Process evaluation of PsyCovidApp, a digital tool for mobile devices aimed at protecting the mental health of healthcare professionals during the COVID-19 pandemic: a mixed method study.

Introduction: PsyCovidApp, a digital intervention aimed at safeguarding the mental health of healthcare workers during the COVID-19 pandemic, demonstrated in a randomized clinical trial to yield significant improvements solely among healthcare workers undergoing psychotherapy or receiving psychotropic medication. Objectives: (1) To identify contextual factors and mechanisms of action that influenced the impact of PsyCovidApp during the aforementioned trial; (2) To pinpoint enhancements for optimizing its efficacy. Materials and methods: For the first objective, a process evaluation was conducted, amalgamating quantitative techniques (surveying 216 healthcare professionals who had utilized PsyCovidApp during the trial) and qualitative methods (in-depth interviews with 16 healthcare workers). The second objective involved a panel of seven experts, utilizing the RAND-UCLA methodology. Results: The quantitative study (response rate = 40%) revealed that 22% of respondents had not fully accessed the content of PsyCovidApp. The average usage time was 22.7 min/day, being higher (p < 0.05) among consumers of psychotropic medications. Contents related to relaxation and mindfulness were most highly rated. Acceptability and usefulness scores ranged between 7.3-7.5/10 points, with higher ratings (p < 0.05) among women and older healthcare workers. The qualitative study uncovered that the primary barriers to using PsyCovidApp were workload, lack of time, and exhaustion. Its primary mechanisms of action included emotion identification, mental health regulation (e.g., insomnia, intense emotions), and learning of techniques and skills. The expert panel reached a consensus on 29 proposals to optimize PsyCovidApp. Conclusion: The knowledge derived from this study could inform the design and implementation of future similar digital tools.

DiabeText, a mobile health intervention to support medication taking and healthy lifestyle in adults with type 2 diabetes: Study protocol for a randomized controlled trial.

AIM: To evaluate the effectiveness of DiabeText, a low-intensity, multifaceted, mobile health (mHealth) intervention to support medication taking and lifestyle change targeted to people with type 2 diabetes (T2D). DESIGN: Phase III, 12-months, two-arm (1:1 allocation ratio), randomized parallel-group trial. METHODS: We will recruit 740 adults with glycated hemoglobin (A1c) >8% (>64 mmol/mol) and with at least one prescription of a non-insulin antidiabetic drug. They will be allocated to a control (usual care) group or an intervention (DiabeText messaging intervention) group. The primary outcome measure will be A1c at 12 months follow-up. Secondary outcomes will include medication possession ratio and behavioral and psychological outcomes. DISCUSSION: Recent trials suggest that digital health interventions can effectively support diabetes self-management improving T2D control and reducing important T2D complications. In Spain this type of interventions is understudied. IMPACT: This trial will strengthen the evidence base of the impact of mHealth interventions to support diabetes self-management. If effective, DiabeText may offer a low-cost and highly scalable strategy to improve health at the population level in a sustainable way. TRIAL REGISTRATION: ClinicalTrials.gov identifier NCT05006872; Official Title: Supporting People with Type 2 Diabetes in Effective Use of their Medicine Through a System Comprising Mobile Health Technology Integrated with Clinical Care.

Non-adherence to non-insulin glucose-lowering drugs: Prevalence, predictors and impact on glycemic control and insulin initiation. A longitudinal cohort study in a large primary care database in Spain.

BACKGROUND: A better understanding of patient non-adherence to type 2 diabetes medication is needed to design effective interventions to address this issue. OBJECTIVES: (1) To estimate the prevalence of non-adherence to diabetes medication; (2) to examine its impact on glycemic control and insulin initiation; (3) to develop and validate a prediction model of non-adherence. METHODS: We conducted a longitudinal cohort study based on data from electronic health records. We included adult patients registered within the Health Service of the Balearic Islands (Spain) starting a new prescription of a non-insulin glucose-lowering drug between January 2016 and December 2018. We calculated non-adherence at 12 months follow-up, defined as medication possession ratio (MPR) ≤ 80%. We fitted multivariable regression models to examine the association between non-adherence and glycemic control and insulin initiation and identified predictors of non-adherence. RESULTS: Of 18,119 patients identified, after 12 months follow-up, 5,740 (31.68%) were non-adherent. Compared with non-adherent, adherent patients presented lower HbA1c levels (mean difference = -0.32%; 95%CI = -0.38%; -0.27%) and were less likely to initiate insulin (aOR = 0.77; 95%CI = 0.63; 0.94). A predictive model explained 22.3% of the variation and presented a satisfactory performance (AUC = 0.721; Brier score = 0.177). The most important predictors of non-adherence were: non-Spanish nationality, currently working, low adherence to previous drugs, taking biguanides, smoker and absence of hypertension. CONCLUSION: Around one-third of the patients do not adhere to their non-insulin glucose-lowering drugs. More research is needed to optimise the performance of the predicting model before considering its implementation in routine clinical practice.

Development and evaluation of DiabeText, a personalized mHealth intervention to support medication adherence and lifestyle change behaviour in patients with type 2 diabetes in Spain: A mixed-methods phase II pragmatic randomized controlled clinical trial.

BACKGROUND: Despite the increasing interest in text-messaging interventions to support healthcare delivery, the available evidence about their effectiveness is still limited. OBJECTIVES: 1) to develop DiabeText, an intervention delivering automated, tailored brief text messages to support diabetes self-management; 2) to explore the potential impact of DiabeText on self-management behavior and glycaemic control, and; 3) to examine the feasibility of conducting a future phase III randomized clinical trial to evaluate the effectiveness of DiabeText. METHODS: 3-month, two-arm, randomized feasibility trial (ClinicalTrials.gov: NCT04738591) with patients with type 2 diabetes (HbA1c > 8%). Participants were allocated to the control (usual care) or DiabeText group (usual care + five text messages per week). Outcomes were: recruitment rate; follow-up rate, missing data; medication adherence; adherence to Mediterranean diet; physical activity; and HbA1c. In addition, after delivering the intervention, we conducted a qualitative study involving 14 semi-structured interviews with participants allocated to the DiabeText group, to understand their views about the intervention. RESULTS: From 444 screened people, we recruited 207 participants (recruitment rate = 47%), of which 179 completed the post-intervention interview (follow-up rate = 86%). We sent 7,355 SMS during the intervention period, of which 99% successfully reached the participants. At post-intervention, DiabeText was associated with non-statistically significant (p > 0.05) improvements in adherence to medication (OR = 2.0; 95%CI 1.0 to 4.2), Mediterranean diet (1.7; 0.9 to 3.2), and physical activity (1.7; 0.9 to 3.1). No between-group differences were observed in mean HbA1c (p = 0.670). The qualitative study indicated that participants perceived DiabeText as a helpful resource because it increased their awareness about the importance of adequate self-management and the sense of being cared for. CONCLUSIONS: DiabeText is the first system in Spain to integrate patient-generated and routinely collected clinical data to deliver tailored text messages to support diabetes self-management. More robust trials are needed to determine its effectiveness and cost-efficacy.

A Diet Profiling Algorithm (DPA) to Rank Diet Quality Suitable to Implement in Digital Tools-A Test Study in a Cohort of Lactating Women.

Although nutrient profiling systems can empower consumers towards healthier food choices, there is still a need to assess diet quality to obtain an overall perspective. The purpose of this study was to develop a diet profiling algorithm (DPA) to evaluate nutritional diet quality, which gives a final score from 1 to 3 with an associated color (green-yellow-orange). It ranks the total carbohydrate/total fiber ratio, and energy from saturated fats and sodium as potentially negative inputs, while fiber and protein are assumed as positive items. Then, the total fat/total carbohydrate ratio is calculated to evaluate the macronutrient distribution, as well as a food group analysis. To test the DPA performance, diets of a lactating women cohort were analyzed, and a correlation analysis between DPA and breast milk leptin levels was performed. Diets classified as low quality showed a higher intake of negative inputs, along with higher energy and fat intakes. This was reflected in body mass index (BMI) and food groups, indicating that women with the worst scores tended to choose tastier and less satiating foods. In conclusion, the DPA was developed and tested in a sample population. This tool can be easily implemented in digital nutrition platforms, contributing to real-time dietary follow-up of patients and progress monitoring, leading to further dietary adjustment.

Development and Evaluation of a Digital Health Intervention to Prevent Type 2 Diabetes in Primary Care: The PREDIABETEXT Study Protocol for a Randomised Clinical Trial.

BACKGROUND: Type 2 diabetes mellitus (T2DM) is a highly prevalent disease associated with an increased risk of comorbidities, premature death, and health costs. Prediabetes is a stage of glucose alteration previous to T2DM, that can be reversed. The aim of the study is to develop and evaluate a low-intensity, multifaceted, digital intervention to prevent T2DM. The intervention comprises: (1) the use of mobile health technology to send tailored text messages promoting lifestyle changes to people at risk of T2DM and (2) the provision of online education to primary healthcare physicians and nurses about management of prediabetes. METHODS: In stages 1-4 we will design, develop and pilot-test the intervention. In Stage 5 we will conduct a phase II, six-month, three-arm, cluster randomized, clinical trial with 42 primary care professionals and 420 patients at risk of T2DM. Patients will be allocated to a control group (usual care), intervention A (patient messaging intervention), or intervention B (patient messaging intervention plus online education to their primary healthcare professionals). The primary outcome will be glycated haemoglobin. All the procedures obtained ethical approval in June 2021 (CEI-IB Ref No: IB4495/21PI). DISCUSSION: Digital health interventions can effectively prevent T2DM and reduce important T2DM risk factors such as overweight or hypertension. In Spain, this type of intervention is understudied. Moreover, there is controversy regarding the type of digital health interventions that are more effective. Findings from this study may contribute to address T2DM prevention, through a low-cost and easily implementable intervention.

Longitudinal association of dietary carbohydrate quality with visceral fat deposition and other adiposity indicators.

BACKGROUND & AIMS: The quality of dietary carbohydrates rather than total carbohydrate intake may determine the accumulation of visceral fat; however, to date, few studies have examined the impact of diet on adiposity using specific imaging techniques. Thus, the aim of this prospective study was to investigate the association between concurrent changes in carbohydrate quality index (CQI) and objectively-quantified adiposity distribution over a year. METHODS: We analyzed a cohort of 1476 participants aged 55-75 years with overweight/obesity and metabolic syndrome (MetS) from the PREDIMED-Plus randomized controlled trial. Dietary intake information was obtained at baseline, 6- and 12-months from a validated 143-item semi-quantitative food-frequency questionnaire, and CQI (range: 4 to 20) was calculated based on four dietary criteria: total dietary fibre, glycemic index, wholegrain/total grain carbohydrate ratio, and solid/total carbohydrate ratio. Overall and regional adiposity (total body fat, visceral fat and android-to-gynoid fat ratio) was quantified using dual-energy X-ray absorptiometry at all three time points. Multiple adjusted linear mixed-effects models were used to assess associations between concurrent changes in repeatedly measured CQI and adiposity over time. RESULTS: After controlling for potential confounding factors, a 3-point increment in CQI over 12-month follow-up was associated with a decrease in visceral fat (ß -0.067 z-score, 95% CI -0.088; -0.046, p < 0.001), android-to-gynoid fat ratio (-0.038, -0.059; -0.017, p < 0.001), and total fat (-0.064, -0.080; -0.047, p < 0.001). Fibre intake and the ratio of wholegrain/total grain showed the strongest inverse associations with all adiposity indicators. CONCLUSIONS: In this prospective cohort of older adults with overweight/obesity and MetS, we found that improvements in dietary carbohydrate quality over a year were associated with concurrent favorable changes in visceral and overall fat deposition. These associations were mostly driven by dietary fibre and the wholegrain/total grain ratio. TRIAL REGISTRATION: The trial was registered at the International Standard Randomized. CONTROLLED TRIAL: (ISRCTN: http://www.isrctn.com/ISRCTN89898870) with number 89898870 and registration date of 24 July 2014, retrospectively registered.

Perspectives and Views of Primary Care Professionals Regarding DiabeText, a New mHealth Intervention to Support Adherence to Antidiabetic Medication in Spain: A Qualitative Study.

BACKGROUND: Antidiabetic medication is effective in preventing diabetes-related complications. However, 40% of type 2 diabetic patients do not adhere to their medication regimes adequately. Brief text messages represent a promising approach to support medication adherence. The aim of this study was to explore the perspectives of primary care professionals (PCPs) concerning the DiabeText intervention, a new text messaging intervention to be developed to support medication adherence in people with type 2 diabetes (T2D) in Mallorca, Spain. METHODS: We conducted four focus groups (n = 28) and eight semi-structured interviews with doctors and nurses. Data collection and analysis were carried out by researchers independently following Braun and Clark's methodology. RESULTS: Three main themes were identified: (1) text messaging interventions have the potential to effectively support diabetes self-management; (2) involving PCPs in the intervention would facilitate its design and implementation; (3) obtaining evidence supporting the cost-effectiveness is a key prerequisite for large-scale implementation of the intervention. PCPs identified barriers and enablers of the design and implementation of the intervention and made suggestions about the content and format of the text messages. CONCLUSION: The DiabeText intervention is perceived as useful and acceptable by PCPs provided its cost-effectiveness.

Nutritional counseling for cow's milk protein allergy in infants from birth to 2 y of ages: Scoping review.

OBJECTIVES: Cow's milk protein allergy (CMPA) is a clinical condition that requires appropriate nutritional counseling during breastfeeding and the introduction of complementary feeding. Using evidence-based dietetic advice is critical for correct growth and development during childhood. The aim of this study was to review the most recent literature on nutritional counseling aimed at infants between 0 and 2 y of age diagnosed with CMPA. METHODS: Six databases were searched and updated on August 22, 2020. Retrieved articles were screened in duplicate and independently by all the authors, and these were selected according to the following inclusion criteria: clinical trials, reviews, meta-analyses, and clinical practice guidelines published since 2013 on any dietetic intervention aimed at infant populations between 0 and 2 y of age with CMPA. Critical appraisal through the AGREE instrument and CASP tools enabled the risk of bias assessment. RESULTS: We obtained 2874 results, of which 40 were included for reviewing. The retrieved information enabled us to answer all the research questions, including aspects of the nutritional counseling aimed at mothers who breastfeed infants with CMPA, as well as infants during breastfeeding and the introduction of complementary feeding. We also reviewed the specific nutritional requirements of infants with CMPA to assess nutritional supplementation and the evidence available on the use of probiotics, prebiotics, and symbiotics. CONCLUSIONS: This scoping review collected, in a structured and comprehensive way, the most recent available information regarding nutritional counseling in CMPA for a successful dietetic intervention of the casuistry that may arise during early infancy.

Feasibility of the SINERGIAPS ("Sinergias entre profesionales y pacientes para una Atención Primaria Segura") intervention for improving patient safety in primary care.

AIM: The primary aim was to examine the feasibility of intervention delivery and of trial procedures. Secondary aims were to study the intervention uptake; its acceptability and perceived utility; and its potential to improve safety culture and avoidable hospital admissions. METHODS: We conducted a 3-month, single-arm feasibility study in 10 primary care (PC) centres in Spain. Centres received information regarding patients' experiences of safety (through the Patient Reported Experiences and Outcomes of Safety in Primary Care [PREOS-PC] questionnaire), and were instructed to plan safety improvements based on that feedback. We used a bespoke online tool to recruit PC professionals, collect patient feedback, and deliver it to the centres, and to collect outcome data (patient safety culture [Medical Office Survey on Patient Safety Culture, MOSPSC questionnaire]). We measured recruitment and follow-up rates and intervention uptake (based on the number of safety improvement plans registered). We conducted semistructured interviews with 9 professionals to explore the intervention acceptability and perceived utility. RESULTS: Of 256 professionals invited, 120 (47%) agreed to participate, and 97 completed baseline and postintervention measures. Of 780 patients invited, 585 (75%) completed the PREOS-PC questionnaire. Five of 10 centres (50%) designed an improvement plan, providing 27 plans in total (range per centre, 1-14). The intervention was perceived as a novel strategy for improving safety, although the healthcare professionals identified several factors limiting its acceptability and utility: lack of feedback at the individual professional level; potentially unrepresentative sample of patients providing feedback; and number of educational materials deemed overwhelming. DISCUSSION: It is feasible to deliver the proposed intervention so long as the identified limitations are addressed.

Patients' Views on the Design of DiabeText, a New mHealth Intervention to Improve Adherence to Oral Antidiabetes Medication in Spain: A Qualitative Study.

BACKGROUND: Type 2 Diabetes Mellitus (T2DM) is a long-term condition affecting around 10% of people worldwide. This study aimed to explore T2DM patients' views on DiabeText, a new text messaging intervention to be developed to support adherence to diabetes medication. METHODS: A total of four focus groups were conducted with a purposive sample of people with T2DM (n = 34). The data were analysed by multiple researchers independently, and coded using thematic analysis. RESULTS: There were two main themes that emerged: (1) "patients' perspectives on unmet needs for diabetes self-management", and (2) "acceptability and perceived utility of DiabeText". The patients identified a number of barriers for diabetes self-management, including lack of appropriate information and support with diet and physical activity. Support for medication-taking was not perceived as urgently needed, although several barriers were identified (eating outside, traveling, polymedication, dispensation at the pharmacy). The participants anticipated that the proposed intervention would present high levels of patient acceptability and perceived utility as long as its content addresses the barriers that were identified, and includes specific features (short and clear messages, and personalized information). CONCLUSION: The proposed intervention has the potential to be well accepted and perceived as useful by T2DM patients who require support not only in terms of medication-taking, but more prominently of lifestyle behaviour.

Impact of Smartphone App-Based Psychological Interventions for Reducing Depressive Symptoms in People With Depression: Systematic Literature Review and Meta-analysis of Randomized Controlled Trials.

BACKGROUND: Depression is a serious, disabling mental disorder that severely affects quality of life. Patients with depression often do not receive adequate treatment. App-based psychotherapy is considered to have great potential to treat depression owing to its reach and easy accessibility. OBJECTIVE: We aim to analyze the impact of app-based psychological interventions for reducing depressive symptoms in people with depression. METHODS: We conducted a systematic literature review and meta-analysis. We searched Medline, Embase, PsycINFO, Web of Science, and Cochrane Central Register of Controlled Trials from inception to December 23, 2020. We selected randomized controlled trials to examine the impact of app-based psychological interventions for reducing depressive symptoms in people with depression. Study selection, data extraction, and critical appraisal (using the Cochrane Risk of Bias tool for randomized studies and the ROBINS-I tool for nonrandomized studies) were conducted independently by 2 reviewers. Where possible, we pooled data using random effects meta-analyses to obtain estimates of the effect size of the intervention. We conducted post hoc meta-regression analyses to explore the factors associated with intervention success. RESULTS: After screening 3468 unique references retrieved from bibliographic searches and assessing the eligibility of 79 full texts, we identified 12 trials (2859 participants) evaluating 14 different interventions. Of 14 trials, 7 (58%) were conducted in the United States; 3 (25%) trials, in Asia (Japan, South Korea, and China); 1 (8%) trial, in Australia; and 1 (8%) trial, in Germany. Of the 12 trials, 5 (42%) trials presented a low risk of bias. The mean duration of the interventions was 6.6 (SD 2.8) weeks. Two-thirds of the interventions were based on cognitive behavioral therapy alone or included it in combination with cognitive control therapy, positive psychology, brief behavioral activation, or mindfulness- and acceptance-based therapy. With no evidence of publication bias, a pooled analysis of 83% (10/12) of the trials and 86% (12/14) of the interventions showed that app-based interventions, compared with a control group receiving usual care or minimal intervention, produced a moderate reduction in depressive symptoms (standardized mean difference [SMD] -0.51, 95% CI -0.69 to -0.33; 2018/2859, 70.58% of the participants; I2=70%). Our meta-regression analyses indicated that there was a greater reduction in symptoms of depression (P=.04) in trials that included participants with moderate to severe depression (SMD -0.67, 95% CI -0.79 to -0.55), compared with trials with participants exhibiting mild to moderate depression (SMD -0.15, 95% CI -0.43 to -0.12). CONCLUSIONS: App-based interventions targeted at people with depression produce moderate reductions in the symptoms of depression. More methodologically robust trials are needed to confirm our findings, determine which intervention features are associated with greater improvements, and identify those populations most likely to benefit from this type of intervention. TRIAL REGISTRATION: PROSPERO CRD42019145689; https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=145689.

Prácticas y creencias habituales en la preparación de la alimentación complementaria infantil en una muestra española: estudio transversal / Common practices and beliefs in the preparation of complementary infant feeding in a Spanish sample: a cross-sectional study

Introducción: la alimentación complementaria junto con la leche materna debe permitir cubrir las necesidades nutricionales de los niños a partir de los 6 meses de edad. Las prácticas alimentarias inadecuadas determinan una ingesta nutricional deficiente. El objetivo de este estudio fue conocer las prácticas alimentarias en los hogares españoles en relación con la preparación y elaboración de la alimentación infantil. Metodología: se realizó un estudio transversal mediante una encuesta online en adultos residentes en España y no institucionalizados, encargados de la preparación de la alimentación infantil de menores de 2 años. Resultados: la encuesta fue respondida por 1944 personas (37,4 ± 6 años; 65,5 % mujeres). El 72 % de los encuestados prepara principalmente triturados y el 21 % utiliza papillas comerciales frecuentemente. El calabacín (39 %), el pollo (62 %), la merluza (64 %) y el plátano (44 %) son los alimentos más utilizados. El hervido (63 %) y la congelación (59 %) son las técnicas culinarias y de conservación más practicadas. Se identificó el uso inadecuado de la sal y algunos alimentos no seguros (pescados de gran tamaño y acelgas), así como un uso por debajo de las recomendaciones para el aceite de oliva y el huevo. Conclusión: los españoles encargados de la alimentación de los niños menores de 2 años prefieren los alimentos triturados. Aunque son conscientes de que la alimentación preparada en casa es nutricionalmente mejor, en ciertas ocasiones ofrecen papillas comerciales. Además, se han detectado algunas prácticas inadecuadas, por lo que parecen necesarias políticas de educación nutricional destinadas a los responsables de la elaboración de la alimentación infantil. (AU)

Introduction: complementary feeding together with breast milk should cover the nutritional needs of children from 6 months onwards. Thus, inadequate dietary practices can lead to poor nutritional intake. The objective of this study was to examine infant food handling and cooking in Spanish households. Methodology: a cross-sectional study was carried out using an online survey in non-institutionalized adults living in Spain who usually prepare infant food for children under 2 years of age. Results: a total of 1,944 people (37.4 ± 6 years; 65.5 % women) answered the survey. Of these, 72 % prepared mainly mashed foods and 21 % used store-bought baby cereals frequently. Zucchini (39 %), chicken (62 %), hake (64 %) and banana (44 %) were the most commonly used foods. Boiling (63 %) and freezing (59 %) were the most widely used culinary and preservation practices. An inappropriate use of salt and some unsafe foods (large fish and chard) was identified, whereas olive oil and eggs were offered below the current nutritional recommendations. Conclusion: the population surveyed preferred to use mashed foods to feed children under 2 years of age. Even though they were aware that homemade food is nutritionally better, on certain occasions they offer store-bought baby cereal. Furthermore, some inappropriate feeding practices were detected, highlighting the need to implement nutritional education policies regarding infant food preparation. (AU)

Vitamin D recommendations in clinical guidelines: A systematic review, quality evaluation and analysis of potential predictors.

BACKGROUND: Vitamin D has been widely promoted for bone health through supplementation and fortification of the general adult population. However, there is growing evidence that does not support these strategies. Our aim is to review the quality and recommendations on vitamin D nutritional and clinical practice guidelines and to explore predictive factors for their direction and strength. METHODS: We searched three databases and two guideline repositories from 2010 onwards. We performed a descriptive analysis, a quality appraisal using AGREE II scores (Appraisal of Guidelines Research and Evaluation) and a bivariate analysis evaluating the association between direction and strength of recommendations, AGREE II domains' scores and pre-specified characteristics. RESULTS: We included 34 guidelines, 44.1% recommended, 26.5% suggested and 29.4% did not recommend vitamin D supplementation. Guidelines that scored higher for "editorial independence" and "overall quality score" were less likely to recommend or suggest vitamin D supplementation (median 68.8 vs 35.4; P = .001 and 58.3 vs 37.5; P = .02). Guidance produced by government organisations and those that reported source of funding were associated with higher AGREE II scores. Unclear role of source of funding was associated with recommending or suggesting vitamin D supplementation (P = .034). Editorial independence was an independent predictor for recommending or suggesting vitamin D supplementation (OR 1.09; CI95% 1.02 to 1.16; P = .006). CONCLUSIONS: Policymakers, clinicians and patients should be aware that lower quality guidelines and those reporting conflicts of interest are more likely to promote vitamin D supplementation. Guideline organisations should improve the quality of their recommendations' development and the management of conflicts of interest. Users and editors should be aware of these findings when using and appraising guidelines.

Insomnia and sleep quality in healthcare workers fighting against COVID-19: a systematic review of the literature and meta-analysis.

The COVID-19 pandemic has the potential to significant- ly affect the mental health of healthcare workers, who stand in the frontline of this crisis. Insomnia is often related to exposure to stressful situations, such as the current health crisis, as well as other mental disorders, physical conditions and work-related problems. The objectives of this systematic review were: 1) to examine the impact of the current health pandemic produced by COVID-19 on insomnia and sleep quality of health professionals, and 2) to identify risk factors associated with insomnia. After a literature search in MEDLINE, EMBASE, and PsycINFO, 18 relevant studies were identified. The prevalence of insomnia estimated by random effects meta-analysis was 38% (95%CI= 37 to 39%), being slightly higher in women (29%, 95%CI= 27% to 30%) than in men (24%, 95%CI= 21 to 27%). The main risk factor associated with insomnia was working in a high-risk environment, followed by female sex and having a lower educational level. The high figures of self-reported insomnia and poor sleep quality observed indicate the need to develop interventions aimed at mitigating and caring for the mental health of healthcare workers fighting against this pandemic.

Insomnio y calidad del sueño en profesionales sanitarios frente a la Covid-19: una revisión sistemática de la literatura y meta-análisis / Children’s adverse experiences and psychotic chronification

La pandemia de COVID-19 tiene el potencial de afectarsignificativamente la salud mental de los profesionales sanitarios que se encuentran en la primera línea de esta crisis.El insomnio está relacionado con la exposición a situacionesestresantes, como la actual, así como con otros trastornosmentales, patologías físicas y problemas laborales. Los objetivos de esta revisión sistemática fueron: 1) examinar el impacto de la actual pandemia sanitaria producida por COVID-19en el insomnio y la calidad del sueño de los profesionalessanitarios, y 2) identificar los factores de riesgo asociados alinsomnio. Tras una búsqueda bibliográfica en MEDLINE, EMBASE y PsycInfo se identificaron 18 estudios relevantes. Laprevalencia de insomnio autoinformado estimada mediantemeta-análisis de efectos aleatorios fue del 38 % (IC95 %: 37a 39 %), siendo ligeramente superior en mujeres (29 %, IC95%: 27 a 30 %) que en hombres (24 %, IC95 %: 21 a 27 %). Elprincipal factor de riesgo asociado al insomnio fue trabajaren un entorno de alto riesgo, seguido del género femenino yun menor nivel educativo. Las cifras de insomnio y la calidaddel sueño observadas indican la necesidad de desarrollar intervenciones destinadas a mitigar y cuidar la salud mental de los sanitarios al frente de esta pandemia. (AU)

COVID-19 pandemic has the potential to significantlyaffect the mental health of healthcare workers, who standin the frontline of this crisis. Insomnia is often related toexposure to stressful situations, such as the current healthcrisis, as well as other mental disorders, physical conditionsand work-related problems. The objectives of this systematicreview were: 1) to examine the impact of the current health pandemic produced by COVID-19 on insomnia and sleepquality of health professionals, and 2) to identify risk factors associated with insomnia. After a literature search inMEDLINE, EMBASE, and PsycInfo, 18 relevant studies wereidentified. The prevalence of insomnia estimated by randomeffects meta-analysis was 38 % (95 % CI: 37 to 39 %), being slightly higher in women (29 %, 95 % CI: 27 % to 30%) than in men (24 %, 95 % CI: 21 to 27 %). The main riskfactor associated with insomnia was working in a high-riskenvironment, followed by female sex and having a lowereducational level. The figures of self-reported insomnia andworse quality of sleep observed indicate the need to developinterventions aimed at mitigating and caring for the mentalhealth of healthcare workers fighting against this pandemic. (AU)

[Common practices and beliefs in the preparation of complementary infant feeding in a Spanish sample: a cross-sectional study]. / Prácticas y creencias habituales en la preparación de la alimentación complementaria infantil en una muestra española: estudio transversal.

INTRODUCTION: Introduction: complementary feeding together with breast milk should cover the nutritional needs of children from 6 months onwards. Thus, inadequate dietary practices can lead to poor nutritional intake. The objective of this study was to examine infant food handling and cooking in Spanish households. Methodology: a cross-sectional study was carried out using an online survey in non-institutionalized adults living in Spain who usually prepare infant food for children under 2 years of age. Results: a total of 1,944 people (37.4 ± 6 years; 65.5 % women) answered the survey. Of these, 72 % prepared mainly mashed foods and 21 % used store-bought baby cereals frequently. Zucchini (39 %), chicken (62 %), hake (64 %) and banana (44 %) were the most commonly used foods. Boiling (63 %) and freezing (59 %) were the most widely used culinary and preservation practices. An inappropriate use of salt and some unsafe foods (large fish and chard) was identified, whereas olive oil and eggs were offered below the current nutritional recommendations. Conclusion: the population surveyed preferred to use mashed foods to feed children under 2 years of age. Even though they were aware that homemade food is nutritionally better, on certain occasions they offer store-bought baby cereal. Furthermore, some inappropriate feeding practices were detected, highlighting the need to implement nutritional education policies regarding infant food preparation.

INTRODUCCIÓN: Introducción: la alimentación complementaria junto con la leche materna debe permitir cubrir las necesidades nutricionales de los niños a partir de los 6 meses de edad. Las prácticas alimentarias inadecuadas determinan una ingesta nutricional deficiente. El objetivo de este estudio fue conocer las prácticas alimentarias en los hogares españoles en relación con la preparación y elaboración de la alimentación infantil. Metodología: se realizó un estudio transversal mediante una encuesta online en adultos residentes en España y no institucionalizados, encargados de la preparación de la alimentación infantil de menores de 2 años. Resultados: la encuesta fue respondida por 1944 personas (37,4 ± 6 años; 65,5 % mujeres). El 72 % de los encuestados prepara principalmente triturados y el 21 % utiliza papillas comerciales frecuentemente. El calabacín (39 %), el pollo (62 %), la merluza (64 %) y el plátano (44 %) son los alimentos más utilizados. El hervido (63 %) y la congelación (59 %) son las técnicas culinarias y de conservación más practicadas. Se identificó el uso inadecuado de la sal y algunos alimentos no seguros (pescados de gran tamaño y acelgas), así como un uso por debajo de las recomendaciones para el aceite de oliva y el huevo. Conclusión: los españoles encargados de la alimentación de los niños menores de 2 años prefieren los alimentos triturados. Aunque son conscientes de que la alimentación preparada en casa es nutricionalmente mejor, en ciertas ocasiones ofrecen papillas comerciales. Además, se han detectado algunas prácticas inadecuadas, por lo que parecen necesarias políticas de educación nutricional destinadas a los responsables de la elaboración de la alimentación infantil.

A Mobile Phone-Based Intervention to Reduce Mental Health Problems in Health Care Workers During the COVID-19 Pandemic (PsyCovidApp): Randomized Controlled Trial.

BACKGROUND: The global health emergency generated by the COVID-19 pandemic is posing an unprecedented challenge to health care workers, who are facing heavy workloads under psychologically difficult situations. Mental mobile Health (mHealth) interventions are now being widely deployed due to their attractive implementation features, despite the lack of evidence about their efficacy in this specific population and context. OBJECTIVE: The aim of this trial is to evaluate the effectiveness of a psychoeducational, mindfulness-based mHealth intervention to reduce mental health problems in health care workers during the COVID-19 pandemic. METHODS: We conducted a blinded, parallel-group, controlled trial in Spain. Health care workers providing face-to-face health care to patients with COVID-19 were randomly assigned (1:1) to receive the PsyCovidApp intervention (an app targeting emotional skills, healthy lifestyle behavior, burnout, and social support) or a control app (general recommendations about mental health care) for 2 weeks. The participants were blinded to their group allocation. Data were collected telephonically at baseline and after 2 weeks by trained health psychologists. The primary outcome was a composite of depression, anxiety, and stress (overall score on the Depression Anxiety Stress Scale-21 [DASS-21]). Secondary outcomes were insomnia (Insomnia Severity Index), burnout (Maslach Burnout Inventory Human Services Survey), posttraumatic stress (Davidson Trauma Scale), self-efficacy (General Self-Efficacy Scale), and DASS-21 individual scale scores. Differences between groups were analyzed using general linear modeling according to an intention-to-treat protocol. Additionally, we measured the usability of the PsyCovidApp (System Usability Scale). The outcome data collectors and trial statisticians were unaware of the treatment allocation. RESULTS: Between May 14 and July 25, 2020, 482 health care workers were recruited and randomly assigned to PsyCovidApp (n=248) or the control app (n=234). At 2 weeks, complete outcome data were available for 436/482 participants (90.5%). No significant differences were observed between the groups at 2 weeks in the primary outcome (standardized mean difference -0.04; 95% CI -0.11 to 0.04; P=.15) or in the other outcomes. In our prespecified subgroup analyses, we observed significant improvements among health care workers consuming psychotropic medications (n=79) in the primary outcome (-0.29; 95% CI -0.48 to -0.09; P=.004), and in posttraumatic stress, insomnia, anxiety, and stress. Similarly, among health care workers receiving psychotherapy (n=43), we observed improvements in the primary outcome (-0.25; 95% CI -0.49 to -0.02; P=.02), and in insomnia, anxiety, and stress. The mean usability score of PsyCovidApp was high (87.21/100, SD 12.65). After the trial, 208/221 participants in the intervention group (94.1%) asked to regain access to PsyCovidApp, indicating high acceptability. CONCLUSIONS: In health care workers assisting patients with COVID-19 in Spain, PsyCovidApp, compared with a control app, reduced mental health problems at 2 weeks only among health care workers receiving psychotherapy or psychotropic medications. TRIAL REGISTRATION: ClinicalTrials.gov NCT04393818; https://clinicaltrials.gov/ct2/show/NCT04393818.

Effect of a mobile-based intervention on mental health in frontline healthcare workers against COVID-19: Protocol for a randomized controlled trial.

AIM: To evaluate the impact of a psychoeducational, mobile health intervention based on cognitive behavioural therapy and mindfulness-based approaches on the mental health of healthcare workers at the frontline against COVID-19 in Spain. DESIGN: We will carry out a two-week, individually randomized, parallel group, controlled trial. Participants will be individually randomized to receive the PsyCovidApp intervention or control App intervention. METHODS: The PsyCovidApp intervention will include five modules: emotional skills, lifestyle behaviour, work stress and burnout, social support, and practical tools. Healthcare workers having attended patients with COVID-19 will be randomized to receive the PsyCovidApp intervention (intervention group) or a control App intervention (control group). A total of 440 healthcare workers will be necessary to assure statistical power. Measures will be collected telephonically by a team of psychologists at baseline and immediately after the 2 weeks intervention period. Measures will include stress, depression and anxiety (DASS-21 questionnaire-primary endpoint), insomnia (ISI), burnout (MBI-HSS), post-traumatic stress disorder (DTS), and self-efficacy (GSE). The study was funded in May 2020, and was ethically approved in June 2020. Trial participants, outcome assessors and data analysts will be blinded to group allocation. DISCUSSION: Despite the increasing use of mobile health interventions to deliver mental health care, this area of research is still on its infancy. This study will help increase the scientific evidence about the effectiveness of this type of intervention on this specific population and context. IMPACT: Despite the lack of solid evidence about their effectiveness, mobile-based health interventions are already being widely implemented because of their low cost and high scalability. The findings from this study will help health services and organizations to make informed decisions in relation to the development and implementation of this type of interventions, allowing them pondering not only their attractive implementability features, but also empirical data about its benefits. CLINICAL TRIAL REGISTRATION: NCT04393818 (ClinicalTrials.gov identifier). APPROVED FUNDING: May 2020.

Specific Quality of Life Assessment by the NutriQoL® Questionnaire Among Patients Receiving Home Enteral Nutrition.

BACKGROUND: Home enteral nutrition (HEN), including tube feeding and oral supplementation, can improve or worsen quality of life (QoL). The specific assessment of factors affecting QoL may identify the inherent problems associated with HEN. The aim of this study was to evaluate whether the validated NutriQoL® questionnaire is useful for assessing the QoL and the factors influencing it in patients receiving HEN. METHODS: A total of 78 patients receiving HEN completed both the NutriQoL and the SF-12 questionnaires during their routine visits to nutrition service at the hospital. RESULTS: Ninety percent of patients receiving HEN had cancer, 58% received oral supplements, and 42% received tube feeding. At recruitment, the mean score ± SD of the NutriQoL was 66 ± 14, whereas that of the SF-12 was 40 ± 9. A positive correlation between NutriQoL and SF-12 scores (ρ = 0.5; P < .001) was found. Multivariate analysis showed that HEN type (oral vs tube) (odds ratio [OR], 5.6; 95% CI 2.0-15.3; P = .001) and the absence of secondary effects (OR, 3.0; 95% CI, 1.2-7.9; P = .024) were both variables explaining NutriQoL results adjusted by sex and age. The SF-12 results did not show associations with nutrition factors. On visit 2, we observed significant improvements in NutriQoL results. CONCLUSION: The NutriQoL questionnaire identifies specific problems that affect the QoL of patients receiving HEN, whereas SF-12 does not. The route of entry and the occurrence of complications influence specific QoL. NutriQoL is a useful tool to identify the factors that worsen the QoL in patients receiving HEN.