Demonstration of the validity of the SF-36 for measurement of the temporal recovery of quality of life outcomes in burns survivors

Objective

Outcome assessment after burn is complex. Determination of quality of life is often measured using the Burns Specific Health Scale (BSHS), a validated tool in the burn population. The SF-36 is a generic quality of life questionnaire that is validated for numerous populations, but not in burns. The aim of the study was to examine the validity of SF-36, using the BSHS as a reference.

Methods

280 burn patients were recruited at Royal Perth Hospital. Each completed SF-36 and BSHS-B at regular intervals to 2 years after burn. Regression modelling was used to assess the temporal validity and the relative sensitivity of the measures.

Results

SF-36 domains and BSHS-B demonstrated significant associations at all time points (r = 0.37–0.76, p < 0.002). In the months after burn, SF-36 domains: role physical; bodily pain; social function and role emotional outperformed BSHS-B total score and domain scores. Greater measurement sensitivity was demonstrated in all SF-36 summary and subscales measures (except General Health) when compared to BSHS-B and sub-domains.

Conclusion

This study demonstrated SF-36 as a valid measure of recovery of quality of life in the burn patient population. The data suggests that SF-36 components were more sensitive to change than the BSHS-B from ∼1 month after injury.     

Patterns of recovery over 12 months following a burn injury in Australia

Objective

To describe patients’ generic health status and health-related quality of life (HRQoL) 12-months following admission to a state-wide burns service.

Methods

A total of 114 injured adults with >10% total body surface area burned (TBSA) or burns less than 10% TBSA to smaller anatomical areas such as the hands and feet participated in this study. Retrospective assessment of pre-burn injury status and prospective assessment of generic health and HRQoL were followed up at 3, 6 and 12-months after injury using the 36-item Short Form Health Survey (SF-36 v.2) and Burns Specific Health Scale-Brief (BSHS-B). The SF-36 v.2 was administered retrospectively during the initial hospital stay to assess pre-injury HRQoL. Changes in instruments scores were assessed using multilevel mixed effects regression models. Mean scores were compared over time and between severity groups as defined by <10%, 10–30% and >30% TBSA.

Results

For the overall sample, the SF-36 v.2 physical component scale (PCS) score between 3 and 12-months post-burn injury were significantly lower than pre-injury scores (p < 0.01), with no significant change over time for the mental component scale (MCS) (p = 0.36). Significant %TBSA-burden by time interactions highlighted changes from pre-burn injury in overall PCS (p = 0.02), physical functioning (p < 0.001) and role-physical (p = 0.03), with subscales worse for the TBSA >30% group. With respect to the BSHS-B, significant improvement from 3 to 12-months post-burn injury was seen for the entire sample in simple abilities (p < 0.001), hand function (p = 0.001), work (p = 0.01), and treatment regime (p = 0.004) subscales. The TBSA >30% group showed a greater rate of improvement in simple abilities (p = 0.01) and hand function (p = 0.005) between 3 and 12 months post-burn injury.

Conclusions

Whilst certain HRQoL measures improve over the 12-months, in most cases they do not reach pre-morbid levels. Patients face ongoing challenges regarding their physical and psychosocial recovery 12-months post-burn injury with respect to generic health and burn-specific health. These challenges vary at different time periods over the 12-month post-burn period, and may provide windows of opportunity in which to address ongoing issues.     

Polish adaptation and validation of Burn Specific Health Scale – Brief

Background

The Burn Specific Health Scale – Brief is a well-described, specific tool to assess health condition (quality of life) of burnt patients. This project was aimed at creating a Polish adaptation and validation of the Burn Specific Health Scale – Brief.

Method

Adaptation of the tool was performed in two stages. The first stage involved translation, back translation, evaluation by a panel of judges and a pre-test of the tool. The second stage consisted of surveying 202 burned patients. Those data were used to conduct a psychometric analysis. Reliability was checked by determining the Cronbach's α internal consistency coefficient and conducting the test–retest procedure (ICC). Content validity was evaluated by a panel of judges. Criterion validity was determined using SF-36. Construct validity was determined using known-groups validation.

Results

Reliability of the tool, determined using the internal consistency coefficient (Cronbach's α = 0.94) and the test–retest procedure (ICC = 0.89), proved to be high. Criterion validity, determined using the relationship of results of comparable BSHS-B and SF-36 subscales, obtained a satisfactory level with a correlation of r = 0.55–0.89 (p < 0.01). Analysis of inter-group differences showed that patients who stayed at a hospital for more than 10 days (p = 0.002), patients after surgical intervention (p = 0.018), patients with a burn larger than 19% of the TBSA (p = 0.01) and patients with 3rd degree burns (p = 0.001) have much poorer results than the rest of the subjects.

Discussion

The Polish version of BSHS-B is a reliable and valid tool for assessing quality of life of burned patients. It may be used to plan the burn treatment process and evaluate its outcomes.     

The influence of advancing age on quality of life and rate of recovery after treatment for burn

Background

With an ageing population the prevalence of burns in the elderly is increasing. The influence of increasing age on post-burn quality of life (QoL) is unquantified.

Aim

To examine the effect of ageing on QoL recovery after burn.

Methods

The Burn Specific Health Scale-Brief (BSHS-B) and Short Form Health Outcomes (SF-36), collected up to 24 months post-injury, for patients treated by the Royal Perth Hospital Burn Service were analysed. Multivariable analysis was adjusted for demographic and injury factors. The impact of ageing on rate of recovery was examined using BSHS-B normative data.

Results

The cohort (n = 1051) was 79.6% male with mean TBSA of 8% and age of 37.3 years. The SF-36 showed advancing age predicted poorer outcomes in physical function, role physical, vitality and role emotional domains but reduced bodily pain. The BSHS-B was affected by injury factors, not ageing. The standardised rate of recovery after burn improved with advancing age. The provision of surgery positively affected most outcomes assessed.

Conclusion

This study quantified the impact of ageing on post-burn QoL recovery and confirmed that physical function suffered to the greatest degree. The results emphasise the importance of pro-active burn surgery and physical rehabilitation strategies with older patients.     

The health status of people claiming compensation for musculoskeletal injuries following road traffic crashes is not altered by an early intervention programme: A comparative study

Objective

To compare health outcomes among claimants compared to those who were ineligible or choose not to lodge a compensation claim. We also evaluated the effect of an early intervention programme on the health outcomes of the participants.

Design

Prospective comparative study using sequential cohorts.

Subjects

People presenting to hospital emergency departments with mild to moderate musculoskeletal injuries following road traffic crashes.

Intervention

referral to an early intervention programme for assessment by musculoskeletal physician, pain management education, promotion of self-management and encouragement of early activity.

Main outcomes

The 36-Item Short-Form Survey (SF-36); Hospital Anxiety and Depression Scale (HADS) and Functional Rating Index (FRI) scores were assessed at post-crash and at 12 months.

Results

At 12 months, mean scores in six and five of the SF-36 domains were significantly lower among participants who claimed compensation versus those who chose not to claim or were ineligible, respectively. Differences in mean SF-36 scores ranged from 3.0 (‘general health perception’) to 8.0 units (‘role limitations due to physical problems’). Participants who claimed compensation had 6.3- and 4.6-units lower SF-36 physical component score compared to those who were ineligible (p = 0.001) or chose not to claim (p = 0.01), respectively. Participants who claimed compensation reported a worse HADS-depression score of 6.46 versus 4.97 and 4.69 observed in those who were ineligible (p = 0.04) or did not claim (p = 0.01). Claimants had worse FRI scores compared to non-claimants (p = 0.01) and those who were ineligible (p = 0.01). The early intervention did not improve health outcomes, 12 months after injury.

Conclusions

Claiming compensation was associated with a worse health status for people with soft tissue injuries caused by road traffic crashes. The health status in people claiming compensation was not altered by an early intervention programme.     

Enhancing the clinical utility of the Burn Specific Health Scale-Brief: Not just for major burns

Introduction

Like many other Western burn services, the proportion of major to minor burns managed at Royal Perth Hospital (RPH) is in the order of 1:10. The Burn Specific Health Scale-Brief (BSHS-B) is an established measure of recovery after major burn, however its performance and validity in a population with a high volume of minor burns is uncertain. Utilizing the tool across burns of all sizes would be useful in service wide clinical practice.

Aim

This study was designed to examine the reliability and validity of the BSHS-B across a sample of mostly minor burn patients.

Method

BSHS-B scores of patients, obtained between January 2006 and February 2013 and stored on a secure hospital database were collated and analyzedCronbach's alpha, factor analysis, logistic regression and longitudinal regression were used to examine reliability and validity of the BSHS-B.

Results

Data from 927 burn patients (2031 surveys) with a mean % total burn surface area (TBSA) of 6.7 (SD 10.0) were available for analysis. The BSHS-B demonstrated excellent reliability with a Cronbach's alpha of 0.95. First and second order factor analyses reduced the 40 item scale to four domains: Work; Affect and Relations; Physical Function; Skin Involvement, as per the established construct. TBSA, length of stay and burn surgery all predicted burn specific health in the first three months of injury (p < 0.001, p < 0.001, p = 0.03). BSHS-B whole scale and domain scores showed significant improvement over 24 months from burn (p < 0.001).

Discussion

The results from this study show that the structure and performance of the BSHS-B in a burn population consisting of 90% minor burns is consistent with that demonstrated in major burns.

Conclusion

The BSHS-B can be employed to track and predict recovery after burns of all sizes to assist the provision of targeted burn care.     

Health-Related Quality of Life in the Finnish Trial of Screening for Prostate Cancer

Background

Evidence of the potential impact of systematic screening for prostate cancer (PCa) on health-related quality of life (HRQoL) at a population-based level is currently scarce.

Objective

This study aims to quantify the long-term HRQoL impact associated with screening for PCa.

Design, setting, and participants

Postal questionnaire surveys were conducted in 1998, 2000, 2004, and 2011 among men in the Finnish PCa screening trial diagnosed with PCa (total n = 7011) and among a random subsample of the trial population (n = 2200). In 2011, for example, 1587 responses were received from men with PCa in the screening arm and 1706 from men in the control arm. In addition, from the trial subsample, 549 men in the screening arm and 539 in the control arm provided responses.

Outcome measurements and statistical analysis

Health-state-value scores were compared between the intervention and control arms using three distinct HRQoL measures (15D, EQ-5D, and SF-6D), and statistical significance was assessed using t tests. In addition, differences over repeated assessments of HRQoL between groups were evaluated using generalised estimating equations.

Results and limitations

In the 2011 survey, a small but statistically significant difference emerged between the trial arms among men diagnosed with PCa (mean scores, screening vs control arm: 15D: 0.872 vs 0.866, p = 0.14; EQ-5D: 0.852 vs 0.831, p = 0.03; and SF-6D: 0.763 vs 0.756, p = 0.06). Such differences in favour of the screening arm were not found among the sample of men from the trial (15D: 0.889 vs 0.892, p = 0.62; EQ-5D: 0.831 vs 0.852, p = 0.08; and SF-6D: 0.775 vs 0.777, p = 0.88). The slight advantage with screening among men with PCa was reasonably consistent across time in the longitudinal analysis and was strongest among men with early-stage disease.

Conclusions

These results show some long-term HRQoL benefit from screening for men with PCa but suggest little impact overall in the trial population.     

Evaluation of long term health-related quality of life in extensive burns: a 12-year experience in a burn center

Objectives

We sought to evaluate the long term health-related quality of life (HRQOL) in patients survived severely extensive burn and identify their clinical predicting factors correlated with HRQOL.

Methods

A cross-sectional study was conducted in 20 patients survived more than 2 years with extensive burn involving ≥70% total body surface area (TBSA) between 1997 and 2009 in a burn center in Shanghai. Short Form-36 Medical Outcomes Survey (SF-36), Brief Version of Burn Specific Health Scale (BSHS-B) and Michigan Hand Outcome Questionnaire (MHQ) were used for the present evaluation. SF-36 scores were compared with a healthy Chinese population, and linear correlation analysis was performed to screen the clinical relating factors predicting physical and mental component summary (PCS and MCS) scores from SF-36.

Results

HRQOL scores from SF-36 were significantly lower in the domains of physical functioning, role limitations due to physical problems, pain, social functioning and role limitations due to emotional problems compared with population norms. Multiple linear regression analysis demonstrated that only return to work (RTW) predicted improved PCS. While age at injury, facial burns, skin grafting and length of hospital stay were correlated with MCS. Work, body image and heat sensitivity obtained the lowest BSHS-B scores in all 9 domains. Improvements of HRQOL could still be seen in BSHS-B scores in domains of simple abilities, hand function, work and affect even after a quite long interval between burns and testing. Hand function of extensive burn patients obtained relatively poor MHQ scores, especially in those without RTW.

Conclusions

Patients with extensive burns have a poorer quality of life compared with that of general population. Relatively poor physical and psychological problems still exist even after a long period. Meanwhile, a trend of gradual improvements was noted. This information will aid clinicians in decision-making of comprehensive systematic regimens for long term rehabilitation and psychosocial treatment.     

Using the Burn Specific Health Scale-brief as a measure of quality of life after a burn-what score should clinicians expect?

Background

How do clinicians determine the acceptable level of recovery of quality of life (QoL) after a burn? Many use the Burn Specific Health Scale (BSHS). The aim of this study was to examine normative values of the BSHS-Brief (BSHS-B) questionnaire in the general population.

Methods

Two random samples of the non-burned public were taken. Each individual completed either the physical or the generic questions adapted from the BSHS-B questionnaire.

Results

Of the 124 subjects who completed the physical questions, >73% rated themselves 36/36. Group mean (SD) = 34.8 (2.9), median (IQR) = 36 (35-36), range 16-36. Advancing age was associated with reduced physical capability (p = 0.016). In contrast, 7.6% of the 105 subjects who answered the generic questions recorded a full score (84/84). Group mean (SD) = 71.3 (13.8), median (IQR) = 76 (66-80), range 10-84.

Conclusion

The study showed the non-burned population do not respond with full scores to all questions in the BSHS-B. The result was more notable in the non-physical questions related to the psychological and environmental factors. The data presented prompts clinicians to collect and define acceptable recovery of quality of life after a burn as measured by the BSHS-B for their local burn population.     

OnabotulinumtoxinA 100 U Significantly Improves All Idiopathic Overactive Bladder Symptoms and Quality of Life in Patients with Overactive Bladder and Urinary Incontinence: A Randomised,Double-Blind,Placebo-Controlled Trial

Background

Overactive bladder (OAB) syndrome with urinary incontinence (UI) is prevalent in the population and impairs health-related quality of life (HRQOL).

Objective

To assess the impact on efficacy, safety, and HRQOL of onabotulinumtoxinA (BOTOX^®, Allergan, Inc.) treatment in patients with OAB with UI.

Design, setting, and participants

This pivotal, multicentre, double-blind, randomised, placebo-controlled, phase 3 study enrolled patients with idiopathic OAB with ≥3 urgency UI episodes over 3 d and ≥8 micturitions per day who were inadequately managed by anticholinergics.

Intervention

OnabotulinumtoxinA at a 100 U dose (n = 277) or placebo (n = 271), administered as 20 intradetrusor injections of 0.5 ml.

Outcome measurements and statistical analysis

Co–primary end points were change from baseline in the number of UI episodes per day and proportion of patients reporting positive treatment response on the treatment benefit scale (TBS) at week 12. Additional end points included other OAB symptoms (episodes of urinary urgency incontinence, micturition, urgency, and nocturia) and HRQOL (Incontinence Quality of Life [I-QOL], King's Health Questionnaire [KHQ]). Safety assessments included adverse events (AEs), postvoid residual (PVR) urine volume, and initiation of clean intermittent catheterisation (CIC).

Results and limitations

OnabotulinumtoxinA significantly decreased UI episodes per day at week 12 (−2.95 for onabotulinumtoxinA versus −1.03 for placebo; p < 0.001). Reductions from baseline in all other OAB symptoms were also significantly greater following onabotulinumtoxinA compared with placebo (p ≤ 0.01). Patients perceived a significant improvement in their condition, as measured by patients with a positive treatment response on the TBS (62.8% for onabotulinumtoxinA versus 26.8% for placebo; p < 0.001). Clinically meaningful improvements from baseline in all I-QOL and KHQ multi-item domains (p < 0.001 versus placebo) indicated positive impact on HRQOL. AEs were mainly localised to the urinary tract. Mean PVR was higher in the onabotulinumtoxinA group (46.9 ml versus 10.1 ml at week 2; p < 0.001); 6.9% of onabotulinumtoxinA patients versus 0.7% of placebo patients initiated CIC.

Conclusions

OnabotulinumtoxinA 100 U was well tolerated and demonstrated significant and clinically relevant improvements in all OAB symptoms, patient-reported benefit, and HRQOL in patients inadequately managed by anticholinergics.

Trial registration

ClinicalTrials.gov: NCT00910520.     

Reoperation following open reduction and plate fixation of displaced mid-shaft clavicle fractures

Background

Operative fixation of displaced, mid-shaft clavicle fractures has become an increasingly common practice. With this emerging trend, data describing patient outcomes with longer follow-up are necessary.

Patients and Methods

We retrospectively reviewed the medical records of subjects treated with plate fixation for displaced mid-shaft clavicle fractures from 2003 to 2009 at a Level I trauma hospital. All subjects were greater than 12 months post-index surgery. Treatment involved ORIF with either a low-contact dynamic compression plate (LCDC) or a contoured plate (pre-contoured or pelvic reconstruction plate). Our primary outcome was reoperation for any indication.

Results

143 subjects were included. The mean age was 36 ± 14 years and the mean time to reoperation or chart review was 33 months. Contoured plates were used in 64% of cases and LCDC plates were used in the remaining subjects. Twenty-nine subjects (20%) underwent reoperation: 23.5% of subjects treated with LCDC plates and 18.5% of subjects treated with contoured plates (p = 0.52). Indications for reoperation included implant irritation (n = 25), implant failure (n = 2), and non-union (n = 2). There was near statistically significant association with reoperation and female gender (p = 0.05) but no association between reoperation and age (p = 0.14), fracture class (p = 0.53), plate type (p = 0.49), or plate location (p = 0.93). The mean QuickDASH score for the population surveyed was 8.8 (5.5–12.1; 95% CI) with near statistically significant and clinically relevant difference between those considering reoperation and those not 22.3 (8.6–36.0; 95% CI) versus 6.7 (3.6–9.8; 95% CI).

Conclusions

This study represents a large series of displaced clavicle fractures treated with open reduction and plate fixation. Reoperation following plate fixation is relatively common, but primarily due to implant irritation. No difference in reoperation rates between plate types or location could be detected in our current sample size. Also, excellent functional outcomes continue to be observed several years after clavicle fracture fixation.     

Differences in patients with systemic sclerosis recruited from associations and tertiary care settings

Objective

To compare patients with systemic sclerosis (SSc) recruited from a patient association or a tertiary care setting.

Methods

We evaluated 248 SSc patients attending 4 annual meetings of a patient association between 2004 and 2007 (177) or during hospitalization (71). health-related quality of life (HRQoL) was assessed by the SF-36, global disability by the health assessment questionnaire (HAQ), hand disability by the Cochin Hand Function Scale (CHFS), mouth disability by the Mouth Handicap in Systemic Sclerosis (MHISS) scale, global hand and wrist mobility by the Kapandji index.

Results

As compared with hospitalized patients, those from the patient association were significantly older (mean age 58.73 ± 12.04 vs 53.818 ± 13.1; p = 0.001) and had a longer disease duration (10.98 ± 8.7 vs 7.13 ± 6.723 p = 0.0001). Association patients had significantly increased disability of the hand (CHFS 21.8 ± 19.8 vs 9.8 ± 14.1; p = 0.0001) and mouth (MHISS 20.65 ± 10.8 vs 13.25 ± 9.3; p = 0.0001) and impaired hand and wrist mobility (Kapandji score 38.05 ± 10.26 vs 43.90 ± 8.26, p = 0.001). The 2 groups did not differ in global disability or physical and mental scores of the SF36.

Conclusion

Patients recruited from a patient association have more severe SSc than do hospitalized patients. This finding must be taken into account in the design of surveys and clinical trials.     

A reliable and valid outcome battery for measuring recovery of lower limb function and balance after burn injury

Introduction

The measurement of recovery after burns to the lower limbs is hampered by an absence validated injury specific tools. This research aimed to select and validate a battery of outcome measures of recovery after lower limb burn injury (LLBI).

Method

Reliability study: Reliability of the single leg stance (SLS), the Timed Up and Go (TUG) and the tandem walk (TW) tests were measured using a test–retest trial involving 28 patients with LLBI. Validity study: Clinical data from 172 patients with LLBI were used to compare changes in each LL outcome measure with changes in the Burn Specific Health Scale-Brief (BSHS-B).

Results

All tests, except the SLS test with eyes closed, demonstrated excellent inter-rater reliability (ICCs = 0.81–0.93). The TUG and the TW-forwards tests were shown to be valid and to provide additional information to the BSHS-B when combined as a battery. The TW-backwards test was redundant while the SLS and ankle DF measures did not correlate highly with the BSHS-B.

Conclusion

This study shows that the TUG test and the TWF are reliable and valid in the burns population and along with the BSHS-B form a useful test battery for measuring recovery from LLBI.     

The primary determinants of radiation use during fixation of proximal femur fractures

Objectives

To establish the primary determinants of operative radiation use during fixation of proximal femur fractures.

Design

Retrospective cohort study.

Setting

Level I trauma centre.

Cohort

205 patients treated surgically for subtrochanteric and intertrochanteric femoral fractures.

Main outcome measures

Fluoroscopy time, dose-area-product (DAP).

Results

Longer fluoroscopy time was correlated with higher body mass index (p = 0.04), subtrochanteric fracture (p < 0.001), attending surgeon (p = 0.001), and implant type (p < 0.001). Increased DAP was associated with higher body mass index (p < 0.001), subtrochanteric fracture (p = 0.002), attending surgeon (p = 0.003), lateral body position (p < 0.001), and implant type (p = 0.05).

Conclusion

The strongest determinants of radiation use during surgical fixation of intertrochanteric and subtrochanteric femur fractures were location of fracture, patient body position, patient body mass index, and the use of cephalomedullary devices. Surgeon style, presumably as it relates to teaching efforts, seems to strongly influence radiation use.     

A Multicentre Year-long Randomised Controlled Trial of Exercise Training Targeting Physical Functioning in Men with Prostate Cancer Previously Treated with Androgen Suppression and Radiation from TROG 03.04 RADAR

Background

Long-term prostate cancer (PCa) survivors are at increased risk for comorbidities and physical deconditioning.

Objective

To determine the effectiveness of a year-long randomised controlled trial of exercise training in PCa survivors >5 yr postdiagnosis on physical functioning.

Design, setting, and participants

Between 2010 and 2011, 100 long-term PCa survivors from Trans-Tasman Radiation Oncology Group 03.04 Randomised Androgen Deprivation and Radiotherapy previously treated with androgen-deprivation therapy and radiation therapy were randomly assigned to 6 mo of supervised exercise followed by 6 mo of a home-based maintenance programme (n = 50) or printed educational material about physical activity (n = 50) for 12 mo across 13 university-affiliated exercise clinics in Australia and New Zealand.

Intervention

Supervised resistance and aerobic exercise or printed educational material about physical activity.

Outcome measurements and statistical analysis

The primary end point was a 400-m walk as a measure of cardiovascular fitness. Secondary end points were physical function, patient-reported outcomes, muscle strength, body composition, and biomarkers. Analysis of covariance was used to compare outcomes for groups at 6 and 12 mo adjusted for baseline values.

Results and limitations

Participants undergoing supervised exercise showed improvement in cardiorespiratory fitness performance at 6 mo (−19 s [p = 0.029]) and 12 mo (−13 s [p = 0.028]) and better lower-body physical function across the 12-mo period (p < 0.01). Supervised exercise also improved self-reported physical functioning at 6 (p = .006) and 12 mo (p = 0.002), appendicular skeletal muscle at 6 mo (p = 0.019), and objective measures of muscle strength at 6 and 12 mo (p < 0.050). Limitations included the restricted number of participants undertaking body composition assessment, no blinding to group assignment for physical functioning measures, and inclusion of well-functioning individuals.

Conclusions

Supervised exercise training in long-term PCa survivors is more effective than physical activity educational material for increasing cardiorespiratory fitness, physical function, muscle strength, and self-reported physical functioning at 6 mo. Importantly, these benefits were maintained in the long term with a home-based programme with follow-up at 12 mo.

Clinical trial registry

The effect of an exercise intervention on cardiovascular and metabolic risk factors in prostate cancer patients from the RADAR study, ACTRN: ACTRN12609000729224.     

Laparoscopic versus Open Nephroureterectomy: Perioperative and Oncologic Outcomes from a Randomised Prospective Study

Background

Laparoscopic nephroureterectomy (LNU) is increasingly being used instead of open nephroureterectomy (ONU) for the treatment of urothelial carcinoma (UC) of the upper urinary tract (UUT), but the evidence of equal oncologic effectiveness is still lacking.

Objective

To present perioperative and oncologic results from a prospective randomised study comparing ONU and LNU.

Design, setting, and participants

Eighty patients with nonmetastatic UUT UC and without previous history of UC were enrolled. Of those, 40 patients (group A) randomly received ONU and 40 patients (group B) randomly received LNU.

Interventions

ONU was performed through a flank incision with a lower quadrant incision to allow excision of a bladder cuff. Transperitoneal LNU was performed with a four-trocar technique, and bladder cuff was detached with a 10-mm LigaSure device.

Measurements

Perioperative data were compared with the student t test. Bladder tumour–free survival (BTFS), metastasis-free survival (MFS), and cancer-specific survival (CSS) curves for both groups were compared with the log-rank test before and after stratifying patients for pT category and tumour grade.

Results and limitations

Operative times were comparable, while mean blood loss and mean time to discharge were significantly lower in group B (both p values <0.001). At a median follow-up of 44 mo, BTFS, CSS, and MFS were not significantly different between the two groups (log rank test; BTFS: p = 0.86; CSS: p = 0.2; MFS: p = 0.124). When matched for pT3 and high-grade tumours, CSS and MFS were significantly different between the two groups in favour of ONU (p = 0.039 and p = 0.004, respectively, for pT3 tumours; p = 0.078 and p = 0.014, respectively, for high-grade tumours).The limitations of our study include the small sample size, the single-centre experience, the personal choice of laparoscopic technique, and not performing lymphadenectomies.Perioperative data and preliminary oncologic results were presented at 22nd Congress of the European Association of Urology, Berlin, Germany.

Conclusions

In patients with organ-confined UUT UCs, LNU has the advantages of minimal invasiveness and oncologic outcomes comparable to those of ONU, while its effectiveness in patients with advanced stage diseases remains to be proven.     

Validation of the Italian version of the Burn Specific Health Scale-Brief

Introduction

A growing awareness of psychological and functional impairment due to burns have led to the development of specific instruments to evaluate Quality of Life in this population, such as the Burn Specific Health Scale – Brief (BSHS-B), whose psychometric properties have been consistently verified. The aim of this study was to translate the BSHS-B into Italian and to investigate its reliability and validity.

Methods

Translation procedures were carried out according to accepted standards. Internal reliability was assessed using Cronbach's alpha coefficient. Concurrent validity was evaluated through correlations between the BSHS-B and the Short-Form 36 Health Survey (SF-36), the Self-report Clinical Inventory (SCL-90), and the Body Uneasiness Test (BUT).

Results

The overall Cronbach's alpha value for the scale was 0.887. Significant correlations were found between the Italian BSHS-B domains, the SF-36 subscales (Spearman's rho: 0.184–0.414), and several SCL-90 subscales (Spearman's rho: −0.173 to −0.477). Furthermore, the affect and relationship domain and the skin domain of the BSHS-B negatively correlated with the compulsive self-monitoring and depersonalization subscales of the BUT.

Conclusion

The Italian translation of BSHS-B has shown satisfactory internal consistency, criterion validity, and convergent validity, supporting its application in routine clinical practice as well as in international studies.     

Prenatally-counseled congenital diaphragmatic hernia parents exhibit positive well-being before and after surgical repair

Background/Purpose

The purpose of this paper was to examine the effect of prenatal counseling in the Advanced Fetal Care Center (AFCC) on the well-being of parents of infants with congenital diaphragmatic hernia (CDH).

Methods

From 2008 through 2012, 26 mothers and fathers of surgically repaired CDH patients who received prenatal counseling at our institution, and 15 who received no prenatal counseling, each completed the Short-Form 36 version 1 (SF-36v1) at the appropriate time points: prenatal, two weeks, and six months post-surgery.

Results

Parents in both groups did not differ by demographic characteristics. Patients who received prenatal counseling had significantly longer ventilatory time and length of stay (LOS) in the ICU and in the hospital compared to those who did not receive prenatal counseling (all P < .01). Mothers and fathers had similar SF-36v1 mental and physical component summary (MCS, PCS) post-surgery scores when compared by counseling status. Prenatal MCS scores for mothers and fathers (47 vs. 41; P = .24) were similar to those at six months post-surgery (47 vs. 47; P = .90).

Conclusions

When hospital LOS was controlled between groups stratified by AFCC counseling status, MCS scores were comparable prenatally and were sustained at six months post-surgery for both parents. These findings may reflect the support services parents received beginning in the prenatal period.     

Bowel perforation in newborn with anorectal malformation and no fistula at presentation

Purpose

Anorectal malformation (ARM) in newborns with no fistula at presentation resembles intestinal obstruction. The aim of this study is to study the factors associated with bowel perforation in this group of patients.

Methods

From 2000 to 2012, 106 newborns with ARM were managed in our hospital. Thirty neonates without fistula at presentation were included in this study. Demographic data and the incidence of bowel perforation were studied.

Results

Twenty-nine male and 1 female were included in the study. Five patients were born premature and six patients had low birth weight. Six patients had Down's syndrome and 12 patients had associated anomalies. Cross-table lateral x-ray in prone position was performed from 20 to 24 hours after birth. All operations were performed within 48 hours after birth. One neonate underwent primary anoplasty. Twenty-nine neonates underwent colostomy. Two males developed bowel perforation before surgery (at 33 and 36 hours after birth). Perforation was associated with low birth weight (p = 0.034) and was not associated with prematurity (p = 0.31), Down's syndrome (p = 0.634) or the presence of other associated anomalies (p = 0.687).

Conclusions

In newborns with ARM, bowel perforation can occur within 36 hours after birth. Forty-eight hours of waiting is too long as it risks perforation. In this study, a neonate with low birth weight was trended toward bowel perforation.