Gender Disparities in Adverse Events Resulting From Low-Value Practices in Family Practice in Spain: A Retrospective Cohort Study.

Objectives: This study aimed to evaluate gender-based disparities in preventable adverse events due to low-value practices (LVPs) in primary care. Methods: A retrospective cohort study in Alicante, Spain. Results: A total of 1,516 patient records were examined, finding that older individuals and women experienced more LVP-related events. Female patients faced a higher volume of such events than males with the same health issue. Interaction analysis revealed patients treated by male physicians had more severe events, while those attended by females experienced milder ones. Adverse events were more frequent in LVPs associated with gender-based reasons. Conclusion: These results highlight the need for tailored healthcare professional awareness programs on overuse's impact on safety. Addressing outcome differences between male and female patients should inform awareness campaigns.

Speaking Up About Patient Safety, Withholding Voice and Safety Climate in Clinical Settings: a Cross-Sectional Study Among Ibero-American Healthcare Students.

Objectives: To explore speaking up behaviours, barriers to openly expressing patient safety concerns, and perceived psychological safety climate in the clinical setting in which healthcare trainees from Ibero-America were receiving their practical training. Methods: Cross-sectional survey of healthcare trainees from Colombia, Mexico, and Spain (N = 1,152). Before the field study, the Speaking Up About Patient Safety Questionnaire (SUPS-Q) was translated into Spanish and assessed for face validity. A confirmatory factor analysis was conducted to establish the construct validity of the instrument, and the reliability was assessed. The SUPS-Q was used to evaluate voice behaviours and the perceived psychological safety climate among Ibero-American trainees. Descriptive and frequency analyses, tests for contrasting means and proportions, and logistic regression analyses were performed. Results: Seven hundred and seventy-one trainees had experience in clinical settings. In the previous month, 88.3% had experienced patient safety concerns, and 68.9% had prevented a colleague from making an error. More than a third had remained silent in a risky situation. Perceiving concerns, being male or nursing student, and higher scores on the encouraging environment scale were associated with speaking up. Conclusion: Patient safety concerns were frequent among Ibero-American healthcare trainees and often silenced by personal and cultural barriers. Training in speaking up and fostering safe interprofessional spaces is crucial.

External validation of the FAscore scale to evaluate the risk of atrial fibrillation in patients with arterial hypertension.

BACKGROUND AND AIM: To use a risk scale or predictive model outside the population of origin, it is necessary to evaluate the predictive indicators through external validation. The aim was to validate the FAscore, originally constructed in hypertensive patients in primary care in the Valencian Region, in an external cohort with hypertension in primary care in the Basque Country. METHODS: A retrospective cohort study was designed to perform an external validation of the FAscore app in patients affiliated with 26 health centers in the municipality of Bilbao. The area under the ROC curve and predictive indicators were calculated with their 95% confidence intervals. RESULTS: Thirty-six thousand eight hundred nine patients were included: 53.6% (n=19,719) were women, the mean age was 75.1 years, 41.8% (n=15,381). Over the four-year follow-up period, 1420 patients were diagnosed with AF (cumulative incidence 3.9%). The median risk estimated by FAscore was 4.5%, and the 5th, 25th, 75th, and 95th percentiles were 1.0%, 2.5%, 6.1%, and 14.8%, respectively. The ROC curve for the risk estimated by FAscore and the cases of atrial fibrillation observed was AUC 0.715 (95% CI 0.703-0.727). The 5% risk cutoff provides a sensitivity of 70.8%, specificity of 61.0%, positive predictive value of 6.8%, negative predictive value of 98.1%, and positive and negative likelihood ratios of 1.82 and 0.48, respectively. CONCLUSION: This study reports on the external validation of the atrial fibrillation risk scale in hypertensive patients, which shows an acceptable predictive capacity. The best-performing risk cutoff, providing good predictive indicators, can be set at 5%.

Identification of low-value practices susceptible to gender bias in primary care setting.

BACKGROUND: Data on overuse of diagnostic and therapeutic resources underline their contribution to the decline in healthcare quality. The application of "Do Not Do" recommendations, in interaction with gender biases in primary care, remains to be fully understood. Therefore, this study aims to identify which low-value practices (LVPs) causing adverse events are susceptible to be applied in primary care setting with different frequency between men and women. METHODS: A consensus study was conducted between November 1, 2021, and July 4, 2022, in the primary care setting of the Valencian Community, Spain. Thirty-three of the 61 (54.1%) health professionals from clinical and research settings invited, completed the questionnaire. Participants were recruited by snowball sampling through two scientific societies, meeting specific inclusion criteria: over 10 years of professional experience and a minimum of 7 years focused on health studies from a gender perspective. An initial round using a questionnaire comprising 40 LVPs to assess consensus on their frequency in primary care, potential to cause serious adverse events, and different frequency between men and women possibly due to gender bias. A second round-questionnaire was administered to confirm the final selection of LVPs. RESULTS: This study identified nineteen LVPs potentially linked to serious adverse events with varying frequencies between men and women in primary care. Among the most gender-biased and harmful LVPs were the use of benzodiazepines for insomnia, delirium, and agitation in the elderly, and the use of hypnotics without a previous etiological diagnosis. CONCLUSIONS: Identifying specific practices with potential gender biases, mainly in mental health for the elderly, contributes to healthcare promotion and bridges the gap in gender inequalities. TRIAL REGISTRATION: NCT05233852, registered on 10 February 2022.

Prevalence of childhood obesity in Spain and its relation with socioeconomic status and health behaviors: Population-based cross-sectional study.

OBJECTIVES: This study aims to assess the current state of childhood overweight and obesity in Spain, and its relationship with socioeconomic status and health-related behaviors. METHODS: Population-based cross-sectional observational study, based on the 2017 National Health Survey in minors in Spain. This study included all children surveyed who were aged 1-14 years. Childhood obesity was estimated from the z-score of the body mass index. RESULTS: The study included 4882 children aged 1-14 years (mean 7.5). The prevalence of obesity was 18.6% (95% confidence interval [CI] 18.5-18.7), while 13.5% (95% CI 13.4-13.6) were overweight. These figures represent over a million children in Spain who are obese and nearly 750,000 who are overweight. A north-south geographic gradient was apparent, with higher prevalence of unhealthy body weight in southern Spain. Factors associated with childhood obesity were low socioeconomic status, poor diet and sedentarism, among others. CONCLUSIONS: Childhood overweight in Spain is strongly associated with socioeconomic status and other factors such as diet and sedentarism. Multidisciplinary public health interventions are needed to reduce this serious health problem in children.

Unveiling the hidden struggle of healthcare students as second victims through a systematic review.

BACKGROUND: When healthcare students witness, engage in, or are involved in an adverse event, it often leads to a second victim experience, impacting their mental well-being and influencing their future professional practice. This study aimed to describe the efforts, methods, and outcomes of interventions to help students in healthcare disciplines cope with the emotional experience of being involved in or witnessing a mistake causing harm to a patient during their clerkships or training. METHODS: This systematic review followed the PRISMA guidelines and includes the synthesis of eighteen studies, published in diverse languages from 2011 to 2023, identified from the databases MEDLINE, EMBASE, SCOPUS and APS PsycInfo. PICO method was used for constructing a research question and formulating eligibility criteria. The selection process was conducted through Rayyan. Titles and abstracts of were independently screened by two authors. The critical appraisal tools of the Joanna Briggs Institute was used to assess the risk of bias of the included studies. RESULTS: A total of 1354 studies were retrieved, 18 met the eligibility criteria. Most studies were conducted in the USA. Various educational interventions along with learning how to prevent mistakes, and resilience training were described. In some cases, this experience contributed to the student personal growth. Psychological support in the aftermath of adverse events was scattered. CONCLUSION: Ensuring healthcare students' resilience should be a fundamental part of their training. Interventions to train them to address the second victim phenomenon during their clerkships are scarce, scattered, and do not yield conclusive results on identifying what is most effective and what is not.

Design and validation of a new questionnaire with a gender perspective to measure medication adherence for secondary prevention of ischaemic heart disease: study protocol.

INTRODUCTION AND OBJECTIVES: Only about 50% of chronic patients in high-income countries adhere to their treatment. There are methods to measure medication adherence but none of them can be considered optimal. This study will aim to design and validate a questionnaire to measure medication adherence in patients with ischaemic heart disease using a direct method as a gold-standard adherence measure and taking into account the gender perspective. Moreover, the profile of low adherence in these patients will be determined. METHODS AND ANALYSIS: First study phase consists on the questionnaire design following the next steps: identification of the dimensions, definition of the target population, questionnaire items and order, response coding, questionnaire instructions, content validity by experts and understandability. In the second phase, a cross-sectional study will be performed to end the questionnaire development and validate it. Four hundred and forty patients (50% female) with acute coronary syndrome receiving treatment within the previous 12 months will be included. Patient will answer the initial questionnaire and adherence to aspirin and statin will be measured using a direct method (drug concentration analysis in blood) and other questionnaires. From the set of preselected questionnaire items, those most closely associated with the gold standard measure will be selected using multivariate statistics. ETHICS AND DISSEMINATION: All participants gave their written informed consent before participating in the study. The study protocol follows the recommendations of the Declaration of Helsinki and was approved by the ethics committees of the three participating centres. The results of this study will be displayed at national and international conferences and in peer-reviewed scientific journals.

Diabetes mellitus as a cause of premature death in small areas of Spain by socioeconomic level from 2016 to 2020: A multiple-cause approach.

OBJECTIVE: This study aimed to assess premature mortality due to Diabetes in small areas of Spain between 2016 and 2020, and its relationship with socioeconomic level and the immediate cause of death. As a secondary objective, we evaluated the effect of the Covid 19 pandemic. METHODS: This was an ecological study of premature mortality due to Diabetes from 2016 to 2020, with a focus on small areas. All deaths in people under 75 years of age due to Diabetes as the underlying cause were included RESULTS: The final sample comprised 7382 premature deaths in 5967 census tracts. Women living in census tracts with an high level of deprivation(RR=2.40) were at a significantly higher risk. Mortality from Diabetes increased with deprivation, especially people aged 0-54(RR=2.40). People with an immediate cause of death related to a circulatory disease, living in census tracts with an high level of deprivation(RR=3.86) was associated with a significantly greater risk of death with underlying Diabetes. When a disease of the circulatory system was recorded as the immediate cause of death, being 65-74 years (RR=71.01) was associated with a significantly higher risk of premature mortality. CONCLUSIONS: Living in geographic areas with higher levels of socioeconomic deprivation is associated with a higher risk of premature death from Diabetes in Spain. This relationship has a greater impact on women, people under 54 years, and people at risk of death caused directly by diseases of the circulatory system. Premature mortality due to diabetes saw a modest increase in 2020.

Opinions and perceptions of patients with cardiovascular disease on adherence: a qualitative study of focus groups.

BACKGROUND: Cardiovascular diseases are becoming more frequent throughout the world. Adherence to both pharmacological and non-pharmacological treatment, as well as lifestyles, is important for good management and control of the disease. This study aims to explore the opinions and perceptions of patients with ischemic heart disease on the difficulties associated with therapeutic adherence. METHODS: An interpretive phenomenological study was carried out using focus groups and one semi-structured interview. The MAXQDA qualitative data analysis program was used for inductive interpretation of the group discourses and interview. Data were coded, and these were grouped by categories and then consolidated under the main themes identified. RESULTS: Two in-person focus groups and one remote semi-structured interview were performed. Twelve participants (6 men and 6 women) from the Hospital de San Juan de Alicante participated, two of them being family companions . The main themes identified were aspects related to the individual, heart disease, drug treatment, and the perception of the health care system. CONCLUSIONS: Adhering to recommendations on healthy behaviors and taking prescribed medications for cardiovascular disease was important for most participants. However, they sometimes found polypharmacy difficult to manage, especially when they did not perceive the symptoms of their disease. Participants related the concept of fear to therapeutic adherence, believing that the latter increased with the former. The relationship with health professionals was described as optimal, but, nevertheless, the coordination of the health care system was seen as limited.

Multicausal analysis of mortality due to diabetes mellitus in Spain, 2016-2018.

OBJECTIVES: This study aimed to assess multicausal mortality due to diabetes from 2016-2018 in Spain. Specific objectives were to quantify the occurrence of diabetes as an underlying cause or as any registered cause on the death certificate. MATERIALS AND METHODS: A cross-sectional descriptive study taking a multicausal approach. RESULTS: Diabetes appears as an underlying cause of 2.3% of total deaths in Spain, and as any cause in 6.2%. In patients in whom Diabetes appears as an underlying cause on the death certificates, the 15 most frequent immediate causes are cardiovascular diseases in men(prevalence ratio 1,59)and women (PR1,31). In men, the causes associated with diabetes as any cause were skin diseases(prevalence ratio 1.33), followed by endocrine diseases(prevalence ratio 1.26)and genitourinary diseases (prevalence ratio1.14). In women, the causes associated with the presence of diabetes as any cause were endocrine (prevalence ratio 1.13)and genitourinary (prevalence ratio 1.04)diseases. CONCLUSIONS: In patients in whom diabetes appears as an underlying cause on the death certificates, the 15 most frequent immediate causes are cardiovascular diseases. In men, the causes associated with the presence of diabetes as any cause of death are skin, endocrine and genitourinary diseases. In women, the causes associated with diabetes as any cause are endocrine and genitourinary.

Association of Visiting the Physiotherapist with Mortality in the Spanish General Population: A Population-Based Cohort Study.

Background and Objectives: The purpose of this retrospective population-based cohort study was to analyse the association between attendance of physiotherapy with mortality in the Spanish general population and describe the profile of people who do not visit a physiotherapist in Spain. Material and Methods: The data sources were the 2011/2012 National Health Survey (ENSE11) and the national database of death in Spain, and the participants were all adult respondents in the ENSE11. Results: Of 20,397 people, 1101 (5.4%) visited the physiotherapist the previous year, and the cumulative incidence of total mortality was 5.4% (n = 1107) at a mean follow-up of 6.2 years. Visiting the physiotherapist was associated with lower all-cause mortality in the population residing in Spain, quantified at 30.1% [RR = 0.699; 95% CI (0.528-0.927); p = 0.013]. The factors associated with not visiting a physiotherapist were the following: rating one's health as good (9.8%; n = 1017; p < 0.001), not having any hospital admission in the previous year (9.6%; n = 1788; p < 0.001), not having visited the general practitioner in the previous month (9.6%; n = 1408; p < 0.001), and not having attended a day hospital in the previous year (9.7%; n = 1836; p < 0.001). Conclusions: Visiting a physiotherapist was associated with a lower mortality from all causes in the population living in Spain.

Risk factors for major adverse cardiovascular events in postmenopausal women: UK Biobank prospective cohort study.

BACKGROUND AND AIMS: Cardiovascular risk increases during menopause, so the medical and scientific community should consider women's specific risk factors to prevent cardiovascular disease. This study aims to assess the risk factors for the incidence of major adverse cardiovascular events (MACE) exclusive to postmenopausal women. METHODS: We conducted a prospective cohort study in postmenopausal women aged 40 years and older, who were included in the UK Biobank cohort between 2006 and 2010 and followed to 2021 (12 years). A total of 156,787 women were followed for a median of 12.5 years (nearly 2 million person-years), and MACE risk was assessed using Fine-Gray competing risk models. RESULTS: The cumulative incidence of cardiovascular morbidity and mortality was 1.2% (0.97 cases per 1000 women-years). Not having taken birth control pills, not having children, and early menarche (≤12 years) were independently associated with cardiovascular morbidity and mortality. CONCLUSIONS: Risk factors for cardiovascular disease that are specific to women include early menarche, not having taken oral contraceptives, and reproductive history, and this relationship is independent of classic cardiovascular risk factors.

Coping Strategies Used by Health Care Workers in Ecuador During the COVID-19 Pandemic: Observational Study to Enhance Resilience and Develop Training Tools.

BACKGROUND: The COVID-19 pandemic has generated immense health care pressure, forcing critical decisions to be made in a socially alarmed environment. Adverse conditions have led to acute stress reactions, affective pathologies, and psychosomatic reactions among health personnel, which have been exacerbated by the successive waves of the pandemic. The recovery of the entire health system and its professionals has been hindered, making it essential to increase their resilience. OBJECTIVE: This study aimed to achieve 2 primary objectives. First, it sought to identify coping strategies, both individual and organizational, used by health care workers in Ecuador to navigate the acute stress during the early waves of the pandemic. Second, it aimed to develop training materials to enhance team leaders' capabilities in effectively managing high-stress situations. METHODS: The study used qualitative research techniques to collect information on institutional and personal coping strategies, as well as consensus-building techniques to develop a multimedia psychological tool that reinforces the resilience of professionals and teams in facing future crises. RESULTS: The findings from the actions taken by health care workers in Ecuador were categorized into 4 types of coping strategies based on Lazarus' theories on coping strategies. As a result of this study, a new audiovisual tool was created, comprising a series of podcasts, designed to disseminate these strategies globally within the Spanish-speaking world. The tool features testimonials from health care professionals in Ecuador, narrating their experiences under the pressures of providing care during the pandemic, with a particular emphasis on the coping strategies used. CONCLUSIONS: Ensuring the preparedness of health professionals for potential future outbreaks is imperative to maintain quality and patient safety. Interventions such as this one offer valuable insights and generate new tools for health professionals, serving as a case study approach to train leaders and improve the resilience capacity and skills of their teams.

Perceptions and attitudes of pediatricians and families with regard to pediatric medication errors at home.

PURPOSE: This study aimed to identify the perceptions and attitudes of pediatricians and parents/caregivers regarding medication errors at home, and to compare the findings from the two populations. METHODS: This was a cross-sectional survey study. We designed a survey for working pediatricians and another one for parents or caregivers of children aged 14 years and younger. The survey's questions were designed to assess provider and parental opinions about the difficulty faced by parents providing medical treatment, specific questions on medication errors, and on a possible intervention program aimed at preventing pediatric medication errors. Pediatrician and parent responses to matching questions in both surveys were compared. RESULTS: The surveys were administered in Spain from 2019 to 2021. In total, 182 pediatricians and 194 families took part. Most pediatricians (62.6%) and families (79.3%) considered that managing medical treatment was not among the main difficulties faced by parents in caring for their children. While 79.1% of pediatricians thought that parents consulted the internet to resolve doubts regarding the health of their children, most families (81.1%) said they consulted healthcare professionals. Lack of knowledge among parents and caregivers was one of the causes of medication errors most frequently mentioned by both pediatricians and parents. Most pediatricians (95.1%) said they would recommend a program designed to prevent errors at home. CONCLUSIONS: Pediatricians and families think that medical treatment is not among the main difficulties faced by parents in caring for their children. Most pediatricians said they would recommend a medication error reporting and learning system designed for families of their patients to prevent medication errors that might occur in the home environment.

Epidemiological study on gender bias and low-value practices in primary care: a study protocol.

INTRODUCTION: Evidence shows that gender has a substantial impact on health behaviours, access to and use of health systems and health system responses. This study aims to assess gender bias in patients subjected to low-value practices in the primary care setting and to develop recommendations for reducing adverse events that women experience for this reason. METHODS AND ANALYSIS: A Delphi study will be performed to reach a consensus on the 'Do Not Do' recommendations with a possible gender bias. A retrospective cohort study in a random selection of medical records will then be carried out to identify the frequency of adverse events that occur when the selected 'Do Not Do' recommendations are ignored. Qualitative research techniques (consensus conference and nominal group) will be carried out to develop recommendations to address any gender bias detected, considering barriers and facilitators in clinical practice. ETHICS AND DISSEMINATION: The study was approved by the ethics committee of San Juan de Alicante Hospital (San Juan de Alicante, Spain) Reference N. 21/061. We will disseminate the research findings via peer-reviewed articles, presentations at national and international scientific forums and webinars. TRIAL REGISTRATION NUMBER: The study was registered at ClinicalTrials.gov (NCT05233852) on 10 February 2022.

Tomographic Findings in the Retina of Unvaccinated Patients with COVID Pneumonia: Prospective Longitudinal Study.

There is no definitive evidence on the extent of SARS-CoV-2's effect on the retina. This study aims to determine if the natural history of SARS-CoV-2 infection affects tomographic findings in the retina of patients with COVID-19 pneumonia. This is a prospective cohort study of patients hospitalized with COVID-19 pneumonia. The patients underwent ophthalmological explorations and optical coherence tomography during the acute phase of the infection and at a follow-up 12 weeks later. The primary outcomes were the central retinal thickness and central choroidal thickness, which were compared longitudinally and with non-COVID-19 historical controls. No statistically relevant differences were observed in the longitudinal analysis of the thickness of the central retina (p = 0.056), central choroid (p = 0.99), retinal nerve fiber layer (p = 0.21), or ganglion cell layer (p = 0.32). Patients with acute COVID-19 pneumonia showed significantly greater central retinal thickness than non-COVID controls (p = 0.006). In conclusion, tomographic measures of the retina and choroid are not influenced by the phase of COVID-19 infection and remain stable during 12 weeks. The central retinal thickness may increase in the acute phase of COVID-19 pneumonia, but more epidemiological studies using optical coherence tomography in the early stages of the disease are needed.

Consensus-based recommendations on physical activity and exercise in patients with diabetes at risk of foot ulcerations: a Delphi study.

BACKGROUND: Patients with diabetes mellitus are exposed to important complications. Currently little evidence exist on the guidelines that these patients, at some risk of foot ulceration, should follow for physical exercise. OBJECTIVES: To reach a consensus among multidisciplinary and international experts on physical activity/exercise recommendations for patients with diabetes, according to foot ulcer risk. METHODS: Using a three-round Delphi method, a panel composed of 28 multidisciplinary experts in the management of diabetic foot assessed 109 recommendations on physical activity/exercise for patients with diabetes mellitus, according to their risk of foot ulcer. Consensus was assumed when 80% of responses matched the same category (agreement/disagreement). RESULTS: Twenty-nine experts participated in the first and second rounds of consultation, and twenty-eight did so in the third, reaching final agreement on 86 of the 109 recommendations considered (78.9%). The study, thus, generated a consensus set of recommendations concerning different aspects of diabetic footcare before, during, and after exercise (e.g. when to examine the foot, how to assess it, what type of sock and insole to use, what types of exercise to perform, and when it is advisable to return to activity after an ulceration). CONCLUSION: This Delphi study generated recommendations based on the consensus of international experts on physical activity and exercise by patient with diabetes at risk of ulceration. Recommendations considered the state of the foot and the patient's history and status before physical activity and included information on intensity, duration, frequency, and progressions of physical activity/exercise, and the use of custom-made plantar orthoses, shoe prescription, and the convenience of returning to physical activity after an ulceration.

Differences in Perception of Healthcare Management between Patients and Professionals.

Patient perception and the organizational and safety culture of health professionals are an indirect indicator of the quality of care. Both patient and health professional perceptions were evaluated, and their degree of coincidence was measured in the context of a mutual insurance company (MC Mutual). This study was based on the secondary analysis of routine data available in databases of patients' perceptions and professionals' evaluations of the quality of care provided by MC Mutual during the period 2017-2019, prior to the COVID-19 pandemic. Eight dimensions were considered: the results of care, coordination of professionals, trust-based care, clinical and administrative information, facilities and technical means, confidence in diagnosis, and confidence in treatment. The patients and professionals agreed on the dimension of confidence in treatment (good), and the dimensions of coordination and confidence in diagnosis (poor). They diverged on confidence in treatment, which was rated worse by patients than by professionals, and on results, information and infrastructure, which were rated worse by professionals only. This implies that care managers have to reinforce the training and supervision activities of the positive coincident aspects (therapy) for their maintenance, as well as the negative coincident ones (coordination and diagnostic) for the improvement of both perceptions. Reviewing patient and professional surveys is very useful for the supervision of health quality in the context of an occupational mutual insurance company.

Psychometric properties of the Clarke questionnaire for hypoglycemia awareness in the Spanish population with type 2 diabetes.

OBJECTIVES: The Clarke questionnaire, validated in Spanish language, assesses hypoglycemia awareness in patients with type 1 diabetes. This study aimed to analyze its psychometric properties in patients with type 2 diabetes (T2DM). METHODS: This was a questionnaire validation study. Patients with T2DM and treated with insulin, sulfonylureas or glinides were consecutively recruited from six endocrinology consultations and six primary care centers. The internal structure of the 8-item Clarke questionnaire was analyzed by exploratory (training sample) and confirmatory (testing sample) factor analysis; the internal consistency using Omega's McDonald coefficient; and goodness of fit with comparative fit index (CFI, cutoff >0.9), Goodness of Fit Index (GFI, cutoff >0.9), and root mean-square error of approximation (RMSEA, cutoff <0.09), as well as unidimensionality indicators. RESULTS: The 265 participants (56.8% men) had a mean age of 67.8 years. Confirmatory factor analysis for one dimension obtained poor indicators: fit test (p < 0.001); CFI = 0.748; RMSEA = 0.122 and SRMR = 0.134. Exploratory factor analysis showed 2 or 3 dimensions with poor adjustment indicators. Omega's McDonald was 0.739. CONCLUSIONS: The Spanish version of the Clarke questionnaire was not valid or reliable for assessing hypoglycemia awareness in people with T2DM in Spanish population.