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PloS One 2023Remote self-administered visual acuity (VA) tests have the potential to allow patients and non-specialists to assess vision without eye health professional input....
BACKGROUND
Remote self-administered visual acuity (VA) tests have the potential to allow patients and non-specialists to assess vision without eye health professional input. Validation in pragmatic trials is necessary to demonstrate the accuracy and reliability of tests in relevant settings to justify deployment. Here, published pragmatic trials of these tests were synthesised to summarise the effectiveness of available options and appraise the quality of their supporting evidence.
METHODS
A systematic review was undertaken in accordance with a preregistered protocol (CRD42022385045). The Cochrane Library, Embase, MEDLINE, and Scopus were searched. Screening was conducted according to the following criteria: (1) English language; (2) primary research article; (3) visual acuity test conducted out of eye clinic; (4) no clinical administration of remote test; (5) accuracy or reliability of remote test analysed. There were no restrictions on trial participants. Quality assessment was conducted with QUADAS-2.
RESULTS
Of 1227 identified reports, 10 studies were ultimately included. One study was at high risk of bias and two studies exhibited concerning features of bias; all studies were applicable. Three trials-of DigiVis, iSight Professional, and Peek Acuity-from two studies suggested that accuracy of the remote tests is comparable to clinical assessment. All other trials exhibited inferior accuracy, including conflicting results from a pooled study of iSight Professional and Peek Acuity. Two studies evaluated test-retest agreement-one trial provided evidence that DigiVis is as reliable as clinical assessment. The three most accurate tests required access to digital devices. Reporting was inconsistent and often incomplete, particularly with regards to describing methods and conducting statistical analysis.
CONCLUSIONS
Remote self-administered VA tests appear promising, but further pragmatic trials are indicated to justify deployment in carefully defined contexts to facilitate patient or non-specialist led assessment. Deployment could augment teleophthalmology, non-specialist eye assessment, pre-consultation triage, and autonomous long-term monitoring of vision.
Topics: Humans; Ophthalmology; Reproducibility of Results; Telemedicine; Visual Acuity
PubMed: 37347757
DOI: 10.1371/journal.pone.0281847 -
Annals of Medicine Dec 2022Psychotropic medications are commonly prescribed among adults with intellectual disability, often in the absence of a psychiatric diagnosis. The aim of this scoping...
BACKGROUND/OBJECTIVE(S)
Psychotropic medications are commonly prescribed among adults with intellectual disability, often in the absence of a psychiatric diagnosis. The aim of this scoping review is to provide an overview of the extent, range, and nature of the available research on medication use and practices and medication management in people with intellectual disability taking psychotropic medications for behaviours that challenge.
MATERIALS AND METHODS
A scoping review of research studies (qualitative, quantitative, and mixed design) and Grey Literature (English) was carried out. Databases included: Ovid MEDLINE, Embase, CINAHL, JBI Evidence Synthesis, Cochrane Central Register of Controlled Trials, Cochrane Database of Systematic Reviews, PsycINFO, and Scopus. A three-step search strategy was followed, with results screened by two independent reviewers. Data was extracted independently by two reviewers using a data extraction tool with results mapped and presented using a narrative form supported by tables and diagrams to the research questions.
RESULTS
Following the removal of duplicates, records were screened, full texts assessed, and 49 studies were included. Medication outcomes included reduced repetitive, stereotypic, and/or aggressive behaviours. High dosing/prescribing in the setting of an absent/unclear clinical indication was associated with worsening of symptoms for which psychotropics were prescribed. While psychotropics had a role in managing behaviours that challenge, reducing or discontinuing psychotropics is sometimes warranted. Study designs were frequently pragmatic resulting in small sample sizes and heterogeneous cohorts receiving different doses and combinations of medications. Access to multidisciplinary teams, guidelines, medication reviews, staff training, and enhanced roles for carers in decision-making were warranted to optimize psychotropic use.
CONCLUSIONS
These findings can inform prescribing interventions and highlight the need for timely and comprehensive patient outcome data, especially on long-term use of high doses of psychotropics and what happens when reduce or stop prescribing these doses.KEY MESSAGESPsychotropic medications are frequently prescribed for people with intellectual disabilities, often at high doses and these medications are associated with both positive and negative patient outcomes.Work to rationalize psychotropic use has been reported with interventions aiming to reduce polypharmacy or deprescribe a single psychotropic medicine. These interventions had mixed success and risk of relapse was documented in some studies.Limitations in sample size and heterogenous patient cohorts make it challenging to understand the risks and benefits associated with reducing or stopping psychotropic medicines.Patient, carer, and clinician partnerships are critical to advance medication management.
Topics: Adult; Databases, Factual; Humans; Intellectual Disability; Polypharmacy; Psychotropic Drugs; Systematic Reviews as Topic
PubMed: 36120887
DOI: 10.1080/07853890.2022.2121853 -
Trials Nov 2020Process evaluations are increasingly conducted within pragmatic randomised controlled trials (RCTs) of health services interventions and provide vital information to... (Review)
Review
BACKGROUND
Process evaluations are increasingly conducted within pragmatic randomised controlled trials (RCTs) of health services interventions and provide vital information to enhance understanding of RCT findings. However, issues pertaining to process evaluation in this specific context have been little discussed. We aimed to describe the frequency, characteristics, labelling, value, practical conduct issues, and accessibility of published process evaluations within pragmatic RCTs in health services research.
METHODS
We used a 2-phase systematic search process to (1) identify an index sample of journal articles reporting primary outcome results of pragmatic RCTs published in 2015 and then (2) identify all associated publications. We used an operational definition of process evaluation based on the Medical Research Council's process evaluation framework to identify both process evaluations reported separately and process data reported in the trial results papers. We extracted and analysed quantitative and qualitative data to answer review objectives.
RESULTS
From an index sample of 31 pragmatic RCTs, we identified 17 separate process evaluation studies. These had varied characteristics and only three were labelled 'process evaluation'. Each of the 31 trial results papers also reported process data, with a median of five different process evaluation components per trial. Reported barriers and facilitators related to real-world collection of process data, recruitment of participants to process evaluations, and health services research regulations. We synthesised a wide range of reported benefits of process evaluations to interventions, trials, and wider knowledge. Visibility was often poor, with 13/17 process evaluations not mentioned in the trial results paper and 12/16 process evaluation journal articles not appearing in the trial registry.
CONCLUSIONS
In our sample of reviewed pragmatic RCTs, the meaning of the label 'process evaluation' appears uncertain, and the scope and significance of the term warrant further research and clarification. Although there were many ways in which the process evaluations added value, they often had poor visibility. Our findings suggest approaches that could enhance the planning and utility of process evaluations in the context of pragmatic RCTs.
TRIAL REGISTRATION
Not applicable for PROSPERO registration.
Topics: Humans; Process Assessment, Health Care; Randomized Controlled Trials as Topic; Research Design
PubMed: 33168067
DOI: 10.1186/s13063-020-04762-9 -
Vascular Health and Risk Management 2023Higher medication adherence reduces the risk of new cardiovascular events. However, there are individual and health system barriers that lead to lower adherence. The... (Review)
Review
BACKGROUND
Higher medication adherence reduces the risk of new cardiovascular events. However, there are individual and health system barriers that lead to lower adherence. The polypill has demonstrated benefits in cardiovascular morbidity and mortality mainly driven by an increase in adherence. We aim to evaluate the impact of the polypill on adherence to cardiovascular medication, its efficacy and safety in cardiovascular disease (CVD) prevention.
METHODS
A systematic review following PRISMA guidelines was conducted. Databases were searched from January 2003 to December 2022. We included randomized, pragmatic, or real-world clinical trials and observational studies. The primary outcome was medication adherence, secondary outcomes were efficacy in cardiovascular disease in primary and secondary prevention and safety.
RESULTS
From the 490 publications screened, 13 met the inclusion criteria and were incorporated into a comparative table Of those included, 70% were randomized controlled trials (RCTs) and 53.8% focused on secondary prevention. Most of the studies received a high and moderate quality rating. Self-report, pill counting and, the Morisky scale were the most frequent methods to evaluate adherence (84.6%). Compared with standard medication, the polypill improved overall medication adherence by 13%, with percentages ranging from 7.6% to 34.9%. Moreover, a potential benefit was also observed in reducing Major Adverse Cardiovascular Events (MACE), particularly in secondary prevention studies, with hazard ratios ranged between 0.43 to 0.76. Compared to standard care, the profile of side effects was similar.
CONCLUSION
The polypill is an effective, safe, and practical strategy to improve adherence in people at risk of CVD. Although there is a demonstrated benefit in reducing MACE, predominantly in secondary prevention, there are still gaps in its efficacy in primary prevention and reducing total mortality. Therefore, the importance of obtaining long-term results of the polypill effect and how this strategy can be implemented in real practice.
Topics: Humans; Cardiovascular Diseases; Secondary Prevention; Cardiovascular Agents; Databases, Factual; Medication Adherence
PubMed: 37719697
DOI: 10.2147/VHRM.S421024 -
Journal of Advanced Nursing Dec 2021To examine the effectiveness of targeted nursing interventions on mobilization, nutrition and cognitive engagement to reduce functional and hospital-associated decline... (Review)
Review
AIMS
To examine the effectiveness of targeted nursing interventions on mobilization, nutrition and cognitive engagement to reduce functional and hospital-associated decline (HAD) in older patients.
DESIGN
Systematic review of experimental studies using randomized and quasi-experimental designs.
DATA SOURCES
We searched electronic databases CINAHL, MEDLINE, EMBASE, Cochrane library, google scholar and BMJ quality reports from January 2009 to February 2020.
REVIEW METHODS
We reviewed intervention studies that targeted ward nursing teams to increase mobilization, nutrition or cognitive engagement of older adults. Inclusion criteria included older patients, acute care (medical, surgical and older adult wards) and reporting patient level outcomes. Quality appraisal included the Joanna Briggs Critical Appraisal Checklist for Quasi-Experimental Studies.
RESULTS
From 1729 papers, 18 studies using quasi-experimental and pre-post designs were selected. Study heterogeneity necessitated a narrative synthesis. The quality of evidence was low to moderate. All studies used multicomponent strategies, and 10 studies used evidence translation frameworks to align interventions to local barriers. Overall, 74% (n = 14) of studies reported a significant improvement in the stated primary outcome. Eight studies reported a significant increase in mobilization (e.g., sitting in a chair or walking), and four reported improved functional outcomes. Five studies improved nutrition outcomes (e.g., protein or energy intake), and three studies reported a significant reduction in delirium.
CONCLUSION
Acknowledging methodological limitations, the evidence indicates that nursing teams using evidence-translation frameworks can improve mobilization, nutrition and cognitive engagement in acute care settings. Future research requires higher-quality pragmatic trial designs, standardized outcomes, staff co-designed interventions, evidence-translation frameworks and patient engagement to make more confident inference about effectiveness.
IMPACT
Nursing teams with the support of hospital management have to address ward and system barriers to prioritize fundamental care to improve patient outcomes. There is sufficient evidence on multicomponent interventions and implementation strategies to inform nurse-led quality improvement.
Topics: Aged; Hospitals; Humans; Nursing, Team
PubMed: 34240755
DOI: 10.1111/jan.14954 -
JMIR MHealth and UHealth Nov 2020Coronary heart disease (CHD) is a leading cause of disability and deaths worldwide. Secondary prevention, including cardiac rehabilitation (CR), is crucial to improve... (Review)
Review
BACKGROUND
Coronary heart disease (CHD) is a leading cause of disability and deaths worldwide. Secondary prevention, including cardiac rehabilitation (CR), is crucial to improve risk factors and to reduce disease burden and disability. Accessibility barriers contribute to underutilization of traditional center-based CR programs; therefore, alternative delivery models, including cardiac telerehabilitation (ie, delivery via mobile, smartphone, and/or web-based apps), have been tested. Experimental studies have shown cardiac telerehabilitation to be effective and cost-effective, but there is inadequate evidence about how to translate this research into routine clinical practice.
OBJECTIVE
This systematic review aimed to synthesize research evaluating the effectiveness of implementing cardiac telerehabilitation interventions at scale in routine clinical practice, including factors underlying successful implementation processes, and experimental research evaluating implementation-related outcomes.
METHODS
MEDLINE, Embase, PsycINFO, and Global Health databases were searched from 1990 through November 9, 2018, for studies evaluating the implementation of telerehabilitation for the self-management of CHD. Reference lists of included studies and relevant systematic reviews were hand searched to identify additional studies. Implementation outcomes of interest included acceptability, appropriateness, adoption, feasibility, fidelity, implementation cost, penetration, and sustainability. A narrative synthesis of results was carried out.
RESULTS
No included studies evaluated the implementation of cardiac telerehabilitation in routine clinical practice. A total of 10 studies of 2250 participants evaluated implementation outcomes, including acceptability (8/10, 80%), appropriateness (9/10, 90%), adoption (6/10, 60%), feasibility (6/10, 60%), fidelity (7/10, 70%), and implementation cost (4/10, 40%), predominantly from the participant perspective. Cardiac telerehabilitation interventions had high acceptance among the majority of participants, but technical challenges such as reliable broadband internet connectivity can impact acceptability and feasibility. Many participants considered telerehabilitation to be an appropriate alternative CR delivery model, as it was convenient, flexible, and easy to access. Participants valued interactive intervention components, such as real-time exercise monitoring and feedback as well as individualized support. The penetration and sustainability of cardiac telerehabilitation, as well as the perspectives of CR practitioners and health care organizations, have received little attention in existing cardiac telerehabilitation research.
CONCLUSIONS
Experimental trials suggest that participants perceive cardiac telerehabilitation to be an acceptable and appropriate approach to improve the reach and utilization of CR, but pragmatic implementation studies are needed to understand how interventions can be sustainably translated from research into clinical practice. Addressing this gap could help realize the potential impact of telerehabilitation on CR accessibility and participation as well as person-centered, health, and economic outcomes.
TRIAL REGISTRATION
International Prospective Register of Systematic Reviews (PROSPERO) CRD42019124254; https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=124254.
Topics: Cardiovascular Diseases; Exercise; Humans; Secondary Prevention; Self-Management; Telerehabilitation
PubMed: 33245286
DOI: 10.2196/17957 -
Nutrients Sep 2022The education sector is recognised as an ideal platform to promote good nutrition and decision making around food and eating. Examining adolescents in this setting is... (Meta-Analysis)
Meta-Analysis Review
The Impact of Modifying Food Service Practices in Secondary Schools Providing a Routine Meal Service on Student's Food Behaviours, Health and Dining Experience: A Systematic Review and Meta-Analysis.
The education sector is recognised as an ideal platform to promote good nutrition and decision making around food and eating. Examining adolescents in this setting is important because of the unique features of adolescence compared to younger childhood. This systematic review and meta-analysis examine interventions in secondary schools that provide a routine meal service and the impact on adolescents’ food behaviours, health and dining experience in this setting. The review was guided by Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) Checklist and Cochrane Handbook recommendations. Studies published in English searched in four databases and a hand search yielded 42 interventions in 35 studies. Risk of bias was assessed independently by two reviewers. Interventions were classified using the NOURISHING framework, and their impact analysed using meta-analysis, vote-counting synthesis or narrative summary. The meta-analysis showed an improvement in students selecting vegetables (odds ratio (OR): 1.39; 1.12 to 1.23; p = 0.002), fruit serves selected (mean difference (MD): 0.09; 0.09 to 0.09; p < 0.001) and consumed (MD: 0.10; 0.04 to 0.15; p < 0.001), and vegetable serves consumed (MD: 0.06; 0.01 to 0.10; p = 0.024). Vote-counting showed a positive impact for most interventions that measured selection (15 of 25; 41% to 77%; p = 0.002) and consumption (14 of 24; 39% to 76%; p = 0.013) of a meal component. Interventions that integrate improving menu quality, assess palatability, accessibility of healthier options, and student engagement can enhance success. These results should be interpreted with caution as most studies were not methodologically strong and at higher risk of bias. There is a need for higher quality pragmatic trials, strategies to build and measure sustained change, and evaluation of end-user attitudes and perceptions towards intervention components and implementation for greater insight into intervention success and future directions (PROSPERO registration: CRD42020167133).
Topics: Adolescent; Child; Food Services; Health Behavior; Humans; Schools; Students; Vegetables
PubMed: 36079897
DOI: 10.3390/nu14173640 -
The Patient Nov 2022Patient support programs aim to provide solutions beyond the medication itself, by enhancing treatment adherence, improving clinical outcomes, elevating patient...
BACKGROUND AND OBJECTIVE
Patient support programs aim to provide solutions beyond the medication itself, by enhancing treatment adherence, improving clinical outcomes, elevating patient experience, and/or increasing quality of life. As patient support programs increasingly play an important role in assisting patients, numerous observational studies and pragmatic trials designed to evaluate their impact on healthcare have been conducted in recent years. This review aims to characterize these studies.
METHODS
A systematic literature review, supplemented by a broad search of gray literature, was conducted following PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) and Cochrane recommendations. Observational studies and pragmatic trials conducted in Europe to evaluate the impact of patient support programs, published in English or Spanish between 17/03/2010 and 17/03/2020, were reviewed. Two patient support program definitions were applied starting with Ganguli et al.'s broad approach, followed by the European Medicines Agency definition, narrowed to Marketing Authorization Holders organized systems and their medicines. The quality of publications was assessed using the STROBE (Strengthening the Reporting of Observational Studies in Epidemiology) statement 22-item checklist.
RESULTS
Of the 49 identified studies following the Ganguli et al. definition, 20 studies met the European Medicines Agency definition and were reviewed. Patient support program impact was evaluated based on a wide range of methodologies: 70% assessed patient support program-related patient-reported outcomes, 55% reported clinical outcomes, and 25% reported economic impacts on health resources. Only 45% conducted a comparative analysis. Overall, 75% of the studies achieved their proposed objectives.
CONCLUSIONS
The heterogeneity of the observational studies reviewed reflects the complexity of patient support programs that are built ad hoc for specific diseases, treatments, and patients. Results suggest that patient support programs play a key role in promoting treatment effectiveness, clinical outcomes, and satisfaction. However, there is a need for standardizing the definition of patient support programs and the methods to evaluate their impact.
Topics: Humans; Quality of Life; Checklist; Treatment Outcome; Europe
PubMed: 35725866
DOI: 10.1007/s40271-022-00582-y -
Frontiers in Medicine 2021Pragmatic trials inform clinical decision with better generalizability and can bridge different streams of medicine. This study collated the expectations regarding...
Pragmatic trials inform clinical decision with better generalizability and can bridge different streams of medicine. This study collated the expectations regarding pragmatic trial design of integrative medicine (IM) for diabetes and kidney diseases among patients and physicians. Dissonance between users' perspective and existing pragmatic trial design was identified. The association between risk of bias and pragmatism of study design was assessed. A 10-group semi-structured focus group interview series [21 patients, 14 conventional medicine (ConM) and 15 Chinese medicine (CM) physicians] were purposively sampled from private and public clinics in Hong Kong. Perspectives were qualitatively analyzed by constant comparative method. A systematic search of four databases was performed to identify existing IM pragmatic clinical trials in diabetes or kidney disease. Primary outcomes were the pragmatism, risk of bias, and rationale of the study design. Risk of bias and pragmatism were assessed based on Cochrane risk-of-bias tool and PRECIS-2, respectively. The correlation between risk of bias and pragmatism was assessed by regression models with sensitivity analyses. The subtheme on the motivation to seek IM service was analyzed, covering the perceived limitation of ConM effect, perceived benefits of IM service, and assessment of IM effectiveness. Patients expected IM service to retard disease progression, stabilize concomitant drug dosage, and reduce potential side effects associated with ConM. In the systematic review, 25 studies from six countries were included covering CM, Korean medicine, Ayurvedic medicine, and western herbal medicine. Existing study designs did not include a detailed assessment of concomitant drug change and adverse events. Majority of studies either recruited a non-representative proportion of patients as traditional, complementary, and integrative medicine (TCIM) diagnosis was used as inclusion criteria, or not reflecting the real-world practice of TCIM by completely dropping TCIM diagnosis in the trial design. Consultation follow-up frequency is the least pragmatic domain. Increase in pragmatism did not associate with a higher risk of bias. Existing IM pragmatic trial design does not match the patients' expectation in the analysis of incident concomitant drug change and adverse events. A two-layer design incorporating TCIM diagnosis as a stratification factor maximizes the generalizability of evidence and real-world translation of both ConM and TCIM.
PubMed: 34513860
DOI: 10.3389/fmed.2021.668913 -
Respiratory Medicine 2019Evidence to support the implementation of telehealth (TH) interventions in the management of chronic obstructive pulmonary disease (COPD) varies throughout Europe.... (Review)
Review
BACKGROUND
Evidence to support the implementation of telehealth (TH) interventions in the management of chronic obstructive pulmonary disease (COPD) varies throughout Europe. Despite more than ten years of TH research in COPD management, it is still not possible to define which TH interventions are beneficial to which patient group. Therefore, informing policymakers on TH implementation is complicated. We aimed to examine the provision and efficacy of TH for COPD management to guide future decision-making.
METHODS
A mapping study of twelve systematic reviews of TH interventions for COPD management was conducted. This was followed by an in-depth review of fourteen clinical trials performed in Europe extracted from the systematic reviews. Efficacy outcomes for COPD management were synthesized.
RESULTS
The mapping study revealed that systematic reviews with a meta-analysis often report positive clinical outcomes. Despite this, we identified a lack of pragmatic trial design affecting the synthesis of reported outcomes. The in-depth review visualized outcomes for three TH categories, which revealed a plethora of heterogeneous outcomes. Suggestions for reporting within these three outcomes are synthesized as targets for future empirical research reporting.
CONCLUSION
The present study indicates the need for more standardized and updated systematic reviews. Policymakers should advocate for improved TH trial designs, focusing on the entire intervention's adoption process evaluation. One of the policymakers' priorities should be the harmonization of the outcome sets, which would be considered suitable for deciding about subsequent reimbursement. We propose possible outcome sets in three TH categories which could be used for discussion with stakeholders.
Topics: Delivery of Health Care, Integrated; Europe; Humans; Pulmonary Disease, Chronic Obstructive; Telemedicine
PubMed: 31614305
DOI: 10.1016/j.rmed.2019.09.005