolment trainings are offered and documented in a personal training log. The external certifier not only proofs the three dimension of quality, they also proof, if training and education was performed properly. Furthermore, in order to also address the patient, information leaflets in several languages were developed and distributed on each ward.th until January 30th, 2012 (immediately after implementation of the PMQP), and the second from October 8th until October 20th, 2015. In-between this time periods, it was the effort to keep implemented PMQP on a high level in order to guarantee compliance and maintenance. Therefore, internal audits were put in place to regularly support physicians and nurses with a feedback on the pain management process. Internal audits focussed on adherence of SOPs, pain management documentation, pain therapy and if regular trainings were performed by screening the training log file.Internal audits and patient and employee surveys were used to assure adherence to the implemented PMQP. The subjective wellbeing of patients treated at nine ICUs of the University Hospital of the Medical University of Graz was assessed prospectively. Simultaneously, we collected data on the attending physicians’ and nurses’ attitude towards the PMQP. Finally, in 2012 the PMQP was certified by Certkom. The evaluations ran during two consecutive periods, the first from January 12The participating patients came from surgical departments, including general surgery, thoracic surgery, vascular surgery, orthopaedics and trauma and neurosurgery, and from the non-surgical departments internal medicine and neurology. All patients staying at the ICU during the respective study periods were asked to participate in the survey. Written informed consent, demographic and treatment parameters were ascertained from each patient. They answered a questionnaire concerning both pain and analgesic treatment effects and side-effects they had experienced during their stay as shown in Age, gender, presence of a malignancy, surgical or conservative management of the underlying disease and need for artificial ventilation or catecholamine requirement were documented of each patient. Regarding pain management, the administration of oral analgesics, parenteral analgesics or transdermal analgesics, and the use of regional anaesthesia was assessed. Orally and parenterally administered analgesics were further categorized according to the WHO analgesic ladder  .Age, gender and working place  were assessed. Each physician working in the respective ICU was asked to participate in the survey and to answer a questionnaire focusing on both the familiarity with the PMQP items and on the subjective appraisal of PMQP standards and processes as shown in Age, gender and years of working experience in intensive care were assessed for registered nurses. Each nurse working in the respective ICU was asked to participate in the survey and to answer the questionnaire as outlined for physicians. In 2012 and 2015, 357 and 227 registered nurses participated in the survey (response rates 69% and 56%), respectively. Further items of the evaluation included the specification of patients treated  and if a special intensive care training had been completed. Each nurse was asked to answer a questionnaire focusing on the familiarity with the PMQP items, on indicators of degree of implementation and on the subjective appraisal of PMQP as shown in Statistical analysis was done with SPSS 23.0 for Windows . A p-value below 0.05 was considered statistically significant.2-test was used for categorical data with more than two characteristics. T-test was applied for the comparison of continuous parameters, and Spearman’s correlation analysis was used for ordinal variables. Whenever present, the option “do not know” as well as missing values were excluded from descriptive analysis.The results of the two survey periods were compared. For binary parameters, Fisher’s Exact Test was used. ChiLinear regression models were used to determine whether changes of the survey results were solely based on the survey period, or were affected by changes of basic demographic or treatment parameters. Questionnaire parameters were related to basic demographic and treatment parameters that showed significant differences between 2012 and 2015 as well as to the survey period itself (2012 or 2015).The 2012 and 2015 periods showed no differences regarding age or gender distribution. Of 225 patients in 2012, 162 answered the survey by themselves, 63 were answered by nurses. Of 147 patients in 2015, 111 answered the survey by themselves, 36 were answered by nurses. In 2015, less surgical patients attended the survey , whereas more patients required artificial ventilation during their ICU stay as shown in Patients reported similar median most severe and minimal pain in both survey periods. Patients from 2015, however, stated that pain levels within 24 hours before the survey were more bearable (p = 0.023). Out of the assessed symptoms, vomiting occurred less often in the 2015 collective as shown in The parameters “artificial ventilation”, “surgical or conservative management of the underlying disease”, “oral WHO1 pain medication” differed significantly between the two survey periods and were related to the results of the questions “How bearable was the pain during the last 24 hours?” and “Did you vomit during your ICU stay?”.In both cases the only factor with significant influence on the changes from the first to the second period was the survey period itself , while the other three factors showed no influence.In the physician collective, no differences were found between the two survey periods regarding age, gender and working place.Comparing both surveys, a similar share of participants knew about the existence of multidisciplinary work groups for pain management, about SOPs about responsibilities in pain management, SOPs for pharmacological treatment of problematic pain and constipation, SOPs for sedation (> 75% of participants for each item) and a SOP for non-pharmacological pain management at their ward (63.1% in 2012 and 70.8% in 2015). Although in 2015 on average more participants stated they were familiar with the respective standards, never was 100% and in only 2 of the 7 items  >90% awareness was achieved , S1 Fig.Physicians from 2015 were more satisfied with their own (p = 0.002), with the nursing staff’s (p = 0.005) and the physiotherapists’ (p = 0.032) knowledge about pain medication. In addition, physicians’ satisfaction with communication between nurses and physicians (p<0.001), communication between physicians (p<0.001), communication between physiotherapists and nurses (p<0.001) as well as communication between physiotherapists and physicians (p = 0.001) improved significantly from 2012 to 2015. Furthermore, the 2015 collective was more pleased with pain management training offered at the department (p = 0.014). No differences were observed regarding the knowledge about non-pharmacological pain management options .In the nursing staff collective, no differences were observed between the two surveys regarding age or gender. However, the 2015 collective reported longer working experience (p = 0.026).Regarding questions concerning practices on the ward, more 2015 participants knew about the written standard for the treatment of constipation (p = 0.001). In 2015, also more participants stated to use transfer protocols which include the patient’s pain management (p = 0.031). Participants from the second survey were more satisfied with their own knowledge about pain medication (p = 0.004), the physician’s knowledge (p = 0.005), with communication between nurses and physicians (p = 0.002) and communication between physiotherapists and physicians (p = 0.001). No other differences were observed , Fig 2.Since the 2015 collective reported significantly longer working experience, linear regression models were performed relating the parameters “survey period” and “years of working experience” to the items of the questionnaire that changed between the two survey periods.Awareness of the written standard for treatment of constipation correlated with both, the second survey period (p = 0.004) and the longer working experience (p<0.001). Satisfaction with the own knowledge of pharmacological pain management or the communication between nurses and physicians was associated with the 2015 collective  and longer working experience . The results of the questions “Do you use transfer protocols that take the patient’s individual pain management into account?”, “How content are you with the physicians’ knowledge?”, and “How content are you with communication between therapists and physicians?” were only influenced by the survey period .This is the first study reporting about the evaluation of the efficacy and medium-term sustainability of a pain PMQP implemented at nine ICUs of a University hospital. Patients, physicians and nurses from the hospital of the Medical University of Graz participated in two consecutive surveys. From the first survey carried out immediately after implementation of PMQP to the second survey three years thereafter, none of the evaluated parameters worsened, whilst the majority remained stable, and some even improved.Overall, further PMQP exists and amongst those the benchmark project “QUIPS” is to improve the postoperative pain therapy through regular data collection, their analyses and feedback to clinics involved . HoweverDuring both surveys, the median NRS scores for the most and least severe pain experienced since admission were 5 and 0 (of 10), respectively. Also in the linear regression analysis, no significant difference could be found between the two collectives. Gerbershagen and colleagues determined an NRS score of ≤4 as cut-off point between mild and moderate pain . AccordiAccording to data from the literature, postoperative nausea and vomiting is considered by most patients as more distressing than postoperative pain . What isThe surveys among the staff showed that both nurses and physicians were by large familiar with PMQP. From 2012 to 2015, participants from both professions reported increased satisfaction with both, intra- and inter-professional communication. Self-perception of medical knowledge, but also appreciation of the knowledge of partners from other professions increased from the first to the second survey. However, this self-perception was only in parts reflected by an increase of the staff’s actual knowledge of the implemented written standards and processes. In fact, knowledge of only one aspect (using structured transfer protocols that include the patient’s pain management) in the nursing staff collective improved, while in the physician collective familiarity with PMQP standards and processes remained fairly stable. Discrepancies between the health care personnel’s self-perception and actual medical knowledge have been described before: In a cross-sectional study amongst medical students, residents and appointed physicians, Aquirre-Raya et al. found that the de-facto familiarity with the cornerstones of evidence-based medicine was lower than estimated by the participants . What isOur PMQP may indeed have helped to solidify quality of pain management in everyday clinical practice. The biggest impact of PMQP seemingly was its strengthening effect on the employees’ self-efficacy concerning their own and their colleagues’ knowledge of pain management as well as the improved communication. These developments may have had beneficial effects on the patient’s wellbeing. This finding is of great importance regarding the effectiveness of the PMQP in a university hospital. It is well known that the turnover rate in university hospitals is higher than in smaller hospital settings as we have the major aim of educating medical and nursing students. Therefore, keeping up the knowledge at a high level over three years is an indicator of well-implemented PMQP.A limitation of the study was the lack of a baseline-evaluation carried out before implementation of PMQP which probably remains the biggest limitation of the study. In addition, the two collectives were not entirely identical regarding the management of their underlying diseases, the presence of artificial ventilation and analgesic treatment. Furthermore, some parameters that further specify the patients’ characteristics, like e.g. length of stay at the ICU was not assessed. Yet another limitation was that the questionnaires used in this study–due to the fact that it was a pilot study–have not been validated beforehand. Since data in the three interrogated groups  was collected independently no statistical link could be made between the groups. The data from the abovementioned audits proved to be too diverse to be statistically analysed. Hence this data was excluded from the study. Nevertheless, with the present study design the sustainability of the program could be evaluated.In summary, although management and treatment of patients need to be individualized and depends on the clinical experience of the attending staff, a PMQP as ours described above helps to focus on high quality care based on Evidence-Based Medicine. Since the minor changes observed in pharmacological treatment and in patient characteristics did not influence the improvements in outcome we observed between the two periods, it does not seem too far-fetched to conclude that these improvements were due to continuous use of the guidelines. Continuous education, ongoing training, regular updates and implementation of feedback-loops ensure continuity, in some parameters even an increase in knowledge and competencies. This is mirrored in high patient and staff member satisfaction. Our pilot study demonstrated that even intensive care units may benefit from the implementation of PMQPs, as in our case in pain management. Further studies with higher number of participants, validated questionnaires, pre- and post-implementation assessments, and long-term evaluation needs to confirm our results.S1 Table(DOCX)Click here for additional data file.S2 Table(DOCX)Click here for additional data file.S1 Fig(DOCX)Click here for additional data file.S2 Fig(DOCX)Click here for additional data file.


To explore the deliberation and enactment processes of nurses in relation to pain and other discomforts in the critically ill patients after the implementation of an analgosedation protocol.Nurses in intensive care units (ICU) face great challenges when managing pain and other discomforts and distinguishing between patients’ needs for analgesics and sedatives. An analgosedation protocol favouring pain management, light sedation and early mobilization was implemented in a university hospital ICU in Norway in 2014. Changing sedation paradigms resulting in an increasing number of awake patients during critical illness is expected to affect nursing practice.Exploratory, single‐unit study in a mixed adult ICU.Data collection with participant observation and semi‐structured interviews in sixteen clinical situations in 2014 and 2015. Thirteen experienced certified critical care nurses were included. Thematic content analysis was conducted.Having the compass–drawing the map” emerged from the analysis. The protocol or strategy of analgosedation appeared to provide a direction for treatment and care, although requiring extensive interpretation of needs and individualization of care, often in challenging situations. The overall theme was abstracted from three themes: “Interpreting a complex whole,” “Balancing conflicting goals” and “Experiencing strain from acting across ideals.”An overall theme “Nurses seem to attend adequately to patient pain, but the approach to discomforts other than pain appears unsystematic and haphazard. More explicit goals of care and strategies to handle discomfort as distinct from pain are needed. More research is needed to identify effective comfort measures for ICU patients. An exploratory design with naturalistic observation and semi‐structured interviews was used. Naturalistic observation provides data on phenomena difficult to understand as it gives access both to what people do and what they say they do . An observation guide was used. Observations focused on activities like handover and shift reports, initial assessment of patient and planned procedures possibly requiring deliberations or enactments regarding pain or other discomforts. Non‐pharmacological and pharmacological responses to patient cues of pain and other discomforts and adherence to the implemented protocol were specifically observed. Nurses were encouraged to care for patients as usual, but to think aloud when relevant regarding pain and other discomforts. Short field notes were taken during observation, especially to capture any occurring dialogues. Extensive notes were written after each observation.An “observer as participant” approach was adopted  were conducted as reflective dialogues  and conducted according to the Declaration of Helsinki WMA, . Written2.6Having the compass–drawing the map.” Table A thematic content analysis was conducted The way the CPOT is built, it is actually based on things we used to assess from before, but now exactly what to do and what points to give is more specified. (..) And earlier, even though you would observe facial expression and cooperation with the ventilator, it was more open to individual interpretation. In spite of the strategy implemented, the nurses were required to collect and combine cues and make interpretations to make decisions and act. Valid assessment tools for pain and sedation levels were widely used and perceived to facilitate a systematic approach to assessment, reduce subjectivity and enhance more consistent reporting. Often elements from tools were incorporated into continuous assessment. Usability was also reflected in comments indicating that tools were just a new wrapping:(field note 6)Nurse: “How bad is your pain right now?” Patient’s eyes are closed. She hesitates…”ehm..3…” Nurse; “But can you perhaps live with it?” Patient: “But it really hurts.” Nurse: “but 3 isn’t that much on the scale…maybe it is more?” Patient: “4?” (with a questioning tone). Despite the availability and usability of valid tools, sedation and impaired communication and cognition often required interpretation beyond scoring. Sometimes messages were conflicting regarding patient self‐reporting of pain and the patient behaviour observed. Other times the scoring alternatives seemed too confining to cover the level of pain or sedation and to reach a common understanding:Nurses discuss patient distress at handover‐ But it is agitation, not pain?(field note 16)‐ Who knows? I don't know why she was crying, I can't get eye‐contact because she's too sedated in a way, but at the same time in distress. In general, it was not clear how the nurses deliberated to distinguish between pain and other discomforts and no systematic assessment of discomforts other than pain was evident. However, one way of describing discomfort was mild pain or a precursor of pain requiring an enactment. There was general agreement that no patient should be in pain, but that not all discomfort could be eliminated. However, when nurses were unable to decide on what was pain and what was discomfort, the assessment and the decision about when and how to intervene were challenging.(interview 2)…and when he has expressed a wish to die ‐ and believes he is going to die, what is agony, what is discomfort, what is pain? I mean what is what? It is really difficult. To know the patient well added depth to the deliberation but did not necessarily facilitate the decision about what to enact. This nurse had been caring for a young man with cancer and septicemia even before he was sedated and intubated:(interview 2)I thought I had to …ehm .. allow myself to see how he actually is – and how it turns out before I decide in a way, because at first I thought I had to give both ketorax and propofol beforehand, but if I give it before I start, I don’t really know anything about him. The nurses assessed pain as part of a daily routine, such as when starting the shift, during daily care and often specifically when turning the patient. The assessment included combining scorings and other measures or input not captured by the tools. Vital signs and other physiological measures like lacrimation and restlessness were used along with information from patient records and from handover and inter‐professional rounds. Patient history, current medication and the reporting nurse's perceptions contributed to interpreting the pain situation in patients who were unable to self‐report. Frequently nurses deliberately performed turning or repositioning without any pre‐emptive or extra medication “to obtain a better impression” of the pain and sedation level:(field note 4)The patient is clearly grimacing when they turn her over. The nurse asks whether she is in pain. She frowns and shakes her head. “Discomfort?” the nurse asks. The patient nods. The nurses discuss whether to give more analgesia or propofol (sedative). The nurse turns to the patient and asks whether she just wants something to make her relax. She nods again and they give her 10 mg propofol. Several nurses described the demanding situation of having more awake patients on MV requiring constant attention and surveillance, frequently disrupting workflow. However, most emphasized the importance of being guided by patients’ responses in making decisions about pain and other discomforts. The nurses felt safer doing the right thing when patients could respond:3.2(interview 8)I feel very anxious about my patients being in pain, so the pharmacological options are often the first priority. The second theme reflects how the nurses needed to prioritize between different and sometimes conflicting goals of relieving pain and other discomforts, yet ensuring goals of progress and rehabilitation. An effort to outweigh the pain and discomfort was made by use of pharmacological and non‐pharmacological interventions and evident in both observations and interviews. Pharmacological treatment was mainly directed towards possibly painful procedures like endotracheal suctioning, repositioning and mobilization in or out of bed:(interview 11)The patients are supposed to be more awake …even though it may result in a bad experience (..) it’s for better or worse I think….but I hope we have sufficient tools to capture whether they can tolerate it. Even though the previously implemented analgosedation protocol itself was seldom mentioned, the nurses gave a general impression of good understanding and adherence to the principles of analgosedation as a general direction for treatment and care. There was, however, a concern about how the goal of keeping patients more lightly sedated or awake was experienced by the patients:(interview 7)When you have someone awake like her, you can't keep going at 110, …you need to slow down and work at a different pace…Nurses acknowledged to a large extent the non‐acute pain and discomfort resulting from being critically ill, insecure and frightened, immobilized and awake. A caring approach using continuous information, therapeutic touch and soothing speech was observable as the enactment in caring for patients who were sedated. A personal repertoire of skills was observed in balancing the aspect of comfort and the rehabilitative aspect when patients were more awake. The skills encompassed creativity, humour, motivational skills, “standing by” and recognition of the individual:(interview 6)It is this knife‐edge we are balancing on – when I provide too much analgesics, I get a sedated patient who is not coughing and who is not moving and who does not communicate. The overall goals of rehabilitation sometimes caused the nurses to withhold analgesics or sedatives to accomplish planned or prescribed events such as waking patients who had been sedated, weaning from the ventilator, maintaining spontaneous breathing or mobilizing in or out of bed:Other times “balancing” implied cancelling physiotherapy and mobilization and letting the patient rest to recover. Such a balance was not always achieved and the nurses sometimes had to handle challenging situations across their ideals of care.3.3Nurses were affected by witnessing and withstanding patient discomfort and suffering and by sometimes having to disregard their professional ideals and personal standards to balance the comfort and rehabilitation of patients.(field note 6)Nurse: “The case is that you got pain medication a while ago and it is important that you don’t get too sleepy”…. she goes on telling the patient that she is aware that she is being pushy, which is difficult because she needs to act according to her heart – not to be a torturer……”but we will work our way through this together – You and I!”. The strain experienced by the nurses seemed linked to their professional and personal involvement. To abide strictly by professional standards might challenge the nurse's personal standards of care. Despite being given both analgesia and tranquillizers, a woman cared for in one situation continuously expressed pain verbally. Because of her reduced respiratory function, withholding intravenous opioids was prescribed:(interview 1)You need a balance to get to an extubation for instance … like if we can manage this short, but steep hill, we can extubate and then things will be much better – then I think I can put up with a bit more. Personal involvement with the patient situation, the history of the patient and the relatives seemed to contribute to vulnerability towards the suffering of a patient. However, the experience and knowledge of specific situations helped nurses withstand better patient discomfort and suffering:Working towards common goals together with the patients when possible, and involvement of fellow nurses and physicians in their deliberations supported the nurses in their enactments.4A central finding in this study was that analgosedation principles were clearly visible in the management of pain and other discomforts in critically ill patients, although the ICU nurses involved seldom referred to the implemented protocol. This finding may indicate that the analgosedation principles are easily adopted and merge well with current clinical practice. We also found that the elements of the pain assessment tools used formed a “natural part” of the nurses’ routine assessments. Although interpretation beyond the tools was needed, there was fair agreement on how to assess and treat pain and that no patient should be in pain. Discomfort, however—although agreed on by the nurses as something that could not be fully eliminated in critically ill patients—seemed ill defined and difficult to distinguish from pain, in line with the findings of Gerber, Thevoz, and Ramelet . The chaDespite constantly considering discomforts like pain, anxiety, incomprehension, immobilization, constipation and equipment attached, nurses in our study seemed to lack systematic deliberations about discomforts other than pain. However, there was a tendency to consider discomfort as mild pain or as a precursor to pain, precipitating pharmacological interventions, mainly increasing of the opioid infusion rate or bolus injections. Non‐pharmacological interventions were applied to prevent or relieve both pain and other discomforts, but no systematic deliberation preceding the enactments was observable or articulated. Sometimes the nurse's deliberation about sources of discomfort was communicated at handover. In Kim's  structurIn a focus group study, although ICU nurses recognized the usefulness of pain and sedation assessment tools, they relied more on their personal knowledge and experience , but one problematic aspect of the deliberation process is how the nurse perceives and prioritizes the different goals. Patient comfort in our study seemed to constitute an implicit goal of care (GOC). According to Stanek , GOCs ar, but oneOver the past few years, strategies and bundles of treatment and care, representing evidence‐based guidance for clinicians, have been introduced and implemented in many ICUs. Focusing on comfort, the e‐CASH concept  pursues the goal of a calm, cooperative and comfortable patient (Vincent et al., A systematic approach with strategies or tools may aid nurses in assessing and handling discomfort as distinct from pain. The lack of sensitivity in current tools may result in overestimation of pain and underestimation of other discomforts. Analgosedation as a strategy promotes pain assessment and treatment first and will enable more patients to express their needs. We need to ensure, however, that other discomforts are not mistaken for pain and treated as such in patients unable to communicate. Despite the need for tools and strategies to avoid haphazard deliberations and enactments, our study shows that nursing practice in intensive care is inevitably dependent on the nurses’ personal and professional engagement, skills and standards.4.1There are several limitations to this study. Firstly, the single‐unit study design may reflect a local culture in the practice of decision‐making and therefore reduce transferability to other units. The nurse:patient ratio is considered high in Nordic ICUs (Egerod, Albarran, Ring, & Blackwood, 5In this study, the use of Kim's framework to guide the analysis contributed to highlighting the differences between the structure of deliberations and enactments with regard to pain and other discomforts in ICU nursing practice. We showed that the processes of deliberation and enactment regarding pain adopted by the nurses, to a large extent relate to existing recommendations for preventing, assessing and treating pain. Protocols or strategies, reflected in our study by the analgosedation protocol, may be regarded as a compass to indicate the direction of treatment and care in nurses’ decision‐making. The “compass” adds to the metaphor “the landscape of critical care” used by Bucknall  in exploAll authors declare no conflict of interest.HB, ITB, HW: Study design, analysis and manuscript preparation. HB: data collection.


While radiotherapy offers pain relief with a mean pain score of 7.25 ±1.5 (p =<.0001), sequential interventional therapy results in better comfort as demonstrated by a mean pain score of 3.9 ± 2.6 (p=.0015). Moreover, all patients who reported oral analgesic use at presentation reported a decrease in their requirement after sequential interventional therapy. Embolization and cryoablation were performed in all patients, while osteoplasty was indicated in 6 cases. There was no difference in postprocedural pain intensity between patients who required osteoplasty and patients who did not (p = 0.7514). There were no complications observed during treatment. This retrospective study shows that sequential intervention with transarterial embolization, cryoablation, and osteoplasty is both safe and efficacious for bone pain refractory to the current standard of care. We demonstrated that this combination therapy has the potential to become an effective mainstay treatment paradigm in the palliative care of osseous neoplasm to improve quality of life.The purpose of this study is to determine if sequential interventional therapy can become a mainstay option in providing palliation from fastidious osseous neoplasms in patients with pain refractory to oral analgesia and radiotherapy. This retrospective monocentric study was approved by our institutional review board. Between July 2012 and August 2014, we reviewed 15 patients  who underwent embolization followed by cryoablation, with or without osteoplasty. Patient demographics and tumor characteristics, including primary histology and the location of metastasis, were included in our review. Pain intensity at baseline, after radiotherapy, and after sequential interventional therapy was reviewed using the hospital electronic medical record. The use of oral analgesia and procedural complications was also noted. Data was then assessed for normality and a two-tailed Student's Metastapatients . Both prpatients . Minimalpatients . Multicepatients . Howeverpatients , 7. Howepatients . Transarpatients . In addipatients . We hypoThis retrospective monocentric study was approved by the institutional review board. All patients who underwent the paradigm of embolization, cryoablation, and osteoplasty received thorough informed consent at the time of procedure. Consent included explaining the risks versus benefits of undergoing their treatments, as well as collection of images and permission for publishing their deidentified imaging and clinical information. All patients were referred to our interventional radiologists and triaged on the basis of their clinical exam and diagnostic imaging. Fifteen patients' medical records from July 2012 to August 2014 from our institution were reviewed and deemed eligible based on our inclusion criteria. Patient's demographics and tumor characteristics are provided in Inclusion criteria included men and women of 19-81 years of ages with primary or secondary osseous neoplasms and inoperable tumor burden who have pretreatment CT or magnetic resonance (MR) imaging charactering the extent of disease. Subjects may or may not have undergone treatment of the underlying condition. Patient must have received sequential embolization and cryoablation. Patients may or may not have been treated with osteoplasty. Subjects must have undergone follow-up imaging in one to three months following treatment to assess effects. Exclusion criteria include absence of any of the above.Cryoablation with preprocedural angiographic embolization was offered as a means of decreasing patient pain. Postablation osteoplasty was offered for improved stabilization in select patients. Informed consent was obtained after explaining the risks and benefits of the procedures, as well as explaining the procedures that would be performed for palliative measures. The discussed risks included bleeding, infection, potential injury to nonpathological bone, and regional organ damage. The patient, prior to pursuing treatment, understood these risks. Data related to the procedures was recorded under an IRB-approved protocolAll procedures were performed under general anesthesia with total intravenous anesthesia (TIVA) in conjunction with succinylcholine administered by a trained anesthesiologist. A certified intraoperative neural monitoring specialist was present in the room at all times. A neurologist oversaw monitoring remotely. Cryoablation and osteoplasty typically follow one to two days after embolization. Angiographic embolization was performed prior to cryoablation to decrease tumor perfusion. Vessels were selected based on the location of the neoplasm. The internal and external iliac vessels were targeted for iliac and ischial lesions. The lateral/median sacral, gluteal, and iliolumbar vessels were targeted for sacral lesions. The thoracoacromial and circumflex humeral vessels were targeted for scapular lesions. Sodium Brevital 3 mg  was injected prior to embolization to assess if changes in recorded transcranial motor evoked potentials (TcMEPs) were visualized. Waveforms remained stable after Brevital injection, following which embolization was performed using 300 to 500 micron polyvinyl alcohol (PVA) particles . Postangiography images showed significantly diminished tumor vascularity .The patients were then brought back within two days to undergo cryoablation. The patients were placed in the appropriate position and prepped and draped in a sterile fashion. Bilateral 10-guage bone biopsy needles serving as introducers were inserted into the osseous lesion. 15 mm cryoablation probes were inserted through each introducer away from adjacent neurovascular structures. Real-time temperature monitoring was accomplished with a temperature probe. Once positioning was verified, a single freeze-thaw-freeze cycle was performed for 10, 8, and 10 minutes, respectively. This resulted in formation of ovoid ice balls within the boundaries of the lesion . While t t-test was performed comparing mean pain scores at baseline and after RT and mean pain scores after RT and after ST. For patients with no reported post-ST pain scores, their baseline and post-RT scores were still included in our analysis. We also assessed mean pain scores between patients who received osteoplasty and patients who did not receive osteoplasty using Mann-Whitney U test. Data are presented as mean ± SD and differences were considered statistically significant at p<0.05. Statistical tests were performed using GraphPad Prism 7.0 software.This was a single-arm retrospective study in which patients were their own controls. Primary endpoints were pain at baseline, pain after RT, and pain after ST. Pain was measured using the numeric rating scale (NRS-11) . SecondaBetween July 2012 and August 2014, nine patients underwent embolization, cryoablation, and osteoplasty. Six patients underwent embolization and cryoablation only. Fourteen patients were treated with RT prior. Postprocedural pain was assessed between one and eight weeks, with an average of 3 weeks. All patients had documented baseline and post-RT pain scores. Twelve of fifteen patients (80%) had documented NRS-11 pain score at follow-up. Technical success was achieved in all procedures. Symptomatic neoplasms were fully embolized with stasis achieved in tumor feeding vessels. Cryoablation was performed with visualization of the ice ball on CT. No complications occurred at any point during the embolization, cryoablation, or osteoplasty.There was no difference in postprocedural pain scores between patients who required osteoplasty and patients who did not (p = 0.7514). One patient did not report postprocedural pain improvements. This patient did, however, report lifestyle improvements with the ability to lay on the side of the tumor.Minimally invasive treatment options for both primary and metastatic osseous neoplasms have been developed and tested over the past decade . Studiesκ-B ligand (RANKL) which interacts with osteoclast expressed RANK resulting in bone resorption. This process involves an acidic area adjacent to the bone that results in upregulation of specific ion channels, such as transient receptor potential cation channel subfamily V member 1 (TrpV1) [Clinically, bone pain is managed with a spectrum of analgesics beginning with nonsteroidal anti-inflammatory drugs and culminating in opiate therapy. Adjuvant therapies such as RT and nerve blocks are also common. Studies suggest that the pathophysiology of bone pain is multifactorial. Cancer cells and the associated stroma express receptor activator of nuclear factor  (TrpV1) , which r (TrpV1) . TherefoOur study results suggest that sequential embolization, cryoablation, and osteoplasty are effective and yield a statistically significant improvement in pain control without complications. This subjective reduction in reported pain scores was confirmed with a uniform reduction in postprocedural oral analgesics in all patients. We have demonstrated that these procedures are safe and efficient and have a role in patients who are symptomatic despite both maximal medical treatment and RT. The pain relief observed is primarily related to cryoablation. Embolization prior to cryoablation provides hemostatic control and allows for targeted therapy of extraosseous disease and osseous sites not amenable to safe cryoablation. Limitations to this study are primarily related to a retrospective design. We were only able to identify 15 patients who underwent ST. This small sample size limited our statistical power. In addition, the histology studied may not be representative of the general population. For example, the primary tumor dictates the characteristics of the metastasis (osteolytic versus osteoblastic), which can impact treatment decisions and outcomes. In addition, we had to rely on chart review to obtain postprocedural pain scores, which were not always quantified. Further studies should be prospectively designed and include a larger sample size with more varied pathology and longer patient follow-up to assess recurrence.In summary, ST of painful osseous neoplasms with transarterial embolization, cryoablation, and osteoplasty results in a dramatic reduction in reported pain and analgesic use without complications. We demonstrated that this combination has the potential to become a mainstay paradigm in the palliative care of osseous neoplasm for patients otherwise resistant to radiotherapy. We suggest that a multidisciplinary team implementing optimal medication, RT, and interventional procedures can provide comprehensive management of these patients and improve their quality of life.