Cross-cultural adaptation, reliability and validity of the Spanish version of the long-term quality of life questionnaire.

Purpose: The aim of this study was to translate, culturally adapt, and evaluate the psychometric properties of the Spanish Long-Term Quality of Life (LTQL) questionnaire. Methods: The LTQL was initially translated into Spanish and cross-culturally adapted based on established guidelines. The Spanish LTQL was administered to patients with breast cancer who had completed their initial treatment 5 years earlier, along with other self-report measures: Quality of Life in Adult Cancer Survivors (QLACS), Hospital Anxiety and Depression Scale (HADS) and EORT-QLQ-BR23. Reliability was evaluated using internal consistency and test-retest. Convergent and known-groups validity were examined. Structural validity as determined by confirmatory factor analysis (CFA) and Rasch analyses was used to assess the unidimensionality and item-functioning of the LTQL domains. Results: Cronbach's alpha were above 0.7 in all domains. Test-retest coefficients were between 0.72 to 0.96 for LTQL domains. LTQL total score was correlated with others total scores of other measures: QLACS (r=-0.39), HADS depression (r=-0.57), HADS anxiety (-0.45) and EORTC-QLQ-BR23 (r=-0.50). CFA provided satisfactory fit indices, with RMSEA value of 0.077 and TLI and CFI values of 0.901 and 0.909, respectively. All factor loadings were higher than 0.40 and statistically significant (P<0.001). Rasch analysis showed that Somatic Concerns domain had 4 misfitting items, and Philosophical/Spiritual View of Life and social Support domains only 1 misfit item. However, unidimensionality was supported for the four domains. Conclusion: The findings support the validity and reliability of the Spanish version of LTQL questionnaire to be used in long-term cancer female survivors.

Main Challenges of Incorporating Environmental Impacts in the Economic Evaluation of Health Technology Assessment: A Scoping Review.

Health technology assessment (HTA) provides evidence-based information on healthcare technology to support decision making in many countries. Environmental impact is a relevant dimension of a health technology's value, but it has been poorly addressed in HTA processes in spite of the commitment that the health sector must have to contribute to mitigating the effects of climate change. This study aims to identify the state of the art and challenges for quantifying environmental impacts that could be incorporated into the economic evaluation (EE) of HTA. We performed a scoping review that included 22 articles grouped into four types of contribution: (1) concepts to draw up a theoretical framework, (2) HTA reports, (3) parameter designs or suitable indicators, and (4) economic or budgetary impact assessments. This review shows that evaluation of the environmental impact of HTAs is still very incipient. Small steps are being taken in EE, such as carbon footprint estimations from a life-cycle approach of technologies and the entire care pathway.

Decision aids linked to the recommendations in clinical practice guidelines: results of the acceptability of a decision aid for patients with generalized anxiety disorder.

BACKGROUND: Generalized anxiety disorder (GAD) is one of the most prevalent mental health problems. Patients with GAD have unmet needs related to the information received about their disorder, its treatments and their participation in the decision-making process. The aim of this study is to develop and assess the acceptability of a patient decision aid (PtDA) for patients with GAD. METHOD: The PtDA was developed following the International Patient Decision Aid Standards. The recommendations of the Spanish clinical practice guideline (CPG) for patients with GAD were used as the basis. The first prototype was developed by an expert committee, further improvements were made with patients (n = 2), clinical experts (n = 13) and the project management group (n = 7). The acceptability of this second draft was assessed by patients non-involved in the previous phases (n = 11). RESULTS: The final PtDA version included a brief description of GAD and its treatments. Most participants agreed that the PtDA was easy to use, visually appealing and useful. At least half of the participants learned new things about treatments and adverse effects. CONCLUSIONS: A PtDA was developed for patients with GAD based on recommendations from the Spanish CPG. It was improved and accepted by patients and clinical experts involved. An evaluation of its effectiveness on the shared decision-making process during the clinical encounter is planned.

Effectiveness of a web-based decision aid for patients with generalised anxiety disorder: a protocol for a randomised controlled trial.

INTRODUCTION: Patients with generalised anxiety disorder (GAD) have concerns and needs about their health and the healthcare they receive. Patient decision aids (PtDAs) are tools that assist patients in making health decisions, when there is uncertainty about treatment choice, incorporating their personal preferences and values about the available treatment options. PtDAs can improve shared decision-making and lead to better treatment outcomes. The aim of this study is to evaluate the effectiveness of a web-based PtDA for patients with GAD in primary care (PC). METHODS AND ANALYSIS: The general study design is comprised of two stages: (1) development of a web-based PtDA for patients with GAD, derived from an evidence-based Clinical Practice Guideline and (2) assessment of the effectiveness of the PtDA in a randomised controlled trial (RCT) design, in PC centres in Tenerife (Spain). This RCT will be carried out with 124 patients with GAD, comparing the PtDA to a fact sheet with general information on mental health. Patients will review the PtDA in one session accompanied by a researcher. Post-intervention measures will be administered immediately after the intervention and at 3-month follow-up. The primary outcome will be decisional conflict. Secondary outcomes will include knowledge about GAD and its treatment, treatment preference, concordance between treatment preference and choice, and decision quality (knowledge ≥60% and concordant decision). ETHICS AND DISSEMINATION: The project received ethics approval from the local committee at Nuestra Señora de la Candelaria (HUNSC) University Hospital in Santa Cruz de Tenerife (code: CHUNSC_2019_58). Informed consent will be obtained from each participant before randomisation. Results from the trial will be submitted for publication in international peer-reviewed scientific journals and will be disseminated through workshops and local and international conferences. TRIAL REGISTRATION NUMBER: NCT04364958.

Standardized languages and notations for graphical modelling of patient care processes: a systematic review.

PURPOSE: The importance of working toward quality improvement in healthcare implies an increasing interest in analysing, understanding and optimizing process logic and sequences of activities embedded in healthcare processes. Their graphical representation promotes faster learning, higher retention and better compliance. The study identifies standardized graphical languages and notations applied to patient care processes and investigates their usefulness in the healthcare setting. DATA SOURCES: Peer-reviewed literature up to 19 May 2016. Information complemented by a questionnaire sent to the authors of selected studies. STUDY SELECTION: Systematic review conducted in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses statement. DATA EXTRACTION: Five authors extracted results of selected studies. RESULTS OF DATA SYNTHESIS: Ten articles met the inclusion criteria. One notation and language for healthcare process modelling were identified with an application to patient care processes: Business Process Model and Notation and Unified Modeling Language™. One of the authors of every selected study completed the questionnaire. Users' comprehensibility and facilitation of inter-professional analysis of processes have been recognized, in the filled in questionnaires, as major strengths for process modelling in healthcare. CONCLUSION: Both the notation and the language could increase the clarity of presentation thanks to their visual properties, the capacity of easily managing macro and micro scenarios, the possibility of clearly and precisely representing the process logic. Both could increase guidelines/pathways applicability by representing complex scenarios through charts and algorithms hence contributing to reduce unjustified practice variations which negatively impact on quality of care and patient safety.

Evaluación económica busca umbral para apoyar la toma de decisiones / Economic evaluation seeks threshold to support decisión-making

Para que la evaluación económica pueda ser incorporada en la toma de decisiones se debe conocer cuánto está dispuesto y es capaz de invertir por un Año de Vida Ajustado por Calidad (AVAC) el Sistema Nacional de Salud. En España se ha extendido el uso de 30.000€ por AVAC como umbral coste-efectividad (CE) pero, como en la mayoría de los sistemas sanitarios, no se ha adoptado un valor formalmente. Esto se debe en parte a la arbitrariedad, la falta de base teórica y científica para su fijación y la controversia que persiste sobre su estimación y lo que dicho umbral CE debe representar. A partir de una revisión sistemática de trabajos empíricos sobre la estimación del umbral CE realizada por este equipo investigador, se llevó a cabo una valoración crítica del estado del arte utilizando un grupo Delphi con la participación de 13 expertos nacionales. Este artículo contribuye a reflexionar cuánto se ha avanzado en investigación sobre el umbral CE en España, a considerar su utilidad para completar el proceso de toma de decisiones bajo evaluación económica, y a plantear líneas de investigación para mejorar lo logrado hasta la fecha (AU)

To incorporate economic evaluation into decision-making, we need to know how much a health system is willing and able to invest in a quality-adjusted life year (QALY). In Spain, the figure of €30,000 per QALY as cost-effectiveness (CE) threshold has been widely cited. However, as in most health systems, no value has been formally adopted; mainly because of the arbitrariness, the lack of theoretical and scientific basis, and the controversy around its estimation and what the threshold should represent. Based on a systematic review of empirical studies on the estimation of the CE threshold undertaken by this research team, we conducted a critical appraisal of the state of the art, using a Delphi with the participation of 13 national experts. This paper contributes to assess the research progress on the CE threshold in Spain, to consider its utility in the decision making process supported by economic evaluation, and to propose further research to improve what has been achieved so far (AU)

Cross-cultural adaptation, reliability and validity of the Spanish version of the Quality of Life in Adult Cancer Survivors (QLACS) questionnaire: application in a sample of short-term survivors.

BACKGROUND: The aim of this study was to validate the Quality of Life in Adult Cancer Survivors (QLACS) in short-term Spanish cancer survivor's patients. METHODS: Patients with breast, colorectal or prostate cancer that had finished their initial cancer treatment 3 years before the beginning of this study completed QLACS, WHOQOL, Short Form-36, Hospital Anxiety and Depression Scale, EORTC-QLQ-BR23 and EQ-5D. Cultural adaptation was made based on established guidelines. Reliability was evaluated using internal consistency and test-retest. Convergent validity was studied by mean of Pearson's correlation coefficient. Structural validity was determined by a second-order confirmatory factor analysis (CFA) and Rasch analysis was used to assess the unidimensionality of the Generic and Cancer-specific scales. RESULTS: Cronbach's alpha were above 0.7 in all domains and summary scales. Test-retest coefficients were 0.88 for Generic and 0.82 for Cancer-specific summary scales. QLACS generic summary scale was correlated with other generic criterion measures, SF-36 MCS (r = - 0.74) and EQ-VAS (r = - 0.63). QLACS cancer-specific scale had lower values with the same constructs. CFA provided satisfactory fit indices in all cases. The RMSEA value was 0.061 and CFI and TLI values were 0.929 and 0.925, respectively. All factor loadings were higher than 0.40 and statistically significant (P < 0.001). Generic summary scale had eight misfitting items. In the remaining 20 items, the unidimensionality was supported. Cancer Specific summary scale showed four misfitting items, the remaining showed unidimensionality. CONCLUSIONS: The findings support the validity and reliability of QLACS questionnaire to be used in short-term cancer survivors.

Patient participation in a Clinical Guideline Development for Systemic Lupus Erythematosus.

OBJECTIVE: To incorporate patients' perspective in the design of a clinical practice guideline (CPG) for Systemic Lupus Erythematosus in Spain. METHODS: A systematic review (SR) of literature and a Delphi-based consultation to patients were carried out. RESULTS: From the SR, most relevant health problems are classified as physical, psychological, familial, and socio-economic. Dissatisfaction is mainly due to unmet information needs and limited access to care. In the consultation (n=102), most frequently reported health problems were pain, fatigue, photosensitivity, mood disorders, renal damage, poor concentration, and memory loss. Dissatisfaction with poor coordination between primary and specialized care was reported. Information to improve self-management and on alternative therapies was requested. Relevant topics from both sources were merged and discussed by the guideline development group (including a patient representative) to set the key questions underpinning the CPG. CONCLUSION: Patient involvement in CPG development by a combination of methods can enhance patient-centered care by achieving clinical practice responsive to their needs. PRACTICE IMPLICATIONS: Involving patients in CPG development is feasible and useful to improve the advance of Health Services toward patient-centered care. A multicomponent strategy for involvement is suggested to address the gap between the available evidence and contextual current patient needs and preferences.

Exposición a plaguicidas persistentes y no persistentes en población no expuesta laboralmente de la isla de Tenerife / Exposure to persistent and non-persistent pesticides in a non-occupationally exposed population in Tenerife Island (Spain)

Objetivo: La exposición crónica a plaguicidas no persistentes se ha relacionado con diversas patologías crónicas; sin embargo, pocos estudios han evaluado la exposición a plaguicidas no persistentes en población española. Métodos: En 2007 se determinó la presencia de 24 plaguicidas mediante cromatografía de gases/espectometría de masas en 363 muestras de suero de adultos no laboralmente expuestos de Tenerife. Resultados: El 99,45% presentaron residuos (6 ± 2 plaguicidas/muestra). Los plaguicidas más frecuentes fueron piretroides (96,1%), organofosforados (93,9%) y organoclorados (92,3%). En el 81% de los sujetos se detectaron bifentrina y malatión, considerados neurotóxicos, y en el 50% hexaclorobenceno, DDT y buprofezina. El malatión, un "obesógeno ambiental", se detectó en el 82%, y plaguicidas considerados "disruptores endocrinos" en el 97,2% de las muestras. Conclusiones: Existe una exposición inadvertida a plaguicidas no persistentes que puede afectar a la salud de nuestra población, por lo que se hace necesario incluirlos en los estudios de monitorización (AU)

Objective: Chronic exposure to non-persistent pesticides (NPPs) is of concern because these substances have been associated with chronic diseases. However, few studies have addressed chronic exposure to NPPs in Spanish populations. Methods: We determined the presence of 24 pesticide residues by gas chromatography/mass spectrometry in 363 serum samples obtained from non-occupationally exposed adults from Tenerife island in 2007. Results: Most of the samples (99.45%) showed detectable residues (6 ± 2 pesticides per sample). The most frequently detected pesticides were pyrethrins (96.1%), organophosphates (93.9%) and organochlorines (92.3%). The neurotoxicants bifenthrin and malathion were detected in 81% of the samples and hexachlorobenzene DDT and buprofezin in more than 50%. Malation, an "environmental obesogen", was detected in 82%, and "endocrine disrupter" pesticides were present in 97.2% of the samples. Conclusions: Because there is clear, continuous and inadvertent exposure to NPPs that may be inducing adverse effects on human health, NPPs should be included in biomonitoring studies (AU)

[Exposure to persistent and non-persistent pesticides in a non-occupationally exposed population in Tenerife Island (Spain)]. / Exposición a plaguicidas persistentes y no persistentes en población no expuesta laboralmente de la isla de Tenerife.

OBJECTIVE: Chronic exposure to non-persistent pesticides (NPPs) is of concern because these substances have been associated with chronic diseases. However, few studies have addressed chronic exposure to NPPs in Spanish populations. METHODS: We determined the presence of 24 pesticide residues by gas chromatography/mass spectrometry in 363 serum samples obtained from non-occupationally exposed adults from Tenerife island in 2007. RESULTS: Most of the samples (99.45%) showed detectable residues (6 ± 2 pesticides per sample). The most frequently detected pesticides were pyrethrins (96.1%), organophosphates (93.9%) and organochlorines (92.3%). The neurotoxicants bifenthrin and malathion were detected in 81% of the samples and hexachlorobenzene DDT and buprofezin in more than 50%. Malation, an "environmental obesogen", was detected in 82%, and "endocrine disrupter" pesticides were present in 97.2% of the samples. CONCLUSIONS: Because there is clear, continuous and inadvertent exposure to NPPs that may be inducing adverse effects on human health, NPPs should be included in biomonitoring studies.

The relationship among mental health status (GHQ-12), health related quality of life (EQ-5D) and health-state utilities in a general population.

AIM: To assess the relationship between mental health and health-related quality of life (HRQL) in the general population, and to map GHQ-12 as a screening test for population psychological distress to a generic health state measure (EQ-5D) in order to estimate health state values and allow deriving quality-adjusted life years. METHODS: Relationship between mental health and HRQL was examined from the 2004 Canary Islands' Health Survey. Participants were classified as probable psychiatric cases according to GHQ-12. HRQL was measured by the EQ-5D index. Multivariate lineal regression analysis was used to examine the association between mental health and HRQL adjusting by socio-demographic variables and comorbidities. A multivariate regression model was built from EQ-5D to estimate health states values using GHQ-12 as exposure. RESULTS: EQ-5D index scores decreased as the GHQ-12 scores increased. Clinical and socio-demographic factors influenced HRQL without changing the overall trend for this negative relationship. The regression equation explained 43% of the variance. For estimation of utility scores, the model showed a high predictive capacity, with a mean forecast errors of 16%. CONCLUSIONS: HRQL progressively decreased when the probability of being a psychiatric case increased. Findings enable health state values to be derived from GHQ-12 scores for populations where utilities has not or cannot be measured directly.