Health-related quality of life in patients with psoriasis: a systematic review of the European literature.

PURPOSE: To summarize the data published over the last 5 years in the European Union related to the health-related quality of life (HRQoL) of patients with psoriasis and its conditioning factors. METHODS: International electronic databases and gray literature were searched to identify studies conducted on patient-reported outcomes in patients with psoriasis, published in Europe between January 1, 2009 and December 31, 2013. Bibliographic references were hand-searched. Editorials, letters, commentaries, opinion papers, and studies related to specific treatments were excluded. RESULTS: A total of 46 studies met the inclusion criteria, 27 of them reporting data related to HRQoL or its conditioning factors. The publications reviewed highlighted the substantial negative impact of psoriasis on patients' HRQoL. Most of the studies that analyzed the relationship between HRQoL and sociodemographic characteristics described a relation between gender (female) and age (young patients) and poorer HRQoL. An association between HRQoL impairment and visibility of skin lesions and disease activity and severity was also established. Skin discomfort and pruritus were identified as elements that negatively influenced HRQoL. Use of biological agents had a positive impact on HRQoL and on treatment satisfaction, a better HRQoL being seen in patients treated with systemic therapies and biologics. CONCLUSIONS: HRQoL has been broadly addressed in patients with psoriasis in Europe. Several disease- and patient-related factors contributed to its deterioration. Therapeutic measures with proven effectiveness in controlling disease symptoms and reducing PASI should be considered in patients with a severe disease who have a poorer HRQoL.

Defining a standard set of health outcomes for patients with relapsing-remitting multiple sclerosis.

BACKGROUND: Standardizing health outcomes is challenging in clinical management, but it also holds the potential for creating a healthcare system that is both more effective and efficient. The aim of the present study is to define a standardized set of health outcomes for managing Relapsing-Remitting Multiple Sclerosis (RRMS). METHODS: The project was led and coordinated by a multidisciplinary scientific committee (SC), which included a literature review, a patient-focused group, three nominal group meetings, and two SC meetings. RESULTS: 36 outcome variables were included in the standard set: 24 clinical (including weight, smoking habit, comorbidities, disability, mobility, diagnosis of secondary progressive multiple sclerosis, relapsed-related variables, radiological variables, cognitive status and disease-related symptoms), nine treatment-related (pharmacological and non-pharmacological information), and 3 related to the impact of RRMS on the patient's life (quality of life, pregnancy desire, work-related difficulties). In addition, experts also agreed to collect 10 case-mix variables that may affect but cannot be controlled as part of the management of the condition: 4 sociodemographic (age, sex, race, and employment status) and 6 clinical (height, date of diagnosis and first episode, serological status, early symptoms, and number of relapses pre-diagnosis). CONCLUSION: The information provided through the present standard set of outcome variables can improve the management of RRMS and promote patient-centred quality care.

Nutritional management of cancer patients in clinical practice in Spain: patients' and multidisciplinary health care professionals' perceptions.

BACKGROUND/OBJECTIVES: Malnutrition is a prevalent problem in patients with cancer and is associated with poor prognosis. The European Society for Clinical Nutrition and Metabolism (ESPEN) recommends the provision of nutritional support and evaluation. This study aims to describe the nutritional management of patients with cancer, including assessment of adherence, from the perspective of both patients and healthcare professionals (HCPs). SUBJECTS/METHODS: A cross-sectional descriptive observational study was carried out through two surveys addressed to patients and HCPs. RESULTS: A total of 230 cancer patients and 461 HCPs completed the questionnaire. The survey found 55.0% of patients experienced eating problems during treatment and 64.0% reported sequelae affecting nourishment. However, 60.1% of patients and 42.6% of HCPs indicated that nutritional status is not generally assessed. While 86.6% of HCPs stated that nutritional information is provided to patients, only 33.5% of patients reported having received it. Regarding nutritional adherence, 87.4% of HCPs stated that it is assessed whereas only 49.2% of patients receiving nutritional supplements confirmed this. General discomfort or gastrointestinal problems were the main issues hampering correct adherence perceived by both patients (41.8%) and HCPs (95.4%). CONCLUSIONS: Our study demonstrate that different perceptions exist between patients and HCPs about nutritional management in cancer and suggests that in Spain nutritional approach is suboptimal in terms of screening/assessment of malnutrition, nutritional information provided to the patient, nutritional intervention and assessment of adherence to nutritional support. Therefore, measure should be taken to foster the adoption of ESPEN recommendations in clinical practice and to promote nutritional education of HCPs.

The Perspective of Patients and Health Professionals on the Prioritization of Assisted Reproductive Techniques. The PRIOFER Study.

Purpose: To determine the perspective of patients and professionals in Assisted Reproduction Units (ARU) on the importance of assisted reproductive techniques (ART) compared to other elective procedures, to highlight the relevance of ART as an elective procedure and the impact of delayed interventions on patients. Design Patients and Methods: An observational, descriptive, cross-sectional, online survey-based study was conducted in infertility patients and partners (n=98) and ARU healthcare professionals (n=83). The survey included a best-worst scaling (BWS) experiment and an ad-hoc questionnaire to analyze the pandemic impact on ART management and infertility patients in Spain. In the BWS, each respondent established priorities choosing which patient profile should be rated as the highest and lowest priority profile on a waiting list. To understand the importance that they give to assisted reproduction compared to other procedures, three very common elective procedures involving different patient profiles were selected: cataract surgery, knee arthroplasty, and varicose vein surgery. For each procedure, three hypothetical patient profiles corresponding to three different degrees of severity on a waiting list were designed. Results: Patients attributed greater importance to ART profiles (BWS score: patients 0.14 vs professionals -0.05; p<0.01) whereas professionals prioritized cataract surgery (patients 0.06 vs professionals 0.23; p<0.01). Concerning the profile severity, more severe profiles were prioritized in all procedures by both groups. Patients' and professionals' perspectives on the impact of the pandemic were similar, with exceptions: information received for resuming ART; health care provision in crisis situations; and reduction of parenting options. The pandemic affected patients' ability to conceive a child (70.4% of those surveyed), their psychological well-being (75.5%), and partner, social, and work relationships (69.4%). Conclusion: Preference studies involving patients and professionals can provide important information to define framework criteria for the management of waiting lists for elective procedures, and to prioritize interventions during pandemic periods. The pandemic impact on infertility patients highlights the relevance of developing measures and strategies to cope with similar future situations in the most appropriate way.

Cancer-Related Pain Management in Suitable Intrathecal Therapy Candidates: A Spanish Multidisciplinary Expert Consensus.

A consensus is needed among healthcare professionals involved in easing oncological pain in patients who are suitable candidates for intrathecal therapy. A Delphi consultation was conducted, guided by a multidisciplinary scientific committee. The 18-item study questionnaire was designed based on a literature review together with a discussion group. The first-round questionnaire assessed experts' opinion of the current general practice, as well as their recommendation and treatment feasibility in the near future (2-3-year period) using a 9-point Likert scale. Items for which consensus was not achieved were included in a second round. Consensus was defined as ≥75% agreement (1-3 or 7-9). A total of 67 panelists (response rate: 63.2%) and 62 (92.5%) answered the first and second Delphi rounds, respectively. The participants were healthcare professionals from multiple medical disciplines who had an average of 17.6 (7.8) years of professional experience. A consensus was achieved on the recommendations (100%). The actions considered feasible to implement in the short term included effective multidisciplinary coordination, improvement in communication among the parties, and an assessment of patient satisfaction. Efforts should focus on overcoming the barriers identified, eventually leading to the provision of more comprehensive care and consideration of the patient's perspective.

Societal Preferences for Meningococcal B Vaccination in Children: A Discrete Choice Experiment in Spain.

INTRODUCTION: Immunization is the most effective strategy for the prevention of invasive meningococcal disease caused by Neisseria meningitidis serogroup B (MenB); however, parents need to weigh the risk-benefit and financial impact of immunizing their children against MenB in the absence of a national immunization program (NIP). This study aimed to explore societal preferences (of parents and pediatricians) regarding the attributes of a MenB vaccine in Spain. METHODS: A discrete choice experiment (DCE) based on cross-sectional surveys was carried out to determine preferences. A literature review and scientific committee determined the six attributes related to the MenB vaccine included in the DCE: vaccination age, cost, duration, percentage of protection, adverse events probability, and expert/authority recommendation. Data were analyzed using a mixed logit model. Relative importance (RI) of attributes was calculated and compared between parents and pediatricians. RESULTS: A total of 278 parents [55.8% female, mean age 40.4 (standard deviation, SD 7.3) years] and 200 pediatricians [73.0% female, mean age 45.8 (SD 12.9) years] answered the DCE. For parents, the highest RI was attributed to vaccine cost, expert/authority recommendation, and percentage of protection (26.4%, 26.1%, and 22.9%, respectively), while for pediatricians the highest RI was assigned to percentage of protection, expert/authority recommendation, and vaccination age (27.2%, 23.7%, and 22.6%, respectively). Significant differences between parents and pediatricians were found in the RI assigned to all attributes (p < 0.001), except for vaccine recommendation. CONCLUSION: In the decision regarding MenB vaccination, cost was a driver in parental decision-making but had a low RI for pediatricians and, conversely, vaccination age was highly valued by pediatricians but was the attribute with least importance for parents. Despite these differences, expert/authority recommendation and percentage of protection were essential criteria for both groups. These results provide relevant information about MenB vaccination, highlighting the importance of considering societal preferences for NIP inclusion.

Pruritus and Pain Constitute the Main Negative Impact of Atopic Dermatitis From the Patient's Perspective: A Systematic Review.

Atopic dermatitis (AD) is an inflammatory skin disease characterized by intense itching and highly visible signs, representing a great burden to the patient. Despite its straightforward diagnosis, AD severity and burden can be underestimated in routine clinical practice. This review aims to determine the impact of AD on patients' lives, establish which domains of life are most affected, and identify symptom drivers of AD burden. A systematic literature review was conducted in Pubmed/Medline, Web of Science, and Scopus following Cochrane and PRISMA recommendations. Observational studies published in English or Spanish between January 1, 2018, and August 31, 2022, evaluating the impact of AD and its symptoms from the patient's perspective, were included. Reviewed studies were assessed for quality following the STrengthening the Reporting of OBservational studies in Epidemiology Checklist. A total of 28 observational studies evaluating the impact of AD and its symptoms from the patient's perspective were included in the review. All domains of the AD patient's life were found to be greatly affected, including health-related quality of life (HRQoL), emotional health, sleep disorders, work impairment, health care resource utilization, cognitive function, and development of comorbidities. The more severe the disease, the greater the impact, worsening in patients with moderate and severe AD. Pruritus and pain are reported to be the disease symptoms with the greatest impact. In conclusion, AD impacts several domains of patients' lives, especially HRQoL and mental health. Pruritus and pain are identified as the main drivers of AD impact, suggesting that optimal symptom control may reduce the burden and improve disease management.

The Impact of Patient Support Programs in Europe: A Systematic Literature Review.

BACKGROUND AND OBJECTIVE: Patient support programs aim to provide solutions beyond the medication itself, by enhancing treatment adherence, improving clinical outcomes, elevating patient experience, and/or increasing quality of life. As patient support programs increasingly play an important role in assisting patients, numerous observational studies and pragmatic trials designed to evaluate their impact on healthcare have been conducted in recent years. This review aims to characterize these studies. METHODS: A systematic literature review, supplemented by a broad search of gray literature, was conducted following PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) and Cochrane recommendations. Observational studies and pragmatic trials conducted in Europe to evaluate the impact of patient support programs, published in English or Spanish between 17/03/2010 and 17/03/2020, were reviewed. Two patient support program definitions were applied starting with Ganguli et al.'s broad approach, followed by the European Medicines Agency definition, narrowed to Marketing Authorization Holders organized systems and their medicines. The quality of publications was assessed using the STROBE (Strengthening the Reporting of Observational Studies in Epidemiology) statement 22-item checklist. RESULTS: Of the 49 identified studies following the Ganguli et al. definition, 20 studies met the European Medicines Agency definition and were reviewed. Patient support program impact was evaluated based on a wide range of methodologies: 70% assessed patient support program-related patient-reported outcomes, 55% reported clinical outcomes, and 25% reported economic impacts on health resources. Only 45% conducted a comparative analysis. Overall, 75% of the studies achieved their proposed objectives. CONCLUSIONS: The heterogeneity of the observational studies reviewed reflects the complexity of patient support programs that are built ad hoc for specific diseases, treatments, and patients. Results suggest that patient support programs play a key role in promoting treatment effectiveness, clinical outcomes, and satisfaction. However, there is a need for standardizing the definition of patient support programs and the methods to evaluate their impact.

Defining a Standard Set of Patient-Reported Outcomes for Patients With Advanced Ovarian Cancer.

Purpose: Advanced ovarian cancer (AOC) and its treatment cause several symptoms and impact on patients' health-related quality of life (HRQoL). We aim to reach a consensus on the most relevant patient-reported outcome (PROs), the corresponding measures (PROMs), and measurement frequency during AOC patients' follow-up from patients' and healthcare professionals' (HCP) perspective. Methods: The project comprised five steps: 1) a literature review, 2) a focus group with patients, 3) a nominal group with HCP, 4) two round-Delphi consultations with patients and HCP, and 5) a final meeting with HCP. Delphi questionnaire was elaborated based on literature review, focus group (n=5 patients), and nominal group (n=16 HCP). The relevance of each PRO and the appropriateness (A) and feasibility (F) of the proposed PROM were assessed (Likert scale 1=strongly agree; 9=strongly disagree). The consensus was reached when at least 75% of the panelists rated it as 'relevant', 'appropriate', or 'feasible' (score 7-9). Results: A total of 56 HCP [51.8% Hospital Pharmacy; 41.1% Oncology; 3.6% Nursing; and 3.6% Psycho-oncology; mean time in specialty 12.5 (8.0) years] and 10 AOC patients [mean time diagnosis 5.4 (3.0) years] participated in the 1st round. All PROs achieved consensus regarding their relevance, except dry skin (58.0%). Agreement was reached for PRO-CTCAE to be used to assess fatigue (A:84.9%; F:75.8%), neuropathy (A:92.4%; F:77.3%), diarrhea (A:87.9%; F:88.7%), constipation (A:86.4%; F:75.8%), nausea (A:89.4%; F:75.8%), insomnia (A:81.8%; F:88.7%), abdominal bloating (A:82.2%; F:82.2%) and sexuality (A:78.8%; F:88.6%); EQ-5D to determine patients' HRQoL (A:87.9%; F:80.3%), pain (A:87.9%; F:75.8%) and mood (A:77.7%; F:85.5%); to assess treatment adherence the Morisky-Green (A:90.9%; F:84.9%) and the dispensing register (A:80.3%; F:80.3%) were chosen. It was agreed to note in the medical record whether the patient's treatment preferences had been considered during decision-making (A:78.8%; F:78.8%) and to use a 5-point Likert scale to assess treatment satisfaction (A:86.4%; F:86.4%). Panelists agreed (A:92.4%; F: 77.3%) to collect these PROs (1) at the time of diagnosis/relapse; (2) one month after starting treatment/change therapeutic strategy; (3) every three months during the 1st-year of treatment; and later (4) every six months until treatment completion/change. Conclusions: The consensus reached represents the first step towards including the patient's perspective in AOC follow-up. The standardized collection of PROs in clinical practice may contribute to optimizing the follow-up of these patients and thus improving the quality of care.

Additional Value of Patient-Reported Symptom Monitoring in Cancer Care: A Systematic Review of the Literature.

BACKGROUND: To describe the benefit of patient-reported symptom monitoring on clinical, other patient-reported, and economic outcomes. METHODS: We conducted a systematic literature review using Medline/PubMed, limited to original articles published between 2011 and 2021 in English and Spanish, and focused on the benefit of patient-reported symptom monitoring on cancer patients. RESULTS: We identified 16 reports that deal with the benefit of patient-reported symptom monitoring (collected mostly electronically) on different outcomes. Five studies showed that patient-reported symptom surveillance led to significantly improved survival compared with usual care-mainly through better symptom control, early detection of tumor recurrence, and extended chemotherapy use. Additionally, three evaluations demonstrated an improvement in Health-Related Quality of Life (HRQoL) associated with this monitoring strategy, specifically by reducing symptom severity. Additionally, six studies observed that this monitoring approach prevented unplanned emergency room visits and hospital readmissions, leading to a substantial decrease in healthcare usage. CONCLUSIONS: There is consistent evidence across the studies that patient-reported symptom monitoring might entail a substantial survival benefit for cancer patients, better HRQoL, and a considerable decrease in healthcare usage. Nonetheless, more studies should be conducted to demonstrate their effectiveness in addition to their cost-effectiveness in clinical practice.

Preferences, satisfaction and decision-making processes in osteoporosis treatment: a systematic review of the literature.

Aim: To synthesize information available in the literature on patients' preferences and satisfaction with osteoporosis treatment and their unmet needs on the treatment decision-making process. Materials & methods: Systematic literature review consulting international database and grey literature of articles published between January 1, 2009 and January 1, 2019. Results: Nineteen publications were reviewed, 79% of them focused on evaluating the importance that patients attached to the mode and frequency of administration, adverse events and treatment efficacy. 21% of them provided information about treatment satisfaction and 26% regarding unmet needs on treatment-decision making process. Conclusion: Aligning treatment with patients' preferences, promoting physician-patient communication and identifying patients' concerns with treatment may contribute to improve treatment satisfaction and adherence and ultimately achieve the treatment goal.

Patient and retina specialists' preferences in neovascular age-related macular degeneration treatment. A discrete choice experiment.

INTRODUCTION AND OBJECTIVE: Neovascular age-related macular degeneration (nAMD) leads to severe and permanent visual impairment, significantly impacting patients' quality of life and functional independence. Although treatment with anti- vascular endothelial growth factor (VEGF) prevents and, in some cases, reverses visual damage, the need for frequent monitoring visits and intravitreal injections represents a significant burden on patients, caregivers and retina specialists. OBJECTIVE: To elicit preferences for nAMD treatment characteristics from the perspectives of patients and retina specialists. METHOD: A discrete choice experiment was conducted. Participants (patients > 50 years with nAMD receiving anti-VEGF drugs for at least 2 years and without previous experience with anti-VEGF and retina specialists working in the Spanish National Healthcare System) were asked to select one of two hypothetical treatments resulting from the combination of five attributes (effects on visual function, effects on retinal fluid, treatment regimen, monitoring frequency, and cost); their levels were identified by reviewing the literature and two focus groups. The relative importance (RI) given to each attribute was estimated using a mixed logit model. The marginal rates of substitution (MRS) were calculated taking cost as the risk attribute. RESULTS: A total of 110 patients (P) [aged 79.0 (SD:7.4) years; 57.3% women; 2.3 (SD:0.7) years with nAMD; 2.1 years (SD:0.1) in treatment] and 66 retina specialists (RS) participated in the study. Participants gave greater RI to improvements in their visual function [60.0% (P); 52.7% (RS)], lower monitoring frequency [20.2% (P); 27.1% (RS)] and reduction in retinal fluid [9.8% (P); 13.0%(RS)]. Patients and retina specialists would agree to an increase in cost by 65.0% and 56.5%, respectively, in exchange for improvements of visual function; and 25.5% and 43.3% on delaying monitoring frequency by one month. CONCLUSIONS: Efficacy of treatment, in terms of visual function improvements, is the main driver for treatment election for both patients and retina specialists. Treatment monitoring requirements are also considered, mainly from the retina specialist's perspective. These results suggest that the use of more efficacious anti-VEGF agents with a longer duration of action may contribute to aligning treatment characteristics with patients/specialists' preferences. A better alignment would facilitate better disease management, fulfilling the unmet needs of patients and retina specialists.

Defining a Standard Set of Health Outcomes for Patients With Squamous Cell Carcinoma of the Head and Neck in Spain.

PURPOSE: A systematic, standardized collection of health outcomes during patient treatment and follow-up, relevant from the perspective of all stakeholders, is a crucial step toward effective and efficient disease management. This project aimed to define a standard set of health outcomes for patients with squamous cell carcinoma of the head and neck (SCCHN). METHODS: The project was led and coordinated by a scientific committee (SC). It comprised: (1) a literature review (to identify variables used during SCCHN management); (2) 1st-SC meeting (to select the variables for presentation during nominal groups-NG); (3) five NG (n=42 experts) and four interviews with patients (to reach consensus on the variables for inclusion); and (4) final-SC meeting (to review the results of NG ensuring consensus on the variables where consensus was not reached). RESULTS: Experts agreed to include the following variables in the standard set: treatment-related (treatment intent and type, response to treatment, treatment toxicity/complication, treatment completion), degree of health (performance status, patient-reported health status, pain, dysphonia, feeding and speech limitations, body image alteration, tracheotomy), survival (overall and progression-free survival, cause of death), nutritional (weight, nutritional intervention), other variables (smoking status, alcohol consumption, patient satisfaction with aftermath care, employment status), and case-mix variables (demographic, tumor-related, clinical and nutritional factors). CONCLUSIONS: This project may pave the way to standardizing the collection of health outcomes in SCCHN and promote the incorporation of patients' perspective in its management. The information provided through the systematic compilation of this standard set may define strategies to achieve high-quality, patient-centered care.

Cost, microbiological, and nutritional properties of pureed food production in nursing homes. The ABADIA Study.

INTRODUCTION: Introduction: although nutritional differences between different types of texture-modified diet (TMD) have been evaluated, the resources and costs associated with their preparation have been less studied. Objective: to describe the nutritional, microbiological properties and costs of: 1) in-home produced pureed food (hTMD); 2) concentrated nutrient-dense commercial food products, hand-blended (cTMD); 3) food prepared using the MixxPro® automatic food mixer (cTMD-Mix). Methods: an observational, prospective study carried out in three geriatric nursing-homes. Patients ≥ 65 years, receiving TMD, with a stable clinical condition, estimated survival/expected internment > 1 month, and sufficient cognitive capacity were included. The following data were recorded: 1) patient socio-demographic and clinical variables; 2) TMD compliance and symptoms related to dysphagia during the meal; 3) patient appetite; and 4) kitchen information and resources used to prepare a TMD. Results: sixty-two residents were included (65.0 % women, 88.3 years (SD: 9.3); 43.5 % malnourished, 79.0 % with good appetite). The proportion of food eaten/median kcal served/portion/mean kcal consumed were: hTMD: 95.5 % (SD: 10.7)/92.4 kcal (IQR: 75.6-128.1)/88.2 kcal (IQR: 72.2-122.3); cTMD: 89.2 % (SD: 15.9)/323.4 kcal (IQR: 284.2-454.1)/288.5 kcal (IQR: 253.5-325.1); and cTMD-Mix: 80.3 % (SD: 21.4)/358.0 kcal (IQR: 344.0-372.1)/287.5 kcal (IQR: 276.5-298.8). No microorganisms were detected. The average time spent in preparing each portion and its costs were: hTMD: 11.2 min (SD: 3.89)/€2.33 (SD: 0.63); cTMD: 1.7 min (SD: 0.28)/€2.01 (SD: 0.39); and cTMD-Mix: 1.6 min (SD: 0.00)/€2.00 (SD: 0.33). Conclusions: in patients with dysphagia and/or chewing difficulties, concentrated nutrient-dense food products, particularly those produced using the MixxPro® automatic food mixer, ensure a high caloric intake and allow quick and safe food preparation.

INTRODUCCIÓN: Introducción: aunque existe evidencia acerca de las diferencias nutricionales entre los distintos tipos de dieta de textura modificada (DTM), los recursos y los costos asociados a su preparación se han estudiado menos. Objetivo: describir las propiedades nutricionales, las microbiológicas y los costes de: 1) una dieta triturada de manera artesanal (hDTM); 2) una dieta preparada con alimentación básica adaptada (ABA) (cDTM); y 3) una ABA preparada con el mezclador automático de alimentos MixxPro® (cDTM-Mix). Métodos: estudio observacional prospectivo realizado en tres residencias. Se incluyeron pacientes ≥ de 65 años que recibían DTM, con estado clínico estable, con supervivencia/internamiento estimado > 1 mes y capacidad cognitiva suficiente. Se registraron: 1) las variables sociodemográficas y clínicas del paciente; 2) el cumplimiento y los síntomas relacionados con la disfagia durante la comida; 3) el apetito del paciente, y 4) la información de la cocina y los recursos utilizados para preparar la DTM. Resultados: se incluyeron 62 residentes (65,0 % mujeres, 88,3 años (SD: 9,3), 43,5 % desnutridos, 79,0 % con buen apetito). La proporción de alimentos consumidos/mediana de kcal servidas/porción/media de kcal media consumidas fueron: hDTM 95,5 % (SD: 10,7)/92,4 kcal (IQR: 75,6-128,1)/88,2 kcal (IQR: 72,2-122,3); cDTM: 89.2 % (SD: 15.9)/323,4 kcal (IQR: 284.2-454.1)/288,5 kcal (IQR: 253.5-325.1), y cDTM-Mix: 80,3 % (SD: 21.4)/358,0 kcal (IQR: 344.0-372.1)/287,5 kcal (IQR: 276.5-298.8). No se detectaron microorganismos. El tiempo medio empleado en la preparación y el coste por porción fueron: hDTM: 11,2 min (SD: 3,89)/2,33 € (SD: 0,63); cDTM: 1,7 min (SD: 0,28)/2,01 € (SD: 0,39), y cDTM-Mix: 1,6 min (SD: 0,00)/2,00 € (SD: 0,33). Conclusiones: en los pacientes con disfagia y/o dificultades para masticar, los productos de ABA comerciales, en particular los que se producen con el mezclador automático de alimentos MixxPro®, aseguran una elevada ingesta calórica y permiten una preparación rápida y segura.

Standardizing Health Outcomes for Lung Cancer. Adaptation of the International Consortium for Health Outcomes Measurement Set to the Spanish Setting.

Purpose: Lung cancer (LC) and its treatment impose a significant burden on patients' life. However, patient-centered outcomes are rarely collected during patient follow-up. Filling this gap, the International Consortium for Health Outcomes Measurement (ICHOM) developed a standard set of variables for newly diagnosed LC patients. In order to facilitate the use of this standard set, the project aims to adapt it to the Spanish setting. Methods: The variables (instrument and periodicity) to be included in Spanish standard set were selected through consensus during 4 nominal groups (13 oncologists, 14 hospital pharmacists, 4 hospital managers and 3 LC patients), under the supervision of a Scientific Committee (1 oncologist, 3 hospital pharmacists, 2 LC patients advocates). Results: The variables agreed upon included: (1) case-mix: demographic [age, sex, education and social-family support], clinical [weight loss, smoking status, comorbidities (Charlson index), pulmonary function (FEV-1)], tumor [histology, clinical, and pathological stage (TNM), EGFR, ALK, ROS-1, PD-L1] and treatment factors [intent and completion] and (2) outcomes: degree of health [performance status (ECOG) and quality-of-life (EQ-5D, LCSS)], survival [overall survival and cause of death], quality of death [place of death, end-of-life care and palliative care, death aligned with living will], treatment complications, and others [date of diagnosis and treatment initiation, productivity loss (sick leave)]. Conclusion: The adaptation of ICHOM standard set to the Spanish setting pave the way to standardize the collection of variables in LC.

What Matters Most to Patients and Rheumatologists? A Discrete Choice Experiment in Rheumatoid Arthritis.

INTRODUCTION: To determine patient and rheumatologist preferences for rheumatoid arthritis (RA) treatment attributes in Spain and to evaluate their attitude towards shared decision-making (SDM). METHODS: Observational, descriptive, exploratory and cross-sectional study based on a discrete choice experiment (DCE). To identify the attributes and their levels, a literature review and two focus groups (patients [P] = 5; rheumatologists [R] = 4) were undertaken. Seven attributes with 2-4 levels were presented in eight scenarios. Attribute utility and relative importance (RI) were assessed using a conditional logit model. Patient preferences for SDM were assessed using an ad hoc questionnaire. RESULTS: Ninety rheumatologists [52.2% women; mean years of experience 18.1 (SD: 9.0); seeing an average of 24.4 RA patients/week (SD: 15.3)] and 137 RA patients [mean age: 47.5 years (SD: 10.7); 84.0% women; mean time since diagnosis of RA: 14.2 years (SD: 11.8) and time in treatment: 13.2 years (SD: 11.2), mean HAQ score 1.2 (SD: 0.7)] participated in the study. In terms of RI, rheumatologists and RA patients viewed: time with optimal QoL: R: 23.41%/P: 35.05%; substantial symptom improvement: R: 13.15%/P: 3.62%; time to onset of treatment action: R: 16.24%/P: 13.56%; severe adverse events: R: 10.89%/P: 11.20%; mild adverse events: R: 4.16%/P: 0.91%; mode of administration: R: 25.23%/P: 25.00%; and added cost: R: 6.93%/P: 10.66%. Nearly 73% of RA patients were involved in treatment decision-making to a greater or lesser extent; however, 27.4% did not participate at all. CONCLUSION: Both for rheumatologists and patients, the top three decision-making drivers are time with optimal quality, treatment mode of administration and time to onset of action, although in different ranking order. Patients were willing to be more involved in the treatment decision-making process.

Patient Decision Aid (PDA) for Patients with Rheumatoid Arthritis Reduces Decisional Conflict and Improves Readiness for Treatment Decision Making.

OBJECTIVES: The aim of this study was to develop and assess the effectiveness of a patient decision aid (PDA) to support treatment decision making in Spanish patients with moderate-to-severe rheumatoid arthritis (RA) who fail to achieve the therapeutic goal with the current disease-modifying antirheumatic treatment strategy. METHODS: The PDA was developed in accordance with the International Patient Decision Aids Standards recommendations. A steering group led the project. Three literature reviews and two focus groups were performed to develop the PDA prototype. To check its comprehensibility, acceptability, and feasibility, alpha-testing was performed using the Decision Support Acceptability Scale (DSAS). Beta-testing was conducted to assess preliminary evidence of PDA efficacy using the Decisional Conflict Scale (DCS) before and after PDA use. Readiness was evaluated using the Preparation for Decision Making Scale (PDMS). RESULTS: The PDA included (1) a brief description of RA, (2) treatment information, and (3) a values clarification section. Alpha-testing revealed that most patients considered that the information was presented in a good or excellent way and it could help clarify their values and facilitate treatment decision making. Most rheumatologists agreed that the PDA was easy to understand, to use, and allowed them to reach a shared decision. Beta-testing showed that PDA significantly reduced overall patients' decisional conflict [33.2 (DE: 21.4) vs 24.6 (23.5); p < 0.001] and prepared the patient for decision making [PDMS: 67.5 (21.0)]. CONCLUSIONS: We developed a PDA for Spanish patients with moderate-to-severe RA that reduces patients' decisional conflict and increases their readiness for decision making. The use of this PDA in routine clinical practice may improve the quality of the decision-making process and the quality of the choices made.

Patient-reported outcomes in European spondyloarthritis patients: a systematic review of the literature.

OBJECTIVE: This review aims to summarize the current literature on patient-reported outcomes (PROs) in spondyloarthritis (SpA). PATIENTS AND METHODS: We performed a systematic literature review to identify studies (original articles and narrative and systematic reviews) regarding PROs (health-related quality of life [HRQoL], satisfaction, preferences, adherence/compliance, and persistence) in SpA patients published in the European Union through December 2016. International databases (Medline/PubMed, Cochrane Library, ISI Web of Knowledge, Scopus) were searched using keywords in English. The methodological quality of the studies was assessed using the Oxford Centre for Evidence-Based Medicine criteria. RESULTS: A total of 26 publications met the inclusion criteria. Generally, studies indicated that SpA has a negative impact on patients' HRQoL. In patients with ankylosing spondylitis, physical domains were more affected than emotional ones, whereas for psoriatic arthritis, both physical and psychological factors were strongly affected by the disease. Data indicated that biological agents (BAs) greatly contributed to improvement in HRQoL in both ankylosing spondylitis and psoriatic arthritis patients. Findings on compliance with BAs were heterogeneous. However, persistence rates exceeded 50% irrespective of the BA administered. Results on preferences indicated that most SpA patients prefer being involved in decisions regarding their treatment and that besides efficacy and safety, frequency and route of administration may influence patients' preferences for BAs. CONCLUSION: Implementing management programs for SpA patients focuses on the physical, emotional, and social consequences of the disease, in addition to assessing and including patient preferences in the treatment decision-making process, could be crucial to improve patients' HRQoL and ensure their satisfaction and compliance with treatment.

Should clinically meaningful outcomes in cancer be based on individual survival rather than median overall survival?

AIM: To assess whether the use of median overall survival to define clinically meaningful outcomes in the area of oncology could yield different decisions compared with those obtained with a more realistic measure such as individual survival. METHODS: Two scenarios that offered equivalent health gains/money spent were presented: 'median overall survival' scenario (new treatment provided small clinical benefits for the average population) and 'individual survival'scenario (new treatment provided substantial clinical benefits for a small percentage of the patients and no benefits for the rest). Responses from both scenarios were compared. RESULTS: Responses between the two scenarios were different for oncologists, healthcare policy makers and patients (p < 0.05). 'Individual survival' scenario obtained higher percentage of positive answers compared with 'median overall survival'. CONCLUSION: Expressing the benefits of new oncologic treatments in terms of 'individual survival' may yield to different healthcare decisions compared with the widely used median overall survival.

Patient preferences for treatment of multiple sclerosis with disease-modifying therapies: a discrete choice experiment.

OBJECTIVES: To assess disease-modifying therapy (DMT) preferences in a population of patients with multiple sclerosis (MS) and to estimate the association between sociodemographic and clinical factors and these preferences. METHODS: Preferences for DMTs attributes were measured using a discrete choice experiment. Analysis of preferences was assessed using mixed-logit hierarchical Bayes regression. A multilinear regression was used to evaluate the association between the preferences for each attribute and patients' demographic and clinical characteristics. A Student's t-test or Welch's t-test was used for subgroup comparisons. RESULTS: A total of 125 patients were included in the final analysis (62.9% female, mean age 44.5 years, 71.5% with relapsing-remitting MS diagnosis). The most important factor for patients was the possibility of suffering from the side effects of the treatment (relative importance [RI] =50%), followed by a delay in disease progression (RI =19.4%), and route and frequency of administration (RI =14.3%). According to maximum acceptable risk, patients were willing to accept an increase of 3.8% in severity of side effects, for a delay of 1 year in disease progression. Treatment duration was the most prevalent factor affecting preferences, followed by the age of patients, type of MS, level of education, and the type of current treatment. Patients treated orally were significantly more concerned about the route and frequency of administration (P=0.026) than patients on injectable therapy. Naïve patients stated significantly less importance to prevention of relapses (P=0.021) and deterioration of the capacity for performing usual daily life activities (P=0.015). Finally, patients with >5 years since diagnosis were significantly less concerned about preventing disease progression (P=0.021), and more concerned about treatment side effects (P=0.052) than compared with patients with <5 years of MS history. CONCLUSION: The most important attribute for MS patients was side effects of DMTs, followed by delay in disability progression. Experience with DMTs and time since MS diagnosis changed patients' preferences. These results give information to adjust new DMT treatment in order to satisfy patients' preferences and therefore, improve adherence to treatment.