Prospective application of implementation science theories and frameworks to inform use of PROMs in routine clinical care within an integrated pain network

Purpose

The objective of this study is to present the implementation science approaches that were used before implementing electronic patient-reported outcome measures (ePROMs) across an integrated chronic pain network that includes primary, rehabilitation, and hospital-based care.

Methods

The Theoretical Domains Framework (TDF) was used to identify potential barriers and enablers to the use of ePROMS by primary care clinicians. In rehabilitation and tertiary care, the Consolidated Framework for Implementation (CFIR) was used to guide the identification of determinants of implementations, through observation of workflow, patient and clinician surveys, and clinician interviews. A mixed-method concurrent design comprising a quantitative and qualitative analysis was used. The results were reviewed by a steering committee to iteratively inform the ePROM implementation plan. The Proctor framework of evaluation was used to guide the development of an evaluation plan for the implementation of ePROMs in the integrated chronic pain network.

Results

Both frameworks provided similar results with respect to healthcare provider knowledge, behaviour, and experience interpreting PROM scores. The TDF and CFIR frameworks differed in identifying organizational-level determinants. The resultant implementation plan was structured around the adoption of PROMs to inform individual treatment planning and quality improvement. The evaluation plan focused on implementation and impact outcomes to evaluate the ePROM intervention.

Conclusions

The TDF and CFIR guided the development of a multi-component knowledge translation and training intervention that will address multiple gaps and barriers to implementation of PROMs across the integrated network. The ePROM intervention will aim to increase clinicians’ knowledge and skills and foster best practices.

     

Physical interventions for the treatment of trauma and stressor-related disorders: A comprehensive systematic review

BackgroundCognitive behavioral therapies for posttraumatic stress disorder (PTSD) are evidence-based and effective for many. However, the reach and impact of these interventions are limited. Physical interventions hold potential to bridge a gap in the unmet treatment of trauma and stressor-related disorders.MethodThis systematic review examined 84 studies from four decades of research on physical interventions for trauma and stressor-related disorders to: 1) describe the state of the field and 2) summarize the best available evidence. Reviewed studies were described in terms of measured sample characteristics and assessed outcomes. Treatment effect patterns were analyzed by intervention content and study design.ResultsThe majority of studies (65.9%) reported statistically significant reductions in posttraumatic stress symptoms; 40.9% used a randomized controlled trial (RCT) design. Among RCTs, one performed rigorous, statistically powered analyses in an intention-to-treat sample.LimitationsHigh variability in reporting strategies among reviewed studies precludes analysis of variables such as intervention length, frequency, and dropout.ConclusionPreliminary evidence for the efficacy of physical interventions for trauma and stressor-related disorders is promising. Larger scale RCTs powered and designed to identify mediators and moderators of these interventions are warranted.     

Interventions for prevention and treatment of tobacco smoking in school-aged children and adolescents: A systematic review and meta-analysis

ObjectivesTo determine the effectiveness of primary health care relevant interventions to prevent and treat tobacco smoking in school-aged children and adolescents.MethodsThis systematic review considered studies included in a prior review. We adapted and updated the search to April 2015. Titles, abstracts and full-text articles were reviewed in duplicate; data extraction and quality assessments were performed by one reviewer and verified by another. Meta-analyses and pre-specified sub-group analyses were performed when possible. PROSPERO #CRD42015019051.ResultsAfter screening 2118 records, we included nine randomized controlled trials. The mostly moderate quality evidence suggested targeted behavioral interventions can prevent smoking and assist with cessation. Meta-analysis showed intervention participants were 18% less likely to report having initiated smoking at the end of intervention relative to controls (Risk Ratio 0.82; 95% confidence interval 0.72, 0.94); the absolute effect is 1.92% for smoking initiation, Number Needed to Treat is 52 (95% confidence interval 33, 161). For cessation, meta-analysis showed intervention participants were 34% more likely to report having quit smoking at the end of intervention relative to controls (Risk Ratio 1.34; 95% confidence interval 1.05, 1.69); the absolute effect is 7.98% for cessation, Number Needed to Treat is 13 (95% confidence interval 6, 77). Treatment harms were not mentioned in the literature and no data were available to assess long-term effectiveness.ConclusionPrimary care relevant behavioral interventions improve smoking outcomes for children and youth. The evidence on key components is limited by heterogeneity in methodology and intervention strategy. Future trials should target tailored prevention or treatment approaches, establish uniform definition and measurement of smoking, isolate optimal intervention components, and include long-term follow-up.     

The 2 × 2 cluster randomized controlled factorial trial design is mainly used for efficiency and to explore intervention interactions: a systematic review

ObjectivesTo describe the health care settings, purposes, and study reporting quality of the 2 × 2 cluster randomized controlled factorial trial design.Study Design and SettingThis study is a systematic review. We searched Medline, Embase, Cochrane Library, and Web of Knowledge for articles published up to May 2012. Cluster randomized controlled 2 × 2 factorial trials in health, evaluating at least one complex intervention, were included. Two authors independently reviewed and extracted data from the studies.ResultsTwenty-nine studies covering a wide range of clinical areas and health care settings were included. The cluster design was mostly used to minimize contamination. The factorial design was mostly used to assess the effects of two interventions in the same study and to explore interactions between interventions. However, although most studies explored the presence or absence of intervention interactions, they were often either not sufficiently powered to detect any interactions or did not provide information on whether the study was sufficiently powered to detect any interactions. There was a considerable variability in the reporting of a number of study characteristics and methodological aspects. Study quality was also variable within and across studies.ConclusionThe design has been used in a wide range of health care settings and clinical areas to minimize contamination, assess the effects of two interventions in the same study, and explore intervention interactions. There is need for improvement on and guidelines for the reporting of factorial trials.     

Impact of a diabetes disease management program on guideline-adherent care,hospitalization risk and health care costs: a propensity score matching study using real-world data

Objective

To evaluate the impact of a DMP for patients with diabetes mellitus in a Swiss primary care setting.

Methods

In a prospective observational study, we compared diabetes patients in a DMP (intervention group; N = 538) with diabetes patients receiving usual care (control group; N = 5050) using propensity score matching with entropy balancing. Using a difference-in-difference (DiD) approach, we compared changes in outcomes from baseline (2017) to 1-year (2017/18) and to 2-year follow-up (2017/19). Outcomes included four measures for guideline-adherent diabetes care, hospitalization risk, and health care costs.

Results

We identified a positive impact of the DMP on the share of patients fulfilling all measures for guideline-adherent care [DiD 2017/18: 7.2 percentage-points, p < 0.01; 2017/19: 8.4 percentage-points, p < 0.001]. The hospitalization risk was lower in the intervention group in both years, but only statistically significant in the 1-year follow-up [DiD 2017/18: – 5.7 percentage-points, p < 0.05; 2017/19: – 3.9 percentage points, n.s.]. The increase in health care costs was smaller in the intervention than in the control group [DiD 2017/18: CHF – 852; 2017/19: CHF – 909], but this effect was not statistically significant.

Conclusion

The DMP under evaluation seems to exert a positive impact on the quality of diabetes care, reflected in the increase in the measures for guideline-adherent care and in a reduction of the hospitalization risk in the intervention group. It also might reduce health care costs, but only a longer follow-up will show whether the observed effect persists over time.

     

Cost–benefit analysis of the CoCare intervention to improve medical care in long-term care nursing homes: an analysis based on claims data

Background

Providing adequate medical care to nursing home residents is challenging. Transfers to emergency departments are frequent, although often avoidable. We conducted the complex CoCare intervention with the aim to optimize nursing staff–physician collaboration to reduce avoidable hospital admissions and ambulance transportations, thereby reducing costs.

Methods

This prospective, non-randomized study, based on German insurance data, includes residents in nursing homes. Health care cost from a payer perspective and cost–savings of such a complex intervention were investigated. The utilisation of services after implementation of the intervention was compared with services in previous quarters as well as services in the control group. To compensate for remaining differences in resident characteristics between intervention and control group, a propensity score was determined and adjusted for in the regression analyses.

Results

The study population included 1240 residents in the intervention and 7552 in the control group. Total costs of medical services utilisation were reduced by €468.56 (p < 0.001) per resident and quarter in the intervention group. Hospital stays were reduced by 0.08 (p = 0.001) and patient transports by 0.19 (p = 0.049). This led to 1.66 (p < 0.001) avoided hospital days or €621.37 (p < 0.001) in costs–savings of inpatient services. More services were billed by general practitioners in the intervention group, which led to additional costs of €97.89 (p < 0.001).

Conclusion

The benefits of our intervention clearly exceed its costs. In the intervention group, avoided hospital admissions led to additional outpatient billing. This indicates that such a multifactorial intervention program can be cost-saving and improve medical care in long-term care homes.

     

Feasibility of Intravenous Iron Isomaltoside to Improve Anemia and Quality of Life During Palliative Chemotherapy for Esophagogastric Adenocarcinoma

Background: Anemia is common with esophagogastric adenocarcinoma, increasing mortality, blood transfusions, and reducing quality of life (QOL). No clear evidence exists for safe and effective treatment.

Methods: Anemic patients (Hb <12?g/dl women, <13?g/dl men) with esophagogastric adenocarcinoma were recruited before initiation of palliative chemotherapy. Patients were randomized to standard care or single dose of intravenous iron isomaltoside (IVI) before chemotherapy. Post-chemotherapy changes in hemoglobin (Hb), ferritin, transferrin saturations (TSAT), blood transfusions, and QOL were recorded for three cycles of chemotherapy.

Results: Twenty-seven patients were randomized to standard care (n?=?13) or IVI (n?=?14). No significant change in Hb was seen (standard care MD –0.6?g/dl 95% CI –0.1–1.1?g/dl, P?=?0.336; IVI MD +0.5?g/dl 95% CI –0.1–1.1?g/dl, P?=?0.903). An increase in ferritin was seen with IVI after cycle one of chemotherapy (standard care 116?ng/ml; IVI 770?ng/ml, P?<?0.05). No difference in blood transfusions was seen between groups (P?=?0.851). IVI improved QOL with physical well-being, emotional well-being, anemia-specific QOL, trial outcome index, and total scores all exceeding minimum clinically important difference. No improvement was seen with standard care.

Conclusions: This feasibility study suggests IVI improves quality of life and ferritin. Larger adequately powered studies are required to definitively conclude if hemoglobin and blood transfusion changes with IVI.     

Telemonitoring in-home complex chronic patients from primary care in routine clinical practice: Impact on healthcare resources use

Background: Recent evidence indicates that home telemonitoring of chronic patients reduces the use of healthcare resources. However, further studies exploring this issue are needed in primary care.

Objectives: To assess the impact of a primary care-based home telemonitoring intervention for highly unstable chronic patients on the use of healthcare resources.

Methods: A one-year follow-up before and after exploratory study, without control group, was conducted. Housebound patients with heart failure or chronic lung disease, with recurrent hospital admissions, were included. The intervention consisted of patient’s self-measurements and responses to a health status questionnaire, sent daily from smartphones to a web-platform (aided by an alert system) reviewed by healthcare professionals. The primary outcome measure was the number of hospital admissions occurring 12 months before and after the intervention. Secondary outcomes were length of hospital stay and number of emergency department attendances. Primary care nurses were mainly in charge of the telemonitoring process and were assisted by the general practitioners when required.

Results: For the 28 patients who completed the follow-up (out of 42 included, 13 patients died and 1 discontinued the intervention), a significant reduction in hospitalizations, from 2.6 admissions/patient in the previous year (standard deviation, SD: 1.6) to 1.1 (SD: 1.5) during the one-year telemonitoring follow-up (P?<0.001), and emergency department attendances, from 4.2 (SD: 2.6) to 2.1 (SD: 2.6) (P?<0.001) was observed. The length of hospital stay was reduced non-significantly from 11.4 to 7.9 days.

Conclusion: In this small exploratory study, the primary care-based telemonitoring intervention seemed to have a positive impact decreasing the number of hospital admissions and emergency department attendances.     

Gestational Women’s Perceptions About the Harms of Cigarette and E-Cigarette Use During Pregnancy

Objectives

The purpose of this study was to examine differences between perceived harm of cigarette and electronic cigarette (e-cigarette) use while pregnant and differences between healthcare providers’ communication about these products during pregnancy.

Methods

A convenience sample of gestational women (n?=?218; ages 18–45) living in the US completed an online survey between May and December 2017. Participants reported perceived likelihood of adverse health outcomes (e.g., low birth weight, sudden infant death syndrome) among infants/children born to mothers who used cigarettes/e-cigarettes. T-tests and two-way ANOVAs examined differences between risk perceptions of using cigarettes/e-cigarettes while pregnant based on pregnancy status (previously pregnant, currently pregnant, future pregnant). Chi-square analyses examined differences between healthcare provider communication about cigarette/e-cigarette use during pregnancy.

Results

Overall, participants believed adverse health outcomes were significantly more likely to be caused by maternal use of cigarettes than e-cigarettes. Participants who planned to be pregnant reported higher endorsement that smoking combustible cigarettes would cause a miscarriage (p?<?.05) or increased blood pressure (p?<?.05) for a child than currently pregnant participants. Participants reported healthcare providers asked about (p?<?.05), advised them not to use (p?<?.001), and talked to them about health effects of smoking combustible cigarettes while pregnant (p?<?.001) significantly more than e-cigarettes.

Conclusions for Practice

Healthcare providers working with pregnant women should perform the 5As behavioral intervention method to provide pregnant women with tobacco cessation care. They should also discuss the absolute harm nicotine exposure (via cigarettes or e-cigarettes) can have on fetal health and development.

     

Potential value of patient record review to assess and improve patient safety in general practice: A systematic review

Background: There is limited research, and guidance, on how to address safety in general practice proactively.

Objectives: This review aimed to synthesize the literature describing the use of patient record review (PRR) to measure and improve patient safety in primary care. The PRR methodologies utilized and the resulting outcomes were examined.

Methods: Searches were conducted using Medline, Embase, CINAHL and PsycINFO in February 2017. Reference lists of included studies and existing review papers were also screened. English language, peer-reviewed studies that utilized PRR to identify patient safety incidents (PSIs) occurring in general practice were included. Two researchers independently extracted data from articles and applied the Quality Assessment Tool for Studies with Diverse Designs.

Results: A total of 3265 studies were screened, with 15 included. Trigger tools were the most frequent method used for the PRRs (n?=?6). The mean number of safety incidents per 100 records was 12.6. Within studies, a mean of 30.6% of incidents were associated with severe harm (range 8.6–50%), and a mean of 55.6% of incidents was considered preventable (range 32.7–93.5%). The most commonly identified types of PSIs related to medication and prescribing, diagnosis, communication and treatment. Three studies reported on improvement actions taken after the PRRs.

Conclusion: This review suggests that PRR may be a promising means of proactively identifying patient safety incidents and informing improvements.     

Effects of a Laxation and Probiotic Bowel Preparation Regimen: A Randomized Controlled Trial in Patients Undergoing Prostate Radiation Therapy

Abstract

Aim: To determine the effect of bulking and osmotic laxation regimens on reducing rectal gas in patients receiving external beam radiation therapy for prostate cancer.

Methods: A single blinded randomized controlled trial was conducted. Participants assigned to the intervention group (IG) were instructed to consume a bulking laxative and probiotic and the standard care group (SC) instructed to consume an osmotic laxative. Both groups followed a standard low gas diet. Rectal gas ratings were determined from cone-beam computed tomography (CBCT) scans. Dietary and laxative compliance, bowel habits, fiber and fluid intakes were determined from food diaries.

Results: Demographic characteristics were not significantly different between the two treatment arms. The mean age was 74?years. Participants were randomized into the IG (n?=?8) and SC group (n?=?9). Analysis of 433 CBCT scans indicate the odds of a higher rectal gas rating were significantly increased for the IG compared with the SC group (OR 3.2, 95% CI 1.77–5.78, P?<?0.001).

Conclusions: The osmotic laxative was more effective at achieving lower rectal gas levels than a bulking laxative with probiotic in this study. Larger studies of commonly used laxatives are required to develop recommendations for bowel preparation during radiotherapy to the prostate.     

Efectividad de las intervenciones basadas en telemedicina sobre resultados en salud en pacientes con multimorbilidad en atención primaria: revisión sistemática

ObjectiveTo evaluate the effectiveness of telemedicine interventions to improve health outcomes in patients with multiple morbidities in Primary Health Care.DesignA systematic review.Data sourcesINAHTA, Health Guidelines, NICE, Cochrane Library, Medline/PubMed and EMBASE up to April 2018.Study selectionInclusion criteria: patients (adults with 2 or more chronic diseases or a Charlson index greater than three); intervention (telemedicine intervention developed entirely in Primary Health Care); comparator (usual care); health outcomes (mortality, hospital admissions, emergency department visits, health-related quality of life, and satisfaction); study design(clinical practice guideline, systematic review, meta-analysis, randomised controlled clinical trial),and quasi-experimental design). English and Spanish language publication. A total of236 references were located.Data extractionDuplicated articles were removed. Titles, abstracts, and full text of references identified were assessed using the selection criteria; methodological quality assessment; data extraction, and qualitative analysis.ResultsFive articles, corresponding to 3 studies, were included, with 2 randomised controlled clinical trials and one quasi-experimental design. No significant results were observed in reducing mortality or improving health-related quality of life. The effectiveness of telemedicine on the number of hospital admissions or emergency visits showed contradictory results. Satisfaction was not measured in the studies included.ConclusionsThe relatively small number of studies, heterogeneity characteristics, and methodological limitations did not confirm the effectiveness of telemedicine intervention on the improvement of mortality, number of hospital admissions, emergency department visits, and health-related quality of life, compared to usual care.     

Exploring patient‐reported outcomes following percutaneous coronary intervention: A qualitative study

Background

Percutaneous coronary intervention (PCI) is a common cardiac procedure used to treat obstructive coronary artery disease. Patient‐centred care is a priority in cardiovascular health having been shown to increase patient satisfaction, engagement with rehabilitation activities and reduce anxiety. Evidence indicates that patient‐centred care is best achieved by routine collection of patient‐reported outcomes (PROs). However, existing patient‐reported outcome measures (PROMs) have limited the patient involvement in their development.

Aims

To identify and explore outcomes, patients perceive as important following PCI.

Methods

A qualitative design was adopted. Eight focus groups and five semi‐structured interviews were conducted with 32 patients who had undergone PCI in the previous 6 months. Outcomes were identified and mapped under the U.S. Food and Drug Administration (FDA) patient‐reported outcome (PROs) domains of feeling (physical and psychological outcomes), function and evaluation. Inductive and deductive analysis methods were used with open, axial and thematic coding.

Results

Consistent with prior studies, patients identified feeling and function outcomes such as reductions in physical and psychological symptoms and the ability to perform usual activities as important. Participants also identified a range of new outcomes, including confidence to return to usual activities and evaluation domains such as adverse effects of medications and the importance of patient communication.

Conclusion

The findings of this research should be considered in the design of a cardiac PROM for PCI patients. A PROM which adequately assesses these outcomes can provide clinicians and hospital staff with a foundation in which to address these concerns or symptoms.     

Together to end violence against women in Tanzania: Results of a pilot cluster randomized controlled trial to evaluate preliminary effectiveness of interpersonal and community level interventions to address intimate partner violence

ABSTRACT

In Tanzania, women suffer high rates of intimate partner violence (IPV). We conducted a pilot cluster randomised controlled trial to test the feasibility, acceptability and preliminary effectiveness of IPV prevention interventions targeting men and communities in nine villages randomly assigned to one of three study arms (n = 450 couples). In the Control Group, women participated in savings groups while male partners received no intervention. In Intervention Group 1, women participated in savings groups and men participated in peer-groups addressing gender relations and IPV prevention. In Intervention Group 2, women participated in savings groups, men participated in peer-groups, and community leaders facilitated dialogues on similar topics. Recruitment was completed within one month with 95% retained in the intervention and 81% retained in the endline survey. Acceptability was high, with men participating in 82% of peer-group session hours. More men in Interventions 1 (24%) and 2 (19%) disagreed with wife-beating compared to men in the Control (13%); and more men reported non-perpetration of IPV in Interventions 1 (16%) and 2 (14%) compared to the Control (?2%). Findings suggest a fully powered RCT may detect significant reductions in men’s justification and use of IPV, paving the way for evidence-based violence prevention programming.

Trial registration: ClinicalTrials.gov identifier: NCT02434796.     

Do Dietary Supplements Have Beneficial Health Effects in Industrialized Nations

Background: Dietary supplements are regularly used by at least half of the American population, yet the health benefits of these agents are unclear. Objective: A systematic review to determine the benefits and risks of dietary supplements in Westernized societies. Data Sources: MEDLINE, Embase, Cochrane Register of Controlled Trials and citation review of relevant articles. Study Selection: Randomized, placebo‐controlled clinical trials in non‐pregnant Westernized adults that evaluated clinical outcomes of nutritional supplements. Data Extraction: Data were abstracted on study design, study size, study setting, patient population, dietary intervention and clinical outcomes. The outcome of each study was classified as non‐beneficial, beneficial or harmful according to whether theend‐point(s) of interest reached statistical significance. Data Synthesis: Sixty‐three studies met the criteria for our systematic review. No benefit was recorded in 45 studies, with 10 of these showing a trend towards harm and with two showing a trend towards benefit. Four studies reported harm with increased cancer deaths (n=2) and increased fractures (n=2). Two studies reported both a harmful as well as a beneficial outcome. A beneficial outcome was reported in 12 studies; 6 which studied vitamin D and three which investigated omega‐3 fatty acids. While a benefit was reported in one study each which investigated Vitamin E, folic acid and Ginkgo biloba this benefit was not confirmed by larger and more adequately powered studies. Conclusions: With the possible exceptions of Vitamin D and omega‐3 fatty acids there is no data to support the widespread use of dietary supplements in Westernized populations; indeed, many of these supplements may be harmful.     

The impact of an integrated care intervention on mortality and unplanned hospital admissions in a disadvantaged community in England: A difference-in-differences study

BackgroundMany health systems are experimenting with integrated care models to improve outcomes and reduce healthcare demand. Evidence for effects on health service utilisation is variable, with few studies investigating impacts on mortality or differences by socioeconomic group.ObjectiveTo examine the impact of a multidisciplinary, integrated care team intervention on emergency admissions and mortality, and whether effects differed by deprivation group.DesignA longitudinal matched controlled study using difference-in-differences analysis comparing the change in unplanned emergency admissions twelve months before and after the intervention, and inverse probability of treatment-weighted survival analysis comparing mortality, between intervention and matched control groups.SettingA relatively deprived city in England, U.K.InterventionA case-management integrated care programme delivered through multidisciplinary teams and aimed at complex needs and/or high hospitalisation risk patients.ResultsThe intervention was associated with a small increase in emergency admissions of 15 per 1,000 patients per month (95% CI 5 to 24, p = 0.003) after the intervention relative to the control group and no significant change in survival between intervention and control groups (HR 0.9, 95% CI 0.84 to 1.13, p = 0.7). Effects were similar across age and deprivation groups.ConclusionsIt is unlikely that similar interventions lead to reduced emergency admissions or increased survival. Further studies should use experimental methods and assess impacts on quality of life.     

EPA but Not DHA Appears To Be Responsible for the Efficacy of Omega-3 Long Chain Polyunsaturated Fatty Acid Supplementation in Depression: Evidence from a Meta-Analysis of Randomized Controlled Trials

Background: Epidemiologic and case-control data suggest that increased dietary intake of omega-3 long-chain polyunsaturated fatty acids (ω3 LC-PUFAs) may be of benefit in depression. However, the results of randomized controlled trials are mixed and controversy exists as to whether either eicosapentaenoic acid (EPA) or docosahexaenoic acid (DHA) or both are responsible for the reported benefits.

Objective: The aim of the current study was to provide an updated meta-analysis of all double-blind, placebo-controlled, randomized controlled trials examining the effect of ω3 LC-PUFA supplementation in which depressive symptoms were a reported outcome. The study also aimed to specifically test the differential effectiveness of EPA versus DHA through meta-regression and subgroup analyses.

Design: Studies were selected using the PubMed database on the basis of the following criteria: (1) randomized design; (2) placebo controlled; (3) use of an ω3 LC-PUFA preparation containing DHA, EPA, or both where the relative amounts of each fatty acid could be quantified; and (4) reporting sufficient statistics on scores of a recognizable measure of depressive symptoms.

Results: Two hundred forty-one studies were identified, of which 28 met the above inclusion criteria and were therefore included in the subsequent meta-analysis. Using a random effects model, overall standardized mean depression scores were reduced in response to ω3 LC-PUFA supplementation as compared with placebo (standardized mean difference = ?0.291, 95% CI = ?0.463 to ?0.120, z = ?3.327, p = 0.001). However, significant heterogeneity and evidence of publication bias were present. Meta-regression studies showed a significant effect of higher levels of baseline depression and lower supplement DHA∶EPA ratio on therapeutic efficacy. Subgroup analyses showed significant effects for: (1) diagnostic category (bipolar disorder and major depression showing significant improvement with ω3 LC-PUFA supplementation versus mild-to-moderate depression, chronic fatigue and non-clinical populations not showing significant improvement); (2) therapeutic as opposed to preventive intervention; (3) adjunctive treatment as opposed to monotherapy; and (4) supplement type. Symptoms of depression were not significantly reduced in 3 studies using pure DHA (standardized mean difference 0.001, 95% CI ?0.330 to 0.332, z = 0.004, p = 0.997) or in 4 studies using supplements containing greater than 50% DHA (standardized mean difference = 0.141, 95% CI = ?0.195 to 0.477, z = 0.821, p = 0.417). In contrast, symptoms of depression were significantly reduced in 13 studies using supplements containing greater than 50% EPA (standardized mean difference = ?0.446, 95% CI = ?0.753 to ?0.138, z = ?2.843, p = 0.005) and in 8 studies using pure ethyl-EPA (standardized mean difference = ?0.396, 95% CI = ?0.650 to ?0.141, z = ?3.051, p = 0.002). However, further meta-regression studies showed significant inverse associations between efficacy and study methodological quality, study sample size, and duration, thus limiting the confidence of these findings.

Conclusions: The current meta-analysis provides evidence that EPA may be more efficacious than DHA in treating depression. However, owing to the identified limitations of the included studies, larger, well-designed, randomized controlled trials of sufficient duration are needed to confirm these findings.     

Screening behaviors for diabetic foot risk and their influencing factors among general practitioners: a cross-sectional study in Changsha,China

Background

Stroke is one of the leading causes of death and the main cause of long-term disability in the United States. The significant risk factors of stroke among Hispanics are well-documented. The majority of stroke survivors return home following a stroke and are cared for by family caregivers. Due to the abrupt nature of strokes, caregivers experience unexpected changes and demands that oftentimes lead to caregiver burden and depression. Given the significant risk factors for stroke in Hispanics and the influence of culture in family norms and family management, we developed a telephone and online problem-solving intervention for Spanish-speaking stroke caregivers. This study tests the impact of a telephone and online problem-solving intervention for Spanish-speaking stroke caregivers on caregiver outcomes.

Methods

The design is a two-arm parallel randomized clinical trial with repeated measures. We will enroll 290 caregivers from 3 Veterans Affairs (VA) medical centers. Participants randomized into the intervention arm receive a problem-solving intervention that uses telephone and online education and care management tools on the previously developed and nationally available RESCUE en Español Caregiver website. In the usual care group, participants receive the information and/or support caregivers of veterans with stroke normally receive through existing VA resources (e.g., stroke-related information and support). The primary outcome is change in caregiver’s depressive symptoms at 1- and 12-weeks post-intervention. Secondary outcomes include changes in stroke caregivers’ burden, self-efficacy, problem-solving, and health-related quality of life (HRQOL) and veterans’ functional abilities. We will also determine the budgetary impact, the acceptability of the intervention and participation barriers and facilitators for Spanish-speaking stroke caregivers.

Discussion

This is an ongoing study. It is the first known randomized controlled trial testing the effect of a telephone and online problem-solving intervention in Spanish for caregivers of veterans post-stroke. If successful, findings will support an evidence-based model that can be transported into clinical practice to improve the quality of caregiving post-stroke.

Trial registration

ClinicalTrials.gov: NCT03142841— Spanish Intervention for Caregivers of Veterans with Stroke (RESCUE Español). Registered on February 23, 2018. Protocol version 8. 08.11.2022.