Implementation of a virtual community of practice to promote the empowerment of middle-aged people with multimorbidity: study protocol of a randomised controlled trial.

INTRODUCTION: Empowering people living with multimorbidity (multiple chronic conditions) to gain greater confidence in managing their health can enhance their quality of life. Education focused on self-management is a key tool for fostering patient empowerment and is mostly provided on an individual basis. Virtual communities of practice (VCoP) present a unique opportunity for online education in chronic condition self-management within a social context. This research aims to evaluate the effectiveness/cost-effectiveness of individualised, online self-management education compared with VCoP among middle-aged individuals living with multiple chronic conditions. METHODS AND ANALYSIS: People aged 30-60, living with ≥2 chronic conditions and receiving care in primary care (PC) centres and outpatient hospital-based clinics in Madrid and Canary Islands will enrol in an 18-month parallel-design, blinded (intervention assessment and data analysts), pragmatic (adhering to the intention-to-treat principle), individually randomised trial. The trial will compare two 12-month web-based educational offers of identical content; one delivered individually (control) and the other with online social interaction (VCoP, intervention). Using repeated measures mixed linear models, with the patient as random effect and allocation groups and time per group as fixed effects, we will estimate between-arm differences in the change in Patient Activation Measure from baseline to 12 months (primary endpoint), including measurements at 6-month and 18-month follow-up. Other outcomes will include measures of depression and anxiety, treatment burden, quality of life. In addition to a process evaluation of the VCoP, we will conduct an economic evaluation estimating the relative cost-effectiveness of the VCoP from the perspectives of both the National Health System and the Community. ETHICS AND DISSEMINATION: The trial was approved by Clinical Research Ethics Committees of Gregorio Marañón University Hospital in Madrid/Nuestra Señora Candelaria University Hospital in Santa Cruz de Tenerife. The results will be disseminated through workshops, policy briefs, peer-reviewed publications and local/international conferences. TRIAL REGISTRATION NUMBER: NCT06046326.

COVID-19 healthcare and social-related needs from the perspective of Spanish patients and healthcare providers: a qualitative analysis of responses to open-ended questions.

Introduction: Identifying stakeholders' needs is crucial to informing decisions and policy development. This study aims to identify healthcare and social-related needs and effective strategies associated with COVID-19 from the first-person perspectives of patients and healthcare providers. Methods: Cross-sectional online survey design including qualitative open-ended questions, conducted in primary care and hospital settings across Spain, with 12 out of 19 regions represented. Adults aged 18 years and older, who (a) resided in Spain and had a history of COVID-19 or (b) worked as healthcare providers delivering direct or indirect care for people with COVID-19 in Spanish primary care or hospitals during 2020 were eligible to participate. Recruitment was conducted via social-media networks (Twitter, LinkedIn, and WhatsApp) and communication channels of key organizations including patient and professional associations and groups. A total of 182 people were invited to complete the surveys and 76 people completed the surveys (71% women), of which 33 were home-isolated patients, 14 were hospitalized patients, 16 were primary care professionals, and 13 were hospital care professionals. Results: A total of 327 needs and 86 effective strategies and positive aspects were identified across surveys and classified into the following overarching themes: (i) Accessibility, (ii) Basic needs, (iii) Clinical care, (iv) Person-and-family centered care, (v) Caring for the healthcare professional, (vi) Protocolization, information, health campaigns, and education, (vii) Resource availability, (viii) and Organizational needs/strategies. Discussion: Findings indicate the Spanish health and social care systems were generally unprepared to combat COVID-19. Implications for research, practice, and policy focus on integrating first-person perspectives as best practice to identify, prioritize and address needs to increase health and social care systems capacity and preparedness, as well as providing well-co-coordinated responses across government, healthcare, and non-government sectors to promote and protect the physical and mental health of all.

Efficacy, Safety, and Evaluation Criteria of mHealth Interventions for Depression: Systematic Review.

BACKGROUND: Depression is a significant public health issue that can lead to considerable disability and reduced quality of life. With the rise of technology, mobile health (mHealth) interventions, particularly smartphone apps, are emerging as a promising approach for addressing depression. However, the lack of standardized evaluation tools and evidence-based principles for these interventions remains a concern. OBJECTIVE: In this systematic review and meta-analysis, we aimed to evaluate the efficacy and safety of mHealth interventions for depression and identify the criteria and evaluation tools used for their assessment. METHODS: A systematic review and meta-analysis of the literature was carried out following the recommendations of the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) statement. Studies that recruited adult patients exhibiting elevated depressive symptoms or those diagnosed with depressive disorders and aimed to assess the effectiveness or safety of mHealth interventions were eligible for consideration. The primary outcome of interest was the reduction of depressive symptoms, and only randomized controlled trials (RCTs) were included in the analysis. The risk of bias in the original RCTs was assessed using version 2 of the Cochrane risk-of-bias tool for randomized trials. RESULTS: A total of 29 RCTs were included in the analysis after a comprehensive search of electronic databases and manual searches. The efficacy of mHealth interventions in reducing depressive symptoms was assessed using a random effects meta-analysis. In total, 20 RCTs had an unclear risk of bias and 9 were assessed as having a high risk of bias. The most common element in mHealth interventions was psychoeducation, followed by goal setting and gamification strategies. The meta-analysis revealed a significant effect for mHealth interventions in reducing depressive symptoms compared with nonactive control (Hedges g=-0.62, 95% CI -0.87 to -0.37, I2=87%). Hybrid interventions that combined mHealth with face-to-face sessions were found to be the most effective. Three studies compared mHealth interventions with active controls and reported overall positive results. Safety analyses showed that most studies did not report any study-related adverse events. CONCLUSIONS: This review suggests that mHealth interventions can be effective in reducing depressive symptoms, with hybrid interventions achieving the best results. However, the high level of heterogeneity in the characteristics and components of mHealth interventions indicates the need for personalized approaches that consider individual differences, preferences, and needs. It is also important to prioritize evidence-based principles and standardized evaluation tools for mHealth interventions to ensure their efficacy and safety in the treatment of depression. Overall, the findings of this study support the use of mHealth interventions as a viable method for delivering mental health care. TRIAL REGISTRATION: PROSPERO CRD42022304684; https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=304684.

The relationship between patient empowerment and related constructs, affective symptoms and quality of life in patients with type 2 diabetes: a systematic review and meta-analysis.

Introduction: The aim of this systematic review is to assess the relationship between patient empowerment and other empowerment-related constructs, and affective symptoms and quality of life in patients with type 2 diabetes. Methods: A systematic review of the literature was conducted, according to the PRISMA guidelines. Studies addressing adult patients with type 2 diabetes and reporting the association between empowerment-related constructs and subjective measures of anxiety, depression and distress, as well as self-reported quality of life were included. The following electronic databases were consulted from inception to July 2022: Medline, Embase, PsycINFO, and Cochrane Library. The methodological quality of the included studies was analyzed using validated tools adapted to each study design. Meta-analyses of correlations were performed using an inverse variance restricted maximum likelihood random-effects. Results: The initial search yielded 2463 references and seventy-one studies were finally included. We found a weak-to-moderate inverse association between patient empowerment-related constructs and both anxiety (r = -0.22) and depression (r = -0.29). Moreover, empowerment-related constructs were moderately negatively correlated with distress (r = -0.31) and moderately positively correlated with general quality of life (r = 0.32). Small associations between empowerment-related constructs and both mental (r = 0.23) and physical quality of life (r = 0.13) were also reported. Discussion: This evidence is mostly from cross-sectional studies. High-quality prospective studies are needed not only to better understand the role of patient empowerment but to assess causal associations. The results of the study highlight the importance of patient empowerment and other empowerment-related constructs such as self-efficacy or perceived control in diabetes care. Thus, they should be considered in the design, development and implementation of effective interventions and policies aimed at improving psychosocial outcomes in patients with type 2 diabetes. Systematic review registration: https://www.crd.york.ac.uk/prospero/display_record.php?ID=CRD42020192429, identifier CRD42020192429.

Digital Health Literacy and Person-Centred Care: Co-Creation of a Massive Open Online Course for Women with Breast Cancer.

The diagnosis of breast cancer (BC) can make the affected person vulnerable to suffering the possible consequences of the use of low-quality health information. Massive open online courses (MOOCs) may be a useful and efficient resource to improve digital health literacy and person-centred care in this population. The aim of this study is to co-create a MOOC for women with BC, using a modified design approach based on patients' experience. Co-creation was divided into three sequential phases: exploratory, development and evaluation. Seventeen women in any stage of BC and two healthcare professionals participated. In the exploratory phase, a patient journey map was carried out and empowerment needs related to emotional management strategies and self-care guidelines were identified, as well as information needs related to understanding medical terminology. In the development phase, participants designed the structure and contents of the MOOC through a Moodle platform. A MOOC with five units was developed. In the evaluation phase, participants strongly agreed that their participation was useful for the MOOC's development and participating in the co-creation process made the content more relevant to them (experience in the co-creation); most of the participants positively evaluated the content or interface of the MOOC (acceptability pilot). Educational interventions designed by women with BC is a viable strategy to generate higher-quality, useful resources for this population.

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.

Global Healthcare Needs Related to COVID-19: An Evidence Map of the First Year of the Pandemic.

The COVID-19 pandemic has exposed gaps and areas of need in health systems worldwide. This work aims to map the evidence on COVID-19-related healthcare needs of adult patients, their family members, and the professionals involved in their care during the first year of the pandemic. We searched the databases MEDLINE, Embase, and Web of Science. Two reviewers independently screened titles and abstracts and assessed full texts for eligibility. Disagreements were resolved by consensus. Descriptive data were extracted and inductive qualitative content analysis was used to generate codes and derive overarching themes. Thirty-six studies met inclusion criteria, with the majority reporting needs from the perspective of professionals (35/36). Professionals' needs were grouped into three main clusters (basic, occupational, and psycho-socio-emotional needs); patients' needs into four (basic, healthcare, psycho-socio-emotional, and other support needs); and family members' needs into two (psycho-socio-emotional and communication needs). Transversal needs across subgroups were also identified and grouped into three main clusters (public safety, information and communication, and coordination and support needs). This evidence map provides valuable insight on COVID-19-related healthcare needs. More research is needed to assess first-person perspectives of patients and their families, examine whether needs differ by country or region, and evaluate how needs have evolved over time.

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.

Shared decision-making in Spain in 2022: An updated revision of the current situation.

In Spain, there is not a national strategy to promote shared decision making (SDM) in clinical practice, and it is still not a requisite for improving the quality of health services, in either the legal norms or professionals' educational curricula. However, several national strategies in specific health areas increasingly include the principles of person centred care (PCC) and SDM into their objectives, promoting patients' empowerment and activation. Furthermore, several institutions continue to develop Patient Decision Aids (PtDAs) and other resources to facilitate patients' involvement in their own care; training programs for professionals; links between PtDAs and clinical practice guidelines; as well as interventional studies assessing the impact of PCC and SDM interventions in clinical practice. Initiatives to involve patients in health research design and health technology assessment are also being developed. We describe an update of the current state of research, policy and implementation of SDM after five years of substantial advances in Spain. Many challenges remain regarding national and regional policies on PCC and SDM, implementation of SDM in real practice and educational curricula, development of quality indicators and evaluation procedures.

Increased Patient Empowerment Is Associated with Improvement in Anxiety and Depression Symptoms in Type 2 Diabetes Mellitus: Findings from the INDICA Study.

Introduction. In cross-sectional analyses, higher levels of patient empowerment have been related to lower symptoms of anxiety and depression. The aims of this study are: (1) to assess if patient empowerment predicts anxiety and depression symptoms after 12 and 24 months among patients with type 2 diabetes mellitus, and (2) to analyze whether a change in patient empowerment is associated with a change in anxiety and depression level. Methods. This is a secondary analysis of the INDICA study, a 24 month-long, multi-arm randomized controlled trial. Patient empowerment (DES-SF), depression (BDI-II), and state-anxiety (STAI-S) were assessed at the baseline (pre-intervention) and after 12 and 24 months. Multilevel mixed linear models with a random intercept were performed to correct for our clustered data. Results. The multilevel regression models showed that the baseline empowerment did not significantly predict anxiety and depression after 12 and 24 months. However, a higher increase in patient empowerment was significantly associated with reductions of anxiety (p < 0.001) and depression levels (p < 0.001). This association was not significantly different between the two follow-ups. Conclusion. This study contributes to the knowledge on how to reduce affective symptoms in patients with uncomplicated T2DM through comprehensive patient-centered interventions, and it highlights patient empowerment as a significant contributor.

Effectiveness of Mantra-Based Meditation on Mental Health: A Systematic Review and Meta-Analysis.

BACKGROUND: Meditation is defined as a form of cognitive training that aims to improve attentional and emotional self-regulation. This systematic review aims to evaluate the available scientific evidence on the effectiveness and safety of mantra-based meditation techniques (MBM), in comparison to passive or active controls, or other active treatment, for the management of mental health symptoms. METHODS: MEDLINE, EMBASE, Cochrane Library, and PsycINFO databases were consulted up to April 2021. Randomised controlled trials regarding meditation techniques mainly based on the repetition of mantras, such as transcendental meditation or others, were included. RESULTS: MBM, compared to control conditions, was found to produce significant small-to-moderate effect sizes in the reduction of anxiety (g = -0.46, IC95%: -0.60, -0.32; I2 = 33%), depression (g = -0.33, 95% CI: -0.48, -0.19; I2 = 12%), stress (g = -0.45, 95% CI: -0.65, -0.24; I2 = 46%), post-traumatic stress (g = -0.59, 95% CI: -0.79, -0.38; I2 = 0%), and mental health-related quality of life (g = 0.32, 95% CI: 0.15, 0.49; I2 = 0%). CONCLUSIONS: MBM appears to produce small-to-moderate significant reductions in mental health; however, this evidence is weakened by the risk of study bias and the paucity of studies with psychiatric samples and long-term follow-up.

Mobile Applications in Mood Disorders and Mental Health: Systematic Search in Apple App Store and Google Play Store and Review of the Literature.

OBJECTIVES: The main objective of this work was to explore and characterize the current landscape of mobile applications available to treat mood disorders such as depression, bipolar disorder, and dysthymia. METHODS: We developed a tool that makes both the Apple App Store and the Google Play Store searchable using keywords and that facilitates the extraction of basic app information of the search results. All app results were filtered using various inclusion and exclusion criteria. We characterized all resultant applications according to their technical details. Furthermore, we searched for scientific publications on each app's website and PubMed, to understand whether any of the apps were supported by any type of scientific evidence on their acceptability, validation, use, effectiveness, etc. Results: Thirty apps were identified that fit the inclusion and exclusion criteria. The literature search yielded 27 publications related to the apps. However, these did not exclusively concern mood disorders. 6 were randomized studies and the rest included a protocol, pilot-, feasibility, case-, or qualitative studies, among others. The majority of studies were conducted on relatively small scales and 9 of the 27 studies did not explicitly study the effects of mobile application use on mental wellbeing. CONCLUSION: While there exists a wealth of mobile applications aimed at the treatment of mental health disorders, including mood disorders, this study showed that only a handful of these are backed by robust scientific evidence. This result uncovers a need for further clinically oriented and systematic validation and testing of such apps.

Co-Creation of Massive Open Online Courses to Improve Digital Health Literacy in Pregnant and Lactating Women.

BACKGROUND: Digital health literacy (DHL) increases the self-efficacy and empowerment of pregnant and lactating women (PLW) in using the Internet for health issues. The European project IC-Health aimed to improve DHL among PLW, through the co-creation of Massive Open Online Courses (MOOCs). METHODS: The co-creation of the MOOCs included focus groups and the creation of communities of practice (CoPs) with PLW and healthcare professionals aimed to co-design the MOOCs. The quantitative measures of MOOCs' acceptability, experience in the co-creation process and increase in DHL (dimensions of finding, understanding and appraisal) were assessed. RESULTS: 17 PLW participated in focus groups, 113 participants were included in CoPs and 68 participants evaluated the acceptability of MOOCs. A total of 6 MOOCs aimed at improving PLW's DHL were co-designed. There was a significant improvement in self-perceived DHL after using MOOCs (p-value < 0.001). The acceptability of MOOCs and co-creation experience were positively valued. CONCLUSIONS: The preliminary results of the quantitative assessment showed a higher self-perceived DHL after the IC-Health MOOCs. These results suggest that IC-Health MOOCs and the co-creation methodology appear to be a viable process to carry out an intervention aimed to improve DHL levels in European PLW.

Cocreation of Massive Open Online Courses to Improve Digital Health Literacy in Diabetes: Pilot Mixed Methods Study.

BACKGROUND: Self-management education is a fundamental aspect in the health care of people with diabetes to develop the necessary skills for the improvement of health outcomes. Patients are required to have the competencies to manage electronic information resources-that is, an appropriate level of digital health literacy. The European project IC-Health aimed to improve digital health literacy among people with diabetes through the cocreation of massive open online courses (MOOCs). OBJECTIVE: We report the preliminary results obtained in 3 participating countries in the IC-Health project (Italy, Spain, and Sweden) regarding (1) experience of the participants during the cocreation process of MOOCs, (2) perceived changes in their digital health literacy level after using MOOCs, and (3) a preliminary assessment of the acceptability of MOOCs. METHODS: The cocreation of the MOOCs included focus groups with adults and adolescents with diabetes and the creation of independent communities of practice for type 1 diabetes and type 2 diabetes participants aimed to co-design the MOOCs. Quantitative measures of the acceptability of MOOCs, experience in the cocreation process, and increase in digital health literacy (dimensions of finding, understanding, and appraisal) were assessed. RESULTS: A total of 28 participants with diabetes participated in focus groups. Adults and adolescents agreed that the internet is a secondary source of health-related information. A total of 149 participants comprised the diabetes communities of practice. A total of 9 MOOCs were developed. Acceptability of the MOOCs and the cocreation experience were positively valued. There was a significant improvement in digital health literacy in both adults and adolescents after using MOOCs (P<.001). CONCLUSIONS: Although the results presented on self-perceived digital health literacy are preliminary and exploratory, this pilot study suggests that IC-Health MOOCs represent a promising tool for the medical care of diabetes, being able to help reduce the limitations associated with low digital health literacy and other communication barriers in the diabetes population.

Transcranial Magnetic Stimulation for the Treatment of Cocaine Addiction: A Systematic Review.

Long-term cocaine use is associated with cognitive deficits and neuro-psychiatric pathologies. Repetitive transcranial magnetic stimulation (rTMS) is an emerging therapeutic strategy relating to changes in brain activity. It stimulates the prefrontal cortex and is involved in inhibitory cognitive control, decision making and care. This systematic review aims to evaluate and synthesize the evidence on the safety, effectiveness, and cost-effectiveness of rTMS for the treatment of cocaine addiction. A systematic review of the literature was carried out. The following electronic databases were consulted from inception to October 2020: MEDLINE, Embase, CINAHL, PsycINFO, Cochrane Central Register of Controlled Trials and Web of Science. Randomised controlled trials, non-randomised controlled trials and case-series and full economic evaluations were included. Twelve studies were included. No identified study reported data on cost-effectiveness. Significant results of the efficacy of TMS have been observed in terms of the reduction of craving to consume and the number of doses consumed. No serious adverse effects have been observed. Despite the low quality of the studies, the first results were observed in terms of reduction of cocaine use and craving. In any case, this effect is considered moderate. Studies with larger sample sizes and longer follow-ups are required.

Shared Decision-Making and Information Needs among People with Generalized Anxiety Disorder.

Shared decision making (SDM) aims to involve patients in the decisions about their care, considering their preferences, values and concerns about the different treatment options. However, research shows that people with mental health problems have considerable unmet information needs about their condition. This community-based cross-sectional study explores the SDM process and information needs among people with Generalized Anxiety Disorder (GAD), as an initial step in the design and development of a Patient Decision Aid for this population. Seventy participants completed an online survey with the Control Preference Scale, and questions about the perceived difficulty of past treatment decisions and the use of the Internet for searching for GAD-related information. Most participants preferred an active (42.9%) or collaborative role (41.4%) in the SDM process, and 53% did not perceive their preferred role. Information provided by healthcare professionals was considered insufficient by 28% of the sample, and over 30% reported using the Internet to look for GAD-related information at least once a week or more. The most relevant GAD-related information needs were general information (71.4%), information on self-help groups (65.7%), recommendations on how to face this disorder (61.4%) and information on treatment options (50%). Exploratory analyses showed that patients who perceived an active participation were more likely to search for information frequently (p = 0.038), and those who felt more involved than desired tended to search for more themes (p = 0.049). In summary, the study showed that a considerable percentage of GAD patients have unmet needs related to decision-making participation and information.

Stepped care for the treatment of depression: a systematic review and meta-analysis.

BACKGROUND: The Stepped Care Model (SCM) proposes a sequential approach in the treatment of depression, applying interventions of increasing intensity according to the level of severity of the individual. METHODS: A systematic review was carried out until January 2020 in eight electronic databases. We included randomized (RCT) and non-randomized controlled trials comparing the SCM to usual non-sequential care. RESULTS: Eighteen RCT with patients with confirmed or probable depression diagnosis were included. Meta-analyses yielded high heterogeneity, and subgroup analyses showed significant effects of the SCM only in studies with baseline moderately severe symptoms on average, compared to samples with mild/moderate depression. In the former subgroup, effects at 3-6 and 9-12 months were small for symptoms' reduction (g = -0.33, 95%CI: -0.55, -0.17 and -0.34, 95%CI: -0.53, -0.16) and moderate-to-strong in response and remission (Risk Ratios between 1.70-1.90). Overall, a significant benefit on quality of life was also observed (6 months: g = 0.31, 95%CI: 0.12, 0.49; 12 months: g = 0.18, 95%CI: 0.06, 0.31). More patients in the SCM groups were prescribed antidepressants at 6 months (RR = 1.31, 95%CI: 1.09, 1.57; I² = 87%). LIMITATIONS: The search does not guarantee the identification of all the relevant literature. Most included studies show uncertain or high risk of bias. CONCLUSIONS: The SCM seems to outperform usual care in populations with at least moderately severe symptoms on average. Results show high heterogeneity and future research should explore its sources.

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.

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

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