Is pain associated with premature mortality in patients with psoriatic arthritis? A nested case-control study using the DANBIO Register.

OBJECTIVES: It has been hypothesized that the presence of chronic pain causes excess mortality. Since chronic pain is prevalent among patients with PsA this potential association should be explored. We aimed to investigate whether higher cumulative pain intensity is associated with an excess mortality risk in patients with PsA. METHODS: A nested case-control study using data from the nationwide DANBIO Register (Danish Database for Biological Therapies in Rheumatology) Register and Danish healthcare registers. Cases were patients who died and corresponding to the date of death, matched on sex, year of birth and calendar period at the time of death with up to five controls. Exposure of interest was mean pain intensity reported during the time followed in routine rheumatology practice. Pain intensity was measured using a visual analogue scale from 0 to 100 and conditional logistic regression was used to calculate odds of mortality per 5 unit increase in pain while adjusting for confounders. RESULTS: The cohort consisted of 8019 patients. A total of 276 cases were identified and matched with 1187 controls. Higher mean pain intensity was associated with increased odds of mortality [odds ratio 1.06 (95% CI 1.02, 1.10)] in the crude model, but there was no association [odds ratio 0.99 (95% CI 0.95, 1.03)] when adjusting for additional confounders. Factors shown to increase the odds of mortality were recent glucocorticoid use, concomitant chronic obstructive pulmonary disease, diabetes mellitus, cancer and cardiovascular disease. CONCLUSION: These results indicate that experienced pain in itself is not associated with premature mortality in patients with PsA. However, recent glucocorticoid use and concurrent comorbidities were.

Association of periprocedural intravenous morphine use on clinical outcomes in ST-elevation myocardial infarction (STEMI) treated by primary percutaneous coronary intervention: Systematic review and meta-analysis.

OBJECTIVES: To conduct a systematic review and meta-analysis of studies examining the impact of periprocedural intravenous morphine on clinical outcomes in patients undergoing primary percutaneous coronary intervention (PCI) for ST-elevation myocardial infarction (STEMI). BACKGROUND: Morphine analgesia may reduce the absorption of co-prescribed P2Y12 antagonists attenuating platelet inhibition. The impact of periprocedural intravenous morphine on clinical outcomes in patients undergoing PCI for STEMI is not well defined. METHODS: Analysis of the electronic databases of MEDLINE, EMBASE, Cochrane Central Register of Controlled Trials (CENTRAL), Scopus, Web of Science and ClinicalTrials.gov for association of peri-PCI intravenous morphine use with in-hospital or 30-day myocardial infarction (MI) (primary outcome) and in-hospital or 30-day mortality. RESULTS: A total of 11 studies were included for systematic review. One study was a randomized controlled trial, 10 were observational studies. Five studies including 3,748 patients were included in meta-analysis of in-hospital or 30-day MI. Within this group, patients were treated concurrently with ticagrelor (n = 2,239), clopidogrel (n = 1,256) and prasugrel (n = 253). There was no significant association of in-hospital or 30-day MI with intravenous morphine (odds ratio 1.88; 95% confidence interval [CI] 0.87-4.09; I2 0%). Across seven studies and 5,800 patients, no increased risk of mortality at the same composite time endpoint was evident (odds ratio 0.70; 95% CI 0.40-1.23; I2 19%). CONCLUSIONS: Periprocedural intravenous morphine administration was not associated with adverse short-term clinical outcomes in patients undergoing primary PCI for STEMI. Further randomized trial data are needed to evaluate the pharmacologic interaction between morphine and P2Y12 antagonists with clinical outcomes.

Effectiveness of Radiofrequency Ablation in the Treatment of Painful Osseous Metastases: A Correlation Meta-Analysis with Machine Learning Cluster Identification.

A systematic review and meta-analysis of pain response after radiofrequency (RF) ablation over time for osseous metastases was conducted in 2019. Analysis used a random-effects model with GOSH plots and meta-regression. Fourteen studies comprising 426 patients, most with recalcitrant pain, were identified. Median pain reduction after RF ablation was 67% over median follow-up of 24 weeks (R2 = -.66, 95% confidence interval -0.76 to -0.55, I2 = 71.24%, fail-safe N = 875) with 44% pain reduction within 1 week. A low-heterogeneity subgroup was identified with median pain reduction after RF ablation of 70% over 12 weeks (R2 = -.75, 95% confidence interval -0.80 to -0.70, I2 = 2.66%, fail-safe N = 910). Addition of cementoplasty after RF ablation did not significantly affect pain scores. Primary tumor type and tumor size did not significantly affect pain scores. A particular, positive association between pain after RF ablation and axial tumors was identified, implying possible increased palliative effects for RF ablation on axial over appendicular lesions. RF ablation is a useful palliative therapy for osseous metastases, particularly in patients with recalcitrant pain.

Radiofrequency Ablation for the Palliative Treatment of Bone Metastases: Outcomes from the Multicenter OsteoCool Tumor Ablation Post-Market Study (OPuS One Study) in 100 Patients.

PURPOSE: To evaluate the effectiveness of radiofrequency (RF) ablation as measured by change in worst pain score from baseline to 3 mo after RF ablation for the palliative treatment of painful bone metastases. MATERIALS AND METHODS: One hundred patients (mean age, 64.6 y) underwent RF ablation for metastatic bone disease and were followed up to 6 mo. Subjects' pain and quality of life were measured before RF ablation and postoperatively by using the Brief Pain Index and European Quality of Life questionnaires. Opioid agent use and device-, procedure-, and/or therapy-related adverse events (AEs) were collected. RESULTS: Eighty-seven patients were treated for tumors involving the thoracolumbar spine and 13 for tumors located in the pelvis and/or sacrum. All ablations were technically successful, and 97% were followed by cementoplasty. Mean worst pain score decreased from 8.2 ± 1.7 at baseline to 3.5 ± 3.2 at 6 mo (n = 22; P < 0.0001 for all visits). Subjects experienced significant improvement for all visits in average pain (P < .0001), pain interference (P < .0001), and quality of life (P < .003). Four AEs were reported, of which 2 resulted in hospitalization for pneumonia and respiratory failure. All 30 deaths reported during the study were attributed to the underlying malignancy and not related to the study procedure. CONCLUSIONS: Results from this study show rapid (within 3 d) and statistically significant pain improvement with sustained long-term relief through 6 mo in patients treated with RF ablation for metastatic bone disease.

Perioperative Outcomes of Lower Extremity Revascularization for Rest Pain and Tissue Loss.

BACKGROUND: Critical limb ischemia (CLI) is the clinical manifestation of severe peripheral artery disease presenting as rest pain (RP) and tissue loss (TL). Most studies compare CLI as a homogenous group with claudication with limited database studies specifically studying these differences. We hypothesize that CLI should be stratified into RP and TL because of significant differences in disease severity, comorbidities, and outcomes. METHODS: The American College of Surgeons National Surgical Quality Improvement Program database from 2012 to 2016 was reviewed. All patients with a postoperative diagnosis of CLI undergoing femoral to popliteal bypass (FPB) with vein or graft were identified. Patients were stratified into cohorts based on International Classification of Disease (ICD)-9 or ICD-10 codes for RP or TL (gangrene or ulcer). Univariate and multivariate analyses were performed to examine 30-day mortality, morbidity, major amputation, and readmission adjusting for demographics, comorbidities, and procedural details. RESULTS: There were 5,304 patients. Compared to RP, patients with TL were older (P < 0.0001) and more likely to be dependent (P < 0.0001). TL patients were also more likely to have diabetes (P < 0.0001), congestive heart failure (P < 0.0001), renal failure (P = 0.004), dialysis (P < 0.0001), history of wound infection (P < 0.0001), and sepsis (P < 0.0001). TL patients had higher American Society of Anesthesiologists class (P < 0.0001), were less likely to be transferred from home (P < 0.0001), and more likely to receive an FPB with vein (P = 0.03). Patients with TL had worse perioperative outcomes compared with RP in terms of pneumonia (P = 0.004), unplanned intubation (P = 0.009), cardiac arrest requiring cardiopulmonary resuscitation (P = 0.003), bleeding requiring transfusions (P < 0.0001), sepsis (P < 0.0001), septic shock (P = 0.02), and reoperation (P < 0.0001). TL was associated with significantly higher 30-day morbidity (P < 0.0001), 30-day mortality (P < 0.0001), major amputation (P = 0.0004), and readmission rates (P = 0.005). Patients with TL compared with those with RP also had longer hospital stays (P < 0.0001) and days between operation to discharge (P < 0.0001). TL was independently associated with increased 30-day morbidity (OR: 1.16 [1.00-1.35]) and major amputation (OR: 2.48 [1.29-4.76]) compared with RP. CONCLUSIONS: Patients with RP and TL have drastic differences that impact perioperative mortality and readmissions. TL is an independent predictor of 30-day morbidity and major amputation. The stratification of CLI into RP and TL can provide insight into variations in outcomes and provide a means to quantify the risks associated with the 2 manifestations of the disease.

Association of Opioid Use in the Week Before Death Among Patients With Advanced Lung Cancer Having Sepsis.

Opioid use can induce immunosuppression; however, it is unclear whether opioid use increases infections in patients with advanced cancers. This study assessed the association between opioid use in the week before death and mortality among patients with advanced lung cancer having sepsis. Data on opioid usage in the week before death, general information, and clinical information of the patients were collected retrospectively. The primary outcome was the association between opioid use in the week before death and mortality after sepsis. The study included 980 patients who died of advanced lung cancer between January 2003 and June 2017 (sepsis related: 413, unrelated to sepsis: 567). The average morphine equivalent daily dose in the final week was higher in the sepsis group (313.5 ± 510.5 mg) than in the nonsepsis group (125.2 ± 246.9 mg, P < .001). A significant association was found between the average morphine equivalent daily dose in the final week and mortality due to sepsis (odds ratio: 1.02, 95% confidence interval: 1.01-1.02, P < .001). This was especially evident when the dose was increased by 10 mg in the final week. Furthermore, older age, male sex, and a lower body mass index were associated with an increased risk of mortality after developing sepsis. Opioid use in the week before death may be associated with mortality for patients with advanced lung cancer having sepsis.

Prophylactic transfusion for pregnant women with sickle cell disease: a systematic review and meta-analysis.

Pregnancy in women with sickle cell disease is associated with adverse maternal and neonatal outcomes. Studies assessing the effects of prophylactic red blood cell transfusions on these outcomes have drawn inconsistent conclusions. The objective of this systematic review was to assess the effect of prophylactic compared with on-demand red blood cell transfusions on maternal and neonatal outcomes in women with sickle cell disease. A systematic search of several medical literature databases was conducted. Twelve studies involving 1291 participants met inclusion criteria. The studies had moderate to high risk of bias. Meta-analysis demonstrated that prophylactic transfusion was associated with a reduction in maternal mortality (7 studies, 955 participants; odds ratio [OR], 0.23; 95% confidence interval [CI], 0.06-0.91), vaso-occlusive pain episodes (11 studies, 1219 participants; OR, 0.26; 95% CI, 0.09-0.76), pulmonary complications (9 studies, 1019 participants; OR, 0.25; 95% CI, 0.09-0.72), pulmonary embolism (3 studies, 237 participants; OR, 0.07; 95% CI, 0.01-0.41), pyelonephritis (6 studies, 455 participants; OR, 0.19; 95% CI, 0.07-0.51), perinatal mortality (8 studies, 1140 participants; OR, 0.43; 95% CI, 0.19-0.99), neonatal death (5 studies, 374 participants; OR, 0.26; 95% CI, 0.07-0.93), and preterm birth (9 studies, 1123 participants; OR, 0.59; 95% CI, 0.37-0.96). Event rates for most of the results were low. Prophylactic transfusions may positively impact several adverse maternal and neonatal outcomes in women with sickle cell disease; however, the evidence stems from a relatively small number of studies with methodologic limitations. A prospective, multicenter, randomized trial is needed to determine whether the potential benefits balance the risks of prophylactic transfusions.

Painful skin lesions and squamous cell carcinoma predict overall mortality risk in organ transplant recipients: a cohort study.

BACKGROUND: Organ transplant recipients (OTRs) have a highly increased risk of cutaneous squamous cell carcinomas (SCCs). Sensation of pain in cutaneous tumours is a powerful patient-reported warning signal for invasive SCCs in OTRs. OBJECTIVES: To investigate the impact of painful vs. painless skin lesions and SCC vs. other skin lesions on the overall mortality risk in OTRs. METHODS: We followed 410 OTRs from 10 different centres across Europe and North America between 2008 and 2015. These patients had been enrolled in an earlier study to define clinically meaningful patient-reported warning signals predicting the presence of SCC, and had been included if they had a lesion requiring histological diagnosis. Cumulative incidences of overall mortality were calculated using Kaplan-Meier survival analysis, and risk factors were analysed with Cox proportional hazard analysis. RESULTS: There was an increased overall mortality risk in OTRs who reported painful vs. painless skin lesions, with a hazard ratio (HR) of 1·6 [95% confidence interval (CI) 0·97-2·7], adjusted for age, sex and other relevant factors. There was also an increased overall mortality risk in OTRs diagnosed with SCC compared with other skin lesions, with an adjusted HR of 1·7 (95% CI 1·0-2·8). Mortality due to internal malignancies and systemic infections appeared to prevail in OTRs with SCC. CONCLUSIONS: We suggest that OTRs have an increased overall mortality risk if they develop painful skin lesions or are diagnosed with cutaneous SCC.

Analgesic Choice in Management of Rib Fractures: Paravertebral Block or Epidural Analgesia?

BACKGROUND: Rib fractures are commonly encountered in the setting of trauma. The aim of this study was to assess the association between the clinical outcome of rib fracture and epidural analgesia (EA) versus paravertebral block (PVB) using the National Trauma Data Bank (NTDB). METHODS: Using the 2011 and 2012 versions of the NTDB, we retrieved completed records for all patients above 18 years of age who were admitted with rib fractures. Primary outcome was in-hospital mortality. Secondary outcomes were length of stay (LOS), intensive care unit (ICU) admission, ICU LOS, mechanical ventilation, duration of mechanical ventilation, development of pneumonia, and development of any other complication. Clinical outcomes were first compared between propensity score-matched EA and PVB patients. Then, EA and PVB patients were combined into the procedure group and the outcomes were compared with propensity score-matched patients that received neither intervention (no-procedure group). RESULTS: A total of 194,766 patients were included in the study with 1073 patients having EA, 1110 patients having PVB, and 192,583 patients having neither procedure. After propensity score matching, comparison of primary and secondary outcomes between EA and PVB patients showed no difference. Comparison of propensity score-matched procedure and no-procedure patients showed prolonged LOS and more frequent ICU admissions in patients receiving a procedure (both P < .0001), yet having no procedure was associated with a significantly increased odds of mortality (odds ratio: 2.25; 95% confidence interval, 1.14-3.84; P = .002). CONCLUSIONS: Using the NTDB, EA and PVB were not found to be significantly different in management of rib fractures. There was an association between use of a block and improved outcome, but this could be explained by selection of healthier patients to receive a block. Prospective study of this association is recommended.

The McGill Brisbane Symptom Score in relation to survival in pancreatic adenocarcinoma: a validation study.

PURPOSE: The McGill Brisbane Symptom Score (MBSS) is a clinical score for pancreatic cancer patients upon initial presentation that takes into account four variables (weight loss, abdominal pain, jaundice, and history of smoking) to stratify them into two MBSS intensity categories. Several studies have suggested that these categories are strongly associated with eventual survival in patients with resectable (rPCa) and unresectable (uPCa) pancreatic cancer. This study aimed to validate the MBSS in a cohort of patients with pancreatic cancer from a single institution. METHODS: Survival time by resection status and MBSS intensity category were analyzed among 633 patients from our institution between 2001 and 2010. Hazard ratios for death using Cox proportional hazards models, with age as the timescale, adjustment for sex and year of diagnosis, and stratified by adjuvant chemotherapy status were estimated. RESULTS: Median survival time was the longest in patients with low-intensity MBSS and rPCa (817 days), whereas the shortest survival time was found among patients with uPCa regardless of MBSS status (144-147 days). After consideration of age and chemotherapy status, high-intensity MBSS was associated with poorer survival for both rPCa (HR 1.64; 95 % CI 1.07-2.52) and uPCa (HR 1.35; 95 % CI 1.06-1.72). CONCLUSIONS: Preoperative MBSS intensity is a useful prognostic indicator of survival in resectable as well as unresectable pancreatic cancer.

Comorbidity Correlates of Death Among New Veterans of Iraq and Afghanistan Deployment.

BACKGROUND: Veterans of the wars in Iraq and Afghanistan who receive care in the Veterans Health Administration (VA) have high disease burden. Distinct comorbidity patterns have been shown to be differentially associated with adverse outcomes, including death. This study determined correlates of 5-year mortality. MATERIALS AND METHODS: VA demographic, military, homelessness, and clinical measures informed this retrospective analysis. Previously constructed comorbidity classifications over 3 years of care were entered into a Cox proportional hazards model of death. RESULTS: There were 164,933 veterans in the cohort, including African Americans (16%), Hispanics (11%), and whites (65%). Most were in their 20s at baseline (60%); 12% were women; 4% had attempted suicide; 4% had been homeless. Having clustered disorders of pain, posttraumatic stress disorder, and traumatic brain injury was associated with death [hazard ratio (HR)=2.0]. Mental disorders including substance abuse were similarly associated (HR=2.1). Prior suicide attempt (HR=2.2) or drug overdose (HR=3.0) considerably increased risk of death over 5 years. CONCLUSIONS: As congressional actions such as Veterans Choice Act offer more avenues to seek care outside of VA, coordination of care, and suicide prevention outreach for recent veterans may require innovative approaches to preserve life.

Pain and Mortality Risk in a Cohort of HIV-Infected Persons with Alcohol Use Disorders.

Pain has been associated with increased risk for mortality in some studies. We analyzed data from a cohort study [HIV-longitudinal interrelationships of viruses and ethanol (HIV-LIVE)] of HIV-infected persons with alcohol use disorders enrolled 2001-2003 to explore whether reporting moderate or greater pain interference was associated with mortality. The main independent variable was pain that at least moderately interfered with work based on a single question from the SF-12. Primary analyses dichotomized at "moderately" or above. Cox proportional hazards models assessed the association between pain interference and death adjusting for demographics, substance use, CD4 count, HIV viral load and co-morbidities. Although significant in unadjusted models (HR = 1.58 (95 % CI 1.03-2.41; p value = 0.04)), after adjusting for confounders, ≥moderate pain interference was not associated with an increased risk of death [aHR = 1.30 (95 % CI 0.81-2.11, p value = 0.28)]. Among HIV-infected persons with alcohol use disorders, we did not detect a statistically significant independent association between pain interference and risk of death after adjustment for potential confounders.

Cohort Study of the Impact of High-Dose Opioid Analgesics on Overdose Mortality.

OBJECTIVE: Previous studies examining opioid dose and overdose risk provide limited granularity by milligram strength and instead rely on thresholds. We quantify dose-dependent overdose mortality over a large spectrum of clinically common doses. We also examine the contributions of benzodiazepines and extended release opioid formulations to mortality. DESIGN: Prospective observational cohort with one year follow-up. SETTING: One year in one state (NC) using a controlled substances prescription monitoring program, with name-linked mortality data. SUBJECTS: Residential population of North Carolina (n = 9,560,234), with 2,182,374 opioid analgesic patients. METHODS: Exposure was dispensed prescriptions of solid oral and transdermal opioid analgesics; person-years calculated using intent-to-treat principles. Outcome was overdose deaths involving opioid analgesics in a primary or additive role. Poisson models were created, implemented using generalized estimating equations. RESULTS: Opioid analgesics were dispensed to 22.8% of residents. Among licensed clinicians, 89.6% prescribed opioid analgesics, and 40.0% prescribed ER formulations. There were 629 overdose deaths, half of which had an opioid analgesic prescription active on the day of death. Of 2,182,374 patients prescribed opioids, 478 overdose deaths were reported (0.022% per year). Mortality rates increased gradually across the range of average daily milligrams of morphine equivalents. 80.0% of opioid analgesic patients also received benzodiazepines. Rates of overdose death among those co-dispensed benzodiazepines and opioid analgesics were ten times higher (7.0 per 10,000 person-years, 95 percent CI: 6.3, 7.8) than opioid analgesics alone (0.7 per 10,000 person years, 95 percent CI: 0.6, 0.9). CONCLUSIONS: Dose-dependent opioid overdose risk among patients increased gradually and did not show evidence of a distinct risk threshold. There is urgent need for guidance about combined classes of medicines to facilitate a better balance between pain relief and overdose risk.

Small-molecule nociceptin receptor agonist ameliorates mast cell activation and pain in sickle mice.

Treatment of pain with morphine and its congeners in sickle cell anemia is suboptimal, warranting the need for analgesics devoid of side effects, addiction and tolerance liability. Small-molecule nociceptin opioid receptor ligands show analgesic efficacy in acute and chronic pain models. We show that AT-200, a high affinity nociceptin opioid receptor agonist with low efficacy at the mu opioid receptor, ameliorated chronic and hypoxia/reoxygenation-induced mechanical, thermal and deep tissue/musculoskeletal hyperalgesia in HbSS-BERK sickle mice. The antinociceptive effect of AT-200 was antagonized by SB-612111, a nociceptin opioid receptor antagonist, but not naloxone, a non-selective mu opioid receptor antagonist. Daily 7-day treatment with AT-200 did not develop tolerance and showed a sustained anti-nociceptive effect, which improved over time and led to reduced plasma serum amyloid protein, neuropeptides, inflammatory cytokines and mast cell activation in the periphery. These data suggest that AT-200 ameliorates pain in sickle mice via the nociceptin opioid receptor by reducing inflammation and mast cell activation without causing tolerance. Thus, nociceptin opioid receptor agonists are promising drugs for treating pain in sickle cell anemia.

Type and course of symptoms demonstrated in the terminal and dying phases by people with dementia in nursing homes.

BACKGROUND: In all, 39 % of people living in Swiss nursing homes suffer from dementia. Detailed data about type and course of symptoms displayed by these patients in their terminal phase are lacking. METHODS: This descriptive, retrospective study analysed 65 nursing documents from deceased people with dementia in four nursing homes in the canton of Zurich, Switzerland. RESULTS: Difficulties with mobility (81 %), pain (71 %) and sleep disturbance (63 %) were the most frequent of the 10 identified symptoms. Towards the end of life, difficulties with mobility, sleep disturbance, agitation and other neuropsychiatric symptoms, such as episodes of depression, decreased (decrescent pattern), while pain, feeding problems, breathing abnormalities, apathy and anxiety increased (crescent pattern). Courses of pain were documented in 17 % of the nursing records. In addition, 76 % of the residents had been visited on a daily basis by next of kin in their last 7 days, compared with only one third of residents previously. Furthermore, daily communication between healthcare professionals and next of kin tripled during this period. CONCLUSION: The documented prevalence of a high and increasing level of pain towards the end of life, combined with the lack of documented courses of pain, shows potential for improvement in pain relief and pain identification for patients with dementia in their terminal phase. The increasing number of visits by next of kin and the increasingly intensive contact between healthcare professionals and next of kin in the last 7 days are a strong indicator that the end of life can be predicted relatively well by the involved participants and appropriate reactions follow.

Functional status and patient-reported outcome 10 years after stroke: the Lund Stroke Register.

BACKGROUND AND PURPOSE: Long-term studies of outcome after stroke are scarce. Our aim was to study functional status and patient-reported outcome 10 years after a first-ever stroke. METHODS: Ten-year follow-up was conducted among the survivors from a population-based group of 416 patients included in the Lund Stroke Register, Sweden, between March 1, 2001, and February 28, 2002. The Barthel index was used to assess the functional status and the modified Rankin Scale to assess the degree of disability. The EQ-5D scale was used for survivors' self-reports about health outcome and the specific Short-Form 36 (SF-36) question for rating their overall health. The patients also reported their frequency of physical activity. RESULTS: Among 145 survivors 10 years after stroke (median age, 78 years), 59% were men, 90% lived in their ordinary housing, 73% were assessed as independent, and 71% had no or slight disability. The need of assistance with mobility and self-care was reported by 14% and with usual activities by 22%. Moderate pain was reported by 39%, and 4% had a high degree of pain. Moderate anxiety/depression was reported by 28% and high degree only by 1%. Overall health status was reported in positive terms by more than two thirds of the survivors. Almost half the cohort reported the same frequency of physical activity (≥4× weekly) as before stroke onset. CONCLUSIONS: This study indicates that 10-year stroke survivors in Sweden are mostly independent in daily activities and report good overall health and frequent physical activity, although half of them are ≥78 years.

Survival, efficacy, and safety of small versus large doxorubicin drug-eluting beads TACE chemoembolization in patients with unresectable HCC.

OBJECTIVE: The purpose of this study was to investigate the overall survival, efficacy, and safety of small (100-300 µm) versus large (300-500 and 500-700 µm) doxorubicin drug-eluting beads transarterial chemoembolization (DEB TACE) in patients with unresectable hepatocellular carcinoma (HCC). MATERIALS AND METHODS: Ninety-four consecutive patients with unresectable HCC who underwent 269 DEB TACE procedures in 48 months were studied. DEB TACE procedures were performed using different DEB sizes: 100-300 µm (Group A, 59 patients) and with mixed 300-500 and 500-700 µm DEB (Group B, 35 patients). Survival rates were compared between the groups. RESULTS: The overall median survival in groups A and B were 15.1 and 11.1 months, respectively (p=0.005). Both groups were similar in demographics, tumor burden, and differential staging (p>0.5). Substratification of overall survival according to Child-Pugh class and Okuda, Cancer of the Liver Italian Program (CLIP), and Barcelona Clinic Liver Cancer (BCLC) staging were significantly higher in group A than in group B (p<0.05). Common terminology criteria for adverse events (CTCAE) grade III adverse events and 30-day mortality were significantly lower in group A than in group B (6.8% vs 20%; p=0.04, and 0% vs 14.3%; p=0.001, respectively). The particle size, Child-Pugh class, and serum α-fetoprotein level were significant prognostic indicators of survival on multivariate analysis. CONCLUSION: TACE with 100-300 µm sized DEB is associated with significantly higher survival rate and lower complications than TACE with 300-500 and 500-700 µm sized DEB.

Could baseline health-related quality of life (QoL) predict overall survival in metastatic colorectal cancer? The results of the GERCOR OPTIMOX 1 study.

BACKGROUND: Health-related quality of life (QoL) has prognostic value in many cancers. A recent study found that the performance of prognostic systems for metastatic colorectal cancer (mCRC) were improvable. We evaluated the independent prognostic value of QoL for overall survival (OS) and its ability to improve two prognostic systems'performance (Köhne and GERCOR models) for patients with mCRC. METHODS: The EQ-5D questionnaire was self-completed before randomization in the OPTIMOX1, a phase III trial comparing two strategies of FOLFOX chemotherapy which included 620 previously untreated mCRC patients recruited from January 2000 to June 2002 from 56 institutions in five countries. The improvement in models' performance (after addition of QoL) was studied with Harrell's C-index and the net reclassification improvement. RESULTS: Of the 620 patients, 249 (40%) completed QoL datasets. The Köhne model could be improved by LDH, mobility and pain/discomfort; the C-index rose from 0.54 to 0.67. The associated NRI for 12-month death was 0.23 [0.05; 0.46]. Mobility and pain/discomfort could be added to the GERCOR model: the C-index varied from 0.63 to 0.68. The NRI for 12 months death was 0.35 [0.12; 0.44]. CONCLUSIONS: Mobility and pain dimensions of EQ5D are independent prognostic factors and could be useful for staging and treatment assignment of mCRC patients. Presented at the 2011 ASCO Annual Meeting (#3632).

Findings of the UK national audit evaluating image-guided or image-assisted liver biopsy. Part II. Minor and major complications and procedure-related mortality.

PURPOSE: To determine the frequency of complications and death following image-guided and/or image-assisted liver biopsy and to identify significant variables associated with an increased risk of complications or death. MATERIALS AND METHODS: Institutional review board approval for this type of study is not required in the United Kingdom. United Kingdom radiology departments with a department leader for audit registered with the Royal College of Radiologists were invited to participate. The first 50 consecutive patients who underwent liver biopsy in 2008 were included. Audit standards were developed for minor pain (<30%), severe pain (<3%), vasovagal hypotension (<3%), significant hemorrhage (<0.5%), hemobilia (<0.1%), puncture of another organ (<0.1%), and death (<0.1%). Organizational, clinical, and coagulation variables were investigated statistically for their association with complications and/or death. RESULTS: Data were obtained from 87 of 210 departments (41%). Audit standards were met for pain, hypotension, hemorrhage, hemobilia, and puncture of another organ. There were four hemorrhage-related deaths, and this target was narrowly missed (rate achieved in practice, 0.11% [four of 3486 patients]). Fifteen additional patients experienced at least one major complication. The international normalized ratio (INR) was absent in 3% of cases (97 of 2951 patients), the platelet count was absent in 1% (32 of 2986 patients), the INR was more than 1 week old in 8% (229 of 2888 patients), and the platelet count was more than 1 week old in 10% (291 of 2955 patients). CONCLUSION: Results of this audit confirm that image-guided and image-assisted biopsy is performed safely in United Kingdom radiology departments, with complication rates within expected parameters. Preprocedural clotting assessment was inadequate in some cases and would merit repeat audit. SUPPLEMENTAL MATERIAL: http://radiology.rsna.org/lookup/suppl/doi:10.1148/radiol.12120224/-/DC1.

Characteristics, treatment and prognostic factors of patients with gynaecological malignancies treated in a palliative care unit at a university hospital.

BACKGROUND: Limited clinical data have been published on patients suffering from advanced gynaecological malignancies treated in palliative care units, and little is known about prognostic factors. METHODS: In a retrospective study, the data of 225 patients with breast, ovarian and cervical cancer treated in the palliative care unit of a university hospital between 1998 and 2009 were assembled. Clinical aspects and baseline symptoms, laboratory parameters, the clinical course, and outcome were evaluated. RESULTS: 225 patients (497 cases; cancer diagnoses: breast 79%, ovarian 13%, and cervix 8%) were included in the analysis. The main symptoms were weakness/fatigue (71%), pain (65%), anorexia/nausea (62%), and dyspnea (46%). Pain control was achieved in 85% of all cases, satisfying control of other symptoms in 80%. The median overall survival (OS) was 59 days. 53% of the patients died at the palliative care unit. In the Cox proportional hazards model, 8 parameters indicated an unfavourable outcome: anorexia/nausea, disordered mental status, elevated lactate dehydrogenase, γ-glutamyltransferase, leukocyte count, hypoalbuminaemia, anaemia and hypercalcaemia. Based on these parameters 3 risk groups were defined: low risk (0-2 factors), intermediate risk (3-5 factors), and high risk (6-8 factors). Median survival for high-risk group was 13 days, for intermediate group 61 days, and for low-risk patients 554 days (p < 0.0001). CONCLUSION: Weakness/fatigue, pain and anorexia were the main symptoms leading to the hospitalisation of patients with gynaecological malignancies. Symptom and pain control was accomplished in 80% of cases. 8 parameters were identified as indicating a poor outcome, and patients showing at least 6 or more of these factors had a very limited prognosis. Although studied retrospectively, these results may be helpful for individual treatment decisions in patients with advanced gynaecological malignancies. Prospective data and the introduction of documentation systems could help to gain more powerful knowledge about the quality of palliative care.