Yolanda Pardo

Quality-of-Life Impact of Primary Treatments for Localized Prostate Cancer in Patients Without Hormonal Treatment

PURPOSE Earlier studies evaluating the effect on quality of life (QoL) of localized prostate cancer interventions included patients receiving adjuvant hormone therapy, which could have affected their outcomes. Our objective was to compare the QoL impact of the three most common primary treatments on patients who were not receiving adjuvant hormonal treatment. PATIENTS AND METHODS This was a prospective study of 435 patients treated with radical prostatectomy, external-beam radiotherapy, or brachytherapy. QoL was assessed before and after treatment with the Short Form-36 and the Expanded Prostate Cancer Index Composite. Differences between groups were tested by analysis of variance. Distribution of outcome at 3 years was examined by stratifying according to baseline status. Generalized estimating equation models were constructed to assess the effect of treatment over time. RESULTS Compared with the brachytherapy group, the prostatectomy group showed greater deterioration on urinary incontinence and sexual scores but better urinary irritative-obstructive results (-18.22, -13.19, and +6.38, respectively, at 3 years; P < .001). In patients with urinary irritative-obstructive symptoms at baseline, improvement was observed in 64% of those treated with nerve-sparing radical prostatectomy. Higher bowel worsening (-2.87, P = .04) was observed in the external radiotherapy group, with 20% of patients reporting bowel symptoms. CONCLUSION Radical prostatectomy caused urinary incontinence and sexual dysfunction but improved pre-existing urinary irritative-obstructive symptoms. External radiotherapy and brachytherapy caused urinary irritative-obstructive adverse effects and some sexual dysfunction. External radiotherapy also caused bowel adverse effects. Relevant differences between treatment groups persisted for up to 3 years of follow-up, although the difference in sexual adverse effects between brachytherapy and prostatectomy tended to decline over long-term follow-up. These results provide valuable information for clinical decision making.

Quality of life impact of treatments for localized prostate cancer: Cohort study with a 5 year follow-up

PURPOSE To assess long-term quality of life (QoL) impact of treatments in localized prostate cancer patients treated with radical prostatectomy, external beam radiotherapy or brachytherapy. MATERIAL AND METHODS Observational, prospective cohort study with pre-treatment QoL evaluation and follow-up until five years after treatment. 704 patients with low or intermediate risk localized prostate cancer were consecutively recruited in 2003-2005. QoL was measured by the EPIC questionnaire, with urinary irritative-obstructive, incontinence, bowel, sexual, and hormonal scores (ranging 0-100). RESULTS Brachytherapys QoL impact was restricted to the urinary domain, Generalized Estimating Equation models showed score changes at five years of -12.0 (95% CI=-15.0, -9.0) in incontinence and -5.3 (95% CI=-7.5, -3.1) in irritative-obstructive scales. Compared to brachytherapy, radical prostatectomy fared +3.3 (95% CI=+0.0, +6.5) points better in irritative-obstructive but -17.1 (95% CI=-22.7, -11.5) worse in incontinence. Sexual deterioration was observed in radical prostatectomy (-19.1; 95% CI=-25.1, -13.1) and external radiotherapy groups (-7.5; 95% CI=-12.5, -2.5). CONCLUSIONS Brachytherapy is the treatment causing the least impact on QoL except for moderate urinary irritative-obstructive symptoms. Our study provides novel long-term valuable information for clinical decision making, supporting brachytherapy as a possible alternative to radical prostatectomy for patients seeking an attempted curative treatment, while limiting the risk for urinary incontinence and sexual impact on QoL.

Assessing quality of life in patients with prostate cancer: a systematic and standardized comparison of available instruments

PurposeThe objective was to obtain a standardized evaluation of available prostate cancer-specific quality of life instruments used in patients with early-stage disease.MethodsWe carried out systematic literature reviews in the PubMed database to identify manuscripts which contained information regarding either the development process or metric properties of prostate cancer-specific quality of life instruments. Each instrument was evaluated by two experts, independently, using the Evaluating Measures of Patient-Reported Outcomes (EMPRO) tool. An overall and seven attribute-specific EMPRO scores were calculated (range 0–100, worst to best): measurement model, reliability, validity, responsiveness, interpretability, burden and alternative forms.ResultsEight instruments and 57 manuscripts (2–15 per instrument) were identified. The Expanded Prostate Cancer Index Composite (EPIC) was the best rated (overall EMPRO score 83.1 points). Good results were also obtained by University of California Los Angeles-Prostate Cancer Index (UCLA-PCI), Patient-Oriented Prostate Utility Scale (PORPUS) and Prostate Cancer Quality of Life Instrument (PC-QoL) with 77.3, 70.5 and 64.8 points, respectively. These four instruments passed with distinction the validity and responsiveness evaluation. Insufficient reliability results were observed for UCLA-PCI and PORPUS.ConclusionsCurrent evidence supports the choice of EPIC, PORPUS or PC-QoL. Attribute-specific EMPRO results facilitate selecting the adequate instrument for every purpose. For longitudinal studies or clinical trials, where responsiveness is the priority, EPIC or PC-QoL should be considered. We recommend the PORPUS for economic evaluations because it allows cost-utility analysis, and EPIC short versions to minimize administration burden.

Comparación de costes de tres tratamientos del cáncer de próstata localizado en España: prostatectomía radical, braquiterapia prostática y radioterapia conformacional externa 3D

OBJECTIVE To compare the initial costs of the three most established treatments for clinically localized prostate cancer according to risk, age and comorbidity groups, from the healthcare providers perspective. METHODS We carried out a cost comparison study in a sample of patients consecutively recruited between 2003 and 2005 from a functional unit for prostate cancer treatment in Catalonia (Spain). The use of services up to 6 months after the treatment start date was obtained from hospital databases and direct costs were estimated by micro-cost calculation. Information on the clinical characteristics of patients and treatments was collected prospectively. Costs were compared by using nonparametric tests comparing medians (Kruskall-Wallis) and a semi-logarithmic multiple regression model. RESULTS Among the 398 patients included, the cost difference among treatments was statistically significant: medians were € 3,229.10, € 5,369.00 and € 6,265.60, respectively, for the groups of patients treated with external 3D conformal radiotherapy, brachytherapy and radical retropublic prostatectomy, (p<0.001). In the multivariate analysis (adjusted R(2)=0.8), the average costs of brachytherapy and external radiotherapy were significantly lower than that of prostatectomy (coefficient -0.212 and -0.729, respectively). CONCLUSIONS Radical prostatectomy proved to be the most expensive treatment option. Overall, the estimated costs in our study were lower than those published elsewhere. Most of the costs were explained by the therapeutic option and neither comorbidity nor risk groups showed an effect on total costs independent of treatment.

Cost comparison of three treatments for localized prostate cancer in Spain: radical prostatectomy, prostate brachytherapy and external 3D conformal radiotherapy

Objective: To compare the initial costs of the three most established treatments for clinically localized prostate cancer according to risk, age and comorbidity groups, from the healthcare provider’s perspective.Methods: Cost comparison study on a sample of patients recruited consecutively between 2003 and 2005 in a functional unit of treatment for prostate cancer in Catalonia. The use of services until 6 months after the treatment start date was obtained from hospital databases and direct costs were estimated by micro-cost calculation. The collection of information on clinical characteristics of patients and treatments was conducted prospectively. The costs were compared using nonparametric test comparing medians (Kruskal-Wallis) and a semi-logarithmic model of multiple regressions.Results: Among the 398 patients included, the cost difference among treatments was statistically significant: medians were €3,229.10, €5,369.00 and €6,265.60 respectively for the groups of patients treated with Radical Retropubic Prostatectomy, Brachytherapy and External 3D Conformal Radiotherapy (P Conclusions: Radical prostatectomy proved to be the most expensive treatment option. Overall, the estimated costs in our study are lower than those published elsewhere. Therapeutic option explains most of the costs, and neither comorbidity nor risk group showed an independent effect from treatment on total costs.

Economic evaluation of treatments for patients with localized prostate cancer in Europe: a systematic review

BackgroundOur objective was to assess the efficiency of treatments in patients with localized prostate cancer, by synthesizing available evidence from European economic evaluations through systematic review.MethodsArticles published 2000–2015 were searched in MEDLINE, EMBASE and NHS EED (Prospero protocol CRD42015022063). Two authors independently selected studies for inclusion and extracted the data. A third reviewer resolved discrepancies. We included European economic evaluations or cost comparison studies, of any modality of surgery or radiotherapy treatments, regardless the comparator/s. Drummond’s Checklist was used for quality assessment.ResultsAfter reviewing 8,789 titles, 13 European eligible studies were included: eight cost-utility, two cost-effectiveness, one cost-minimization, and two cost-comparison analyses. Of them, five compared interventions with expectant management, four contrasted robotic with non robotic-assisted surgery, three assessed new modalities of radiotherapy, and three compared radical prostatectomy with brachytherapy. All but two studies scored ≥8 in the quality checklist. Considering scenario and comparator, three interventions were qualified as dominant strategies (active surveillance, robotic-assisted surgery and IMRT), and six were cost-effective (radical prostatectomy, robotic-assisted surgery, IMRT, proton therapy, brachytherapy, and 3DCRT). However, QALY gains in most of them were small. For interventions considered as dominant strategies, QALY gain was 0.013 for active surveillance over radical prostatectomy; and 0.007 for robotic-assisted over non-robotic techniques. The highest QALY gains were 0.57–0.86 for radical prostatectomy vs watchful waiting, and 0.72 for brachytherapy vs conventional radiotherapy.ConclusionsCurrently, relevant treatment alternatives for localized prostate cancer are scarcely evaluated in Europe. Very limited available evidence supports the cost-effectiveness of radical prostatectomy over watchful waiting, brachytherapy over radical prostatectomy, and new treatment modalities over traditional procedures. Relevant disparities were detected among studies, mainly based on effectiveness. These apparently contradictory results may be reflecting the difficulty of interpreting small differences between treatments regarding QALY gains.

Memories of parenting practices are associated with psychopathy in juvenile male offenders

Despite the large body of research documenting parenting practices as risk factors for the development of child and adolescent disruptive behaviour, the association with psychopathy is notably less known. The goal was to examine, in 75 institutionalized juvenile male offenders, the association between self-reported memories of parenting practices during childhood (Alabama Parenting Questionnaire) and psychopathy (Psychopathy Checklist: Youth Version). Results showed that ineffective parenting practices as inconsistent discipline and poor monitoring/supervision were significantly associated with increased levels of psychopathic traits. Interestingly, only two of the four facets of the construct, lifestyle and antisocial, were associated with these parenting behaviours. Findings highlight the importance of considering parenting practices in the study of the early development of psychopathy and suggest that the facets could be rooted in distinct underlying etiologic-dispositional factors with differentiated developmental pathways and different psychosocial correlates. The study lends support to the multidimensional approach of psychopathy as a syndrome.

Adaptation and validation of the Spanish version of the Patient-Oriented Prostate Utility Scale (PORPUS)

AbstractObjective The Patient-Oriented Prostate Utility Scale (PORPUS) is a combined profile and utility-based quality of life measure for prostate cancer patients. Our objectives were to adapt the PORPUS into Spanish and to assess its acceptability, reliability, and validity.MethodsThe PORPUS was adapted into Spanish using forward and back translations and cognitive debriefing. PORPUS was administered jointly with the SF-36 and the Expanded Prostate Index Composite (EPIC) to 480 Spanish prostate cancer patients treated with radical prostatectomy or radiotherapy. The Spanish PORPUS scores’ distribution and reliability were examined and compared with the original instrument. To evaluate construct validity, relationships were assessed between PORPUS and other instruments (testing hypotheses of the original PORPUS study), and among known groups defined by side effect severity.ResultsReliability coefficient was 0.76 (similar to the original PORPUS’ 0.81). Spanish PORPUS items presented correlations ranging 0.57–0.88 with the corresponding EPIC domains, as in the original PORPUS study (0.60–0.83). Both PORPUS-P and PORPUS-U showed significant differences and large effect sizes (0.94–1.90) when comparing severe versus no problem groups on urinary, bowel, sexual and hormonal side effects defined by EPIC.ConclusionsA conceptually equivalent Spanish version was obtained, with high reliability and good construct validity, similar to the original Canadian PORPUS version. It can therefore be used to measure health-related quality of life and utilities in Spanish prostate cancer patients.

Head-to-head comparison between the EQ-5D-5L and the EQ-5D-3L in general population health surveys

BackgroundThe EQ-5D has been frequently used in national health surveys. This study is a head-to-head comparison to assess how expanding the number of levels from three (EQ-5D-3L) to five in the new EQ-5D-5L version has improved its distribution, discriminatory power, and validity in the general population.MethodsA representative sample (N = 7554) from the Catalan Health Interview Survey 2011–2012, aged ≥18, answered both EQ-5D versions, and we evaluated the response redistribution and inconsistencies between them. To assess validity of this redistribution, we calculated the mean of the Visual Analogue Scale (VAS), which measures perceived health. The discriminatory power was examined with Shannon Indices, calculated for each dimension separately. Spanish preference value sets were applied to obtain utility indices, examining their distribution with statistics of central tendency and dispersion. We estimated the proportion of individuals reporting the best health state in EQ-5D-5L and EQ-5D-3L within groups of specific chronic conditions and their VAS mean.ResultsA very small reduction in the percentage of individuals with the best health state was observed, from 61.8% in EQ-5D-3L to 60.8% in EQ-5D-5L. In contrast, a large proportion of individuals reporting extreme problems in the 3 L version moved to severe problems (level 4) in the 5 L version, particularly for pain/discomfort (75.5%) and anxiety/depression (66.4%). The average proportion of inconsistencies was 0.9%. The pattern of the perceived health VAS mean confirmed the hypothesis established a priori, supporting the validity of the observed redistribution. Shannon index showed that absolute informativity was higher in the 5 L version for all dimensions. The means (SD) of the Spanish EQ-5D-3L and EQ-5D-5L indices were 0.87 (0.25) and 0.89 (0.22). The proportion of individuals with the best health state within each specific chronic condition was very similar, regardless of the EQ-5D version (≤ 30% in half of the 28 chronic conditions).ConclusionAlthough the proportion of individuals with the best possible health state is still very high, our findings support that the increase of levels provided by the EQ-5D-5L contributed to the validity and discriminatory power of this new version to measure health in general population, as in the national health surveys.

Assessing oral health-related quality of life in children and adolescents: a systematic review and standardized comparison of available instruments

ObjectivesTo obtain a systematic and standardized evaluation of the current evidence on development process, metric properties, and administration issues of oral health-related quality of life instruments available for children and adolescents.Materials and methodsA systematic search until October 2016 was conducted in PubMed, Embase, Lilacs, SciELO, and Cochrane databases. Articles with information regarding the development process, metric properties, and administration issues of pediatric instruments measuring oral health-related quality of life were eligible for inclusion. Two researchers independently evaluated each instrument applying the Evaluating Measures of Patient-Reported Outcomes (EMPRO) tool. An overall and seven attribute-specific EMPRO scores were calculated (range 0–100, worst to best): measurement model, reliability, validity, responsiveness, interpretability, burden, and alternative forms.ResultsWe identified 18 instruments evaluated in 132 articles. From five instruments designed for preschoolers, the Early Childhood Oral Health Impact Scale (ECOHIS) obtained the highest overall EMPRO score (82.2). Of nine identified for schoolchildren and adolescents, the best rated instrument was the Child Perceptions Questionnaire 11–14 (82.1). Among the four instruments developed for any age, the Family Impact Scale (FIS) obtained the highest scores (80.3).ConclusionThe evidence supports the use of the ECOHIS for preschoolers, while the age is a key factor when choosing among the four recommended instruments for schoolchildren and adolescents. Instruments for specific conditions, symptoms, or treatments need further research on metric properties.Clinical relevanceOur results facilitate decision-making on the correct oral health-related quality of life instrument selection for any certain study purpose and population during the childhood and adolescence life cycle.