Information needs and research priorities in long-term survivorship of breast cancer: Patients and health professionals' perspectives.

OBJECTIVE: The objective of this work is to identify unmet information needs of long-term-survivors of breast cancer (BC) and future research needs from the perspectives of patients and health care professionals. METHODS: Two online Delphi surveys were conducted. Participants in Survey 1 were patients. Participants in Survey 2 were health care professionals from both primary and secondary care involved in BC care. Both surveys included three successive rounds. The first round aimed to identify research and information needs; the second round aimed to rank the relative importance of those needs; the third round aimed to find consensus. RESULTS: The most important information needs were self-management recommendations of common health problems after treatment and complications of breast reconstruction after 5 years. The most important research priorities were related to interventions and tools to increase information provision by professionals about certain tests, diet, and coordinated action between primary and specialised care during follow-up, and indications and safety issues of pregnancy in survivors. CONCLUSIONS: Two fundamental ideas were identified: (1) Patients request information about self-management common health problems after treatment and breast reconstruction complications. (2) Health care professionals emphasise the need for a standardised approach based on protocols, recommendations, and coordinated actions in the provision of information. IMPLICATIONS FOR CANCER SURVIVORS: Given the increasing number of BC survivors, it is essential to identify information and research needs to improve their care and health outcomes.

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.

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.

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.

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.

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.

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.

Effectiveness, safety and costs of the FreeStyle Libre glucose monitoring system for children and adolescents with type 1 diabetes in Spain: a prospective, uncontrolled, pre-post study.

OBJECTIVES: This study aimed to evaluate the effectiveness, safety and costs of FreeStyle Libre (FSL) glucose monitoring system for children and adolescents with type 1 diabetes mellitus (T1DM) in Spain. DESIGN: Prospective, multicentre pre-post study. SETTING: Thirteen Spanish public hospitals recruited patients from January 2019 to March 2020, with a 12-month follow-up. PARTICIPANTS: 156 patients were included. PRIMARY AND SECONDARY OUTCOME MEASURES: Primary: glycated haemoglobin (HbA1c) change. Secondary: severe hypoglycaemic events (self-reported and clinical records), quality of life, diabetes treatment knowledge, treatment satisfaction, adverse events, adherence, sensor usage time and scans. Healthcare resource utilisation was assessed for cost analysis from the National Health System perspective, incorporating direct healthcare costs. Data analysis used mixed regression models with repeated measures. The intervention's total cost was estimated by multiplying health resource usage with unit costs. RESULTS: In the whole sample, HbA1c increased significantly (0.32%; 95% CI 0.10% to 0.55%). In the subgroup with baseline HbA1c≥7.5% (n=88), there was a significant reduction at 3 months (-0.46%; 95% CI -0.69% to -0.23%), 6 months (-0.49%; 95% CI -0.73% to -0.25%) and 12 months (-0.43%; 95% CI -0.68% to -0.19%). Well-controlled patients had a significant 12-month worsening (0.32%; 95% CI 0.18% to 0.47%). Self-reported severe hypoglycaemia significantly decreased compared with the previous year for the whole sample (-0.37; 95% CI -0.62 to -0.11). Quality of life and diabetes treatment knowledge showed no significant differences, but satisfaction increased. Adolescents had lower sensor usage time and scans than children. Reduction in HbA1c was significantly associated with device adherence. No serious adverse effects were observed. Data suggest that use of FSL could reduce healthcare resource use (strips and lancets) and costs related to productivity loss. CONCLUSIONS: The use of FSL in young patients with T1DM was associated with a significant reduction in severe hypoglycaemia, and improved HbA1c levels were seen in patients with poor baseline control. Findings suggest cost savings and productivity gains for caregivers. Causal evidence is limited due to the study design. Further research is needed to confirm results and assess risks, especially for patients with lower baseline HbA1c.

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.

Neuronal Activity during Exposure to Specific Phobia through fMRI: Comparing Therapeutic Components of Cognitive Behavioral Therapy.

Cognitive behavioral therapy (CBT) packages for anxiety disorders, such as phobias, usually include gradual exposure to anxious contexts, positive self-verbalizations, and relaxation breathing. The objective of this research was to analyze the specific neural activation produced by the self-verbalizations (S) and breathing (B) included in CBT. Thirty participants with clinical levels of a specific phobia to small animals were randomly assigned to three fMRI conditions in which individuals were exposed to phobic stimuli in real images: a group underwent S as a technique to reduce anxiety; a second group underwent B; and a control group underwent exposure only (E). Simple effects showed higher brain activation comparing E > S, E > B, and S > B. In particular, in the E group, compared to the experimental conditions, an activation was observed in sensory-perceptive and prefrontal and in other regions involved in the triggering of emotion (i.e., amygdala, supplementary motor area, and cingulate gyrus) as well as an activation associated with interoceptive sensitivity (i.e., insula and cingulate cortex). According to the specific tool used, discrepancies in the neural changes of CBT efficacy were observed. We discuss the theoretical implications according to the dual model of CBT as a set of therapeutic tools that activate different processes.

A Voxel-Based Morphometric Study of Gray Matter in Specific Phobia.

The objective of this study was to analyze the neurostructural abnormalities of brain areas responsible for the acquisition and maintenance of fear in small animal phobia by comparing gray matter volume (GMV) in individuals with phobia and non-fearful controls. Structural magnetic resonance imaging was obtained from 62 adults (79% female) assigned to one of two groups: 31 were diagnosed with small animal phobia and 31 were non-fearful controls. To investigate structural alterations, a whole-brain voxel-based morphometry analysis was conducted to compare the GMV of the brain areas involved in fear between both groups. The results indicated that individuals with a small animal specific phobia showed smaller GMV in cortical regions, such as the orbitofrontal (OFC) and medial frontal cortex, and greater GMV in the putamen than non-fearful controls. These brain areas are responsible for avoidant behavior (putamen) and emotional regulation processes or inhibitory control (prefrontal cortex (PFC)), which might suggest a greater vulnerability of phobic individuals to acquiring non-adaptive conditioned responses and emotional dysregulation. The findings provide preliminary support for the involvement of structural deficits in OFC and medial frontal cortex in phobia, contributing to clarify the neurobiological substrates for phobias.

Patient experience, satisfaction and shared decision-making in colorectal cancer screening: protocol of the mixed-methods study CyDESA.

INTRODUCTION: Colorectal cancer (CRC) screening programmes can reduce incidence and mortality from this condition if adherence to them is high. As patient experience and satisfaction are key factors in determining adherence to screening programmes, they need to be measured. Furthermore, to promote highly patient-centred healthcare, the perception of patients regarding shared decision-making during CRC screening needs to be known. This study aims to assess the experience, satisfaction and participation in decision-making of participants in a CRC screening programme and of patients diagnosed with CRC through this programme in relation to the diagnostic and therapeutic processes of cancer. METHODS AND ANALYSIS: The CyDESA study is a mixed-methods study with a four phase sequential design. In phase 1, we will conduct a systematic review of patient-reported experience measures (PREMs) for patient experience or satisfaction with CRC screening. In case no located PREM can be applied, in phase 2, we will develop a new PREM. We will use the Delphi methodology to reach consensus among experts and patients and will conduct a pilot test of the developed PREM. Phase 3 is a multicentric cross-sectional study based on self-reported questionnaires that will be conducted at three Spanish hospitals (n=843). The objective is to find out about the experience, satisfaction and participation in decision-making of participants in the CRC screening programme who have had a positive screening test result according to their final screening diagnosis: false positives, colorectal polyps or CRC. Phase 4 is a qualitative phenomenological study based on individual interviews. It will explore the experiences of participants in the CRC screening programme and of those diagnosed with CRC. ETHICS AND DISSEMINATION: Ethics approval by the Ethics Committees of Corporació Sanitària Parc Taulí, Hospital de Sant Pau and Parc de Salut Mar. Findings will be published in peer-reviewed journals and presented at conferences. TRIAL REGISTRATION NUMBER: NCT04610086.

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.

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.

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.