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Abstract 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.

Introduction: Suicide poses a severe public health challenge worldwide, impacting individuals, families, work, and society. The multifaceted nature of suicide demands a complex approach involving psychological, biological, social, cultural, and environmental factors. Recognizing suicide's status as the leading external cause of death in Spain, prevention increasingly incorporates technology, specifically mobile and software applications. Methods: A systematic review of the effectiveness and safety of mobile and software applications was conducted (MEDLINE, Embase, CINAHL, and PsycINFO databases). Outcome variables included: suicide; suicidal behavior; suicidal intent; suicidal ideation/thinking; self-perceived suicide risk; using/seeking mental health services; associated mental symptoms; mental health-related quality of life; satisfaction of the user and the health professional; adverse events related to the app, as defined in the included studies. Studies that do not include suicidal behavior, intention, or ideation were excluded. Where available data allowed, a meta-analysis was conducted for each outcome variable. Results: One systematic review and 13 randomized controlled trials (n=2,952) were analyzed. No significant differences were found in deaths by suicide or suicide attempts. At post-intervention, small but significant reductions were observed in suicidal ideation, hopelessness, depression, and worry, with anxiety reduction slightly above statistical significance. At follow-up (8 to 52 weeks), these variables also obtained significant results, except depression and suicidal ideation. Regarding safety, there was no significant difference in safety phone calls for participants with suicidal ideation. Conclusions: The evidence on suicide prevention app effectiveness is of low quality, precluding conclusive findings. Attempt reduction is suggested at 21 percent, but the confidence interval includes a potential 60 percent increase. Evidence on suicide-related psychological variables (suicide ideation, depression, hopelessness, and anxiety) is of higher quality (low–moderate), but effects are small and clinically uncertain. Safety findings are uncertain, impacting risk/benefit balance. [ABSTRACT FROM AUTHOR]

Introduction: Epilepsy affects approximately 10.5 million individuals under the age of 15 years worldwide. In Spain, 3.7 per 1,000 inhabitants aged 6 to 14 years have epilepsy, making it the third most common neurological emergency. Drug resistance is observed in eight to 33 percent of cases. Responsive neurostimulation (RNS) systems could improve seizure control in pediatric patients who are not eligible for brain surgery. Methods: We systematically searched for articles published up to September 2022 in the following bibliographic databases: MEDLINE, Embase, Web of Science, and CINAHL. We included primary experimental and observational studies as well as case series studies addressing the safety, efficacy, and cost effectiveness of RNS in the treatment of drug-resistant pediatric epilepsy. Results: Two systematic reviews of prospective and retrospective case series studies and four primary experimental studies were identified. The case series studies found that a large proportion of pediatric patients responded to RNS, with a reduction of between 50 and 75 percent in the frequency of seizures. The intensity and duration of seizures also decreased after using RNS. Adverse effects of the RNS implantation process were related to infections, erythema, and hematomas. Only one study (n=17) reported moderate adverse effects related to stimulation (dysesthetic pain in the upper and lower right limb), but there were no serious reactions leading to RNS discontinuation. Conclusions: Randomized controlled trials in pediatric drug-resistant populations ineligible for brain surgery with adequate sample sizes are needed to determine the effectiveness of RNS in terms of seizure frequency, duration, and intensity. No cost-effectiveness studies have been conducted on RNS in this cohort. [ABSTRACT FROM AUTHOR]

Introduction: Fibromyalgia, a musculoskeletal ailment of unknown origin, profoundly affects quality of life. Emerging bioelectrical stimulation techniques, including transcranial magnetic stimulation (TMS), transcranial direct current stimulation (tDCS), and pulsed low-frequency magnetic field stimulation (PEMF), show promise in short-term pain alleviation. This study aimed to rigorously evaluate the effectiveness and safety of these techniques in treating fibromyalgia. Methods: A systematic review (SR) of available literature on the effectiveness and safety of bioelectrical stimulation techniques was carried out according to the Cochrane Collaboration methodology and PRISMA reporting guideline. Evaluated studies included SRs (with or without meta-analyses) and randomized controlled trials (RCTs) published after the SRs. SRs were appraised with the AMSTAR-2 tool and RCTs were assessed with version two of the Cochrane Collaboration risk-of-bias tool for randomized trials. The findings were synthesized narratively. In the absence of SRs with meta-analyses for specific techniques, we conducted a meta-analysis for each available outcome measure, including pain, fatigue, symptom severity, quality of life, anxiety, and depression. Results: Seven SRs incorporating 35 RCTs were included. Two SRs evaluated TMS effectiveness, while five focused on tDCS. Additionally, 17 RCTs were included: two on repetitive TMS, six on tDCS, and eight on PEMF (three assessing targeted PEMF). General confidence in the SR results varied, with most having critically low confidence. Three additional RCTs were rated as low risk of bias, seven were rated as unclear risk of bias, and the remaining seven were rated as high risk of bias. A meta-analysis covered additional RCTs on PEMF and assessed pain intensity, symptom severity, general health-related quality of life, and fibromyalgia-related quality of life. Conclusions: Overall, the results suggest that repetitive TMS, tDCS, and PEMF could improve pain and quality of life in patients with fibromyalgia. It is, however, necessary to conduct high quality studies to demonstrate the clinical relevance of these effects. While the techniques evaluated appear to be safe, mild adverse effects involving the area of stimulation may occur. [ABSTRACT FROM AUTHOR]

Introduction: Cardiac rehabilitation (CR) with physical exercise is crucial for the secondary prevention of myocardial infarction and heart failure. However, according to published studies there are differences in access to hospital-based CR depending on sex, age, ethnicity, and geographical region. An alternative is CR in non-hospital settings such as primary care, the patient's home, or another place by means of telerehabilitation. Methods: We conducted a systematic review of full economic evaluations where non-hospital CR was compared with hospital CR in patients with ischemic heart disease or heart failure. Other eligibility criteria were model-based or clinical trial-based evaluations; studies reporting quality-adjusted life-years, years gained, or other clinical outcomes relevant to CR; and studies published in English or Spanish. Searches were conducted in June 2023 in various literature databases, including MEDLINE, Embase, CINAHL, Web of Science, INAHTA, PEDro, the Cost-Effectiveness Analysis Registry, and others. Study selection, data extraction, quality assessment, and evidence synthesis were conducted by one economist and checked by a second reviewer. Results: Nine studies were selected from the 673 references identified. Another study was identified through previous systematic reviews. Ten randomized clinical trials were included in the review. None of the studies found differences in effectiveness between hospital CR and non-hospital CR. Two studies found that non-hospital CR was less costly than hospital CR, whereas the remainder did not find any differences in costs between the two groups or were unable to demonstrate the statistical significance of any differences observed. The best conducted studies concluded that non-hospital CR was as effective as and less costly than hospital CR. Conclusions: Non-hospital CR was as cost effective as hospital CR for low- to-moderate risk patients. Based on the evidence, CR can be recommended in non-hospital settings. However, any form of CR should be evaluated after implementation because its complexity limits the generalizability of results across regions. [ABSTRACT FROM AUTHOR]

Introduction: The use of apps represents a revolution in mental health. Fast, versatile, and manageable, mHealth apps allow empowerment of patients and professionals and can even reduce stigmatization. There is not yet a standardized method to assess their effectiveness and safety. The objective of the EvalDepApps project is to develop an assessment tool for apps that have management of depression as the main goal. Methods: The EvalDepApps project follows several stages: (i) Systematic review and meta-analysis following the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) statement, to identify evidence about effectiveness and safety of mHealth interventions to manage depressive symptoms among adults, and criteria to be included in the app assessment tools. The primary outcome was the reduction of depressive symptoms, and only randomized controlled trials (RCTs) were included. (ii) Delphi process with 30 participants (patients and healthcare professionals) to reach consensus about the criteria to be included in the tool. (iii) Co-creation workshops with 12 healthcare professionals and 12 patients to co-design the EvalDepApps tool. Results: Twenty-nine RCTs were included. The most common elements were psychoeducation, goal setting, and gamification. Significant effect for mHealth interventions in reducing depressive symptoms compared with non-active control (95% confidence interval: −0.87, −0.37; I2=87%) was identified. Hybrid interventions combining mHealth with face-to-face sessions were the most effective. Any study-related adverse events were reported. Response rate was 59 percent (26/44) in round one and 52 percent (23/44) in round two. Twenty-eight out of 51 criteria (54.9%) were accepted by consensus. Proposals were received about the look and feel of the content, usability aspects, sections, and main features of the EvalDepApps tool. Conclusions: mHealth interventions, particularly hybrid ones, can be effective in reducing depressive symptoms. There is a need for personalized approaches. It is important to prioritize evidence-based principles and standardized evaluation tools. A set of 25 criteria will be included in the EvalDepApps tool that will be co-created thanks to the input given by healthcare professionals and people diagnosed with depression. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

Background: Shared decision-making (SDM) is a crucial aspect of patient-centered care. While several SDM training programs for health care professionals have been developed, evaluation of their effectiveness is scarce, especially in mental health disorders such as generalized anxiety disorder., Objective: This study aims to assess the feasibility and impact of a brief training program on the attitudes toward SDM among primary care professionals who attend to patients with generalized anxiety disorder., Methods: A feasibility randomized controlled trial was conducted. Health care professionals recruited in primary care centers were randomized to an intervention group (training program) or a control group (waiting list). The intervention consisted of 2 web-based sessions applied by 2 psychologists (VR and YA), based on the integrated elements of the patient-centered care model and including group dynamics and video viewing. The outcome variable was the Leeds Attitudes Towards Concordance scale, second version (LATCon II), assessed at baseline and after the second session (3 months). After the randomized controlled trial phase, the control group also received the intervention and was assessed again., Results: Among 28 randomized participants, 5 withdrew before the baseline assessment. The intervention significantly increased their scores compared with the control group in the total scale (b=0.57; P=.018) and 2 subscales: communication or empathy (b=0.74; P=.036) and shared control (ie, patient participation in decisions: b=0.68; P=.040). The control group also showed significant pre-post changes after receiving the intervention., Conclusions: For a future effectiveness trial, it is necessary to improve the recruitment and retention strategies. The program produced a significant improvement in participants' attitude toward the SDM model, but due to this study's limitations, mainly the small sample size, more research is warranted., (© Vanesa Ramos-García, Amado Rivero-Santana, Wenceslao Peñate-Castro, Yolanda Álvarez-Pérez, Andrea Duarte-Díaz, Alezandra Torres-Castaño, María del Mar Trujillo-Martín, Ana Isabel González-González, Pedro Serrano-Aguilar, Lilisbeth Perestelo-Pérez. Originally published in JMIR Medical Education (https://mededu.jmir.org).)