A comparison of the validity of two indirect utility instruments as measures of postoperative recovery

Background

Cost-effectiveness analyses of surgical interventions require valid measures of postoperative recovery. The objective of this study was to compare the validity of two indirect utility instruments, the Short Form 6D (SF-6D) and EuroQol 5D (EQ-5D), as measures of postoperative recovery.

Materials and methods

A prospective cohort of patients undergoing elective colorectal resection at two university-affiliated institutions from October 2012–October 2013 completed the SF-6D and EQ-5D (including the EQ-visual analog scale [EQ-VAS]) at baseline (before surgery), and at 4 and 8 wk after surgery. Responsiveness and construct validity were assessed through a priori hypotheses.

Results

A total of 165 patients were included. The SF-6D was the most responsive to the expected postoperative changes at 4 and 8 wk compared with the EQ-5D and the EQ-VAS. The 4-wk SF-6D, EQ-5D, and EQ-VAS discriminated between patients with and without complications after controlling for confounders with adjusted mean differences of −0.070 (95% confidence interval [CI] −0.126 to −0.015), −0.133 (95% CI −0.231, −0.030), and −7.91 (95% CI −14.77, −1.04), respectively. Mean SF-6D and EQ-5D values were significantly different from the US population norms at all time points, but the magnitude of change was highest for the SF-6D. The strength of correlation between all three instruments was moderate at all time points (r = 0.550–0.684, all P < 0.05).

Conclusions

The SF-6D preference-based health index appears to be a more valid measure of postoperative recovery than the EQ-5D and EQ-VAS in surgical cost-effectiveness analyses.     

Valuing postoperative recovery: validation of the SF-6D health-state utility

Background

Many surgical innovations are costly but may result in faster patient recovery. Economic analyses of these innovations require utility measures that reflect the construct of “postoperative recovery.” We investigated the validity of Short Form 6D (SF-6D) utility value as a measure of postoperative recovery in patients undergoing elective colorectal resection.

Materials and methods

Patients undergoing elective colorectal resection completed the Short Form 36 and the 6-min walk test at baseline (before surgery) and at 4 and 8 wk postoperatively. SF-6D utilities were derived from the Short Form 36. Longitudinal validity (responsiveness) was assessed using standardized response means (SRM). Construct validity was assessed by comparing the difference in mean SF-6D between patients with and without complications (discriminant) and by correlating the SF-6D with other measures of recovery (convergent).

Results

A total of 191 patients were included (58% male; mean age 63.0 (SD 14.2) y, 81% malignancy, and 54% laparoscopic). SF-6D values dropped significantly from baseline to 4 wk after surgery (SRM −0.54, P < 0.001) and returned to baseline by 8 wk (SRM −0.12, P = 0.111). At 4 wk after surgery, the SF-6D was lower in patients with complications than in those without (mean difference −0.047, 95% CI −0.088, −0.006). At all time points, the SF-6D correlated significantly with the physical and mental component scales of the SF-36 (Pearson r 0.67–0.80, all P < 0.001) and the 6-min walk test (r 0.21–0.29, all P < 0.05).

Conclusions

The SF-6D is a valid measure of postoperative recovery following elective colorectal resection and may be used to measure quality-adjusted life years for cost-effectiveness analyses of surgical technologies and interventions hypothesized to impact recovery.     

Factors Predicting Health-Related Quality of Life Recovery in Patients Undergoing Surgical Treatment for Renal Tumors: Prospective Evaluation Using the RAND SF-36 Health Survey

Background

Most newly diagnosed kidney cancers present at localized stages. With appropriate treatments, the cancer-specific survival rates of such patients are extremely high, which makes patients’ health-related quality of life (HRQoL) a relevant issue. To date, most of the available studies on HRQoL have been biased by the absence of baseline HRQoL assessments and by retrospective designs.

Objective

To evaluate the baseline HRQoL of patients with kidney cancer, comparative HRQoL during the first year after surgery, and the prognostic factors predictive of HRQoL recovery.

Design, setting, and participants

We prospectively collected the data of all patients undergoing surgery for kidney tumors at a tertiary academic referral center from February 2006 to September 2007.

Interventions

Patients underwent nephron-sparing surgery (NSS) or radical nephrectomy (RN).

Measurements

Patients were invited to self-complete the validated, Italian version of the RAND 36-Item Health Survey 1.0 (SF-36) before surgery, 6 mo after surgery, and 12 mo after surgery.

Results and limitations

Overall, 129 consecutive patients were evaluated. No significant differences were found between the baseline scores of our patients and age- and sex-matched normative data for the Italian general population. Comparing the baseline SF-36 scores to those at 6 mo and 12 mo, there was statistically significant worsening in the physical domains and improvement in the emotional domains (all p < 0.05). About 50–80% of patients returned to baseline scores 6 mo and 12 mo after surgery. Age, body mass index (BMI), educational level, occupational status, New York Heart Association (NYHA) functional class, tumor mode of presentation, pathologic stage, size, and histologic subtype were associated with 6-mo and 12-mo return to the baseline HRQoL scores. The main limitation of the study was the lack of a disease-specific questionnaire.

Conclusions

Most patients returned to preoperative HRQoL within 12 mo after RN or NSS. Several patient features, clinical variables, and pathologic tumor variables predict the return of HRQoL.     

Oral Mucosa as a Reservoir of Human Papillomavirus: Point Prevalence,Genotype Distribution,and Incident Infections Among Males in a 7-year Prospective Study

Background

In addition to the anogenital malignancies, human papillomavirus (HPV) has been linked to oropharyngeal cancer as an important risk factor in both men and women. Knowledge of oral HPV infection among males is needed to elucidate the transmission routes and potential for prevention.

Objective

To assess the prevalence, genotype distribution, and incidence of oral HPV infections among healthy Finnish men followed for 7 yr.

Design, setting, and participants

Oral scrapings for HPV testing were taken from 131 fathers-to-be (mean age: 28.9 yr) at baseline and at 2-mo, 6-mo, 12-mo, 24-mo, 36-mo, and 7-yr follow-up visits to detect prevalent and incident HPV infections. Purified DNA extracted from scrapings was used for HPV genotyping, with the Multimetrix kit (Progen Biotechnik, Heidelberg, Germany) detecting 24 genotypes.

Outcome measurements and statistical analysis

Point prevalence, genotype distribution, and incident rates of oral HPV infections. Demographic data were collected using structured questionnaires, and covariates of incident oral HPV infections were analysed using uni- and multivariate Poisson regression (for panel data).

Results and limitations

The point prevalence of oral HPV infection fluctuated from 15.1% to 31.1% during the follow-up period. In total, 17 different HPV genotypes were found. At baseline, the single most frequent genotype among the HPV-positive samples was HPV16 (33.3%; 8 of 24), followed by HPV33 (12.5%) and HPV82 (12.5%). Multiple-type infections comprised 16.7% (4 of 24), HPV16 being involved in all combinations. For baseline-negative men, the mean time to the first incident infection ranged from 3.9 mo (HPV82) to 25.7 mo (HPV56). None of the demographic factors was a significant independent predictor of incident oral HPV infections in multivariate models.

Conclusions

Detection of oral HPV DNA carriage in men is common, HPV16 being the most prevalent genotype. Oral mucosa may play a significant role in HPV transmission.     

Can Low-Intensity Extracorporeal Shockwave Therapy Improve Erectile Function? A 6-Month Follow-up Pilot Study in Patients with Organic Erectile Dysfunction

Background

Low-intensity extracorporeal shockwave therapy (LI-ESWT) is currently under investigation regarding its ability to promote neovascularization in different organs.

Objective

To evaluate the effect of LI-ESWT on men with erectile dysfunction (ED) who have previously responded to oral phosphodiesterase type 5 inhibitors (PDE5-I).

Design, setting, and participants

We screened 20 men with vasculogenic ED who had International Index of Erectile Function ED (IIEF-ED) domain scores between 5–19 (average: 13.5) and abnormal nocturnal penile tumescence (NPT) parameters. Shockwave therapy comprised two treatment sessions per week for 3 wk, which were repeated after a 3-wk no-treatment interval.

Intervention

LI-ESWT was applied to the penile shaft and crura at five different sites.

Measurements

Assessment of erectile function was performed at screening and at 1 mo after the end of the two treatment sessions using validated sexual function questionnaires, NPT parameters, and penile and systemic endothelial function testing. The IIEF-ED questionnaire was answered at the 3- and 6-mo follow-up examinations.

Results and limitations

We treated 20 middle-aged men (average age: 56.1 yr) with vasculogenic ED (mean duration: 34.7 mo). Eighteen had cardiovascular risk factors. At 1 mo follow-up, significant increases in IIEF-ED domain scores were recorded in all men (20.9 ± 5.8 vs 13.5 ± 4.1, p < 0.001); these remained unchanged at 6 mo. Moreover, significant increases in the duration of erection and penile rigidity, and significant improvement in penile endothelial function were demonstrated. Ten men did not require any PDE5-I therapy after 6-mo follow-up. No pain was reported from the treatment and no adverse events were noted during follow-up.

Conclusions

This is the first study that assessed the efficacy of LI-ESWT for ED. This approach was tolerable and effective, suggesting a physiologic impact on cavernosal hemodynamics. Its main advantages are the potential to improve erectile function and to contribute to penile rehabilitation without pharmacotherapy. The short-term results are promising, yet demand further evaluation with larger sham-control cohorts and longer follow-up.     

Surgical Treatment of Peyronie's Disease by Plaque Incision and Grafting with Buccal Mucosa

Background

Plaque incision and tunical grafting is widely used to correct penile curvatures secondary to Peyronie's disease (PD), but there is no consensus on the ideal graft to be used.

Objective

To evaluate the efficacy, safety, and reproducibility of plaque incision and buccal mucosa grafting (BMG) in the correction of severe penile curvatures secondary to PD.

Design, setting, and participants

Fifteen patients reporting normal erections and stable curvature (>12-mo duration) entered this prospective study carried out at two university hospitals.

Intervention

All patients underwent plaque incision and BMG.

Measurements

Preoperative evaluation included the International Index of Erectile Function (IIEF-5) and penile duplex ultrasounds with measurement of curvature and length of affected side. Follow-up visits were scheduled at 1, 3, 6, and 12 mo postoperatively, then yearly. Three-mo postoperative evaluation included IIEF-5, patient and partner satisfaction, and intracavernous injection test with evaluation of penile rigidity, straightness, and length; patient and partner satisfaction was recorded at all subsequent visits.

Results and limitations

Mean patient age was 56.3 yr and mean penile curvature 72°; five patients had a two-sided curvature with mean second curvature of 37°. There were no complications. All patients resumed unassisted intercourse 1 mo after surgery. Three-mo postoperative evaluation showed 100% penile straightening, 1.8-cm mean increase in length of affected side, no curvature recurrence or de novo erectile dysfunction, 1.6 mean increase in IIEF-5 score, and patient and partner satisfaction of 93.3% and 100%, respectively. Although results remained stable at subsequent follow-up (mean 13.1 mo), a greater number of patients and longer follow-up are needed before drawing any definite conclusions.

Conclusions

BMG provided excellent short-term results, probably because its prompt revascularisation, suggested by the fast return of spontaneous erections, prevented shrinkage, which is the main cause of graft failure. It also proved to be safe and reproducible, thus representing a valuable treatment option for PD.     

Technical refinement and learning curve for attenuating neurapraxia during robotic-assisted radical prostatectomy to improve sexual function

Background

While radical prostatectomy surgeon learning curves have characterized less blood loss, shorter operative times, and fewer positive margins, there is a dearth of studies characterizing learning curves for improving sexual function. Additionally, while learning curve studies often define volume thresholds for improvement, few of these studies demonstrate specific technical modifications that allow reproducibility of improved outcomes.

Objective

Demonstrate and quantify the learning curve for improving sexual function outcomes based on technical refinements that reduce neurovascular bundle displacement during nerve-sparing robot-assisted radical prostatectomy (RARP).

Design, setting, and participants

We performed a retrospective study of 400 consecutive RARPs, categorized into groups of 50, performed after elimination of continuous surgeon/assistant neurovascular bundle countertraction.

Surgical procedure

Our approach to RARP has been described previously. A single-console robotic system was used for all cases.

Outcome measurements and statistical analysis

Expanded Prostate Cancer Index Composite sexual function was measured within 1 yr of RARP. Linear regression was performed to determine factors influencing the recovery of sexual function.

Results and limitations

Greater surgeon experience was associated with better 5-mo sexual function (p = 0.007) and a trend for better 12-mo sexual function (p = 0.061), with improvement plateauing after 250–300 cases. Additionally, younger patient age (both p < 0.02) and better preoperative sexual function (<0.001) were associated with better 5- and 12-mo sexual function. Moreover, trainee robotic console time during nerve sparing was associated with worse 12-mo sexual function (p = 0.021), while unilateral nerve sparing/non–nerve sparing was associated with worse 5-mo sexual function (p = 0.009). Limitations include the retrospective single-surgeon design.

Conclusions

With greater surgeon experience, attenuating lateral displacement of the neurovascular bundle and resultant neurapraxia improve postoperative sexual function. However, to maximize outcomes, appropriate patient selection must be exercised when allowing trainee nerve-sparing involvement.     

Robotic Kidney Transplantation with Regional Hypothermia: A Step-by-step Description of the Vattikuti Urology Institute–Medanta Technique (IDEAL Phase 2a)

Background

We recently reported on preclinical and feasibility studies (Innovation, Development, Exploration, Assessment, Long-term study [IDEAL] phase 0–1) of the development of robotic kidney transplantation (RKT) with regional hypothermia. This paper presents the IDEAL phase 2a studies of technique development.

Objectives

To describe the technique of RKT with regional hypothermia developed at two tertiary care institutions (Vattikuti Urology Institute and Medanta Hospital). We report on the safety profile and early graft function in these patients.

Design, setting, and participants

This is a prospective study of 50 consecutive patients who underwent live-donor RKT at Medanta Hospital following a 3-yr planning/simulation phase at the Vattikuti Urology Institute. Demographic details, and perioperative and postoperative outcomes are reported for the initial 25 recipients who have completed a minimum 6-mo follow-up.

Surgical procedure

Positioning and port placement were similar to that used for robotic radical prostatectomy. Allograft cooling was achieved by ice slush delivered through a GelPOINT device. The accompanying video details the operative technique.

Outcome measurements and statistical analysis

The primary outcome was posttransplant graft function. Secondary outcomes included technical success or failure and complication rates.

Results and limitations

Fifty patients underwent RKT successfully, 7 in the phase 1 and 43 in the phase 2 stages of the study. For the initial 25 patients, mean console, warm ischemia, arterial, and venous anastomotic times were 135, 2.4, 12, and 13.4 min, respectively. All grafts were cooled to 18–20°C with no change in core body temperature. All grafts functioned immediately posttransplant and the mean serum creatinine level at discharge was 1.3 mg/dl (range: 0.8–3.1 mg/dl). No patient developed anastomotic leaks, wound complications, or wound infections. At 6-mo of follow-up, no patient had developed a lymphocele detected on CT scanning. Two patients underwent re-exploration, and one patient died of congestive heart failure (1.5 mo posttransplant).

Conclusions

RKT with regional hypothermia is safe and reproducible when performed by a team skilled in robotic surgery.

Patient summary

RKT is safe and effective when performed by surgeons experienced in robotic techniques.     

Preoperative computer-based simulations for the correction of kyphotic deformities in ankylosing spondylitis patients

Background context

A preoperative plan is important to obtain appropriate balance of the sagittal plane in patients with kyphotic deformity. Previous methods to calculate the correction angle are inconvenient and complicated, whereas the method using computer simulations may be very effective and much simpler than existing methods.

Purpose

To evaluate the efficacy of preoperative measurements using a computer simulation for corrective osteotomy for the surgical treatment of kyphosis caused by ankylosing spondylitis (AS).

Study design

Retrospective clinical data analysis.

Patient sample

The sample comprises 18 AS patients with fixed kyphotic deformity who underwent corrective osteotomies at our hospital between October 2007 and January 2010.

Outcome measures

Thoracic kyphosis, lumbar lordosis, and the sagittal vertical axis (SVA) of the spine were evaluated by preoperative computer simulation and radiologic measurement. Clinical assessments were performed according to the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), Bath Ankylosing Spondylitis Functional Index (BASFI), Short Form-36 (SF-36), and EuroQol-5 dimension (EQ-5D) before and after the surgery.

Methods

The coincidence between the preoperative computer simulation and postoperative radiologic parameters was evaluated. We also analyzed the changes derived from each clinical and radiologic measurement before and after the surgery.

Results

Mean thoracic kyphosis changed from 32.4° to 31.9°, mean lumbar lordosis was corrected from 11.5° to 26.9°, and the SVA was improved from 125.7 to 65.1 mm after surgery (p<.001). The correlation coefficients within groups between the computer simulations and radiologic parameters were 0.9, 0.6, and 0.7, showing significant congruency. Although BASDAI and BASFI did not significantly differ (p=.53 and p=.45, respectively), SF-36 and EQ-5D were significantly increased (p<.05 and p<.001, respectively).

Conclusions

Comparisons of preoperative simulations and actual surgical outcomes showed significant coincidences; thus, evaluations through computer simulations before surgery are expected to help predict the level of correction possible after surgery and improve surgical planning.     

Validation of the EQ-5D questionnaire in burn injured adults

Background

Health-related quality of life (HRQoL) is an important aspect of adaptation after burn. The EQ-5D is a standardized generic instrument for assessing HRQoL. Its psychometric properties in a group of burn injured individuals are, however, not known.

Methods

Seventy-eight consecutive patients admitted to a burn unit were included in a prospective longitudinal study. The participants completed the EQ-5D during acute care, and at 3, 6, and 12 months after the burn. At 6 and 12 months after the burn they also completed the Short-Form 36 Health Survey (SF-36) and the Burn Specific Health Scale-Brief (BSHS-B).

Results

High feasibility of the EQ-5D was demonstrated through a high response rate and a low proportion of missing or invalid answers. The floor and ceiling effects were small. Construct validity was demonstrated through good differentiation between health states and good discrimination of health states over time. The EQ-5D was associated with burn severity and discriminated between clinical subgroups in an expected manner. Criterion validity was demonstrated through significant correlations between the EQ-5D and subscales of the SF-36 and the BSHS-B.

Conclusions

The EQ-5D has good psychometric properties, it is short and easy to administer and thus useful in assessment of HRQoL after burn.     

Randomized Double-blind,Active-controlled Phase 3 Study to Assess 12-Month Safety and Efficacy of Mirabegron,a β3-Adrenoceptor Agonist,in Overactive Bladder

Background

Despite several antimuscarinic treatment options for overactive bladder (OAB), there is still a need for distinct treatment approaches to manage this condition. Mirabegron, a β₃-adrenoceptor agonist, has demonstrated efficacy and tolerability for up to 12 wk in phase 3 trials.

Objective

To assess the 12-mo safety and efficacy of mirabegron.

Design, setting, and participants

Patients ≥18 yr of age with OAB symptoms for ≥3 mo.

Interventions

After a 2-wk single-blind placebo run-in, patients with eight or more micturitions per 24 h and three or more urgency episodes in a 3-d micturition diary were randomized 1:1:1 to once-daily mirabegron 50 mg, mirabegron 100 mg, or tolterodine extended release (ER) 4 mg for 12 mo.

Outcome measurements and statistical analysis

Primary variable: incidence and severity of treatment-emergent AEs (TEAEs). Secondary variables: change from baseline at months 1, 3, 6, 9, and 12 in key OAB symptoms.

Results and limitations

A total of 812, 820, and 812 patients received mirabegron 50 mg, mirabegron 100 mg, and tolterodine ER 4 mg, respectively. Baseline demographic and OAB characteristics were similar across groups. TEAEs were reported in 59.7%, 61.3%, and 62.6% of patients, respectively; most were mild or moderate. Serious TEAEs were reported in 5.2%, 6.2%, and 5.4% of patients, respectively. The most common TEAEs were similar across groups. Dry mouth was reported by 2.8%, 2.3%, and 8.6% of patients, respectively. Adjusted mean changes from baseline to final visit in morning systolic blood pressure were 0.2, 0.4, and −0.5 mm Hg for mirabegron 50 mg, 100 mg, and tolterodine ER 4 mg, respectively. Mirabegron and the active control, tolterodine, improved key OAB symptoms from the first measured time point of 4 wk, and efficacy was maintained throughout the 12-mo treatment period. The study was not placebo controlled, which was a limitation.

Conclusions

The safety and tolerability of mirabegron was established over 1 yr, with sustained efficacy observed over this treatment period.

Trial registration

ClinicalTrials.gov identifier: NCT00688688.     

Prediction of functional outcomes after nerve-sparing radical prostatectomy: results of conditional survival analyses

Background

In prostate cancer (PCa) patients treated with radical prostatectomy (RP), the rate of urinary continence (UC) and erectile function (EF) recovery may change significantly depending on the time interval between surgery and patient assessment. This effect, known as conditional survival, has not yet been assessed.

Objective

Evaluate the conditional rates of UC and EF recovery after nerve-sparing RP (NSRP).

Design, setting, and participants

We included 1135 PCa patients treated between January 2000 and June 2011 at a single referral center.

Intervention

All patients underwent NSRP.

Outcome measurements and statistical analysis

The Kaplan-Meier method assessed the time to recovery of UC (defined as an International Consultation on Incontinence Questionnaire score <6) and of EF (defined as an International Index of Erectile Function-Erectile Function score ≥22). Cumulative survival estimates were used to generate conditional recovery rates assessed at a 6-mo interval. Multivariable Cox regression analyses were performed to predict functional outcomes recovery after accounting for confounders.

Results and limitations

UC recovery rates were 89.5%, 94.7%, and 97.0% at 6-, 24-, and 36-mo follow-up, respectively. Corresponding EF recovery rates were 53.6%, 65.0%, and 67.5%, respectively. In patients who were still incontinent at 1, 6, 12, 18, 24, 30, and 36 mo after surgery, UC recovery rates in the following 6-mo period significantly decreased as the time from surgery increased: 74.9%, 58.2%, 41.4%, 14.9%, 24.8%, 24.6%, and 13.3%, respectively. Similarly, in patients still impotent at the same time points, the 6-mo rate of sexual potency recovery was 36.9%, 26.8%, 17.8%, 8.2%, 3.1%, 4.0%, and 0%, respectively. Multivariable analyses confirmed these results. The study is limited by its retrospective design.

Conclusions

In incontinent and/or impotent patients, the period elapsed from surgery represents an important predictor of the recovery of subsequent functional outcomes. The highest increments in UC and EF recovery were observed during the first year after surgery; they were virtually null after 36 mo.     

Relationships between the Quality of Life Questionnaire (QLQ) and the SF-36 among young adults burned as children

Objective

To examine the relationship between two measures that can be used to examine quality life among pediatric burn survivors.

Design

Prospective, correlational study.

Setting

Acute and rehabilitation pediatric burn care facility.

Participants

Eighty young adult survivors of pediatric burns, who were 18–28 years of age, with burns of 30% or greater, and were at least 2 years after burn.

Interventions

Not applicable.

Main outcome measures

The SF-36 and the Quality of Life Questionnaire (QLQ) were used to assess participant's self-reported general health and long-term adjustment.

Results

Significant correlations (p ≤ 0.001) were found between the total quality of life score of the QLQ and the mental component scale of the SF-36. However, no significant correlations were found between the total quality of life score of the QLQ and the SF-36 physical component scale.

Conclusions

Approximately 100,000 children are treated for burns annually, with a high percentage surviving, creating a challenge for health care professionals who need to prepare burn survivors with their psychosocial and physical well-being as adults. This study found that the SF-36 and QLQ are measuring somewhat different aspects of psychosocial and physical adjustment. It is recommended that both tools could be useful to the burn practitioner in assessing quality of life.     

A Randomized Comparison of a Single-incision Midurethral Sling and a Transobturator Midurethral Sling in Women with Stress Urinary Incontinence: Results of 12-mo Follow-up

Background

Midurethral sling procedures have become the prime surgical treatment for women with stress urinary incontinence (SUI). Single-incision mini-slings (SIMS) potentially offer similar efficacy with reduced morbidity. This international multicenter trial compared the efficacy and morbidity of a SIMS (MiniArc) and a transobturator standard midurethral sling (SMUS) (Monarc).

Objective

To compare subjective and objective cure, morbidity, and surgery-related discomfort following SIMS and transobturator SMUS.

Design, setting, and participants

Prospective randomized controlled trial with an initial follow-up period of 12 mo. Women with symptomatic SUI were eligible.

Outcome measurements and statistical analysis

Primary outcome was subjective cure, defined as an improvement on the Patient Global Impression of Improvement (PGI-I). Coprimary outcome was the mean visual analog scale (VAS) pain score (0–100) during 3 d after surgery. Secondary outcomes were objective cure based on the cough stress test (CST), disease-specific quality of life determined by the Urogenital Distress Inventory (UDI-6) score, surgical parameters, and physical performance during recovery. Analysis was by intent to treat. Differences between the MiniArc and Monarc groups on dichotomous variables were chi-square tested and presented as relative risks (RR) with corresponding 95% confidence intervals. We hypothesized that MiniArc was noninferior to Monarc concerning subjective cure and superior concerning postoperative pain.

Results and limitations

We randomized 97 women to MiniArc and 96 to Monarc. At 12-mo follow-up, subjective cure was 83% following MiniArc and 86% following Monarc (p = 0.46). Objective cure was 89% following MiniArc and 91% following Monarc (p = 0.65). The mean pain VAS score during the first three postoperative days was 9 following MiniArc and 22 following Monarc (Mann-Whitney U test, p < 0.01).

Conclusions

At 1-yr follow-up, MiniArc was noninferior to Monarc with respect to subjective and objective cure and superior with respect to postoperative pain.

Patient summary

This 1-yr randomized clinical trial showed that MiniArc, a single-incision midurethral sling, is noninferior to Monarc, a transobturator sling, with respect to cure and superior with respect to pain and recovery.     

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.     

Perioperative indicators of hypocalcemia in total thyroidectomy: the role of vitamin D and parathyroid hormone

Background

Hypocalcemia is a common complication of thyroidectomy. The aim of this study was to identify risk factors for this problem.

Methods

This prospective analysis included 111 patients undergoing total or completion thyroidectomy. Preoperative vitamin D levels and postoperative day 1 parathyroid hormone levels were analyzed for their predictive effects on postoperative hypocalcemia.

Results

Patients with ionized calcium <4.4 mg/dL had significantly lower mean parathyroid hormone levels than normocalcemic patients (13.0 vs 28.4 pg/mL, P < .001). Parathyroid hormone levels were also significantly lower in symptomatic patients (11.0 vs 28.4 pg/mL, P < .001). Preoperative vitamin D level, body mass index, gender, and pathologic findings were not associated with low calcium levels or symptoms of hypocalcemia.

Conclusions

Younger age and low postoperative parathyroid hormone levels are predictive of symptomatic hypocalcemia. A parathyroid hormone level outside of the reference range may indicate a need for more aggressive postoperative calcium supplementation and treatment with activated vitamin D. Older patients with normal postoperative parathyroid hormone levels may be safely discharged with appropriate calcium supplementation.     

Abordaje laparoscópico de la acalasia. Resultados clínicos,de calidad de vida y funcionales a largo plazo

Introduction

Laparoscopic Heller myotomy has become the gold standard procedure for patients with achalasia. This study evaluates the clinical status, quality of life, and functional outcomes after laparoscopic Heller myotomy.

Material and methods

We analyzed patients who underwent laparoscopic Heller myotomy with an associated anti-reflux procedure from October 1998 to December 2010. Before surgery, we administered a clinical questionnaire and as of 2002, we also evaluated quality of life using a specific questionnaire (GIQLI). In 2011, we performed a follow up for all available patients. We administered the same clinical questionnaire and quality of life test as before surgery and performed manometry and 24-hour pH monitoring. According to the length of follow up, patients were divided into 3 groups. Group 1 with a follow-up between 6 and 47 months; group 2 follow-up between 48 and 119 months, and group 3 with a follow-up of more than 120 months). Moreover, 27 patients had already been evaluated with this same protocol in 2003. Pre- and postoperative data were compared for the 3 groups and for patients who completed follow up in 2003 and 2011.

Results

Ninety-five patients underwent laparoscopic Heller myotomy. Seventy-six (80%) were available for follow-up. Mean follow-up was 56 months (range 6-143). Global improvement in dysphagia was 89%. Total DeMeester score decreased in the 3 groups. GIQLI scores improved after surgery, reaching normal values. Manometric determinations showed normal LES pressures after myotomy in the 3 groups. Ten percent of overall 24-hour pH monitoring was abnormal. The group of patients followed up in 2003 and in 2011 showed no impairment in the variables studied in the long term.

Conclusions

Long-term follow up of the laparoscopic approach to achalasia showed good results concerning clinical status and quality of life, with normal sphincteric pressures and a low incidence of gastroesophageal reflux.     

Transpubic access using pedicle tubularized labial urethroplasty for the treatment of female urethral strictures associated with urethrovaginal fistulas secondary to pelvic fracture

Background

Female urethral injury is rare, and there is no accepted standard approach for the repair of urethral strictures.

Objective

To evaluate the efficacy of transpubic access using pedicle tubularized labial urethroplasty for urethral reconstruction in female patients with urethral obliterative strictures and urethrovaginal fistulas.

Design, setting, and participants

Between January 1996 and December 2006, eight cases of female urethral strictures associated with urethrovaginal fistulas were treated using pedicle labial skin flaps.

Interventions

A flap of approximately 3 × 3.5 × 3 cm of the labia minora or majora with its vascular pedicle was tubularized over an 18–22 Fr fenestrated silicone stent to create a neourethra. This technique was used in five women. Two flaps, approximately 1.5–3.5 cm, were taken from bilateral labia minora or majora and were pieced together to create a neourethra. This technique was used in three patients.

Measurements

We performed voiding cystourethrography and uroflowmetry to assess postoperative results.

Results and limitations

The patients were followed up for 10–118 mo (mean 48.25 mo) after the procedure. There were no postoperative complications. Two patients complained of dysuria, which resolved spontaneously after 2 wk. One patient experienced stress incontinence that resolved after 4 wk. At 3-mo follow-up, one patient complained of difficulty voiding; the urinary peak flow was 13 ml/s, and the patient was treated successfully with urethral dilation. All other patients had normal micturition following catheter removal.

Conclusions

Pedicle labial urethroplasty is a reliable technique for the repair of extensive urethral damage, and a transpubic surgical approach provides wide and excellent exposure for the management of complex obliterative urethral strictures and urethrovaginal fistulas secondary to pelvic fracture.     

Improvement in Gastrointestinal and Health-related Quality of Life Outcomes After Conversion From Mycophenolate Mofetil to Enteric-coated Mycophenolate Sodium in Liver Transplant Recipients

Objective

To evaluate improvement in gastrointestinal (GI) symptoms and health-related quality of life (HRQoL) in liver transplant recipients switched from mycophenolate mofetil (MMF) to enteric-coated mycophenolate sodium (EC-MPS).

Methods

A multicenter, open-label, single-arm study was undertaken in maintenance liver transplant recipients who reported GI complications with MMF therapy. The patients were switched to equimolar doses of EC-MPS at baseline. The primary end point was the change in the Gastrointestinal Symptom Rating Scale (GSRS) total score after 6 to 8 weeks of treatment with EC-MPS. Other key assessments for GI symptoms and HRQoL included the GSRS subscores, the Gastrointestinal Quality of Life Index (GIQLI), the Psychological General Well-Being Index, and the Overall Treatment Effect (OTE). Paired t-test was used to assess the difference in the mean score changes over time.

Results

A total of 34 patients were enrolled and switched to equimolar doses of EC-MPS. After 6 to 8 weeks of EC-MPS treatment, mean GSRS total score improved significantly from 2.88 ± 0.66 to 2.10 ± 0.78. Mean improvement in GSRS total score (−0.77 score points; P = .001) exceeded the minimal clinically important difference. Significant improvements were observed in all GSRS subscales (P < .05), GIQLI total scores (P = .001), and GIQLI subscales “GI symptoms” (P < .001) and “physical function” (0.013). Patients who continued EC-MPS reported sustained benefits compared with patients who switched back to MMF after 6 to 8 weeks of treatment with EC-MPS. On the OTE scale, improvement in symptoms was reported in 76.5% and 61.8% of the patients as perceived by the physicians and the patients. Improvement in HRQoL was reported by 41.2% of the patients. No deaths, biopsy proven acute rejections, or graft losses were reported during the study.

Conclusion

Conversion from MMF to EC-MPS was associated with a significant improvement in GI symptoms and HRQoL in liver transplant recipients.     

Donors' Quality of Life Evaluated by Short Form-36 Analysis After Living Donor Liver Transplantation in a Single-Center Experience

Background and Purpose

The purpose of this study was to compare the quality of life of donors using the Short Form 36 (SF-36) analysis between the left and right graft periods of living donor liver transplantation.

Patients and Methods

In the left graft period (July 1991 to July 2003), 68 donors were eligible for analysis and 76 were eligible in the right graft period (August 2003 to October 2010). Nine right lobe grafts were included in the left graft period, and 52 right lobe grafts were included in the right graft period. We investigated the risks of donation and evaluated the following: blood loss, operation time, postoperative liver function, and duration of hospitalization. We also assessed quality of life in donors, who were mailed a structured questionnaire and the SF-36.

Results

Ten of the 68 donors in the left graft period and 12 of the 76 in the right graft period had postoperative complications. Most postoperative complications were treated without surgical procedures. There was no donor death in our series. Forty-eight donors in the left graft period and 36 in the right graft period responded to our investigation. Compared with published Japanese norms in SF-36, our donors scored similar or higher than the general population in both groups. Two donors in the left graft period and one in the right graft period regretted their decisions to donate. All donors returned to normalcy.

Conclusions

These results suggested that the donors' quality of life was guaranteed in terms of the SF-36 investigation regardless of the donation period in our series.