Advance care planning in patients with advanced cancer: A 6-country, cluster-randomised clinical trial

Background Advance care planning (ACP) supports individuals to define, discuss, and record goals and preferences for future medical treatment and care. Despite being internationally recommended, randomised clinical trials of ACP in patients with advanced cancer are scarce. Methods and findings To test the implementation of ACP in patients with advanced cancer, we conducted a cluster-randomised trial in 23 hospitals across Belgium, Denmark, Italy, Netherlands, Slovenia, and United Kingdom in 2015–2018. Patients with advanced lung (stage III/IV) or colorectal (stage IV) cancer, WHO performance status 0–3, and at least 3 months life expectancy were eligible. The ACTION Respecting Choices ACP intervention as offered to patients in the intervention arm included scripted ACP conversations between patients, family members, and certified facilitators; standardised leaflets; and standardised advance directives. Control patients received care as usual. Main outcome measures were quality of life (operationalised as European Organisation for Research and Treatment of Cancer [EORTC] emotional functioning) and symptoms. Secondary outcomes were coping, patient satisfaction, shared decision-making, patient involvement in decision-making, inclusion of advance directives (ADs) in hospital files, and use of hospital care. In all, 1,117 patients were included (442 intervention; 675 control), and 809 (72%) completed the 12-week questionnaire. Patients’ age ranged from 18 to 91 years, with a mean of 66; 39% were female. The mean number of ACP conversations per patient was 1.3. Fidelity was 86%. Sixteen percent of patients found ACP conversations distressing. Mean change in patients’ quality of life did not differ between intervention and control groups (T-score −1.8 versus −0.8, p = 0.59), nor did changes in symptoms, coping, patient satisfaction, and shared decision-making. Specialist palliative care (37% versus 27%, p = 0.002) and AD inclusion in hospital files (10% versus 3%, p < 0.001) were more likely in the intervention group. A key limitation of the study is that recruitment rates were lower in intervention than in control hospitals. Conclusions Our results show that quality of life effects were not different between patients who had ACP conversations and those who received usual care. The increased use of specialist palliative care and AD inclusion in hospital files of intervention patients is meaningful and requires further study. Our findings suggest that alternative approaches to support patient-centred end-of-life care in this population are needed

Total and corrected antioxidant capacity in hemodialyzed patients

BACKGROUND: Oxidative stress may play a critical role in the vascular disease of end stage renal failure and hemodialysis patients. Studies, analyzing either discrete analytes and antioxidant substances, or the integrated total antioxidant activity of human plasma during hemodialysis, give contradictory results. METHODS: Recently, we have introduced a new automated method for the determination of Total Antioxidant Capacity (TAC) of human plasma. We have serially measured TAC and corrected TAC (cTAC: after subtraction of the interactions due to endogenous uric acid, bilirubin and albumin) in 10 patients before the onset of the dialysis session, 10 min, 30 min, 1 h, 2 h and 3 h into the procedure and after completion of the session. RESULTS: Our results indicate that TAC decreases, reaching minimum levels at 2 h. However, corrected TAC increases with t(1/2 )of about 30 min. We then repeated the measurements in 65 patients undergoing dialysis with different filters (36 patients with ethylene vinyl alcohol copolymer resin filter -Eval-, 23 patients with two polysulfone filters -10 with F6 and 13 with PSN140-, and 6 patients with hemophan filters). Three specimens were collected (0, 30, 240 min). The results of this second group confirm our initial results, while no significant difference was observed using either filter. CONCLUSIONS: Our results are discussed under the point of view of possible mechanisms of modification of endogenous antioxidants, and the interaction of lipid- and water-soluble antioxidants

Trained facilitators’ experiences with structured advance care planning conversations in oncology : an international focus group study within the ACTION trial

Background In oncology, Health Care Professionals often experience conducting Advance Care Planning (ACP) conversations as difficult and are hesitant to start them. A structured approach could help to overcome this. In the ACTION trial, a Phase III multi-center cluster-randomized clinical trial in six European countries (Belgium, Denmark, Italy, the Netherlands, Slovenia, United Kingdom), patients with advanced lung or colorectal cancer are invited to have one or two structured ACP conversations with a trained facilitator. It is unclear how trained facilitators experience conducting structured ACP conversations. This study aims to understand how facilitators experience delivering the ACTION Respecting Choices (RC) ACP conversation. Methods A qualitative study involving focus groups with RC facilitators. Focus group interviews were recorded, transcribed, anonymized, translated into English, and thematically analysed, supported by NVivo 11. The international research team was involved in data analysis from initial coding and discussion towards final themes. Results Seven focus groups were conducted, involving 28 of in total 39 trained facilitators, with different professional backgrounds from all participating countries. Alongside some cultural differences, six themes were identified. These reflect that most facilitators welcomed the opportunity to participate in the ACTION trial, seeing it as a means of learning new skills in an important area. The RC script was seen as supportive to ask questions, including those perceived as difficult to ask, but was also experienced as a barrier to a spontaneous conversation. Facilitators noticed that most patients were positive about their ACTION RC ACP conversation, which had prompted them to become aware of their wishes and to share these with others. The facilitators observed that it took patients substantial effort to have these conversations. In response, facilitators took responsibility for enabling patients to experience a conversation from which they could benefit. Facilitators emphasized the need for training, support and advanced communication skills to be able to work with the script. Conclusions Facilitators experienced benefits and challenges in conducting scripted ACP conversations. They mentioned the importance of being skilled and experienced in carrying out ACP conversations in order to be able to explore the patients’ preferences while staying attuned to patients’ needs

Psychological factors as predictors of early postoperative pain after open nephrectomy

Purpose: There is an increasing interest in the identification of predictors for individual responses to analgesics and surgical pain. In this study, we aimed to determine psychological factors that might contribute to this response. We hence investigated patients undergoing a standardized surgical intervention (open nephrectomy). Patients and methods: Between May 2014 and April 2015, we conducted a prospective observational cohort study. The following psychological tests were administered preoperatively: Mini-Mental State Examination, Amsterdam Preoperative Anxiety and Information Scale (APAIS), Hamilton Anxiety Rating Scale, Hamilton Depression Rating Scale, and Pain Catastrophizing Scale. The primary outcome, postoperative pain intensity (11-point numerical rating scale, [NRS]), was assessed in the “immediate early” (first 8 hours), “early” (12 and 24 hours), and “late early” periods (48 and 72 hours). Results: A total of 196 patients were assessed, and 150 were finally included in the study. NRS scores improved from 4.9 (95% confidence interval [CI]: 4.7–5.1) in the “immediate early” to 3.1 (95% CI: 2.9–3.3) in the “early” and 2.3 (95% CI: 2.1–2.5) in the “late early” postoperative period. Most (87%) patients received intravenous opioids, while 13% received analgesics epidurally. Repeated measures analysis of variance indicated better pain management with epidural analgesia in the first two postoperative periods (F=15.01, p<0.00). Postoperative pain correlated strongly with analgesic strategy and preoperative psychological assessment. Multiple linear regression analysis showed “expected pain” was the only predictor in the “immediate early” phase, and “anxiety” was most important in the “early” postoperative period. In the “late early” phase, catastrophizing was the predominant predictor, alongside “preoperative analgesic usage” and “APAIS anxiety”. Conclusion: After open nephrectomy, epidural analgesia conveys a clear advantage for pain management only within the first 24 hours. Moreover, as the psychological phenotype of patients changes distinctively in the first 72 postoperative hours, psychological variables increasingly determine pain intensity, even surpassing employed analgesic strategy as its main predictor

Psychological factors as predictors of early postoperative pain after open nephrectomy

Ana Mimic,1 Carsten Bantel,2,3 Jelena Jovicic,1 Branko Mimic,4 Darija Kisic-Tepavcevic,5 Otas Durutovic,6,7 Nebojsa Ladjevic1,7 1Department of Anaesthesia, Urology Clinic, Clinical Centre of Serbia, Belgrade, Serbia; 2Department of Anaesthetics, Klinikum Oldenburg A&ouml;R, Oldenburg, Germany; 3Section of Anaesthetics, Department of Surgery and Cancer, Faculty of Medicine, Imperial College London, London, UK; 4East Midlands Congenital Heart Centre, University Hospital Leicester, Leicester, UK; 5Institute of Epidemiology, School of Medicine, University of Belgrade, Belgrade, Serbia; 6Department of Urology, Urology Clinic, Clinical Centre of Serbia, Belgrade, Serbia; 7Department of Surgery and Anaesthesiology, School of Medicine, University of Belgrade, Belgrade, Serbia Purpose: There is an increasing interest in the identification of predictors for individual responses to analgesics and surgical pain. In this study, we aimed to determine psychological factors that might contribute to this response. We hence investigated patients undergoing a standardized surgical intervention (open nephrectomy). Patients and methods: Between May 2014 and April 2015, we conducted a prospective observational cohort study. The following psychological tests were administered preoperatively: Mini-Mental State Examination, Amsterdam Preoperative Anxiety and Information Scale (APAIS), Hamilton Anxiety Rating Scale, Hamilton Depression Rating Scale, and Pain Catastrophizing Scale. The primary outcome, postoperative pain intensity (11-point numerical rating scale, [NRS]), was assessed in the &ldquo;immediate early&rdquo; (first 8 hours), &ldquo;early&rdquo; (12 and 24 hours), and &ldquo;late early&rdquo; periods (48 and 72 hours).Results: A total of 196 patients were assessed, and 150 were finally included in the study. NRS scores improved from 4.9 (95% confidence interval [CI]: 4.7&ndash;5.1) in the &ldquo;immediate early&rdquo; to 3.1 (95% CI: 2.9&ndash;3.3) in the &ldquo;early&rdquo; and 2.3 (95% CI: 2.1&ndash;2.5) in the &ldquo;late early&rdquo; postoperative period. Most (87%) patients received intravenous opioids, while 13% received analgesics epidurally. Repeated measures analysis of variance indicated better pain management with epidural analgesia in the first two postoperative periods (F=15.01, p&lt;0.00). Postoperative pain correlated strongly with analgesic strategy and preoperative psychological assessment. Multiple linear regression analysis showed &ldquo;expected pain&rdquo; was the only predictor in the &ldquo;immediate early&rdquo; phase, and &ldquo;anxiety&rdquo; was most important in the &ldquo;early&rdquo; postoperative period. In the &ldquo;late early&rdquo; phase, catastrophizing was the predominant predictor, alongside &ldquo;preoperative analgesic usage&rdquo; and &ldquo;APAIS anxiety&rdquo;.Conclusion: After open nephrectomy, epidural analgesia conveys a clear advantage for pain management only within the first 24 hours. Moreover, as the psychological phenotype of patients changes distinctively in the first 72 postoperative hours, psychological variables increasingly determine pain intensity, even surpassing employed analgesic strategy as its main predictor. Keywords: psychological variables, postoperative analgesia, postoperative pain, open nephrectomy, numeric rating scal

Development Towards a Protocol to Test for the Creation of a “Diabetic” Environment in a Blood Vessel Mimic

Diabetes mellitus affects a huge proportion of people; about 6% of the population in the US had diabetes in 2007 (16). Diabetes promotes dyslipidemia, an imbalance in the circulating levels of lipids and lipoproteins, and diabetes is one of the leading risk factors for coronary artery and peripheral vascular diseases (11, 51, 52). There are two types of diabetes; type 1 diabetes accounts for about 10% of diagnosed cases and type 2 accounts for about 90% (11). Diabetic patients react differently to stents and there is a great need to enhance the treatment. The goal of this project was, and continues to be, to create a “diabetic” environment in which stents can be tested to characterize the potential of the stent to continue with animal testing