Exploring value creation in a virtual community of practice: a framework analysis for knowledge and skills development among primary care professionals.

BACKGROUND: Healthcare professionals traditional education reflects constraints to face the complex needs of people with chronic diseases in primary care settings. Since more innovative and practical solutions are required, Virtual Community of Practices (vCoP) seem to better respond to learning updates, improving professional and organizational knowledge. However, little is known about the value created in vCoPs as social learning environments. The objective of this project was to explore the value creation process of a gamified vCoP ("e-mpodera vCoP") aimed at improving the knowledge and attitudes of primary healthcare professionals (PCPs) (nurses and general practitioners) to the empowerment of people with chronic conditions. METHODS: A framework analysis assessed the value creation process using a mixed methods approach. The framework provided awareness about knowledge and usefulness in a learning community through five cycles: (1) immediate value, (2) potential value, (3) applied value, (4) realized value, and (5) reframing value. Quantitative data included vCoP analytics such as logins, contributions, points, badges, and performance metrics. Qualitative data consisted of PCPs' forum contributions from Madrid, Catalonia, and Canary Islands over 14 months. RESULTS: A total of 185 PCPs had access to the e-mpodera vCoPs. The vCoP showed the dynamic participation of 146 PCPs, along 63 content activities posted, including a total of 3,571 contributions (including text, images, links to webpages, and other files). Regarding the value creation process, the e-mpodera vCoP seems to encompass a broad spectrum of value cycles, with indicators mostly related to cycle 1 (immediate value - activities and interactions) and cycle 2 (potential value - knowledge capital); and to a lesser extent for cycle 3 (applied value - changes in practice) and for cycle 4 (realized value - performance improvement). The presence of indicators related to cycle 5 (reframing value), was minimal, due to few individual redefinitions of success. CONCLUSION: To reach a wider range of value possibilities, a combination of learning objectives, competence framework, challenged-based gamified platform, and pathway model of skill development seems crucial. However, additional research is required to gain clearer insights into organizational values, professionals' lifelong educational needs in healthcare, and the long-term sustainability of performance improvement. TRIAL REGISTRATION: ClinicalTrials.gov, NCT02757781. Registered on 02/05/2016.

Assessment of a venous thromboembolism prophylaxis shared decision-making intervention (DASH-TOP) using the decisional conflict scale: a mixed-method study.

BACKGROUND: Venous thromboembolism (VTE) in pregnancy is a major cause of maternal morbidity and death. The use of low-molecular-weight heparin (LMWH), despite being the standard of care to prevent VTE, comes with some challenges. Shared decision-making (SDM) interventions are recommended to support patients and clinicians in making preference-sensitive decisions. The quality of the SDM process has been widely assessed with the decisional conflict scale (DCS). Our aim is to report participants' perspectives of each of the components of an SDM intervention (DASH-TOP) in relation to the different subscales of the DCS. METHODS: Design: A convergent, parallel, mixed-methods design. PARTICIPANTS: The sample consisted of 22 health care professionals, students of an Applied Clinical Research in Health Sciences (ICACS) master program. INTERVENTION: We randomly divided the participants in three groups: Group 1 received one component (evidence -based information), Group 2 received two components (first component and value elicitation exercises), and Group 3 received all three components (the first two and a decision analysis recommendation) of the SDM intervention. ANALYSIS: For the quantitative strand, we used a non-parametric test to analyze the differences in the DCS subscales between the three groups. For the qualitative strand, we conducted a content analysis using the decisional conflict domains to deductively categorize the responses. RESULTS: Groups that received more intervention components experienced less conflict and better decision-making quality, although the differences between groups were not statistically significant. The decision analysis recommendation improved the efficacy with the decision-making process, however there are some challenges when implementing it in clinical practice. The uncertainty subscale showed a high decisional conflict for all three groups; contributing factors included low certainty of the evidence-based information provided and a perceived small effect of the drug to reduce the risk of a VTE event. CONCLUSIONS: The DASH-TOP intervention reduced decisional conflict in the decision -making process, with decision analysis being the most effective component to improve the quality of the decision. There is a need for more implementation research to improve the delivery of SDM interventions in the clinical encounter.

A Virtual Community of Practice to Improve Primary Health Care Professionals' Attitudes Toward Patient Empowerment (e-MPODERA): A Cluster Randomized Trial.

PURPOSE: We aimed to evaluate the effectiveness of a virtual community of practice (vCoP) in improving primary health care professionals' (HCPs') attitudes toward empowering patients with chronic disease. METHODS: We conducted a cluster randomized controlled trial. Practices were units of randomization, and primary HCPs and patients were units of analysis. Sixty-three practices in Madrid, Catalonia, and the Canary Islands were randomly allocated to the intervention or control groups. Randominzation of practices was performed after HCP and patient recruitment. The patients and statistician were anonymized to group allocation; it was not possible to anonymize HCPs. The intervention was a 12-month multicomponent tailored vCoP built on the Web 2.0 concept and focused on skills toward patient empowerment. The primary outcome was Patient-Provider Orientation Scale (PPOS) score at baseline and at 12 months. The secondary outcome was the Patient Activation Measure (PAM) score. RESULTS: A total of 321 HCPs and 1,921 patients were assessed. The intervention had a positive effect on PPOS total score (0.14 points higher in the vCoP arm; 95% CI, 0.03-0.25; P = .011) and the PPOS Sharing subscale (0.3 points higher in the vCoP arm; 95% CI, 0.15-0.44; P < .001). No effect was found for the PPOS Caring subscale, and no significant differences were found for PAM scores. CONCLUSIONS: A vCoP led to a minor increase in the PPOS Sharing component and the total score but not in the Caring component. However, considerable uncertainty remains, given the observed attrition and other limitations of the study. Further research is needed on the effectiveness of the vCoP model and on how to improve HCP engagement.VISUAL ABSTRACT.

Women's values and preferences on low-molecular-weight heparin and pregnancy: a mixed-methods systematic review.

BACKGROUND: Venous thromboembolism (VTE) in pregnancy is an important cause of maternal morbidity and mortality. Low-molecular-weight heparin (LMWH) is the cornerstone of prophylaxis and treatment of thrombotic events during pregnancy. LMWH has fewer adverse effects than other anticoagulants, does not cross the placenta, and is safe for the fetus. However, the use of LMWH during pregnancy is sensitive to womens' underlying preferences. The objective of this review is to systematically assess women's values and preferences research evidence on this topic. METHODS: We searched four electronic databases from inception to March 2022, and included studies examining values and preferences of using LMWH among pregnant women at risk of VTE. We followed a convergent integrated mixed-methods design to compare and contrast quantitative outcomes (utility and non-utility measures) and qualitative findings. We assessed the certainty of the values and preferences evidence with the GRADE approach for quantitative findings, and with GRADE-CERqual for qualitative evidence. Results were presented in a conjoint display. RESULTS: We screened 3,393 references and identified seven eligible studies. The mixed methods analysis resulted in four themes. Datasets confirmed each other in that: 1) the majority of women consider that benefits of treatment outweigh the inconveniences of daily injections; and 2) main concerns around medication are safety and injections administration. Quantitative outcomes expanded on the qualitative findings in that: 3) participants who perceived a higher risk of VTE were more willing to take LMWH. Finally, we found a discrepancy between the datasets around: 4) the amount of information preferred to make the decision; however, qualitative data expanded to clarify that women prefer making informed decisions and receive support from their clinician in their decision-making process. CONCLUSIONS: We are moderately confident that in the context of pregnancy, using LMWH is preferred by women given its net beneficial balance. Integrating data from different sources of evidence, and representing them in a jointly manner helps to identify patient's values and preferences. Our results may inform clinical practice guidelines and support shared decision-making process in the clinical encounter for the management of VTE in the context of pregnancy.

Factors associated with patient empowerment in Spanish adults with type 2 diabetes: A cross-sectional analysis.

OBJECTIVE: The aim of the present study is to identify factors associated with patient empowerment in people living with type 2 diabetes mellitus (T2DM) in the Canary Islands (Spain). METHODS: Secondary cross-sectional analysis was carried out of data obtained in the INDICA study: A 24-month cluster randomized-controlled trial evaluating the effectiveness of educational interventions supported by new technology decision tools for T2DM patients. Sociodemographic variables, clinical data (years since diagnosis, glycated haemoglobin level, creatine, triglycerides, waist hip index, body mass index and number of comorbidities), diabetes knowledge (DIATEK), affective outcomes (Beck Depression Inventory-II, the State subscale of the State-Trait Anxiety Inventory and The Diabetes Distress Scale) and diabetes-related quality of life (The Audit of Diabetes-Dependent Quality of life) were assessed as potential correlates of patient empowerment, assessed using the Diabetes Empowerment Scale-Short Form. Multilevel mixed linear regression models on patient empowerment were developed. RESULTS: The analysis included the baseline data of 2334 patients. Results showed that age (B = -0.14; p < .001), diabetes knowledge (B = 0.61; p < .001) and state-anxiety (B = -0.09; p < .001) are significantly associated with patient empowerment. Sex, education level, living alone, employment status, country of birth, time since diagnosis, number of comorbidities, glycated haemoglobin level, depression and distress were not independently associated with patient empowerment in the multivariate analyses. CONCLUSION: Younger age, lower state-anxiety and greater diabetes-specific knowledge are important correlates of patient empowerment. In line with the results of the INDICA study, interventions based on patient-centred care might be effective in improving patient empowerment in adults with T2DM. Understanding the factors associated with empowerment may help clinicians and policymakers to identify high-risk groups, prioritize resources and target evidence-based interventions to better support people with T2DM to be actively involved in their own care. PATIENT OR PUBLIC CONTRIBUTION: Patients with T2DM were actively involved in the design of the INDICA study. Two patient associations were included as part of the research team and actively participated in designing the interventions and selecting outcome measures.

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

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

Processes for evidence summarization for patient decision aids: A Delphi consensus study.

BACKGROUND: Patient decision aids (PDAs) should provide evidence-based information so patients can make informed decisions. Yet, PDA developers do not have an agreed-upon process to select, synthesize and present evidence in PDAs. OBJECTIVE: To reach the consensus on an evidence summarization process for PDAs. DESIGN: A two-round modified Delphi survey. SETTING AND PARTICIPANTS: A group of international experts in PDA development invited developers, scientific networks, patient groups and listservs to complete Delphi surveys. DATA COLLECTION: We emailed participants the study description and a link to the online survey. Participants were asked to rate each potential criterion (omit, possible, desirable, essential) and provide qualitative feedback. ANALYSIS: Criteria in each round were retained if rated by >80% of participants as desirable or essential. If two or more participants suggested rewording, reordering or merging, the steering group considered the suggestion. RESULTS: Following two Delphi survey rounds, the evidence summarization process included defining the decision, reporting the processes and policies of the evidence summarization process, assembling the editorial team and managing (collect, manage, report) their conflicts of interest, conducting a systematic search, selecting and appraising the evidence, presenting the harms and benefits in plain language, and describing the method of seeking external review and the plan for updating the evidence (search, selection and appraisal of new evidence). CONCLUSION: A multidisciplinary stakeholder group reached consensus on an evidence summarization process to guide the creation of high-quality PDAs. PATIENT CONTRIBUTION: A patient partner was part of the steering group and involved in the development of the Delphi survey.

Cross-cultural validation of the patient-practitioner orientation scale among primary care professionals in Spain.

BACKGROUND: In recent decades, many self-report instruments have been developed to assess the extent to which patients want to be informed and involved in decisions about their health as part of the concept of person-centred care (PCC). The main objective of this research was to translate, adapt and validate the Patient-Practitioner Orientation Scale (PPOS) using a sample of primary care health-care professionals in Spain. METHODS: Baseline analysis of PPOS scores for 321 primary care professionals (general practitioners and nurses) from 63 centres and 3 Spanish regions participating in a randomized controlled trial. We analysed missing values, distributions and descriptive statistics, item-to-scale correlations and internal consistency. Performed were confirmatory factor analysis (CFA) of the 2-factor model (sharing and caring dimensions), scale depuration and principal component analysis (PCA). RESULTS: Low inter-item correlations were observed, and the CFA 2-factor model only obtained a good fit to the data after excluding 8 items. Internal consistency of the 10-item PPOS was acceptable (0.77), but low for individual subscales (0.70 and 0.55). PCA results suggest a possible 3-factor structure. Participants showed a patient-oriented style (mean = 4.46, SD = 0.73), with higher scores for caring than sharing. CONCLUSION: Although the 2-factor model obtained empirical support, measurement indicators of the PPOS (caring dimension) could be improved. Spanish primary care health-care professionals overall show a patient-oriented attitude, although less marked in issues such as patients' need for and management of medical information.

Information needs and research priorities for fertility preservation in women with breast cancer: patients and experts' perspectives.

OBJECTIVE: To identify the information needs and research priorities that women with breast cancer (BC), their families and BC experts perceive on the fertility preservation. METHODS: We conducted two Delphi-based studies through three online rounds. The first was aimed to identify information and research needs; the second one to assess the importance of those needs and the third one to obtain consensus, defined as an interquartile range ≤2. RESULTS: The participation rate was 76.2% in study 1 and 53.7% in study 2. The most important information needs were the referral protocol, pregnancy options for women with BC, side effects of tamoxifen and menopause as a consequence of treatment. The most important research priorities were the participation of different health professionals to provide oncofertility information, referral protocols and efficacy and safety of FP options. CONCLUSION: Information about fertility preservation in the context of BC and different ways to get pregnant, considering risks and benefits, has emerged as an unmet need for patients and careers. The need for a participatory and coordinated approach to the provision of information on oncofertility has been agreed. Other research needs are described in an attempt to focus future research in the most necessary areas.

Postlaunch evidence-generation studies for medical devices in Spain: the RedETS approach to integrate real-world evidence into decision making.

The Monitoring Studies (MS) program, the approach developed by RedETS to generate postlaunch real-world evidence (RWE), is intended to complement and enhance the conventional health technology assessment process to support health policy decision making in Spain, besides informing other interested stakeholders, including clinicians and patients. The MS program is focused on specific uncertainties about the real effect, safety, costs, and routine use of new and insufficiently assessed relevant medical devices carefully selected to ensure the value of the additional research needed, by means of structured, controlled, participative, and transparent procedures. However, despite a clear political commitment and economic support from national and regional health authorities, several difficulties were identified along the development and implementation of the first wave of MS, delaying its execution and final reporting. Resolution of these difficulties at the regional and national levels and a greater collaborative impulse in the European Union, given the availability of an appropriate methodological framework already provided by EUnetHTA, might provide a faster and more efficient comparative RWE of improved quality and reliability at the national and international levels.

Development of a decisional flowchart for meaningful patient involvement in Health Technology Assessment.

INTRODUCTION: This paper aims to describe the development of a flowchart to guide the decisions of researchers in the Spanish Network for Health Technology Assessment of the National Health System (RedETS) regarding patient involvement (PI) in Health Technology Assessment (HTA). By doing so, it reflects on current methodological challenges in PI in the HTA field: how best to combine PI methods and what is the role of patient-based evidence. METHODS: A decisional flowchart for PI in HTA was developed between March and April 2019 following an iterative process, reviewed by the members of the PI Interest Group and other RedETS members and validated during an online deliberative meeting. The development of the flowchart was based on a previous methodological framework assessed in a pilot study. RESULTS: The guidelines on how to involve patients in HTA in the RedETS were graphically represented in a flowchart. PI must be included in all HTA reports, except those that assess technologies with no relevant impact on patients' experiences, values, and preferences. Patient organizations or expert patients related to the topic of the HTA report must be identified and invited. These patients can participate in protocol development, outcomes' identification, assessment process, and report review. When the technology assessed affects in a relevant way patient experiences, values, and preferences, patient-based evidence should be included through a systematic literature review or a primary study. CONCLUSIONS: The decisional flowchart for PI in HTA contributes to the current methodological challenges by proposing a combination of direct involvement and patient-based evidence.

Framing the process in the implementation of care for people with generalized anxiety disorder in primary care: a qualitative evidence synthesis.

BACKGROUND: Generalized anxiety disorder (GAD) is one of the most common mental disorders in primary care (PC). GAD has low remission and high relapse rates over long follow-up periods. Qualitative evidence was synthesized to understand the implementation of care and treatment options for people with GAD in PC. METHODS: Research published from 2008 to September 2020 was searched in five databases (MEDLINE, EMBASE, CINAHL, WOS and PsycArticles). Studies that used qualitative methods for data collection and analysis to investigate the implementation of care and treatment options for people with GAD in PC and outpatient settings were included. Non-qualitative studies, mixed methods studies that did not separately report qualitative findings and studies in languages other than English or Spanish were excluded. We used the Confidence in the Evidence from Reviews of Qualitative Research (CERQual) framework to assess the overall confidence in the findings. RESULTS: The results with a moderate level of confidence showed that the trajectory of care for people with GAD in PC and outpatient settings is long and fluctuates over time, involving multiple difficulties in accessing and maintaining initial treatment or successive treatment options. In addition, there are wide variations in the preferences for and acceptability of different treatment options. The results with a high level of confidence indicated that more information on GAD and its treatment options is needed for PC practitioners, GAD patients and their carers. The results with a low level of confidence suggested that patients use antidepressants for longer than recommended and that the interruption of treatment is not usually planned. CONCLUSIONS: Initial resistance to new treatments among people with GAD can make access and adherence to treatment difficult. Improving care may require patients to be informed of possible trajectories in stepped care pathways before the initiation of treatment so they are aware that they may need to try a number of options until the most effective treatment for them is found. Increased awareness of and information materials on GAD may facilitate both appropriate diagnosis and long-term care.

Acceptability and feasibility of a virtual community of practice to primary care professionals regarding patient empowerment: a qualitative pilot study.

BACKGROUND: Virtual communities of practice (vCoPs) facilitate online learning via the exchange of experiences and knowledge between interested participants. Compared to other communities, vCoPs need to overcome technological structures and specific barriers. Our objective was to pilot the acceptability and feasibility of a vCoP aimed at improving the attitudes of primary care professionals to the empowerment of patients with chronic conditions. METHODS: We used a qualitative approach based on 2 focus groups: one composed of 6 general practitioners and the other of 6 practice nurses. Discussion guidelines on the topics to be investigated were provided to the moderator. Sessions were audio-recorded and transcribed verbatim. Thematic analysis was performed using the ATLAS-ti software. RESULTS: The available operating systems and browsers and the lack of suitable spaces and time were reported as the main difficulties with the vCoP. The vCoP was perceived to be a flexible learning mode that provided up-to-date resources applicable to routine practice and offered a space for the exchange of experiences and approaches. CONCLUSIONS: The results from this pilot study show that the vCoP was considered useful for learning how to empower patients. However, while vCoPs have the potential to facilitate learning and as shown create professional awareness regarding patient empowerment, attention needs to be paid to technological and access issues and the time demands on professionals. We collected relevant inputs to improve the features, content and educational methods to be included in further vCoP implementation. TRIAL REGISTRATION: ClinicalTrials.gov , NCT02757781 . Registered on 25 April 2016.

Toward a Strategy to Involve Patients in Health Technology Assessment in Spain.

OBJECTIVES: The aim of this study was to develop a feasible and effective strategy to involve patients in the Spanish Network of Agencies of Health Technology Assessment (RedETS). METHODS: The framework for patient involvement (PI) in the assessment activities and processes of RedETS were developed through a research project that included: (i) a systematic search of the international literature describing a strategy and/or a methodology linking health technology assessment (HTA) and PI; (ii) a qualitative study through interviews with RedETS members to analyze the perceptions of PI among HTA managers in the Spanish context; (iii) a Delphi consultation with three large platforms of patients, carers and consumer organizations in Spain about their perspectives of PI; (iv) a consensus process with the members of the RedETS Governing Council to define the final strategy. RESULTS: Three main themes were identified in the literature and Web site review: (i) PI methods for the different HTA phases; (ii) Participant definition and selection; (iii) Resources needed. A three-step implementation strategy was proposed: (i) short-term actions: piloting and testing patient participation in HTA and building patients' capacity; (ii) medium-term actions: broadening the participation of patients, and building internal capacity; (iii) long-term actions: consolidating and mainstreaming patient involvement CONCLUSIONS: Patient participation can be incorporated into almost all the HTA phases and products with greater or lesser degrees of difficulty. However, a progressive implementation strategy is suggested for a feasible PI process.

Effectiveness of a decision aid for promoting colorectal cancer screening in Spain: a randomized trial.

BACKGROUND: Colorectal cancer (CRC) screening has shown to reduce incidence and mortality rates, and therefore is widely recommended for people above 50 years-old. However, despite the implementation of population-based screening programs in several countries, uptake rates are still low. Decision aids (DAs) may help patients to make informed decisions about CRC screening. METHODS: We performed a randomized controlled trial to assess the effectiveness of a DA developed to promote CRC screening, with patients from two primary care centers in Spain who never had underwent CRC screening. Contrary to center B (n = 24), Center A (n = 83) attended patients from an area where the population-based screening program was not implemented at that moment. Outcome measures were decisional conflict, knowledge of the disease and available screening options, intention to uptake the test, and concordance between patients' goals/concerns and intention. RESULTS: In center A, there were significant differences favoring the DA in decisional conflict (p < 0.001) and knowledge (p < 0.001). The absolute differences favoring DA group in intention to undergo fecal occult blood test (10.5%) and colonoscopy (13.7%) were significant only before correction for attenuation. In center B the differences were significant only for knowledge (p < 0.001). Patients' goals and concerns regarding the screening did not significantly predict their intention, and therefore we could not calculate a measure of concordance between the two constructs. CONCLUSIONS: A DA improved the decisional process of participants who had never been invited to participate in the Spanish public CRC screening program, replicating previous results in this field. Future research is needed to identify subgroups that could benefit more from these interventions. TRIAL REGISTRATION: International Standard Registered Clinical/social Study Number: ISRCTN98108615 (Retrospectively registered on 27 December 2018).

Clinical effectiveness and safety of Weil's osteotomy and distal metatarsal mini-invasive osteotomy (DMMO) in the treatment of metatarsalgia: A systematic review.

BACKGROUND: Weil's osteotomy (WO) is the most applied surgical treatment for metatarsalgia, a persistent pain in the lesser metatarsals' heads. We aim to review its effectiveness and safety compared to the percutaneous technique known as distal metatarsal mini-invasive osteotomy (DMMO). METHODS: Systematic review in Medline, Pubmed, Embase, Cinahl and Cochrane Library. We included studies that directly compared WO and DMMO for the treatment of primary metatarsalgia. Data on pain, function, complications and patients' satisfaction were extracted and narratively synthesized. RESULTS: Four retrospective studies were identified. There were no significant differences in clinical effectiveness or patients' satisfaction. Time to bone healing was significantly longer for DMMO, whereas WO showed more wound problems and metatarsophalangeal stiffness. Other complications were infrequent in the two procedures. CONCLUSION: Evidence on the direct comparison of WO and DMMO is scarce and of low quality. Randomized studies are needed in order to control for potential confounders.

Effectiveness of a decision aid for patients with depression: A randomized controlled trial.

BACKGROUND: Shared decision making is an important component of patient-centred care and decision aids are tools designed to support patients' decision making and help patients with depression to make informed choices. OBJECTIVE: The study aim was to assess the effectiveness of a web-based decision aid for patients with unipolar depression. DESIGN: Randomized controlled trial. SETTING AND PARTICIPANTS: Adults diagnosed with a major depressive disorder and recruited in primary care centres were included and randomized to the decision aid (n=68) or usual care (n=79). INTERVENTION: Patients in the decision aid group reviewed the decision aid accompanied by a researcher. OUTCOME MEASURES: Knowledge about treatment options, decisional conflict, treatment intention and preference for participation in decision making. We also developed a pilot measure of concordance between patients' goals and concerns about treatment options and their treatment intention. RESULTS: Intervention significantly improved knowledge (P<.001) and decisional conflict (P<.001), and no differences were observed in treatment intention, preferences for participation, or concordance. One of the scales developed to measure goals and concerns showed validity issues. CONCLUSION: The decision aid "Decision making in depression" is effective improving knowledge of treatment options and reducing decisional conflict of patients with unipolar depression. More research is needed to establish a valid and reliable measure of concordance between patients' goals and concerns regarding pharmacological and psychological treatment, and the choice made.

Patient Empowerment and Involvement in Research.

Patients with rare diseases often face difficulties in clinical care due to the low prevalence of their diseases and the resulting healthcare professionals' lack of expertise. Valid and standardized guidelines for clinical management are also lacking due to the scarcity of research and the variability of the clinical expressivity within each disease. In addition, in cases of rare diseases, the patient and health professional relationship may not fit with the traditional assumptions of medical care. Although the communication process between patients and healthcare professionals shares most of the general features of the standard patient-health professional interaction, rare diseases may be burdened with additional issues.In this sense, clinical decision-making in an uncertainty context should take advantage of involving patients in deeper informational process to promote valid shared decision-making between patients/caregivers and healthcare professionals. This process of patient/caregiver empowerment is a priority in the context of rare diseases, as it encourages acquisition of information that will help improving patient-healthcare professional's interaction, and building a collaborative relationship. It is also a chance for healthcare professionals to learn about rare diseases from the perspective of patients.Engagement of patients and other stakeholders in clinical research may help to ensure that research efforts in rare diseases address relevant clinical questions and patient-centered health outcomes. However, the effectiveness of patient-engagement approaches, particularly for the study of rare diseases, has not been well studied.

Validation of the Spanish version of the 9-item Shared Decision-Making Questionnaire.

OBJECTIVE: To translate and assess the psychometric properties of the 9-item Shared Decision-Making Questionnaire (SDM-Q-9) for measuring patients' perceptions of how clinicians' performance fits the SDM process. DESIGN: Cross-sectional study. SETTING AND PARTICIPANTS: Data were collected in primary care health centres. Patients suffering from chronic diseases and facing a medical decision were included in the study. MEASUREMENTS: The original German SDM-Q-9 was translated to Spanish using the process of cross-cultural adaptation of self-reported measures as the methodological model for Spanish translation. Reliability (internal consistency) and construct validity [exploratory (EFA) and confirmatory factor analysis (CFA)] were assessed. RESULTS: The final Spanish version of the SDM-Q-9 was tested in a primary care sample of 540 patients. The SDM-Q-9 presented adequate reliability and acceptable validity. Internal consistency yielded a Cronbach's alpha of 0.885 for the whole scale. EFA showed a two-factorial solution, and for the CFA, the best solution was obtained with a one-dimensional factor with the item 1 excluded, which produced the best indexes of fit. DISCUSSION AND CONCLUSIONS: The Spanish version of the SDM-Q-9 showed adequate reliability and acceptable validity parameters among primary care patients. The SDM-Q-9 is suitable for use in Spain and other Spanish-speaking countries with similarly organized health-care systems. The use of the SDM-Q-9 may contribute to the evaluation of SDM process from the patient's perspective.