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.
Background
There is a growing interest in identifying strategies to achieve safer primary health‐care provision. However, most of the research conducted so far in this area relies on information ...supplied by health‐care providers, and limited attention has been paid to patients’ perspectives.
Objective
To explore patients’ experiences and perceptions of patient safety in English general practices with the aim of eliciting patient‐centred recommendations for improving patient safety.
Methods
The Patient Reported Experiences and Outcomes of Safety in Primary Care questionnaire was sent to a random sample of 6736 primary care users registered in 45 English practices. We conducted a qualitative content analysis of responses to seven open‐ended items addressing patients’ experiences of safety problems, lessons learnt as a result of such experiences and recommendations for safer health care.
Results
A total of 1244 (18.4%) participants returned completed questionnaires. Of those, 678 (54.5%) responded to at least one open‐ended question. Two main themes emerged as follows: (i) experiences of safety problems and (ii) good practices and recommendations to improve patient safety in primary care. Most frequent experiences of safety problems were related to appointments, coordination between providers, tests, medication and diagnosis. Patients’ responses to these problems included increased patient activation (eg speaking up about concerns with their health care) and avoidance of unnecessary health care. Recommendations for safer health care included improvements in patient‐centred communication, continuity of care, timely appointments, technical quality of care, active monitoring, teamwork, health records and practice environment.
Conclusion
This study identified a number of patient‐centred recommendations for improving patient safety in English general practices.
Aim
To evaluate the effectiveness of a nurse‐led personalized telephone lifestyle intervention versus automated SMSs in the reduction of fasting plasma glucose in adults with prediabetes.
Design
The ...PREDIPHONE is a randomized controlled, parallel, two arms, superiority trial with 15 months of follow‐up. Participants will be randomized to either the intervention group (teleconsultations) or the active control group (SMSs).
Methods
A total of 428 participants will be randomized in a 1:1 ratio to one of the two arms and followed up during 9 months. The teleconsultations group will receive nurse‐led personalized advice, while the SMSs group will receive 4–5 brief SMSs a week. Participants in both groups will receive evidence‐based recommendations for diet and physical activity (PA). Outcome measures will be collected at baseline, months 4 and 9 and at month 15, to evaluate post‐intervention effects.
Discussion
Prevention of diabetes through the implementation of lifestyle interventions remains an important priority. The current pandemic situation has magnified its urgency as it heavily affected the functionality of the healthcare system. Moreover, it created the need of remotely delivering preventative interventions. This study will provide insights on the effectiveness and feasibility of a telephone‐based intervention led by nurses in the amelioration of risk factors associated with diabetes.
Impact
Findings from this study will offer health services decision‐makers sound evidence regarding an alternative method to face‐to‐face consultations that could be practical, acceptable and inexpensive, and that concretely answers the need for easily implementable prevention strategies.
Trial Registration
NCT04735640 (ClinicalTrials.gov identifier).
Protocol version
V1.0, 18/02/2021.
To investigate the impact of patient and public involvement (PPI) on rates of enrolment and retention in clinical trials and explore how this varies with the context and nature of PPI.
Systematic ...review and meta-analysis.
Ten electronic databases, including Medline, INVOLVE Evidence Library, and clinical trial registries.
Experimental and observational studies quantitatively evaluating the impact of a PPI intervention, compared with no intervention or non-PPI intervention(s), on participant enrolment and/or retention rates in a clinical trial or trials. PPI interventions could include additional non-PPI components inseparable from the PPI (for example, other stakeholder involvement).
Two independent reviewers extracted data on enrolment and retention rates, as well as on the context and characteristics of PPI intervention, and assessed risk of bias. Random effects meta-analyses were used to determine the average effect of PPI interventions on enrolment and retention in clinical trials: main analysis including randomised studies only, secondary analysis adding non-randomised studies, and several exploratory subgroup and sensitivity analyses.
26 studies were included in the review; 19 were eligible for enrolment meta-analysis and five for retention meta-analysis. Various PPI interventions were identified with different degrees of involvement, different numbers and types of people involved, and input at different stages of the trial process. On average, PPI interventions modestly but significantly increased the odds of participant enrolment in the main analysis (odds ratio 1.16, 95% confidence interval and prediction interval 1.01 to 1.34). Non-PPI components of interventions may have contributed to this effect. In exploratory subgroup analyses, the involvement of people with lived experience of the condition under study was significantly associated with improved enrolment (odds ratio 3.14
1.07; P=0.02). The findings for retention were inconclusive owing to the paucity of eligible studies (odds ratio 1.16, 95% confidence interval 0.33 to 4.14), for main analysis).
These findings add weight to the case for PPI in clinical trials by indicating that it is likely to improve enrolment of participants, especially if it includes people with lived experience of the health condition under study. Further research is needed to assess which types of PPI work best in particular contexts, the cost effectiveness of PPI, the impact of PPI at earlier stages of trial design, and the impact of PPI interventions specifically targeting retention.
PROSPERO CRD42016043808.
Objective
To study the relationships between the different domains of quality of primary health care for the evaluation of health system performance and for informing policy decision making.
Data ...Sources
A total of 137 quality indicators collected from 7,607 English practices between 2011 and 2012.
Study Design
Cross‐sectional study at the practice level. Indicators were allocated to subdomains of processes of care (“quality assurance,” “education and training,” “medicine management,” “access,” “clinical management,” and “patient‐centered care”), health outcomes (“intermediate outcomes” and “patient‐reported health status”), and patient satisfaction. The relationships between the subdomains were hypothesized in a conceptual model and subsequently tested using structural equation modeling.
Principal Findings
The model supported two independent paths. In the first path, “access” was associated with “patient‐centered care” (β = 0.63), which in turn was strongly associated with “patient satisfaction” (β = 0.88). In the second path, “education and training” was associated with “clinical management” (β = 0.32), which in turn was associated with “intermediate outcomes” (β = 0.69). “Patient‐reported health status” was weakly associated with “patient‐centered care” (β = −0.05) and “patient satisfaction” (β = 0.09), and not associated with “clinical management” or “intermediate outcomes.”
Conclusions
This is the first empirical model to simultaneously provide evidence on the independence of intermediate health care outcomes, patient satisfaction, and health status. The explanatory paths via technical quality clinical management and patient centeredness offer specific opportunities for the development of quality improvement initiatives.
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.
•Healthcare workers are at high risk of mental health problems during viral epidemic outbreaks.•This review of 117 studies offers pooled estimations of prevalence of acute stress disorder (40%), ...followed by anxiety (30%), burnout (28%), depression (24%), and post-traumatic stress disorder (13%).•It identifies a number of factors (sociodemographic, occupational and social) associated with mental health problems.•Interventional high-quality research is urgently needed to inform evidence-based policies for viral pandemics.
Background: This study aimed at examining the impact of providing healthcare during health emergencies caused by viral epidemic outbreaks on healthcare workers' (HCWs) mental health; to identify factors associated with worse impact, and; to assess the available evidence base regarding interventions to reduce such impact.
Method: Rapid systematic review. We searched MEDLINE, Embase, and PsycINFO (inception to August 2020). We pooled data using random-effects meta-analyses to estimate the prevalence of specific mental health problems, and used GRADE to ascertain the certainty of evidence.
Results: We included 117 studies. The pooled prevalence was higher for acute stress disorder (40% (95%CI 39 to 41%)), followed by anxiety (30%, (30 to 31%)), burnout (28% (26 to 31%)), depression (24% (24 to 25%)), and post-traumatic stress disorder (13% (13 to 14%)). We identified factors associated with the likelihood of developing those problems, including sociodemographic (younger age and female gender), social (lack of social support, stigmatization), and occupational (working in a high-risk environment, specific occupational roles, and lower levels of specialised training and job experience) factors. Four studies reported interventions for frontline HCW: two educational interventions increased confidence in pandemic self-efficacy and in interpersonal problems solving (very low certainty), whereas one multifaceted intervention improved anxiety, depression, and sleep quality (very low certainty).
Limitations: We only searched three databases, and the initial screening was undertaken by a single reviewer.
Conclusion: Given the very limited evidence regarding the impact of interventions to tackle mental health problems in HCWs, the risk factors identified represent important targets for future interventions.
The growing prevalence of metabolic syndrome as well as its impact on public health has garnered increased attention in recent years. As a result, metabolic syndrome is now considered one of the ...world's leading public health problems. Bioactive peptides deriving from milk proteins may play an important role in the prevention and treatment of metabolic syndrome and its complications via several mechanisms, such as the satiety response, the regulation of insulinemia levels and blood pressure, the uptake of free radicals, and alteration of the lipid profile. These peptides can be incorporated into functional foods or administered via nutraceuticals to decrease the risk of obesity, atherogenesis, arterial hypertension, and type 2 diabetes. Recent findings have generated considerable scientific and commercial interest in milk‐derived bioactive peptides, leading to numerous publications on the effectiveness of these substances. This review summarizes the current knowledge on bioactive peptides derived from milk proteins and examines the potential value of these peptides in the treatment and prevention of metabolic syndrome and its complications.
•This research update effectiveness data to telephone-delivered psychotherapy.•It is the first that determine adherence to telephone-administered psychotherapy.•Telephone-delivered psychotherapy ...shows beneficial effects on depression compared to control conditions.•There is no evidence that it is less effective compared to active comparators.•Telephone-delivered psychotherapy shows an adequate treatment adherence.
The aim of this systematic review was to evaluate the effectiveness of telephone-administered psychotherapy for depression in adults when compared to control conditions or other active treatments, and to determine adherence to telephone-administered psychotherapy.
A bibliographic search was conducted in MEDLINE, Embase, PsycINFO, the Cochrane library, and a number of sources of grey literature. We included randomised controlled trials (RCTs) examining the impact of telephone-administered psychotherapy on depressive symptomatology. Two reviewers independently screened citations, extracted the relevant data, and assessed risk of bias using Cochrane tools. Random effects meta-analyses were used to determine the average effect of the interventions on depressive symptomatology: main analysis including randomised trials only, and several exploratory subgroup and sensitivity analyses.
We identified ten trials. Telephone-administered psychotherapy showed beneficial effects on depression severity when compared to control conditions ((standardized mean difference SMD= −0.85 (95% CI −1.56 to −0.15)). When compared to active comparators, the meta-analysis showed a non-significant small effect size (SMD= −0.18 (95% CI −0.45 to 0.09)), in favour of telephone-administered psychotherapy. Total weighted mean adherence was 73%.
Some of the included studies presented a small sample size. Due to variations in time points follow-ups among the studies, it was not possible to determine long term post intervention effects.
Available evidence suggests that telephone-delivered psychotherapy may be an effective strategy to reduce depression symptoms when compared to control conditions, and shows an adequate treatment adherence. Future research is needed to determine its cost-effectiveness and long-term effects.
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