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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 -
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 -
BMC Nursing Apr 2022The Covid-19 pandemic has produced unprecedented challenges across all aspects of health and social care sectors globally. Nurses and healthcare workers in care homes...
BACKGROUND
The Covid-19 pandemic has produced unprecedented challenges across all aspects of health and social care sectors globally. Nurses and healthcare workers in care homes have been particularly impacted due to rapid and dramatic changes to their job roles, workloads, and working environments, and residents' multimorbidity. Developed by the World Health Organisation, Psychological First Aid (PFA) is a brief training course delivering social, emotional, supportive, and pragmatic support that can reduce the initial distress after disaster and foster future adaptive functioning.
OBJECTIVES
This review aimed to synthesise findings from studies exploring the usefulness of PFA for the well-being of nursing and residential care home staff.
METHODS
A systematic search was conducted across 15 databases (Social Care Online, Kings Fund Library, Prospero, Dynamed, BMJ Best Practice, SIGN, NICE, Ovid, Proquest, Campbell Library, Clinical Trials, Web of Knowledge, Scopus, Ebsco CINAHL, and Cochrane Library), identifying peer-reviewed articles published in English language from database inception to 20th June 2021.
RESULTS
Of the 1,159 articles screened, 1,146 were excluded at title and abstract; the remaining 13 articles were screened at full text, all of which were then excluded.
CONCLUSION
This review highlights that empirical evidence of the impact of PFA on the well-being of nursing and residential care home staff is absent. PFA has likely been recommended to healthcare staff during the Covid-19 pandemic. The lack of evidence found here reinforces the urgent need to conduct studies which evaluates the outcomes of PFA particularly in the care home staff population.
PubMed: 35468786
DOI: 10.1186/s12912-022-00866-6 -
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 -
BMC Public Health Jun 2021Youth suicide prevention in high-schools and universities is a public health priority. Our aim was to propose a research agenda to advance evidence-based suicide...
BACKGROUND
Youth suicide prevention in high-schools and universities is a public health priority. Our aim was to propose a research agenda to advance evidence-based suicide prevention in high-schools and universities by synthesizing and critically reviewing the research focus and methodologies used in existing intervention studies.
METHODS
Fourteen databases were systematically searched to identify studies which evaluate suicide prevention interventions delivered on high-school or university campuses, with before and after measures. Data from included studies (n = 43) were extracted to identify what, where, how and for whom interventions have been tested. Narrative synthesis was used to critically evaluate research focus and methodology. Study quality was assessed.
RESULTS
Research has focused primarily on selective interventions, with less attention on indicated and universal interventions. Most evidence comes from North America and high-income countries. The target of interventions has been: non-fatal suicidal behaviour; confidence and ability of staff/students to intervene in a suicidal crisis; suicide-related knowledge and attitudes; and suicide-related stigma. No studies included suicide deaths as an outcome, evaluated eco-systemic interventions, explored how context influences implementation, used multisite study designs, or focused explicitly on LGBTQ+ youth. Two studies evaluated digital interventions. Quality of the majority of studies was compromised by lack of methodological rigour, small samples, and moderate/high risk of bias. Interventions often assume the existence of an external well-functioning referral pathway, which may not be true in low-resource settings.
CONCLUSION
To advance evidence-based suicide prevention in educational settings we need to: conduct more high-quality clinical and pragmatic trials; promote research in low- and middle-income countries; test targeted interventions for vulnerable populations (like LGBTQ+ youth), evaluate interventions where death by suicide is the primary outcome; include translational studies and use implementation science to promote intervention uptake; evaluate the potential use of digital and eco-systemic interventions; and conduct multisite studies in diverse cultural settings.
Topics: Adolescent; Evidence-Based Practice; Humans; North America; Schools; Universities; Suicide Prevention
PubMed: 34112141
DOI: 10.1186/s12889-021-11124-w -
The Cochrane Database of Systematic... Mar 2021Inhalation of the enzyme dornase alfa reduces sputum viscosity and improves clinical outcomes of people with cystic fibrosis. This is an update of a previously published... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Inhalation of the enzyme dornase alfa reduces sputum viscosity and improves clinical outcomes of people with cystic fibrosis. This is an update of a previously published Cochrane Review.
OBJECTIVES
To determine whether the timing of dornase alfa inhalation (in relation to airway clearance techniques or morning versus evening inhalation) has an impact on objective and subjective measures of clinical efficacy in people with cystic fibrosis.
SEARCH METHODS
Relevant randomised and quasi-randomised controlled trials were identified from the Cochrane Cystic Fibrosis Trials Register, the Physiotherapy Evidence Database (PEDro), clinical trial registries and international cystic fibrosis conference proceedings. Date of the most recent search: 12 October 2020.
SELECTION CRITERIA
Any trial of dornase alfa in people with cystic fibrosis where timing of inhalation was the randomised element in the trial with either: inhalation before compared to after airway clearance techniques; or morning compared to evening inhalation. DATA COLLECTION AND ANALYSIS: Both authors independently selected trials, assessed risk of bias and extracted data with disagreements resolved by discussion. Relevant data were extracted and, where possible, meta-analysed. We assessed the quality of the evidence using GRADE.
MAIN RESULTS
We identified 115 trial reports representing 55 trials, of which five trials (providing data on 122 participants) met our inclusion criteria. All five trials used a cross-over design. Intervention periods ranged from two to eight weeks. Four trials (98 participants) compared dornase alfa inhalation before versus after airway clearance techniques. Inhalation after instead of before airway clearance did not significantly change forced expiratory volume at one second (very-low quality evidence). Similarly, forced vital capacity (low-quality evidence) and quality of life (very-low quality evidence) were not significantly affected; forced expiratory flow at 25% was significantly worse with dornase alfa inhalation after airway clearance, mean difference -0.17 litres (95% confidence interval -0.28 to -0.05), based on the pooled data from two small trials in children (7 to 19 years) with well-preserved lung function. All other secondary outcomes were statistically non-significant. In one trial (25 participants), morning versus evening inhalation had no impact on lung function or symptoms (low-quality evidence).
AUTHORS' CONCLUSIONS
The current evidence derived from a small number of participants does not indicate that inhalation of dornase alfa after airway clearance techniques is more or less effective than the traditional recommendation to inhale nebulised dornase alfa 30 minutes prior to airway clearance techniques, for most outcomes. For children with well-preserved lung function, inhalation before airway clearance may be more beneficial for small airway function than inhalation after. However, this result relied on a measure with high variability and trials with variable follow-up. In the absence of strong evidence to indicate that one timing regimen is better than another, the timing of dornase alfa inhalation can be largely based on pragmatic reasons or individual preference with respect to the time of airway clearance and time of day. Further research is warranted.
Topics: Administration, Inhalation; Adolescent; Child; Combined Modality Therapy; Cystic Fibrosis; Deoxyribonuclease I; Drug Administration Schedule; Forced Expiratory Volume; Humans; Quality of Life; Randomized Controlled Trials as Topic; Recombinant Proteins; Respiratory Therapy; Time Factors; Vital Capacity; Young Adult
PubMed: 33686652
DOI: 10.1002/14651858.CD007923.pub6 -
Journal of Medical Internet Research Aug 2023Video recordings of patients may offer advantages to supplement patient assessment and clinical decision-making. However, little is known about the practice of video... (Review)
Review
BACKGROUND
Video recordings of patients may offer advantages to supplement patient assessment and clinical decision-making. However, little is known about the practice of video recording patients for direct care purposes.
OBJECTIVE
We aimed to synthesize empirical studies published internationally to explore the extent to which video recording patients is acceptable and effective in supporting direct care and, for the United Kingdom, to summarize the relevant guidance of professional and regulatory bodies.
METHODS
Five electronic databases (MEDLINE, Embase, APA PsycINFO, CENTRAL, and HMIC) were searched from 2012 to 2022. Eligible studies evaluated an intervention involving video recording of adult patients (≥18 years) to support diagnosis, care, or treatment. All study designs and countries of publication were included. Websites of UK professional and regulatory bodies were searched to identify relevant guidance. The acceptability of video recording patients was evaluated using study recruitment and retention rates and a framework synthesis of patients' and clinical staff's perspectives based on the Theoretical Framework of Acceptability by Sekhon. Clinically relevant measures of impact were extracted and tabulated according to the study design. The framework approach was used to synthesize the reported ethico-legal considerations, and recommendations of professional and regulatory bodies were extracted and tabulated.
RESULTS
Of the 14,221 abstracts screened, 27 studies met the inclusion criteria. Overall, 13 guidance documents were retrieved, of which 7 were retained for review. The views of patients and clinical staff (16 studies) were predominantly positive, although concerns were expressed about privacy, technical considerations, and integrating video recording into clinical workflows; some patients were anxious about their physical appearance. The mean recruitment rate was 68.2% (SD 22.5%; range 34.2%-100%; 12 studies), and the mean retention rate was 73.3% (SD 28.6%; range 16.7%-100%; 17 studies). Regarding effectiveness (10 studies), patients and clinical staff considered video recordings to be valuable in supporting assessment, care, and treatment; in promoting patient engagement; and in enhancing communication and recall of information. Observational studies (n=5) favored video recording, but randomized controlled trials (n=5) did not demonstrate that video recording was superior to the controls. UK guidelines are consistent in their recommendations around consent, privacy, and storage of recordings but lack detailed guidance on how to operationalize these recommendations in clinical practice.
CONCLUSIONS
Video recording patients for direct care purposes appears to be acceptable, despite concerns about privacy, technical considerations, and how to incorporate recording into clinical workflows. Methodological quality prevents firm conclusions from being drawn; therefore, pragmatic trials (particularly in older adult care and the movement disorders field) should evaluate the impact of video recording on diagnosis, treatment monitoring, patient-clinician communication, and patient safety. Professional and regulatory documents should signpost to practical guidance on the implementation of video recording in routine practice.
TRIAL REGISTRATION
PROSPERO CRD42022331825: https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=331825.
Topics: Humans; Aged; Patient Participation; Empirical Research; Communication; Narration; Clinical Decision-Making
PubMed: 37585249
DOI: 10.2196/46478