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Background: Systemic lupus erythematosus (SLE) may result in great impact on patients' quality of life, social relationships, and work productivity. The use of patient-reported outcome measures (PROMs) in routine care could help capture disease burden to guide SLE management and optimize disease control. We aimed to explore the current situation, appropriateness, and feasibility of PROMs to monitor patients with SLE in routine care, from healthcare professionals' and patients' perspectives., Methods: A scientific committee developed a Delphi questionnaire, based on a focus group with patients and a literature review, including 22 statements concerning: 1) Use of PROMs in routine care (n = 2); 2) PROMs in SLE management (n = 13); 3) Multidisciplinary management of patients with SLE (n = 4), and 4) Aspects on patient empowerment (n = 3). Statements included in Sects. 2-4 were assessed from three perspectives: current use, appropriateness, and feasibility (with currently available resources). For each statement, panellists specified their level of agreement using a 7-point Likert scale. A consensus was reached when ≥ 70% of the panellists agreed (6,7) or disagreed (1,2) on each statement., Results: Fifty-nine healthcare professionals and 16 patients with SLE participated in the Delphi-rounds. A consensus was reached on the value of PROMs to improve SLE management (83%) and the key role of healthcare professionals (77%) and the need for a digital tool connected to the electronic medical record (85%) to promote and facilitate PROMs collection. PROMs most frequently used in clinical practice are pain (56%), patient's global assessment (44%) and fatigue (39%), all on visual analogue scales. Panellists agreed on the need to implement multidisciplinary consultation (79%), unify complementary tests (88%), incorporate pharmacists into the healthcare team (70%), and develop home medication dispensing and informed telepharmacy programmes (72%) to improve quality of care in patients with SLE. According to panellists, patient associations (82%) and nurses (80%) are critical to educate and train patients on PROMs to enhance patient empowerment., Conclusions: Although pain, fatigue, and global assessment were identified as the most feasible, PROMs are not widely used in routine care in Spain. The present Delphi consensus can provide a road map for their implementation being key for SLE management., (© 2024. The Author(s).)

Psoriasis is a chronic skin disease that negatively impacts on patient's life. A holistic approach integrating well-being assessment could improve disease management. Since a consensus definition of well-being in psoriasis is not available, we aim to achieve a multidisciplinary consensus on well-being definition and its components. A literature review and consultation with psoriasis patients facilitated the design of a two-round Delphi questionnaire targeting healthcare professionals and psoriasis patients. A total of 261 panellists (65.1% patients with psoriasis, 34.9% healthcare professionals) agreed on the dimensions and components that should integrate the concept of well-being: emotional dimension (78.9%) [stress (83.9%), mood disturbance (85.1%), body image (83.9%), stigma/shame (75.1%), self-esteem (77.4%) and coping/resilience (81.2%)], physical dimension (82.0%) [sleep quality (81.6%), pain/discomfort (80.8%), itching (83.5%), extracutaneous manifestations (82.8%), lesions in visible areas (84.3%), lesions in functional areas (85.8%), and sex life (78.2%)], social dimension (79.5%) [social relationships (80.8%), leisure/recreational activities (80.3%), support from family/friends (76.6%) and work/academic life (76.5%)], and satisfaction with disease management (78.5%) [treatment (78.2%), information received (75.6%) and medical care provided by the dermatologist (80.1%)]. This well-being definition reflects patients' needs and concerns. Therefore, addressing them in psoriasis will optimise management, contributing to better outcomes and restoring normalcy to the patient's life., (© 2024. The Author(s).)

Background: Advanced practice nurses (APN) growth depends on the implementation and acceptance of APNs in each country., Introduction: Given the diversity of the different contexts and varying population health needs where APNs are developing, this study focuses on exploring the viewpoints of the multidisciplinary and management team who have worked with APNs in public hospitals in Catalonia, Spain., Methods: A cross-sectional study with previously identified APNs, health professionals, and health managers. EVOHIPA, a valid and reliable scale, was used. The STROBE checklist was followed., Findings: The results showed high levels of agreement among the 746 participants (predominantly physicians and nurses), with statements relating to the APN's contribution in enhancing care continuity and processes, resulting in safer and more patient-centered care. The results showed low levels of agreement with statements relating to legal support for the APN position, regulation, and practice scope., Discussion: The study provides discussion elements and reflection to determine the axes on which it will be necessary to act to promote APNs and their conditions of service in the context of practice within hospital teams., Conclusion: The study highlights the differences in opinion on APN roles among health professionals and managers who have worked with APNs and allows exploring expectations about current changes in workflows and clinical activities among healthcare team members., Implications for Nursing and Health Policy: Results highlight the importance of fostering a common understanding among healthcare teams to maximize the benefits of collaborative work and recognize the significant contributions of APNs within the multidisciplinary team. Health policy plays a crucial role in recognizing and promoting the contribution of APNs within hospital healthcare teams, acknowledging their autonomy and expertise in improving patient outcomes., (© 2023 International Council of Nurses.)

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.

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., Competing Interests: Declaration of competing interest MLG has received fees from the following pharmaceutical companies for his participation in advisory groups, talks, workshops, seminars, conferences, studies or clinical trials: Bayer, Biogen, Teva, Novartis, Sanofi-Genzyme, Almirall, Roche, Bristol Myers Squibb, Merk and Janssen. PCR has served as a speaker for several pharmaceutical companies. ODS reports fees as a study investigator with Pfizer and Bristol Myers Squibb. MB declares relationships with Bristol Myers Squibb, Roche and Biogen. ARA has participated in scientific consultancies and has been a speaker at scientific meetings organized by Merk, Biogen, Novartis, Sanofi, Teva and Bristol Myers Squibb. AMB has no conflicts of interest to disclose. NBR declares relationships with Roche, Merck, Biogen, Sanofi, Janssen and Bristol Myers Squibb. AR serves on scientific advisory boards for Bristol Myers Squibb, Novartis, Sanofi-Genzyme, Synthetic MR, Tensor Medical, Roche, Biogen, and OLEA Medical and has received speaker honoraria from Bayer, Sanofi-Genzyme, Merck-Serono, Teva Pharmaceutical Industries Ltd, Novartis, Roche, Bristol Myers Squibb, and Biogen. AR is also a member of the editorial boards of Neurology and Neuroradiology and the executive committee of MAGNIMS. VML has not declared conflicts of interest. LBP and MC are employees of Outcomes 10, an independent research entity that has received fees from Bristol Myers Squibb for conducting this research. DV and AE are employees and may be shareholders of Bristol Myers Squibb. CO-G has received speaker and consultation fees from Alexion, Biogen Idec, Bristol Myers Squibb, Janssen, Merck, Novartis, Roche, Sanofi-Genzyme and Teva., (Copyright © 2024. Published by Elsevier B.V.)

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., Competing Interests: The authors report no conflicts of interest in this work., (© 2023 Lizán Tudela et al.)

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.

Introduction: Migraine symptoms vary significantly between patients and within the same patient. Currently, an increasing number of therapeutic options are available for symptomatic and preventive treatment. Guidelines encourage physicians to use shared decision-making (SDM) in their practice, listening to patients' treatment preferences in order to select the most suitable and effective therapy. Although training for healthcare professionals could increase their awareness of SDM, results concerning its effectiveness are inconclusive. This study aimed to analyze the impact of a training activity to promote SDM in the context of migraine care. This was addressed by evaluating the impact on patients' decisional conflict (main objective), patient-physician relationship, neurologists' perceptions of the training and patient's perception of SDM., Methods: A multicenter observational study was conducted in four highly specialized headache units. The participating neurologists received SDM training targeting people with migraine in clinical practice to provide techniques and tools to optimize physician-patient interactions and encourage patient involvement in SDM. The study was set up in three consecutive phases: control phase, in which neurologists were blind to the training activity and performed the consultation with the control group under routine clinical practice; training phase, when the same neurologists participated in the SDM training; and SDM phase, in which these neurologists performed the consultation with the intervention group after the training. Patients in both groups with a change of treatment assessment during the visit completed the Decisional conflict scale (DCS) after the consultation to measure the patient's decisional conflict. Also, patients answered the patient-doctor relationship questionnaire (CREM-P) and the 9-item Shared Decision-Making Questionnaire (SDM-Q-9). The mean ± SD scores obtained from the study questionnaires were calculated for both groups and compared to determine whether there were significant differences (p < 0.05)., Results: A total of 180 migraine patients (86.7% female, mean age of 38.5 ± 12.3 years) were included, of which 128 required a migraine treatment change assessment during the consultation (control group, n = 68; intervention group, n = 60). A low decisional conflict was found without significant differences between the intervention (25.6 ± 23.4) and control group (22.1 ± 17.9; p = 0.5597). No significant differences in the CREM-P and SDM-Q-9 scores were observed between groups. Physicians were satisfied with the training and showed greater agreement with the clarity, quality and selection of the contents. Moreover, physicians felt confident communicating with patients after the training, and they applied the techniques and SDM strategies learned., Conclusion: SDM is a model currently being actively used in clinical practice for headache consultation, with high patient involvement in the process. This SDM training, while useful from the physician's perspective, may be more effective at other levels of care where there is still room for optimization of patient involvement in decision-making., (© 2023. The Author(s).)

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., (© 2022. The Author(s), under exclusive licence to Springer Nature Limited.)

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., (© 2022. GSK.)

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 1 st 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 1 st -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., Competing Interests: VE-V received support to continuing education/advisory fees from Astellas, Bristol-Myers Squibb, GlaxoSmithKline, Janssen, Merck Sharp & Dohme, Novartis, Roche, and Sanofi. RC-B has received support to continuing education/advisory fees: Boehringer-Ingelheim, Janssen, Merck Sharp & Dohme, Hoffmann-La Roche, Amgen Inc, GlaxoSmithKline, and Pfizer. EG has received advisory/consultancy honorarium from AstraZeneca-MSD, Clovis Oncology, GSK-Tesaro, PharmaMar, Roche; has received speaker bureau/expert testimony honorarium from AstraZeneca-MSD, PharmaMar, Roche, GSK-Tesaro, Clovis; and has received travel/accommodation/expenses from Roche, GSK-Tesaro and Baxter. MV works for an independent research entity that received funding from GlaxoSmithKline to coordinate and conduct the study. The remaining authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (Copyright © 2022 Escudero-Vilaplana, Bernal, Casado, Collado-Borrell, Diez-Fernández, Fernández Román, Folguera, González-Cortijo, Herrero-Fernández, Marquina, Martínez Nieto, Rodríguez, Rubio, Sanmartin-Fenollera, Vazquez Castillo, Comellas and Guerra.)

Background: Stronger healthcare models are increasingly sought to address new population needs, health workforce inefficiencies and nursing shortages. One strategy is to focus on employees' strengths to capitalize on their competencies and maximize their scope of practice., Introduction: Globally, there is an exponential demand for advanced practice nursing services. This study aimed to identify the roles and positions of nurses who align with APN defining criteria at all levels of care in Catalonia, Spain., Methods: The first step of the study included the translation and validation to Catalan of the Advanced Practice Nurse Role Delineation Tool (IDREPA) and step 2 comprised a multicentre cross-sectional study, in which 126 healthcare centres participated: 1209 nurses were included in the study. The STROBE checklist was used to report this study., Results: Transcultural equivalence and validation of the instrument showed a content validity index of 0.958 and the reliability of the questionnaire. The instrument identified 269 nurses who align with international APN defined criteria. They worked in specialized care, mental healthcare and primary and community care, especially in chronic conditions, ageing and end-of-life care., Discussion: Most areas of Catalonia have access to nurses practicing at APN defining criteria. These nurses were developed as an optimal resource to respond to patient needs in the context of study. Both recognition and strategic implementation are necessary to apply their full competencies to solve healthcare problems., Conclusion: Understanding the supply of services delivered by nurses practicing at an advanced level and their scope of practice may lay the foundations for effective workforce planning in a dynamic context. Nurses who align with APN defining criteria are working mainly in large acute services without regulation and recognition., Implications for Nursing: Advanced practice nurses show the value of their role and activities in healthcare services., Implications for Health Policy: Promoting the establishment of APN defining criteria that includes credentialing and a regulatory framework within international guidelines should be a priority to make an impact on healthcare policy., (© 2021 The Authors. International Nursing Review published by John Wiley & Sons Ltd on behalf of International Council of Nurses.)

Introduction: There is currently a degree of divergence among the main clinical practice guidelines on the management of risk factors for peripheral arterial disease (PAD). This project aims to gain understanding of the management of PAD risk factors in clinical practice and to reach a multidisciplinary consensus on the strategies to be followed in order to optimize its identification, treatment, and follow-up., Methodology: A multidisciplinary consensus following the Delphi methodology., Results: Professionals (n = 130) with extensive experience in PAD participated in this consultation. The results suggest that in order to optimize the control of risk factors, efforts should be aimed at: (1) promoting the involvement and awareness of all specialists in the identification of and screening for the disease; (2) guaranteeing the possibility of evaluating the ankle-brachial index (ABI) in all the medical specialties involved; (3) promoting strategies for patients to quit smoking through the use of drugs, programs, or referrals to specialized units; (4) promoting an appropriate Mediterranean-based diet and the prescription of daily exercise; (5) raising awareness of the importance of ensuring LDL cholesterol values below 70 mg/dL, especially in symptomatic but also in asymptomatic patients (<55 mg/dL following the publication of the ESC/EAS guide); (6) recommending the use of antiplatelet therapy in asymptomatic patients with diabetes mellitus (DM) and/or a pathological ABI; and (7) protocolizing the annual evaluation of ABI in high-risk patients., Conclusion: This document presents the 22 agreed-upon strategies which are intended to help professionals optimize multidisciplinary management of PAD risk factors., (Copyright © 2021 The Authors. Published by Elsevier España, S.L.U. All rights reserved.)

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) 1 st -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., Competing Interests: JS and AM are employees of Bristol Myers Squibb. MC and LL work for an independent research entity that received funding from Bristol Myers Squibb to coordinate and conduct the study. The remaining authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (Copyright © 2022 Arrazubi, Cajaraville, Cantero, Giralt, Mesia, Monje, Rueda, Sistiaga, Suarez, Mut, Comellas and Lizán.)

Arm movement recovery after stroke can improve with sufficient exercise. However, rehabilitation therapy sessions are typically not enough. To address the need for effective methods of increasing arm exercise outside therapy sessions we developed a novel armrest, called Boost. It easily attaches to a standard manual wheelchair just like a conventional armrest and enables users to exercise their arm in a linear forward-back motion. This paper provides a detailed design description of Boost, the biomechanical analysis method to evaluate the joint torques required to operate it, and the results of pilot testing with five stroke patients. Biomechanics results show the required shoulder flexion and elbow extension torques range from -25% to +36% of the torques required to propel a standard pushrim wheelchair, depending on the direction of applied force. In pilot testing, all five participants were able to exercise the arm with Boost in stationary mode (with lower physical demand). Three achieved overground ambulation (with higher physical demand) exceeding 2 m/s after 2-5 practice trials; two of these could not propel their wheelchair with the pushrim. This simple to use, dynamic armrest provides people with hemiparesis a way to access repetitive arm exercise outside of therapy sessions, independently right in their wheelchair. Significantly, Boost removes the requirements to reach, grip, and release the pushrim to propel a wheelchair, an action many individuals with stroke cannot complete.

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., Competing Interests: Two of the authors of the manuscript (LGB and CB) are Novartis employees, however this does not alter their adherence to PLOS ONE policies on sharing data and materials.

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.

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.

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.

Background and Objectives: Epidemiologic and disease burden data are essential for disease control and optimal health care resource planning. The aims of this study were to estimate the epidemiologic burden of psoriasis and evaluate associated comorbidities, health care utilization, and sick leave., Material and Methods: We collected data from the 2016 Catalan Health Survey (ESCA), the Catalan Registry of Morbidity and Utilization of Health Care Services (MUSSCAT) (2016), and the database of the Catalan Medical Evaluations Institute (ICAM) (2012-2016)., Results: The prevalence of psoriasis in Catalonia according to 2016 ESCA data is approximately 1.8%. The MUSSCAT registry data indicate that the incidence has remained stable in recent years. The most common comorbidities associated with psoriasis are hypertension (35%) and diabetes (15%). Forty percent of patients with psoriasis have a moderate to high risk for death or high health resource utilization. Annual use of resources by psoriasis patients is high: they make a mean of 8.7 primary care visits, 2.8 outpatient visits, 0.5 emergency and day hospital visits, 0.2 mental health visits, and use 6.1 medications. Sick leave due to psoriasis or psoriatic arthritis accounted for 0.04% of all cases., Conclusions: The prevalence of psoriasis in Catalonia is high at 1.8%. The disease burden is also high, both in terms of comorbidities and health care utilization., (Copyright © 2020 AEDV. Publicado por Elsevier España, S.L.U. All rights reserved.)

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., (Copyright © 2020 Escudero-Vilaplana, Calles, Collado-Borrell, Belén Marzal-Alfaro, Polanco, Garrido, Suarez, Ortiz, Appierto, Comellas and Lizán.)

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.

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.

Aim: To assess the age and its association with glycemic control (GC) among adults with type 2-diabetes in the United States., Materials and Materials: Data were collected from the National Nutrition Examination Survey (NHANES) 2013-2014 (n = 697), cross-sectional national survey adults with Type2 diabetes. Characteristics included retinopathy diagnosis, blood pressure, albumin-creatinine ratio, hemoglobin A1c (HbA1c), BMI, cholesterol, smoking status, pills/insulin, exercise, age, age at diagnosis, education, sex, race, and marital status. Diabetes preventive behaviors were included. Predictors of GC were assessed using logistic regression., Results: The mean age was 61 (SD ±13); the average age at diagnosis 50 (SD ±12.9) and women (51%). Age ≥60, diabetes length >10yrs, taking pills/on insulin, albumin-creatinine ratio ≤30mg/g, optimal BP, no retinopathy diagnosis, optimal cholesterol, seeing a doctor for diabetes, doctors checkup ≥2 times and checking HbA1c annually were significant predictors of GC. The association between GC and age (OR=.97, p<.001; CI: .96-.98) diabetes length >10yrs (OR=1.55, p<.05; CI: 1.02-2.34), creatinine-albumin ratio ≤30mg/g (OR=1.97, p<.001; CI: 1.32-2.94) and checking HbA1c annually (OR=1.86, p<.01; CI: 1.16-3.00) remained significant after adjustment for the effects of all other statistically significant covariates., Conclusions: GC was prevalent among older individuals; suggestive of intervention programs for young adults with diabetes and continuous HbA1c assessment at least annually., (Copyright © 2019 Diabetes India. Published by Elsevier Ltd. All rights reserved.)

Mucin-1 (MUC1) is one of the top ranked tumor associated antigens. In order to generate effective anti-MUC1 immune responses as potential anticancer vaccines, MUC1 peptides and glycopeptides have been covalently conjugated to bacteriophage Qβ. Immunization of mice with these constructs led to highly potent antibody responses with IgG titers over one million, which are among the highest anti-MUC1 IgG titers reported to date. Furthermore, the high IgG antibody levels persisted for more than six months. The constructs also elicited MUC1 specific cytotoxic T cells, which can selectively kill MUC1 positive tumor cells. The unique abilities of Qβ-MUC1 conjugates to powerfully induce both antibody and cytotoxic T cell immunity targeting tumor cells bode well for future translation of the constructs as anticancer vaccines.

Objectives: To reach a consensus amongst experts on the most feasible actions to be undertaken to facilitate patient access to specialised care and orphan drugs (OD) in the public health sector in Spain., Methods: Two Delphi rounds were completed. The questionnaire was based on a literature review and 2 focus groups. Agreement was sought on the desire (D) and prognosis (P) for the implementation within the next 5 years, on a 5-point Likert scale. Consensus was reached when ≥75% participants chose agreement (1-2) or disagreement options (4-5)., Results: 82 experts on rare disease (RD) participated. Agreement on the D and P was reached in 66.07% statements: OD pricing review [absence of clinical effectiveness (D:85.37%; P:85.90%), target population increase (D:79.27%; P:91.03%)]; reference team definition of referral protocols and clinical practice guidelines (D: 97.56%; P: 89.74%); and a unified, usable, etiology-based registry (D:97.56%; P:84.62%). D and P assessment diverged in 32.14% items: creation of a specific funding system for OD (D: 97.56%; P: 60.25%); and a network of medical teams to coordinate the care of RD patients (D: 99%; P: 62%)., Conclusions: The results have shown the need to promote dialogue between stakeholders, introduce European recommendation to national and regional Spanish policies and set up priorities and undertake actions to drive relevant changes in current medical practice in managing RD patients., (Copyright © 2018 Elsevier B.V. All rights reserved.)

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., Competing Interests: Disclosure This study was funded by Novartis Farmacéutica SA. CB works for Novartis Farmacéutica SA. MC and LL work for an independent research entity that received remuneration for development of the original research and writing this manuscript. The remaining authors report no conflicts of interest in this work.

The closure of the abdominal wall after making a laparotomy is a major challenge for surgeons, since a significant percentage of closures fail and incisional hernias rise. The suture has to withstand the forces required to close the incision, while not hindering the adequate wound healing progression. Currently, there is no surgical measuring device that could be used to determine the required closing forces, which can be very different depending on the patient. This paper presents a dynamometer to measure the tension forces to be applied while closing a surgical incision, and it simultaneously measures the distance between wound edges. It is a compass-like instrument. A mechanism between the two legs incorporates a load cell, whose signal is read by an electronic device that computes the values of the tension forces between wound edges. An angular position sensor at the pin joint between legs provides the distance between both sides of the incision. Measuring capabilities of the instrument prototype were verified at the laboratory. Thereafter, its functionality was demonstrated in experimental surgery tests. Therefore, the instrument could be very useful in clinical applications, assisting personalized surgical techniques., Competing Interests: The authors declare no conflict of interest. The founding sponsors had no role in the design of the study; in the collection, analyses, or interpretation of data; in the writing of the manuscript, and in the decision to publish the results.

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.

Vaccines targeting glycan structures at the surface of pathogenic microbes must overcome the inherent T cell-independent nature of immune responses against glycans. Carbohydrate conjugate vaccines achieve this by coupling bacterial polysaccharides to a carrier protein that recruits heterologous CD4 T cells to help B cell maturation. Yet they most often produce low- to medium-affinity immune responses of limited duration in immunologically fit individuals and disappointing results in the elderly and immunocompromised patients. Here, we hypothesized that these limitations result from suboptimal T cell help. To produce the next generation of more efficacious conjugate vaccines, we have explored a synthetic design aimed at focusing both B cell and T cell recognition to a single short glycan displayed at the surface of a virus-like particle. We tested and established the proof of concept of this approach for 2 serotypes of Streptococcus pneumoniae. In both cases, these vaccines elicited serotype-specific, protective, and long-lasting IgG antibodies of nanomolar affinity against the target glycans in mice. We further identified a requirement for CD4 T cells in the anti-glycan antibody response. Our findings establish the design principles for improved glycan conjugate vaccines. We surmise that the same approach can be used for any microbial glycan of interest.

Background and Objective: Adherence to treatment in patients with psoriasis is often poor. An investigation of patient preferences and satisfaction with treatment may be important, based on the expected correlation with therapy compliance. This paper aims to examine and describe the current literature on patient preferences, satisfaction and adherence to treatment for psoriasis in the European Union (EU)., Methods: Electronic searches were conducted using PubMed, ISI Web of Knowledge, Scopus, Spanish databases and Google Scholar. European studies published in English or Spanish between January 1, 2009 and December 31, 2014 regarding patient-reported outcomes in psoriatic patients were included. Studies conducted in non-EU countries, letters to the editor, editorials, experts' opinions, case studies, congress proceedings, publications that did not differentiate between patients with psoriasis and psoriatic arthritis or studies related to specific treatment were excluded., Results: A total of 1,769 titles were identified, of which 1,636 were excluded as they were duplicates or did not provide any relevant information. After a full-text reading and application of the inclusion/exclusion criteria, 46 publications were included. This paper will describe publications on adherence (n=4), preferences (n=5) and satisfaction with treatment (n=7). Results related to health-related quality of life articles (n=30) have been published elsewhere. Adherence rates are generally low in psoriasis patients regardless of the type of treatment, severity of disease or methods used to measure adherence. Biologic therapy is associated with greater clinical improvement. There is a direct association between physician recommendations, patient preferences and several domains of treatment satisfaction., Conclusion: The results of this review support the conclusion that adherence rates in patients with psoriasis are suboptimal and highlight the need to improve patient compliance and satisfaction with treatment. Patients' preferences should be taken into account in the treatment decision-making process in order to improve patients' clinical outcomes by ensuring satisfaction and adherence., Competing Interests: DisclosureThe study was sponsored by Novartis Farmacéutica S.A. The authors report no other conflicts of interest in this work.

Introduction: The purpose of this study was to explore the main factors explaining the relative weight of the different attributes that determine the value of oncologic treatments from the different perspectives of healthcare policy makers (HCPM), oncologists, patients and the general population in Spain., Methods: Structured interviews were conducted to assess: (1) the importance of the attributes on treatment choice when comparing a new cancer drug with a standard cancer treatment; (2) the importance of survival, quality of life (QoL), costs and innovation in cancer; and (3) the most worrying side effects related to cancer drugs., Results: A total of 188 individuals participated in the study. For all participants, when choosing treatments, the best rated characteristics were greater efficacy, greater safety, treatment adaptation to patients' individual requirements and the rapid reincorporation of patients to their daily activities. There were important differences among participants in their opinion about survival, QoL and cost. In general, oncologists, patients, and the general population gave greater value to gains in QoL than healthcare policy makers. Compared to other participants healthcare policy makers gave greater importance to the economic impact related to oncology treatments., Conclusions: Gains in QoL, survival, safety, cost and innovation are perceived differently by different groups of stakeholders. It is recommended to consider the perspective of different stakeholders in the assessment of a new cancer drugs to obtain more informed decisions when deciding on the most appropriate treatment to use., Funding: Eli Lilly & Co, Madrid (Spain).

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.

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.

The development of advanced practice nurses (APN) has proved a challenge for nurses in countries such as the USA, Canada, Great Britain, and Australia among others. It is only in recent years that the system has been considered in Catalonia and Spain as a way to develop new roles to bring effectiveness and efficiency to the health system. From the standpoint of training and implementation of the above-mentioned new nursing roles, the following article aims to conceptualise APN and its reference models, as well as to contextualise and reflect on APN in Catalonia in order to assimilate them into advanced practice.

Objectives: To determine the prevalence of the risk of depression, major defining characteristics and factors associated with., Design: Sub-study of comprehensive geriatric assessment cross-study., Setting: Primary health center., Participants: For an estimated 14% prevalence we need a sample of 288 people. From 3854, 290 people ≥75 years were selected. Excluding terminals, chemotherapy, recent surgery, temporary residence, mental retardation, serious psychiatric illness, or under home care., Outcome: risk of depression (≥2 points on the Goldberg depression subscale., Dependent Variables: Sociodemographic and five study areas of the Comprehensive Geriatric Assessment: medical -comorbidity, polypharmacy, falls and hospital admissions-, functional -Up&Go Test, Lawton-Brody and Barthel Index-, nutritional -Mini Nutritional Assessment (MNA)-, mental-affective -Pfeiffer Questionnaire and Goldberg scale-, and social. Descriptive analysis and logistic regression., Results: We obtained 290 interviews, with 102 (35.1%) male and mean age of 79.4 years (SD:3.2). The prevalence of the risk of depression was 37.2%, 26.5% in men and 43.1% in women (p=0.005). Association of risk of depression is observed with arterial hypertension (OR:3.87 95% CI:1.61-9.34), cancer (OR:4.12 95%, CI:1.58-10.76), lack of leisure activity (OR:2.75 95%, CI:1.33-5.67), increase of anxiety scale (OR:1.87 95%, CI:1.57-2.22) and decrease in MNA (OR:0.78 95%, CI:0.68-0.9)., Conclusions: The prevalence of risk of depression is higher than expected, although overestimated until being confirmed with a diagnostic test. We appreciate new associations of comorbidity variables with risk of depression and corroborate other known. The studied factors that were associated with the risk of depression should be included in future studies of geriatric depression., (Copyright © 2014 Elsevier España, S.L.U. All rights reserved.)

Background: Treatment adherence is one of the key factors for achieving optimal clinical outcomes. In order to assess costs related to adherence to, and persistence and compliance with, disease-modifying therapies (DMTs) in patients with multiple sclerosis (MS), a narrative review of the literature was performed. Satisfaction with and preference for DMTs and their delivery devices were also assessed, as both can have an influence on patients' adherence and persistence., Methods: Electronic databases (MEDLINE, PubMed, Google Scholar, congress proceedings) were searched to identify publications analyzing MS costs related to adherence, persistence, satisfaction, and preferences for MS treatments. Bibliographic references were hand searched. English or Spanish studies published between January 2007 and January 2013 were selected., Results: A total of 398 titles were identified, of which 12 met the inclusion criteria. Six studies evaluated the impact of adherence, persistence, and compliance on treatment costs; four publications analyzed satisfaction with DMTs; and two assessed treatment preferences based on attributes of the delivery device. Increased adherence and persistence were associated with better clinical outcomes, leading to lower relapse risk (odds ratio [OR]: 0.71; 95% confidence interval [CI]: 0.59-0.85) and a decrease in health care resource use, such as MS-related hospitalizations (OR: 0.63; 95% CI: 0.47-0.83) and emergency department visits (OR: 0.80; 95% CI: 0.60-1.07). This reduction in resource use led to a patient/year total cost reduction (excluding DMT costs) of up to 22%., Conclusion: This review highlights the importance of ensuring adequate adherence in MS patients through treatments and devices better tailored to patients' needs that could enhance clinical outcomes and reduce MS costs. Understanding the factors underlying satisfaction and compliance with treatment and patients' preference for certain therapies could help in the development of strategies that can improve adherence.

Engineering of anisotropic tissues demands extracellular matrix (ECM) mimicking scaffolds with an asymmetric distribution of functionalities. We here describe a convenient, modular approach based on supramolecular building blocks to form electrospun bilayered scaffolds with tailorable properties. Polymers and peptides functionalized with hydrogen-bonding ureido-pyrimidinone (UPy) moieties can easily be mixed-and-matched to explore new material combinations with optimal properties. These combinatorial supramolecular biomaterials, processed by electrospinning, enable the formation of modular fibrous scaffolds. We demonstrate how UPy-functionalized polymers based on polycaprolactone and poly(ethylene glycol) enable us to unite both cell-adhesive and non-cell adhesive characters into a single electrospun bilayered scaffold. We furthermore show that the non-cell adhesive layer can be bioactivated and made adhesive for kidney epithelial cells by the incorporation of 4 mol% of UPy-modified Arg-Gly-Asp (RGD) peptide in the electrospinning solution. These findings show that the UPy-based supramolecular biomaterial system offers a versatile toolbox to form modular multilayered scaffolds for tissue engineering and regenerative medicine applications such as the formation of membranes for a living bioartificial kidney.

The development of an effective immunotherapy is an attractive strategy toward cancer treatment. Tumor associated carbohydrate antigens (TACAs) are overexpressed on a variety of cancer cell surfaces, which present tempting targets for anticancer vaccine development. However, such carbohydrates are often poorly immunogenic. To overcome this challenge, we show here that the display of a very weak TACA, the monomeric Tn antigen, on bacteriophage Qβ virus-like particles elicits powerful humoral responses to the carbohydrate. The effects of adjuvants, antigen display pattern, and vaccine dose on the strength and subclasses of antibody responses were established. The local density of antigen rather than the total amount of antigen administered was found to be crucial for induction of high Tn-specific IgG titers. The ability to display antigens in an organized and high density manner is a key advantage of virus-like particles such as Qβ as vaccine carriers. Glycan microarray analysis showed that the antibodies generated were highly selective toward Tn antigens. Furthermore, Qβ elicited much higher levels of IgG antibodies than other types of virus-like particles, and the IgG antibodies produced reacted strongly with the native Tn antigens on human leukemia cells. Thus, Qβ presents a highly attractive platform for the development of carbohydrate-based anticancer vaccines.

Caregivers might represent an opportunity to improve cardiovascular disease outcomes, but prospective data are limited. We studied 3,188 consecutive patients (41% minority, 39% women) admitted to a university hospital medical cardiovascular service to evaluate the association between having a caregiver and rehospitalization/death at 1 year. The clinical outcomes at 1 year were documented using a hospital-based clinical information system supplemented by a standardized questionnaire. Co-morbidities were documented by hospital electronic record review. At baseline, 13% (n = 417) of the patients had a paid caregiver and 25% (n = 789) had only an informal caregiver. Having a caregiver was associated with rehospitalization or death at 1 year (odds ratio [OR] 1.68, 95% confidence interval [CI] 1.45 to 1.95), which varied by paid (OR 2.46, 95% CI 1.96 to 3.09) and informal (OR 1.40, 95% CI 1.18 to 1.65) caregiver status. Having a caregiver was significantly (p <0.05) associated with age ≥65 years, racial/ethnic minority, lack of health insurance, medical history of diabetes mellitus or hypertension, a Ghali co-morbidity index >1, chronic obstructive pulmonary disease, or taking ≥9 prescriptions medications. The relation between caregiving and rehospitalization/death at 1 year was attenuated but remained significant after adjustment (paid, OR 1.64, 95% CI 1.26 to 2.12; and informal, OR 1.20, 95% CI 1.00 to 1.44). In conclusion, the risk of rehospitalization/death was significantly greater among cardiac patients with caregivers and was not fully explained by the presence of traditional co-morbidities. Systematic determination of having a caregiver might be a simple method to identify patients at a heightened risk of poor clinical outcomes., (Copyright © 2012 Elsevier Inc. All rights reserved.)

Background and Objectives: Cardiac caregivers may represent a novel low-cost strategy to improve patient adherence to medical follow-up and guidelines and, ultimately, patient outcomes. Prior work on caregiving has been conducted primarily in mental health and cancer research; few data have systematically evaluated caregivers of cardiac patients. The purpose of this study was to evaluate the patterns of caregiving and characteristics of caregivers among hospitalized patients with cardiovascular disease (CVD) to assess disparities in caregiver burden and to determine the potential for caregivers to impact clinical outcomes., Subjects and Methods: Consecutive patients admitted to the cardiovascular service line at a university medical center during an 11-month period were included in the Family Cardiac Caregiver Investigation To Evaluate Outcomes (FIT-O) study. Patients (n=4500; 59% white, 62% male, 93% participation rate) completed a standardized interviewer-assisted questionnaire in English or Spanish regarding assistance with medical care, daily activities, and medications in the past year and plans for posthospitalization. In univariate and multiple variable analyses, caregivers were categorized as either paid/professional (eg, nurse/home aide) or nonpaid (eg, family member/friend)., Results and Conclusions: Among CVD patients, 13% planned to have a paid caregiver and 51% a nonpaid caregiver at discharge. Planned paid caregiving was more prevalent among racial/ethnic minority versus white patients (odds ratio, 1.5; 95% confidence interval, 1.2-1.8); planned nonpaid caregiving prevalence did not differ by race/ethnicity. Most nonpaid caregivers were female (78%). Patients who had nonpaid caregivers in the year prior to hospitalization (28%) reported grocery shopping/meal preparation (32%), transport to/arranging doctor visits (30%), and medication adherence/medical needs (25%) as top tasks caregivers assisted with. Following hospitalization, a majority of patients expect nonpaid caregivers, primarily women, to assist with tasks that have the potential to improve CVD outcomes such as medical follow-up, medication adherence, and nutrition, suggesting that these are important targets for caregiver education., (Copyright © 2011 Lippincott Williams & Wilkins.)

Objective: To develop, implement, and evaluate a peer-led diabetes self-management support program in English and Spanish for a diverse, urban, low-income population. The program goals and objectives were to improve diabetes self-management behaviors, especially becoming more physically active, healthier eating, medication adherence, problem solving, and goal setting., Methods: After a new training program for peers led by a certified diabetes educator (CDE) was implemented with 5 individuals, this pilot evaluation study was conducted in 2 community settings in the East and South Bronx. Seventeen adults with diabetes participated in the new peer-led 5-session program. Survey data were collected pre- and postintervention on diabetes self-care activities, quality of well-being, and number of steps using a pedometer., Results: This pilot study established the acceptance and feasibility of both the peer training program and the community-based, peer-led program for underserved, minority adults with diabetes. Significant improvements were found in several physical activity and nutrition activities, with a modest improvement in well-being. Feedback from both peer facilitators and participants indicated that a longer program, but with the same educational materials, was desirable., Conclusions: To reduce health disparities in urban communities, it is essential to continue program evaluation of the critical elements of peer-led programs for multiethnic adults with diabetes to promote self-management support in a cost-effective and culturally appropriate manner. Practice Implications A diabetes self-management support program can be successfully implemented in the community by peers, within a model including remote supervision by a CDE.

In this paper, we describe the controlled incorporation of two synthetic polymers with different structures in the cowpea chlorotic mottle virus (CCMV) capsid. Poly(ethylene glycol) (PEG) chains have been attached to the amine groups of lysine residues on the outer surface of the viral capsid. The functionalization of CCMV with PEG chains provoked a slow but irreversible dissociation of the virus into PEG-coat protein (CP) subunits, likely due to steric interference between the protein-protein subunits as a result of the presence of the PEG chains. This thermodynamic instability, however, can be overcome if a second polymer, such as polystyrene sulfonate (PSS), is present within the capsid. After complete disassembly of the PEG-CCMV conjugates and removal of the viral RNA, incubation of the PEG-functionalized coat proteins with PSS resulted in the formation of much more robust PSS-CCMV-PEG capsids with a diameter of 18 nm (T = 1 capsids). These are the first virus-like particles bearing synthetic organic polymers both inside and outside the viral capsid, opening a new route to the synthesis of biohybrid nanostructured materials based on viruses.

Bacteria and archaea import molybdenum and tungsten from the environment in the form of the oxyanions molybdate (MoO(4) (2-)) and tungstate (WO(4) (2-)). These substrates are captured by an external, high-affinity binding protein, and delivered to ATP binding cassette transporters, which move them across the cell membrane. We have recently reported a crystal structure of the molybdate/tungstate binding protein ModA/WtpA from Archaeoglobus fulgidus, which revealed an octahedrally coordinated central metal atom. By contrast, the previously determined structures of three bacterial homologs showed tetracoordinate molybdenum and tungsten atoms in their binding pockets. Until then, coordination numbers above four had only been found for molybdenum/tungsten in metalloenzymes where these metal atoms are part of the catalytic cofactors and coordinated by mostly non-oxygen ligands. We now report a high-resolution structure of A. fulgidus ModA/WtpA, as well as crystal structures of four additional homologs, all bound to tungstate. These crystal structures match X-ray absorption spectroscopy measurements from soluble, tungstate-bound protein, and reveal the details of the distorted octahedral coordination. Our results demonstrate that the distorted octahedral geometry is not an exclusive feature of the A. fulgidus protein, and suggest distinct binding modes of the binding proteins from archaea and bacteria.

Transport across cellular membranes is an essential process that is catalyzed by diverse membrane transport proteins. The turnover rates of certain transporters are inhibited by their substrates in a process termed trans-inhibition, whose structural basis is poorly understood. We present the crystal structure of a molybdate/tungstate ABC transporter (ModBC) from Methanosarcina acetivorans in a trans-inhibited state. The regulatory domains of the nucleotide-binding subunits are in close contact and provide two oxyanion binding pockets at the shared interface. By specifically binding to these pockets, molybdate or tungstate prevent adenosine triphosphatase activity and lock the transporter in an inward-facing conformation, with the catalytic motifs of the nucleotide-binding domains separated. This allosteric effect prevents the transporter from switching between the inward-facing and the outward-facing states, thus interfering with the alternating access and release mechanism.

Carboxypeptidase A1 has been the subject of extensive research in the last 30 y and is one of the most widely studied zinc metalloenzymes. However, the three-dimensional structure of the human form of the enzyme is not yet available. This report describes the three-dimensional structure of human carboxypeptidase A1 (hCPA1) derived from crystals that belong to the tetragonal space group P4(3)2(1)2 and diffract to 1.6 angstroms resolution. A description of the ternary complex hCPA1-Zn2+-poly(acrylic acid) is included as a model of the interaction of mucoadhesive polymers with proteases in the gastrointestinal tract. The direct mode of interaction between poly(acrylic acid) and the active site of the target protease was confirmed by in vitro inhibition assays. The structure was further analyzed in silico through the optimal docking-area method. The characterization of binding sites on the surface of hCPA1 and a comparison with other available carboxypeptidase structures provided further insights into the formation of multiprotein complexes and the activation mechanisms of carboxypeptidase zymogens. The high-resolution structure of hCPA1 provides an excellent template for the modelling of physiologically relevant carboxypeptidases and could also contribute to the design of specific agents for biomedical purposes.