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Increasing the reach of evidence-based interventions for weight management and diabetes prevention among Medicaid patients: study protocol for a pilot Sequential Multiple Assignment Randomised Trial

Por: Schlechter · C. R. · Del Fiol · G. · Jones · D. R. · Orleans · B. · Gibson · B. · Nahum-Shani · I. · Maxfield · E. · Locke · A. · Cornia · R. · Bradshaw · R. · Wirth · J. · Jaggers · S. J. · Lam · C. Y. · Wetter · D. W.
Introduction

Over 40% of US adults meet criteria for obesity, a major risk factor for chronic disease. Obesity disproportionately impacts populations that have been historically marginalised (eg, low socioeconomic status, rural, some racial/ethnic minority groups). Evidence-based interventions (EBIs) for weight management exist but reach less than 3% of eligible individuals. The aims of this pilot randomised controlled trial are to evaluate feasibility and acceptability of dissemination strategies designed to increase reach of EBIs for weight management.

Methods and analysis

This study is a two-phase, Sequential Multiple Assignment Randomized Trial, conducted with 200 Medicaid patients. In phase 1, patients will be individually randomised to single text message (TM1) or multiple text messages (TM+). Phase 2 is based on treatment response. Patients who enrol in the EBI within 12 weeks of exposure to phase 1 (ie, responders) receive no further interventions. Patients in TM1 who do not enrol in the EBI within 12 weeks of exposure (ie, TM1 non-responders) will be randomised to either TM1-Continued (ie, no further TM) or TM1 & MAPS (ie, no further TM, up to 2 Motivation And Problem Solving (MAPS) navigation calls) over the next 12 weeks. Patients in TM+ who do not enrol in the EBI (ie, TM+ non-responders) will be randomised to either TM+Continued (ie, monthly text messages) or TM+ & MAPS (ie, monthly text messages, plus up to 2 MAPS calls) over the next 12 weeks. Descriptive statistics will be used to characterise feasibility (eg, proportion of patients eligible, contacted and enrolled in the trial) and acceptability (eg, participant opt-out, participant engagement with dissemination strategies, EBI reach (ie, the proportion of participants who enrol in EBI), adherence, effectiveness).

Ethics and dissemination

Study protocol was approved by the University of Utah Institutional Review Board (#00139694). Results will be disseminated through study partners and peer-reviewed publications.

Trial registration number

clinicaltrials.gov; NCT05666323.

Access to therapy for child sexual abuse survivors: Preliminary dialogue of barriers and facilitators between caregivers

by Jonathan Jin, Huda Al-Shamali, Lorraine Smith-MacDonald, Matthew Reeson, Wanda Polzin, Yifeng Wei, Hannah Pazderka, Peter H. Silverstone, Andrew J. Greenshaw

Background

Difficulties in access to therapy were highlighted by COVID-19 measures restricting in-person gatherings. Additional challenges arise when focusing on caregivers of child sexual abuse (CSA) survivors in particular, which are a population that has been historically difficult to engage with due to issues of stigma and confidentiality.

Objectives

To present preliminary qualitative results from caregivers of CSA survivors.

Methods

This study was conducted with caregivers of CSA survivors. Two hybrid webinar/focus groups were conducted using a video conferencing platform in fall of 2021 with two groups of stakeholders (11 caregivers and 5 moderators/clinical staff at Little Warriors, an intensive episodic treatment facility). Sessions were recorded, transcribed, and thematically-analyzed using standard qualitative methodology.

Results

A total of 11 caregivers contributed to the data. Themes include: (1) Challenges of starting and maintaining treatment (i.e., emotional impact of intake day, challenges of enrolling), (2) Therapeutic benefits of specialized treatment (i.e., feeling safe and supported and the importance of trauma-informed care), and (3) Barriers and facilitators of treatment (i.e., avenues to scale-up and self-care).

Conclusion

The importance of a strong therapeutic alliance was highlighted by both caregivers/clinical staff and further support is needed for families post-treatment. The present hybrid webinar/focus group also achieved engagement goals in a population that is typically difficult to reach. Overall, the response rate (12%) was equivalent to reported registrant attendance rates for general business to consumer webinars and the recommended focus group size. This preliminary approach warrants replication in other populations outside our clinical context.

OptiBreech collaborative care versus standard care for women with a breech-presenting fetus at term: A pilot parallel group randomised trial to evaluate the feasibility of a randomised trial nested within a cohort

by Shawn Walker, Emma Spillane, Kate Stringer, Lauren Trepte, Siân M. Davies, Jacana Bresson, Jane Sandall, Andrew Shennan, the OptiBreech Collaborative

OptiBreech collaborative care is a multi-disciplinary care pathway for breech presentation at term, with continuity from a breech specialist midwife, including where chosen, for vaginal breech birth (VBB). Pilot randomised trial using unblinded 1:1 parallel group allocation to OptiBreech versus standard care, within a cohort. Participants were women with a breech-presenting fetus > 33 weeks, at four sites in England, January–June 2022. A two-stage consent process was used. Participants consented to undergo random selection to be offered a ‘new care process’, with a choice to accept it, or not. Primary objectives were to identify recruitment, acceptance, and attrition rates. Randomisation procedures and potential primary outcomes for a substantive study were also feasibility-tested. 68 women were randomised between January–June 2022. The consent process was acceptable to participants, but randomisation was unacceptable to women who specifically sought OptiBreech care. Two women withdrew due to concerns about sharing personal information. More women planned a VBB when randomised to OptiBreech Care (23.5% vs 0, p = .002, 95% CI = 9.3%,37.8%). Women randomised to OptiBreech care had: lower rates of cephalic presentation at birth (38.2% vs 54.5%), higher rates of vaginal birth (32.4% vs 24.2%), lower rates of in-labour caesarean birth (20.6% vs 36.4%), lower rates of neonatal intensive care (5.9% vs 9.1%), and lower rates of severe neonatal morbidity (2.9% vs 9.1%). Randomisation was stopped on the advice of the steering committee before the planned sample of 104, as lack of access to VBB within standard care prohibited comparison of outcomes. Demand for VBB is sufficient for a cohort study, but comparison of outcomes by 1:1 randomisation is not feasible. OptiBreech care would be best evaluated using stepped wedge cluster randomisation. Funded by the United Kingdom National Institute for Health and Care Research (NIHR300582). Clinical trial registration: ISRCTN 14521381.

Relationship between self-reported listening and communication difficulties and executive function: a protocol for a systematic review and meta-analysis

Por: Stacey · J. E. · Danielsson · H. · Heinrich · A. · Batinovic · L. · Holmer · E. · Ingo · E. · Henshaw · H.
Introduction

Listening and communication difficulties can limit people’s participation in activity and adversely affect their quality of life. Hearing, as well as listening and communication difficulties, can be measured either by using behavioural tests or self-report measures, and the outcomes are not always closely linked. The association between behaviourally measured and self-reported hearing is strong, whereas the association between behavioural and self-reported measures of listening and communication difficulties is much weaker, suggesting they assess different aspects of listening. While behavioural measures of listening and communication difficulties have been associated with poorer cognitive performance including executive functions, the same association has not always been shown for self-report measures. The objective of this systematic review and meta-analysis is to understand the relationship between executive function and self-reported listening and communication difficulties in adults with hearing loss, and where possible, potential covariates of age and pure-tone audiometric thresholds.

Methods and analysis

Studies will be eligible for inclusion if they report data from both a self-report measure of listening difficulties and a behavioural measure of executive function. Eight databases are to be searched: MEDLINE (via Ovid SP), EMBASE (via Ovid SP), PsycINFO (via Ovid SP), ASSIA (via ProQuest), Cumulative Index to Nursing and Allied Health Literature or CINAHL (via EBSCO Host), Scopus, PubMed and Web of Science (Science and Social Science Citation Index). The JBI critical appraisal tool will be used to assess risk of bias for included studies. Results will be synthesised primarily using a meta-analysis, and where sufficient quantitative data are not available, a narrative synthesis will be carried out to describe key results.

Ethics and dissemination

No ethical issues are foreseen. Data will be disseminated via academic publication and conference presentations. Findings may also be published in scientific newsletters and magazines.

PROSPERO registration number

CRD42022293546.

Systematic literature review and network meta-analysis of therapies for psoriatic arthritis on patient-reported outcomes

Por: Nash · P. · Dutz · J. P. · Peterson · S. · Patel · B. P. · Eaton · K. · Shawi · M. · Zazzetti · F. · Wei · J. C.-C.
Objectives

Head-to-head clinical trials are common in psoriasis, but scarce in psoriatic arthritis (PsA), making treatment comparisons between therapeutic classes difficult. This study describes the relative effectiveness of targeted synthetic (ts) and biologic (b) disease-modifying antirheumatic drugs (DMARDs) on patient-reported outcomes (PROs) through network meta-analysis (NMA).

Design

A systematic literature review (SLR) was conducted in January 2020. Bayesian NMAs were conducted to compare treatments on Health Assessment Questionnaire Disability Index (HAQ-DI) and 36-item Short Form (SF-36) Health Survey including Mental Component Summary (MCS) and Physical Component Summary (PCS) scores.

Data sources

Ovid MEDLINE (including Epub Ahead of Print, In-Process & Other Non-Indexed Citations and Daily),Embase and Cochrane Central Register of Controlled Trials.

Eligibility criteria

Phase III randomised controlled trials (RCTs) evaluating patients with PsA receiving tsDMARDS, bDMARDs or placebo were included in the SLR; there was no restriction on outcomes.

Data extraction and synthesis

Two independent researchers reviewed all citations. Data for studies meeting all inclusion criteria were extracted into a standardised Excel-based form by one reviewer and validated by a second reviewer. A third reviewer was consulted to resolve any discrepancies, as necessary. Risk of bias was assessed using the The National Institute for Health and Care Excellence clinical effectiveness quality assessment checklist.

Results

In total, 26 RCTs were included. For HAQ-DI, SF-36 PCS and SF-36 MCS scores, intravenous tumour necrosis factor (TNF) alpha inhibitors generally ranked higher than most other classes of therapies available to treat patients with PsA. For almost all outcomes, several interleukin (IL)-23, IL-17A, subcutaneous TNF and IL-12/23 agents offered comparable improvement, while cytotoxic T-lymphocyte-associated antigen 4, phosphodiesterase-4 and Janus kinase inhibitors often had the lowest efficacy.

Conclusions

While intravenous TNFs may provide some improvements in PROs relative to several other tsDMARDs and bDMARDs for the treatment of patients with PsA, differences between classes of therapies across outcomes were small.

How digital health translational research is prioritised: a qualitative stakeholder-driven approach to decision support evaluation

Por: Bamgboje-Ayodele · A. · McPhail · S. M. · Brain · D. · Taggart · R. · Burger · M. · Bruce · L. · Holtby · C. · Pradhan · M. · Simpson · M. · Shaw · T. J. · Baysari · M. T.
Objectives

Digital health is now routinely being applied in clinical care, and with a variety of clinician-facing systems available, healthcare organisations are increasingly required to make decisions about technology implementation and evaluation. However, few studies have examined how digital health research is prioritised, particularly research focused on clinician-facing decision support systems. This study aimed to identify criteria for prioritising digital health research, examine how these differ from criteria for prioritising traditional health research and determine priority decision support use cases for a collaborative implementation research programme.

Methods

Drawing on an interpretive listening model for priority setting and a stakeholder-driven approach, our prioritisation process involved stakeholder identification, eliciting decision support use case priorities from stakeholders, generating initial use case priorities and finalising preferred use cases based on consultations. In this qualitative study, online focus group session(s) were held with stakeholders, audiorecorded, transcribed and analysed thematically.

Results

Fifteen participants attended the online priority setting sessions. Criteria for prioritising digital health research fell into three themes, namely: public health benefit, health system-level factors and research process and feasibility. We identified criteria unique to digital health research as the availability of suitable governance frameworks, candidate technology’s alignment with other technologies in use,and the possibility of data-driven insights from health technology data. The final selected use cases were remote monitoring of patients with pulmonary conditions, sepsis detection and automated breast screening.

Conclusion

The criteria for determining digital health research priority areas are more nuanced than that of traditional health condition focused research and can neither be viewed solely through a clinical lens nor technological lens. As digital health research relies heavily on health technology implementation, digital health prioritisation criteria comprised enablers of successful technology implementation. Our prioritisation process could be applied to other settings and collaborative projects where research institutions partner with healthcare delivery organisations.

Best practices for communication while wearing facemasks: A scoping review

Abstract

Introduction

Facemasks are an important piece of personal protective equipment (PPE) to mitigate the spread of respiratory illnesses, but they can impede communication between patients and healthcare providers. The purpose of this scoping review is to identify effective communication practices while wearing facemasks.

Design

Scoping review using a systematic search of articles from the PubMed, CINAHL, and Embase databases.

Methods

The PEO (population, exposure, outcome) methodology was selected for this systematic scoping review. The population of interest (P) includes humans of all ages (children, adults, and older adults); the exposure of interest (E) is PPE that covers the mouth (i.e., facemasks); and the outcome of interest (O) is successful or unsuccessful communication practices. The Johns Hopkins Evidence-Based Practice for Nurses and Healthcare Professionals appraisal guidelines were used to determine the level and quality of the research.

Results

Thirty-nine articles met the inclusion criteria. Seventeen of these were high- or good-quality research studies, and the remaining 22 were non-research articles included with separate analysis as part of the scoping review. The 17 articles encompassed 2656 participants. The highest quality evidence indicated that standard surgical masks have the least impact on speech perception compared to other non-transparent mask types, and that recognizing emotions is less accurate with facemasks, necessitating compensatory actions (i.e., reducing extraneous noise, using a microphone to amplify voice, and employing clear speech). Evidence was contradictory regarding the use of transparent masks. Evidence was of limited quality for other non-verbal and verbal communication strategies.

Conclusion

Awareness of communication challenges is crucial when wearing facemasks. More high-quality studies are needed to evaluate communication techniques when speakers are wearing facemasks. Basic strategies such as selecting an appropriate mask type, reducing extraneous noise, using microphones, verbalizing emotions, and employing clear speech appear to be beneficial.

Clinical Relevance

The findings of this scoping review highlight the importance of considering communication challenges while wearing facemasks in the healthcare settings. The review suggests that selecting an appropriate mask type, reducing extraneous noise, verbalizing emotions, and employing clear speech are some strategies that may be effective in mitigating the impact of facemasks on communication between patients and healthcare providers.

Exploring the validity of allostatic load in pregnant women

The theory of allostatic load has gained momentum in perinatal research to understand the biological pathways of the impact of maternal chronic stress on adverse perinatal outcomes. However, due to physiological changes of pregnancy, including large variations across gestation, the extent to which allostatic load measured in pregnancy is valid has not been queried in depth.
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