Burns to the head and neck: Epidemiology and predictors of surgery

Background

The face is a frequent site of burn, but prevalence rates vary and reports are often limited to one healthcare setting. We examined the incidence of facial burns in the Netherlands in Emergency Departments (ED), hospitals and burn centres. Additionally, we identified which patient, injury and burn-related characteristics were predictors of facial burns, facial surgery and facial reconstruction in burn centres.

Methods

A retrospective, observational study was conducted including data from the Dutch Injury Surveillance System, the National Hospital Discharge Register and burn centres in a 5-year period (2003–2007).

Results

Facial burn incidences per 100,000 were 15.1 for ED visits, 1.3 for hospital admissions and 1.4 for burn centre admissions. A total of 2691 patients were admitted to Dutch burn centres; 47.5% (n = 1277) had facial burns of which 20.5% received primary facial surgery and 5.3% received facial reconstruction in follow-up. Predictors of facial burns and facial surgery were identified. Predictors of facial reconstructive surgery were burns to the neck (ventral), fire/flame burns and number of facial surgeries in the acute phase of the burn.

Conclusions

One in five patients with facial burns admitted to a Dutch burn centre received primary facial surgery and 1 in 20 received facial reconstructive surgery within a follow-up of minimum 2 years.     

Laser Doppler Imaging prediction of burn wound outcome in children: Is it possible before 48 h?

Background

Laser Doppler Imaging (LDI) assists in prediction burn wound outcome. Previous data has validated this technique in children between 48 and 72 h after burn.

Aim

To evaluate the ability of Laser Doppler Imaging (LDI) to predict burn wound outcome in paediatric patients prior to and after 48 h from the time of injury.

Methods

A prospective evaluation was performed in 400 children over a 12-month period that presented to our burns clinic. Patients were divided into two groups: those that presented within 48 h of injury (n = 160) and those that presented after 48 h (n = 240). Patients were reviewed until healing had occurred or operative intervention was required.

Results

The median age of the patients was 2.4 years (range 0.1–15.9 years). For patients who presented within 48 h, the sensitivity and specificity of the LDI was 78% and 74% respectively compared to 75% and 85% for those scanned after 48 h. This difference was not statistically significant.

Conclusions

LDI predicted burn wound outcome in children within 48 h of the burn wound. Moderate degrees of movement, infection, whether first aid was administered and type of dressing did not impact on the accuracy of LDI.     

The impact of laser Doppler imaging on the early decision-making process for surgical intervention in adults with indeterminate burns

Objective

We aimed to analyze whether laser Doppler imaging (LDI) can lead to earlier decision-making regarding the need for surgery in adults with indeterminate burns.

Methods

In a retrospective cohort study, we developed a prediction model for surgery in adults with indeterminate burns. Patient data (n = 101) from January 2007 to December 2009 were used for model development, and those (n = 40) from January 2010 to October 2010 for external validation.

Results

Between non-surgical and surgical groups, there were significant differences for mean age (p = 0.009), % total body surface area burn (p = 0.016), site of burn wound (p = 0.033), and mean perfusion units (PU) (p < 0.001). Multiple logistic regression showed that only the mean PU differed significantly between the groups. The area under the curve (AUC) of the equation derived from multiple logistic regression was 0.938, which did not differ from that of the mean PU alone (0.931; p = 0.453). Using a cut-off point of 154.7PU, the sensitivity of LDI was 78.3% and the specificity was 92.7%. This cut-off point also yielded a sensitivity of 77.8% and specificity of 95.5% in the external validation dataset.

Conclusion

LDI can help make a decision for surgery in the early stages of care for adults with indeterminate burns.     

Incidence of non-candidal fungal infections in severe burn injury: An Australian perspective

Introduction

Infection remains the primary cause of morbidity and mortality in the burns patient population. While candidal infection in burns patients is well described, there is dearth of information regarding non-candidal fungal infections in this setting.

Method

All adult burns patients who developed non-candidal fungal infections over a period of 10 years (between January 2001 and June 2011) were included. Retrospective data analyzed included patient demographics, organisms cultured, antibiotic susceptibility patterns, treatment, length of stay and overall mortality.

Results

The incidence of non-candidal fungal infections at our centre over the time period studied was 0.04%. A total of 12 patients had a fungus other than Candida isolated. Of these 12 patients, seven were thought to have clinically significant fungal infections and were treated with targeted anti-fungal therapy. Between them, seven species of fungus were isolated: Aspergillus fumigatus (n = 7), Scedosporium prolificans (n = 2), Fusarium solani (n = 2), Mucor spp. (n = 2), Absydia corymbifera (n = 1), Penicillium (n = 1) and Alternaria spp. (n = 1). Of those definitively treated, two died, although fungal infection was not believed to be a contributing factor to these deaths.

Conclusion

We demonstrate a low incidence and attributable mortality of non-candidal fungal infections in the setting of early antifungal therapy and extensive surgical debridement at our state-wide Burns Service.     

Modernized standards in burns management: A comparative study in Komfo Anokye Teaching Hospital,Kumasi, Ghana

Background

Management of burns patients before May 2009 was very difficult at the Komfo Anokye Teaching Hospital (KATH).

Aim

To compile burns patients’ information in the new Burns Intensive Care Unit (BICU), analyze it and draw comparisons to information from the old BICU at KATH.

Methods

This retrospective study involves data from May 2007 to April 2009 (Group 1 – old BICU) and May 2009 to April 2011 (Group 2 – new BICU). The parameters of burn patients recorded included: record of admission, gender, age, aetiology of injury, Total Burns Surface Area (TBSA), the patients’ treatment regime and record of discharge/death. This information was analyzed with SPSS version 18.0.

Results

The total number of patients in the study was 511; Group 1 constituted 47.36% (n = 242) patients; males (n = 307, 61%) outnumbering females (n = 204, 39%). The overall mean, median and interquartile range (IQR) ages of the patients were 12.4 ± 2; 9.5 and 18.0 years respectively. The main aetiology of burns in Group 1 was flame burns (n = 115, 47.5%) and for Group 2 was scald (n = 151, 56.1%). The median TBSA recorded for Groups 1 and 2 were 32% and 41% respectively. A mortality rate of 19.1% (n = 46) and 12.7% (n = 34) were recorded for Groups 1 and 2 respectively which was statistically significant (p < 0.05). We found no differences for age and TBSA (P = 0.7168 and P = 0.8020 respectively). A Chi Square analysis for gender and aetiology of burn revealed no significant difference between Groups 1 and 2. A risk factor analysis for mortality within the Groups (using multiple regression analysis) identified only aetiology of burn in Group 1 to be a factor (P = 0.044).

Conclusion

This comparative study reveals that a significant difference in mortality was recorded for both groups. The mortality difference does not appear to be due to socio-demographic features. This study may demonstrate that modernized and advanced equipment with the adequate personnel play an essential role in burn management in low income countries such as Ghana.     

Use of nebulized antimicrobial agents in burned and mechanically ventilated patients with persistent Acinetobacter baumannii, Pseudomonas aeruginosa, or Enterobacteriacea

Background

Nebulized antibiotics are used to locally treat colonizations of multi-resistant organisms. Prior systemic nephrotoxic antibiotic use with serum creatinine rises warranted an alternative therapy in 69 ventilator-dependent patients with persisting sputum cultures and need for ventilatory support.

Materials and methods

Following IRB approval, retrospective patient data were reviewed. Analysis included comparison of these 69 patients (71 treatments) to 142 Gram-negative infected burn patients matched for age and burn size.

Results

Mean pooled age and burn wound percent for the 71 triplicates (n = 211 patients) were 55.6 ± 18.3 years and 27.4 ± 22.3% burns. Fifty-seven of 69 (83%) patients had inhalation injuries and 54 of 69 (78%) patients survived. Nebulizations averaged 6.8 ± 3.3 days (range 3–12 days). Serum creatinine rose in 2 patients receiving colistimethate nebulizations, known to cause nephrotoxicity following nebulization. Triplicate comparisons via ANOVA noted prolonged ventilatory support (F = 13.39; p ? 0.05) and length of stay (F = 6.11; p ? 0.5). Variance was attributed to the sicker nebulized patients. Twenty-four inhalation injury-only triplicates further confirmed that nebulized patient subgroup was more ill.

Conclusion

Short duration antibiotic nebulization may allow higher intra-tracheal antibiotic concentrations and may facilitate weaning from the ventilator by reducing bacterial bioburden.     

Predictors of re-epithelialization in pediatric burn

Introduction

An important treatment goal for burn wounds is to promote early wound closure. This study identifies factors associated with delayed re-epithelialization following pediatric burn.

Methods

Data were collected from August 2011 to August 2012, at a pediatric tertiary burn center. A total of 106 burn wounds were analyzed from 77 participants aged 4–12 years. Percentage of wound re-epithelialization at each dressing change was calculated using Visitrak™. Mixed effect regression analysis was performed to identify the demographic factors, wound and clinical characteristics associated with delayed re-epithelialization.

Results

Burn depth determined by laser Doppler imaging, ethnicity, pain scores, total body surface area (TBSA), mechanism of injury and days taken to present to the burn center were significant predictors of delayed re-epithelialization, accounting for 69% of variance. Flame burns delayed re-epithelialization by 39% compared to all other mechanisms (p = 0.003). When initial presentation to the burn center was on day 5, burns took an average of 42% longer to re-epithelialize, compared to those who presented on day 2 post burn (p < 0.000). Re-epithelialization was delayed by 14% when pain scores were reported as 10 (on the FPS-R), compared to 4 on the first dressing change (p = 0.015) for children who did not receive specialized preparation/distraction intervention. A larger TBSA was also a predictor of delayed re-epithelialization (p = 0.030). Darker skin complexion re-epithelialized 25% faster than lighter skin complexion (p = 0.001).

Conclusions

Burn depth, mechanism of injury and TBSA are always considered when developing the treatment and surgical management plan for patients with burns. This study identifies other factors influencing re-epithelialization, which can be controlled by the treating team, such as effective pain management and rapid referral to a specialized burn center, to achieve optimal outcomes.     

Prognostic factors for amputation in severe burn patients

Introduction

Amputation is a rare procedure among burned patients. However, it has significant physical and psychological consequences which impact quality of life.

Objective

To study the incidence, etiology and prognostic factors associated with amputation among burned patients in Chile.

Methods

Cohort study of patients admitted to the Reference Burn Center of Chile from 2006 to 2011. Association of demographic, event and injury variables with the likelihood of amputation were evaluated by using multivariable analysis.

Results

Amputation incidence was 5.8% in 1090 admitted patients. Male amputee patients were significantly more frequent (p = 0.01), with more electrical and high voltage burns (p < 0.01) and had greater frequency of impaired consciousness (p = 0.03). Multivariable analysis identified electrical burns (OR 13.7; 95% CI 6.7–28.1) and impaired consciousness (OR 2.8; 95% CI 1.4–5.7) as prognostic factors for amputation.

Conclusion

Amputation is a low incidence procedure among burned patients. Patients who underwent amputations are frequently at working age. Patients with high-voltage electrical burns and impaired consciousness are more likely to undergo amputation. Since these are highly incapacitating injuries, it is very important to implement preventive measures.     

Cologne burn centre experience with assault burn injuries

Objective

To evaluate demographic and socioeconomic factors associated with assault burn injuries.

Background

Assault by burning demonstrates a rare but severe public health issue and accounts for unique injury characteristics in the burn intensive care unit (BICU).

Methods

We conducted a retrospective cohort study involving patients with thermal injuries admitted to the BICU of a university hospital. The patient cohort was divided into two groups (ABI group: patients with assault burns, n = 41; Control group: population of all other burned patients admitted to the BICU, n = 1202). Bivariate and multivariate analyses including demographic and socioeconomic data were used to identify factors associated with assault burns.

Results

Forty-one assault-related burn victims were identified in the study period. This represents 3.3% of all significant burns admitted. Comparing battery victims with the control population, assault patients were more likely to be young (mean age 36.2 years vs. 42.2 years) and immigrants (41.5% vs. 15.1%). Furthermore, marital status (65.9% vs. 40.8% singles), employment status (36.6% vs. 9.7% unemployed) and insurance status (41.5% vs. 12.3% social insurance) were significantly different in the bivariate analysis. Logistic regression evaluation identified three variables that were independently associated with assault burns: younger age (≤25 years) (odds ratio, 2.54 [95% confidence interval, 1.29–5.02]; p = 0.007), ethnic minority (odds ratio, 3.71 [95% confidence interval, 1.91–7.20]; p < 0.001) and unemployment (odds ratio, 4.02 [95% confidence interval, 2.03–7.97]; p < 0.001).

Conclusions

The high incidence of youngsters, unemployment and the great proportion of immigrants in victims of assault might provide several opportunities for community-based psychosocial and occupational programs. A multidisciplinary approach targeting issues specific to the violent nature of the injury and the socioeconomic background of the victims may be of benefit to improve their perspectives for rehabilitation.     

Time course of pro- and anti-inflammatory cytokine levels in patients with burns—Prognostic value of interleukin-10

Introduction

Trends and the prognostic value of cytokine responses to severe burns have not been fully examined in humans. Therefore, the aim of this study was to determine the time course and prognostic value of pro- and anti-inflammatory cytokines in the immediate post-burn period.

Patients and methods

Blood samples were taken for measuring IL-1β, IL-6, IL-8, IL-10, IL-12p70 and TNF-α concentrations from patients with more than 20% burned surface area on admission and on 5 consecutive days. Development of sepsis was assessed using standard criteria twice a day.

Results

IL-12p70 remained under assay detection levels in the study period. IL-1β and TNF-α could be detected in stimulated blood samples with higher levels in survivors (n = 21). IL-6 on days 4–5 and IL-8 on days 4–6 in non-stimulated plasma showed significant elevation in non-survivors (n = 18) whereas in stimulated blood its levels did not differ significantly. IL-10 levels were significantly higher in non-survivors during the study period in non-stimulated, and except day 6 in stimulated blood. Using the cut-off level of 14 pg ml⁻¹ for IL-10 predicted ICU mortality with 85.4% sensitivity and 84.2% specificity on admission.

Conclusion

Early anti-inflammatory excess had a bad prognosis for patients suffering from severe burns.     

Epidemiology of hospitalized burn patients in a tertiary care hospital in South India

Background

The epidemiological pattern of burns varies widely in different parts of the world. To suggest effective preventive measures, an insight into the pattern of injury is desirable. However, data on burn victims and outcome is limited from this part of the world.

Methods

This study was conducted in the Department of Surgery, from April 2006 to April 2007. All consecutive patients with major burns admitted for in-hospital treatment during the study period were included in the study. The data collected included age, gender, cause and mode of burns, presence or absence of inhalational injury, facial burns, time delay from burn injury to admission in the hospital, burns depth, total body surface area distribution of burns, associated injuries and co-morbid illness, microbiological profile and outcome. Inhalational injury was assessed by clinical examination as bronchoscopy was not available.

Results

A total of 222 consecutive patients admitted for in-hospital treatment of burn injury were included in the study. 177 patients were adults and 45 were <13 years of age. The female:male ratio was 1.7:1. In adults, 52.5% of burns were due to non-intentional injury and 43.9% were due to self-immolation. In patients <13 years of age, 95.6% of cases were due to non-intentional injury. The mean TBSA was 48.75% and 30.18% of patients had predominantly deep burns. The overall mortality was 60.8%. The predominant organisms colonizing the burn wound were Pseudomonas aeruginosa (81.1%) followed by Acinetobacter species and MRSA. Multivariate logistic regression analysis of factors predicting survival in patients with burn injury showed that TBSA > 30%, age > 20 years, female gender and presence of facial injury were statistically significant as predictors of risk of death.

Conclusions

In patients with burns, total body surface area involvement more than 30%, age more than 20 years, female gender and presence of facial injury are statistically significant, as predictors of poor outcome and risk of death. The strongest association was seen with facial injury, which increased the risk of death by fourfold.     

Acute burn induced coagulopathy

Background

Acute traumatic coagulopathy is well described in the trauma population. Major burns are characterised by a similar endothelial injury and cellular hypoperfusion. These features could be a driver for an acute burn induced coagulopathy (ABIC).

Methods

Patients admitted to a regional burn centre over a 71 months period with a total body surface area burn of 30% or more were identified. The metavision electronic patient database was scrutinised for a predetermined list of demographics, interventions and admission investigations to identify any clinically significant ABIC.

Results

On admission 39.3% of the 117 patients analysed met our criteria for a coagulopathy. Of the patients with a coagulopathy, 71.7% had an elevated Prothrombin Time (PT), 2.2% had an elevated Activated Partial Thromboplastin time (APPT) and 26.1% had an elevation of both. Patients with a coagulopathy received a similar volume of fluid (p = 0.08). There was a statistically significant correlation between the PT and the abbreviated burn severity index (p = 0.0013, r = 0.292) and serum lactate (p = 0.0013, r = 0.292). ABIC was an independent predictor of 28 day mortality, OR 3.42(1.11–10.56).

Conclusion

In patients with major thermal injuries a clinically significant ABIC exists. Early diagnosis and treatment of ABIC should be considered particularly in those undergoing total burn wound excision.     

Procalcitonin in the Burn Unit and the Diagnosis of Infection

Objective

To determine the usefulness of procalcitonin (PCT) in decision-making when faced with suspected infection in patients with extensive burns.

Study

Retrospective, observational follow-up study.

Institution

Burn Unit of the Complexo Hospitalario Universitario A Coruña (CHUAC), Spain.

Patients and method

We included all patients admitted to the Unit from June 2011 to March 2012 with ≥20% total body surface area burned or ≥10% full-thickness body surface area burned with suspected infection (17 patients with 34 events of suspected infection).

Results

The infections were confirmed in 16/34 episodes (47.1%), and documented in 44.1% (n = 15). There were no statistically significant differences in the PCT figures at the time the infection was suspected between the cases with confirmed and unconfirmed infection (p = 0.682). The PCT values showed no discriminative value for differentiating patients with SIRS from those with sepsis, severe sepsis and septic shock (area under ROC curve (AUC) = 0.546; 95% CI: 0.326–0.766). No significant correlation was found between SOFA and PCT, although there were differences in the PCT values in the patients who had tissue hypoperfusion.

Conclusion

Results show that PCT is not a precise indicator of sepsis at the time of diagnosis. A correlation between PCT levels and hypoperfusion was observed.     

Effets de l’hydroxyzine sur l’acceptation du masque à l’induction de l’enfant

Objective

To evaluate the effectiveness of hydroxyzine as a premedication agent for the acceptance of facial mask during induction of general anaesthesia in children.

Study design

Prospective randomized single-blind study including ASA 1 and 2 children, aged between 1 and 9 years and undergoing outpatient surgery.

Patients and methods

Patients were randomly allocated to receive orally either 1 mg/kg hydroxyzine (G1) or water 0.1 ml/kg (G2) one hour before induction of standardized inhalational anaesthesia. Tolerance of facial mask was assessed with a 3-points scale (good, moderate or poor). Chi-square and Student's t-test were used in statistical analysis; p values less than 0.05 were considered statistically significant.

Results

One hundred patients were included (G1 = 49, G2 = 51). Demographic data were similar in both groups. Acceptance of facial mask was significantly better in G1 than in G2 (p = 0,002).

Conclusion

Hydroxyzine provided better acceptance of facial mask than placebo during induction of general anaesthesia in children.     

Randomized controlled single center study comparing a polyhexanide containing bio-cellulose dressing with silver sulfadiazine cream in partial-thickness dermal burns

Objective

A prospective, randomized, controlled single center study was designed to evaluate clinical efficacy of a polyhexanide containing bio-cellulose dressing (group B) compared to a silver-sulfadiazine cream (group A) in sixty partial-thickness burn patients.

Patients and methods

Local ethics committee approval was obtained and patients consented. Parameters were: pain reduction (VAS), healing time and wound bed condition, comparing day 0 (start) versus day 14 (end), as well as, ease of dressing use and treatment costs.

Results

All completed the study (n = 30/n = 30) and were included in the ITT analysis, with a total of 72 burns (group A: n = 38, group B: n = 34). We noted no differences in healing time. Pain reduction was significantly faster and better in group B (p < 0.01). There were fewer dressing changes in group B, compared to group A. Ease of use for the bio-cellulose dressing was rated better compared to group A. In group B, € 95.20 was saved for a 10 day treatment period, compared to group A.

Conclusion

Group B demonstrated a better and faster pain reduction in the treated partial-thickness burns, compared to group A. The results indicate the polyhexanide containing bio-cellulose dressing to be a safe and cost effective treatment for partial-thickness burns.     

The Clinical Effectiveness of Retropubic (IVS-02) and Transobturator (IVS-04) Midurethral Slings: Randomized Trial

Background

Few series comparing the clinical efficacy of retropubic slings versus transobturator slings for the treatment of female stress urinary incontinence (SUI) are available.

Objective

To compare clinical efficacy of retropubic tape operations and transobturator suburethral tape operations for the surgical treatment of female SUI.

Design, setting, and participants

From January 2003 to December 2005, 611 patients underwent clinical and urodynamic evaluation before surgical treatment for SUI. Patients with advanced urogenital prolapse (pelvic organ prolapse-quantification scale [POP-Q] scale grade >1) were excluded, and 537 patients were included in this study. After 18 mo, 398 women were available for follow-up efficacy evaluation at a tertiary academic center.

Intervention

All patients underwent either a retropubic sling procedure or a transobturator sling procedure. Patients were randomly allocated into two study groups at a ratio of 1:1.

Measurements

After 18 mo all enrolled patients were clinically checked for clinical efficacy of both procedures.

Results and limitations

Demographic and urodynamic parameters of patients were similar in both groups. No bladder injury occurred in the transobturator sling group (IVS-04), whereas 13 intraoperational bladder perforations (6.5%) occurred in the retropubic sling group (IVS-02) (p < 0.001). The tape erosion rate was <2.5% in both groups (p = 0.7). After 18 mo, 398 patients (201 in the IVS-02 group and 197 in the IVS-04 group) were evaluated in terms of clinical efficacy of the procedures. We found out that there was no statistically significant difference in clinical efficacy between these two procedures (χ² = 1.88, p = 0.39). In the IVS-02 group, 75.1% of patients (n = 151) remained dry (cured), 16.9% of patients (n = 34) reported significant improvement, and 8.0% of patients (n = 16) were considered as failures. In the IVS-04 group, 74.1% of patients (n = 146) remained dry, 14.2% of patients (n = 28) reported significant improvement, and 11.7% (n = 23) were considered as failures.

Conclusions

Based on an 18-mo follow-up, the efficacies of both techniques are comparable; however, the retropubic route appears to be more efficient in the intrinsic sphincter deficiency (ISD) group.     

A systematic review of the literature to support an evidence-based Precepting Program

Aim

To provide a systematic review of the literature regarding development of an evidence-based Precepting Program for nurses transitioning to burn specialty practice.

Background

Burned patients are admitted to specialty Burn Centers where highly complex nursing care is provided. Successful orientation and integration into such a specialized work environment is a fundamental component of a nurse's ability to provide safe and holistic patient care.

Design

A systematic review of the literature was performed for the period 1995–2011 using electronic databases within PUBMED and Ovid search engines.

Data sources

Databases included Medline, CINHAL, ProQuest for Dissertations and Thesis, and Cochran Collaboration using key search terms: preceptor, preceptee, preceptorship, precept*, nurs*, critical care, personality types, competency-based education, and learning styles.

Review methods

Nurses graded the level and quality of evidence of the included articles using a modified 7-level rating system and the Johns Hopkins Nursing Quality of Evidence Appraisal during journal-club meetings.

Results

A total of 43 articles related to competency (n = 8), knowledge acquisition and personality characteristics (n = 8), learning style (n = 5), preceptor development (n = 7), and Precepting Programs (n = 14).

Conclusions

A significant clinical gap existed between the scientific evidence and actual precepting practice of experienced nurses at the Burn Center. Based on this extensive review of the literature, it was determined that a sufficient evidence base existed for development of an evidence-based Precepting Program.     

Disease Control Outcomes from Analysis of Pooled Individual Patient Data from Five Comparative Randomised Clinical Trials of Degarelix Versus Luteinising Hormone-releasing Hormone Agonists

Background

Studies comparing the gonadotropin-releasing hormone antagonist, degarelix, with luteinising hormone-releasing hormone (LHRH) agonists indicate differences in outcomes.

Objective

To assess differences in efficacy and safety outcomes in a pooled analysis of trials comparing degarelix with LHRH agonists.

Design, setting, and participants

Data were pooled from five prospective, phase 3 or 3b randomised trials (n = 1925) of degarelix and leuprolide or goserelin in men requiring androgen deprivation therapy for the treatment of prostate cancer. Patients received either 3 mo (n = 467) or 12 mo (n = 1458) of treatment.

Intervention

Men were randomised to receive degarelix (n = 1266), leuprolide (n = 201), or goserelin (n = 458).

Outcome measurements and statistical analysis

Unadjusted Kaplan-Meier analyses were supported by the Cox proportional hazards model, adjusted for disease-related baseline factors, to estimate hazard ratios (HRs) of efficacy and safety outcomes. The Fisher exact test compared crude incidences of adverse events.

Results and limitations

Prostate-specific antigen (PSA) progression-free survival (PFS) was improved in the degarelix group (HR: 0.71; p = 0.017). For patients with baseline PSA levels >20 ng/ml, the HR for PSA PFS was 0.74 (p = 0.052). Overall survival (OS) was higher in the degarelix group (HR: 0.47; p = 0.023). OS was particularly improved with degarelix in patients with baseline testosterone levels >2 ng/ml (HR: 0.36; p = 0.006). In terms of disease-related adverse events, there were, overall, fewer joint-related signs and symptoms, musculoskeletal events, and urinary tract events in the degarelix group.

Conclusions

These data indicate clinical benefits with degarelix, including a significant improvement in PSA PFS and OS, as well as reduced incidence of joint, musculoskeletal, and urinary tract adverse events, compared with LHRH agonists.     

Prognostic Significance of Bone Metastases and Bisphosphonate Therapy in Patients with Renal Cell Carcinoma

Background

Bone metastases (BMs) are frequently present in patients with metastatic renal cell carcinoma (mRCC) and cause significant morbidity.

Objective

The purpose of this analysis was to assess the impact of BMs and bisphosphonate therapy (BT) on outcomes in mRCC.

Design, setting, and participants

We conducted a pooled analysis of patients with mRCC treated from 2003 to 2011 in phase 2 and 3 trials.

Outcome measurements and statistical analysis

Statistical analyses were performed using Cox regression and the Kaplan-Meier method.

Results and limitations

We identified 2749 patients treated with sunitinib (n = 1059), sorafenib (n = 355), axitinib (n = 359), temsirolimus (n = 208), temsirolimus plus interferon-α (IFN-α) (n = 208), or IFN-α (n = 560), with 28% (n = 781) having BMs. A total of 285 patients (10.4%) received BT. The presence of BMs in patients was associated with shorter overall survival (OS) when compared with patients without BMs (13.2 vs 20.2 mo, respectively; p < 0.0001) and shorter progression-free survival (PFS) (5.1 vs 6.7 mo, respectively; p < 0.0008). When stratified by risk groups, the presence of BMs was associated with shorter OS in all risk groups. The use of BT in patients with BMs was not associated with improved OS compared with patients who did not receive BT (13.3 vs 13.1 mo, respectively; p = 0.3801) or improved PFS (5.1 vs 4.9 mo, respectively; p = 0.1785). Bisphosphonate users with BMs did not have a decreased rate of skeletal-related events (SREs) compared with nonusers (8.6% vs 5.8%, respectively; p = 0.191). In addition, BT was associated with increased rates of hypocalcemia, renal insufficiency, and osteonecrosis of the jaw (p < 0.0001). Data were analyzed retrospectively.

Conclusions

We confirm that the presence of BMs is associated with shorter survival in mRCC. BT did not affect survival or SRE prevention and was associated with increased toxicity.

Patient summary

In this analysis, we demonstrate that bone metastases are associated with shorter survival in patients with metastatic renal cell carcinoma. In addition, we call into question the utility of bisphosphonate therapy in this population.     

Mental disorders among acute burn patients

Objective

To investigate mental disorders among acute hospitalized burn patients.

Method

Consecutive acute adult burn patients (n = 107) admitted to Helsinki Burn Centre were interviewed by an experienced psychiatrist with the Structured Clinical Interview for DSM-IV-TR for Axis I and II mental disorders assessed in three time frames (lifetime, the month prior to burn, and in acute care). Information on clinical features, psychiatric symptoms, personality traits, and burn severity (total body surface area, TBSA) was gathered.

Results

The mean TBSA was 9%. Most (61%) acute burn patients had at least one lifetime Axis I or II mental disorder. Prevalences of lifetime substance-related disorders (47%), psychotic disorders (10%), and Axis II personality disorders (23%) were high. The overall prevalence of Axis I mental disorders increased significantly (Q = 6.40, df = 1, p = 0.011) from the month prior to burn (40%) to acute care (48%). The prevalence of delirium for this period was significantly higher (0.9% vs. 13%; Q = 13.00, df = 1, p < 0.001) in acute care.

Conclusions

Mental disorders, particularly substance use disorders, psychotic disorders, and personality disorders are common among acute burn patients before injury. These disorders may predispose to burns. Burn itself may also predispose to mental disorders, particularly delirium.